IDFAs HACCP REFERENCE MANUAL

2010 EDITION

Advanced HACCP Short Course for Dairy & Juice Products

Reference Manual Table of Contents

Tab 1 2 3 4

Document NACMCF Open Book Test NACMCF HACCP "Bible"

Tab 15

Document Food Allergen Labeling & Consumer Protection Act of 2004. FDA Guidance on Labeling of Products Containing Lecithin from Soy IDFA HACCP Forms NCIMS HACCP Forms

16 NCIMS HACCP Appendix K NCIMS Dairy Hazards & Controls Guide NCIMS Dairy HACCP Questions & Answers FDA Foreign Objects Guidance FDA Juice HACCP Rule FDA Juice Hazards & Controls Guide FDA Juice HACCP Questions & Answers FDA Juice HACCP Compliance Guide FDA Guidance on Patulin in Apple Juice FDA Juice HACCP Training Curriculum FDA Miscellaneous Juice HACCP Guidance FDA Allergen Guidance Document

17 18

6 7 8

10

11

12

13

14

NACMCF Open Book Test

NACMCF Open Book Test

Hazard Analysis and Critical Control Point Principles and Application Guidelines Adopted -- August 14, 1997

Questions: 1. __________________ must be committed to a HACCP approach for a successful HACCP program implementation? True or False - HACCP is a food quality management system? True or False - The HACCP team should be made up entirely of quality control personnel? The use of __________________ testing is seldom an effective means of monitoring CCPs because of the time required to obtain results. In most instances, monitoring of CCPs can best be accomplished through the use of physical and chemical tests, and through visual observations. __________________ is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The production of safe food products requires that the HACCP system be built upon a solid foundation of __________________ . Preliminary Tasks in the Development of the HACCP Plan - fill in the empty box. Assemble the HACCP Team

2. 3.

5.

6.

7.

Describe the Intended Use and Consumers of the Food Develop a Flow Diagram Which Describes the Process

Verify the Flow Diagram

8.

After the list of potential hazards is assembled (hazard identification), stage two, the __________________ is conducted. In stage two of the hazard analysis, the HACCP team decides which potential hazards must be addressed in the HACCP plan. During this stage, each potential hazard is evaluated based on the severity of the potential hazard and its likely occurrence. A __________________ is a maximum and/or minimum value to which a biological, chemical, or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard. __________________ serves three main purposes. First, __________________ is essential to food safety management in that it facilitates tracking of the operation. If __________________ indicates that there is a trend towards loss of control, then action can be taken to bring the process back into control before a deviation from a critical limit occurs. Second, __________________ is used to determine when there is a loss of control and a deviation occurs at a CCP, i.e., exceeding or not meeting a critical limit. When a deviation occurs, an appropriate corrective action must be taken. Third, it provides written documentation for use in verification. __________________ is defined as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to plan. Two examples of common Prerequisite Programs are: a. b.

9.

10.

11.

12.

13.

Two examples of questions to be considered when conducting hazard analysis are: a. b.

14.

Two examples of Verification activities are: a. b.

15.

Two examples of HACCP records are:

a. b. Bonus Questions: What do the following acronyms represent? a. b. c. d. e. f. g. PP CCP HACCP CL GMP SSOP NACMCF _______________________________________ _______________________________________ _______________________________________ _______________________________________ _______________________________________ _______________________________________ _______________________________________

How frequently must a CCP be monitored to assure its critical limits are being met?

NACMCF HACCP "Bible"

NACMCF HACCP "Bible"

Hazard Analysis and Critical Control Point Principles and Application Guidelines
Adopted August 14, 1997

NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS

The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is an advisory committee chartered under the U.S. Department of Agriculture (USDA) and comprised of participants from the USDA (Food Safety and Inspection Service), Department of Health and Human Services (U.S. Food and Drug Administration and the Centers for Disease Control and Prevention) the Department of Commerce (National Marine Fisheries Service), the Department of Defense (Office of the Army Surgeon General), academia, industry and state employees. NACMCF provides guidance and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services regarding the microbiological safety of foods.

TABLE OF CONTENTS
1. 2. 3. 4. EXECUTIVE SUMMARY DEFINITIONS HACCP PRINCIPLES GUIDELINES FOR APPLICATION OF HACCP PRINCIPLES 1. Introduction 2. Prerequisite Programs 3. Education and Training 4. Developing a HACCP Plan 1. Assemble the HACCP team 2. Describe the food and its distribution 3. Describe the intended use and consumers of the food 4. Develop a flow diagram which describes the process 5. Verify the flow diagram 6. Conduct a hazard analysis (Principle 1) 7. Determine critical control points (CCPs) (Principle 2) 8. Establish critical limits (Principle 3) 9. Establish monitoring procedures (Principle 4) 10. Establish corrective actions (Principle 5) 11. Establish verification procedures (Principle 6) 12. Establish record-keeping and documentation procedures (Principle 7) IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN APPENDIX A - Examples of common prerequisite programs APPENDIX B - Example of a flow diagram for the production of frozen cooked beef patties. APPENDIX C - Examples of questions to be considered when conducting a hazard analysis

5. 6. 7. 8.

9. APPENDIX D - Examples of how the stages of hazard analysis are used to identify and evaluate hazards 10. APPENDIX E - Example I of a CCP decision tree 11. APPENDIX F - Example II of a CCP decision tree 12. APPENDIX G - Examples of verification activities 13. APPENDIX H - Examples of HACCP records

EXECUTIVE SUMMARY
The National Advisory Committee on Microbiological Criteria for Foods (Committee) reconvened a Hazard Analysis and Critical Control Point (HACCP) Working Group in 1995. The primary goal was to review the Committee's November 1992 HACCP document, comparing it to current HACCP guidance prepared by the Codex Committee on Food Hygiene. Based upon its review, the Committee made the HACCP principles more concise; revised and added definitions; included sections on prerequisite programs, education and training, and implementation and maintenance of the HACCP plan; revised and provided a more detailed explanation of the application of HACCP principles; and provided an additional decision tree for identifying critical control points (CCPs). The Committee again endorses HACCP as an effective and rational means of assuring food safety from harvest to consumption. Preventing problems from occurring is the paramount goal underlying any HACCP system. Seven basic principles are employed in the development of HACCP plans that meet the stated goal. These principles include hazard analysis, CCP identification, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and record-keeping and documentation. Under such systems, if a deviation occurs indicating that control has been lost, the deviation is detected and appropriate steps are taken to reestablish control in a timely manner to assure that potentially hazardous products do not reach the consumer. In the application of HACCP, the use of microbiological testing is seldom an effective means of monitoring CCPs because of the time required to obtain results. In most instances, monitoring of CCPs can best be accomplished through the use of physical and chemical tests, and through visual observations. Microbiological criteria do, however, play a role in verifying that the overall HACCP system is working. The Committee believes that the HACCP principles should be standardized to provide uniformity in training and applying the HACCP system by industry and government. In accordance with the National Academy of Sciences recommendation, the HACCP system must be developed by each food establishment and tailored to its individual product, processing and distribution conditions. In keeping with the Committee's charge to provide recommendations to its sponsoring agencies regarding microbiological food safety issues, this document focuses on this area. The Committee recognizes that in order to assure food safety, properly designed HACCP systems must also consider chemical and physical hazards in addition to other biological hazards. For a successful HACCP program to be properly implemented, management must be committed to a HACCP approach. A commitment by management will indicate an awareness of the benefits and costs of HACCP and include education and training of employees. Benefits, in addition to enhanced assurance of food safety, are better use of resources and timely response to problems. The Committee designed this document to guide the food industry and advise its sponsoring agencies in the implementation of HACCP systems.

DEFINITIONS
CCP Decision Tree: A sequence of questions to assist in determining whether a control point is a CCP. Control: (a) To manage the conditions of an operation to maintain compliance with established criteria. (b) The state where correct procedures are being followed and criteria are being met. Control Measure: Any action or activity that can be used to prevent, eliminate or reduce a significant hazard. Control Point: Any step at which biological, chemical, or physical factors can be controlled. Corrective Action: Procedures followed when a deviation occurs. Criterion: A requirement on which a judgement or decision can be based. Critical Control Point: A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Critical Limit: A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard. Deviation: Failure to meet a critical limit. HACCP: A systematic approach to the identification, evaluation, and control of food safety hazards. HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed. HACCP System: The result of the implementation of the HACCP Plan. HACCP Team: The group of people who are responsible for developing, implementing and maintaining the HACCP system. Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Hazard Analysis: The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan. Monitor: To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification.

Prerequisite Programs: Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system. Severity: The seriousness of the effect(s) of a hazard. Step: A point, procedure, operation or stage in the food system from primary production to final consumption. Validation: That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards. Verification: Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.

HACCP PRINCIPLES
HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles: Principle 1: Conduct a hazard analysis. Principle 2: Determine the critical control points (CCPs). Principle 3: Establish critical limits. Principle 4: Establish monitoring procedures. Principle 5: Establish corrective actions. Principle 6: Establish verification procedures. Principle 7: Establish record-keeping and documentation procedures.

GUIDELINES FOR APPLICATION OF HACCP PRINCIPLES

Introduction
HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. For successful implementation of a HACCP plan, management must be strongly committed to the HACCP concept. A firm commitment to HACCP by top management provides company employees with a sense of the importance of producing safe food. HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world. The following guidelines will facilitate the development and implementation of effective HACCP plans. While the specific application of HACCP to manufacturing facilities is emphasized here, these guidelines should be applied as appropriate to each segment of the food industry under consideration.

Prerequisite Programs
The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs. Examples of common prerequisite programs are listed in Appendix A. Each segment of the food industry must provide the conditions necessary to protect food while it is under their control. This has traditionally been accomplished through the application of cGMPs. These conditions and practices are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are specified in federal, state and local regulations and guidelines (e.g., cGMPs and Food Code). The Codex Alimentarius General Principles of Food Hygiene describe the basic conditions and practices expected for foods intended for international trade. In addition to the requirements specified in regulations, industry often adopts policies and procedures that are specific to their operations. Many of these are proprietary. While prerequisite programs may impact upon the safety of a food, they also are concerned with ensuring that foods are wholesome and suitable for consumption (Appendix A). HACCP plans are narrower in scope, being limited to ensuring food is safe to consume.

The existence and effectiveness of prerequisite programs should be assessed during the design and implementation of each HACCP plan. All prerequisite programs should be documented and regularly audited. Prerequisite programs are established and managed separately from the HACCP plan. Certain aspects, however, of a prerequisite program may be incorporated into a HACCP plan. For example, many establishments have preventive maintenance procedures for processing equipment to avoid unexpected equipment failure and loss of production. During the development of a HACCP plan, the HACCP team may decide that the routine maintenance and calibration of an oven should be included in the plan as an activity of verification. This would further ensure that all the food in the oven is cooked to the minimum internal temperature that is necessary for food safety.

Education and Training

The success of a HACCP system depends on educating and training management and employees in the importance of their role in producing safe foods. This should also include information the control of foodborne hazards related to all stages of the food chain. It is important to recognize that employees must first understand what HACCP is and then learn the skills necessary to make it function properly. Specific training activities should include working instructions and procedures that outline the tasks of employees monitoring each CCP. Management must provide adequate time for thorough education and training. Personnel must be given the materials and equipment necessary to perform these tasks. Effective training is an important prerequisite to successful implementation of a HACCP plan.

Developing a HACCP Plan

The format of HACCP plans will vary. In many cases the plans will be product and process specific. However, some plans may use a unit operations approach. Generic HACCP plans can serve as useful guides in the development of process and product HACCP plans; however, it is essential that the unique conditions within each facility be considered during the development of all components of the HACCP plan. In the development of a HACCP plan, five preliminary tasks need to be accomplished before the application of the HACCP principles to a specific product and process. The five preliminary tasks are given in Figure 1.

Figure 1. Preliminary Tasks in the Development of the HACCP Plan Assemble the HACCP Team

Describe the Food and its Distribution

Describe the Intended Use and Consumers of the Food

Develop a Flow Diagram Which Describes the Process

Verify the Flow Diagram

Assemble the HACCP Team

The first task in developing a HACCP plan is to assemble a HACCP team consisting of individuals who have specific knowledge and expertise appropriate to the product and process. It is the team's responsibility to develop the HACCP plan. The team should be multi disciplinary and include individuals from areas such as engineering, production, sanitation, quality assurance, and food microbiology. The team should also include local personnel who are involved in the operation as they are more familiar with the variability and limitations of the operation. In addition, this fosters a sense of ownership among those who must implement the plan. The HACCP team may need assistance from outside experts who are knowledgeable in the potential biological, chemical and/or physical hazards associated with the product and the process. However, a plan which is developed totally by outside sources may be erroneous, incomplete, and lacking in support at the local level. Due to the technical nature of the information required for hazard analysis, it is recommended that experts who are knowledgeable in the food process should either participate in or verify the completeness of the hazard analysis and the HACCP plan. Such individuals should have the knowledge and experience to correctly: (a) conduct a hazard analysis; (b) identify potential hazards; (c) identify hazards which must be controlled; (d) recommend controls, critical limits, and procedures for monitoring and verification; (e) recommend appropriate corrective actions when a deviation occurs; (f) recommend research related to the HACCP plan if important information is not known; and (g) validate the HACCP plan.

Describe the food and its distribution

The HACCP team first describes the food. This consists of a general description of the food, ingredients, and processing methods. The method of distribution should be described along with information on whether the food is to be distributed frozen, refrigerated, or at ambient temperature.

Describe the intended use and consumers of the food

Describe the normal expected use of the food. The intended consumers may be the general public or a particular segment of the population (e.g., infants, immunocompromised individuals, the elderly, etc.).

Develop a flow diagram which describes the process

The purpose of a flow diagram is to provide a clear, simple outline of the steps involved in the process. The scope of the flow diagram must cover all the steps in the process which are directly under the control of the establishment. In addition, the flow diagram can include steps in the food chain which are before and after the processing that occurs in the establishment. The flow diagram need not be as complex as engineering drawings. A block type flow diagram is sufficiently descriptive (see Appendix B). Also, a simple schematic of the facility is often useful in understanding and evaluating product and process flow.

Verify the flow diagram

The HACCP team should perform an on-site review of the operation to verify the accuracy and completeness of the flow diagram. Modifications should be made to the flow diagram as necessary and documented. After these five preliminary tasks have been completed, the seven principles of HACCP are applied.

Conduct a hazard analysis (Principle 1)

After addressing the preliminary tasks discussed above, the HACCP team conducts a hazard analysis and identifies appropriate control measures. The purpose of the hazard analysis is to develop a list of hazards which are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled. Hazards that are not reasonably likely to occur would not require further consideration within a HACCP plan. It is important to consider in the hazard analysis the ingredients and raw materials, each step in the process, product storage and distribution, and final preparation and use by the consumer. When conducting a hazard analysis, safety concerns must be differentiated from quality concerns. A hazard is defined as a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Thus, the word hazard as used in this document is limited to safety.

A thorough hazard analysis is the key to preparing an effective HACCP plan. If the hazard analysis is not done correctly and the hazards warranting control within the HACCP system are not identified, the plan will not be effective regardless of how well it is followed. The hazard analysis and identification of associated control measures accomplish three objectives: Those hazards and associated control measures are identified. The analysis may identify needed modifications to a process or product so that product safety is further assured or improved. The analysis provides a basis for determining CCPs in Principle 2. The process of conducting a hazard analysis involves two stages. The first, hazard identification, can be regarded as a brain storming session. During this stage, the HACCP team reviews the ingredients used in the product, the activities conducted at each step in the process and the equipment used, the final product and its method of storage and distribution, and the intended use and consumers of the product. Based on this review, the team develops a list of potential biological, chemical or physical hazards which may be introduced, increased, or controlled at each step in the production process. Appendix C lists examples of questions that may be helpful to consider when identifying potential hazards. Hazard identification focuses on developing a list of potential hazards associated with each process step under direct control of the food operation. A knowledge of any adverse health-related events historically associated with the product will be of value in this exercise. After the list of potential hazards is assembled, stage two, the hazard evaluation, is conducted. In stage two of the hazard analysis, the HACCP team decides which potential hazards must be addressed in the HACCP plan. During this stage, each potential hazard is evaluated based on the severity of the potential hazard and its likely occurrence. Severity is the seriousness of the consequences of exposure to the hazard. Considerations of severity (e.g., impact of sequelae, and magnitude and duration of illness or injury) can be helpful in understanding the public health impact of the hazard. Consideration of the likely occurrence is usually based upon a combination of experience, epidemiological data, and information in the technical literature. When conducting the hazard evaluation, it is helpful to consider the likelihood of exposure and severity of the potential consequences if the hazard is not properly controlled. In addition, consideration should be given to the effects of short term as well as long term exposure to the potential hazard. Such considerations do not include common dietary choices which lie outside of HACCP. During the evaluation of each potential hazard, the food, its method of preparation, transportation, storage and persons likely to consume the product should be considered to determine how each of these factors may influence the likely occurrence and severity of the hazard being controlled. The team must consider the influence of likely procedures for food preparation and storage and whether the intended consumers are susceptible to a potential hazard. However, there may be differences of opinion, even among experts, as to the likely occurrence and severity of a hazard. The HACCP team may have to rely upon the opinion of experts who assist in the development of the HACCP plan. Hazards identified in one operation or facility may not be significant in another operation producing the same or a similar product. For example, due to differences in equipment and/or an effective maintenance program, the probability of metal contamination may be significant in one facility but not in another. A summary of the HACCP team deliberations and the rationale

developed during the hazard analysis should be kept for future reference. This information will be useful during future reviews and updates of the hazard analysis and the HACCP plan. Appendix D gives three examples of using a logic sequence in conducting a hazard analysis. While these examples relate to biological hazards, chemical and physical hazards are equally important to consider. Appendix D is for illustration purposes to further explain the stages of hazard analysis for identifying hazards. Hazard identification and evaluation as outlined in Appendix D may eventually be assisted by biological risk assessments as they become available. While the process and output of a risk assessment (NACMCF, 1997)(1) is significantly different from a hazard analysis, the identification of hazards of concern and the hazard evaluation may be facilitated by information from risk assessments. Thus, as risk assessments addressing specific hazards or control factors become available, the HACCP team should take these into consideration. Upon completion of the hazard analysis, the hazards associated with each step in the production of the food should be listed along with any measure(s) that are used to control the hazard(s). The term control measure is used because not all hazards can be prevented, but virtually all can be controlled. More than one control measure may be required for a specific hazard. On the other hand, more than one hazard may be addressed by a specific control measure (e.g. pasteurization of milk). For example, if a HACCP team were to conduct a hazard analysis for the production of frozen cooked beef patties (Appendices B and D), enteric pathogens (e.g., Salmonella and verotoxinproducing Escherichia coli) in the raw meat would be identified as hazards. Cooking is a control measure which can be used to eliminate these hazards. The following is an excerpt from a hazard analysis summary table for this product. Hazard to be addressed in plan? Y/N Y

Step

Potential Hazard(s)

Justification

Control Measure(s)

5. Cooking Enteric pathogens: e.g., Salmonella, verotoxigenicE. coli

Enteric pathogens have been associated with outbreaks of foodborne illness from undercooked ground beef

Cooking

The hazard analysis summary could be presented in several different ways. One format is a table such as the one given above. Another could be a narrative summary of the HACCP team's hazard analysis considerations and a summary table listing only the hazards and associated control measures.

Determine critical control points (CCPs) (Principle 2)

A critical control point is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The potential hazards that are reasonably likely to cause illness or injury in the absence of their control must be addressed in determining CCPs. Complete and accurate identification of CCPs is fundamental to controlling food safety hazards. The information developed during the hazard analysis is essential for the HACCP team in identifying which steps in the process are CCPs. One strategy to facilitate the identification of each CCP is the use of a CCP decision tree (Examples of decision trees are given in Appendices E and F). Although application of the CCP decision tree can be useful in determining if a particular step is a CCP for a previously identified hazard, it is merely a tool and not a mandatory element of HACCP. A CCP decision tree is not a substitute for expert knowledge. Critical control points are located at any step where hazards can be either prevented, eliminated, or reduced to acceptable levels. Examples of CCPs may include: thermal processing, chilling, testing ingredients for chemical residues, product formulation control, and testing product for metal contaminants. CCPs must be carefully developed and documented. In addition, they must be used only for purposes of product safety. For example, a specified heat process, at a given time and temperature designed to destroy a specific microbiological pathogen, could be a CCP. Likewise, refrigeration of a precooked food to prevent hazardous microorganisms from multiplying, or the adjustment of a food to a pH necessary to prevent toxin formation could also be CCPs. Different facilities preparing similar food items can differ in the hazards identified and the steps which are CCPs. This can be due to differences in each facility's layout, equipment, selection of ingredients, processes employed, etc.

Establish critical limits (Principle 3)

A critical limit is a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. Critical limits should not be confused with operational limits which are established for reasons other than food safety. Each CCP will have one or more control measures to assure that the identified hazards are prevented, eliminated or reduced to acceptable levels. Each control measure has one or more associated critical limits. Critical limits may be based upon factors such as: temperature, time, physical dimensions, humidity, moisture level, water activity (aw), pH, titratable acidity, salt concentration, available chlorine, viscosity, preservatives, or sensory information such as aroma and visual appearance. Critical limits must be scientifically based. For each CCP, there is at least one criterion for food safety that is to be met. An example of a criterion is a specific lethality of a cooking process such as a 5D reduction in Salmonella. The critical limits and criteria for food safety may be derived from sources such as regulatory standards and guidelines, literature surveys, experimental results, and experts.

An example is the cooking of beef patties (Appendix B). The process should be designed to ensure the production of a safe product. The hazard analysis for cooked meat patties identified enteric pathogens (e.g., verotoxigenic E. coli such as E. coli O157:H7, and salmonellae) as significant biological hazards. Furthermore, cooking is the step in the process at which control can be applied to reduce the enteric pathogens to an acceptable level. To ensure that an acceptable level is consistently achieved, accurate information is needed on the probable number of the pathogens in the raw patties, their heat resistance, the factors that influence the heating of the patties, and the area of the patty which heats the slowest. Collectively, this information forms the scientific basis for the critical limits that are established. Some of the factors that may affect the thermal destruction of enteric pathogens are listed in the following table. In this example, the HACCP team concluded that a thermal process equivalent to 155 F for 16 seconds would be necessary to assure the safety of this product. To ensure that this time and temperature are attained, the HACCP team for one facility determined that it would be necessary to establish critical limits for the oven temperature and humidity, belt speed (time in oven), patty thickness and composition (e.g., all beef, beef and other ingredients). Control of these factors enables the facility to produce a wide variety of cooked patties, all of which will be processed to a minimum internal temperature of 155 F for 16 seconds. In another facility, the HACCP team may conclude that the best approach is to use the internal patty temperature of 155 F and hold for 16 seconds as critical limits. In this second facility the internal temperature and hold time of the patties are monitored at a frequency to ensure that the critical limits are constantly met as they exit the oven. The example given below applies to the first facility. Process Step CCP 5. Cooking YES Critical Limits Oven temperature:___ F Time; rate of heating and cooling (belt speed in ft/min): ____ft/min Patty thickness: ____in. Patty composition: e.g. all beef Oven humidity: ____% RH

Establish monitoring procedures (Principle 4)

Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification. Monitoring serves three main purposes. First, monitoring is essential to food safety management in that it facilitates tracking of the operation. If monitoring indicates that there is a trend towards loss of control, then action can be taken to bring the process back into control before a deviation from a critical limit occurs. Second, monitoring is used to determine when there is loss of control and a deviation occurs at a CCP, i.e., exceeding or not meeting a critical limit. When a deviation occurs, an appropriate corrective action must be taken. Third, it provides written documentation for use in verification. An unsafe food may result if a process is not properly controlled and a deviation occurs. Because of the potentially serious consequences of a critical limit deviation, monitoring procedures must be effective. Ideally, monitoring should be continuous, which is possible with many types of

physical and chemical methods. For example, the temperature and time for the scheduled thermal process of low-acid canned foods is recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufficient, as recorded on the chart, the product from the retort is retained and the disposition determined as in Principle 5. Likewise, pH measurement may be performed continually in fluids or by testing each batch before processing. There are many ways to monitor critical limits on a continuous or batch basis and record the data on charts. Continuous monitoring is always preferred when feasible. Monitoring equipment must be carefully calibrated for accuracy. Assignment of the responsibility for monitoring is an important consideration for each CCP. Specific assignments will depend on the number of CCPs and control measures and the complexity of monitoring. Personnel who monitor CCPs are often associated with production (e.g., line supervisors, selected line workers and maintenance personnel) and, as required, quality control personnel. Those individuals must be trained in the monitoring technique for which they are responsible, fully understand the purpose and importance of monitoring, be unbiased in monitoring and reporting, and accurately report the results of monitoring. In addition, employees should be trained in procedures to follow when there is a trend towards loss of control so that adjustments can be made in a timely manner to assure that the process remains under control. The person responsible for monitoring must also immediately report a process or product that does not meet critical limits. All records and documents associated with CCP monitoring should be dated and signed or initialed by the person doing the monitoring. When it is not possible to monitor a CCP on a continuous basis, it is necessary to establish a monitoring frequency and procedure that will be reliable enough to indicate that the CCP is under control. Statistically designed data collection or sampling systems lend themselves to this purpose. Most monitoring procedures need to be rapid because they relate to on-line, "real-time" processes and there will not be time for lengthy analytical testing. Examples of monitoring activities include: visual observations and measurement of temperature, time, pH, and moisture level. Microbiological tests are seldom effective for monitoring due to their time-consuming nature and problems with assuring detection of contaminants. Physical and chemical measurements are often preferred because they are rapid and usually more effective for assuring control of microbiological hazards. For example, the safety of pasteurized milk is based upon measurements of time and temperature of heating rather than testing the heated milk to assure the absence of surviving pathogens. With certain foods, processes, ingredients, or imports, there may be no alternative to microbiological testing. However, it is important to recognize that a sampling protocol that is adequate to reliably detect low levels of pathogens is seldom possible because of the large number of samples needed. This sampling limitation could result in a false sense of security by those who use an inadequate sampling protocol. In addition, there are technical limitations in many laboratory procedures for detecting and quantitating pathogens and/or their toxins.

Establish corrective actions (Principle 5)

The HACCP system for food safety management is designed to identify health hazards and to establish strategies to prevent, eliminate, or reduce their occurrence. However, ideal circumstances do not always prevail and deviations from established processes may occur. An important purpose of corrective actions is to prevent foods which may be hazardous from reaching consumers. Where there is a deviation from established critical limits, corrective actions are necessary. Therefore, corrective actions should include the following elements: (a) determine and correct the cause of non-compliance; (b) determine the disposition of non-compliant product and (c) record the corrective actions that have been taken. Specific corrective actions should be developed in advance for each CCP and included in the HACCP plan. As a minimum, the HACCP plan should specify what is done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be developed and maintained of the actions taken. Individuals who have a thorough understanding of the process, product and HACCP plan should be assigned the responsibility for oversight of corrective actions. As appropriate, experts may be consulted to review the information available and to assist in determining disposition of non-compliant product.

Establish verification procedures (Principle 6)

Verification is defined as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. The NAS (1985) (2) pointed out that the major infusion of science in a HACCP system centers on proper identification of the hazards, critical control points, critical limits, and instituting proper verification procedures. These processes should take place during the development and implementation of the HACCP plans and maintenance of the HACCP system. An example of a verification schedule is given in Figure 2. One aspect of verification is evaluating whether the facility's HACCP system is functioning according to the HACCP plan. An effective HACCP system requires little end-product testing, since sufficient validated safeguards are built in early in the process. Therefore, rather than relying on end-product testing, firms should rely on frequent reviews of their HACCP plan, verification that the HACCP plan is being correctly followed, and review of CCP monitoring and corrective action records. Another important aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled. Information needed to validate the HACCP plan often include (1) expert advice and scientific studies and (2) in-plant observations, measurements, and evaluations. For example, validation of the cooking process for beef patties should include the scientific justification of the heating times and temperatures needed to obtain an appropriate destruction of pathogenic microorganisms (i.e., enteric pathogens) and studies to confirm that the conditions of cooking will deliver the required time and temperature to each beef patty. Subsequent validations are performed and documented by a HACCP team or an independent expert as needed. For example, validations are conducted when there is an unexplained system

failure; a significant product, process or packaging change occurs; or new hazards are recognized. In addition, a periodic comprehensive verification of the HACCP system should be conducted by an unbiased, independent authority. Such authorities can be internal or external to the food operation. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as on-site review of all flow diagrams and appropriate records from operation of the plan. A comprehensive verification is independent of other verification procedures and must be performed to ensure that the HACCP plan is resulting in the control of the hazards. If the results of the comprehensive verification identifies deficiencies, the HACCP team modifies the HACCP plan as necessary. Verification activities are carried out by individuals within a company, third party experts, and regulatory agencies. It is important that individuals doing verification have appropriate technical expertise to perform this function. The role of regulatory and industry in HACCP was further described by the NACMCF (1994) (3).

Examples of verification activities are included as Appendix G.

Figure 2. Example of a Company Established HACCP Verification Schedule Activity Verification Activities Scheduling Initial Validation of HACCP Plan Subsequent validation of HACCP Plan Frequency Responsibility Reviewer Plant Manager HACCP Team HACCP Team

Yearly or Upon HACCP HACCP System Change Coordinator Prior to and During Initial Implementation of Plan When Critical Limits Changed, Significant Changes in Process, Equipment Changed, After System Failure, etc. According to HACCP Plan (e.g., once per shift) Independent Expert(s)(a) Independent Expert(s)(a)

Verification of CCP Monitoring as Described in the Plan (e.g., monitoring of patty cooking temperature) Review of Monitoring, Corrective Action Records to Show Compliance with the Plan Comprehensive HACCP System Verification
(a)

According to HACCP Plan (e.g., Line Supervisor)

According to HACCP Plan (e.g., Quality Control)

Monthly

Quality Assurance

HACCP Team

Yearly

Independent Expert(s)(a)

Plant Manager

Done by others than the team writing and implementing the plan. May require additional technical expertise as well as laboratory and plant test studies.

Establish record-keeping and documentation procedures (Principle 7)

Generally, the records maintained for the HACCP System should include the following: 1. A summary of the hazard analysis, including the rationale for determining hazards and control measures. 2. The HACCP Plan 1. Listing of the HACCP team and assigned responsibilities. 2. Description of the food, its distribution, intended use, and consumer. 3. Verified flow diagram. 4. HACCP Plan Summary Table that includes information for: 1. Steps in the process that are CCPs 2. The hazard(s) of concern. 3. Critical limits 4. Monitoring* 5. Corrective actions* 6. Verification procedures and schedule* 7. Record-keeping procedures* * A brief summary of position responsible for performing the activity and the procedures and frequency should be provided Example HACCP Plan Summary Table CCP Hazards Critical Corrective Monitoring Verification Records limit(s) Actions

3. Support documentation such as validation records. 4. Records that are generated during the operation of the plan. Examples of HACCP records are given in Appendix H.

IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN

The successful implementation of a HACCP plan is facilitated by commitment from top management. The next step is to establish a plan that describes the individuals responsible for developing, implementing and maintaining the HACCP system. Initially, the HACCP coordinator and team are selected and trained as necessary. The team is then responsible for developing the initial plan and coordinating its implementation. Product teams can be appointed to develop HACCP plans for specific products. An important aspect in developing these teams is to assure that they have appropriate training. The workers who will be responsible for monitoring need to be adequately trained. Upon completion of the HACCP plan, operator procedures, forms and procedures for monitoring and corrective action are developed. Often it is a good idea to develop a timeline for the activities involved in the initial implementation of the HACCP plan. Implementation of the HACCP system involves the continual application of the monitoring, record-keeping, corrective action procedures and other activities as described in the HACCP plan. Maintaining an effective HACCP system depends largely on regularly scheduled verification activities. The HACCP plan should be updated and revised as needed. An important aspect of maintaining the HACCP system is to assure that all individuals involved are properly trained so they understand their role and can effectively fulfill their responsibilities.

National Advisory Committee on Microbiological Criteria for Foods. 1997. The principles of risk assessment for illness caused by foodborne biological agents. Adopted April 4, 1997.

(1)

(2)

An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. 1985. National Academy of Sciences, National Academy Press, Washington, DC.

National Advisory Committee on Microbiological Criteria for Foods. 1994. The role of regulatory agencies and industry in HACCP. Int. J. Food Microbiol. 21:187-195.

(3)

APPENDIX A
Examples of Common Prerequisite Programs
The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs. Each segment of the food industry must provide the conditions necessary to protect food while it is under their control. This has traditionally been accomplished through the application of cGMPs. These conditions and practices are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Common prerequisite programs may include, but are not limited to: Facilities. The establishment should be located, constructed and maintained according to sanitary design principles. There should be linear product flow and traffic control to minimize cross-contamination from raw to cooked materials.

Supplier Control. Each facility should assure that its suppliers have in place effective GMP and food safety programs. These may be the subject of continuing supplier guarantee and supplier HACCP system verification.

Specifications. There should be written specifications for all ingredients, products, and packaging materials.

Production Equipment. All equipment should be constructed and installed according to sanitary design principles. Preventive maintenance and calibration schedules should be established and documented.

Cleaning and Sanitation. All procedures for cleaning and sanitation of the equipment and the facility should be written and followed. A master sanitation schedule should be in place.

Personal Hygiene.

All employees and other persons who enter the manufacturing plant should follow the requirements for personal hygiene.

Training. All employees should receive documented training in personal hygiene, GMP, cleaning and sanitation procedures, personal safety, and their role in the HACCP program.

Chemical Control. Documented procedures must be in place to assure the segregation and proper use of nonfood chemicals in the plant. These include cleaning chemicals, fumigants, and pesticides or baits used in or around the plant.

Receiving, Storage and Shipping. All raw materials and products should be stored under sanitary conditions and the proper environmental conditions such as temperature and humidity to assure their safety and wholesomeness.

Traceability and Recall. All raw materials and products should be lot-coded and a recall system in place so that rapid and complete traces and recalls can be done when a product retrieval is necessary.

Pest Control. Effective pest control programs should be in place. Other examples of prerequisite programs might include quality assurance procedures; standard operating procedures for sanitation, processes, product formulations and recipes; glass control; procedures for receiving, storage and shipping; labeling; and employee food and ingredient handling practices.

APPENDIX B
Example of a Flow Diagram for the Production of Frozen Cooked Beef Patties 1. Receiving (Beef)

2. Grinding

3. Mixing

4. Forming

5. Cooking

6. Freezing

7. Boxing

8. Distributing

9. Reheating

10. Serving

APPENDIX C
Examples of Questions to be Considered When Conducting a Hazard Analysis
The hazard analysis consists of asking a series of questions which are appropriate to the process under consideration. The purpose of the questions is to assist in identifying potential hazards. A. Ingredients 1. Does the food contain any sensitive ingredients that may present microbiological hazards (e.g., Salmonella, Staphylococcus aureus); chemical hazards (e.g., aflatoxin, antibiotic or pesticide residues); or physical hazards (stones, glass, metal)? 2. Are potable water, ice and steam used in formulating or in handling the food? 3. What are the sources (e.g., geographical region, specific supplier) B. Intrinsic Factors - Physical characteristics and composition (e.g., pH, type of acidulants, fermentable carbohydrate, water activity, preservatives) of the food during and after processing. 1. What hazards may result if the food composition is not controlled? 2. Does the food permit survival or multiplication of pathogens and/or toxin formation in the food during processing? 3. Will the food permit survival or multiplication of pathogens and/or toxin formation during subsequent steps in the food chain? 4. Are there other similar products in the market place? What has been the safety record for these products? What hazards have been associated with the products? C. Procedures used for processing 1. Does the process include a controllable processing step that destroys pathogens? If so, which pathogens? Consider both vegetative cells and spores. 2. If the product is subject to recontamination between processing (e.g., cooking, pasteurizing) and packaging which biological, chemical or physical hazards are likely to occur? D. Microbial content of the food 1. What is the normal microbial content of the food? 2. Does the microbial population change during the normal time the food is stored prior to consumption? 3. Does the subsequent change in microbial population alter the safety of the food? 4. Do the answers to the above questions indicate a high likelihood of certain biological hazards? E. Facility design 1. Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat (RTE) foods if this is important to food safety? If not, what hazards should be considered as possible contaminants of the RTE products? 2. Is positive air pressure maintained in product packaging areas? Is this essential for product safety? 3. Is the traffic pattern for people and moving equipment a significant source of contamination? F. Equipment design and use

G.

H.

I.

J.

1. Will the equipment provide the time-temperature control that is necessary for safe food? 2. Is the equipment properly sized for the volume of food that will be processed? 3. Can the equipment be sufficiently controlled so that the variation in performance will be within the tolerances required to produce a safe food? 4. Is the equipment reliable or is it prone to frequent breakdowns? 5. Is the equipment designed so that it can be easily cleaned and sanitized? 6. Is there a chance for product contamination with hazardous substances; e.g., glass? 7. What product safety devices are used to enhance consumer safety? metal detectors magnets sifters filters screens thermometers bone removal devices dud detectors 8. To what degree will normal equipment wear affect the likely occurrence of a physical hazard (e.g., metal) in the product? 9. Are allergen protocols needed in using equipment for different products? Packaging 1. Does the method of packaging affect the multiplication of microbial pathogens and/or the formation of toxins? 2. Is the package clearly labeled "Keep Refrigerated" if this is required for safety? 3. Does the package include instructions for the safe handling and preparation of the food by the end user? 4. Is the packaging material resistant to damage thereby preventing the entrance of microbial contamination? 5. Are tamper-evident packaging features used? 6. Is each package and case legibly and accurately coded? 7. Does each package contain the proper label? 8. Are potential allergens in the ingredients included in the list of ingredients on the label? Sanitation 1. Can sanitation have an impact upon the safety of the food that is being processed? 2. Can the facility and equipment be easily cleaned and sanitized to permit the safe handling of food? 3. Is it possible to provide sanitary conditions consistently and adequately to assure safe foods? I. Employee health, hygiene and education 1. Can employee health or personal hygiene practices impact upon the safety of the food being processed? 2. Do the employees understand the process and the factors they must control to assure the preparation of safe foods? 3. Will the employees inform management of a problem which could impact upon safety of food? Conditions of storage between packaging and the end user

1. What is the likelihood that the food will be improperly stored at the wrong temperature? 2. Would an error in improper storage lead to a microbiologically unsafe food? K. K. Intended use 1. Will the food be heated by the consumer? 2. Will there likely be leftovers? L. L. Intended consumer 1. Is the food intended for the general public? 2. Is the food intended for consumption by a population with increased susceptibility to illness (e.g., infants, the aged, the infirmed, immunocompromised individuals)? 3. Is the food to be used for institutional feeding or the home?

APPENDIX D
Examples of How the Stages of Hazard Analysis are used to Identify and Evaluate Hazards*
Hazard Analysis Stage Frozen cooked beef Product containing patties produced in a eggs prepared for manufacturing plant foodservice Enteric pathogens Salmonella in (i.e., E. coli O157:H7 finished product. and Salmonella) Commercial frozen precooked, boned chicken for further processing Staphylococcus aureus in finished product.

Stage 1 Determine potential Hazard hazards associated Identification with product Assess severity Stage 2 Hazard of health Evaluation consequences if potential hazard is not properly controlled.

Epidemiological evidence indicates that these pathogens cause severe health effects including death among children and elderly. Undercooked beef patties have been linked to disease from these pathogens. E. coli O157:H7 is of very low probability and salmonellae is of moderate probability in raw meat.

Salmonellosis is a food borne infection causing a moderate to severe illness that can be caused by ingestion of only a few cells of Salmonella.

Certain strains of S. aureus produce an enterotoxin which can cause a moderate foodborne illness.

Determine likelihood of occurrence of potential hazard if not properly controlled.

Product is made with liquid eggs which have been associated with past outbreaks of salmonellosis. Recent problems with Salmonella serotype Enteritidis in eggs cause increased concern. Probability of Salmonella in raw eggs cannot be ruled out. If not effectively controlled, some consumers are likely to be exposed to Salmonella from

Product may be contaminated with S. aureus due to human handling during boning of cooked chicken. Enterotoxin capable of causing illness will only occur as S. aureus multiplies to about 1,000,000/g. Operating procedures during boning and subsequent freezing prevent growth of S. aureus, thus the potential for enterotoxin formation is very low.

this food. Using information above, determine if this potential hazard is to be addressed in the HACCP plan. HACCP team determines that if the potential hazard is not properly controlled, consumption of Hazards must be product is likely to addressed in the result in an unacceptable health plan. risk. The HACCP team decides that enteric pathogens are hazards for this product. The HACCP team determines that the potential for enterotoxin formation is very low. However, it is still desirable to keep the initial number of S. aureus organisms low. Employee practices that minimize contamination, rapid Hazard must be carbon dioxide freezing addressed in the and handling instructions have been plan. adequate to control this potential hazard. Potential hazard does not need to be addressed in plan. * For illustrative purposes only. The potential hazards identified may not be the only hazards associated with the products listed. The responses may be different for different establishments.

APPENDIX E
Example I of a CCP Decision Tree
Important considerations when using the decision tree:

The decision tree is used after the hazard analysis. The decision tree then is used at the steps where a hazard that must be addressed in the HACCP plan has been identified. A subsequent step in the process may be more effective for controlling a hazard and may be the preferred CCP. More than one step in a process may be involved in controlling a hazard. More than one hazard may be controlled by a specific control measure.

Q1. Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control?

YES

NO

Not a CCP

Q2.

Does a control measure for the hazard exist at this step?

YES

NO

Modify the step, Process or product

Is control at this step necessary for safety?

YES

NO

Not a CCP

STOP*

Q3. Is control at this step necessary to prevent, eliminate, or reduce the risk of hazard to consumers?

YES

NO

Not a CCP

STOP*

CCP

*Proceed to the next step in the process.

APPENDIX F
Example II of a CCP Decision Tree
Q1. Do control measure(s) exist for the identified hazard? YES NO Modify step, process or product

Is control at this step necessary for safety?

YES

NO

Not a CCP

STOP*

Q2. Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level?

NO

YES

Q3.

Could contamination with the identified hazard(s) occur in excess of acceptable level(s) or could it increase to an unacceptable level(s)?

YES

NO

Not a CCP

STOP*

Q4.

Will a subsequent step eliminate the identified hazard(s) or reduce its likely occurrence to an acceptable level?

YES

Not a CCP

STOP*

NO

CRITICAL CONTROL POINT

*Proceed to next step in the described process

APPENDIX G
Examples of Verification Activities
A. Verification procedures may include: 1. Establishment of appropriate verification schedules. 2. Review of the HACCP plan for completeness. 3. Confirmation of the accuracy of the flow diagram. 4. Review of the HACCP system to determine if the facility is operating according to the HACCP plan. 5. Review of CCP monitoring records. 6. Review of records for deviations and corrective actions. 7. Validation of critical limits to confirm that they are adequate to control significant hazards. 8. Validation of HACCP plan, including on-site review. 9. Review of modifications of the HACCP plan. 10. Sampling and testing to verify CCPs. B. Verification should be conducted: 1. Routinely, or on an unannounced basis, to assure CCPs are under control. 2. When there are emerging concerns about the safety of the product. 3. When foods have been implicated as a vehicle of foodborne disease. 4. To confirm that changes have been implemented correctly after a HACCP plan has been modified. 5. To assess whether a HACCP plan should be modified due to a change in the process, equipment, ingredients, etc. C. Verification reports may include information on the presence and adequacy of. 1. The HACCP plan and the person(s) responsible for administering and updating the HACCP plan. 2. The records associated with CCP monitoring. 3. Direct recording of monitoring data of the CCP while in operation. 4. Certification that monitoring equipment is properly calibrated and in working order. 5. Corrective actions for deviations. 6. Sampling and testing methods used to verify that CCPs are under control. 7. Modifications to the HACCP plan. 8. Training and knowledge of individuals responsible for monitoring CCPs. 9. Validation activities.

APPENDIX H
Examples of HACCP Records
A. Ingredients for which critical limits have been established. 1. Supplier certification records documenting compliance of an ingredient with a critical limit. 2. Processor audit records verifying supplier compliance. 3. Storage records (e.g., time, temperature) for when ingredient storage is a CCP. B. Processing, storage and distribution records 1. Information that establishes the efficacy of a CCP to maintain product safety. 2. Data establishing the safe shelf life of the product; if age of product can affect safety. 3. Records indicating compliance with critical limits when packaging materials, labeling or sealing specifications are necessary for food safety. 4. Monitoring records. 5. Verification records. C. Deviation and corrective action records. D. Employee training records that are pertinent to CCPs and the HACCP plan. E. Documentation of the adequacy of the HACCP plan from a knowledgeable HACCP expert.

NCIMS HACCP Appendix K

NCIMS HACCP Appendix K

PMO 2007

Appendix K - HACCP Program

Grade "A" Pasteurized Milk Ordinance (2007 Revision)

PMO references not in Appendix K can be found in the References for NCIMS HACCP Audit Form per 2005 NCIMS Documents 1. 2. 3. 4. 5. The HACCP System Introduction Implementation of a HACCP System Employee Education and Training Training and Standardization HACCP Audits and Follow-up Actions

I. The HACCP System Introduction

History of HACCP: The use of the HACCP System is not new to the dairy industry. HACCP is a logical, simple, effective, but highly structured system of food safety control. The HACCP System was introduced to the food industry as a spin-off of the space program during the 1960's. The National Aeronautics and Space Administration (NASA) used HACCP to provide assurance of the highest quality available for components of space vehicles. This program, to develop assurance of product reliability, was carried over into the development of foods for astronauts. The U.S. Army Natick Laboratories, in conjunction with NASA, began to develop the foods needed for manned space exploration. They contracted with the Pillsbury Company to design and produce the first foods used in space. While Pillsbury struggled with certain problems, such as how to keep food from crumbling in zero gravity, they also undertook the task to come as close as possible to one-hundred percent (100%) assurance that the foods they produced would be free of bacterial or viral pathogens. Using traditional quality control methods for the food industry was soon proven to be unworkable for the task Pillsbury had undertaken. The degree of safety desired was not provided by the current programs, and the product sampling necessary to provide an adequate degree of safety would have been prohibitive to commercialization of space foods. Pillsbury discarded its standard quality control methods and began an extensive evaluation, in conjunction with NASA and Natick Labs, to evaluate food safety. They soon realized that to be successful they would have to have control over their process, raw materials, environment, and their people. In 1971,

they introduced HACCP as a preventive system that enables manufacturers to produce foods with a high degree of assurance that the foods were produced safely. Background: HACCP is a management tool that provides a structured and scientific approach to the control of identified hazards. HACCP is a logical basis for better decision-making with respect to product safety. HACCP has international recognition as an effective means of controlling food safety hazards and is endorsed as such by the joint Food and Agriculture Organization of the World Health Organization (FAO)/World Health Organization (WHO) Codex Alimentarius Commission. The U.S. National Advisory Committee on Microbiological Criteria for Foods (NACMCF) has also endorsed it. The HACCP concept will enable those operating under and regulating under a HACCP Plan to move to a preventive approach, whereby potential hazards are identified and controlled in the manufacturing environment, i.e., prevention of product failure. HACCP allows for a preventive, systematic approach to food safety. Voluntary Participation: This Appendix describes a voluntary, NCIMS HACCP Program alternative to the traditional inspection system. No milk plant, receiving station or transfer station may participate in the voluntary NCIMS HACCP Program unless the Regulatory Agency responsible for the oversight of the facility agrees to participate with the dairy plant(s), receiving station(s) and transfer station(s) in the NCIMS HACCP Program. Both parties must provide written commitment to each other that the necessary resources to support participation in the NCIMS HACCP Program will be made available. Management responsible for both the State and dairy plant, receiving station or transfer station must be willing to provide the resources needed to develop and implement a successful HACCP System. HACCP Principles: Following are the seven (7) HACCP principles to be included in a HACCP Plan: 1. 2. 3. 4. 5. 6. 7. Conduct a hazard analysis; Determine the critical control points; Establish critical limits; Establish monitoring procedures; Establish corrective actions; Establish verification procedures; and Establish record-keeping and documentation procedures.

Prerequisite Programs (PPs): Prior to the implementation of a HACCP Plan, there is a requirement for dairy plants, receiving stations and transfer stations to develop, document and implement written PPs. PPs provide the basic environment and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are specified in Federal and State regulations and guidelines. PPs, and the HACCP System in total, address public health concerns such as those identified in 21 CFR Part 7, Recalls; Part 110, Good Manufacturing Practices (GMPs); Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Part 131, Milk and

Cream; the Grade "A" PMO; and the current edition of the NACMCF HACCP Principles and Application Guidelines. Summary: The seven (7) principles of HACCP are also called the HACCP Plan. When combined with the PPs, they constitute a HACCP System. The NCIMS HACCP Program described in this Appendix includes the HACCP System and other prescribed Grade "A" PMO criteria, such as drug residue testing and traceback; use of milk only from supplies that have been awarded a milk sanitation compliance rating of ninety percent (90%) or better or from an acceptable IMS HACCP listed source; and the labeling requirements of Section 4. When properly implemented, the HACCP program described in this Appendix will provide assurance of milk and milk product safety that is equivalent to that provided under the traditional inspection system.

II. Implementation of a HACCP System

Note: The superscripted section numbers appearing below are linked to PMO text that applies to Sections of the Milk Plant, Receiving Station, or Transfer Station NCIMS HACCP System Audit Report, Form FDA 2359m (also available in PDF.). --> Preliminary Steps: Preliminary steps as listed in the NACMCF document should be followed when producing a HACCP Plan. Complete, up-to-date process flow diagrams are required for all milk and milk products manufactured. Flow diagrams may be combined when processes, products and hazards are similar. (1A) Prerequisite Program: HACCP is not a stand-alone program, but is part of a larger control system. PPs are the universal procedures used to control the conditions of the milk plant environment that contribute to the overall safety of the milk or milk product. They represent the sum of programs, practices and procedures that must be applied to produce and distribute safe milk and milk products in a clean, sanitary environment. They differ from CCPs in that they are basic sanitation programs that reduce the potential occurrence of a milk or milk product safety hazard. Frequently, both HACCP Plan CCPs and PPs control measures are necessary to control a food safety hazard. HACCP may be implemented only in a facility that is constructed and operated to provide a sanitary environment. Milk plant, receiving station or transfer station premises, building construction, maintenance, and housekeeping shall be maintained in a manner sufficient to provide such an environment. These factors shall be controlled by effective milk plant, receiving station or transfer station programs or by PPs, as the milk plant, receiving station or transfer station chooses.(10I)
(9F) (10I) (1A)

The exact set of PPs will vary since their application is milk or milk product and process specific. The existence and effectiveness of PPs should be assessed during the design and implementation of each HACCP Plan. PPs should be documented and regularly audited. An audit review consists of verifying that the company has a program implemented that indicates

how the company monitors and controls each of the PPs.(9F) PPs are established and managed separately from the HACCP Plan. 1. Required PPs: The following required PPs shall have a brief written description or checklist that the PPs can be audited against to ensure compliance. PPs shall include procedures that can be monitored; records that specify what is monitored; and how often it will be monitored. Each milk plant, receiving station or transfer station shall have and implement PPs that address conditions and practices before, during, and after processing. The PPs shall address:(9A) 1. 2. 3. Safety of the water that comes into contact with milk or milk products or product-contact surfaces, including steam and ice; (9A1) (9A2) Condition and cleanliness of equipment product-contact surface; (9A2) (9A3) Prevention of cross-contamination from insanitary objects and or practices to milk or milk products or product-contact surfaces, packaging material and other food-contact surfaces, including utensils, gloves, outer garments, etc., and from raw product to processed product; (9A3) (9A4) Maintenance of handwashing, hand sanitizing, and toilet facilities; (9A4) (9A5) Protection of milk or milk product, packaging material, and product-contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and other chemical, physical and biological contaminants; (9A5) (9A6) Proper labeling, storage, and use of toxic compounds; (9A6) (9A7) Control of employee health conditions, including employee exposure to high risk situations, that could result in the microbiological contamination of milk or milk products, packaging materials, and product-contact surfaces; (9A7) and (9A8) Pest exclusion from the milk plant.(9A8)
(9A1) (9A)

4. 5.

6. 7.

8.
(9B)

In addition to the required PPs specified above, any other PPs that are being relied upon in the Hazard Analysis to reduce the likelihood of hazards such that they are not reasonably likely to occur, shall also be monitored, audited, and documented as required PPs.(9B)

2.

Monitoring and Correction: The milk plant, receiving station or transfer station shall monitor the conditions and practices of all required PPs with sufficient frequency to ensure conformance with those conditions and that are appropriate both to the milk plant, receiving station or transfer station and to the safety of the milk or milk product being processed. Each milk plant, receiving station or transfer station shall document the correction of those conditions and practices that are not in conformance. Devices, such as indicating and recording thermometers that are used to monitor PPs shall be calibrated to assure accuracy at a frequency determined by the milk plant, receiving station, or transfer station.

(9C, 9D, 9E)

3. Required Records: Each milk plant, receiving station or transfer station shall maintain records that document the monitoring and corrections required by this Appendix. These records are subject to the record keeping requirements of this Appendix. (9C, 9E)
(1A)

Hazard Analysis: Each milk plant, receiving station or transfer station shall develop, or have developed for it, a written hazard analysis to determine whether there are milk or milk product hazards that are reasonably likely to occur for each type of milk or milk product processed or handled by the milk plant, receiving station or transfer station and to identify the control measures that the milk plant, receiving station or transfer station can apply to control those hazards.(1A)

The hazard analysis shall include hazards that can be introduced both within and outside the milk plant, receiving station or transfer station environment, including hazards that can occur during handling, transportation, processing and distribution. A hazard that is reasonably likely to occur is one for which a prudent milk plant, receiving station or transfer station operator would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absence of these controls, the hazard will occur in the particular type of milk or milk product being processed. The hazard analysis shall be developed by an individual(s) trained in accordance with this Appendix and shall be subject to the record keeping requirements as described in this Appendix. 1. In evaluating what milk or milk product hazards are reasonably likely to occur, at a minimum, consideration should be given to the following: 1. Microbiological contamination; 2. Parasites; 3. Chemical contamination; 4. Unlawful drug and pesticide residues; 5. Natural toxins; 6. Unapproved use of food or color additives; 7. Presence of undeclared ingredients that may be allergens; and 8. Physical hazards. 2. Milk plant, receiving station or transfer station operators should evaluate product ingredients, processing procedures, packaging, storage, and intended use; facility and equipment function and design; and milk plant sanitation, including employee hygiene, to determine the potential effect of each on the safety of the finished milk or milk product for the intended consumer.(1B) HACCP Plan: 1.
(2A, 2B)

(1B)

HACCP Plan: Every milk plant, receiving station or transfer station shall have and implement a written HACCP Plan whenever a hazard analysis reveals one (1) or more hazards that are reasonably likely to occur.(2B) The HACCP Plan shall be developed by an individual(s) who has been trained and shall be subject to record keeping requirements in accordance with this Appendix. A HACCP Plan shall be specific to each

location and milk or milk product. The plan may group similar types of milk and milk products together, or similar types of production methods together, if the hazards, CCPs, CLs, and procedures required to be identified and performed by 2. of this Section are essentially identical, provided that any required features of the plan that are unique to a specific milk or milk product or method are clearly delineated in the plan and are observed in practice.(2A) 2. (1A) Contents of the HACCP Plan: The HACCP Plan shall, at a minimum: 1. Include complete up-to-date process flow diagrams for all milk and milk products manufactured. Flow diagrams may be combined when processes, milk and milk products and hazards are similar. (1A) (2C) 2. List all hazards that are reasonably likely to occur as identified in the hazard analysis specified above, and that must be controlled for each type of milk or milk product.(2C) 3. (3A, 3B, 3C) List the CCPs for each of the identified hazards, including the appropriate: 1. (1) CCPs designed to control hazards that could occur or could be introduced in the milk plant, receiving station or transfer station environment; 2. (2) CCPs designed to control hazards introduced outside the milk plant, receiving station or transfer station environment, including hazards that occur before arriving at the milk plant, receiving station and/or transfer station;(3A, 3B, 3C) and 3. (4A, 4D) (3) List the CLs that shall be met at each of the CCPs.(4A, 4D) (4C, 5A) 4. List the procedures and the frequency with which they are to be performed that will be used to monitor each of the CCPs to ensure compliance with the CLs;(4C, 5A) 5. (6A)Include any corrective action plans that have been developed in accordance with the corrective action requirements as described in this Appendix, and that are to be followed in response to deviations from CLs at CCPs;(6A) 6. (7A)List the verification and validation procedures, and the frequency with which they are to be performed, that the milk plant, receiving station or transfer station will use in accordance with verification and validation requirements as described in this Appendix;(7A) and 7. (5D, 5B)Provide a record keeping system that documents the monitoring of the CCPs in accordance with the record requirements as described in this Appendix. The records shall contain the actual values and observations obtained during monitoring.(5D, 5B) 3. (2C)Sanitation: Sanitation controls may be included in the HACCP Plan. However, to the extent that they are monitored in accordance with the PPs, they need not be included in the HACCP Plan.(2C)
(6A-6G)

Corrective Actions: Whenever a deviation from a CL occurs, a milk plant, receiving station or transfer station shall take corrective action by following the procedures set forth in 1. or 2. of this Section.

1. Milk plants, receiving stations or transfer stations may develop written corrective action plans, which become a part of their HACCP Plan(s), in accordance with this Appendix. These corrective action plans may predetermine the corrective actions that milk plants, receiving stations and transfer stations will take whenever there is a deviation from a CL. A corrective action plan that is appropriate for a particular deviation is one (1) that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that: 1. No milk or milk product is allowed to enter commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; or 2. If such milk or milk product has entered commerce, it is expeditiously removed; and 3. The cause of the deviation is corrected. 2. When a deviation from a CL occurs, and the milk plant, receiving station or transfer station does not have a corrective action plan that is appropriate for that deviation, the milk plant, receiving station or transfer station shall: 1. Segregate and hold the affected milk or milk product, at least until the requirements of paragraphs 2.b and 2.c of this Section are met; 2. Perform or obtain a review to determine the acceptability of the affected milk or milk product for distribution. The review shall be performed by an individual or individuals qualified by training or experience to perform such a review; 3. Take corrective action, when necessary, with respect to the affected milk or milk product to ensure that no milk or milk product is allowed to enter commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; 4. Take corrective action, when necessary, to correct the cause of the deviation; and 5. Perform or obtain timely validation by a qualified individual(s), as required in this Appendix, to determine whether modification of the HACCP Plan is required to reduce the risk of recurrence of the deviation, and modify the HACCP Plan as necessary. 3. All corrective actions taken in accordance with this Section shall be fully documented in records that are subject to verification.(6A-6G) Verification and Validation: 1. Verification: Every milk plant, receiving station or transfer station shall verify that the HACCP System is being implemented according to design, except that critical factors for aseptically processed Grade "A" milk and milk products, as determined by the process authority and listed on the scheduled process under 21 CFR 113 shall be managed separately from the NCIMS HACCP System, even if identified as a CCP in the hazard analysis. Critical factors shall be monitored under the operating supervision of an individual who has successfully completed an approved course of instruction in low-acid canned foods as required under 21 CFR 108.35. Compliance with the provisions of 21 CFR 113 shall satisfy the requirements of this Section, regardless of whether a critical factor has also been designated as a CCP. 1. Verification activities shall include: 1. (1) The calibration of CCP process-monitoring instruments, i.e., pasteurization tests, etc.;
(7B)

2. (2) At the option of the milk plant, receiving station or transfer station, the performance of periodic end-product or in-process testing; 3. (7H, 11C)(3)A review, including signing and dating, by an individual who has been trained in accordance with the training requirements of this Appendix, of the records that document:(7H, 11C) 1. (7E)The Monitoring of CCPs: The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that the recorded document values are within the CLs. This review shall occur at a frequency that is appropriate to the importance of the record and as specified in the HACCP Plan;(7E) 2. (7F)The Taking of Corrective Action: The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective action(s) was taken in accordance with the corrective action requirements cited before. This review shall occur at a frequency that is appropriate to the importance of the record. A centralized deviation log is required;(7F) and 3. (7G) The purpose of these reviews shall be, at a minimum, to ensure that the records are complete and that these activities occurred in accordance with the milk plant's, receiving station's or transfer station's written procedures. These reviews shall occur within a reasonable time after the records are made. 4. (4) The taking of corrective action procedures whenever any verification procedure establishes the need to take a corrective action.(7B) (7D) 2. The calibration of CCP process-monitoring instruments, and the performance of any periodic end-product and in-process testing, in accordance with 1.a.(3)ii) and 1.a.(3)iii) of this Section, shall be documented in records that are subject to the record keeping requirements in this Appendix.(7D) 2. (7C) Validation of the HACCP Plan: Every milk plant, receiving station or transfer station shall validate that the HACCP Plan is adequate to control hazards that are reasonably likely to occur. This validation shall occur at least once within twelve (12) months after implementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP Plan. Such changes may include changes in the following: 1. Raw materials or source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or intended consumers of the finished product and consumer complaints. The validation shall be performed by a qualified individual(s) trained in accordance with the requirements described in this Appendix and shall be subject to the record keeping requirements cited below. (11B)The HACCP Plan shall be modified immediately
(11B)

whenever a validation reveals that the plan is no longer adequate to fully meet the requirements of this document.(7C) 3. Validation of the Hazard Analysis: Whenever a milk plant, receiving station or transfer station does not have a HACCP Plan, because a hazard analysis has revealed no hazards that are reasonably likely to occur, the milk plant, receiving station or transfer station shall reassess the adequacy of the hazard analysis whenever there are any changes in the process that could reasonably affect whether a hazard exists. Such changes may include changes in the following: 1. Raw materials or source of raw materials; 2. Product formulation; 3. Processing methods or systems, including computers and their software; 4. Packaging; 5. Finished product distribution systems; or 6. The intended use or intended consumers of the finished product; and 7. Consumer complaints.
(11B) (1C)

A qualified individual(s) trained in accordance with the training requirements of this Appendix shall perform the validation. (1C) (11B) Records: 1.
(1D), (2D), (9H), (8E)

Required Records: It is essential that milk plants, receiving stations and transfer stations use consistent terminology to identify each piece of equipment, record, document, or other program throughout their written HACCP System. A milk plant, receiving station or transfer station shall maintain the following records documenting the milk plant, receiving station or transfer station's HACCP System:(8E) 1. Records documenting the ongoing application of the PP, including a brief written description, monitoring and correction records; 2. The written hazard analysis; 3. The written HACCP Plan;(1D), (2D) , (9H) 4. (8A)Required HACCP documents and forms specified in 1.a. through c. of this Section shall be dated or identified with a version number. Each page shall be marked with a new date or version number whenever that page is updated; 5. A Table of Contents and centralized list of the HACCP program records, by title, documenting the ongoing application of the HACCP System shall be maintained and provided for review; 6. A document change log; 7. Records documenting the ongoing application of the HACCP Plan that include: 1. (5D)(1) Monitoring of CCPs and their CLs, including the recording of actual times, temperatures, or other measurements, as prescribed in the milk plant's, receiving station's or transfer station's HACCP Plan;(5D) 2. (2) Corrective actions, including all actions taken in response to a deviation; 3. (3) A centralized deviation log is required; and 4. (4) Plan validation dates.

2.

3.

4.

5. 6.

8. Records documenting verification and validation of the HACCP System, including the HACCP Plan, hazard analysis and PPs. General Requirements: Records required by this Section shall include: 1. The identity and location of the milk plant, receiving station or transfer station; 2. The date and time of the activity that the record reflects; 3. The signature or initials of the person(s) performing the operation or creating the record; and 4. (8B, 9G) Where appropriate, the identity of the milk or milk product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed. The records shall contain the actual values and observations obtained during monitoring.(8A) (8B, 9G) (1D, 2D), (9H) Documentation: 1. The records in paragraphs 1.a. through c. of this Section shall be signed and dated by the most responsible individual onsite at the milk plant, receiving station or transfer station. This signature shall signify that these records have been accepted by the firm. 2. The records in paragraphs 1.a. through c. of this Section shall be signed and dated: 1. (1) Upon initial acceptance; 2. (2) Upon any modification; and 3. (3) Upon verification and validation in accordance with the requirements cited above.(1D, 2D), (9H) (8C) Record Retention: 1. All records, required by this Section, shall be retained at the milk plant, receiving station or transfer station for perishable or refrigerated products, for at least one (1) year after the date that such products were prepared, and in the case of frozen, preserved, or shelf-stable products, for two (2) years after the date that the products were prepared or the shelf-life of the product, whichever is greater, unless longer retention time is required by other regulations.(8C) 2. (8D)b. Records that relate to the adequacy of equipment or processes used, such as commissioning or process validation records, including the results of scientific studies and evaluations, shall be retained at the milk plant, receiving station or transfer station facility for at least two (2) years after the date that the milk plant, receiving station or transfer station last used such equipment or process. (8D) 3. (8E)Off-site storage of processing records is permitted after six (6) months following the date that the monitoring occurred, if such records can be retrieved and provided on-site within twenty-four (24) hours of a request for official review. Electronic records are considered to be on-site if they are accessible from an on-site location. 4. If the processing facility is closed for a prolonged period, the records may be transferred to some other reasonably accessible location(s) but shall be immediately returned to the processing facility for official review upon request. Official Review: All records required by this Section shall be available for official review at reasonable times. Records Maintained on Computers: The maintenance of records on computers, in accordance with the requirements cited above, is acceptable.(8E)

III. Employee Education and Training

(11A, 11D)

The success of a HACCP system depends on educating and training management and employees in the importance for their role in producing safe milk and milk products. This should also include information in the control of milk borne hazards related to all stages of dairy production and processing. Specific training activities should include working instructions and procedures that outline the tasks of employees monitoring specific CCPs and PPs. (11A, 11D)

IV. Training and Standardization

(11A)

HACCP training for industry and regulatory personnel will be based on the current "Hazard Analysis and Critical Control Point Principles and Application Guidelines" of NACMCF, the current FDA HACCP recommendations, and the regulatory requirements of this Appendix and related Sections of this Ordinance.(11A) Regulatory Agency personnel responsible for the evaluation, licensing and regulatory audits of facilities using the NCIMS HACCP Program will have equivalent training to the training required to perform traditional NCIMS functions. They shall also have specialized training in conducting HACCP System audits. Industry, State and Federal regulatory and listing personnel should be trained together. HACCP Training: 1. Core Curriculum: The Dairy HACCP Core Curriculum consists of: 1. Basic HACCP training; plus 2. An orientation to the requirements of the NCIMS HACCP Program. Basic HACCP training consists of instruction in the application of the NACMCF Principles of HACCP to Food Safety. This training includes practical exercises in conducting a hazard analysis and evaluating potential hazards; in writing a HACCP Plan; and in the validation of the plan. It should be taught by experienced instructors. The orientation component ideally is coupled with the basic HACCP training, but can be taught separately. The content of the orientation will be conducted under the guidance of the NCIMS. It is intended to familiarize industry and regulatory personnel with specific dairy HACCP concerns and the regulatory requirements under the NCIMS HACCP Program. It is to be taught by instructors experienced in the application of HACCP under the NCIMS HACCP Program. The industry individual(s) performing the functions listed in Part 2 of this Section shall have successfully completed appropriate training in the application of HACCP principles to milk and milk product processing at least equivalent to that received under the Dairy

HACCP Core Curriculum. Alternatively, job experience may qualify an individual to perform these functions if the experience has provided knowledge at least equivalent to that provided through the standardized curriculum. 2. Industry Personnel: Only industry individuals who have met the requirements of Part 1 of this Section shall be responsible for the following functions: 1. (1A)Developing the hazard analysis, including delineating control measures, as required;(1A) 2. (2A)Developing a HACCP Plan that is appropriate for the specific milk plant, receiving station or transfer station, in order to meet these requirements;(2A) 3. (11B)Validating and modifying the HACCP Plan in accordance with the corrective action procedures and the validation activities as specified;(11B) and 4. (11C)Performing required HACCP Plan records reviews. (11C) 3. (12C)Regulatory Personnel: Regulatory personnel performing HACCP audits shall have successfully completed appropriate training in the application of HACCP principles for milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum.

V. HACCP Audits and Follow-up Actions

State Regulatory Audits, Enforcement Audits, Actions and Follow-up: Audits shall be conducted of the milk plant, receiving station, or transfer station facility, and NCIMS HACCP Program to ensure compliance with the HACCP System and other associated NCIMS regulatory requirements. The audit may be announced at the discretion of the auditor under certain circumstances, i.e., initial audit, follow-up audit, new construction, pasteurizer checks, etc. When unannounced audits are conducted, the audits shall not be completed until appropriate milk plant personnel have had an opportunity to make all pertinent records available for review by the auditor. Auditing Procedures: 1. Pre-Audit Management Interview: Review and discuss the milk plant HACCP System including: 1. Changes in the management structure; 2. The Hazard Analysis - Ensure that all milk or milk product hazards are addressed; 3. Changes in the HACCP Plan; 4. Changes in the PPs; 5. Changes in the flow diagram; and 6. Changes in milk or milk products or processes. 2. Review past Audit Reports(AR) and corrections of deficiencies and non-conformities, if any; 3. n-milk plant review of the implementation and verification of the HACCP System; 4. Review records of the HACCPSystem; 5. Review compliance with other applicable NCIMS regulatory requirements*;

6. Discuss findings and observations; 7. Prepare and issue an AR based on findings of deficiencies and non-conformities. The AR shall include timelines for the correction of all identified deficiencies and nonconformities; and 8. Conduct the exit interview. *Note: Examples of Other Applicable NCIMS Requirements: 1. 2. 3. 4. 5. 6. 7. 8. Raw Milk Supply Source; Labeling Compliance; Adulteration; Licensing Requirements; Drug Residue Testing and Traceback Requirements; Regulatory Samples in Compliance; Approved Laboratory Utilized for the Required Regulatory Tests; and Pasteurization Equipment Design and Installation.(10I)
(10I)

State Regulatory Enforcement Action/Follow-up: The State Regulatory Agency shall: 1. Prepare and issue ARs based on findings of deficiencies and non-conformities and other NCIMS requirements; 2. Review the AR with the milk plant and establish time lines for the correction of all identified deficiencies and non-conformities and other NCIMS requirements; 3. (12A)Follow-up to ensure corrections are made as a result of the issuance of the AR;(12A) 4. Take immediate action when an imminent health hazard is observed to prevent further movement of milk and milk products until such hazards have been eliminated and 5. (12B)Initiate regulatory enforcement action, such as permit suspension, revocation, hearings, court actions, and/or other equivalent measures when the milk plant, receiving station or transfer station has failed to recognize or correct a deficiency(ies) or nonconformity(ies).(12B) Audit Timeframes: Frequency Minimums Initial audit; First Year after Initial Next audit in thirty (30) to forty-five (45) days; and four (4) month Regulatory Audit: intervals thereafter, unless the Regulatory Agency determines that a greater frequency is warranted. Every six (6) months unless the Regulatory Agency determines that a Subsequent Audits greater frequency is warranted*. Compliance follow-ups shall be made as frequently as necessary to Compliance Followassure that problems observed by the Regulatory Agency have been Ups resolved. *The Regulatory Agency may elect to extend the minimum audit frequency from four (4) to six (6) months as long as the following conditions exist: Audits

1. Item 12b on FORM FDA 2359m MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT is not marked on the regulatory audit for the current HACCP audit; 2. No current two (2) out of four (4) warning letter(s) or three (3) out of five (5) violation letter(s) for finished milk or milk product, or violative water sample results; and 3. No CLEs on the current or prior audit.

NCIMS Dairy Hazards & Controls Guide

NCIMS Dairy Hazards & Controls Guide

Hazards and Controls Guide For Dairy Foods HACCP Guidance for Processors
Version 1.1 June 16, 2006

LIST OF REASONS FOR REVISONS TO THIS HAZARD GUIDE

DATE 03/21/2006 06/16/2006 REASON Editorial revisions made in page numbering and minor heading numbering corrections. Title changed from Dairy Foods HACCP Hazards and Controls Guide to Hazards and Controls Guide Dairy Foods HACCP

Dairy Foods HACCP Standard and Controls Guide Guidance for Processors
Table of Contents I. Introduction A. Status B. Purpose C. Comparison with the FDA Juice HACCP Regulations D. Scope and Limitations II. Terms and Definitions III. Overview of the NCIMS HACCP Program A. Voluntary Nature of the Program B. Key Requirements of the NCIMS HACCP Program IV. Prerequisite Programs A. Required Prerequisite Programs B. Acceptable Level of Protection by Prerequisite Programs V. Hazard Analysis A. Preparing for a Hazard Analysis Five Preliminary Steps B. Overview of the Hazard Analysis VI. HACCP Decision Trees A. NACMCF CCP Decision Tree #1 B. NACMCF CCP Decision Tree #2 C. IDFA Modified Decision Tree for HACCP VII. Control Measures A. HACCP Control Measures B. Activities Not Considered to be HACCP Control Measures VIII. Preparing for HACCP A. Getting People Ready B. HACCP Training and HACCP Resource Materials IX. Hazards and Control Guide A. Table 1 Milk Plant Raw Materials B. Table 2 Milk Plant Processing Operations X. References

I. Introduction
A. Status This Hazards and Controls Guide represents the National Conference on Interstate Milk Shipments (NCIMS) perspective on identifying and evaluating potential hazards in milk and milk products and their control. It is designed to assist processors in the development of Hazard Analysis Critical Control Point (HACCP) systems to satisfy the requirements of the NCIMS HACCP alternative to the traditional regulatory system for Grade A dairy products that are regulated by the states under the NCIMS milk safety system. The guide should also be useful to State Regulators who are responsible for the evaluating the completeness of a plants hazard analysis. This Hazards and Controls Guide provides a framework for answering some of the questions to be considered when conducting a hazard analysis for the processing of milk and milk products. This guide has been separated into two parts. The first part provides background information that can be useful in understanding the basic food safety concerns and goals to be addressed by the hazard analysis. The second part of the hazard guide is an evaluation of specific potential hazards associated with the processing of milk and milk products. It is also divided into two major sections. The first section identifies many potential food safety hazards associated with ingredients and packaging materials. In the second section, a unit operations approach has been used to identify food safety potential hazards which may be associated with processing. HACCP, as it relates to the NCIMS HACCP alternative, is a food safety system whose design is based on practical experience and the scientific understanding of the potential hazards associated with various types of milk and milk products. References to the available scientific literature can be found throughout this document. A list of references can be found at the end of this guide. B. Purpose The purpose of this guidance is to assist you in the development of a written HACCP program, as defined by the NCIMS Voluntary HACCP System. You will find information in this guidance that will help you identify hazards that may potentially occur in your products and help you identify and use methods of controlling and preventing hazards. This guidance is also intended to serve as a tool for Federal and State regulatory officials in the evaluation of HACCP systems for dairy products. To help understand some key aspects of the NCIMS Voluntary HACCP System and plan how you will initiate your HACCP activities, we have included information on some other important aspects of the Dairy HACCP System. C. Comparison with the FDA Juice HACCP Regulations The following table is provided to dairy processors as a visual comparison of the FDA Juice HACCP regulations and the NCIMS Voluntary Dairy System.

Requirements
Regulation

FDA Juice HACCP

1/22/02 Large Business

NCIMS HACCP
January 1, 2004

Requirements
Implementation Dates:

FDA Juice HACCP

(>500 employees) 1/21/03 for Small Business (<500 employees) 1/20/04 for Very Small Businesses (<100 employees)

NCIMS HACCP

Prerequisite Program Concept Written Sanitation Standard Operating Procedure (SSOP) or Required PP Sanitation Monitoring & Documentation (SSOP) or Required PP Perform Hazard Analysis Written Hazard Analysis Written HACCP Plan Written Corrective Action Plan Required: HACCP Plan shall be signed and dated Plan Revalidation Upon plan development Upon any change that affect ingredients, process, hazard analysis or HACCP Plan At least annually Regulator Consumer Complaint Record Access Maintain Customer Complaint Summary Monitoring & Corrective Action Records Review Required Info on Records Name & Location Date & Time Monitors Initials or

Yes (GMP & SSOP) No Yes (8 elements) Yes Yes Yes Yes Yes, updated annually Yes, at least once within 12 months of implementation Yes

Yes (PP) Yes Yes (8 elements) Yes Yes Yes Yes Yes Yes Yes

Yes No Yes Within 7 days

Yes No Yes No minimum specified, appropriate to records being kept Yes Yes Yes

Yes (if more than 1 location) Yes Yes, where appropriate

Requirements
Signature ID of product & Code Record Retention

FDA Juice HACCP

Yes, where appropriate 1 year after the production of the product 2 years for frozen, preserved or shelf stable, or the shelf life of the product, whichever is greater.

NCIMS HACCP
Yes At least 1 year after the date that such products were prepared. In the case of frozen, preserved or shelf stable products 2 years or the shelf life of the product whichever is greater, after the date that the products were prepared unless longer retention time is required by other regulations. YES (NCIMS Dairy HACCP Core Curriculum) Not Addressed Not Addressed Yes Mandatory CCP for pasteurization Hazards addressed as critical factors by process authority are not required to be addressed in the HACCP Plan Summary Table

Industry Training (HACCP plan developers, validators and record reviewers) or equivalent experience Confidentiality Copying Records Electronic Records 5-Log Pathogen Reduction Performance Standard LACF or One Step Thermally Processed ShelfStable Juice or Juice Concentrates

Yes (Juice HACCP Core Curriculum) Yes, within the limits of FOIA Yes Yes Yes Exempt from the 5-log performance standard. Other hazards must be controlled. Shelf-stable and concentrate processors must include a copy of their thermal process in their written hazard analysis. Must be packaged in final form under single roof or 5-log needs to be done.

D. Scope and Limitations This guide addresses development of a product flow diagram, description of the product, hazard identification and hazard evaluation. It is not intended to provide examples for development of prerequisite programs, formation of the HACCP team, product distribution, risk analysis, etc. Prior to conducting the hazard analysis, the HACCP team must complete the following preliminary steps: 1. Develop a product description; 2. Develop and verify a process flow diagram 3. Describe the intended use and distribution parameters.

II. Terms and Definitions

A. AUDIT: An evaluation of the entire milk plant, receiving station or transfer station facility and NCIMS HACCP System to ensure compliance with the NCIMS HACCP System and other NCIMS regulatory requirements. B. Centralized Deviation Log: A centralized log or file identifying data detailing any deviation of critical limits and the corrective actions taken as required in Appendix K of the Pasteurized Milk Ordinance (PMO). C. Control: To manage the conditions of an operation to maintain compliance with established criteria. The state where correct procedures are being followed and criteria are being met. D. Control Measure: Any action or activity that can be used to prevent, eliminate or reduce a significant hazard that is managed at a Critical Control Point. E. Corrective Action: Procedures followed when a deviation occurs. F. Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or eliminate a milk or milk product safety hazard or reduce it to an acceptable level. G. Critical Limit (CL): A maximum and/or minimum value to which a biological, chemical, or physical parameter must be controlled at a CCP to prevent, eliminate, or reduce to an acceptable level the occurrence of a milk or milk product safety hazard. H. CRITICAL LISTING ELEMENT (CLE): An item on the MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT identified with a double star (**). The marking of a CLE by a State Rating Officer or FDA auditor, indicates a condition that constitutes a major dysfunction likely to result in a potential compromise to milk or milk product safety, or that violate NCIMS requirements regarding drug residue testing and trace back or raw milk sources, whereby a listing may be denied or withdrawn. I. DAIRY HACCP CORE CURRICULUM: The core curriculum consists of:

1. Basic HACCP training; plus 2. An orientation to the requirements of the NCIMS HACCP Program
J. DEFICIENCY: An element inadequate or missing from the requirements of the HACCP System or Appendix K of the PMO.

K. DEVIATION: A failure to meet a Critical Limit. L. FOOD ALLERGENS: Are proteins in foods that are capable of inducing an allergic reaction or response in some individuals. There is specific consensus that the following foods account for more than 90% of all food allergies: peanuts, soybeans, milk, eggs, fish, crustaceans, tree nuts, and wheat.

M. HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP): A Systematic approach to the identification, evaluation, and control of significant milk or milk product safety hazards. N. HACCP PLAN: The written document, which is based upon the principles of HACCP and delineates the procedures to be followed. O. HACCP SYSTEM: The implemented HACCP Plant and Prerequisite Program, including other applicable NCIMS requirements. P. HACCP TEAM: The group of people who are responsible for developing, implementing, and maintaining the HACCP system. Q. HAZARD: A biological, chemical, or physical agent that is reasonable likely to cause illness or injury in the absence of its control. R. HAZARD ANALYSIS: The process of collecting and evaluating information on hazards associated with the milk under consideration, to decide which are reasonable likely to occur and must be addressed in the HACCP Plan. S. MONITOR: To conduct a planned sequence of observations or measurements to assess that a CCP is under control or to assess the conditions and practices of all required Prerequisite Programs. T. NON-CONFORMITY: A failure to meet specified requirements of the HACCP System as described in Appendix K of the PMO. U. POTENTIAL HAZARD: Any hazard to be evaluated by the hazard analysis. V. PREREQUISITE PROGRAMS (PPs): Procedures, including Good Manufacturing Practices (GMPs), which address operational conditions that provide the foundation for the HACCP System. The required PPs specified in Appendix K of the PMO, are something called Sanitary Standard Operating Procedures (SSOPs) in other HACCP Systems. W. VALIDATION: The element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP Plan, when properly implemented, will effectively control the hazards. X. VERIFICATION: Those activities, other than monitoring, that determine the validity of the HACCP Plan and that the HACCP System is operating according to the plan.

III. Overview of the NCIMS HACCP Program

The following section is a brief synopsis of Appendix K of the PMO detailing the requirements of the NCIMS alternative HACCP program. For a complete understanding of the NCIMS HACCP Alternative, please refer to the most recent version of the PMO. A. Voluntary Nature of the Program The NCIMS HACCP Program alternative to the traditional inspection system is a voluntary system as described in the applicable sections and Appendices of the Pasteurized Milk Ordinance (PMO). No plant, receiving station or transfer station may participate in the voluntary NCIMS HACCP Program unless the Regulatory Agency responsible for the oversight of the facility agrees to participate with the dairy plant(s), receiving station(s) and transfer station(s) in the NCIMS HACCP Program. Both parties must provide written commitment to each other that the necessary resources to support participation in the NCIMS HACCP Program will be made available. Management responsible for both the State and plant, receiving station or transfer station must be willing to provide the resources needed to develop and implement a successful HACCP System. B. Key Requirements of the NCIMS HACCP Program 1. Specialized Training in NCIMS HACCP Principles Required HACCP training for industry and regulatory personnel will be based on the current Hazard Analysis and Critical Control Point Principles and Application Guidelines of NACMCF, the current FDA HACCP recommendations, and the regulatory requirements of Appendix K and related Sections of the PMO. Regulatory Agency personnel responsible for the evaluation, licensing and regulatory audits of facilities using the NCIMS HACCP Program will have equivalent training to the training required to perform traditional NCIMS functions. They shall also have specialized training in conducting HACCP System audits. Industry, State and Federal regulatory and listing personnel should be trained together. a. HACCP Training Core Curriculum: The Dairy HACCP Core curriculum consists of: 1. Basic HACCP training; plus 2. An orientation to the requirements of the NCIMS HACCP Program.

Basic HACCP training consists of instruction in the application of the NACMCF Principles of HACCP to Food Safety. This training includes practical exercises in conducting a hazard analysis and evaluating potential hazards; in writing a HACCP Plan, and in the validation of the plan. It should be taught by experienced instructors.

The orientation component ideally is coupled with the basic HACCP training, but can be taught separately. The content of the orientation will be conducted under the guidance of the NCIMS. It is intended to familiarize industry and regulatory personnel with specific dairy HACCP concerns and the regulatory requirements under the NCIMS HACCP Program. It is to be taught by instructors experienced in the application of HACCP under the NCIMS HACCP Program. The industry individual(s) performing the functions listed in Part 2 of this Section shall have successfully completed appropriate training in the application of HACCP principles to milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum. Alternatively, job experience may qualify an individual to perform these functions if the experience has provided knowledge at least equivalent to that provided through the standardized curriculum. Industry Personnel: Only industry individuals who have met the requirements of Part 1 of Appendix K Section III of the Pasteurized Milk Ordinance (PMO) Training and Standardization, shall be responsible for the following functions. a. Developing the hazard analysis, including delineating control measures as required. b. Developing a HACCP Plan that is appropriate for the specific milk plant, receiving station or transfer station, in order to meet these requirements. c. Validating and modifying the HACCP Plan in accordance with the corrective action procedures and the validation activities as specified; and d. Performing required HACCP Plan records reviews. Regulatory Personnel: Regulatory personnel performing HACCP audits shall have successfully completed the appropriate training in the application of HACCP principles for milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum.

2. Recordkeeping and Electronic Records a. Required Records: It is essential that plants, receiving stations and transfer stations use consistent terminology to identify each piece of equipment, record, document, or other program throughout their written HACCP System. A milk plant, receiving station or transfer station shall maintain the following records documenting the milk plant, receiving station or transfer stations HACCP System: A brief description of the monitoring and correction records shall be written documenting the ongoing application of the prerequisite program. A hazard analysis shall be written The written HACCP Plan; Required HACCP documents and forms specified in a.1) through 3) of this Section shall be dated or identified with a version number. Each page shall be marked with a new date or version number whenever that page is updated.

A Table of Contents and centralized list of the HACCP program records, by title, documenting the ongoing application of the HACCP System shall be maintained and provided for review. A document change log shall be kept. Records documenting the ongoing application of the HACCP Plan that include: 1. Monitoring of Critical Control Points and their Critical Limits, including the recording of actual times, temperatures, or other measurements, as prescribed in the plants receiving stations or transfer stations HACCP Plan; a. Corrective actions, including all actions taken in response to a deviation. b. A centralized deviation log is required; and c. Plan validation dates.

d. Records documenting verification and validation of the HACCP System, including the HACCP Plan, hazard analysis and PPs. 2. General Requirements: Records required include: a. The identity and location of the milk plant, receiving station or transfer station; b. The date and time of the activity that the record reflects; c. The signature or initials of the person(s) performing the operation or creating the record; and

d. Where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed. The records shall contain the actual values and observations obtained during monitoring. 3. Documentation: a. The records in paragraphs a.1) through 3) of this Section shall be signed and dated by the most responsible individual onsite at the milk plant, receiving station or transfer station. This signature shall signify that these records have been accepted by the firm. b. The records in paragraphs a.1) through 3) of this Section shall be signed and dated: 1. Upon initial acceptance; 2. Upon any modification; and

3. Upon verification and validation in accordance with the requirements cited above 4. Record Retention: a. All records, required by this section, shall be retained at the milk plant, receiving station or transfer station for perishable or refrigerated products, for at least one (1) year after the date that such products were prepared, and in the case of frozen, preserved, or shelf-stable products, for two (2) years after the date that the products were prepared or the shelf-life of the product, whichever is greater, unless longer retention time is required by other regulations. b. Records that relate to the adequacy of equipment or processes used, such as commissioning or process validation records, including the results of scientific studies and evaluations, shall be retained at the milk plant, receiving station or transfer station facility for at least two (2) years after the date that the milk plant, receiving station or transfer station last used such equipment or process. c. Off-site storage of processing records is permitted after six (6) months following the date that the monitoring occurred, if such records can be retrieved and provided on-site within twenty-four (24) hours of a requires for official review. Electronic records are considered to be on-site if they are accessible from an onsite location.

IV. Prerequisite Programs

The following required Prerequisite Programs shall have a brief written description or checklist that the prerequisite programs can be audited against to ensure compliance. Prerequisite Programs shall include procedures that can be monitored, records that specify what is monitored, and how often it will be monitored. A. Required Prerequisite Programs 1. Safety of the water that comes into contact with milk or milk products or product contact surfaces, including steam and ice. 2. Condition and cleanliness of equipment product contact surface. 3. Prevention of cross-contamination from unsanitary objects and or practices to milk or milk products or product contact surfaces, packaging material and other food contact

surfaces, including utensils, gloves, outer garments, etc., and from raw product to processed product; 4. Maintenance of hand washing, hand sanitizing and toilet facilities. 5. Protection of milk or milk product, packaging material, and product contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and other chemical, physical and biological contaminants; 6. Proper labeling, storage and use of toxic compounds; 7. Control of employee health conditions, including employee exposure to high risk situations, that could result in the microbiological contamination of milk or milk products, package materials, and product contact surfaces; and 8. Exclusion of pests. 9. Required Programs (PPs) used as justification in the Hazard Analysis In addition to the required PPs specified above, any other prerequisite programs that are being relied upon in the Hazard Analysis to reduce the likelihood of occurrence of hazards such that they are not reasonably likely to occur must also be monitored, audited, and documented as required PPs. B. Acceptable level of protection by prerequisite programs Prior to the implementation of a HACCP Plan, there is a requirement for dairy plants, receiving stations and transfer stations to develop, document and implement written PPs. PPs provide the basic environment and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are specified in Federal and State regulations and guidelines. HACCP is not a stand-alone program, but is part of a larger control system. PPs are the universal procedures used to control the conditions of the plant environment that contribute to the overall safety of the product. They represent the sum of programs, practices and procedures that must be applied to produce and distribute safe products in a clean, sanitary environment. They differ from CCPs in that they are basic sanitation programs that reduce the potential occurrence of a milk or milk product safety hazard. Frequently, both HACCP Plan CCPs and PPs control measures are necessary to control a food safety hazard. HACCP may be implemented only in a facility that is constructed and operated to provide a sanitary environment. Milk plant, receiving station or transfer station premises, building construction, maintenance, and housekeeping shall be maintained in a manner sufficient to provide such an environment. These factors shall be controlled by effective plant, receiving station or transfer station programs or by PPs, as the plant, receiving station or transfer station chooses. PPs are the universal procedures used to control the condition of the plant environment that contribute to the overall safety of the product. They represent the sum of programs, practices and procedures that must be applied to produce and distribute safe products in a clean, sanitary environment. They differ from CCP's in that they are basic sanitation programs that reduce the potential occurrence of a food safety hazard. Frequently, both HACCP Plan CCPs and PP's control measures are necessary to control a food safety hazard. The exact set of PPs will vary since their application is product and

process specific. The existence and effectiveness of PPs should be assessed during the design and implementation of each HACCP Plan. PPs should be documented and regularly audited. An audit review consists of verifying that the company has a program implemented that indicates how the company monitors and controls each of the PPs. PPs are established and managed separately from the HACCP Plan.

V. Hazard Analysis
A. Preparing for a Hazard Analysis Five Preliminary Steps Although not required by the NCIMS HACCP alternative, the 5 preliminary steps of HACCP as outlined by the National Advisory Committee of Microbiological Criteria for Foods (NACMCF) will help you in conducting your hazard analysis and developing your HACCP plan, and will prove valuable for other HACCP functions. The steps you should follow are: 1. 2. 3. 4. 5. Step 1 Step 2 Step 3 Step 4 Step 5 Assemble a HACCP Team. Describe the food and its distribution. Identify the intended use and consumers of the food. Develop a flow diagram that describes the process. Verify the accuracy of the flow diagram.

For more information, see the NACMCF publication Hazard Analysis and Critical Control Point Principles and Application Guidelines, Journal of Food Protection, Vol. 61, No. 9, pp. 1246-1259 (1998), (the HACCP Principles and Guidelines publication). B. Overview of the Hazard Analysis 1. Description The dairy hazard analysis is a process of collecting and evaluating information on hazards associated with dairy products, to determine which hazards are reasonably likely to occur and must be addressed in a HACCP Plan. Under the dairy HACCP alternative, you are required to produce, for each type of Grade A dairy product you process, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur and to identify measures that you can apply to control those hazards. The dairy alternative requires a written hazard analysis for each type of dairy product unless different types of dairy products have identical hazards and control measures that can be combined into one hazard analysis. Do not conduct the hazard analysis until the prerequisite programs have been developed, implemented and documented. This Hazard and Controls Guide may be used to aid in constructing and evaluating those prerequisite programs to be considered in the hazard analysis. The hazard analysis may point out the need for additional prerequisites. 2. Relevance to HACCP Plan and Prerequisite Programs All processors that decide to participate in the NCIMS HACCP alternative are required to prepare a written hazard analysis. If you determine that any hazard is reasonably likely to occur in a particular product, you must control that hazard in

the product by applying control measures as part of a properly designed and implemented HACCP plan, except that some hazards can be managed under your PPs. If you determine that no hazards are reasonably likely to occur, you are not required to develop a HACCP Plan, but you must establish and implement PPs. Your PP monitoring and correction records and your hazard analysis are still subject to the record keeping and official record review requirements. Under the NCIMS HACCP system, pasteurization must always be managed as a CCP. Useful examples of both batch and continuous flow pasteurization can be found in the PMO, Appendix H. 3. Developed by HACCP-trained Employee or Consultant Your hazard analysis must be developed by an appropriately trained individual (or individuals) based on the Core Curriculum or comparable experience, as specified in the NCIMS HACCP Alternative. This person may be your employee or a hired outside expert. 4. Basic Steps of the Hazard Analysis a. Identify All Potential Hazards 1. Biological Hazards a. Bacteria The vegetative pathogens of concern associated with milk and processed milk products are Salmonella spp., L. monocytogenes, enterohemorrhagic E. coli, and Campylobacter jejuni. Spore forming bacteria of concern includeC. botulinum, and B. cereus. All these organisms occur in raw milk and most have been associated with illness outbreaks in milk products. These pathogens in milk have the potential for causing severe adverse health effects with the very young, the elderly, and immune-compromised individuals being at the greatest risk. While enteric pathogens have been implicated as the cause of most food-borne illness outbreaks associated with milk products, these are not the only organisms that could occur in milk. The potential of hazards associated with toxin-producing bacteria and spore-formers should be evaluated in processing circumstances where unusual conditions exist. In the case of toxin-producers such as S. aureus and B. cereus, these organisms must multiply to significant levels to produce sufficient toxin to be a public health risk. This is a concern when levels reach above 106 or greater. However, the rule of thumb for temperature control of a food is that controls should be implemented when conditions indicate that there might be a 3- log increase in S. aureus or B. cereus.1 The hazard of C. botulinum associated with aseptically processed milk products is effectively managed in aseptic milk plants though the filed process that is required under 21 CFR 108 and 113. Validation of processes requiring measurement of the production of enterotoxin is expensive and difficult. However, during the 2005 NCIMS, the NCIMS Scientific Committee reviewed and accepted some useful guidelines that have been actually incorporated into the

PMO. These guidelines, below, should be construed generally as "safe harbor" when conducting hazard analyses and validating control measures: Balance tanks or surge tanks with an average retention time of one hour or less may be safely operated for up to 24 hours regardless of product temperature in both pasteurized and unpasteurized dairy products. Pasteurized milk and milk products to be condensed and/or dried, can be maintained at a temperature of 10C (50F) or less until pasteurized. Tanks used to hold pasteurized milk and milk products to be condensed or dried that are operated above 10C (50F) must be emptied, cleaned and sanitized after each 6 hours or less. All whey and whey products for condensing and/or drying can be safely maintained at a temperature of 7C (45F) or less; or 57C (135F) or greater. Tanks used to hold whey and whey products between 7C (45F) and 57C (135F), must be emptied, cleaned and sanitized after each 4 hours or less. Except that, acid-type whey with a titratable acidity of 0.40% or above, or a pH of 4.6 or below, can be safely held at any temperature. Crystallization of condensed whey and whey products may be accomplished without the formation of toxins if the whey or whey products being crystallized are cooled to 10C (50F) or less; within 72 hours of condensing including the filling and emptying time, unless filling occurs above 57C (135F), in which case, the 72 hour time period begins when the cooling is started.

Other properly validated times and temperatures that have been recognized by FDA and that are approved by the State Regulatory Agency may also be considered to be safe. This guidance does not cover the hazards associated with the formation of C. botulinum toxin in milk products that are classified as shelf-stable acidified foods or low acid canned foods.
Bad Bug Book U.S. Food & Drug Administration Center for Food Safety & Applied Nutrition Foodbourne Pathogenic Microorganisms And Natural Toxins Handbook

Factors Affecting the Growth of Some Foodbourne Pathogens

Organism

Salmonella spp. Clostridium botulium

A&B Nonproteolytic B E F

Growth Temperature (oC) 6.5 - 47 10 50 5-? 3.3 15 - 30 4-? 7 45 25 42

Growth pH 4.5 - ? 4.7 9 (b) (b) (b) 4.2 9.3 5.5 8

Growth aw > 0.95 (a) > 0.93 NR (c) > 0.965 NR (c) > 0.86 NR

Staphylococcus aureus Campylobacter jejuni

Yersinia enterocolitica Yersinia pseudotuberculosis Listeria monocytogenes Vibrio cholerae O1 Vibrio cholerae non-O1 Vibrio parahaemolyticus Clostridium perfringens Bacillus cereus Escherichia coli Shigella spp. Streptococcus pyogenes

1 5 0 8

44 43 45 42

4.4 9 (b) 4.4 9.4 6 9.6

(b)

NR NR > 0.92 (d) > 0.95

(b)

(b)

12.8 40 10 52 10 49 2.5 45 > 8 - < 45 >10 - < 45

5 9.6 5.5 8 4.9 9.3 4.6 9.5 ? 9 11 4.8 - < 9.2

> 0.94 > 0.93 > 0.95 > 0.935 NR NR

(a) For a genus as large as Salmonella, the aw lower limit for species growth may vary, e.g., S. Newport = 0.941, S. typhimurium = 0.945. (b) The value, though unreported, is probably close to other species of the genus. (c) NR denotes that no reported value could be found, but for most vegetative cells, an aw of > 0.95 would be expected. (d) Updated values from the 1996 ICMSF Microorganisms in Foods 5: Characteristics of Microbiological Pathogens. Most values taken from Microbial Survival in the Environment, E. Mitscherlich and E.H. Marth (eds.), Springer-Verlag, Berlin and Heidelberg, 1984. This is a valuable, recommended reference. [ISBN 3540-13726-2 Springer-Verlag, Berlin, New York, Tokyo] [ISBN 0-387-13726-2 Springer-Verlag, Heidelberg, Berlin, Tokyo].

b. Viruses Contamination of food by viruses, if it occurs, is most likely to be caused by contaminated water or an ill individual.2 Contamination of milk by viruses is not likely to occur in a processing facility that controls employee health and hygiene conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces under its Prerequisite Programs (PPs). 2. Chemical Hazards a. Undeclared food allergens in dairy products due to cross-contact from shared processing equipment. Allergens, or proteins derived from allergenic foods, may be present in foods as the result of cross-contact during processing and handling. The term "cross-contact" describes the inadvertent introduction of an allergen into a product that would not intentionally contain that allergen as an ingredient. Eight major foods or food groups--milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans-- account for 90 percent of food allergies. In addition, some food ingredients can cause food sensitivities in certain individuals. Certain ingredients which cause food sensitivities, such as sulfites, Yellow #5 (21 CFR 74.1705), and aspartame (21 CFR 172.804), require special labeling statements to alert consumers to their presence. Cross-contact is generally the result of environmental exposure during processing or handling, which may occur when multiple foods are produced in the same facility or on the same processing line, through poor re-work management or ineffective cleaning. Cross-

contact of foods with allergens has been shown to lead to allergic reactions in consumers on numerous occasions (Gern et al., 1991; Jones et al., 1992; Yunginger et al., 1983). Most cross-contact can be avoided by controlling the production environment. Procedures to ensure that these ingredients of concern are properly identified on the label should be a part of the HACCP system. Dairy plants should implement label control as part of their allergen control program. This label control program includes verification that the label reflects the current formulation and the correct ingredient statement. Prerequisite Programs addressing product changeover(s), scheduling, and sanitation practices normally assist in managing products containing allergens or substances that cause food sensitivities.

The following references may prove useful in the area of allergen control. 1. This section of the FDA's Compliance Policy Guide Deals with Food Allergens
http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm

2. FDA Allergy Inspection Guide http://www.fda.gov/ora/inspect_ref/igs/Allergy_Inspection_Guide. htm 3. Food Allergen Labeling and Consumer Protection Act of 2004 http://www.cfsan.fda.gov/~dms/alrgact.html 4. IDFA, IDFAs Dairy HACCP Plant Manual 5. Deibel, Kurt, Tom Trautman, Tom DeBoom, William H. Sveum, George Dunaif, Virginia N. Scott, and Dane T. Bernard. 1997. A Comprehensive Approach to Reducing the Risk of Allergens in Food. Journal of Food Protection. Vol. 60, No. 4: 436-441.
While not within the scope of the NCIMS Dairy product safety HACCP system, it is necessary for milk plants that manufacture juice or other food products using common equipment for both milk or milk products and these other foods to take precautions to prevent contamination of these foods with milk allergens. b. Allergens and substances that cause food sensitivities added to dairy products as ingredients. Allergens are not present in all products. Scheduling product changeovers and run matrices, labeling, and sanitation practices are suggested prerequisite programs used to manage products containing allergens. Some products (e.g., flavored bottled waters, cultured products of dairy-based beverages with juice) can contain ingredients such as soy protein or preservatives, such as sulfites, that can cause allergic or food intolerance reactions in sensitive individuals. The presence of any ingredient must be declared on the label in accordance with the food labeling regulations in 21 CFR Part

101. Programs to ensure that the proper labels are used should be part of the PP within the HACCP Program. Ingredient controls should be implemented for the big eight allergens and ingredients which cause food sensitivities. c. Cleaning and Sanitizing Chemical Residues Cleaning chemical and sanitizers are used widely in dairy plants. The proper use of cleaning and sanitizing compounds renders the risk of contamination a hazard not likely to occur when managed by a properly implemented prerequisite program. Numerous U.S. government regulatory programs address aspects of cleaning and / or sanitizer usage. Cleaning and sanitizing chemicals should be used in accordance with the manufacturers instructions and recommendations. These chemicals must be used at proper concentrations for effective use and in the case of sanitizers for their no-rinse properties. Proper cautions must be taken to fully drain all processing equipment of cleaners and sanitizers prior to use. During processing, pipelines and equipment used to contain or conduct milk products shall be effectively separated from tanks or circuits containing cleaning and / or sanitizing solutions. Proper guidelines for proper chemical and product separation can be found in the PMO section 15p (B). d. Agricultural Chemical Residues (Chemicals used in animal and health and crop production). Pesticides are used widely to treat (e.g., for insect control) fruits, vegetables, grains and other foods, and may be present in small amounts as residues on these foods. Numerous U.S. government regulatory programs address aspects of pesticide usage. Experience in the U.S. has demonstrated that domestically grown fruits and vegetables have a high level of compliance with U.S. pesticide tolerance regulations and that the occurrence of unlawful pesticide residues in food is likely to be infrequent and unlikely to have a severe public health impact. Based on current regulatory programs and FDA market basket surveys, pesticide residues do not present food hazard likely to occur in dairy products and do not need to be addressed in the hazard analysis. Animal drug residues are present at low levels in a very low percentage of raw milk received at milk plants in the U.S. These residues are regulated under PMO Appendix N for both the traditional and the HACCP alternative systems. Information in recent National Milk Drug Residue Database Reports showed that less than one-tenth of 1 percent of milk samples from bulk milk pick-up tankers (the form in which raw milk is received at milk plants) tested positive for drug residues last year. The report contains data on samples and tests conducted during fiscal year 2003 (October 1, 2002 September 30, 2003). During this period,

4,382,974 total samples were analyzed for drug resides. Samples included bulk milk pickup tankers (78 percent, or 3,571,834 samples), producer milk (18 percent), pasteurized products (2 percent), and other (2 percent). Fifty-three methods were used to analyze these samples for residues. The most recent National Drug Residue data base should be consulted to obtain the latest information on drug residues in milk. e. Over Fortification of Pasteurized Fluid Milk with Vitamin A and D. Jacobus et al3 reported that Vitamin D has been added to milk in the United States since the 1930s. In an article published in the New England Journal of Medicine, Holick3 discusses vitamin D intoxication caused by drinking milk fortified with excess vitamin D over an extended period of time that led to questions about the level of vitamin D in milk. Jacobus3 also reported an analysis of the amount of vitamin D, in milk from a dairy implicated in an intoxication that revealed concentrations that ranged from undetectable to as high as 232,565 IU per quart. Vitamin A can also be toxic if consumed at extremely high levels (see PMO Appendix O). f. Mycotoxins In many parts of the country mycotoxins are not normally a potential hazard. However in those milk plants that receive milk from an area that has a history of aflatoxin contaminated feed or if weather conditions are appropriate for mycotoxin growth, it should be considered. 3. Physical Hazards Foreign material includes such things as metal, glass, or plastic fragments or any other material that might cause injury or present a choking hazard. Consideration of potential hazards associated with metal fragments should be a part of the hazard analysis when metal fatigue, wear of metal parts, or metal to metal contact can occur in processing equipment. See FDA compliance policy guide chapter 5 sub 555 section 555.425 (Adulteration involving hard or sharp objects March 1999)

VI. The HACCP Hazard Decision Process

a. Evaluate All Potential Hazards Evaluate each of the potential hazards (from Step 1) by assessing the likelihood of occurrence and the severity of health consequences associated with the potential hazard. For instance: Although potential hazards that may be introduced into food through pests in your facility may be of low to moderate severity, they are unlikely to occur if

your facility carries out an effective pest control program as part of its required PPs. b. Determine If Potential Hazards Will Require Controls in Your HACCP Plan c. Potential Hazards Reasonably Likely to Occur If a potential hazard has a severe, acute public health impact, that hazard is reasonably likely to occur, even at an extremely low frequency of occurrence, and thus should be identified as a hazard that is reasonably likely to occur (e.g., pathogenic microorganisms or injury caused by ingestion of metal fragments). Milk containing enteric microbial pathogens such as E. coli O157:H7 and various Salmonella species have caused serious food borne illness outbreaks. Those hazards which are determined to be reasonably likely to occur in the hazard analysis must be controlled by a CCP. d. Potential Hazards Not Reasonably Likely to Occur The determination that a potential hazard is not reasonably likely to occur is made in the hazard analysis and takes into account existing PPs, GMPs, etc. This determination is based on the unique conditions at the plant making the hazard analysis. If conditions in the plant change, the hazard needs to be reevaluated. If the hazard analysis is performed correctly, based on the individual conditions at the milk plant and if the HACCP system is validated at least once each year as required, these types of determinations will be more likely to be sustained during regulatory and listing audits of the plants HACCP system. e. Hazards Related to Facility Sanitation When the hazard analysis identifies hazards classified as hazards not reasonably likely to occur, they should be managed by the PPs or GMPs. HACCP may be implemented only in a facility that is constructed and operated to provide a sanitary environment. Milk plant premises, building construction, maintenance and housekeeping shall be maintained in a manner sufficient to provide such an environment. These factors shall be controlled by effective plant, receiving station or transfer station programs or by PPs, as plant, receiving station or transfer station chooses. f. Controls for Potential Hazards Arising from Food Contact Surfaces Hazards can occur in milk due to unsanitary food contact surfaces that can contaminate milk with pathogens or with residual allergens from product processed on the equipment in prior runs that can cause allergic reactions in sensitive individuals. Hazards that arise from unsanitary food contact surfaces have the potential to affect the safety of a milk product because they arise from points within the process and not from general conditions within the facility. Control of these hazards may be accomplished by the use of Prerequisite Programs. For example, an appropriate PP could be to

establish a procedure for cleaning equipment with a cleaning solution, e.g., a pre-rinse followed by a caustic wash followed by a rinse. The procedure could include maintaining a log of which foods, e.g., juice, eggnog, soy drinks, were processed on the equipment, the sequence in which the foods were processed, and how/when the equipment was cleaned. The operator could check that log prior to starting any production run for milk. The procedure could provide that the equipment would not be used for milk until the prescribed cleaning procedure was carried out, recorded in the log, and the equipment was visually checked for cleanliness. g. Identify Control Measures and CCPs. h. HACCP Control Measures Under the voluntary HACCP alternative, you are required to implement HACCP control measures if you determine in your hazard analysis that a food hazard is reasonably likely to occur in your dairy product. Examples of HACCP control measures used in the processing of dairy products include measures carried out at CCPs specified in a HACCP plan such as pasteurization of dairy products for the elimination or reduce to an acceptable level of micobiological pathogens. 1. Control Measures for Biological Hazards The pasteurization of milk is the most effective single control measure for protecting consumers from pathogenic microorganisms. Therefore, the pasteurization process is a required control measure for pathogens. 2. Control Measures for Chemical Hazards When a chemical hazard is identified that is reasonably likely to occur in milk, a control measure needs to be established in the HACCP plan for that hazard. Chemical hazards that are most commonly identified in the hazard analysis include equipment cleaning and sanitizing chemicals, animal drug residues and over addition of food grade vitamins. The likelihood of occurrence of each of these hazards will vary according to the plant and its procedures. If control measures are warranted for any of these hazards they are addressed below. a. Equipment Cleaning and sanitizing chemicals Control of his hazard, if deemed reasonably likely to occur must address establishing CCPs at all product storage tanks, all processing equipment that is not self-draining, and at each CIP system. In the case of product storage tanks and non-draining processing equipment, the critical limit will be presence of no cleaning or sanitizing chemicals prior to use. The monitoring record for this CCP can be manual check logs, electronic sensor logs, etc. For each CIP system, the critical limits will be the measurements used for controlling cleaning and sanitizing chemical concentration. The monitoring record will usually be a graph or computer-generated CIP monitoring document. b. Animal drug residues This chemical hazard, if deemed reasonably likely to occur, will be controlled through a CCP

c.

at raw milk receiving with the critical limit being the no detectable animal drug residue present in the raw milk. The monitoring record for this CCP will be the animal drug residue testing record maintained by the on-site industry laboratory. Food-grade vitamins This chemical hazard, if deemed reasonably likely to occur will be controlled by a CCP at the point of injection or addition into the milk stream. The critical limit will be the FDA-established levels of vitamin A and D for fluid drinking milk and possible the actual measurement of the vitamin addition via pump speed or volume per batch. Monitoring will be based on manual logs capturing the actual measurements of vitamin addition (pump speed recorded at least daily, volume of addition per batch, etc.), as well as the theoretical versus actual vitamin reconciliation records required by the PMO.

3. Control Measures for Physical Hazards The necessity for control measures for any potential physical hazard is dependent upon a conclusion from the hazard analysis that the specific hazard is reasonably likely to occur in the milk product. FDA has issued a Compliance Policy Guide (CPG Section 555.425) describing when hard or sharp foreign objects in food, such as glass or metal fragments, could pose a health hazard. If it is reasonably likely that the milk product may become contaminated with hard or sharp foreign objects that meet the criteria in this CPG, you should regard the object as a potential hazard in the milk. i. Other Interventions The hazard analysis may identify hazards that can be eliminated or reduced to hazards not likely to occur if adequate changes are made in the plant facility or its environment, by equipment replacement or modifications, or adjustments to operating procedures. Engineering the hazard out of the process is usually the best alternative to eliminate or reduce the likelihood of occurrence.

VII. HACCP Decision Trees

CCP decision trees have been developed to assist HACCP developers in determining CCPs in the facilities process. Three example CCP decision trees are in the following pages of this hazard guide. Two decision trees are prepared by the NACMCF and the third has been developed by IDFA. The HACCP team may use decision trees to evaluate each hazard to determine if each hazard can be prevented, eliminated or reduced to an acceptable level. A common problem with using existing HACCP decision trees is trying to apply the questions prior to completion of the hazard analysis. Decision trees sometimes also show results which common sense says is incorrect. Thus, decision trees should be used with caution.

Decision trees are only tools that can be used to assist in determining CCPs. Milk plants are not required to use them to determine CCPs. Many HACCP teams determine CCPs based on the knowledge and experience of their process and existing plant control measures.

NACMCF CCP Decision Tree #1

Do preventive measures exist at this step or subsequent steps for the identified hazard?

Yes

No

Modify step, process or product

Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level?

Yes

Is control at this step necessary for safety? No

Could contamination with identified hazards occur in excess of acceptable levels or could these increase to unacceptable levels? Yes Yes No No

Will a subsequent step eliminate identified hazards or reduce the likely occurrence to an acceptable level?

No

CRITICAL CONTROL POINT

STOP NOT A CRITICAL CONTROL POINT

NACMCF CCP Decision Tree #2

Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control?

Yes

No

Does a control measure for the hazard exist at this step?

Modify the step, process or product

Yes

No

Yes

Is control at this step necessary for safety?

No

Is control at this step necessary to prevent, eliminate or reduce the risk of the hazard to consumers?

Yes

CRITICAL CONTROL POINT

STOP NOT A CRITICAL CONTROL POINT

IDFA CCP Decision Tree #3 Q1. Is the hazard identified at this step of sufficient likelihood of occurrence to warrant its control? Q3. Does the control measure for the hazard exist at this step?

Not a CCP

Q2. Identify the Prerequisite Program or procedure that manages the hazard to ensure that control at this step is not necessary.

Is control at this step necessary?

Modify this step, process, or product to eliminate this hazard or provide a control measure, then revisit the hazard analysis

Proceed to the step where a control measure exists for this hazard and begin at Q4.

Q4. Does this step prevent, reduce or eliminate the likely occurrence of the hazard to an acceptable level?

CCP

Q5. Could contamination with the identified hazard occur in excess of the safe or acceptable level or could it increase to an unacceptable level?

Q6. Will a subsequent step eliminate the identified hazard or reduce its likely occurrence to a safe level?

This step is not a CCP

Subsequent step is the CCP.

CCP (Control at this step is necessary to prevent or

reduce the risk of a hazard but may not eliminate it )

VII.

Control Measures
A. HACCP Control Measures Under the voluntary HACCP alternative, you are not required to implement control measures if you determine in your hazard analysis that a food hazard is not reasonably likely to occur in your dairy product. Examples of HACCP control measures used in the processing of dairy products include measures carried out at CCPs specified in a HACCP plan such as pasteurization of dairy products for the elimination or reduction to an acceptable level of microbiological pathogens. B. Activities Not Considered to be HACCP Control Measures 1. Other Regulatory Requirements that are not a part of the NCIMS HACCP System a. b. c. d. e. f. g. h. Raw Milk Supply Source; Labeling Compliance; Adulteration; Licensing Requirements; Drug Residue and Trace Back Requirements; Regulatory Samples in Compliance; Approved Laboratory Utilized for the Regulatory Tests; and Pasteurization Equipment Design and Installation

2. GMPs (note building and facilities) Some activities that firms may undertake in processing milk and milk products and in related functions are not HACCP control measures. These include Good Agricultural Practices (GAPs) and Current Good Manufacturing Practices (cGMP). 3. GAPs GAPs are measures voluntarily undertaken by these parties which are not HACCP controls. However, if a hazard originating from the agricultural environment is determined to be reasonably likely to occur in your incoming dairy products, it must be identified in your hazard analysis and controlled through your HACCP plan. If control of such a hazard involves actions that will be carried out by your supplier, your control measure could be based upon a supplier guarantee to this effect implemented as part of your HACCP plan. However, we encourage you to work with your suppliers to evaluate and modify agricultural practices in accordance with FDAs GAPs guidance document.

4. CGMPs
As noted above, dairy processors are still required to comply with the CGMPs requirements of 21 CFR Part 110. One common misconception about HACCP is that some hazards that are reasonably likely to occur can be controlled under a firms CGMP programs under 21 CFR Part 110. Because programs to comply

with 21 CFR Part 110 are general in nature and are not designed to control specific hazards, they are not HACCP control measures. Therefore, you cannot use CGMP programs to control a specific hazard that you have concluded is reasonably likely to occur in your hazard analysis. You must use HACCP controls for any such hazard.

VIII.

Preparing for HACCP

A. Getting People Ready Successful implementation of HACCP requires trained people who cooperate from the preliminary stages to the implementation and ongoing operation of the HACCP system. We strongly recommend that you begin with Step 1 of NACMCFs 5 preliminary steps of HACCP, by assembling a HACCP team that includes plant level and corporate level personnel. B. HACCP Training and HACCP Resource Materials 1. Dairy Foods HACCP Core Curriculum Training 2. USDA / FDA HACCP Training Programs and Resources Database

IX. HAZARDS AND CONTROL GUIDE

These tables may be used by the milk plant HACCP team as a guide to the identification of potential hazards that may be associated with the incoming raw materials (Table 1) and the processing steps (Table 2) used by a typical dairy processing plant. This guide may, or may not, be relevant to the conditions found at a specific milk plant. Each milk plant HACCP team must determine, for itself, the relevance of the potential hazards identified in the tables or other potential hazards, identified independently by the milk plant HACCP Team or by experts the HACCP Team may employ when developing its HACCP system.

The Ingredient or Process column presents typical steps used in milk processing. It is not intended to be complete or accurate for any specific milk plant or to serve as a template for describing process steps in specific milk plants. The Potential Hazard column identifies some hazards that might be expected at various processing steps. Additional hazards may exist in individual circumstances and MUST be identified and considered in the hazard analysis. The Hazard Rationale column provides the reasons why each hazard was listed in the Hazard Identity column for a particular processing step. The Hazard Management Controls column provides examples used to illustrate the accepted level of public health protection that is likely to be found acceptable for regulatory licensing and IMS listing. Any measure that can be demonstrated to provide a similar level of public health protection, but is not listed in this Guide, is also acceptable, as long as it meets the requirements of the NCIMS Dairy HACCP Program and is consistent with relevant state and federal laws or regulations.

The Additional Resources column provides references to the following sources of information: Key to Abbreviations and References Used in Tables 1 and 2
1. 2. 3. 4. Pasteurized Milk Ordinance (PMO) U. S. Code of Federal Regulations (CFR) Interpretive Memoranda published by the FDA IMS List, M-a, M-b, and M-I memoranda IMS List Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (www.cfsan.fda.gov/~ear/ims-toc.html) 5. FDA Compliance Policy Guides (CPG) 6. 3-A Sanitary Standards (3-A SS) and 3-A Accepted Practices (3-A AP) 7. Dairy Practices Council (DPC) Guidelines. References are to specific guideline identification numbers, DPC 8. 8. Good Agricultural Practices (GAPs) 9. Current Good Manufacturing Practices (cGMPs) 10. National Drug Residue Database (NMDRD) Report

TABLE 1 - MILK PLANT RAW MATERIALS

HAZARD RATIONALE HAZARD MANAGEMENT OR CONTROLS B-1: Minimize the incoming bacterial load by purchasing Grade A IMS listed raw milk and testing incoming product. Verify that tank trucks were cleaned and sanitized prior to picking up the milk being unloaded (wash tags or in the case of trucks that only deliver to one plant, plant cleaning records) and that milk has been maintained at the proper temperature. ADDITIONAL RESOURCES PMO Sec 4 PMO Item 12p IMS List PMO Item 17p DPC 25 DPC 50 B-1: Scientific studies have shown that a wide range of pathogens (organisms which can cause illness in humans) can be present in unpasteurized milk. 4, 5

INGREDIENT OR PROCESS Raw Milk

POTENTIAL HAZARD Biological B-1: Presence of vegetative Pathogens

Chemical C-1: Presence of Therapeutic Drugs C-1: This hazard must be addressed based on Other NCIMS Requirements.

M-a-75 M-a-86 PMO Appendix N DPC 22

C-2: Presence of Mycotoxins

C-2: Mold growth in animal feed can contaminate milk with aflatoxin M1.

C-1: At a minimum, screen all tankers for animal drug residues as required by Appendix N or other regulatory mandates. In addition, plants are encouraged to screen for other residues as indicated by available information. C-2: Aflatoxin has been shown to be present in raw milk dependent on geographic locations, growing season conditions and past history. Other management controls may include supplier guarantees and COAs. P-1: Not to be included in the hazard analysis if purchasing milk from Grade A IMS listed sources to minimize the contamination.

Physical P-1: Extraneous Material

P-1: If dairy cattle are not kept clean or if milk is drawn in an unclean environment and is not properly protected, physical objects from the farm environment may become incorporated into the milk.

Pasteurized

Biological -

TABLE 1 - MILK PLANT RAW MATERIALS

HAZARD RATIONALE B-1: Heat-treated milk products may not have been heated sufficiently to deactivate these organisms. B-2: Bulk shipped pasteurized milk products may have been subject to recontamination during transit. ADDITIONAL RESOURCES IMS List PMO Sec 7 PMO Items 12p, 17p, & 21p 3-A SS 605 HAZARD MANAGEMENT OR CONTROLS B-1: Heat-treated milk or cream should be treated as raw milk and come from approved sources. B-1: Verify that tank trucks were cleaned and sanitized prior to picking up the milk being unloaded (wash tags or in the case of trucks that only deliver to one plant, plant cleaning records) and that milk has been maintained at the proper temperature.

INGREDIENT OR PROCESS milk, heat treated milk or cream, and condensed skim milk

POTENTIAL HAZARD B-1: Presence of vegetative Pathogens B-2: Contamination by vegetative pathogens

Other Ingredients / Packaging Materials B-1: Pathogens may be present in ingredients.6, 7, 8 C-1: Adulteration with toxic or carcinogenic chemicals has been documented.9, 10, 11

B-1: Supplier certificates of analysis.

21 CFR 110.80(a)

C-1: IMS Listed packaging suppliers. Supplier letter of guarantee.

21 CFR 110.80(a) 21CFR 176.260 21CFR 178.010 P-1: Supplier letter of guarantee. 21 CFR 110.80(a) CPG 555.425

Chemical None Physical None Biological B-1: Presence of vegetative Pathogens Chemical C-1: Presence of toxic or carcinogenic substances Physical P-1: Extraneous Material P-1: Free of foreign materials which constitute food safety hazards.7, 12

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE HAZARD MANAGEMENT OR CONTROLS B-1: Truck unloading are should be constructed to protect the milk (at a minimum overhead protection and concrete, or equivalent surface under the truck that is properly drained). Maintain the truck unloading area and equipment clean. Protect the milk that is being unloaded by closing in the unloading area or using filters over the vent /personnel access port area. Using equipment meeting sanitary design guidelines. C-1: Maintain proper separation or a physical break between circuits containing cleaning solutions and vessels and lines used to contain or conduct product. P-1: Use a filter, screen or other appropriate device at some point in the system. ADDITIONAL RESOURCES DPC 8 PMO Item 5p(4) & 15p(A)(3) 3-A SS 02-, 11-, 28-,29-,53-, 58-, 59-, 62-, 63-, 74B-1: The truck unloading area has the potential to contaminate liquid milk products. These products are normally transmitted through equipment that if unclean, (or uncleanable) can result in bacterial contamination.

INGREDIENT OR PROCESS Receiving Materials shipped by bulk tanker, e.g. fluid milk and milk products

POTENTIAL HAZARD Biological B-1: Contamination with vegetative pathogens

Chemical C-1: Cleaning & Sanitizing Residues C-1: Without proper separation between cleaning & sanitizing solutions and product there could be contamination of the product.9

PMO Item 15p(B)(1) 3-A AP 605 21CFR178.1010(a)

Physical P-1: Extraneous Materials

P-1: Free of foreign material which constitute food safety hazards.7, 12

3-A SS 10- & 42PMO Item 11p(8)

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE P-2: Equipment in poor repair or improperly assembled may contaminate product with foreign material. HAZARD MANAGEMENT OR CONTROLS P-2: An effective preventive maintenance program and routine (daily) inspection of equipment for wear or missing parts. Use of a filter, screen or other appropriate device at some point in the system. B-1: Inspect product during unloading operations for damage. ADDITIONAL RESOURCES PMO Item 11p 3-A SS 10- & 42-

INGREDIENT OR PROCESS

Receiving Materials shipped by common carrier, e.g. dry ingredients, flavors and packaging materials. B-1: Product may become contaminated if product containers are damaged during shipment. C-1: Delivery trucks may have been used to transport toxic chemicals prior to food products or packaging materials.9

DPC 8 21CFR 110.80(a)(2)

POTENTIAL HAZARD P-2: Metal shavings, gasket material & other foreign material from receiving equipment Biological B-1: Contamination with vegetative pathogens Chemical C-1: Toxic Chemicals C-1: Inspect vehicles prior to unloading for evidence of unsanitary conditions, spilled chemicals, off odors, of evidence that might indicate the delivered product may have been contaminated. P-1: Inspect vehicles prior to unloading for evidence of foreign materials that may have contaminated the product. DPC 8

Physical P-1: Extraneous Materials

P-1: Vehicles may have not been maintained in good repair or have been used to carry metal or wood articles.12

DPC 8

Raw Milk

Biological

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE B-1: These products are normally stored in vessels that, if unclean (or uncleanable), can result in bacterial contamination. 9, 11 ADDITIONAL RESOURCES PMO Item 12p 3-A SS 22- & 633-A AP 60521CFR 110.35(d) PMO Item 15p(A)(3)

INGREDIENT OR PROCESS Storage

POTENTIAL HAZARD B-1: Contamination with vegetative pathogens

B-2 : Growth of vegetative pathogens

B-2: Without proper temperature and time controls, vegetative pathogens can multiply to levels that may be capable of overwhelming the pasteurization process with out proper temperature and time controls.9, 11

HAZARD MANAGEMENT OR CONTROLS B-1: Verify that storage vessels and associated lines and valves similar appurtenances are constructed in such a way that they can be cleaned. Maintain records storage vessels are cleaned after each use. Maintain records that the associated lines, valves and similar appurtenances are cleaned as needed but at least each day used. Pipeline openings (e.g., flow control panels) and outlet valves are capped when not in use, other openings are closed with tight fitting covers. Associated pipelines and similar appurtenances are similarly protected. B-2: Maintain the temperature sufficiently low to minimize the growth of pathogens. Clean the storage vessels and associated lines and valves similar appurtenances at frequencies that do not allow for bacterial growth of pathogens in the product at the product temperature used. Note: If times or temperatures less stringent than specified in the PMO are used, they must be reviewed and found acceptable to the State and FDA.

PMO Item 17p PMO Item 12p 21CFR 110.35(d) PMO Item 12p

Chemical

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9 HAZARD MANAGEMENT OR CONTROLS C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. ADDITIONAL RESOURCES PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

INGREDIENT OR PROCESS

Storage, Blending & Addition of Ingredients B-1: Pathogens can be present in the environment in the dry blending area. Product is usually exposed during blending. Ingredients may become contaminated by equipment that is unclean or uncleanable.9

POTENTIAL HAZARD C-1: Cleaning & Sanitizing Solution Residues Physical None Biological B-1: Contamination with vegetative pathogens B-1: Verify that blending equipment and associated lines and valves similar appurtenances are constructed in such a way that they can be cleaned. Maintain records that they are cleaned as needed but at least each day used. Maintain the addition / blending environment clean and relatively free of dust or soil that could contaminate product during addition / blending. Equipment used for addition / blending is constructed to minimize product or ingredient exposure. C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product.

DPC 8 3-A SS 32-, 63-, & 7321CFR 110.35(d) 3-A AP 605PMO Item 9p(3) & 9p(4)

Chemical C-1: Cleaning & Sanitizing Solution Residues

C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9

PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-2: Foods which contain undeclared allergens may cause life threatening reactions in sensitive individuals. HAZARD MANAGEMENT OR CONTROLS C-2: Documented PPs or other effective practices and programs must be in place and monitored in such a way that will assure allergen containing ingredients (other than milk and milk products) are used only in Grade A milk and milk products that are properly labeled as containing those allergens in the ingredients. These documented and monitored programs need, at a minimum to include requirements and procedures to assure: Separation and identification of such allergens during storage. Addition only of those products that are properly labeled must be monitored and documented. Equipment that is used for storage, blending or addition of both ingredients that do not, must be thoroughly cleaned after the equipment has been used for allergen containing ingredients for foods which do not declare that allergen. If plant programs other than PPs or CCPs are used, those records needed to ensure allergens are adequately addressed at this step must be part of the overall HACCP system in such a way that those records are available for regulatory review. ADDITIONAL RESOURCES FDA CPG 555.250

INGREDIENT OR PROCESS

POTENTIAL HAZARD C-2: Allergens being mixed with products that are not labeled as containing allergens

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE HAZARD MANAGEMENT OR CONTROLS P-1: Opening of ingredients is conducted in a manner that will minimize the opportunity for bits of packaging, cutting tools, etc. from entering the product. Verification that, at some point in the process ingredient or the milk product to which the ingredient is added, will pass through a filter, screen, small orifice (such as occurs during homogenization or other appropriate device. B-1: Verify that the separation equipment and associated lines and valves and similar appurtenances are constructed in such a way that they can be cleaned. Maintain records that the equipment is cleaned after each day used. ADDITIONAL RESOURCES DPC 8 3-A SS 10- & 42PMO Item 9p(3) & 9p(4) P-1: Inadvertent addition of packaging material and other objects which are present in the blending area.

INGREDIENT OR PROCESS

POTENTIAL HAZARD Physical P-1: Extraneous Materials

Separation

Biological B-1: Contamination with vegetative pathogens B-1: If this equipment is unclean or uncleanable, it can contaminate products that pass through it.12

DPC 8 3-A AP 60521CFR 178.1010(a)

Skim and / or

Chemical None Physical None Biological

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE B-1: Vegetative pathogens can multiply to levels that may be capable of overwhelming a pasteurization process.11 HAZARD MANAGEMENT OR CONTROLS B-1: Maintain the temperature sufficiently low to minimize the growth of pathogens. Clean the storage vessels and associated lines and valves and similar appurtenances at frequencies that do not allow for bacterial growth of pathogens in the product at the product temperature used. Note: If times or temperatures less stringent than specified in the PMO are to be used, they must be reviewed and found acceptable to the State and FDA. C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. ADDITIONAL RESOURCES 3-A AP 6053-A SS 22- & 63-

INGREDIENT OR PROCESS Cream Cooling and Storage

POTENTIAL HAZARD B-1: Cold separated or heat treated skim or cream can have vegetative pathogens

C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9

PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

Pasteurization

Chemical C-1: Cleaning & Sanitizing Solution Residues Physical None Biological

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE B-1: Minimum pasteurization times and temperatures have been well documented and are required for the elimination of pathogens normally present in unpasteurized milk. 9, 11, 13, 14 ADDITIONAL RESOURCES PMO Items 12p, 15p(B), 16p and Appendices H & I 3-A AP 6033-A AP 605-

INGREDIENT OR PROCESS

POTENTIAL HAZARD B-1: Survival of vegetative pathogens

B-2: Contamination with vegetative pathogens

B-2: Pasteurizer regenerator sections have been documented to occasionally leak. Raw and pasteurized milk are on opposite sides of a metal barrier (plate or tubular) in these regenerator sections. 11

HAZARD MANAGEMENT OR CONTROLS B-1: Under NCIMS Dairy HACCP program, pasteurization and the design, construction and operation and testing of pasteurization equipment must conform to all of the requirements of the Grade A Pasteurized Milk Ordinance. Note: If cleaning frequencies are to be performed at frequencies less than those specified in PMO Item 12p, the cleaning frequencies are to be reviewed and found acceptable to the State and FDA. B-2: Under NCIMS Dairy HACCP program, pasteurization and the design, construction and operation and testing of pasteurization equipment must conform to all of the requirements of the Grade A Pasteurized Milk Ordinance.

PMO Item 16p 3-A AP 6033-A AP 605-

Chemical

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9 ADDITIONAL RESOURCES PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

INGREDIENT OR PROCESS

POTENTIAL HAZARD C-1: Cleaning & Sanitizing Solution Residues

C-2: Allergens being mixed with products that are not labeled as containing allergens C-2: Foods which contain undeclared allergens may cause life threatening reactions in sensitive individuals. C-3: Some boiler water compounds used in the production of steam to be used in contact with food or food contact surfaces may contain toxic substances.

3-A 6033-A 605FDA CPG 555.250

C-3: Boiler Additives

HAZARD MANAGEMENT OR CONTROLS C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. Particular attention is needed to assure that the required separation remains in place during partial washes, sometimes called short washes or interwashes that may be done during an operating day. C-2: Pasteurization equipment and associated piping and valves that are used for both Grade "A" milk and milk products foods that do not, must be thoroughly cleaned after use for allergen containing foods before it is used for foods that do not declare that allergen. C-3: If indicated by the hazard analysis, boiler water additives may be managed by PP #1 Safety of Water. Compliance to 21CFR 173.310 may be verified by a letter of guarantee from the chemical supplier.

21CFR 173.310

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-4: Some cooling water / media additives that may come in contact with food or food contact surfaces may contain toxic substances. HAZARD MANAGEMENT OR CONTROLS C-4: Cooling water additives that are nontoxic under the condition of use should be used and their safety verified by a letter of guarantee form the chemical supplier. ADDITIONAL RESOURCES

INGREDIENT OR PROCESS

POTENTIAL HAZARD C-4: Cooling water / Media Additives

Pasteurized Milk & Milk Product Storage (Except dry products) B-1: Human illness outbreaks have been linked to post-pasteurization contamination of milk and milk products.11, 15, 16, 17

Physical None Biological B-1: Contamination with vegetative pathogens

B-1: Openings and outlet valves are capped when not in use, other openings are closed with tight fitting covers. Associated pipelines and similar appurtenances are similarly protected. Verify that storage vessels and associated lines and valves and similar appurtenances are constructed in such a way they can be cleaned. Maintain records storage vessels are cleaned after each use. Maintain records that associated lines and valves and similar appurtenances are cleaned as needed but at least each day used.

3-A AP 605 3-A SS 22- & 63-

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE B-2: Human illness outbreaks have been linked to post-pasteurization contamination of milk and milk products.11, 15, 16, 17 HAZARD MANAGEMENT OR CONTROLS B-2: Maintain the temperature sufficiently low to minimize the growth of pathogens. Clean the storage vessels and associated lines and valves and similar appurtenances at frequencies that do not allow for bacterial growth of pathogens in the product at the product temperature used. Note: If times or temperatures less stringent than specified in the PMO are to be used, they must be reviewed and found acceptable to the State and FDA. C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. ADDITIONAL RESOURCES 3-A AP 605

INGREDIENT OR PROCESS

POTENTIAL HAZARD B-2: Growth of Vegetative Pathogens

C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9

PMO Item 15p(B) 21CFR 178.1010(a)

Pasteurized Milk

Chemical C-1: Cleaning & Sanitizing Solution Residues Physical None Biological

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE B-1: Human illness outbreaks have been linked to post-pasteurization contamination of milk and milk products.9 HAZARD MANAGEMENT OR CONTROLS B-1: Packaging may come from an IMS listed source with associated letters of guarantee, or the milk plant may perform tests to verify the ongoing safety of the packaging. After receipt, single service containers and other single service items must be protected from recontamination. Filling equipment and appurtenances must be cleanable and inspectable and must be constructed and operated to protect the product being packaged from contamination. Acceptable criteria for such construction can be found from such sources as the PMO and 3A Sanitary Standards and Practices. ADDITIONAL RESOURCES IMS List 3-A SS 17- & 2321CFR 178.1010

INGREDIENT OR PROCESS and Milk Product Packaging (Except Dry Products)

POTENTIAL HAZARD B-1: Contamination with vegetative pathogens

C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9 C-2: Packaging material that does not meet CFR requirements may contain non-food grade substances.18

PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) CFR IMS List

Chemical C-1: Cleaning & Sanitizing Solution Residues C-2: Toxic or Carcinogenic substances in the packaging

C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. C-2: Packaging material or components comes from a sourced from suppliers to be free of certain toxic or carcinogenic substances. One way to do this is to use packaging from IMS listed sources

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-3: Foods that contain undeclared allergens may cause life threatening reactions in sensitive individuals. HAZARD MANAGEMENT OR CONTROLS C-3: Packaging machinery and associated piping and valves that are used for both Grade A milk and milk products foods that contain allergens (other than milk) and Grade A milk and milk products that do not, must be thoroughly cleaned after use for allergen containing foods before it is used for foods that do not declare that allergen. P-1: Maintain a glass free zone. ADDITIONAL RESOURCES FDA CPG 555.250

INGREDIENT OR PROCESS

POTENTIAL HAZARD C-3: Allergens being mixed with products that are not labeled as containing allergens

Physical P-1: Glass P-1: Glass fragments may be present in processors packaging in glass.

Packaged Milk Product Storage (Except Dry Products)

Biological B-1: Contamination with vegetative pathogens B-1: Condensate which drips on the pouring lip of the container may contaminate the pouring lip of the container with pathogens. B-2: Lack of temperature control in coolers may result in growth of pathogens if present in the product.19

B-1: Product needs to be stored away from areas where condensate could drip on the container. B-2: Thermometers need to be located in the warmest sections of product coolers and monitored to be sure that the coolers will hold product below the bacterial growth range. Temperature meets the NCIMS requirements.

B-2: Growth of Pathogens

Chemical None Physical

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE HAZARD MANAGEMENT OR CONTROLS ADDITIONAL RESOURCES

INGREDIENT OR PROCESS

Bulk Pasteurized Product Load Out (Except Dry Products) B-1: Pathogens have been found in bulk pasteurized product either from the load out process or from loading into tankers which have not been cleaned and sanitized.9, 11 B-1: Load out product fitting to fitting with the truck openings closed or otherwise adequately protected. Use and properly maintain a system of lies and valves for load out that is separate from that used to receive products for pasteurization or repasteurization. Tank trucks must not be used to haul contaminating substances such as unpasteurized liquid eggs without a through cleaning and a detailed inspection. Verify that the trucks were clean and sanitized prior to loading (wash tags or in the case of trucks that only deliver to one plant, plant cleaning records). C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product.

POTENTIAL HAZARD None Biological B-1: Contamination with vegetative pathogens

3-A AP 605PMO Section 4 3-A SS 02- & 62-

C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9

PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

Starter Media

Chemical C-1: Cleaning & Sanitizing Solution Residues Physical None Biological

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE B-1: Starter media and culture is added to product post-pasteurization. B-2: Dairy products are cultured under conditions conductive to the growth of pathogens. ADDITIONAL RESOURCES PMO Item 16p 3-A AP 6033-A SS 253-A SS 02-, 25-, & 383-A AP 6053-A AP 604-

INGREDIENT OR PROCESS Preparation, Starter Media Culturing and Product Culturing

POTENTIAL HAZARD B-1: Contamination with vegetative pathogens B-2: Growth of Pathogens

B-3 Development of Toxins

B-3: Dairy products are cultured under conditions that may allow toxin-producing bacteria to grow and produce toxins in the case of starter culture failure or partial failure.

HAZARD MANAGEMENT OR CONTROLS B-1, B-2: Starter media is pasteurized as required in the PMO prior to culturing and is protected during culturing of the media and during addition to the product to be cultured. Dairy products being cultured will be protected from contamination during set either by enclosing or covering the vats during set or by controlling environmental conditions around the vats during set. Some environmental controls would include, positive air pressure in the set room (the incoming air must be filtered or otherwise treated to prevent it from being a source of bacterial contamination). Pallets of packaging or other potential sources of contamination must not be present during set. Packaging or other operations that could be a source of contamination must be isolated from the vats being set. A separate room for setting open vats is preferred. B-3: The plant needs a procedure to handle Slow vats that will eliminate the possibility that cultured products containing toxins sold or distributed as food.

Chemical

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9 HAZARD MANAGEMENT OR CONTROLS C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. If curd wash water is treated with a disinfectant, the levels shall be controlled to prevent adulteration. P-1: Openings on the starter media and cultured products vessels and associated equipment are kept closed. All producthandling equipment is properly designed and maintained in good repair. ADDITIONAL RESOURCES PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

INGREDIENT OR PROCESS

POTENTIAL HAZARD C-1: Cleaning & Sanitizing Solution Residues

Physical P-1: Extraneous Material P-1: Market withdrawals and recalls have occurred for foreign materials in dairy products.12

3-A SS 24- & 25-

Milk or Milk Product Direct Set

Biological

C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9

C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. P-1: Openings on the starter media and cultured products vessels and associated equipment are kept closed.

PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

None Chemical C-1: Cleaning & Sanitizing Solution Residues Physical P-1: Extraneous Material P-1: Market withdrawals and recalls have occurred for foreign materials in dairy products.12

3-A SS 24- & 25-

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE HAZARD MANAGEMENT OR CONTROLS All producthandling equipment is properly designed and maintained in good repair. B-1: Ingredients to be added after pasteurization are verified / certified to be sterilized and hermetically sealed, incapable of supporting bacterial growth (salt and some alcohol based flavors, etc.) or otherwise rendered incapable of carrying pathogens into the product. Use of fresh fruit having a pH of 4.7 or less, or ingredients having a water activity of 0.85 or less, or a high acid content product or roasted nuts, or flavoring extracts having high alcohol content as part of a plant quality assurance programs to assure that these ingredients do not contaminate the dairy product. C-1: Supplier guarantees obtained for all post pasteurization added ingredients. ADDITIONAL RESOURCES

INGREDIENT OR PROCESS

POTENTIAL HAZARD

Ingredient / Flavoring other than dry Added Post Pasteurization B-1: Ingredient / flavorings are added post pasteurization.

Biological B-1: Contamination with vegetative pathogens

Chemical C-1: Contaminates in the Ingredient

C-1: Ingredients may contain unintended contaminates.

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-2: Foods that contain undeclared allergens may cause life threatening reactions in sensitive individuals. HAZARD MANAGEMENT OR CONTROLS C-2: Ingredient addition equipment such as hoppers and feeders and associated piping and valves that are used for milk and milk products that contain allergens (other than milk) and milk and milk products that do not , must be thoroughly cleaned after use for allergens before it is used for foods that do not declare that allergen. ADDITIONAL RESOURCES 3-A SS 02-, 32-, 35-, 51-, 52-, 63-, 68-, 73-, 81FDA CPG 555.250

INGREDIENT OR PROCESS

POTENTIAL HAZARD C-2: Allergens being mixed with products that are not labeled as containing allergens

Physical P-1: Extraneous Material P-1: Market withdrawals and recalls have occurred for foreign materials in dairy products.12

P-1: Openings on the starter media and cultured products vessels and associated equipment are kept closed. All producthandling equipment is properly designed and maintained in good repair. B-1: Verify that storage vessels and associated lines and valves and similar appurtenances are constructed in such a way they can be cleaned. Maintain records storage vessels are cleaned after each use. Maintain records that associated lines and valves and similar appurtenances are cleaned as needed but at least each day used.

3-A SS 24- & 25-

Whey Handling and Storage

Biological B-1: Contamination with vegetative pathogens

B-1: Pathogens may be introduced during whey handling and storage.

3-A SS 01-, 02-, 22-, 25-, 32-, 573-A AP 605-

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE B-2: Pathogens, if present, may grow during storage. HAZARD MANAGEMENT OR CONTROLS B-2: Condensed products (including foam and splash) are not held in bacteria growth range. Maintain the temperature sufficiently low to minimize the growth of pathogens. Clean the storage vessels and associated lines and valves and similar appurtenances at frequencies that do not allow for bacterial growth of pathogens in the product at the product temperature used. Note: If times or temperatures less stringent than specified in the PMO are to be used, they must be reviewed and found acceptable to the State and FDA. C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. ADDITIONAL RESOURCES

INGREDIENT OR PROCESS

POTENTIAL HAZARD B-2: Growth of Pathogens

C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9

PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

Milk and Whey Product Membrane Filtration

Chemical C-1: Cleaning & Sanitizing Solution Residues Physical None Biological B-1: Contamination with vegetative pathogens Chemical B-1: Pathogens may be introduced during membrane filtration.

B-1: Product balance bowl and other openings into the system must be kept tightly closed during processing.

3-A AP 610 3-A SS 26PMO Item 16p 3-A A 603

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9 HAZARD MANAGEMENT OR CONTROLS C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. ADDITIONAL RESOURCES PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

INGREDIENT OR PROCESS

POTENTIAL HAZARD C-1: Cleaning & Sanitizing Solution Residues Physical None

Milk and Whey Product Condensing B-1: Pathogens, if present, may grow during storage.10

Biological B-1: Growth of Pathogens

B-1: Product to be condensed must be pasteurized prior to entering the condenser. C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product.

3-A AP 607

C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9

PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

Whey Product Crystallization

B-1: Pathogens may be introduced during crystallization. B-2: Pathogens, if present, may grow during the crystallization process.

B-1: Openings into crystallization vessel are closed with tight fitting covers. B-2: The control limit is the maximum limit on the crystallization time.

Chemical C-1: Cleaning & Sanitizing Solution Residues Physical None Biological B-1: Contamination with vegetative pathogens B-2: Growth of Vegetative Pathogens Chemical

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9 HAZARD MANAGEMENT OR CONTROLS C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. ADDITIONAL RESOURCES PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

INGREDIENT OR PROCESS

Condensed Milk and Whey Product Storage B-1: Pathogens may be introduced during storage. B-2: Pathogens, if present, may grow during storage.

POTENTIAL HAZARD C-1: Cleaning & Sanitizing Solution Residues Physical None Biological B-1: Contamination by Pathogens B-1: Outlet valves and other openings into tanks are protected with tight fitting covers. B-2: Condensed product (including foam and splash) are not held in bacterial growth range. C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product.

B-2: Growth of Pathogens

C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9

PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

Milk and Whey Product - Drying

Chemical C-1: Cleaning & Sanitizing Solution Residues Physical None Biological B-1: Contamination by Pathogens B-1: Cracks and crevices in dryers have been found to contain Salmonella capable of surviving in dry environment. 12

B-1: Dryers need to be carefully inspected and any cracks, crevices or similar dead end areas repaired or the dryer removed from service.

3-A AP 607 & 608

Chemical

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE HAZARD MANAGEMENT OR CONTROLS ADDITIONAL RESOURCES

INGREDIENT OR PROCESS

POTENTIAL HAZARD None Physical P-1: Extraneous Material P-1: Market withdrawals and recalls have occurred for foreign materials in dairy products.12 P-1: Openings on the dryer and associated equipment are kept closed. All producthandling equipment is properly designed and maintained in good repair. Product should pass through screens to remove extraneous materials. B-1: Keep dry product storage areas, including overhead ledges and beams as well as electrical boxes and similar areas clean. Do not salvage damaged bags for human food. Bags, bulk containers & totes in storage areas are dust tight. Bulk powder storage must be of sanitary construction and cleanable.

3-A SS 24- & 25-

Packaged and Bulk Dry Milk and Whey Products Storage and Shipment B-1: Salmonella has been found in environmental testing in dry product storage areas. 9, 12

Biological B-1: Contamination with Pathogens such as Salmonella that can survive in dry environments and products

T14 3-A SS 34-

Aseptic Product

Chemical None Physical None Biological

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE B-1: Botulism toxin is one of the most toxic substances that can be found in food.15, 20,

INGREDIENT OR PROCESS - Processing

21

POTENTIAL HAZARD B-1: Contamination by pathogens, such as C.

botulinium

ADDITIONAL RESOURCES PMO Section 5 21 CFR 108 & 113 PMO Items 12p, 15p(B), 16p & Appendices H & I PMO Item 16p(D)

B-2: Survival of pathogens such as C.

21

B-2: Botulism toxin is one of the most toxic substances that can be found in food.15, 20,

21 CFR 108 & 113 PMO Item 16p(C)

botulinium

HAZARD MANAGEMENT OR CONTROLS B-1: Under the NCIMS Dairy HACCP program, aseptic processing and the design, construction and operation and testing of aseptic processing equipment must conform to all of the requirements of the Grade A Pasteurized Milk Ordinance, 21CFR 108 and 113, and the filed process for the products being produced. Note: If cleaning frequencies are to be performed at frequencies less than those specified in the PMO Item 12p, they are to be reviewed and found acceptable to the State and FDA. B-2: Under the NCIMS Dairy HACCP program, aseptic processing and the design, construction and operation and testing of aseptic processing equipment must conform to all of the requirements of the Grade A Pasteurized Milk Ordinance, 21CFR 108 and 113, and the filed process for the products being produced.

Chemical

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9 HAZARD MANAGEMENT OR CONTROLS C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. Particular attention is needed to assure that the required separation remains in place during partial washes, sometimes called short washes or interwashes that may be done during an operating day. ADDITIONAL RESOURCES PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a)

INGREDIENT OR PROCESS

POTENTIAL HAZARD C-1: Cleaning & Sanitizing Solution Residues

Aseptically Processed Product (bulk) Storage B-1: Pathogens, if present, can grow during storage.15, 20, 21

Physical None Biological B-1: Survival of pathogens such as C.

botulinium

B-1: Aseptic processing and the design, construction and operation and testing of aseptic processing equipment must conform to all of the requirements of the Grade A Pasteurized Milk Ordinance, 21CFR 108 and 113, and the filed process for the products being produced. Note: If cleaning frequencies are to be performed at frequencies less than those specified in the PMO Item 12p, they are to be reviewed and found acceptable to the State and FDA.

Chemical

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-1: Without proper separation between cleaning & sanitizing solutions and product there could be product contamination.9 C-2: Packaging material, which does not meet CFR requirements, may contain toxic or carcinogenic substances.18 ADDITIONAL RESOURCES PMO Item 15p(B) 3-A AP 605 21CFR 178.1010(a) IMS List 21CFR 110.80 HAZARD MANAGEMENT OR CONTROLS C-1: Maintain proper separation or physical break between circuits containing cleaning solution and vessels and lines used to contain product. C-2: Packaging material comes from a source that has been verified to be free of toxic or carcinogenic substances. One way to do this is to use packaging from IMS listed sources.

INGREDIENT OR PROCESS

POTENTIAL HAZARD C-1: Cleaning & Sanitizing Solution Residues C-2: Toxic or carcinogenic substances in the packaging

Product lines and Equipment (General Concerns) B-1: May introduce pathogens if unclean or uncleanable.

Physical None Biological B-1: Contamination by Vegetative Pathogens

B-1: Verify that product lines and equipment are constructed in such a way that they can be cleaned. Maintain records that storage vessels are cleaned after each use. Maintain records that the product lines and equipment cleaned as needed nut at least each day unless a longer interval has been reviewed and found acceptable to the State and FDA.

3-A AP 605PMO Item 10p, 11p, &12p

Chemical

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-1: Foods may contain undeclared allergens may cause life threatening reactions in sensitive individuals. HAZARD MANAGEMENT OR CONTROLS C-1: Ingredient addition equipment such as hoppers and feeders and associated piping and valves that are used for milk and milk products that contain allergens (other than milk) and milk and milk products that do not , must be thoroughly cleaned after use for allergens before it is used for foods that do not declare that allergen. ADDITIONAL RESOURCES 3-A SS 02-, 32-, 35-, 51-, 52-, 63-, 68-, 73-, 81FDA CPG 555.250

INGREDIENT OR PROCESS

POTENTIAL HAZARD C-1: Allergens being mixed with products that are not labeled as containing allergens

P-1: Maintain equipment in good repair.12

P-1: Foreign materials that may have contaminated the product. B-1: Properly implemented mandatory PP #1 - Safety of Water may reduce the likelihood of the occurrence of pathogens.

3-A SS 10- & 42-

Use of water reclaimed from condensing or membrane processing of milk or whey Products B-1: Water used in contact with product and product contact surfaces must be free of pathogens.

Physical P-1: Extraneous Materials Biological B-1: Contamination by & growth of pathogen

PMO Appendix D IV PMO Appendix K

Direct Addition of Steam

Chemical None Physical None Biological None Chemical

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE C-1: Some boiler water compounds used in the production of steam may contain toxic substances. HAZARD MANAGEMENT OR CONTROLS C-1: Supplier guarantees that boiler water additives comply with 21CFR 173.310 and PMO requirements for culinary steam. ADDITIONAL RESOURCES 3-A AP 609 PMO Appendix H(III) 21CFR 173.310

INGREDIENT OR PROCESS

POTENTIAL HAZARD C-1: Toxic Substances

Air Under Pressure (Incorporated into product or directed at a food contact surface.) B-1: Pathogens may be introduced in the air supply.

Physical None Biological B-1: Contamination by Pathogens

B-1: Air is drawn from a clean area, is filtered at the intake as needed, and is provided to the point of use oil free and with free of excess moisture. A final filter is provided as near as possible to the point of use to verify these aspects. C-1: Air is drawn from a clean area, is filtered at the intake as needed, and is provided to the point of use oil free and with free of excess moisture. A final filter is provided as near as possible to the point of use to verify these aspects.

PMO Appendix H (II) PMO Item 15p(A)(4) DPC 8

Chemical C-1: Toxic Substances C-1: Air compressor lubricants may be carried over into air and may be toxic.

3-A AP 604 21CFR 110.40(g)

Addition of reworked or reclaimed product

Physical None Biological

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE B-1: Reclaimed or reworked product may have been handled in such a way to subject it to contamination with pathogens. HAZARD MANAGEMENT OR CONTROLS B-1: Product, which has not been continuously in control of the plant, to be reclaimed or reworked is assumed to contain pathogens. When product is no longer under the control of the plant, it can not be assumed to have been held to preclude temperature abuse or adulteration. Only product that has not left the control of the plant should be used, kept segregated, handled, protected and cooled as appropriate for the product with the exception of product approved by the regulatory agency. Reworking is done in a clean area and in a manner that will not contaminate the product being salvaged. C-1: Rework foods containing allergens like into like. ADDITIONAL RESOURCES PMO 15p(A)(2), 15p(B)(4), 5p(3) & 18p(3) 21CFR 110.80(a) DPC 8 DPC 63

INGREDIENT OR PROCESS

POTENTIAL HAZARD B-1: Contamination by Pathogens

C-1: Foods may contain undeclared allergens may cause life threatening reactions in sensitive individuals.

21CFR 110.80(a)(5) 21CFR 101.100(a)(3) FDA CPG 555.250

Chemical C-1: Allergens being mixed with products that are not labeled as containing allergens Physical P-1: Extraneous Materials P-1: These can result in choking or other physical harm to consumers.9, 12

P-1: Opening of products is conducted in a manner that will minimize the opportunity for bits of packaging,

3-A 10 & 42

TABLE 2 - MILK PLANT PROCESSING OPERATIONS

HAZARD RATIONALE HAZARD MANAGEMENT OR CONTROLS cutting tools, etc. from entering the product. Verification that, at some point in the process ingredient or the milk product to which the ingredient is added, will pass through a filter, screen, small orifice (such as occurs during homogenization or other appropriate device. ADDITIONAL RESOURCES

INGREDIENT OR PROCESS

POTENTIAL HAZARD

OTHER USEFUL REFERENCES

Published Text
Alzamora, S. M., M. S. Tapia, and A. Lpez-Malo; Minimally Processed Fruits and Vegetables; Aspen Publishers, Inc. (2000) Bergeys Manual of Systematic Bacteriology, Volume 2; Williams & Wilkins Publishers

(1986) Cliver, D. O. (editor); Foodborne Diseases; Academic Press (1990) Defigueiredo, M. P. and D. F. Splittstoesser (editors); Food Microbiology- Public Health & Spoilage Aspects; AVI Publishing Company (1976) Doyle, M. P., L. R. Beuchat, and J. M. Thomas (editors); Food Microbiology: Fundamentals and Frontiers; ASM Press Downing, D. L.; A Complete Course in Canning, 13th edition (in 3 volumes); CTI Publications, Inc. (1996) Hanlon, J. F.; Handbook of Package Engineering, 2ed edtion; Technomic Publishing Co., Inc. (1992) Heldman, D. R. and R. W. Hartel; Principles of Food Processing; Chapman & Hall (1997) Hobbs, B. C. and R. J. Gilbert; Food Poisoning & Food Hygiene, 4th edition; Food & Nutrition Press (1978) IDF Bulletin No. 275; Bacillus cereus in Milk and Milk Products; 1992 Imholte, T. J.; Engineering for Food Safety and Sanitation; Technical Institute of Food Safety (1984) Jay, J. M.; Modern Food Microbiology, 4th edition; Chapman & Hall publishers (1992) Lund, B. M., T. C. Baird-Parker, and G. W. Gould (editors); The Microbiological Safety and Quality of Food, Volumes I and II; Aspen Publishers (2000) Marshall, R. T. (editor); Standard Methods For The Examination Of Dairy Products, 16th edition; American Public Health Association (1992) Oliveira, F. A. R. and J. C. Oliveira (editors); Processing Foods- Quality Optimization and Process Assessment; CRC Press (1999) Ray, B.; Fundamental Food Microbiology; CRC Press (1996) Roberts, T. A., A. C. Baird-Parker, and R. B. Thompkin (editors); Microorganisms in Foods 5- Characteristics of Microbial Pathogens; International Commission on Microbiological Specifications for Foods, Blackie Academic & Professional publishers (1996) Roberts, T. A., J. I. Pitt, J. Farkas, and F. H. Grau (editors); Microorganisms in Foods 6Microbial Ecology of Food Commodities; International Commission on Microbiological Specifications for Foods, Blackie Academic & Professional publishers (1998) Robinson, R. K. and R. A. Wilbey; Cheesemaking Practice, 3rd edition; Aspen Publishing (1998) Shapton, D. A. and N. F. Shapton (editors); Principles and Practices for the Safe Processing of Food; Woodhead Publishing Limited (1998) Shibamoto T and L. F. Bjeldanes; Introduction to Food Toxicology; Academic Press (1993) Silliker, J. H., R. P. Elliott, A. C. Baird-Parker, F. L. Bryan, J. H. B. Christian, D. S. Clark, J. C. Olson, and T. A. Roberts (editors); Microbial Ecology of Foods 2- Food Commodities; International Commission on Microbiological Specifications for Foods, Academic Press (1980) Silliker, J. H., R. P. Elliott, A. C. Baird-Parker, F. L. Bryan, J. H. B. Christian, D. S. Clark, J. C. Olson, and T. A. Roberts (editors); Microbial Ecology of Foods 1- Factors Affecting Life and Death of Microorganisms; International Commission on Microbiological Specifications for Foods, Academic Press (1980) Spreer, E.; Milk and Milk Product Technology; Marcel Dekker, Inc. (1998)

Vanderzant, C. and D. F. Splittstoesser (editors); Compendium of Methods for the Microbiological Examination of Foods, 3rd edition; American Public Health Association (1992) Vanderzant, C., D. F. Splittstoesser, and others (editors); An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients; National Academy Press (1985)

Articles Published in Peer Reviewed Scientific Journals

Ahmed, Moustafa, and Marth; Incidence of Bacillus cereus in Milk and Some Milk Products; J Food Prot 1983 Feb;46(2):126-8 Andrade, Bridgeman, and Zottola; Bacteriocidal activity of sanitizers against

Disposition of Milk Constituents on Plates of Heat Exchangers During Long Operating Times; J Food Prot 1982 Sep;45(9):806-12 Bradshaw, Peeler, Corwin, Hunt and Twedt; Thermal Resistance of Listeria monocytogenes in Dairy Products; J Food Prot 1987 Jul;50(7):543-4 Buchanan, Damert, Whiting, and Schothorst; Use of Epidemiologic and Food Survey Data to Estimate a Purposefully Conservative Dose-Response Relationship for Listeria monocytogenes Levels and Incidence of Listeriosis; J Food Prot 1997 Aug;60(8):91822 Budu-Amoako, Toora, Ablett and Smith; A Research Note: Competitive Growth of Listeria monocytogenes and Yersinia enterocolitica in Milk; J Food Prot 1993 Jun;56(6):528-32 Bunning, Crawford, Tierney and Peeler; Thermotolerance of heat-shocked Listeria monocytogenes in milk exposed to high temperature, short-time pasteurization; Appl Environ Microbial 1992 Jun;58(6):2096-8 Bunning, Crawford, Tierney, and Peeler; Thermotolerance of Listeria monocytogenes and Salmonella typhimurium after sublethal heat shock; Appl Environ Microbial 1990 Oct;56(10);3216-9 Buncic and Avery; Relationship between variations in pathogenicity and lag phase at 37 degrees C of Listeria monocytogenes previously stored at 4 degrees C; Lett Appl Microbial 1996 Jul;23(1):18-22 Butzler and Oosterom; Campylobacter: pathogenicity and significance in foods; Int J Food Microbiol 1991 Jan;12(1):1-8 Collins; Mycobacterium paratuberculosis: a potential food-borne pathogen?; J Dairy Sci 1997 Dec;80(12):3445-8 Cotton and White; Listeria monocytogenes, Yersinia enterocolitica, and Salmonella in dairy plant environments; J Dairy Sci 1992 Jan;75(1):51-7 Crawford, Beliveau, Peeler, Donnelly, and Bunning; Comparative recovery of uninjured and heat-injured Listeria monocytogenes cells from bovine milk; Appl Environ Microbiol 1989 Jun;55(6):1490-

Dairy Research 1995; 62:509-19 Baker and Griffiths; A Research Note: Evidence for Increased Thermostability of Bacillus cereus Enterotoxin in Milk; J Food Prot 1995 Apr;58(4):443-5 Berry and Foegeding; Cold Temperature Adaptation and Growth of Microorganisms; J Food Prot 1997 Dec;60(12):1583-94 Bouman, Lund, Driessen, and Schmidt; Growth of Thermoresistant Streptococci and

Enterococcus faecium attached to stainless steel as determined by plat count and impedance methods; J Food Prot 1998 Jul;61(7):833-8 Arizcun, Vasseur, and Labadie; Effect of several decontamination procedures on Listeria monocytogenes growing in biofilms; J Food Prot 1998 Jun;61(6):731-4 Assanta, Roy, and Montpetit; Adhesion of Aeromonas hydrophila to water distribution system pipes after different contact times; J Food Prot 1998 Oct;61(10):1321-9 Austin and Bergeron; Development of Bacterial Biofilms in Dairy Processing Lines; J

Campylobacter species, Yersinia enterocolitica, and hemorrhagic Escherichia coli O157:H7 in fluid milk; J Dairy Sci 1988 Dec;71(12):3230-6 Doyle and Roman; Prevalence and survival of Campylobacter jejuni in unpasteurized milk; Appl Environ Microbiol 1982 Nov;44(5):1154-8 Evenson, Hinds, Bernstein, and Bergdoll; Estimation of human dose of staphylococcal enterotoxin A from a large outbreak of staphylococcal food poisoning involving chocolate milk; Int J Food Mictobiol 1988 Dec 31;7(4):311-6 Fernandez et al; Listeria monocytogenes in pasteurized milk; Can J Microbiol 1986

DAoust, Park, Szabo, Todd, Emmons, and McKellar; Thermal inactivation of

holding times at 72 degrees C, on the inactivation of Mycobacterium paratuberculosis in milk; Lett Appl Microbiol 1999 Jun;28(6):461-5 Grant, Ball, Neill, and Rowe; Inactivation of Mycobacterium paratuberculosis in cows milk at pasteurization temperatures; Appl Environ Microbiol 1996 Feb;62(2):631-6 Greenwood, Hooper, and Rodhouse; The source of Yersinia spp. in pasteurized milk: an investigation at a dairy; Epidemiol Infect 1990 Jun;104(3):351-60 Gruetzmacher and Bradley; Identification and Control of Processing Variables That Affect the Quality and Safety of Fluid Milk; J Food Prot 1999 Jun;62(6):625-31 Harp, Fayer, Pesch, and Jackson; Effect of pasteurization on infectivity of Cryptosporidium parvum oocysts in water and milk; Appl Environ Microbiol 1996
Aug;62(8):2866-8 Helke and Wong; Survival and Growth Characteristics of Listeria monocytogenes and Salmonella typhimurium on Stainless Steel and Buna-N Rubber; J Food Prot 1994 Nov;57(11):963-8 Helke, Sommers and Wong; Attachment of Listeria monocytogenes and Salmonella

Feb;32(2):149-50 Fleming et al; Pasteurized milk as a vehicle of infection in an outbreak of listeriosis; N Engl J Med 1985 Feb;312(7):404-7 Fonden, Fitger, and Pettersson; Salmonella bacteria in double cream; Nord Vet Med 1976 Jul-Aug;28(7-8):385-9 Francis, Spaulding, and Lovett; Enterotoxin production and thermal resistance of Yersinia enterocolitica in milk; Appl Environ Microbiol 1980 Jul;40(1):174-6 Gomez-Lucia et al; Production of enterotoxin A by supposedly non-enterotoxigenic Staphylococcus aureus strains; Appl Environ Microbiol 1989 Jun;55(6):1447-51 Gruetzmacher and Bradley; Identification and control of processing variables that affect the quality and safety of fluid milk; J Food Prot 1999 Jun;62(6):625-31 Grant, Ball, and Rowe; Effect of high-temperature, short-time (HTST) pasteurization on milk containing low numbers of Mycobacterium paratuberculosis; Lett Appl Microbiol 1998 Feb;26(2):166-70 Grant, Ball, and Rowe; Effect of higher pasteurization temperatures, and longer

typhimurium to Stainless Steel and Buna-N in the Presence of Milk and Individual Milk Components; J Food Prot 1993 Jun;56(6):479-84 Holick, M. F., Q. Shao, W. W. Liu, and T. C. Chen; The Vitamin D Content of Fortified Milk and Infant Formula; New England Journal of Medicine 1992 Apr;326(18): 1178of Pseudomonas fragi, Salmonella typhimurium, and Listeria monocytogenes Cells to Stainless Steel; J Food Prot 1997 Sep;60(9):1034-7
1181 Hood and Zottola; Growth Media and Surface Conditioning Influence the Adherence

Jacobus, C. H., M. F. Holick, Q. Shao, T. C. Chen, I. A. Holm, J. M. Kolodny, G. E. Fuleihan, and E. W. Seely; Hypervitaminosis D Associated With Drinking Milk; New England Luornal of Medicine 1992 Apr;326(18):1173-1177 Jacquet, Rocourt, and Reynaud; Study of Listeria monocytogenes contamination in a dairy plant and characterization of the strains isolated; Int J Food Microbiol 1993 Oct;20(1):13-22

Junttila, Niemela and Hirn; Minimum growth temperatures of Listeria monocytogenes and non-haemolytic Listeria; J Appl Bacteriol, 1988 Oct;65(4):321-7 Keswani and Frank; Thermal Inactivation of Mycobacterium paratuberculosis in Milk; J Food Prot 1998 Aug;61(8):974-8 Kim and Frank; Effect of Nutrients on Biofilm Formation by Listeria monocytogenes on Stainless Steel; J Food Prot 1995 Jan;58(1):24-8 Knabel, Walker, Hartman and Mendonca; Effects of growth temperature and strictly anaerobic recovery on the survival of Listeria monocytogenes during pasteurization; Appl Environ Microbiol, 1990 Feb;56(2):370-6 Krysinski, Brown and Marchisello; Effect of Cleaners and Sanitizers on Listeria monocytogenes Attached to Product Contact Surfaces; J Food Prot 1992 Apr;55(4):246-51 Lin, Schraft, Odumeru, and Griffiths; Identification of contamination sources of Bacillus cereus in pasteurized milk; Int J Food Microbiol 1998 Sep 8;43(3):159-71 Lou and Yousef; Resistance of Listeria monocytogenes to Heat after Adaptation to Environmental Stresses; J Food Prot, 465-71, Vol. 59(5), 1996 Lovett, Wesley, Vandermaaten, Bradshaw, Francis, Crawford, Donnelly, and Messer; High-Temperature, Short-Time Pasteurization Inactivates Listeria monocytogenes; J Food Prot, 734-8, Vol. 53(9), 1990 Lovett, Bradshaw, and Peeler; Thermal inactivation of Yersinia enterocolitica in milk; Appl Environ Microbiol 1982 Aug;44(2):517-9 Mackey, Boogard, Hayes and Baranyi; Recovery of heat-injured Listeria monocytogenes; Int J Food Microbiol, 1994 Jun;22(4):227-37 Olsvik and Kapperud; Enterotoxin production in milk at 22 and 4 degrees C by Escherichia coli and Yersinia enterocolitica; Appl Environ Microbiol 1982 May;43(5):997-1000 Pagan, Condon, and Sala; Effects of several factors on the heat-shock-induced thermotolerance of Listeria monocytogenes; Appl Environ Microbiol 1997 Aug;63(8):3225-32 Palumbo, Call, Schultz, and Williams; Minimum and Maximum Temperatures for Growth and Verotoxin Production by Hemorrhagic Strains of Escherichia coli; J Food Prot, 352-6, Vol. 58(4), 1995 Patchett, Watson, Fernandez, and Kroll; The effect of temperature and growth rate on the susceptibility of Listeria monocytogenes to environmental stress conditions; Lett Appl Microbiol 1996 Feb;22(2):121-4 Pearson and Marth; Listeria monocytogenes threat to a safe food supply: a review; J Dairy Sci 1990 Apr;73(4):912-28 Pritchard, Beliveau, Flanders, and Donnelly; Environmental Surveillance of Dairy Processing Plants for the Presence of Yersinia Species; J Food Prot, 395-7, Vol. 58(4), 1995 Pritchard, Flanders, and Donnelly; Comparison of the incidence of Listeria on equipment versus environmental sites within dairy processing plants; Int J Food Microbiol 1995 Aug;26(3):375-84 Radmore, Holzapfel, and Luck; Proposed guidelines for maximum acceptable airborne microorganism levels in dairy processing and packaging plants; Int J Food Microbiol 1988 Feb;6(1):91-5 Rajkowski, Calderone, and Jones; Effect of polyphosphate and sodium chloride on

the growth of Listeria monocytogenes and Staphylococcus aureus in ultra-high temperature milk; J Dairy Sci 1994 Jun;77(6):1503-8 Rushing, J. E. and D. P. Wesen; Preventing Antibiotic Residues in Milk; Department
of Food Science, North Carolina State University (FSE 99-21) Schiemann; Yersinia enterocolitica in milk and dairy products; J Dairy Sci 1987 Feb;70(2):383-91

Environ Microbiol 1998 Mar;64(3):999-1005 Wang, Zhao, and Doyle; Survival and Growth of Escherichia coli O157:H7 in Unpasteurized and Pasteurized Milk; J Food Prot, 610-3, Vol. 60(6), 1997 Williams and Ingham; Changes in Heat Resistance of Escherichia coli O157:H7 Following Heat Shock; J Food Protection, 1128-1131, Vol. 60, No. 9 (1997) Wong; Biofilms in Food Processing Environments; J Dairy Science, 2765-2770, Vol. 81, No. 10 (1998) Wong, Chang, and Fan; Incidence and characterization of Bacillus cereus isolates contaminating dairy products; Appl Environ Microbiol 1988 Mar;54(3):699-702 Wong and Cerf; Biofilms: Implications for Hygiene Monitoring of Dairy Plant Surfaces; IDF Bulletin 302 (1995) Zottola; Scientific Status Summary: Microbial Attachment and Biofilm Formation- A New Problem for the Food Industry?; Food Tech, 107-14, Vol. 48(7), 1994

of Attachment of Listeria monocytogenes Scott A to Buna-N Rubber and Stainless Steel; J Food Prot, 1286-1292, Vol. 61, No. 10 (1998) Soudah and Boor; Persistence of Escherichia coli O157:H7 in Dairy Fermentation Systems; J Food Prot, 1602-8, Vol. 61(12), 1998 Sung and Collins; Thermal tolerance of Mycobacterium paratuberculosis; Appl

Skirrow; Epidemiology of Campylobacter eneritis; Int J Food Microbiol 1991 Jan;12(1):9-16 Smoot and Pierson; Effect of environmental stress on ability of Listeria monocytogenes Scott A to attach to food contact surfaces; J Food Prot 1998 Oct;61(10):1293-8 Smoot and Pierson; Influence of Environmental Stress on the Kenetics and Strength

Endnotes
IFT, 2001. Evaluation and Definition of Potentially Hazardous Foods. Report for IFT/FDA Contract No. 223-98-2333, Task Order No. 4. Chapter 6, Microbiological Challenge Testing. 2 Cliver, D. O.; Virus Transmission via Food; Institute of Food Technologists (1997) 3 Jacobus, C. H. , M. F. Holick, Q. Shao, T. C. Chen, I. A. Holm, J. M. Kolodny, G. E. Fuleihan, and E. W. Seely; Hypervitaminosis D Associated With Drinking Milk; New England Journal of Medicine 1992 Apr; (18):1173-1177 4 Robinson, R. K. and R. A. Wilbey; Cheesemaking Practice, 3 rd edition; Aspen Publishing (1998) 5 Shibamoto T. and L. F. Bjeldanes; Introduction to Food Toxicology; Academic Press (1993) 6 Alzamora, S. M., M. S. Tapia, and A. Lopaz-Malo; Minimumally Processed Fruits and Vegetables; Aspen Publishers, Inc. (2000) 7 Roberts, T. A., J. I. Pitt, J. Farkes, and F. H. Grau (editors); Microorganisms in Foods 6 Microbial Ecology of Food Commodies; International Commission on Microbiological Specifications for Foods, Blackie Academic & Professional Publishers (1998) 8 Silliker, J. H., R. P. Elliott, A. C. Baird-Parker, F. L. Bryan, J. H. B. Christian, D. S. Clark, J. C. Olson, and T. A. Roberts (editors); Microbial Ecology of Foods 2 Food Commodities; International Commission on Microbiological Specifications for Foods, Academic Press (1980) 9 Lund, B. M., T. C. Baird-Parker, and G. W. Gould (editors); The Microbiological Safety and Quality of Food, Volumes I and II; Aspen Publishers (2000) 10 Spreer, E.; Milk and Milk Product Technology; Marcel Dekker, Inc. (1998) 11 Vanderzant, C. and D. F. Splittstoesser (editors); Compendium of Methods for the Microbiological Examination of Foods, 3 rd edition; American Public Health Association (1992) 12 Shaton, D. A., and N. F. Shapton (editors); Principles and Practices for the Safe Processing of Food; Woodhead Publishing Limited (1998) 13 Heldman, D. R., and R. W. Hartel; Principles of Foods Processing; Chapman & Hall (1997) 14 Oliveria, F. A. R. and J. C. Oliveira (editors); PROCESSING Foods Qualtiy Optimization and Process Assessment; CRC Press (1999) 15 Cliver, D. O. (editor); Foodbourne Diseases; Academic Press (1990) 16 Defigueiredo, M. P. and D. F. Splittstoesser (editors); Food Microbiology Public Health and Spoilage Aspects; AVI Publishing Company (1976) 17 Jay, J. M.; Modern Food Microbiology, 4 th edition; Chapman & Hall Publishers (1997)
1

18 19

Hanlon, J. F.; Handbook of Package Engineering, 2 nd edition; Technomic Publishing Co., Inc. (1992) Ray, B.: Fundamental Food Microbiology; CRC Press (1996) 20 Bergeys Manual of Systematic Bacteriology, Volume 2; Williams & Wilkins Publishers (1986) 21 Roberts, T. A., A. C. Baird-Parker, and R. B. Thompkin (editors); Microorganisms in Foods 5 Characteristics of Microbiological Pathogens; International Commission on Microbiological Specifications for Foods, Blackie Academic & Professional Publishers (1996)

NCIMS Dairy HACCP Questions & Answers

NCIMS Dairy HACCP Questions & Answers

NCIMS Dairy HACCP Questions and Answers

June 2002; Updated February 24, 2005, October 2007, February 2008, November 2008

National Conference on Interstate Milk Shipments (NCIMS)

Questions and Answers

The answers to these questions have been prepared by the NCIMS HACCP Technical Resource Team and are based on the NCIMS HACCP Requirements. The Technical Resource Team is comprised of federal, state, and industry representatives. Additional questions and answers, accepted by the NCIMS HACCP Technical Resource Team after the issuance ofMI-07-4, are indicated by a note in square brackets, [like this], preceeding each addition. Questions and answers are organized into the following categories. 1. 2. 3. 4. 5. 6. 7. 8. 9. General Prerequisite Programs Preliminary Steps Hazard Analysis Verification/Validation Audits Testing Records Training and Standardization

General
1. What is the NCIMS HACCP committee mission? A: To address how a voluntary HACCP System should be implemented, evaluated, monitored and enforced under the National Conference on Interstate Milk Shipments (NCIMS) as an alternative to the traditional Inspection/Rating/Check Rating System. This program will:
o

Utilize current National Advisory Committee on Microbiological Criteria for Foods (NACMCF) HACCP principles that are consistent with current FDA HACCP recommendations.

Continue to assure at least the same level of milk safety provided by the traditional Inspection/Rating/Check Rating System. o Continue to provide uniformity and reciprocity under the HACCP alternative to the traditional Inspection/ Rating/Check Rating System.
o

2. Why would the NCIMS choose the HACCP system for study? A: HACCP is the internationally-accepted, science-based system for ensuring food safety controls, harmonized with the current recommendations of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). In the U.S., Meat and Poultry are regulated under HACCP by the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS). Seafood is regulated under HACCP by the FDA and new regulations have been proposed for juices. In addition, FDA also has an Advance Notice of Proposed Rule Making (ANPRM) published for HACCP for the rest of the food industry. 3. What is HACCP? A: HACCP is a science-based system used to ensure that food safety hazards are controlled to prevent unsafe food from reaching the consumer. 4. How does HACCP differ from traditional food safety systems? A: HACCP places more ownership of the responsibility on the food processor to identify and control hazards and to document the effectiveness of the system. In addition, it requires constant verification that the system is working. 5. How much authority is given up by the regulatory agency when HACCP is adopted? A: None. The regulatory agency retains its authority and responsibility for oversight to verify that food is manufactured according to the firm's HACCP plan and is handled in such a way that its safety is assured. 6. What are the advantages of adopting the HACCP System? A: Safety is enhanced by a proactive approach of continuous monitoring of food safety controls and documentation of results and corrective actions. This monitoring takes place in "real time" rather than a reactive, after-the-fact approach. 7. How does HACCP enhance food safety? A: HACCP requires monitoring to reveal when food safety limits have been violated. This results in taking corrective actions to reinstate control and through documented procedures to prevent recurrence. The operation of the system is constantly verified.

8. What is the regulatory agency's role in HACCP? A: As noted previously, regulatory authority and responsibility for oversight in the safety of food have not changed, but HACCP allows more flexibility to use resources wisely and gives the regulator a continuous picture of food safety controls applied and documentation of corrective actions. 9. What is wrong with the PMO that it requires new HACCP regulations? A: Nothing. The committee is developing guidelines for an alternative voluntary HACCP program. This is another tool the states and industry have available for assuring the safety of milk and milk products. 10. Is mandatory HACCP under the NCIMS program on the horizon? A: No, HACCP is a voluntary alternative to the traditional system under the Pasteurized Milk Ordinance. 11. What food safety issues does HACCP address? A: HACCP evaluates and addresses potential biological, physical, and chemical hazards. These hazards may be introduced from raw materials, the process, equipment, the environment, and employees. 12. How will the components of the PMO be addressed in HACCP? A: The PMO represents the cumulative wisdom and knowledge for producing safe dairy products. The expectation of the committee is that food safety controls addressed in the PMO will be addressed in HACCP to provide an equivalent margin of safety to the consumer. 13. How much of HACCP did the committee have to "reinvent"? A: The committee turned to the 1997 National Advisory Committee on Microbiological Criteria for Foods (NACMCF) document for guidance on the HACCP system. This document provided guidance for the United States Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) "MegaReg", the FDA seafood HACCP regulation, and the FDA juice regulation, as well as being harmonized with Codex Alimentarius international guidelines. The committee did not make major departures from the structure of the internationally accepted HACCP system. 14. How can input be provided to the HACCP Implementation committee? A: The committee welcomes and encourages outside input, which will assist it in accomplishing its tasks in an effective and timely manner. The committee asks that comments honor its mission statement, its previous deliberations, and its time constraints.

Observers are welcome at meetings and are welcome to provide relevant input during deliberations. However, time does not allow for reviewing and revisiting past deliberations during committee meetings. For the current Chair, see the list of HACCP Implementation Committee members. 15. Why do we need a voluntary alternative to the PMO? If there are two programs available, that makes it harder to manage and support. Is the goal for HACCP to replace the PMO system if it is proven to work? Why was HACCP formed? Is it that the current operating system is not adequate? A: It has never been said that the current system is not adequate. HACCP allows processors to take a systematic approach in identifying and managing food safety hazards when the NACMCF principles are applied. HACCP is a science-based system used to ensure that food safety hazards are controlled to prevent unsafe food from reaching the consumer. 16. How does the fact that some plants could be under the HACCP program and others under the current program promote uniformity within the NCIMS? A: FDA State program evaluations will continue to be conducted and include plants utilizing the traditional system and plants utilizing the HACCP system to promote uniformity within NCIMS. 17. Could the critical control limit be a range? A: No, the critical limit must have a specific cut off. 18. By definition, a critical limit is based on scientific evidence. If this is so, why can a critical limit for pasteurization not be based on thermal death curve values rather than on regulatory definitions such as 145 F for 30 minutes or 161 F for 15 seconds? (i.e. Why not 170 F for 10 seconds, if based on thermal death curve data? A: The definitions of pasteurization, which are cited in the question, are based on science. These temperatures and times have been adjusted over the years to help insure the destruction of pathogens in milk and milk products. If a firm wanted to use different definitions, the data must be submitted to FDA for approval. 19. Should we get caught up in definitions of deviation, deficiency and non-conformity? In our plant's quality system any deviation is a non-conformity and is either major or minor. Internal to plant understanding that an outside auditor will use deviation and deficiency terms, can we continue to say any deviation is considered a non-conformity? A: Internally, plant personnel can use their own definitions, but the plant needs to recognize that the NCIMS HACCP program has specific definitions for these terms and we would encourage that they be used.

20. Have any state regulators been part of an industry HACCP team? A: No, but the plant should utilize the resources provided by FDA and the state regulator. 21. Should states lacking the authority to issue permits under the NCIMS HACCP Program because they have failed to adopt the 2003 Grade "A" PMO be automatically excluded from participating in the HACCP alternative until they do have the authority? A: The question was sent to the NCIMS Executive Board for resolution. The following motion was agreed to by the NCIMS Executive Board and FDA. "After further discussion a motion passed unanimously for FDA to continue to accept HACCP listings from states already participating in the HACCP pilot program and additional states that wish to participate in HACCP listings, and recognize that they may not have the enabling legislation, but point out they must have legislation adopted within the 6 year time frame as recommended by the Liaison Committee for State Program Evaluations." "It was agreed that if a State does not adopt legislation within the 6 year period they may be considered in non-compliance on the next State Program Evaluation, which would trigger an Action Plan, and if the Action Plan is not followed the issue would be turned over to the Executive Board." 22. [Added November 2008] On the Milk plant, Receiving Station or Transfer Station NCIMS HACCP System Audit Report Form FD 2359m (10/06) is Section 12-c necessary as it applies to a requirement of the state regulatory agency, not the HACCP plant? A: Yes, during a State HACCP listing audit or an FDA audit of HACCP a listing. Part of the milk plants HACCP system (as it is audited by the State for an IMS listing, or by FDA for continuation of an IMS listing) is that the State Regulatory agency issue a report, set timelines (normally with the HACCP plants concurrence) to complete the identified deficiencies of the HACCP audit, and follow up on the timelines to be sure that corrections were made. During State regulatory audits and State follow-up audits, Section 12-c would not normally be marked but would serve as a reminder to issue a report, set time frames (normally with plant concurrence) for correction and follow up to verify that the corrections were made.

Prerequisite Programs
1. What is the time requirement for retaining Prerequisite Program (PP) records?

A: In Appendix K of the PMO it explains that "All records required by this part shall be retained at the milk plant, receiving station or transfer station facility for, in the case of perishable or refrigerated products, at least one (1) year after the date that such products were prepared, and for, in the case of frozen, preserved, or shelf- stable products, two (2) years or the shelf life of the product, whichever is greater, after the date that the products were prepared unless longer retention time is required by other regulations. 2. Should the cleaning and sanitizing of milk tankers that leave the establishment destined for a co-op be included in the plant's PP for cleaning even though those tankers may not deliver milk back to the firm? A: Yes, tanker cleaning should be part of the PP since there is a possibility that some of the tankers will deliver milk back to the firm. 3. We understood that the plant was to determine what Prerequisite Programs (through the hazard analysis process) would be monitored, controlled, and verified. The regulators understanding, on the other hand, is that many if not all of the PP's listed in the Grade "A" PMO, Appendix K, PP's must be written and implemented. Can you please tell us how and who determines which basic PP's should be implemented? What is acceptable documentation for these basic prerequisites programs? A: Grade "A" PMO, Appendix K. PP's indicates that dairy plants are required to develop, document and implement brief written PP's and that PP's shall address public health concerns identified in the various regulations. Mandatory programs include the eight required PP's listed in the GRADE "A" PMO, Appendix K, which must be implemented by the plant, if applicable. The exact set of PP's to be implemented should be determined by the plant. In fact, the plant's hazard analysis should clearly identify the PP's that reduce the likelihood of potential food safety hazards. The regulator must determine if the PPs developed by the plant adequately address food safety issues. The regulator should also determine if PPs are implemented, monitored and verified by the plant. 4. Is dirty equipment OK under HACCP? A: Dirty equipment is not acceptable under the PMO and is covered in the Grade "A" PMO, Appendix K. PP's. 5. A milk plant wants to use the same piping system to deliver product recovery water and cleaning and/or sanitizing solutions. What safeguards are needed to protect the public health? A: The Grade "A" Pasteurized Milk Ordinance (PMO) Item 15p(B) 1 prohibits direct piping connections between pipelines and equipment used to contain or conduct milk and milk products with tanks or circuits containing cleaning and/or sanitizing solutions except when a specific type of block and bleed valve system is used.

Sub-item (7) of this item allows variations from those specifications if the variations have been individually evaluated and found acceptable and the level of protection is not compromised. A variation must be validated under the milk plant HACCP system. These variations must be accepted by the state and FDA. The criteria to be used to accept a variation could include an individual processing plant review of the design of their system. SOPs must be identified to manage potential crosscontamination and must be monitored, documented, and verified. All monitoring and verification records would be reviewed during the regulatory audit including the FDA audit. 6. With regard to PP's, must all of our records of monitoring, review and corrective action created as part of the PPs be assembled in a central location as is the HACCP Plan and CCP data? A: Centralization of PP records is not required, however, to help analyze trends, it may be helpful to consolidate these records. 7. Should a recall procedure be part of the PPs? A: The industry may choose to include its recall procedure in its HACCP system but this is not a requirement of the Grade "A" PMO. The plant must be able to quickly remove product from commerce when it is injurious to health or it is otherwise adulterated. 8. How are such things as equipment construction (materials, finish, etc.) controlled under HACCP? Are the current requirements (conformance with the PMO or 3A) still applicable or mandatory? Is equipment review still applicable? A: Equipment meeting 3-A standards is not required under the current system or under the Grade "A" PMO. Equipment construction is covered in the Grade "A" PMO, Appendix K. Required PPs b. and e. as listed in the Grade "A" PMO, Appendix K or 2 and 5 as they are listed on the Form FDA 2359m. 9. Are monitoring and record keeping for vitamin addition required under HACCP in the Grade "A" PMO? A: The PMO requires vitamin testing and vitamin use volume control in Grade "A" milk plants. No exception is provided for HACCP plants. Section 6 requires: Assays of milk and milk products as defined in this Ordinance, to which vitamin(s) A and/or D have been added, shall be made at least annually in a laboratory, which has been accredited by FDA and which is acceptable to the Regulatory Agency, using test methods acceptable to FDA or other official methodologies, which gives statistically equivalent results to the FDA methods. Vitamin testing laboratories are accredited if they have one (1) or more certified analysts and meet the quality control requirements of the program

established by FDA. Laboratory accreditation and analyst certification parameters are specified in the EML manual. In addition, all facilities fortifying milk or milk products with vitamins must keep volume control records. These volume control records must cross reference the form and amount of vitamin D, vitamin A and/or vitamins A and D used with the amount of products produced and indicate a percent of expected use, plus or minus".

Preliminary Steps (flow diagram)

1. Should the Product or Process flow diagram include a "flow diagram" of the pasteurization process used? A: No, it is not necessary or advisable to provide a detailed "flow diagram" of the pasteurization process in the process flow diagram. The purpose of the process flow diagram is to simply show all processing steps from raw material receipt through to finished product distribution, which are directly under the control of the manufacturing facility. The process flow diagram should show pasteurization as a processing step, whereas the details of pasteurization would be described in the hazard analysis. It would be important to discuss the mechanics and maintenance of the pasteurizer during the hazard analysis to determine if the pasteurizer itself could introduce a biological, chemical, or physical hazard. Therefore, the design, operation, and maintenance of the pasteurizer should be assessed during the hazard analysis and during the HACCP system validation to determine if pressure differential and other pasteurizer design features are adequately addressed and monitored. This assessment would be written under the justification column in the hazard analysis form and in the HACCP system validation report, but would not be detailed in the process flow diagram. The inspector/state listing auditor/FDA Regional Milk Specialist may continue to diagram a flow of the pasteurizing system as part of the verification of the hazard analysis.

Hazard Analysis
1. Must the Prerequisite Program (PP) be identified as controlling a significant hazard before the PP is considered justified OR are PP's identified as controlling Potential Hazard Analysis considered justified? A: The hazard analysis is a step by step process: the initial step asks you to identify all potential hazards, the next step asks if any potential hazards are reasonably likely to occur (are they significant)? This is the step where you justify if an existing PP reduces

the likelihood of that potential hazard, if yes - you document the justification (list the PP) and assure that the PP is written, monitored, with corrective action and appropriate records. If a PP is not in place to reduce the likelihood of a hazard, then that hazard is considered "likely to occur" or "significant" and needs to be controlled by a control measure, a CCP. The HACCP team would then document in the hazard analysis the appropriate control measure (CCP) to control the "significant" or "likely to occur" hazard. 2. If the hazard analysis determines that certain processing equipment under the HACCP program can be operated for more than 24 hours without creating a food safety hazard, is the "once each day" PMO requirement for equipment cleaning a requirement under the HACCP program? A: Extended runs were accepted into the PMO when acceptable to states and FDA. The firm wishing to extend runs must submit justification for the length of run desired. Data to be submitted should be based on HACCP principles and may include but should not be limited to: a. b. c. d. e. f. g. h. i. Statement of proposal including desired cleaning frequency Product and equipment description Intended use and consumers Distribution and storage temperatures of product Diagram of process of interest Process parameters (including temperatures and times) Hazard evaluation/safety assessment Review of equipment for sanitary design When indicated by hazard evaluation/safety assessment, a plan for initial qualification shall be developed to address identified critical process parameters

Any significant equipment or processing changes shall be communicated to the Regulatory Agency, and may result in a re-verification of the extended run proposal, if it is determined that the change could potentially affect the safety of the finished milk or milk product(s). 3. If the hazard analysis has determined potable water used by the dairy plant (tested microbiologically every six months) does not constitute a hazard to the dairy products processed at the plant, is it acceptable under the HACCP program to use this potable water to "chase" pasteurized dairy products? A: The use of unpasteurized potable water was accepted into the PMO when it has undergone an equivalent process found to be acceptable to states and FDA. A firm wishing to use unpasteurized potable water must justify its use in writing and this justification should reside in the hazard analysis. Each individual processing plant must review the source and treatment of their own water system both internally and externally for food safety hazards. Preventive measures and prevention of cross-contamination measures used to reduce the likelihood of the food

safety hazards must be documented and verified. PP's, which monitor and document the sanitary quality of the water supply, are required under the PP portion of the document. Frequency of testing will be dependent upon where the water is incorporated into the process, e.g. testing would be more frequent for cases where water is added postpasteurization. All monitoring and verification records would be reviewed during the regulatory audit including the FDA audit. 4. If a company chooses a consultant to do the hazard analysis entirely, does the consultant need to be trained in this program? A: Yes. 5. An NCIMS HACCP plant would like to use potable water to flush the raw milk lines in receiving to the plant's raw milk silos. Even though this is an economic adulteration issue and not a health hazard, a representative of the plant has indicated that a hazard analysis would be completed and their proposal would prevent the accidental addition of water to the raw milk. If the plant's hazard analysis can show that their proposal would prevent the addition of water to raw milk, does HACCP give them the flexibility to follow through with this installation without approval from the state regulatory agency or FDA? A: The plan's PP should address the prevention of added water. Proper implementation of the PP should be verified during the regulatory and rating audits. Since it is an economic concern, failure of a plant to prevent adulteration falls under "Other Applicable NCIMS Requirements, adulteration" in Appendix K of the PMO. The state regulatory agency has the legal authority to take action against plants that fail to comply with this and other NCIMS requirements. 6. [Added January 2008] Would it be safe to say the plants regulated under HACCP should consider vitamin addition during the hazard analysis? A: Yes, as an ingredient, vitamins need to be included in the Hazard Analysis process. 7. [Added January 2008] Does the HACCP program need to address vitamin under or over fortification if a state regulatory vitamin sample results shows under or over fortification? A: Yes, page 23 of the 2005 PMO states, "Each milk plant regulated under the NCIMS HACCP Program shall adequately document its response to each regulatory sample test result that exceeds any maximum level specified in Section 7 of this Ordinance. The Regulatory Agency will monitor and verify that appropriate action(s) was taken by the milk plant." In the case of annual state vitamin analysis, this could be interpreted to include under fortification as well as over fortification. The hazard on vitamin under or

over fortification is commonly addressed in the plant's HACCP prerequisite program on adulteration. 8. [Added January 2008] Does a manufacturer of "Pasteurized" bulk cream need to control biological hazards with a pasteurization CCP even though the cream will be sold to a customer that will further process the cream (provide kill step)? A: Yes.

Verification/Validation
1. Please clarify plant review of consumer complaints, does regulatory have access to actual complaints? A: No, the regulator does not have access to consumer complaints. The HACCP program requires the plant to review any consumer complaints they may receive. The regulator should, therefore, verify that the facility has a program to receive and review consumer complaints. 2. For verification should all or most records be reviewed within 24 hours even when most of the plant's products are shipped within 12 hours? A: The frequency of verification is not specified in the Grade "A" PMO. The plant should consider the risks involved with shipping product prior to verification. 3. Our HACCP plan states "All equipment of new design will be reviewed and/or inspected for compliance with State Regulatory." We send blueprints of the equipment/piping changes to the State for review. In the yearly validation form, it questions new equipment. I stated we added a new HTST and a new culture filler. I am questioning whether or not I need to indicate tanks and pumps in the new equipment validation form? We changed from a positive displacement pump to a diaphragm pump and we added some additional yogurt holding tanks. A: The Grade "A" PMO states that the HACCP plan shall be validated at least annually or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan and PP. Such changes may include changes in processing methods or systems. This would include equipment changes. Replacing equipment may or may not affect the HACCP plan or PP depending on what is replaced and the type of equipment substituted for it. Replacing a pasteurizer timing pump is a significant change requiring that the holding time be tested and seals be affixed. The change of a CIP pump from manufacturer A to manufacturer B which both have the same specifications may not be. Changing from a positive displacement pump to

a diaphragm pump may impact cleanability and flow and most likely would need to be addressed. 4. While it has been traditional to define HTST or HHST pasteurization by time and temperature, does the CCP for HTST or HHST pasteurization require the critical limit also include differential pressure? A: Maintaining minimum pressure differentials between the raw and pasteurized regenerator sections is covered under the "CCP Verification" section, not the "Critical Limits" section of an NCIMS HACCP Plan. 5. [Added November 2007] When the lid was put back on the homogenizer after preventive maintenance one of the seals was sheared. The other seal remained intact. Both seals must be removed before changes can be made to the homogenizer. The pasteurizer did not notice the seal was broken, the state inspector noticed it during the HTST quarterly check. Is this a deviation of a critical control point, since a critical limit was not exceeded? It certainly needs to be addressed under verification. A: No, a broken seal does not represent a failure to meet a Critical Limit- in this case required holding time. The HTST/HHST HACCP Plan Model places seal integrity under the area of Verification of the HACCP plan. 6. [Added January 2008] When the lid was put back on the homogenizer after preventive maintenance one of the seals was sheared. The other seal remained intact. Both seals must be removed before changes can be made to the homogenizer. The pasteurizer did not notice the seal was broken, the state inspector noticed it during the HTST quarterly check. Is this a deviation of a critical control point, since a critical limit was not exceeded? It certainly needs to be addressed under verification. A: No, a broken seal does not represent a failure to meet a Critical Limit- in this case required holding time. The HTST/HHST HACCP Plan Model places seal integrity under the area of Verification of the HACCP plan. 7. [Added January 2008] When the lid was put back on the homogenizer after preventive maintenance one of the seals was sheared. The other seal remained intact. Both seals must be removed before changes can be made to the homogenizer. The pasteurizer did not notice the seal was broken, the state inspector noticed it during the HTST quarterly check. Is this a deviation of a critical control point, since a critical limit was not exceeded? It certainly needs to be addressed under verification. A: No, a broken seal does not represent a failure to meet a Critical Limit- in this case required holding time. The HTST/HHST HACCP Plan Model places seal integrity under the area of Verification of the HACCP plan. 8. [Added November 2008] I am making an entirely new product in my HACCP listed facility. How do I handle this on the NCIMS HACCP Validation Checklist?

A: Addition of a new product in an existing NCIMS HACCP Plant would trigger two validation related activities. Each may be documented using the "NCIMS HACCP Validation Checklist". Use of this specific form is not mandatory but it is strongly suggested and can be an extremely useful tool. The new product will require a validation prior to beginning production of the new product (the first checkbox on the "NCIMS HACCP Validation Checklist") for that product including; creation of a flow diagram, and a hazard analysis as well as identification of applicable Critical Control Points and applicable Prerequisite Programs etc. Production of a new product in an existing NCIMS HACCP plant would also trigger a reassessment validation (the second checkbox on the "NCIMS HACCP Validation Checklist") of the existing validated HACCP plan(s) at least to the point of determining whether production of this new product could affect the Hazard Analysis for the existing validated HACCP plan(s). If the Hazard Analysis for the existing validated HACCP plan(s) could be affected, a more complete reassessment validation for each affected HACCP plan may be needed. Both parts of this validation work must be completed and any needed HACCP system adjustments made BEFORE production of the new product begins. 9. [Added November 2008] The Milk plant, Receiving Station or Transfer Station NCIMS HACCP System Audit Report Form FD 2359m (10/06) Section 7 Item C. 2. requires a reassessment of the HACCP plan be conducted after significant changes in the operation including raw materials and/or source, etc. The milk plant is responsible to be sure this happens. During an audit is there some specific required record of milk plant sources that can be audited by the State regulatory or listing or FDA auditor from which the auditor can know that there was a significant change in a source that would require a HACCP plan reassessment? A: No.

Audits
1. If a plant has an IMS listing for condensed/dry products and a listing for their receiving area under the traditional system, how many HACCP listings should this facility have? A: One listing with product codes as needed to cover all currently listed products.

2. Who is responsible for conducting the 30 to 45 day follow-up after a listing? The HACCP listing officer or the state plant inspector? A: The regulatory inspector. 3. As you are aware, state agencies are required to "evaluate" milk plant receivers for sampling. Under HACCP, does the plant assume responsibility for this activity? A: No, since Appendix N must be followed regardless of the HACCP program. 4. Must the regulator evaluate every HACCP plan for every product every time? Or is looking thoroughly at one plan (that in general contains most of the same info as all plans) sufficient to give the regulator confidence in the system? A: The degree to which each area of the HACCP system is examined is up to the discretion of the auditor. Initially (or whenever there are changes), the HACCP system review may be more extensive to verify that the system is working effectively. 5. We reference pasteurization time and temperature as a CCP. If a plant has operated for 10 years and has never had a divert valve failure (or recorder and thermometer failure) and the preventative maintenance is part of the PP, can a plant justify not having the HTST as a CCP or is this a sacred cow? A: Pasteurization is a sacred cow and fits the classical definition of a CCP. The PMO contains CCP model HACCP Plan Summaries for continuous flow and batch pasteurizers. 6. If a plant does not have a written prerequisite or hazard analysis, can it be listed? A: No, the lack of a written Hazard Analysis is a critical listing element. Appendix K of the PMO requires a written Hazard Analysis as well as a brief written description or checklist for each of the 8 required PP's and any PP's that are relied upon in the Hazard Analysis to reduce the likelihood of a hazard such that it is not reasonably likely to occur. 7. Have plants been listed in the program without prerequisites being written in the HACCP program? A: No 8. What action is taken on any audit if equipment tests are not performed per frequency required? A: Lack of these equipment tests is a Critical Listing Element. 9. In HACCP, how do you deal with a repeat violation?

A: Take regulatory action like you would under the traditional system 10. Which has taken longer, a regular plant inspection or a HACCP plant audit? A: Initially a HACCP plant audit will take longer since all parties involved are on a learning curve. 11. How should prescriptive requirements like the 72 hour time limit on holding milk products contained in the PMO be considered and evaluated by state auditors in plants participating in the NCIMS HACCP program? More specifically, if an auditor in a HACCP plant determines that a plant has not complied with the 72 hour time limit on more than one occasion and for more than one milk product, then how should the auditor proceed? Hopefully, the answer will provide a template or step-by-step process for arriving at a conclusion that is applicable to most; if not all prescriptive requirements in the PMO. A: The 72 hour time limit is a requirement of the PMO and thus constitutes "safe harbor" that may be used without further justification in the hazard analysis, and that will be considered to be acceptable during State Licensing, State Listing or FDA Check-audits. If the milk plant selects a less stringent standard (in this case a longer time limit) this must be justified in the Hazard Analysis and prerequisite programs and will be subject to review during State Licensing, State Listing or FDA Check audits. 12. What would be a rough estimate of how long an audit will take? I realize this will depend on the size of the plant. For instance, how long would the audit take at a plant putting up 7-8 different Grade "A" products? A: Two days minimum. 13. If during an audit it were observed that a chocolate milk product was processed at 163 F but the HTST was still in forward flow because the cut-out was set at 161 F, would this deviation in the process require a product recall? What if the temperature went under 166 F for only a few seconds? Would this require a product recall? A: Yes, both problems would require a product recall. We would follow the same rules as the traditional system. 14. What happens if the auditor does not agree with the HACCP plan? A: The auditor would have to justify and document their concerns and the plan may have to be modified. 15. Who determines the time frame (Industry/state) for the correction of problems found during a State enforcement audit?

A: The same way corrections are made in the traditional system. The state regulatory agency has the final say as to the time frame. The correction should be discussed with the plant to determine the time frame that is appropriate. 16. How will the voluntary HACCP program affect the listing if a plant has not chosen to have a HACCP plan? A: If the plant chooses to be listed under the HACCP alternative, they must have a HACCP system that conforms to the requirements of the program. If the hazard analysis (as verified by State licensing and listing officials) determines that there is a need for a HACCP plan, the plant may not be listed without one. 17. Are the states and FDA required to provide pre-notification to the plants of upcoming audits? A: As under the traditional system, inspections are usually performed without notification. HACCP audits will normally be performed in the same manner. The audit may be announced at the discretion of the auditor under certain circumstances, e.g. initial audit, follow-up audit, new construction, pasteurizer checks. When unannounced audits are conducted, the audits shall not be completed until appropriate plant personnel have had an opportunity to make all pertinent records available for review by the auditor. 18. Should we use Appendix N of the PMO to justify why antibiotic testing is required by the NCIMS HACCP program since there is little scientific evidence to use as justification? A: Complying with drug residue and trace back requirements of Appendix N. is required under Appendix K and is a critical listing element. 19. A firm receives pasteurized milk to which it blends dry ingredients such as sugar and starch all with Certificates of Analysis from approved suppliers. Can a case be made for pasteurization being a PP rather than a Critical Control Point? A: No, since historical food-borne illness data overwhelmingly shows us that pasteurization is milk safety's "sacred cow". 20. Is it required that a chart remain on a pasteurizer recorder after completion of CIP and prior to the next start up? If yes, what about if the plant has extended down time between runs? A: No, it is not required under the current program or under the HACCP Program. 21. How do you establish the measure by which you determine the adequacy and effectiveness of procedures? These may be subjective methods but a measure should be quantitative?

A: The plant's HACCP system must be evaluated against the plant's written HACCP system procedures and the requirements of the NCIMS HACCP Program as described in PMO Appendix K and related documents. 22. If a deviation occurs which violates a cook critical limit but subsequent testing shows the cook step was effective, can the processor routinely refer to the incident as an acceptable response to similar deviations or is a change in the critical limit required? A: An operating limit should not be used as critical limit. The plant should change its HACCP plan to reflect the critical limit. 23. Under the concept of HACCP, can a firm that has validated a heat process step for an aseptic operation under the low acid can food requirements of the CFRs consider this an acceptable control point for the production of extended shelf life (ESL) product? Does this step have to have a flow diversion device as outlined in the PMO? A: The NCIMS HACCP Program includes all of the pasteurization requirements of the PMO. 24. Does the state regulatory agency or rating officer need to be notified when there is a change in the plant's HACCP plan? Will a copy of our HACCP plan be maintained by someone other than by our plant? A: Changes in the plant's HACCP plan or HACCP system will be reviewed by the state at the next audit. The plant must document any changes in its HACCP plan and maintain a current copy at the plant. 25. Can I as a regulator insist on a change to a PP? Example: A firm using a spring for a water supply decides that monthly bacteria examination will be adequate to monitor the supply and ensure safe water. I as the regulator have knowledge that upstream contamination can occur from a pasture. Can I insist on a change to the PP? If the firm shows documentation and procedures they believe will be effective can I accept their PP? A: It is not the responsibility of the regulatory auditor to change the firm's PP. The regulator must evaluate the PP. Then the regulator must document any deficiencies or non-conformities found during an audit and establish timelines for correction. The firm must address any adverse regulatory findings. 26. Do timelines need to be recorded for all corrective actions including PP's and plant selfaudits? A: The regulator will work with the plant to establish timelines for corrections resulting from a regulatory audit. The plant will need to record timelines for correction if the particular PP or plant self-audit is part of the plant's HACCP system. Written timelines for correction are required for all deviations, deficiencies and non-conformities that are marked by the regulatory agency during a regulatory audit.

27. When we as regulators review a HACCP plan, do we review such things as how something were determined to be a hazard and the rationale that went into it including the references consulted? A: Yes, the auditor needs to review the references and rationale considered in developing the HACCP plan. 28. If I as a regulator am going to pre-announce my audit to the plant, should I also share my audit plan ahead of time with the plant? A: There is no requirement that you share your audit plan with the plant ahead of time. However, if the regulatory auditor has certain needs to review specific equipment, for example, these needs might be shared with the plant ahead of time. 29. Are CLEs the only items addressed under the Corrective Actions in the PMO? If vitamins, adulteration and allergen issues are handled as a PP and over fortification of adulteration occurs, it does not appear to get the same scrutiny as if it was listed as a CLE. Should the Corrective Actions part of Appendix K include and define PP's that could cause a food safety/public health concern to be handled in the same manner as a CLE under Corrective Actions? A: The NCIMS HACCP Program defines corrective actions as, "Procedures followed when a deviation occurs." A deviation is defined as, "A failure to meet a critical limit." For example, if the required time and temperature is not met during HTST pasteurization, the corrective action is to manually divert the flow of the product, isolate the product, evaluate and determine its disposition and document these actions. If a plant includes vitamin addition as a critical control point, any deviation would be dealt with in this part of the HACCP plan. The plant may determine that its PP for vitamin addition reduces the potential of a food safety hazard resulting from vitamin over fortification to the point that it is not reasonably likely to occur. In either case, the auditor must review the plan's procedures to make sure they are adequate and being followed by the plant. A Critical Listing Element (CLE) is defined as, "An item on the NCIMS HACCP System Audit Report identified with a double star (**). The marking of a critical listing element by a state listing or FDA auditor indicates a condition that constitutes a major dysfunction likely to result in a potential compromise to food safety whereby a listing may be denied or withdrawn." Critical Listing Elements have been identified to assist the auditor in determining condition(s) which constitute a major dysfunction in the NCIMS HACCP system or that violate NCIMS requirements regarding drug residue testing and trace back requirements or raw milk sources.

30. If an item is marked on a HACCP audit for a particular reason and on the next audit, the same item is marked, but for a different reason, does this count as a repeat violation? An example would be that Section 9., Item A was marked on our last audit for the ceiling not being in good repair in the processing room, then on our most recent audit, Section 9., Item A was marked because the spray ball assembly in milk receiving was assembled improperly. According to the state, this is a repeat violation. A: It is important to remember that HACCP is a program that requires a structured, systematic and preventive approach to food safety. If a deviation, deficiency, or nonconformity occurs in the plan's HACCP system, it is the auditor's responsibility, along with the plant, to determine the root cause for the occurrence. In the example given, it appears on the surface that two completely different issues have been identified by the auditor and, in this case, would not be repeat violations. However, after the auditor and the plant thoroughly investigate the reason for the violations, it is possible that the same root cause could be identified for both issues. For example, an incomplete PP. The regulatory auditor and the plant should work together to establish a timeline for correction of the items identified in the root cause analysis. This timeline and corrections must be documented in an Audit Report. If, after a thorough root cause analysis, the same violation occurs at the next audit because of the same root cause, this would be considered a repeat violation. 31. The table of regulatory audit timeframes at the end of Appendix K of the PMO requires that a milk plant that meets the requirements for a 6 month minimum regulatory audit frequency revert to a 4 month minimum audit frequency if the plant has a violative water sample, or a current warning letter for 2 of the last 5 finished milk or milk product sample results that are violative. If the milk plant water sample result is found to be violative, or if the milk plant receives a "2 of 4" sample result warning letter before the 6 month audit is due, is the next audit due 4 months after the previous audit or 6 months after the previous audit? Stated another way, may the milk plant remain at the 6 month audit frequency until the next audit is due even though the requirements for this frequency are no longer being met. A: No. The milk plant no longer qualifies for a 6-month audit frequency and will immediately revert to the 4-month minimum frequency. Audits will become due within the remaining days of the 4th month (or within the remaining days of the month if the violation occurs in the 5th or 6th month). During State listing audits and FDA audits, professional judgment must be used in evaluating this item under item 2 of the NCIMS

HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT when less than a full month remains before the 4 month frequency would expire. 32. If the plant fails to conduct the quarterly equipment tests on time, should this be considered a violation of a Critical Listing Element (CLE) and result in a delisting of the plant? A: Inconsistent verification of CCP's is to be regarded as a serious issue. Clearly, professional judgment is to be used as with violations of any CLE. CLE's are intended to flag those items, which are likely to result in the failure of the HACCP system to the extent that the uniform compliance with the provisions of the PMO is not assured and the rights of reciprocity should be denied, resulting in delisting. Several factors may affect the decision of the person performing the survey or the check rating. The most obvious factor is the impact on the assurance of the level of safety required for the public health. If there is any indication that the public health is reasonably likely to be adversely affected, the CLE violation should be considered a reason for delisting. A second consideration is whether this indicates that the HACCP system is not being properly managed. Usually, this will be indicated by a pattern of related violations or previous violations in this category, without reasonable extenuating circumstances. Reasonable extenuating circumstances might be in the area of plant emergencies. The following guidance was provided for a specific case scenario during the 2004 training in Albany. Scenario - "How Highs' It Got to Be?" Following the retirement of a state regulatory co-worker, you have been assigned new field territory that includes a Grade "A" milk plant listed under NCIMS HACCP. During an audit of this plant and while reviewing the HTST pasteurization system in the plant, you note that the product discharge from the HTST system rises to an opening to the atmosphere (provided by a vacuum breaker) located only 4 inches above the raw homogenizer line, which is the highest raw milk line in the system. The homogenizer is the timing pump for the system, and the system does contain a booster pump. In reviewing the current recording chart, you note that the HTST system had been shut down 3 times during the run while waiting for additional milk for pasteurization. Neither the HTST operator nor the plant manager, are able to understand your concern about the relative height of the two lines. They indicate that the system was last changed about a year ago when a new homogenizer was installed. Later, while reviewing the HTST equipment test records, you note that the plant representatives failed to perform the required quarterly PMO tests including the Appendix I., Test 9.3 (Additional HTST Tests for Booster Pumps). The plant management offers no explanation for this deficiency and requests that you highlight your concerns in the audit report. 1. (A) As a state regulatory auditor, prepare your NCIMS Milk Plant HACCP System Audit Report following this first audit of the firm.

Suggested regulatory response for completing the NCIMS HACCP System Audit Report: Mark Item 7D. Calibration of CCP Process Monitoring Instruments Performed as Required and at the Frequency Defined in the HACCP Plan. ** CLE "The plant has failed to complete the necessary calibration of process control instruments listed as verification activities in the HACCP plan. Specifically, the required quarterly tests were not performed by the industry during the last year." Mark Item 10G. Pasteurization equipment design and construction. "The plant pasteurization equipment design and construction failed to conform with applicable requirements, specifically the pasteurized product exiting the regenerator failed to rise at least 12 inches higher than the highest raw milk in the system. During the three times that the HTST system was shut down, pasteurized product in the regenerator may have been compromised by the failure to assure at least 1 lb higher pressure in the pasteurized side of the regenerator." Take immediate action to assure product safety and provide written documentation concerning corrections and the timeframes for their implementation." During your discussion of the above findings and observations, the plant superintendent provides the following response: (Plant Response) We will take immediate action regarding these findings as follows: i. ii. The pasteurized discharge line will be raised 12 inches above the highest raw line in the system. Each of the regenerator plates will be tested by an outside firm for defects. If any cracks or pinholes are found, we will initiate a recall of all products processed on this pasteurizer that are coded Feb. 8 or later. We will attend a meeting with the State Regulatory Agency at 10:00 am tomorrow regarding the pasteurization testing responsibilities. Plant management and pasteurizer operators will attend special HTST Operator's training.

iii. iv.

(Regulatory Response) Based upon this response, the audit report is concluded with the following timelines for correction: v. The pasteurized discharge line must be corrected prior to running additional product through the HTST system. I will inspect the modification for compliance with Item 16p.(D) 1 and 2 once completed. Additionally, I will complete all the applicable HTST tests at this time to

assure that the system meets all the criteria of Appendix I prior to further operation on product. vi. Regenerator plate testing to be completed within 24 hours. vii. "An operator's workshop should be completed within 10 days. Training in required HTST design requirements is also necessary and should be completed as soon as practical, based upon an appropriate training opportunity that is acceptable to the Department." 2. (B) As a state Milk Sanitation Rating Officer, prepare your reports in response to this situation. Suggested rating response for completing the NCIMS HACCP System Audit Report: Mark Item 7D. Calibration of CCP Process Monitoring Instruments Performed as Required and at the Frequency Defined in the HACCP Plan **CLE "The plant has failed to complete the necessary calibration of process control instruments listed as verification activities in the HACCP plan. Specifically, required quarterly HTST tests for booster pumps were not performed by the industry during the last twelve month period." Mark Item 10G. Pasteurization equipment design and construction. "The plant pasteurization equipment design and construction failed to conform with applicable requirements, specifically the pasteurized product exiting the regenerator failed to rise and be opened to the atmosphere the minimum 12 inches above the highest raw milk in the system. Pasteurization records indicated that the system had been shut down 3 times during the milk production run included in the audit." "As a result of the above findings, the result of this HACCP listing is "Unacceptable." FDA form 2359i will be completed accordingly and FDA and all known receiving states will be notified. The regulatory auditor is currently working with plant management to evaluate product safety, to recall product in the market place as needed, and to meet suitable timelines for correction for these findings." Suggested language for completing the NCIMS HACCP System Regulatory Agency Review Report Form: a. Under the "requirements interpreted in accordance with the Grade "A" PMO as indicated by past audits," comment that "regulatory audits during the past 12 months have failed to identify the improper HTST atmospheric break location on the pasteurized discharge side of the regenerator." Under the "pasteurization equipment tested at required frequency," comment that "the regulatory agency failed to assure that the trained plant

b.

representatives performed the required quarterly tests. Regulatory audits on 2/8/04 and 8/2/04 failed to address these verification failures. c. Under "milk plant, receiving station, or transfer station audited by the Regulatory Agency at the minimum required frequency," comment that "critical listing element items that would have existed during the prior regulatory audits, but were not marked, should have resulted in a 4 month audit frequency." 2. Who may perform the required review (verification) of HTST & HHST pasteurization charts and if this is not being done by the proper individual, where would it be marked on the Audit Report? A: In Section III, Training and Standardization of Appendix K it states "Only industry individuals who have met the requirements of Part 1 of this Section shall be responsible for the following functions: d. Performing required HACCP Plan records reviews." and "The industry individual(s) performing the functions listed in Part 2 of this Section shall have successfully completed appropriate training in the application of HACCP principles to milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum. Alternatively, (emphasis added) job experience may qualify an individual to perform these functions if the experience has provided knowledge at least equivalent to that provided through the standardized curriculum." Therefore, these charts may be reviewed (verified) by individuals that have successfully completed the required training OR whose job experience qualifies them to perform these functions. In other words "the proof is in the performance." If this is not being done by the proper individual, it would be indicated in Section 11 C. of the Audit Report. 2. How does the HACCP guidelines provide for deviations or failure in the HACCP system? A: State enforcement action and follow-up includes: 4. The state agency shall prepare and issue audit reports based on findings of deficiencies and non-conformities, 5. The state agency shall review the audit report with the plant and establish time lines for correction of all identified deficiencies and non-conformities, 6. The state agency shall follow-up to ensure corrections are made as a result of the issuance of the audit report, 7. The state agency shall take immediate action when an imminent health hazard is observed to prevent further movement of milk and milk products until such hazards have been eliminated,

8. When the plant has failed to recognize or correct a deficiency(s) or nonconformity(s), the state shall initiate regulatory action such as permit/license suspension, revocation, hearings, court actions, and/or other equivalent measures. 2. How would a firm lose its IMS listing? A: The criteria and procedures for denial or withdrawal of a listing are stated in the NCIMS "Methods of Making Sanitation Ratings" and "Procedures" documents. 3. If there have been changes to the HACCP plan, shouldn't regulatory have been notified at the time the changes were made for their approval? A: No, regulatory does not need to be notified since regulatory agencies do not preapprove HACCP plans. 4. Earlier it was stated that the records must be kept for 1 year or the shelf life but according to the audit its 1 year. A: In Appendix K of the PMO it explains that "All records required by this part shall be retained at the milk plant, receiving station or transfer station facility for, in the case of perishable or refrigerated products, at least one (1) year after the date that such products were prepared, and for, in the case of frozen, preserved, or shelf- stable products, two (2) years or the shelf life of the product, whichever is greater, after the date that the products were prepared unless longer retention time is required by other regulations. 5. Can a dairy plant that produces many products opt to have a HACCP program for only one product (e.g. sour cream, yogurt etc.)? A: No, the plant must have all Grade "A" products on the HACCP alternative or they must all be on the traditional system. 6. Both of our HACCP plants produce single service containers as part of their plant processing operations. In both cases the bottles are not produced for sale but only for use by the plant. Under the traditional system, we have been rating and listing their single service facilities at the same frequency as the milk plant. Would you please clarify the procedures that should be followed by the plant HACCP team, the regulatory auditor, and the listing auditor with regard to these SSC facilities under the HACCP system? A: The NCIMS HACCP program applies to the single service portion of the plant when the single service operation is included in the dairy plant listing. If the single service operation is listed and rated separately, it does not need to be included in the HACCP program. Refer to the PMO, Appendix J, Section E. Criteria for Listing Certified SingleService Manufacturers in the IMS List. 7. Can you clarify what is meant by "Other NCIMS Requirements" with regard to packaged products vs. raw bulk products?

A: All ingredients required to be Grade "A", including raw milk, must come from an Interstate Milk Shippers (IMS) listed source. 8. Since there has been wide agreement that the HACCP voluntary alternative is focused on food safety and tamper detect ability has very little to do with food safety, is it necessary for plants operating under the NCIMS HACCP alternative to address tamper detectability? A: Tamper detectability is a required provision of the PMO and should be handled as an "Other NCIMS Requirement". It will be evaluated under Section 10, Item I of The Milk Plant, Receiving Station, or Transfer Station HACCP System Audit Report. 9. [Added November 2007] The plant auditor writes a report at the end of the audit and timelines are established to address some issues that were noticed during the walk through. The auditor comes back to the plant on the due date to see if these items have been taken care of. The auditor does a complete walk through and writes another report asking for timelines on issues that have come up since the original audit. These new observed items are minor issues. Is this an appropriate approach? A: Assuming that these were truly minor issues, the auditor should be focused upon the items for which he or she established the timelines for correction. The auditor may verbally comment on the observations, and indicate that he/she may be focusing in on these issues again during the next regulatory audit. Note: The NCIMS HACCP program has established routine audit frequencies, with flexibility to allow state regulators to establish their own audit frequencies. These audit frequencies should be based on actual conditions observed at the plant. 10. [Added January 2008] The plant auditor writes a report at the end of the audit and timelines are established to address some issues that were noticed during the walk through. The auditor comes back to the plant on the due date to see if these items have been taken care of. The auditor does a complete walk through and writes another report asking for timelines on issues that have come up since the original audit. These new observed items are minor issues. Is this an appropriate approach? A: Assuming that these were truly minor issues, the auditor should be focused upon the items for which he or she established the timelines for correction. The auditor may verbally comment on the observations, and indicate that he/she may be focusing in on these issues again during the next regulatory audit. Note: The NCIMS HACCP program has established routine audit frequencies, with flexibility to allow state regulators to establish their own audit frequencies. These audit frequencies should be based on actual conditions observed at the plant. 11. [Added January 2008] The plant auditor writes a report at the end of the audit and timelines are established to address some issues that were noticed during the walk

through. The auditor comes back to the plant on the due date to see if these items have been taken care of. The auditor does a complete walk through and writes another report asking for timelines on issues that have come up since the original audit. These new observed items are minor issues. Is this an appropriate approach? A: Assuming that these were truly minor issues, the auditor should be focused upon the items for which he or she established the timelines for correction. The auditor may verbally comment on the observations, and indicate that he/she may be focusing in on these issues again during the next regulatory audit. Note: The NCIMS HACCP program has established routine audit frequencies, with flexibility to allow state regulators to establish their own audit frequencies. These audit frequencies should be based on actual conditions observed at the plant.

Testing
1. The Grade "A" PMO Section 7 Item 16p.(E)(2.) states that industry personnel conducting the Pasteurization and Aseptic Processing Equipment Testing must be adequately trained and must be able to demonstrate acceptable ability to the regulatory agency. To assure adequate qualifications and uniformity in conducting these tests, one State would like to require industry to attend an FDA or equivalent pasteurizer course. Under the NCIMS HACCP program may a State insist on accepting only this FDA or equivalent training? A: No, industry must physically demonstrate to the state regulatory agency that they understand and can perform the required equipment tests according to the requirements of the PMO. The State regulatory agency shall accept a regulatory field practical, a written exam, formal classroom training, OR on the job training or any combination of these. If industry personnel do not demonstrate the appropriate capability to perform the tests adequately to the satisfaction of the regulator, they are not acceptable for conducting such tests.

Continued training such as, but not limited to, on the job training with supervision or an acceptable pasteurizer training course should be completed before they reapply for pasteurizer equipment testing approval. 2. When pasteurizer seals are broken by industry due to the 3-month pasteurizer tests or more importantly due to some other reason, e.g. maintenance, does the state regulator need to reapply the seal? A: The Grade "A" PMO Section 7 Item 16p.(E)(2.) provides the following guidance: "Sealing guidance for pasteurization equipment by industry is as follows: 1. "(1) All equipment that is required to be sealed within this Ordinance shall also be sealed under the HACCP System. The sealing shall be done by a trained, qualified individual who is acceptable to the milk plant and the Regulatory Agency; and 2. (2) The Regulatory Agency may verify any equipment sealing and evaluate (accept or reject) the skills and knowledge of the individual performing the sealing." For those instances where a seal is broken for another reason (e.g. maintenance), the industry can reseal, however, they must continue to notify regulatory of the broken seal and document why the seal was broken and date resealed. 3. The Grade "A" Pasteurized Milk Ordinance Section 6 states "Each milk plant regulated under the NCIMS HACCP Program shall adequately document its response to each regulatory sample test result that exceeds any maximum level specified in Section 7 of the PMO." While it is clear that a firm must document appropriate actions taken in their investigation, must the firm also document any findings that may have led to the violation? A: No, however, the findings may very well be part of the corrective actions. 4. If a HACCP plant has a violative sample, should the state collect another sample between 3 and 21 days, even if it is the first violative sample? A: No, the regulatory agency sampling and sample enforcement program will be the same as the traditional system. 5. In order for the State regulatory agency to be able to determine if an industry person is qualified to conduct an HTST equipment test, what type of training is required for the industry personnel? Is it similar to the requirements for industry HTST sealers? A: Item 16p.(E)2 of the Grade "A" PMO states: "The Regulatory Agency shall accept a field practical exercise, a written exam, formal classroom training, on the job training or any combination of these except that, if industry personnel do not physically demonstrate

the appropriate capability to perform the tests to the satisfaction of the Regulatory Agency, they are not acceptable for conducting such tests." 6. How will regulatory equipment checks and seals be addressed in HACCP? A: Pasteurization and aseptic processing equipment tests shall be done at a frequency not less than the PMO standards. Industry shall have responsibility for the performance of all required tests. The semi-annual (six month) tests should be performed at a time that is mutually convenient to all parties. Industry personnel conducting the Pasteurization and Aseptic Processing Equipment testing must be adequately trained and must be able to demonstrate acceptable ability to the regulatory agency. For more details, please refer to the PMO Item 16p.(E) 2. 7. Can a state regulatory agency deny evaluation of any adequately trained plant employee to conduct routine quarterly pasteurized equipment checks required in the PMO, Appendix K and detailed in Appendix H in order to maintain their current system of having state employees conduct all quarterly pasteurized equipment checks? A: The current wording of the PMO in regards to industry performing their own pasteurizer checks would indicate that there needs to be cooperation between the facility and the state regulatory agency to determine the adequacy of the firm's knowledge and training. The same cooperation which was exhibited in the acceptance of the HACCP alternative program should be performed between the industry and the regulatory agency to accomplish the task of testing pasteurization equipment. This wording is meant to give the flexibility to the regulators and industry in performing these tasks.

Records
1. Under the NCIMS HACCP Program what records are required to be kept at the plant and what records are required to be kept by the state regulatory agency? A: Under the HACCP Program the plant must maintain records of its PP, HACCP plan, flow diagram, pasteurization equipment tests, drug residue screening tests, regulatory sample test results, as well as any other records pertaining to the plant's HACCP system including a table of contents and centralized list of the HACCP program records by title, documenting the ongoing application of the HACCP system.(See PMO Appendix K, II. Subsection - "Records" for more details). The state regulatory agency must keep records of its regulatory audits, listing audits, regulatory sample results, and pasteurization equipment tests. The regulatory agency must have access at the plant to the HACCP plan, flow diagram, product description and all records pertinent to the plant's HACCP system.

Training and Standardization

1. Define "HACCP - trained". Now that I have attended NCIMS HACCP audit training, can I train people within the plant to review records? A: The person responsible for the oversight of verification of CCP's must have attended the NCIMS HACCP orientation and must have basic HACCP training as well. However, the individual who actually signs the records may qualify by on-the-job training or other training. 2. Who is required to take the NCIMS HACCP auditing training? Is the industry person conducting the hazard analysis and developing the HACCP plan required to take this auditing training? A: The PMO Appendix K, III. and the "Procedures Governing the Cooperative StatePublic Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments," Section VIII, C. 2. d. 4.) and Section VIII., E. 4.b. taken together say that state regulatory, listing and FDA auditors must take the NCIMS HACCP auditing training. Industry is not required to take this training but may find it helpful as it participates in the NCIMS HACCP program. 3. Is training of milk plant associates required under Appendix K? A: Yes. Appendix K, HACCP PROGRAM, III. Training and Standardization states the following: III. EMPLOYEE EDUCATION AND TRAINING The success of a HACCP system depends on educating and training management and employees in the importance for their role in producing safe milk and milk products. This should also include information in the control of milk borne hazards related to all stages of dairy production and processing. Specific training activities should include working instructions and procedures that outline the tasks of employees monitoring specific CCPs and PPs. and 1. Core Curriculum: The Dairy HACCP Core Curriculum consists of: a. Basic HACCP training; plus b. An orientation to the requirements of the NCIMS HACCP Program. Basic HACCP training consists of instruction in the application of the NACMCF Principles of HACCP to Food Safety. This training includes practical exercises in conducting a hazard analysis and evaluating potential hazards; in writing a HACCP Plan; and in the validation of the plan. It should be taught by experienced instructors.

The orientation component ideally is coupled with the basic HACCP training, but can be taught separately. The content of the orientation will be conducted under the guidance of the NCIMS. It is intended to familiarize industry and regulatory personnel with specific dairy HACCP concerns and the regulatory requirements under the NCIMS HACCP Program. It is to be taught by instructors experienced in the application of HACCP under the NCIMS HACCP Program. The industry individuals performing the functions listed in Part 2 of this section shall have successfully completed appropriate training in the application of HACCP principles to milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum. Alternatively, job experience may qualify an individual to perform these functions if the experience has provided knowledge at least equivalent to that provided through the standardized curriculum. 2. Industry Personnel: Only industry individuals who have met the requirements of Part 1 of this Section shall be responsible for the following functions: a. Developing the hazard analysis, including delineating control measures, as required; b. Developing a HACCP Plan that is appropriate for the specific milk plant, receiving station or transfer station, in order to meet these requirements; c. Validating and modifying the HACCP Plan in accordance with the corrective action procedures and the validation activities as specified; and d. Performing required HACCP Plan records reviews. Therefore, Plant Associates performing the functions listed in 2 above are required to have training as stated in 1. Core Curriculum or equivalent job experience. Plant Associates not performing the functions listed in 2. above need to have sufficient training to perform their jobs within the plant as is the case under the traditional system. For example, during the course of a HACCP audit, the auditor will check the cleaning of milk storage tanks and other product contact surfaces within the plant, a required PP. If the milk storage tanks are found to be unclean and monitoring records indicate a malfunctioning CIP system and the plant did not correct the problem, the cause might be lack of employee training in this particular job area and could be debited under on the HACCP Audit Form Section 11 D, "Employees trained in PP programs". However, employees performing the job of tank cleaning are not required to be trained in the HACCP Core Curriculum specified in 1. above. 4. May a State Rating Officer be certified for the first time using a plant that has never been HACCP listed? If yes, then how and in what areas?

A:Yes, provided that the milk plant is working toward being HACCP licensed and listed and has a viable NCIMS HACCP system in place and a minimum of 60 days of the required HACCP records available for review. 5. What training is required and what is the procedure for FDA to approve a new State Rating Officer to make milk sanitation ratings of HACCP plants? A: Procedures... Section VIII. Procedures Governing the Certification of Milk Plant, receiving station and transfer station NCIMS HACCP Systems for IMS Listed shippers., E. Qualifications and Certifications states in part: 6. Certification Procedure for SRO's Who Will Conduct HACCP Listing Audits a. Candidate Background 1. 1.)Training and Experience 1. A.) The Candidate shall provide a statement describing their background and experience that qualifies them to perform this work. 2. B.) Candidates are encouraged to gain practical milk plant experience in the application of HACCP and in conducting milk plant NCIMS HACCP audits by working with SRO's that are certified to perform NCIMS HACCP Listings audits whenever practical. 3. C.) The Candidate shall complete a basic HACCP training course that is acceptable to the NCIMS and FDA; NCIMS HACCP Orientation; as well as training in general auditing requirements for the auditing of milk plants, receiving stations and transfer stations under the NCIMS HACCP Program. 4. D.) Candidate shall be a certified SRO for milk plants. b. Original Certification Process 1. 1.) Knowledge of HACCP and NCIMS HACCP Auditing Standards and Requirements A standardized FDA Regional Milk Specialist (RMS), qualified to conduct HACCP Audits, will accompany the Candidate during the course of one (1) mock-listing audit conducted separate from an official HACCP listing audit. The candidate may be certified to conduct HACCP listings after successfully completing one (1) mock-listing audit, with the certification valid for three (3) years. In the case of an original HACCP certification, the date of expiration of the other SRO certification shall be automatically extended to correspond with the original HACCP certification expiration date. 2. 2.) Knowledge of HACCP and NCIMS HACCP Auditing Standards and Requirements

The RMS shall accompany the Candidate during the mock-listing audit and shall evaluate the Candidate's HACCP knowledge and NCIMS HACCP auditing skills. Particular attention shall be given to the Candidate's observations, evaluation, and decision making skills related to planning and conducting the mock-listing audit, identifying and recording the findings, communicating with industry representatives, and arriving at a listing audit determination. The RMS will categorize the Candidate's HACCP knowledge and NCIMS HACCP auditing skills into one (1) of the following three (3) categories: 1. A.) The Candidate's work is acceptable; or 2. B.) The Candidate's work is acceptable with written recommendations identifying areas that need improvement; or 3. C.) The Candidate is not certified. NOTE: The cause shall be documented and provided to the candidate and the State Rating Agency. c. Continuous Certification After the initial successful Conditional HACCP Certification, subsequent certification of a SRO to make NCIMS HACCP Listing Audits will be valid for three (3) years unless revoked for cause. 1. 1.) Milk Plant Technical Knowledge The Candidate shall continue to meet the requirements for certification of a SRO for milk plants. During the three (3) year certification period, the SRO, certified to conduct NCIMS HACCP listings, will complete the minimum training requirements established to maintain proficiency regarding the NCIMS HACCP Program. Small group training with practical exercises and other appropriate training that may include written examinations will be used to evaluate the SRO's technical knowledge for continuing certification. 2. 2.) Knowledge of HACCP and NCIMS HACCP Auditing Standards and Requirements During the three (3) year certification period, a RMS, will accompany the SRO during the course of at least one (1)

recertification listing audit. The recertification listing audit can be done independent as a mock-listing audit or as part of an official HACCP listing audit, at the discretion of the RMS and SRO. This decision will be made prior to the beginning of the recertification listing audit. In the absence of an agreement, the recertification listing audit shall be conducted during a mock listing audit. The standardizing official (RMS) shall accompany as a "silent observer" during this recertification listing audit. The RMS shall evaluate the SRO's HACCP knowledge and NCIMS HACCP auditing skills. Particular attention shall be given to the SRO's observations, evaluation, and decision making skills related to planning and conducting the listing or mock-listing audit, identifying and recording the findings, communicating with industry representatives, and arriving at an audit listing or mocklisting audit determination. The RMS will categorize the SRO's HACCP knowledge and NCIMS HACCP auditing skills into one (1) of the following three (3) categories: 1. A.) The SRO is recertified to conduct NCIMS HACCP Listing Audits; or 2. B.) The SRO is recertified with written recommendations identifying areas that need improvement; or 3. C.) The SRO is not recertified. NOTE: The cause shall be documented and provided to the SRO and the State Rating Agency. d. Paperwork Review THE MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP AUDIT REPORT, with attachments, the NCIMS HACCP system regulatory agency review report, and the permission for the publication of an interstate milk shipper's listing shall be submitted with Form FDA 2359i for each NCIMS HACCP Listing Audit to the FDA Regional Office for quality assurance review. These reviews will be used to enhance uniformity and strengthen each individual's skills and will be used to assist in identifying needs for future training. 6. [Added November 2008] Task Force noted that Form FDA 2359m (10/06), Milk Plant, Receiving Station or Transfer Station NCIMS HACCP Audit Report, Section 11 a - d used the word "trained" when in fact the NCIMS HACCP program does not require training for industry. Follow up needed with the NCIMS HIC regarding use of the word "trained" individual to either change wording to "trained or experienced" or clearly identify that experience qualifies as "training" for 11 a - d.

A: Appendix K does require training of Industry personnel. The training requirements vary based on the sub-section of 11 that is being evaluated. For Section 11 a, training in monitoring activities (for monitoring prerequisite program activities and for original monitoring of CCP records), this training may be provided locally at the milk plant by milk plant personnel. For section 11 b and c, Industry personnel may be trained in the requirements of the core curriculum either formally (by attending a training course) or informally (based on job experience) in order to satisfy the training requirements of Appendix K for the following activities: -- Developing the hazard analysis, including delineating control measures, as required (11 b); o -- Developing a HACCP Plan that is appropriate for the specific milk plant, receiving station or transfer station, in order to meet these requirements (11 b); o --Validating and modifying the HACCP Plan in accordance with the corrective action procedures and the validation activities as specified (11 b); and o -- Performing required HACCP Plan records reviews (11 c).
o

During regulatory, listing and FDA check audits, the acceptability of an industry persons job experience may be evaluated based on a review of these records specified as Appendix K that apply to the audit report sub-sections 11 b and c. For section 11 d, employees who perform PP activities may be trained in their specific duties at milk plant by milk plant personnel. A determination of the adequacy of their training may be based on an evaluation of their work. For all of Section 11, appropriate training records must be maintained. No proposal needs to be submitted to the 2009 NCIMS Conference.

FDA Foreign Objects Guidance

FDA Foreign Objects Guidance

Updated: 2005-11-29

SECTION 555.425

Foods - Adulteration Involving Hard or Sharp Foreign Objects

BACKGROUND: Hard or sharp foreign objects in food may cause traumatic injury including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine as well as damage to the teeth and gums. From 1972 through 1997, the FDA Health Hazard Evaluation Board evaluated approximately 190 cases of hard or sharp foreign objects in food. These include cases of both injury and non-injury reported to FDA. The Board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients, and the elderly. The scientific and clinical literature supports this conclusion. Hard or sharp natural components of a food ( e.g. bones in seafood, shell in nut products) are unlikely to cause injury because of awareness on the part of the consumer that the component is a natural and intrinsic component of a particular product. The exception occurs when the food="s" label represents that the hard or sharp component has been removed from the food, e.g., pitted olives. The presence of the naturally occurring hard or sharp object in those situations (e.g., pit fragments in pitted olives) is unexpected and may cause injury. FDA has established Defect Action Levels for many of these types of unavoidable defects in other Compliance Policy Guides and therefore they are not subject to the guidance in this document. REGULATORY ACTION GUIDANCE: The following represent the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and direct reference import detention to the districts. a. The product contains a hard or sharp foreign object that measures 7 mm to 25 mm, in length. and b. The product is ready-to-eat, or according to instructions or other guidance or requirements, it requires only minimal preparation steps, e.g., heating, that would not eliminate, invalidate, or neutralize the hazard prior to consumption. Samples found to contain foreign objects that meet criteria a. and b., above should be considered adulterated within the meaning of 21 U.S.C. 342(a)(1).

The following represent the criteria for recommending legal action to CFSAN Office of *Compliance, Division of Enforcement* (HFS-605). c. The product contains a hard or sharp foreign object that measures 7 mm to 25 mm in length, and the product requires additional preparation or processing that may have an effect on the presence of the foreign objects in the finished food. For example, additional sifting of a product may or may not remove foreign objects, depending on the measurements of the objects and the mesh aperture of the sifter. In these situations, the preparation or processing of the food must be described in the recommendation submitted by the District. or d. The product contains a hard or sharp foreign object less than 7 mm in length and if a special-risk group, as defined in the background section, is among the intended consumers of the product. or e. The product contains a hard or sharp foreign object over 25 mm in length. A sample found to contain a foreign object that meets criterion c., d., or e., above should be considered adulterated within the meaning of 21 U.S.C. 342(a)(1) if a health hazard is established by CFSAN review. The CFSAN health hazard review in this case will consider various factors including the intended use of the product, subsequent processing steps, official guidance and requirements concerning unavoidable natural defects, and other mitigating factors that could eliminate, invalidate or neutralize the hazard prior to consumption of the food product. REMARKS: If CFSAN review finds no health hazard associated with a sample containing a hard or sharp foreign object that meets criterion c., or d., above, the sample should be considered adulterated within the meaning of *21 U.S.C. 342(a)(3)* if a CFSAN review finds the article unfit for food. The CFSAN review in this case will consider various factors including subsequent processing steps, extent of contamination, and intended use of the product. CPG 515.350 addresses imbedded objects in confectionary, which may cause such foods to be adulterated within the meaning of 21 U.S.C. 342(d)(1). SPECIMEN CHARGES: The following charges are appropriate for a product that satisfies criteria a. and b. for direct reference seizure: Article (was adulterated when introduced into and while in interstate commerce)(is adulterated while held for sale after shipment in interstate commerce), within the meaning of 21 U.S.C. 342 (a)(1), in that it bears or contains a deleterious substance which may render the food injurious to health.

Article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to bear or contain a deleterious substance which may render it injurious to health. *Material between asterisks is new or revised* Issued: 3/23/1999 Revised: 5/2005

Guidance for Industry

Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4)
Final Guidance
October 2006 Comments and suggestions regarding this document may be submitted at any time. Submit comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For questions regarding this document, contact Rhonda R. Kane at the Center for Food Safety and Applied Nutrition (CFSAN) at 301-436-2371 or rhonda.kane@fda.hhs.gov. Additional copies are available from: Office of Nutritional Products, Labeling, and Dietary Supplements, HFS-800 Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740 http://www.cfsan.fda.gov/guidance.html

U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition October 2006

This guidance represents the current thinking of the Food and Drug Administration on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. If you wish to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this document.

I. Introduction
As originally enacted in 1938, section 403(i) of the Federal Food, Drug, and Cosmetic Act required that the label of a food that is fabricated from two or more ingredients declare each ingredient by its common or usual name (except that spices, flavorings, and colors could be declared as a class.) Although ingredient declarations complying with section 403(i) provide some information to food allergic consumers, in some cases, the common or usual name of an ingredient may be unfamiliar to consumers and many consumers do not recognize that certain ingredients contain or are derived from a food allergen. This situation led, at least in part, to the enactment of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Pub. L. 108-282). This is a revision of the third edition of a guidance document that contains questions and answers relating to food allergens, including questions and answers about the Food Allergen Labeling and Consumer Protection Act. FDA expects to continue to issue subsequent editions of this guidance document by adding new questions and answers to the guidance; new questions and answers will be identified by the date that they are added to the guidance. FDA's guidance documents, including this document, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

II. Questions and Answers

1. What is the Food Allergen Labeling and Consumer Protection Act of 2004? The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Public Law 108-282) was enacted in August 2004, and addresses, among other issues, the labeling of foods that contain certain food allergens. 2. When do the labeling requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA) become effective for packaged foods sold in the United States? All packaged foods regulated under the Federal Food, Drug, and Cosmetic Act (FFD&C Act) that are labeled on or after January 1, 2006, must comply with FALCPA's food allergen labeling requirements. 3. Must products with labels that do not comply with FALCPA be removed from the market place once the new labeling law is effective? No. FALCPA does not require any action with respect to products labeled before January 1, 2006. 4. What is a "major food allergen?" Under FALCPA, a "major food allergen" is an ingredient that is one of the following five foods or from one of the following three food groups or is an ingredient that contains protein derived from one of the following:
o o o o o o o o

milk egg fish Crustacean shellfish tree nuts wheat peanuts soybeans

5.

Does FALCPA provide any specific direction for declaring the presence of ingredients from the three food groups that are designated as "major food allergens (i.e., tree nuts, fish, and Crustacean shellfish?") Yes. FALCPA requires that in the case of tree nuts, the specific type of nut must be declared (e.g., almonds, pecans, or walnuts). The species must be declared for

fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or shrimp). 6. Are there food allergens other than those directly addressed by FALCPA? Congress designated eight foods or food groups as "major food allergens." These foods or food groups account for 90 percent of all food allergies. Although there are other foods to which sensitive individuals may react, the labels of packaged foods containing these other allergens are not required to be in compliance with FALCPA. 7. What types of foods are covered by the FALCPA labeling requirements? FALCPA's requirements apply to all packaged foods sold in the U.S. that are regulated under the Federal Food, Drug, & Cosmetic Act, including both domestically manufactured and imported foods. FDA regulates all foods except meat products, poultry products, and egg products. 8. Are fresh fruits and vegetables in their natural state subject to FALCPA's requirements? No. Raw agricultural commodities such as fresh fruits and vegetables in their natural state are not affected by FALCPA. 9. Does FALCPA affect the labeling of packaged meat, poultry, and egg products regulated by the U.S. Department of Agriculture (USDA)? FALCPA's requirements apply only to those foods regulated by the Food and Drug Administration under the FFD&C Act. We recommend that producers of meat products, poultry products, and egg products regulated by USDA contact the appropriate USDA agency regarding the labeling of such products. 10. May the terms "soybean," "soy," and "soya" be considered synonyms for the term "soybeans" for the purpose of satisfying the FALCPA labeling requirements? Yes. "Soybean," "soy," and "soya" are reasonable synonyms for the common or usual name "soybeans," and any one of these terms may be used to identify the food source of the major food allergen "soybeans." 11. When is it appropriate to use the term "soybeans" versus a synonym in food labeling? Packaged foods that are made using soybeans as an ingredient or as a component of a multi-component ingredient (e.g., soy sauce or tofu) should continue to use the word "soybeans" as the appropriate common or usual name for this ingredient

to identify properly the ingredient (e.g., "soy sauce (water, wheat, soybeans, salt)"). 12. May the singular term "peanut" be substituted for the plural term "peanuts," and may the singular terms (e.g., almond, pecan, or walnut) be used to describe the different types of "tree nuts" (e.g., almonds, pecans, or walnuts) to satisfy the labeling requirements of FALCPA? Yes. FDA believes that "peanut" is an acceptable substitute for "peanuts" and that the names of the different types of tree nuts may be expressed in either the singular or plural form for the purpose of satisfying the FALCPA labeling requirements. 13. May a "Contains" statement on a food label provided in accordance with FALCPA list only the names of the food sources of the major food allergens that are not already identified in the ingredient list for a packaged food? No. If a "Contains" statement is used on a food label, the statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food. For example, if "sodium caseinate," "whey," "egg yolks," and "natural peanut flavor" are declared in a product's ingredients list, any "Contains" statement appearing on the label immediately after or adjacent to that statement is required to identify all three sources of the major food allergens present (e.g., "Contains milk, egg, peanuts") in the same type (i.e., print or font) size as that used for the ingredient list.. 14. Is there more than one way to word a "Contains" statement used to declare the major food allergens in a packaged food? Yes. The wording for a "Contains" statement may be limited to just stating the word "Contains" followed by the names of the food sources of all major food allergens that either are or are contained in ingredients used to make the packaged product. Alternatively, additional wording may be used for a "Contains" statement to more accurately describe the presence of any major food allergens, provided that the following three conditions are met: 1. The word "Contains" with a capital "C" must be the first word used to begin a "Contains" statement. (The use of bolded text and punctuation within a "Contains" statement is optional.)

2. The names of the food sources of the major food allergens declared on the food label must be the same as those specified in the FALCPA, except that the names of food sources may be expressed using singular terms versus

plural terms (e.g., walnut versus walnuts) and the synonyms "soy" and "soya" may be substituted for the food source name "soybeans."

3. If included on a food label, the "Contains" statement must identify the names of the food sources for all major food allergens that either are in the food or are contained in ingredients of the food. 15. Is there a penalty for non-compliance with FALCPA? Yes. A company and its management may be subject to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act if one of its packaged food products does not comply with the FALCPA labeling requirements. FDA may also request seizure of food products where the label of the product does not conform to FALCPA's requirements. In addition, FDA is likely to request that a food product containing an undeclared allergen be recalled by the manufacturer or distributor. 16. Does FALCPA require food manufacturers to label their products with advisory statements, such as "may contain [allergen]" or "processed in a facility that also processes [allergen]?" No. FALCPA does not address the use of advisory labeling, including statements describing the potential presence of unintentional ingredients in food products resulting from the food manufacturing process. FALCPA does require FDA to submit a report to Congress, a part of which assesses the use of, and consumer preferences about, advisory labeling. In earlier guidance, FDA advised that advisory labeling such as "may contain [allergen]" should not be used as a substitute for adherence to current Good Manufacturing Practices (cGMPs). In addition, any advisory statement such as "may contain [allergen]" must be truthful and not misleading. 17. Does FALCPA require FDA to set so-called thresholds for any food allergen? FALCPA does not require FDA to establish a threshold level for any food allergen. It is not unlikely, however, that FDA will at some point need to consider a threshold level for one or more food allergens in the context of reviewing a petition or a notification submitted to request that an ingredient be exempt from FALCPA's labeling requirements. 18. [Added December, 2005] Is a major food allergen that has been unintentionally added to a food as the result of cross-contact subject to FALCPA's labeling requirements?

No. FALCPA's labeling requirements do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact. In the context of food allergens, "cross-contact " occurs when a residue or other trace amount of an allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food. Cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment. 19. [Added April, 2006] What information has been added to the 2005 FDA Food Code related to food allergens? FDA's Food Code is a model code available for adoption by local, state, and other jurisdictions to apply to all food establishments at the retail level that provide food directly to consumers, including: restaurants, grocery stores, supermarkets, hospitals, nursing homes, child care centers, and temporary food establishments. The following new food allergen information has been added to the 2005 Food Code: A definition of "major food allergen," which is consistent with the definition in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) [Paragraph 1-201.10(B)]. o A new provision under Demonstration of Knowledge [Subparagraph 2102.11(C)(9)] specifying that the person in charge of a food establishment shall have an understanding of the foods identified as major food allergens and the symptoms that a major food allergen could cause in a sensitive individual. This additional element is significant because nationally recognized certifiers of food managers who provide training and testing of such managers consult these elements when the certifiers routinely upgrade their training and testing programs. o Integration of FALCPA's labeling provisions to reflect the additional requirements that apply to food that is packaged at the retail level [Subparagraph 3-602.11(B)(5)]. o Additional background information on food allergens in Annex 4, including common characteristics of a food allergic response and detailed information regarding the requirements of FALCPA. 20. [Added April, 2006] Do retail and foodservice establishments have to comply with FALCPA's labeling requirements?
o

FALCPA's labeling requirements extend to foods packaged by a retail or foodservice establishment that are offered for human consumption. However, FALCPA's labeling requirements do not apply to foods provided by a retail food establishment that are placed in a wrapper or container in response to a consumer's order - such as the paper or box used to convey a sandwich that has been prepared in response to a consumer's order.

21. [Added April, 2006] Do the FALCPA requirements apply regardless of whether a jurisdiction has adopted the 2005 FDA Food Code? Yes. Although the 2005 FDA Food Code contains provisions to integrate FALCPA's requirements into the model code as well as additional food allergen information in its Annexes, FALCPA is a federal law that amends the Federal Food, Drug, & Cosmetic Act (FFDCA). Thus, regardless of whether a jurisdiction has adopted the 2005 Food Code, FALCPA's requirements apply to all packaged foods in interstate commerce, both domestically manufactured and imported, sold in the U.S. that are regulated under the FFDCA. FDA regulates all foods except meat products, poultry products, and certain egg products. FALCPA is specifically preemptive, which means that other governmental entities (such as those at the state or local level) may not adopt labeling requirements that are different from those in FALCPA. 22. [Added April, 2006] Does FALCPA address the use of advisory labeling (such as "may contain") by a retail or food service establishment? No. FALCPA does not address the use of advisory labeling, including statements describing the potential presence of unintentional ingredients in food products resulting from the manufacturing of the ingredients or the preparation and packaging of the food in a retail or food service establishment. All food labeling, including advisory labeling, must be truthful and not misleading. See FDA's 1996 Notice to Manufacturers. 23. [Added April, 2006] Are molluscan shellfish considered a major food allergen under FALCPA? No. Under FALCPA, Crustacean shellfish (such as crab, lobster, or shrimp), and ingredients that contain protein derived from Crustacean shellfish, are major food allergens, but molluscan shellfish (such as oysters, clams, mussels, or scallops) are not. 24. [Added April, 2006] Does FDA intend to issue additional guidance for retail and foodservice establishments on the proper handling of food allergens? As stipulated in FALCPA, FDA is engaged in an on-going effort to work with the Conference for Food Protection on the development of guidelines for retail and foodservice establishments on the proper handling and labeling of food allergens. 25. [Added October, 2006] Section 201(qq) of the Act defines the term "major food allergen" to include "tree nuts." In addition to the three examples provided in section 201(qq) (almonds, pecans, and walnuts), what nuts are considered "tree nuts?"

The following are considered "tree nuts" for purposes of section 201(qq). The name listed as "common or usual name" should be used to declare the specific type of nut as required by section 403(w)(2). Scientific name Prunus dulcis (Rosaceae) Beech nut Fagus spp. (Fagaceae) Brazil nut Bertholletia excelsa (Lecythidaceae) Butternut Juglans cinerea (Juglandaceae) Cashew Anacardium occidentale (Anacardiaceae) Chestnut (Chinese, American, Castanea spp. European, Seguin) (Fagaceae) Chinquapin Castanea pumila (Fagaceae) Coconut Cocos nucifera L. (Arecaceae (alt. Palmae)) Filbert/hazelnut Corylus spp. (Betulaceae) Ginko nut Ginkgo biloba L. (Ginkgoaceae) Hickory nut Carya spp. (Juglandaceae) Lichee nut Litchi chinensis Sonn. Sapindaceae Macadamia nut/Bush nut Macadamia spp. (Proteaceae) Pecan Carya illinoensis (Juglandaceae) Pine nut/Pinon nut Pinus spp. (Pineaceae) Pili nut Canarium ovatum Engl. in A. DC. (Burseraceae) Pistachio Pistacia vera L. (Anacardiaceae) Sheanut Vitellaria paradoxa C.F. Gaertn. (Sapotaceae) Walnut ( English, Persian, Black, Japanese, Juglans spp. California), Heartnut, Butternut (Juglandaceae) Almond Common or usual name

The foregoing list reflects FDA's current best judgment as to those nuts that are "tree nuts" within the meaning of section 201(qq). In order to be comprehensive, this list employs broad scientific categories that may include a species that currently has no food use. The fact that a species falls within a scientific category on this list does not mean that the species is appropriate for food use. FDA further advises that, as with any guidance, the list may be revised consistent with the process for revising guidance documents in our regulation on good guidance practices in 21 CFR 10.115. 26. [Added October, 2006] Under section 403(w)(1), a major food allergen must be declared using the name of the food source from which the major food allergen is derived. Section 403(w)(2) provides that, in the case of fish or Crustacean shellfish, the term "name of the food source from which the major food allergen is derived" means the "species" of fish or Crustacean shellfish. What is the "species" of fish or Crustacean shellfish for purposes of section 403(w)(2)? A declaration of the "species" of fish or Crustacean shellfish for purposes of complying with section 403(w)(2) should be made using the acceptable market name provided in FDA's Seafood List. FDA's Seafood List is a compilation of existing acceptable market names for imported and domestically available seafood. The list is available at http://www.cfsan.fda.gov/~frf/seaintro.html [Added October, 2006] Section 201(qq) includes "wheat" in the definition of major food allergen. What is considered "wheat" for purposes of section 201(qq)? The term "wheat" in section 201(qq) means any species in the genus Triticum. Thus, for the purposes of section 201(qq), wheat would include grains such as common wheat (Triticum aestivum L.), durum wheat (Triticum durum Desf.), club wheat (Triticum compactum Host.), spelt (Triticum spelta L.), semolina (Triticum durum Desf.), Einkorn (Triticum monococcum L. subsp. monococcum ), emmer (Triticum turgidum L. subsp. dicoccon (Schrank) Thell.), kamut (Triticum polonicum L.), and triticale ( x Triticosecale ssp. Wittm.). 27. [Added October, 2006] Are single ingredient foods required to comply with section 403(w)(1)? Yes. Single ingredient foods must comply with the allergen declaration requirements in section 403(w)(1). A single ingredient food that is, or contains protein derived from milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, or soybeans, may identify the food source in the name of the food (e.g.,

"all-purpose wheat flour") or use the "Contains" statement format. FDA recommends that if a "Contains" statement format is used, the statement be placed immediately above the manufacturer, packer, or distributor statement. For single ingredient foods intended for further manufacturing where the "Contains" statement format is used, the statement should be placed on the principal display panel of the food.

This is a revision of the third edition of the FDA guidance "Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004," which FDA issued on April 6, 2006.

d Allergens Labeling

Section Contents Menu

Labeling & Nutrition Food Allergens Labeling Exemptions from Food Allergen Labeling Petition & Notification Process o Industry/Regulator Information

Inventory of Notifications Received under 21 U.S.C. 343(w)(7) for Exemptions from Food Allergen Labeling
The Federal Food, Drug, and Cosmetic Act (the Act) governs the labeling of all foods (except meat products, poultry products, and certain egg products, which are regulated by the U.S. Department of Agriculture.) The Food Allergen Labeling and Consumer Protection Act (FALCPA) (Pub L. 108-282) amends the Act's labeling requirements for food ingredients. FALCPAs requirements apply to packaged foods, including conventional foods, dietary supplements, infant formula, and medical foods, all of which are "food" within the Act's definition, 21 U.S.C. 321(f). FALCPA requires that an ingredient (including a flavor, color, or incidental additive) that is a major food allergen, as defined by 21 U.S.C. 321(qq), be more explicitly identified on the food label. Under FALCPA, a "major food allergen" is one of eight foods or food groups (milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) or an ingredient that contains protein derived from one of the eight. 21 U.S.C. 321(qq). "Major food allergen" does not include a highly refined oil derived from one of the eight foods or food groups or any ingredient derived from such an oil, as well as any ingredient exempt under a statutory exemption process. FALCPA establishes a process under 21 U.S.C. 343(w)(7) by which any person may file a notification containing scientific evidence demonstrating that an ingredient does not contain allergenic protein. The scientific evidence must include the analytical method used and the ingredient must be derived by the specified method. FDA has 90 days to object to a notification. Absent an objection, the food ingredient is exempt from FALCPA's labeling requirements for major food allergens. FDA is required to post to a public site notifications received under 21 U.S.C. 343(w)(7). This posting is to be made within 14 days of receipt of a notification. The list below reflects the notifications received by FDA that are required at this time to be posted to a public site.

FALN Docket Date No. No. Received 2006FL- Dec 7, 0510 2006

Notifier / Ingredient Manufacturer Ferrosan A/S

Description

Major Food Allergen fish

Agency Response Objection letter dated March 6, 2007 Objection letter dated September 29, 2006 Objection letter dated May 31, 2006 Objection letter dated March 27, 2006 Objection letter dated February 21, 2006 Objection letter dated January 23, 2006 Objection letter dated December 27, 2005

007

deep sea fish extract

006

2006FL- July 5, 0287 2006

lyophilized Nutraceutix, Inc. probiotic cultures anhydrous lactitol and lactitol monohydrate

milk

005

2006FL- Mar 3, 120 2006

Danisco USA

milk

004

2006FL- Dec 27, 0017 2005

Purity Foods, Inc. Vita Spelt F & A Dairy and International starter growth Media and media Cultures, Inc. Ross Products Division, Abbot Laboratories Mead Johnson Nutritionals extensively hydrolyzed casein extensively hydrolyzed casein

wheat

003

2005FL- Nov 23, 0488 2005

soy

002

2005FL- Oct 26, 0434 2005

milk

001

2005N0416

Sep 30, 2005

milk

Page Last Updated: 05/18/2009

FDA Juice HACCP Rule

FDA Juice HACCP Rule

Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice
Final Rule

Subpart AGeneral Provisions

120.1 Applicability. 120.3 Definitions. 120.5 Current good manufacturing practice. 120.6 Sanitation standard operating procedures. 120.7 Hazard analysis. 120.8 Hazard Analysis and Critical Control Point (HACCP) plan. 120.9 Legal basis. 120.10 Corrective actions. 120.11 Verification and validation. 120.12 Records. 120.13 Training. 120.14 Application of requirements to imported products.

Subpart BPathogen Reduction

120.20 General. 120.24 Process controls. 120.25 Process verification for certain processors.

Authority: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381, 393; 42 U.S.C. 241, 242l, 264. Source: 66 FR 6197, Jan. 19, 2001, unless otherwise noted.

Subpart AGeneral Provisions

120.1 Applicability.
(a) Any juice sold as such or used as an ingredient in beverages shall be processed in accordance with the requirements of this part. Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree. The requirements of this part shall apply to any juice regardless of whether the juice, or any of its ingredients, is or has been shipped in interstate commerce (as defined in section 201(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321(b)). Raw agricultural ingredients of juice are not subject to the requirements of this part. Processors should apply existing agency guidance to minimize microbial food safety hazards for fresh fruits and vegetables in handling raw agricultural products. (b) The regulations in this part shall be effective January 22, 2002. However, by its terms, this part is not binding on small and very small businesses until the dates listed in paragraphs (b)(1) and (b)(2) of this section. (1) For small businesses employing fewer than 500 persons the regulations in this part are binding on January 21, 2003. (2) For very small businesses that have either total annual sales of less than $500,000, or if their total annual sales are greater than $500,000 but their total food sales are less than $50,000; or the person claiming this exemption employed fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of juice were sold in the United States, the regulations are binding on January 20, 2004.

120.3 Definitions.
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act, 101.9(j)(18)(vi), and part 110 of this chapter are applicable to such terms when used in this part, except where redefined in this part. The following definitions shall also apply: (a) Cleaned means washed with water of adequate sanitary quality. (b) Control means to prevent, eliminate, or reduce. (c) Control measure means any action or activity to prevent, reduce to acceptable levels, or eliminate a hazard. (d) Critical control point means a point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level.

(e) Critical limit means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard. (f) Culled means separation of damaged fruit from undamaged fruit. For processors of citrus juices using treatments to fruit surfaces to comply with 120.24, culled means undamaged, tree-picked fruit that is U.S. Department of Agriculture choice or higher quality. (g) Food hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control. (h) Importer means either the U.S. owner or consignee at the time of entry of a food product into the United States, or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the United States. The importer is responsible for ensuring that goods being offered for entry into the United States are in compliance with all applicable laws. For the purposes of this definition, the importer is ordinarily not the custom house broker, the freight forwarder, the carrier, or the steamship representative. (i) Monitor means to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification. (j)(1) Processing means activities that are directly related to the production of juice products. (2) For purposes of this part, processing does not include: (i) Harvesting, picking, or transporting raw agricultural ingredients of juice products, without otherwise engaging in processing; and (ii) The operation of a retail establishment. (k) Processor means any person engaged in commercial, custom, or institutional processing of juice products, either in the United States or in a foreign country, including any person engaged in the processing of juice products that are intended for use in market or consumer tests. (l) Retail establishment is an operation that provides juice directly to the consumers and does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers. Provides includes storing, preparing, packaging, serving, and vending. (m) Shall is used to state mandatory requirements.

(n) Shelf-stable product means a product that is hermetically sealed and, when stored at room temperature, should not demonstrate any microbial growth. (o) Should is used to state recommended or advisory procedures or to identify recommended equipment. (p) Validation means that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the identified food hazards. (q) Verification means those activities, other than monitoring, that establish the validity of the HACCP plan and that the system is operating according to the plan.

120.5 Current good manufacturing practice.

Part 110 of this chapter applies in determining whether the facilities, methods, practices, and controls used to process juice are safe, and whether the food has been processed under sanitary conditions.

120.6 Sanitation standard operating procedures.

(a) Sanitation controls. Each processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing. The SSOP shall address: (1) Safety of the water that comes into contact with food or food contact surfaces or that is used in the manufacture of ice; (2) Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; (3) Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product; (4) Maintenance of hand washing, hand sanitizing, and toilet facilities; (5) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; (6) Proper labeling, storage, and use of toxic compounds; (7) Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and

(8) Exclusion of pests from the food plant. (b) Monitoring. The processor shall monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with those conditions and practices specified in part 110 of this chapter that are appropriate both to the plant and to the food being processed. Each processor shall correct, in a timely manner, those conditions and practices that are not met. (c) Records. Each processor shall maintain SSOP records that, at a minimum, document the monitoring and corrections prescribed by paragraph (b) of this section. These records are subject to the recordkeeping requirements of 120.12. (d) Relationship to Hazard Analysis and Critical Control Point (HACCP) plan. Sanitation standard operating procedure controls may be included in the HACCP plan required under 120.8(b). However, to the extent that they are implemented in accordance with this section, they need not be included in the HACCP plan.

120.7 Hazard analysis.

(a) Each processor shall develop, or have developed for it, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice processed by that processor and to identify control measures that the processor can apply to control those hazards. The written hazard analysis shall consist of at least the following: (1) Identification of food hazards; (2) An evaluation of each food hazard identified to determine if the hazard is reasonably likely to occur and thus, constitutes a food hazard that must be addressed in the HACCP plan. A food hazard that is reasonably likely to occur is one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absence of those controls, the food hazard will occur in the particular type of product being processed. This evaluation shall include an assessment of the severity of the illness or injury if the food hazard occurs; (3) Identification of the control measures that the processor can apply to control the food hazards identified as reasonably likely to occur in paragraph (a)(2) of this section; (4) Review of the current process to determine whether modifications are necessary; and (5) Identification of critical control points. (b) The hazard analysis shall include food hazards that can be introduced both within and outside the processing plant environment, including food hazards that can occur before, during, and after harvest. The hazard analysis shall be developed by an individual or

individuals who have been trained in accordance with 120.13 and shall be subject to the recordkeeping requirements of 120.12. (c) In evaluating what food hazards are reasonably likely to occur, consideration should be given, at a minimum, to the following: (1) Microbiological contamination; (2) Parasites; (3) Chemical contamination; (4) Unlawful pesticides residues; (5) Decomposition in food where a food hazard has been associated with decomposition; (6) Natural toxins; (7) Unapproved use of food or color additives; (8) Presence of undeclared ingredients that may be allergens; and (9) Physical hazards. (d) Processors should evaluate product ingredients, processing procedures, packaging, storage, and intended use; facility and equipment function and design; and plant sanitation, including employee hygiene, to determine the potential effect of each on the safety of the finished food for the intended consumer. (e) HACCP plans for juice need not address the food hazards associated with microorganisms and microbial toxins that are controlled by the requirements of part 113 or part 114 of this chapter. A HACCP plan for such juice shall address any other food hazards that are reasonably likely to occur.

120.8 Hazard Analysis and Critical Control Point (HACCP) plan.

(a) HACCP plan. Each processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing, as described in 120.7. The HACCP plan shall be developed by an individual or individuals who have been trained in accordance with 120.13 and shall be subject to the recordkeeping requirements of 120.12. A HACCP plan shall be specific to: (1) Each location where juice is processed by that processor; and

(2) Each type of juice processed by the processor. The plan may group types of juice products together, or group types of production methods together, if the food hazards, critical control points, critical limits, and procedures required to be identified and performed by paragraph (b) of this section are essentially identical, provided that any required features of the plan that are unique to a specific product or method are clearly delineated in the plan and are observed in practice. (b) The contents of the HACCP plan. The HACCP plan shall, at a minimum: (1) List all food hazards that are reasonably likely to occur as identified in accordance with 120.7, and that thus must be controlled for each type of product; (2) List the critical control points for each of the identified food hazards that is reasonably likely to occur, including as appropriate: (i) Critical control points designed to control food hazards that are reasonably likely to occur and could be introduced inside the processing plant environment; and (ii) Critical control points designed to control food hazards introduced outside the processing plant environment, including food hazards that occur before, during, and after harvest; (3) List the critical limits that shall be met at each of the critical control points; (4) List the procedures, and the frequency with which they are to be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits; (5) Include any corrective action plans that have been developed in accordance with 120.10(a), and that are to be followed in response to deviations from critical limits at critical control points; (6) List the validation and verification procedures, and the frequency with which they are to be performed, that the processor will use in accordance with 120.11; and (7) Provide for a recordkeeping system that documents the monitoring of the critical control points in accordance with 120.12. The records shall contain the actual values and observations obtained during monitoring. (c) Sanitation. Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with 120.6, they are not required to be included in the HACCP plan.

120.9 Legal basis.

Failure of a processor to have and to implement a Hazard Analysis and Critical Control Point (HACCP) system that complies with 120.6, 120.7, and 120.8, or otherwise to operate in accordance with the requirements of this part, shall render the juice products of that processor adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Whether a processor's actions are consistent with ensuring the safety of juice will be determined through an evaluation of the processor's overall implementation of its HACCP system.

120.10 Corrective actions.

Whenever a deviation from a critical limit occurs, a processor shall take corrective action by following the procedures set forth in paragraph (a) or paragraph (b) of this section. (a) Processors may develop written corrective action plans, which become part of their HACCP plans in accordance with 120.8(b)(5), by which processors predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that: (1) No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and (2) The cause of the deviation is corrected. (b) When a deviation from a critical limit occurs, and the processor does not have a corrective action plan that is appropriate for that deviation, the processor shall: (1) Segregate and hold the affected product, at least until the requirements of paragraphs (b)(2) and (b)(3) of this section are met; (2) Perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform such review; (3) Take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; (4) Take corrective action, when necessary, to correct the cause of the deviation; and (5) Perform or obtain timely verification in accordance with 120.11, by an individual or individuals who have been trained in accordance with 120.13, to determine whether modification of the HACCP plan is required to reduce the risk of recurrence of the deviation, and to modify the HACCP plan as necessary.

(c) All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with 120.11(a)(1)(iv)(B) and the recordkeeping requirements of 120.12.

120.11 Verification and validation.

(a) Verification. Each processor shall verify that the Hazard Analysis and Critical Control Point (HACCP) system is being implemented according to design. (1) Verification activities shall include: (i) A review of any consumer complaints that have been received by the processor to determine whether such complaints relate to the performance of the HACCP plan or reveal previously unidentified critical control points; (ii) The calibration of process monitoring instruments; (iii) At the option of the processor, the performance of periodic end-product or in-process testing; except that processors of citrus juice that rely in whole or in part on surface treatment of fruit shall perform end-product testing in accordance with 120.25. (iv) A review, including signing and dating, by an individual who has been trained in accordance with 120.13, of the records that document: (A) The monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that the records document values that are within the critical limits. This review shall occur within 1 week (7 days) of the day that the records are made; (B) The taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with 120.10. This review shall occur within 1 week (7 days) of the day that the records are made; and (C) The calibrating of any process monitoring instruments used at critical control points and the performance of any periodic end-product or in-process testing that is part of the processor's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete and that these activities occurred in accordance with the processor's written procedures. These reviews shall occur within a reasonable time after the records are made; and (v) The following of procedures in 120.10 whenever any verification procedure, including the review of consumer complaints, establishes the need to take a corrective action; and (vi) Additional process verification if required by 120.25.

(2) Records that document the calibration of process monitoring instruments, in accordance with paragraph (a)(1)(iv)(B) of this section, and the performance of any periodic end-product and in-process testing, in accordance with paragraph (a)(1)(iv)(C) of this section, are subject to the recordkeeping requirements of 120.12. (b) Validation of the HACCP plan. Each processor shall validate that the HACCP plan is adequate to control food hazards that are reasonably likely to occur; this validation shall occur at least once within 12 months after implementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan in any way. Such changes may include changes in the following: Raw materials or source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or consumers of the finished product. The validation shall be performed by an individual or individuals who have been trained in accordance with 120.13 and shall be subject to the recordkeeping requirements of 120.12. The HACCP plan shall be modified immediately whenever a validation reveals that the plan is no longer adequate to fully meet the requirements of this part. (c) Validation of the hazard analysis. Whenever a juice processor has no HACCP plan because a hazard analysis has revealed no food hazards that are reasonably likely to occur, the processor shall reassess the adequacy of that hazard analysis whenever there are any changes in the process that could reasonably affect whether a food hazard exists. Such changes may include changes in the following: Raw materials or source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or intended consumers of the finished product. The validation of the hazard analysis shall be performed by an individual or individuals who have been trained in accordance with 120.13, and, records documenting the validation shall be subject to the recordkeeping requirements of 120.12.

120.12 Records.
(a) Required records. Each processor shall maintain the following records documenting the processor's Hazard Analysis and Critical Control Point (HACCP) system: (1) Records documenting the implementation of the sanitation standard operating procedures (SSOP's) (see 120.6); (2) The written hazard analysis required by 120.7; (3) The written HACCP plan required by 120.8; (4) Records documenting the ongoing application of the HACCP plan that include: (i) Monitoring of critical control points and their critical limits, including the recording of actual times, temperatures, or other measurements, as prescribed in the HACCP plan; and

(ii) Corrective actions, including all actions taken in response to a deviation; and (5) Records documenting verification of the HACCP system and validation of the HACCP plan or hazard analysis, as appropriate. (b) General requirements. All records required by this part shall include: (1) The name of the processor or importer and the location of the processor or importer, if the processor or importer has more than one location; (2) The date and time of the activity that the record reflects, except that records required by paragraphs (a)(2), (a)(3), and (a)(5) of this section need not include the time; (3) The signature or initials of the person performing the operation or creating the record; and (4) Where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed. The records shall contain the actual values and observations obtained during monitoring. (c) Documentation. (1) The records in paragraphs (a)(2) and (a)(3) of this section shall be signed and dated by the most responsible individual onsite at the processing facility or by a higher level official of the processor. These signatures shall signify that these records have been accepted by the firm. (2) The records in paragraphs (a)(2) and (a)(3) of this section shall be signed and dated: (i) Upon initial acceptance; (ii) Upon any modification; and (iii) Upon verification and validation in accordance with 120.11. (d) Record retention. (1) All records required by this part shall be retained at the processing facility or at the importer's place of business in the United States for, in the case of perishable or refrigerated juices, at least 1 year after the date that such products were prepared, and for, in the case of frozen, preserved, or shelf stable products, 2 years or the shelf life of the product, whichever is greater, after the date that the products were prepared. (2) Offsite storage of processing records required by paragraphs (a)(1) and (a)(4) of this section is permitted after 6 months following the date that the monitoring occurred, if such records can be retrieved and provided onsite within 24 hours of request for official review. Electronic records are considered to be onsite if they are accessible from an onsite location and comply with paragraph (g) of this section.

(3) If the processing facility is closed for a prolonged period between seasonal packs, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack but shall be immediately returned to the processing facility for official review upon request. (e) Official review. All records required by this part shall be available for review and copying at reasonable times. (f) Public disclosure. (1) All records required by this part are not available for public disclosure unless they have been previously disclosed to the public, as defined in 20.81 of this chapter, or unless they relate to a product or ingredient that has been abandoned and no longer represent a trade secret or confidential commercial or financial information as defined in 20.61 of this chapter. (2) Records required to be maintained by this part are subject to disclosure to the extent that they are otherwise publicly available, or that disclosure could not reasonably be expected to cause a competitive hardship, such as generic type HACCP plans that reflect standard industry practices. (g) Records maintained on computers. The maintenance of computerized records, in accordance with part 11 of this chapter, is acceptable.

120.13 Training.
(a) Only an individual who has met the requirements of paragraph (b) of this section shall be responsible for the following functions: (1) Developing the hazard analysis, including delineating control measures, as required by 120.7. (2) Developing a Hazard Analysis and Critical Control Point (HACCP) plan that is appropriate for a specific processor, in order to meet the requirements of 120.8; (3) Verifying and modifying the HACCP plan in accordance with the corrective action procedures specified in 120.10(b)(5) and the validation activities specified in 120.11(b) and (c); and 120.7; (4) Performing the record review required by 120.11(a)(1)(iv). (b) The individual performing the functions listed in paragraph (a) of this section shall have successfully completed training in the application of HACCP principles to juice processing at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration, or shall be otherwise qualified through job experience to perform these functions. Job experience may qualify an individual to perform these functions if such experience has provided knowledge at least equivalent to

that provided through the standardized curriculum. The trained individual need not be an employee of the processor.

120.14 Application of requirements to imported products.

This section sets forth specific requirements for imported juice. (a) Importer requirements. Every importer of juice shall either: (1) Obtain the juice from a country that has an active memorandum of understanding (MOU) or similar agreement with the Food and Drug Administration, that covers the food and documents the equivalency or compliance of the inspection system of the foreign country with the U.S. system, accurately reflects the relationship between the signing parties, and is functioning and enforceable in its entirety; or (2) Have and implement written procedures for ensuring that the juice that such importer receives for import into the United States was processed in accordance with the requirements of this part. The procedures shall provide, at a minimum: (i) Product specifications that are designed to ensure that the juice is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act because it may be injurious to health or because it may have been processed under insanitary conditions; and (ii) Affirmative steps to ensure that the products being offered for entry were processed under controls that meet the requirements of this part. These steps may include any of the following: (A) Obtaining from the foreign processor the Hazard Analysis and Critical Control Point (HACCP) plan and prerequisite program of the standard operating procedure records required by this part that relate to the specific lot of food being offered for import; (B) Obtaining either a continuing or lot specific certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported food has been processed in accordance with the requirements of this part; (C) Regularly inspecting the foreign processor's facilities to ensure that the imported food is being processed in accordance with the requirements of this part; (D) Maintaining on file a copy, in English, of the foreign processor's hazard analysis and HACCP plan, and a written guarantee from the foreign processor that the imported food is processed in accordance with the requirements of this part; (E) Periodically testing the imported food, and maintaining on file a copy, in English, of a written guarantee from the foreign processor that the imported food is processed in accordance with the requirements of this part; or

(F) Other such verification measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of this part. (b) Competent third party. An importer may hire a competent third party to assist with or perform any or all of the verification activities specified in paragraph (a)(2) of this section, including writing the importer's verification procedures on the importer's behalf. (c) Records. The importer shall maintain records, in English, that document the performance and results of the affirmative steps specified in paragraph (a)(2)(ii) of this section. These records shall be subject to the applicable provisions of 120.12. (d) Determination of compliance. The importer shall provide evidence that all juice offered for entry into the United States has been processed under conditions that comply with this part. If assurances do not exist that an imported juice has been processed under conditions that are equivalent to those required of domestic processors under this part, the product will appear to be adulterated and will be denied entry.

Subpart BPathogen Reduction

120.20 General.
This subpart augments subpart A of this part by setting forth specific requirements for process controls.

120.24 Process controls.

(a) In order to meet the requirements of subpart A of this part, processors of juice products shall include in their Hazard Analysis and Critical Control Point (HACCP) plans control measures that will consistently produce, at a minimum, a 5 log ( i.e., 105 ) reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism. For the purposes of this regulation, the pertinent microorganism is the most resistant microorganism of public health significance that is likely to occur in the juice. The following juice processors are exempt from this paragraph: (1) A juice processor that is subject to the requirements of part 113 or part 114 of this chapter; and (2) A juice processor using a single thermal processing step sufficient to achieve shelfstability of the juice or a thermal concentration process that includes thermal treatment of all ingredients, provided that the processor includes a copy of the thermal process used to achieve shelf-stability or concentration in its written hazard analysis required by 120.7. (b) All juice processors shall meet the requirements of paragraph (a) of this section through treatments that are applied directly to the juice, except that citrus juice processors may use treatments to fruit surfaces, provided that the 5-log reduction process begins

after culling and cleaning as defined in 120.3(a) and (f) and the reduction is accomplished within a single production facility. (c) All juice processors shall meet the requirements of paragraphs (a) and (b) of this section and perform final product packaging within a single production facility operating under current good manufacturing practices. Processors claiming an exemption under paragraph (a)(1) or (a)(2) of this section shall also process and perform final product packaging of all juice subject to the claimed exemption within a single production facility operating under current good manufacturing practices.

120.25 Process verification for certain processors.

Each juice processor that relies on treatments that do not come into direct contact with all parts of the juice to achieve the requirements of 120.24 shall analyze the finished product for biotype I Escherichia coli as follows: (a) One 20 milliliter (mL) sample (consisting of two 10 mL subsamples) for each 1,000 gallons of juice produced shall be sampled each production day. If less than 1,000 gallons of juice is produced per day, the sample must be taken for each 1,000 gallons produced but not less than once every 5 working days that the facility is producing that juice. Each subsample shall be taken by randomly selecting a package of juice ready for distribution to consumers. (b) If the facility is producing more than one type of juice covered by this section, processors shall take subsamples according to paragraph (a) of this section for each of the covered juice products produced. (c) Processors shall analyze each subsample for the presence of E. coli by the method entitled Analysis for Escherichia coli in Citrus JuicesModification of AOAC Official Method 992.30 or another method that is at least equivalent to this method in terms of accuracy, precision, and sensitivity in detecting E. coli. This method is designed to detect the presence or absence of E. coli in a 20 mL sample of juice (consisting of two 10 mL subsamples). The method is as follows: (1) Sample size. Total-20 mL of juice; perform analysis using two 10 mL aliquots. (2) Media. Universal Preenrichment Broth (Difco, Detroit, MI), EC Broth (various manufacturers). (3) Method. ColiComplete (AOAC Official Method 992.30modified). (4) Procedure. Perform the following procedure two times: (i) Aseptically inoculate 10 mL of juice into 90 mL of Universal Preenrichment Broth (Difco) and incubate at 35 C for 18 to 24 hours.

(ii) Next day, transfer 1 mL of preenriched sample into 10 mL of EC Broth, without durham gas vials. After inoculation, aseptically add a ColiComplete SSD disc into each tube. (iii) Incubate at 44.5 C for 18 to 24 hours. (iv) Examine the tubes under longwave ultra violet light (366 nm). Fluorescent tubes indicate presence of E. coli. (v) MUG positive and negative controls should be used as reference in interpreting fluorescence reactions. Use an E. coli for positive control and 2 negative controlsa MUG negative strain and an uninoculated tube media. (d) If either 10 mL subsample is positive for E. coli, the 20 mL sample is recorded as positive and the processor shall: (1) Review monitoring records for the control measures to attain the 5-log reduction standard and correct those conditions and practices that are not met. In addition, the processor may choose to test the sample for the presence of pathogens of concern. (2) If the review of monitoring records or the additional testing indicates that the 5-log reduction standard was not achieved ( e.g., a sample is found to be positive for the presence of a pathogen or a deviation in the process or its delivery is identified), the processor shall take corrective action as set forth in 120.10. (e) If two samples in a series of seven tests are positive for E. coli, the control measures to attain the 5-log reduction standard shall be deemed to be inadequate and the processor shall immediately: (1) Until corrective actions are completed, use an alternative process or processes that achieve the 5-log reduction after the juice has been expressed; (2) Perform a review of the monitoring records for control measures to attain the 5-log reduction standard. The review shall be sufficiently extensive to determine that there are no trends towards loss of control; (i) If the conditions and practices are not being met, correct those that do not conform to the HACCP plan; or (ii) If the conditions and practices are being met, the processor shall validate the HACCP plan in relation to the 5-log reduction standard; and (3) Take corrective action as set forth in 120.10. Corrective actions shall include ensuring no product enters commerce that is injurious to health as set forth in 120.10(a)(1).

FDA Juice Hazards & Controls Guide

FDA Juice Hazards & Controls Guide

Guidance for Industry

Juice HACCP Hazards and Controls Guidance First Edition

Final Guidance
Contains Nonbinding Recommendations

March 3, 2004

Comments and suggestions regarding this document may be submitted at any time. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the Docket Number 02D-0333. For questions regarding this document, contact Michael E. Kashtock at the Center for Food Safety and Applied Nutrition (CFSAN) at (Tel) 301-436-2022, (Fax) 301-436-2651, or e-mail mkashtoc@.fda.hhs.gov. Additional copies are available from: Office of Plant and Dairy Foods Center for Food Safety and Applied Nutrition Food and Drug Administration; 5100 Paint Branch Parkway College Park, MD 20740 http://www.cfsan.fda.gov/guidance.html

U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) February 2004

Contains Nonbinding Recommendations

Guidance for Industry(1) Juice HACCP Hazards and Controls Guidance First Edition
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

Highlights of the Juice HACCP Regulation

Both interstate and intrastate juice processors must evaluate their processing operations using HACCP principles. Effective dates for the regulation are January 20, 2002, January 21, 2003, or January 22, 2004, depending upon the size of your business. The regulation does not preempt the existing requirements to follow the current Good Manufacturing Practice (CGMP) regulations for your juice processing operations. The HACCP plan and other records of your sanitation standard operating procedures (SSOPs) and HACCP operations must be available for official inspection and copying. Employees involved in developing, or in certain aspects of implementing, a HACCP plan, must be trained in HACCP principles. The 5-log pathogen reduction must o be accomplished for the microbe you identify as the "pertinent microorganism," which is the most resistant microorganism of public health significance that is likely to occur in the juice, e.g., E. coli O157:H7, (2) o take place in one facility just prior to or after packaging, and o be applied directly to the juice, except for citrus juices. Fruit surface treatments may be used to accomplish the 5-log reduction for citrus fruits, but cleaned and undamaged tree-picked fruit must be used and the effectiveness of the treatment must be verified by regularly testing your product for generic E. coli. Shelf stable juices made using a single thermal processing step and juice concentrates made using a thermal concentration process that includes all of the ingredients are

exempt from the requirement to include control measures in your HACCP plan to achieve the 5-log pathogen reduction, but a copy of the thermal process must be included in your hazard analysis. Low-acid canned juice and juice subject to the acidified foods regulation is exempt from the requirement to include control measures in your HACCP plan to achieve the 5-log pathogen reduction, but the juice is still subject to the low-acid canned food regulation, or the acidified foods regulation, as appropriate, and all of the other requirements of the juice HACCP regulation. Retail establishments or businesses that make and sell juice directly to consumers and do not sell or distribute juice to other businesses are exempt from the juice HACCP regulation, but must comply with FDA's food labeling regulation in 21 CFR 101.17(g) that requires a warning statement on packaged fruit and vegetable juice products that have not been processed to prevent, reduce, or eliminate pathogenic microorganisms that may be present, and with any applicable state regulations.

Table of Contents
I. Introduction A. Status B. Purpose C. Scope and Limitations Terms and Definitions Overview of the Juice HACCP Regulation A. Compliance Required for All Juice Processors 1. 1.0 Intrastate and Interstate Firms 2. 2.0 Effective Dates-Very Small Businesses, Small Businesses, All Others 3. 3.0 Juice Importers 4. 4.0 If You Process a Non-Juice Beverages with a Juice Ingredient B. Some Key Requirements of the Juice HACCP Regulation 1. 1.0 Warning Label Statement Versus HACCP System 2. 2.0 Specialized Training in HACCP Principals Required 3. 3.0 Trained Employee or Consultant Acceptable 4. 4.0 Record Keeping and Electronic Records 1. 4.1 Official Review of Records C. Part 110 (CGMPs) Applicable to Firms Subject to Juice HACCP Regulation D. Exemptions and Items Not Subject to the Regulation 1. 1.0 Retail Businesses 2. 2.0 Non-Beverage Foods with Juice Ingredient (a fruit-flavored candy) 3. 3.0 Processors of Ingredients From Fruit Other Than Juice Juice Hazard Analysis

II. III.

IV.

V.

Overview of the Hazard Analysis 1. 1.0 Description 2. 2.0 Relevance to HACCP Plan and SSOPs 3. 3.0 Developed by HACCP-trained Employee or Consultant B. Preparing for a Hazard Analysis--Five Preliminary Steps C. Basic Steps of the Hazard Analysis 1. 1.0 Identify All Potential Hazards 1. 1.1 Biological Hazards 1. 1.11 Pathogens that may Occur in Acidic Juices (pH 4.6 or less) 2. 1.12 Pathogens that may Occur in Low-acid Juices (pH greater than 4.6) 3. 1.13 Viruses 2. 1.2 Chemical Hazards 1. 1.21 Patulin 2. 1.22 Undeclared Food Allergens in Juice Due to CrossContact from Shared Processing Equipment 3. 1.23 Allergens and Food Intolerance Substances Added to Juice as Ingredients 4. 1.24 Pesticide Residues 5. 1.25 Lead 6. 1.26 Tin 3. 1.3 Physical Hazards 1. 1.31 Glass Fragments 2. 1.32 Metal Fragments 2. 2.0 Evaluate All Potential Hazards 3. 3.0 Determine Whether Potential Hazards Will Require Controls in Your HACCP Plan 1. 3.1 Potential Hazards "Reasonably Likely to Occur" 2. 3.2 Potential Hazards Not "Reasonably Likely to Occur" 3. 3.3 Hazards Related to Facility Sanitation 4. 3.4 Controls for Allergens Arising from Food Contact Surfaces 4. 4.0 Identify Control Measures and CCPs 1. 4.1 NACMCF CCP Decision Tree 2. 4.2 Location of CCPs Control Measures A. HACCP Control Measures B. Activities Not Considered to be HACCP Control Measures 1. 1.0 GAPs 2. 2.0 CGMPs C. Control Measures for Biological Hazards 1. 1.0 Minimum Requirement of 5-Log Pathogen Reduction 1. 1.1 What Does "Pertinent Microorganism" Mean? 2. 1.2 Shelf Life and Moderate Temperature Abuse Conditions 3. 1.3 5-Log Treatment Performed on Juice After Extraction with One Exception

A.

VI.

VII.

2.0 Location of Juice Extraction, Processing and Packaging 3.0 Requirements for Certain Citrus Juices 1. 3.1 Compliance with Requirement to Use Tree-Picked, Culled Fruit 2. 3.2 Positive E. coli Test Results for Citrus Juices Made Using Surface Treatment of Fruit to Achieve 5-Log Reduction 4. 4.0 Heat Treated Shelf Stable Juices and Concentrates, and Other NonHeat Treated Juices 1. 4.1 Heat Treated Shelf Stable Juices and Concentrates 2. 4.2 Example of a Process for a Shelf Stable Juice 3. 4.3 Thermal Concentrate Processes 4. 4.4 Juices Subject to the Low-Acid Canned Foods and Acidified Foods Regulations 5. 4.5 Other Non-Thermal Treatments for Juice 5. 5.0 Process Validation 1. 5.1 Role of a "Process Authority" 2. 5.2 Validated Pasteurization Treatments for Juice 3. 5.3 Equipment and System Considerations 1. 5.31 Pasteurization Equipment 2. 5.32 UV Processing Systems 3. 5.33 High Pressure Processing Systems 4. 5.34 Dense Phase CO2 Processing Systems 5. 5.35 Extraction Equipment for Certain Citrus Juice Processes D. Control Measures for Chemical Hazards 1. 1.0 Control Strategies for Patulin for Apple Juice Processors 1. 1.1 Hazard Analysis 2. 1.2 Control Measures 3. 1.3 If You Make Apple Juice from Purchased Concentrate 2. 2.0 Control Measures for Food Allergens That Can Contaminate Juice from Improperly Cleaned Shared Processing Equipment E. Control Measures for Physical Hazards 1. 1.0 Physical Hazards 1. 1.1 Glass Fragments 2. 1.2. Metal Fragments F. Table of Most Likely Hazards/Control Measures for Juice Preparing for HACCP A. Getting People Ready B. HACCP Training and HACCP Resource Materials 1. 1.0 Juice HACCP Alliance Training Curriculum 2. 2.0 USDA/FDA HACCP Training Programs and Resources Database Example Documents A. Hazard Analysis Examples 1. 1.0 Hazard Identification and Evaluation Exercise for Apple Juice 1. 1.1 Step 1 - Hazard Identification 2. 1.2 Step 2 - Hazard Evaluation

2. 3.

B.

C.

2.0 Example Hazard Analysis for Pasteurized Refrigerated Apple Juice 3.0 Example Hazard Analysis for Fresh Orange Juice 4.0 Example Hazard Analysis for Not-from-concentrate Pasteurized Orange Juice HACCP Plan Examples 1. 1.0 Example HACCP Plan for Pasteurized Refrigerated Apple Juice 2. 2.0 Example HACCP Plan for Fresh Orange Juice 3. 3.0 Example HACCP Plan for Not-from-Concentrate Pasteurized Orange Juice Example CCP and SSOP for prevention of occurrence of undeclared milk residues in juice

2. 3. 4.

I. Introduction
A. Status
This is the first edition of the Food and Drug Administration's (FDA) "Juice HACCP Hazards and Controls Guidance." FDA recommends that this guidance be used in conjunction with FDA's final regulation (21 CFR Part 120) that requires a processor of juice to evaluate its operations using Hazard Analysis Critical Control Point (HACCP) principles and, if necessary, to develop and implement HACCP systems (i.e., a system of preventive control measures based upon HACCP principles) for it's operations. The final regulations were published in the Federal Register on January 19, 2001, and become effective one, two, or three years from that date, depending upon the size of your business. We may revise and reissue this guidance from time to time as the state of knowledge advances relative to juice hazards and controls. We will accept public comment on this edition of the guidance at any time for consideration in drafting a future edition. Comments should be submitted to: U.S. Food and Drug Administration Dockets Management Branch Room 1-23 12420 Parklawn Drive Rockville, MD 20857 Comments should be identified with Docket Number 02D-0333.

B. Purpose
The purpose of this guidance is to assist you in the development of a HACCP plan, should your hazard analysis show that such a plan is necessary under 21 CFR 120.8(a). You will find information in this guidance that will help you identify hazards that may potentially occur in

your products, and help you identify and use methods of controlling and preventing hazards. This guidance is also intended to serve as a tool for federal and state regulatory officials in the evaluation of HACCP plans for juice products. To help you understand some key aspects of the juice HACCP regulation and plan how you will initiate your HACCP activities, we have included information on some other important aspects of the juice HACCP regulation such as effective dates, use of the label warning statement, and training. Additional information on juice HACCP is available at www.cfsan.fda.gov under "Program Areas" and "HACCP." The information available at this website includes the HACCP regulation, the publication, "The Juice HACCP Regulation Questions and Answers," and additional guidance FDA has issued related to the juice HACCP regulation. By periodically checking this website you will have access to the most up-to-date FDA information on juice HACCP. The documents at this website also are available by mail from the address given in section I. C below. In addition, all FDA Compliance Policy Guide (CPG) documents referred to in this guidance are available at http://www.fda.gov/ora/compliance_ref/cpg/default.htm. On our website, you can also find background information on fruit and vegetable juice safety, and in particular, foodborne illness outbreaks involving juice that in part, led to the establishment of the juice HACCP regulation. This information can be viewed at http://www.foodsafety.gov/~dms/fs-toc2.html#juice.

C. Scope and Limitations

The controls and practices provided in this guidance are recommendations and guidance from FDA primarily to the juice industry. This guidance is not a set of binding requirements. Importantly, this guidance may not identify all hazards that need to be controlled, and it is the ultimate responsibility of the juice processor to identify all hazards that are reasonably likely to occur and all appropriate controls for such hazards. You may choose to use other control measures, as long as they meet the requirements of the juice HACCP regulation and are consistent with relevant state and federal laws or regulations. The information contained in section IV provides guidance for determining which hazards are "reasonably likely to occur" in specific types of juice products under ordinary circumstances. This section lists potential hazards for specific types of juice products. We recommend that this information be combined with other relevant information available to you and used in conducting the hazard analysis to determine the likelihood of occurrence of a hazard. This guidance is not a substitute for a processor's performance of its own hazard analysis as required by FDA's regulations. Hazards not covered by this guidance may be relevant to certain products under certain circumstances. In particular, you should be alert to new or emerging problems. This guidance does not cover the hazard associated with the formation of Clostridium botulinum toxin in juices that are low acid canned foods or shelf stable acidified foods. Mandatory controls for this hazard are contained in the Low Acid Canned Foods regulation (21 CFR Part 113) and

the Acidified Foods regulation (21 CFR Part 114). As explained in section VI, such controls need not be included in HACCP plans for these juice products. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required.

II. Terms and Definitions

This section lists definitions of several terms as they appear in FDA's juice HACCP regulation. Following many of the definitions below, you will find Additional helpful information about the defined term. Although not formally defined in the juice HACCP regulation, this section also describes the terms "fallen fruit," "hazard analysis," "HACCP," "HACCP plan," HACCP team," "juice concentrate," "pasteurization," "process authority," and "retail establishment." Cleaned means washed with water of adequate sanitary quality. Control means to prevent, eliminate, or reduce. Control measure means any action or activity that is used to prevent, reduce to acceptable levels, or eliminate a hazard. Additional helpful information: You are required to identify control measures in your hazard analysis for all hazards that were determined to be "reasonably likely to occur" in your hazard analysis. This is illustrated in Column 5 of the Hazard Analysis examples in section VII. A. Critical control point (CCP) means a point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to prevent, reduce to an acceptable level, or eliminate an identified food hazard. Additional helpful information: You are required to identify CCPs in your hazard analysis for all hazards that were determined to be "reasonably likely to occur" in your hazard analysis. This is illustrated in Column 6 of the Hazard Analysis examples in section VII. A. Critical limit means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable levelthe occurrence of the identified food hazard. Additional helpful information: You are required to specify critical limits in your HACCP plan for each hazard to be controlled at a critical control point. This is illustrated in Column 3 of the HACCP plan examples in section VII. B.

Culled means separation of damaged fruit from undamaged fruit. Under this guidance, for processors of citrus juices using treatments to fruit surfaces to comply with 21 CFR 120.24, FDA will consider tree-picked, undamaged citrus fruit to be "culled" for purposes of compliance with the juice HACCP regulation. (Note: The definition of the term "culled" in 21 CFR 120.3(f) includes the requirement that the fruit is of U.S. Department of Agriculture (USDA) choice or higher quality, however, there is no current USDA standard for choice or higher quality.) Fallen fruit means fruit that has fallen naturally from the tree to the ground in an orchard. It does not include mechanically harvested fruit, which is obtained by shaking the tree and collecting the fruit from the ground with appropriate mechanical machinery; also called grounders, windfall fruit, or drops. Food hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Hazard Analysis and Critical Control Points (HACCP) means a systematic approach to the identification, evaluation, and control of food safety hazards. HACCP Plan means the written document that is based upon the principles of HACCP and delineates the procedures to be followed. HACCP Team means the group of people who are responsible for developing, implementing, and maintaining the HACCP system. Hazard Analysis means the process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan. Additional helpful information: All juice processors subject to the juice HACCP regulation are required to prepare a written hazard analysis. The hazard analysis process for juice products is covered in section IV. Example hazard analyses for refrigerated pasteurized apple juice, fresh orange juice, and not-from-concentrate pasteurized orange juice are covered in section VII. A. Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree. Additional helpful information: The juice HACCP regulation requires that processors apply HACCP principles if they make juice or juice concentrates for subsequent beverage use. Any processor making a product that could be labeled as 100 percent juice under 21 CFR 101.30, or a concentrate of that juice for subsequent beverage use must apply HACCP principles. For beverages containing less than 100 percent juice, only the juice ingredient must be made applying HACCP principles. Juice concentrate means the aqueous liquid expressed or extracted from one or more fruits or vegetables and reduced in weight and volume through the removal of water from the juice.

Monitor means to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for future use in verification. Additional helpful information: You are required to specify monitoring procedures including what, how, how often, and who is performing the monitoring, in your HACCP plan for each hazard to be controlled at a critical control point. This is illustrated in the HACCP Plan examples in section VII. B. Pasteurization means a heat treatment sufficient to destroy vegetative cells of pathogens. Process Authority means an expert in the processes for controlling pathogenic microorganisms in food, and as such, is qualified by training and experience to evaluate all of the aspects of your pathogen control measures, e.g., process time, temperature, type of equipment, etc., and determine that your control measures, if properly implemented, will control pathogens effectively. Retail Establishment means an operation that provides juice directly to consumers and does not sell or distribute juice to other businesses. The term "provides" includes storing, preparing, packaging, serving, and selling juice. Shelf stable product means a product that is hermetically sealed and, when stored at room temperature, should not demonstrate any microbial growth. Additional helpful information: If you process certain types of shelf stable juice products, you are exempt from the requirements in 21 CFR 120.24 to include control measures in your HACCP plans for those products for achieving a 5-log reduction in the pertinent microorganism. This exemption applies to the following types of products:

products subject to the requirements of the Low Acid Canned Foods and Acidified Foods regulations in 21 CFR Parts 113 and 114, respectively acidic juices such as canned orange juice and "juice box" style grape juice, which are made shelf stable using a single thermal processing step juice concentrates like orange juice concentrate or apple juice concentrate in which all ingredients of the concentrate receive a thermal concentration process

Validation means that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP system, when properly implemented, will control effectively the identified food hazards. Additional helpful information: A person trained in accordance with the requirements of 21 CFR 120.13 must validate your HACCP plan initially and at least annually thereafter, or whenever changes in the process occur that could affect the hazard analysis or alter the HACCP plan in any way.

Even if your hazard analysis shows that there are no food hazards that are reasonably likely to occur during the processing of your juice, a person with appropriate training or experience must validate your hazard analysis. In addition, your hazard analysis must be reassessed (e.g., revalidated) by a person with appropriate training or experience whenever there is any change in the process that could reasonably affect whether a food hazard exists. Section 120.25 of the juice HACCP regulation also describes circumstances in which it may be necessary to revalidate your HACCP plan due to process deviations, problems noted in the weekly review of monitoring records, or positive generic E. coli test results for certain citrus juices. Verification means those activities, other than monitoring, that establish the validity of the HACCP plan and that the system is operating according to the plan. It includes validation procedures. Additional helpful information: Section 120.11 specifies certain actions, e.g., a review of consumer complaints and a review of records of the monitoring of CCPs, which you must carry out as part of your verification activities. You should review this section and take note that review of records for verification purposes must be carried out by an appropriately trained or qualified individual (as set forth in Section 120.13) within a specified period of time.

III. Overview of the Juice HACCP Regulation

Section III provides a brief discussion of the juice HACCP regulation. The section includes details on who must comply, the deadlines for compliance, the key requirements, the CGMPs requirements, and the exemptions to the regulation.

A. Compliance Required for All Juice Processors

All juice (as defined in 21 CFR 120.1(a)) sold as juice or for use as an ingredient in other beverages is subject to the requirements of the juice HACCP regulation, with the exception of juice produced at a retail establishment (i.e., for sale directly to consumers only; see definition of "Retail Establishment"), (However, see subpart D 1.0 of this section for information about labeling requirements for certain juices produced at a retail establishment). 1. 1.0 Intrastate and Interstate Firms The regulation's requirements apply equally to juices produced and sold within the same state as well as juices sold in interstate commerce. 2. 2.0 Effective Dates--Very Small Businesses, Small Businesses, All Others The requirements take effect on the following dates. However, FDA recommends that all firms implement HACCP as quickly as possible.

January 20, 2004, for very small businesses (as defined in 21 CFR 120.1(b)(2)) which are those operations that have either total annual sales of less than $500,000, or have total annual sales greater than $500,000 but their total food sales are less than $50,000, or are operations that employ fewer than an average of 100 full-time equivalent employees and sell fewer than 100,000 units of juice in the United States. o January 21, 2003, for small businesses (as defined in 21 CFR 120.1(b)(1)) which are those operations employing fewer than 500 persons. o January 22, 2002, for all businesses not defined as "small businesses" or "very small businesses." 3. 3.0 Juice Importers
o

Section 120.14 of the juice HACCP regulation specifically describes requirements for imported juice. In brief, if you are an importer of juice you must either: ensure that all juice offered for import into the U.S. has been processed in compliance with the juice HACCP regulation, or o import juice from a country that has an appropriate memorandum of understanding (MOU) with the U.S. that covers juice and documents the equivalency or compliance of the inspection system of the foreign country with the U.S. system, accurately reflects the relationship between the signing parties, and is functioning and enforceable in its entirety (At this time, no such MOU has been established with any country concerning juice. Should an MOU be established with any country concerning juice, FDA will publish a notice to this effect in the Federal Register and make the MOU available on its website.)
o

In addition, if you import juice, you are required to maintain records that document the performance and the results of your affirmative steps as specified in 21 CFR 120.14 (a)(2)(ii). 4. 4.0 If You Process a Non-Juice Beverage with a Juice Ingredient The juice HACCP regulation applies to the processing of any product that may be labeled as 100 percent juice under 21 CFR 101.30 that is sold either as "juice" or for use as an ingredient in beverages. Non-juice beverages that contain juice as an ingredient, e.g., carbonated beverages that contain juice, or fruit flavored drinks that contain juice, are not required to be produced under a HACCP system. However, juice that is used as an ingredient in the non-juice beverage is required to be produced under a HACCP system.

B. Some Key Requirements of the Juice HACCP Regulation

1. 1.0 Warning Label Statement Versus HACCP System Since September 8, 1998, for apple juice (including apple cider) and November 5, 1998, for all other juices, 21 CFR 101.17(g) has required that any container of juice that has not been treated to achieve a 5-log reduction in the most resistant pathogen bear a warning

label informing consumers of the risk associated with consuming untreated juice. Upon your applicable date of coverage under the HACCP regulation, you may no longer sell juice that has not been treated to achieve the 5-log pathogen reduction, even if you use the label warning statement. You may continue to use the label warning statement until your applicable effective date. For example, after January 22, 2003, very small businesses may still use label-warning statements for an additional year. After the respective effective date, the label warning statement is no longer an alternative to compliance with the HACCP regulation. 2. 2.0 Specialized Training in HACCP Principles Required Individuals who perform certain functions, such as developing the hazard analysis and HACCP plan and reviewing the HACCP records, must have successfully completed training in the application of HACCP principles to juice processing. The training must be at least equivalent to that received under the standardized curriculum described in section VI. B. Alternatively, job experience may qualify an individual to perform these functions if the experience has provided knowledge at least equivalent to that provided through the standardized curriculum. The training requirements are in 21 CFR 120.13. Insection VI. B. we have listed several sources of information about HACCP resource materials and HACCP training. 3. 3.0 Trained Employee or Consultant Acceptable The trained individual who performs functions under the juice HACCP regulation, such as development of your HACCP plan, may be an employee of the processing firm, an outside consultant, or both. For example, you may retain a qualified consultant to carry out the hazard analysis and use a trained plant employee to carry out the periodic review of HACCP records. 4. 4.0 Record Keeping and Electronic Records You must maintain several types of records to document each HACCP system. These records include records pertaining to sanitation standard operating procedures (SSOPs), the hazard analysis, the HACCP plan, and operational records such as records of monitoring, corrective actions, and verification and validation activities. These requirements are listed in 21 CFR 120.12. When the records required by the HACCP regulation are to be collected electronically, we recommend that the systems used to generate the electronic records comply with the electronic records and electronic signature provisions of 21 CFR Part 11. These regulations address procedures for system validation, system access, audit trails, authority and data checks, user education, documentation control, and if used in conjunction with electronic signatures, electronic signature control. Most of today's processing systems of

today have incorporated an electronic record keeping system for all of the process control variables. For example, if pasteurization, which is a heat treatment sufficient to destroy the vegetative cells of pathogens, is used as a control step, and the system incorporates an electronic control/recording system, the electronic record data generated for temperature and time would be an electronic record and the data c ollection system should be in compliance with 21 CFR Part 11. 5. 4.1 Official Review of Records You must make certain records available for review and copying by the regulatory agency at reasonable times. 21 CFR 120.12 lists these records.

C. Part 110 (CGMPs) Applicable to Firms Subject to Juice HACCP Regulation

When your firm becomes subject to the juice HACCP regulation, you must still comply with the CGMPs requirements in 21 CFR Part 110. Compliance with the juice HACCP regulation does not substitute for compliance with 21 CFR Part 110. In fact, compliance with 21 CFR Part 110, e.g., maintaining appropriate sanitation, employee hygiene, and pest control practices in a facility, is an essential foundation for a successful HACCP system.

D. Exemptions and Items Not Subject to the Regulation

1. 1.0 Retail Businesses If you qualify as a retail establishment, you are not required to process juice under a HACCP system. However, packaged juice produced at a retail establishment is subject to FDA's food labeling regulation in 21 CFR 101.17(g), which requires a warning statement on fruit and vegetable juice products that have not been processed to prevent, reduce, or eliminate pathogenic microorganisms. A retail establishment is an operation that provides juice directly to consumers and does not sell or distribute juice to other businesses. The term "provides" includes storing, preparing, packaging, serving, and selling juice. If you hire someone to make juice from your fruit and sell the juice at your roadside stand, you, the retailer, are exempt from the juice HACCP regulation, but the processor who makes your juice is subject to the regulation. That processor is not a retail establishment because the processor is not selling the juice directly to consumers. If you produce your own juice and sell it at your roadside stand, and also sell or distribute some of your juice to other businesses to sell or resell, your juice must be processed under a HACCP system because you are not providing all of the juice directly to consumers.

For more information on what types of businesses qualify as retail establishments, see the publication, "Juice HACCP Regulation Questions and Answers (see section I. C for availability information). 2. 2.0 Non-Beverage Foods with Juice Ingredient (e.g., fruit flavored candy) The juice HACCP regulation only applies to the processing of juice that is sold either as juice or for use as an ingredient in beverages. Thus, in the case of a non-beverage food, such as a fruit flavored candy that contains juice as an ingredient, neither the candy nor the juice ingredient is subject to the requirements of the juice HACCP regulation. Processors may find it beneficial to use HACCP systems voluntarily to produce such foods. 3. 3.0 Processors of Ingredients from Fruit Other than Juice Food ingredients other than juice that are derived from fruits and vegetables, e.g., citrus oil, are not subject to the juice HACCP regulation. The juice HACCP regulation applies only to juice that is sold either as juice or for use as an ingredient in beverages and not to any other fruit or vegetable product.

IV. Juice Hazard Analysis

Section IV begins with a definition of hazard analysis and outlines a process that will help prepare you to conduct the analysis, covers the basic steps of a hazard analysis, and identifies potential hazards for juice and juice products.

A. Overview of the Hazard Analysis

1. 1.0. Description The juice hazard analysis is a process of collecting and evaluating information on hazards associated with juice, to determine which hazards are reasonably likely to occur and, thus, pursuant to 21 CFR 120.8(a) must be addressed in a HACCP plan. Under 21 CFR 120.7(a), you are required to produce, for each type of juice you process, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur and to identify measures that you can apply to control those hazards. This is illustrated in the hazard analysis examples in section VII.A. The regulation requires a written hazard analysis for each type of juice unless different types of juice have identical hazards and control measures and then they may be grouped in one hazard analysis. 2. 2.0 Relevance to HACCP Plan and SSOPs

All juice processors subject to the juice HACCP regulation are required to prepare a written hazard analysis. If you determine that any hazard is "reasonably likely to occur" in a particular juice product, pursuant to 21 CFR 120.8(a), you must control that hazard in the product by applying control measures as part of a properly designed and implemented HACCP plan, except that some hazards for which you could reach this conclusion may be controlled under your SSOPs as discussed in section IV.(3) C. 3.2. If you produce a shelf stable juice or a thermally concentrated juice as described in 21 CFR 120.24, and you determine that no hazards are "reasonably likely to occur" in your juice, you are not required to develop a HACCP plan, but you must establish and implement SSOPs as required under 21 CFR 120.6. Your SSOP monitoring and corrective action records and your hazard analysis are still subject to the record keeping and official record review requirements in 21 CFR 120.12. 3. 3.0 Developed by HACCP-trained Employee or Consultant Your hazard analysis must be developed by an appropriately trained individual (or individuals), as specified in 21 CFR 120.13. This person may be your employee or a hired outside expert.

B. Preparing for a Hazard Analysis - Five Preliminary Steps

Although not required by FDA, the 5 preliminary steps of HACCP as outlined by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will help you in conducting your hazard analysis and developing your HACCP plan, and will prove valuable for other HACCP functions. The recommended steps are: 1. 2. 3. 4. 5. Step 1 Assemble a HACCP team. Step 2 Describe the food and its distribution. Step 3 Identify the intended use and consumers of the food. Step 4 Develop a flow diagram that describes the process. Step 5 Verify the flow diagram, i.e., ensure that it is accurate.

For more information, see the NACMCF publication "Hazard Analysis and Critical Control Point Principles and Application Guidelines," Journal of Food Protection, Vol. 61, No. 9, pp. 1246-1259 (1998) (the "HACCP Principles and Guidelines" publication).

C. Basic Steps of the Hazard Analysis

In order to prepare the written hazard analysis, your HACCP team should carry out the basic steps of a hazard analysis as described in the following sections 1.0-4.0 of this guidance. In carrying out these steps, we recommend that your team refer to Appendix C, "Examples of Questions to be Considered When Conducting a Hazard Analysis" and Appendix D, "Examples of How the Stages of Hazard Analysis Are Used to Identify and Evaluate Hazards" in the HACCP Principles and Guidelines publication.

1. 1.0 Identify All Potential Hazards Step 1 -- We recommend that you shouldidentify all potential physical, chemical, and biological hazards associated with the juice. Section 120.7 (c) lists specific types of hazards, e.g., natural toxins, microbial contaminants, undeclared allergenic ingredients, that at a minimum, we recommend be considered in your hazard analysis. In this section, we have included some specific biological, chemical, and physical hazards that we recommend you consider in your hazard analysis. However, depending on your product, process, equipment, and facility, you may need to consider additional hazards in your hazard analysis. 2. 1.1 Biological Hazards 3. 1.11 Pathogens that may Occur in Acidic Juices (pH 4.6 or less) Acidic juices (pH 4.6 or less) containing enteric bacterial pathogens such as E. coli O157:H7, various Salmonella species, and the protozoan parasite Cryptosporidium parvum have caused serious foodborne illness outbreaks. Some of the illnesses associated with juices have been very severe (e.g., cases of long-term reactive arthritis and severe chronic illness). In one case, consumption of contaminated juice resulted in the death of a child and in another case, consumption of contaminated juice contributed to the death of an elderly man. These microorganisms inhabit the intestinal tracts of animals; when animals and their manure or feces share proximity in an environment, produce can become contaminated, either directly or indirectly through such means as contaminated irrigation water or runoff. The use of contaminated produce to produce the juice, and the ability of some of these pathogens to survive in acidic foods like juices, along with use of inadequate controls for these pathogens during juice processing, are believed to be among the causative factors for these outbreaks. Illness-causing organisms that are ubiquitous in nature, such as Listeria monocytogenes, have also been identified as possible contaminants in juice. Guidance on selecting the pertinent microorganism for acidic juices for purposes of meeting the 5-log pathogen reduction requirement is provided in Section V. C. 1.1. 4. 1.12 Pathogens that may Occur in Low-acid Juices (pH greater than 4.6) While enteric pathogens present in acidic fruit juices have been the cause of most foodborne illness outbreaks associated with juice, these are not the only types of harmful microorganisms that could occur in juice. We recommend that a processor of low acid juices, such as carrot juice, that are distributed under refrigeration and that are not subject to the Low Acid Canned Foods regulation (in 21 CFR Part 113) give consideration to toxins produced by non-proteolytic and proteolytic strains of Clostridium botulinum as potential hazards to be controlled under its HACCP plan. Guidance on control measures and on selecting the pertinent microorganism for low-acid juices for purposes of meeting the 5-log pathogen reduction requirement is provided in Section V. C. 1.1. 5. 1.13 Pathogen Hazard Identification/Evaluation for Acidic Shelf Stable Juices

If you produce acidic shelf stable juice, under 21 CFR 120.24 (a)(2), you are exempt from the requirement to include control measures in your HACCP plan for the control of microbial pathogens. We recommend that you identify the relevant pertinent microorganism for your juice, e.g., salmonella, as a potential hazard in the hazard identification phase of your hazard analysis, but in the hazard evaluation phase, you may conclude that such hazards are not reasonably likely to occur because the product is processed to achieve shelf stability. A partial hazard analysis summary table (illustrating only the receipt of raw fruit and pasteurization steps) for such an analysis could be as follows:

(1) Ingredient/Processi ng Step

(3) (4) (2) Justify Are any Identify your potential potential decision foodhazards for safety introduce Column 3 hazards d, controlled significant ? or enhanced (Yes/No) at this step. BNo pathogens such as Salmonella Product is shelf stable per attached process. 21 CFR 120.24 (a) (2) provides exemption for 5-log reduction requireme nt for juice processors producing shelf stable product Product is shelf

(5) What preventative measure(s) can be applied to prevent/reduce/elimi n-ate the hazard?

(6) Is this step a critical control point? (Yes//No )

Receipt of raw fruit

Pasteurization

Bpathogens

No

such as Salmonella

stable per attached process. 21 CFR 120.24 (a) (2) provides exemption for 5-log reduction requireme nt for juice processors producing shelf stable product

1. 1.14 Viruses Juices contaminated with viruses have been implicated in foodborne illness outbreaks. Contamination of food by viruses is most likely to be caused by an ill individual, such as a farm worker or food handler. Thus, contamination of juice by viruses is not likely to occur in a processing facility that controls, under its SSOPs, employee health and hygiene conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces. We also encourage you to work with your suppliers to promote their use of FDA's "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables," (FDA's GAPs guidance document). This guidance document (see Section V. B. 1.0 below for availability information) includes provisions that address worker health and hygiene for individuals that handle the fruits and vegetables you use to produce juice. 2. 1.2 Chemical Hazards 3. 1.21 Patulin Patulin is a mycotoxin that is produced by fungi commonly found on apples. High levels of patulin can be produced in rotting or moldy apples. Fallen fruit, apples that have been damaged, e.g., by insects or birds, or bruised, e.g., during handling, are more susceptible to the growth of patulin-producing molds. Storage of apples under conditions that are not inhibitory to the growth of molds also can lead to high levels of patulin in the apples. If fallen fruit, moldy, rotten, bruised or damaged apples, or improperly stored apples, are used to make juice, high levels of patulin may occur in the juice, including pasteurized juice, because thermal processing does not destroy patulin.

Exposure over time to high levels of patulin may pose a health hazard. FDA has established an action level(4) for patulin in apple juice of 50 micrograms per kilogram (50 parts per billion) as determined on single strength apple juice or reconstituted single strength apple juice. (See FDA's Compliance Policy Guide (CPG Section 510.150) concerning patulin; section I. C provides availability information.) In fact, if one rotten apple (containing >10,000 parts per billion (ppb) patulin) is used along with 200 sound apples to make juice, the resulting patulin level in the juice could exceed FDA's action level for patulin. 4. 1.22 Undeclared Food Allergens(5) in Juice due to Cross-Contact from Shared Processing Equipment If you are a juice processor and handle other foods containing allergenic food ingredients in the same facility, you should consider the potential for hazards from cross-contact of your juice by other food substances that can cause allergic reactions. A chemical hazard (specifically, an undeclared food allergen) can occur when juice is processed on equipment that has been used to process a potentially allergenic food without adequate cleaning prior to the juice run. FDA believes that there is scientific consensus that the following foods can cause serious allergic reactions in some individuals and account for more than 90% of all food allergies: 1. 2. 3. 4. 5. 6. 7. 8. Peanuts Soybeans Milk Eggs Fish Crustacea Tree nuts Wheat

For instance, inadvertent introduction of milk protein into juice can occur if juice is processed using inadequately cleaned equipment previously used to produce milk or a dairy-based beverage. An individual who is allergic to milk could face a potentially serious and unexpected health risk upon consuming the juice containing the milk protein. Under 21 CFR 120.6 of the juice HACCP regulation, you may address these types of potential hazards by establishing effective equipment cleaning procedures at a CCP in your process, or as part of your SSOPs. (Section IV. C. 3.4, discusses this issue.) FDA has issued a Compliance Policy Guide (CPG Section 555.250) entitled "Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens" (see Section I. C for availability) and an inspection guide entitled "Guide to Inspections of Firms Producing Products Susceptible to Contamination with Allergenic Ingredients" (available at http://www.fda.gov/ora/inspect_ref/igs/Allergy_Inspection_Guide.htm). We

encourage you to read these documents and consider the information in them as you establish your HACCP system. 5. 1.23 Allergens and Food Intolerance Substances Added to Juice as Ingredients The juice HACCP regulation applies to any juice, juice concentrate, or puree product that could be labeled as 100 percent juice in accord with the requirements of 21 CFR 101.30, "Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice." Some products that may be labeled as 100 percent juice under 21 CFR 101.30 also may contain added ingredients such as soy protein or a preservative such as sulfites, which can cause allergic or allergic-type (food intolerance) reactions in sensitive individuals. Because these types of products are juice with added ingredients, and not beverages that contain juice as an ingredient (e.g., a flavored bottled water or a dairybased beverage with juice), these products are subject to the HACCP regulation. Should any ingredient of a 100 percent juice product have the potential to cause allergic or allergic-type (food intolerance) reactions in sensitive individuals, the presence of the ingredient must be declared on the label in accord with the food labeling regulations in 21 CFR Part 101. Controls to ensure that proper labels are used should be part of your HACCP plan. The following is a list of some ingredients for which we recommend that you implement such controls: 1. Any of the 8 foods listed in Section 1.22 2. Sulfites, in concentrations of 10 parts per million (ppm) or greater 3. FD&C Yellow No. 5 6. 1.24 Pesticide Residues Pesticides are used widely to treat (e.g., for insect control) fruits, vegetables, grains, and other foods, and may be present in small amounts as residues on these foods. Before a pesticide may be sold in the United States, the Environmental Protection Agency (EPA) evaluates the pesticide and determines whether or not to grant a registration that permits its sale and use. For pesticides used on foods, EPA also must establish a tolerance, which is the amount of residue legally permitted to remain in or on each treated food commodity, or an exemption from the requirement of a tolerance for the pesticide residue on the particular commodity. Residues from unapproved pesticides, or residues in excess of pesticide tolerances, are illegal and could pose a potential hazard in juice warranting control in a HACCP plan if the residues occurred over a period of time at levels capable of causing health effects from repeated exposure, or if they occurred for only a brief period of time at levels capable of causing acute health effects. See additional information on pesticides in section IV. C. 2.0. 7. 1.25 Lead Juice can become contaminated with lead if lead-contaminated produce is used to make the juice. Lead contamination of produce can occur as a result of past use of lead in

agricultural settings. For example, past use of lead arsenate as a pesticide in what were apple orchards is believed to have caused persistent lead contamination of the soil causing carrots presently grown on these sites to contain elevated lead levels. Produce could also become contaminated with airborne lead if it is handled at sites where vehicles or equipment are operated that use leaded fuel, if the equipment is operated in a manner that exposes the produce to excessive emissions from the equipment. Lead is especially hazardous to young children. In 1993, FDA established an emergency action level of 80 ppb and above for lead in juice packed in lead soldered cans. (See the Federal Register notice of April 1, 1993 (58 FR 17233).) However, based upon a recent toxicological assessment for lead carried out by the Joint WHO/FAO Expert Committee on Food Additives, the Codex Alimentarius Commission, an international food standards organization that establishes safe levels for the protection of consumers, has recently established a maximum level of 50 ppb for lead in ready-to-drink fruit juices, including fruit nectars that are in international trade, to protect the public health. FDA concurs with this recent assessment that lead levels in juice above 50 ppb may constitute a health hazard, and FDA may in the future establish an action level for lead in juice at levels above 50 ppb. If you determine that lead is a hazard that is reasonably likely to occur in your juice, we recommend that you establish controls to ensure that lead levels do not exceed 50 ppb. If produce used to make your juice is to be purchased from a source, e.g., a country, a geographic region, or a local region, that is known or suspected to have lead contamination problems with produce, you should consider in your hazard analysis whether lead is a hazard that is reasonably likely to occur. If you determine that lead is a hazard that is reasonably likely to occur, you could control this hazard by requiring a supplier guarantee specifying that the shipment of fruit supplied was harvested from sources known not to yield lead-contaminated fruit. (See section V. D on "Control strategies for patulin for apple juice processors" for examples of how control measures for incoming fruit based upon a supplier guarantee could be incorporated into your HACCP plan.) It also would be useful as a periodic verification activity to test your juice to affirm the efficacy of your controls for lead. 8. 1.26 Tin Tin is used frequently as a coating in unlacquered metal cans used to pack light colored juices, such as pineapple juice. Typically, some tin plating leaches into the juice in small amounts that help retain the light color of the juice due to the antioxidant activity of tin. These small amounts generally do not pose any potential harm. However, some factors that may be encountered in juice processing can contribute to excessive amounts of tin leaching into juice. The manner in which these factors affect the leaching of tin into juice is complex. These factors include the amount of ions such as nitrate and sulfate in the juice (e.g., as affected by the level of nitrate in the soil in which a fruit or vegetable is grown and the level of nitrate in water used to reconstitute juice concentrate), the amount of residual oxygen in the metal can after the juice is packed, the

thickness of the tin layer of the container, the presence of certain food components in the juice (such as organic acids and pigments), the length of time and the temperature of storage of the juice, and the pH of the juice, including the presence of any additive that can affect its pH. Consumption of juice containing excessive levels of tin can lead to acute gastrointestinal illness. The Codex Alimentarius Commission is considering establishing a maximum level of 200 ppm for tin in canned liquid foods for the protection of consumers. Although it is not common for levels of tin in canned juice to approach 200 ppm, if you pack juice in unlacquered metal cans, we recommend that you know what levels of tin are present in your juice after the longest anticipated storage time at the highest anticipated storage temperature for the juice. If the tin levels in your juice may approach 200 ppm, you should consider whether excessive levels of tin is a hazard that is reasonably likely to occur, i.e., if it is necessary for you to establish control measures to ensure that your juice will not contain harmful tin levels due to leaching of tin from the container into the juice. 9. 1.3 Physical Hazards 10. 1.31 Glass Fragments We recommend that consideration of potential hazards associated with glass breakage be a part of your hazard analysis if you package your juice in glass. Glass fragments in juice caused by glass bottle breakage may result in serious injury and can be caused in a number of ways, including damage to bottles in transit to the juice processing facility, damage to bottles during mechanized handling (cleaning, filling, or capping) of bottles, and thermal shock to the glass during hot filling or pasteurization. If you conclude in your hazard analysis that glass fragments are a hazard that is reasonably likely to occur in your juice, you must establish controls for glass fragments in your HACCP plan. Glass fragments originating from facility related sources and not from glass containers, e.g., from a broken light bulb, may be addressed where applicable under your SSOPs (See 21 CFR 120.6 (a)(5)). 11. 1.32 Metal Fragments We recommend that consideration of potential hazards associated with metal fragments be a part of your hazard analysis if you conduct operations such as the grinding of fruit, or cutting operations, where metal fatigue or metal to metal contact can occur in your processing equipment. If your process includes such operations, we recommend that you classify metal fragments as a hazard that is reasonably likely to occur in the absence of data or experience about your operation that shows that your process does result in the presence of metal fragments in juice when there are no controls in place. For instance, if you have used a metal detector in your process for a year, and have had no occurrences of metal fragments in your juice, you could conclude that metal fragments are not a hazard that is reasonably likely to occur in your process. If you conclude in your hazard analysis

that metal fragments are a hazard that is reasonably likely to occur in your juice, you must establish controls for metal fragments in your HACCP plan. 12. 2.0 Evaluate All Potential Hazards Step 2 -- The second step of a hazard analysis is to evaluate each of the potential hazards (from Step 1) by assessing the likelihood of occurrence and the severity of health consequences associated with the potential hazard. For instance: Microbial pathogens such as E. coli O157:H7, various Salmonella species, and the protozoan parasite Cryptosporidium parvum, have caused serious foodborne illness outbreaks due to consumption of contaminated juice, which resulted in hospitalizations and deaths. Any occurrence of pathogens such as these in juice is capable of causing severe adverse health effects, including death, particularly in the very young, the elderly, and immune-compromised persons. The juice HACCP regulation includes a 5-log pathogen reduction performance standard that requires you to establish controls in your HACCP plan for the "pertinent microorganism." Because a mandatory control measure for pathogens is part of the juice HACCP regulation, your responsibility in the hazard evaluation step is not to assess the severity of the illness or injury that a pathogen could cause (to determine whether control is necessary), but to determine which pathogen is the "pertinent microorganism" in your juice (that is, the most resistant pathogen among those potentially present), which is the pathogen that your process controls must be designed to eliminate. See section V.C.1.1 for more information on selecting the pertinent microorganism and establishing process controls to meet the 5-log pathogen reduction performance standard. o Although potential hazards that may be introduced into food through pests in your facility may be of low to moderate severity, they are unlikely to occur if your facility carries out an effective pest control program as part of its SSOPs. o Numerous U.S. government regulatory programs address aspects of pesticide usage, e.g., applicator licensure, usage instructions on the label, official monitoring of pesticide residues in foods, and enforcement actions against violators. Experience in the U.S. has demonstrated that domestically grown fruits and vegetables have a high level of compliance with U.S. pesticide tolerance regulations and that the occurrence of unlawful pesticide residues in food is likely to be infrequent and unlikely to have a severe public health impact. While pesticide compliance experience for imported fruits and vegetables is generally comparable to that for domestic produce, you should ensure that government controls in the foreign country that supplies your produce result in a high rate of compliance with U.S. pesticide tolerance regulations. If you can't achieve this assurance you should evaluate carefully whether pesticide residues pose a hazard that may warrant control under your HACCP plan. o Exposure over time to high levels of patulin may pose a health hazard. Available information indicates that high levels of patulin may occur in apple juice if controls are not carried out to prevent this occurrence.
o

13. 3.0 Determine Whether Potential Hazards Will Require Controls in Your HACCP Plan Step 3 -- The third step of the written hazard analysis is to determine, based upon the information gathered in steps 1 and 2, whether each potential hazard will require controls in your HACCP plan pursuant to 21 CFR 120.8(a). A hazard that will require control is referred to in the juice HACCP regulation as a hazard that is "reasonably likely to occur." Section 120.7(a)(2) describes such a hazard as "one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absence of those controls, the food hazard will occur in the particular type of product being processed." A hazard that is "reasonably likely to occur" is one that presents an identifiable and significant food safety risk that you, acting as a responsible processor, would act to reduce to an acceptable level, prevent or eliminate, by establishing and carrying out control measures for that hazard. Generally, you will carry out your control measures at CCPs (which are specific points in the process for producing juice) identified in your HACCP plan. 14. 3.1 Potential Hazards "Reasonably Likely to Occur" If a potential hazard has a severe, acute public health impact (e.g., cuts in the mouth caused by ingestion of glass container fragments), that hazard presents a significant risk, even at an extremely low frequency of occurrence, and thus, should be identified as a hazard that is reasonably likely to occur. Hazards that require exposure over time to cause harm would need to occur over time at levels of concern in the juice to be classified as a hazard that is reasonably likely to occur. The mycotoxin, patulin, which can occur at high levels in apple juice, is an example of a hazard that could result over time from exposure to a contaminant and thus, may need to be controlled through your HACCP plan. 15. 3.2 Potential Hazards "Not Reasonably Likely to Occur" Your HACCP team may identify a potential hazard for your juice, that upon further evaluation is determined not to require control. For example, processors of carrot juice may identify lead as a potential hazard because high lead levels have recently occurred in some carrot products apparently due to the carrots being grown in soils contaminated with lead from the past application of a no longer permitted, lead-containing pesticide to orchards formerly on the land. However, you may be able to establish that the land upon which your supplier grows carrots is not contaminated with lead, or that crops were never grown on that land that would have had lead-containing pesticides applied to them. Having established either of these premises, you could conclude appropriately that elevated levels of lead are not reasonably likely to occur in the carrots that you use to

make juice. However, if you acquire a new supplier of carrots, you should reassess the potential for elevated levels of lead to pose a hazard in your juice as part of the revalidation of your hazard analysis required in 21 CFR 120.11 (b). 16. 3.3 Hazards Related to Facility Sanitation FDA recognizes that hazards controlled by most types of sanitation programs may be impractical to manage in a HACCP plan format because it is often difficult to determine appropriate critical limits and corrective actions for sanitation controls. Therefore, when you conduct your hazard analysis, and identify hazards that derive from any of the eight areas listed in 21 CFR 120.6 (a), you may usually classify such hazards as "not reasonably likely to occur," and control those hazards under your SSOP program. As provided in 21 CFR 120.6 (d), you also have the option to control any of these sanitation- related hazards under your HACCP plan using a control measure implemented at a CCP. Examples of potential hazards that may be controlled under your SSOP program include substances used on juice processing equipment, such as lubricants and sanitizing chemicals, or substances applied to juice packaging materials under the provisions of a food additive regulation, such as hydrogen peroxide that is used to sterilize packaging materials on aseptic packaging lines for juice. If you have SSOPs designed to ensure that the substance will be used in accord CGMPs or with the provisions of the applicable food additive regulation, you may, in your hazard analysis, cite the SSOP as a justification for determining that the hazard is not reasonably likely to occur. Examples of this approach are included in the Example Hazard Analyses in section VII A for pasteurized refrigerated apple juice (the sanitizer used for cleaning the holding tank) and for notfrom-concentrate pasteurized orange juice (the lubricant used on the extraction equipment). In addition, the following partial hazard analysis summary table for an aseptic juice packaging operation (illustrating only the aseptic filling and packaging step) where hydrogen peroxide is used as a sterilant illustrates the same approach.

(1) Ingredient/Processi ng Step

(5) (4) (3) (2) Justify What preventative Are any Identify your measure(s) can be potential potential applied to decision foodhazards prevent/reduce/elimin for safety introduce ate the hazard? hazards Column 3 d, controlled significant ? or enhanced (Yes/No) at this step.

(6) Is this step a critical control point? (Yes//N o)

Aseptic filling and packaging

Hydrogen peroxide

No

Not reasonabl y likely to occur due to SSOP to ensure complianc e with the maximum level of hydrogen peroxide residual allowed by regulation (21 CFR 178.1005; of 0.5 ppm in water filled and packaged in the system.)

1. However, a special concern exists with respect to unsanitary food contact surfaces that can contaminate juice with residues of food processed on the equipment in prior runs that contain allergens. If the allergen containing food is not declared on the ingredient label, consumption of the juice and that can cause allergic reactions in sensitive individuals. Undeclared food allergens that arise from unsanitary food contact surfaces could pose a severe food safety hazard, if they occur in juice. As such, we recommend that these types of hazards should be classified as "reasonably likely to occur" and controlled in your HACCP plan if you determine that control measure(s) are necessary for the hazard. However, as provided in 21 CFR 120.6 (d), you may elect to control such a hazard under your SSOP program. 2. 3.4 Controls for Allergens Arising from Food Contact Surfaces As noted in the previous section, hazards that arise in juice processing from unsanitary food contact surfaces that can contaminate juice with residues of food allergens should be considered to be "reasonably likely to occur." We recommend that you control such hazards under your HACCP plan and not under your SSOPs when the hazard is amenable to control at a CCP because we believe that control at a CCP will afford a greater level of assurance of public health protection due to the validation and verification activities that

are carried out for CCP controls and due to inclusion of the written CCP control procedures in the HACCP plan. To be amenable to control at a CCP, the control measure must lend itself to validation and to the establishment of critical limits. We may question the adequacy of a HACCP plan to control hazards that may arise from unsanitary food contact surfaces when the plan does not include rigorous SSOP controls, or where applicable (as discussed in the next paragraph), CCP controls for such hazards. For example, if you produce juice on equipment that also is used to process milk, we recommend that you identify undeclared milk residues in your juice as a hazard that is "reasonably likely to occur." If a control measure for cleaning food contact surfaces to avoid contamination with milk residues from prior product runs is available to you and it can be validated, and critical limits can be established, we recommend that you incorporate such a control measure into your HACCP plan at a CCP rather than control the hazard under your SSOP program. If it is not possible to validate control measures for cleaning food contact surfaces, and critical limits cannot be established, your control activity would not be amenable to incorporation into a CCP and you would have to control the hazard through a rigorous SSOP procedure. Examples of a CCP and an SSOP for cleaning operations are given in Section VII. C. 3. 4.0 Identify Control Measures and CCPs Step 4 -- The fourth step in a written hazard analysis is to identify control measures and critical control points for hazards determined in step 3 to be reasonably likely to occur, and to review your current process to identify needed modifications to the process control measures are discussed in section V. 4. 4.1 NACMCF CCP Decision Tree This NACMCF CCP decision tree may assist you in determining critical control points for controlling the hazards that were identified in your hazard analysis as reasonably likely to occur.

1. 4.2. Location of CCPs A CCP may be established at any process step where you can effectively apply controls. See the Example Hazard Analyses and Example HACCP Plans in sections VII A and B. For instance, for a pasteurized apple juice process that includes controls for pathogens and for the mycotoxin patulin: CCPs for the control of patulin may be established at the receiving step at the processing facility at which time the shipment of apples can be checked to ensure that it originated from a supplier who has provided a guarantee that only apples harvested to exclude fallen fruit were supplied in the shipment, and at the culling or trimming steps, where bruised, damaged, moldy and rotten apples are removed from the product stream. o A CCP may be established at the pasteurization step where treatment to achieve the 5-log pathogen reduction will be carried out.
o

Similarly, for a fresh orange juice process, for the control of pathogens:
o

A CCP may be established at the step where oranges are received at the processing facility at which time the shipment can be checked to ensure that it originated from a supplier who has provided a guarantee that only tree-picked oranges were supplied in the shipment.

V. Control Measures
A. HACCP Control Measures

Under 21 CFR 120.8(a), you are required to implement HACCP control measures if you determine in your hazard analysis that a food hazard is reasonably likely to occur in your juice product. Examples of HACCP control measures used in the processing of juice include measures carried out at CCPs specified in a HACCP plan such as the pasteurization of juice for the elimination of microbial pathogens; the culling or trimming of apples after storage to eliminate moldy, damaged, bruised, or rotten apples to ensure that patulin will not be present at levels of concern in the finished apple juice; and periodically monitoring processing lines for evidence of glass breakage.

B. Activities Not Considered to be HACCP Control Measures

Some activities firms may undertake in processing juice and in related functions are not HACCP control measures. These include Good Agricultural Practices (GAPs) and Current Good Manufacturing Practices. 1. 1.0 GAPs The HACCP regulation applies to firms engaged in the processing of juice. It does not apply to firms that conduct activities such as the growing, harvesting, and transporting of fruits and vegetables that will be processed into juice. Growers may voluntarily implement GAPs based upon FDA's GAPs guidance document which is available at http://www.foodsafety.gov/~dms/prodguid.html, and by mail from the address given in section I. C above. Because growers and transporters of raw agricultural ingredients of juice are not subject to the requirements of the HACCP regulation, GAPs measures voluntarily undertaken by these parties are not HACCP controls. However, if a hazard originating from the agricultural environment is determined to be reasonably likely to occur on your incoming fruit, e.g., patulin on incoming apples, or pathogens on incoming raw fruit, pursuant to 21 CFR 120.8 (a), that hazard must be identified in your hazard analysis and controlled through your HACCP plan. If control of such a hazard involves actions that will be carried out by your grower, e.g., supplying you with only tree-picked fruit or fruit that does not include fallen fruit, your control measure could be based upon a supplier guarantee to this effect implemented as part of your HACCP plan. However, we encourage you to work with your suppliers to evaluate and modify agricultural practices in accordance with FDA's GAPs guidance document. 2. 2.0 CGMPs As noted above, juice processors are still required to comply with the CGMPs requirements of 21 CFR Part 110. One common misconception about HACCP is that some hazards that are reasonably likely to occur may be controlled under a firm's CGMP programs under 21 CFR Part 110. Because programs to comply with 21 CFR Part 110 are general in nature and are not designed to control specific hazards, they are not HACCP control measures. Therefore, you cannot use CGMP programs to control a specific hazard

that, based upon your hazard analysis, you have concluded is reasonably likely to occur in your juice. You must use HACCP controls for any such hazard.

C. Control Measures for Biological Hazards

1. 1.0 Minimum Requirement of 5-Log Pathogen Reduction The 5-log pathogen reduction requirement in 21 CFR 120.24 describes the minimum level of pathogen "kill" that your pathogen control measures must consistently achieve. Processing experts evaluate treatments intended to destroy or inactivate pathogens in food in terms of "logs" of kill, where the term "log" is a shorthand expression of the mathematical term logarithm. A logarithm is "the exponent of the power to which a base number must be raised to equal a given number." If the base number is ten, it must be raised to the second power to equal 100, so the exponent is 2, i.e., 10 X 10 = 100. Again, if the base number is ten, it must be raised to the third power to equal 1000, so the exponent is 3, i.e., 10 X 10 X 10 = 1000. The HACCP regulation requires you to use treatments capable of consistently achieving at least a 5-log reduction (using ten as the base number) in the level of the pertinent microorganism in your juice. The important thing to understand is that each log of kill is capable of causing a tenfold reduction in the number of organisms of the pathogen that the treatment is designed to kill, i.e., the "pertinent microorganism." A 1-log process would be one that is capable of reducing the level of the pertinent microorganism in the food by 10 fold, e.g., from 100 organisms (of the pathogen) per gram of food to 10 organisms (of the pathogen) per gram of food. A 2-log process further reduces the level of the target pathogen by another factor of 10, i.e., from 10 organisms (of the pathogen) per gram to 1 organism (of the pathogen) per gram of food. Thus, the 5-log performance standard means that you must treat your juice using a process capable of reducing levels of the pertinent pathogen in the juice by at least 100,000-fold (10 X 10 X 10 X 10 X 10 = 100,000). This is illustrated in the following table:

Initial number of Log pertinent reduction microorganism bacteria per gram of food 100,000 (105) 100,000 (105) 100,000 (105) 1 2 3

Decrease in pertinent microorganism bacteria levels

Percent of change

Final number of bacteria per gram of food 10,000 (104) 1,000 (103) 100 (102)

10-fold 10x10 = 100 fold 10x10x10=1000 fold

90 % 99 % 99.9 %

100,000 (105) 100,000 (105)

4 5

10x10x10x10=10,000 fold 10x10x10x10x10=100,000 fold

99.99 % 99.999 %

10 (101) 1 (100)

1. The initial number of pathogens present in your untreated juice is likely to be far less than 105 organisms per gram, i.e., only 101 or 102 organisms per gram. Applying a 5-log treatment to juice that may contain such levels of pathogens achieves a tolerable level of risk by ensuring that the process is adequate to destroy microorganisms of public health significance or to prevent their growth. Thus, if you use pasteurization as your pathogen control measure, that treatment must be carried out to achieve consistently at least a 5-log reduction in the "pertinent microorganism." Likewise, if you use UV radiation as your pathogen control measure, that UV treatment must be carried out to achieve consistently at least a 5-log reduction in the "pertinent microorganism." If you are a citrus juice processor and rely on, as your pathogen control measure, a series of surface sanitization treatments and an extraction process that limits juice/peel contact as provided for under 21 CFR 120.24 (b), these treatments must consistently achieve at least a 5-log reduction in the "pertinent microorganism." Multiple processing steps, such as a series of surface sanitization treatments for citrus fruit, may be used to achieve the 5-log reduction. However, under 21 CFR 120.24 (b) and (c), all of the processing steps you perform to meet the 5-log pathogen reduction requirement must be carried out in a single production facility. We recommend that all juice processors consult with a process authority (see "Process Validation" in section V.C.5) to establish their control measures for achieving the 5-log pathogen reduction required under the HACCP regulation. 2. 1.1 What Does the "Pertinent Microorganism" Mean? The "pertinent microorganism" is the most resistant microorganism of public health significance that is likely to occur in the juice and is the pathogen that you must target for the 5-log pathogen reduction treatment (21 CFR 120.24(a)). By choosing the most resistant pathogen as your target, you are also treating the product for all other pathogens that are less resistant to the means of treatment. One way to identify the pertinent microorganism for your juice is to consider whether there have been any illness outbreaks associated with this type of juice, and what microorganisms have caused the outbreaks. If certain pathogens have been demonstrated,

i.e., through outbreaks, to be potential contaminants in certain juices, then the pertinent microorganism for your process typically should be one of these pathogens. For example, Salmonella species have been the cause of several illness outbreaks related to orange juice and may be considered the "pertinent microorganism" for orange juice products. E. coli O157:H7, a bacterial pathogen, and Cryptosporidium parvum, a protozoan parasite, have both been the cause of outbreaks in untreated apple juice, and both should be identified as potential hazards in a hazard analysis for apple juice. Which of these two pathogens is determined to be the pertinent microorganism will depend upon which of the two is most resistant to the means of treatment, e.g., pasteurization, UV radiation, that you will use to achieve the 5-log reduction of pathogens that is required under the juice HACCP regulation. The pertinent microorganism for apple juice is discussed further in section V. C. 5.0. Although Listeria monocytogenes has not been linked specifically to an illness outbreak from juice, it is ubiquitous in nature. For this reason, we recommend that Listeria monocytogenes be considered as a possible "pertinent microorganism" for juices that have not been associated with illness outbreaks caused by Salmonella species, E. coli O157:H7, or Cryptosporidium parvum. Alternatively, for juices other than apple juice, you may generically designate "vegetative bacterial pathogens" as your pertinent microorganism if your juice is an acidic juice, i.e., pH of 4.6 or less, no illness outbreaks believed to have been caused by non-bacterial pathogens have been attributed to that juice type, and you are processing your juice using a process that has been validated to achieve a 5-log reduction for Salmonella species, E. coli O157:H7, and Listeria monocytogenes, such as the general process which is discussed in section V.C.5.0 under "Process Validation." Low-acid juices, such as carrot juice, that are distributed under refrigeration, and are not subject to the Low Acid Canned Foods regulation (21 CFR Part 113) may pose hazards associated with spore forming pathogens, specifically, toxins of non-proteolytic and proteolytic strains of Clostridium botulinum. Control measures for such juices are likely to involve multiple measures, e.g., a combination of a process step to destroy the nonproteolytic spores and measures to ensure that "Keep Refrigerated" labeling is used for the juice if the juice does not receive a treatment sufficient to destroy the proteolytic spores (Destruction of spores of the proteolytic strains requires a more severe heat treatment but germination and growth of these spores may be prevented by keeping the product under refrigeration during its lifecycle. Destruction of spores of the nonproteolytic strains requires a less severe heat treatment, but these spores can germinate and produce toxin even under refrigerated storage conditions). 3. 1.2 Shelf Life and Moderate Temperature Abuse Conditions The 5-log pathogen reduction treatment must last through the normal shelf life of the product when held under moderate temperature abuse conditions (21 CFR 120.24(a)). This requirement is intended to ensure the effectiveness of the treatment if any microorganisms that may be injured in processing, might be capable of surviving if held

under optimal growing conditions. Normal handling of juice includes the movement of the juice from the plant to retail (e.g., transportation, warehouse storage) and consumer handling after purchase (e.g., transport home, setting out on a counter or table). Moderate abuse may occur when unusual circumstances occur during customary handling. For example, unloading a truck on a hot day where the product may sit on a loading dock for a short period of time could constitute moderate abuse. In addition, moderate abuse could occur if consumers purchase a product on a warm day, place it in their car, and run errands before refrigerating the product. Moderate abuse does not include exposure to warm temperatures for extended periods of time. Your "process authority" (see "Process Validation" in section V.C.5) should be able to determine that the process you use, e.g., pasteurization, UV irradiation, will ensure that pathogens will not proliferate in your juice should it undergo moderate temperature abuse. 4. 1.3 5-Log Treatment Performed on Juice after Extraction, with One Exception You must meet the 5-log pathogen reduction requirement by treating the juice directly, i.e., after it has been extracted from the fruit, with one exception provided by 21 CFR 120.24(b). However, for citrus juices, you may meet this requirement by applying pathogen reduction treatments to the surface of the citrus fruit prior to extracting the juice. Such treatments usually are carried out through a series of washing, brushing, and sanitizing steps. Use of extraction methods that limit juice/peel contact may also be counted towards the 5-log reduction. If you use such treatments to meet the 5-log pathogen reduction requirement, you must also adhere to certain specific requirements in 21 CFR 120.24 (b) that are summarized in subsection 3.0 of this section. 5. 2.0 Location of Juice Extraction, Processing, and Packaging Pursuant to 21 CFR 120.24(c), you must carry out the 5-log pathogen reduction, whether it is via a one-step process or a multi-step process, in a single facility, and that facility must be the same facility in which the product is packaged in final form for sale. There are two potential exceptions discussed in the following paragraphs. If you do treat your juice at a different facility than the one in which the final packaging is carried out, the treatments applied at the first facility cannot be counted towards meeting the 5-log pathogen reduction requirement. The first exception noted in the previous paragraph applies to producers and users of high degree Brix juice concentrate. In a letter dated January 22, 2002 (and a January 25, 2002 letter of correction), FDA stated that it would consider the exercise of enforcement discretion with respect to the "single facility" requirement as applied to producers and users of high degree Brix concentrate(6) where the following three conditions are satisfied: (1) the producer and user establish appropriate prerequisite programs and SSOPs for the transport of high Brix juice concentrate; (2) the producer and user designate as a CCP in their respective HACCP plans the transport of high Brix concentrate from the production facility to a second facility for formulation and final

packaging of concentrates; and (3) the producer and user establish control measures to prevent, reduce, or eliminate the risk of recontamination of the concentrate during transport (The January 22, 2002, letter and a correction to that letter dated January 25, 2002, are available at the website listed in section I. B.) The second exception applies to the bulk transport and packaging of shelf-stable single strength juice that is transported in aseptic packaging. FDA also stated in the January 22, 2002, letter that it would consider using its enforcement discretion with respect to processors that transport in bulk and package shelf-stable single strength juice that is transported in aseptic packaging. FDA also stated in the January 22, 2002, letter that it intended to develop and issue guidance that will contain FDA's basic recommendations for appropriate control measures for several transport modalities (modes of transportations), including tankers, mobile tank farms within cargo ships, single-use sanitary containers (e.g., bag-in-box containers), and reusable containers with single-use liners (e.g., 55 gallon drums with single-use liners). This guidance entitled "Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices," is available on the website listed in section I. B above. You may extract juice from the fruit in one location and ship the untreated juice to a second location for processing (i.e., to achieve the 5-log pathogen reduction requirement) and packaging. If you do this, we recommend that you obtain assurance, e.g., a letter from the juice processor receiving the untreated juice, that the juice will be given the required 5-log treatment at the second location, and you should cite this assurance in your hazard analysis as the justification for not carrying out the 5-log reduction in your facility. We also recommend that the label of the untreated juice, or if transported in bulk, the invoice or other shipping documents, state that the juice has not received a treatment sufficient to yield a 5 log pathogen reduction. 6. 3.0 Requirements for Certain Citrus Juices If you produce a citrus juice and you choose to meet the 5-log pathogen reduction requirement by surface treatment of the fruit, the following additional requirements apply: The fruit must be tree-picked, cleaned, and culled prior to application of treatments to achieve the 5-log pathogen reduction (see 21 CFR 120.24(b)). o All treatments to achieve the 5-log pathogen reduction, e.g., cumulative treatments, must be performed in a single facility. Final product packaging must also be performed in that same facility (see 21 CFR 120.24 (b)). o Certain process verification requirements (testing of finished product for generic E. coli) set out in 21 CFR 120.25 are required. If E. coli is found in the processed juice, it may be an indication of failure of the HACCP system, or that the system may be approaching failure. See the discussion in the next section. A rapid method for testing the finished product for generic E. coli entitled "Comparative
o

evaluation of a rapid method for detecting Escherichia coli in artificially contaminated orange juice," by Stephen D. Weagant and Peter Feng (FDA Laboratory Information Bulletin 4239, Vol. 17, March 2001) is available by mail at the address given in section I. C. 7. 3.1 Compliance with Requirement to Use Tree-Picked, Culled Fruit If you produce a citrus juice using surface treatments to meet the 5-log pathogen reduction requirement, FDA recommends that you do the following to meet the requirement that you use tree-picked and culled fruit: You obtain a written guarantee from your supplier for each fruit shipment stating that the shipment contains only tree-picked fruit, and establish a CCP at the receiving step for the citrus fruit, citing the existence of the guarantee as a critical limit to be met for acceptance of the lot of fruit. An additional critical limit at this CCP (the receiving step) should be that a sample of fruit from the shipment shows no evidence of inclusion of fallen fruit. o You establish a CCP at a culling step in the process at which any damaged fruit is removed prior to any pathogen reduction treatments on the fruit surface. The culling step is important because damage to the peel of citrus fruit (e.g., punctures, cuts, splitting, rot, or mold) may allow pathogens to contaminate the edible portion of the fruit from which the juice is made. 8. Under such an approach, for the CCP at the receiving step: o The existence of a supplier guarantee for each shipment of incoming fruit specifying that the shipment contains only tree-picked fruit would be one critical limit. A monitoring procedure would be to confirm visually the existence of the guarantee for each incoming shipment of fruit. o The second critical limit would be that a sample of fruit from the shipment shows no evidence of fallen fruit. Monitoring could consist of visual inspection of fruit sampled from each incoming shipment to ensure that the fruit shows no evidence of inclusion of fallen fruit, e.g., flat dirty spots on the fruit. o The corrective action procedure would be to reject any shipment of fruit from a supplier not accompanied by a guarantee, or any shipment that does not meet the inspectional criterion, e.g., shows evidence of containing fallen fruit. o The verification procedure could consist of periodic auditing of the supplier to ensure that the supplier is following the provisions of the guarantee. Generally in HACCP, wherever you rely on guarantees or certificates from suppliers to control a hazard, we recommend that you couple these types of controls with a strong verification procedure, such as visiting the farm periodically or periodically testing the juice. 9. 3.2 Positive E. coli Test Results for Citrus Juices Made Using Surface Treatment of Fruit to Achieve 5-Log Reduction
o

If your verification testing yields a single positive for E. coli, 120.25(d) requires that you review monitoring records for the control measures used to attain the 5-log pathogen reduction standard and correct those conditions and practices that are not met. We recommend that you conduct these activities as quickly as possible. You also must look

at results for the preceding six tests for that product; under 21 CFR 120.25(e), if a second positive result is found within seven consecutive tests, the control measures used to attain the 5-log reduction standard are inadequate and you must start immediate corrective action. In the juice HACCP final rule, we also suggested that if you get a single positive test result, you should review your test results over a larger window of tests (more than just the last 7 tests) to see if these test results are an early warning that the process may be approaching failure. We stated that review should be sufficiently extensive to allow you to spot a trend towards loss of process control. Here, we provide how far back we recommend you review your records. The 2-out-of-7 criterion, which is established in the final juice HACCP regulation, was chosen because it offers appropriate consumer protection while simultaneously having a low rate of "false alarms" (because the likelihood of 2 positives occurring by chance in 7 consecutive tests when citrus juice is appropriately treated is about 1 in 1000 (p=0.001)). As the window gets larger (i.e., you review a larger set of consecutive tests), the chance of finding two positives, even when juice is appropriately treated, increases. Therefore, looking at results over a larger window is not required and finding two positive results in the larger window does not impose any additional regulatory requirements. However, as noted above, looking at test results over an extended time period may allow you to spot a trend towards loss of process control and take appropriate action before your system fails. How far back you choose to look may depend on a number of factors, including production volume, testing frequency, and experience. We recommend that you start by considering 2 positives in any series of 17 tests (or 3 positives in any series of 52 tests) as a potential warning. The likelihood of 2 positives occurring by chance in 17 consecutive tests, or 3 times in 52 tests, when citrus juice is appropriately treated is about 7 in 1000 (p=0.007). Thus, a finding of 2 positives in 17 tests, or 3 positives in 52 tests, could be an indication that your controls are not functioning as intended and that they may fail at some point. You would then be able to investigate the operation of your control measures and take any necessary action to ensure that they are functioning as intended before a failure occurs. As window width increases to 20, 25, and 30 tests, the probabilities of finding two positives when the system is functioning correctly are 9.4 in 1000 (p=0.0094), 14.6 in 1000 (p=0.0146), and 20.6 in 1000 (p=0.0206), respectively. 10. 4.0 Heat Treated Shelf Stable Juices and Concentrates, and Other Non-Heat Treated Juices Our recommendations for factors to consider when establishing control measures for heat treated shelf stable juices and concentrates, and other non heat- treated juices are discussed in 4.1, 4.2, 4.3, 4.4 and 4.5.

11. 4.1 Heat Treated Shelf Stable Juices and Concentrates If you use a single thermal processing step to produce a shelf stable juice, or a thermal concentration process that includes all of the ingredients of a juice, you are not required to include control measures in your HACCP plan for achieving the 5-log pathogen reduction. However, under 21 CFR 120.24(a)(2), you must include a copy of the thermal process or the concentration process in your written hazard analysis and you must establish controls in your HACCP plan for any chemical and physical hazards identified in your hazard analysis. 12. 4.2 Example of a Process for a Shelf Stable Juice The National Food Processors Association states that a typical hot fill/hold process used for shelf stable juices might be to treat the juice at 90 degrees C (194 degrees F) for 2 seconds, followed by filling at 85 degrees C (185 degrees F) and holding for 1 minute at that temperature. Based upon research it conducted for E. coli O157:H7, Salmonella species (spp.) and Listeria monocytogenes in fruit juices, NFPA calculated that this typical process used for shelf stable juices would achieve a 50,000 log reduction for these pathogens without taking into account the cumulative lethality during the cool down period. (See reference to publication by Mazzotta in section V. C. 5.0). 13. 4.3 Thermal Concentration Processes To obtain the exemption from the requirement to include controls in your HACCP plan to achieve the 5-log pathogen reduction, the juice HACCP regulation requires a copy of the process used to produce the thermally processed juice concentrate to be included in your hazard analysis. The thermal process must be applied to the concentrate and all of its ingredients. We recommend that the copy of the thermal process used to achieve concentration describe the steps in the process, such as the pre-evaporation heat treatment and the evaporation steps. We also recommend that it describe the type of equipment used in each process step such as a "continuous flow tubular heat exchanger" for the preevaporation step and a "X effect high temperature short time evaporator" (X-representing the number of effects) for the evaporation steps. In addition, we recommend that it describe the product temperature and exposure time for the pre-treatment step, the product temperature for each of the evaporation effects, and the process time and temperature for the thermal process for any ingredient of the concentrate that is processed separately and then added to the concentrate. To ensure the safety of a "thermally processed concentrate" we recommend all of the juice receive a pretreatment consisting of a thermal treatment of at least 80 degrees Centigrade for thirty seconds. Such a process delivers a degree of thermal inactivation of pathogens that is extraordinarily beyond the required 5-log reduction (see Reference #68 in the juice HACCP final rule). FDA is not likely to question whether a product processed in such a manner is a "thermal concentrate" and thus, qualifies for the

exemption from a process control to achieve the 5-log performance standard for pathogen reduction. However concentrates produced using unconventional processes that involve low temperatures might not receive enough heat to ensure a comparable level of inactivation of potentially harmful microorganisms that might be present in the juice. If we encounter a concentrate that is processed in such an unconventional manner, we may ask for additional data demonstrating that the process delivers a level of thermal inactivation of microorganisms that is comparable to that delivered by a conventional thermal concentration process. Absent providing such data, we may advise you of our view that the exemption from a process control to achieve the 5-log performance standard for pathogen reduction is not available for the product and that you should include control(s) (CCP(s)) in your HACCP plan for achieving the 5-log reduction. 14. 4.4 Juices Subject to the Low-Acid Canned Foods and Acidified Foods Regulations If you produce a juice that is subject to the requirements of 21 CFR Parts 113 or 114, i.e., the regulations for low acid canned foods and acidified foods, you do not have to include control measures in your HACCP plan for the potential hazards that are addressed through compliance with 21 CFR Parts 113 or 114, e.g., hazards associated with the formation of Clostridium botulinum toxin. You may identify such hazards as potential hazards in the hazard identification phase of your hazard analysis, but in the hazard evaluation phase, you may conclude that such hazards are not reasonably likely to occur because they are controlled through compliance with the requirements of 21 CFR Parts 113 or 114. However, the hazard analysis and HACCP plan should completely address any other hazards associated with such juices, i.e., any chemical and physical hazards such as metal or glass fragments. 15. 4.5 Other Non-Thermal Treatments for Juice If the treatment includes the use of a source of radiation, e.g., UV irradiation, pulsed light, FDA approval of the means of treatment for the control of microorganisms is required. Both UV radiation and pulsed light have been approved by FDA for the control of microorganisms, and the regulations specifying the conditions under which they may be safely used are at 21 CFR 179.39 (UV radiation) and 21 CFR 179.41 (Pulsed light). If the treatment includes the use of a chemical anti-microbial agent, such as a sanitizer, to reduce pathogen levels on the surface of citrus fruit, the chemical agent must be approved by FDA for that use (i.e., to control or reduce levels of microorganisms) under the agency's food additive regulations in 21 CFR Parts 170-199, or it must be generally recognized as safe (GRAS) for such use. If you use sanitizing agents as surface treatments on fruit used in the production of citrus juice, you should secure documentation from your supplier that the sanitizing agent is either GRAS, or is approved by the FDA for this use.

Treatment technologies that do not involve the use of a source of radiation or a chemical agent, e.g., high pressure processing, are not likely to require FDA approval. However you should verify any such assumption with your process authority (see following section). Whether you use a form of radiation (UV radiation or pulsed light), a chemical treatment, or some other type of treatment for pathogen reduction purposes, the process used for pathogen control must be validated for this purpose according to the validation requirements in 21 CFR 120.11 of the juice HACCP regulation. 16. 5.0 Process Validation You must ensure that the process you will use has been validated, i.e., that at all times it will deliver, at a minimum, the required 5-log pathogen reduction (21 CFR 120.24(a)). 17. 5.1 Role of a "Process Authority" In order to ensure the validity of your process, FDA recommends that you employ or consult with a "process authority." A process authority is an expert in the processes for controlling pathogenic microorganisms in food, and as such, is qualified by training and experience to evaluate all aspects of your pathogen control measures, e.g., process time, temperature, type of equipment, etc., and to determine that your control measures, if properly implemented, will effectively control pathogens such as E. coli O157:H7, Salmonella, Listeria monocytogenes, and Cryptosporidium parvum. Many different types of processes may be used to reduce the level of the organism of concern. For each of these processes, the critical control points and critical limits must be identified. A process authority should know what critical limits, such as time and temperature, would be effective for treating juice. Other processing factors such as flow rate, turbulence, pressure, concentration, composition, intensity, penetration depth, and absorbance may also be important to a process. Your process authority should be able to evaluate such other aspects of your processing system that could affect its performance. Although your process authority will likely be your source for information on the critical limits for your pathogen reduction process, you will have to know what those limits are, e.g., the time and temperature parameters for a pasteurization process, or the amount of UV energy to which the juice is exposed; these values serve as the critical limits in your HACCP plan. We will need this information to be able to conduct an official review of your HACCP system. You may employ a process authority as a member of your staff, or alternatively, you may be able to identify a process authority through your national or regional food processors trade association, or through educational institutions such as food science and technology departments in state universities. Some state government agencies, e.g., state departments of agriculture or public health, may have such experts on their staffs. Some processing equipment vendors employ or retain (as consultants) such experts who also have detailed

knowledge about the performance capabilities of the vendor's equipment and can work with you to establish that the equipment will effectively control pathogens in your processing operation. 18. 5.2 Validated Pasteurization Treatments for Juice At this time there are some published studies on pasteurization processes for controlling pathogens in juice that we can comment on to assist you in developing your HACCP plan. Study #1 Summary: A study done by the NFPA(7) has resulted in a recommended general thermal process of 3 seconds at 71.1 degrees C (160 degrees F), for achieving a 5-log reduction for E. coli O157:H7, Salmonella, and Listeria monocytogenes in fruit juices. The efficacy of this process was measured using single strength apple, orange, and white grape juices adjusted to a pH of 3.9. The authors noted that a pH in the range of 3.6 to 4.0 has been reported as a non-significant variable in the heat resistance of E. coli O157:H7. The authors also noted that the heat resistance of these vegetative bacterial pathogens might be considerably greater at pH values of 4.0 and higher. This process assumes that the pathogens will have increased thermal resistance due to their being acid-adapted. Study #2 Summary: A study done at the University of Wisconsin(8) has shown that treatments of 68.1 degrees C (155 degrees F) for 14 seconds (recommended treatment conditions in Wisconsin) and 71.1 degrees C (160 degrees F) for 6 seconds (recommended treatment conditions in New York) are capable of achieving a 5-log reduction of acid adapted E. coli O157:H7 in apple cider (pH values of 3.3 and 4.1). The Wisconsin study also confirmed the adequacy of the treatment conditions of the NFPA study (71.1 degrees C (160 degrees F) for 3 seconds) for achieving a 5-log reduction for E. coli O157:H7 in apple cider. FDA Comments/Recommendations: We believe that the process recommended in the NFPA study is adequate to ensure a 5-log reduction of the three stated vegetative bacterial pathogens, (E. coli O157:H7, Salmonella and Listeria monocytogenes) at juice pH values comparable to those in the study. However, other validation studies may be needed for juices that have pH values greater than 4.0. We also believe that either of the processes evaluated in the University of Wisconsin study is adequate to ensure a 5-log reduction of the three stated bacterial pathogens, (E. coli O157:H7, Salmonella, and Listeria monocytogenes) (at juice pH values comparable to those in the study) if any of these pathogens are the pertinent microorganism in your juice. Neither of these two studies evaluated thermal processes for achieving a 5-log reduction for oocysts of the protozoan parasite Cryptosporidium parvum that has been a cause of illness outbreaks associated with the consumption of apple juice. In fact, the thermal destruction of Cryptosporidium parvum oocysts has not been as widely studied in the published literature as it has for the vegetative bacterial pathogens; however, the available scientific literature suggests that Cryptosporidium parvum(9) oocysts may be more resistant to thermal processing than the three vegetative bacterial pathogens.

Therefore, we recommend that you consider Cryptosporidium parvum to be the pertinent microorganism when you are establishing a HACCP plan for apple juice. For apple juice at pH values of 4.0 or less, we are recommending the following thermal processes to achieve a 5-log reduction for oocysts of Cryptosporidium parvum (in addition to the three aforementioned vegetative bacterial pathogens) based upon a conservative evaluation of the available scientific data;
o o o o o

160 degrees F for 6 seconds (recommended treatment conditions in New York), 165 degrees F for 2.8 seconds, 170 degrees F for 1.3 seconds, 175 degrees F for 0.6 seconds, or 180 degrees F for 0.3 seconds

Also, while it appears that Cryptosporidium parvum may be more resistant to thermal processing than the vegetative bacterial pathogens noted, in view of the limited data on the thermal destruction of Cryptosporidium parvum, processors may designate both E. coli O157:H7 and Cryptosporidium parvum as the pertinent microorganism in their HACCP plans for apple juice, and use one of the recommended thermal processes given above for the a 5-log reduction of Cryptosporidium parvum oocysts, until more definitive data become available on the relative resistance to thermal processing of these two pathogens. We also believe that the process that is typically carried out for milk pasteurization, 71.7 degrees C (161 degrees F) for 15 seconds, is adequate to achieve a 5-log reduction of oocysts of Cryptosporidium parvum and the aforementioned three vegetative bacterial pathogens when this process is used for apple juice (at juice pH values of 4.0 or less). 19. 5.3 Equipment and System Considerations Equipment and Systems that should be considered are discussed in 5.31, 5.32, 5.33, 5.34 and 5.35. 20. 5.31 Pasteurization Equipment If you use batch pasteurization equipment, we recommend that you continuously monitor both the time and temperature of the juice treatment as critical limits to ensure that your process is achieving the 5-log pathogen reduction. If you use continuous (high temperature short time (HTST)) pasteurization equipment, we recommend that you designate the juice temperature and juice heating time as critical limits in your HACCP plan. Under your HACCP plan, we recommend that you continuously monitor the juice temperature; we do not recommend continuous monitoring of the heating time if the equipment (the positive displacement timing pump and holding tube length, volume and slope) is constructed to deliver a controlled flow rate of the juice through the heat exchanger to ensure that it is heated for the minimum

required time. In this case, as a monitoring procedure for flow rate, we recommend that you periodically perform a visual check of the set point of the positive displacement pump to ensure that it is at the point that has been documented to deliver the proper flow rate. As a verification procedure, we recommend that you check the actual flow rate semi-annually (or whatever is needed to keep the system working properly) by performing testing of the timing pump to ensure that it is effectively controlling the flow rate. A magnetic flow-based timing system is another type of flow rate timing system for an HTST pasteurizer. In such a system, we recommend that the flow rate (heating time), in addition to the juice temperature, be continuously monitored. 21. 5.32 UV Processing Systems UV systems for treating juice have recently begun to be commercialized. FDA approval in 2000 of UV radiation to treat juice to reduce human pathogens in (21 CFR 179.39) requires that the UV radiation be provided by low pressure mercury lamps emitting 90 percent of the emission at a wavelength of 253.7 nanometers (2,537 Angstroms), and that during the treatment, the juice undergo turbulent flow through tubes with a minimum Reynolds number of 2,200. If you are considering using UV radiation to process your juice, you should confirm with your process authority that the system you are considering meets the requirements of 21 CFR 179.39. We also recommend that you consider the following questions in consultation with your process authority: Have you identified the appropriate pathogen as the "pertinent microorganism" considering that UV radiation is the means of treatment for achieving the 5-log pathogen reduction? For instance, if you are processing apple juice, you need to know whether E. coli O157:H7, Crytopsporidium parvum, or some other pathogen is more resistant to UV radiation to determine which of these is the pertinent microorganism. The relative resistance of pathogens to UV radiation may not be the same as it is for thermal treatment. o Has the UV system been validated to achieve effectively a 5-log pathogen reduction for the "pertinent microorganism" (see previous bullet) in the juice that you will be processing?(10) The effectiveness of given UV treatment conditions can vary from one juice to another due to factors such as the opacity of the juice. The treatment parameters, e.g., flow rate, UV energy level, needed to achieve a 5log pathogen reduction, may vary from one juice to another juice. We recommend that you consult with your process authority to ensure yourself that the system and processing parameters you will use have been validated to achieve a 5-log pathogen reduction in your juice. o What are the critical limits for the process? Is the flow rate of the juice through the UV exposure chamber critical to the effectiveness of the process? Is the delivery of a minimum level of UV energy critical to the process? If so what are
o

o o

the critical flow rate and UV energy parameters? You need to know what the critical limits are to be able to enter them into your HACCP plan. What monitoring procedures will you have to carry out to ensure that the critical limits are met? Is it necessary to monitor flow rate continuously, or does the design of the equipment regulate the flow rate to not exceed the critical limit? What monitoring procedure, e.g., UV sensors, will indicate that the juice continually receives the critical level of UV energy? Is the system designed to shut down if a sensor fails or if a sensor indicates that a critical limit is not being met? What verification procedures will you have to carry out? These may include checking the UV sensors periodically to ensure that they are operating properly. What cleaning procedures should be carried out between runs to ensure that residues, e.g., particulates, do not accumulate in the equipment that would reduce the effectiveness of the treatment? What corrective action procedures will you specify in your HACCP plan? Your corrective action procedures should ensure that if the system fails, e.g., due to failure of a UV lamp, any juice that may not have received the 5-log pathogen reduction is segregated and, if necessary, treated again to ensure a 5-log reduction, and that the failed lamp is replaced.

22. 5.33 High Pressure Processing Systems High pressure processing, a technology in which pressure (in excess of 30,000 to 45,000 psig) is the principal anti-microbial agent, has been shown to be effective in reducing vegetative pathogens. Both semi-continuous and batch processes have been developed using high pressure processing. We recommend that the process time and pressure be critical limits for both types of processes. However, temperature may or may not need to be a critical limit. During high pressure processing, the temperature of the product does increase. This increase in temperature is dependent on the composition of the food product, the initial temperature of the product/vessel, the pressure transmitting fluid for batch systems, and the time the product is held at the processing pressure. Many highpressure systems do not control the temperature of the product during treatment, and the temperature of the product tends to decrease with time due to heat loss to the surrounding pressure vessel. For many systems, a minimum initial temperature of the product/vessel may be specified and controlled. However, the temperature during the process may not be monitored as a critical limit. For batch systems, we recommend that changes in the composition of the pressure transmitting fluid should be controlled and checked periodically. 23. 5.34 Dense Phase CO2 Processing Systems Dense phase carbon dioxide processing, a technology in which carbon dioxide under moderate pressure (1200-1500 psig) is the principal anti-microbial agent, has been shown to be effective in reducing vegetative pathogens. In the gas industry, supercritical and

liquid carbon dioxide (CO2) are known collectively as dense phase CO2. Continuous processes have been developed using this technology. Pathogen challenge tests showed that microbial inactivation increases as CO2 concentration increases. It appears that pressure and residence time may be used to optimize the bactericidal effects of CO2. For these processes, CO2 concentration is critical to the process. The process is performed under ambient conditions, and temperature is not monitored as a critical factor. 24. 5.35 Extraction Equipment for Certain Citrus Juice Processes If you process citrus juice using surface treatment of fruit to achieve the 5-log pathogen reduction, it is important that the extraction of the juice be performed in a manner that avoids any potential for contamination of the juice by pathogens that may be present on the peel during the extraction operation. Juice extractors are available that have been designed to limit juice/peel contact during the extraction process for this purpose. We recommend that, as part of meeting the validation requirements of 21 CFR 120.11, you ensure that studies have been done to establish that contamination of juice by pathogens that may be present on the peel will not occur during the extraction operation. We recommend that such studies be included among the records you make available for official review under 21 CFR 120.12.

D. Control Measures for Chemical Hazards

There are no specific chemical hazards for which HACCP control measures are required explicitly under the juice HACCP regulation. If you identify a chemical hazard that is reasonably likely to occur in your juice, you will need to establish control measures for that hazard in your HACCP plan. However, because FDA has recently established an action level for patulin, a mycotoxin, which can occur in apple juice, we have included information on control strategies for patulin. The information in this section includes examples of control measures for incoming fruit based upon a supplier guarantee. These examples may be useful for devising control measures for other chemical hazards, such as lead and tin, if such control measures also are based upon a supplier guarantee. We have also included information about appropriate controls to prevent cross contamination of juice by other foods, e.g., milk, that may cause allergic reactions in sensitive individuals when these other foods are produced on the same processing equipment. 1. 1.0 Control Strategies for Patulin for Apple Juice Processors This section discusses factors you may wish to consider in your hazard analysis to determine whether patulin is a hazard that is reasonably likely to occur in your juice. It also discusses control measures and CCPs you may wish to consider for your HACCP plan, should you determine that patulin is reasonably likely to occur in your juice. The potential for high levels of patulin to occur depends on several factors. There is no single factor that will, in all cases, determine whether your apple juice may contain high levels of patulin. The most significant factors are:

Whether the apples used include fallen fruit - Apple juice made from apples that include fallen fruit is more likely to contain high levels of patulin than juice made from apples harvested to exclude fallen fruit. The condition of apples at the time of harvest - Juice made from apples with visible damage (e.g., from birds or insects, mold, or rot), is more likely to contain high levels of patulin than juice made from apples without such visible defects. Proper agricultural control practices by the grower, e.g., insect control, anti-fungal applications when needed, can assist in minimizing mold growth and rot on apples. How apples are handled prior to storage - Patulin production can occur during the storage of apples, particularly in apples that are bruised in handling prior to and during storage. Storage conditions for apples - Apples stored without proper temperature and atmospheric control of the storage environment are more likely to contain high levels of patulin than apples stored under controlled conditions. Monitoring apples during storage for core rot - Patulin production in stored apples can be caused by core rot that is not visible by observation of the exterior of the apple. Lots of apples that are experiencing core rot may be identified by cutting and cross-sectional examination. Eliminating lots of apples with high levels of core rot from the juice production stream will reduce patulin levels in the juice. Culling or trimming apples prior to juice production - Growth of patulin producing molds is evidenced frequently by the appearance of visible mycelia or rot on the apple. Culling or trimming apples just prior to juice production to eliminate damaged, bruised, moldy, and rotting apples will reduce patulin levels in the juice.

Not all apples are equally affected by these factors. For example, recently published research(11) indicates that different apple varieties, e.g., Red Rome, Granny Smith, and Red Delicious, may differ in how patulin levels in their juices are affected by factors such as whether fallen fruit is used or whether apples are culled prior to juice production. 2. 1.1 Hazard Analysis You may be able to gather a substantial amount of data pertinent to your juice and process and perform a comprehensive hazard analysis, considering all of the factors in the previous section, and determine that no controls (in rare instances), or relatively limited measures, are necessary to control patulin for your apple juice process. For instance, you may determine, based upon data for the type of apples you use, that the use of apples that include fallen fruit would likely lead to excessive levels of patulin in your juice. You may opt to control for patulin via a CCP at the receiving step for apples based upon a supplier guarantee specifying that no fallen fruit is included among the apples supplied in the shipment. However, you also may determine that because you produce juice from apples that are stored only for very brief periods, during which data indicate that significant patulin production will not occur in the varieties of apple you use, the culling or trimming of apples prior to juice production is not necessary for the

control of it, provided that you establish a control to ensure that apples are stored for a maximum period of time before juice production. However, because patulin levels in juice can be affected by many factors as noted previously, not all processors may be able to acquire data or other information to perform a comprehensive hazard analysis considering all of the factors noted in the previous section. In such cases, it may be prudent for you to assume that patulin is a hazard that is reasonably likely to occur and to control for patulin by requiring a supplier guarantee for each shipment specifying that no fallen fruit is included among the apples supplied, and also by establishing a culling or trimming step in your process after the storage step, at which rotten, moldy, bruised, and damaged apples are removed from the production stream. Thus, you might elect to have two CCPs for the control of patulin, the receipt of apples and the culling (or trimming) step prior to juice production. If you store apples for extended periods of time, we recommend a third control measure, inspecting apples taken from stored lots by cutting the apples and visually checking for core rot at various times during the storage period. Lots of apples showing significant levels of core rot may not be acceptable for juice production. These checks for core rot would constitute a third CCP. By establishing the three aforementioned controls, i.e., exclusion of fallen fruit, culling or trimming of rotten, moldy, bruised and damaged apples from production stream, and eliminating stored apples with high levels of core rot, it is likely that you will be able to adequately control patulin levels in your juice. We suggest that you test some of your juice to show that your control measures will effectively control patulin. A commercial laboratory can do this testing for you. We suggest that an appropriate basis for determining that your control measures are effective is, if upon analysis of at least 3 samples of your juice for patulin taken during one year (each analyzed in duplicate and sampled under conditions where the occurrence of patulin is most likely, e.g., after apples are stored for the longest potential storage time), you find that all patulin levels are below FDA's action level and that the value achieved by adding 2 standard deviations to the mean is below FDA's action level of 50 parts per billion. This is illustrated in the following examples for hypothetical juices A, B and C: Juice Patulin level, Mean (std dev) (derived from 6 data points; 3 analyses during the year, each in duplicate) 40.2 (7.2) 0.97 (1.67) 3.43 (31.9) Patulin level at mean plus 2x std deviations. 54.6 4.31 67.23 Is patulin being effectively controlled? No Yes No

A B C

Processors in the same geographic region that use common varieties of apples and common production techniques may wish to consider pooling resources to test

representative samples of their juices to develop baseline data on patulin for use in their hazard analyses. If there are significant changes in your process or in factors that may affect patulin levels, e.g., a change in the variety of apples you use to make juice, a change in your storage practices, a new supplier, or abnormal weather conditions, we also recommend that you re-validate your hazard analysis by testing juice made under the new conditions. 3. 1.2 Control Measures If the receiving of apples is a CCP: A supplier guarantee specifying that only apples harvested to exclude fallen fruit were supplied in the shipment is likely to be an effective control measure for patulin. Under such an approach: The existence of the supplier guarantee for each shipment of incoming fruit specifying that only apples harvested to exclude fallen fruit were supplied in the shipment would be the critical limit. For a small processor who harvests apples from his own orchard, we recommend, in lieu of a supplier guarantee, that the processor's apple pickers be instructed not to harvest fallen fruit and the processor confirm that the workers are adhering to the instructions. o A monitoring procedure would be to confirm visually the existence of the guarantee for each incoming shipment of apples. o The corrective action procedure would be to reject any shipment of fruit not accompanied by a guarantee from the supplier. o The verification procedure could consist of periodic auditing of the supplier to ensure that the supplier is following the provisions of the guarantee, or testing the juice periodically to confirm that it does not contain high levels of patulin. We recommend that processor's who rely on guarantees or certificates from suppliers to control a hazard couple these types of controls with a strong verification procedure, such as visiting the farm periodically or periodically testing the juice.
o

If culling or trimming apples after storage is a CCP: The culling or trimming of the fruit during the sorting step after storage to eliminate moldy, rotten, bruised, and damaged (e.g., from birds or insects) fruit is likely to be an effective control measure. o The use of only apples or apple portions free of mold, rot, bruising, and other damage would be the critical limit. o A monitoring procedure would be to inspect apples at the sorting step to ensure that the apples are free of rot, mold, bruising, and other damage. o The corrective action procedure would be to cull or trim any apples that show mold, rot, bruising, or other damage. In practice, we recommend that you establish visual or other criteria for what constitutes a damaged apple that should be culled. We further recommend that criteria be established based upon
o

validation data showing that juice made from apples culled using the criteria do not contain unacceptable levels of patulin. o The verification procedure could consist of periodically testing the juice to confirm that the juice does not contain high levels of patulin and reviewing records of monitoring, corrective action, and verification. 4. 1.3 If You Make Apple Juice from Purchased Concentrate If you make apple juice from purchased concentrate, your concentrate supplier is responsible under his/her HACCP program for controlling patulin if it is reasonably likely to occur in the concentrate. In such a situation, it is reasonable for the processor who, for example, purchases concentrate and processes it into single strength apple juice, to conclude in his hazard analysis that patulin is not reasonably likely to occur because it is controlled under the HACCP plan of the concentrate supplier. 5. 2.0 Control Measures for Allergens that Can Contaminate Juice from Improperly Cleaned Shared Processing Equipment If you process juice on equipment that also has been used to process a food that can cause allergic reactions, we recommend that you implement CCP or rigorous SSOP controls that will ensure that the equipment has been cleaned properly before it is used to process juice. (See discussion about when FDA recommends use of a CCP vs. an SSOP for contaminants from food contact surfaces in section IV. C. 3.3.) A list of eight foods that can cause serious allergic reactions in some individuals and account for more than 90% of all food allergies is found in section IV C. 1.22. For example, if you process milk on equipment also used to process juice, we recommend that you clean the equipment to eliminate the milk residues before using the equipment to process juice. An appropriate SSOP might be to establish a procedure for cleaning your equipment with a cleaning solution, e.g., a pre-rinse, followed by a caustic wash, followed by a rinse. The procedure could include maintaining a log of what foods, e.g., milk, eggnog, soy drinks, were processed on your equipment, the sequence in which the foods were processed, and how/when the equipment was cleaned. Your operator could check that log prior to starting any production run for juice. Your control could provide that the equipment would not be used for juice until the prescribed cleaning procedure was carried out, and recorded in the log (See Example SSOP in section VII C). We recommend that you initially validate the effectiveness of the cleaning procedure by conducting tests for milk protein residue on the equipment after running the cleaning. We also recommend that you establish a procedure to monitor the efficacy of the cleaning process, e.g., swabbing the equipment surfaces and testing the swabs for milk protein residue. A CCP procedure could similarly be based upon a pre-rinse, caustic wash, followed by rinse procedure. We do recommend that the parameters of the procedure such as time, temperature, and percent caustic, initially be validated for the effective removal of milk

protein from the processing equipment and monitoring of the parameters as critical limits be carried out (See Example CCP in section VII C). Whether an SSOP or a CCP is used, you should consider whether the equipment's design makes cleaning difficult absent disassembly of the equipment. If necessary to achieve effective cleaning, we recommend that you disassemble the equipment as part of the cleaning process.

E. Control Measures for Physical Hazards

1. 1.0 Physical Hazards There are no specific physical hazards, e.g., glass or metal fragments, for which control measures are explicitly required under the juice HACCP regulation. The necessity for control measures for any potential physical hazard is dependent upon a finding in your hazard analysis that the specific hazard is reasonably likely to occur in your juice. FDA has issued a Compliance Policy Guide (CPG Section 555.425) (see section I. C for availability information) describing when hard or sharp foreign objects in food, such as glass or metal fragments, could pose a health hazard. If it is reasonably likely that your juice may become contaminated with hard or sharp foreign objects that meet the criteria in this CPG, we recommend that you regard the object as a potential hazard in your juice. 2. 1.1 Glass Fragments We can recommend several ways to establish control measures for glass fragments in juice. One way is the use of on-line glass detection equipment such as x-ray detection. In this method, the product itself is continuously monitored after the last step at which glass inclusion is reasonably likely to occur (e.g. after bottling and sealing of the juice). This could be, for example, at a process step designated for x-ray examination. The critical limit might be designated as "no glass fragments in the finished product." The following illustrates the elements that might be entered into your HACCP plan. What is the critical limit? No glass fragments in finished product (Note: FDA's Health Hazard Evaluation Board has supported regulatory action against product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. See also FDA Compliance Policy Guide 555.425). o What will be monitored? The presence of glass fragments in containers passing the CCP o How is monitoring done? Use of x-ray equipment or other defect rejection system o How often? Continuous; each container is subjected to detection. For x-ray equipment and other defect rejection systems, we recommend that you confirm that the device is operating correctly, at least at the start of each production day
o

Who will perform the monitoring? For x-ray detection and other defect rejection systems, the equipment itself performs monitoring. We recommend that you check at least once per day to ensure that the device is operating.

Another way to control glass fragments, applicable in operations where the containers are manually (not mechanically) handled and sealed, involves inspecting glass containers visually before they are filled to ensure that glass fragments are not present in the containers. An appropriately trained individual at a container inspection step in the process may do this. We recommend that there be a check at the start of production to ensure that the appropriate personnel are assigned to the processing step where the inspection will occur. The critical limit might be designated as "no glass fragments in empty glass containers at the container inspection step." A third way to control glass fragments is visual inspection at steps in the process where glass breakage can result in glass entering the juice, such as the glass container receiving, glass container storage, mechanical conveying, mechanical filling, and mechanical capping. The inspection looks for any evidence of glass breakage in those areas. CCPs might be identified as the glass receiving and storage steps and the mechanical conveying, filling and capping steps. The critical limit might be designated as "no broken glass at the CCPs for glass inclusion." If broken glass is observed, the line is stopped, the glass is removed, and the product that has moved through that area since the last inspection is placed on hold for further action as appropriate, e.g. to be run through offline glass detection equipment, to be destroyed, to be diverted to non-food use, or to be re-run through a process that includes a glass detection step. What is the critical limit? No broken glass at the CCPs for glass inclusion What will be monitored? The presence of broken glass on or near equipment at the CCPs o How is monitoring done? Visual check of the glass handling areas for broken glass o How often? We recommend that you check before starting operations each day, check at least every four hours during operation, check at the end of operations each day, and check whenever there is an equipment or other malfunction that could increase the likelihood that glass containers could be damaged o Who should perform the monitoring? Any person who has a thorough understanding of the proper condition of the glass handling equipment and surrounding area may perform monitoring. In assigning the responsibility for this monitoring function, we recommend that you consider the complexity of the equipment and the level of understanding necessary to evaluate its condition.
o o

If broken glass is observed at a CCP, we recommend that the corrective action procedure be to stop the line, remove the broken glass, and then place on hold any product that has moved through the area where the glass breakage was observed since the last inspection, for further action as appropriate, e.g., to be run through off-line glass detection equipment, to be destroyed, to be diverted to non-food use, or to be re-run through a process that includes a glass detection step.

3. 1.2 Metal Fragments We can recommend several possible ways to establish control measures for metal fragments in juice. One way involves the use of on-line metal detection equipment. With this method, the equipment continuously monitors the product after the last step at which metal inclusion is reasonably likely to occur (e.g., after bottling and sealing of the juice) at a process step designated for metal detection. The critical limit might be designated as "no metal fragments in the finished product." The following illustrates some of the elements that might be entered into your HACCP plan.
o

o o o

What is the critical limit? No metal fragments in finished product (Note: FDA's Health Hazard Evaluation Board has supported regulatory action against product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. See also FDA Compliance Policy Guide 555.425). What will be monitored? The presence of metal fragments in containers passing the CCP. How is monitoring done? By the use of metal detection equipment. How often? Continuously. Each container is subjected to detection. We recommend that you confirm that the device is operating correctly at least at the start of each production day. Who should perform the monitoring? Monitoring is performed by the equipment itself. We recommend that a check be made at least once per day to ensure that the device is operating correctly.

A second way to control metal fragments involves the use of a separation device such as a screen after the last step at which metal inclusion is reasonably likely to occur, at a process step designated for screening. For this approach (see example HACCP plans for Pasteurized Refrigerated Apple Juice and Not-from-concentrate Orange Juice in section VII):
o o o

The critical limit might be designated as "screen is functional." Monitoring may be done by a daily visual check for screen integrity. We recommend that verification include periodic calibration testing to ensure that the screen retains its separation capability for metal particles of a specific size. In establishing this size, we recommend that you consider that FDA's Health Hazard Evaluation Board has supported regulatory action against product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. (See also FDA Compliance Policy Guide 555.425).

A third way to control metal fragments involves visually inspecting equipment for damage or missing parts at process steps such as extraction and grinding, where such damage or loss of parts could lead to metal fragments in your juice. This approach may only be feasible for relatively simple equipment that can be fully inspected visually in a reasonable time period. Under this approach, CCPs might be identified as the fruit

grinding and extraction steps in a process. The critical limit might be designated as "no broken or missing metal parts from equipment at the CCPs for metal inclusion." If broken or missing metal parts are observed, the line is stopped, the equipment is repaired and, if necessary, adjusted or modified, and the product that has moved through that area since the last inspection is placed on hold for further action as appropriate, e.g., to be run through off-line metal detection equipment, to be destroyed, to be diverted to non-food use, or to be re-run through a process that includes a metal detection step. The following illustrates the elements that might be entered into your HACCP plan.
o o o o

What is the critical limit? No broken or missing metal parts from grinding (or extraction) equipment What will be monitored? The presence of broken or missing metal parts on or near the grinder How is monitoring done? By visual check of the grinder and immediate vicinity for broken or missing metal parts How often? Check before starting operations each day, check at least every four hours during operation, check at the end of operations each day, and check whenever there is an equipment or other malfunction that could increase the likelihood that metal inclusion could occur. Who will perform the monitoring? Any person who has a thorough understanding of the proper condition of the equipment and surrounding area may perform monitoring. If broken or missing metal parts are observed at a CCP, the corrective action procedure would be to stop the line, repair, adjust, and modify the equipment as necessary; the product that has moved through that area since the last inspection is placed on hold for further action as appropriate, e.g., to be run through off-line metal detection equipment, to be destroyed, to be diverted to non-food use, or to be re-run through a process that includes a metal detection step.

F. Table of Most Likely Hazards/Control Measures for Juice

The following table lists the hazards that you are most likely to address under your HACCP program, some of the control measures you may use for those hazards, and where to find information in this guidance about those control measures.

Table 1. Most Likely Hazards/Control Measures for Juice Hazard Identity Hazard rationale Possible control measures(12) For additional controls information see section ...

Pathogens(13)/biological Unless you produce one of the types of

1. Pasteurization 2. UV radiation

V. C. 1.1 -

juice listed in footnote #12, or a low acid juice not subject to the Low Acid Canned Foods regulations (21 CFR Part 113) one of the pathogens listed in footnote #13 is likely to be the "pertinent microorganism" for your required 5-log pathogen reduction treatment.

3. Pulsed light 4. High pressure processing 5. Dense phase CO2 processing 6. For fresh citrus juice only: Supplier guarantee for each shipment (only tree-picked fruit was supplied), culling to remove damaged fruit that may have pathogens in edible portion, washing/sanitizin g fruit surface, extraction process that minimizes juice/peel contact

Pertinent microor ganism V. C. 5.0 Process validatio n V. C. 5.31 Pasteuri zation Equipme nt V. C. 5.32 UV Processi ng Systems V. C. 5.33 High Pressure Processi ng Systems V. C. 5.34 Dense Phase CO2 Processi ng Systems V. C. 3.1 and 3.2 Fresh citrus juices, also Example HACCP plan for fresh

citrus juice in VII. B. 2.0. Patulin/chemical Patulin is a mycotoxin that can occur on rotten, moldy, bruised or damaged apples, and may occur at hazardous levels if such apples are used to make juice 1. Supplier guarantee for each shipment; only apples harvested to exclude fallen fruit were supplied 2. Cull or trim apples after storage to remove rotten, moldy, bruised and damaged apples CCP or SSOP control for adequate cleaning of processing equipment between a milk run and a juice run V. D. 1.2 and Example HACCP Plan for apple juice in VII. B. 1.0.

Milk residue (an undeclared allergen) in juice/chemical

May occur in juice processed using equipment also used to process milk or dairy products

V. D. 2.0 and Example CCP and SSOP in VII. C. V. E. 1.1

Fragments from glass containers/physical

Glass fragments in Check processing line juice can pose a risk for evidence of glass of injury if ingested breakage (if containers are mechanically handled) Pass product through xray equipment or other defect rejection system Pass product through separation device such as a screen Check containers prior to filling for glass breakage (if containers are manually handled)

Metal Fragments

Metal fragments in Check equipment for juice can pose a risk evidence of broken or of injury if ingested missing metal parts that may enter the juice Pass product through metal detection equipment Pass product through separation device such as a screen or magnet (if the metal is ferrous, e.g., a steel grinder blade)

V. E. 1.2

VI. Preparing for HACCP

A. Getting people ready
In implementing your HACCP system, you will rely on people to perform a variety of tasks that will begin well before you produce any juice under your HACCP system, e.g., the development of your hazard analysis and HACCP plan. To carry out these tasks, your employees should familiarize themselves, as appropriate, with HACCP principles and acquire any necessary HACCP training. InPart B of this section, we have listed several sources of information about HACCP resource materials and HACCP training. You also may wish to retain outside experts to assist your staff in these tasks. For instance, a process authority can provide specialized expertise to validate the processing parameters, e.g., time/temperature, that you will use to meet the 5-log pathogen reduction requirement. Successful implementation of HACCP requires trained people who cooperate from the preliminary stages to the implementation and ongoing operation of the HACCP system. We strongly recommend that you begin with step 1 of NACMCF's 5 preliminary steps of HACCP, by assembling a HACCP team that includes plant level and corporate level personnel. (See the HACCP Principles and Guidelines publication discussed in section IV. B.)

B. HACCP Training and HACCP Resource Materials

1. 1.0 Juice HACCP Alliance Training Curriculum The Juice HACCP Alliance has produced a manual for a training curriculum designed to instill the principles of HACCP as applied to the processing of juice under the requirements of the juice HACCP regulation.(14) In a guidance document entitled "Standardized Training Curriculum for Application of HACCP Principles to Juice Processing" (see section I. C. for availability information) FDA has advised that this manual, the 1st Edition of the Juice HACCP Training Curriculum of the Juice HACCP Alliance (the standardized curriculum), is adequate for use in training individuals to meet the requirements of the juice HACCP regulation in 21 CFR 120.13 issued. FDA also stated that other curricula that are equivalent in coverage to that of the standardized curriculum may also be used to meet this training requirement (see 21 CFR 120.13(b)). The manual for the standardized curriculum is available for purchase from the National Center for Food Safety and Technology at the Illinois Institute of Technology, and is available for viewing and downloading at no cost at www.ncfst.iit.edu. 2. 2.0 USDA/FDA HACCP Training Programs and Resources Database The USDA and FDA created the HACCP Training Programs and Resources Database to support the increasing educational information needs of industry and food service professionals in implementing HACCP programs. This database provides up-to-date listings of HACCP training programs and HACCP resource materials. Its intended users are educators, trainers, field staff in Extension, Food Safety and Inspection Service (FSIS) personnel, FDA personnel, private sector food processing plants and organizations, and others interested in identifying HACCP training resources. The internet address is http://www.nal.usda.gov/fnic/foodborne/haccp/index.shtml.

VII. Example Documents

This section includes example documents showing components of hazard analyses and HACCP plans for a pasteurized refrigerated apple juice, a fresh orange juice, and a not-from-concentrate pasteurized orange juice. Hazard analysis summary tables, and excerpts from HACCP plans for the three juices, and a hazard identification and evaluation exercise for apple juice are included. These are provided as examples for you to consider when you conduct your hazard analysis and write your HACCP plan. However, we recommend that as you develop your hazard analysis and HACCP plan, you consider whether other control measures, monitoring activities, and verification activities, etc., are appropriate for your particular process. Most importantly, in your hazard analysis, we recommend that you should consider the factors that are specific to your juice and your process, and any unique conditions in your facility, to identify appropriate control measures for your HACCP plan.

A. Hazard Analysis Examples

1. 1.0 Hazard Identification and Evaluation Exercise for Apple Juice

2. 1.1 Step 1. Hazard identification The team develops a list of potential biological, chemical, and physical hazards that may be introduced, increased, or controlled at each step in the production process. Vegetative and Protozoan Enteric Pathogens Enteric pathogens such as the bacterium Esherichia coli O157:H7 and the protozoan parasite Cryptosporidium parvum may be present on and in apples and can contaminate apple juice at the time the juice is extracted from the fruit. o Patulin High levels of patulin can occur in juice made from fallen apples or damaged apples that contain mold, rot, or other damage. Patulin present in the extracted juice will carry through to the final product because patulin is not destroyed by pasteurization. o Metal Fragments Metal fatigue or worn/damaged blades in equipment used for grinding apples can introduce metal fragments into juice. o Pesticides Residues from unapproved pesticides or residues in excess of pesticide tolerances in juice could pose a potential hazard if they occurred over an extended period of time at levels capable of causing health effects from chronic exposure, or if they occurred for only a brief period of time at levels capable of causing acute health effects. 3. 1.2 Step 2. Hazard evaluation
o

The team assesses the severity of the health consequences if a potential hazard is not properly controlled. Vegetative and Protozoan Enteric Pathogens Epidemiological evidence indicates that E.coli O157:H7 and Cryptosporidium parvum can cause severe and life-threatening foodborne illness. Unpasteurized apple cider has been linked to illness outbreaks from these pathogens. o Patulin Exposure over a period of time to high levels of patulin may pose a health hazard. o Metal Fragments If large enough, metal fragments in juice can cause injury when ingested. o Pesticides Acute or chronic exposure to unapproved pesticide residues can cause a variety of adverse health effects, some of which could be severe.
o

The team determines the likelihood of a potential hazard occurring if not properly controlled.

Vegetative and Protozoan Enteric Pathogens Because the entire fruit will be extracted, there is a reasonable chance for the pathogen to be present in the extracted juice if it is present in or on the fruit. o Patulin Available data indicates that if dropped or damaged apples are used to make juice, high levels of patulin may be reasonably expected to occur in the juice. o Metal Fragments Without controls, there is no means in the process by which metal fragments from grinding equipment would be removed from the juice. o Pesticides Harmful pesticide residues in the juice are not likely because in U.S. produce, unapproved pesticide residues occur infrequently and the public health impact is typically not severe.
o

The HACCP team decides that E.coli O157:H7, Cryptosporidium parvum, patulin, and metal fragments are hazards that are reasonably likely to occur in the apple juice. 4. 2.0 Example Hazard Analysis for Pasteurized Refrigerated Apple Juice On the following page is an example of a "Hazard Analysis Summary Table" for a pasteurized refrigerated apple juice packed in plastic bottles. In the example, the process steps are simplified as compared with what may be performed in an actual process, but all critical process steps for this type of juice are included. For this example, we assumed that patulin was a hazard that was reasonably likely to occur if fallen fruit was used to make the juice or if the apples were not culled or trimmed after storage to remove rotten, moldy, damaged, or bruised fruit. See the discussion in section V. C. 5.2 about why two pathogens are identified as the pertinent microorganism in this hazard analysis. 5. Pasteurized Refrigerated Apple Juice 6. Procedures/Steps 7. Incoming Materials o Locally grown fresh apples are received directly from farms. o Packaging materials are delivered in clean, well-maintained and covered vehicles. 8. Processing o Fruit is unloaded and placed into cold storage. o Fruit is transferred from cold storage to the processing area, and dumped onto a slotted hopper where stems, leaves and other extraneous materials are removed. o From the slotted hopper, the fruit goes to a flume tank containing sanitizer treated water. o Fruit is elevated, dewatered, and moved over inspection rollers where visually defective apples are culled and fruit is rinsed with potable water. o Fruit continues on to a wet scrubber where it is brushed and sprayed with treated water. Fruit then passes along a rubberized roller where it is partially dried.

Fruit is elevated, rinsed in potable water, drained, and dropped into a hammermill grinder. o After grinding, the slurry goes to a continuous belt press where the pomace and juice slurry are separated. o The juice slurry is screened to separate the juice from the pulp, achieve a particle size compatible with the pasteurizer manufacturer's recommendations, and to remove metal fragments. o The juice is pumped to a holding tank. o The juice is pasteurized in a plate heat exchanger, which heats the juice to a predetermined temperature, holds the juice for a set time, and cools the juice as it exits. o The juice is pumped into a refrigerated bulk storage tank. 9. Packaging and Shipping o Juice is filled into High Density Polyethylene (HDPE) blow-molded bottles of various sizes. Bottles are capped, labeled, coded, cased, palletized and stored refrigerated until shipping.
o

Table 2. Hazard Analysis Summary Table (for Pasteurized Refrigerated Apple Juice) (1) Ingredient/processin g step (2) Identify potential hazards introduced, controlled, or enhanced at this step Biological(B) Vegetative and protozoan enteric pathogens (i.e., E.coli O157:H7 and Cryptosporidiu m parvum) Chemical(C) 1. Pesticides (3) (4) (5) What control measure(s) can be applied to prevent the significant hazards? (6) Is this step a Critical Control Point? (Yes/No ) No

Are any Justify your potential decision for food-safety Column 3 hazards significant ? (Yes/No)*

Receiving (raw apples)

Yes

History of Pasteurizatio outbreaks for n apple juice.

No

In U.S. produce unapproved pesticide

No

residues occur infrequently and public health impact is typically not severe. 2. Patulin Yes May have adverse effects Supplier guarantee (apples harvested to exclude fallen fruit) and culling or trimming defective (i.e., moldy, rotten, bruised and damaged) apples. Yes

Physical(P) None Receiving (plastic bottles/caps) B - None C - None P - None Dry Storage (plastic bottles/caps) Cold Storage B - None C - None P - None B - Growth of No pathogens such as salmonella and E. coli O157:H7 due to temperature abuse C - Patulin Yes Growth not likely due to the pH of apples.

Patulin levels Cull or trim may increase defective in storage. apples

No

P - None Remove Debris (slotted hopper) Wash (flume tank) B - None C - None P - None BNo Contamination with pathogens such as salmonella from water C - None P - None Cull B - None C - Patulin Yes Patulin levels Cull or trim are reduced defective by culling apples. defective apples. Yes Not likely to occur due to SSOP for water quality

P - None Brush/Wash B - None C - None P - None Partially Dried B - None C - None P - None Grind B - None C - None P - Metal fragments Yes Metal Screen fatigue, worn and damaged blades can cause contaminatio n of slurry. No

Press

B - None C - None P - None

Screen

B - None C - None P - Metal fragments Yes Intact screen Screen filters out the metal fragments Yes

Holding Tank

B - None C - Sanitizing chemicals No Not likely to occur because of SSOP for cleaning and sanitizing; residue levels not reasonably likely to cause illness.

P - None Pasteurize/Cool B - Vegetative Yes and protozoan enteric pathogens (E. coli O157:H7 and Cryptosporidiu m parvum are the pertinent microorganisms C - None P - None Holding Tank B - None C - Sanitizing chemicals No Not likely to occur Microbial contaminatio n on incoming apples. Pasteurizatio n Yes

because of SSOP for cleaning and sanitizing; residue levels not reasonably likely to cause illness. P - None Fill B - None C - None P - None Cap B - None C - None P - None Code/Case/ Palletize Cold Storage B - None C - None P - None B - None C - None P - None Ship B - None C - None P - None * For the purpose of this example hazard analysis, a "significant hazard" is one that meets the definition of a hazard that is reasonably likely to occur in 120.7(a)(2) of the juice HACCP regulation, i.e., it is one for which a prudent processor would establish controls, i.e., at CCPs in his HACCP plan.

1. 3.0 Example Hazard Analysis for Fresh Orange Juice

On the following page is an example of a "Hazard Analysis Summary Table" for a fresh orange juice packed in plastic bottles for which the 5-log pathogen reduction process is achieved through surface treatment of the oranges. In the example, the process steps are simplified as compared with what may be performed in an actual process, but all critical process steps for this type of juice are included. A hazard identification and evaluation exercise is not shown for this juice, but for enteric pathogens, it would be similar to the one shown above for apple juice, except that Salmonella species would be identified as the pathogen of concern (the pertinent microorganism) because of the history of illness outbreaks caused by Salmonella in orange juice. For pesticides, the hazard identification and evaluation exercise would be identical to the one shown for apple juice. Patulin is not a concern for citrus juices. For this example, we assume that the processor has data of the type discussed in section IV. C. 1.32, indicating that there were no occurrences of metal fragments in the juice, and thus was able to conclude that the potential hazard of metal fragments from the extraction equipment was not reasonably likely to occur. 2. Fresh Orange Juice 3. Procedures/Steps 4. Incoming Materials o Locally grown tree-picked oranges of various varieties are received either directly from the field or from local cold storage facilities. o Packaging materials are delivered in clean, well-maintained, and covered vehicles. 5. Processing o Fruit is visually inspected prior to unloading and placed into cold storage. o Fruit is washed prior to primary culling. o During primary culling, damaged fruit is culled out and disposed of (primary cull step). o Fruit is rinsed with potable water. o Fruit is sprayed with sanitizer solution. o Fruit passes through a brush washer while being sprayed with a detergent/sanitizer. o Fruit is graded (secondary cull step). o Fruit is sprayed with a sanitizer solution and rinsed with potable water. o Juice is extracted using a process that limits juice/peel contact. o Juice is chilled using a tube-in-shell heat exchanger. o Juice is batched in a chilled surge tank. 6. Packaging and Shipping o Juice is filled into HDPE blow-molded bottles of various sizes. Bottles are capped, passed through a metal detector, labeled, cased, and stored refrigerated until shipping.

Table 3. Hazard Analysis Summary Table (for Fresh Orange Juice) (1) Ingredient/ processing step (2) (3) (4) (5) (6)

Identify Are any Justify What control Is this potential potential your measure(s) can be step a hazards fooddecision applied to Critical introduced, safety for prevent/reduce/elimin Control controlled or hazards Column 3 ate the hazard? Point? enhanced at significant this step ? (Yes/N o) (Yes/No)* BPathogens in raw fruit have been known to cause illness C - In U.S. produce, unapprove d pesticide residues occur infrequentl y and public health impact is typically not severe B - Supplier agreement Yes specifying that only tree-picked fruit will be supplied, culling to remove damaged fruit that may contain pathogens in edible portion, brush washing and sanitizing fruit. No

1. Receiving (raw B - Pathogens Yes (Salmonella fruit) spp. was determined to be the pertinent microorganis m) C - Pesticides No

P - None 2. Inspect, Wash, B - None Cold Storage C - None P - None 3. Primary cull

No No

No No

B - Pathogens Yes

Pathogens in raw

Cull visually damaged fruit, e.g., punctures,

Yes

fruit have been known to cause illness 4. Potable Water B - Pathogens No from water Rinse C - None P - None 5. Sanitize B - Pathogens Yes Not likely to occur due to SSOP for water quality. BPathogens in raw fruit have been known to cause illness BPathogens in raw fruit have been known to cause illness

splitting, cuts, rot, mold in peel

Sanitized wash used to achieve portion of cumulative 5-log pathogen reduction

Yes

B - Pathogens Yes 6. Brush Washing with Detergent/Sanitiz er

Sanitized wash used with brusher used to achieve portion of cumulative 5-log pathogen reduction

Yes

7. Grading (secondary cull)

B - None C - None P - None

No

No

8. Re-sanitize

B - Pathogens Yes

BPathogens in raw fruit have been known to cause illness

Sanitized wash used to achieve portion of cumulative 5-log pathogen reduction

Yes

9. Extract

B - None P - Metal P - No P-

No **

fragments

Processor has metal detector data for more than one year showing that no metal metal fragments capable of causing injury have occurred in juice from the extraction equipment No

10. Chill

B - None C - None P - None

11. Batch in chilled surge tank

B - None C - None P - None

No

No

12. Package, cap B - None C - None P - None 13. Label, case, palletize B - None C - None P - None 14. Store, ship B - None C - None P - None

No

No

No

No

No

No

B=Biological; C=Chemical; P=Physical *For the purpose of this example hazard analysis, a "significant hazard" is one that meets the definition of a hazard that is reasonably likely to occur in 120.7(a)(2) of the juice HACCP regulation, i.e., it is one for which a prudent processor would establish controls, i.e., at CCPs in his HACCP plan. ** In this example hazard analysis, the extraction step was not determined to be a CCP because the extractor is of a design that facilitates the 5-log pathogen reduction by by limiting juice/peel contact during extraction, and is the only extractor in the facility. Should a different extractor be used in the facility, the processor would have to re-validate the HACCP plan under 120.11 (b).

1. 4.0 Example Hazard Analysis for Not-from-Concentrate Pasteurized Orange Juice On the following page is an example of a "Hazard Analysis Summary Table" for a notfrom-concentrate pasteurized orange juice in cartons. The orange juice is derived from oranges that are extracted at the facility, and from un-pasteurized juice received in tankers. FDA permits unpasteurized juice to be shipped in bulk if the processor receives assurance that another processor will treat the juice to achieve the 5-log pathogen reduction in the facility where final packaging is to be performed (see "The Juice HACCP Regulation Questions and Answers," at the web address given in section I. B above). In the example, the process steps are simplified as compared with what may be performed in an actual process, but all critical process steps for this type of juice are included. A hazard identification and evaluation exercise is not shown for this juice, but for enteric pathogens, it would be similar to the one shown above for apple juice, except that Salmonella species would be identified as the pathogen of concern (the pertinent microorganism) because of the history of illness outbreaks caused by Salmonella in orange juice. For pesticides, the hazard identification and evaluation exercise would be identical to the one shown for apple juice. Patulin is not a concern for citrus juices. Metal fragments could occur in the orange juice, but they would originate from the extraction equipment in this example, because no grinding of fruit (as was performed in the apple juice process) is performed in this process. Metal fragments in the unpasteurized juice received in tankers would be handled under the HACCP Plan of the processor of that juice (see section V. D. 1.3). 2. Not-from-Concentrate Pasteurized Orange Juice 3. Procedures/Steps 4. Incoming materials

Locally grown fresh oranges of various varieties are received directly from the field. Un-pasteurized juice is also received in tankers. o Packaging materials are delivered in clean, well-maintained, and covered vehicles. 5. Processing o At fruit receiving/bin staging, fruit is unloaded, de-stemmed. o Fruit is rinsed with potable water. o Fruit is graded (initial culling) o Graded fruit is stored in bins. o Upon removal from bins, fruit is rinsed and then brush washed with detergent/sanitizer. o Fruit is rinsed with potable water. o Fruit is graded (final culling). o Fruit is sized and the juice is extracted. o Pulp is removed from the extracted juice by finishers and the juice is pumped to a jacketed surge tank. o Incoming juice (unpasteurized) from tankers is pumped to a jacketed storage tank. o Juices are then blended in a surge tank for pasteurization. o Juice is pasteurized using a tube-in-shell heat exchanger. o Pasteurized juice is chilled and pumped to a jacketed surge tank. 6. Packaging and Shipping o Chilled pasteurized juice is screened and filled into cartons o Cartons are sealed, coded, cased, palletized, and put into refrigerated storage. o Products are shipped in clean, well-maintained refrigerated tractor-trailers.
o

Table 4. Hazard Analysis Summary Table (for Not-from-concentrate Pasteurized Orange Juice) (1) Ingredient/ processing step (2) Identify potential hazards introduced, controlled or enhanced at this step (3) Are any potential foodsafety hazards significan t? (Yes/No)* B - Pathogens Yes 1. Receiving/Stagi (Salmonella ng (raw fruit) spp. were determined to B - Possible B - Controlled at the presence of pasteurization step. pathogens on No (4) Justify your decision for Column 3 (5) (6)

What preventative Is this measure(s) can be step a applied to Critical prevent/reduce/elimin Control ate the hazard? Point? (Yes/No )

be the pertinent microorganis m) C - Pesticides No

incoming fruit

C - In U.S. produce, unapproved pesticide residues occur infrequently and public health impact is typically not severe

No

P - None 2. Destemming B - None C - None P - None 3. Rinse B - None C - None P - None 4. Primary Culling B - None C - None P - None 5. Bin Storage B - None C - None P - None 6. Rinse and Brush Wash w/Detergent Sanitizer 7. Potable B - None C - None P - None B - None No No No No No No No No No No No No

Water Rinse

C - None P - None

8. Final Culling B - None C - None P - None 9. Sizing B - None C - None P - None 10. Extraction B - None CLubricants

No

No

No

No

No

Not likely to occur due to preventative maintenanc e SSOP and use of food grade lubricants. P - Controlled at screen Metal step fragments from extraction equipment due to wear, metal fatigue, and breakage may cause injury if ingested Possible presence of pathogens in unpasteuriz ed juice B - Controlled at the pasteurization step No controlle d at screen step

P - Metal fragments

Yes

11. Receipt of B un-pasteurized Pathogens, juice in tankers Salmonella spp.

Yes

No

C - None

P - None (metal fragments are handled under shipper's HACCP plan) 12. Blend B - None C - None P - None 13. Pasteurize BPathogens, Salmonella spp. Yes Possible presence of pathogens on incoming fruit and in unpasteuriz ed juice Pasteurization Yes No No

C - None P - None 14. Chill B - None C - None P - None 15. Surge Tank B - None C - None P - None 16. Screen B - None C - None P - Metal fragments Yes Eliminates metal fragments introduced at extraction step Screen Yes No No No No

17. Fill in

B - None

No

No

Cartons

C - None P - None

18. Seal Cartons

B - None C - None P - None

No

No

19. Code, case, palletize

B - None C - None P - None

No

No

20. Store

B - None C - None P - None

No

No

21. Ship

B - None C - None P - None

No

No

B. HACCP Plan Examples

Included in this section are three examples of how to write components of a HACCP plan. The first example is for a pasteurized refrigerated apple juice, the second example is for a fresh orange juice, and the third example is for a not-from-concentrate pasteurized orange juice. 1. 1.0 Example HACCP Plan for Pasteurized Refrigerated Apple Juice The following table represents excerpts from a Summary HACCP Plan for a pasteurized refrigerated apple juice packed in plastic bottles. For this example, it is assumed that the pasteurization process is performed using a continuous (non-batch) system with a positive displacement (constant flow) timing pump. (See Discussion of Pasteurization Equipment in section V.C.5.11.) The excerpts included in this example are for the control of enteric pathogens, patulin, and metal fragments. An actual HACCP plan for such a product might be more detailed, but the summary table format lists all of the elements that we recommend be included in the plan.

Table 5. Excerpts from Summary HACCP Plan (For Pasteurized Refrigerated Apple Juice) Critica l Contro l Point (CCP) Hazard(s) Critical Limits Monitoring A. What B. How C. Freque ncy Each incomin g fruit shipmen t Correcti Verificatio ve n D. Who Action Record keeping

CCP1 Patulin Receivi ng

A supplier guarante e specifyi ng that the shipmen t includes only apples harveste d to exclude fallen fruit.

Ensure supplier guarantee exists for each incoming shipment of fruit.

Supplier guarantee is visually confirmed.

Receivi ng manage r

Reject fruit if not accompa nied by supplier guarantee .

Review monitoring corrective action and verificatio n records within one week of preparation Audit the supplier periodicall y for adherence to guarantee Periodicall y test juice for patulin levels

Supplier guarantee Receiving log Supplier audit report Patulin test results

CCP 2 Patulin Culling

Undama ged apples(15 )

Moldy, rotten, bruised or otherwise damaged apples

Visual inspection

Continu Culling ous inspect or

Stop belt and remove damaged fruit AND

Adjust belt Periodicall speed if necessary y test juice for patulin levels CCP 3 Screen Metal inclusion Screen is intact and in place Integrity of screen Visual Daily Product ion Employ ee Segregat e product and rework to eliminate metal pieces, run product Calibrate screen to ensure metal pieces 7 mm or greater do not pass screen,

Review monitoring , corrective action, and verificatio n records within one week of preparation

Culling log Patulin test results

Screen integrity log Screen calibratio n log

through metal detector, divert to nonfood use, or destroy AND Replace screen. CCP 4 E. coli Pasteur O157:H7 ize and Cryptospori dium parvum Minimu m 160 F and 6 seconds (provide s a 5-log reductio n) 1.Tempera 1.Tempera Continu ture of ture ous juice recorder monitori ng with visual 2. Flow 2. Visual check rate check of hourly positive displacem ent pump Daily setting Pasteuri zer operato r Segregat e and hold affected product Pasteuri for evaluatio zer operato n, destroy, r or divert to nonfood use AND Adjust pasteuriz er (temperat ure or flow rate) to achieve the critical limit. AND

semiannually. Review monitoring corrective action and verificatio n records within one week of preparation Document ation of process establishm ent; Check the accuracy of the temperatur e recording device (TRD) against a mercury and glass thermomet er daily; Calibrate the mercury and glass (MIG) thermomet er annually; Operator' s log Recorder Thermom eter Chart TRD, MIG and pump check and calibratio n records

Flow rate test and Reproces resealing of pump s any speed product monthly; that did not undergo Review monitoring 5-log pathogen , corrective reduction action, and verificatio n records

within one week of preparation .

1. 2.0 Example HACCP Plan for Fresh Orange Juice The following table represents excerpts from a HACCP plan for fresh orange juice packed in plastic bottles. For this example, surface treatment of the orange peel is performed to achieve the 5-log pathogen reduction. The excerpts in this example show five critical control points (steps 1, 3, 5, 6, and 8 in the summary table shown in the Hazard Analysis example for this juice) for ensuring that the incoming fruit is properly culled to remove damaged fruit that may contain pathogens in the edible portion of the fruit, that the orange peel is effectively sanitized to achieve a cumulative 5-log pathogen reduction before extracting the juice. Processing steps other than those cited as critical control points are also important to ensuring a safe juice. For example, the effectiveness of the pathogen reduction process depends upon ensuring that juice is not contaminated by any pathogens that may be present on the peel during the extraction operation. For this hypothetical process, it was assumed that the juice was extracted using an extraction process, which limits juice/peel contact during the extraction operation. 2. 2.0 Example HACCP Plan for Fresh Orange Juice

Table 6. Excerpts from Summary HACCP Plan Critical Control Point (CCP) CCP 1 (biological) Receiving Hazard Critical (s) Limits Monitoring What How Frequenc y Each incoming fruit shipment Who Correcti ve Action Reject fruit if not accompa nied by supplier guarante e. Verifica tion Recor d keepin g Suppli er guaran tee Receiv ing log

Pathoge nsSalmon ella

A supplier guarante e specifyi ng that the shipmen

Ensure supplier guarant ee exists for each incomin g

Supplier guarantee is visually confirme d.

Receivi ng manage r

Review monitori ng correctiv e action and verificati on

t shipme includes nt of only fruit. treepicked oranges.

records within one week of preparati on. Audit the supplier annually for adherenc e to guarante e.

Suppli er audit report

CCP 2 (biological) Primary cull

Pathoge Undama Damage Visual nsged fruit d peel, inspectio Salmon e.g., n ella punctur es, cuts, splitting , rot, mold

Continuo us

Culling Stop belt inspecto and r remove damaged fruit. AND Adjust belt speed if necessar y.

Review Cullin monitori g log ng, correctiv e action, and verificati on records within one week of preparati on. Test alarm daily Log of alarm test, belt speed test

CCP 3 (biological) Sanitize

Pathoge nsSalmon ella

1. Minimu m of 200ppm of availabl e chlorine 2. 30 sec contact time

1. Free availabl e chlorine 2. Belt speed (RPM)

1. Low 1. Contin concentra uous tion alarm 2. Daily 2. Measure belt marking speed with stopwatc h

1. Oper ator 2. Oper ator

1. Stop line, adjust sanitizer strength to achieve critical limit, AND segregate and hold affected product for evaluatio n, destroy or divert to nonfood

Review monitori ng correctiv E. coli e action test and results verificati on records within one week of preparati on. Review of required

use

testing for Stop line, biotype 1 E. coli. adjust belt speed to achieve critical limit, AND segregate and hold affected product for evaluatio n, destroy or divert to nonfood use CCP 4 (biological) Brush wash with Detergent/Sa nitizer Pathoge nsSalmon ella Minimu m of 200ppm of availabl e chlorine Contact time ___ seconds (process or should include appropri ate entry in HACCP plan) Strengt h of sanitize r Belt speed ___ RPM (process or should include appropr iate entry in HACCP plan) Chlorine test kit or equivalen t At the Operato Stop line, beginning r adjust of the sanitizer operation strength and or belt hourly speed to thereafter achieve critical limit, AND segregate and hold affected product for evaluatio n, destroy, or divert to nonfood use. At the Operato Same as beginning r CCP 4 of the operation and hourly thereafter. Review monitori ng, correctiv e action, and verificati on records within one week of preparati on. Review of required testing for biotype 1 E. coli. Same as CCP 4 Same as CCP 4 Operat or test log E. coli test results

CCP 5 (biological) Re-sanitize

Pathoge nsSalmon ella

Minimu m of 200ppm of availabl e

Strengt h of sanitize r Belt speed

Chlorine test kit or equivalen t

chlorine ___ RPM Contact time ___ (process seconds or (process should or include should appropr include iate appropri entry in ate entry HACCP in plan) HACCP plan)

1. 3.0 Example HACCP Plan for Not-from-concentrate Pasteurized Orange Juice The following table represents excerpts from a Summary HACCP Plan for a not-fromconcentrate pasteurized orange juice packed in cartons. For this example, it is assumed that the pasteurization process is performed using a continuous (non-batch) system with monitoring of the flow rate of the juice through the heat exchanger. (See Discussion of Pasteurization Equipment in section V.C 5.31) The excerpts included in this example are for the control of enteric pathogens and metal fragments. An actual HACCP plan for such a product might be more detailed, but the summary table format lists all of the elements that we recommend be included in the plan.

Table 7. Excerpts from Summary HACCP Plan Critical Control Point (CCP) Hazar d(s) Critic al Limit s Monitoring What How Freque ncy Chart Contin recor uous with der hourly Flow visual meter check. s Contin uous with Who Correc Verificati Recor tive on d Action keepin g Isolate affecte d product . Reproc ess, destroy , or Document ation of process establish ment. Operat or inspect ion log

CCP 1 Pathog Pasteuriz ensation Salmon ella

Minim Temper um ature 160 deg. F Flow rate AND Min. 3 sec. Hold

Operat or Operat or

Calibra Check tion accuracy records of temperatu Fill test

loop

daily visual check.

divert (to nonfood use) the affecte d product Adjust pasteur izer to achieve critical limit.

log re recording device against mercury in glass thermome ter daily. Calibrate MIG thermome ter annually. Weekly fill test for flow rate. Review monitorin g, corrective action, and verificatio n records w/in one week of preparatio n.

CCP 2 Screen

Metal fragme nts

Screen Integrity Visu is of al intact screen and in place

Daily

Produc tion employ ee

Segreg ate product and rework to elimina te metal pieces, run product through metal

Calibrate screen to ensure metal pieces 7 mm or greater do not pass screen, semiannually. Review monitorin

Screen integrit y log. Calibra tion log.

detecto r, divert to nonfoo d use, or destroy AND Replac e screen.

g, corrective action, and verificatio n records within one week of preparatio n.

C. Example CCP and SSOP for prevention of occurrence of undeclared milk residues in juice

Example SSOP Item This example SSOP illustrates how contamination of juice with milk residues due to cross contact from the use of processing equipment also used to process milk or dairy products may be prevented. Such an SSOP would be applicable in a facility that processes both dairy beverages, e.g., milk, and juice. Goal: All surfaces of equipment that contact juice during processing are pre-rinsed, then cleaned with caustic cleaning solution and rinsed, prior to processing juice on any equipment that has been used to process milk during the previous production run. Procedure: An equipment log is to be maintained for each piece of processing equipment, e.g., pasteurizer, filler, that may contact milk, dairy products, or juice that indicates what foods were processed using the equipment and the time of the processing. The log also will record all cleanings of the equipment, and will denote the cleaning procedure, e.g., pre-rinse, then caustic followed by rinse, and the time of the cleaning. The efficacy of the cleaning procedure will be monitored by swabbing the surfaces of the equipment and testing the swabs for milk protein residue. The production supervisor will review the equipment log prior to every juice production run to determine whether milk was processed during the previous production run on the equipment to be used for the juice run. If milk was processed in the previous run, the supervisor will verify that the equipment has been cleaned using the prescribed procedure.

Weekly Equipment Log Equipment Pasteurizer #1 Food Processed (date/time) Swab Test Result

Pasteurizer #2

Filler #1

Filler #2

Holding Tank #1

Holding Tank #2

1. Example CCP Item This example CCP illustrates how contamination of juice with milk residues due to cross contact from the use of processing equipment also used to process milk may be prevented. Such a CCP would be applicable in a facility that processes both dairy beverages, e.g., milk, and juice.

Critica Hazard( Critical l s) Limits Contro l Point (CCP) Product change over from product contain ng a known food allerge n to product that does not contain Chemica lundeclar ed food allergen Validate d cleaning process paramet ers: e.g., Product values changeo for prerinse ver presents time & tempera an unintenti ture; alkali onal opportun cleaner %, time, ity for product and

Monitoring What How Freque ncy Who

Correc Verifica Record tive tion keepin Action g

Critical cleanin g parame ters

Monito ring devices used to measur e cleanin g parame ters

Every Opera During Review time tor cleanin monitori the g: If ng, cleanin monitor correcti g ing ve process indicate action is s nonand perfor complia verificat med nce ion with the records critical w/in one limits, week of use preparat alternat ion. e method Calibrati

Monitor ing, correcti ve action and CCP verifica tion records

that allerge nic materia l. Equipm ent cleanin g after produci ng the allerge ncontain -ing product , prior to produci ng the nonallerge n (or differen t allerge n) contain ing product .

that contains an allergen( s) to crosscontact product that doesn't contain that particula r allergen, thus resulting in an undeclar ed allergen.

tempera ture; and/or rinse time and tempera ture whateve r values for control measure s that are critical for allergen control

olo-gy to clean the equipm ent surface s to remove the residue prior to running the nonallergen (or differen t allergen ) containi ng product , and docume nt the cleanin g on the equipm ent inspecti on log.

on of all monitori ng, correcti ve action and verificat ion instrume nts.

Periodic check to verify the CCP is effective and under control (e.g., testing of CIP solution, final product, or certain equipme nt swabs for allergeni c After produc protein). tion If records review indicate s that critical limits may not have been met,

place the entire product ion of product on hold and assess for allergen hazard.

Notes:
This guidance has been prepared by the Division of Plant Product Safety in the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration. Except for high Brix juice concentrates and certain shelf-stable juices as discussed in section V. C. 2.0. Comments on the draft of this guidance requested clarification on how to classify probable hazards, i.e., "reasonably likely to occur," or "not reasonably likely to occur," that fall under the realm of facility sanitation related hazards that may be addressed under SSOPs or under the HACCP plan (at the processor's option). We believe that it is only necessary to classify this type of hazard as "reasonably likely to occur" when you have opted to control the hazard through your HACCP plan at a CCP, as we have recommended in Section IV. C. 3.3 for undeclared allergens in juice arising from inadequately cleaned processing equipment previously used to process milk. If you have opted to control a facility sanitation related hazard through your SSOPs, it is not necessary to classify it as reasonably likely to occur. An action level is a guideline that FDA uses in considering whether the level of a contaminant in a food may constitute a health hazard sufficient to warrant regulatory action by FDA against the product. Food allergens (see CPG chapter 555.250) are naturally occurring proteins in certain foods that cause abnormal responses of the immune system involving the production of allergen specific IgE antibodies in some individuals.
5 4 3 2 1

In the January 22, and January 25, 2002 letters, FDA described high degree Brix juice concentrate as a concentrate that is diluted and repackaged as either frozen juice concentrate for consumer use or as institutional concentrate, and also stated that high degree Brix juice concentrates that are diluted to single strength and repackaged are not covered under the FDA policy stated therein. Mazzotta, Alejandro S., Thermal Inactivation of Stationary-Phase and Acid-Adapted Escherichia coli O157:H7, Salmonella, and Listeria monocytogenes in Fruit Juices, Journal of Food Protection, Vol. 64, No. 3, 2001, pp. 315-320 Mak, Peggy P., Ingham, Barbara H., and Ingham, Steven C., Validation of Apple Cider Pasteurization Treatments against Escherichia coli O157:H7, Salmonella, and Listeria monocytogenes, Journal of Food Protection: Vol. 64, No. 11, 2001 pp. 1679-1689. See Deng, Ming Qi, and Cliver, Dean O., Inactivation of Cryptosporidium parvum Oocysts in Cider by Flash Pasteurization, Journal of Food Protection, Vol. 64, No. 4, 2001, pp. 523-527, and Harp, James A., Fayer, Ronald, Pesch, Bruce A., and Jackson, George J., Effect of Pasteurization on Infectivity of Cryptosporidium parvum Oocysts in Water and Milk, Applied and Environmental Microbiology, Vol. 62, No. 8, 1996, pp. 2866-2868. See Hanes, D.E., Orlandi, P.A., Burr, D.H., Miliotis, M.D., Robl, M.G., Bier, J.W., Arrowood, M.J., Churey, J.J., Jackson, G.J., and Worobo, R.W., Inactivation of Crytposporidium parvum Oocysts in Fresh Apple Cider by UV Irradiation, Applied and Environmental Microbiology, Vol. 68 No. 8, 2002, pp. 4168-4172. Jackson, Lauren S., Beacham-Bowden, Tina, Keller, Susanne E., Adhikari, Chaitali, Taylor, Kirk T., Chirtel, Stewart J., and Merker, Robert I., Apple Quality, Storage, and Washing Treatments Affect Patulin Levels in Apple Cider, Journal of Food Protection: Vol. 66, No. 4, 2003, pp. 618-624 The juice HACCP regulation requires control measures that will achieve a 5-log reduction in the "pertinent microorganism" for all juices except shelf stable juices, juice concentrates, and juices subject to the low acid canned foods or acidified foods regulations. Pathogens include enteric pathogens (e.g., E. coli O157:H7, Cryptosporidium parvum, Salmonella spp.) and Listeria monocytogenes, which is ubiquitous in nature. The Juice HACCP Alliance was formed through the voluntary participation of industry, government, and academic members interested in guiding the juice industry to the higher level of food safety assurance provided by HACCP. The Alliance was coordinated through the efforts of the National Center for Food Safety and Technology at the Illinois Institute of Technology. Staff from the FDA participated as technical advisors in the development of the curriculum. In practice, this processor should establish visual criteria for what constitutes a damaged apple that should be culled. The criteria should be established based upon validation data
15 14 13 12 11 10 9 8 7

showing that juice made from apples culled using the criteria do not contain unacceptable levels of patulin.

This document supercedes Draft Guidance: Juice HACCP Hazards and Controls Guidance First Edition (September 12, 2002) January 19, 2001 Federal Register: Procedures for the Safe and Sanitary Processing and Importing of Juice (Final Rule) June 2007: For recommendations concerning the processing and labeling of refrigerated carrot juice and other refrigerated low-acid juices see Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices

FDA Juice HACCP Questions & Answers

FDA Juice HACCP Questions & Answers

Guidance for Industry

The Juice HACCP Regulation Questions & Answers

August 31, 2001 Contains Nonbinding Recommendations (See additional Questions & Answers on the Juice HACCP Regulation (September 4, 2003)) Final Rule: Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Juice (Federal Register, November 9, 2001)

A. Coverage | B. Retail Exemption C. Relationship to CGMP's | D. The Juice Hazard Analysis E. Control Measures | F. The 5-log Reduction Performance Standard G. Control Measures for Chemical and Physical Hazards H. Records | I. Training | J. Imports and Exports K. Labeling Questions | Appendix 1--Definitions

A. Coverage 1. What types of juice and juice products are covered by the regulation? The regulation applies to juice sold as such or used as an ingredient in beverages. Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree. Juice produced by a person who operates a retail establishment as defined in 120.3(e) are not covered by the regulation. The regulation requires that processors apply HACCP principles if they make juice or juice concentrates for subsequent beverage use. Any processor making a product that could be labeled as 100 percent juice or a concentrate of that juice for subsequent beverage use must apply HACCP principles. For beverages containing less than 100 percent juice, only the juice ingredient must be made applying HACCP principles.

2. If I pasteurize my juice, do I need to comply with the regulation? Yes. All juice processors (except retail processors as defined in the regulation) must comply with part 120 for each type of juice they produce. 3. Does this regulation cover fruit and vegetable purees? The regulation applies to products sold as juice or used as an ingredient in beverages, including fruit and vegetable purees that are used in juices and beverages. 4. If my juice is sold only within my state, do I need to comply with the new regulation? Yes. This regulation applies equally to juices produced and sold within the same state as well as juices sold in interstate commerce. 5. When do I need to comply with the juice HACCP regulation? FDA encourages all juice processors to begin to comply with the regulation as soon as possible. The effective date is January 22, 2002. However, if your firm meets the definition for a small business, the effective date is January 21, 2003. If your firm meets the definition of a very small business, the effective date is January 20, 2004. 6. What are the definitions of a small business and a very small business? Small businesses employ fewer than 500 persons (120.1(b)(1)). Very small businesses must meet one of the following three criteria: annual sales of less than $500,000, total annual sales greater than $500,000 but total food sales less than $50,000, or operations that employ fewer than an average of 100 full-time equivalent employees and sell fewer than 100,000 units of juice in the United States (120.1(b)(2)). The size of the business is determined by the magnitude of the corporate operation, not of the business unit. 7. I am a dairy processor who purchases pasteurized apple juice concentrate to make a 5% apple juice beverage and a 15% apple juice beverage. Am I required to comply with the juice HACCP regulation, including the 5-log reduction? Because you are not making juice as defined by 120.1(a), you are not required to produce your juice beverage under a HACCP system, although it is highly recommended. However, the juice ingredient (i.e., the pasteurized apple juice concentrate) must have been made under a HACCP program (including compliance with 120.24). 8. I make a carbonated beverage that contains juice. Am I required to comply with the regulation? As discussed in the response to question 7, because the carbonated beverage is not "juice" as defined by the regulation, you are not required to produce your carbonated beverage under a

HACCP system. However, the juice ingredient of the carbonated beverage must have been made under a HACCP program. 9. I buy pasteurized orange juice concentrate (made under HACCP) and repack the concentrate into large volume bag-in-box containers that I sell to retail businesses to be used in an orange juice dispenser where it is mixed with water and dispensed to the consumer. Do I have to also comply with the regulation? Yes. Each processor (including the repacker), except the retail processor, must do a hazard analysis and determine whether there are any hazards that are reasonably likely to occur during its process. If a processor identifies any hazards as reasonably likely to occur, it must have a HACCP plan to address those hazards. Because the juice beverage made from the orange juice dispenser is produced at a retail establishment, the seller of that juice is not a processor subject to the regulation. The retail establishment should comply with applicable provisions in the Food Code. 10. Are non-beverage foods that contain juice as an ingredient, e.g., a fruit flavored candy, required to be produced under a HACCP system? No. The juice HACCP regulation applies to the processing of juice that is sold either as juice or sold for use as a beverage ingredient. Thus, a fruit flavored candy that contains juice as an ingredient is not required to be produced under a HACCP system. 11. Are food ingredients other than juice that are derived from fruit, e.g., citrus oil, required to be produced under a HACCP system? No, the juice HACCP regulation applies only to the aqueous extract of fruits and vegetables that is sold either as juice or for use as an ingredient in beverages and not to other fruit or vegetable by-products such as citrus oil. 12. Would pulp from a fruit or vegetable used to make a juice or diluted juice beverage be considered juice under the juice HACCP regulation? Yes. As noted, fruit and vegetable purees used as a juice ingredient are considered "juice" under the regulation. Pulp (i.e., pressed edible fruit or vegetable matter) is often a part of the aqueous liquid stream expressed or extracted from fruits and vegetables (e.g., citrus juice) and is comparable to puree except that it may not undergo the same degree of maceration. Pulp in a juice or a diluted juice beverage is considered juice or a juice ingredient; with a diluted juice beverage, processors are only required to comply with part 120 when making the juice ingredient (e.g., the pulp). 13. Are coffee and tea covered under the regulation? No. Coffee and tea are infusions produced from dried ingredients and have traditionally not been considered to be juices. Thus, they are not covered under the regulation.

14. Would juice concentrates intended for uses such as flavors or sweeteners in foods other than beverages be subject to the regulation? Juice concentrates intended for use as flavors, sweeteners, or similar uses in products that are not beverages are not subject to the regulation. However, because there may be problems segregating product used in beverages from that used in other foods, prudent juice concentrate processors should consider implementing HACCP for all of their juice products, not just those products that will be made into juice or used in beverages.

B. Retail Exemption 15. If a retailer decides to pasteurize his apple cider, does he need to have a HACCP system? Retail producers of juices are not covered by the regulation and would not be required to establish a HACCP system regardless of whether they pasteurize their products. A retail establishment is an operation that only provides juice directly to consumers. "Provides" includes storing, preparing, packaging, serving, and vending. A retail establishment does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers. FDA's Food Code provides guidance to retail producers for making safe products. 16. Does the regulation cover apple cider that I make from my own apples and sell over the internet directly to consumers? What about apple cider that I make from my own apples and sell at a farmers market? If you make cider from your own apples (or apples that you have purchased) and only sell it directly to consumers (e.g., internet sales, farmers markets), you are considered a retailer and thus, your cider does not need to be processed under a HACCP system. 17. If I hire someone to make cider from my apples and I sell this cider at my roadside stand, is this juice producer required to have a HACCP system? Yes. Only retail establishments are exempt from the regulation. Under the regulation, a retail establishment stores, prepares, packages, serves, and vends its product exclusively and directly to consumers. If someone else processes juice for a retail establishment, that processor is required to operate under HACCP principles. 18. Company A processes juice in a central kitchen and sells the juice to consumers from its own retail outlets. Is Company A's central kitchen considered a retail establishment? Are Company A's retail outlets considered retail establishments?

Company A's central kitchen is not a retail establishment that is exempt from the regulation because it does not sell juice directly to consumers at that location. However, Company A's retail outlets are retail establishments under part 120, if they sell juice directly to consumers and do not sell juice to other business entities (i.e., retail outlets owned by another company). 19. Company B processes juice in a central kitchen that sells juice directly to consumers from its central kitchen as well as supplying its retail outlets. Is the central kitchen a retail establishment? Are Company B's outlets retail establishments? Company B's central kitchen is a retail establishment under part 120, because it (1) sells juice directly to consumers and (2) does not sell juice to other business entities (i.e., it provides juice only to the retail establishments it owns). If the retail outlets owned by Company B sell juice directly to consumers, but not to other business entities, they are also retail establishments under part 120. FDA encourages central kitchens that are retail establishments under the rule to establish a HACCP system in the processing of juice. 20. If Company C processes juice in a central kitchen that sells juice directly to consumers from its central kitchen and from its retail outlets, but also sells juice to other business entities, is the central kitchen a retail establishment? Even though Company C sells juice directly to consumers at its central kitchen, the central kitchen is not a retail establishment for purposes of part 120 because it sells juice to business entities that it does not own.

C. Relationship to CGMP's 21. Do FDA's "Current Good Manufacturing Practices" (CGMP) regulations in 21 CFR Part 110 apply to firms that are subject to the juice HACCP regulation? Does compliance by these firms with the juice HACCP regulation replace the need to comply with the CGMP regulations? Firms covered by the juice HACCP regulation are still subject to the CGMP regulations in Part 110. In fact, CGMP's are an essential foundation for a successful HACCP system.

D. The Juice Hazard Analysis 22. What is a hazard analysis? The hazard analysis is an evaluation of potential microbiological, chemical, and physical hazards associated with a particular product and process and is used to determine which hazards are

reasonably likely to occur and, if they occur, how they can best be controlled. The regulation requires that the hazard analysis be written. 23. Who should conduct the hazard analysis? The regulation requires that a trained individual, whether an employee or consultant, conduct the written hazard analysis that juice processors (except retail processors) are required to have for their process. 24. What is a "hazard that is reasonably likely to occur?" A food hazard that is reasonably likely to occur is defined in 120.7(a)(2) as one for which a prudent processor would establish controls to reduce to acceptable levels, prevent, or eliminate the hazard because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absence of those controls, the food hazard will occur in the particular type of product being processed. A potential hazard that has a severe, acute public health impact (e.g., injury caused by ingestion of glass fragments) and that presents a significant risk, even at an extremely low frequency of occurrence, should be identified as a hazard that is reasonably likely to occur. A hazard that requires long-term (chronic) exposure to cause harm would need to occur at a higher frequency to be identified as a hazard that is reasonably likely to occur. The mycotoxin, patulin, which can occur at high levels in apple juice made from damaged, moldy or rotten apples, is an example of a chronic exposure hazard that could occur at such a frequency that it may need to be controlled through a HACCP plan if drops are used to make juice or if apples are stored inappropriately prior to use for juice production. 25. What is the best way to begin a hazard analysis? FDA believes that carrying out the five preliminary steps as outlined by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will assist processors in conducting a hazard analysis, as well as in other HACCP functions. These are:

Assemble a HACCP team Describe the food and its distribution Identify the intended use and consumers of the food Develop a flow diagram that describes the process Verify the flow diagram

(See "Hazard Analysis and Critical Control Point Principles and Application Guidelines," Journal of Food Protection, Vol. 61, No. 6, pp. 762-775). Although FDA is not specifically requiring that juice processors use the preliminary steps, these steps will aid them in focusing on their specific product and process.

Flow diagrams that identify each significant step in the process are particularly helpful in conducting a hazard analysis, by facilitating determination as to whether a hazard may be introduced or controlled at each process point. 26. How do I conduct a hazard analysis? You must do the following in a written hazard analysis (see 120.7(a)): (1) List all potential physical, chemical, and biological hazards that might occur in your juice. (2) For each of the hazards identified in step 1, assess the likelihood of occurrence and the severity of health consequences in the absence of control. Then, determine, based upon the information gathered, whether each hazard is reasonably likely to occur in your product. You do not have to include hazards in your HACCP plan that are not reasonably likely to occur. (3) Identify the measures that you can apply to control the food hazards identified in step 2 as reasonably likely to occur. (4) Review the current process to determine whether modifications are needed. (5) Identify critical control points for hazards determined in step 2 to be reasonably likely to occur. 27. What is a control measure? A control measure is any action or activity to prevent, reduce to acceptable levels, or eliminate a hazard ( 120.3(c)). Control measures are further discussed in the next section. 28. What is a critical control point? A critical control point (CCP) is a point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level ( 120.3(d)).

E. Control Measures 29. When am I required to implement a HACCP control measure? You are required to implement a HACCP control measure if you determine in your hazard analysis that a food hazard (e.g., a microbial pathogen, potentially hazardous levels of patulin, glass shards) is reasonably likely to occur in a juice product you produce.

30. What are some examples of HACCP control measures? Examples of control measures include thermal processing of juice and culling produce to eliminate visibly moldy, rotten, or damaged fruit. 31. If a grower implements FDA's "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables," also referred to as FDA's Good Agricultural Practices (GAP) guidance document, is it considered a HACCP control measure? No. However, juice processors are encouraged to work with growers of the produce they use to produce juice to evaluate and modify agricultural practices consistent with FDA's GAP guidance. 32. If I sell juice in bulk to company X for final processing and packaging of juice, who is responsible for determining whether HACCP controls for chemical and physical hazards are needed for the juice? Both firms are responsible for ensuring that the products they make are safe. Both you, the first processor, and company X who is packaging the juice must conduct a hazard analysis and have a written HACCP plan for all hazards that are reasonably likely to occur. You are the primary processor and are responsible for controlling hazards that are reasonably likely to occur from the raw materials you use and from your processing facility (e.g., patulin, lead) in your HACCP plan. Subsequent processors may no longer need to identify these hazards as reasonably likely to occur, because you, the primary processor, have established measures for controlling these hazards. However, there may be other chemical and physical hazards that are reasonably likely to occur during subsequent processing (e.g., glass) that company X must control in their HACCP plan. 33. If I sell juice in bulk to company X for final processing and packaging of a diluted juice product, who is responsible for determining whether HACCP controls for chemical and physical hazards are needed for the juice? As in the response to the previous question, both firms are responsible for ensuring that the products they make are safe. However, only juice processors must comply with the juice HACCP regulation. Therefore, you must conduct a hazard analysis and determine whether there are chemical, physical, and microbial hazards that are reasonably likely to occur. You are responsible for controlling in your HACCP plan all hazards that are reasonably likely to occur. As a processor of a diluted juice beverage, company X is not a juice processor as defined by the HACCP regulation, and thus, is not required to have a HACCP system. However, company X must ensure that the juice ingredient used in the diluted juice beverage complies with part 120.

F. The 5-log Reduction Performance Standard 34. What is the 5-log pathogen reduction performance standard?

Performance standard requirements in general are goals that processors should achieve but provide flexibility on how processors accomplish them. The 5-log pathogen reduction performance standard required by the regulation means that you must treat your juice (or citrus fruit if using surface treatments) using a process that will achieve at least a 100,000 fold decrease in the number of microorganisms (see next question). Juice processors must apply controls (e.g., heat, UV light) to achieve the 5-log reduction required by the regulation. 35. Does a 5-log reduction in the bacterial plate count (i.e., aerobic plate count or total plate count) of a juice sample meet the performance standard requirement? No. Under the rule, the 5-log reduction must be targeted to the "pertinent pathogen." The "pertinent pathogen" is the most resistant microorganism of public health concern that may occur in the juice. The pertinent pathogen may vary with the type of juice and the type of treatment used, though typically it would be Salmonella or Escherichia coli O157:H7. 36. What times and temperatures should I use to pasteurize my juice? Precise times and temperatures depend on the type of juice you make and your process. Scientific literature is an excellent source of information. (See "Thermal Inactivation of Stationary-Phase and Acid-Adapted Escherichia coli 0157:H7, Salmonella, and Listeria moncytogenes in Fruit Juices," by Alejandro S. Mazzotta, Journal of Food Protection, 1998, Vol. 64, No. 3, 2001, pages 315-320.) 37. How can I achieve a 5-log reduction without pasteurizing the product? You can achieve a 5-log reduction by using control measures that have been shown to be effective in reducing the number of microorganisms. You can use one control measure that has been shown to reduce the pertinent microorganism by at least 5-log (e.g., high pressure) or a combination of control measures that have a cumulative effect of a 5-log reduction. Citrus juice processors may use surface treatments of the fruit to contribute towards attaining the 5-log reduction. All other juice processors must apply the 5-log process to the juice. 38. May I do the 5-log reduction on the fruit before extracting the juice? Producers of juice other than citrus must apply the 5-log reduction treatment on the extracted juice. Citrus processors have the option of treating the surface of the fruit because it is unlikely that pathogens will enter sound, intact citrus fruit under current industry processing practices. If citrus juice processors use surface treatments to achieve all or part of the 5-log reduction, they must conduct tests to verify that the surface treatment is effective. Process verification procedures are found in 120.25. (Note that the 5-log reduction treatment must occur within a single processing facility. See question 40.) 39. May cleaning (i.e., washing of the produce) and culling (i.e., removal of damaged produce) be included among the control measures used to meet the 5-log reduction requirement?

No. All produce used for making juice must be cleaned and culled prior to extraction or, in the case of surface treated citrus fruit, prior to control measures used to meet the 5-log reduction requirement. For surface treated citrus, culled fruit is undamaged, tree-picked fruit. 40. May juice be treated in one processing facility to achieve part of a 5-log pathogen reduction, i.e., a 2-log reduction, and then transported to another facility for treatment to achieve the remainder of the 5-log reduction? No. The entire 5-log reduction must be accomplished within a single production facility operating under CGMP's. 41. May I use fruit that has fallen from the tree to the ground (i.e., drops) to make juice? You may use drops if the fruit is cleaned and culled (i.e., damaged fruit removed) and the 5-log treatment is applied to the extracted juice. Citrus juice manufacturers using surface treatments must use undamaged tree-picked fruit. 42. I make shelf-stable juice that receives over a 10,000-log reduction. Am I still required to have microbial control measures in a HACCP plan? What about juice concentrates that are processed with over a 100-log reduction? If you make thermally processed juice that is shelf stable or thermally processed juice concentrate, you are not required to include control measures in the HACCP plan for achieving the 5-log pathogen reduction. However, you must include a copy of the thermal process in your hazard analysis. 43. If I use a heat treatment process on my juice, can I assume that the process meets the 5-log pathogen reduction requirement of the HACCP regulation? No. Except for processors of thermally processed shelf stable juices and juice concentrates, juice processors must establish and meet critical limits to ensure that the heat process is effective and consistently fulfills the 5-log reduction standard. Critical limits are the maximum or minimum values to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard. 44. If a juice product is treated by a means other than heat to meet the 5-log pathogen reduction requirement, is FDA approval required for the treatment? A food additive regulation is required for treatments that use irradiation (e.g., pulsed light, UV light, ionizing radiation) and may be required for the use of certain chemicals. You are responsible for ensuring that all treatments, regardless of compliance with food additive regulations, achieve the 5-log pathogen reduction for your juice and process. 45. Does each processor handling a juice have to do a 5-log reduction?

Each processor handling the juice (except retail processors) must conduct a hazard analysis to determine whether there are hazards, including microbial hazards, that are reasonably likely to occur. Each processor must have controls for microbial hazards. This may be assurances that the juice will be given the required 5-log treatment at another processing location. 46. If I produce a consumer frozen juice concentrate from a higher concentrated juice that comes from another location via tanker truck (whether or not under direct company control), do I need to redo the 5-log reduction? Yes. As discussed in the response to question 40, the 5-log reduction must be conducted in the same processing facility where final product packaging of the consumer concentrate occurs ( 120.24(c)). Tanker trucks may be a source of contamination because it is particularly difficult to adequately sanitize them between shipments. 47. In the past, some processors have added a small amount of untreated juice to pasteurized juice for flavor enhancement. May I do this? No. All ingredients of the juice must have received a 5-log reduction. Pathogens may be present in untreated juice and could contaminate the treated juice. 48. Can a flavor essence recovered during a juice concentration operation be added back to a juice after the juice has received a 5-log pathogen reduction treatment without requiring an additional 5-log treatment? If you can demonstrate that the recovery process used to capture the flavor essence achieved the 5-log reduction, you can add the essence to the treated juice and you will have complied with 120.24. Otherwise, the flavor essence must undergo a 5-log reduction process before it is added to treated juice or the juice with the flavor essence must undergo a 5-log reduction to comply with 120.24. If the essence is not treated along with the juice, you must ensure that the process by which the essence is added to the juice does not allow for contamination.

G. Control Measures for Chemical and Physical Hazards 49. Are there any mandatory HACCP control measures for chemical hazards such as patulin or lead? HACCP controls for specific chemical hazards such as patulin and lead are required when a processor determines that the presence of the chemical in the juice is a hazard that is reasonably likely to occur. In conducting a hazard analysis, a juice processor must consider all potential hazards and determine whether any of these hazards are reasonably likely to occur. If a hazard is reasonably likely to occur, a processor must include controls for that hazard in its HACCP plan.

50. I am a dairy processor who also makes juice using my milk processing equipment. Should I be concerned about milk residues (allergenic proteins) being present in the juice? What are the controls to prevent possible allergen cross-contamination (cross-contact) in this situation, and should these controls be included in my HACCP Plan?? Yes, when using milk processing equipment to process juice, cross-contact of milk protein into the juice is a concern. Allergens, such as milk, soy (soy milk), or egg (egg nog) should be considered chemical hazards that need to be addressed in your hazard analysis. Controls to prevent cross contact may include a rigorous sanitation regime in between a production run of milk products and a production of juice products. In addition to sanitation, production scheduling can have a large impact on minimizing cross-contact from shared equipment. Processors should try to schedule all non-allergen containing products first, followed by allergen containing products, with a full clean-up before again running a non-allergen product. Depending on the outcome of the hazard analysis, sanitation and production scheduling may be managed through SSOP's or as part of the HACCP plan. See Compliance Policy Guide 555.250 for the list of common food allergens recognized by the Agency. 51. Are HACCP control measures required for any specific physical hazards such as glass? HACCP controls for specific physical hazards, e.g., glass, are required under the juice HACCP regulation when the processor determines in its hazard analysis that the specific physical hazard is reasonably likely to occur in the juice (see the response to question 49 above).

H. Records 52. What types of records will I be required to maintain to document my HACCP system? You must maintain records pertaining to:

Sanitation standard operating procedures monitoring and corrective actions The hazard analysis The HACCP plan Operational records such as records of process monitoring, corrective actions, verification, and validation activities Importer verification

General requirements and documentation requirements for records are included in 120.12 (b) and (c) of the regulation. 53. How long must I keep the required HACCP records?

A processor of perishable or refrigerated juices and an importer of such juices must retain required HACCP records at the processing facility (processors) or at the importer's place of business in the United States (importers) for at least 1 year after the date that the products were prepared. A processor of frozen, preserved, or shelf stable products and an importer of such products must retain the required records at the processing facility (processors) or at the importer's place of business in the United States (importers) for 2 years or the shelf life of the product, whichever is greater, after the date that the products were prepared. 54. Are juice processors required to make all of their records related to juice available to FDA inspectors? Only those records that are specifically required under 120.12 must be made available for review and copying by FDA at reasonable times. These records are listed in the response to question 52. 55. What records are necessary to show that consumer complaints have been reviewed? You must make a record that documents that you have performed a review of the consumer complaints that you have received. However, you are not required to show consumer complaints to FDA.

I. Training 56. What specialized training is needed to establish a HACCP system? Certain key aspects of HACCP require training in HACCP principles. Individuals who perform certain functions related to the development of the hazard analysis and HACCP plan, and the verification, validation, corrective action, and record review requirements of the regulation must be trained (see 120.13(a)). Training must be equivalent to a standardized curriculum that FDA recognizes as adequate. Job experience may qualify an individual to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum. The Juice Alliance is in the process of establishing a standardized curriculum, and FDA has been providing input to the Alliance's effort. 57. Does the person(s) doing the key aspects of the HACCP system need to be an employee(s) of the juice processing firm? No, the trained individual need not be an employee of the processor. However, regardless of who the trained individual is, the firm processing the juice is ultimately responsible for the safety of the juice and for compliance with part 120.

J. Imports and Exports 58. Does imported juice that will only be used as an ingredient in beverages have to be produced in compliance with part 120? Yes. All imported juice, even if the juice is for use as an ingredient in a beverage, must comply with the juice HACCP regulation. 59. What are the responsibilities of juice importers under the juice HACCP regulation? In brief, importers of juice either must ensure that all juice they offer for entry into the U.S. has been processed in compliance with Part 120, or import such juice from a country that has an appropriate memorandum of understanding (MOU) with the U.S. In addition, importers must maintain records that document the performance and results of the affirmative steps taken to demonstrate compliance with the regulation. Requirements for importers of juice are set out in 120.14 of the regulation. 60. Does the regulation apply to juices and juice concentrates produced in the U.S. and intended for export either as bulk shipment or in consumer packages? Processors of juice intended for export must comply with the juice regulation unless the juice at issue satisfies all of the following conditions:

Meets the specifications of the foreign purchaser; Conforms to the laws of the importing country; Is labeled on the outside of the shipping package that the product is intended for export; and Is not sold or offered for sale in domestic commerce.

61. Are there any established memoranda of understanding (MOUs) for juice? How does someone go about establishing an MOU? There are currently no established MOUs for juice HACCP. Normally, the process is started by a letter to FDA from a foreign government requesting initiation of the MOU process. Letters to establish MOUs for juice should be submitted to: Mr. Charles W. Cooper Director, International Activities HFS-585 Center for Food Safety and Applied Nutrition Food and Drug Administration 200 C St., S.W. Washington, DC 20204 Examples of FDA MOUs can be found at the Food and Drug Administration International Cooperative Agreements web page.

K. Labeling Questions 62. If I want to label my product as pasteurized, what criteria do I need to meet? Pasteurization is a heat treatment sufficient to destroy pathogens. Therefore, to be labeled as "pasteurized," a juice must be heat treated to destroy pathogens. 63. May I use the warning label statement on my products in lieu of implementing a HACCP system? Generally speaking, use of the juice label warning statement is not an alternative to compliance with the HACCP regulation. All juice that is not appropriately treated to achieve a 5-log reduction in the pertinent pathogen is required to comply with the warning statement regulation; in the case of HACCP, all juice processors are required to comply with the regulation according to the staggered effectiveness dates ( 120.1(b)) except retail establishments as defined by the regulation. Juice required to be produced under a HACCP system that is not so produced will be considered adulterated. 64. How can I label my apple cider that is processed using ultraviolet (UV) light? Can I label it as "pasteurized" or "UV treated?" Can it be called "fresh?" As discussed above, pasteurization is a heat treatment sufficient to destroy pathogens. Therefore, use of the term "pasteurized" on products that have been treated with UV light to attain the 5-log reduction is misleading and the product would be considered to be misbranded under section 403(a) of the Food, Drug, and Cosmetic Act. Possible terms you may use that would convey to consumers that the product has been treated with UV to control pathogens are "treated with UV light to control pathogens," "treated with UV light to control harmful bacteria," or "UV treated." Juice processed using UV light cannot be labeled "fresh."

Appendix 1--Definitions (a) Cleaned means washed with water of adequate sanitary quality. (b) Control means to prevent, eliminate, or reduce. (c) Control measure means any action or activity to prevent, reduce to acceptable levels, or eliminate a hazard.

(d) Critical control point means a point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level. (e) Critical limit means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard. (f) Culled means separation of damaged fruit from undamaged fruit. For processors of citrus juices using treatments to fruit surfaces to comply with 120.24, culled means undamaged, treepicked fruit that is U.S. Department of Agriculture choice or higher quality. (g) Food hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control. (h) Importer means either the U.S. owner or consignee at the time of entry of a food product into the United States, or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the United States. The importer is responsible for ensuring that goods being offered for entry into the United States are in compliance with all applicable laws. For the purposes of this definition, the importer is ordinarily not the custom house broker, the freight forwarder, the carrier, or the steamship representative. (i) Monitor means to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification. (j) (1) Processing means activities that are directly related to the production of juice products. (2) For purposes of this part, processing does not include: (i) Harvesting, picking, or transporting raw agricultural ingredients of juice products, without otherwise engaging in processing and (ii) The operation of a retail establishment. (k) Processor means any person engaged in commercial, custom, or institutional processing of juice products, either in the United States or in a foreign country, including any person engaged in the processing of juice products that are intended for use in market or consumer tests. (l) Retail establishment is an operation that provides juice directly to the consumers and does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers. "Provides" includes storing, preparing, packaging, serving, and vending. (m) Shall is used to state mandatory requirements. (n) Shelf-stable product means a product that is hermetically sealed and, when stored at room temperature, should not demonstrate any microbial growth.

(o) Should is used to state recommended or advisory procedures or to identify recommended equipment. (p) Validation means that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the identified food hazards. (q) Verification means those activities, other than monitoring, that establish the validity of the HACCP plan and that the system is operating according to the plan.

See additional Questions & Answers on the Juice HACCP Regulation (September 2, 2003).

Page Last Updated: 05/22/2009

Guidance for Industry:

The Juice HACCP Regulation - Questions and Answers

Contains Nonbinding Recommendations September 4, 2003 See additional Questions & Answers on the Juice HACCP Regulation (August 31, 2001) Comments and suggestions regarding this document may be submitted at any time. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the Docket Number 2003D-0348. For questions regarding this document, contact Amy Green at the Center for Food Safety and Applied Nutrition (CFSAN) at (Tel) 301-436-2025, (Fax) 301-436-2651, or e-mail amy.green@cfsan.fda.gov. Additional copies are available from: Office of Plant and Dairy Foods and Beverages Division of Plant Product Safety HFS-306 Center for Food Safety and Applied Nutrition Food and Drug Administration, 5100 Paint Branch Parkway College Park, MD 20740 http://www.cfsan.fda.gov/guidance.html

U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition September 2003

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
I. INTRODUCTION | II. QUESTIONS & ANSWERS A. Applicability | B. Implementation Dates C. Sanitation Standard Operating Procedures (SSOPs) D. Hazard Analysis | E. HACCP Plan | F. Validation G. Verification | H. Records | I. Training | J. Imported Juice K. The 5-Log Reduction Performance Standard

I. INTRODUCTION
On January 19, 2001, the FDA published a final rule in the Federal Register that requires processors of juice to develop and implement Hazard Analysis and Critical Control Point (HACCP) systems for their processing operations (66 FR 6138). To help the industry understand key aspects of the juice HACCP regulation, the FDA has published several guidance documents that included information on important aspects of the juice HACCP regulation such as effective dates, use of the label warning statement, and training. On August 31, 2001, the FDA published "The Juice HACCP Regulation Questions and Answers," a document that addressed important aspects of the regulation in a simple question and answer format. As a follow-up to that first set of questions and answers, this document contains a second set of questions and answers designed to further clarify the juice HACCP regulation and to address frequently asked questions. Additional information on juice HACCP is available at www.cfsan.fda.gov under "Program Areas" and "HACCP." The information available at this website includes the juice HACCP regulation, the August 31, 2001, publication, "The Juice HACCP Regulation Questions and Answers," and additional guidance FDA has issued related to the juice HACCP regulation. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are

cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. QUESTIONS & ANSWERS

A. Applicability
1. Is fruit nectar covered by the regulation? The term "nectar" is generally accepted as the common or usual name in the U.S. and in international trade for a diluted juice beverage that contains fruit juice or puree, water, and may contain sweeteners. Therefore, to the extent that nectar is a beverage containing juice, it is not subject to part 120. However, the juice or puree ingredient in that nectar is subject to the regulation (120.1(a)). 2. Is coconut milk and/or water covered by the regulation? Yes. Coconut is considered to be a fruit and any liquid extracted from coconut (i.e., water or milk from the meat) is considered a juice and is therefore subject to the regulation (see 58 FR 2892 at 2910; January 6, 1993, and 63 FR 20450 at 20451; April 24, 1998). 3. Is juice used in alcoholic beverages (e.g., wines, alcoholic cider) covered under the regulation? It depends. The regulation applies to any unfermented juice that is added to an alcoholic beverage (e.g., wine or cider) as an ingredient to adjust flavor or sweetness and retains and expresses its organoleptic (e.g., color, taste) and nutritional characteristics in the finished beverage (120.1(a)). The regulation does not apply to juice used solely as a starting material for a fermented alcoholic product that is fermented such that the organoleptic and nutritional characteristics associated with the juice are modified to the extent that the original juice becomes an alcoholic beverage and is no longer recognizable as juice at the time processing is complete (comment #5, 58 FR 2897 at 2899; 101.3(k)).

B. Implementation Dates
4. If one juice processor makes a concentrate before the applicable effective date and stores it for a period of time, and a second juice processor processes the concentrate into juice after the applicable effective date, which processor is required to comply with the regulation? The second juice processor must comply with the regulation (120.1(a)).

C. Sanitation Standard Operating Procedures (SSOPs)

5. Are office toilets included in the mandatory SSOP for maintenance of such facilities? It depends. If office toilet facilities are accessible to processing personnel, or if processing area toilet facilities are accessible to office personnel, the processor must make the determination as to how to control potential hazards that may be introduced through such use of facilities. This may involve including both office toilet facilities and processing area toilet facilities in the SSOP procedures (120.6(a)(4)).

D. Hazard Analysis
6. Should a processor incorporate the receipt of raw ingredients into a juice HACCP plan? If a processor decides that raw ingredient receipt is a Critical Control Point (CCP), then the firm must establish in its HACCP plan critical limits, corrective actions (optional), monitoring procedures, record keeping procedures, and verification activities related to the CCP (120.8(b)). 7. How extensive does the hazard analysis have to be? The type of product, the process, and the number and nature of potential hazards and hazards that are reasonably likely to occur will determine the extent of a hazard analysis. All hazards that are reasonably likely to occur must be identified in the course of the hazard analysis, whether those hazards are introduced within or outside the processing environment including hazards that can occur before, during, or after harvest (120.8). 8. Where can I find more information on conducting a hazard analysis? For more information on conducting a hazard analysis, see the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) publication, "Hazard Analysis and Critical Control Point Principles and Applications Guidelines," Journal of Food Protection, Vol. 61, No. 9, pp. 1246-1259 (1998), the Juice Alliance's "Juice HACCP Training Curriculum," and FDA's Juice HACCP Hazards and Controls Guide. 9. Does the industry have to have original scientific reports (papers) available to substantiate its hazard analysis decisions? There is no requirement that the processor keep the original scientific reports on hand. However, processors may want to keep on hand information that is not readily accessible both for their own use and to aid inspectors.

10. Can similar products such as pulp free orange juice and orange juice with extra pulp share the same hazard analysis and HACCP plan? Yes. Similar products may share the same hazard analysis and HACCP plan when the food hazards, CCPs, critical limits, control measures, recordkeeping, etc. are essentially identical, provided that any required features of the plan that are unique to a specific product or method are clearly delineated in the plan and followed in practice (120.8(a)(2)). In the example given, the presence of pulp may affect a critical limit such as the heating time needed to inactivate pathogenic microorganisms during pasteurization, and, if these critical limits differ, the HACCP plan would need to list both critical limits and identify which critical limit applies to which product, one for the orange juice with extra pulp and one for the orange juice without pulp. It is the responsibility of each processor to look at their own products and processes to determine whether the similarities and differences warrant a separate hazard analysis and HACCP plan or whether the products and processes can share all or parts of the same analysis and plan.

E. HACCP Plan
11. How should added ingredients in a product considered to be 100 percent juice according to the "Percent Juice Labeling" regulation (21 CFR 101.30) be taken into account in the product's HACCP plan? Added ingredients (e.g., 100 % orange juice with added calcium) are considered "juice," as defined in 120.1(a), and subject to the regulation. In conducting a hazard analysis for the juice, processors should include an evaluation of the added ingredients (120.7(d)). If the processor determines that hazards are reasonably likely to occur due to those ingredients, controls for such hazards must be included in the product's HACCP plan (120.7(e)). For example, if ingredients such as soy protein or preservatives (e.g., sulfites that can cause allergic or food intolerance reactions in sensitive individuals), or other ingredients that have the potential to cause severe allergic or food intolerance reactions in sensitive individuals are added, controls to ensure that the presence of such ingredients are declared on the label should be part of the HACCP plan. 12. How many critical control points (CCPs) should there be in a HACCP plan? A HACCP plan need only have as many CCPs as the processor deems necessary to control the hazards that are reasonably likely to occur as identified in the hazard analysis for that product. 13. Can a firm use its existing juice HACCP plan and still comply with the regulation? Yes. There is no requirement that juice processors develop new juice HACCP plans. If existing procedures in a firm's HACCP plan comply with the requirements in part 120, the processor may continue to use that HACCP plan.

14. Where can I find an example of a good juice HACCP plan? Examples of juice HACCP plans that processors may modify for their product to address specific hazards in their processing facility can be found in the FDA's "Juice HACCP Hazards and Controls Guide".

F. Validation
15. How often should a juice manufacturer validate their HACCP plan(s)? Each HACCP plan must be validated at least once within 12 months after implementation and no less than every 12 months thereafter (120.11(b)). Validation of the HACCP plan also will be necessary when any changes have occurred in the process that might affect the hazard analysis or alter the HACCP plan in any way (120.11(b)).

G. Verification
16. Will FDA be recommending or certifying laboratories for processing and end product testing of juice beverages in order to verify the reliability of the testing data? No. Processors are responsible for choosing laboratories that are able to perform appropriate and accurate tests to ensure that their product meets all requirements and is safe for human consumption.

H. Records
17. Will Clean-In-Place (CIP) recording charts be required for juice beverage fillers in order to provide records and verify cleaning under the mandatory equipment cleaning SSOP? No. CIP recording charts are not required. The processor is only required to maintain records that, at a minimum, document the monitoring and corrective actions prescribed by 120.6(b) and meet recordkeeping requirements of 120.12. 18. When does a juice processor have to start keeping HACCP records? A processor should start keeping HACCP records once the HACCP system has been accepted and implemented by the firm. 19. Are we able to scan records and store them electronically?

Yes, the maintenance of computer records, in accordance with 21 CFR part 11, is acceptable, provided the records also comply with record requirements of the regulation, are readily accessible, and are signed to signify that the records have been accepted by the firm (120.12). 20. Does the regulation require that records be used exclusively for juice (e.g., juice pasteurization charts) or can they be combined with records for other products? No. There is no requirement that processors have exclusive juice records as long as all records required by 120.12 are clearly marked and available.

I. Training
21. Since processors of shelf-stable and thermally concentrated juice are already controlling a majority of their hazards, are they required to have as much HACCP training as other juice processors? All processors subject to the regulation must comply with the training requirements of the regulation, regardless of what type of product they process (120.13).

J. Imported Juice
22. Are foreign processors subject to the regulation? Yes. Both domestic and foreign juice processors that ship juice products to the U.S. are subject to the regulation (120.1(a)). 23. Do the same effective dates for domestic processors apply to foreign processors and importers? Yes. The effective dates for large, small, and very small processors apply to both domestic and foreign processors and importers (120.1(b)). 24. Must an importer ensure that the juice ingredient in a beverage has been processed in accordance with part 120? No. The HACCP import requirements found in 120.14(d) apply only to importers of juice. Importers of beverages that contain juice (e.g., dilute juice beverages) are not covered by the regulation. 25. Will FDA conduct on-site inspections of foreign juice processors? Yes. FDA does conduct some inspections of foreign firms, including juice firms.

26. Does an importer have to keep records for shipments of juice being imported into the United States? Yes. The importer must have the necessary records for each shipment of juice to ensure that the juice was processed in accordance with the regulation (120.14(c)). 27. What documentation is an importer required to have if imported juice or juice concentrate was prepared by a foreign firm prior to the applicable effective date (i.e. prepared under CGMPs but not under HACCP) then offered for import into the U.S. after the applicable effective date? The importer should provide documentation sufficient to show that the juice was produced before the effective date of the regulation for that juice processor (120.14(a)(2)(ii)). Documentation might include, but is not limited to, a letter from the processor that shows that the juice was produced before the effective date. For example, if juice or juice concentrate was prepared by a very small foreign firm prior to January 20, 2004, and then offered for import into the U.S. after January 20, 2004, the importer of that product should show that the juice or concentrate was produced before January 20, 2004. 28. If paperwork from an importer indicates that a particular lot of juice concentrate has a deviation and corrective action, can that concentrate be co-mingled with domestic concentrate for use in a pasteurized juice? Yes. The concentrate can be co-mingled provided that corrective action was taken using an appropriate corrective action plan or by following the procedures listed in 120.10(b). A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that "no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation" and "the cause of the deviation is corrected" (120.10(a)).

K. The 5-Log Reduction Performance Standard

29. Are imported juice concentrates exempt from the 5-log pathogen reduction standard? Imported juice concentrates are exempt from the 5-log performance standard if thermal concentration and final product packaging occur in a single facility (120.24(a)(2) and (c)). The thermal process used to achieve concentration must be included in the firm's hazard analysis (120.24(a)(2)). 30. If a dairy processor purchases a juice concentrate from a juice manufacturer, then proceeds to put it into a beverage (e.g., 50% juice), does the concentrate need a 5-log treatment prior to being mixed with the other beverage ingredients?

No. If a dairy processor is not making juice as defined in 120.1(a), that product is not subject to the provisions in part 120. Therefore, a 5-log treatment is not required for the beverage made from that concentrate nor is an additional 5-log treatment required for that juice concentrate (i.e., the juice ingredient). However, the juice ingredient must have been produced under a HACCP system (120.1(a)). 31. Do milk pasteurization times and temperatures provide sufficient heat treatment to meet the 5-log pathogen reduction requirement for juice covered under the regulation? It depends. Pasteurization times and temperatures to achieve a 5-log reduction will vary depending on the type of product, the process, target microorganism, pH of the product, etc. In most cases, milk pasteurization treatment conditions of 161 degrees F for 15 seconds, will effectively achieve a 5-log pathogen reduction for juice; however, the processor must show that he or she has validated that the HACCP plan (including the processing conditions) is adequate to control food safety hazards that are reasonably likely to occur in that product ( 120.11(b)). 32. I am a dairy processor who purchases juice concentrate from a concentrator and reconstitutes it to a single strength juice prior to packaging. Is a 5-log reduction at the concentrator's facility sufficient to address the 5-log performance standard? No. Because you are making juice as defined in 120.1(a), you must treat the juice to achieve a 5-log reduction prior to final packaging as outlined under 120.24(c). The 5-log exemption for concentrates only applies when the product is processed and packaged at a single facility. 33. If I purchase a fruit puree that has been treated to achieve a 5-log reduction and blend it with juice that I have manufactured and treated to achieve a 5-log reduction, does the resulting blend need to be treated again to achieve a 5-log reduction? Yes. Section 120.24(c) requires that the blended juice, including the puree, must receive a 5-log treatment at the final packaging facility. 34. What processing treatment and temperature is required for a juice to be considered shelfstable? Section 120.3(n) defines a shelf-stable product as a product that is hermetically sealed and, when stored at room temperature, does not demonstrate any microbial growth. The regulation does not provide for specific processing parameters for attaining shelf-stability.

(1)

This guidance has been prepared by the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration. See additional Questions & Answers on the Juice HACCP Regulation (August 31, 2001).

FDA Juice HACCP Compliance Guide Guidelines

FDA Juice HACCP Compliance Guide Guidelines

Compliance Policy Guide

Apple Juice, Apple Juice Concentrates, and Apple Juice Products - Adulteration with Patulin
Updated: 2005-11-29

Sec.510.150 This guidance document represents the Agency's current thinking on its enforcement process concerning the adulteration of apple juice, apple juice concentrates, and apple juice products with patulin. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. INTRODUCTION This compliance guidance document is an update to the Compliance Policy Guides Manual (August 2000 edition). It is a new CPG and will be included in the next printing of the Compliance Policy Guides Manual. It is intended for FDA personnel and is available electronically to the public. BACKGROUND Patulin is a toxic substance produced by molds that may grow on apples. In the past, patulin has been found to occur at high levels in some apple juice products offered for sale in or import into the U.S. REGULATORY ACTION GUIDANCE The following criteria should be considered in deciding whether to recommend legal action or whether to recommend detention of imports to CFSAN/Office of *Compliance/Division of Enforcement* (HFS-605): The sample is analyzed in accordance with applicable methods of the current Official Methods of Analysis of the Association of Official Analytical Chemists1, and its supplements, and both of the following conditions are met: 1. Original and check analysis show patulin at or above 50 micrograms per kilogram (50 parts per billion) as determined on single strength apple juice, reconstituted single strength apple juice (if the food is an apple juice concentrate), or the single strength apple

juice component of the food (if the food contains apple juice as an ingredient); (For the purpose of this guidance, single strength juice is 100 percent juice that is unconcentrated (see 21 CFR 101.30(h)).) and 2. Identity of patulin is confirmed by gas chromatography/mass spectrometry. SPECIMEN CHARGE For domestic goods: The article (apple juice, apple juice concentrate, or apple juice product) was adulterated when introduced into and while in interstate commerce and is adulterated while held for sale after shipment in interstate commerce within the meaning of 21 U.S.C. 342 (a)(1), in that it bears or contains an added poisonous or deleterious substance, patulin, which may render the article of food injurious to health. For imported goods: The article (apple juice, apple juice concentrate, or apple juice product) is subject to refusal of admission pursuant to 21 U.S.C. 381 (a)(3) in that it appears to bear or contain an added poisonous or deleterious substance, patulin, which may render the article injurious to health (adulteration under 21 U.S.C. 342 (a)(1)). At the time of this issuance, the current method can be found in the Seventeenth Edition, section 995.10 - Patulin in apple juice, liquid chromatographic method, AOAC-IUPAC-IFJU Method. This method was adopted by AOAC International in 1995. The method was published in JAOAC 79(2):452-455, 1996. *Material between asterisks is new or revised.* Issued: 10/22/2001 Revised: 5/2005
1

FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM GUIDANCE MANUAL
PROGRAM

7303.847

CHAPTER 03 - FOODBORNE BIOLOGICAL HAZARDS

SUBJECT: IMPLEMENTATION DATE

Juice HACCP Inspection Program (FY 07/08/09) (Processor and Importer Inspections) This Program has completed a Good Guidance Practice clearance by CFSANs OC/DFP&G/FPB in May 2007 per CFSANs ORP instructions
PRODUCT CODES

UPON RECEIPT
COMPLETION DATE

09/30/09 or until revised

DATA REPORTING PRODUCT/ASSIGNMENT CODES

INDUSTRY CODES:

20-22, 24,25 03847H 03847 03847H 03S004

REPORT TIME FOR HACCP INSPECTIONS UNDER THE FOLLOWING PACS: Processor HACCP Component of Inspection Processor Filth/Sanitation Component of Inspection Importer HACCP Inspection (use Establishment Type A) State Contract Inspections REPORT VERIFICATION SAMPLES UNDER THE FOLLOWING PACS: 03847H 04847H 07847H 09847H 21847H HACCP Microbiological/Physical Hazards HACCP Toxic Elements (Lead) HACCP Mycotoxins (Patulin) HACCP Color and Food Additives Labeling REPORT FOR CAUSE SAMPLES UNDER THE FOLLOWING PACS: 03847 04847 07847 09847 For Cause Microbiological, Filth or Physical Hazards For Cause Toxic Elements (Lead), Pesticides, Contaminants For Cause Mycotoxins (Patulin) For Cause Color and Food Additives

USE APPROPRIATE PRODUCT CODES

Note: Material that is not releasable under the Freedom of Information Act (FOIA) has been redacted/deleted from this electronic version of the program. Deletions are marked as follows: (#) denotes one or more words were deleted, (&) denotes one or more paragraphs were deleted, and (%) denotes an entire attachment was deleted.

Note: The performance of non HACCP inspection work may be guided by instructions in the current Domestic Food Safety Program, CP 7303.803 but reported under 03847, 04847, 07848, 09847 and not 03803. Exceptions are possible, (i.e., performing major functions outside the juice HACCP program in a dairy plant, e.g., bottled water, ice manufacturing, etc.) during a juice HACCP inspection. But normally, PAC 03803 should not be used for reporting time in performing juice HACCP and non-HACCP inspections. 1

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Districts are no longer required to complete or submit a Juice HACCP Questionnaire (Attachment A in the FY03 Juice HACCP Inspection Program).

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FIELD REPORTS TO HEADQUARTERS Domestic and Importer enforcement action recommendations (including copies of Warning and Untitled Letters) should be submitted directly to Division of Enforcement #. LABORATORY REPORTING Report the following analytical results into the FACTS Data System using the identified Problem Area Flags (PAF): A. B. C. D. E. Microbiology: PAF = MIC Filth: PAF = FIL Mycotoxins: PAF = MYC Toxic Elements in Foods: PAF = ELE Pesticides: PAF = PES F. Food Additives: PAF= FAD G. Color Additives: PAF= COL H. Labeling: PAF= FDF then FDL

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PART I - BACKGROUND On January 19, 2001, the Food and Drug Administration (FDA) published a final rule requiring the application of Hazard Analysis and Critical Control Point (HACCP) principles to the processing of fruit and vegetable juices (66 FR 6137 Hazard Analysis and Critical Control Point (HACCP): Procedures for Safe and Sanitary Processing and Importing of Juice). FDA took this action because there have been a number of food hazards associated with juice products and because a system of preventive control measures is the most effective and efficient way to ensure that these products are safe. The regulation (21 CFR 120) took a phased-in approach for compliance to permit the regulated industry time to accomplish the training of personnel and adjust its activities to include necessary HACCP components. This approach resulted in the regulation becoming effective 1 year after the date of publication of the final rule, with special provisions that extended the phase-in to up to 3 years after publication of the final rule. In addition, FDA elected to make the first juice HACCP inspection educational, rather than regulatory, as long as there was sufficient progress to implement HACCP and there were no adulteration issues unrelated to the HACCP plan. FDA chose this approach because the first inspection would provide the first direct feedback from the agency on the status of the firm's HACCP system. As of January 20, 2004, all processors and importers of juice and juice products have been subject to the juice HACCP regulation and the phased-in approach for compliance has ended. Furthermore, the educational inspections have been phased-out. The compliance program covers domestic processors and importers of fruit and vegetable juices and provides instructions to ensure that they are being operated in accordance to the existing juice HACCP regulation.

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PART II - IMPLEMENTATION OBJECTIVE The program objective is to ensure the safe and sanitary processing of fruit and vegetable juices. This will be accomplished by conducting inspections of domestic processors and importers in accordance to the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act, and the regulations promulgated under the authority of these acts. APPROACH Processor Inspection: Note: A HACCP inspection is not a stand-alone part of Inspection Program but is one part of a larger system For HACCP to function effectively, non HACCP areas of working properly and therefore, non-HACCP elements of reviewed. the Juice HACCP of controls procedures. production should be production should be

The processor inspection component of the Juice HACCP Inspection Program consists of two parts: 1. A HACCP inspection for food safety by investigators trained to conduct juice HACCP inspections, at which investigators should inspect HACCP records and HACCP controls as they relate to safety hazards and 2. Inspectional coverage of non-HACCP areas (i.e., cGMPs, SSOPs) for those areas such as filth, sanitation, personal hygiene, etc., at which investigators will perform traditional inspections for the non-HACCP areas for all firms. Importer Inspection: The Importer inspection component of the Juice HACCP Inspection Program includes an inspection of the importers place of business to determine compliance with the importer requirements found in 21 CFR 120.14 by investigators trained to conduct juice HACCP inspections. When the importer does not obtain the juice from a country that has an active MOU or similar agreement that covers the product, investigators should review the importers records that document product specifications, the performance and results of the affirmative steps taken by that importer to determine the adequacy of those records for ensuring that the products being offered for entry by that importer were processed in accordance with 21 CFR Part 120. PROGRAM MANAGEMENT INSTRUCTIONS A. Program Resources 1. Domestic resources in the ORA Field Workplan have been provided to cover inspections and anticipated For Cause samples and juice HACCP verification samples. Districts should collect sufficient Juice HACCP verification samples, so that when added to their For Cause collections, meets their full domestic sample collection workplan obligation. Import resources in the ORA Field Workplan are to be used to carry out inspections of importers for verification of HACCP. No samples are to be collected.

2.

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B.

Inspectional Priority #

Note: At the discretion of the district, attempt to determine the inspectional priority as resources permit 1. Processors: Priority of inspections of firms should be given in the following order: Juice processors that have been linked to recent outbreaks # Unpasteurized juice processors # Processors whose previous inspections were OAI Processors that have not been inspected (all sizes) Processors whose previous inspections were NAI/VAI 2. Importers: Priority of inspections of importers should be given in the following order: Importers importing unpasteurized juice products # Importers with the highest number of entry lines for juice products (the greater number of juice entries, the higher the priority for inspection). Importers with previous Juice HACCP violations (after initial inspection) Importers whose previous inspections were NAI/VAI C. Sample Collection Domestic Processor Inspections Only Refer to Part III, Section A, Number 4 Sampling for complete sampling instructions. Verification samples are Official Samples which are analyzed for one or more of the safety hazards identified in the firms juice HACCP plan. They are used as a means of judging the overall effectiveness of the HACCP system. The results of these samples enable the Agency to make determinations about the likelihood of the occurrence of particular safety defects in products that are produced under HACCP preventive controls. Samples must be of the product/process combination covered during the HACCP inspection. When collecting Verification samples, one sample per inspection should be collected, unless the products HACCP plan includes Patulin as a chemical hazard, then collect a split sample and ship one portion of the sample to the assigned chemical lab and the other portion to the assigned microbiological lab. When collecting apple juice at an initial processor (a processor who expresses juice from the apples themselves), try to obtain evidence regarding the type of apples used to produce the specific lot of juice sampled and document this evidence in the collection report, inspection report, and affidavit. D. Interaction with Other Programs 1. Mycotoxins in Domestic Foods, CP7307.001 Juice samples collected only For Cause or HACCP Verification for the hazard, patulin, should be reported against this Juice HACCP Inspection Program CP7303.847 (PACs 07847 and 07847H, respectively). Generally, surveillance samples of apple juice for patulin analyses for the Domestic Mycotoxin Compliance Program (CP 7307.001) should not be collected at processors when conducting a Juice HACCP inspection, unless the firm produces different juices and apple juice was not the product covered during the HACCP
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inspection. However because of limited resources and travel funds, the field may consider collecting surveillance samples at the same time as the EI so long as the lot samples is not the same as the production lot during the EI. For Cause and HACCP Verification samples are the only samples appropriate for the juice product covered during the inspection. 2. Toxic Elements in Food and Foodware and Radionuclides in Food, CP7304.019 Juice samples collected only For Cause or HACCP Verification for the hazard, lead, should be reported against this Juice HACCP Inspection Program CP 7303.847 (PACs 04847 and 04847H, respectively). No surveillance samples are to be collected for lead or other toxic element analyses per the Toxic Elements in Food and Foodware and Radionuclides in Food, CP 7304.019. 3. Domestic Acidified and Low Acid Canned Foods, CP7303.803A Resources expended for inspections of firms under the Low-Acid Canned Foods Regulation (21 CFR 113) or the Acidified Foods Regulation (21 CFR 114) must be reported under CP 7303.803A. 4. Domestic and Import NLEA, Nutrient Sample Analysis and General Food Labeling Program, CP 7321.005 Refer to the current version of CP 7321.005 for instructions on the Nutrition Labeling and Education Act (NLEA). Coverage of the NLEA is to be accomplished during Juice HACCP inspections. Firms that are covered under the Juice HACCP regulation cannot use the Juice Warning Statement (21 CFR 101.17(g)Juices that have not been specifically processed to prevent, reduce, or eliminate the presence of pathogens) as a means of reducing the incidence of foodborne illness and death caused by the consumption of juice and juice products. These firms must now ensure the safety of the juice and juice products that they produce by complying with the Juice HACCP regulation. 5. Import Programs: Sampling of imported juice and juice products should continue to be conducted and reported as directed under import alerts and bulletins, and appropriate import compliance programs (i.e.: Import Foods General; Pesticides and Industrial Chemicals in Imported and Domestic Foods; Toxic Elements in Foods and Foodware, and Radionuclides in Food; Mycotoxins in Import Foods; and Domestic and Import NLEA, Nutrient Sample Analysis, and General Food Labeling Requirements Program). There are no import juice sample collections planned under the Juice HACCP Inspection Program at this time. E. Federal/State Contracts The current states where contracts have been established to perform Juice HACCP inspections are the following: #. All Juice HACCP inspections conducted under state contract must be HACCP based and consistent this compliance program, the contract Statement of Work (SOW), and with the methods included in the Juice HACCP Regulator Training Manual. Districts must ensure that current or future state
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contractors staffs that will conduct HACCP inspections have completed the FDA Juice HACCP Regulator Training Course. This will be verified through contract oversight (FMD-76) or the annual District/State contract workplanning meeting. F. Interstate Milk Shippers (IMS) Listed Firms Juice-producing firms which are also on the IMS list are to be inspected under this compliance program. It is the responsibility of the investigator to make this determination and contact the Regional Milk Specialist (RMS)/or its equivalent and confirm whether or not a check rating will be conducted within that particular fiscal year and if so, the RMS is trained in Juice HACCP. If a check rating will not be completed during the fiscal year, districts should conduct an inspection covering ONLY the juice product to complete its responsibility of covering high risk firms. Districts and RMSs/or its equivalent should work together to coordinate these inspections. If RMSs/or its equivalent are conducting check ratings of IMS firms and have completed the required Juice HACCP training, they are to conduct Juice HACCP inspections per this compliance program. All inspections are to be reported under the appropriate Juice HACCP PACS.

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PART III - INSPECTIONAL For inspectional instructions and procedures, investigators are advised to refer to the following references (websites are active): Juice HACCP Regulator Training Manual HACCP inspection procedures/activities Juice HACCP Hazards and Controls Guidance Potential hazards and recommended controls for juice processing Juice HACCP Questions and Answers (August 31, 2001) Juice HACCP Questions and Answers (September 4, 2003) FDA Investigations Operations Manual (IOM) Federal Register: January 19, 2001 (66 FR 6138) Procedures for the Safe and Sanitary Processing and Importing of Juice; Final Rule Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes Previous minimum training requirement for conducting Juice HACCP inspections: Completion of the FDA Juice HACCP Regulator Training Course The current training requirements for investigators performing domestic processor and importer Juice HACCP inspections: Attendance at the FDA three day Juice HACCP Alliance Training Course, the 3 day Juice HACCP Alliance Training course, or any other acceptable training course using the standardized curriculum or an equivalent alternative curricula covering the application of HACCP principles to the processing of juice, and: The Juice HACCP for Regulators videotaped training (10/30/02). Note: all of the training materials are posted on ORAs website. Districts are reminded to ensure that state investigators doing HACCP inspections under contract (if one exists) have been trained to conduct HACCP inspections, as described above. The investigators role includes evaluating the adequacy of a processors HACCP plan and its implementation and an importers verification procedures and their implementation. In situations where instructions provided to the field is not definitive with regard to a particular hazard being reasonably likely to occur (such as with Patulin and Metal/Glass Fragments), the investigator should obtain additional evidence to show that the hazard has a reasonable possibility to occur. Such evidence may include firm record showing that a hazard has occurred, analysis of the finished product, or direct observations by the investigator that the hazard did occur. If a question arises about the adequacy of a processors plan or its implementation or and importers verification procedures and their implementation, the investigator is encouraged to seek instructions from the district, region, National Expert, DFI, or CFSAN. A. Processor Inspection Component
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1.

HACCP Inspection The HACCP component of a processor inspection should be performed in a manner consistent with the Juice HACCP Regulator Training Manual. When an investigator encounters a facility with no HACCP plan or an inadequate HACCP plan, a full HACCP inspection must still be performed following the instructions established in the Juice HACCP Regulator Training Manual. The investigator should, among other things: [1] construct a flow chart for the product(s) being evaluated (to be incorporated into EIR narrative or as attachment); [2] independently identify the appropriate significant hazards and Critical Control Points (CCPs); and [3] document if the CCPs are being adequately monitored. On the Form FDA 483, document all deficiencies from the juice HACCP regulation and other regulations, as they always have been. While the inspector must do a full HACCP inspection, this should not be interpreted to mean that either the flow chart or the HACCP plan will be prepared for the firm by the investigator. The type of juice product chosen for an inspection should be one that is actively being processed at the time of the inspection and ideally the one that has the most significant potential hazard. Where past inspections of a firm detected significant problems with HACCP programs for a particular product, the follow-up inspections should concentrate on those, or similar products before moving on to other products. Document deficiencies of the HACCP regulation on the Form FDA 483 in a manner consistent with the Juice HACCP Regulator training manual. Narrative EIRs should be completed as directed by existing instructions. Consistent with such instructions, these narrative reports should describe the firms HACCP control program and sanitation monitoring program deficiencies noted during the inspection. Citations for Juice HACCP are available in Turbo EIR and should be used for 483s and EIRs. Firms subject to the Juice HACCP regulation can not use the Juice Warning Statement (21 CFR 101.17(g)) in their HACCP plan as a means of reducing the incidence of foodborne illness and death caused by the consumption of juice and juice products. These firms must ensure the safety of the juice and juice products that they produce by complying with the Juice HACCP regulation. Please refer to CP 7321.005 for instructions on labeling for firms that are not subject to the Juice HACCP regulation. If GMP deficiencies are observed during an inspection, the investigator should, if appropriate, list them on the Form FDA 483 using a GMP citation, and thoroughly describe in the EIR the significance of the GMP deficiencies by including observations that indicate there is a reasonable likelihood of a potential problem occurring.

2.

Intrastate Firm Inspections The Juice HACCP regulation, in conjunction with the PHS Act, gives FDA the authority to regulate intrastate juice processing firms. When performing inspections of intrastate firms, investigators should follow the same inspectional instructions as for interstate firms. If imminent public health conditions exist, contact

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CFSAN/OC/ Division of Enforcement contact, for assistance (See Part VI, Program Contacts). 3. Non-HACCP Inspection Component It is important to remember that the primary component of a juice inspection is HACCP, but also includes sanitation monitoring. Investigators should apply existing skills to look for issues outside of the HACCP portion of the inspection; for example, misbranding associated with labeling violations and conditions that may be indicative of economic fraud. In addition, investigators are responsible for conducting a thorough GMP inspection, including issues that do not fall under HACCP, for example, the use of hairnets or issues with safety lighting. If problems with sanitation are observed during the inspection, focus on the firms sanitation practices and monitoring records. As in the past, citations are available in Turbo EIR and deficiencies should be noted on Form FDA 483. Filth Care should be taken during the inspection to fully identify sources of and possible routes of contamination of the product. For example, report the number and type of flies and times when they were on the product, open doors or damaged screens providing the flies a route to a toilet or to the outside, and the specific distances to animal feces, garbage or decaying animals. For instructions, refer to: IOM, Current Edition, 5.4.7.2: Microbiological Concerns IOM, Current Edition, 8.3.4.6: Possible Contamination Source CPG, Section 555.425: Foods Adulteration Involving Hard or Sharp Foreign Objects

Refer to the appropriate sections of the Domestic Food Safety Program, CP 7303.803, for inspectional instructions regarding the following non-HACCP issues: 4. In-plant Pesticides and Contaminants Non-HACCP Color and Food Additives

Sampling Finished Products For specific instructions on sample/subsample sizes, refer to Sampling Schedule for Juice HACCP Inspection Program (Attachment A) and the instructions outlined below which distinguishes between Verification and For Cause samples. HACCP Verification Samples HACCP Verification samples are Official Samples of finished products and are to be collected at juice processing firms. Each district should collect a representative number of Verification samples correlating with the number of NAI/VAI inspections. The special verification PACs (those ending in 847H) are only to be used for these physical samples (refer to Compliance Program cover sheet). Verification samples are to be collected only when the investigator expects the inspection to be either NAI or VAI.

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All Verification samples should be analyzed for all relevant safety hazards listed in the firms HACCP plan. The investigator who collects the sample is responsible for listing the hazards (as listed in the HACCP plan) needed to be analyzed on the FACTS Collection Report in the box labeled Reason for Collection. Refer to the current ORA Workplan for assigned servicing laboratories. NOTE: If a Verification sample requires both patulin and micro analyses and the assigned chemical and microbiological laboratories differ, collect a split sample and send a portion to the appropriate chemical and microbiological labs. For Cause Safety Sample Collection Physical HACCP (e.g. safety issue) samples are not to be routinely collected For Cause but are to be collected ONLY when it is necessary to determine the extent of a safety problem and to facilitate an appropriate follow-up. Collect For Cause samples of finished product to determine if an imminent public health hazard exists. Only us PACs: 03847, 04847, 07847, 09847 when collecting For Cause samples (refer to Compliance Program cover sheet for additional details). NOTE: Most deficiencies of the Juice HACCP regulation should not require a physical sample to confirm or document them. Some examples of situations when For Cause samples may be taken include: If the investigator observes moldy apples being mixed into batch (for Patulin). If investigator observes broken bottles on the processing line (for Glass).

Surveillance samples of apple juice for patulin analyses for the Domestic Mycotoxin Compliance Program (CP 7307.001) should follow the instruction listed in Part II, Page 3. Non-HACCP Sample Collection Samples for Non-HACCP defects are to be collected if inspectional conditions warrant (i.e. For Cause). Refer to Attachment A for non-HACCP food and color additive samples. Refer to the DFI Miscellaneous Inspection Guide, Section 10 and 11, for economic adulteration samples. Please collect in duplicate to provide for the 702(b) portion. Documentary Samples All documentary samples (e.g., to support interstate commerce) are to be reported only under PAC 03847. Documentary samples are not to use the PACs (those ending in 847H) reserved for Verification samples nor are they to count towards district workplan obligations. Importer Inspection Component An importer inspection should be performed in a manner consistent with the Juice HACCP Regulator Training Manual, Chapter 13, Importer
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Inspections and Imports. priorities of importers.

Refer to Part II, Section B, for inspectional

The inspection must be performed following the instructions established in the Juice HACCP Regulator Training Manual. The investigator should, among other things, [1] Determine the foreign sources of the selected imported juice product(s), [2] Review importer's product safety specifications, [3] Review importer's verification plans, and [4] Review importer's verification records. On the Form FDA 483, document all deficiencies for imported products from the requirements in the juice HACCP regulation. Narrative EIRs should be completed as directed by the most current instructions with documentation of the firms HACCP deficiencies noted during the inspection. Citations for Juice HACCP are available in Turbo EIR and should be used for 483s and EIRs. Report time for Importer HACCP Inspections under PAC 03847H and use the Establishment Type A for Importer/Broker.

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PART IV - ANALYTICAL Use the most current compendial method that exists for particular project areas where applicable. Note: Reserve samples should be held under refrigeration until such time as the analyses are completed. After analysis, all reserve samples from opened containers and all non shelf stable products (including 702(b) samples) should be frozen until destruction is authorized. When HACCP Verification and For Cause samples are warranted, use the methods referenced in the appropriate section of the Part as follows: A B C D E F Project 03: Project 03: Project 04: Project 07: Project 09: Project 21: Filth, Mold and Foreign Objects: Microbiological Toxic Elements Natural Toxins (Patulin) Food and Color Additives Food Composition, Standards, Labeling and Economics Microscopic/Macroscopic

Please refer to the current ORA Field Workplan for servicing laboratories. A. Project 03: Methodology: Each subsample should be examined individually (not composited). Filth Microscopic (non-HACCP sample) 1. 2. 3. AOAC (current edition) Chapter 16, Extraneous Materials: Isolation JAOAC (Interim Official First Action Methods) Microanalytical Procedures Manual (MPM) Filth, Mold and Foreign Objects: Microscopic/Macroscopic

Hard/Sharp Objects Macroscopic (HACCP Physical Hazard) 1. 2. B. Please reference MPM website: http://vm.cfsan.fda.gov/~dms/mpm-toc.html In the interim or if inspectional evidence is found, call CFSAN Contact for special instructions. Microbiological

Project 03:

General Information for All Pathogen Isolates: All cultures should be shipped by FedEx overnight and should conform to the rules and regulations regarding shipment of infectious agents. Record all analytical results in FACTS using PAF = MIC, and sub PAFs = SAL, ABR, as appropriate.
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Ensure that the appropriate servicing laboratory is selected and identified in FACTS MIC screen. Special Method Instructions: 1. E. coli O157:H7 Please refer to eBAM Chapter 4a, Section M, Media Preparation: In preparing, EEB, in lieu of using 0.05 mg/L cefixime, use 0.0125 mg/L. Each subsample should be analyzed on an individual basis. Take 200ml of each subsample and centrifuge the juice at 10,000 X g for 10 minutes. After decanting the supernate, the pelleted material can then be transferred to 225 ml of 1X EEB for incubation by the standard procedure. After addition of the pellet, the pH of the enrichment broth should be checked with pHydrion paper and adjusted to pH 7.0 with 1N NaOH if necessary. a. After 24 hrs of enrichment, spread plating 0.1 ml of 1:102 through 1:104 dilutions of the enriched sample will help assure that individual colonies will be observed without competitor overgrowth on the TCSMAC plates. The appropriate dilutions to be used may vary. Refer to the reagent section of 4a for specific diluents. Continue with methodology as outlined in eBAM, Chapter 4a, Section O, Isolation.

b.

For positive E. coli O157:H7 isolates: One (1) isolate from each E. coli O157:H7 positive subsample is to be sent to the appropriate servicing laboratory as outlined under ORA/DFS Standard Operating Procedure: Routine Subtyping of Salmonella sp., Listeria monocytogenes, or E. coli O157:H7 isolated from Food and Environment for PFGE analysis. 2. Listeria monocytogenes Samples should be analyzed on a composite basis (i.e. 2 analyses per sample). Each composite for L. monocytogenes will consist of 250 ml. Prepare each composite by removing 50 ml from each of five (5) subsamples for a composite size of 250 ml. Remove 25 ml from the composite and add 225 ml enrichment broth (EB). Check the pH of juice samples. If a juice is quite acidic (pH 2.2-4.2), it may be necessary to adjust pH to 7.3 (0.1) by the aseptic addition of an appropriate amount of sterile aqueous NaOH solution (M or 5M strength as necessary). The pH and amount of NaOH solution to add should be determined in advance on a separate portion of the sample. Alternatively, the pH of a juice and enrichment broth mixture can be checked and adjusted aseptically to pH 7.3 (0.1) if necessary. Refer to the following methods of analysis:
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BAM, Chpt. 10, Listeria monocytogenes Bad Bug Book, Food pH Table IV 2

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For Positive Isolates of Listeria: One (1) isolate from each L. monocytogenes positive composite is to be sent to the appropriate servicing laboratory as outlined under ORA/DFS Standard Operating Procedure: Routine Subtyping of Salmonella sp., Listeria monocytogenes, or E. coli O157:H7 isolated from Food and Environment for PFGE and ribotyping analyses. 3. Salmonella Samples should be analyzed on a composite basis (i.e., 2 composites per sample). Each composite for Salmonella analysis will consist of 375 ml. Prepare each composite by removing 75 ml from each of five (5) subsamples and place into a sterile 6 L flask. Add 3,375 ml Universal broth. Please refer to the BAM Method, Chpt. 5 Salmonella For positive Salmonella isolates: One (1) isolate from each Salmonella positive composite is to be sent simultaneously to each of the specified laboratories as outlined under ORA/DFS Standard Operating Procedure: Routine Subtyping of Salmonella sp., Listeria monocytogenes, or E. coli O157:H7 isolated from Food and Environment for PFGE and serotyping (speciation). Following serotyping, one slant from each serotyped isolate will be sent for antibiotic resistance testing. All laboratories are to send Salmonella isolates for serotyping and PFGE analyses within 24 hours after completion of the analytical portion of the sample analysis. The serotyping laboratory should ship isolates of Salmonella within 24 hours of completion of the analysis to the identified laboratory for antibiotic resistance testing. For Salmonella serotyping, all bacterial cultures should be prepared and submitted according to BAM On-Line, Chapter 5, Salmonella, E. Identification of Salmonella, #11 Submission of cultures for serotyping. C. Project 04: Methodology: Do not analyze individual sub samples. Composite an equal volume or weight portion of each subsample. Thoroughly homogenize the composite (analytical sample) before taking analytical portion. For lead analysis, please refer to the following method, which is available from the Center Toxic Elements Contact for Lead: Draft EAM Method 4.3 Graphite Furnace Atomic Absorption Spectrometric Determination of Cadmium and Lead in Food Using Microwave Assisted Decomposition. C. Project 07: Natural Toxins (Patulin) Toxic Elements (Lead)

This analysis is for apple juice, apple juice concentrate and apple juice products only. Split samples (with the same sample number) need
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to be collected for verification samples requiring patulin analysis in addition to other microbiological analyses. Methodology: General: Samples of frozen concentrate should be diluted either as per recommendation for dilution or to a Brix value of 11.5 (single strength) before analysis (Federal Register 56 No. 127, pp. 30452-30466, 1991). Follow the procedures and methods in the most current edition of the Official Methods of Analysis of AOAC International (2000), Section 49.7.02 AOAC Method 995.10 Patulin in apple juice, liquid chromatographic method, AOAC-IUPAC-IFJU Method. AOAC Method 2000.02 Patulin in clear and cloudy apple juices and apple puree (McDonald, S., Long, M., and Gilbert, J., Liquid chromatographic method for determination of patulin in clear and cloudy apple juices and apple puree: collaborative study, J. AOAC Intl. 83: 1387-1394). Confirmation of Identity of Patulin: For regulatory samples, identity of patulin is confirmed by mass spectroscopy. The recommended procedures are: Rupp, H.S., Turnipseed, S.B., Confirmation of patulin and 5hydroxymethylfurfural in apple juice by gas chromatography/mass spectrometry, J. AOAC Intl. 83: 612-626, (2000). Roach, J.A.G., White, K.D., Trucksess, M.W., and Thomas, F.S., Capillary gas chromatography/mass spectrometry with chemical ionization and negative ion detection for confirmation of identity of patulin in apple juice, J. AOAC Intl., 104-112, (2000).

LC/MS/MS full scan can also be used for confirmation of identity of patulin provided significant fragmentation is observed in the MS/MS spectrum of patulin: Sewram, V., Nair, J.J., Nieuwoudt, T.W., Leggott, N.L., and Shephard, G.S., Determination of patulin in apple juice by high-performance liquid chromatography-atmospheric pressure chemical ionization mass spectrometry, J. Chromatography A, 897, 365-374, (2000). Food and Color Additives

E.

Project 09:

Please refer to the Domestic Food Safety Program (CP7303.803), Attachment A Project 09 Food Additives and Color Additives for analytical instructions. F. Project 21: Food Composition, Standards, Labeling and Economics

Domestic and Import NLEA, Nutrient Sample Analysis and General Food Labeling Program, CP 7321.005. Report resources utilized for NLEA against PAC 21005. Do not report inspections under NLEA. See current NLEA Compliance Program for reporting instructions.
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Contact: Glenn Bass CFSAN, Office of Compliance, Division of Field Programs & Guidance, Field Programs Branch, HFS-615, (301) 436-2774, glenn.bass@fda.hhs.gov

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PART V - REGULATORY/ADMINISTRATIVE STRATEGY This program addresses both juice HACCP and non-HACCP deficiencies. In instances where a district believes that a juice product poses an imminent public health hazard (e.g., juice processor that has been linked to a recent active outbreak), the district should contact CFSAN/OC/ Division of Enforcement to discuss an appropriate response. The Agency established Procedures for Clearing FDA Warning Letters and Untitled Letters, updated March 2005 which is now Exhibit 4-1 in the RPM and can be located at the following website: http://www.fda.gov/ora/compliance_ref/rpm/pdf/ch4.pdf Domestic and Importer enforcement action recommendations (including copies of Warning and Untitled Letters) should be submitted directly to Division of Enforcement # All model Warning Letters and Untitled Letters including appropriate Regulatory Citations (both for domestic and importers) referenced below will eventually be located on ORAs Office of Enforcement Warning Letters and Untitled Letters Main Page # after being cleared by CFSANs OC/Division of Enforcement and Office of General Counsel. PROCESSOR STRATEGY This part contains information in: Section A: To address deficiencies of the Juice HACCP regulations, 21 CFR Part 120. Section B: To address deficiencies of the Federal Food, Drug and Cosmetic Act and related Acts and regulations, such as sanitation, labeling, etc. A. Juice HACCP Deficiencies FDA adopted final regulations on HACCP requirements for the processing of juice and juice products commercially distributed in the United States to ensure food safety to the maximum extent practical. The HACCP requirements became mandatory for all juice firms on January 20, 2004. The following information may assist in responding to Juice HACCP deficiencies: 1. Juice Processors that have been linked to recent Outbreaks and Unpasteurized Juice Processors # that have deficiencies associated with Critical Control Points If deficiencies are not corrected appropriately and immediately, contact CFSAN/OC/Division of Enforcement contact about pursuing other options. 2. Pasteurized Juice Processors that have deficiencies associated with Critical Control Points If deficiencies are not corrected appropriately and immediately, the district may schedule a re-inspection of the firm as resources permit. If the firms response is inadequate, the district should attempt to resolve issues through additional correspondence, meetings, etc with the firm. However, if the firm does not respond or appears unwilling to
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correct the deficiencies, the district should re-inspect the firm # from the last correspondence date. If after re-inspection, the district determines that one or more of the original deficiencies are still present, contact CFSAN/OC/Division of Enforcement contact to discuss other options. 3. Intrastate Only Juice Processors that have deficiencies associated with Critical Control Points The district should consider leveraging follow-up action with State or Local Authorities, when the district determines that one or more of the documented deficiencies in an intrastate only juice firm. However, if the State and Local Authorities do not have the jurisdiction, the district should consult with CFSAN/OC/Division of Enforcement contact to discuss other options. B. Non - Juice HACCP Deficiencies Non-HACCP juice products will continue to be addressed per the Federal Food, Drug and Cosmetic Act (the Act) and the regulations promulgated under the Act that relate to food sanitation, wholesomeness, and labeling, including nutritional content labeling. If deficiencies that are not related to the HACCP regulations are encountered at a firm, the district may contact CFSAN/OC/Division of Enforcement contact to discuss an appropriate response. C. State Inspections under Contracts These inspections should document deficiencies from the HACCP regulations on form FDA 483, and if needed consult with CFSAN/OC/Division of Enforcement contact to discuss other options. D. District Discretion Districts should notify CFSAN/OC/Division of Enforcement contact of any juice products sampled For Cause and/or Verifications samples that are found to be non-compliant. Situations where there could be a significant health issue will be handled on a case-by-case basis by CFSAN. Please refer to the following instructions for each individual problem area: Filth, mold, and foreign objects: Filth and mold: Microscopic/Macroscopic

Please consult with CFSAN Regulatory Contacts.

Foreign Objects: Refer to FDA/ORA CPG, SECTION 555.425 -Foods Adulteration Involving Hard or Sharp Foreign Objects. Microbiological Pathogens (E. coli O157:H7, Salmonella, and Listeria) If one positive sample or subsample is found from one lot of juice, then, the district should determine whether the lot in question involves interstate commerce. If interstate commerce can be documented, the district should consider voluntary recall and contact the CFSAN recall team. If the owner refuses to voluntarily remove the product from the domestic marketplace and the product is still available, the district should contact CFSAN/OC/Division of Enforcement contact about pursuing other options. If there is no interstate commerce, notify state officials of FDA laboratory
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findings so that the states officials can follow-up. Toxic Elements (Lead) The Codex Alimentarius Commission adopted a standard of 50 ppb lead in fruit juices for international trade. The FDA supports this level to protect the consumer, especially infants and young children who consume high amounts of fruit juices and who are the most sensitive to the adverse health effects of lead. Analyzing laboratories should first call CFSAN Juice HACCP Inspection Program Monitor to report all lead levels detected above 50 ppb. CFSAN will review on a case-bycase basis to determine the appropriate follow-up. Information about the initial sample such as the product type, detected lead levels, where and when collected, and the consignee for the lot would be needed for follow-up. Natural Toxins (Patulin) For apple juice, apple juice concentrate, and apple juice product samples only (refer to CPG Section 510.150 Apple Juice, Apple Juice Concentrates, and Apple Juice Products Adulteration with Patulin). Food and Color Additives Please Refer to the Domestic Food Safety Program (CP7303.803). Food Composition, Standards, Labeling and Economics. Please refer to the Domestic and Import NLEA, Nutrient Sample, Analysis, and General Food Labeling Program (CP7321.005) for general labeling instructions. IMPORTER STRATEGY If importers use Maintaining on file a copy, in English, of the foreign processors HACCP plan and a written guarantee from the foreign processor as an Affirmative Step to comply with the Juice HACCP Regulation, the district should determine whether or not the plan is adequate. Importers should only be cited for an inadequate affirmative step, in this situation, if the HACCP plan fails to list a hazard that is associated with the product and is reasonably likely to occur. In addition, if the Foreign Processors HACCP plan is not adequate for any reason, the district should refer to the Foreign Processor Strategy (below). A. District Discretion:

Importer Juice HACCP deficiencies, if left uncorrected, jeopardize the operational, or performance aspects of the HACCP system. In addition there may be other deficiencies that involve paper-type problems. Districts should notify CFSAN/OC/Division of Enforcement contact to discuss options (e.g., DWPE). B. Unpasteurized Juice Importers # If the district determines that one or more deficiencies exist, consult with the CFSAN/OC/Division of Enforcement contact, to discuss options (e.g., DWPE). C. Pasteurized Juice Importers
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When the district has documented one or more deficiencies and if the firms response is inadequate, the district should attempt to resolve issues through additional correspondence, meetings, etc. However, if the firm does not respond or appears unwilling to correct the deficiencies, the district should re-inspect the firm # from the last correspondence date as resources permit. If after re-inspection, the district documented that one or more of the deficiencies are still present, the district should contact CFSAN/OC/Division of Enforcement contact about pursuing other options (e.g., DWPE of the products being offered for entry by the Importer). FOREIGN PROCCESSOR STRATEGY (Importer Inspection) If there are deficiencies in the foreign processors HACCP plan that has been obtained by the district during an importer inspection, and that importer also has a written guarantee from the foreign processor, which indicates that the imported food is processed in accordance with the requirements of Part 120, consult with the OC/Division of Enforcement, about pursuing other options (e.g., DWPE of the implicated products from the foreign processor).

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PART VI - ATTACHMENT, REFERENCES, AND PROGRAM CONTACTS ATTACHMENT Attachment A: REFERENCES Juice HACCP Regulator Training Manual HACCP inspection procedures/activities Juice HACCP Hazards and Controls Guidance Potential hazards and recommended controls for juice processing Juice HACCP Questions and Answers (August 31, 2001) Juice HACCP Questions and Answers (September 4, 2003) FDA Investigations Operations Manual (IOM) Federal Register: January 19, 2001 (66 FR 6138) Procedures for the Safe and Sanitary Processing and Importing of Juice; Final Rule Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes DFI Miscellaneous Inspection Guide, Section 10 and 11 PROGRAM CONTACTS Program Contact: Glenn Bass CFSAN, Office of Compliance, Division of Field Programs and Guidance, Field Programs Branch, HFS-615, (301) 436-2575, Fax (301) 436-2657 glenn.bass@fda.hha.gov; (301)-436-2774 Sampling Size and Preparation for Juice HACCP Inspection Program

General Investigational Contact: Barbara Marcelletti ORA, ORO, DFI, Investigations Branch, HFC-132, (301) 827-5635, barbara.marcelletti@fda.hhs.gov

General Juice HACCP Questions: Martin Stutsman CFSAN, Office of Food Safety, Division of Plant and Dairy Food Safety Plant Products Branch, HFS-317, (301) 436-1642, martin.stutsman@fda.hhs.gov

General Analytical Questions: ORA, Division of Field Science, HFC-141,

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(301) 827-7605 Microbiological Marsha Hayden Filth Larry DHoostelaere Natural Toxins George Salem Toxic Elements Steve Robbs ORA/ORO/Division of Field Science, HFC-141, (301) 827-1039, marsha.hayden@fda.hhs.gov ORA/ORO/Division of Field Science, HFC-141, (301) 827-1032, lawrence.dhoostelaere@fda.hhs.gov ORA/ORO/Division of Field Science, HFC-141, (301) 827-1031, george.salem@fda.hhs.gov ORA/ORO/Division of Field Science, HFC-141, (301) 827-9555, steven.robbs@fda.hhs.gov

Center Filth and Natural Toxins Analysis Contact: George Ziobro CFSAN, Office of Food Safety, Division of Plant and Diary Food Safety, HFS-316, (301) 436-1965, george.ziobro@fda.hhs.gov

Center Microbial Analysis Contact: E. coli O157:H7: Peter Feng Listeria: Anthony Hitchins Salmonella: Wallace Andrews Center Toxic Elements Contact: Lead: Stephen Capar CFSAN, Office of Regulatory Science, Division of Bioanalytical Chemistry, HFS-716, (301) 436-2003, stephen.capar@fda.hhs.gov CFSAN, Office of Regulatory Science, Division of Microbiological Studies, HFS-711, (301) 436-1650, peter.feng@fda.hhs.gov CFSAN, Office of Regulatory Science, Division of Microbiological Studies, HFS-711, (301) 436-1649, anthony.hitchins@fda.hhs.gov CFSAN, Office of Regulatory, Division of Microbiological Studies, HFS-711, (301) 4362008, wallace.andrews@fda.hhs.gov

CFSAN Recall Coordinator: Cecilia Wolyniak CFSAN, Office of Compliance, Division of Enforcement, Recall Team, HFS-605, (301) 4362082, cecilia.wolyniak@fda.hhs.gov

Compliance Matters:
TRANSMITTAL NO: PAGE

FORM FDA 2438c (5/84)

PROGRAM

7303.847

Millie Benjamin (Leader)

CFSAN, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch, HFS-607, (301) 436-1424, millie.benjamin@fda.hhs.gov* CFSAN, Office of Compliance, Division of Enforcement, Product Adulteration Branch, HFS606, (301) 436-2164, Salvatore.evola@fda.hhs.gov

Salvatore Evola (Leader)

TRANSMITTAL NO:

PAGE

FORM FDA 2438c (5/84)

PROGRAM

7303.847

PART VII - CENTER RESPONSIBILITIES Program Evaluation During the course of this program the Office of Food Safety (OFS), will identify any deficiencies in program operations or program quality. OFS will prepare an annual evaluation of this program in accordance with #.

TRANSMITTAL NO:

PAGE

FORM FDA 2438c (5/84)

PROGRAM

7303.847

ATTACHMENT A

Sample Size and Preparation for Juice HACCP Inspection Program Samples do not reflect 702(b) portion (except Food and Color Additives). Please collect in duplicate to provide for 702(b) portion.

Analysis General Micro:

Specific Instructions

Collect ten (10) subsamples (Retail Containers) with a minimum sub-sample size of 32 fl oz. (i.e. 946 ml). NOTE: If finished product juice retail container is greater than gallon (i.e. 1893 ml), then notify Program Monitor for further instructions This amount is enough to cover all E. coli O157:H7, Listeria monocytogenes, and Salmonella analyses. Please refer to each analytical section for specific subsample and compositing instructions. 1 sample = 12 randomly selected subs with each sub minimum of 4 oz. If consumer size containers, collect 12 random containers. If bulk size containers, collect 12 subs minimum 4 oz. each. For Apple Juice and Apple Cider Only Frozen Concentrate: Collect six subsamples with a minimum volume of 400 ml (approx. 12 fl oz.) per sub. Single Strength: Collect six subsamples with a minimum volume of 500 ml (approx. 16 fl oz.) per sub. Non-HACCP Filth samples: Filth, Macro/ Microscopic 1 sample = 6 subsamples 1 sample = 12 subsamples

Microbiological

Toxic Elements (Lead)

Patulin

HACCP Hard/Sharp Object samples:

Subsample Size = Consumer Retail Container Analyze each subsample individually (no compositing). These sample sizes include the 702(b) portion: 1 sample = 6 subsamples Color Additives: oz.) Subsample = Two retail packages (minimum 8

Food and Color Additives

Food Additives: In most cases the size of sample collected for filth will be sufficient for the food additive analysis as well. However, it may be necessary to consult with the analyzing laboratory on the amount of sample required for specific food additives.

TRANSMITTAL NO: FORM FDA 2438b (2/95)

PAGE

FDA Guidance on Patulin in Apple Juice Guidelines

FDA Guidance on Patulin in Apple Juice Guidelines

Compliance Policy Guide

Compliance Policy Guidance for FDA Staff

CHAPTER - 5 SUB CHAPTER - 510

Sec. 510.150 Apple Juice, Apple Juice Concentrates, and Apple Juice Products Adulteration with Patulin This guidance document represents the Agency's current thinking on its enforcement process concerning the adulteration of apple juice, apple juice concentrates, and apple juice products with patulin. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. INTRODUCTION This compliance guidance document is an update to the Compliance Policy Guides Manual (August 2000 edition). It is a new CPG and will be included in the next printing of the Compliance Policy Guides Manual. It is intended for FDA personnel and is available electronically to the public. BACKGROUND: Patulin is a toxic substance produced by molds that may grow on apples. In the past, patulin has been found to occur at high levels in some apple juice products offered for sale in or import into the U.S. REGULATORY ACTION GUIDANCE: The following criteria should be considered in deciding whether to recommend legal action or whether to recommend detention of imports to CFSAN/Office of Field Programs/Division of Enforcement and Programs (HFS-605): The sample is analyzed in accordance with applicable methods of the current Official Methods of Analysis of the Association of Official Analytical Chemists1, and its supplements, and both of the following conditions are met: 1. Original and check analysis show patulin at or above 50 micrograms per kilogram (50 parts per billion) as determined on single strength apple juice, reconstituted single strength apple juice (if the food is an apple juice concentrate), or the single strength apple juice component of the food (if the food contains apple juice as an ingredient); (For the purpose of this guidance, single strength juice is 100 percent juice that is unconcentrated (see 21 CFR 101.30(h)).) and

166

2. Identity of patulin is confirmed by gas chromatography/mass spectrometry. SPECIMEN CHARGE: For domestic goods: The article (apple juice, apple juice concentrate, or apple juice product) was adulterated when introduced into and while in interstate commerce and is adulterated while held for sale after shipment in interstate commerce within the meaning of 21 U.S.C. 342 (a)(1), in that it bears or contains an added poisonous or deleterious substance, patulin, which may render the article of food injurious to health. For imported goods: The article (apple juice, apple juice concentrate, or apple juice product) is subject to refusal of admission pursuant to 21 U.S.C. 381 (a)(3) in that it appears to bear or contain an added poisonous or deleterious substance, patulin, which may render the article injurious to health (adulteration under 21 U.S.C. 342 (a)(1)). Issued: 10/22/2001
1

At the time of this issuance, the current method can be found in the Seventeenth Edition, section 995.10 Patulin in apple juice, liquid chromatographic method, AOAC-IUPAC-IFJU Method. This method was adopted by AOAC International in 1995. The method was published in JAOAC 79(2):452-455, 1996.

167

Patulin in Apple Juice, Apple Juice Concentrates and Apple Juice Products
Table of Contents
I. II. Introduction Safety Assessment and Risk Management for Patulin 1. Synopsis 2. Reviews of Toxicity Data; NOAEL 3. Provisional Tolerable Daily Intake 4. Assessment of exposure to patulin versus PTDI A. Initial assessment B. Revised assessment 5. Action Level Additional Considerations 1. Review by FDA's Food Advisory Committee Conclusion

III. IV.

References

I.

Introduction
Patulin is a mycotoxin that is produced by certain species of Penicillium, Aspergillus, and Byssochylamys molds that may grow on a variety of foods including fruit, grains and cheese. Patulin has been found to occur in a number of foods including apple juice, apples and pears with brown rot (Harwig et al. 1973, Brain et al. 1956), flour (Hasseltine and Graves, 1966), and malt feed (Ukai et al. 1954). However, given the nature of the food, the manufacturing processes, or consumption practices for many foods, patulin does not appear to pose a safety concern, with the exception of apple juice (Fritz, 1981). For instance, the rotten portions of most fruits and grains are typically removed prior to consumption. In foods such as cheese, the high cysteine content of the food interacts with patulin to render it inactive (Ciegler et al., 1977). Patulin is reported to be destroyed by fermentation and thus is not found in either alcoholic fruit beverages or vinegars produced from fruit juices. Thermal processing appears to cause only moderate reductions in patulin levels, thus patulin present in apple juice will survive the pasteurization processes (IARC 1986, WHO 1990, Harrison 1989, McKinley and Carlton, 1991). Patulin has been found to occur at high levels in some apple juice products offered for sale or import in the U.S. FDA is currently soliciting public comment on a draft Compliance Policy Guide (CPG) that describes FDA's internal enforcement guidance concerning patulin in apple juice products.

In this supporting document, FDA presents the scientific information and the risk management considerations it took into account in arriving at the 50 g/kg action level which is part of the draft CPG.

II.

Safety Assessment and Risk Management for Patulin

1. Synopsis FDA employed the "safety assessment" method as the risk assessment approach for considering the available safety data on patulin. The outcome of the safety assessment was used by FDA to evaluate whether processors may need to implement controls for patulin in apple juice, and to identify a level, (i.e., an "action level") at which FDA would consider taking legal action against apple juice products bearing patulin under Section 402(a)(1) of the Federal Food Drug and Cosmetic Act, which states that a food is "adulterated" if it bears or contains an added poisonous or deleterious substance which may render it injurious to health. The safety assessment method, originally described in a 1954 paper by Lehman and Fitzhugh (Lehman and Fitzhugh, 1954), introduced the use of 10-fold safety factors, which later also became known as "uncertainty factors," in assessing the safety of substances, e.g. contaminants, in food. Lehman and Fitzhugh described the application of the 10-fold safety/uncertainty factors as useful for establishing a "target" margin of safety. However, they concluded there were no scientific or mathematical means by which absolute values for these factors could be derived. Over the years these factors have been routinely used both in the U.S. and internationally to ensure an adequate margin of safety (WHO, 1987). Typically, for a contaminant in a food such as apple juice, where there is a potential for chronic exposure to the contaminant, FDA would determine the exposure level that would ensure an adequate safety margin by applying two 10fold safety factors (equating to a 100-fold safety factor) to the "no observed adverse effect level" (NOAEL) from lifetime animal feeding studies. One safety factor accounts for the extrapolation from animal data to humans (i.e., interspecies variation), and the second accounts for variation in sensitivity to the contaminant's effects within humans (i.e., intraspecies variation). This calculation yields a provisional tolerable daily intake (PTDI) or provisional tolerable weekly intake (PTWI) for the contaminant. The margin of safety for eaters is determined by estimating the daily or weekly exposure to the contaminant (using food consumption data and occurrence data for the contaminant in food) for a representative segment of eaters, and comparing that estimated exposure to the PTDI or PTWI. An action level may be identified by calculating a maximum level for the contaminant in the food that would ensure that exposure to the contaminant results in an acceptable margin of safety, considering the PTDI or PTWI.

In deriving the proposed action level for patulin, FDA considered consumption of apple juice by drinkers of all ages and by small children in two age categories, children less than one year old and children 1-2 years old. The two age categories for small children were considered because small children consume higher amounts of apple juice relative to their body weight than other age groups. 2. Reviews of Toxicity Data; NOAEL Patulin toxicity data are reviewed in detail in: "IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans" (IARC, 1986) and "Toxicological evaluation of certain food additives and contaminants" (WHO, 1990). In addition to considering these reviews, FDA independently reviewed the available information on patulin toxicity (FDA Memorandum, 1994). FDA's review found that the toxicological studies on patulin demonstrate that patulin is toxic upon repeated administration of oral doses around 1.5 mg/kg body weight (bw), which caused premature death in rats (Becci et al., 1981). Studies have not demonstrated convincing evidence of carcinogenicity or of germ cell mutagenic potential. The studies demonstrate that feto- or embryotoxic effects in rodents occurred only after administration of patulin doses that were also overtly toxic to the mothers. The studies demonstrate that immunotoxic effects are associated only with patulin doses that are much higher than those to which humans are exposed (Llewellyn et al., 1998). The NOAEL for patulin was derived from a 109 week feeding study (Becci, et al. (1981)) in which doses of 0.0, 0.1, 0.5, and 1.5 mg/kg bw, were administered to both male and female rats three days per week by gastric intubation. Patulin at the high dose level caused a significant increase, compared to controls, in the mortality rate in both sexes. These effects could have resulted from the mechanics of repeated intubation. No adverse effects were observed in the group receiving the lowest dose level, i.e., 0.1 mg/kg bw three times per week. That group received a cumulative weekly dose of 0.3 mg/kg bw, which is the NOAEL FDA used in its safety assessment. Generally, animal studies are considered by safety experts to be appropriate models for assessing potential adverse effects in humans. However, animal studies that demonstrate adverse effects would not be used in assessing potential human health effects if it was established by mechanistic or other studies, that the toxic effects observed in animals would not occur in humans. FDA is not aware of any mechanistic or other data that would suggest that the effects observed in the study of Becci, et al. will not occur in humans at some level of exposure to patulin. Therefore, based upon adverse effects due to patulin in animal studies, FDA believes that humans may be at risk of harm at some level of exposure to patulin.

3.

Provisional Tolerable Daily Intake After its own independent evaluation of the data, FDA concurs with the PTDI for patulin, which was established at the 44th meeting of the Joint Expert Committee on Food Additives (JECFA) in 1995. JECFA is an international organization that provides science based toxicological evaluations of food additives and contaminants and advises the Codex Committee on Food Additives and Chemical Contaminants on risk assessment of substances of interest to that committee. JECFA had originally established a PTWI for patulin at its 35th meeting in 1990. JECFA subsequently took into account the fact that most of the patulin ingested by rats is eliminated within 48 hours. The absence of accumulation ultimately led JECFA to establish a maximum provisional tolerable daily intake (PTDI) of 0.43 g /kg bw per day. The PTDI is derived from the NOAEL for patulin from the Becci study, i.e. 0.3 mg/kg bw per week. That weekly intake is converted to a daily intake by dividing it by 7, and that result is divided by 100 to apply the two 10-fold safety factors to arrive at the PTDI, as follows: 0.3 mg/kg bw per week divided by 7 = 0.043 mg/kg bw per day 0.043 mg/kg bw per day divided by 100 (safety factor) = 0.00043 mg/kg bw per day, or 0.43 g/kg bw per day, which is the PTDI. Assessment of exposure to patulin versus PTDI Two exposure assessments were calculated, FDA's initial assessment and a revised assessment that was carried out after FDA's Food Advisory Committee reviewed the scientific information supporting an action level for patulin, as discussed below. In evaluating the estimated exposure to patulin with respect to the PTDI, FDA considered the estimated exposure to patulin for drinkers of "all ages" and for small children in two age categories, children less than one year old, and children 1-2 years old. The interpretation of the exposure estimates for the various age categories with respect to the PTDI is discussed below in section 4 B., "Revised assessment." To estimate exposure to a dietary contaminant FDA must obtain intake (consumption) data for the food bearing the contaminant, and data on the occurrence level for the contaminant in that food. If age specific intake data are available, exposure may be calculated for specific age groups, as was done in this instance. In making both sets of estimates, the FDA used a probablistic modeling method known as a "Monte Carlo analysis" to estimate patuliin exposure (Rubinstein, 1981). Monte Carlo simulations can be used to evaluate models in which one or more inputs (in this case, food intakes and patulin levels) can be defined by a distribution of values. A Monte Carlo simulation takes a random value from the distribution of possible values for the input, uses that value in calculating the 1. 2.

4.

outcome of the model, stores the result, and then repeats the procedure a determined number of times (iterations) using new random values of the input taken from the distribution for each iteration. The resulting output from this procedure (e.g., exposures) is a range of possible outcomes for the model. A probability distribution function can be prepared from the range and can be used to estimate exposures (typically mean and/or 90th percentile) to substances in the diet. It should be stressed, however, that the model FDA used assumes that food choices are random, which might not be appropriate for a "visible" additive, such as a high-intensity sweetener. The availability of distributions of food intakes, patulin levels in apple juice and apple juice containing products, and survey information evaluating the percentage of eaters of each food in the population, as well as the invisibility of patulin in food, enable the use of Monte Carlo modeling for evaluating patulin exposure. The juice intake data used to calculate exposure were taken from the 1994-1996 United States Department of Agriculture Nationwide Food Consumption Survey (category: Apple Juice Specified as an Ingredient). This category encompasses apple juice intake as pure juice, as well as an ingredient in juice blends and other foods. The food consumption data are based on 2 day food consumption surveys of consumers, which are very short survey times that result in overestimation of actual long-term consumption. Long-term food consumption surveys would be most appropriate to use considering that the PTDI was based upon a lifetime animal bioassay. However, since long-term consumption data are seldom available, the 90th percentile exposure from short term food consumption surveys are usually used, and this approach is considered by experts to be a conservative approach that ensures that an appropriate degree of protection is obtained in the safety assessment. A. Initial assessment Patulin occurrence data were taken from 2977 samples of apple juice analyzed for patulin levels. The majority of the samples were commercial samples taken from lots of bulk juice and analyzed privately for the industry, and the results were made available to FDA. Such analyses are typically performed by industry to determine the acceptability of a lot of juice offered by the supplier. The remaining samples were collected and analyzed by FDA as part of its monitoring and enforcement activities. The patulin level inputs were taken from patulin occurence data in apple juice that were categorized into groups with ranges of <5, 5-49, 50-99, 100-199, 200-500, and >500 g/kg. For each iteration during the Monte Carlo analysis, a patulin group was first selected from one of these groups based on the frequency of samples in each group. After a group was selected, a patulin value was then calculated by the computer based upon the assumption that the patulin values would be uniformly distributed

about the mid-value of each range. This approach was used because at the time FDA conducted the initial assessment it did not have the actual measured patulin levels for many of the apple juice samples tested for industry. Rather, much of the industry data was originally reported to FDA as categorized data, i.e. the number of samples with patulin levels within the above ranges. The estimated exposures to patulin are presented in Tables 1 and 2 (Apple juice intakes are expressed as grams per person per day; Patulin exposures are expressed as g/kg bw per day; Mean body weights used in the calculations are 8 kg for <1 year olds, 12 kg for 1-2 year olds, and 64 kg for the all ages group (Johnson, 1974)). The estimated patulin exposures shown in Table 1 were calculated using patulin levels from all 2977 apple juice samples. Industry sources have informed FDA that the samples analyzed by industry include many commercial lots that were rejected by the importers for excessive patulin. Thus, the estimated patulin exposures presented in Table 1 likely exaggerate actual patulin exposures and reflect upper bound potential exposures if processors exercise no controls for patulin. In Table 2, the 545 samples with a patulin level greater than 50 g /kg were excluded from the Monte Carlo simulation to represent the expected impact on exposure of processors implementing controls for patulin to limit its occurrence in accord with the level set out in the guidance.

Table 1 No Juice Samples Excluded Mean Apple Juice Intake (g/p/d) 200 216 128 Mean Patulin Exposure (g/kg bw/d) 0.094 0.58 0.50 90th Percentile Apple Juice Intake (g/p/d) 250 434 372 90th Percentile Patulin Exposure (g/kg bw/d) 0.22 1.3 1.1

Age Group

All ages 1 -2 years <1 year

Table 2 Juice Samples with Patulin Levels > 50 g /kg Excluded Mean Apple Juice Intake (g/p/d) 200 216 128 Mean Patulin Exposure (g/kg bw/d) 0.031 0.17 0.13 90th Percentile Apple Juice Intake (g/p/d) 250 434 372 90th Percentile Patulin Exposure (g/kg bw/d) 0.078 0.42 0.38

Age Group

All ages 1 -2 years <1 year

The results in Table 1 indicate that if processors do not implement controls for patulin, the estimated 90th percentile patulin exposure for apple juice drinkers of all ages would be below the PTDI of 0.43 g /kg bw per day. However, the exposure for children under 1 year of age would be nearly 3 times the PTDI and exposure for children 1-2 years old would be 3 times the PTDI (equating to only a 33-fold margin of safety compared to the NOAEL). The results in Table 2 indicate that if processors implement controls for patulin at the 50 g/kg level, the estimated 90th percentile patulin exposure for all the age groups considered would not exceed the PTDI of 0.43 g /kg bw per day. In fact, the exposure for apple juice drinkers of all ages, would be 5-fold less than the PTDI, providing a 500 fold safety factor (considering the PTDI incorporates a 100-fold safety factor) for lifetime consumption. Exposure would be slightly below the PTDI for children under 1 year of age, and essentially at the PTDI for 1-2 year old children, meaning that at least a 100-fold safety factor would exist for children in these age categories under this assessment. B. Revised assessment FDA presented the above scientific information supporting the establishment of an action level for patulin to its Food Advisory Committee (FAC) in June 1999 (see discussion below). In response to comments made by some members of the FAC, FDA subsequently carried out a revised assessment of exposure to patulin to ensure the best possible assessment of exposure to patulin.

FDA subsequently obtained the measured patulin levels for 2647 apple juice samples, including many of the 2977 samples considered in the initial assessment and also some more recently analyzed samples. In addition, industry provided the patulin results for 118 samples of apple juice intended for infants. In the revised assessment, the Monte Carlo calculations were based upon the actual values for patulin in the 2647 samples for the "all ages" group and the 1-2 year old group. For each iteration, an actual patulin value was selected from the sample population. For the <1 year old group, detailed analysis of available intake data, determined that 71% of the time these infants receive apple juice intended for infants. Therefore, for this group, the simulation selected a sample from juice intended for infants 71% of the time and from the large sample population the remainder of the time. The results from the revised assessment are presented in Tables 3 and 4.

Table 3 No Juice Samples Excluded Mean Apple Juice Intake (g/p/d) 200 216 128 Mean Patulin Exposure (g/kg bw/d) 0.14 0.80 0.21 90th Percentile Apple Juice Intake (g/p/d) 250 434 372 90th Percentile Patulin Exposure (g/kg bw/d) 0.26 1.7 .40

Age Group

All ages 1 -2 years <1 year

Table 4 Juice Samples with Patulin Levels > 50 g /kg Excluded Mean Apple Juice Intake (g/p/d) Mean Patulin Exposure (g/kg bw/d) 90 Percentile Apple Juice Intake (g/p/d)
th

Age Group

90th Percentile Patulin Exposure (g/kg bw/d)

All ages 1 -2 years <1 year

200 216 128

0.04 0.22 0.13

250 434 372

0.10 0.67 0.27

The results of the revised assessment in Table 3 indicate that if no controls for patulin levels are carried out by processors, the estimated 90th percentile patulin exposure for apple juice drinkers of all ages would be approximately one half of the PTDI of 0.43 g /kg bw per day. However, the exposure for children under 1 year of age is approximately the same as PTDI and exposure for children 1-2 years is 4 times the PTDI (equating to only a 25-fold margin of safety compared to the NOAEL). The results of the revised assessment in Table 4 indicate that if processors implement controls for patulin at the 50 g/kg level, the estimated 90th percentile patulin exposure for drinkers of all ages would be 4-fold less than the PTDI, providing a 400 fold safety factor for lifetime consumption. The estimated exposure for the <1 year old age group would be approximately one-half of the PTDI. The estimated exposure for 1-2 year old children would be slightly above the PTDI; however, a 64-fold margin of safety in comparison to the NOAEL would still exist for this group. In carrying out a safety assessment, FDA generally considers only the estimated exposure for "all ages" when the PTDI has been derived from a lifetime feeding study, as is the case for patulin. In such a case, FDA would consider that there is an adequate margin of safety if the estimated patulin exposure for the 90th percentile apple juice drinker of "all ages" is less than or equal to the PTDI. In the lifetime feeding study, the animals in each dosage group were exposed to a single patulin dose level (relative to body weight) throughout their lives. In contrast, FDA recognizes that human exposure to patulin varies substantially according to age. Patulin exposure in small children is higher relative to body weight because small children consume significantly greater amounts of apple juice relative to their body weight. Thus, FDA also considered the estimated exposure to patulin by children in these two age categories with respect to the PTDI. FDA believes that in view of the greater exposure to patulin by small children, the exposure for drinkers of all ages should be significantly below the PTDI to ensure an adequate margin of safety for long term consumption of apple juice. If long term exposure to patulin is

significantly below the PTDI, FDA believes that it is not necessary for patulin exposure for small children to be at or below the PTDI during this relatively short portion of the lifespan. However, during this portion of the lifespan, e.g., ages 1-2, the estimated exposure for 90th percentile drinkers should still provide for a substantial margin of safety with respect to the NOAEL. In this manner, Table 4 indicates that public health protection will be achieved if processors control patulin levels in apple juice to not exceed the action level. Estimated exposure for drinkers of all ages is significantly below the PTDI (i.e., there is a 400 fold margin of safety for lifetime consumption) and a 64-fold margin of safety exists for 1-2 year old children. Conversely, if processors do not control patulin levels in apple juice, the exposure estimates in Table 3 indicate that for children 1-2 years old, the margin of safety with respect to the NOAEL would be only 25-fold. FDA believes that this relatively low margin of safety and the accompanying greater long-term exposure may not provide optimum long-term protection for consumers. Furthermore, the exposure estimate in Table 4 likely overestimates the exposure to patulin that will occur if processors of apple juice implement controls for patulin. This is because FDA expects that, in order to have a high degree of confidence that their products will not exceed the action level, juice manufacturers will exercise the necessary degree of control (e.g. strict quality specifications on incoming apples), to ensure that their products are actually well below the action level. This appears to have occured in the United Kingdom (U.K.). In 1993, the U.K. Ministry of Agriculture, Food, and Fisheries (MAFF) set a patulin advisory level of 50 g /kg in apple juice. Since that time, the percentage of apple juice samples in the U.K. containing patulin levels above the advisory level has been reduced and patulin levels have also been reduced in samples that comply with the advisory level. Prior to the implementation of the advisory level, 27% of samples in the U.K. had less than 10 g /kg patulin and 7% of the samples contained 10-24 g /kg. The 300 samples analyzed in Britain in 1998 had 69% and 22%, respectively, in those two categories (MAFF, 1999). A similar change in the distribution of patulin levels in apple juice samples in the U.S. would change the exposure estimates presented in Table 4. When, for example, the 300 patulin samples from the 1998 British survey were used to calculate the exposure of the 90th percentile U.S. apple juice drinker for the age groups "<1 year", "1-2 years", and "all ages", the exposure values were 0.34, 0.40, and 0.06 g/kg bw per day respectively. The exposures for children <1 year of age and children 1-2 years old

would be essentially at the PTDI. This further supports that a 50 g/kg action level would provide an adequate margin of safety for consumers. In addition, the exposure estimates in Table 4 may overestimate exposure to patulin for children who often consume apple juice that has been diluted with water. In fact, the American Academy of Pediatrics advises parents who frequently offer juice to their children to dilute the juice, portion of juice to portion of water (Dietz and Stern, 1999). FDA has not attempted to quantify any additional margin of safety that would be realized for children who consume diluted apple juice because not all parents may dilute the juice they serve to their children and an adequate margin of safety exists without accounting for the practice of dilution. 5. Action Level Based upon the above discussion FDA believes that if processors do not implement controls for patulin, consumers may not be optimally protected from potential adverse effects due to long-term exposure to patulin from the consumption of apple juice. FDA thus believes that it is appropriate that apple juice processors voluntarily establish controls for patulin. Based upon the exposure estimates in Table 4, FDA believes that drinkers of apple juice would be at negligible risk of adverse health effects from patulin if patulin levels in apple juice were controlled by processors to a level of 50 g/kg or below. Control of patulin levels in apple juice is achievable in practice. Most frequent patulin contamination results from contamination with mold on apples with surface damage. For example, in a study, Lovett et al. (1975) purposefully contaminated apples in a controlled manner with patulin-producing mold. The investigators then successfully reduced patulin contamination approximately 90% by trimming away the rotten portion of the fruit. FDA believes that control by processors of patulin levels to 50 g/kg or below can be achieved principally by removing spoiled and visually damaged apples from the product stream used for the production of apple juice. Other measures such as water treatment may also be effective in reducing patulin levels. Sydenham et al. (1995) found a significant reduction of patulin levels following an initial water treatment step and following removal by hand of rotten and damaged fruit prior to juice production. Evidence also suggests that certain varieties of apples with an open calyx (blossom end) are particularly susceptible to patulin formation within the core of the apple. In such a situation, damage to the fruit it is not easily observed and the apple may not be removed from juice production (British Code of Practice, 1993). Therefore, the presence of patulin in juice made from seemingly wholesome fruit cannot be totally avoided.

III.

Additional Considerations
1. Review by FDA's Food Advisory Committee FDA presented the scientific information supporting an action level of 50 g/kg for patulin in apple juice and apple juice containing products to its Food Advisory Committee (FAC) in June of 1999. The presentation to the FAC was based upon the "Initial assessment" presented above. The FAC supported FDA's recommendation that an action level be set for patulin in apple juice and apple juice containing products. It further agreed with FDA's analysis that a patulin level of 50 g/kg of apple juice on a ready-to-eat basis would be sufficient for protection of human health. Some FDA members qualified their agreement with the level of 50 g/kg by expressing a desire for more information in three areas. The FDA has researched these areas as requested and the results are discussed below. Some members of the FAC asked whether more current information about apple juice consumption by young children was available. The agency looked for more current information about apple juice consumption for the two age groups considered, but was unable to locate any more recent or reliable information. The data from the 1994-1996 United States Department of Agriculture Nationwide Food Consumption Survey are the best consumption data available, and FDA is not aware of any reason why these data are not suitable for use in the safety assessment for patulin. However, in response to the comments of these members of the FAC that stressed the need to ensure adequate protection for small children, FDA carried out the "Revised assessment" of exposure to patulin described above. Commenting on the data in one of the tables presented in the Becci study, a member of the FAC also questioned whether FDA in its safety assessment, had properly incorporated the doses of patulin received by the rats in the study. FDA subsequently checked with one of the authors of the study who stated that the doses of patulin presented in the published paper, e.g., 0.0, 0.1, 0.5, and 1.5 mg/kg bw, were the doses given by gavage three times per week. FDA did properly incorporate the doses received by the rats in its safety assessment, as did JECFA when calculating the PTDI. A member of the FAC expressed concern that the elderly in institutional settings (e.g., nursing homes) may consume high amounts of apple juice. The agency did not evaluate intake by the elderly as a separate class. Instead, their intake was considered in the "all ages" category. In response to the committee member's comment, the agency did review the information it had available on the intake of apple juice by the elderly. Although data on intake by the elderly in institutional settings were not available, intake by the elderly among the general population was not significantly different than intake for the all ages group. Given the 400fold margin of safety for drinkers in the all ages group, if in fact, the elderly in institutional settings consume significantly more apple juice than the elderly in

the general population, FDA believes that a substantial margin of safety would still exist for the elderly in institutional settings.

IV.

Conclusion
The information presented in this paper supports a 50 g/kg action level for patulin in apple juice, apple juice concentrates, and apple juice products based on the level found or calculated to be found in single strength apple juice or in the single strength apple juice component of the product.

References
Becci, P. J., Hess, F. G., Johnson, W. D., Gallo, M. A., Babish, J. G., Dailey, R. E., & Parent, R. A. (1981) Long-term carcinogenicity and toxicity studies of patulin in the rat. J. Appl Toxicol 1(5):256-261. Brain, P. W. (1956) Production of patulin in apple fruits by Penicillium expansum, Nature (London) 178: 263. British Code of Practice for the Production of Apple Juice, British Soft Drinks Association, November 1993. Ciegler, A. (1977) Patulin. Rodericks JV et al. (ed) Mycotoxins in human and animal health. Pathotox Publ. p 609-623. Dietz, W.H. and Stern, L. (ed) (1999) American Academy of Pediatrics, "Expanding your baby's diet." Ch. 2, p 33. Villard Books. FDA Memorandum, "Hazards or Patulin in Apple Juice." May 5, 1994. Fritz, W. and Engst, R. (1981) Survey of Selected Mycotoxins in Food. J. Environ. Sci. Health B16(2): 193-210. Harrison, M A (1989) Presence and stability of patulin in apple products: A review. J Food Safety 9: 147-153. Hasseltine, C.W. and Graves, R.R. (1966) Microbiology of flours, Econ. Bot. 20: 156. Harwig, J. et al. (1973) Occurrence of patulin and patulin-producing strains of Penicillium expansum in natural rot of apples in Canada. Can. Inst. Food Technol. J. 6: 22. IARC (1986). Patulin, IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. 40: 8398.

Johnson, P.E. (1974) Nutrition Standards: Man, Part 1, United States: Children and Adults. Altman, P. L. & Dittmer, D.S. (ed) Biology Data Book, 2nd Ed. Fed Am Soc Biol. Bethesda, MD, 3: 1447. Lehman, AJ and Fitzhugh OG (1954) Ten-fold safety factor studies. Assoc Food Drug Officials of the US Quarterly Bulletin XVIII(1): 33-35. Lovett, J., Thompson, R.G. and Boutin, B. (1975) Trimming as a means of removing patulin from Fungus-rotted apples. J Assoc Off Anal Chem Sep;58(5): 909-11. Llewellyn, G.C., McCay, J.A., Brown, R.D., Musgrave, D.L., Butterworth, L.F., Munson, A.E., and white, K.L. Jr. (1998) Immunological evaluation of the mycotoxin patulin in female B6C3F1 mice. Food Cosmet. Tox. 36: 1107-1115. MAFF, Joint Food Safety and Standards Group, Food Surveillance, Number 173, April 1999. McKinley E R, Carlton WW (1991) Patulin. In Mycotoxins and Phytoalexins, Ed. Sharma R P, Salunkhe D K. CRC Press Atlanta. Rubinstein, R. Simulation and the Monte Carlo Method. J. Wiley and Son, 1981. Sydenham et al. (1995) Reduction of patulin in apple juice samples-influence of initial processing. Food Control 6: 195-200. Ukai, T. et al. (1954) Studies on the poisonous substance from a strain of Penicillium (HoriYamamoto strain), II. Culture method of Hori-Yamamoto strain and chemical structure of its poisonous substance. Proc. Phar. Soc. Jpn. 74: 450. WHO (1987) Principles for Food Safety Assessment of Food Additives and Contaminants in Food, Environmental Health Criteria 70. WHO IARC (1990) Patulin. WHO Food Additives Series. 26: 143-165.

FDA Juice HACCP Training Curriculum idelines

FDA Juice HACCP Training Curriculum Guidelines

FDA Juice HACCP Training Curriculum

Guidance for Industry:

Standardized Training Curriculum for Application of HACCP Principles to Juice Processing

Final Guidance
Contains Nonbinding Recommendations June 2003 Comments regarding this document may be submitted at any time to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For questions regarding this document, contact Michael Kashtock at (301) 436-2022.

U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition June 2003

Contains Nonbinding Recommendations The guidance represents FDA's current thinking on curricula for training juice processing personnel in the application of Hazard Analysis and Critical Control Point (HACCP) principles to juice processing. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of applicable statutes and regulations.

Purpose of the Guidance

The purpose of this guidance is to advise juice processors of FDA's view that the 1st Edition of the Juice HACCP Training Curriculum of the Juice HACCP Alliance (the standardized curriculum) is adequate for use in training individuals to meet the requirements of the juice HACCP regulation in 21 CFR 120.13. This guidance also advises processors and educators on how the requirements of the juice HACCP regulation may be met using the standardized curriculum or alternative curricula for training individuals and on how they can view, download, or purchase the standardized curriculum. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statuatory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

What is the Standardized Curriculum?

The standardized curriculum is a curriculum that may be used to train individuals in the application of HACCP principles to the processing of juice. The curriculum was developed by the Juice HACCP Alliance (coordinated through the efforts of the National Center for Food Safety and Technology (NCFST) at the Illinois Institute of Technology), which was formed through the voluntary participation of industry, government, and academic members interested in guiding the juice industry to the higher level of food safety assurance provided by HACCP. Staff from the U.S. Food and Drug Administration participated as technical advisors in the development of the standardized curriculum.

Background
The juice HACCP regulation includes in 21 CFR 120.13 a requirement that individuals who perform certain specified functions, e.g., developing the hazard analysis or the HACCP plan, "shall have successfully completed training in the application of HACCP principles to juice processing at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration, or shall be otherwise qualified through job experience to perform these functions."

How Juice Processors May Meet the Requirements of 21 CFR 120.13

Juice processors may meet the requirement 120.13 by having affected employees, or consultants, undergo training using the standardized curriculum designated in this guidance. Processors are not required to have employees or consultants trained using the standardized curriculum. Other curricula may be used that are at least equivalent to the standardized curriculum in covering the application of HACCP principles to the processing of juice. FDA authorization to use an alternative curriculum is not required under the juice HACCP regulations. However, processors and educators considering the use of alternative curricula should evaluate the equivalency of the other curriculum by comparing it to the standardized curriculum and ensuring that a curriculum covers the following: 1. Biological, chemical and physical hazards; 2. Applicability of Current Good Manufacturing Practices and Sanitation Standard Operating Procedures; 3. The 5 Preliminary Steps of HACCP with application to juice processing; 4. The 7 Principles of HACCP with application to juice processing; and 5. FDA's Juice HACCP Regulation (21 CFR Part 120) and related FDA guidance documents.

To View or Purchase the Standardized Curriculum

The standardized curriculum may be viewed and downloaded as a .pdf file free of charge at the website of the NCFST at http://www.ncfst.iit.edu. Bound copies of the curriculum may be purchased from the NCFST as directed on the website.

U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Field Programs September 2002

Juice HACCP Regulator Training

Table of Contents
1. Introduction 2. Review of HACCP Principles 3. Components of a HACCP Inspection 4. Conducting the Initial Interview 5. Performing Your Own Hazard Analysis 6. Evaluating the Processor's Hazard Analysis 7. Evaluating the Processor's HACCP Plan 8. Determining If the HACCP Plan is Properly Implemented 9. 5-Log Reduction Performance Standard 10. Reviewing Records: HACCP Records 11. Determining if Sanitation Monitoring is Properly Implemented 12. Reporting HACCP Violations 13. Importer Inspections and Imports 14. Special Considerations

Chapter 1

Introduction
This guidance document for regulator training represents FDA's current thinking on the individual components of a juice HACCP inspection and attempts to provide the tools necessary to conduct inspections of juice processing firms operating under HACCP and to effectively assess their compliance with the Juice HACCP regulation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of applicable statutes and regulations. In addition, this regulator training manual references the Juice HACCP Hazards and Controls Guide which is a draft guidance document that is subject to change, therefore this manual is also subject to change.

Background
In January 2001, the Food and Drug Administration (FDA) issued juice regulations based on the principles of Hazard Analysis and Critical Control Point (HACCP) 21 CFR Part 120. The FDA issued these regulations to ensure the safe processing and importing of juice. All juice sold as juice, or for use as an ingredient in other beverages except juice produced at retail establishments, is subject to the juice HACCP regulations. This includes juice sold in both intrastate and interstate commerce (21 CFR Part 120.1). Juice processors must implement a HACCP based system to be in compliance with the new regulations. Certain critical jobs must be performed by individuals trained in HACCP. These persons are responsible for developing and modifying the HACCP plan and reviewing records. This course, the Juice HACCP Regulator Training Course, is a continuation of the training provided by the Juice HACCP Alliance Training or equivalent. This course will provide you with tools to conduct inspections of juice processing firms operating under HACCP and to effectively assess their compliance with the regulation.

Components and Presentation of Training

The training program begins with a quick review of the seven principles of HACCP in the context of the juice HACCP regulation (21 CFR Part 120). It is not our intent to re-teach the HACCP concept. We expect that you already know this from your prior training. We will then cover the individual components of a HACCP inspection, including special considerations for imported juice products. We will discuss performing the initial interview, performing your own hazard analysis, reviewing a processor's hazard analysis, evaluating the processor's HACCP plan, determining whether the plan is being properly implemented, the 5-log reduction performance standard, reviewing records, and documenting objectionable conditions. At the conclusion of this course you will complete a course evaluation.

Chapter 2

Review of HACCP Principles

Purpose
The intent of this review is to refresh your memory on how a HACCP plan is developed. Knowing all the stages that a processor goes through in developing a HACCP plan is essential if you are going to audit the processor's HACCP program.

Prerequisite Programs
Before a HACCP plan can be developed, a firm must have their prerequisite programs in place. Of particular importance is a sound sanitation control program. Each processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing (21 CFR Part 120.6). SSOPs outline the firm's controls for ensuring: 1. The safety of the water that contacts the food or food contact surfaces or that is used in the manufacture of ice; 2. The condition and cleanliness of food contact surfaces; including utensils, gloves, and outer garments; 3. The prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product; 4. The maintenance of hand washing, hand sanitizing, and toilet facilities; 5. The protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; 6. The proper labeling, storage, and use of toxic compounds; 7. The control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and 8. The exclusion of pests from the food plant. Processors must keep records that document their compliance with the requirements of Good Manufacturing Practice regulations (21 CFR Part 110). Records (21 CFR Part 120.12) are required that document monitoring and any corrections that are made as a result of the monitoring.

Preliminary Steps

Once a firm's prerequisite programs are in place, the firm should then address the five preliminary steps of HACCP, although these are not mandated by the regulation. They are: 1. 2. 3. 4. Obtain Top Management Support Obtain HACCP Training Assemble HACCP Team Identify Product o product description o method of distribution and storage o intended customer o intended use of the product 5. Develop Flow Diagram The processor or individual(s) who will develop the HACCP plan must receive HACCP training (21 CFR Part 120.13), such as training provided by the Juice HACCP Alliance Course. The firm should assemble a HACCP team to conduct the hazard analysis, and to develop and oversee the HACCP plan. The team may consist of management, maintenance personnel, quality control personnel, line workers, and others, including experts, as necessary, from outside the company. The processor's first duty should be to describe the product to be covered under the HACCP plan. The description should include the characteristics of the product, the method of distribution and storage, the intended customer, and the intended use of the product. This information is useful in performing a hazard analysis. The processor's second duty should be to develop a flow diagram for the product, listing each step in the process, although once again, this is not required by the regulation. Once the flow diagram is complete, the team should verify the accuracy of the flow diagram by walking through the process on the processing floor.

HACCP Principles

Principle 1. Conduct Hazard Analysis

Once the processor completes the five preliminary steps, if they chose to do so, remember these five preliminary steps are not mandated by the regulation, and determines that the prerequisite programs are adequate, the processor must then conduct a hazard analysis (21 CFR Part 120.7). The hazard analysis begins with the HACCP team brainstorming the potential ingredient-related and process-related food safety hazards that could affect the product. They then determine the significance of each potential hazard - whether it is reasonably likely to occur. For each reasonably likely to occur hazard the team needs to identify control measures. The Juice HACCP Hazards and Controls Guide and the Juice HACCP Questions and Answers document are two references that may be used to assist the team in their hazard analysis. The results of the hazard analysis can then be recorded on the Hazard Analysis Worksheet.

Remember that the regulation requires that every processor perform a written hazard analysis to be included in their HACCP plan (21 CFR Part 120.7).

Principle 2. Determine Critical Control Points (CCPs)

After completing the hazard analysis, the processor determines the appropriate critical control points for each of the significant hazards (21 CFR Part 120.8). Remember that a critical control point is a point, step or procedure in a food process at which control can be applied, and a foodsafety hazard can be prevented, eliminated, or reduced to an acceptable level. The processor may use the CCP decision tree as a tool in identifying critical control points.

Principle 3. Establish Critical Limits

Once the critical control points are determined for each of the significant hazards, the processor establishes critical limits for each control measure (21 CFR Part 120.8). The definition of a critical limit is the minimum or maximum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard (21 CFR Part 120.3).

Principle 4. Establish Monitoring Procedures

The processor then establishes monitoring procedures (21 CFR Part 120.8), to ensure that the critical limits were consistently met. Each procedure should specify:

what has to be monitored; how it is to be monitored; the frequency of monitoring; and who is to perform the monitoring.

Monitoring is usually performed using physical or chemical measurements or by observation. It must provide real-time data, but may be continuous or intermittent.

Principle 5. Establish Corrective Action Procedures

After monitoring, the processor may establish corrective action procedures to be followed when critical limits are not met (21 CFR Part 120.10). If corrective actions are predetermined, they must be included in the HACCP plan (21 CFR Part 120.10). Corrective action procedures must be sufficient to restore control to the process and to ensure that no unsafe product is distributed (21 CFR Part 120.10). The regulations do not require that processors predetermine their corrective actions; but if they do not, they must follow the standard procedure prescribed by the regulation (21 CFR Part 120.10).

Principle 6. Establish Verification Procedures

The processor then establishes verification procedures (21 CFR Part 120.11). Verification is the use of methods, procedures or tests, in addition to those used in monitoring, to determine if the HACCP system is in compliance with the HACCP plan and whether the plan is adequate to address the significant hazards. Verification may include calibration, product testing at the option of the processor, record review, and plan reassessment. As with the monitoring principle, verification procedures should state both the method and frequency of the procedure.

Principle 7. Establish Recordkeeping System

Finally, the processor develops a system of recordkeeping to document the accomplishment of the monitoring procedures, corrective action procedures, and verification procedures (21 CFR Part 120.12). The regulations require that monitoring records be listed in the HACCP plan (21 CFR Part 120.12). With that, the processor has developed a HACCP plan. The information may be recorded on the HACCP Plan form, an example of which is provided in the Juice HACCP Hazards and Controls Guide.

Chapter 3

Components of a HACCP Inspection

General
It is important to remember that HACCP is only one element of a juice inspection, not the entire agenda. You will need to continue to apply your existing skills to look for violations of other regulations and statutes, such as those relating to economic fraud, filth, sanitation, and good manufacturing practice. HACCP is another tool in addition to those which you are already using, one which is designed to address the safety of the product. Keep in mind that every inspection is unique. Conditions during an inspection may require you to adjust the inspectional approach provided in this course. You will need to use your judgment at these times. As the course progresses, you will see that your existing inspectional skill of interviewing will be called upon even more than before. Communication between you, plant management, and line

employees is important for you to fully understand how the firm's HACCP program works, and to resolve disagreements over whether it is adequate. To begin, the steps of the HACCP portion of the inspection are: 1. 2. 3. 4. 5. 6. 7. 8. Conduct the Initial Interview Perform Your Own Hazard Analysis Evaluate the Processor's Hazard Analysis Evaluate the Processor's HACCP Plan and Determine Whether the HACCP Plan is Properly Implemented Understanding and Evaluating the Processor's 5-Log Reduction Performance Standard Review Records Document Objectionable Conditions

Conducting the Initial Interview

In addition to identifying yourself, displaying your credentials, and issuing a Notice of Inspection, the primary purpose of the initial interview is to determine which product or products you will be covering during the inspection. This portion of the inspection should be as brief as possible, so that you can take full advantage of the nature of the unannounced inspection.

Performing Your Own Hazard Analysis

The second component of the inspection, developing your own hazard analysis, is conducted primarily during your initial "walk-through" of the firm. In this phase of the inspection, you will be gathering as much information about the process flow and the firm's controls as you can, both by observation and by interview. This will help you to deduce the significant hazards. This is also an important phase of the inspection for documenting other types of violations.

Evaluating the Processor's Hazard Analysis

You will then compare your hazard analysis to the firm's written hazard analysis. The firm's opinion of the significant hazards may differ from yours so you will need to be prepared to discuss your judgments and to review the basis of their decisions. Communication is critical at this stage of the inspection.

Evaluating the Processor's HACCP Plan

After you and the processor have reached agreement on the significant hazards of the processor's juice process, you will evaluate the firm's written HACCP plan. During the evaluation, you will make decisions about the adequacy of the critical limits and the monitoring procedures, among other things.

Determining Whether the HACCP Plan is Properly Implemented

Next, you will evaluate the firm's implementation of the HACCP plan. This evaluation is best accomplished by observing what occurs on the production floor. It is a continuation of the initial "walk-through." The goal is to see whether the monitoring procedures contained in the HACCP plan are being accomplished, and that the plan is otherwise being followed.

Understanding and Evaluating the Processor's 5-Log Reduction Performance Standard

You will then evaluate what the processor is using to accomplish the required 5-log reduction performance standard. During this evaluation, you will make decisions about the adequacy of the 5-log reduction and how it is being implemented. Communication and date gathering is critical at this stage of the inspection.

Reviewing Records
An integral part of your evaluation of a firm's HACCP plan implementation is an evaluation of the firm's HACCP records. The records you will be reviewing include implementation of SSOPs, the written hazard analysis, written HACCP plan, monitoring records, corrective action records, verification, and validation documents.

Documenting Objectionable Conditions

You should document any violations of the requirements of the juice HACCP regulations that you encounter during your inspection. FDA inspectors will continue to use the form FDA-483.

Chapter 4

Conducting the Initial Interview

Information You Will Need to Perform a HACCP Inspection
The first part of the inspection is the initial interview. The initial interview is important because it sets the stage for the rest of the inspection. After you present your credentials and the proper paper work to management, take a brief period of time to collect the information that will help you properly focus your inspection. You will be able to perform the interview more efficiently if you have taken the time before hand to learn what types of juice products the firm processes and how the processing is performed and controlled. This kind of information can generally be acquired from previous inspection reports. Some relevant questions to ask at the start of the inspection include:

What juice products do you process? What are you processing today? How many employees work at the firm? What production lines will you be producing them on? What time does processing begin and when will it end today? How are the products that are being produced today shipped and stored? What is the intended use of the products that are being produced today? Do you have HACCP plans for these products? Do you have sanitation SOPs?

You may notice that some of these questions are asked during the preliminary steps in establishing a HACCP plan. You will need this information in order to develop your own hazard analysis, which will be discussed in the next section.

Choose a Product to Develop Your HACCP Plan

Unless your inspection is specifically directed towards a particular product, you should cover one of the products being produced on the day of the inspection. This is important because the adequacy of the HACCP plan and its implementation cannot be fully judged by an in-office review of the plan and the records. If a firm is producing more than one product on the day of the inspection, you will need to determine which product(s) to evaluate. Several factors should be considered in making this decision:

The product's potential for a safety hazard The products covered during the previous inspections The firm's compliance history

The Juice HACCP Hazards and Controls Guide provides information about the kinds of hazards to expect in the various types of juice. Where past inspections of a firm detected significant problems with HACCP programs for a particular product, your follow-up inspections should concentrate on those, or similar products before moving on to other products.

Chapter 5

Performing Your Own Hazard Analysis

Reasons for Conducting an Independent Hazard Analysis
Performing a complete hazard analysis is crucial to the successful implementation of a HACCP system. It is usually best to avoid looking at the firm's Hazard Analysis, HACCP plan, or Sanitation Standard Operating Procedures until after you have performed your initial "walkthrough" and have completed your own hazard analysis. To establish a plan that effectively prevents food-safety hazards it is important to identify all significant food safety hazards and control measures. Although the processor is required to perform a hazard analysis (21 CFR Part 120.7), it is equally important that you develop your own hazard analysis independent of the processors. The purpose of this independent assessment is to determine whether or not the processor has addressed all of the relevant hazards. This is done by:

considering the intended use of the product; determining the method of distribution and storage; watching the processing operation.

By doing this before you review the firm's hazard analysis, you independently reach tentative conclusions about the food safety hazards that are reasonably likely to occur, without being swayed by the firm's hazard analysis. It's also necessary to develop your own hazard analysis if the firm did not perform a hazard analysis or performed it improperly.

Performing the Hazard Analysis

You will conduct your hazard analysis in much the same way as the processor conducts their hazard analysis. However, where the processor may use a HACCP team, you must make decisions on your own. For this reason, your hazard analysis will involve asking a lot of questions of plant management and line employees to learn about the process and where in the process a loss of control could lead to a food safety hazard. Conducting the hazard analysis also involves using your own experience with the industry and applying the information contained in the Juice HACCP Hazards and Controls Guide. The hazard analysis process usually starts with a "walk-through" of the processing facility, from receipt of raw materials to finished product shipping including any alternative product paths for byproducts resulting from fruit extraction that may be added back to the juice later. Depending on the firm, you may or may not be accompanied during this walk-through. During this process, you should:

Develop a flow diagram Write a brief process description at each step in the flow diagram Observe the processing operation and ask yourself questions such as: o How long does product remain at a processing step? o At what temperature is the product held? o What is the potential for delay beyond the conditions that you noted? o Is there equipment that could cause metal fragments to become incorporated into the product? o Are any food additives used? o How are raw materials delivered and stored? o What instruments are in place for measuring or controlling the process? Ask questions of plant management and line employees, e.g.,: o Where do your raw materials come from? o What checks do you make on your raw materials? o What, if any, information does your supplier provide to you about your raw materials? o What time/temperature combination is used to pasteurize the product? (if applicable) o How long do you usually hold this product under refrigeration? o At what temperature do you hold the product? o What is the maximum amount of time that you will hold the product? Brainstorm biological, chemical, and physical hazards at each processing step in the flow diagram and judge whether the hazard is "reasonably likely to occur" and needs to be controlled. You may want to use a tool such as a CCP decision tree to help you during this process. Determine if the processor is applying any control measures at some point in the process to control the significant hazards, such as: o time/temperature controls o metal detection o raw material screening Document non-HACCP violations as you encounter them, such as insanitation, economic fraud, and filth, etc. Your initial "walk-through" is very often the most likely time to encounter these kinds of violations, so you should pace your HACCP inspection accordingly.

Independent Evaluation
After you perform the "walk-through" portion of the inspection it is important that you independently evaluate the information that you have gathered. You may wish to transfer the information collected onto a Hazard Analysis Worksheet. If you have any questions concerning the hazards or controls that you identified during the walkthrough this is the time to consult other sources of information that are available, including:

Juice HACCP Hazards and Controls Guide; Juice HACCP Questions and Answers;

National, district, and state experts; Center for Food Safety and Applied Nutrition experts.

The Juice HACCP Hazards and Controls Guide will ordinarily be the first reference. This is a valuable reference for juice processors. You may also contact national, district and state Experts, including those at the Center for Food Safety and Applied Nutrition. At this time, you should make your best judgment about the significant hazards, control measures, and critical control points that the processor is utilizing to provide a safe juice product.

Chapter 6

Evaluating the Processor's Hazard Analysis

Comparing Flow Diagrams
After you have performed your own hazard analysis you will review the processor's hazard analysis. The first step in this process is to make sure the firm has included all of the process steps in their hazard analysis; you can do this by comparing your flow diagram to the steps outlined in the processor's hazard analysis. Some firms may not have prepared a flow diagram or may not choose to share it with you. There is no regulatory requirement for either. If the process steps do not match, you should revalidate your own flow diagram and discuss the differences with the firm's management. It is possible that either you or the firm missed something during the development of the flow diagram. It is important that no process step is missed, including process steps that involve diverted product because it could affect the validity of the hazard analysis and could add or eliminate a hazard or critical control point.

Comparing Hazard Analyses

Under the regulations, juice processors are required to have a written hazard analysis (21 CFR Part 120.7) in addition to or as part of their HACCP plan. You're now ready to look at the firm's hazard analysis. The goal of this step is to compare the processor's list of potential hazards, their decisions about the significance of the potential hazards, their list of control measures, and their CCP determinations, with the information contained in your own notes. The firm should identify the specific hazards that are present, not just the type. For example, the term "microbiological hazards" may not be descriptive enough. Controlling Salmonella and Escherichia coli, may require distinct control strategies and therefore should be identified.

In your hazards analysis, determine if the same significant hazards that you identified are named as significant in the firm's written hazard analysis. When they are not, interview the processor to determine the reason(s) for the difference(s). Does the firm's reasoning concur or conflict with:

Information contained in the Juice HACCP Hazards and Controls Guide? Your own experience? The experience(s) of national, regional, or district experts?

Do your best to resolve differences between your hazard analysis and the processor's. There may be a good reason a processor controlled a hazard in a way that is different than that outlined in the Juice HACCP Hazards and Controls Guide. However, understand that if there is a control measure utilized that is different from that listed in the Guide, it is the burden of the processor to provide an equivalent level of control. Remember the Guide is a guideline and not a regulation. It is possible, and appropriate, that a processor judged some hazards as insignificant because of the existence of prerequisite programs, such as sanitation. For example a pasteurized juice processor may determine that pathogen recontamination is a significant hazard after the heat process, but because their existing sanitation program controls the hazard, a CCP was not mandated. In this case, the firm's sanitation monitoring program should include checks on their recontamination controls. Also, hazards should not be ruled as not reasonably likely to occur because of the existence of control measures. For example, it would be inappropriate for an apple juice processor to conclude that the hazard of patulin is not significant because the firm is controlling the hazard by buying apples from reputable growers. In this case, the control measure(s) is purchasing apples from known growers and that should be monitored as part of their HACCP plan. As was previously referenced, some hazards may be controlled by controlling sanitation, in a program separate from HACCP. You should consider sanitation controls at the very beginning of your inspection. By determining which hazards are controlled by a processor's sanitation monitoring program - "ruling them out," so to speak - you will be left with fewer significant hazards that need to be controlled in the HACCP plan. If the firm's hazard analysis relies upon sanitation controls to control certain hazards, the firm's sanitation records should indicate that the hazard is being controlled. If after reviewing the sanitation records you determine that the controls are ineffective, you should consider whether the hazard analysis was based on inappropriate assumptions. This could result in an inadequate HACCP plan. After reviewing the firm's Hazard Analysis, compare the firm's number and placement of CCPs and control measures with your own determinations.

Hazard Analyses that Do Not Match

You may find that the firm has additional hazards or CCPs, fewer hazards or CCPs, or CCPs in different locations. What if the processor does not have a written hazard analysis?

The firm is in violation of 21 CFR Part 120. This condition should be documented as such. Collect as much information as available and submit it with your establishment inspection report. This will help agency experts review the case. What if the processor identified MORE CCPs than I did in my Hazard Analysis? If the firm has additional hazards, you will first need to determine if they are all food safety related. You may find that some relate to quality or economic fraud. For these non-food safety hazards, tell the firm that the hazard is not referenced as a food safety hazard in the Juice HACCP Hazards and Controls Guide; and you will concentrate your efforts on food safety related hazards and CCPs. The firm is free, however, to include such hazards in their plan. You may find the firm has identified some significant food safety hazards that you did not consider, or which you determined to be insignificant. Or, you may agree on the hazards, but the firm may have identified CCPs that you did not identify. In either case, engage the firm's management in a discussion about why they selected the hazards or the CCPs. There may be something about the food or the process you did not know that caused the firm to make the determination they did. The goal is to understand the firm's rationale for the extra controls. You will have to use judgment about whether to change your initial determination, using any available references. If you remain unconvinced about the significance of the hazard, do not expend any effort to review controls for the hazard or the CCP. If appropriate, you can point out that a HACCP plan may lose focus if points are unnecessarily identified as CCPs, and that too many CCPs may reduce the effectiveness of the HACCP plan. If you see some validity in the firm's contention that the hazard is significant, and that the CCP is appropriate, you should proceed as if it were a significant hazard or a CCP. Be sure to collect any documentation that supports the firm's contentions. A final agency position on the significance of the hazard or the CCP can be made, if necessary, during the agency's review process. What if the processor has identified FEWER CCPs than I did in my Hazard Analysis? If the processor has identified fewer hazards or CCPs then you determined were present, you should ask the processor to justify the difference. If the processor does not convince you that the additional hazard(s) you identified are insignificant, or that the hazard is being properly controlled through other CCPs, you should document the condition. Again, remember to use any available references. It is important to collect documentation supporting the firm's point of view, and submit it with your establishment inspection report. That will help agency experts review the case. What if the firm has identified CCPs in different locations? A critical control point can be established at any process step where you can effectively apply control. If the firm has different locations for CCPs than those you determined, again find out why. When you use the Juice HACCP Hazards and Controls Guide as a reference, remember that control strategies other than those specified in the document may also be effective. When a

processor is using another control strategy, compare the level of safety assurance that you believe it provides to the level of assurance that the strategies contained in the Hazards and Controls Guide provide. Document the condition if you remain unconvinced that the firm's strategy provides at least the same level of assurance.

Chapter 7

Evaluating the Processor's HACCP Plan

HACCP Plan Overview
After you have settled on the appropriate hazards reasonably likely to occur and critical control points, the next step is to take a look at the firm's HACCP plan to see whether these hazards are properly controlled at the CCPs. You should look at the in-plant operations for a product even if the firm does not have a HACCP plan. In this case, you must determine whether the necessary controls may be in place, despite the absence of a written plan. Therefore, existence or absence of a HACCP plan should not ordinarily affect your selection of a product for coverage during an inspection. The HACCP plan itself may consist of a one-page document or a group of related documents. For example, a process authority may have provided a process establishment letter that sets the critical limits for a pasteurization process. This should be listed as part of the firm's verification procedures in the HACCP plan, and may be attached to the plan as a supporting document. Additionally, not every processor will use the standardized HACCP Plan Form that is provided in the Juice HACCP Hazards and Controls Guide.

Reviewing the Firm's HACCP Plan Development

Next, determine who developed the plan. The juice HACCP regulation requires that the person or persons developing, verifying and modifying the plan be trained in the application of HACCP principles to juice processing (21 CFR Part 120.13). This can be accomplished either by completing a standardized course, or through experience. The trained individual does not have to be an employee of the processing firm (21 CFR Part 120.13). The most straight-forward way for a processor to meet this requirement is to have the person who is going to develop and modify the plan and perform record review attend a training course based on a standardized curriculum recognized as adequate by the FDA or an equivalent (21 CFR Part 120.13). HACCP training is also available from a variety of other sources. None of these have been specifically recognized as meeting the requirements of the regulation, although many probably

do. You should collect relevant information about the course(s) the individual(s) attended - the course date, and provider in order to confirm appropriate HACCP training. If the individual's training requirement is met by on-the-job experience, you should collect relevant information about that position, responsibilities of the individual, and years of experience. Unless the firm has clearly not met the training requirement, you should not ordinarily challenge the HACCP-trained person's qualifications. The real test is whether the firm can properly develop and implement a HACCP plan. If your inspection discloses serious violations of the regulation that cast doubt on the processor's understanding of HACCP concepts, you should document those findings, with the information that you collected about training, in your inspection report for review by the agency.

Signature of the HACCP Plan

The signature or initials on the HACCP plan identifies the creator of the record. If the plan is developed by an outside contractor, the signature or initials identify the processors official who accepted the plan (21 CFR Part 120.12). The person signing the plan must be the most responsible individual on site at the processing facility or a higher company official (21 CFR Part 120.12). The plan must be signed initially, whenever it is modified, and at least annually (21 CFR Part 120.11 and 120.12). Determine if it has been signed within one year of your inspection. Also, if during the inspection you learn about a modification in plant operations within the last year that caused the plan to be modified, look to see that the plan was re-signed at that time, or shortly thereafter.

Firms Without HACCP Plans

The regulation requires juice processors to have and implement a HACCP plan whenever the hazard analysis reveals one or more food safety hazards that are reasonably likely to occur during processing (21 CFR Part 120.8). We don't expect a large percentage of the industry will be able to support a claim that there are no significant hazards in their products, but some probably will. Therefore, some firms may not have a HACCP plan because they do not need one. Others may not have a plan because they did not know that they needed one or because they chose to ignore the requirement. Not having a HACCP plan when one is required is a serious violation of the regulation (21 CFR Part 120.9).

Technical Requirements of a HACCP Plan

You need to evaluate the technical aspects of the plan. It is here where you will really begin to apply your understanding of HACCP.

You may begin by asking yourself the following questions:

Is the HACCP plan specific to this processing location and this type of juice? Does the plan include a written hazard analysis that identifies all food safety hazards that are reasonably likely to occur for that product? (Principle 1) Does the plan list the critical control points for each of the identified food safety hazards that are reasonably likely to occur? (Principle 2) Does the plan identify critical limits for each CCP? (Principle 3) Are the critical limits appropriate? (Principle 3) Does the plan list the procedures that will be used to monitor each of the CCPs to ensure compliance with the critical limits? (Principle 4) Does the plan list the frequency of the monitoring procedures? (Principle 4) Is the monitoring and the frequency of that monitoring appropriate for the product? (Principle 4) Does the plan describe corrective action procedures that are both process and product specific for each critical limit? Keep in mind that processors are not required to predetermine corrective actions. If not, does the processor understand the regulation mandated corrective actions? (Principle 5) Are any corrective action procedures that are listed appropriate for the product? (Principle 5) Does the plan provide for a record-keeping system that documents the monitoring of the CCPs, corrective actions, and verification procedures? (Principle 6) Do these monitoring records contain actual values and observations? (Principle 6) Are verification and validation procedures, such as product testing and HACCP plan review, included in the plan? (Principle 7) Is the frequency of verification and validation procedures included in the plan? (Principle 7)

As will be discussed later in this course, the juice HACCP regulation specifies that processors of juice products must include in their HACCP plans control measures that will consistently produce, at a minimum, a 5-log (or 100,000 fold) reduction in the pertinent microorganism for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions (21 CFR Part 120.24). If the firm's hazard analysis indicates microbiological hazards, you should see in the firm's HACCP plan, validated treatments intended to achieve a 5log pathogen reduction.

Review of the HACCP Plan Hazards, CCPs and Critical Limits

The plan may or may not list all of the reasonably likely to occur hazards, critical control points or critical limits that you have identified. Those which are not included but which you have identified as necessary should be cited as objectionable conditions, as we discussed in the previous session. The initial step in reviewing the firm's control strategy is to compare it to those strategies that are described in the Hazards and Controls Guide.

Remember to use the Hazards and Controls Guide as a guideline and compare controls included in the processor's plan to those in the Hazards and Controls Guide to determine whether they provide an equivalent level of control. For example, a firm may base its critical limits on information other than the Hazards and Controls Guide. In this instance you'll need to review the information and determine if the critical limit is sufficient to control the identified hazard. You should rely on experience and any available references. You may not be able to make that determination during the inspection if the firm's scientific data needs to be evaluated by other FDA personnel. In this case, you should gather all pertinent information and submit it with your inspection report. Examples of HACCP control measures used in the processing of juice that you may encounter include: the thermal processing of juice for the elimination of microbial pathogens, culling (or trimming) of apples after storage to eliminate moldy, damaged, or rotten apples to ensure that patulin will not be present at levels of concern in the finished apple juice, or observing processing lines for evidence of glass breakage. Remember that some actions undertaken in processing juice are not HACCP control measures, such as Good Agriculture Practices (GAPs), Current Good Manufacturing Practices (CGMPs), and Sanitation Standard Operating Procedures (SSOPs).

Reviewing Monitoring Procedures

When reviewing the firm's monitoring procedures, check to see that the monitoring frequency is sufficient to detect any deviations from the critical limits. Continuous monitoring is not always required, but, in many cases, it is the only way to assure that the limit is consistently met. If discontinuous monitoring is used, look carefully to see whether the critical limit could be violated between monitoring events, without being detected. Do not be bound by traditional means of monitoring. Industry implementation of HACCP will undoubtedly require some changes, and one likely area of change is monitoring equipment. Ask the firm for an example of each monitoring record that is listed in the plan, so that you can determine whether the documentation is sufficient to cover the monitoring being performed at the prescribed frequency, and that the critical limits were met. When you review the firm's completed monitoring records later, you will be able to take a closer look at the firm's ability to monitor the critical limits.

Reviewing Corrective Actions

If the firm includes predetermined corrective actions in its HACCP plan, you should assess the adequacy of those actions. The corrective action must return control to the process by fixing the cause of the deviation, and it must ensure the safety of the product produced under the deviation (21 CFR Part 120.10). Keep any predetermined corrective actions in mind, so that when you review the firm's records you can verify that the prescribed corrective action was taken when needed.

Reviewing Verification Procedures

There are three basic verification procedures. These include records review, calibration of process monitoring instruments (or other instruments), and product testing. Virtually all process-monitoring instruments need to be calibrated. Look for calibration procedures and frequencies in the plan. When monitoring procedures are weak, verification procedures should be strong to compensate. For example, if a processor uses a supplier's guarantee as his monitoring procedure, he may need to couple it with periodic product testing as a verification tool, in order to ensure control. The entire control strategy for a particular food safety hazard is interrelated. You should not look at one component, for example, the monitoring procedure, individually. You should look at the entire strategy and determine whether it is likely to control the hazard. One example is the coupling of monitoring and verification procedures. Another example is the inter-relationship between the critical limit and the corrective action. The point at which a processor sets his critical limit will, in part, determine what options are available to him when the limit is not met. Remember, in essence, verification is ensuring that the processor is following what they say they will follow. A mandatory verification procedure for citrus juice processors that use exterior cumulative surface treatments to achieve the 5-log reduction performance standard is conducting finished product analysis. The regulation is very specific regarding the analysis; you must ensure that the firm is following the steps as outlined in the regulation. The regulation is also very specific in regards to corrective actions that must be taken in response to positive identification of E. coli. You need to ensure that the firm is following these corrective action procedures, when necessary, as outlined in the regulation. Obviously, ensuring that the juice processor is following their HACCP plan and sanitation monitoring through a comprehensive records review is one of the primary functions of verification.

Reviewing Validation Procedures

Validation is a subset of the overall verification system. In validation, the processor is checking to ensure that the system, as set up, will actually control those hazards identified in the HACCP plan. For example, is the process time and temperature (and other related critical factors) in a flash-pasteurizer adequate to ensure a 5-log reduction of the most pertinent microorganism of concern? A prudent processor would have support documentation available to "back-up" their decisions at critical control points. For example, a study to show a certain time/temperature setup is effective to ensure microbiological inactivation at the 5-log level. Validations of the HACCP plan must occur at least once within 12 months after implementation of the HACCP plan and at least annually after that or whenever any changes in the process could affect the hazard analysis or the HACCP plan. If a processor does not have a HACCP plan because they

have determined that no reasonably likely food hazards are likely to occur, the processor must still validate the adequacy of the hazard analysis whenever there are changes in the process (21 CFR Part 120.11).

Chapter 8

Determining if the HACCP Plan is Properly Implemented

Basis for Determining HACCP Plan Implementation
After you conduct your own hazard analysis, compare that analysis to the firm's hazard analysis, and evaluate the firm's HACCP plan, the next step is to determine whether or not the firm has properly implemented their HACCP plan. In other words, is the firm doing what they say they are doing in their HACCP plan? This element of the HACCP inspection may be one of the most important aspects of your inspection. You start this process by asking, "Does this plan reflect what is happening in the plant?" This is accomplished in two ways: observation and interview.

Observation
A large part of your job is observation. For example, you determine whether or not a plant is clean by observing the clean up operations at the facility first and then observing any evidence of insanitation after the cleanup. In the same way, if a firm's HACCP plan says that they are monitoring product temperatures every four (4) hours, you should observe the firm's employees to see if they in fact take the temperatures at the proper frequency and in an appropriate manner. Time in the plant also helps to verify the integrity of the records. Are they really prepared in the manner that they appear to be? Remember, during the in-plant portions of your inspections, you should always continue to look for other kinds of violations, such as insanitation, filth, economic fraud, decomposition, etc.

Interview
Interviewing managers and line employees can serve the same purpose. Properly conducted, they are an important tool for sorting through the large number of issues that must be addressed in assessing whether the processor is properly implementing their HACCP plan. These interviews will, in many cases, enable you to identify those areas where you are satisfied that things are under control and those areas where you believe that further investigation is warranted.

Wherever possible, negative findings from an interview, especially an interview of a line employee, should be verified by observation, or checked with other evidence. Interviewing line employees may be necessary to further an investigation. However, it is not appropriate to interview an employee when it is clear that they are busy. Distracting an employee not only disrupts the firm's production but may also create safety hazards.

Purpose of Observation and Interview Information

The purpose of interviews and observations is not only to determine whether or not the firm is following their HACCP plan but also give you valuable information to use during record review. You will do a much better job of reviewing records if you have a good understanding of how the firm and its employees implement the plan. Through observation and interviewing, you can determine how, at what time, and under what conditions the monitoring is being performed. You can determine who performs the monitoring and judge their competency. You can learn about the equipment and instrumentation and its limitations. The answers to these questions and other questions will help make sense of what otherwise might appear to be a stack of sterile paper. The bottom line is you will know what the employee is filling out on the records and why.

Verification of HACCP Plan Components

In order to determine if the firm's HACCP plan is being properly implemented, there are several components of the plan that should be verified in-plant. Some of the more important issues are:

Is monitoring performed as prescribed by the plan? Is monitoring performed at the prescribed frequency? e.g., If the plan calls for hourly monitoring, are they actually checking every hour, or is the employee too busy or disinterested to monitor that often?

Is the appropriate monitoring equipment available? Sometimes the plan will prescribe specific equipment. In other cases, you will have to use your judgement to determine whether a particular piece of equipment is right for the job.

Is the monitoring equipment operated properly, and in good working order? e.g., If the equipment is provided with a mercury-in-glass thermometer does it have a divided column? Is the recording thermometer accurately keeping time?

Is the monitoring equipment calibrated as prescribed by the plan? e.g., Is the mercury-in-glass thermometer calibrated yearly as outlined in the plan?

Are the monitoring results accurately and promptly recorded?

Monitoring results must be recorded at the time of the observation, not beforehand, and not significantly after-the-fact. The actual values must be recorded, not judgements, such as "meets," or "exceeds." You should check the readings on monitoring equipment to see if the values correspond with what the firm has recorded. For example, check the temperature of the cooler with your own calibrated thermometer, and check the concentration of a sanitizer solution with your own test strips.

Are corrective actions taken after critical limit deviations? Corrective actions should correct the cause of the deviation and ensure that no unsafe product is distributed. Remember that the firm does not have to predetermine their corrective action (s). If corrective actions are predetermined, processors must follow their own HACCP plan or the standard procedures outlined in the regulations. If corrective actions are not predetermined, processors must follow the standard procedures (21 CFR Part 120.10).

Are corrective actions properly documented? Are other verification procedures, such as product testing, performed as prescribed? Where required, are verification procedures properly documented?

Chapter 9

5-Log Reduction Performance Standard

Background
Processors of juice products must include in their HACCP plans control measures that will consistently produce, at a minimum, a 5 log (or 100,000 fold) reduction in the pertinent microorganism for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions (21 CFR Part 120.20). The 5-log pathogen reduction standard is intended to assure that juice is safe regardless of the method used to process it. The standard is based on the expert advice of a panel of recognized food safety experts, the National Advisory Committee on Microbiological Criteria for Food (NACMCF).

"Pertinent Microorganism"
The likelihood that a pathogen present on fruit will survive in the juice depends on the type of pathogen and its ability to survive in the conditions of the juice. There are many factors that may affect the survival of any microorganism in a juice product such as the pH of the juice or pH of the treatment process, brix, viscosity, total solids, the presence of particulate material, temperatures of treatment(s), and even color. The pertinent microorganism is defined as the most

resistant microorganism of public health significance that is likely to occur in the juice (21 CFR Part 120.24). The 5-log reduction performance standard is applied to the population of the most pertinent microorganism. The pertinent pathogen may not be the same for all juice products or all processes. For example, E. coli O157:H7 and Cryptosporidium parvum are both pathogens likely to occur in apple cider. However, Cryptosporidium parvum is more heat resistant than E. coli O157:H7 is, therefore, if you were pasteurizing apple cider, Cryptosporidium parvum would be the pertinent organism of concern. On the other hand, if the firm is using UV light to treat the juice, the pertinent pathogen may or may not be Cryptosporidium parvum as the relative resistance of a pathogen is not necessarily the same as its resistance to heat treatment.

Exemptions
There are exemptions from the mandatory 5-log reduction that are to be included in a processor's HACCP plan. Firms that may claim exemptions include (21 CFR Part 120.24): 1. a juice processor that is subject to the requirements of 21 CFR part 113 or part 114 and 2. a juice processor who uses a single thermal processing step sufficient to achieve shelfstability of the juice or a thermal concentration process that includes thermal treatment of all ingredients. However, these processors must include a copy of their thermal process used to achieve shelfstability or concentration in their written hazard analysis (21 CFR Part 120.24). During the inspection you will have access to the firm's hazard analysis and you should confirm that their process does result in a shelf-stable product, therefore exempting their juice from the 5-log pathogen reduction requirement.

Parameters of the 5-Log Treatment

The 5-log reduction must be applied to the population of the pertinent microorganism that may be in a juice product (21 CFR Part 120.24). For our purposes, each log represents a 10-fold difference in the number of bacterial cells in a juice, for example, 1-log is equal to 10, 2-log is equal to 100, 3-log is equal to 1000, 4-log is equal to 10,000, and 5-log is equal to 100,000 cells. Therefore, if you were going to reduce 100,000 bacterial cells by 5-log, you would need to reduce the population to 1 cell. Alternatively, if you started with 100 bacterial cells, you would need to go down to 0.001, less than one cell. Of course, the 5-log reduction standard doesn't apply to a hypothetical number. So, while you cannot reduce 100 cells to less than 1 cell, you can go from finding 100 bacterial cells in one cup of juice to finding 1 cell in 100 cups of juice. All juice processors subject to the 5-log pathogen reduction performance standard must achieve the 5-log reduction by treatment of the extracted juice with the exception of citrus juice processors (21 CFR Part 120.24). The 5-log reduction, whether applied as a single treatment or as cumulative treatments, must be accomplished within a single production facility where the juice will be packaged into its final form (21 CFR Part 120.24). The facility must be operating under current GMPs. Note that processors who claim the exemption must also process and

perform final product packaging of all juice subject to the exemption within a single production facility that is operating under current GMPs (21 CFR Part 120.24). [NOTE: A new guidance document from CFSAN regarding bulk concentrate transport and the 5log reduction is currently under review by the Center and General Counsel]. During your "walk-through," make a note of the 5-log treatment that the firm is employing. You should ask yourself:

Is the facility operating under cGMPs? Is the 5-log treatment applied in a single production facility where the final product will be packaged? Is the 5-log treatment applied to the extracted juice for non-citrus juices?

Citrus
Although many citrus juice processors may elect to apply 5-log reduction treatments to the extracted juice, they also have the option to utilize treatments applied to the fruit surfaces provided that the treatment process begins after culling and cleaning of the fruit. Cleaning is defined as washing with water of adequate sanitary quality and culling means the separation of damaged fruit from tree-picked, undamaged fruit. No dropped fruit, damaged fruit or ground harvested may be used for this type of juice product. Surface treatment processes to accomplish the 5-log standard for citrus juices may involve a series of cleaning, brush washing, and sanitizing steps. The 5-log pathogen reduction standard, whether it is applied as a single surface treatment or as cumulative surface treatments on citrus must be validated (21 CFR Part 120.24). Furthermore, all such cumulative treatments for the 5log reduction must occur in one facility prior to final consumer product packaging (21 CFR Part 120.24). For some citrus products, the extraction method may also be part of the cumulative 5-log reduction. Validated extraction methods that may be included consist of a single pinpoint extraction method. For this method, only a single puncture is made and care is taken that the peel of the fruit is not brought into contact with the extracted juice. Remember that the use of cumulative surface treatments will require a number of validation and monitoring steps that must be detailed in the firm's HACCP plan (21 CFR Part 120.24). You should expect the firm to validate and monitor such things as:

the concentration of the chemical used; the pH of the treatment; the duration of exposure to the treatment; and the temperature of treatment.

Validation of the 5-Log Treatment

Once the pertinent pathogen for the product has been determined, the firm must validate the process they use for the 5-log reduction (21 CFR Part 120.11 and 120.24). Validation needs to be performed with clearly defined physical and chemical parameters. In addition, if the firm is using a model pilot system, whole citrus fruit or other juices that have been artificially inoculated or inoculated at higher then normal pathogen levels, confirm that additional studies have been conducted to ensure that the pilot production method accurately mimics real plant production conditions. Under the juice HACCP regulation, use of surface treatments on citrus for achieving the 5-log pathogen reduction standard requires that end product microbial testing be implemented as part of the verification process. End product testing for citrus juice is detailed in 21 CFR 120.25. Testing consists of examining a specific amount of juice for the presence of non-pathogenic E. coli. One 20 mL sample consisting of two 10 mL subsamples for each 1,000 gallons of juice produced must be sampled each production day (21 CFR Part 120.25). If less than 1,000 gallons of juice is produced per day, the sample must be taken for each 1,000 gallons produced but not less than once every 5 working days (21 CFR Part 120.25). Each subsample shall be a randomly selected package of juice ready for consumption by the consumer.

If either 10 mL subsample is positive for E. coli, the 20 mL sample is recorded as positive and the processor must take and document appropriate corrective actions to ensure that the process achieves a 5-log reduction in the pertinent microorganism (21 CFR Part 120.25). If, in a series of 7 tests, 2 samples are found to be positive for E. coli, then the process to achieve the 5-log reduction standard will be assumed to be inadequate and corrective steps must be taken (21 CFR Part 120.25).

A review of the firm's HACCP plan and records should verify the procedures for end-product testing, implementation and monitoring of the testing, and any deviations and subsequent corrective actions taken in response to positive identification of E. coli. Corrective actions may include the use of an alternate process to achieve the 5-log reduction on the extracted juice, an extensive review of monitoring records to determine if control measures were properly applied. The corrective action taken must ensure that no product enters commerce that is dangerous to the health of consumers. Validation of the HACCP system will need to be documented within 12 months of implementation and at least once annually. If, at any time, the firm's process or product changes significantly from the original HACCP plan, the entire process may need to be re-validated (21 CFR Part 120.11).

In addition, once a system is in place, the processor must maintain records to verify that the firm is following the procedure and monitoring as required by the HACCP plan (21 CFR Part 120.12).

5-Log Treatment Methods for Extracted Juices Pasteurization

Pasteurization is a heating method commonly used to reduce the number of pathogens in fluid products. The purpose of pasteurization is to provide only enough heat to destroy pathogenic microorganisms and possibly to inactivate food enzymes in the juice. Pasteurization will not kill all microorganisms present and will not provide a shelf-stable product. Some processors will use a heat treatment that goes far beyond pasteurization that will result in a shelf-stable product. As discussed previously, shelf-stable products are exempt from the 5-log pathogen reduction requirement provided that the processor includes a copy of their heat treatment with the written hazard analysis (21 CFR Part 120.24). Pasteurization has historically been used for fluid milk and appropriate heating requirements for dairy products are well established. Unfortunately, appropriate parameters for juice products are not as well established. However, factors that will influence the efficacy of such a heat treatment are well known and characterized, for example, higher solids content in the product will require a more extensive heat treatment. Given the many factors that may influence the efficacy of thermal treatment, it is important that any pasteurization process be validated for each specific product. The actual validation process requires a high level of expertise in the field of food processing. Processors will most likely consult with process authorities for assistance with validation procedures. The Juice Guide will also provide assistance in this area. You should be aware of the two types of thermal pasteurization methods used in juice processing.

Batch Method
The first type of thermal pasteurization is known as the batch method. In the batch method, heat is applied to one large lot, or batch, of juice. The temperature is brought up to the point where it will result in the inactivation of pathogenic organisms. The entire batch of juice is held long enough to ensure the pathogens are reduced in population by at least 5-log. Following the holding period, the juice is cooled. During your walk-though and when you review the firm's records, you should observe that the temperature is monitored to ensure adequate heat treatment. Also, it is important the firm monitors the length of holding time, and the cooling step as detailed in their HACCP plan. If the critical temperatures and times deviate from those specified in the HACCP plan the firm must make and document corrective actions.

Continuous Method
The second type of thermal pasteurization is known as the continuous method. In this process, juice is pumped at a specific rate from a storage vessel to heat exchanger plates and brought to the temperature required for pathogen destruction. From the heat exchanger the juice continues through holding tubes. The holding tubes are insulated pipes that will maintain the juice at the temperature required for pathogen destruction. These holding tubes need to be designed long enough and large enough, with proper slope to ensure the juice maintains the appropriate temperature for an appropriate length of time to achieve the 5-log standard. How long the juice remains in the holding tubes will be determined by the pump rate. Therefore calibration and proper operation of the pump will be important to the success of such a process. Following the holding period, the juice will once again pass through heat exchangers to bring the temperature back to what is required for hot or cold filling and packaging. Continuous systems have an advantage over batch systems in the speed at which they can heat and cool the product. Consequently, the amount of heat applied can be better controlled. Temperatures used in the continuous method are usually higher than those used in a batch system. This results in faster destruction of the pathogen and a much shorter holding time is required. For this reason, such systems are called "high temperature short time" or HTST pasteurization. Some processors will use very high temperatures in order to further reduce holding times to seconds instead of minutes. Such systems are referred to as "flash pasteurization" or ultra-high temperature, UHT systems. In addition to heat exchangers and holding tubes, HTST systems frequently contain "flow diversion valves." The purpose of such values is to redirect any juice that does not meet the minimum temperature requirement back to the storage tank for reprocessing. Such flow diversion valves are a very important safety feature of this type of equipment. If the firm's equipment does not have such a feature, and the juice fails to meet minimum temperature requirements specified in the HACCP plan as critical limits, the firm must document that the juice was separated to be reprocessed at a later time (corrective actions as specified in 21 CFR Part 120.10). For all such systems, the firm is required to monitor temperatures throughout the processing and ensure that appropriate holding times and temperatures for the process are maintained as outlined as critical limits in their HACCP plan (21 CFR Part 120.8), unless the firm qualifies for the shelf stable/concentrate exemption as outlined in the regulation in 21 CFR Part 120.24.

Alternative Treatments
Although pasteurization is currently the most common and well-studied process for achieving the 5-log standard, other methods do exist and are becoming more popular. However, as with pasteurization, the use of any new technology will require proper validation and documentation of the 5-log reduction process. After validation, proper controls and records must be maintained to assure the process is properly implemented (21 CFR Part 120.12).

One of these alternative treatments is the use of UV irradiation, which was approved in 2000 for use on juices. UV radiation works primarily by breaking apart the DNA of organisms. The amount of radiation required to kill microorganisms may vary dramatically since UV radiation is absorbed by many of the components in juice. In general, the more colored a juice is and the more particles there are in a juice, the more difficult it will be to kill any microorganisms present. Consequently, each type of juice will likely require its own processing parameters and UV irradiation may not be applicable to all types of juices. Current requirements for the use of UV radiation on juice specify the use of low-pressure mercury lamps emitting 90% of the emission at a wavelength of 253.7 nanometers or 2,537 Angstroms. In addition, any juice treated with UV irradiation must undergo turbulent flow through tubes with a minimum Reynolds number of 2,200. Ozone was also approved for food use in June 2001. Ozone is a strong oxidizing agent that has historically been used to clean and disinfect water. Its mode of action is similar to chlorine. Ozone is a highly unstable chemical and is also toxic to people at very low concentrations. Although it is approved for food use, the firm should take care to prevent excessive exposure of workers. As with UV irradiation, parameters for usage are not well characterized and the use of a process authority is highly recommended. A number of other processes are used to a more limited extent. Most of these processes, such as pulsed-light, use of high hydrostatic pressure, or the use of CO2 in combination with high pressure are still in the developmental stages and may become more generally available in the future.

Chapter 10

Reviewing Records: HACCP Records

Record Review - General
Records play a vital role in the HACCP inspection process. Records enable you to determine whether the HACCP plan is being properly and consistently implemented. It is usually best to save your intensive record review until near the end of the inspection, because records are more meaningful when you understand their relationship to the operation of the plant and after you have seen how they are prepared. It is also often advisable to take advantage of the unannounced feature of the inspection by first performing certain in-plant activities, such as a review of the plant's sanitary conditions. By the time you review the records you will have already reviewed the firm's HACCP plan. As part of that review, you will have determined whether the monitoring procedures specified in the plan are adequate to ensure critical limits are consistently being met. You will also have made a

determination about whether the specified monitoring records are adequate to document that the monitoring procedures have been accomplished. These records must be listed in the HACCP plan.

Types of Mandatory Records

Each processor is required to maintain certain records documenting their HACCP system (21 CFR Part 120.12). These include: 1. Records documenting the implementation (monitoring and corrective actions) of the SSOPs; 2. The written hazard analysis; 3. The written HACCP plan; 4. Records documenting the ongoing application of the HACCP plan that includes CCP monitoring and corrective actions; and 5. Records documenting verification of the HACCP system and validation of the HACCP plan or hazard analysis, as appropriate. Importer verification records are required elsewhere in the regulation. These will be covered in Chapter 13. However, the principles included in this chapter should be applied to those records as well. As a regulator, you have access to all of these records. This includes the right to copy the records.

Record Selection
You should initially select sufficient numbers of each of the monitoring, verification, and corrective action records to evaluate whether:

The records are complete and accurate; The appropriate critical limits are consistently met; Appropriate corrective actions are taken when the critical limits were not met; Calibration and product testing are performed in accordance with the HACCP plan; and Record review is performed in a timely manner.

Initially, select complete record sets for given production days. This should include the relevant sanitation monitoring records. Looking at all of the records for a particular production day gives you a complete picture of the plant operations on that day, and also provides you with some tools for judging the integrity of the records. Unless you are directed to cover a particular product during the inspection, select records that relate to the product or products that are being produced on the day of the inspection. This enables you to understand how the records relate to the operation and how they are prepared. If you uncover a problem, during the in-plant portion of the inspection or during record review that

you believe may affect other products as well, you should also review records for those products. Your goal should be to determine the extent of the problem over time, and across product lines. There are a number of ways to select the records that you will review. Many inspectors develop their own system, and some of these methods are quite good. Here is one approach: First, determine the number of production days, and their dates, since the last inspection or since a HACCP plan was first implemented for the product. Remember that monitoring records must be retained for one year for refrigerated products and two years for frozen, preserved, and shelfstable products (21 CFR Part 120.12). Second, take the square root of the number of production days. This is the number of dates that you should select, except that you should always select at least twelve dates. Third, the dates selected should be distributed over the months of production. Attempt to select dates from a month proportionate to the number of production days in that month - more from months with high production and fewer from low production months. Finally, within the month, selectively chose the dates, targeting potentially worst-case dates, such as:

After seasonal shut-downs or changes; After HACCP plan revisions; After equipment changes; After personnel changes; During peak production, especially where production volume exceeds design capacity; During long shifts or overtime situations; During holidays or weekends.

If the firm operates properly under these conditions, they are likely to operate well under more ideal conditions. If you encounter significant problems during the review of this initial selection of records, you should select more records from the time period from which you detected the problem, expanding outward until you have determined the scope of the problem. It is important to know whether the problem is an isolated event, or if it represents a pattern of noncompliance.

Review of Monitoring Records

Of primary importance in the review of monitoring records is to determine:

Has monitoring been performed as specified? Have the critical limits been met? Has corrective action been taken when necessary and is it adequate to address the product and the process?

Are actual values and observations recorded, rather than conclusions, such as "OK," "Met," or "Exceeded?"

The records should be designed so that these kinds of determinations can be made. Of secondary importance is to determine:

Is the date and time of the monitoring activity recorded? Is the signature or initials of the person performing the monitoring activity recorded? Is the identity of the product and the production code, if any, recorded? Is the name and location of the processor recorded? Is the signature and date of review recorded? Is the date of review within one week of the date of the record?

During record review, you should pay particular attention to those areas in which problems or indications of problems were detected during the in-plant portion of the inspection.

Review of Corrective Action Records

Corrective action records should be reviewed to ensure that any critical limit deviations that you noted during your monitoring record review or in-plant inspection have been properly addressed, and that the corrective action was documented. If a processor maintains a separate file of critical limit deviations you should review the entire contents of the file for products produced since the last inspection of the firm, or since a HACCP plan was first implemented for the product. Corrective actions must either conform to the standard procedures described in the regulations, or must be detailed in the processor's HACCP plan (21 CFR Part 120.10). The regulations do not give you access to consumer complaints - only to the records of corrective actions that are taken in response to consumer complaints. Of primary importance when reviewing corrective action records is to determine:

Is the nature of the corrective action described? Is the date of the corrective action recorded? Is the signature or initials of the person taking the corrective action recorded? Is the identity of the product and the production code, if any, recorded? Is the name and location of the processor recorded? Is the signature of the person performing the record review and the date of the review recorded? Is the date of the review within one week of the date of the record.

Review of Verification Records

Your selection of verification records for review will depend primarily upon the frequency of the verification activity. If, for example, a thermometer used at a critical control point is calibrated semi-annually it would be reasonable for you to request all of the calibration records since the

date of the last inspection. If, however, a pH meter used at a critical control point is calibrated daily, it may only be necessary for you to request calibration records for the same dates as the monitoring records that you requested for review. Of primary importance when reviewing verification records is to determine:

Is instrument calibration and product testing conducted in the manner and at the frequency specified in the HACCP plan? Is appropriate corrective action taken when the verification procedures reveal a need? For example, if, during calibration the processor determined that a pasteurizer thermometer was registering too high the following corrective actions might have been taken: the thermometer should be adjusted, if possible; and the pastuerizer temperature monitoring records generated since the last calibration should have been reviewed again by the firm and adjusted for the instrument error. You should also review the same records, looking for any deviations from the critical limits after adjustment for the instrument error.

Are the actual values and observations recorded?

Of secondary importance when reviewing verification records is to determine:

Is the date of the calibration or testing recorded? Is the signature or initials of the person performing the calibration or testing recorded? Is the identity of the product and the production code, if any, recorded? Is the name and location of the processor recorded? Is the signature of the person performing the record review and the date of the review recorded?

Records Falsification
A lot hinges on the legitimacy of HACCP records. For this reason, looking for signs of records falsification is an important part of the HACCP inspection. There are some "tricks-of-the-trade," but most inspectors find that they develop their own as they get used to the kinds of records that processors use and how they look under ordinary circumstances. Records falsification can sometimes be detected during the in-plant portion of the inspection. In fact, that is the best time to detect one type of falsification - the pre-recording of data. For example, you may discover when you arrive at the start of a day's operations, that the results of the visual check of the pasteurizer temperature for a pasteurized product, which were to have been performed every 1/2 hour over the course of the day, are already recorded for the entire day. This information should be documented as evidence of falsification. The documentation should include information about: whether the visual checks were ever really performed; if they were, whether the results differed from the pre-recorded data; and, if they did, whether the data was corrected. This kind of information helps establish the employee's motive for falsification.

The motive might be a scheme to disguise a problem, such as expected poor results or a lack of intent to perform the check, or it might be that the employee simply found it easier to pre-record the data, which might have historically been very consistent. Interviewing employees who are responsible for performing monitoring functions is another good way to expose records falsification. If you suspect falsification, discretely watch the monitoring operation. At some point later in the inspection ask the employee responsible for monitoring to describe how and at what frequency he performs the monitoring function. Look for inconsistencies. Sometimes employees falsify monitoring records because they do not know how to perform the operation, because they are too busy to accomplish it at the required frequency, or because they are afraid of management's reaction to adverse monitoring results. Other evidence of falsification can be detected during record review. Some of the most obvious signs are:

Monitoring frequencies that are uncharacteristically regular. It is not often possible for processing employees to perform monitoring functions at precise intervals - for example, 7:00, 7:30, 8:00, etc. - because they must also accomplish their production function. When you see this kind of record-keeping you should become suspicious about the possibility of data pre-recording.

Monitoring data that is unusually constant. For example, it is unusual for the temperature of a cooler to hold consistently at 40F for extended periods of time. Likewise, it is unusual for product weights or counts to remain constant for extended periods of time. There is a natural variation in most attributes that are measured in a HACCP program. Become suspicious when you don't see it in records, especially if your in-plant experience tells you that it should be there.

Unusually neat monitoring records. Some monitoring records and many corrective action and verification records are generated in an office or laboratory setting. In these cases, they are often very neat in appearance. Of course, some production employees will also maintain their records in an orderly manner. However, if, based on your in-plant experience, you know that a record is generated in a processing area where it is exposed to wet conditions, lubricants, or food, become suspicious if some records are immaculate.

The absence of handwriting or ink changes when a record covers more than one personnel shift. If you suspect falsification, you should also compare handwriting styles on dissimilar records that were reportedly prepared by the same or different employees.

The absence of characteristic instrument markings on mechanically generated records.

For example, most temperature recorders leave four pinholes in the chart, the result of contact with the drive mechanism. Other instruments may leave different types of impressions or markings on the record, the absence of which is an indication of possible falsification.

Improbable events. Again, your in-plant experience will help you identify improbable events that may be chronicled in records. For example, if you see that it takes about one hour for a processor to refill a pasteurizing vat under ordinary circumstances, you should become suspicious when a record shows a series of turn-around times of only twenty minutes. You should also become suspicious when the heating curves on a temperature-recording chart are different for a single record or group of records than for other records for the same product and pasteurizer. To recognize these improbable events, you will have to become familiar with the plant's normal operations.

Perhaps one of the best ways to uncover falsification during your record review is to look at the "overlap" between records. Processors will often use separate records to document the monitoring of separate critical control points. However, you can often link the records by considering the relationship of the product covered by one record with product covered by another record. Is it the same product? If so, do the records cover the same processing step or sequential steps? By comparing the times that monitoring operations are recorded and keeping in mind the answers to the previous questions and your in-plant experience, you may be able to detect irregularities. When you discover records that you suspect have been falsified, it is usually important to investigate the magnitude of such falsification before discussing the situation with management of the firm. You should copy the records as soon as possible. This may be your only opportunity to obtain them. They may subsequently be removed or altered by the firm. It is usually best to discuss your findings with management and provide them with an opportunity to explain the events represented by the records. However, in some circumstances, especially where you suspect that there was intent to conceal a problem, it may be necessary to discuss the situation with your supervisor before you disclose the information to the firm's management. Remember that falsification with the intent to defraud may be a felony violation of Title 18 of the Code of Federal Regulations.

Copying Records
There are four reasons to copy records: 1. 2. 3. 4. To document records falsification; To document deficiencies; To provide information for agency review; To facilitate the next inspection

Records are often needed to document deviations from the regulations, such as: inadequate corrective actions; inadequate monitoring or inadequate monitoring frequency; inadequate verification activities as specified in the HACCP plan; and, incomplete records. In some cases, it may be necessary for you to collect the complete set of records for that day's production, to facilitate a full review of the significance of the deficiency. Records may be needed to enable an agency review of the adequacy of a processor's HACCP plan, critical control parameters, certain control measures, or corrective actions. For example, if you are not sure about the suitability of a critical limit that a processor has selected, you should collect any data that the processor has to support his selection. If you are not sure of the appropriateness of a corrective action that a processor has taken, you should collect records that document the monitoring activities and the corrective action, as well as any data that the processor may have to support the adequacy of the corrective action that was taken. These records should be submitted by the district office to the Center for Food Safety and Applied Nutrition for review. Finally, records may be collected to facilitate the performance of the next inspection. If you believe that having a copy of the HACCP plan, blank copies of records, or other documents to which the regulations grant access, will assist in the efficient enforcement of the regulations by helping prepare the next inspector, you may copy the documents and include them in the district's files.

Chapter 11

Determining if Sanitation Monitoring is Properly Implemented

You should view compliance with the sanitation monitoring requirements of the Juice HACCP regulation in the larger context of the existing requirements of the Part 110 GMP's. Although sanitation-monitoring requirements are new, sanitation standards for all foods have been in place for many years as part of FDA's Good Manufacturing Practice Regulation - 21 CFR Part 110 or GMP's - which still apply to juice processors. With the advent of HACCP, many have recognized that sanitation is a prerequisite to HACCP and provides a foundation for safe food production. In writing the Juice HACCP regulation, FDA recognized that monitoring sanitation conditions would be necessary to achieve and maintain improvements in sanitation in juice processing operations (21 CFR Part 120.6). When looking for compliance with the regulation the investigator will need to:

Determine what key areas of sanitation need to be monitored Determine if the processor has implemented sanitation monitoring in those areas

Determine if monitoring is at a sufficient frequency to ensure conformance with the GMP's Determine if the processor makes corrections to sanitation deficiencies detected during monitoring Determine if the processor maintains sanitation monitoring records and sanitation correction records.

Determining what key areas of sanitation need to be monitored. The regulation requires monitoring in eight key areas of sanitation (21 CFR Part 120.6). Not all of these areas are relevant to all processing facilities. For example, many are not relevant to warehouses that store finished packaged juice. The key areas are somewhat arbitrary and overlapping, but were designed to include those aspects of GMP's that are most likely to have an impact on the safety of the product. The eight key areas cited in the regulation are:

1. Safety of Water
This area relates to the sourcesave treatment of water that comes in contact with food or food contact surfaces, or is used in the manufacture of ice. It also relates to cross connections between potable and non-potable water systems. In juice processing plants cross connections can be found in: hard plumbing between potable and non-potable water lines; unprotected hose bibs (i.e. those with no backflow prevention devices) lying in pooled water or submerged in a wash tanks; or metering pumps used for cleaning chemicals without a backflow prevention device.

2. Conditions and Cleanliness of Food Contact Surfaces

This area relates to the design, workmanship, materials, and maintenance of food contact surfaces and the cleaning and sanitizing of those surfaces. It includes gloves and outer garments that may contact the food. Processing equipment must be designed to be easily cleaned and maintained in a sanitary condition and, it must withstand the environment of its intended use and the action of cleaners and sanitizers. This includes equipment for ice production and storage. At a minimum, cleaning and sanitizing of all equipment that contacts food must be done daily. All equipment should be cleaned at the end of each day's operation, and sanitized either after cleaning or before the day's operations begin.

3. Prevention of Cross Contamination

This area relates to:

employee practices to prevent product contamination; physical separation of raw and cooked product; and plant design to prevent contamination

Hands, gloves, outer garments, utensils, food contact surfaces of equipment that come in contact with waste, the floor, or other unsanitary objects can contribute to product contamination. Employees should be trained on how and when to properly wash and sanitize their hands, gloves

and outer wear, as well as equipment such as shovels, or buckets that come in contact with the floor or waste. It is important to stress that in order to effectively clean equipment, all residual product should be removed, equipment cleaned with hot water and detergent, and then sanitized. Also be aware of cross contamination between raw and cooked products. If a facility does not dedicate employees to work in either the raw or cooked side, when these employees move from the raw to the cooked side, their hands, gloves and outer wear should be washed and sanitized. Un-packaged finished product should also be separate from raw products during storage and processing.

4. Maintenance of hand washing, hand sanitizing and toilet facilities

This area relates to the location and maintenance of hand washing, sanitizing and toilet facilities, as well as the adequacy of sewage disposal. Hand washing and hand sanitizing facilities should be located in all processing areas where good sanitary practices require employees to wash and sanitize their hands. Hand washing should always precede hand sanitizing so hand sanitizing stations must have hand washing stations located adjacent to them. It is important that there is a supply of hot water, soap and sanitizer at each station. Toilet facilities must have adequate sanitary supplies and be in good repair.

5. Protection from adulterants

This area covers protection of food, food-packaging material and food contact surfaces from various microbiological, chemical and physical contaminants, such as lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and floor splash.

6. Proper labeling, storage and use of toxic compounds

This area is covers labeling, storage and use of toxic compounds. Improper use of toxic compounds is a frequent cause of product adulteration.

7. Control of Employee Health Conditions

This area relates to the exclusion of persons who appear to have an illness, wound or other affliction that could be a source of microbial contamination to the food. It is imperative that owners encourage employees not to work when they are ill or have an infectious wound that might contaminate the product.

8. Exclusion of Pests
This area relates to the presence of pests, such as rodents, birds, and insects. These pests carry a variety of human disease agents, which can be introduced into the processing environment. The presence of rodents, insects, birds or other pests in the processing plant is unacceptable. Even if pest control is contracted to an outside company, it is still the responsibility of the plant owner to make sure that there are no pests in the facility.

The table that follows takes each of the eight key areas of sanitation and relates them to specific parts of the GMP. You can use the table to help evaluate the adequacy of the processor's sanitation self-monitoring efforts. SANITATION PROVISIONS OF THE JUICE HACCP REGULATION AND RELEVANT REQUIREMENTS OF THE FOOD GMPs CORRESPONDING PART 110 PART 120.6(a)REQUIREMENT REQUIREMENT(S) (1): Safety of water that comes into contact with food or food-contact surfaces or that is used in the manufacture of ice 110.37(a): The water supply shall be sufficient for the operations intended and shall be derived from an adequate source. Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. 110.80(b)(16): When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary quality, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in part 110. (2): Condition and cleanliness of food contact 110.10(b)(5): Maintaining gloves, if they are surfaces, including utensils, gloves, and outer used in food handling, in an intact, clean, and garments sanitary condition. The gloves should be of an impermeable material. 110.35(d): All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food. 110.40(a): All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if

applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives. (3): Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product 110.10(b)(5): Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material. 110.35(d): All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food. 110.40(a): All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives. (4): Maintenance of hand washing, hand sanitizing, and toilet facilities 110.37(d): Each plant shall provide its employees with adequate, readily accessible toilet facilities. 110.37(e): Hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing:

(1) Hand washing and, where appropriate, handsanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands. (2) Effective hand-cleaning and sanitizing preparations. (3) Sanitary towel service or suitable drying devices. (4) Devices or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands. (5): Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants 110.20(b)(4): Plant construction and designconstructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact. 110.40(a): All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any

source, including unlawful indirect food additives. 110.80(b)(12)(iv): Providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them. (6): Proper labeling, storage, and use of toxic 110.35(b)(2): Toxic cleaning compounds, compounds sanitizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of food, foodcontact surfaces, or food-packaging materials. All relevant regulations promulgated by other Federal, State, and local government agencies for the application, use, or holding of these products should be followed. 110.35(c): Pest control - The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials. (7): Control of employee health conditions 110.10(a): Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, and illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors. 110.35(c): No pests shall be allowed in any area of a food plant.

(8): Exclusion of pests

During an inspection, consider whether each standard in the table is relevant to the firm's operations. If it is, the processor should be monitoring its own operations to ensure compliance with the standard. Remember, the insanitary condition need not have a direct impact on product safety in order to judge it relevant. The insanitary condition need only have an impact on product adulteration. Poor employee hygienic practices or vermin activity in a juice processing plant are not reasonably likely to affect the safety of the product, but either of these insanitary conditions

certainly could cause the product to be deemed adulterated, and are, therefore, relevant. Because of this, most of the standards listed in the table are relevant to most processors, but there are some exceptions. For example, it would not be relevant to monitor employee hand washing in a facility such as a warehouse where there is no employee contact with exposed product. During your "walk-through," in addition to looking at the process flow and controls, you should be making judgments about the relevance of the listed sanitation standards. You will also need to determine where in the plant the relevant standards should be monitored. For example, hand washing may need to be monitored in certain processing areas, but not in the packaged finished product storage areas, or on the loading docks. Basis for Determining Sanitation Monitoring Implementation Once you have determined the relevant areas of sanitation that the plant must monitor, you should evaluate the firm's monitoring efforts to determine whether they are adequate. Remember that sanitation monitoring can be performed either as part of the HACCP program or as part of a separate sanitation program. If a processor elects to perform some or all of the sanitation monitoring as part of their HACCP program, you should evaluate those sanitation components as you would any other part of the HACCP program. This discussion covers how to evaluate the adequacy of sanitation monitoring that is part of a separate sanitation program, the option that most processors will likely select. The scope and effectiveness of a processor's sanitation monitoring program is determined in the same way the HACCP Plan is:

Reviewing the firm's sanitation monitoring records; Observing sanitation monitoring operations; and Interviewing the person responsible for sanitation monitoring.

After reviewing the firm's records and while you accompany the person performing the monitoring you should determine:

The key areas of sanitation their monitoring covers What areas of the plant are monitored; and How often the monitoring is performed.

Sanitation Standard Operating Procedures (SSOP's) Processors are required to have SSOPs, but the regulation does not specify that they must be written (21 CFR Part 120.6). The standard that you are bound to apply toward sanitation is the standard that is contained in 21 CFR Part 110. If you judge that the standard the firm has set is inadequate because it does not meet the standard contained in 21 CFR Part 110, you will need to document the firm is not meeting the proper standard. If through observation you determine that the equipment is unclean or a cleaning procedure is inadequate, you should link the deficient item to the corresponding weakness in the SSOP in order to strengthen the observation.

Determining if Monitoring Is At a Sufficient Frequency and Corrections to Deficiencies Are Adequate Compliance with the sanitation monitoring requirements require:

observing and recording on the conditions in the plant; and making and recording corrections for any deficiencies noted.

There are also two factors to consider in sanitation monitoring. First is the frequency sufficient to meet the requirements in 21 CFR Part 110, and is that frequency reasonable. For example, if the equipment were cleaned daily, it would meet the standards set forth in 21 CFR Part 110 if the processor checks the condition of the equipment each time the equipment is cleaned (e.g. daily). On the other hand, to meet the requirements of 21 CFR Part 110 employees wash their hands every time they use the restroom, or handle unsanitary objects either at or away from their workstation, it isn't reasonable that the processor would have to check hand washing each time. It is reasonable to check periodically over the course of the day, particularly at times when large numbers of employees would be required to wash their hands such as after breaks or returning from lunch. Secondly, you need to consider if there are any special circumstances that might affect your judgment about a reasonable frequency. For example, did you note any sanitation deficiencies during your walk through, or did the firm's monitoring records note problems in a particular area; or is there something about the operation that would affect the firm's ability to meet the sanitation standard such as equipment that is difficult to clean. There are many ways the processor can set up a sanitation-monitoring program to comply with the regulation. One way is to place the sanitation elements into groups based on the frequency of monitoring. For example, monthly or daily, etc. with monitoring records prepared accordingly. This can be done as follows (Note: recommended frequencies in these examples below are based on 21 CFR Part 110 and used for illustrative purposes; other frequencies may be adequate to comply with the regulation):

Monthly monitoring
Areas that can be covered in a monthly monitoring report are:

Safety of water; and Condition and cleanliness of food contact surfaces; and Prevention of cross contamination.

Common terms for reporting conditions are "satisfactory" or "unsatisfactory, or "pass"/"fail".

1. Safety of water
How a firm monitors their water supply is dependent on the source of their water.

Municipal source: Frequency: For a municipal source it is usually sufficient that a firm attaches a copy of the water bill to their monthly SSOP monitoring report or they can also request verification of the water quality from the city and maintain that record on file. Private source: Frequency: The firm could have the water tested for total coliform on a semi-annual basis. The results of analysis could be maintained with the monthly report. Cross Connections: Monitoring of hard plumbing between potable and non-potable water: Frequency: Once a month and more often if there are any changes to the plumbing.

2. Conditions and Cleanliness of Food Contact Surfaces:

Monitoring the condition of processing equipment and utensils to assure it's properly designed, constructed and maintained and determine if it is necessary to replace inadequate equipment. Frequency: Once a month and more often if equipment is replaced to make sure that it meets the construction standards.

3. Prevention of Cross Contamination:

The monitoring requirement for proper plant design can be as simple as a monthly walk-through to assure that the plant layout and structure does not contribute to contamination of the product. Frequency: Monthly, or more if modifications are made to the facility to verify the change did not contribute to the possibility of cross-contamination.

Daily monitoring
Areas that could be covered in a daily monitoring report are:

Safety of water; and Condition and cleanliness of food contact surfaces; and Prevention of cross contamination.

And all of:

Maintenance of hand-washing, hand-sanitizing, and toilet facilities; and Protection from adulterants; Proper labeling, storage and use of toxic compounds; Employee health conditions; Exclusion of pests

Note: just like the monthly monitoring records, daily monitoring records need to reflect the actual observations made in the plant, as well as any corrections taken as a result of an observed deficiency.

1. Safety of water:
In addition to concerns about cross connections between hard plumbed water and sewage lines covered in monthly monitoring, there could be daily monitoring of cross connections in the plant environment such as unprotected hose bibs with the hose submerged in the wash tank, or metering of cleaning chemicals. Frequency: Before operations begin (pre-op) and every 4 hours of operation.

2. Condition and cleanliness of food contact surfaces:

Daily monitoring of the: cleaning and sanitizing of all equipment, utensils, gloves and outer garments that come in contact with food; and the condition of gloves and outer garments. Frequency: Cleaning and sanitizing of all equipment could be monitored every time the equipment is cleaned and sanitized. That should include monitoring and recording of sanitizer strength. Frequency: Cleaning and sanitizing of gloves and outer garments could be done at the start of operations and every 4 hours after.

3. Prevention of cross contamination:

Includes daily monitoring of: employee practices and physical separation of raw and cooked products. Employee practices Frequency: In general, employee practices could be monitored at the beginning of the day's operation and at least every four hours of production, and more often if necessary - concentrating on employee breaks. Monitoring employees that move from working in the raw side of the operation to the cooked side of the operation could be done at 4 hour intervals or when necessary. Separation of raw and cooked product Frequency: Coolers and processing areas could be monitored during the pre-op and post operative inspections and every four hours in between.

4. Hand-washing, hand-sanitizing, and toilet facilities:

Hand-washing, hand-sanitizing facilities

Frequency: Monitoring of hand-washing and sanitizing stations could be done during the pre-op inspection. Also, the concentration of hand sanitizing solutions could be monitored every four hours during operation. Toilet facilities Frequency: Monitoring is to assure that toilet facilities are adequate and in good repair. Seals around the bottom of each toilet, the functioning of the toilet, and toilet supplies could be monitored at least before the start of the day.

5 & 6. Protection from adulterants/Labeling, storage and use of toxic compounds:

Protection from adulterants, labeling, storage, and use of toxic compounds can be combined in monitoring and reporting. Protection from adulterants Frequency: Monitoring must be done to ensure that the food is protected from all contaminants including such things as condensate, floor splash, glass breakage, use of toxic chemical and other sources of contamination. Frequency of monitoring these conditions could be at start-up and every four hours after. Labeling, storage and use of toxic compounds Frequency: Once per day during the pre-op inspection could be an established frequency.

7. Employee health conditions:

Employee health conditions must be monitored. Frequency: Daily, before the start of production.

8. Pest control:
Frequency: Monitoring for pest could be done daily, during the pre-op inspection.

Sanitation Corrections
It is important to remember that the sanitation correction requirements of the regulations are different than the corrective action requirements for critical limit deviations in the HACCP plan. In many cases corrections will not involve corrective action to the product itself, but more often will involve such actions as repairing or re-cleaning the equipment, providing training to employees, improving ventilation, or moving cleaning supplies out of the processing area. These corrections must be timely, but don't always need to be immediate. For example, if an employee returns from the restroom without washing their hands and then handles the product, it would not

be reasonable to expect the processor to hold and evaluate the product or destroy the product. A more reasonable correction would be to re-train the employee. Under other circumstances, action against the product might be warranted, for example, an overhead sewage pipe found leaking on exposed product. Critical to the success of both the monthly and daily monitoring record is the correction column where corrections that have been taken as a result of an observed deficiency are recorded. Examples could include: If the monthly monitoring of a well water supply showed high total coliform counts, correction may be for the firm to stop processing and to resample immediately. If the resample is satisfactory, processing can begin. Another acceptable corrective action would be to find an alternative water source until the problem is corrected. All of this information is to be recorded in the correction column. If the daily check of the storage warehouse found rodent excreta pellets, correction made might be to remove the pellets, assure no raw material has been contaminated, and clean the area before start-up, and call the pest control company. This correction would be recorded in the correction column of the daily report.

Sanitation Records
The regulations require that sanitation monitoring and corrections be documented in records. All sanitation records must have (21 CFR Part 120.12):

Firm name; Firm location; Date of record; Signature or initials of the person performing the monitoring; and The actual time the observation was made.

All of the principles discussed in the HACCP records chapter of this course apply to sanitation records. You should select sanitation records for the same product days for which you select HACCP records. This ensures a complete package of records for those days and affords a greater opportunity to look at the overlap between records.

Monthly and Daily Sanitation Monitoring Records Examples

Following are example sanitation monitoring forms based on frequency of monitoring the 8 key areas of sanitation. These example forms can be used during the inspection to help determine if the processor is covering all of the sanitation monitoring requirements. However, these example forms are only one way to record sanitation monitoring and may not apply to every situation. "FOR EXAMPLE ONLY"

DAILY SANITATION REPORT Report Date:____________________ Line 1: Apple juice Line 2: Grape Juice Sanitation Area and Goal Firm Name:________________________________ Firm Address:______________________________ _________________________________________ Pre-Op Time: Start Time: 4 Hour Time: 8 Hour Time: Post-Op Time: Comments / Corrections

1) Safety of Water (See Monthly Sanitation Report) Back Siphonage - Hoses

(circle one)

S/U

2) Condition and cleanliness of food contact surfaces (See Monthly Sanitation Report) Equipment cleaned and sanitized
Line 1: (circle one)

S/U
(circle one)

Line 2:

S/U
___ ppm

Sanitizer Strength Sanitizer Type:_______________

Line 1:

Line 2:

___ ppm

Minimum Strength: ___ ppm Gloves and aprons clean and in good repair
Line 1: (circle one)

S/U
(circle one)

Line 2:

S/U

3) Prevention of cross-contamination (See Monthly Sanitation Report) Hands, gloves, equipment, and utensils washed / sanitized after contact with unsanitary objects Employees working on raw products, wash and sanitize hands / gloves / outerwear
(circle one) (circle one) (circle one)

S/U

S/U

S/U

(circle one) (circle one)

S/U

S/U

before working with cooked products Unpackaged cooked products separated from raw products
(circle one) (circle one) (circle one)

S/U

S/U

S/U

4) Maintenance of hand-washing, hand-sanitizing, and toilet facilities Hand-wash and hand-sanitizing stations adequate
Line 1: (circle one)

Hand-wash station
Line 2:

S/U
(circle one)

S/U
___ ppm ___ ppm ___ ppm

Hand-sanitizing station Sanitizer Type:_______________

Line 1:

Line 2:

___ ppm

___ ppm

___ ppm

Minimum Strength: ___ ppm Toilets clean, properly functioning, and adequately supplied
(circle one)

S/U

5) Protection from adulterants and 6) Labeling, storage, and use of toxic compounds Product protected from contamination Cleaning compounds, lubricants, and pesticides labeled and stored properly 7) Employee health conditions Employees do not show signs of medical problems 8) Exclusion of Pests Pests excluded from processing area Other area(s)
(circle one) (circle one) (circle one) (circle one) (circle one) (circle one)

S/U

S/U

S/U

S/U

S/U

S/U

Additional Comments: S = Satisfactory U = Unsatisfactory Signature (or Initials): ________________________________________________

"FOR EXAMPLE ONLY" MONTHLY SANITATION REPORT Report Date:____________________ Line 1: Apple juice Line 2: Grape Juice Sanitation Area and Goal Firm Name:________________________________ Firm Address:______________________________ _________________________________________ Decision Comments / Corrections

1) Safety of Water Safe and sanitary source (semi-annual)

(circle one)

S/U
(circle one)

No cross-contamination - Hard Plumbing

S/U

2) Condition and cleanliness of food contact surfaces Processing equipment and utensils in suitable condition 3) Prevention of cross-contamination Physical conditions of plant and layout of equipment
(circle one) (circle one)

S/U

S/U

Additional Comments: S = Satisfactory U = Unsatisfactory Signature (or Initials): ________________________________________________

Chapter 12

Reporting HACCP Violations

Background
It is important to recognize that approaches for reporting objectionable conditions may vary from district to district. It is not the intention here to change or debate the various philosophies for reporting inspectional findings. Rather, it is to provide the basics so that you can apply them in a manner consistent with the agency's policies. The Federal Food, Drug and Cosmetic Act (FD&C Act) requires that FDA Investigators leave processors with a written list of any conditions or practices they observe during the inspection. These written observations typically indicate that the food processed in the establishment may consist in whole or in part of any filthy, putrid, or decomposed substance, or may have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The HACCP deficiencies that you will report will most likely fall under the portion of the FD&C Act that talks about foods that are prepared, packed, or held under insanitary conditions. Preparing a list of the objectionable conditions and practices observed during an inspection and presenting that list to management can be done in many different ways. Some state agencies present their findings verbally unless they are issuing some type of warning or order. FDA investigators also handle some of their objections verbally, when there are only a few minor problems. Written lists of objectionable conditions may take the form of a checklist, an abbreviated outline, or a detailed narrative. FDA Investigators report their findings in writing to management on a FDA-483 form. Some state agencies use similar forms. This chapter will address the FDA-483 format.

Basics of Writing FDA-483 Items

Listing objectionable conditions for HACCP deficiencies should follow the same rules and guidelines as for GMP problems and other deficiencies. The following information about 483s is a summary of information contained in FDA's Investigations Operations Manual. Your written objections should be:

Factual, what you actually observed. Written in a succinct and direct manner. The facts should be written in such a way that the person receiving the list can easily understand them. You should get a feel for the background and expertise of the people you are dealing with and adjust your vocabulary and writing style accordingly. Significant and related to observed or potential problems. Potential problems should have a reasonable likelihood of occurrence. Concise, with similar observations grouped to avoid redundancy. The significance of the items, not the number of items, is important. Free of opinions or assumptions. Factual conclusions may be reported, but you should not draw unqualified conclusions that are not strongly supported by what you observed. For example, if you observe a person entering the wrong temperatures on a HACCP document, you should state that the entry or entries are not the correct temperatures. You should not conclude in writing that the employee was falsifying the document or the entries. Free of any reference to the juice HACCP Regulations or the Juice Hazards & Controls Guide.

Additional Suggestions for Writing FDA-483 Items

The following are some additional tips and suggestions for 483 writing that are not contained in the IOM. One of the easiest traps to fall into is the need or desire to be original. This almost always gets you into trouble. If a particular word, phrase, or format describes an objectionable condition directly and succinctly, then use it when appropriate. If you see the same or similar problem in different areas, the same wording can be used to emphasize the similarity of the problem. Eliminating redundancy does not mean that you need to vary how you describe the objectionable conditions or how you refer to a particular observation. Redundancy in the context of FDA-483s refers to repeated items that are similar and should be grouped together. The phrase, "During an inspection of your firm (I) (We) Observed:" precedes the block on the FDA-483 where individual items are to be written. This lets you write items as incomplete sentences without a verb. For example, you might write: 1. No HACCP plan for the processing of apple juice outlining the controls measures for the hazard of Cryptosporidium parvum.

In this case "we observed" is understood to be the verb for each item. This can be confusing to the reader. Consider, instead using full sentences. This allows the verb to be varied and better fit the situation. The previous examples could be written in full sentences as follows: 1. There is no written HACCP plan for the processing of apple juice outlining the controls measures for the hazard of Cryptosporidium parvum. You should lead with the deficiency or problem in the first part of the written observation. This identifies the problem right up front instead of burying the problem in a lot of verbiage. This is particularly important when the written observations get quite lengthy. You should use words that indicate frequency, like repeatedly or routinely, carefully and very deliberately. When an item can be counted, such as the number of deficient documents or the number of times an objectionable practice occurred, you should include that number in the written observation. For example: "On three occasions corrective actions were not taken for....;" or, "On five occasions employees did not...." You should fully describe the magnitude of the problem. For example, if your HACCP record review revealed eight pasteurization records that did not have the required temperature entries, you might simply write: "Record review revealed eight pasteurization records that did not have the required recording chart temperature entries." But this does not make it clear whether the observation was the result of reviewing an entire year's worth of monitoring records or just a limited number of monitoring records during a period when the employee monitoring the cook step was out sick. A more appropriate way to write this item would be: "Eight out of the 20 pasteurization records reviewed for the week of 6/12/02 did not list the required recording chart temperatures." When the deficiency recurs on an irregular basis but the number of documented occurrences is limited only by the number of documents you choose to review or the length of time you choose to watch the operations, then you should cite this as a repeated occurrence. For example, "The employee operating and monitoring the pasteurizer repeatedly failed to list the recording chart temperatures on the Pasteurization Log, as observed during the inspection and after review of 25 production records." In other words the more records you would have looked at or the longer you would have watched the operations, the more instances of this intermittent deficiency you would likely have found. When the deficiency occurs all the time, or almost all the time and it is a regular practice of the firm, then this would be reported as a routine occurrence. For example, "The temperature recording charts for the pasteurizer are routinely not signed or dated by the operator or reviewed by a reviewing official."

Violations Other Than HACCP Violations

You should continue to object to GMP violations and other violations on your FDA-483s, just as you have in the past.

Examples of HACCP Regulation Deficiencies

Following is a list of some of the types of violations of the HACCP regulation that you should expect to encounter during juice HACCP inspections. This is not a definitive, all-inclusive list, and the relative significance of items may vary depending upon the circumstances.

Falsification of records. No corrective action or inadequate corrective action when deviations from the critical limits occur. No monitoring or inadequate monitoring at CCPs. No HACCP plan when required. Inadequate HACCP plan with some or all of the significant hazards not addressed or inadequately addressed. No or inadequate monitoring records or inadequate records No correction or recording of correction for sanitation deficiencies. No monitoring of sanitation. No record review. No trained individual available for HACCP reviews. No signature/date on HACCP plan. No signature/dates on required records. No annual review of HACCP plan.

Examples of FDA-483 Items for Specific Situations

Following are some examples of HACCP regulation violations that might be encountered during an inspection of a juice processor that primarily produces pasteurized, refrigerated apple juice in glass bottles and one way that the condition(s) can be reported.

HACCP Records
1. Problem: When the investigator arrived at the firm he checked the locations where data was being entered on HACCP records. When he checked the Pasteurization Temperature Record at 8:20 AM, the blanks for the rest of the day were prematurely filled in with false numbers. This is a falsified document and a very serious violation, because the validity of all Pasteurization Temperature Records from this firm was immediately questionable. FDA-483 Item: At 8:20 AM on 6/12/02 the times and temperatures on the Pasteurization Temperature Record were filled out in advance for the entire day in half hour intervals from 8:30 AM through 1:30 PM.

HACCP Plan

2. Problem: This firm processes apple juice and orange juice. The firm has made no attempt to prepare a HACCP plan for either of the products FDA-483 Item: There are no written HACCP plans outlining controls for Cryptosporidium parvum or Salmonella during processing of apple juice and orange juice processed at your facility.

Hazards
3. Problem: This firm also processes fresh apple juice, but did not identify patulin formation as one of the hazards in their HACCP plan. However, the firm does control the condition of the incoming apple, as part of their operating procedures. FDA-483 Item: The written HACCP plan for fresh apple juice does not address the hazard of patulin formation.

Hazards and Controls

4. Problem: The firm's processing includes grinding apples into juice with a hammer mill grinder. There is a significant potential for metal fragments to be incorporated into the finished product. The firm's HACCP plan does not cover the possibility of metal fragments and they have no system or procedures to detect metal in their finished product. FDA-483 Item: The written HACCP plan for pasteurized apple juice does not address the hazard of metal fragments and there is no control measure in place.

Critical Limit Deviations

5. Problem: This firm has identified the pasteurization step as a Critical Control Point and set critical limits for time and temperature of pasteurization for their apple juice. Review of the pasteurization records found that the Pasteurization Temperature Record for 6/12/02 documented two occasions where the temperature was at least 5F below the critical limit set by the firm. There were no notations or comments on the record and a review of the Corrective Action Reports for that date also found no mention of critical limits not being met or correction of the deficiency. FDA-483 Item: A review of the Pasteurization Temperature Record dated 6/12/02 found that on two occasions the pasteurization temperature was below the critical limit by 5F and no correction to the deficiency was noted on the record or on file.

Verification
6. Problem: The juice firm changed the way they monitor for glass fragments. Previously, the firm used visual monitoring to prevent the incorporation of glass fragments into the finished apple juice. Now the firm is using x-ray equipment to continuously monitor for

glass. The HACCP plan states that a quality assurance technician will challenge the x-ray equipment at the start of the day's production and at four-hour intervals after that. The investigator observed that a quality assurance technician did not challenge the x-ray equipment either after start-up or any other time during the processing day. FDA-483 Item: The verification procedures at the x-ray machine are not being implemented as outlined in the HACCP plan in that the x-ray equipment was not challenged at the start of processing or at 4 hour intervals after that.

Verification
7. Problem: The plant manager, who is the reviewing official has not signed and dated any monitoring records showing they were reviewed. Observation revealed that the monitoring records are placed on his desk but are routinely filed without being reviewed. FDA-483 Item: Review of the Pasteurization Temperature Log and the Metal Detection Log monitoring records for all dates reviewed found they are not signed and dated as being reviewed as outlined in the HACCP Plan.

Chapter 13

Importer Inspections and Imports

General
Reviewing an importer for compliance is different than inspecting a domestic processor in that, in most cases, the importer was not directly involved in the processing of the product that they are importing. The importer must rely on the foreign processing firm to produce the product according to the HACCP regulation. The importer's role is to verify that the foreign processor is complying with the HACCP regulation (21 CFR Part 120.14). In the control of imports, you may or may not see the foreign processor's HACCP plan. Even, if you do, you will not have the luxury to compare that HACCP plan to the processing plant. In addition, the process to conduct an inspection of an importer or review documents at entry is more involved.

Memorandum of Understanding (MOU)

Let us begin by reviewing the import requirements as stated in the juice HACCP regulation (21 CFR Part 120.14). All juice products offered for entry into the United States must be processed under conditions that comply with the HACCP regulations. It is the responsibility of the importer

to verify that this is occurring. The easiest way for the importer to do this is to obtain juice from a country that has an active Memorandum of Understanding (MOU) with FDA. If an importer obtains product from an MOU country, the importer has no further obligations as a result of the juice HACCP regulation, relative to that importation. A juice HACCP MOU acknowledges that a foreign country's juice inspection system is equivalent to the U.S. FDA inspection system. With an MOU in place, it becomes the responsibility of the participating country government, not the importer, to verify compliance with the HACCP regulations. An MOU may deal with all juice products that a particular country exports to the United States or may just deal with a particular juice product. In addition, an MOU may cover all juice processors in the country, or only selected processors.

Written Verification Procedures

When importing juice from countries without a juice HACCP MOU, the importer must have and must implement written verification procedures to ensure that the juice is being processed in accordance with the juice HACCP regulation (21 CFR Part 120.14). The written verification must provide (21 CFR Part 120.14): 1) product specifications, and 2) affirmative steps, as discussed below.

Product Specifications
The importer must develop product specifications that are designed to ensure that each imported product is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act. These product specifications must list limits for relevant safety issues (21 CFR Part 120.14). For example, a specification for Salmonella could be listed as "no Salmonella present."

Affirmative Steps
In addition to the written specifications, the importer must have and follow written procedures that describe the affirmative steps that the importer will take to ensure that the juice product is being produced in accordance with the regulations (21 CFR Part 120.14). The juice HACCP regulation lists five affirmative steps. The importer may use one or more of these steps. The importer may: 1. Obtain from the foreign processor the HACCP and sanitation monitoring records that relate to the specific lot offered for import; 2. Obtain a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported juice was processed in accordance with the HACCP regulation; 3. Inspect the foreign processor's facilities to ensure that the product is produced in accordance with the HACCP regulation; 4. Maintain a copy, in English, of the foreign processor's hazard analysis and HACCP plan along with along with a written guarantee from the processor that the juice was processed according to the HACCP regulation; or

5. Periodically test the imported juice and maintain a written guarantee from the processor that the juice was processed according to the juice HACCP regulation. The regulation also allows importers to develop their own affirmation procedures as long as they provide an equivalent level of assurance of compliance with the HACCP regulation. The importer must also maintain records that document the performance and results of their affirmative steps. These records are subject to the record retention, access, and other record provisions of the regulation.

Components of an Importer HACCP Inspection

The components of a HACCP inspection of an importer are:

Conduct the initial interview Select product(s) to review Determine the foreign sources of the selected imported juice product(s) Review importer's product safety specifications Review importer's verification plans Review importer's verification records Document objectionable conditions

Conduct Initial Interview

The initial interview is the same as the initial interview for a domestic processor. During this time, you will be identifying yourself, displaying your credentials, issuing a Notice of Inspection and learning what juice products the importer imports.

Select Product
Importers may only deal with one or two products but, most likely, they will handle numerous juice products and you will need to determine which product or products to evaluate. You should consider the same factors that you use in inspecting domestic processors when you make this determination. Examples are:

the product's potential to contain a safety hazard, products covered during previous inspections, and the product's compliance history.

Where past inspections of an importer detected significant problems with a particular product, your follow-up inspections should, as usual, concentrate on those or similar products. However, in the absence of past compliance problems, you should ordinarily review products which have not yet been inspected.

Determine Foreign Sources

Next you need to determine the countries from which the importer receives their juice products. If the specific juice products are obtained from countries with active juice HACCP MOUs with FDA, you should use your judgement to determine whether it is necessary to look at some of the importer's invoices to verify that the juice the importer imports is indeed from such countries.

Review Product Safety Specifications

When importers import juice from countries that do not have active juice HACCP MOUs with the United States, you should review their written verification procedures. One component of verification procedures must be product specifications (21 CFR Part 120.14). These specifications must address the safety attributes of the product. In most cases, the specifications will be derived from existing Federal food safety standards, including tolerances and guidelines. In other cases the specifications may need to be tailored to the circumstances. Importers may seek the advice of qualified experts, as needed, in setting safety specifications.

Review Written Verification Plans

The second part of the importer's written verification procedures must be affirmative steps to verify that their foreign suppliers are in fact operating in a manner that is consistent with the juice HACCP regulation (21 CFR Part 120.14). The regulations allow the importers to select affirmative steps that are workable for their circumstances. The importer can use any one or more of the five affirmative steps, as long as the steps provide assurance that the foreign processor is in compliance with the regulation. At this point in your inspection, review the affirmative step(s) the importer is using for the products that you have selected for coverage. If the affirmative step is not one of the five affirmative steps as stated in the regulation, then you must determine whether it provides an equivalent assurance of foreign processor compliance.

Review Verification Records

Once you have established which affirmative step is being used, you should review the importer's verification records. Importer records must meet the same requirements as domestic processing records (21 CFR Part 120.12 and 120.14). These include their name and address on the records, signature or initials, proper record retention time, etc. During this review, you will be determining whether the verification procedures have been carried out. The regulation does allow the importer to use the services of a competent third party to perform the affirmative steps (21 CFR Part 120.14). However, the importer is still the responsible party and must have the verification documents at their disposal. The most difficult element of reviewing verification records is evaluating foreign processor HACCP plans when the importer has elected to use them as an affirmative step. If an importer has HACCP plans on hand for products that you have chosen for coverage, you should choose

several and review them using the procedures that were taught in earlier chapters. The difficulty is that you will not be able to compare the HACCP plan with the actual processing plant nor will you have the opportunity to ask questions of the processor. You will have to rely solely on the Hazards and Controls Guide, other references, and your experience to evaluate the adequacy of the hazards and controls contained in the plan. If the HACCP plan is inadequate, then the imported product is deemed to be adulterated.

Inspection Frequency
Inspections of importers will be conducted at a frequency and under conditions specified by the agency, independent of the entry process. Districts will be assigned a number of such inspections to be performed. The compliance program will also provide a prioritization system to assist the districts in selecting importers for inspection.

Chapter 14

Special Considerations
Overview
There are three special considerations relating to HACCP inspections, which will be discussed in this chapter. They are:

Collecting physical samples Federal - state contracts Preliminary HACCP inspections

Collecting Physical Samples

Sampling has always been an important component of inspections (Section 702(b) of the FD&C Act). Therefore, inspectors frequently ask what to do about sampling under the new juice HACCP regulation. Inspectors want to know if they are to collect a physical sample to help verify that a HACCP plan is controlling the significant hazard or collect the sample only when a firm is having problems with their HACCP program. Some states only collect physical or environmental samples when they are likely to support observations of significant objectionable conditions made during an inspection. They do not have the resources to routinely collect and analyze samples without cause. Even if every regulatory agency had the resources, sampling is not a very effective way of identifying certain kinds of problems, such as low-level microbiological or physical contamination. Large sample sizes of perhaps 10% or more of the total lot, may be needed to determine if the product is contaminated. The time and cost of analyzing samples that large is, in most cases, prohibitive.

When performing a HACCP inspection, the general rule is not to obtain a physical sample of the product for compliance purposes. The HACCP regulation is based on various sections of the Federal Food, Drug, and Cosmetic Act, but most notably section 402(a)(4). Documentation of a deficient HACCP program, in most cases, will demonstrate that the product had been prepared, packed, or held under insanitary conditions and is therefore adulterated under section 402(a)(4) of the Act. A physical sample is not needed to support a 402(a)(4) charge. There are, however, situations when collecting a physical sample may be appropriate. Generally speaking, physical samples may be collected when, in your judgement, they are likely to disclose the presence of a defect and would be useful to support a 402(a)(1) charge in that the product "bears or contains any poisonous or deleterious substance which may render it injurious to health." For example, you may want to collect an apple juice sample to show patulin formation when you have documented visually moldy apples being processed into juice. During any inspection you also may need to obtain a physical sample to fulfill the requirement of a compliance program or special assignment, such as the collection of survey samples. For example, it is anticipated that a number of surveillance samples will be collected to assess the overall effectiveness of the national HACCP program. Physical samples may be collected to document that a product is violative because of a nonsafety defect. An example would be the need to collect a physical sample to document filth. While filth is not a health hazard, and therefore is not covered by the juice HACCP regulation, it is an adulterant. In this case, the physical sample would be used to document a violation of 402(a)(3) of the Act.

Federal - State Contracts

Another special consideration are the contracts between the FDA and state agencies in enforcing the juice HACCP regulation. The main objective of a contract is to harmonize and eliminate duplication in juice processing inspections. Doing so should more effectively utilize the expenditure of resources by the agencies. Another benefit will be information sharing including current, pertinent enforcement data.

Preliminary Inspections
FDA recommends that all firms implement HACCP as quickly as possible in the interest of public health safety. However, under the regulation, the effective dates vary depending on the size of the business. The effective dates for compliance with the juice HACCP regulation are January 22, 2002 for all businesses not defined as "small businesses" or "very small businesses," January 21, 2003 for small businesses, and January 20, 2004 for very small businesses. Initial inspections are planned as educational, i.e., to assist the processor in determining deficiencies in their plan. It will also provide you, the inspectors, with hands-on experience in HACCP-based juice inspections. These evaluations should serve to aid the development of both the industry's HACCP programs and the inspector's HACCP inspection skills. However,

violations unrelated to the implementation of the HACCP system, or, if no attempt has been made to implement HACCP, FDA will take regulatory action.

~Safer Processing of Juice ~

A Food Safety Training Program Developed by the California Department of Health Services
Many consumers enjoy juice products for the taste and nutritional value. However, as evidenced by recent outbreaks, unpasteurized juice can also serve as a vehicle for foodborne illness. The California Department of Health Services, Food and Drug developed this video in cooperation with the U.S. Food and Drug Administration, Centers for Disease Control & Prevention, university researchers, and industry representatives to assist the industry in producing a safer product. The video may also be useful for retailers, regulators, and anyone working with the industry who wants to better understand the product and current recommendations for best production practices.

Topics covered in the video:

Introduction to food safety, juice products as a special case Regulations, Requirements, and Guidance Personnel Practices Cleaning and Sanitizing Agricultural Practices and Raw Materials Processing, Design and Packaging Performance Standards and Intervention

*To order just complete this form and send with your payment to:
CA Dept of Health Services, Food and Drug Branch, (MS 7602), P.O. Box 997413, Sacramento, CA 95899-7413 for questions call (916) 650-6500
PRODUCT Safer Processing of Juice video, Domestic Shipping & Handling (NTSC Format) Safer Processing of Juice video, International Shipping & Handling (NTSC Format) PRICE $28.00 $53.00 QTY. TOTAL Name*: Company*: Address* City * Phone # * Required information 9/04 State* SHIP TO:

FDA Miscellaneous Juice HACCP Guide idelines

FDA Miscellaneous Juice HACCP Guide idelines

Guidance for Industry Final Guidance U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition April 24, 2003
This guidance represents FDA's current thinking on the control measures juice processors may need to use to ensure that juice concentrates and certain shelf stable juices do not become contaminated or recontaminated with microbial pathogens during bulk transport. The guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of applicable statutes and regulations. Purpose of guidance The purpose of this guidance is to provide industry with recommendations for appropriate control measures to use in the bulk transport of: 1. high degree Brix juice concentrate that is transported to a separate facility for final packaging or for dilution to a consumer strength concentrate and final packaging, and 2. shelf stable single strength juice that is transported in aseptic packaging to a separate facility for final packaging. For the bulk transport of high degree Brix juice concentrate, two container types are considered in the guidance: multi-use or reusable containers (e.g., tankers, reusable drums without liners, and reusable totes without liners) and single-use sanitary containers or liners (e.g., single-use sanitary totes, single-use sanitary drums, bag-in-box containers, totes with single-use sanitary liners, and drums with single-use sanitary liners). Background The juice industry produces thermally treated commercial or institutional concentrate that may be transported to a separate facility for further processing and packaging. At the subsequent facility, the commercial concentrate may be repacked or diluted to a consumer strength concentrate and packed in final packaging. This guidance is concerned with the bulk transport of juice concentrates1 that are put in final packaging or further processed and put into final packaging at a location different than where the juice was processed. Also included in this guidance are recommendations for the bulk transport of aseptically packaged shelf stable single strength juices that are put into final packaging at a location different than where the juice was processed. The juice HACCP regulation (21 CFR Part 120) requires that a processor of juice evaluate its operations using Hazard Analysis Critical Control Point (HACCP) principles. If the evaluation shows that one or more hazards is reasonably likely to occur in the absence of controls, the processor must develop and establish control measures for the hazard(s). For the hazard of contamination with a pathogenic microorganism, the regulation requires the processor to incorporate control measures into its HACCP plan that will consistently produce a 5-log pathogen reduction in the facility where the final packaging is done (120.24(a) and (c)).

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A processor of shelf stable or concentrated juice (referred to as "covered products") made at a single facility that includes thermal treatment of all ingredients is exempt from the requirement to include in its HACCP plan a critical control point that achieves the 5-log pathogen reduction. The thermal process that is integral to the manufacture of these products consistently delivers a microbial pathogen reduction that far exceeds the 5-log pathogen reduction standard in the juice HACCP regulation. Under the juice HACCP regulation, to qualify for these exemptions from the 5-log pathogen reduction requirement, the processor must include a copy of the thermal process in its hazard analysis (120.24(a)(2)), the thermal processing step must be accomplished within a single production facility, and the final product packaging must be performed in the facility where the thermal processing is accomplished (120.24(c)). The requirement in 120.24 (c) that the 5-log pathogen reduction and final packaging occur within a single facility ("single facility requirement") was established because FDA is concerned about post-process contamination of juice. Specifically, the agency is concerned that separating the pathogen reduction steps and final packaging in time and space may compromise the HACCP system, including the pathogen reduction. FDA received a citizen petition from industry asking the agency to exempt processors of the covered products from the requirement to perform a second 5-log pathogen reduction treatment when the covered product manufactured in one facility is sent to another facility for final packaging because the transportation hazards that 120.24 (c) was designed to address could be adequately controlled as part of a processor's HACCP plan. Although FDA is concerned with the potential for contamination during bulk transport of juice, as noted below, we have decided to consider the exercise of enforcement discretion as to the single facility requirement provided that certain conditions are met. Scope of guidance This guidance applies to the covered products, containers used to carry the covered products, and equipment used to load, carry, and unload the covered products. Covered products 1. High degree Brix juice concentrate that is transported, diluted, and packaged at a separate facility as either frozen juice concentrate for consumer use or as institution concentrate. This guidance does not apply to concentrate processed into single strength juice. 2. Shelf stable juice that is transported in bulk aseptic packaging and repackaged into final packaging at a separate facility. Containers 1. Multi-use containers used to carry the covered product; after transporting the product, multi-use containers are cleaned, sanitized, and reused. This guidance addresses three types of multi-use containers: 1) tankers, i.e., tankers transported by truck, ship, or railroad, 2) reusable totes without liners, and 3) reusable drums without liners. 2. Single-use sanitary containers and reusable containers with single-use sanitary liners used to carry the covered product; the five types of single-use containers or liners covered in this guidance are: 1) sanitary bag-in-box (BIB) containers, 2) reusable totes with sanitary single-use liners, 3) reusable drums with sanitary single-use liners, 4) sanitary single-use drums, and 5) sanitary single-use totes. The term "sanitary" is used with single-use containers and liners to mean that the containers and liners are produced, handled,

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dispensed, and disposed of in a manner that protects against the contamination of food and food-contact surfaces. Other equipment Equipment other than containers used in bulk transport of the covered product includes equipment used to: 1) load the covered product into an empty container at the producer's facility and 2) unload the covered product at the user's (receiver's) facility. In general, pumps and fittings (e.g., elbows, hoses, gaskets, valves, nozzles, clamps, seals) are the two types of equipment used to perform these tasks. Specific equipment may vary depending on the type of container used. Conditions for the exercise of enforcement discretion FDA intends to consider the exercise of enforcement discretion for covered products when the following three conditions are met: 1. The producer and user (receiver) establish appropriate prerequisite programs and sanitation standard operating procedures (SSOPs) for the bulk transport of covered products. 2. The producer and user designate as a critical control point (CCP) in their respective HACCP plans, the bulk transport of covered products from the production facility to a separate facility for further processing and final packaging. 3. The producer and user establish control measures to prevent, reduce to acceptable levels, or eliminate the risk of contamination or recontamination of covered products during bulk transport. General Recommendations FDA is providing this guidance to producers and users to aid their development of measures to prevent, reduce to acceptable levels, or eliminate the risk of contamination or recontamination of covered products during bulk transport. The guidance describes five major areas of concern with bulk transport systems, special considerations for tankers, examples of control measures for loading and unloading covered product into tankers, and an example of critical control points a producer could use to include bulk transport in its HACCP plan. FDA recommends that producers and users evaluate their bulk transport operations (loading, carrying, and unloading covered product) using HACCP principles and implement control measures to ensure that bulk transport does not contaminate or recontaminate the covered product with microbial pathogens. The producer and user may address some hazards with control measures in their prerequisite programs and SSOPs, while other hazards should be incorporated into HACCP plans at critical control points (CCPs) where critical limits, monitoring, and verification will provide additional assurances that the covered product will not become contaminated. An example of when a producer should address the hazard of microbial contamination as a critical control point in bulk transport would be at the receipt of an empty tanker because no subsequent step in transport could eliminate this hazard. To establish control measures for bulk transport, the producer and user of the covered product should have a thorough understanding of the procedures and equipment used to load, carry, and unload the covered product and the procedures and materials used to maintain and

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clean such equipment. Additionally, to help ensure that the control measures are effective, the producer, transporter, and user should make communication a high priority. FDA recommends that the producer and user conduct their hazard analyses focusing on five areas of concern with bulk transport: 1) sanitation operations, 2) equipment design, 3) equipment maintenance, 4) employee practices, and 5) loading and unloading areas. These are areas of concern for both multi-use containers (e.g., tankers) and single use containers (e.g., sanitary bag-in-box) used in bulk transport. Sanitation operations Consistent with the juice HACCP regulation, sanitation operations for equipment and containers used in bulk transport must be in accordance with the Current Good Manufacturing Practices (CGMPs) regulation (21 CFR Part 110) and the Sanitation Standard Operating Procedures (SSOPs) as described in the Juice HACCP regulation under 120.5 and 120.6, respectively. Under 110.35 (d) of the CGMPs, food contact surfaces of the equipment must be cleaned as frequently as necessary to protect against contamination of food. Similarly, under 110.35(d)(3), non-food contact surfaces of the equipment should also be cleaned as frequently as necessary. Cleaning and sanitizing protocols should be tailored to the size and configuration of the container and other equipment and the type of food grade product carried in the previous load. Cleaning and sanitizing systems for multi-use equipment may include both clean-out-of-place (COP) systems for removable components and clean-in-place (CIP) systems for large containers, i.e., tankers. A previous load of an oil-based food in a multi-use container may indicate that an alkaline detergent should be used and that the cleaning and sanitizing protocol should have an additional step to degrease the container before cleaning. Only sanitizing solutions that are covered by appropriate FDA food additive regulations should be used (21 CFR 178.1010). Sanitizers and cleaning solutions should be used in the concentration recommended by the manufacturer. The temperature, pressure, and potability of the water used in cleaning, sanitizing, and rinsing should be sufficient to ensure that the equipment is adequately sanitized.2 The producer and user should obtain, review, and verify sanitizing protocols used by the transporter. Verification activities may include periodic audits of the transporter's wash station. Equipment design Equipment and containers that come in contact with the food being transported should be constructed of food grade materials and designed to have a smooth, easily cleanable, nonabsorbent, corrosion-resistant surface (e.g., stainless steel AISI series 200 and 300 with a minimum chromium content of 16 percent and a No. 3 finish or higher). The surfaces should be clean and sanitary without physical defects or corrosion. Seals used on containers should be uniquely numbered and tamper-evident. Single-use containers without liners (i.e., bag-in-box containers, single-use totes, and single-use drums) and liners should be clean and sanitary with inner surfaces compatible with food materials and should present no physical defects or abnormalities. Single-use containers with liners, i.e., totes with liners and drums with liners, should be designed for use with liners. Single-use liners and their closures should be of sufficient structural integrity to prevent food

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materials from contacting outer containers. Liners should be produced in a manner that results in clean, sanitary inner surfaces. Like single-use containers, multi-use containers (e.g., tankers, reusable totes without liners, and reusable drums without liners) should be designed with inner surfaces clean and sanitary, compatible with food materials and should present no physical defects or abnormalities. Unlike single-use containers, multi-use containers will be reused and should be adequately cleaned and sanitized before they are used again. Multi-use containers should be designed to be easily and adequately cleanable. Seams on the food contact surfaces should be smoothly bonded and maintained to minimize accumulation of food particles, dirt, and organic matter, and thus minimize the opportunity for the growth of microorganisms. Preventive maintenance Preventive maintenance programs should be established to ensure the proper functioning of the equipment and integrity of the food contact surfaces. Periodic inspection of containers and equipment and periodic replacement of gaskets and flexible hoses are examples of preventive maintenance programs. Employee practices Employee practices must be in conformance with the CGMPs and the SSOPs as described in the Juice HACCP regulation under sections 120.5 and 120.6, respectively. In accordance with the Juice HACCP regulation, all employees working in the loading and unloading areas in direct contact with the covered product must employ hygienic practices to protect against microbiological contamination of the covered product. Employees responsible for the loading and unloading of the covered product should be trained about the measures to prevent contamination of the covered product. Competent supervisory personnel should oversee employee practices. Loading and unloading areas In addition to the equipment used in bulk transport, the loading and unloading areas should be designed and maintained in accordance with the CGMPs in 21 CFR Part 110. The areas should be maintained in sanitary condition and in good repair to prevent contamination of the covered product. Special Considerations for Tankers Because of the complexity, size, multiple configurations and accessories, and the potential for contamination from previously transported product, the producer and user should carefully scrutinize tanker operations, i.e., cleaning, sanitizing, loading, carrying, and unloading, to ensure that sufficient control measures are in place to adequately safeguard against contamination of the juice concentrate. FDA recommends that a producer use tankers dedicated to carrying only treated juice products. If it is not feasible to use a dedicated tanker, the producer should demonstrate in its hazard analysis that the cargo permitted as a load prior to carrying the juice concentrate does not add to the risk of microbial contamination of the concentrate. An example of cargo that would have a similar low level of risk would be a treated food or food grade product that is easily cleanable, e.g., citric acid.3 The producer should demonstrate that the permitted cargo offers the same low level of risk of microbial contamination, as does a treated juice product.

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Producers and users should have written agreements between each other and with the transporter as a means of control. To make such controls effective, producers and users should perform verification activities such as periodic inspection of the hauler and cleaning stations, environmental testing of containers, product testing, periodic inspection of employee practices, e.g., hand washing, and periodic inspection of the condition of the equipment. An example of an agreement with a transporter that both the producer and user should consider is an agreement regarding the transporter's cleaning and sanitizing protocol. The provisions of a cleaning and sanitizing protocol will depend on the configuration of the container and the previous load. A cleaning and sanitizing protocol for a complex container such as a tanker that has many removable parts and a venting system will differ from a cleaning and sanitizing protocol for a 55-gallon reusable drum. A cleaning and sanitizing protocol for a tanker with a previous load that was oil-based should include a degreasing step, but if the previous load was a water-based food, the degreasing step should not be used. An example of a cleaning and sanitizing protocol for a tanker is set out below: Recommended protocol for cleaning and sanitizing a tanker 1. Before cleaning and sanitizing Determine previous load and cleaning and sanitizing protocol. Protocol should eliminate pathogenic microorganisms and other hazardous contaminants. Drain completely. High-pressure rinse or scrub interior surfaces if residue is still present. 2. Pre-rinse interior of tanker Rinse with potable water. Degrease if previous load was oil-based material. Use degreaser/detergent in accordance with manufacturer's recommendations. Drain. 3. Clean--primary interior tanker surfaces Use appropriate cleaner in accordance with cleaner manufacturer's recommendations. Drain completely. 4. Clean--removable components (COP) Hand clean (or use automatic COP system) rear valve, gaskets, and other removable parts. Use appropriate cleaner in accordance with the cleaner manufacturer's recommendations. 5. Rinse (if required) interior of tanker Rinse with ambient, potable water until completely clear. Test by measuring pH of rinse water (pH=neutral). Drain thoroughly. 6. Inspection of tanker interior Visually inspect from exterior with inspection light. Verify removal of residues and excess liquids.

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7. Sanitize--interior of tanker and removable parts Sanitize all food contact surfaces and all removable parts and components. Use food-grade sanitizer diluted with potable water according to sanitizer manufacturer's recommendations for concentrations and time/temperature of use. 8. Rinse (if required) interior of tanker Rinse with ambient, potable water until completely clear. Test by measuring pH of rinse water (pH=neutral). Drain thoroughly. 9. Seal Immediately after draining, seal all points of entry and discharge. Use numbered tamper-evident seals.

10. Record information about the wash Include date and time, seal numbers, trailer number, and cleaning and sanitizing protocol on the current wash ticket. Maintain copies of wash records for period of time agreed upon by customer. Clean exterior of tanker only after sealing tanker.

Examples of control measures for tanker transport of covered product The producer and user should each establish control measures for bulk transport of covered products. The producer and user should determine where each of its control measures should be incorporated, i.e., into prerequisite programs or as a critical control point in its HACCP plan. Examples of control measures that may be appropriate for the producer in loading a covered product into a tanker and for the user in unloading a covered product from a tanker follow:

Recommended control measures for loading a tanker 1. Inspect the empty tanker upon arrival to verify that: The tanker is marked for food grade use. The tanker access points were sealed at the wash station with numbered, tamperevident seals at all major points of entry and discharge. (Sealing points may include the dome cover, tank outlet, vent cap, pump inlet, pump outlet, and hose tube covers.) The hoses and pump outlets were capped and sealed after cleaning and sanitizing. The integrity and cleanliness of the tanker and its component parts are apparent. o The interior of the tank is clean, dry, and free of cracks, corrosion, and residues from the prior load. o The seals, gaskets, pumps, valves, hoses, and all hose tubing is clean and free of cracks, corrosion, and residues from prior load.

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There is no presence of off-odors when opening the dome cover of the tanker.

2. Review and verify that the wash ticket from the transporter contains: Certification of the last load. Cleaning and sanitizing protocol used for the last load. Seal identification. (Seal numbers should be recorded on the wash ticket and verified by the producer.) 3. Prior to loading the tanker, producer should verify that: The loading facility is maintained according to CGMPs. The employees follow CGMPs and SSOPs. The integrity and cleanliness of the transfer equipment (i.e., pumps, hoses, and associated equipment) are apparent. 4. Immediately after loading the tanker, the producer should verify that: The tanker is closed and numbered, tamper-evident seals are affixed to any access ports that were unsealed during inspection. The bill of lading contains correct seal numbers and cargo identification. A copy of the wash ticket is provided to the outbound tanker for the user. Recommended control measures for unloading a tanker 1. Review and verify documentation from the transporter, including Bill of lading from the producer containing security seal numbers and identification of cargo. Wash ticket. 2. Inspect the loaded tanker to verify that- The tanker is marked for food grade use. The tanker access points were sealed at the producer's facility with numbered, tamper-evident seals at all points of entry and discharge. The numbers of the tamper-evident seals match those listed on the bill of lading. The integrity and cleanliness of the transfer equipment are apparent. The integrity and cleanliness of the tanker and its component parts are apparent. Conduct periodic review of these activities performed upstream to verify that appropriate controls are in place and effective. An example of tanker transport: a producer's critical control points, conditions to be monitored and verified, and critical limits Some hazards in tanker transport may be addressed adequately in SSOPs, while others may require additional assurances in the form of critical control points in the processor's HACCP plan. In the following example, a producer of a high degree Brix juice concentrate determines that

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tanker transport in his facility can be divided into three separate processes, two of which are critical control points: Recommended critical control points and critical limits for a producer Product description High degree Brix juice concentrate transported by tankers Tanker transport processes 1. Receipt of empty tanker (critical control point). 2. Loading of empty tanker (controlled by prerequisite programs and SSOPs). 3. Preparation of loaded tanker for shipping (critical control point). CCP 1-Receipt of empty tanker For the first CCP, the producer should have a written agreement from the transporter that the empty tanker has been adequately sanitized. The agreement should identify the transporter's cleaning and sanitizing protocol and provide assurances that the cleaning and sanitizing protocol has been followed. The producer should monitor and verify the following three conditions: 1. Intact seals on empty tanker. 2. Presence of complete wash ticket, including: a. Certification of last load. b. Cleaning and sanitizing protocols used for last load. c. Seal numbers that match seals on the tanker. 3. Integrity of the tanker and its component parts. Critical Limit for CCP 1 The critical limit for the three conditions is that the conditions must be satisfied, i.e., the tanker seals must be uncompromised, the wash ticket must be complete and correct, and the tanker and its component parts must be without corrosion or cracks. If any one of these three conditions is not met, the tanker should be rejected. CCP 2-Preparation of loaded tanker for shipping For the second CCP, the producer should provide assurances to the user that a clean, intact, properly sanitized tanker was used to carry the product, the tanker was adequately sealed, and the documentation accompanying the tanker is correct and complete, i.e., the seal numbers listed in the documentation match those on the tanker. The producer should monitor and verify the following three conditions: 1. Seals are applied correctly on the loaded tanker. 2. Complete and correct wash ticket accompanies loaded tanker. 3. The current bill of lading has correct product identification and seal numbers on loaded tanker.

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Critical Limit for CCP 2 As with CCP 1, the critical limit for the conditions in CCP 2 is that the conditions must be satisfied, i.e., the seals must be applied properly and the appropriate documentation, the wash ticket and bill of lading, must accompany the loaded tanker. Until all of these conditions are met, the tanker should not be shipped to the user.
Commercial concentrate may also be sold to processors making single strength juice, juice blends, or beverages containing juice. However, manufacturing and packaging processes for single strength juice or beverages containing juice differ from processes for concentrated juice products. Single strength juice products made from concentrate are typically treated to control spoilage organisms immediately before final consumer packaging or are made into shelf stable products. In both cases the final heat treatment achieves a 5-log or greater pathogen reduction. Adequately sanitized means treated by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. Although this guidance is focused on microbial contamination in bulk transport, a producer should also consider the potential for chemical contamination if cargo in prior loads could cause allergic reactions (e.g., milk and eggs) or could be carcinogenic or toxic (e.g., non-food grade dyes, inks, pigments).
3 2 1

Notes:

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Guidance for Industry Guidance for Industry (1) This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if such approach satisfies the requirements of the applicable statute and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this document.

Table of Contents
I. Introduction II. Background III. Discussion I. INTRODUCTION This guidance is intended for processors of refrigerated carrot juice and other refrigerated lowacid juices, which can pose a risk of botulism poisoning if juice that is not processed to eliminate or prevent the growth of Clostridium botulinum spores that may be present is subsequently stored without proper refrigeration. The recommendations in this guidance only pertain to low-acid juice products subject to the pathogen reduction provisions of the Hazard Analysis and Critical Control Point (HACCP) requirements of 21 CFR Part 120 (the juice HACCP regulations). This guidance does not pertain to low acid and acidified juice products subject to the requirements of 21 CFR Parts 108, 113 and 114. (Such products are not subject to the pathogen reduction provisions in the juice HACCP regulations, 21 CFR 120.24.) Further, these recommendations do not pertain to any other foods that need refrigeration by consumers to maintain product safety. For other foods that need refrigeration by consumers to maintain product safety, see the guidance for the labeling of such foods at http://www.cfsan.fda.gov/guidance.html. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency's current thinking on a topic and should be viewed only as a recommendation, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required. II. BACKGROUND Botulism is a rare but serious paralytic illness caused by botulinum toxin, a nerve poison that under certain conditions is produced by C. botulinum, a bacterium commonly found in soil. Botulism can be fatal and is considered a medical emergency. Foodborne botulism is not common in the United States. Four cases of botulism linked to refrigerated carrot juice occurred in the United States and two cases occurred in Canada in September and October of 2006. The implicated products, all of which came from a single firm, were pasteurized but were not heated to a temperature that would eliminate spores of proteolytic (the most heat resistant type) C. botulinum. Subsequent testing of

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leftover carrot juice recovered from the home of one of the affected persons found botulinum toxin in the juice. The carrot juice products involved in these illness cases were distributed under refrigeration with one or more of the following label statements "Keep Chilled," "Keep Refrigerated," "Perishable Keep Refrigerated," or "Extremely Perishable Keep Refrigerated." Because proteolytic C. botulinum spores are known to grow and produce toxin only under severe temperature abuse conditions,(2) FDA suspects that the juice involved in these outbreaks may have been left unrefrigerated for an extended period, either during distribution or while being held by consumers, allowing C. botulinum spores to grow and produce toxin. Given the recent botulism illnesses associated with refrigerated carrot juice, FDA believes that its existing guidance does not adequately address the risk of serious illness if carrot and other low acid juices that need refrigeration to maintain product safety are subject to severe temperature abuse. FDA is therefore modifying its earlier guidance on this issue(3) and is issuing these recommendations for industry concerning the processing and labeling of refrigerated carrot juice and other refrigerated low-acid juices subject to the pathogen reduction provisions of the juice HACCP regulations. III. DISCUSSION The juice HACCP regulation requires processors to conduct a science-based analysis of potential hazards that can occur in their juice products to determine where hazards can occur in their processing operations. The regulation also requires that processors implement control measures at points where hazards can occur to prevent safety problems with their products, e.g., the presence of bacterial contamination that may cause illness. FDA established the juice HACCP regulation in response to a rise in illness outbreaks associated with juice products. These outbreaks were primarily due to the contamination of juice products by enteric pathogens such as E. coli O157:H7 and Salmonella spp. In the preamble of the HACCP final rule published in the Federal Register of January 19, 2001, (66 FR 6148), FDA addressed a comment about the status of spore forming bacteria, e.g., C. botulinum, under the HACCP regulations. It stated that "spore forming bacteria have not been associated with public health problems in juice that has been properly handled (e.g., refrigerated) after leaving the processing plant. Therefore, FDA does not anticipate that processors' hazard analyses will establish that spore forming bacteria are a hazard that is reasonably likely to occur." However, after additional consideration of this matter, FDA, in its Juice HACCP Hazards and Controls Guidance issued in 2004, expressed concern that proteolytic strains of C. botulinum, if present in refrigerated low acid juices such as carrot juice, could produce toxin in the juice if it was subjected to severe temperature abuse. FDA recommended (See Section V. C. 1.1) that processors include a label statement on the product stating that the juice should be kept refrigerated: Low-acid juices, such as carrot juice, that are distributed under refrigeration, and are not subject to the Low Acid Canned Foods regulation (21 CFR Part 113) may pose hazards associated with spore forming pathogens, specifically, toxins of non-proteolytic and proteolytic strains of Clostridium botulinum. Control measures for such juices are likely to involve multiple measures, e.g., a combination of a process step to destroy the non-proteolytic spores and measures to ensure that "Keep Refrigerated" labeling is used for the juice if the juice does not receive a treatment sufficient to destroy the proteolytic spores (Destruction of spores of the proteolytic strains requires a more severe heat treatment but germination and growth of these spores may be prevented by keeping the product under refrigeration during its lifecycle. Destruction of spores of

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the non-proteolytic strains requires a less severe heat treatment, but these spores can germinate and produce toxin even under refrigerated storage conditions). The juice HACCP regulation only addressed the control of hazards that could occur in juice stored under normal and moderate abuse conditions during the product's shelf life (21 CFR 120.24(a)). In light of the recent botulism cases, FDA believes that it is now also necessary to address the control of hazards that could occur in low acid refrigerated juice subjected to severe temperature abuse. Therefore, FDA is modifying its previous guidance on this issue. FDA is now recommending that firms subject to the pathogen reduction provisions of the juice HACCP regulation incorporate validated control measures for all C. botulinum spores into their HACCP plans that will be applied in the processing facility and that will ensure that C. botulinum growth and toxin production will not occur should the juice, as offered for sale by the processor, be kept unrefrigerated in distribution or by consumers. This objective could be achieved by any validated treatment method that is effective for this purpose, e.g., acidification of the juice to a pH of 4.6 or below, thermal treatment of the juice. As part of these control measures or a firm's sanitation standard operating procedures, we recommend that firms ensure that all post processing equipment that contacts the juice, e.g., container filling equipment, is cleaned and sanitized adequately to prevent post processing contamination of the juice by C. botulinum spores from equipment surfaces. We also recommend that these include control measures to provide for the effective performance of their container closures (plastic caps, foil seals) in minimizing any risk of post process contamination of the juice by C. botulinum spores. Furthermore, FDA recommends that firms continue to utilize a label statement such as "Keep Refrigerated," along with implementation of the pathogen reduction control measures set forth in this guidance. Such labeling, when prominently displayed, serves as an additional precautionary measure to minimize the risk that these juices could become unsafe if post processing contamination of the juice by spores of C. botulinum should occur for any reason.
(1) This guidance has been prepared by the Division of Plant Product Safety in the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration. (2) The juice would have to be left unrefrigerated for a period sufficient to allow the juice to attain and remain at temperatures of 50 or above for an extended period. This is considered to be severe temperature abuse. (3) See the Juice HACCP Hazards and Controls Guidance - First Edition

180

Guidance for Industry

Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices

June 2007 Additional copies are available from: Office of Plant and Dairy Foods Division of Plant Product Safety, HFS-305 Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740 (Tel) 301-436-2022 http://www.cfsan.fda.gov/guidance.html

U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition June 2007

Contains Nonbinding Recommendations This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if such approach satisfies the requirements of the applicable statute and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this document.

Table of Contents
I. II. III. Introduction Background Discussion

I. INTRODUCTION
This guidance is intended for processors of refrigerated carrot juice and other refrigerated lowacid juices, which can pose a risk of botulism poisoning if juice that is not processed to eliminate or prevent the growth of Clostridium botulinum spores that may be present is subsequently stored without proper refrigeration. The recommendations in this guidance only pertain to low-acid juice products subject to the pathogen reduction provisions of the Hazard Analysis and Critical Control Point (HACCP) requirements of 21 CFR Part 120 (the juice HACCP regulations). This guidance does not pertain to low acid and acidified juice products subject to the requirements of 21 CFR Parts 108, 113 and 114. (Such products are not subject to the pathogen reduction provisions in the juice HACCP regulations, 21 CFR 120.24.) Further, these recommendations do not pertain to any other foods that need refrigeration by consumers to maintain product safety. For other foods that need refrigeration by consumers to maintain product safety, see the guidance for the labeling of such foods at http://www.cfsan.fda.gov/guidance.html.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as a recommendation, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. BACKGROUND
Botulism is a rare but serious paralytic illness caused by botulinum toxin, a nerve poison that under certain conditions is produced by C. botulinum, a bacterium commonly found in soil. Botulism can be fatal and is considered a medical emergency. Foodborne botulism is not common in the United States. Four cases of botulism linked to refrigerated carrot juice occurred in the United States and two cases occurred in Canada in September and October of 2006. The implicated products, all of which came from a single firm, were pasteurized but were not heated to a temperature that would eliminate spores of proteolytic (the most heat resistant type) C. botulinum. Subsequent testing of leftover carrot juice recovered from the home of one of the affected persons found botulinum toxin in the juice. The carrot juice products involved in these illness cases were distributed under refrigeration with one or more of the following label statements "Keep Chilled," "Keep Refrigerated," "Perishable Keep Refrigerated," or "Extremely Perishable Keep Refrigerated." Because proteolytic C. botulinum spores are known to grow and produce toxin only under severe temperature abuse conditions,(2) FDA suspects that the juice involved in these outbreaks may have been left unrefrigerated for an extended period, either during distribution or while being held by consumers, allowing C. botulinum spores to grow and produce toxin. Given the recent botulism illnesses associated with refrigerated carrot juice, FDA believes that its existing guidance does not adequately address the risk of serious illness if carrot and other low acid juices that need refrigeration to maintain product safety are subject to severe temperature abuse. FDA is therefore modifying its earlier guidance on this issue(3) and is issuing these recommendations for industry concerning the processing and labeling of refrigerated carrot juice and other refrigerated low-acid juices subject to the pathogen reduction provisions of the juice HACCP regulations.

III. DISCUSSION
The juice HACCP regulation requires processors to conduct a science-based analysis of potential hazards that can occur in their juice products to determine where hazards can occur in their processing operations. The regulation also requires that processors implement control measures at points where hazards can occur to prevent safety problems with their products, e.g., the presence of bacterial contamination that may cause illness. FDA established the juice HACCP regulation in response to a rise in illness outbreaks associated with juice products. These

outbreaks were primarily due to the contamination of juice products by enteric pathogens such as E. coli O157:H7 and Salmonella spp. In the preamble of the HACCP final rule published in the Federal Register of January 19, 2001, (66 FR 6148), FDA addressed a comment about the status of spore forming bacteria, e.g., C. botulinum, under the HACCP regulations. It stated that "spore forming bacteria have not been associated with public health problems in juice that has been properly handled (e.g., refrigerated) after leaving the processing plant. Therefore, FDA does not anticipate that processors' hazard analyses will establish that spore forming bacteria are a hazard that is reasonably likely to occur." However, after additional consideration of this matter, FDA, in its Juice HACCP Hazards and Controls Guidance issued in 2004, expressed concern that proteolytic strains of C. botulinum, if present in refrigerated low acid juices such as carrot juice, could produce toxin in the juice if it was subjected to severe temperature abuse. FDA recommended (See Section V. C. 1.1) that processors include a label statement on the product stating that the juice should be kept refrigerated: Low-acid juices, such as carrot juice, that are distributed under refrigeration, and are not subject to the Low Acid Canned Foods regulation (21 CFR Part 113) may pose hazards associated with spore forming pathogens, specifically, toxins of non-proteolytic and proteolytic strains of Clostridium botulinum. Control measures for such juices are likely to involve multiple measures, e.g., a combination of a process step to destroy the non-proteolytic spores and measures to ensure that "Keep Refrigerated" labeling is used for the juice if the juice does not receive a treatment sufficient to destroy the proteolytic spores (Destruction of spores of the proteolytic strains requires a more severe heat treatment but germination and growth of these spores may be prevented by keeping the product under refrigeration during its lifecycle. Destruction of spores of the non-proteolytic strains requires a less severe heat treatment, but these spores can germinate and produce toxin even under refrigerated storage conditions). The juice HACCP regulation only addressed the control of hazards that could occur in juice stored under normal and moderate abuse conditions during the product's shelf life (21 CFR 120.24(a)). In light of the recent botulism cases, FDA believes that it is now also necessary to address the control of hazards that could occur in low acid refrigerated juice subjected to severe temperature abuse. Therefore, FDA is modifying its previous guidance on this issue. FDA is now recommending that firms subject to the pathogen reduction provisions of the juice HACCP regulation incorporate validated control measures for all C. botulinum spores into their HACCP plans that will be applied in the processing facility and that will ensure that C. botulinum growth and toxin production will not occur should the juice, as offered for sale by the processor, be kept unrefrigerated in distribution or by consumers. This objective could be achieved by any validated treatment method that is effective for this purpose, e.g., acidification of the juice to a pH of 4.6 or below, thermal treatment of the juice. As part of these control measures or a firm's sanitation standard operating procedures, we recommend that firms ensure that all post processing equipment that contacts the juice, e.g., container filling equipment, is cleaned and sanitized adequately to prevent post processing contamination of the juice by C.

botulinum spores from equipment surfaces. We also recommend that these include control measures to provide for the effective performance of their container closures (plastic caps, foil seals) in minimizing any risk of post process contamination of the juice by C. botulinum spores. Furthermore, FDA recommends that firms continue to utilize a label statement such as "Keep Refrigerated," along with implementation of the pathogen reduction control measures set forth in this guidance. Such labeling, when prominently displayed, serves as an additional precautionary measure to minimize the risk that these juices could become unsafe if post processing contamination of the juice by spores of C. botulinum should occur for any reason.

(1)

This guidance has been prepared by the Division of Plant Product Safety in the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.

The juice would have to be left unrefrigerated for a period sufficient to allow the juice to attain and remain at temperatures of 50 or above for an extended period. This is considered to be severe temperature abuse.
(3)

(2)

See the Juice HACCP Hazards and Controls Guidance - First Edition

Guidance for Industry

Guidance on Bulk Transport of Juice Concentrates and Certain Shelf-Stable Juices

Final Guidance
Contains Nonbinding Recommendations April 24, 2003

Comments regarding this document may be submitted at any time to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with the Docket Number 02P-0009. For questions regarding this document, contact Amy Green at (301) 436-2025.

U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition April 24, 2003

Contains Nonbinding Recommendations This guidance represents FDA's current thinking on the control measures juice processors may need to use to ensure that juice concentrates and certain shelf stable juices do not become contaminated or recontaminated with microbial pathogens during bulk transport. The guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of applicable statutes and regulations. Purpose of guidance The purpose of this guidance is to provide industry with recommendations for appropriate control measures to use in the bulk transport of: 1. high degree Brix juice concentrate that is transported to a separate facility for final packaging or for dilution to a consumer strength concentrate and final packaging, and 2. shelf stable single strength juice that is transported in aseptic packaging to a separate facility for final packaging. For the bulk transport of high degree Brix juice concentrate, two container types are considered in the guidance: multi-use or reusable containers (e.g., tankers, reusable drums without liners, and reusable totes without liners) and single-use sanitary containers or liners (e.g., single-use sanitary totes, single-use sanitary drums, bag-in-box containers, totes with single-use sanitary liners, and drums with single-use sanitary liners). Background The juice industry produces thermally treated commercial or institutional concentrate that may be transported to a separate facility for further processing and packaging. At the subsequent facility, the commercial concentrate may be repacked or diluted to a consumer strength concentrate and packed in final packaging. This guidance is concerned with the bulk transport of juice concentrates1 that are put in final packaging or further processed and put into final packaging at a location different than where the juice was processed. Also included in this guidance are recommendations for the bulk transport of aseptically packaged shelf stable single strength juices that are put into final packaging at a location different than where the juice was processed. The juice HACCP regulation (21 CFR Part 120) requires that a processor of juice evaluate its operations using Hazard Analysis Critical Control Point (HACCP) principles. If the evaluation

shows that one or more hazards is reasonably likely to occur in the absence of controls, the processor must develop and establish control measures for the hazard(s). For the hazard of contamination with a pathogenic microorganism, the regulation requires the processor to incorporate control measures into its HACCP plan that will consistently produce a 5-log pathogen reduction in the facility where the final packaging is done (120.24(a) and (c)). A processor of shelf stable or concentrated juice (referred to as "covered products") made at a single facility that includes thermal treatment of all ingredients is exempt from the requirement to include in its HACCP plan a critical control point that achieves the 5-log pathogen reduction. The thermal process that is integral to the manufacture of these products consistently delivers a microbial pathogen reduction that far exceeds the 5-log pathogen reduction standard in the juice HACCP regulation. Under the juice HACCP regulation, to qualify for these exemptions from the 5-log pathogen reduction requirement, the processor must include a copy of the thermal process in its hazard analysis (120.24(a)(2)), the thermal processing step must be accomplished within a single production facility, and the final product packaging must be performed in the facility where the thermal processing is accomplished (120.24(c)). The requirement in 120.24 (c) that the 5-log pathogen reduction and final packaging occur within a single facility ("single facility requirement") was established because FDA is concerned about post-process contamination of juice. Specifically, the agency is concerned that separating the pathogen reduction steps and final packaging in time and space may compromise the HACCP system, including the pathogen reduction. FDA received a citizen petition from industry asking the agency to exempt processors of the covered products from the requirement to perform a second 5-log pathogen reduction treatment when the covered product manufactured in one facility is sent to another facility for final packaging because the transportation hazards that 120.24 (c) was designed to address could be adequately controlled as part of a processor's HACCP plan. Although FDA is concerned with the potential for contamination during bulk transport of juice, as noted below, we have decided to consider the exercise of enforcement discretion as to the single facility requirement provided that certain conditions are met. Scope of guidance This guidance applies to the covered products, containers used to carry the covered products, and equipment used to load, carry, and unload the covered products. Covered products 1. High degree Brix juice concentrate that is transported, diluted, and packaged at a separate facility as either frozen juice concentrate for consumer use or as institution concentrate. This guidance does not apply to concentrate processed into single strength juice. 2. Shelf stable juice that is transported in bulk aseptic packaging and repackaged into final packaging at a separate facility. Containers

1. Multi-use containers used to carry the covered product; after transporting the product, multi-use containers are cleaned, sanitized, and reused. This guidance addresses three types of multi-use containers: 1) tankers, i.e., tankers transported by truck, ship, or railroad, 2) reusable totes without liners, and 3) reusable drums without liners. 2. Single-use sanitary containers and reusable containers with single-use sanitary liners used to carry the covered product; the five types of single-use containers or liners covered in this guidance are: 1) sanitary bag-in-box (BIB) containers, 2) reusable totes with sanitary single-use liners, 3) reusable drums with sanitary single-use liners, 4) sanitary single-use drums, and 5) sanitary single-use totes. The term "sanitary" is used with single-use containers and liners to mean that the containers and liners are produced, handled, dispensed, and disposed of in a manner that protects against the contamination of food and food-contact surfaces. Other equipment Equipment other than containers used in bulk transport of the covered product includes equipment used to: 1) load the covered product into an empty container at the producer's facility and 2) unload the covered product at the user's (receiver's) facility. In general, pumps and fittings (e.g., elbows, hoses, gaskets, valves, nozzles, clamps, seals) are the two types of equipment used to perform these tasks. Specific equipment may vary depending on the type of container used. Conditions for the exercise of enforcement discretion FDA intends to consider the exercise of enforcement discretion for covered products when the following three conditions are met: 1. The producer and user (receiver) establish appropriate prerequisite programs and sanitation standard operating procedures (SSOPs) for the bulk transport of covered products. 2. The producer and user designate as a critical control point (CCP) in their respective HACCP plans, the bulk transport of covered products from the production facility to a separate facility for further processing and final packaging. 3. The producer and user establish control measures to prevent, reduce to acceptable levels, or eliminate the risk of contamination or recontamination of covered products during bulk transport. General Recommendations FDA is providing this guidance to producers and users to aid their development of measures to prevent, reduce to acceptable levels, or eliminate the risk of contamination or recontamination of covered products during bulk transport. The guidance describes five major areas of concern with bulk transport systems, special considerations for tankers, examples of control measures for loading and unloading covered product into tankers, and an example of critical control points a producer could use to include bulk transport in its HACCP plan.

FDA recommends that producers and users evaluate their bulk transport operations (loading, carrying, and unloading covered product) using HACCP principles and implement control measures to ensure that bulk transport does not contaminate or recontaminate the covered product with microbial pathogens. The producer and user may address some hazards with control measures in their prerequisite programs and SSOPs, while other hazards should be incorporated into HACCP plans at critical control points (CCPs) where critical limits, monitoring, and verification will provide additional assurances that the covered product will not become contaminated. An example of when a producer should address the hazard of microbial contamination as a critical control point in bulk transport would be at the receipt of an empty tanker because no subsequent step in transport could eliminate this hazard. To establish control measures for bulk transport, the producer and user of the covered product should have a thorough understanding of the procedures and equipment used to load, carry, and unload the covered product and the procedures and materials used to maintain and clean such equipment. Additionally, to help ensure that the control measures are effective, the producer, transporter, and user should make communication a high priority. FDA recommends that the producer and user conduct their hazard analyses focusing on five areas of concern with bulk transport: 1) sanitation operations, 2) equipment design, 3) equipment maintenance, 4) employee practices, and 5) loading and unloading areas. These are areas of concern for both multi-use containers (e.g., tankers) and single use containers (e.g., sanitary bagin-box) used in bulk transport. Sanitation operations Consistent with the juice HACCP regulation, sanitation operations for equipment and containers used in bulk transport must be in accordance with the Current Good Manufacturing Practices (CGMPs) regulation (21 CFR Part 110) and the Sanitation Standard Operating Procedures (SSOPs) as described in the Juice HACCP regulation under 120.5 and 120.6, respectively. Under 110.35 (d) of the CGMPs, food contact surfaces of the equipment must be cleaned as frequently as necessary to protect against contamination of food. Similarly, under 110.35(d)(3), non-food contact surfaces of the equipment should also be cleaned as frequently as necessary. Cleaning and sanitizing protocols should be tailored to the size and configuration of the container and other equipment and the type of food grade product carried in the previous load. Cleaning and sanitizing systems for multi-use equipment may include both clean-out-of-place (COP) systems for removable components and clean-in-place (CIP) systems for large containers, i.e., tankers. A previous load of an oil-based food in a multi-use container may indicate that an alkaline detergent should be used and that the cleaning and sanitizing protocol should have an additional step to degrease the container before cleaning. Only sanitizing solutions that are covered by appropriate FDA food additive regulations should be used (21 CFR 178.1010). Sanitizers and cleaning solutions should be used in the concentration recommended by the manufacturer. The temperature, pressure, and potability of the water used in cleaning, sanitizing, and rinsing should be sufficient to ensure that the equipment is adequately sanitized.2

The producer and user should obtain, review, and verify sanitizing protocols used by the transporter. Verification activities may include periodic audits of the transporter's wash station. Equipment design Equipment and containers that come in contact with the food being transported should be constructed of food grade materials and designed to have a smooth, easily cleanable, nonabsorbent, corrosion-resistant surface (e.g., stainless steel AISI series 200 and 300 with a minimum chromium content of 16 percent and a No. 3 finish or higher). The surfaces should be clean and sanitary without physical defects or corrosion. Seals used on containers should be uniquely numbered and tamper-evident. Single-use containers without liners (i.e., bag-in-box containers, single-use totes, and single-use drums) and liners should be clean and sanitary with inner surfaces compatible with food materials and should present no physical defects or abnormalities. Single-use containers with liners, i.e., totes with liners and drums with liners, should be designed for use with liners. Singleuse liners and their closures should be of sufficient structural integrity to prevent food materials from contacting outer containers. Liners should be produced in a manner that results in clean, sanitary inner surfaces. Like single-use containers, multi-use containers (e.g., tankers, reusable totes without liners, and reusable drums without liners) should be designed with inner surfaces clean and sanitary, compatible with food materials and should present no physical defects or abnormalities. Unlike single-use containers, multi-use containers will be reused and should be adequately cleaned and sanitized before they are used again. Multi-use containers should be designed to be easily and adequately cleanable. Seams on the food contact surfaces should be smoothly bonded and maintained to minimize accumulation of food particles, dirt, and organic matter, and thus minimize the opportunity for the growth of microorganisms. Preventive maintenance Preventive maintenance programs should be established to ensure the proper functioning of the equipment and integrity of the food contact surfaces. Periodic inspection of containers and equipment and periodic replacement of gaskets and flexible hoses are examples of preventive maintenance programs. Employee practices Employee practices must be in conformance with the CGMPs and the SSOPs as described in the Juice HACCP regulation under sections 120.5 and 120.6, respectively. In accordance with the Juice HACCP regulation, all employees working in the loading and unloading areas in direct contact with the covered product must employ hygienic practices to protect against microbiological contamination of the covered product.

Employees responsible for the loading and unloading of the covered product should be trained about the measures to prevent contamination of the covered product. Competent supervisory personnel should oversee employee practices. Loading and unloading areas In addition to the equipment used in bulk transport, the loading and unloading areas should be designed and maintained in accordance with the CGMPs in 21 CFR Part 110. The areas should be maintained in sanitary condition and in good repair to prevent contamination of the covered product. Special Considerations for Tankers Because of the complexity, size, multiple configurations and accessories, and the potential for contamination from previously transported product, the producer and user should carefully scrutinize tanker operations, i.e., cleaning, sanitizing, loading, carrying, and unloading, to ensure that sufficient control measures are in place to adequately safeguard against contamination of the juice concentrate. FDA recommends that a producer use tankers dedicated to carrying only treated juice products. If it is not feasible to use a dedicated tanker, the producer should demonstrate in its hazard analysis that the cargo permitted as a load prior to carrying the juice concentrate does not add to the risk of microbial contamination of the concentrate. An example of cargo that would have a similar low level of risk would be a treated food or food grade product that is easily cleanable, e.g., citric acid.3 The producer should demonstrate that the permitted cargo offers the same low level of risk of microbial contamination, as does a treated juice product. Producers and users should have written agreements between each other and with the transporter as a means of control. To make such controls effective, producers and users should perform verification activities such as periodic inspection of the hauler and cleaning stations, environmental testing of containers, product testing, periodic inspection of employee practices, e.g., handwashing, and periodic inspection of the condition of the equipment. An example of an agreement with a transporter that both the producer and user should consider is an agreement regarding the transporter's cleaning and sanitizing protocol. The provisions of a cleaning and sanitizing protocol will depend on the configuration of the container and the previous load. A cleaning and sanitizing protocol for a complex container such as a tanker that has many removable parts and a venting system will differ from a cleaning and sanitizing protocol for a 55-gallon reusable drum. A cleaning and sanitizing protocol for a tanker with a previous load that was oil-based should include a degreasing step, but if the previous load was a water-based food, the degreasing step should not be used. An example of a cleaning and sanitizing protocol for a tanker is set out below:

Recommended protocol for cleaning and sanitizing a tanker 1. Before cleaning and sanitizing o Determine previous load and cleaning and sanitizing protocol. Protocol should eliminate pathogenic microorganisms and other hazardous contaminants. o Drain completely. o High-pressure rinse or scrub interior surfaces if residue is still present.

2. Pre-rinse interior of tanker o Rinse with potable water. o Degrease if previous load was oil-based material. Use degreaser/detergent in accordance with manufacturer's recommendations. o Drain.

3. Clean--primary interior tanker surfaces o Use appropriate cleaner in accordance with cleaner manufacturer's recommendations. o Drain completely.

4. Clean--removable components (COP) o Hand clean (or use automatic COP system) rear valve, gaskets, and other removable parts. o Use appropriate cleaner in accordance with the cleaner manufacturer's recommendations.

5. Rinse (if required) interior of tanker o Rinse with ambient, potable water until completely clear. o Test by measuring pH of rinse water (pH=neutral). o Drain thoroughly.

6. Inspection of tanker interior o Visually inspect from exterior with inspection light. o Verify removal of residues and excess liquids.

7. Sanitize--interior of tanker and removable parts o Sanitize all food contact surfaces and all removable parts and components. o Use food-grade sanitizer diluted with potable water according to sanitizer manufacturer's recommendations for concentrations and time/temperature of use.

8. Rinse (if required) interior of tanker o Rinse with ambient, potable water until completely clear. o Test by measuring pH of rinse water (pH=neutral). o Drain thoroughly.

9. Seal
o o

Immediately after draining, seal all points of entry and discharge. Use numbered, tamper-evident seals.

10. Record information about the wash o Include date and time, seal numbers, trailer number, and cleaning and sanitizing protocol on the current wash ticket. o Maintain copies of wash records for period of time agreed upon by customer.

11. Clean exterior of tanker only after sealing tanker.

Examples of control measures for tanker transport of covered product The producer and user should each establish control measures for bulk transport of covered products. The producer and user should determine where each of its control measures should be incorporated, i.e., into prerequisite programs or as a critical control point in its HACCP plan. Examples of control measures that may be appropriate for the producer in loading a covered product into a tanker and for the user in unloading a covered product from a tanker follow: Recommended control measures for loading a tanker 1. Inspect the empty tanker upon arrival to verify that--

The tanker is marked for food grade use. The tanker access points were sealed at the wash station with numbered, tamperevident seals at all major points of entry and discharge. (Sealing points may include the dome cover, tank outlet, vent cap, pump inlet, pump outlet, and hose tube covers.) o The hoses and pump outlets were capped and sealed after cleaning and sanitizing. o The integrity and cleanliness of the tanker and its component parts are apparent. The interior of the tank is clean, dry, and free of cracks, corrosion, and residues from the prior load. The seals, gaskets, pumps, valves, hoses, and hose tubings are clean and free of cracks, corrosion, and residues from prior load. There is no presence of off-odors when opening the dome cover of the tanker.
o o

2. Review and verify that the wash ticket from the transporter contains-o Certification of the last load. o Cleaning and sanitizing protocol used for the last load. o Seal identification. (Seal numbers should be recorded on the wash ticket and verified by the producer.)

3. Prior to loading the tanker, producer should verify that-o The loading facility is maintained according to CGMPs. o The employees follow CGMPs and SSOPs. o The integrity and cleanliness of the transfer equipment (i.e., pumps, hoses, and associated equipment) are apparent.

4. Immediately after loading the tanker, the producer should verify that-o The tanker is closed and numbered, tamper-evident seals are affixed to any access ports that were unsealed during inspection. o The bill of lading contains correct seal numbers and cargo identification. o A copy of the wash ticket is provided to the outbound tanker for the user.

Recommended control measures for unloading a tanker 1. Review and verify documentation from the transporter, including-

Bill of lading from the producer containing security seal numbers and identification of cargo. o Wash ticket.
o

2. Inspect the loaded tanker to verify that-o The tanker is marked for food grade use. o The tanker access points were sealed at the producer's facility with numbered, tamper-evident seals at all points of entry and discharge. o The numbers of the tamper-evident seals match those listed on the bill of lading. o The integrity and cleanliness of the transfer equipment are apparent. o The integrity and cleanliness of the tanker and its component parts are apparent.

3. Conduct periodic review of these activities performed upstream to verify that appropriate controls are in place and effective.

An example of tanker transport: a producer's critical control points, conditions to be monitored and verified, and critical limits Some hazards in tanker transport may be addressed adequately in SSOPs, while others may require additional assurances in the form of critical control points in the processor's HACCP plan. In the following example, a producer of a high degree Brix juice concentrate determines that tanker transport in his facility can be divided into three separate processes, two of which are critical control points: Recommended critical control points and critical limits for a producer Product description High degree Brix juice concentrate transported by tankers Tanker transport processes 1. Receipt of empty tanker (critical control point). 2. Loading of empty tanker (controlled by prerequisite programs and SSOPs). 3. Preparation of loaded tanker for shipping (critical control point). CCP 1-Receipt of empty tanker For the first CCP, the producer should have a written agreement from the transporter that the

empty tanker has been adequately sanitized. The agreement should identify the transporter's cleaning and sanitizing protocol and provide assurances that the cleaning and sanitizing protocol has been followed. The producer should monitor and verify the following three conditions: 1. Intact seals on empty tanker. 2. Presence of complete wash ticket, including 1. Certification of last load. 2. Cleaning and sanitizing protocols used for last load. 3. Seal numbers that match seals on the tanker.

3. Integrity of the tanker and its component parts. Critical Limit for CCP 1 The critical limit for the three conditions is that the conditions must be satisfied, i.e., the tanker seals must be uncompromised, the wash ticket must be complete and correct, and the tanker and its component parts must be without corrosion or cracks. If any one of these three conditions is not met, the tanker should be rejected. CCP 2-Preparation of loaded tanker for shipping For the second CCP, the producer should provide assurances to the user that a clean, intact, properly sanitized tanker was used to carry the product, the tanker was adequately sealed, and the documentation accompanying the tanker is correct and complete, i.e., the seal numbers listed in the documentation match those on the tanker. The producer should monitor and verify the following three conditions: 1. Seals are applied correctly on the loaded tanker. 2. Complete and correct wash ticket accompanies loaded tanker. 3. The current bill of lading has correct product identification and seal numbers on loaded tanker. Critical Limit for CCP 2 As with CCP 1, the critical limit for the conditions in CCP 2 is that the conditions must be satisfied, i.e., the seals must be applied properly and the appropriate documentation, the wash ticket and bill of lading, must accompany the loaded tanker. Until all of these conditions are met, the tanker should not be shipped to the user.

Notes:

Commercial concentrate may also be sold to processors making single strength juice, juice blends, or beverages containing juice. However, manufacturing and packaging processes for single strength juice or beverages containing juice differ from processes for concentrated juice products. Single strength juice products made from concentrate are typically treated to control spoilage organisms immediately before final consumer packaging or are made into shelf stable products. In both cases the final heat treatment achieves a 5-log or greater pathogen reduction.

Adequately sanitized means treated by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.

Although this guidance is focused on microbial contamination in bulk transport, a producer should also consider the potential for chemical contamination if cargo in prior loads could cause allergic reactions (e.g., milk and eggs) or could be carcinogenic or toxic (e.g., non-food grade dyes, inks, pigments). Page Last Updated: 05/22/2009

Letter Concerning Single Facility Requirement

Robert P. Parker, Esq. Paul, Weiss, Rifkind, Wharton, & Garrison 1615 L Street, N.W. Washington, D.C. 20036-7420 Re: Citizen Petition of the Florida Dept. of Citrus, et al concerning Juice HACCP Dear Mr. Parker: This letter reiterates the position of the Food and Drug Administration regarding the enforcement of the "single facility" requirement( 1 ) in the juice HACCP final rule( 2 ), which we discussed at our January 15 meeting. On January 10, 2002, the Florida Department of Citrus, the Florida Citrus Processors Association, and the National Juice Products Association submitted a citizen petition( 3 ). The petition asked that FDA (1) amend the juice HACCP final rule to exempt processors of shelfstable and concentrated juice products from the "single facility" requirement; and (2) stay the effective date of the requirement until the Agency had disposed of the citizen petition. The petitioners contend that transportation hazards (which the "single facility" requirement was designed to address( 4 )) could be adequately addressed as part of a processor's HACCP plan. Petition at p. 3-4. At our meeting, representatives of the Florida juice industry described in some detail the measures they represented are used widely by Florida juice concentrate producers to ensure that concentrates are not contaminated after processing when shipped to another facility for final packaging. The industry representatives argued that, in light of these measures, the "single facility" requirement is unnecessary for these producers. Based in part upon this presentation and these representations, FDA has agreed to consider the exercise of enforcement discretion with respect to the "single facility" requirement as applied to producers and users of high Brix juice concentrate( 5 ). FDA is considering the exercise of its discretion where the following three conditions are satisfied: (1) the producer and the user establish appropriate prerequisite and sanitation standard operating procedures (SSOPs) for the transport of high Brix juice concentrate; (2) the producer and user designate as a critical control point (CCP) in their respective HACCP plans the transport of high Brix concentrate from the production facility to a second facility for formulation and final packaging of concentrates; and (3) the producer and user establish control measures to prevent, reduce, or eliminate the risk of recontamination of the concentrate during transport( 6 ). The Agency expects that any producer of high Brix juice concentrate whose HACCP plan does not designate such transport as a CCP and establish appropriate control measures will comply with the "single facility" requirement on the effective date of the final rule( 7 ).

As noted, the petition also requests that the final rule be amended to exempt producers of shelfstable juices from the "single facility" requirement. In light of our January 15 discussion, FDA is considering the exercise of enforcement discretion only for the bulk transport and repackaging of shelf-stable single strength juice that is transported in aseptic packaging. The agency intends to develop and promptly issue guidance that will contain FDA's basic recommendations for appropriate control measures for several transport modalities, including tankers, mobile tank farms within cargo ships, single-use sanitary containers (e.g., bag-in-box containers), and reusable containers with single-use liners (e.g., 55 gallon drums with single-use liners). In issuing this guidance, FDA will adhere to the Agency's Good Guidance Practices (GGPs), 21 CFR 10.115. Please call me at 301-827-1137 or Catherine Copp of my staff at 301-827-1139 if you have any questions regarding the Agency's position. Technical questions should be directed to Terry Troxell, Ph.D., director of the Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, at 202-205-4064.

Sincerely, Daniel E. Troy Chief Counsel

1. The relevant portion of the so-called "single facility" requirement provides that "Processors claiming an exemption under paragraph (a)(1) or (a)(2) of this section [which includes the juice concentrate producers in question] shall also process and perform final product packaging of all juice subject to the claimed exemption within a single production facility operating under current good manufacturing practices." 21 CFR 120.24 (c). 2. 66 Fed. Reg. 6138 (January 19, 2001). 3. Although the issues discussed at the January 15 meeting and in this letter are raised in the citizen petition, this letter is not a response to that petition. FDA will respond to the petition consistent with 21 CFR 10.30. 4. See 66 Fed. Reg. at 6172-6173. 5. High Brix juice concentrate is a concentrate that is diluted and repackaged as either frozen orange juice concentrate for consumer use or as institutional concentrate. 6. FDA does not intend to consider the exercise of its enforcement discretion for producers and users of high Brix juice concentrates that are diluted to single strength and repackaged.

7.

The final rule has staggered effective dates for juice processors of various sizes. The rule is effective January 22, 2002, for all processors except small processors and very small processors, as defined in the regulation; the rule is effective January 21, 2003, for small processors, and January 20, 2004, for very small processors.

Correction to January 22, 2002 Letter Concerning Single Facility Requirement January 25, 2002

Juice Imports: Affirmative Steps

January 22, 2004

Lists of Foreign Processors Approved by their Governments

FDA is providing, below, the website locations of lists provided by foreign government inspection authorities of processors of juice that, according to those authorities, are in good standing and are meeting the requirements of the FDA juice Hazard Analysis Critical Control Point (HACCP) regulation. The regulation for the Safe and Sanitary Processing and Importing of Juice and Juice Products (21 CFR Part 120) requires that all juice in interstate commerce in the United States must have been processed in accordance with both the HACCP principles and the sanitation prerequisite requirements that are specified in the regulation. These requirements apply to imported as well as domestic products. Importers have a responsibility under the regulation to ensure that the juice they are importing meets those requirements. There are essentially two ways in which importers may satisfy their regulatory obligations. First, they may obtain products from a country that has an active equivalence or compliance agreement with FDA covering juice. Under such an agreement, FDA has determined that government of the foreign country is operating a regulatory system for juice safety that ensures that the products being exported to the U.S. satisfy U.S. safety concerns. Second, if no such agreement exists with the country of origin, importers must take their own "affirmative steps" to ensure that the products they are offering for entry have been processed under controls that meet the requirements of the regulation (21 CFR 120.14). FDA is inspecting importers to review the adequacy of these "affirmative steps." The regulation does not mandate what affirmative steps importers must take, but gives examples of affirmative steps that importers may select. One of these examples include obtaining either a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or from a competent private party certifying that the products were produced in accordance with the U.S. requirements (21 CFR 120.14(a)(2)(ii)(B)).

The inspection authorities of some countries are issuing lists of processors that are in good standing with those authorities and are, according to the authorities, processing in accordance with the U.S. requirements. These lists, if regularly updated, may serve the same purpose as the issuance of "continuing" certificates by the foreign government inspection authority. Importers may consider purchasing from processors that are on such lists, and documenting that they are doing so, as one way of meeting their affirmative steps responsibility. Importers should always consider, however, whether the steps they have chosen adequately ensure that the juice they receive has been processed in accordance with 21 CFR Part 120. Thus, importers should assess the credibility of the lists by considering factors such as those that will be considered by FDA (as discussed below) when doing so. In addition, importers should be aware that FDA has not verified the lists or the information on them. In considering whether to accept importation of products from processors on foreign government-supplied lists as satisfying the affirmative step obligation, FDA may consider such factors as the length of time since the foreign government inspection authority updated its list, the compliance history of the country and the individual foreign processor, and what is known generally about the regulatory structure of the foreign country.

Requests by foreign government inspection authorities for FDA to provide links to official website locations that lists processors that, according to those authorities, are in good standing and are meeting the requirements of FDAs Hazard Analysis Critical Control Point (HACCP) regulation should submitted to: Dr. Robin Woo International Affairs Staff HFS-550 Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740-3835 E-mail: robin.woo@fda.hhs.gov

Guidance for Industry

Juice HACCP
Small Entity Compliance Guide
Contains Nonbinding Recommendations April 4, 2003

The Food and Drug Administration has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (P.L. 104-121). This guidance document restates in plain language, the legal requirements set forth in 21 CFR part 120 concerning the safe and sanitary processing of fruit and vegetable juices. The regulations at 21 CFR part 120 are binding and have the force and effect of law. However, this guidance document represents the agency's current thinking on this subject and does not, itself, create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

SUMMARY
On January 19, 2001, the FDA published a final rule in the Federal Register that requires processors of juice to develop and implement HACCP systems for their processing operations (66 FR 6138). For all but small and very small businesses, the Juice HACCP regulations (21 CFR part 120) became effective on January 22, 2002. For small businesses regulations became effective on January 21, 2003, and for very small businesses, the regulations will become effective on January 20, 2004. This guidance focuses on key aspects of the juice HACCP regulations to assist small and very small businesses in implementing the regulations. The "Draft Juice HACCP Hazards and Controls Guide" is another source of information that small and very small businesses may find helpful in meeting the requirements of the regulations.

A. Coverage
1. What types of juice and juice products are covered by the regulations? The regulations apply to juice sold as such or used as an ingredient in beverages. Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible

portions of one or more fruits or vegetables, or any concentrates of such liquid or puree as defined in 120.1(a). Juice produced by a person who operates a retail establishment as defined in 120.3(e) is not covered by the regulations. The regulations require that processors apply HACCP principles if they make juice or juice concentrates for subsequent beverage use. Any processor making a product that could be labeled as 100 percent juice or a concentrate of that juice for subsequent beverage use must apply HACCP principles. For beverages containing less than 100 percent juice, only the juice ingredient must be made applying HACCP principles. 2. When do I need to comply with the juice HACCP regulations? FDA encourages all juice processors to begin to comply with the regulations as soon as possible. The effective date was January 22, 2002. However, if your firm meets the definition for a small business, the effective date was January 21, 2003. If your firm meets the definition of a very small business, the effective date is January 20, 2004. 3. What are the definitions of a small business and a very small business? Small businesses employ fewer than 500 persons (120.1(b)(1)). Very small businesses meet one of the following three criteria: annual sales of less than $500,000, total annual sales greater than $500,000 but total food sales less than $50,000, or operations that employ fewer than an average of 100 full-time equivalent employees and sell fewer than 100,000 units of juice in the United States (120.1(b)(2)). The size of the business is determined by the magnitude of the corporate operation, not of the business unit. 4. If my juice is sold only within my state, do I need to comply with the new regulations? Yes. These regulations apply equally to juices produced and sold within the same state as well as juices sold in interstate commerce. 5. If I pasteurize my juice, do I need to comply with the regulations? Yes. All juice processors (except retail processors as defined in the regulations) must comply with part 120 for each type of juice they produce. 6. I am a dairy processor who purchases pasteurized apple juice concentrate to make a 5% apple juice beverage and a 15% apple juice beverage. Am I required to comply with the juice HACCP regulations, including the 5-log reduction? Because you are not making juice as defined by 120.1(a), you are not required to produce your juice beverage under a HACCP system, although it is highly recommended. However, the juice ingredient (i.e., the pasteurized apple juice concentrate) must have been made under a HACCP program (including compliance with 120.24). 7. Do these regulations cover fruit and vegetable purees?

The regulations apply to products sold as juice or used as an ingredient in beverages, including fruit and vegetable purees that are used in juices and beverages. 8. Are non-beverage foods that contain juice as an ingredient, e.g., a fruit flavored candy, required to be produced under a HACCP system? No. The juice HACCP regulations apply to the processing of juice that is sold either as juice or sold for use as a beverage ingredient. Thus, a fruit flavored candy that contains juice as an ingredient is not required to be produced under a HACCP system. 9. Are food ingredients, other than juice, that are derived from fruit, e.g., citrus oil, required to be produced under a HACCP system? No, the juice HACCP regulations apply only to the aqueous extract of fruits and vegetables that is sold either as juice or for use as an ingredient in beverages and not to other fruit or vegetable by-products such as citrus oil. 10. Would pulp from a fruit or vegetable used to make a juice or diluted juice beverage be considered juice under the juice HACCP regulations? Yes. As noted, fruit and vegetable purees used as a juice ingredient are considered "juice" under the regulations. Pulp (i.e., pressed edible fruit or vegetable matter) is often a part of the aqueous liquid stream expressed or extracted from fruits and vegetables (e.g., citrus juice) and is comparable to puree except that it may not undergo the same degree of maceration. Pulp in a juice or a diluted juice beverage is considered juice or a juice ingredient; with a diluted juice beverage, processors are only required to comply with part 120 when making the juice ingredient (e.g., the pulp). 11. Would juice concentrates intended for uses such as flavors or sweeteners in foods other than beverages be subject to the regulations? Juice concentrates intended for use as flavors, sweeteners, or similar uses in products that are not beverages are not subject to the regulations. However, because there may be problems segregating product used in beverages from that used in other foods, prudent juice concentrate processors should consider implementing HACCP for all of their juice products, not just those products that will be made into juice or used in beverages.

B. Retail Exemption
12. If a retailer decides to pasteurize his apple cider, does he need to have a HACCP system? Retail producers of juices are not covered by the regulations and would not be required to establish a HACCP system regardless of whether they pasteurize their products.

A retail establishment is an operation that only provides juice directly to consumers. "Provides" includes storing, preparing, packaging, serving, and vending. A retail establishment does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers. FDA's Food Code provides guidance to retail producers for making safe products. 13. Do the regulations cover apple cider that I make from my own apples and sell over the Internet directly to consumers? What about apple cider that I make from my own apples and sell at a farmers market? If you make cider from your own apples (or apples that you have purchased) and only sell it directly to consumers (e.g., internet sales, farmers markets), you are considered a retailer and thus, your cider does not need to be processed under a HACCP system. 14. If I hire someone to make cider from my apples and I sell this cider at my roadside stand, is this juice producer required to have a HACCP system? Yes. Only retail establishments are exempt from the regulations. Under the regulations, a retail establishment stores, prepares, packages, serves, and vends its product exclusively and directly to consumers. If someone else processes juice for a retail establishment, that processor is required to operate under HACCP principles.

C. Relationship to CGMP's
15. Do FDA's "Current Good Manufacturing Practices" (CGMP) regulations in 21 CFR Part 110 apply to firms that are subject to the juice HACCP regulations? Does compliance by these firms with the juice HACCP regulations replace the need to comply with the CGMP regulations? Firms covered by the juice HACCP regulations are still subject to the CGMP regulations in Part 110. In fact, CGMP's are an essential foundation for a successful HACCP system.

D. The Juice Hazard Analysis

16. What is a hazard analysis? The hazard analysis is an evaluation of potential microbiological, chemical, and physical hazards associated with a particular product and process and is used to determine which hazards are reasonably likely to occur and, if they occur, how they can best be controlled. The regulations require that the hazard analysis be written. 17. Who should conduct the hazard analysis?

The regulations require that a trained individual, whether an employee or consultant, conduct the written hazard analysis that juice processors (except retail processors) are required to have for their process. 18. What is a "hazard that is reasonably likely to occur?" A food hazard that is reasonably likely to occur is defined in 120.7(a)(2) as one for which a prudent processor would establish controls to reduce to acceptable levels, prevent, or eliminate the hazard because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absence of those controls, the food hazard will occur in the particular type of product being processed. A potential hazard that has a severe, acute public health impact (e.g., injury caused by ingestion of glass fragments) and that presents a significant risk, even at an extremely low frequency of occurrence, should be identified as a hazard that is reasonably likely to occur. A hazard that requires long-term (chronic) exposure to cause harm would need to occur at a higher frequency to be identified as a hazard that is reasonably likely to occur. The mycotoxin, patulin, which can occur at high levels in apple juice made from damaged, moldy or rotten apples, is an example of a chronic exposure hazard that could occur at such a frequency that it may need to be controlled through a HACCP plan if drops, i.e., apples that have fallen from the tree to the ground, are used to make juice or if apples are stored inappropriately prior to use for juice production. 19. What is the best way to begin a hazard analysis? FDA believes that carrying out the five preliminary steps as outlined by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will assist processors in conducting a hazard analysis, as well as in other HACCP functions. These are:

Assemble a HACCP team Describe the food and its distribution Identify the intended use and consumers of the food Develop a flow diagram that describes the process Verify the flow diagram

(See "Hazard Analysis and Critical Control Point Principles and Application Guidelines," Journal of Food Protection, Vol. 61, No. 6, pp. 762-775). Although FDA is not specifically requiring that juice processors use the preliminary steps, these steps will aid them in focusing on their specific product and process. Flow diagrams that identify each significant step in the process are particularly helpful in conducting a hazard analysis, by facilitating determination as to whether a hazard may be introduced or controlled at each process point. 20. How do I conduct a hazard analysis?

You must do the following in a written hazard analysis (see 120.7(a)):

(1) List all potential physical, chemical, and biological hazards that might occur in your juice. (2) For each of the hazards identified in step 1, assess the likelihood of occurrence and the severity of health consequences in the absence of control. Then, determine, based upon the information gathered, whether each hazard is reasonably likely to occur in your product. You do not have to include hazards in your HACCP plan that are not reasonably likely to occur. (3) Identify the measures that you can apply to control the food hazards identified in step 2 as reasonably likely to occur. (4) Review the current process to determine whether modifications are needed. (5) Identify critical control points for hazards determined in step 2 to be reasonably likely to occur.

21. What is a control measure? A control measure is any action or activity to prevent, reduce to acceptable levels, or eliminate a hazard ( 120.3(c)). Control measures are further discussed in the next section. 22. What is a critical control point? A critical control point (CCP) is a point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level ( 120.3(d)).

E. Control Measures
23. When am I required to implement a HACCP control measure? You are required to implement a HACCP control measure if you determine in your hazard analysis that a food hazard (e.g., a microbial pathogen, potentially hazardous levels of patulin, glass shards) is reasonably likely to occur in a juice product you produce. 24. What are some examples of HACCP control measures? Examples of control measures include thermal processing of juice and culling produce to eliminate visibly moldy, rotten, or damaged fruit. 25. If a grower implements FDA's "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables," also referred to as FDA's Good Agricultural Practices (GAP) guidance document, is it considered a HACCP control measure?

No. However, juice processors are encouraged to work with the growers of the produce that they use to produce juice to evaluate and modify agricultural practices consistent with FDA's GAP guidance. 26. If I sell juice in bulk to company X for final processing and packaging of a diluted juice product, who is responsible for determining whether HACCP controls for chemical and physical hazards are needed for the juice? Both firms are responsible for ensuring that the products they make are safe. However, only juice processors must comply with the juice HACCP regulations. Therefore, you must conduct a hazard analysis and determine whether there are chemical, physical, and microbial hazards that are reasonably likely to occur. You are responsible for controlling in your HACCP plan all hazards that are reasonably likely to occur. As a processor of a diluted juice beverage, company X is not a juice processor as defined by the HACCP regulations, and thus, is not required to have a HACCP system. However, company X must ensure that the juice ingredient used in the diluted juice beverage complies with part 120.

F. The 5-log Reduction Performance Standard

27. What is the 5-log pathogen reduction performance standard? Performance standard requirements in general are goals that processors should achieve but provide flexibility on how processors accomplish them. The 5-log pathogen reduction performance standard required by the regulations means that you must treat your juice (or citrus fruit if using surface treatments) using a process that will achieve at least a 100,000 fold decrease in the number of microorganisms (see next question). Juice processors must apply controls (e.g., heat, UV light) to achieve the 5-log reduction required by the regulations. 28. Does a 5-log reduction in the bacterial plate count (i.e., aerobic plate count or total plate count) of a juice sample meet the performance standard requirement? No. Under the rule, the 5-log reduction must be targeted to the "pertinent pathogen." The "pertinent pathogen" is the most resistant microorganism of public health concern that may occur in the juice. The pertinent pathogen may vary with the type of juice and the type of treatment used, though typically it would be Salmonella, Escherichia coli O157:H7 or Cryptosporidium parvum. 29. What times and temperatures should I use to pasteurize my juice? Precise times and temperatures depend on the type of juice you make and your process. Scientific literature is an excellent source of information. See the following articles:

Mazzota, Alejandro S., "Thermal Inactivation of Stationary-Phase and Acid-Adapted Escherichia coli 0157:H7, Salmonella, and Listeria moncytogenes in Fruit Juices," Journal of Food Protection, 1998, Vol. 64, No. 3, 2001, pp. 315-320, Deng, Ming Qi, and Cliver, Dean O., "Inactivation of Cryptosporidium parvum Oocysts in Cider by Flash Pasteurization," Journal of Food Protection, Vol. 64, No. 4, 2001, pp.523-527, Harp, James A., Fayer, Ronald, Pesch, Bruce A., and Jackson, George J., "Effect of Pasteurization on Infectivity of Cryptosporidium parvum Oocysts in Water and Milk," Applied and Environmental Microbiology, Vol. 62, No. 8, 1996, pp. 2866-2868, and Mak, Peggy P., Ingham, Barbara H., and Ingham, Steven C., "Validation of Apple Cider Pasteurization Treatments against Escherichia coli 0157:H7, Salmonella, and Listeria moncytogenes, Journal of Food Protection, Vol. 64, No. 11, pp. 1679-1689.)

30. How can I achieve a 5-log reduction without pasteurizing the product? You can achieve a 5-log reduction by using control measures that have been shown to be effective in reducing the number of microorganisms. You can use one control measure that has been shown to reduce the pertinent microorganism by at least 5-log (e.g., high pressure) or a combination of control measures that have a cumulative effect of a 5-log reduction. Citrus juice processors may use surface treatments of the fruit to contribute towards attaining the 5-log reduction. All other juice processors must apply the 5-log process to the juice. 31. May I do the 5-log reduction on the fruit before extracting the juice? Producers of juice other than citrus must apply the 5-log reduction treatment on the extracted juice. Citrus processors have the option of treating the surface of the fruit because it is unlikely that pathogens will enter sound, intact citrus fruit under current industry processing practices. If citrus juice processors use surface treatments to achieve all or part of the 5-log reduction, they must conduct tests to verify that the surface treatment is effective. Process verification procedures are found in 120.25. (Note that according to 120.24, the 5-log reduction treatment must occur within a single processing facility.) 32. May cleaning (i.e., washing of the produce) and culling (i.e., removal of damaged produce) be included among the control measures used to meet the 5-log reduction requirement? No. All produce used for making juice must be cleaned and culled prior to extraction or, in the case of surface treated citrus fruit, prior to control measures used to meet the 5-log reduction requirement. For surface treated citrus, culled fruit is undamaged, tree-picked fruit. 33. May juice be treated in one processing facility to achieve part of a 5-log pathogen reduction, i.e., a 2-log reduction, and then transported to another facility for treatment to achieve the remainder of the 5-log reduction? No. The entire 5-log reduction must be accomplished within a single production facility operating under CGMP's.

34. May I use fruit that has fallen from the tree to the ground (i.e., drops) to make juice? You may use fallen apples if the fruit is cleaned and culled (i.e., damaged fruit removed) and the 5-log treatment is applied to the extracted juice. Citrus juice manufacturers using surface treatments must use undamaged tree-picked fruit. 35. I make shelf-stable juice that receives over a 10,000-log reduction. Am I still required to have microbial control measures in a HACCP plan? What about juice concentrates that are processed with over a 100-log reduction? If you make thermally processed juice that is shelf stable or thermally processed juice concentrate, you are not required to include control measures in the HACCP plan for achieving the 5-log pathogen reduction. However, you must include a copy of the thermal process in your hazard analysis. 36. If I use a heat treatment process on my juice, can I assume that the process meets the 5-log pathogen reduction requirement of the HACCP regulations? No. Except for processors of thermally processed shelf stable juices and juice concentrates, juice processors must establish and meet critical limits to ensure that the heat process is effective and consistently fulfills the 5-log reduction standard. Critical limits are the maximum or minimum values to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard. 37. If a juice product is treated by a means other than heat to meet the 5-log pathogen reduction requirement, is FDA approval required for the treatment? Food additive regulations are required for treatments that use irradiation (e.g., pulsed light, UV light, ionizing radiation) and may be required for the use of certain chemicals. You are responsible for ensuring that all treatments, regardless of compliance with food additive regulations, achieve the 5-log pathogen reduction for your juice and process. 38. Does each processor handling a juice have to do a 5-log reduction? Each processor handling the juice (except retail processors) must conduct a hazard analysis to determine whether there are hazards, including microbial hazards, that are reasonably likely to occur. Each processor must have controls for microbial hazards. This may be assurances that the juice will be given the required 5-log treatment at another processing location. 39. In the past, some processors have added a small amount of untreated juice to pasteurized juice for flavor enhancement. May I do this? No. All ingredients of the juice must have received a 5-log reduction. Pathogens may be present in untreated juice and could contaminate the treated juice.

40. Can a flavor essence recovered during a juice concentration operation be added back to a juice after the juice has received a 5-log pathogen reduction treatment without requiring an additional 5-log treatment? If you can demonstrate that the recovery process used to capture the flavor essence achieved the 5-log reduction, you can add the essence to the treated juice and you will have complied with 120.24. Otherwise, the flavor essence must undergo a 5-log reduction process before it is added to treated juice or the juice with the flavor essence must undergo a 5-log reduction to comply with 120.24. If the essence is not treated along with the juice, you must ensure that the process by which the essence is added to the juice does not allow for contamination.

G. Control Measures for Chemical and Physical Hazards

41. Are there any mandatory HACCP control measures for chemical hazards such as patulin or lead? HACCP controls for specific chemical hazards such as patulin and lead are required when a processor determines that the presence of the chemical in the juice is a hazard that is reasonably likely to occur. In conducting a hazard analysis, a juice processor must consider all potential hazards and determine whether any of these hazards are reasonably likely to occur. If a hazard is reasonably likely to occur, a processor must include controls for that hazard in its HACCP plan. 42. I am a dairy processor who also makes juice using my milk processing equipment. Should I be concerned about milk residues (allergenic proteins) being present in the juice? What are the controls to prevent possible allergen cross-contamination (cross-contact) in this situation, and should these controls be included in my HACCP Plan? Yes, when using milk processing equipment to process juice, cross-contact of milk protein into the juice is a concern. Allergens, such as milk, soy (soy milk), or egg (egg nog) should be considered chemical hazards that need to be addressed in your hazard analysis. Controls to prevent cross contact may include a rigorous sanitation regime in between a production run of milk products and a production of juice products. In addition to sanitation, production scheduling can have a large impact on minimizing cross-contact from shared equipment. Processors should try to schedule all non-allergen containing products first, followed by allergen containing products, with a full clean-up before again running a non-allergen product. Depending on the outcome of the hazard analysis, sanitation and production scheduling may be managed through Sanitation Standard Operating Procedures (SSOPs) or as part of the HACCP plan. See Compliance Policy Guide 555.250 for the list of common food allergens recognized by the Agency. 43. Are HACCP control measures required for any specific physical hazards such as glass?

HACCP controls for specific physical hazards, e.g., glass, are required under the juice HACCP regulations when the processor determines in its hazard analysis that the specific physical hazard is reasonably likely to occur in the juice.

H. Records
44. What types of records will I be required to maintain to document my HACCP system? You must maintain records pertaining to:

SSOPs monitoring and corrective actions The hazard analysis The HACCP plan Operational records such as records of process monitoring, corrective actions, Verification, and validation activities Importer verification

General requirements and documentation requirements for records are included in 120.12 (b) and (c). 45. How long must I keep the required HACCP records? A processor of perishable or refrigerated juices and an importer of such juices must retain required HACCP records at the processing facility (processors) or at the importer's place of business in the United States (importers) for at least 1 year after the date that the products were prepared. A processor of frozen, preserved, or shelf stable products and an importer of such products must retain the required records at the processing facility (processors) or at the importer's place of business in the United States (importers) for 2 years or the shelf life of the product, whichever is greater, after the date that the products were prepared. 46. Are juice processors required to make all of their records related to juice available to FDA inspectors? Only those records that are specifically required under 120.12 must be made available for review and copying by FDA at reasonable times. These records are listed in the response to question 44. 47. What records are necessary to show that consumer complaints have been reviewed? You must make a record that documents that you have performed a review of the consumer complaints that you have received. However, you are not required to show consumer complaints to FDA.

I. Training
48. What specialized training is needed to establish a HACCP system? Certain key aspects of HACCP require training in HACCP principles. Individuals who perform certain functions related to the development of the hazard analysis and HACCP plan, and the verification, validation, corrective action, and record review requirements of the regulations must be trained (see 120.13(a)). Training must be equivalent to a standardized curriculum that FDA recognizes as adequate. Job experience may qualify an individual to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum. The Juice HACCP Alliance developed a standardized curriculum with input from FDA. The guidance document and the first edition of the Juice HACCP Training Curriculum can be accessed at: www.iit.edu/~ncfs/juice/JUICEHACCP.HTML. 49. Does the person(s) doing the key aspects of the HACCP system need to be an employee(s) of the juice processing firm? No, the trained individual need not be an employee of the processor. However, regardless of who the trained individual is, the firm processing the juice is ultimately responsible for the safety of the juice and for compliance with part 120.

J. Imports and Exports

50. Does imported juice that will only be used as an ingredient in beverages have to be produced in compliance with part 120? Yes. All imported juice, even if the juice is for use as an ingredient in a beverage, must comply with the juice HACCP regulations. 51. What are the responsibilities of juice importers under the juice HACCP regulations? In brief, importers of juice either must ensure that all juice they offer for entry into the U.S. has been processed in compliance with Part 120, or import such juice from a country that has an appropriate memorandum of understanding (MOU) with the U.S. In addition, importers must maintain records that document the performance and results of the affirmative steps taken to demonstrate compliance with the regulations. Requirements for importers of juice are set out in 120.14. 52. Do the regulations apply to juices and juice concentrates produced in the U.S. and intended for export either as bulk shipment or in consumer packages? Processors of juice intended for export must comply with the juice regulations unless the juice at issue satisfies all of the following conditions:

Meets the specifications of the foreign purchaser; Conforms to the laws of the importing country; Is labeled on the outside of the shipping package that the product is intended for export; and Is not sold or offered for sale in domestic commerce.

53. Are there any established memoranda of understanding (MOUs) for juice? How does someone go about establishing an MOU? There are currently no established MOUs for juice HACCP. Normally, the process is started by a letter to FDA from a foreign government requesting initiation of the MOU process. Letters to establish MOUs for juice should be submitted to: Mr. Charles W. Cooper Director, International Activities HFS-585 Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740 Examples of FDA MOUs can be found at the Food and Drug Administration International Cooperative Agreements web page.

K. Labeling Questions
54. If I want to label my product as pasteurized, what criteria do I need to meet? Pasteurization is a heat treatment sufficient to destroy pathogens. Therefore, to be labeled as "pasteurized," a juice must be heat treated to destroy pathogens. 55. May I use the warning label statement on my products in lieu of implementing a HACCP system? Generally speaking, use of the juice label warning statement is not an alternative to compliance with the HACCP regulations. All juice that is not appropriately treated to achieve a 5-log reduction in the pertinent pathogen is required to comply with the warning statement regulations; in the case of HACCP, all juice processors are required to comply with the regulations according to the staggered effectiveness dates ( 120.1(b)) except retail establishments as defined by the regulations. Juice required to be produced under a HACCP system that is not so produced will be considered adulterated. 56. How can I label my apple cider that is processed using ultraviolet (UV) light ? Can I label it as "pasteurized" or "UV treated?" Can it be called "fresh?"

As discussed above, pasteurization is a heat treatment sufficient to destroy pathogens. Therefore, use of the term "pasteurized" on products that have been treated with UV light to attain the 5-log reduction is misleading and the product would be considered to be misbranded under section 403(a) of the Food, Drug, and Cosmetic Act. Possible terms you may use that would convey to consumers that the product has been treated with UV to control pathogens are "treated with UV light to control pathogens," "treated with UV light to control harmful bacteria," or "UV treated." Juice processed using UV light cannot be labeled "fresh."

FDA Allergen Guidance Document idelines

FDA Allergen Guidance Document idelines

Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food
March 2006

Prepared by The Threshold Working Group

Table of Contents
Executive Summary Acknowledgements Preface I. Overview A. Purpose B. Definitions of Thresholds C. FALCPA II. Food Allergy Adverse Reactions to Foods A. Mechanism of Allergic Reaction B. Range of Adverse Effects C. Prevalence D. Allergenic Foods of Concern E. Measuring Thresholds F. Exposure G. Collective Allergens H. Published Challenge Studies I. Food Treatments to Reduce Allergenicity III. Celiac Disease Introduction A. Mechanism of Pathogenesis B. Range of Adverse Effects C. Prevalence D. Celiac Foods of Concern E. Gluten Contamination of Grains F. Gluten Challenge Studies G. Measuring Gluten in Food H. Gluten-Free Labeling Discussion and Recommendations . General Approaches

IV.

A. General Criteria for Evaluating and Selecting Approaches to Establish Thresholds B. Allergen Thresholds: Evaluation and Findings C. Gluten Threshold: Evaluation and Findings V. References VI. Appendices 0. Appendix 1: Evaluation of Analytical Methods for Food Allergens 1. Appendix 2: Evaluation of Available Allergen Oral Challenge Studies 2. Appendix 3: Evaluation of Published Measurements of Protein Concentrations in Oils 3. Appendix 4: Evaluation of Gluten Testing Methods 4. Appendix 5: Evaluation of Gluten Oral Challenge Studies VII. List of Tables 0. Table I-1. Summary of Various Types of Thresholds 1. Table II-1. Signs and Symptoms of Allergic Reactions 2. Table II-2. Allergy Prevalence in the United States 3. Table III-1. Estimated Daily Gluten Consumption from Combinations of Different Amounts of Food Containing Different Levels of Gluten 4. Table IV-1. Approaches to Establishing Thresholds 5. Table IV-2. General Criteria for Evaluating and Selecting Recommended Approaches to Establish Thresholds 6. Table IV-3. Specific Criteria for Evaluating Analytical Methods for Food Allergens 7. Table IV-4. Specific Criteria for Evaluating Allergen Oral Challenge Studies 8. Table IV-5. Summary of Published LOAELs for Food Allergens 9. Table IV-6. Example of Uncertainty Factors for the Safety-Assessment-Based Approach Using Peanuts 10. Table IV-7. Specific Criteria for Evaluating Protein in Oil Studies 11. Table IV-8. Specific Criteria for Evaluating Gluten Analytical Methods 12. Table IV-9. Specific Criteria for Evaluating Gluten Oral Challenge Studies 13. Table IV-10. Example of Uncertainty Factors for the Safety Assessment-Based Approach VIII. List of Figures 0. Figure II-1. Adverse Reactions to Foods 1. Figure II-2. Mechanism of Allergic Reactions 2. Figure III-1 Mechanism of Celiac Disease

Executive Summary
Background
The Food Allergen Labeling and Consumer Protection Act of 2004 (P.L. 108-282) (FALCPA) amends the Federal Food, Drug, and Cosmetic Act (FFDCA) and requires that the label of a food product that is or contains an ingredient that bears or contains a "major food allergen" declare the presence of the allergen as specified by FALCPA. FALCPA defines a "major food allergen" as one of eight foods or a food ingredient that contains protein derived from one of those foods. A food ingredient may be exempt from FALCPA's labeling requirements if it does not cause an allergic response that poses a risk to human health or if it does not contain allergenic protein. FALCPA also requires FDA to promulgate a regulation defining the term "gluten-free." This report summarizes the current state of scientific knowledge regarding food allergy and celiac disease, including information on dose-response relationships for major food allergens and for gluten, respectively. The report presents the biological concepts and data needed to evaluate various approaches to establish thresholds that would be scientifically sound and efficacious in relation to protection of public health. Each approach has strengths and weaknesses, and the application of each is limited by the availability of appropriate data. It is likely that there will be significant scientific advances in the near future that will address a number of the limitations identified in this report. The Threshold Working Group expects that any decisions on approaches for establishing thresholds for food allergens or for gluten would require consideration of additional factors not covered in this report. Furthermore, one option that is implicit in the report's discussion of potential approaches is a decision not to establish thresholds at this time.

Approaches to Establish Thresholds

The report identifies four approaches that could be used to establish thresholds:

Analytical methods-based-thresholds are determined by the sensitivity of the analytical method(s) used to verify compliance. Safety assessment-based-a "safe" level is calculated using the No Observed Adverse Effect Level (NOAEL) from human challenge studies and an appropriate Uncertainty Factor (UF) applied to account for knowledge gaps. Risk assessment-based-examines known or potential adverse heath effects resulting from human exposure to a hazard; quantifies the levels of risk associated with specific exposures and the degree of uncertainty inherent in the risk estimate. Statutorily-derived-uses an exemption articulated in an applicable law and extrapolates from that to other potentially similar situations.

Any approach used to establish a threshold to protect consumers with food allergies or those susceptible to celiac disease should be reexamined periodically to consider new knowledge, data, and approaches.

Threshold Working Group Findings For Major Food Allergens

Finding 1. The initial approach selected to establish thresholds for major food allergens, the threshold values, and any uncertainty factors used in establishing the threshold values should be reviewed and reconsidered periodically in light of new scientific knowledge and clinical findings. Finding 2. The analytical methods-based approach can be used to establish thresholds for those major food allergens for which validated analytical methods are available. However, if this approach is used, the thresholds should be replaced by thresholds established using another approach as quickly as possible. Finding 3. The safety assessment-based approach, based on currently available clinical data, is a viable way to establish thresholds for the major food allergens. If this approach is employed, the Lowest Observed Adverse Effect Level (LOAEL) or No Observed Adverse Effect Level (NOAEL) determinations used should be based on evidence of the "initial objective sign." Individual thresholds should be established for each of the major food allergens. If it is not feasible to establish individual thresholds, a single threshold based on the most potent food allergens should be established. In those instances where a LOAEL is used rather than a NOAEL to establish a threshold, an appropriate uncertainty factor should be used. Thresholds established using this approach should be reevaluated periodically as new data and tools become available. Finding 4. Of the four approaches described, the quantitative risk assessment-based approach provides the strongest, most transparent scientific analyses to establish thresholds for the major food allergens. However, this approach has only recently been applied to food allergens, and the currently available data are not sufficient to meet the requirements of this approach. A research program should be initiated to develop applicable risk assessment tools and to acquire and evaluate the clinical and epidemiological data needed to support the quantitative risk assessment-based approach. Thresholds established using this approach should be reevaluated periodically as new data and tools become available. Finding 5. The statutorily-derived approach provides a mechanism for establishing thresholds for allergenic proteins in foods based on a statutory exemption. Potentially, this approach could be used to set a single threshold level for proteins derived from any of the major food allergens. This approach might yield thresholds that are unnecessarily protective of public health as compared with thresholds established using the safety assessment-based approach or the risk assessment-based approach. However, confirming this would require additional data. If this approach is employed to establish thresholds, it should be used only on an interim basis and should be reevaluated as new knowledge, data, and risk assessment tools become available.

Threshold Working Group Findings For Gluten

Finding 6. The initial approach selected to establish a threshold for gluten, the threshold value selected, and any uncertainty factors used to establish the threshold should be reviewed and reconsidered periodically in light of new scientific knowledge and clinical findings.

Finding 7. The analytical methods-based approach can be used to establish a threshold for gluten. However, if this approach is used, the threshold should be replaced by a threshold established using another approach as quickly as possible. Finding 8. The safety assessment-based approach is a viable approach to establish a threshold for gluten using currently available LOAEL data for celiac disease. An overall uncertainty factor should be estimated from the data and applied to the LOAEL to establish a threshold for gluten. Any threshold derived from this approach should be reevaluated as new research data become available. Available data are insufficient at the current time to use this approach to establish a threshold for oat gluten for those individuals with celiac disease who may also be sensitive to oats. However, it is likely that a threshold level based on wheat gluten would be protective for individuals susceptible to oat gluten. Finding 9. Use of the quantitative risk assessment-based approach to establish a threshold for gluten does not appear to be feasible at the present time. However, considering the benefits that could be gained from using the risk assessment-based approach, priority should be given to establishing a research program to acquire the knowledge and data needed. Finding 10. There appear to be no suitable legal requirements or exemptions that would serve as the rationale for using the statutorily-derived approach to establish a threshold for gluten. This approach is not viable.

Acknowledgements
Threshold Working Group Robert Buchanan (Lead) Sherri Dennis (Associate Lead) Core Writing Team Steven Gendel (Lead) David Carlson Sherri Dennis Working Group Members David Acheson Sue Anne Assimon Nega Beru Philip Bolger Ricardo Carvajal Catherine Copp Kenneth Falci Elizabeth Harden Rhonda Kane

John Kvenberg Stefano Luccioli Douglas Park Richard Raybourne Terry Troxell Katherine Vierk The Threshold Working Group would also like to acknowledge the assistance provided by: Curtis Barton for information on statistics and study designs, Hugh Dallas for assistance with the reference database, Eric Garber for information on methods of analysis, Michael Landa for consultations on the FALCPA, Lori Pisciotta in preparation of the report, and Meredith Todd for assistance summarizing the public comments.

Preface
In preparing this report, the Threshold Working Group conducted literature searches, gathered extensive scientific information about food allergy and celiac disease, and consulted technical experts. This information was used to identify approaches that could be used to establish thresholds, and to evaluate the strengths, weaknesses, and data needs of each approach. A notice of availability for the draft report was published in the Federal Register (70 FR 35258), and the report was made available through the FDA Docket and the CFSAN web site. The FDA requested that interested persons submit comments, scientific data, and information to FDA Docket No. 2005N-0231 during a 60-day period, ending August 16, 2005. Eighteen letters were received, including comments from consumer groups, the food industry, trade associations, experts on food allergens and gluten, and individual consumers. In the Federal Register of May 23, 2005 (70 FR 29528), FDA announced a meeting of the Food Advisory Committee (FAC) to be held on July 13, 14, and 15, 2005. Members of the public were invited to participate in the meeting. The FAC was asked to consider whether the draft report was scientifically sound in its analyses and approaches and whether the report adequately considered available relevant data on food allergens and on gluten. The meeting included presentations on issues related to the diagnosis and treatment of food allergies and celiac disease, the quality of life for affected consumers, analytical methods to measure allergens and gluten in foods, and clinical studies to characterize dose-response relationships. In seeking the Committee's advice, FDA posed a series of specific scientific questions. The transcript of the meeting is available at CFSAN 2005 Meeting Documents. The Committee's answers to the specific scientific questions is available (available in PDF, 460 Kb). A summary of the public comments received at the Food Advisory Committee meeting and in the public docket with a brief indication as to how the revised report responds to each comment is available.

The Committee concluded that CFSAN's draft report includes a comprehensive evaluation of the currently available data and descriptions of all relevant approaches that could be used to establish thresholds for major allergens and gluten in food. The Committee suggested that, while the safety assessment-based and risk assessment-based approaches are distinct, they are not mutually exclusive. For example, statistical analyses could be incorporated into a traditional safety assessment by considering dose-response distributions. The Committee felt that the risk assessment-based approach is scientifically the strongest of the approaches, and that it should be used in a transparent manner with appropriate consideration of data uncertainties, when sufficient data become available. The Committee agreed that the criteria identified in the draft report for evaluating the available data were appropriate. The Committee also recommended that data from highly relevant, well designed studies be considered in establishing thresholds, even if they have not yet been published or peer-reviewed. We wish to acknowledge and express our appreciation to those who provided written and oral comments. Both the public comments and recommendations and comments and recommendations of the FAC were considered in revising the report. These revisions addressed the use of technical terminology, clarification where needed, the inclusion of additional data, and minor editorial changes. Based on the comments and recommendations, FDA determined that it was not necessary to significantly revise the report or its findings. The specific comments made regarding the strengths and weakness of each approach will inform any decision as to whether to establish thresholds and, if so, which approach to use. The Agency also appreciates the suggestion that it may be possible to combine the safety assessment-based approach and the risk assessment-based approach to provide quantitative information on the uncertainties associated with thresholds established using the available published LOAELs and NOAELs. The Agency also takes note of the discussions that addressed issues beyond the scope of this report that may become relevant if a decision is made to establish thresholds.

I. Overview
A. Purpose
Accurate and informative labeling is critical for allergic consumers, individuals with celiac disease, and their families because they need to rely on strict avoidance of specific foods and ingredients to prevent potentially serious reactions. The Food Allergen Labeling and Consumer Protection Act of 2004 (P.L. 108-282) (FALCPA) amends the Federal Food, Drug, and Cosmetic Act (FFDCA) and requires that the label of a food product that is or contains an ingredient that bears or contains a "major food allergen " declare the presence of the allergen as specified by FALCPA. FALCPA defines a "major food allergen " as one of eight foods or food groups (milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) or a food ingredient that contains protein derived from one of those foods.

An important scientific issue associated with the implementation of FALCPA is the existence of threshold levels below which it is unlikely that a food allergic individual would experience an adverse effect. FALCPA provides two processes by which an ingredient may be exempted from the FALCPA labeling requirements, a petition process [21 U.S.C. 343(w)(6)] and a notification process [21 U.S.C. 343(w)(7)]. Under the petition process, an ingredient may be exempt if the petitioner demonstrates that the ingredient "does not cause an allergic reaction that poses a risk to human health." Under the notification process, an ingredient may be exempt if the notification contains scientific evidence that demonstrates that the ingredient "does not contain allergenic protein," or if FDA previously has determined, under section 409 of the FFDCA, that the food ingredient does not cause an allergic response that poses a risk to human health. Thus, understanding food allergen thresholds and developing a sound scientific framework for such thresholds are likely to be centrally important to FDA's analysis of, and response to, FALCPA petitions and notifications. FALCPA also requires FDA to promulgate a regulation to define and permit the use of the term "gluten-free" on the labeling of foods. Such labeling is important to patients suffering from celiac disease, an immune-mediated illness. Strict avoidance of gluten at levels that will elicit an adverse effect is the only means to prevent potentially serious reactions. Thus, consumers susceptible to celiac disease need accurate, complete, and informative labels on food. Understanding thresholds for gluten will help FDA develop a definition of "gluten-free" and identify appropriate uses of the term. Section 204 of FALCPA directs FDA to prepare and submit a report to Congress. The report is to focus principally on the issue of cross-contact of foods with food allergens, and is to describe the types, current use of, and consumer preferences with respect to advisory labeling. Cross-contact may occur as part of the food production process where residues of an allergenic food are present in the manufacturing environment and are unintentionally incorporated into a food that is not intended to contain the food allergen, and thus, the allergen is not declared as an ingredient on the food's label. In some cases, the possible presence of the food allergen is declared by a voluntary advisory statement. Understanding food allergen thresholds and developing a sound scientific framework for such thresholds is also likely to be useful in addressing food allergen cross-contact issues, including the use of advisory labeling. Both as part of its ongoing risk management of food allergens and in response to FALCPA, CFSAN established an ad hoc internal, interdisciplinary group (the Threshold Working Group) to evaluate the current state of scientific knowledge regarding food allergies and celiac disease, to consider various approaches to establishing thresholds for food allergens and for gluten, and to identify the biological concepts and data needed to evaluate the scientific soundness of each approach. This report is the result of the working group's deliberations. This report summarizes the current state of scientific knowledge regarding food allergies and celiac disease, including information on dose-response relationships for major food allergens and for gluten, respectively. The ability to establish a threshold depends on understanding the doseresponse relationship between the ingestion of an allergen or gluten and the elicitation of an adverse response. Implicit in establishing such dose-response relationships is the identification of susceptible populations and characterization of any exposure levels below which all, or part, of

the susceptible population does not respond. There is no consensus in the scientific literature regarding thresholds for major food allergens or gluten. Therefore, the Threshold Working Group identified the biological concepts and data needed to evaluate various approaches for establishing thresholds that would be scientifically sound and efficacious in relation to protection of public health.

B. Definitions of Thresholds
The term "threshold" has been used to refer to a variety of different concepts (Table I-1) that apply either to individuals or populations. Thresholds can be measured experimentally in animals or humans [i.e., No Observed Adverse Effect Level (NOAEL) or Lowest Observed Adverse Effect Level (LOAEL)], derived from epidemiological data, estimated by modeling (statistical or simulation), established by statute, or arising as the result of the selection of an analytical method. The ability to measure or determine a threshold may be limited by the sensitivity and specificity of the methods available to measure either the stimulus or the response. Understanding the strengths and limitations of the data underpinning the different approaches is particularly important when dealing with adverse effects that have low probabilities of occurring. Table I-1. Summary of Various Types of Thresholds Type Description Etymological "The intensity below which a mental or physical stimulus cannot be Definition perceived and can produce no response." (Webster's Dictionary). Toxicological The dose at, or below which, an adverse effect is not seen in an experimental setting. Methodological The limit of detection of an analytical method. Statutory The establishment of a limit by statute, below which no regulatory action will be taken.

C. FALCPA
As noted, FALCPA amends the FFDCA to prescribe the manner in which food labels must disclose that a food is, or contains an ingredient that bears or contains, a major food allergen. The law also requires the FDA to issue a regulation to define and permit use of the term "glutenfree." FALCPA establishes a petition process through which a food ingredient may be exempt from FALCPA's labeling requirements if the ingredient does not cause an allergic response that poses a risk to human health. FALCPA also establishes a notification process under which a food ingredient described in section 201(qq)(2) of the FFDCA may be exempt from FALCPA's labeling requirements if the ingredient does not contain allergenic protein, or if FDA previously has determined, under section 409 of the FFDCA, that the food ingredient does not cause an allergic response that poses a risk to human health. From the perspective of the Working Group, implementation of the FALCPA petition and notification provisions could present several key scientific issues. First, what is an "allergic response?" Second, do all allergic responses pose a risk to human health, or do some allergic

responses pose more of a risk than others? Third, can allergens occur in a food either in a form or at a level that is too low to cause harm (i.e., either the allergen does not cause a biological response or the response is too mild to be considered hazardous)? Under FALCPA, a "highly refined oil" derived from one of eight foods or food groups and "any ingredient derived from such highly refined oil" are exempt from the definition of "major food allergen " and from FALCPA's labeling requirements. As discussed further below, there is evidence that consumption of highly refined oils does not appear to be associated with allergic responses despite the potential presence of low levels of protein in these oils. Section 202 of FALCPA requires FDA to issue a proposed rule to define and permit use of the term "gluten-free" on labeling of foods. Section 203 of FALCPA recognizes that "the current recommended treatment is avoidance of glutens in foods that are associated with celiac disease." FALCPA does not directly state how the term "gluten-free" should be defined.

II. Food Allergy

A. Adverse Reactions to Foods
Many consumers consider a wide variety of adverse reactions associated with the ingestion of foods to be "food allergies." While adverse reactions may occur for a variety of immunological, toxicological, or metabolic reasons only a small fraction of these are related to food allergies (figure II-1). The signs and symptoms associated with these reactions can range from oral irritation and swelling to cardiovascular collapse (Jackson, 2003). Although adverse reactions caused by microbial and toxicological agents can affect any most individual, immunological reactions only affect a small group of sensitive individuals. Reactions caused by the presence of toxic compounds such as histamine in seafood (e.g., scombroid poisoning) or from metabolic (e.g., lactose intolerance) are not true food allergies. The nomenclature used to describe these well documented reactions in sensitive individuals is not consistent in the scientific literature. Generally, reactions not involving immune responses are termed food intolerances (Johansson et al., 2001; Sampson, 2004). Immunological responses to foods, including food allergies, occur in a sensitive population of individuals. The major immunological responses to foods, termed food hypersensitivities, can be divided into two major categories based on mechanism: (1) immunoglobulin E (IgE)-mediated hypersensitivity (e.g., oral allergy syndrome, anaphylaxis) and (2) non-IgE-mediated hypersensitivity (e.g., celiac disease, food protein-induced enterocolitis) (Johansson et al., 2001; Wershil et al., 2002, Sampson, 2004). A group of food-related disorders (e.g., allergic eosinophilic gastropathies, atopic dermatitis) may involve both IgE- and non-IgE-mediated immune mechanisms (Sampson, 2004). For the purposes of this report, the term "food allergy" will be used to describe IgE-mediated immune responses resulting from the ingestion of specific foods (Johansson et al., 2001; Jackson, 2003; Sampson, 2004). The most severe and immediately life-threatening adverse reactions to foods are associated with IgE-mediated hypersensitivity (Johansson et al., 2001; Jackson, 2003; Zarkadas et al., 1999).

Figure II-1. Adverse Reactions to Foods

B. Mechanism of Allergic Reaction

An allergic reaction stems from an abnormal, or exaggerated, immune system response to specific antigens, which in foods are proteins (Sampson, 1999). This immune response occurs in two phases, an initial "sensitization" to an allergen and the "elicitation" of an allergic reaction on subsequent exposure to the same allergen. Sensitization occurs when a susceptible individual produces IgE antibodies against specific proteins in a food. Upon re-exposure to the same food, the allergenic proteins bind to IgE molecules on immune mediator cells (basophiles and mast cells), leading to activation of these mediator cells. This elicitation causes the release of inflammatory molecules (e.g., leukotrienes and histamine). The specific effects that are seen and the severity of an allergic reaction are affected by the concentration and type of allergen, route of exposure, and the organ systems involved (e.g., skin, GI tract, respiratory tract, and blood) (Taylor and Hefle, 2001).

Figure II-2. Mechanism of Allergic Reactions

C. Range of Adverse Effects

The clinical manifestations of food allergic reactions range from mild irritation to severe, lifethreatening respiratory distress and shock. Specific signs and symptoms may involve the skin (e.g., pruritis, erythema, urticaria, angiodemia, eczema), eyes (e.g., conjunctivitis, periorbital swelling), nose (e.g., rhinitis, sneezing), oral cavity (e.g., swelling and itching of lips, tongue, or palate), or gastrointestinal tract (e.g., reflux, colic, abdominal pain, nausea, vomiting, diarrhea). In more severe reactions, involvement of the respiratory tract (e.g., cough, asthma, difficulty breathing, swelling around the larynx and vocal cords) and cardiovascular system (e.g., faintness, hypotension) can lead to loss of consciousness, asphyxiation, shock, or death. The term "anaphylaxis" is used to describe multisystemic severe reactions to an allergen requiring immediate medical intervention (Jackson, 2003). Table II-1 provides a summary of the signs and symptoms that may be experienced during an allergic reaction. Allergic reactions usually occur within a few minutes to hours after ingestion of an offending food and often progress on a continuum from mild to severe, with higher doses causing more severe reactions (Sampson et al., 2005). Once exposure occurs, individuals may experience immediate numbness or pruritis at the site of contact or experience general uneasiness. These symptoms are characterized as "subjective" since they cannot be observed by others. As the effects progress, "objective" signs such as flushed skin, hives, or swelling of the lips and face may occur. These signs are often mild and short-lived. However, in some cases,

they may be associated with more severe responses involving the respiratory and/or cardiovascular systems. Such responses can lead to hospitalization or death, even with appropriate medical intervention. Not all severe, or anaphylactic, reactions are necessarily preceded by milder signs and not all reactions are immediate. In some cases, anaphylactic reactions may be delayed by a few hours after the initial response (Sampson et al., 2005). Anaphylaxis is a poorly defined condition representing a severe or multisystemic allergic reaction (Sampson et al., 2005). Allergic reactions described by objective signs involving the respiratory or cardiovascular systems would be considered severe and managed as an anaphylactic reaction by most clinicians. In some classifications, reactions involving two or more of the categories shown in Table II-1 (e.g., cutaneous, gastrointestinal, respiratory), would also be classified as anaphylaxis, if they are relatively mild. Anaphylactic "shock" denotes a consequence of anaphylaxis where heart irregularities and leakage of blood vessels leads to extreme blood volume loss (usually greater than 25% of resting blood volume) and extreme hypotension. Table II-1. Signs and Symptoms of Allergic Reactions to Food Subjective Symptoms Objective Signs CUTANEOUS Skin Pruritus (Itching) Skin flushing or erythema (redness) Pilor erection ("goosebumps") Rash: Urticaria (hives) - acute Eczema (usually delayed, >6 hours) Angioedema (swelling, especially face) Oral cavity Pruritus (Itching), Edema (swelling, may also include the (lips, tongue, numbness, dryness uvula) palate) Eyes, Periorbital (around eyes) edema, Pruritus (Itching) conjunctiva redness of conjunctiva and tearing GASTROINTESTINAL Nausea, pain (except Vomiting, diarrhea, abdominal pain infants/young child) (infants) RESPIRATORY Nose Pruritus (Itching) Nasal congestion or runniness, sneezing Swelling around the larynx and vocal Pruritus (Itching), Larynx, throat cord, voice hoarseness, stridor dryness/tightness (inspiratory wheeze), cough Respiratory distress (i.e., breathing rate, difficulty catching breath, peak Shortness of breath, Lungs chest pain/tightness expiratory flow measurement), cough, wheezing HEART and Chest pain/ tightness, Syncope (fainting, loss of CARDIOVASCULAR feeling of faintness, consciousness), hypotension (low) or dizziness shock (very low blood pressure), dysrhythmia (abnormal heart rhythm)

OTHER

"Sense of impending doom"

Uterine contractions (women)

The severity of an allergic reaction is affected by several factors that include genetic predisposition (atopy), age, type of food allergen, nature of any food processing, environment, and physiological conditions (Taylor and Hefle, 2001; Sampson, 2003; Maleki, 2004). For example, exercise, medications (e.g., non-steroidal anti-inflammatories), alcohol consumption, and asthma may enhance the severity of an allergic reaction (Sampson, 2005). Most severe and fatal allergic reactions to foods have occurred in adolescents and teens whom were highly atopic and had a history of asthma (Sampson, 2003; Pumphrey, 2004). It is generally assumed that a history of previous serious allergic reaction(s) indicates an increased risk of future severe reaction(s). However, a history of mild reactions does not preclude the possibility of a future severe reaction. For example, Sicherer et al. (1998) observed that mild reactions to peanut in childhood tend to become more severe and unpredictable in later childhood and adulthood. This may be due to the fact that these children tend to develop asthma later in life (Sampson, 2005). Also, a recent review of anaphylactic fatalities in the United Kingdom showed that in 85% of fatal food reactions the patient had previously experienced a non-severe reaction (Pumphrey, 2004). Pumphrey (2004) stated that the severity of previous reactions is not a risk factor for fatal reactions in nut allergic patients. These data imply that any individual with a clinical history of IgE-specific food allergy may be predisposed to anaphylaxis or severe reaction.

D. Prevalence
Information on the prevalence of food allergies in the U.S. suggests that up to 6% of children and 4% of the total population have IgE-mediated food allergies (Sampson, 1997; Sampson, 2004; Sicherer et al., 2003; Sicherer et al., 2004). The estimated prevalence in the U.S. population of allergies to each of the food allergens identified by the FALCPA is given in Table II-2. Severe food-related allergic reactions result in an estimated 30,000 emergency room visits, 2,000 hospitalizations, and 150 deaths per year (Sampson, 2004). Clinical data and surveys indicate that the prevalence of allergy, including food allergy, has been rising in recent years, though there are limited historical data to compare to more recent estimates (Sicherer et al., 2003; Grundy et al., 2002). Peanut allergy has received the most attention in the U.S., and data indicate an apparent doubling of peanut allergy in children under 5 years old from 1997 to 2002 (Sicherer et al., 2003). An increase in peanut allergy has also been seen in the United Kingdom (Ewan, 1996; Grundy et al., 2002). Peanuts and tree nuts are the most common cause for fatal reactions in the US, although seafood allergy is increasingly being recognized in adults (Yunginger et al., 1988; Sampson et al., 1992b; Bock et al., 2001, Sicherer et al., 2004, Ross et al., 2006). Table II-2. Allergy Prevalence in the United States Age Group Percentage of the Population All Allergens Milk Egg Peanut Tree nuts Fish Shellfisha Wheat Soy Children 6.0 2.5 1.3 0.8 0.2 0.1 0.0 UNKb 0.2 Adults 3.7 0.3 0.2 0.6 0.5 0.4 2.0 UNKb UNKb

Shellfish includes both crustaceans and mollusks. bUNK = unknown.

Sources: Cordle, 2004; Sampson, 1997; Sampson, 2004; Sampson, 2005; Sicherer et al., 2003; Sicherer et al., 2004.

E. Allergenic Foods of Concern

1. Whole foods The FALCPA identifies eight major foods or food groups: milk, eggs, fish (e.g., bass, flounder, cod), crustacean shellfish (e.g., shrimp, crab, lobster), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and soybeans. These eight foods are believed to account for 90 percent of food allergies and most serious reactions to foods (FALCPA section 202(2)(A); Bousquet et al., 1998; Hefle et al., 1996). More than 160 other foods are known to cause food allergies; however, these allergies are relatively rare with prevalence rates ranging from a few percent of the allergic population to single cases (Hefle et al., 1996). Each of the eight major food allergens contains multiple allergenic proteins, many of which have not been fully characterized (Gendel, 1998). 2. Food Ingredients Some food ingredients such as edible oils, hydrolyzed proteins, lecithin, gelatin, starch, lactose, flavors, and incidental additives (e.g., processing aids), may be derived from major food allergens (Taylor and Hefle, 2001). The role that these ingredients play in food allergy has not been fully characterized. For example, lecithin is a common food ingredient which is often derived from soybeans. It is possible that soy lecithin, which contains residual protein, could elicit an allergic reaction in sensitive individuals (Muller et al., 1998; Gu et al., 2001). Another example is protein hydrolysate, which is often made from major food allergens such as soybeans, wheat, peanuts, or milk protein. Partially hydrolyzed protein ingredients can elicit allergic reaction. For example, hot dogs formulated with partially hydrolyzed casein have elicited allergic reactions in children allergic to cow's milk (Gern, et al., 1991; Kocabas and Sekerel, 2003). Allergic reactions to partially hydrolyzed protein ingredients are more common than are reactions to extensively hydrolyzed protein ingredients (Bock and Atkins, 1989; Ellis et al., 1991; Saylor and Bahna, 1991; Kelso and Sampson, 1993; Niggemann et al., 1999). Gelatins are ingredients derived from animals (e.g., cows, pigs) but also from the skin of various species of fish. A study of 10 fish allergic patients and 15 atopic individuals with eczema revealed that 3 and 5 individuals respectively had specific IgE to fish gelatin, suggesting the presence of allergenic protein (Sakaguchi et al., 2000). However, in a recent double-blind placebo-controlled food challenge (DBPCFC) study, all 30 fish allergic subjects in the study showed no response to a cumulative dose of 3.61 g of fish gelatin (Hansen et al., 2004). Edible oils can be derived from major food allergens such as soybeans and peanuts, and they may contain variable levels of protein (Taylor and Hefle, 2001). The consumption of highly refined oils derived from major food allergens by allergic individuals does not appear to be associated with allergic reactions. For example, Taylor et al. (1981) and Bush et al. (1985) did not observe any reactions to refined peanut or soy oils in 10 and 7 allergic patients, respectively.

On the other hand, unrefined or cold-pressed oils that contain higher levels of protein residues (Taylor and Hefle, 2001) may cause allergic reactions. For example, Hourihane et al. (1997b) reported that 6 of 60 peanut allergic individuals reacted to crude peanut oil but none responded to refined peanut oil. Similarly, Kull et al. (1999) reported that 15 of 41 peanut allergic children responded positively to crude peanut oil in skin prick tests, but none responded to refined peanut oil. The actual protein levels reported in various edible oils varies, probably due to differences in the oil, refining process, and the protein detection analytical method used. Crevel et al. (2000) reported that crude peanut and sunflower oils contained 100 to 300 g/ml of protein, but that the most highly refined oils contained 0.2 to 2.2 g/ml of protein. Intermediate protein concentrations were seen for partially processed oils. Teuber et al. (1997) showed that the amount of protein in both crude and refined gourmet nut oils varied both by type of oil and degree of processing; the reported values ranged from 10 to 60 g/ml for various unrefined oils and from 3 to 6 g/ml for the refined oils. Other investigators reported undetectable levels of proteins in refined edible oils (Hoffman et al., 1994; Yeung and Collins, 1996; Peeters et al., 2004) using assays with detection sensitivities of <0.3 ng/ml (Peeters et al., 2004) and 0.4 mg/kg (Yeung and Collins, 1996). Starch, which is a widely used ingredient, is often derived from corn which is not a major food allergen. However, starch can also be derived from wheat, and may contain trace levels of wheat protein. For example, Lietze (1969) reported the presence of antibodies to wheat starch in several wheat sensitive individuals. However, the allergenicity of wheat starch for sensitive individuals has not been clinically evaluated (Taylor and Hefle, 2001). A wide variety of flavoring substances are used in foods, but only a few are derived from known allergens (Taylor and Dormedy, 1998). As such, IgE-mediated allergic reactions to flavorings are rare, although a few cases have been documented involving hydrolyzed proteins. For example, several milk allergic individuals reacted to either hot dogs or bologna containing partially hydrolyzed casein as part of the natural flavoring used in the formulation of these products (Gern et al., 1991). Two other milk-allergic individuals reacted to milk protein in the natural flavoring used in a dill pickle-flavored potato chip (St. Vincent and Watson, 1994). The presence of peanut flour in the natural flavoring of a packaged soup elicited a reaction in a peanut-allergic individual (McKenna and Klontz, 1997). 3. Cross-Contact Allergens, or proteins derived from allergenic foods, may be present in foods as the result of cross-contact during processing and handling. The term "cross-contact" describes the inadvertent introduction of an allergen into a product that would not intentionally contain that allergen as an ingredient. Cross-contact may occur when a residue or other trace amount of a food allergen is present on food contact surfaces, production machinery, or is air-borne, and unintentionally becomes incorporated into a product not intended to contain, and not labeled as containing, the allergen. Cross-contact may also result when multiple foods are produced in the same facility or on the same processing line, through the misuse of rework, as the result of ineffective cleaning, or may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment. Cross-contact of foods with allergens has been shown to lead to allergic reactions in consumers on numerous occasions (Gern et al.,

1991; Jones et al., 1992; Yunginger et al., 1983). Much cross-contact can be avoided by controlling the production environment.

F. Measuring Thresholds
1. Design of Food Challenge Studies A history of clinical reaction to a food and a positive skin prick test or the presence of foodspecific IgE antibodies in serum are sufficient to establish that an individual has an allergy to that food. However, none of these reliably predicts the level of patient sensitivity to low doses of the food. At present, the level of individual sensitivity can only be determined using food challenge studies (including open, single-blind, and double-blind, placebo-controlled food challenges). The double-blind, placebo-controlled food challenge (DBPCFC) is the "gold standard" diagnostic measure for determining clinical reactivity to low concentrations of an allergen. In this type of study, neither the subject nor the researcher knows which test foods contain the allergen. Open (where both the subject and the researcher know which test foods contain the allergen) and single-blinded (where only the researcher knows which foods contain the allergen) challenges are used primarily for screening foods of low allergenic importance or for determining tolerance to food allergens. Single-blinded challenges can be placebo-controlled (SBPC). However, in open and SBPC challenges, experimenter bias may play a role in interpreting patient reactions. The typical diagnostic food challenge protocol is a dose escalation study, usually with 15 to 30 minute dose intervals, which proceeds until a clinical effect is observed or the final dose is achieved. The test substance, starting dose and successive incremental doses vary between protocols. Because reactions are assumed to be less severe at lower doses, the starting dose for most diagnostic studies is generally in the milligram range for whole foods (Bindslev-Jensen et al., 2004). In the few studies designed to determine minimal eliciting doses, the initial doses are in the low microgram range for the whole food or whole food protein (Hourihane et al. 1997; Wensing et al. 2002a; Wensing et al. 2002b). Incremental doses are usually doubled or increased logarithmically, so that a reasonable number of incremental doses (i.e., 6 to 10) separate the starting dose from the end dose. This final dose is usually chosen to be the normal amount in a food serving, usually 8 to 10 gm of dried food or 60 to 100 gm of wet food (Bock et al., 1988; Bindslev-Jensen et al., 2004). The ability to tolerate this amount, followed by a negative open challenge on a different day, is considered to be evidence that the individual is not allergic to that allergen (Taylor et al., 2004). Most oral challenge studies are designed to establish a diagnosis of food allergy rather than to determine safety (Taylor et al., 2004). Consequently, these studies do not start at doses below a known LOAEL. Thus, individuals who react to the starting dose are not necessarily demonstrating a true LOAEL because it is not possible to know whether these individuals would have reacted to a lower dose without further testing. A NOAEL cannot be established as long as one or more study participants react to the starting dose. Most elicited reactions occur within 3 to 15 minutes after a challenge (Bindslev-Jensen et al., 2004). Thus, an interval of 15 minutes between challenge doses may be sufficient to confirm a negative response. Most challenge studies report the dose that elicits the first objective sign.

Because subjective symptoms may have preceded the first objective sign at lower doses, it is often difficult to ascertain whether the reported LOAEL truly represents the lowest dose to elicit a reaction. The measurement and interpretation of allergic reactions is discussed below. 2. Inclusion/Exclusion of Sensitive Populations Individuals with a history of anaphylaxis to foods, infants and children are often excluded from challenge studies for ethical reasons (Taylor et al., 2002). Moreover, individuals with very high food allergen IgE serum titers are often excluded. Thus, food challenge studies may not include subpopulations of those allergic individuals who may be the most sensitive to allergen exposure. Individuals with allergies to a specific food have different genetic backgrounds and express a wide distribution of sensitivity and reactivity. Studies have shown that there may be a range of as much as one-million-fold (106) in eliciting doses from the least sensitive to the most sensitive individuals (Leung et al., 2003; Wensing et al., 2002b; Bindslev-Jensen et al., 2002). Moreover, sensitivity and reactivity may change with age for individuals within a population. For example, unpublished challenge data described in Moneret-Vautrin and Kanny (2004) show that 83% of wheat allergic children reacted to less than 2 g of wheat flour compared to 18% of wheat allergic adults. Therefore, the inclusion or exclusion of data for highly sensitive individuals can greatly affect the NOAEL determination for the population. To add to this uncertainty, the most sensitive individuals also may have more severe reactions (Wensing et al., 2002b; Perry et al., 2004). The thresholds measured for populations that exclude these individuals may not apply to those with severe allergic disease. 3. Testing Materials Food challenges vary in the type of testing material used (e.g., peanut flour versus ground peanut), oral challenge vehicle (e.g., whole food versus capsules), and in the efficacy of blinding. Differences in these variables could modify the distribution or concentration of allergen within the test material, affect digestibility and absorption, influence false-positive subjective reactions, and therefore, affect interpretation of the dose-response data. The nature of the testing material is very important, as this can enhance or diminish the overall immunogenicity of the native allergen (Beyer et al., 2001; Maleki et al., 2003). The matrix used (e.g., fatty substances) can delay absorption, thus affecting the time interval to a reaction, or may affect the intrinsic allergenic properties of the food. Also, gustatory differences in the challenge doses (because of the food matrix used) may influence subjective reactions due to poor taste or fear of consuming the allergen. The use of capsules eliminates problems caused by taste, but bypasses the oral cavity. Because the oral cavity plays an important role in the initial contact and metabolism of food allergens, this may affect the subsequent severity or character of response to the challenge dose. 4. Subjective Versus Objective Reactions There are two types of physiologic reactions or effects that can occur during a food challenge subjective symptoms, those reported by the subject, and objective signs, those observed by the

researcher. Because subjective symptoms may be the result of non-immunological mechanisms, elicitation of objective signs is believed to be the more reliable indicator of clinical reactivity to the food allergen (Taylor et al., 2004). The signs of a severe allergic reaction are associated with life-threatening conditions, e.g., anaphylaxis. However, there is no consensus as to which of the less serious signs or symptoms should be considered adverse effects. For example, can eczema be seen as a "safer" reaction than angioedema? Unlike well-defined toxicity endpoints, reactions to allergenic food ingredients are part of a wide spectrum of severity that includes trivial injury, objective systemic reactions, anaphylaxis, and death. Further, allergic reactions may involve multiple organ systems. For example, in Scibilia et al. (2006) 62% of responses involved more than one organ system. Subjective symptoms may be good indicators of a subsequent objective reaction, i.e., subjective symptoms may precede or signal objective signs in a dose-dependent manner (Moneret-Vautrin, 2004). However, most challenge studies base their LOAEL determinations on the first objective sign rather than a subjective symptom. For example, although the Hourihane et al. (1997a) study reported a threshold for peanut proteins in the milligram range, mild subjective reactions were noted in two individuals at doses of 100 g of peanut protein. Other studies do not report specific types of reactions but rather characterize reactions as mild, moderate, or severe. For example, a retrospective review of 253 failed challenges at one clinic showed that the initial reaction was severe in 72 (28%) and moderate in 88 (33%) of the challenges (Perry et al., 2004). There is only one published study (Wensing et al., 2002b) that evaluated reproducible subjective symptoms. Currently, there is no universally accepted endpoint or response that can be used to predict significant harm from an allergic reaction. Anaphylaxis, a clearly significant endpoint, is a syndrome which is poorly described and subject to variable interpretation (Sampson et al., 2005). Moreover, anaphylactic reactions are at one extreme of a continuum of severity. There are a number of additional factors (e.g., use of medicine, alcohol consumption, anxiety) that can significantly reduce or potentiate the impact of exposure to an allergen. Given this combination of factors, a particular dose could result in mild symptoms one day and life-threatening reactions the next. 5. Anecdotal Evidence Although a great deal of attention has been focused on the use of challenge studies to determine threshold doses or reaction patterns for food allergens, anecdotal reports of individuals suffering life-threatening allergic reactions from minute exposures to food allergens suggests that there may not be a measurable allergen threshold level, especially for sensitive individuals. For example, literature reports have linked kissing (Hallett et al., 2002; Steensma, 2003; Eriksson et al., 2003) and exposure to airborne particles (Crespo et al., 1995; Casimir et al., 1997; Sackesen and Adalioglu, 2003) to allergic reactions. Although in many of these cases the amount of allergen exposure cannot be assessed, it is conceivable that the whole food exposure level needed to elicit a harmful reaction is extremely low. In this context, it should be noted that the statistical model developed by Bindslev-Jensen et al. (2002) suggested that concentrations as low as 700 ng for peanut and in the low microgram ranges for egg, soy flour, and cow's milk may elicit a reaction in one in a million allergic individuals. Although this model also suggests that a

majority of allergic individuals would likely tolerate food allergen concentrations in the milligram range, it supports the anecdotal evidence that very low concentrations of allergen may, at some low but finite probability, elicit harm in highly sensitive individuals.

G. Exposure
1. Matrix Effects Food allergens often occur as components of processed foods, and many allergic reactions occur following exposure to such allergens (Bock et al., 2001). Therefore, it is important to understand how the nature or composition of the food (i.e., the food matrix) affects the elicitation of a reaction. Very little information exists on matrix effects for the majority of allergens. It has been reported that fat content can modify the reactions in a peanut DBPCFC (Grimshaw et al., 2003). Three of four subjects challenged with peanut flour in a matrix containing 31.5% fat reacted at a higher than expected dose, and had reactions that were more severe than expected, based on previous exposures to a standard recipe containing 22.9% fat. Upon rechallenge with the 22.9% recipe, their reactions returned to expected levels with respect to dose and severity. The cumulative dose of peanut protein required to elicit reactions was 12 to 31 times higher when using the higher fat recipe. The authors suggested that the peanut allergens in the higher fat recipe were not readily available to react with IgE on mast cells in the mouth. This was based on the observation that radioallergosorbent test (RAST) inhibition assays and enzyme linked immonosorbent assay (ELISA) detection tests showed that peanut allergens in the higher fat mixture were less available in vitro. In addition, these three patients all had histories of an initial oral challenge response. The lack of an oral early warning with a high-fat food may have caused these patients to consume more allergen prior to the onset of other symptoms. By the time digestion of the fat took place in the stomach and intestine, the total dose consumed was higher, resulting in a more severe reaction. Grimshaw et al. (2003) further reported that the slopes of RAST-inhibition curves did not change for peanut allergens in high-fat versus low-fat mixtures, indicating that there was no change in antibody-binding properties. Thus, it appears that the antigenic properties of the peanut flour were not altered by the higher fat matrix, and that the changes in apparent threshold may have resulted from a combination of physiological and behavioral factors. Kato et al. (2001) also observed a matrix effect with the major egg allergen ovomucoid. The ability of ovomucoid to bind IgE was reduced in a model pasta composed of durum wheat and egg white. This decrease was attributed to changes in antigenicity associated with formation of disulfide bonds between the ovomucoid and wheat gliadins. 2. Processing Effects Numerous studies have described alterations in allergens as a result of processing or cooking. Various types of processing (e.g., heating, milling, fermentation) may alter the antigenic properties of allergens because these processes can affect the three-dimensional structure of

proteins and thus the IgE binding epitopes. The type and extent of structural alterations may vary depending on the processing method. This is especially true for conformational epitopes because they are dependant on tertiary structure (Cooke and Sampson, 1997; Vila et al., 2001). For many food allergens, processing effects are inherent in the data used to characterize thresholds because the test articles used in DBPCFCs are processed. For practical reasons, the test material must be concealed in some way for the study to be "blinded." For example, the taste of peanut butter or peanut flour must be disguised in DBPCFCs for peanut allergies. Preparation of the test material typically involves cooking or processing of the allergenic food. In addition to altering existing epitopes, processing might also induce chemical or structural changes that result in the formation of new antigenic epitopes, or neoantigens (Maleki, 2004). Altered antigenic reactivity is most commonly assessed by measuring changes in the binding of antibodies to extracts of raw and processed foods. Reduced or enhanced IgE binding in such studies would suggest that the threshold for an allergic reaction could be affected by processing. However, definitive proof of an altered threshold requires DBPCFC testing. The effects of processing on some specific major allergens have recently been reviewed, and are discussed below (Besler et al., 2001; Poms and Anklam, 2004). Variable patient responses make it difficult to conclude that a particular processing or cooking procedure affects allergenicity in all cases. Peanuts. Extracts of roasted peanuts have been shown to bind IgE from patients at 90-fold higher levels than do similar extracts of raw peanuts in competitive, IgE-based ELISAs (Maleki et al., 2000). Using immunoblot techniques, two of the major allergenic proteins in peanut, Ara h 1 and Ara h 2, were shown to be highly resistant to heat and gastrointestinal digestion following treatment in the Maillard Reaction (which occurs during the processing or browning of foods in the presence of heat and sugars). Earlier studies also observed increased IgE binding and altered IgE epitopes in roasted versus raw peanuts (Nordlee et al., 1981). The allergenic proteins Ara h 1, Ara h 2, and Ara h 3 from fried or boiled peanuts bound significantly less IgE than the same proteins from roasted peanuts (Beyer et al., 2001), even though there were similar amounts of the allergenic proteins in peanuts processed by each method. These studies suggest that thresholds for boiled or fried peanuts may be higher than for roasted or raw peanuts, at least for the three major peanut allergens. In practical terms, the vast majority of peanuts consumed whole or in processed foods in the U.S. are roasted. Boiled or fried peanuts are an ethnic or regional specialty and are usually eaten whole, rather than as a component of processed foods. Milk. Pasteurization and homogenization did not reduce allergenicity in skin prick tests or DBPCFC (Host and Samuelsson, 1988). However, boiling milk for 10 minutes reduced IgE binding of the allergenic proteins alpha-lactoglobulin and casein by 50 to 66% and eliminated beta-lactoglobulin and serum albumin reactivity in skin prick tests (Besler et al., 2001; Norgaard et al., 1996). Hypoallergenic infant formulas produced from heat denatured or enzymatically hydrolyzed caseins or whey proteins showed reduced allergic reactivity by immunoblot, RAST, and DBPCFC in most milk-allergic children. However, some severe reactions have been reported (Sampson et al., 1991; Saylor and Bahna, 1991). Maillard reaction products in milk are reported to have increased allergenicity in skin tests (Maleki, 2004). Allergic reactions have also been reported involving both hard and soft cheeses (Besler et al., 2001).

Egg. Both soft and hard boiling of eggs decreased, but did not eliminate, antigen binding of rabbit antiserum to ovomucoid and ovalbumin (Besler et al., 2001). Heated egg white showed a 58% decrease in IgE binding in RAST (Anet et al., 1985). A decrease in positive reactions was seen with heated egg white in 55% of egg allergic patients using DBPCFC (Urisu et al., 1997). There are reports of allergic reaction to egg contained in cooked meatballs or hamburger (Sampson et al., 1992b; Besler et al., 2001). Fish. Boiling ten species of fish failed to eliminate allergenicity in DBPCFC (BernhiselBradbent et al., 1992b). IgE binding to fish proteins in immunoblots was reduced, but not eliminated. Canning (presumably due to the heat processing) appears to reduce allergic reactions to tuna and salmon in allergic patients tested by DBPCFC (Bernhisel-Broadbent et al., 1992b). IgE binding of allergenic proteins from canned fish was reduced by 98 to 99% compared to boiled fish. IgE binding studies indicate that fish allergens are present in surimi (Mata et al, 1994). Shellfish. Boiling does not reduce the allergenicity of shrimp allergens (Daul et al., 1988; Naqpal et al., 1989). Soy. Heating soybeans at 100C for 60 minutes does not completely eliminate IgE binding to allergenic soy proteins (Burks et al., 1992). Various soybean products including sprouts, soy sauce, hydrolyzed soy protein tofu, miso, and lecithin all retained IgE-binding activity (Besler et al., 2001). IgE binding proteins have been found in soy lecithin (Gu et al., 2001; Porras et al., 1985; Paschke et al., 2001). Allergic reactions to soy lecithin have also been reported (Renaud, 1996; Palm, 1999). The protein content of soy lecithin has been reported to vary between 2.8-202 mg per 100 g (Besler et al., 2001; Paschke et al., 2001). IgE binding proteins have been consistently detected in unrefined soybean oils (Paschke et. al., 2001), but inconsistently in refined oil (Awazuhara et al., 1998; Paschke et al., Errahali et al., 2002) Tree nuts. Protein extracts of several hazelnut-containing products demonstrated less IgE binding than raw hazelnut aqueous extracts suggesting that heating reduced allergenicity. However, some IgE binding capacity remained (Wigotzki et al., 2001). Several cases of anaphylaxis have been described for a variety of processed nut-containing products, suggesting that tree nuts in general retain allergenic activity after heating (Besler et al., 2001).Roasting, blanching, autoclaving, or microwaving did not change the ability of animal antisera to bind almond proteins (Venkatachalam et al., 2002). Wheat. Baking of wheat flour-containing foods results in the loss of IgE binding to one group of recognized wheat allergens, the alpha-amylase inhibitors. However, baking does not affect the ability of wheat prolamins to bind IgE from wheat allergic individuals (Simonato et al. 2001). The wheat allergen omega-5 gliadin also retains allergenic activity after cooking. For example, Daengsuwan et al. (2005) found IgE to omega-5 gliadin in seven children who had anaphylactic reactions to breads, buns, noodles, macaroni and pizza. 3. Detecting and Measuring Allergens

There are several factors that make it difficult to detect and measure food allergens. These include sampling problems and difficulties in quantifying proteins, particularly allergenic proteins, in a wide variety of foods. Further, an allergen may be a minor component of a highly complex, heterogeneous food. The food matrix can sequester allergens, hindering detection, while not significantly affecting allergenicity. It is also difficult to estimate the amount of a food allergen that may be present from the result of an assay that only measures protein, particularly when there is more than one allergenic protein. The only commercial methods that have been shown to detect food allergens reliably use immunological techniques such as ELISA (Poms et al., 2004; Krska et al., 2003), although noncommercial PCR assays have been described (e.g., Popping et al., 2004). In some cases, these methods were designed to detect representative biomarkers, not necessarily a specific allergenic protein. Many kits contain polyclonal antibodies that detect both non-allergenic and allergenic proteins (e.g., Nogueira et al., 2004). For example, the peanut ELISA assays that have completed Multiple Laboratory Performance Tested validation are designed to detect multiple proteins indicative of the presence of the food (e.g., peanuts), not to detect or quantify specific allergenic proteins (Park et al., 2005). There are no validated detection methods or commercially available kits for most food allergens or allergenic proteins. The FDA and AOAC investigated the ability of three commercial peanut test kits [BioKits Peanut Testing Kit (Tepnel), Veratox for Peanut Allergens (Neogen Corp.), and RiDASCREEN Peanut (R-Biopharm GmbH)] to accurately measure peanuts in four food matrices (cookies, ice cream, milk chocolate, and breakfast cereal) (Park et al., 2005). The validation study, requiring 60 analyses of test samples at the target level of 5g peanut/g of food and 60 analyses of "peanut-free" controls, was designed to ensure that the lower 95% confidence limit on the true sensitivity and specificity rates exceeded 90% (Park et al., 2005). The results from this study showed that all the test kits correctly allocated the test samples at the target level. No comparable studies have been completed for any other food allergen. Scientific practice is to calibrate, standardize, and validate assays and commercial test kits for each food product because minor differences in the matrix change the recovery and detection of specific food proteins. Standardization requires the preparation of samples identical to the test sample and containing known amounts of a specific food allergen. Nevertheless, because different antibody-based assays recognize different protein epitopes, variable results may be obtained using different test systems. This variability was evident in results obtained in the Food Analysis Performance Assessment Scheme (FAPAS) supervised proficiency studies of wheat (Central Science Laboratory, 2003a; Central Science Laboratory, 2004b), peanut (Central Science Laboratory, 2003b), egg (Central Science Laboratory, 2004a), and milk test kits (Central Science Laboratory, 2004a). Highly variable food matrices and the nature of food production also create sampling challenges. The distribution of allergenic proteins within whole foods is not necessarily homogenous, and allergenic ingredients may not be evenly distributed throughout processed foods. In addition, cross-contact may result in a heterogeneous distribution of allergens within or on a food. For example, nuts may be introduced into chocolate on a production line where nut-containing and nut-free products are processed sequentially. In this case, cross-contact is most likely to occur at

the beginning of a production run for the nut-free product. Thus, allergen testing using chocolate taken from the end of a production run might not adequately characterize the risk. For a food product, development of a scientifically sound sampling plan that includes a statistical analysis of the probability that any allergens present are detected and measured accurately. Important sampling questions that need to be considered include whether the allergen is likely to be heterogeneously distributed within the batch; the number of samples per batch that should be tested; which batches should be tested; which portion of a run should be tested; and how to obtain a specific degree of confidence (e.g., 95% confidence) that no allergen is present.

H. Collective Allergens
Three of the major food allergens identified in the FALCPA are actually groups of foods: crustaceans, fish, and tree nuts. It is possible that proteins from two or more species within each of these "collective allergens" might be present in a food and the available analytical methods are unable to distinguish between species in a group. Therefore, it may be necessary to consider total protein levels from all species in a group rather than the level of protein from each species. In addition, an individual allergic to one species is likely to also be allergic to other species in the group. The ability of available test methods to distinguish different species within each group of "collective allergens" varies. To date, there are no commercially available test kits for finfish proteins and only one for crustacean tropomyosin. Ben Rejeb et al. (2003) reported the development of an ELISA for shrimp that showed significant cross-reactivity with other crustaceans. There are three commercially available tree nut test kits (two for hazel nut, one for almond), but the species specificity of these kits is not clear. Hlywka et al. (2000) showed that an almond ELISA detected protein from seven other tree nuts. The hazel nut ELISA developed by Holzhauser et al. (2002) showed cross-reactivity with other nuts, and the walnut assay developed by Niemann and Hefle (2003) reacted with three other nut species. Wei et al. (2003) developed an ELISA for cashew that showed cross-reactivity with several other nuts. Ben Rejeb et al. (2003) developed a hazel nut-specific ELISA that did not cross-react with other nuts, and Clemente et al. (2004) developed a Brazil nut assay with "negligible" cross reactivity to five other nut species. Although not likely to be useful for routine screening or testing, techniques such as liquid chromatography/mass spectrometry (LC/MS) are being used to identify specific allergenic proteins in complex food matrices (Shefcheck and Musser, 2004). These approaches may be useful either as confirmatory tests or for characterization of foods containing several allergens. Crustacean Shellfish. Allergenic cross-reactivity among crustaceans is considered to be common. Sicherer (2001) estimated that there is a 75% probability that a shrimp-allergic individual will also react to at least one other crustacean. Waring et al. (1985) reported that 11 of 12 (92%) patients with skin prick reactions to shrimp also had positive skin prick reactions to at least one other crustacean. Similarly, Daul et al. (1987) showed that between 73 and 82% of shrimp allergic patients had positive skin prick tests to another crustacean. Chiou et al. (2003) showed that sera from 20 of 32 individuals with either shrimp- or crab-reactive IgE were reactive to both

species. Further, inhibition studies with 15 of these cross-reactive sera showed relatively high affinity for both allergens. The basis for this high rate of cross-reactivity appears to be sensitivity to the highly conserved protein tropomyosin, which is considered to be a panallergen (Daul et al., 1993; Leung et al., 1999; Sicherer, 2001). Fish. Allergenic cross-reactivity among fish species has been described in the clinical literature, but appears to be less common than among species of crustacea. Both Sicherer (2001) and Sampson (1999) estimate that there is a 50% probability that an individual allergic to one fish species will react to at least one other fish species. Helbling et al. (1999) reported that 4 of 14 (29%) fish allergic patients reacted to two or more species in DBPCFC tests. BernhiselBroadbent et al. (1992a) reported that 3 of 10 (30%) fish allergic patients responded to more than one fish species in oral challenges, but that skin prick tests were positive to multiple species for all of these patients. Similarly, Hansen et al. (1997) showed that eight cod allergic patients all had positive skin prick tests with two other fish species. The data presented in Pascual et al. (1992) suggest that at least 80% of a group of 79 fish allergic children had IgE antibodies to two or more fish species. In some cases, cross-reactivity has been shown to reflect the presence of one of more closely related allergenic proteins (e.g., paralbumins) in different species (Pascual, 1992; Hansen et al., 1997; Leung et al., 1999; Hamada et al., 2003). Tree Nuts. The prevalence of cross-reactivity among tree nuts is difficult to determine accurately for several reasons: the high proportion of severe reactions among nut-allergic patients makes it dangerous to carry out oral challenge studies, many published works test for reactivity to a small number (and variable assortment) of tree nuts, and studies often combine tests for tree nuts and peanuts. Nevertheless, Sicherer (2001) estimates that a tree nut allergic patient has a 37% chance of being allergic to two or more species of tree nut, and Sampson (1999) estimates that the probability of multiple tree nut sensitivities at greater than 50%. Ewan (1996) reported that 12 of 22 (55%) of tree nut allergic patients responded to multiple tree nuts by skin prick tests. Sicherer et al. (1998) and Pumphrey et al. (1999) both used in vitro IgE testing and found multiple sensitivities in 37% and 61% of tree nut allergic patients, respectively. There are a number of studies that report cross-reactions in one or a few patients (e.g., Teuber and Peterson, 1999; Ibanez et al., 2003; de Leon et al., 2003; Asero et al., 2004). The complex pattern of crossreactivity among the tree nuts may reflect the fact that several different panallergens (lipid transfer proteins, profilins, Bet v1-related proteins) and evolutionarily conserved proteins (seed storage proteins) occur in various tree nuts (Roux et al., 2003).

I. Published Challenge Studies

An extensive literature review was conducted from November 2004 through April 2005 that included key word, author, and "related article" searches of the PubMed database and analysis of citations found in the published literature. Seventeen publications with quantitative doseresponse data from DBPCFC testing were reviewed to identify those that contained data that could be used to estimate LOAEL levels for the major food allergens. These studies are described in more detail in Appendix 2. Fourteen (82%) of these report results from testing adults; the remaining three tested infants and children. In four cases, the population being studied was not specifically chosen to be food allergic, and a large fraction of the individuals in these populations did not respond to the highest doses tested. In eight studies (47%), patients reacted to

the lowest dose tested, and in three studies there was insufficient information to determine either the lowest dose used or the number of patients who responded to that dose. The most sensitive population was seen by Hourihane et al. (1997b), who reported that 67% of the patients tested reacted to "peanut rubbed on the lip," including one severe reaction. Peanut. Hourihane et al. (1997b) observed the lowest measured dose of an allergen that provoked a reaction (i.e., a LOAEL), 0.1 mg of peanut protein provoked subjective reactions in two patients and 2 mg of peanut protein provoked an objective reaction in one patient. Objective reactions were observed in two other patients on exposure to 5 mg of peanut protein. Wensing et al. (2002a) also reported a LOAEL of 0.1mg for subjective reactions in two of 26 peanut allergic individuals tested. The LOAEL for the initial objective symptom was 10 mg. Several other papers reported LOAELs of 25-100 mg of peanut protein for objective reactions (May, 1976; Hourihane et al., 1997a; Bock et al., 1978). Egg. A wide range of LOAELs have been observed for egg. Caffarelli et al. (1995) reported a LOAEL of 0.5 mg of dried whole egg (approximately 0.42 mg protein). Bock et al. (1978) reported observing an objective reaction with 25 mg of whole egg (approximately 1 mg protein), although the data are difficult to interpret as presented. In contrast, Eggesbo et al. (2001) report a LOAEL of 1 g of whole egg (approximately 260 mg of protein) for an objective reaction. Milk. Relatively consistent LOAELs have been reported for milk. Bellioni-Businco et al. (1999) found a LOAEL of 1 ml of whole milk (approximately 362 mg of protein) with children, and Pastorello et al. (1989) found a LOAEL of 0.5 g of freeze-dried milk (approximately 187 mg of protein) with adults. Soy. LOAELs of approximately 522 and 88 mg protein have been reported for soy (Zeiger et al., 1999; Magnolfi et al., 1996). Tree Nut. Hazel nut is the most commonly studied tree nut. Wensing et al. (2002b) observed reactions to 1 mg of hazel nut protein in 4 of 29 patients, which was the lowest dose tested. Hansen et al. (2003) found a LOAEL of approximately 32 mg of hazel nut protein, although it is not clear whether this was the lowest dose tested. Fish. Hebling et al. (1999) reported a LOAEL of 50 mg for catfish protein. Wheat. Unpublished data described in Moneret-Vautrin and Kanny (2004) show that 83% of wheat allergic children reacted to less than 2 g of wheat flour while only 18% of wheat allergic adults responded at this level. Unpublished data described in Moneret-Vautrin (2004) on wheat flour challenges using 32 children and 32 adults with wheat allergy, reported a LOAEL of 1.8 mg protein for allergic children (the lowest tested dose) and 52.8 mg protein for allergic adults. Scibilia et al. (2006) reported that 2 of 13 responders reacted to the lowest dose of wheat flour tested (100 mg of a mix of bread and durum flour, approximately 15 mg protein) in DBPCFCs. In total, 31% of the patients who reacted did so to challenge doses less than or equal to 240 mg of wheat protein.

J. Food Treatments to Reduce Allergenicity

The best example of food products that are processed to render them less allergenic are hydrolyzed infant formulas derived from cow's milk proteins (i.e., casein and whey). Enzymatic hydrolysis of these proteins has been shown to significantly reduce the levels of both total and allergenic (e.g., b-lactoglobulin in whey) protein (Host and Halken, 2004). The degree of protein reduction depends on the method of hydrolysis. There is ample clinical evidence to suggest that both partially hydrolyzed formulas (PHF) and extensively hydrolyzed formulas (EHF) have reduced allergenicity in comparison to intact milk formulas (Amer. Acad. Ped., 2000; Host and Halken, 2004). Furthermore, there is preliminary evidence that the use of these hydrolyzed formulas may also delay or prevent the development of cow's milk allergy (CMA) in high-risk infants (Host and Halken, 2004). Both PHF and EHF contain varying amounts of residual protein, including allergenic proteins, which can be detected using either in vitro or in vivo methods (Giampietro et al., 2001; Docena et al., 2002), that have been shown to retain immunologic activity. Both PHF and EHF can cause allergic reactions, including anaphylaxis, in sensitive infants (Saylor and Bahna, 1991; Schwartz and Amonette, 1991; Tarim et al., 1994; Ammar et al., 1999; Giampietro et al., 2001; Host and Halken, 2004). In general, the higher the level of residual protein, the higher the risk for an allergic response. Although the level of residual protein tends to be higher in PHF, the degree of hydrolysis cannot always be used as a predictor of the degree of allergenicity. Hydrolysis methods are not standardized, and formulas undergoing similar treatments may vary considerably in their residual protein levels. Additional processing, such as heat treatment and ultrafiltration, may further reduce residual protein levels in certain products (Host and Halken, 2004). In 1989, the American Academy of Pediatrics (AAP) concluded that a formula could be considered "hypoallergenic" if challenge studies showed, at a minimum, 95% confidence that 90% of allergic infants would not react adversely to the formula (AAP, 1989). Since this time, a number of DBPCFC studies using various infant formula preparations have been performed in infants with CMA (Sampson et al., 1991; Sampson et al., 1992b; Giampietro et al., 2001; Sicherer et al., 2001), and a substantial number of infant formulas (most EHF) have met this criterion for hypoallergenicity. Even though they note that EHF contain residual proteins and may provoke allergic reactions in infants with CMA, the AAP currently recommends these formulas as alternatives for infants with CMA stating that at least 90% of these infants will tolerate the formula (AAP, 2000). Newer technologies, such as genetic modification, are being developed to reduce allergenicity by removing, silencing, or modifying the genes for specific allergenic proteins within foods (Tada et al., 1996; Herman et al., 2003; Dodo et al., 2005; Gilissen, 2005). To date, however, there is no example of a food allergen that has been rendered completely devoid of allergenic activity using these methods. This is due to the fact that each food contains a number of allergenic proteins, each with multiple allergenic epitopes. Unless these methods can eliminate all of these proteins, or modify all allergenic epitopes, the remaining proteins or epitopes could still elicit a reaction in sensitive individuals.

Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food. III, IV, V.
III. Celiac Disease
A. Introduction
Celiac disease (also known as celiac sprue and gluten sensitive enteropathy) is a chronic inflammatory disorder characterized by mucosal damage to the small intestine leading to gastrointestinal illness, nutrient malabsorption, and a wide range of clinical manifestations (NIH, 2004; Shan, et al. 2002). There is a consensus opinion that celiac disease is caused by an aberrant (T lymphocyte) immune response to dietary glutens predominantly found in wheat, barley, and rye (NIH, 2004). However, there is evidence that at least some persons who have celiac disease may not tolerate oats (Lundin et al., 2003; Arentz-Hansen et al., 2004). Those individuals who have a genetic predisposition to celiac disease react to peptides within the proline- and glutamine-rich protein fractions of the grains (Dewar et al., 2004). For affected individuals, celiac disease is a lifelong condition and, if not treated, is associated with significant morbidity and increased mortality (Fasano, 2003; Corrao et al., 2001; Dewar et al., 2004). There is no cure for celiac disease (NIH, 2004). Strict avoidance of potentially harmful concentrations of glutens in the diet is the only known means of completely preventing the clinical and pathological complications of celiac disease (NIH, 2004; Fasano and Catassi, 2001).

B. Mechanism of Pathogenesis
Celiac disease is characterized by injury to the mucosa of the small intestine and specifically targets the fingerlike projections, called villi, where absorption of key nutrients takes place (Figure III-1). This injury is believed to be due to an autoimmune disorder involving modification of the antigenic presentation of gluten in the intestinal tract of genetically predisposed individuals expressing the major histocompatibility haplotypes HLA-DQ2 or HLADQ8 (Farrell and Kelly, 2002; Fasano, 2003). In these individuals, binding of the enzyme tissue transglutaminase (tTG) to wheat gluten (a glutamine rich protein) potentiates uptake and presentation by antigen-presenting cells in the lamina propria, triggering a vigorous T-cell response (Schuppan and Hahn, 2002), leading to production of IgG and IgA antibodies directed to wheat gluten peptides (i.e., gliadins and glutenins) and to tissue transglutaminase (tTG). The activated T-cells are responsible for the mucosal damage seen in celiac disease (Fasano and Catrassi, 2001). This immune-mediated damage occurs in two compartments, the epithelium and the lamina propria (Green and Jabri, 2003). Early intestinal disease is characterized by an increased number of intestinal intraepithelial lymphocytes (IELs). As the disease progresses, increasing numbers of lymphocytes and plasma cells infiltrate the lamina propria. This increase in the numbers of cells leads to elongation of intestinal crypts and shortening of villi, which eventually results in partial or total villous atrophy (James, 2005). Elimination of intestinal

gluten results in modification of T lymphocyte and antibody responses and, in most cases, full mucosal recovery (Kaukinen et al., 1999; Fasano and Catassi, 2001).

Figure III-1. Mechanism of Celiac Disease

C. Range of Adverse Effects

The clinical manifestations of celiac disease are highly variable in character and severity. The reasons for this diversity are unknown but may depend on the age and immunological status of the individual, the amount, duration, or timing of exposure to gluten, and the specific area and extent of the gastrointestinal tract involved by disease (Dewar et al., 2004). These clinical manifestations can be divided into gastrointestinal, or "classic," and non-gastrointestinal manifestations. Gastrointestinal manifestations usually present in children 4 to 24 months old and include abdominal pain and cramping, bloating, recurrent or chronic diarrhea in association with weight loss, poor growth, nutrient deficiency, and (in rare cases) a life-threatening metabolic emergency termed celiac crisis, characterized by hypokalemia and acidosis secondary to profuse diarrhea (Farrell and Kelly, 2002; Baranwal et al., 2003). Non-gastrointestinal manifestations are more insidious and highly variable and are the common presenting signs in older children and adults. These manifestations are frequently the result of long-term nutrient malabsorption, including iron deficiency anemia, short stature, delayed puberty, infertility, and osteoporosis or osteopenia (Fasano, 2003). In children, progressive malabsorption of nutrients may lead to growth, developmental, or neurological delays (Catassi and Fasano, 2004). Extraintestinal manifestations such as dermatitis herpetiformis, hepatitis, peripheral neuropathy, ataxia, and epilepsy have also been associated with celiac disease (Fasano and Catassi, 2001). Individuals with untreated celiac disease are also at increased risk for potentially serious medical conditions, such as other autoimmune diseases (e.g., Type I diabetes mellitus) and intestinal cancers associated with high mortality (Farrell and Kelly, 2002; Peters et al., 2003; Catassi et al., 2002). For example, individuals with celiac disease have an 80-fold greater risk of developing adenocarcinoma of the small intestine, a greater than two-fold increased risk for intestinal or

extraintestinal lymphomas (Green and Jabri, 2003) and a 20-fold greater risk of developing enteropathy-associated T cell lymphoma (EATL) (Catassi et al., 2005a). These are rare intestinal malignancies with a high mortality rate. In addition, the relative risk for developing nonHodgkin's lymphomas, intestinal or extraintestinal, is three fold greater than in the general population (Catassi et al., 2002). These cancers contribute to nearly two thirds of deaths due to celiac disease and are a major reason for the nearly two-fold increase in overall mortality of adult patients with celiac disease compared to the general population (Corrao et al., 2001). Currently, individuals with clinical manifestations, or "symptomatic" celiac disease, are believed to represent a small portion of the total affected population (Mki and Collin, 1997). A larger number of individuals are believed to have "silent" celiac disease, characterized by positive serology and intestinal mucosal abnormalities in the absence of symptoms or nutritional deficiencies. Mki and Collin (1997) also suggested that there is an even larger population with "latent" celiac disease, individuals who are positive for serological markers or genetic susceptibility to disease and are entirely asymptomatic. It is generally accepted that individuals with silent or latent disease, although asymptomatic, have the capability to manifest aberrant immune responses following exposure to dietary glutens and are, therefore, at increased risk for both acute and long-term complications of celiac disease (Fasano, 2003; Schuppan, 2000). However, the long-term benefit of strict gluten avoidance for these individuals is unproven (Green and Jabri, 2003).

D. Prevalence
Until recently, celiac disease was considered to be a rare disorder in the U.S., with an estimated prevalence rate of 1:5,000 (Talley, 1994). However, a large epidemiological study screened more than 13,000 people in 23 states and estimated a prevalence rate of 1:133 within the general U.S. population (Fasano et al., 2003). The National Institutes of Health Consensus Development Conference Statement on Celiac Disease currently estimates that 3 million Americans, a little less than 1 percent of the population, may have celiac disease (NIH, 2004). Celiac disease occurs widely among North American and European populations, where wheat is a staple food, but is infrequent among native descendents of China and Japan and those with an African-Caribbean background, where wheat is not as widely consumed (Farrell and Kelly, 2002). Precise prevalence data for celiac disease are not available. This disease is often misdiagnosed as another gastrointestinal malabsorptive disorder (e.g., irritable bowel syndrome) due to similarities in their symptoms (Sanders et al., 2001). Due to the existence of silent or latent cases, it is assumed that the incidence of celiac disease is underreported (Mki and Collin, 1997). These forms of celiac disease may go undetected in individuals for years before they develop symptoms causing them to seek medical attention (Green and Jabri, 2003). Mki and Collin (1997) postulated that there are many more currently healthy individuals who are genetically predisposed to developing celiac disease in future years than there are individuals who are now affected by celiac disease. Only recently has the medical community become more aware of the need to screen for celiac disease when patients experience health problems that may be associated with the disease or when patients have family members, especially first- and seconddegree relatives, who have celiac disease (NIH, 2004).

E. Celiac Foods of Concern

Celiac disease is caused by an immune response in genetically predisposed individuals to specific storage proteins, commonly referred to as "glutens," that occur naturally in cereal grains (Shan et al., 2002). Technically, "gluten" is a term applied specifically to the combination of the prolamin proteins called "gliadins" and the glutelin proteins called "glutenins" found in wheat (Brown, 2004). However, the term "gluten" has been used generically to refer to prolamin and glutelin protein mixtures found in other cereal grains (Kasarda, 2005, personal communication). Although all cereal grains contain prolamin and glutelin proteins, these proteins are not identical in different grains. These proteins differ in their amino acid sequences in different grains, and not all have been shown to evoke an abnormal immune response that affects the intestinal lining of persons genetically susceptible to celiac disease (Kasarda, 2003). The term "gluten" will be used in this report in the more general sense of the combination of both prolamin and glutelin proteins found in cereal grains. The grains considered to be capable of producing adverse effects in individuals with celiac disease include the different species of wheat (e.g., durum, spelt, kamut), barley, rye, and their cross-bred hybrids (e.g., triticale, which is a genetic cross between wheat and rye) (Kasarda, 1994; Kasarda, 2004). There is also evidence that some individuals with celiac disease may react adversely to oats (Lundin et al., 2003; Arentz-Hansen, 2004). These grains are all members of the grass family (Gramineae, also known as Poaceae) and are closely related taxonomically. The cereal grains assumed to be safe for persons with celiac disease include amaranth, buckwheat, corn, Indian ricegrass, Job's tears, millet, quinoa, ragi, rice, sorghum, teff (or tef), and wild rice (Kasarda, 2001; Johnson et al., 2002; Kasarda, 2004b; Kupper, 2004). The grain prolamins of concern include gliadin in wheat, secalin in rye, hordein in barley (Thompson, 2001; Green and Jabri, 2003; Kagnoff, 2005) and possibly avenin in oats (ArentzHansen, et al. 2004; Lundin, et al., 2003). There is substantial evidence that both prolamin proteins (i.e., gliadins) and glutelin proteins (i.e., glutenins) in wheat affect individuals with celiac disease (Shan et al., 2002; Hausch et al., 2002; Vader et al., 2002; van de Wal et al., 1999; Molberg et al., 2003). Wheat gliadin subtypes alpha, beta, gamma, and omega, have been shown to affect individuals with celiac disease (Ciclitira et al., 1984; EFSA, 2004). Rye, barley and triticale are taxonomically related to wheat, express peptides structurally similar to those found in wheat, and have been reported to affect individuals with celiac disease (Vader et al., 2002; Kasarda, 2001; Kasarda, 2004b). In contrast, the prolamins in other cereal grains (e.g., zein in corn and orzenin in rice) have been shown not to affect individuals with celiac disease (EFSA, 2004; Kasarda, 2004b). However, much is still unknown about which proteins in the different grains can affect individuals with celiac disease (Kasarda, 2001). Analytical information is not available on the actual amount of gluten proteins in different grainderived food ingredients or finished foods. For single ingredient foods made from wheat, rye, barley, triticale, and oats, the simple presence of "protein" in that food may be used as an indicator that gluten proteins are present. The USDA National Nutrient Database for Standard Reference, Release 17 (USDA, 2004), the major source of composition data for foods in the

U.S., includes hundreds of food items that contain wheat, rye, barley, triticale or oats as an ingredient. Wheat, in particular, is used to manufacture a wide range of food ingredients and finished foods. Rye, barley, triticale, and oats are used to make substantially fewer food products. Koehler and FDA (2005) estimated the average amount of total grain and individual types of grain available for consumption per person in the U.S., and the total exposure to gluten-forming proteins that would result from this grain consumption. The estimated mean daily consumption rate was approximately 250 grams of grain per capita. Wheat provided 180 of the 187 grams per person per day of grains that are of concern for individuals with celiac disease. There is no consensus as to whether oats present a hazard for all individuals with celiac disease. Several studies, including one that lasted 5 years, have reported that most celiac study participants tolerated moderate amounts (e.g., 50-70 grams daily) of oats (Janatuinen et al., 1995; Janatuinen et al., 2000; Janatuinen et al., 2002; Lundin et al., 2003; Arentz-Hansen et al., 2004). The oats used by Lundin et al. (2003) and Arentz-Hansen et al. (2004) were tested to ensure that they did not contain any gluten proteins from wheat, rye, or barley.

F. Gluten Contamination of Grains

In the U.S., most commercially available oat products are believed to contain some gluten proteins from wheat, rye, or barley due to cross-contact with these grains during growth, harvest, transport, storage, or processing (Kasarda, 1999; Kasarda, 2001; AGA, 2001; Thompson, 2003). In a recent study, Thompson (2004) analyzed four lots of three brands of rolled or steel-cut oats commercially available in the U.S. for prolamins from wheat, barley, or rye. For one brand, all samples contained 338 to 1807 ppm gluten (expressed as the mean of duplicate determinations). For each of the other two brands, the level of gluten detected in all but one lot ranged from 12725 ppm in one brand and 120-131 ppm in the other brand (expressed as the mean of duplicate determinations). Thus, only one lot of these two brands was negative for gluten. Thompson (2004) concluded that none of these three brands could be considered a reliable source of oats free of potentially harmful gluten proteins. Grains that do not contain gluten can become contaminated with grains that contain gluten at any step in the farm-to-table continuum, particularly if shared equipment is not thoroughly cleaned between uses. It is difficult, if not impossible, to prevent all cross-contact situations, considering the tons of grain handled by farm equipment, bulk storage, and transport containers on a daily basis. In fact, the Official United States Standards for Grains (USDA, 1999) assume that most grains that have an established U.S. standard will contain a small percentage of other grains.

G. Gluten Challenge Studies

There is little information in the literature on minimal disease-eliciting doses of gluten for sensitive individuals. Gluten challenges have generally been performed in individuals where diagnosis is uncertain (e.g., infants, Laurin et al., 2002) or in individuals with unclear intestinal pathology results (Wahab et al., 2001). Challenges have also been performed to determine the time of disease relapse after a prolonged period of gluten avoidance (Mayer et al., 1989). In most

cases, gluten challenges have been performed to elicit or confirm disease rather than to measure the level of sensitivity (Farrell and Kelly, 2002). There is no standard protocol for gluten challenges, and challenge studies have varied greatly in amount and duration of gluten exposure. Although some studies have been designed to determine the acute effects (i.e., after 4 hours) of exposure to gluten (Sturgess et al., 1994; Ciclitira et al., 1984), most challenges consist of an open challenge to a fixed or incremental dose of daily gluten over a minimum period of 4 weeks. Many challenge studies use a high exposure ( 10 g/day) to gluten, because this is believed to shorten time to disease confirmation or relapse and, therefore, to minimize discomfort to subjects (Rolles and McNeish, 1976). However, some studies have shown that low daily exposures to gluten also can elicit a disease response (Catassi et al., 1993; Laurin et al., 2002; Hamilton and McNeill, 1972). Catassi et al. (1993) reported that children, whose celiac disease had previously been controlled on gluten-free diet, had evidence of intestinal mucosal or immunological changes (changes in intraepithelial lymphocyte counts and the villous height to crypt depth ratio) following 100 mg or 500 mg of daily gliadin over 4 weeks; this corresponds to 200 mg and 1000 mg of daily gluten respectively (Collin et al., 2004). The degree of inflammation was dose dependent. However, this study had several important limitations, which include the short-term follow up (4 weeks), testing in young children, the small number of subjects (n=20), and the lack of control groups. In addition, although gliadin is believed to be the major immunogenic portion of gluten, T cells from the small intestine of celiac disease patients have been shown to be responsive to peptides from the glutenin portion as well (Van de Wal et al., 1999). Thus, the Castissi et al. (1993) study was also limited by the use of gliadin rather than gluten. Estimating potential harm by extrapolating from gliadin levels may not be representative of the harm from total gluten exposure. A study currently in progress [The Italian Microchallenge Study] has extended the scope of these earlier findings by evaluating the effects of exposure to either 10 or 50 mg of purified gluten per day for 3 months with a population of 36 celiac disease individuals in a double-blind, placebocontrolled study (Catassi et al., 2005b). Preliminary unpublished results suggest that minimal mucosal abnormalities occur with a strict gluten-free diet, that both 10 mg and 50 mg daily gluten are well-tolerated, but that there is a trend for mucosal changes to occur at the 50 mg dose. These results can be compared to estimated gluten exposures from gluten-free diets containing various levels of gluten contamination (Table III-1, from Collin et al., 2004, reproduced below). Fasano (2005 personal communication) used these values to suggest that a conservative threshold for gluten exposure for sensitive individuals would lie between 20 and 100 ppm.

Table III-1. Estimated Daily Gluten Consumption from Combinations of Different Amounts of Food Containing Different Levels of Gluten Gluten Content in Food (ppma) Daily Amount of Gluten-Free Food Consumed (g) 50 100 200 300 ------Daily Amount of Gluten Consumed (mg)------200 10 20 40 60 100 5 10 20 30 50 2.5 5 10 15 20 1 2 4 6

Source: Collin et al., 2004.

ppm=mg/kg

Note: Gluten content in food multiplied by food consumed equals gluten consumed. Six slices of bread is equivalent to approximately 100 g baking mix. In an alternate approach, Collin et al. (2004) analyzed gluten levels in a number of different types of wheat starch (n=24) and naturally gluten-free (n=59) flours consumed by 76 individuals with celiac disease who had been on gluten-free diets for 1 to 10 years. These individuals had no reported evidence of mucosal deterioration or significant provocation of signs or symptoms while on this diet. The range of gluten found in these products was 0 to 200 ppm. Collin et al. (2004) then estimated that the total daily flour consumption for these individuals to be 10-300 gm (median 80 gm). Based on this estimate and the gluten content of the flour, a chart depicting estimated daily gluten exposures was devised (Collin et al., 2004). Collin et al. (2004) used this chart and data from low dose gluten challenge studies to suggest the use of a threshold of 100 ppm gluten. The main limitations of this study include lack of a prospective study design (for actual dose-response information) and the lack of information detailing diagnostic assessment (i.e., minimal mucosal involvement) for characterizing mucosal relapse in these individuals.

H. Measuring Gluten in Food

Currently, commercial immunology-based ELISA test kits for the detection of gluten in foods are manufactured by Immunotech (Czech Republic), Ingenasa (Spain), Morinaga (Japan), Diffchamb (Sweden), Neogen Corporation (U.S.), R-Biopharm (Germany), and Tepnel BioSystems (U.K.). All of these detect prolamins, the proteins found in soluble aqueous-alcohol extracts from cereals. None is designed to detect all proteins associated with celiac disease. Five of the assays have separately undergone multi-laboratory validation studies (Skerritt and Hill, 1991; Akiyama et al., 2004; Gabrovsk et al., 2004; Immer et al., 2003). Each of these studies employed different target levels and matrices. The Tepnel kit was validated by AOAC at >160 ppm gluten (Skerritt and Hill, 1991). All the ELISA kits rely on the preparation of an aqueousalcohol extracts as analytical samples, and four of the manufacturers include the use of reducingdenaturing conditions for the analysis of baked goods. During the 25th session of the Codex Committee on Nutrition and Foods for Special Dietary Uses in 2003, the R5-Mendez ELISA method, which entails the use of reducing/denaturing conditions, was forwarded to the Codex Committee on Methods of Analysis and Sampling for endorsement (Codex Alimentarius Commission, 2003). These ELISA test kits cross-react, to differing degrees, with prolamins derived from wheat, rye, and barley. None of the test kits cross-reacts with protein extracts from oats (Gabrovsk et al., 2004; Nonaka, 2004; Abouzied, 2004; Brewer et al., 2004). As such, the ELISA test kits do not provide protection to individuals with celiac disease who are sensitive to oats (Peraaho et al., 2004; Storsrud et al., 2003; Arentz-Hansen et al., 2004; Lundin et al., 2003). Proficiency testing studies conducted by the Food Analysis Performance Assessment Scheme (FAPAS) have shown variability between the prolamin ELISA test kits (Central Science Laboratory, FAPAS Series 27 Round 05, Report No. 2705, 2003), indicating that further validation studies for these kits need to be carried out under comparable conditions. In addition to ELISA test kits, two of the manufacturers, Tepnel BioSystems and R-Biopharm, market lateral flow devices for the detection of gluten. To date, neither of these has been validated.

At this time there is no correlative information on the efficacy of using these tests to predict or help prevent adverse effects in individuals with celiac disease.

I. Gluten-Free Labeling
Although gluten-free diets are considered the only effective treatment for individuals with celiac disease, it has been recognized that it is difficult, if not impossible, to maintain a diet that is completely devoid of gluten (Collin et al., 2004). Therefore, several attempts have been made to define gluten-free in regulatory contexts. Efforts by the Codex Alimentarius to define an international standard for "gluten-free" labeling date back to 1981. At that time, due to the lack of sensitive, specific analytical methods, a threshold value of 0.05 g nitrogen per 100 g dry matter was set for wheat starch, on the assumption that wheat protein would be the only source of nitrogen in starch (Codex Standard 118-1981). The Codex Committee on Nutrition and Foods for Special Dietary Uses is developing a revised standard. The current draft proposal would define three categories of gluten-free foods: processed foods that are naturally "gluten-free" ( 20 ppm of gluten), products that had been rendered "gluten-free" by processing ( 200 ppm), and any mixture of the two ( 200 ppm). The Australia New Zealand Food Agency (ANZFA) defines gluten to mean "the main protein in wheat, rye, oats, barley, triticale and spelt relevant to the medical conditions, Coeliac disease and dermatitis hepetiformis." ANZFA recognizes two classes of foods, gluten-free foods (" ...no detectable gluten") and low-gluten foods (" ...no more than 20 mg gluten per 100 gm of the food") (ANZFA Food Code Standard 1.2.8). The Canadian standard for "gluten-free" is more general, simply stating that "No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is a "gluten-free" food unless the food does not contain wheat, including spelt and kamut, or oats, barley, rye, triticale or any part thereof" (Canadian Food and Drugs Act Regulation B.24.018).

IV. Discussion and Recommendations

A. General Approaches
Four general approaches were identified that could be used to establish thresholds for allergens and glutens: analytical methods-based, safety assessment-based, risk assessment-based, and statutorily-derived. With any of these approaches, planned iterative reevaluation of threshold values should be carried out as new knowledge becomes available. These approaches are summarized in Table IV-1 and described in detail below.

Table IV-1. Approaches to Establishing Thresholds Type of Approach Examples Analytical methodsLabeling of sulfiting agents based "Zero" tolerance policy for Listeria monocytogenes in ready-to-eat foods Safety assessment-based Evaluation of food additive petitions Risk assessment-based Guidance levels for Vibrio parahaemolyticus in raw oysters Statutorily-derived Labeling exemption for highly refined oil in the FALCPA 1. Analytical Methods-Based Approach. In an analytical methods-based approach, thresholds are determined by the sensitivity of the analytical method(s) that can be used to verify compliance. This effectively establishes a "regulatory threshold," although this threshold is not necessarily correlated to biological effects. This approach has been used in food labeling. For example, the requirement to declare sulfiting agents on product labels when foods contain 10 ppm or greater is based on the limit of sensitivity of the analytical method used to measure these agents. The issues that need to be considered when using an analytical methods-based approach to establish a threshold include:

What are the sensitivity and specificity of the method? Has the method been adequately validated? How will the method be used? How will the threshold be modified when improved methods are developed?

The strength of this approach is that it is relatively simple, straightforward, and easy to implement. However, it is appropriate to use an analytical methods-based approach to establish thresholds for allergens or gluten only if analytical techniques are available for the food allergen and celiac-associated glutens. 2. Safety Assessment-Based Approach. Safety assessments are routinely applied to public health issues related to substances in foods, such as chemical contaminants or food additives, particularly when a biological threshold can be justified scientifically. The definition of "safe" varies according to the applicable legal provision. For example, for contaminants, the statutory definitions of safety are proscribed in section 402(a)(1). Food is considered adulterated if an added contaminant is in the food in a quantity"...which may render it [the food] injurious to health", or, if the substance is an inherent natural constituent of the food (i.e. "not an added substance") and is in the food in a quantity that would "ordinarily render it [the food] injurious to health". As another example, the phrase "reasonable certainty that no harm will result" is used in section 408 (a)(4) regarding the safety of tolerances for a pesticide chemical residue in or on a food. For a safety assessment, the term "safety" has connotations involving both the degree of certainty and an assumption of "negligible risk." The prototype chemical safety assessment is the

Acceptable Daily Intake (ADI) method which was first articulated by Fitzhugh and Lehman (1954) for use in considering the significance of available animal data. This approach or variations of it are used throughout the world (WHO, 1987). The ADI for a chemical is calculated from the No Observed Adverse Effect Level (NOAEL) and Uncertainty Factor (UF) using the following equation: ADI = NOAEL / UF. The same basic methodology can be used to derive other regulatory standards such as Tolerable Daily Intake (TDI), Reference Dose (RfD), and Minimal Risk Level (MRL). These values are derived from controlled animal studies, human clinical studies, or epidemiological studies that provide the exposure level for which there is no apparent adverse effect or which identify the lowest observable adverse effect level (i.e., NOAEL, LOAEL). These adverse effect levels are also considered in conjunction with one or more uncertainty factor(s). Uncertainty factors are applied to account for inter-species and inter-individual differences and other uncertainties in the data (WHO, 2004). There have been consistent efforts to improve this process to make better use of scientific knowledge. These efforts have focused on both replacing the NOAEL approach and refining the development of uncertainty factors. One example is the development of the benchmark dose (BMD) concept (Crump, 1984; Kimmel and Gaylor, 1988). The BMD concept involves fitting a dose-response model to all the available data and to determine the statistical lower bound of the BMD (i.e., the BMDL). The major advantage of the approach is that the BMDLis not constrained to one of the experimental doses from a controlled study, as is the case with the NOAEL (Crump, 1994). The U.S. Environmental Protection Agency (EPA) uses the BMD method in health risk assessments (Filipsson et al., 2003). 3. Risk Assessment-Based Approach. A risk assessment is a systematic, scientific examination of known or potential adverse heath effects resulting from human exposure to a hazard. The generally accepted paradigm separates risk assessment into four components: hazard identification, exposure assessment, hazard characterization (dose-response), and risk characterization. This framework allows for organization of information, definition of uncertainties, and identification of data gaps. Risk assessments can describe the likelihood of adverse health effects either quantitatively or qualitatively depending on the extent of the knowledge available, the complexity of the problem, and the time available to conduct the assessment. In quantitative risk assessments, risk is expressed as a numerical estimate of the chance of illness or death after exposure to a specific hazard. This estimate represents the cumulative probabilities of certain events happening and the uncertainty associated with those events. A qualitative risk assessment, on the other hand, uses verbal descriptors of the risk and uncertainties, and often involves the aggregation of expert opinions. Of the four approaches, the quantitative risk assessment-based approach is the most scientifically rigorous and provides insight into the level of risk associated with specific exposures and the degree of uncertainty inherent in the risk estimate. An example of the use of a risk estimate and associated uncertainty is the current standard for hypoallergenic infant formulas, where there is 95% certainty that 90% of the sensitive population will not react (American Academy of

Pediatrics, 2000). The risk assessment-based approach is preferred when a biological threshold cannot be justified scientifically. Several recent papers have discussed the application of the risk assessment-based approach to food allergens (Bindslev-Jensen et al., 2002; Moneret-Vautrin and Kanny, 2004; Cordle, 2004; Wensing et al., 2002a). The issues that need to be considered when using a risk assessment-based approach include:

What is the biological endpoint or biomarker of concern? Is the response measurable? What is the population (or sub-population) of interest? What are the exposure levels? What data and assumptions are needed for the assessment, and how do gaps in the existing data affect the level of uncertainty?

Other issues that should be considered in regard to understanding the relationship between the exposure level and nature of the response include:

How sensitive and accurate are the available analytical methods? How do changes in individual sensitivities over time and within populations contribute to the overall uncertainty? What are the limitations of the clinical studies (e.g., small number of volunteers, not testing the most sensitive subpopulation) that are used to determine the dose-response relationship and how do these limitations contribute to the overall uncertainty? Which dose-response models (e.g., threshold, non-threshold) are appropriate?

It is not clear whether the data and modeling techniques available at the present time are sufficient to allow use of the risk assessment-based approach to establish thresholds for food allergens and for gluten. As an example of the complexity of this approach, the following describes the process of developing a dose-response model that can be used in a quantitative risk assessment: Steps in Developing a Dose-Response Model 1. Determine the population of concern (e.g., infants, children, pregnant women). 2. Determine the endpoint or biomarker of concern (e.g., death, severe illness requiring hospitalization, subjective reactions such as tingling of lip). 3. Identify available relevant data including animal studies, human clinical studies, and epidemiological data that relate dose to frequency or severity of response. 4. Select the appropriate dose-response model(s) that characterize the shape of the doseresponse curve. 5. Fit the selected model(s) to the data. 6. Characterize the uncertainty (i.e., curve weighting and/or use of alternative plausible models). 4. Statutorily-Derived Approach. The statutorily-derived approach establishes a threshold by extrapolating from an exemption established by Congress for another purpose. For example, the

FALCPA defines "major food allergen " to include a food ingredient "that contains protein derived " from one of eight foods or food groups, "except... any highly refined oil " derived from one of those foods. If consumption of highly refined oils is not associated with allergic reactions, and if there is nothing unique about the proteins in highly refined oils, then consumption of another food containing levels of protein that result in an exposure that is equal to or less than the level in a typical serving of highly refined oils should not be associated with allergic reactions. Thus, a threshold could be established for all food allergen proteins based on the level of protein in highly refined oils. There is no comparable statutory standard for gluten.

B. General Criteria for Evaluating and Selecting Approaches to Establish Thresholds

The general criteria used to evaluate the four approaches to establish thresholds for allergens and gluten are shown in Table IV-2. Specific criteria related to food allergens are given in Section IV-C and gluten in section IV-D. The specific criteria should be weighted appropriately when implementing a particular approach. The general criteria focus on data availability and data quality. The Threshold Working Group recognizes that scientific knowledge is the product of a process which is inherently imperfect and often incomplete. As such, the degree of uncertainty in the data is a key consideration. It is expected that any decisions on approaches for establishing thresholds for food allergens or for gluten would require consideration of additional factors not covered in the current report. For example, ease of compliance and enforcement, stakeholder concerns (i.e., industry, consumers, and other interested parties), economics (e.g., cost/benefit analysis), trade issues, and legal authorities are all significant factors that are likely to influence the practicality of implementing any approach. One option that is implicit in the following discussion of potential approaches is a decision not to establish thresholds at this time, at least for food allergens. Table IV-2. General Criteria for Evaluating and Selecting Recommended Approaches to Establish Thresholds Criteria Description Data Identification and review of currently available data that can be used in any of the Availability four approaches to establish a specific threshold. Data Quality Evaluation of the available data for utility, completeness, and scientific soundness. Evaluation of the degree of uncertainty associated with the data. 1. Feasibility. The published and unpublished literature summarized in Sections II and III of this report were reviewed to determine the availability of the specific types of data needed for each of the approaches to establish thresholds. When necessary information was not available, the following questions were used to evaluate the existing information:

Is there surrogate or alternate information available that could be used? Is the existing knowledge sufficient to support reasonable assumptions when specific data are not available? What is the level of uncertainty associated with these data and assumptions?

2. Uncertainty. Uncertainty is typically thought to arise from the lack of data or information. Other sources of uncertainty are often considered to be relevant to scientific evaluations such as subjective judgment, statistical variation, sampling errors, and inherent randomness (Byrd and Cothern, 2000). Techniques are available to account for or measure some of these uncertainties. For example, the uncertainty in a dose-response model can be characterized using advanced techniques, such as model weighting, that measure the degree of credibility associated with the model results (Carrington, 1997). State-of-the-art food safety risk assessment models, such as the HHS/USDA Listeria monocytogenes risk assessment for ready-to-eat foods (HHS/USDA, 2003) also used techniques that separate uncertainty from biological variability. It is important to note that uncertainty is different from variability. Uncertainty reflects incomplete knowledge about a system or population which can be reduced with additional study. Variability reflects the fact that all systems or populations have inherent, biological heterogeneity that is not reducible through further measurement or study (Voysey et al., 2002). Sufficient knowledge is needed to account for both variability and uncertainty in order to evaluate the four approaches for establishing thresholds. As described above, uncertainty factors are used in safety assessment calculations. Fitzhugh and Lehman (1954) originally proposed a single safety factor of 100-fold applied to animal data. The justification for this factor included both scientific issues and social values. The scientific issues included the possibility that humans may be more sensitive to chemicals than the rodents used in laboratory tests and that there may be substantial variability among individuals in a population. In general, as uncertainty increases, the uncertainty factor employed in a safety assessment should increase proportionally. As a matter of practice, uncertainty is not characterized in a safety assessment, either formally or subjectively, as is done in a quantitative risk assessment. A minimum uncertainty factor of 10 is generally used to account for variation within the population when relying on human data and additional uncertainty factors may be included as appropriate. For example, the Food Quality Protection Act (FQPA) of 1996 requires, in certain cases, a 10fold factor in addition to any other uncertainty factors to protect infants and children from exposure to pesticides. Similarly, the EPA uses uncertainty factors of 3 for inter-species differences,10 for variability among humans (intra-species variability), 10 for extrapolation from subchronic to chronic exposures, 10 for extrapolation from LOAELs to NOAELS, and 1 to 10 for data deficiencies in safety assessments related to continuous inhalation exposures (U.S. EPA, 2002; Jarabek, 2002). The assignment of uncertainty factors should be based on science but typically will include the application of expert judgment. 3. Data Quality. The FDA Information Quality Guidelines and the Agency for Healthcare Research and Quality (AHRQ) guidelines on systems for rating the strength of scientific evidence were used in evaluating the scientific data contained in this report (West et al., 2002). The FDA guidelines describe policies and procedures for ensuring the quality of the information disseminated by FDA. In these guidelines, data quality is defined in terms of utility, objectivity, and integrity. Utility is defined as the usefulness of the information to its intended users; objectivity as presentation of the data in an accurate, clear, complete, and unbiased manner; and integrity as protecting the information from unauthorized access or revision. In particular, the guidelines provide transparency standards and ensure clarity. The AHRQ guidelines describe systems for evaluating the strength of scientific studies, including randomized clinical studies. In these guidelines, quality is defined as "the extent to which a study's design, conduct, and analysis

has minimized selection, measurement, and confounding biases." In addition, the AHRQ guidelines suggest specific factors (called Domains and Elements) that should be considered in evaluating individual studies. These factors were considered in developing the criteria described below.

C. Allergen Thresholds: Evaluation and Findings

This section provides an evaluation of the data needed to establish thresholds for the major food allergens. Based on the availability and quality of the data, the Threshold Working Group provides findings that can be applied to establish such thresholds. 1. Evaluation of Data Availability and Data Quality a. Sensitive Populations. Individuals within an allergic population express a wide degree of sensitivity to low dose allergen exposures. Moreover, the individuals who react to low dose allergen exposures may also have the most severe reactions following these exposures. Thus, there may be a distinct, highly sensitive population within the general population of food allergic individuals. Because most clinical studies exclude patients who have had previous anaphylactic reactions or who have high specific IgE titers, it is possible that the most sensitive individuals within the allergic population may be systematically excluded from these studies. Therefore, it is possible that the doses reported to elicit "initial objective signs" are higher than would be expected for the entire allergic population. The observed data may also not be representative of the allergic population in studies that use patient populations that are not known to be allergic to the food being tested (e.g., testing milk allergic patients for sensitivity to soy). In addition, individual sensitivity varies over time and "high sensitivity" may be a transient condition for an individual. There are a number of case reports in the scientific literature documenting allergic reactions to incidental exposures to allergens. These reports are difficult to interpret because the level of exposure and potential influence of other factors (e.g., medications, exercise) are not known. Nevertheless, if these reports document true allergic reactions, this suggests that these individuals could be considered to be highly sensitive when compared to the general population of food allergic individuals. Based on currently available data, the Threshold Working Group was unable to identify any scientifically-based studies that indicate that the standard 10-fold uncertainty factor used in safety assessments for inter-individual variability is not adequate to account for variation within the sensitive population. However, because of the limitations in the clinical studies and the case reports discussed above, this assumption should be reexamined as more data on the distribution of sensitivities within the population become available. b. Biomarkers. Because there are no in vitro markers that can be used to assess the severity of an allergic reaction, and a number of different signs and symptoms are associated with allergic reactions, clinical symptoms elicited during challenge are currently viewed as the best indicators, or biomarkers, of an allergic response. The manifestations of an allergic reaction can be either subjective (reported by the patient but not overtly measurable) or objective (overt reactions that

are observed or measured by another person). Objective signs vary on a continuum of severity from mild rashes to fatal anaphylaxis. Although each of these is an "adverse effect," there is no consensus about where on this continuum they become "serious adverse effects." This makes it difficult to apply either risk assessment- or safety assessment-based approaches to establish thresholds for food allergens because both approaches require that the adverse end point be well defined. Most clinical studies expose patients to increasing doses of an allergen until the first objective sign is observed. This is often, but not always, a relatively mild reaction. For ethical and technical reasons, few studies measure dose-response relationships for individual patients beyond the initial objective sign. Therefore, the currently available literature provides data based on the "initial objective sign." Although the "initial objective sign" is the biomarker measured in most available allergen clinical studies, it is unclear whether these signs are consistently considered across these studies. It is also not clear whether and when subjective reactions should be considered "adverse effects," or should influence the selection of a NOAEL or LOAEL for safety assessments. Normally, the use of the "initial objective sign" would lead to threshold values that are "protective" in relation to the overall risk to food allergic consumers. However, it should be noted that severe reactions have been reported as the initial objective sign in some cases. For example, Perry et al. (2004) reported that almost 30% of initial reactions were severe and stated that "reaction severity did not increase as the amount of challenge food ingested increased." Likewise, the only severe reaction observed by Hourihane et al. (1997a) in a population of 100 patients occurred at the lowest dose tested. However, considering that the use of the "initial objective sign" does appear to be generally protective, and that such data would be used in conjunction with appropriate uncertainty factors, it may not be necessary to differentiate among "mild," "serious," or "life-threatening" signs when establishing a safety assessment-based threshold from existing clinical data. c. Analytical Methods for Food Allergens. The criteria used to evaluate the available analytical methods for the major food allergens are shown in Table IV-3 and are applied in Appendix 1. Table IV-3. Specific Criteria for Evaluating Analytical Methods for Food Allergens Criteria Comments 1. Has the method been Methods that have been validated (such as by AOAC) are validated? preferred. Alternatively, the sensitivity, precision, and reproducibility of the method have been demonstrated in a peerreviewed publication. 2. Is the method sufficiently The limit of detection and the limit of quantitation should be below sensitive? the levels that appear to cause biological reactions. 3. Does the method detect The relevant processing methods (e.g., boiling, roasting, retorting) both raw and processed food will depend on the food. allergens? 4. Has the species This is most relevant to methods for allergens such as fish and tree specificity of the method nuts.

been determined? 5. Has the protein target (or This is relevant to determining whether the assay detects specific targets) for the method been allergenic proteins or general biomarkers. determined? 6. Is the method practical? The method should use common laboratory equipment and supplies. The response of sensitive consumers to exposure to an allergen is dependent on the levels of the allergen in the food and the amount of food consumed, two factors for which there is both variability and uncertainty. The levels of allergen in foods may not be known for a number of reasons, particularly when the presence of the allergen is the result of cross-contact. Even in highly controlled clinical studies, questions regarding the level of allergen arise due to differences in the methods used to process and prepare the test material, incomplete characterization of this material, variability in allergen levels among different sources of the food, lack of standardized reference materials, and differences in the analytical methods used to quantify the levels of the allergen. The methods used to quantify and express the doses received during clinical studies and adverse event investigations are not consistent, and this increases the uncertainty associated with the available data. The amount of an allergen consumed has been described in terms of total weight of a food consumed, total protein from an allergenic ingredient, or amount of specific allergenic proteins. Although the last description is scientifically the most accurate, it is also the most difficult to use because not all individuals are allergic to the same proteins in a food allergen and all the allergenic proteins may not have been identified for a particular food. Measurements based on the whole foods are simple, but increase the level of uncertainty because the composition of the food may vary. For example, changes in water content of a food would change the relative amount of allergenic protein present in serving sizes of a specified mass. Further, the amount of protein present as a percent of the total weight of the food may vary due to maturation, environmental factors, seasonal factors, production variability, or between different cultivars or strains. The Threshold Working Group recognized that the scientifically most accurate means of assessing exposure would be to quantify individual allergenic proteins, but concluded that the most practical approach for evaluating the currently available data is to measure exposure in terms of the total protein from a food allergen. This is also consistent with current technology for detecting food allergens. It should also be noted that, while clinical exposures are expressed in terms of doses (i.e., g, mg, or g), allergen levels in foods are actually measured as concentrations (i.e., ppm, percent, or mg/kg). These values can be related by defining a standard serving size, usually 100 g. However, it is well documented that the actual serving eaten by consumers should be treated as a variable and a source of uncertainty when assessing exposures. d. Challenge Studies. Clinical food challenge studies are recognized to be the most accurate way to diagnose allergies and to measure sensitivity to an allergen (Sampson, 2005). Unfortunately, the design of these food challenge studies varies widely. The lack of standardized protocols, variations in the dosing regimes (including number of doses, the interval between doses, and the relative size of the doses), and differences in the food sources (including

differences in preparation and presentation) result in uncertainties when comparing the results of different studies. Double-blind placebo-controlled food challenges (DBPCFC) are considered the most robust clinical studies and data from these studies should be given preference whenever they are available. Food challenge studies are generally not designed to determine a lack of reaction (i.e., NOAEL). Instead, the doses that produce positive allergic reactions are generally reported, providing an estimate of the LOAEL for the population being studied. Despite the uncertainties associated with food challenge data from the literature, LOAELs from human clinical trials currently provide the best data for estimating population-based reactions to food allergens. In a safety assessment-based approach, the use of LOAELs instead of NOAELs would introduce additional uncertainty. A standard DBPCFC protocol has been proposed to identify NOAELs for various food allergens, but few publicly available, peer-reviewed data of this nature are available at this time. The specific criteria used to evaluate food challenge studies are shown in Table IV-4, and applied in Appendix 2. Table IV-4. Specific Criteria for Evaluating Allergen Oral Challenge Studies Criteria Comments 1. Has the study been published in a peerPublished, peer-reviewed studies are preferred reviewed journal? although unpublished studies may be considered. 2. Were the criteria for selecting the test This information is needed to evaluate how the population clearly and completely described, study results apply to at-risk populations (i.e., and are they appropriate? was the tested population allergic to the tested food?). 3. Was the test material clearly and completely This information is needed to determine the described? amount of allergenic protein in the test material. 4. Was the lowest tested dose of allergen This information is needed to determine a described, or can it be calculated? NOAEL or LOAEL. 5. Were the total number and progression of This information is not needed for a safety dose levels described, or can they be calculated? assessment, but is needed for a risk assessment. (i.e., can the entire dose series be explicitly determined?) 6. Did some of the test population respond to the NOAELs and LOAELs cannot be determined lowest dose? in studies in which reactions occurred at the lowest dose tested. 7. Were the allergic reactions observed clearly Objective reactions are preferred for both described? safety and risk assessments. 8. Were the data sufficient to describe the dose- This information is needed for a risk response pattern for the population tested (e.g. assessment. for determining a cumulative dose-response curve)?

e. Differences Among Food Allergens. Allergens differ widely both in their potential to elicit allergic reactions and in the severity of these reactions. The simplest approach to dealing with these differences would be to establish a single threshold based on sensitivities to the most potent allergens. This threshold is likely to be unduly restrictive for many allergic consumers. Alternatively, separate thresholds could be established for each food allergen. However, the data needed for the separate threshold approach are not available for many allergens. The Threshold Working Group concluded that, to the extent possible, each food allergen should be treated independently but that a single threshold should be established if independent treatment is not possible. If a single threshold is established, it could be based on the allergenic food that elicits an allergenic reaction at the lowest total protein level. Some of the major allergens identified in the FALCPA consist of multiple species (i.e., tree nuts, fish, crustacean shellfish). Because consumers who are sensitive to one species in a group are also likely to be sensitive to other members of the group, the Threshold Working Group concluded that any thresholds established for these allergens should be based on the combined amount of protein from these species present. f. Processing and Matrix Effects. Most of the food allergens identified in the FALCPA are eaten in a processed form. The existing data show that processing can increase, decrease, modify, or have no affect on allergenicity depending on the allergen, the process, and the matrix involved. A process that modifies the structure of an allergenic protein could reduce allergenicity for one population of susceptible individuals while simultaneously increasing allergenicity for a separate susceptible population. Most clinical studies are conducted using test materials that have been processed, such as peanut butter prepared from roasted peanuts. Therefore, these studies are likely to mimic actual consumer exposure to the allergen. However, some uncertainty remains because consumers are exposed to food allergens processed in many different ways and in many matrices. It would not be practical to conduct the large number of clinical studies that would be necessary to reduce this uncertainty. Fish appears to be an important exception because raw fish is often used as a test material. Most people eat cooked fish and this should be taken into account when evaluating the results of these studies. 2. Options and Findings There are four general approaches that could be used to establish thresholds for food allergens analytical methods-based, safety assessment-based, risk assessment-based, and statutorilyderived. Each approach has strengths and weaknesses, and the application of each is limited by the availability of appropriate data. It is likely that there will be significant scientific advances in the near future that will address a number of the limitations identified in this report. The Threshold Working Group was aware of several potentially important studies that are currently in progress, but was unable to fully consider them because the data or analyses were incomplete. Finding 1. The initial approach selected to establish thresholds for major food allergens, the threshold values, and any uncertainty factors used in establishing the threshold values should be

reviewed and reconsidered periodically in light of new scientific knowledge and clinical findings. a. Analytical Methods-Based Approach. The analytical methods-based approach could be used to establish thresholds if the available data are insufficient to establish thresholds using one of the other approaches. This approach requires that analytical methods be available to detect each major food allergen. Thresholds would be defined by the limits of detection of the available analytical methods, but there would be no relationship between these thresholds and the biological response thresholds. Currently, the lower detection limits for commercially available allergen ELISA or immunoassay test kits are in the range of 0.1 to 1.0 g protein/g of food, but such kits are not available for all food allergens. Establishing thresholds at levels higher than the lower detection limits of the analytical methods would require the use of assumptions about the biological response thresholds. In that case, the thresholds are actually based on using another approach and should not be considered an analytical methods-based threshold. Advantages. When accurate, validated methods are available to measure food allergens, determining a threshold based on these methods can be a straightforward way to establish that products are in compliance with this defined level. Limitations. There are several disadvantages to using this approach in determining thresholds for food allergens: 1. The approach is not risk-based and it is likely that the appropriateness of any thresholds established using this approach will be questioned as existing methods are improved or new methods are developed. Further, in the absence of information on biological response thresholds, it is difficult to assess how well thresholds established using this approach protect public health. 2. Validated analytical methods are currently not available for all of the major food allergens. However, this is likely to change rapidly if there is a need for such analytical capability. 3. There is uncertainty as to the performance of the available analytical methods in the wide variety of food matrices that are likely to be encountered. Theoretically, the test methods should be validated for all foods and food matrices, but this is not practical. 4. Current methods, which are based on a food's total protein content, will not be sufficient in the future if techniques and technologies for reducing the levels of specific allergenic proteins are developed. Presumably, the analytical methods used to establish thresholds in this approach could also be used to evaluate compliance with any applicable legal requirements. However, the ability to use these methods to help prevent the introduction of unlawful product into the market place would require that the methods be applied in a scientifically supportable manner. This would require the establishment of a statistically supportable sampling plan. The cost of the sampling to a degree sufficient to provide reasonable statistical confidence is potentially an issue. Finding 2. The analytical methods-based approach could be used to establish thresholds for those food allergens for which validated analytical methods are available. However, if this

approach is used, the thresholds should be replaced by thresholds established using another approach as quickly as possible. b. Safety Assessment-Based Approach. The safety assessment-based approach could be used to establish thresholds based on NOAELs or LOAELs reported in the literature in combination with appropriate uncertainty factors. Because very few publications report NOAELs or present results in a form that allows NOAELs to be calculated, this type of analysis would, for most food allergens, be based on LOAELs. NOAELs should be used when they are available or can be calculated (see Appendix 2). As discussed previously, there are substantial differences in the relative potency of different food allergens (e.g., peanut vs. soy). As noted in Appendix 2 and summarized in Table IV-5, the reported LOAELs for peanuts are considerably lower (maximum of 10 mg protein) compared to soy (maximum 522 mg protein). A single threshold for food allergens, based on the most potent food allergens, could be employed if, as a matter of risk management policy, a single threshold is considered desirable. However, this could be considered overly protective, particularly in the case of soy. Table IV-5. Summary of Published LOAELs for Food Allergens Food Range of LOAEL (mg protein) Egg 0.13 to 1.0 Peanut 0.25 to 10 Milk 0.36 to 3.6 Tree Nuts 0.02 to 7.5 Soy 88 to 522 Fish 1 to 100 Advantages. Calculation of threshold levels based on NOAELs or LOAELs and the application of appropriate uncertainty factors to estimate exposure is relatively straightforward. When there are limited data in the literature, the application of appropriate uncertainty factors provides confidence that the majority of the sensitive populations will be protected. For a number of the major food allergens, there is reasonably good agreement among the reported LOAEL values. Establishing thresholds using the safety assessment-based approach and currently available clinical data has the advantage of being directly linked to biological effects. Limitations. There are limited clinical trial data for most allergens and most available clinical food challenge studies have not been designed to identify a NOAEL. Furthermore, an inherent, but unexamined, assumption in all clinical studies is that the reactions seen in a clinical setting are representative of the reactions to food allergen exposure that occur in the real world. Most available clinical data are primarily limited to identifying LOAELs, and there is no way to know whether doses below the observed LOAEL would still elicit a reaction. Thus, the selection of appropriate factors to account for uncertainty and inherent variability is critical in using the safety assessment-based approach. Until there is a consensus as to whether subjective symptoms are acceptable biomarkers or which objective signs are considered harmful, it appears prudent to consider as adverse any objective reaction observed in a clinical trial.

We have identified several data gaps for allergens that add to the uncertainty associated with setting thresholds. Critical areas of uncertainty and variability include:

Intraspecies differences. Safety assessments typically apply a 10-fold uncertainty factor to account for the variability both between individuals and variability in responses for a particular individual. Sensitive population of interest. The existence and size of highly sensitive subpopulations of allergenic individuals and their lack of participation in reported clinical trials is a potential data gap and should be included in the uncertainty factors. It is unclear whether the standard 10-fold uncertainty factor for variability within a species is sufficient to account for potential highly sensitive subpopulations. Because of the potential severity of reaction for this subpopulation it seems prudent to include an additional margin of safety (e.g., a 10-fold uncertainty factor) for this uncertainty. It is not unusual for safety assessments to provide additional protection for susceptible populations. For example, EPA uses an additional safety factor in reevaluating pesticides as per the Food Quality Protection Act (FQPA, 1996) to account for the greater susceptibility of children to certain pesticides. Adequacy of clinical trial data. Most of the available data from clinical trials report LOAELs. There is uncertainty associated with using LOAELs rather than NOAELs to establish a threshold. For peanuts, one of the few food allergens for which NOAEL values are available, the LOAELs for objective signs are approximately 2 to 3 fold greater than the NOAELs. Other. Additional data gaps have been identified by the Threshold Working Group; however, concluded that uncertainties associated with these factors were not sufficient to warrant additional uncertainty factors. These data gaps include the following: (1) the use of total protein from a food as a surrogate for measuring the level of specific allergenic proteins in clinical trials; (2) variability in serving sizes and related exposure factors; and (3) the incompletely defined effects of food processing on the levels and reactivity of allergenic proteins.

The Threshold Working Group acknowledges that it is difficult to estimate uncertainty factors that apply in all situations for all allergen threshold determinations when using a safety assessment-based approach. We can, however, assume that a standard uncertainty factor of 10fold should be applied for intraspecies differences in humans. Additional uncertainty factors could be added if justified from data gaps. In Table IV-6, we use peanuts, widely considered to be among the most potent food allergens, to illustrate how specific uncertainty factors may be developed for use in a safety assessment-based approach to set a threshold if that approach is adopted.

Table IV-6. Example of Uncertainty Factors for the Safety Assessment-Based Approach Using Peanuts. Description Uncertainty Justification Factor Intraspecies 10 Standard factor for intraspecies variability difference1 Estimation of Not applicable Two studies were identified that report NOAELs NOAEL2 Sensitive Used to account for additional margin of protection for more 10 population3 susceptible populations not included in clinical trials Overall Uncertainty Factor for Peanuts = 100
1 2

This includes both between- and within-individual variability.

This includes both a factor for converting the LOAEL to a NOAEL and an additional factor for the uncertainty associated with that conversion. In this example for peanuts, there are data on both subjective and objective NOAELs and LOAELs. If the NOAEL values are used, the uncertainty factor is 1-fold (i.e., not applicable). If the LOAELs had been used, this value would have been higher. If subjective symptoms observed at lower levels are used, a different uncertainty factor may be considered.
3

This includes uncertainty associated with an additional margin of protection to account for the potential severity of reaction (e.g., lethality) for the highly sensitive subpopulation. Finding 3. The safety assessment-based approach, based on currently available clinical data, is a viable way to establish thresholds for food allergens. If this approach is employed, the LOAEL or NOAEL determinations used should be based on evidence of the "initial objective sign." Individual thresholds should be established for each of the major food allergens. If it is not feasible to establish individual thresholds, a single threshold based on the most potent food allergens should be established. In those instances where a LOAEL is used rather than a NOAEL to establish a threshold, an appropriate uncertainty factor should be used. Thresholds established using this approach should be reevaluated periodically as new data and tools become available. c. Risk Assessment-Based Approach. The use of the risk assessment-based approach requires analysis of the population distributions of allergic sensitivities for each of the major food allergens. These distributions would then be used in conjunction with data on exposures to assess the probability of an adverse effect. These distributions could also be used to evaluate the likely efficacy of different risk reduction strategies. Advantages. The quantitative risk assessment-based approach is the most scientifically rigorous approach and provides the most insight into both the level of protection and the degree of uncertainty associated with an exposure level. Several recent publications that present preliminary quantitative risk assessments based on data from clinical trials suggest that this approach shows promise (Bindslev-Jensen et al., 2002; Moneret-Vautrin and Kanny, 2004; Cordle, 2004; Wensing et al., 2002a).

Limitations. Quantitative risk assessments require the most data of any approach to establish thresholds for food allergens, because they are based on determining the entire dose-response curve, not simply a NOAEL or LOAEL. The data currently available in the literature for food allergens are generally not detailed enough to be useful for quantitative risk assessment. Further, the underlying mathematical procedures and assumptions have not been fully described for the models that have been published. No consensus has been reached regarding the most appropriate mathematical model to use for analyzing allergen reaction data. Finding 4. Of the four approaches described, the quantitative risk assessment-based approach provides the strongest, most transparent scientific analyses to establish thresholds for the major food allergens. However, this approach has only recently been applied to food allergens, and the currently available data are not sufficient to meet the requirements of this approach. A research program should be initiated to develop applicable risk assessment tools and to acquire and evaluate the clinical and epidemiological data needed to support the quantitative risk assessmentbased approach. Thresholds established using this approach should be reevaluated periodically as new data and tools become available. d. Statutorily-Derived Approach. As discussed above, an allergen threshold could be extrapolated from a statutory exemption established by Congress for another purpose, such as the FALCPA exemption for "highly refined oils." Thus, a threshold could be established for all food allergen proteins based on the level of protein in highly refined oils. There are surprisingly few data available in the published scientific literature reporting on the levels of proteins in highly refined oils. The criteria used to evaluate studies measuring protein levels in food oils are shown in Table IV-7 and applied in Appendix 3. Table IV-7. Specific Criteria for Evaluating Protein in Oil Studies Criteria Comments 1. Has the study been published in Published, peer-reviewed studies are preferred, although a peer-reviewed journal? unpublished studies can be considered. 2. Was the oil completely The level of processing must be known both to compare described, including all refining values among studies and because each processing step may and treatment steps? change the level of protein in oil. 3. Was the method used to extract Extraction procedures should be described in sufficient the protein completely described? detail to allow the extraction to be reproduced and, ideally, extraction efficiencies should be measured and reported. 4. Was the method used to quantify The lack of these data increases the level of uncertainty. protein levels completely described? 5. Were replicate samples or The lack of these data and statistical analysis increase the batches tested, and was there a level of uncertainty. statistical analysis of these data? Based on the data presented in those studies that reported levels other than "not detected," the overall range of protein concentrations for highly refined oils was 0.014 to 16.7 g protein/ml

oil, with a mean of 2.35 g/ml. The combined mean protein concentration for the two most widely used oils derived from food allergens, soy and peanut, is 0.74 g/ml with a standard deviation (std) of 1.3 g/ml. A threshold could be based on the mean protein concentrations or on the mean plus some multiple of the standard deviation. For example, using the mean protein concentrations for peanut and soy oils, protein levels for the mean, mean + 1 std, mean + 2 std, or mean + 3 std would be the 0.74, 2.05, 3.36, and 4.67 g/ml, respectively. Advantages. The primary advantage to the statutorily-derived approach is that it is derived from FALCPA's exemption for highly refined oils from labeling provisions in the FALCPA. Limitations. The primary limitation of this approach is that it is based on an extrapolation of a level derived from a statutory exemption rather than a rigorous, systematic evaluation of all the available scientific data. Because not all the eight major food allergens are used to produce highly refined oil, the use of a statutorily-derived threshold for all food allergens would be based primarily on the protein levels in highly refined soy or peanut oil. Another current significant limitation is the lack of data on the levels of protein in highly refined oils. Based on the data that are currently available and estimates of the amount of oil consumed as a food or food ingredient, it is likely that a threshold based on this approach would be unnecessarily protective of public health. Finding 5. The statutorily-derived approach provides a mechanism for establishing thresholds for allergenic proteins in foods based on a statutory exemption. Potentially, this approach could be used to set a single threshold level for proteins derived from any of the major food allergens. This approach might yield thresholds that are unnecessarily protective of public health compared to thresholds established using the safety assessment-based approach or the risk assessmentbased approach. However, confirming this would require additional data. If this approach is employed to establish thresholds, it should be used only on an interim basis and should be reevaluated as new knowledge, data, and risk assessment tools become available.

D. Gluten Threshold: Evaluation and Findings

Section 206 of the FALCPA requires that the term "gluten-free " be defined for use on food labels. The law neither describes how gluten-free should be defined nor states whether there is a safe level of gluten. This section provides an evaluation of the available data to support various approaches for establishing a threshold for gluten. A threshold, if established, could be the basis for decisions on whether to use the term "gluten-free" on product labels. 1. Evaluation of Data Availability and Data Quality a. Sensitive Populations. Like food allergies, celiac disease affects only a small proportion of the U.S. population (estimated at 1%) (NIH, 2004). Susceptibility to celiac disease is genetically determined and is linked to the presence of the DQ2 or DQ8 HLA alleles. However, carrying these alleles does not necessarily lead to celiac disease. Both acute and chronic morbidity have been well documented for individuals with symptomatic celiac disease. A gluten-free diet has

been shown to greatly reduce the risk for cancer and overall mortality for these individuals. The potential benefit of a gluten-free diet has not been established for individuals with silent or latent celiac disease. b. Biomarkers. Unlike food allergies, clinical signs and symptoms do not appear to be reliable markers of disease activity because many individuals affected with celiac disease may be entirely asymptomatic. Furthermore, although biomarkers of genetic susceptibility (e.g., presence of DQ2 and/or DQ8 HLA alleles) and gluten exposure [e.g., antibodies for gliadin (AGA), endomysial (EMA), and tissue transglutaminase (tTG)] have been defined for use in noninvasive diagnosis of individuals with celiac disease, these biomarkers have not been shown to correlate with disease severity nor to be useful in assessing daily responses to gluten exposures. Rather, evidence of intestinal mucosal inflammation is the gold standard biomarker for diagnosis of celiac disease and for assessment of disease severity. Intestinal mucosal inflammation may occur long before the development of clinical signs or a rise in antibody titers following a gluten challenge. Intestinal inflammation is assessed by intestinal biopsy, which is an invasive procedure, associated with false negatives (due to sampling error), and is impractical for frequent monitoring of disease activity or severity. c. Foods of Concern. The foods of concern for individuals with, or susceptible to, celiac disease are the cereal grains that contain the storage proteins prolamin and glutelin (commonly referred to as glutens in wheat), including all varieties of wheat (e.g., durum, spelt, kamut), barley (where the storage proteins are called hordiens), rye (where the storage proteins are called secalins), and their cross-bred hybrids (such as triticale). The proportion of individuals with celiac disease that are also sensitive to the storage proteins in oats (avenins) has not been determined but is likely to be less than 1% (Kelly, 2005). d. Methods of Analysis. The criteria used to evaluate the available methods of analysis for gluten in food are shown in Table IV-8 and are applied in Appendix 4. A number of commercial immunology-based ELISA test kits for the detection of gluten in foods are available, and one has been validated by AOAC (the Tepnel kit, validated at 160 ppm). One limitation of these kits is that they only detect prolamins. This is not likely to limit the detection of gluten in foods because in most cases prolamins and glutelin occur together. However, it may lead to an underestimate of the level of gluten present. Also, none of the test kits cross-reacts with protein extracts from oats, which limits their efficacy for the small portion of celiac patients who are also sensitive to oats. Test kits suitable for the detection of oat proteins should be developed.

Table IV-8. Specific Criteria for Evaluating Gluten Analytical Methods Criteria Comments 1. Has the method been Methods that have been validated (such as by AOAC) are preferred. validated? Alternatively, the sensitivity, precision, and reproducibility of the method should have been demonstrated in a peer-reviewed publication. 2. Is the method The limit of detection and the limit of quantitation should be below sufficiently sensitive? the levels that appear to cause biological responses in most patients with celiac disease. 3. Are extraction methods Different methods may be needed; each should be validated. available for both raw and baked foods? 4. Does the method The cereal grains associated with celiac disease include wheat, measure proteins from all barley, rye, and their cross-bred hybrids. Oats may be of concern for relevant foods? some celiac patients. 5. Does the method The storage proteins in cereal grains (generally referred to as gluten) measure both gliadins and include both prolamin proteins (gliadins) and glutelin proteins glutenins? (glutenins). Ideally, both of these should be measured. 6. Is the method practical? The method should use common laboratory equipment and be reasonably priced. e. Oral Challenge Studies. The criteria used to evaluate the available gluten oral challenge studies are provided in Table IV-9 and applied in Appendix 5. Only a limited number of gluten or gliadin challenge studies have been conducted. Of these, many have monitored the subjects' acute responses to a single high dose of gluten or gliadin. These acute studies were not designed to establish a NOAEL or (in most cases) a LOAEL, and the results may not be directly applicable to the chronic, low-level exposures that may lead to long-term consequences. Moreover, most clinical studies only test one or two dose levels and do not directly measure daily intestinal responses to gluten. Based on the criteria in Table IV-9, two currently available studies are considered to be of high utility. The data in these studies can be used to calculate LOAELs for short-term exposures. Although one study retrospectively assessed the effects of trace amounts of gluten consumption in diets of individuals for up to 10 years (Collin et. al., 2004), there are no prospective data on the impact of chronic or long-term consumption of lower gluten levels. Table IV-9. Specific Criteria for Evaluating Gluten Oral Challenge Studies Criteria Comments 1. Has the study been published Published, peer-reviewed studies are preferred although in a peer-reviewed journal? unpublished studies may be considered. 2. Were the criteria for selecting This information is needed to evaluate how the study results the test population clearly and apply to the at-risk population. completely described? 3. Was the tested food material It is important to know the level of gluten in the test material. clearly and completely described?

Table IV-9. Specific Criteria for Evaluating Gluten Oral Challenge Studies Criteria Comments 4. Was the dose regime clearly A study designed to measure chronic exposure (low doses over and completely described? a long period of time) is preferable. Extrapolation of long-term effects from short-term studies increases the level of uncertainty. 5. Were the criteria for This information is needed to evaluate the relevance of the characterizing responses clearly response measured. A definitive diagnostic assessment described? showing clinical signs or intestinal mucosal changes compared to controls is preferred. 6. Are response data available These data are needed to develop a risk assessment-based for each individual tested? dose-response model. 2. Options and Findings The feasibility of using each of the four methods to establish a threshold for gluten was evaluated in light of the available data. As with food allergens, it is likely there will be significant scientific advances in the near future that will address a number of the limitations identified in this report. The Threshold Working Group was aware of several potentially important studies that are currently in progress, but we were unable to evaluate them because the data or analyses are incomplete. In particular, the Threshold Working Group is aware of unpublished data from an ongoing clinical trial of the subchronic effects of gluten on celiac patients. The "Italian Microchallenge Study" is utilizing intestinal biopsies to relate changes in the intestinal mucosa to antibody biomarkers (Fasano, 2005 personal communication). Preliminary results indicate that daily consumption of both 10 mg and 50 mg of dietary gluten were well tolerated after three months of continuous consumption, but that minimal histological changes were seen in patients consuming 50 mg of gluten daily. Because these data have not yet been published, these results were not considered further. Finding 6. The initial approach selected to establish a threshold for gluten, the threshold value selected, and any uncertainty factors that were used to establish the threshold should be reviewed and reconsidered periodically in light of new scientific knowledge and clinical findings. a. Analytical Methods-Based Approach. As with food allergens, an analytical methods-based approach could be used to establish a threshold for gluten if the available clinical and epidemiological data are insufficient to use one of the other approaches. This approach requires that analytical methods be available to detect all relevant glutens. Thresholds are defined by the limits of detection of the available analytical methods, but there is no relationship between these thresholds and the biological response thresholds. At the time of this report, the lower limits of detection for the commercially available gluten test kits are in the range of 10 g gluten/g of food, and the ability to robustly quantify samples is in the range of 20 g gluten/g of food. Establishing thresholds at levels higher than the lower detection limits of the analytical methods requires the use of assumptions about the biological response thresholds. In that case, the

thresholds are actually based on using one of the other three approaches and should not be considered an analytical methods-based threshold. Advantages. A threshold established using the analytical methods-based approach can easily be incorporated into any applicable FDA compliance programs that combine a specific standard method with a standardized sampling scheme. Limitations. Several factors limit the applicability of the analytical methods-based approach to establish a threshold for gluten. At this time, only one commercially available analytical method has been AOAC validated, and that method was validated for detection at a relatively high concentration of gluten. In addition, there are limited data on the performance of the available methods in the wide variety of food matrices that could potentially contain gluten. Therefore, further characterization of available methods would be necessary before an analytical methodsbased threshold could be established. Appropriate methods would need to be developed for the detection of oat gluten. Finding 7. The analytical methods-based approach could be used to establish a threshold for gluten. However, if this approach is used, the threshold should be replaced by a threshold established using another approach as quickly as possible. b. Safety Assessment-Based Approach. The safety assessment-based approach could be used to establish a threshold for gluten based on NOAELs or LOAELs reported in the literature in combination with appropriate uncertainty factors. Clinical data in the literature are limited, but a few studies are available that meet the Threshold Working Group's data quality criteria. The currently available clinical studies do not report NOAELs. However, studies are available that could be used to establish a LOAEL from which a threshold could be derived. Advantages. Establishing a threshold based on NOAELs or LOAELs and the application of appropriate uncertainty factors to estimated exposure levels is fairly straightforward. When there are limited data in the literature, the application of appropriate uncertainty factors can provide confidence that the majority of the sensitive populations will be protected. Establishing thresholds using the safety assessment-based approach and currently available clinical data has the advantage of being directly linked to biological effects. Limitations. The primary limitation of this approach is the dearth of available prospective clinical data and the general lack of information about the impact of chronic low-level consumption of gluten on the emergence of symptomatic disease in individuals with latent or silent celiac disease. At the current time, the size of the combined uncertainty factors needed would be substantial due to the general lack of data; applying large uncertainty factors to the available data could lead to a gluten threshold that is not achievable, as a practical matter, in foods. We have identified several data gaps for gluten that contribute to current uncertainty about setting gluten thresholds. The critical areas of uncertainty and variability are:

Intraspecies differences. Safety assessments typically apply a 10-fold uncertainty factor to account for the variability both between individuals and variability in responses for a particular individual. Chronic low-level exposure to gluten in "gluten-free " diets. Data, from either prospective studies or long-term clinical trials, are severely limited on the effect of a long-term gluten-free diet on the manifestations of celiac disease. Adequacy of clinical trial data. There is uncertainty as to whether 4-week studies, or even 4-month studies, are of sufficient duration to predict the consequences of long-term ingestion of low levels of gluten. There is additional uncertainty as to whether currently available clinical trials include the most sensitive individuals. Accordingly, there is uncertainty as to whether the standard 10-fold uncertainty factor for variability within a species is sufficient to account for potential highly sensitive individuals. Additional uncertainty arises from the fact that the published clinical trials were designed to identify LOAELs rather than NOAELs. Other. Additional data gaps have been identified by the Threshold Working Group; however, the working group concluded that uncertainties associated with these factors were not sufficient to warrant additional uncertainty factors. These other data gaps include the following: (1) it is uncertain what percentage of individuals with celiac disease are sensitive to oat gluten and whether the levels to which they are sensitive are equivalent to those observed for wheat; (2) variability in serving sizes and related exposure factors; and (3) the incompletely defined effect of food processing on the levels of gluten tolerated by individuals with celiac disease.

The uncertainty associated with gluten thresholds arises primarily from the limited amount of clinical data. The critical knowledge gap about individuals with celiac disease is whether chronic, low-level exposure to gluten in a gluten-free diet will cause any harm over a lifetime. We are not aware of any prospective clinical trials that have examined the health of individuals with celiac disease on a gluten-free diet for more than a few months. There is uncertainty as to whether data from these short-term clinical trials will accurately predict reactions following chronic, low-level gluten exposure. Conversely, there appears to be only a small degree of uncertainty as to whether the most sensitive celiac disease populations were included in the available clinical trials since most of the participants had evidence of disease. As discussed in Section III, there may be an oat-sensitive subpopulation. The possible existence of this oat-sensitive subpopulation raises questions related to the definition of "gluten. " Because there are limited clinical data on the sensitivity of this subpopulation of individuals with celiac disease, the uncertainty related to the LOAELs or NOAELs for these individuals is high. Nevertheless, it is unlikely that theses individuals are substantially more sensitive to oat gluten than they are to wheat gluten. Table IV-10 presents an example of how an overall uncertainty factor could be derived when estimating a threshold for gluten using the safety assessment-based approach. A standard uncertainty factor of 10 might be applied for intraspecies differences in human responses to gluten.

Table IV-10. Example of Uncertainty Factors for the Safety-Assessment-Based Approach. Description Uncertainty Justification Factor Intraspecies difference1 10 Standard for intraspecies variability. Extrapolation from LOAEL 10 Standard if NOAEL data not available. Supported 2 by clinical trial data. Chronic, low-level gluten 6 Estimate using data from gluten clinical trials. 3 exposure Overall Uncertainty Factor4 = 600
1 2

This includes both between- and within-individual variability.

This includes both a factor for converting the LOAEL to a NOAEL and an additional factor for the uncertainty associated with that conversion factor. Preliminary NOAEL data from an unpublished clinical trial (Fasano, 2005 personal communication) support an approximate 10fold difference between a NOAEL and published LOAELs (Catassi et al., 1993). Estimated by comparing published LOAELs in an acute, single dose exposure (Ciclitira et al., 1984) with repeated exposure over four weeks (Catassi et al., 1993).
4 3

Uncertainty is likely to decrease as clinical trial data become available.

Finding 8. The safety assessment-based approach is a viable approach to establish a threshold for gluten using currently available LOAEL data for celiac disease. An overall uncertainty factor should be estimated from the data and applied to the LOAEL to establish a threshold for gluten. Any threshold derived from this approach should be reevaluated as new research data become available. Available data are insufficient at the current time to use this approach to establish a threshold for oat gluten for those individuals with celiac disease who may also be sensitive to oats. However, it is likely that a threshold based on wheat gluten would be protective for individuals susceptible to oat gluten. c. Risk Assessment-Based Approach. There are few data from human clinical trials that can be used to develop a dose-response model for gluten and celiac disease. In addition, limited data are available on exposure; for example, there are limited data on the actual levels of gluten in the diet of individuals on "gluten-free diets" and on the effects of low-level, chronic gluten exposure in individuals with silent or latent celiac disease. These limitations would lead to a very high level of uncertainty associated with models designed to predict the health effects of gluten in the diet. Therefore, a scientifically defensible hazard characterization and exposure assessment are not possible at the current time. Finding 9. Use of the quantitative risk assessment-based approach to establish a threshold for gluten does not appear to be feasible at the present time. However, considering the benefits that could be gained from using the risk assessment-based approach, priority should be given to establishing a research program to acquire the knowledge and data needed.

d. Statutorily-Derived Approach. The FALCPA does not include requirements or exemptions that could be used to establish a statutorily-derived threshold for gluten. Also, the law does not define the term "gluten-free. " Potentially, a threshold could be established using the international standards currently under review by Codex (Codex Alimentarius Commission, 2003. However, the proposed Codex standards do not appear to be based on either a scientific rationale for a distinction between naturally gluten-free foods and foods processed to be free of gluten, or a systematic evaluation of clinical data related to the effect of gluten on acute or chronic celiac disease etiology. The levels being considered by Codex seem to be based on anecdotal evidence and on the levels of gluten that are presumed to be historically present in foods that have been called "gluten-free." Finding 10. There appear to be no suitable statutory requirements or exemptions that would serve as the rationale for using for a statutorily-derived approach to establish a threshold for gluten. This approach is not viable. Although the FALCPA directs FDA to establish a definition for the term "gluten-free" for food labeling, the quantity and quality of the data needed to accomplish this on a scientific basis are severely limited at the current time relative to all three of the potentially viable approaches. This was aptly summarized by the consensus statement published after a conference of experts convened by the National Institutes of Health which noted that "The strict definition of a glutenfree diet remains controversial due to the lack of an accurate method to detect gluten in food products and the lack of scientific evidence for what constitutes a safe amount of gluten ingestion " (NIH, 2004). These experts concluded that additional research is needed to "Define the minimum safe exposure threshold of gluten in the diet relative to celiac disease " (NIH, 2004). In view of the consensus opinion stated in the NIH report, the Threshold Working Group concluded that Finding 6 should be reemphasized. Any approach used to establish a threshold for gluten to protect consumers with, or susceptible to, celiac disease should be used in an iterative manner and reexamined periodically to consider new knowledge, data, and approaches.

V. References

Abouzied, M. M., Carroll, M., Mozola, M. A., (2004). A Sandwich ELISA test for detection and quantitation of gluten in food products and ingredients. Abstract of presentation at AOAC Annual Meeting, September 19-23, 2004. Akiyama, H., Isuzugawa, K., Harikai, N., Watanabe, H., Iijima, K., Yamakawa, H., Mizuguchi, Y., Yoshikawa, R., Yamamoto, M., Sato, H., Watai, M., Arakawa, F., Ogasawara, T., Nishihara, R., Kato, H., Yamauchi, A., Takahata, Y., Morimatsu, F., Mamegoshi, S., Muraoka, S., Honjoh, T., Watanabe, T., Sakata, K., Imamura, T., Toyoda, M., Matsuda, R., Maitani, T. (2004). Inter-laboratory evaluation studies for

development of notified ELISA methods for allergic substances (wheat). Shokuhin Eiseigaku Zasshi, 45(3):128-134. American Academy of Pediatrics Committee on Nutrition (1989). Hypoallergenic infant formulas. Pediatrics, 83:1068-1069. American Academy of Pediatrics Committee on Nutrition. (2000). Hypoallergenic infant formulas. Pediatrics, 106:346-349. American Gastroenterological Association (AGA) (2001). Medical position statement: Celiac sprue. Gastroenterology, 120:1522-1525. Ammar, F., de Boissieu, D., Dupont, C. (1999). Allergy to protein hydrolysates. Report of 30 cases. Arch Pediatr, 6:837-843. Anet, J., Back, J. F., Baker, R. S., Barnett, D., Burley, R. W., Howden, M. E. (1985). Allergens in the white and yolk of hen's egg. A study of IgE binding by egg proteins. Int Arch Allergy Appl Immunol, 77(3):364-371. Arentz-Hansen, H., Fleckenstein, B., Molberg, O., Scott, H., Koning, F., Jung, G., Roepstorff, P., Lundin, K. E., Sollid, L. M. (2004). The molecular basis for oat intolerance in patients with celiac disease. Plos Med, 1:84-92. Asero, R., Lorini, M., Chong, S. U., Zuberbier, T., Tedeschi, A. (2004). Assessment of histamine-releasing activity of sera from patients with chronic urticaria showing positive autologous skin test on human basophils and mast cells. Clin Exp Allergy, 34:1111-1114. Australian New Zealand Food Agency (ANZFA) (2005). Australian New Zealand food standards code: Chapter 1 - General food standards, Part 1.2 - Labeling and other information requirements, Standard 1.2.8 - Nutrition information requirements. p.3, 15, 16. Accessible December 2005 at http://www.foodstandards.gov.au/foodstandardscode. Awazuhara, H., Kawai, H., Baba, M., Matsui, T., Komiyama, A. (1998). Antigenicity of the proteins in soy lecithin and soy oil in soybean allergy. Clin. Exp. Allergy, 28: 15591564. Baranwal, A. K., Singhi, S. C., Thapa, B. R., Kakkar, N. (2003). Celiac crisis. Indian J Pediatr, 70:433-435. Bellioni-Businco, B., Paganelli, R., Lucenti, P., Giampietro, P. G., Perborn, H., Businco, L. (1999). Allergenicity of goat's milk in children with cow's milk allergy. J Allergy Clin Immunol, 103(6):1191-1194. Ben Rejeb, S., Abbott, M., Davies, D., Querry, J., Cleroux, C., Streng, C., Delahaut, P., Yeung, J. M. (2003). Immunochemical-based method for detection of hazelnut proteins in processed foods. J AOAC Int, 86(3):557-563. Bernhisel-Broadbent, J., Scanlon, S. M., Sampson, H. A. (1992a). Fish hypersensitivity. I. In vitro and oral challenge results in fish-allergic patients. J Allergy Clin Immunol, 89(3):730-737. Bernhisel-Broadbent, J., Strause, D., Sampson, H. A. (1992b). Fish hypersensitivity. II: Clinical relevance of altered fish allergenicity caused by various preparation methods. J Allergy Clin Immunol, 90(4 Pt 1):622-629. Besler, M., Steinhart, H., Paschke, A. (2001). Stability of food allergens and allergenicity of processed foods. J Chromatogr B Biomed Sci Appl, 756(1-2):207-228. Beyer, K., Morrow, E., Li, X. M., Bardina, L., Bannon, G. A., Burks, A. W., Sampson, H. A. (2001). Effects of cooking methods on peanut allergenicity. J Allergy Clin Immunol, 107(6):1077-1081.

Bindslev-Jensen C. (2001). Standardization of double-blind, placebo-controlled food challenges. Allergy, 56(Suppl.):75-77. Bindslev-Jensen, C., Ballmer-Weber, B. K., Bengtsson, U., Blanco, C., Ebner, C., Hourihane, J., Knulst, A. C., Moneret-Vautrin, D. A., Nekam, K., Niggemann, B., Osterballe, M., Ortolani, C., Ring, J., Schnopp, C., Werfel, T. (2004). Standardization of food challenges in patients with immediate reactions to foods position paper from the European Academy of Allergology and Clinical Immunology. Allergy, 59: 690-697. Bindslev-Jensen, C., Briggs, D., Osterballe, M. (2002).Hypothesis paper: Can we determine a threshold level for allergenic foods by statistical analysis of published data in the literature? Allergy, 57:741-746. Bock, S. A. and Atkins, F. M.(1989). The natural history of peanut allergy. J Allergy Clin Immunol, 83:900-904. Bock, S. A., Lee, W. Y., Remigio, L. K., May, C. D. (1978). Studies of hypersensitivity reactions to foods in infants and children. J Allergy Clin Immunol, 62:327-334. Bock, S. A., Munoz-Furlong, A., Sampson, H. A. (2001). Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol, 107(1):191-193. Bock, S. A., Sampson, H. A., Atkins, F. M., Zeiger, R. S., Lehrer, S., Sachs, M., Bush, R. K., Metcalfe, D. D. (1988). Double-blind, placebo-controlled food challenge (DBPCFC) as an office procedure: a manual. J Allergy Clin Immunol, 82(6):986-997. Bousquet, J., Bjorksten, B., Bruijnzeel-Koomen. C. A. F. M., Huggett, A., Ortolani, C., Warner, J. O., Smith, M. (1998). Scientific criteria and the selection of allergenic foods for product labeling. Allergy, 53S:3-21. Brewer, V. A., Thomas, F. S., Garber, A. E., Nguyen, J., X., Amato, S. P. (2004). The detection of wheat using commercial ELISA-based assays. Abstract of presentation at AOAC Annual Meeting, September 19-23, 2004. Brown, A. (2004). Understanding Food Principles and Preparation, Second Edition, Wadsworth/Thomson Learning, Belmont, CA, USA, pp. 402-403. Burks, A. W., Williams, L. W., Thresher, W., Connaughton, C., Cockrell, G., Helm, R. M. (1992). Allergenicity of peanut and soybean extracts altered by chemical or thermal denaturation in patients with atopic dermatitis and positive food challenges. J Allergy Clin Immunol, 90:889-897. Bush, R. K., Taylor, S. L., Nordlee, J. A., Busse, W. W. (1985). Soybean oil is not allergenic to soybean-sensitive individuals. J Allergy Clin Immunol, 76(2 Pt 1):242-245. Byrd, D. M. and Cothern, C. R. (2000). Chapter II: functions, models, and uncertainties IN: Introduction to risk analysis: a systematic approach to science-based decision making, Government Institutes, pp. 87. Caffarelli, C., Cavagni, G., Giordano, S., Stapane, I., Rossi, C. (1995). Relationship between oral challenges with previously uningested egg and egg-specific IgE antibodies and skin prick tests in infants with food allergy. J Allergy Clin Immunol, 95(6):12151220. Canadian Government: The Food and Drugs Act, Part 2 Food and Drugs Regulations, Part B Foods, Division 21 Foods for special dietary uses, Regulation B.24.018. Accessible December 2005 at http://www.hc-sc.gc.ca/fn-an/alt_formats/hpfbdgpsa/pdf/legislation/e_d-text-2.pdf . Carrington, C. (1997). An administrative view of model uncertainty in public health. Accessible December 2005 at www.piercelaw.edu/risk/vol8/summer/Carringt.htm

Casimir, G. and Duchateau, J. (1997). Discriminant epitopes (EP) in allergy to cow's milk (CM). Characteristics of the immune response and clinical presentation. Pediatr Pulmonol Suppl, 16:22. Catassi C., Bearzi, I., Holmes, G. (2005a) Association of celiac disease and intestinal lymphomas and other cancers. Gastroenterology; 128(Suppl 1):S79-86) Catassi, C., Fabiani, E., Corrao, G., Barbato, M., De Renzo, A., Carella, A. M., Gabrielli, A., Leoni, P., Carroccio, A., Baldassarre, M., Bertolani, P., Caramaschi, P., Sozzi, M., Guariso, G., Volta, U., Corazza, G. R. (2002). Risk of non-Hodgkin lymphoma in celiac disease. Jama, 287:1413-1419. Catassi, C., Fabiani, E., Iacono, G., Francavilla, R., D'Agate, C., Volta, U., Accomando, S., Picarelli, A., Corazza, G., De Vitis, I., Nardone, G., Bardella, M., Bearzi, I., Mandolesi, A., Fasano, A. (2005b). Toxicity of gluten traces in patients on treatment for celiac disease. Results of a prospective, placebo-controlled, double-blind, randomized study. Abstract of presentation at Digestive Disease Week, May 14-19, 2005. Catassi, C. and Fasano, A. (2004). Celiac disease as a cause of growth retardation in childhood. Curr Opin Pediatr, 16:445-449. Catassi, C., Rossini, M., Ratsch, I. M., Bearzi, I., Santinelli, A., Castagnani, R., Pisani, E., Coppa, G. V., Giorgi, P. L. (1993). Dose dependent effects of protracted ingestion of small amounts of gliadin in coeliac disease children: a clinical and jejunal morphometric study. Gut, 34(11):1515-1519. Central Science Laboratory, Food Analysis Performance Assessment Scheme (FAPAS) Series 27 Round 05 Report 2705 (2003a). Wheat. Central Science Laboratory, Food Analysis Performance Assessment Scheme (FAPAS) Series 27 Round 08. Report No. 2708 (2003b). Peanuts. Central Science Laboratory, Food Analysis Performance Assessment Scheme (FAPAS) Series 27 Round 10 Report No. 2710 (2004a). Eggs and Milk. Central Science Laboratory, Food Analysis Performance Assessment Scheme (FAPAS) Supplement Report 2705 (2004b). Wheat. Chiou, Y. H., Yuo, C. Y., Wang, L. Y., Huang, S. P. (2003). Detection of cross-reactivity for atopic immunoglobulin E against multiple allergens. Clin Diagn Lab Immunol, 10(2):229-232. Ciclitira, P. J., Cerio, R., Ellis, H. J., Maxton, D., Nelufer, J. M., Macartney, J. M. (1985). Evaluation of a gliadin-containing gluten-free product in coeliac patients. Hum Nutr Clin Nutr, 39(4):303-308. Ciclitira, P. J., Evans, D. J., Fagg, N. L., Lennox, E. S., Dowling, R. H. (1984). Clinical testing of gliadin fractions in coeliac patients. Clin Sci (Lond), 66:357-364. Clemente, A., Chambers, S. J., Lodi, F., Nicoletti, C., Brett, G. M. (2004). Use of the indirect competitive ELISA for the detection of Brazil nut in food products. Food Control, 15:65-69. Codex Alimentarius Commission (2003). Report of the 25th session of the Codex Committee on nutrition and foods for special dietary uses. Bonn, Germany, 3-7 November 2003. Alinorm 04/27/26. Accessible December 2005 at http://www.codexalimentarius.net . Collin, P., Thorell, L., Kaukinen, K., Maki, M. (2004). The safe threshold for gluten contamination in gluten-free products. Can trace amounts be accepted in the treatment of coeliac disease? Aliment Pharmacol Ther, 19:1277-1283.

Cooke, S. K. and Sampson, H. A. (1997). Allergenic properties of ovomucoid in man. J Immunol, 159(4):2026-2032. Cordle, C. T. (2004). Soy protein allergy: Incidence and relative severity. J. Nutr, 134:1213S-1219S. Corrao, G., Corazza, G. R., Bagnardi, V., Brusco, G., Ciacci, C., Cottone, M., Sategna Guidetti, C., Usai, P., Cesari, P., Pelli, M. A., Loperfido, S., Volta, U., Calabro, A., Certo, M. (2001). Mortality in patients with coeliac disease and their relatives: a cohort study. Lancet, 358:356-361. Crespo, J. F., Pascual, C., Dominguez, C., Ojeda, I., Muoz, F. M., Esteban, M. M. (1995). Allergic reactions associated with airborne fish particles in IgE-mediated fish hypersensitive patients. Allergy, 50(3):257-261. Crevel, R. W. R., Kerkhoff, M. A. T., Koning, M. M. G. (2000). Allergenicity of refined vegetable oils. Food Chem Toxicol, 38:385-393. Crump, K.S. (1994). Overview of the benchmark dose method for use in determining acceptable exposures. Society for Risk Analysis Annual Meeting. Abstract. Daengsuwan, T., Palosuo, K., Phankingthongkum, S., Visitsunthorn, N., Jirapongsananuruk, O., Alenius, H., Vichyanond, P., Reunala, T. (2005). IgE antibodies to omega-5 gliadin in children with wheat-induced anaphylaxis. Allergy, 60:506-509. Daul, C. B., Morgan, J. E., Waring, N. P., McCants, M. L., Hughes, J., Lehrer, S. B. (1987). Immunologic evaluation of shrimp-allergic individuals. J Allergy Clin Immunol, 80(5):716-722. Daul, C. B., Morgan, J. E., Lehrer, S. B. (1993). Hypersensitivity reactions to Crustacea and mollusks. Clin Rev Allergy, 11:201-222. Daul, C. B., Morgan, J. E., Hughes, J., Lehrer, S. B. (1988). Provocation-challenge studies in shrimp-sensitive individuals. J Allergy Clin Immunol, 81(6):1180-1186. de Leon, M. P., Glaspole, I. N., Drew, A. C., Rolland, J. M., O'Hehir, R. E., Suphioglu, C. (2003). Immunological analysis of allergenic cross-reactivity between peanut and tree nuts. Clin Exp Allergy, 33(9):1273-1280. Dewar, D., Pereira, S. P., Ciclitira, P. J. (2004). The pathogenesis of coeliac disease. Int J Biochem Cell Biol, 36:17-24. Diffchamb Transia Plate Gluten. (2005). Accessible December 2005 at http://www.diffchamb.com . Diffchamb Transia Plate Prolamins. (2005). Accessible December 2005 at http://www.diffchamb.com . Docena, G., Rozenfeld, P., Fernandez, R., Fossati, C. A. (2002). Evaluation of the residual antigenicity and allergenicity of cow's milk substitutes by in vitro tests. Allergy, 57:83-91. Dodo, H., Konan, K., Viquez, O. (2005). A genetic engineering strategy to eliminate peanut allergy. Curr Allergy Asthma Rep, 5:67-73. European Food Safety Agency (2004). Opinion of the scientific panel on dietetic products, nutrition and allergies on a request from the commission relating to the evaluation of allergenic foods for labeling purposes. EFSA J, 32:1-197. Accessible December 2005 at http://www.efsa.eu.int/science/nda/nda_opinions/341/opinion_nda_04_en1.pdf. Eggesbo, M., Botten, G., Halvorsen, R., Magnus, P. (2001). The prevalence of allergy to egg: a population-based study in young children. Allergy, 56:403-411.

Ellis, M. H., Short, J. A., Heiner, D. C. (1991). Anaphylaxis after ingestion of a recently introduced hydrolyzed whey protein formula. J Pediatr, 118:74-77. Eriksson, N. E., Moller, C., Werner, S., Magnusson, J., Bengtsson, U. (2003). The hazards of kissing when you are food allergic. A survey on the occurrence of kissinduced allergic reactions among 1139 patients with self-reported food hypersensitivity. J Investig Allergol Clin Immunol, 13(3):149-154. Errahali, Y., Morisset, M., Moneret-Vautrin, D. A., Kanny, G., Metche, M., Nicolas, J. P., Fremont, S. (2002). Allergen in soy oils. Allergy, 57(7):648-649. Ewan, P. W. (1996). Clinical study of peanut and nut allergy in 62 consecutive patients: new features and associations. BMJ, 312:1074-1078. Farrell, R. J. and Kelly, C. P. (2002). Celiac sprue. N Engl J Med, 346:180-188. Fasano, A. (2005). Celiac Disease. Personal communication. Fasano, A. (2003). Celiac disease--how to handle a clinical chameleon. N Engl J Med, 348:2568-2570. Fasano, A., Berti, I., Gerarduzzi, T., Not, T., Colletti, R.B., Drago, S., Elitsur, Y., Green, P.H.R., Guandalini, S., Hill, I,D., Pietzak, M., Ventura, A., Thorpe, M., Kryszak, D., Fornaroli, F., Wasserman, S.S., Murray, J.A., Horvath, K. (2003). Prevalence of Celiac Disease in At-Risk and Not-At-Risk Groups in the United States. Acrh Intern Med, 163:286-292. Fasano, A. and Catassi, C. (2001). Current approaches to diagnosis and treatment of celiac disease: an evolving spectrum. Gastroenterology, 120(3):636-651. Filipsson, A.F., Sand, S., Nilsson J., and Victorin K. (2003). The benchmark dose method--review of available models and recommendations for application in health risk assessment. Crit Rev Toxicol, 33(5):505-542. Fiocchi, A., Travainiw, M., D'Auriaw, E., Banderaliw, G., Bernardow, L., Riva, E. (2003). Tolerance to a rice hydrolysate formula in children allergic to cow's milk and soy. Clin Exp Allergy, 33:1576-1580. Food and Agricultural Organization of the United Nations (FAO). 1995. Chapter 4: Chemical Composition. IN: Quality and Quality Changes in Fresh Fish. FAO Fisheries Technical Paper - 348. FAO, Rome, Italy. Accessible December 2005 at http://www.fao.org/documents/show_cdr.asp?url_file=/docrep/V7180E/V7180E05.htm . Food Quality Protection Act, FQPA (1996). Public Law 104-107. Accessible December June 2005 at http://www.epa.gov/oppfead1/fqpa/gpogate.pdf . Gabrovsk, D., Rysov, J., Burkhard, M., Cuhra, P., Kubk, M., Barsov, S. (2004). Collaborative study of a new developed ELISA kit for gluten determination. J Food, Ag & Envir, 2(1):113-115. Gendel, S. M. (1998). Sequence databases for assessing the potential allergenicity of proteins used in transgenic foods. Adv Food Nutr Res, 42:63-92. Gern, J. E., Yang, E., Evrard, H. M., Sampson, H.A. (1991). Allergic reactions to milkcontaminated "nondairy" products. N Engl J Med, 324:976-979. Giampietro, P. G., Kjellman, N. I., Oldaeus, G., Wouters-Wesseling, W., Businco, L. (2001). Hypoallergenicity of an extensively hydrolyzed whey formula. Pediatr Allergy Immunol, 12:83-86. Gilissen, L. J., Bolhaar, S. T., Matos, C. I., Rouwendal, G. J., Boone, M. J., Krens, F.A., Zuidmeer, L., Van Leeuwen, A., Akkerdaas, J., Hoffmann-Sommergruber, K., Knulst, A. C., Bosch, D., Van de Weg, W. E., Van Ree, R. (2005). Silencing the major apple

allergen Mal d 1 by using the RNA interference approach. J Allergy Clin Immunol, 115:364-369. Green, P. H. and Jabri, B. (2003). Coeliac disease. Lancet, 362:383-391. Grimshaw, K. E., King, R. M., Nordlee, J. A., Hefle, S. L., Warner, J. O., Hourihane, J. O. (2003). Presentation of allergen in different food preparations affects the nature of the allergic reaction--a case series. Clin Exp Allergy, 33(11):1581-1585. Grundy, J., Matthews, S., Bateman, B., Dean, T., Arshad, S. H. (2002). Rising prevalence of allergy to peanut in children: data from 2 sequential cohorts. J Allergy Clin Immunol, 110:784-789. Gu, X., Beardslee, T., Zeece, M., Sarath, G., Markwell, J. (2001). Identification of IgEbinding proteins in soy lecithin. Int Arch Allergy Immunol, 126(3):218-225. Hallett, R., Haapanen, L. A., Teuber, S. S. (2002). Food allergies and kissing. N Engl J Med, 346:1833-1834. Hamada, Y., Tanaka, H., Ishizaki, S., Ishida, M,, Nagashima, Y., Shiomi, K. (2003). Purification, reactivity with IgE and cDNA cloning of parvalbumin as the major allergen of mackerels. Food Chem Toxicol, 41(8):1149-1156. Hamilton, I., Hill, A., Bose, B., Bouchier, I. A., Forsyth, J. S. (1987). Small intestinal permeability in pediatric clinical practice. J Pediatr Gastroenterol Nutr, 6:697-701. Hamilton, J. R., McNeill, L. K. (1972). Childhood celiac disease: response of treated patients to a small uniform daily dose of wheat gluten. J Pediatr, 81:885-893. Hansen, K. S., Ballmer-Weber, B. K., Luttkopf, D., Skov, P. S., Wuthrich, B., BindslevJensen, C., Vieths, S., Poulsen, L. K. (2003). Roasted Hazelnuts - allergenic activity evaluated by a double-blind placebo-controlled food challenge. Allergy, 58(2):132-138. Hansen, T. K., Bindslev-Jensen, C., Skov, P. S., Poulsen, L. K. (1997). Codfish allergy in adults: IgE cross-reactivity among fish species. Ann Allergy Asthma Immunol, 78(2):187194. Hansen, T. K., Poulsen, L. K., Stahl Skov, P., Hefle, S. L., Hlywka, J. J., Taylor, S. L., Bindslev-Jensen, U., Bindslev-Jensen, C. (2004). A randomized, double-blinded, placebo-controlled oral challenge study to evaluate the allergenicity of commercial, foodgrade fish gelatin. Food Chem Toxicol, 42(12):2037-2044. Hausch, F., Shan, L., Santiago, N. A., Gray, G. M., Khosla, C. (2002). Intestinal digestive resistance of immunodominant gliadin peptides. Am J Physiol Gastrointest Liver Physiol, 283:G996-G1003. Hefle, S. L., Nordlee, J. A., Taylor, S. L. (1996). Allergenic foods. Crit Rev Food Sci Nutr, 36:S69-S89. Helbling, A., Haydel, R. Jr., McCants, M. L., Musmand, J. J., El-Dahr, J., Lehrer, S. B. (1999). Fish allergy: is cross-reactivity among fish species relevant? Double-blind placebo-controlled food challenge studies of fish allergic adults. Ann Allergy Asthma Immunol, 83(6 Pt 1):517-523. Herman, E. M., Helm, R. M., Jung, R., Kinney, A. J. (2003). Genetic modification removes an immunodominant allergen from soybean. Plant Physiol, 132:36-43. Hlywka, J. J., Hefle, S. L., Taylor, S. L. (2000). A sandwich enzyme-linked immunosorbent assay for the detection of almonds in foods. J Food Prot, 63(2):252-257. Hoffman, D. R. and Collins-Williams, C. (1994). Cold-pressed peanut oils may contain peanut allergen. J Allergy Clin Immunol, 93(4):801-802.

Holzhauser, T., Stephan, O., Vieths, S. (2002). Detection of potentially allergenic hazelnut (corylus avellana) residues in food: a comparative study with DNA pcr-ELISA and protein sandwich-ELISA. J Agric Food Chem, 50:5808-5815. Host, A. and Halken, S. (2004). Hypoallergenic formulas--when, to whom and how long: after more than 15 years we know the right indication! Allergy, 59 Suppl 78:45-52. Host, A. and Samuelsson, E. G. (1988). Allergic reactions to raw, pasteurized, and homogenized/pasteurized cow milk: A comparison. A double-blind placebo-controlled study in milk allergic children. Allergy, 43:113-118. Hourihane, J. O., Kilburn, S. A., Nordlee, J. A., Hefle, S. L., Taylor, S. L., Warner, J. O. (1997a). An evaluation of the sensitivity of subjects with peanut allergy to very low doses of peanut protein: A randomized, double-blind, placebo-controlled food challenge study. J Allergy Clin Immunol, 100:596-600. Hourihane, J. O., Bedwani, S. J., Dean, T. P., Warner, J, O. (1997b). Randomised, double-blind, crossover challenge study of allergenicity of peanut oils in subjects allergic to peanuts. BMJ, 314(7087):1084-1088. Ibanez, M. D., Lombardero, M., San Ireneo, M. M., Munoz, M. C. (2003). Anaphylaxis induced by pine nuts in two young girls. Pediatr Allergy Immunol, 14(4):317-319. Immer, U., Vela, C., Mendez, E., Janssen, F. (2003). PWG collaborative trial of gluten in gluten-free food through cocktail ELISA. Zwickau, Germany: Verlag Wissenschaftliche Scripten, pp. 23-33. Jackson, W. F. (2003). Food allergy. ILSI Europe Concise Monograph Series, International Life Sciences Institute, 1-46. James, S. P. (2005). Prototypic disorders of gastrointestinal mucosal immune function: Celiac disease and Crohn's disease. J Allergy Clin Immunol, 115:25-30. Janatuinen, E. K., Kemppainen, T. A., Julkunen, R. J., Kosma, V. M., Maki, M., Heikkinen, M., Uusitupa, M. I. (2002). No harm from five year ingestion of oats in coeliac disease. Gut, 50(3):332-335. Janatuinen, E. K., Kemppainen, T. A., Pikkarainen, P. H., Holm, K. H., Kosma, V.M., Uusitupa, M.I., Maki, M., Julkunen, R. J. (2000). Lack of cellular and humoral immunological responses to oats in adults with coeliac disease. Gut, 46(3):327-331. Janatuinen, E. K., Pikkarainen, P. H., Kemppainen, T. A., Kosma, V. M., Jrvinen, R. M., Uusitupa, M. I., Julkunen, R. J. (1995). A Comparison of Diets with and without Oats in Adults with Celiac Disease. N Engl J Med, 333(16):1033-1037. Jarabek, A.M. (1994) Inhalation RfC methodology; dosimetric adjustments and doseresponse estimation of non-cancer toxicity in the upper respiratory tract. Inhal Toxicol 6:301-325. Johansson, S. G., Hourihane, J. O., Bousquet, J., Bruijnzeel-Koomen, C., Dreborg, S., Haahtela, T., Kowalski, M. L., Mygind, N., Ring, J., van Cauwenberge, P., van HageHamsten, M., Wuthrich, B.; EAACI (2001). A revised nomenclature for allergy. An EAACI position statement from the EAACI nomenclature task force. Allergy, 56(9):813824. Johnson, D.L., Sands, D., Pilgeram, A. (2002). Indian RiceGrass: A Gluten-Free Cereal. (Abstract). Association for the Advancement of Industrial Crops Annual Meeting, August 25-28, 2002. Saskatoon, Saskatchewan, Canada. Accesible December 2005 at http://www.aaic.org/02progrm.htm.

Jones, R. T., Squillace, D. L., Yunginger, J. W. (1992). Anaphylaxis in a milk-allergic child after ingestion of milk-contaminated kosher-pareve-labeled "dairy-free" dessert. Ann Allergy, 68:223-227. Kagnoff, M.F. (2005). Overview and pathogenesis of celiac disease. Gastroenterology, 128(4 Suppl 1):S10-S18. Kasarda, D. D. (1994). Toxic cereal grains in coeliac disease IN: Gastrointestinal immunology and gluten-sensitive disease. Proceedings of the sixth international symposium on coeliac disease, Trinity College, Dublin, July 1992. editors: Feighery and O'Farrelly. pp. 203-220. Kasarda, D. D. (1999). U.S. Department of Agriculture, Agricultural Research Service. Grains in Relation to Celiac (Coeliac) Disease. Accessible December 2005 at http://wheat.pw.usda.gov/ggpages/topics/celiac.html . Kasarda, D. D. (2001). Grains in relation to celiac disease. Cereal Foods World, 46(5):209-10. Kasarda, D. D. (2003). Celiac Disease and Safe Grains. Accessible December 2005 at http://wheat.pw.usda.gov/ggpages/topics/Celiac.vs.grains.html . Kasarda, D. D. (2004). What we know about grain safety. Paper presented at the Columbia University Celiac disease and other food intolerances conference, Columbia Medical Center, NY, NY, pp. 1-11. Kasarda, D. D. (2005). Personal communication. Kato, Y., Oozawa, E., Matsuda, T. (2001). Decrease in antigenic and allergenic potentials of ovomucoid by heating in the presence of wheat flour: dependence on wheat variety and intermolecular disulfide bridges. J Agric Food Chem, 49(8):3661-3665. Kaukinen, K., Collin, P., Holm, K., Rantala, I., Vuolteenaho, N., Reunala, T., Maki, M. (1999). Wheat starch-containing gluten-free flour products in the treatment of coeliac disease and dermatitis herpetiformis. A long-term follow-up study. Scand J Gastroenterol, 34:163-169. Kelly, C. (2005). Letter submitted to FDA Docket #2005N-0231 on July 28, 2005. Comment number EC4. Kelso, J. M. and Sampson, H. A. (1993). Food protein-induced enterocolitis to casein hydrolysate formulas. J Allergy Clin Immunol, 92(6):909-910. Kimmel, C.A. and Gaylor, D. W. (1988). Issues in qualitative and quantitative risk analysis for development toxicology. Risk Anal, 8:15-20. Klurfeld, D. M. and Kritchevsky, D. (1987). Isolation and quanititation of lectins from vegetable oils. LIPIDS, 22(9):667-668. Kocabas, C. N. and Sekerel, B. E. (2003). Cow's milk allergic patients should be informed of the sources of caseinate. Turk J Pediatr, 45(2):165-166. Koehler, K. and U.S. Food and Drug Administration (2005). Mean per capita consumption of selected foods and gluten-forming grain proteins in the U.S., 2000, based upon disappearance data. Unpublished data. Krska, R., Welzig, E., Baumgartner, S. (2003). Immunoanalytical detection of allergenic proteins in food. Anal Bioanal Chem, 378(1):63-65. Kull, I., Hallner, E., Lilja, G., Ohman-Johansson, A. C., Oman, H., Wickman, M. (1999). Peanut oil in vitamin A and D preparations: reactions to skin test and manifestation of symptoms. Pediatr Allergy Immunol, 10(1):21-26.

Kupper, C. (2004). Dietary guidelines for celiac disease and implementation. (Abstract) National Institutes of Health Consensus Development Conference on Celiac Disease Program & Abstracts, pp. 91-95. Accessible December 2005 at http://consensus.nih.gov/2004/2004CeliacDisease118Program.pdf . Laurin, P., Wolving, M., Falth-Magnusson, K. (2002). Even small amounts of gluten cause relapse in children with celiac disease. J Pediatr Gastroenterol Nutr, 34:26-30. Lehman, A. and Fitzhugh, O. (1954). Ten-fold Safety Factor Studies. Assoc. Food Drug Officials of the US Quarterly Bulletin XVIII (1):33-35. Leung, D. Y., Sampson, H. A., Yunginger, J. W., Burks, A. W., Jr., Schneider, L. C., Wortel, C. H., Davis, F. M., Hyun, J. D., Shanahan, W. R., Jr. (2003). Effect of anti-IgE therapy in patients with peanut allergy. N Engl J Med, 348:986-93. Leung, P. S., Chen, Y. C., Chu, K. H. (1999). Seafood allergy: tropomyosins and beyond. J Microbiol Immunol Infect, 32(3):143-154. Lietze A. (1969). The role of particulate insoluble substances in food allergy. 3. Heat labile antibody to wheat starch in sera of wheat sensitive patients. Ann Allergy 27; 9-12. Lundin, K. E., Nilsen, E.M., Scott, H.G., Loberg, E. M., Gjoen, A., Bratlie, J., Skar, V., Mendez, E., Lovik, A., Kett, K. (2003). Oats induced villous atrophy in coeliac disease. Gut, 52(11):1649-1652. Magnolfi, C. F., Zani, G., Lacava, L., Patria, M. F., Bardare, M. (1996). Soy allergy in atopic children. Ann Allergy Asthma Immunol, 77(3):197-201. Maki, M. and Collin, P. (1997). Coeliac disease. Lancet, 349:1755-1759. Maleki, S. J. (2004). Food processing: effects on allergenicity. Curr Opin Allergy Clin Immunol, 4(3):241-245. Maleki, S. J., Chung, S.Y., Champagne, E. T., Raufman, J. P. (2000). The effects of roasting on the allergenic properties of peanut proteins. J Allergy Clin Immunol, 106(4):763-768. Maleki, S. J., Viquez, O., Jacks, T., Dodo, H., Champagne, E. T., Chung, S. Y., Landry, S. J. (2003). The major peanut allergen, Ara h 2, functions as a trypsin inhibitor, and roasting enhances this function. J Allergy Clin Immunol, 112:190-195. Mata, E., Favier, C., Moneret-Vautrin, D., Nicolas, J., Ching, L., Gueant, J. (1994). Surimi and native codfish contain a common allergen identified as a 63-kDa protein. Allergy 49: 442-447. May, C. D. (1976). Objective clinical and laboratory studies of immediate hypersensitivity reactions to foods in asthmatic children. J Allergy Clin Immunol, 58:500515. Mayer, M., Greco, L., Troncone, R., Grimaldi, M., Pansa, G. (1989). Early prediction of relapse during gluten challenge in childhood celiac disease. J Pediatr Gastroenterol Nutr, 8:474-479. McKenna, C. and Klontz, K. C. (1997). Systemic allergic reaction following ingestion of undeclared peanut flour in a peanut-sensitive woman. Ann. Allergy Asthma Immunol, 79:234-236. Molberg, O., Solheim Flaete, N., Jensen, T., Lundin, K. E., Arentz-Hansen, H., Anderson, O. D., Kjersti Uhlen, A., Sollid, L. M. (2003). Intestinal T-cell responses to high-molecular-weight glutenins in celiac disease. Gastroenterology, 125(2):337-344. Moneret-Vautrin, D. A., (2004) Wheat Allergy. Third Food Allergy Research and Resource Program Threshold Conference, Mallorca, Spain, October 5, 2004.

Moneret-Vautrin, D. A. and Kanny, G. (2004). Update on threshold doses of food allergens: implications for patients and the food industry.Current Opinion in Allergy and Clinical Immunology, 4:215-219. Moneret-Vautrin, D. A., Rance, F., Kanny, G., Olsewski, A., Gueant, J. L., Dutau, G., Guerin, L. (1998). Food allergy to peanuts in France--evaluation of 142 observations. Clin Exp Allergy, 28:1113-1119. Montgomery, A. M., Goka, A. K., Kumar, P. J., Garthing, M. J., Clark, M. L. (1988). Low gluten diet in the treatment of adult coeliac disease: effect on jejunal morphology and serum anti-gluten antibodies. Gut, 29:154-1568. Morisset, M., Moneret-Vautrin, D. A., Kanny, G., Gunard, L., Beaudouin, E., Flabbe, J., Hatahet, R. (2003). Thresholds of clinical reactivity to milk, egg, peanut and sesame in immunoglobulinE-dependent allergies: evaluation by double-blind or single-blind placebo-controlled oral challenges. Clin Exp Allergy, 33 (8):1046-1051. Muller, U., Weber, W., Hoffmann, A., Franke, S., Lange, R., Vieths, S. (1998). Commercial soybean lecithins: a source of hidden allergens? Z Lebensm Unters Forsch A, 207:341-351. Naqpal, S., Rajappa, L., Metcalfe, D. D., Subba Rao, P. V. (1989). Isolation and characterization of heat-stable allergens from shrimp (Penaeus indicus). J Allergy Clin Immunol, 83(1):26-36. National Institutes of Health (NIH) (2004). Consensus statement on celiac disease, June 28-30. Accessible December 2005 at http://consensus.nih.gov/2004/2004CeliacDisease118PDF.pdf. Nelson, H. S., Lahr, J., Rule, R., Bock, A., Leung, D. (1997). Treatment of anaphylactic sensitivity to peanuts by immunotherapy with injections of aqueous peanut extract. J Allergy Clin Immunol, 99(6 Pt.1):744-751. Neogen Alert for Gliadin. Food allergens. Available December 2005 at http://www.neogen.com/pdf/FS_CatalogPages/AlertGliadin.pdf . Niemann, L., and Hefle, S. L., (2003). Validated ELISA for detection of undeclared walnut residues in food. Journal of Allergy and Clinical Immunology, 111(Suppl.):248. Abstract. Niggemann, B., Binder, C., Klettke, U., Wahn, U. (1999). In vivo and in vitro studies on the residual allergenicity of partially hydrolyzed infant formulae. Acta Paediatr, 88(4):394-398. Nogueira, M., McDonald, R., Westphal, C., Maleki, S., Yeung, J. (2004) Can commercial peanut assay kits detect peanut allergens? J AOAC, 87(6): 1480-1484. Nonaka, I., Kamiya, K., Takashi. (2004). Development of food allergen rapid detection kits by immunochromatography. Abstract of presentation at AOAC Annual Meeting, September 19-23, 2004. Nordlee, J. A., Neimann, L. M., Hefle, S. L., Taylor, S. L. (2002). Determination of proteins in soybean oil from distinct processing steps. Abstracts of the IFT Annual Meeting. Nordlee, J. A., Taylor, S. L., Jones, R. T., Yunginger, J. W. (1981). Allergenicity of various peanut products as determined by RAST inhibition. J Allergy Clin Immunol, 68(5):376-382.

Norgaard, A., Bernard, H., Wal, J. M., Peltre, G., Skov, P. S., Poulsen, L.K., BindslevJensen, C. (1996). Allergenicity of individual cow milk proteins in DBPCFC-positive milk allergic adults. J Allergy Clin Immunol, 97:237(abstract). Olszewski, A., Pons, L., Moutete, F., Aimone-Gastin, I., Kanny, G., Moneret-Vautrin, D. A., Gueant, J. L. (1998). Isolation and characterization of proteic allergens in refined peanut oil. Clin. Exp. Allergy, 28:850-859. Ortolani, C., Ballmer-Weber, B. K., Hansen, K. S., Ispano, M., Wuthrich, B., BindslevJensen, C., Ansaloni, R., Vannucci, L., Pravettoni, V., Scibilia, J., Poulsen, L. K., Pastorello, E. A. (2000). Hazelnut allergy: a double-blind, placebo-controlled food challenge multicenter study. J Allergy Clin Immunol, 105:577-581. Osterballe, M. and Bindslev-Jensen, C. (2003).Threshold levels in food challenge and specific IgE in patients with egg allergy: Is there a relationship. J. Allergy Clin Immunol, 112(1):196-201. Palm, M., Moneret-Vautrin, D. A., Kanny, G., Denery-Papini, S., Fremont, S. (1999). Food allergy to egg and soy lecithins. Allergy, 54:1116-1117. Park, D. (2005). FDA and AOAC peanut allergens test kits performance validations. Memo to record. U. S. Food and Drug Administration. Park, D. L., Coates, S., Brewer, V. A., Garber, A. E., Abouzied, M., Johnson, K., Ritter, B., McKenzie, D. (2005). Performance tested method: Multiple laboratory validation study of ELISA-based assays for the detection of peanuts in food. J AOAC Intern, Vol.88(1):156-160. Paschke, A., Zunker, K., Wigotzki, M., Steinhart, H. (2001). Determination of the IgEbinding activity of soy lecithin and refined and non-refined soybean oils. J Chromatogr B Biomed Sci Appl, 756(1-2):249-254. Pascual, C., Esteban, M. M., Crespo, J. F. (1992). Fish Allergy: Evaluation of the importance of cross-reactivity. J of Pediatrics, 121(5:2)S29-S34. Pastorello, E. A., Stocchi, L., Pravettoni, V., Bigi, A., Schilke, M. L., Incorvaia, C., Zanussi, C. (1989). Role of the elimination diet in adults with food allergy. J Allergy Clin Immunol, 84:475-483. Peeters, K. A. B. M., Knulst, A. C., Rynja, F. J., Bruijnzeel-Koomen, C. A. F. M., Koppelman, S. J., (2004). Peanut allergy: sensitization by peanut oil-containing local therapeutics seems unlikely. J Allergy Clin Immunol, 113:1000-1001. Peraaho, M., Collin, P., Kaukinen, K., Kekkonen, L., Miettinen, S., Maki, M. (2004). Oats can diversify a gluten-free diet in celiac disease and dermatitis herpetiformis. J Am Diet Assoc, 104(7):1148-1150. Perry, T. T., Matsui, E. C., Conover-Walker, M. K., Wood, R. A. (2004). Risk of oral food challenges. J Allergy Clin Immunol, 114:1164-1168. Peters, U., Askling, J., Gridley, G., Ekbom, A., Linet, M. (2003). Causes of death in patients with celiac disease in a population-based Swedish cohort. Arch Intern Med, 163:1566-1572. Poms, R. E. and Anklam, E. (2004). Effects of chemical, physical and technological processes on the nature of food allergens. J AOAC Int, 87(6):1466-1474. Poms, R.E., Klein, C.L., Anklam, E. (2004). Methods for allergen analysis in food: a review. Food Addit Contam, 21(1):1-31. Popping, B., Pardigol, A., Dan, A., Guillet, S., Schneede, A., Koelln, S., Pinero, D. (2004). Development and in-house validation of a DNA-based rapid and cost-effective

multi-allergen screening system. Abstract of presentation at AOAC Annual Meeting, September 19-23, 2004. Porras, O., Carlsson, B., Fallstrom, S. P., Hanson, L. A. (1985). Detection of soy protein in soy lecithin, margarine and, occaisionally, soy oil. Int Arch Aller Appl Immunol, 78:3032. Public Law 108-282 (2004). Title II-Food allergen labeling and consumer protection. Accessible December 2005 at http://www.cfsan.fda.gov/~dms/alrgact.html . Pumphrey, R. S., Wilson, P. B., Faragher, E. B., Edwards, S. R. (1999). Specific immunoglobulin E to peanut, hazelnut and brazil nut in 731 patients: similar patterns found at all ages. Clin Exp Allergy, 29(9):1256-1259. Pumphrey, R. (2004). Anaphylaxis: can we tell who is at risk of a fatal reaction? Curr Opin Allergy Clin Immunol, 4:285-290. R-Biopharm Ridascreen Fast Gliadin (2004). Enzyme immunoassay for the quantitative analysis of gliadins and corresponding prolamines. Accessible December 2005 at http://www.r-biopharm.com/foodandfeed/pdf/fast_gliadin_03_06_04_%20k.pdf . R-Biopharm Ridascreen Fast Peanut. (2005). Enzyme immunoassay for the quantitative analysis of peanut. Accessible December 2005 at http://www.rbiopharm.com/foodandfeed/ridascreenfast_peanut.php?act=foodandfeed&p_nav=allerge ns . R-Biopharm Ridascreen Gliadin R7001 (2005). Enzyme immunoassay for the quantitative analysis of gliadins and corresponding prolamines. Accessible December 2005 at http://www.r-biopharm.com/foodandfeed/pdf/R7001%20Gliadin%2005-0111.pdf . Reeves, R. M. (1999). Letter from Institute of Shortening and Edible Oils to Joint FAO/WHO Expert Committee on Food Additives, Food and Nutrition Division. Unpublished data analytical results for protein in oil. Reindl, J., Anliker, M. D., Karamloo, F., Vieths, S., Wuthrich, B. (2000). Allergy caused by ingestion of zucchini (Cucurbita pepo): Characterization of allergens and crossreactivity to pollen and other foods. J Allergy Clin Immunol, 106:379-385. Renaud, C., Cardiet, C., Dupont, C. (1996). Allergy to soy lecithin in a child. J Pediatric Gastroenterology and Nutrition 22(3): 328-329. Rolles, C. J. and McNeish, A. S. (1976). Standardised approach to gluten challenge in diagnosing childhood coeliac disease. Br Med J, 1:1309-1311. Ross, M., Street, D, Ferguson, M, Klontz, K, and Luccioli, S. (2006). Emergency Department Visits for Food Allergy Reactions from theNational Electronic Injury Surveillance System. Unpublished data. Submitted to the Society for Epidemiology Research Conference. Roux, K. H., Teuber, S. S., Sathe, S. K. (2003). Tree nut allergens. Int Arch Allergy Immunol, 131(4):234-244. Sackesen, C. and Adalioglu, G. (2003). Hidden fish substance triggers allergy. J Investig Allergol Clin Immunol, 13(3):216-217. Sakaguchi, M., Toda, M., Ebihara, T., Irie, S., Hori, H., Imai, A., Yanagida, M., Miyazawa, H., Ohsuna, H., Ikezawa, Z., Inouye, S. (2000) IgE antibody to fish gelatin (type I collagen) in patients with fish allergy. J Allergy Clin Immunol, 106(3):579-584. Sampson, H. A. (1997). Food allergy. JAMA, 278(22):1888-1894.

Sampson, H. A. (1999). Food allergy. Part 1: Immunopathogenesis and clinical disorders. J Allergy Clin Immunol, 103(5):717-728. Sampson, H. A. (2003). Anaphylaxis and emergency treatment. Pediatrics, 111 (6 Pt 3):1601-1608. Sampson, H. A. (2004). Update on food allergy. J Allergy Clin Immunol, 113(5):805-819. Sampson, H. A. (2005). Food allergy - accurately identifying clinical reactivity. Allergy, 60 Suppl 79:19-24. Sampson, H. A., Bernhisel-Broadbent, J., Yang, E., Scanlon, S. M. (1991). Safety of casein hydrolysate formula in children with cow milk allergy. J Pediatr, 118(4:Pt 1):520525. Sampson, H. A., James, J. M., Bernhisel-Broadbent, J. (1992a). Safety of an amino acidderived infant formula in children allergic to cow milk. Pediatrics, 90:463-465. Sampson, H. A., Mendelson, L., Rosen, J. P. (1992b). Fatal and near-fatal anaphylactic reactions to food in children and adolescents. N Engl J Med, 327(6):380-384. Sampson, H.A., Munoz-Furlong, A., Bock, S.A., Schmitt. C., Bass, R., Chowdhury, B.A., Decker, W.W., Furlong, T.J., Galli, S.J., Golden, D.B., Gruchalla, R.S., Harlor, A.D., Hepner, D.L., Howarth, M., Kaplan, A.P., Levy, J.H., Lewis, L.M., Lieberman, P.L., Metcalfe, D.D., Murphy, R., Pollart, S.M., Pumphrey, R.S., Rosenwasser, L.J., Simons, F.E., Wood, J.P., Camargo, C.A . (2005). Symposium on the definition and management of anaphylaxis: summary report. J Allergy Clin Immunol,115(3):571-574. Sanders, D.S., Carter, M.J., Hurlstone, D.P., Pearce, A., Ward, A.M., McAlindon, M.E., Lobo, A.J. (2001). Association of adult celiac disease with irritable bowel syndrome: a case-control study in patients fulfilling ROME II criteria referred to secondary care. The Lancet, 358:1504-1508. Saylor, J. D. and Bahna, S. L. (1991). Anaphylaxis to casein hydrolysate formula. J Pediatr, 118(1):71-4. Schuppan, D. (2000). Current concepts of celiac disease pathogenesis. Gastroenterology, 119:234-242. Schuppan, D., Hahn, E. G. (2001). IgA anti-tissue transglutaminase: Setting the stage for coeliac disease screening. Eur J Gastroenterol Hepatol, 13:635-637. Schuppan, D., Hahn, E. G. (2002). Biomedicine. Gluten and the gut-lessons for immune regulation. Science, 297:2218-2220. Schwartz, R. H., Amonette, M. S. (1991). Cow milk protein hydrolysate infant formulas not always "hypoallergenic ". J Pediatr, 119:839-840. Scibilia, J., Pastorello, E.A., Zisa, G., Ottolenghi, A., Bidslev-Jensen, C., Pravettoni, V., Scovena, E., Robino, A., Ortolani, C. (2006) Wheat allergy: A double-blind, placebocontrolled study in adults. J Allergy Clin Immunol, 117 (2):433-439. Shan, L., Molberg, O., Parrot, I., Hausch, F., Filiz,F., Gray, G. M., Sollid, L. M., Khosla, C. (2002). Structural basis for gluten intolerance in celiac sprue. Science, 297:2275-2279. Shefcheck, K. J. and Musser, S. M. (2004). Confirmation of the allergenic peanut protein, Ara h 1, in a model food matrix using liquid chromatography/tandem mass spectrometry (LC/MS/MS). J Agric Food Chem, 52:2785-2790. Sicherer, S. H. (2001). Clinical implications of cross-reactive food allergens. J Allergy Clin Immunol, 108:881-890. Sicherer, S. H., Burks, A. W., Sampson, H. A. (1998). Clinical features of acute allergic reactions to peanut and tree nuts in children. Pediatrics, 102:1-6.

Sicherer, S. H., Noone, S. A., Koerner, C. B., Christie, L., Burks, A. W., Sampson, H. A. (2001). Hypoallergenicity and efficacy of an amino acid-based formula in children with cow's milk and multiple food hypersensitivities. J Pediatr, 138:688-693. Sicherer, S. H., Morrow, E. H., Sampson, H. A. (2000). Dose-response in double-blind, placebo-controlled oral food challenges in children with atopic dermatitis. J Allergy Clin Immunol, 105:582-586. Sicherer, S. H., Munoz-Furlong, A., Sampson, H. A. (2003). Prevalence of peanut and tree nut allergy in the United States determined by means of a random digit dial telephone survey: A 5-year follow-up study. J Allergy Clin Immunol, 112(6):1203-1207. Sicherer, S. H., Munoz-Furlong, A., Sampson, H. A. (2004). Prevalence of seafood allergy in the United States determined by a random telephone survey. J Allergy Clin Immunol, 114(1):159-165. Simonato, B., Pasini, G., Giannattasio, M., Peruffo, A., DeLazzari, F., Curioni, A. (2001). Food allergy to wheat products: the effect of bread baking and in vitro digestion on wheat allergenic proteins. A study with bread dough, crumb, and crust. J Agric Food Chem 49; 5668-5673. Skerritt, J. H. and Hill, A. S. (1991). Enzyme immunoassay for determination of gluten in foods: collaborative study. J Assoc Off Anal Chem, 74(2):257-264. Skinner and Haynes. (1998). Seed crushers and oil processors association report as reported in: WHO Food Additive Series 44 and in EFSA Notification. St. Vincent, J. C. M., Watson, W. T. A. (1994). Unsuspected sources of cow's milk protein in food. J Allegy Clin. Immunol, 93:209. Abstract. Steensma, D. P. (2003). The kiss of death: a severe allergic reaction to a shellfish induced by a good-night kiss. Mayo Clin Proc, 78(2):221-222. Storsrud, S., Hulthen, L.R., Lenner, R. A. (2003). Beneficial effects of oats in the glutenfree diet of adults with special reference to nutrient status, symptoms and subjective experiences. Br J Nutr, 90(1):101-107. Sturgess, R., Day, P., Ellis, H. J., Lundin, K. E., Gjertsen, H. A., Kontakou, M., Ciclitira, P. J. (1994). Wheat peptide challenge in coeliac disease. Lancet, 343:758-761. Tada, Y., Nakase, M., Adachi, T., Nakamura, R., Shimada, H., Takahashi, M., Fujimura, T., Matsuda, T. (1996). Reduction of 14-16 kDa allergenic proteins in transgenic rice plants by antisense gene. FEBS Lett, 391(3):341-345. Talley, N. J., Valdovinos, M., Petterson, T. M., Carpenter, H. A., Melton, L. J.(1994). Epidemiology of celiac sprue: a community-based study. Am J Gastroenterol, 89(6):843846. Tarim, O., Anderson, V. M., Lifshitz, F. (1994). Fatal anaphylaxis in a very young infant possibly due to a partially hydrolyzed whey formula. Arch Pediatr Adolesc Med, 148:1224-1229. Tattrie, N. and Yaguchi, M. (1973). Protein content of various processed edible oils. Journal of the Institute for Cancer, Science Technology and Alimentation, 6:289-290. Taylor, S. L., Busse, W. W., Sachs, M. I., Parker, J. L., Yunginger, J. W. (1981). Peanut oil is not allergenic to peanut-sensitive individuals. J Allergy Clin Immunol, 68(5):372375. Taylor, S. L. and Dormedy, E. S. (1998). The role of flavoring substances in food allergy and intolerance. Adv Food Nutr Res, 42:1-44.

Taylor, S. L. and Hefle, S. L. (2001). Ingredient and labeling issues associated with allergenic foods. Allergy, 56 Supple 67:64-69. Taylor, S. L., Hefle, S. L., Bindslev-Jensen, C., Atkins, F. M., Andre, C., BruijnzeelKoomen, C., Burks, A. W., Bush, R. K., Ebisawa, M., Eigenmann, P. A., Host, A., Hourihane, J. O., Isolauri, E., Hill, D. J., Knulst, A., Lack, G., Sampson, H. A., MoneretVautrin, D. A., Rance, F., Vadas, P. A., Yunginger, J. W., Zeiger, R. S., Salminen, J. W., Madsen, C., Abbott, P. (2004). A consensus protocol for the determination of the threshold doses for allergenic foods: how much is too much? Clin Exp Allergy, 34:689695. Taylor, S. L., Hefle, S. L., Bindslev-Jensen, C., Bock, S. A., Burks, A. W., Jr., Christie, L., Hill, D. J., Host, A., Hourihane, J. O., Lack, G., Metcalfe, D. D., Moneret-Vautrin, D. A., Vadas, P. A., Rance, F., Skrypec, D. J., Trautman, T. A., Yman, I. M. and Zeiger, R. S. (2002). Factors affecting the determination of threshold doses for allergenic foods: How much is too much? J Allergy Clin Immunol, 109: 24-30. Tepnel - BioKits food allergen protein additive kits. (2005). Accessible December 2005 at http://www.tepnel.com/ag_bio_and_food_testing/allergen_products.asp . Tepnel - BioKits product information summary. (2005). Accessible December 2005 at http://www.tepnel.com/ag_bio_and_food_testing/allergens_product_summary.asp Tepnel Biosystems. Bio Kits peanut assay kit. (2005). For the detection of peanut content in foods. Accessible December 2005 at http://www.tepnel.com/ag_bio_and_food_testing/downloads/LA0035%20BK%20P%20P eanut%20Flyer%20v01.pdf . Teuber, S. S., Brown, R. L., Haapanen, L. A. D., (1997). Allergenicity of gourmet nut oils processed by different methods. J Allergy Clin Immunol, 99:502-507. Teuber, S. S. and Peterson, W. R. (1999). Systemic allergic reaction to coconut (Cocos nucifera) in 2 subjects with hypersensitivity to tree nut and demonstration of crossreactivity to legumin-like seed storage proteins: new coconut and walnut food allergens. J Allergy Clin Immunol, 103(6):1180-1185. Thompson, T. (2001). Wheat starch, gliadin, and the gluten-free diet. J Am Diet Assoc, 101(12):1456-1459. Thompson, T. (2003). Oats and the gluten-free diet. J Am Diet Assoc, 103(3):376-379. Thompson, T. (2004), Gluten contamination of commercial oat products in the United States. N Engl J Med, 351(19):2021-2022. United States Department of Agriculture (USDA) (1999). Official United States Standards for Grain. Subpart A: General Provisions. Accessible December 2005 at http://151.121.3.117/reference-library/standards/810101.pdf. [Note standards for specific grains are also available at http://151.121.3.117/referencelibrary/standards/standards.htm]. United States Department of Agriculture (USDA) (2004). Agricultural Research Service (2004), USDA National Nutrient Database for Standard Reference, Release 17. Accessible December 2005 at http://www.nal.usda.gov/fnic/foodcomp. United States Department of Health and Human Services and United States Department of Agriculture (DHHS/USDA). (2003).Quantitative assessment of the relativerisk to public health from foodborne Listeria monocytogenes among selected categories of ready-to-eat foods. College Park, Maryland. Accessible on December 2005 at http://www.foodsafety.gov .

United States Environmental Protection Agency (EPA). (1994). Methods for derivation of inhalation reference concentrations and application of inhalation dosimetry. Office of Research and Development, Washington DC, EPA/600/8-90/066F. United States Food and Drug Administration (FDA). (2001).Draft risk assessment on the public health impact of Vibrio parahaemolyticus in raw molluscan shellfish. Washington, D.C.Accessible December 2005 at http://www.foodsafety.gov . Urisu, A., Ando, H., Morita, Y., Wada, E., Yasaki, T., Yamada, K., Komada, K., Torii, S., Goto, M., Wakamatsu, T. (1997). Allergenic activity of heated and ovomucoiddepleted egg white. J Allergy Clin Immunol, 100(2):171-176. Vader, W., Kooy, Y., Van Veelen, P., De Ru, A., Harris, D., Benckhuijsen, W., Pena, S., Mearin, L., Drijfhout, J. W., Koning, F. (2002). The gluten response in children with celiac disease is directed toward multiple gliadin and glutenin peptides. Gastroenterology, 122(7):1729-1737. van de Wal, Y., Kooy, Y. M., van Veelen, P., Vader, W., August, S. A., Drijfhout, J. W., Pena, S. A., Koning, F. (1999). Glutenin is involved in the gluten-driven mucosal T cell response. Eur J Immunol, 29(10):3133-3139. Venkatachalam, M., Teuber, S. S., Roux, K. H., Sathe, S. K. (2002). Effects of roasting, blanching, autoclaving, and microwave heating on antigenicity of almond (Prunus dulcis L.) proteins. J Agric Food Chem, 50(12):3544-3548. Vila, L., Beyer, K., Jarvinen, K. M., Chatchatee, P., Bardina, L., Sampson, H. A. (2001). Role of conformational and linear epitopes in the achievement of tolerance in cow's milk allergy. Clin Exp Allergy, 31(10):1599-1606. Voysey, P., Jewell, K., and Stringer, M. (2002). Risk Characterization. IN: Microbiological risk assessment in food processing. Ed. M. Brown and M. Stringer. Woodhead Publishing Limited, Cambridge England. Wahab, P. J., Crusius, J. B., Meijer, J. W., Mulder, C. J. (2001). Gluten challenge in borderline gluten-sensitive enteropathy. Am J Gastroenterol, 96:1464-1469. Waring, N. P., Daul, C. B., deShazo, R. D., McCants, M. L., Lehrer, S. B. (1985). Hypersensitivity reactions to ingested crustacea: clinical evaluation and diagnostic studies in shrimp-sensitive individuals., J Allergy Clin Immunol, 76(3):440-445. Wei, Y., Sathe, S. K., Teuber, S. S., Roux, K. H. (2003). A sensitive sandwich ELISA for the detection of trace amounts of cashew (Anacardium occidentale L.) nut in foods. J Agric Food Chem, 51(11):3215-3221. Wensing, M., Penninks, A. H., Hefle, S. L., Akkerdaas, J. H., van Ree, R., Koppelman, S. J., Bruijnzeel-Koomen, C. A., Knulst, A. C. (2002a). The range of minimum provoking doses in hazelnut-allergic patients as determined by double-blind, placebo-controlled food challenges. Clin Exp Allergy, 32:1757-1762. Wensing, M., Penninks, A. H., Hefle, S. L., Koppelman, S. J., Bruijnzeel-Koomen, C. A., Knulst, A. C. (2002b). The distribution of individual threshold doses eliciting allergic reactions in a population with peanut allergy. J Allergy Clin Immunol, 110:915-920. West, S., King, V., Carey, T., Lohr, K., McKoy, N., Sutton, S., Lux, L. 2002. Systems to rate the strenght of scientific evidence. Evidence Report/Technology Assessment No. 47. AHRQ Publication No. 02-E016. Agency for Healthcare Research and Quality, Rockville, MD.

Wigotzki, M., Steinhart, H., Paschke, A. (2001). Determination of the allergenicity of various hazelnut products by immunoblotting and enzyme allergosorbent test inhibition. J Chromatogr B Biomed Sci Appl, 756(1-2): 239-248. Wirshil, B., Butzner, D., Sabra, A., Savilahti, E., Seidman, E., Strobel, S., Yamashiro, Y. (2002) Allergy and Immunologic Disease: Working Group Report of the First World Congress of Pediatric Gastroelterologu, Hepatology, and Nutrition. J Pediatric Gastroenterology and Nutrition, 35: S74-S77. Wood, R. A. (2002). Food manufacturing and the allergic consumer: accidents waiting to happen. J Allergy Clin Immunol, 109(6):920-922. World Health Organization (1987). Principles for the Safety assessment of food additives and contaminants in Food Environmental Health Criteria 70, International Programme on Chemical Safety, Geneva. Accessible December 2005 at http://www.inchem.org/documents/ehc/ehc/ehc70.htm . World Health Organization (2004). Principles for modeling dose-response for the risk assessment of chemicals. Accessible December 2005 at http://www.who.int/en/ . Wuthrich, B., Ballmer-Weber, B. K. (2001). Food-induced anaphylaxis. Allergy, 56:102104. Yeung, J. M., Collins, P. G. (1996). Enzyme immunoassay for determination of peanut proteins in food products. J AOAC Int, 79(6):1411-1416. Yunginger, J. W., Ahlstedt, S., Eggleston, P. A., Homburger, H. A., Nelson, H. S., Ownby, D. R., Platts-Mills, T. A., Sampson, H. A., Sicherer, S. H., Weinstein, A. M., Williams, P. B., Wood, R. A., Zeiger, R. S. (2000). Quantitative IgE antibody assays in allergic diseases. J Allergy Clin Immunol, 105:1077-1084. Yunginger, J. W., Gauerke, M. B., Jones, R. T., Dahlberg, M. J. E., Ackerman, S. J. (1983). Use of radioimmunoassay to determine the nature, quantity and source of allergenic contamination of sunflower butter. J Food Protection, 46:625-628. Yunginger, J. W., Sweeney, K. G., Sturner, W. Q., Giannandrea, L. A., Teigland, J. D., Bray, M., Benson, P. A., York, J. A., Biedrzycki, L., Squillace, D. L., Helm, R. M. (1988). Fatal food-induced anaphylaxis. JAMA, 260(10):1450-1452; Zarkadas, M., Scott, F. W., Salminen, J., Ham Pong A. (1999). Common allergenic foods and their labeling in Canada - A review. Canadian Journal of Allergy & Clinical Immunology, 4(3):118-141. Zeiger, R. S., Sampson, H. A., Bock, S.A., Burks, A.W. Jr., Harden, K., Noone, S., Martin, D., Leung, S., Wilson, G. (1999). Soy allergy in infants and children with IgEassociated cow's milk allergy. J Pediatr, 134(5):614-622.

Appendices

Appendix 1: Evaluation of Commercially Available Analytical Methods for Proteins from Major Food Allergen Sensitivity Quantitation Raw and Species Protein(s) a b Allergen Manufacturer Method Validation (LODc) (LOQc) Processed Practicality Specificity Detected (ppm) (ppm) Foods? No Not Not reported Yes (for Not Not reported Yes Peanut Abkem Iberia Peanut DiagnoKit reported specified reported foods) Elisa Systems Peanut JRC 0.5 1 Yes Peanut Ara h2 Yes Elisa Systems Total Peanut No 0.5 1 Yes Peanut Total Neogen Alert for No 5 No Not Not Not reported Yes Peanut reported reported Neogen Reveal for No 5 No Not Not Not reported Yes Peanut reported reported Neogen Veratox for AOAC Not 2.5 Yes (for Peanut Not reported Yes Peanut MLPT reported specified foods) R-BioPharm RiDASCREEN No 2.5 Not reported Yes Not Total Yes Peanut reported R-BioPharm RIDASCREEN AOAC 1.5 2.5 Yes (for Peanut Total Yes FAST Peanut MLPT specified foods) Tecra Peanut Visual No 0.5 2.5 Yes Not Not reported Yes Immunoassay reported Tepnel BioKits Peanut AOAC 0.1 1 Yes (for Peanut Conarachin Yes MLPT specified (Ara h 1) foods) Tepnel BioKits Rapid No Not No Not Not Not reported Yes Peanut reported reported reported

Milk Casein DiagnoKit No No 1 1 0.5 1 No Not reported 0.16 Casein Yes

Abkem Iberia

Elisa Systems

Elisa System

Yes (for Not specified reported foods) Yes Not reported Yes Not reported BetaYes Lactoglobulin BetaYes Lactoglobulin Casein Yes Not reported Yes Yes Yes

Elisa Systems No

No

Neogen

Betalactoglobulin Enhanced Betalactoglobulin Enhanced Casein Alert for Total Milk Not reported Not reported

Neogen

Veratox for Total Milk 0.2 5

No

5 whole No milk10 dry nonfat milk Not 2.5 reported Yes (for specified foods) Not reported

Not reported Not reported

Not reported Yes

R-BioPharm

BetaYes Lactoglobulin

SafePath BioKits BLG No

RIDASCREEN No BetaLactoglobulin Milk Residue No Not reported 7.5

Tepnel

Not reported Not reported 25 Yes

Not reported Not reported 25 Yes Not reported

Tepnel

BioKits BSA

No

10

Tepnel

BioKits Casein No BioKits Casein No

1 Not

Yes Not reported Yes (for

Tepnel

Not reported Not

BetaYes Lactoglobulin Primarily Yes BetaLactoglobulin Bovine Yes Serum Albumin Primarily Yes Alpha-Casein Casein Yes

Rapid Egg Alert for Egg No 5 No 0.5

reported

Egg

Elisa Systems

Neogen

Not reported Yes

Neogen

Veratox for Egg RIDASCREEN No Egg Protein Egg Residue No 2

No

Not reported

Yes

R-BioPharn

Yes

SafePath

Yes Yes

Tecra 0.1 0.06 0.08 1 0.25 5 No Not 0.5 No 2.5 0.5

Not reported 0.5 Yes

specified reported foods) 1 Yes Ovalbumin, Yes Ovamucoid N Yes (for Not Not reported specified reported foods) 2.5 Yes (for Not Not reported specified reported foods) Not reported Yes (for Not White specified reported foods) Not reported Not Not Ovomucoid reported reported 0.6 Yes Total Ovomucoid Yes Not reported Yes Not reported Yes Not reported Yes Yes Not reported Yes Not reported Yes Not reported Yes

Tepnel No No No No No

Egg Visual No Immunoassay BioKits Egg No

Tree Nuts Abkem Iberia

Abkem Iberia

Elisa System Hazelnut

Almond DiagnoKit Hazelnut DiagnoKit Almond

Not reported Not reported 0.5

Not reported Not reported Yes

Elisa System

Neogen

Neogen

Alert for Almond Veratox for

Not reported Not

Not reported Not reported Not reported Not reported Not reported Not reported Not

R-BioPharm 1.7 1 Trypsin Inhibitor Soy flour proteins Total Yes Yes

reported 3.3 Total Yes

R-BioPharm

Soy

Elisa System

Almond RIDASCREEN No Hazelnut RIDASCREEN No FAST Almond Soy No

reported Not reported Not reported Not reported Not reported Yes

Elisa Systems

Enhanced Soy No

SafePath No No No 2.5 2.5 Yes

Soy Residues

No

Neogen

Not reported 5

reported Not reported Not reported 2.5 Not reported 1 Yes (for specified foods) 2.5 Yes (for specified foods) Not reported Not reported Not reported Yes Trypsin Not Inhibitor reported Not reported Yes Not reported Yes Not reported Yes

Neogen

Tepnel

Alert for Soy Flour Veratox for Soy Flour Soya Protein

Not 0.5% soy reported protein in food sample 0.005 Not reported

Not reported Not reported Not reported Not reported

Crustaceans Abkem Iberia

Crustacean DiagnoKit

No

0.5% soy protein in food sample Not reported

Elisa Systems

Crustacean (18 No species)

0.05

0.05

shrimp, Tropomyosin Yes crab, lobster and scampi. Yes (for Not Tropomyosin Yes specified reported foods)

Fish

No commercial methods are available.

Wheat

See Appendix 4 for gluten methods. No other commercial methods are available.

Information from manufacturers web sites, except for information on the Elisa System Crustacean test kit from FDA Docket #2005N-0231, comment number EC1.

MLPT - Multiple Laboratory Performance Tested; JRC- European Commission Joint Research Centre; AOAC = AOAC International.

LOD = Limit of detection, LOQ = Limit of quantitation.

Study

May, 1976

Bock et al., 1978

Appendix 2: Evaluation of Available Allergen Oral Challenge Studies. Published Test Food Test Lowest Dose Responses LOAEL Sign(s)s or Population Population Allergen Material Dose Progression at lowest Observed symptom(s) Dose/Response Tested Tested used to Data dose (mg (mg tested? proteina, determine b proteina) LOAEL ) Yes 38 Peanut, Raw 25 2-10 fold Yes 25 Objective Not reported asthmatic peanut increase children, 8 Milk Whole Not 2-10 fold No Not Objective Not reported reacted to reported increase reported peanut, 1 to Egg Whole Not 2-10 fold No Not Objective Not reported milk, 4 t o reported increase reported egg Eggs Dried Not 2-10 fold No 250 Objective Not reported reported increase Yes 68 children Peanut Unroasted Not Not reported Not 25 Objective No with reported reported suspected Milk Dried Not Not reported Not 280 Objective No allergy, 12 nonfat reported reported reacted to Egg Dried Not Not reported Not 1 Objective No peanut, 10 whole reported reported to milk, 10 Protein Not Not reported Not Not Objective No to egg, 5 to Soy isolate reported reported reported soy, 2 to Not Not reported Not Not Objective No cashew, 1 Cashew Not reported reported reported reported each to pecan, Pecan Not Not Not reported Not Not Objective No filbert, reported reported reported reported pistachio Filbert Not Not Not reported Not Not Objective No reported reported reported reported Cashew Not Not Not reported Not Not Objective No reported reported reported reported

Pasterello Yes et al., 1989 Egg white Dried 1500 Objective No

Pistaschio Not reported Milk Dried Objective No

Not reported 187

Objective

No

Hazelnut Ground

Not Not reported Not reported reported Not Not clear Dose reported - differed doubling for No different foods No 2775 Objective No

Fish

Not reported Not reported

Not reported

Not reported

No

Bernhisel- Yes Broadbent et al., 1992b Caffarelli Yes et al., 1995 Egg Not reported No

Raw and Not cooked reported extracts of 9 species Dried egg 0.042

0.42

Objective

No

Magnolfi Yes et al., 1996

Soy

Formula

No Yes

360 88

Objective Objective

No No

23 adults with suspected allergy, 4 reacted t milk, 2 to hazelnut, and 1 each to egg and wheat 11 fish allergic children and adults 21 infants and children with no previous egg exposure, 14 reacted 131 skin prick positive children, 8 reacted 14 peanut allergic Peanut Peanut flour "1 drop" 6 defined for infants doses 88 mg soy 7 defined protein doses for older children 0.01 12 defined doses No 0.1 Subjective Yes

Hourihane Yes et al.,

1997a Peanut Whole peanut Defatted peanut "Fresh" "1 drop" whole milk 4 specified Yes levels 50 Not reported 3.65 Objective 0.45 12 defined doses Not reported Not reported Subjective No ? (Labial 4 defined challenge) doses Yes Not reported Objective No

Objective

Hourihane Yes et al., 1997b Nelson et Yes al., 1997 Peanut Milk No

Bellioni- Yes Businco et al., 1999 Hebling et Yes al., 1999 Fish

adults, 8 reacted 60 peanut allergic adults 12 peanut allergic adults 26 milk allergic children 9 fish allergic adults Subjective and Objective 522 Objective Yes Cooked 50 meat from 3 species of fish Formula 1 drop to 5 ml 6 to 7 doublings No No

Zeiger et Yes al., 1999

Otolani et Yes al., 2000

93 milk Soy allergic infants and children, 13 reacted to soy 86 hazelnut Hazelnut Ground allergic nuts adults 224 Peanut Milk Egg Dose doubling, possibly 4 levels 400 or 6 or 7 500 mg of specified food levels Yes

Not reported

Not reported

Not reported

No

Sicherer et al., 2000

Yes

No No No

196 children with a variety of food allergiesc

Not reported Not reported Not reported

Not reported Not reported Not reported

Not reported Not reported Not reported

Soy Fish Wheat 260 No No No

No

Eggesbo et al., 2001

Yes

Not reported Not reported Not reported Pancakes

Not reported Not reported Not reported 260

Not reported Not reported Not reported Objective

Cod Mackerel Herring Plaice Ground

Bindslev- No Jensen and Hansen in Taylor et al., 2002

41 children Egg with reported allergy, 5 tested by DBPCFC 14 patients, Fish not clear whether all were challenged with each fish Dose Yes doubling until reaction or maximum dose Not reported 5 patients Peanut Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported 5 mg of fish 500mg of fish 5mg of fish 6000mg of fish 40 Not reported

No

Whole

180 0.65

No No

Bindslev- No Jensen and Mortz in Taylor et al., 2002 Bindslev- No Jensen and Norgaard in Taylor 3 milk Milk allergic, 7 egg allergic Egg patients Not reported Whole raw Not reported

Not reported Not reported Not reported Not reported

Not reported Not reported

et al., 2002 Bock in No Taylor et al., 2002 Peanut Milk Egg Fish No No No No No No No No No No 69 peanut allergic, 66 milk allergic, 91 egg allergic, 8 fish allergic patients 10 peanut Peanut allergic, 21 milk Milk allergic, 25 egg allergic Egg patients Peanut Milk Egg 100 patients each for peanut, milk, egg Ground 1.25 No

Burks and No Christie in Taylor et al., 2002

Hill in No Taylor et al., 2002

Not reported Nonfat Not dried reported Whole or Not dried reported Minced Not reported Peanut Not butter reported Nonfat Not dried reported Whole Not dried reported Peanut Not butter reported Whole Not reported Raw white Not reported Forumula Not reported Ground Whole Cooked 125 150 10 No No No

Host in No Taylor et al., 2002 Lack in No Taylor et al., 2002 Egg

15 milk Milk allergic patients 6 peanut, 6 Peanut milk, 18 egg allergic Milk patients

Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not Not reported Not reported Not

Not reported 67 Not reported Not Not reported reported 200 mg of Not fish reported 100 Not reported 140 Not reported 200 Not reported 6 Not reported 0.6 Not reported 2 Not reported 75 Not reported

Not reported Not reported Not

20 No

Moneret- No Vautrin #1 in Taylor et al., 2002 Whole Not reported Not reported Not reported Not reported No

28 peanut Peanut allergic, 6 milk allergic, 19 egg allergic, 4 Milk fish allergic patients

white reported Raw white Not reported Ground Not reported No

reported Not reported Not reported Not reported Not reported

reported Not reported Not reported

Egg

White

Not reported

Not reported Not reported

Not reported

No

Fish

Minced

Not reported

Not reported Not reported

Not reported

No

Ground White

1.25 (single blind)2.5 (double blind) 30 (double blind)150 (single blind)0.2 15mg of fish (single blind) 65mg of fish (double blind) 66 No 26.5 No Not reported Not reported Not reported Not reported Not reported Not reported

9 peanut Peanut allergic, 8 egg allergic Egg patients 3 peanut allergic patients 74 peanut Peanut Ground Peanut Ground Not reported

Not reported Not reported

Moneret- No Vautrin #2 in Taylor et al., 2002 "National No Jewish" in Taylor et al., 2002 Rance in No Not

Not reported Not reported

Not reported

No

Not reported Not

0.25

Not

No

Taylor et al., 2002 15 0.13 No No No No

allergic, 31 milk Milk allergic, 38 egg Egg allergic, 6 fish allergic Fish patients reported Whole Not reported Whole raw Not reported Minced Not reported Formula Not reported 16mg of fish 1.5 Raw nuts 1 7 specified Yes doses 10 specified No doses 4 specified Yes doses 0.1 1 Yes reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported Not reported reported Not reported Not reported Not reported Not reported

No

Yes

Yes

0.030

Yes

Zeiger in Taylor et al., 2002 Wensing et al., 2002a Wensing et al., 2002b Fiocchi et al., 2003 Roasted peanut meal Whole 43.2 21.8 Formula 43.2 21.8

Yes

Subjective and Objective Subjective and Objective Objective Objective

Yes

Hansen et Yes al., 2003

Not reported

Not reported Not reported 5 specified Yes levels No Yes Yes

Oral allergy No syndrome Objective Objective Objective 0.2 Objective No No No No

Morisset et al., 2003 Milk Egg

Yes

56 milk Milk allergic patients 31 hazelnut Hazelnut allergic adults 26 peanut Peanut allergic adults 18 children Milk with allergy to both Soy milk and soy 17 hazelnut Hazelnut allergic adults Undefined Peanut Raw and roasted nuts Crushed Oil Lactose free Raw white 0.2 1.25 Not reported 0.36 32 roasted16 - raw 1.25 Not reported 0.36

Soy 56 egg allergic children Egg 8 specified Yes doses Objective No

Not reported Pasteurized 2.9 whole egg

Oil

No

Not reported 2.9

Objective

No

Osterballe Yes and BindslevJensen, 2003 Perry et Yes al., 2004 Not reported Milk, egg, peanut, soy, wheat Wheat Flour, raw 15 and cooked 7 specified Yes doses 15 Not reported Not reported Not reported Not reported Not reported Not reported No

Scibilia et Yes al., 2006

27 wheat allergic adults

Objective

Yes

Note: Question marks (?) in the table indicate either that the information was not given or could not be determined.

Calculated based on the following estimate protein levels: 16% in raw hazelnuts, 20% in fish meat, 3.6% in whole milk, 37.5% in dried milk, 25% in whole peanut, 45% in defatted peanut flour, 10% in egg white, 84% in dried whole egg , 26% in raw egg, 1.8% in soy formula (FAO, 1995; Wensing et al., 2002; Bindslev-Jensen et al., 2002). In studies involving fish, the amount of fish is given when there is insufficient information to calculate protein levels.

When responses are observed at the lowest dose tested, the reported LOAEL may not represent the lowest dose at which a reaction could occur.

It is not clear if all children were tested with all allergens.

Appendix 3: Evaluation of Published Measurements of Protein Concentrations in Oils. Oil Reference Protein Description of Oil Published Protein Separation Protein Quantitation Type Concentration Method Method (ug/g) Soy Tattrie and 0.96 Refined, deodorized Yes Chromatography Amino Acid Analysis Yaguchi, 1973 Klurfeld and Yes Aqueous Extraction Commercial Bradford 1.93 Crude Kritchevsky, 1987 Assay 0.72 "Processed" Uncharacterized, Yes Aqueous Extraction Lowery Assay Awazuhara et al., 0.014 commercial 1998 0.017
a

0.018 0.023 0.027

Reeves, 1999 0.042 0.049 0.057 0.082 0.114

0.040 0.033 Fully refined, commercial

No

Unknown

Amino Acid Analysis

0.222 Paschke et al., 2001 0.0332 Refined Unrefined Yes Acetone Precipitation Bradford Assay 0.0353 0.0898 0.1010

0.1380 Errahali et al., 2002 0.32 Deodorized Yes

Aqueous Extraction Unknown

1.80 Nordlee et al., 2002 0.16 - 20.8 No 0.043 - 6.8 0.033 - 3.1 Deodorized Processed Bleached Refined

Cold pressed Degummed

Aqueous Extraction Amino Acid Analysis

Peanut Klurfeld and Kritchevsky, 1987 0.154 0.204 0.206

0.021 - 0.443 0.120

Yes

Aqueous Extraction Bradford Assay

Hoffman and Collins-Williams, 1994

0.580 0.2

Cold pressed

Yes

Aqueous Extraction Commercial Coomassie Dye Assay

0.6 3.3

3.3 Teuber et al., 1997 3.0 0.3 Refined, bleached, deodorized Unrefined 10.5 0.4 Yes 5.7 1.2

Aqueous Extraction Commercial Bradford Assay

Olszewski et al., 1998 0.13 0.15 0.16 0.20 187 Crude

10.7 0.8 0.10 Refined, commercial Yes

Aqueous Extraction Commercial Bicinchoninic Acid (BCA) Assay

Skinner and Haynes, 1998 60 15 2.2 0.047

No

Aqueous Extraction Lowery and Commercial BCA Assay

ISEO, 1999

Alkali refined, neutralized Alkali refined, neutralized, bleached Alkali refined, neutralized, bleached, deodorized Fully refined, commercial

No

Unknown

Amino Acid Analysis

0.049 0.063 0.828 Partially refined, commercial Refined, neutralized, bleached, deodorized No Crude Crude, noncommercial Yes Unknown

Crevel et al., 2000 b 48

Aqueous Extraction Commercial BCA Assay

91 220 Peeters et al., 2004 0.09

ELISA (not described)

Tree Nut

Cold pressed Refined, bleached, deodorized Yes

Aqueous Extraction Commercial Bradford Assay

6.4 2.55 Teuber et al., 1997 2.2 0.7 (Almond) 16.7 0.8 12.7 2.8 62.2 2.2 Teuber et al., 1997 7.0 2.5 (Walnut) 7.0 0.8 Blend Unrefined Refined, bleached, deodorized Yes 9.2 3.1 16.5 2.4 20.4 1.8 Unrefined Blend

Aqueous Extraction Commercial Bradford Assay

Note: Protein levels too low to detect or measure were reported by Tattrie and Yaguchi (1973), Hoffman and Collins-Williams (1994), Yeung and Collins (1996), Peeters et al. (2004) for peanut oils and by Tattrie and Yaguchi (1973), Porras et al. (1985) for soy oils. These values were not included due to the lack of methodological information.

None of the publications provide sufficient information to evaluate the overall extraction efficiency, accuracy, reproducibility, or precision of the method used. In addition, in most cases, it was not clear whether replicate samples were tested or whether replicate measurements were carried out for individual samples.

Crevel et al. (2000) is a review paper that includes previously unpublished data. These data are given here, but are considered unpublished because the research that generated these values has not specifically been peer-reviewed.

Method

Practicality

Diffchamb Transia Plate Gluten

Yes

Diffchamb Transia Plate Prolamins

Yes

Ingensa Gluten EIA

Not reported Yes Yes Yes

Appendix 4: Evaluation of Gluten Testing Methods. Validation Sensitivity Quantitation Raw and Species Protein(s) (LOD) (ppm (LOQ) (ppm Baked Specificity Detected gluten) gluten) Foods? No 10 Not reported Not Wheat, Gliadin reported triticale, rye, barley Working Group on 3 Not reported Yes Wheat, Gliadin Prolamin Analysis triticale, rye, and Toxicity barley No 3 Not reported Not Wheat, rye, Gliadin reported barley No 10 No Not Wheat, rye, Gliadin reported barley No 5 5 Not Wheat, rye, Gliadin reported barley Prolamin Working 3 5 Yes Wheat, rye, Gliadin Group Ring Study b barley No 10 10 Yes Wheat, rye, barley Gliadin

Neogen Alert for Gliadin Neogen Veratox for Gliadin R-BioPharm RIDASCREEN Gliadin R-BioPharm RIDASCREEN

Yes

Method

Validation

Appendix 4: Evaluation of Gluten Testing Methods. Sensitivity Quantitation Raw and Species (LOD) (ppm (LOQ) (ppm Baked Specificity gluten) gluten) Foods? 5 160 16 Yes Omega gliadin No Yes Gliadin Yes Yes Wheat, rye, barley Wheat, triticale, rye

Protein(s) Practicality Detected

FAST Gliadin R-BioPharm No RIDAQUICK Gliadin Tepnel BioSystems AOAC Wheat Gluten

Tepnel BioSystems No Gluten Rapid Test Kit 200 - "highly processed flour

2 - not validated 50 - breads, etc No Yes Wheat, triticale, rye

Omega gliadin

Yes

Information from manufacturers web sites:

Ingensa

Neogen Food Allergen Test Kits

R-BioPharm Food and Feed Analysis RIDASCREEN Gliadin

Tepnel BioSystems

Immer et al., 2003.

Study

Appendix 5: Evaluation of Gluten Oral Challenge Studies. Published Test Test Material Dose Level(s) Duration Population 33 of 46 adults completed study Commercial crude gliadin White flour milled from Kolibri strain of wheat White flour milled from Kolibri strain of wheat 1000 mg of 4 gliadin subfractions 10, 600, and 1000 mg gliadin 100 mg or 500 4 weeks mg gliadin/day Intestinal biopsy, symptoms Intestinal biopsy Not reported 0, 10 or 50 mg 3 months gluten/day Diagnostic Assessment (Biomarker) Intestinal biopsy, symptoms Individual Response Data? Not reported

Fasano, 2005; No; analysis is ongoing Abstract: Catassi et al., 2005b Catassi et al., Yes 1993 20 children (10 each dose level) 1 adult

Yes

Ciclitera et al., 1984

Yes

Yes

Ciclitera et al., 1984

Yes

3 adults

Intestinal biopsy, symptoms

Yes

Ciclitera et al., 1985

Yes

10 adults

6 slices/day Juvela glutenfree bread; oral

Intraduodenal infusion over 2 hr period; 3 doses on separate days Intraduodenal infusion each subfraction at variable intervals of 3 to 11 days 6 weeks

Intestinal biopsy,symptoms

Yes

Montgomery Yes et al, 1988

Not reported; article states that glutenfree bread usually contains 0.2 to 0.4 mg gliadin/30-g slice 12 adults on Not reported strict glutenfree diet and 13 adults on

Gluten-free diet Gluten-free diet: 6 Intestinal biopsy, to 27 months symptoms, antigluten Ab Low-gluten diet (mean 13 months); (2.5 to 5 gm gluten/day)

Yes, graphs

Study

Appendix 5: Evaluation of Gluten Oral Challenge Studies. Published Test Test Material Dose Level(s) Duration Population Diagnostic Assessment (Biomarker) Individual Response Data? low-gluten diet 4 adults

Sturgess et al, Yes 1994

Low-gluten diet: 3 to 14 months (mean 6 months) Undigested gliadin 1 gm gliadin or 2 hours by Intestinal biopsy prepared from 200 mg of infusion hourly for 6 hrs Kolibri wheat flour synthetic after start infusion by standard method; peptides/dose oligopeptides synthesized and analyzed

Yes; as percentage enteropathic change

June 2005 Draft Report: Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food

Food Allergen Labeling & Consumer Protection Act of 2004 idelines

Food Allergen Labeling & Consumer Protection Act of 2004 idelines

Food Allergen Labeling and Consumer Protection Act of 2004

(Public Law 108-282, Title II)
SEC. 201. SHORT TITLE. This title may be cited as the Food Allergen Labeling and Consumer Protection Act of 2004. SEC. 202. FINDINGS. Congress finds that-1. (1) it is estimated that-1. (A) approximately 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies; and 2. (B) each year, roughly 30,000 individuals require emergency room treatment and 150 individuals die because of allergic reactions to food; 2. (2) 1. (A) eight major foods or food groups--milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans-- account for 90 percent of food allergies; 2. (B) at present, there is no cure for food allergies; and 3. (C) a food allergic consumer must avoid the food to which the consumer is allergic; 3. (3) 1. (A) in a review of the foods of randomly selected manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin in 1999, the Food and Drug Administration found that 25 percent of sampled foods failed to list peanuts or eggs as ingredients on the food labels; and 2. (B) nationally, the number of recalls because of unlabeled allergens rose to 121 in 2000 from about 35 a decade earlier; 4. (4) a recent study shows that many parents of children with a food allergy were unable to correctly identify in each of several food labels the ingredients derived from major food allergens; 5. (5) 1. (A) ingredients in foods must be listed by their ``common or usual name''; 2. (B) in some cases, the common or usual name of an ingredient may be unfamiliar to consumers, and many consumers may not realize the ingredient is derived from, or contains, a major food allergen; and 3. (C) in other cases, the ingredients may be declared as a class, including spices, flavorings, and certain colorings, or are exempt from the ingredient labeling requirements, such as incidental additives; and 6. (6)

1. (A) celiac disease is an immune-mediated disease that causes damage to the gastrointestinal tract, central nervous system, and other organs; 2. (B) the current recommended treatment is avoidance of glutens in foods that are associated with celiac disease; and 3. (C) a multicenter, multiyear study estimated that the prevalence of celiac disease in the United States is 0.5 to 1 percent of the general population. SEC. 203. FOOD LABELING; REQUIREMENT OF INFORMATION REGARDING ALLERGENIC SUBSTANCES. 1. (a) In General.--Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following: (w) 1. (1) If it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either-1. (A) the word 'Contains', followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients (in a type size no smaller than the type size used in the list of ingredients) required under subsections (g) and (i); or 2. (B) the common or usual name of the major food allergen in the list of ingredients required under subsections (g) and (i) is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when-1. (i) the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived; or 2. (ii) the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen under section 201(qq)(2)(A) or (B). 2. (2) As used in this subsection, the term `name of the food source from which the major food allergen is derived' means the name described in section 201(qq)(1); provided that in the case of a tree nut, fish, or Crustacean shellfish, the term `name of the food source from which the major food allergen is derived' means the name of the specific type of nut or species of fish or Crustacean shellfish.
Federal Register, publication.

3. (3) The information required under this subsection may appear in labeling in lieu of appearing on the label only if the Secretary finds that such other labeling is sufficient to protect the public health. A finding by the Secretary under this paragraph (including any change in an earlier finding under this paragraph) is effective upon publication in the Federal Register as a notice.

4. (4) Notwithstanding subsection (g), (i), or (k), or any other law, a flavoring, coloring, or incidental additive that is, or that bears or contains, a major food allergen shall be subject to the labeling requirements of this subsection. 5. (5) The Secretary may by regulation modify the requirements of subparagraph (A) or (B) of paragraph (1), or eliminate either the requirement of subparagraph (A) or the requirements of subparagraph (B) of paragraph (1), if the Secretary determines that the modification or elimination of the requirement of subparagraph (A) or the requirements of subparagraph (B) is necessary to protect the public health. 6. (6) 1. (A) Any person may petition the Secretary to exempt a food ingredient described in section 201(qq)(2) from the allergen labeling requirements of this subsection. 2. (B) The Secretary shall approve or deny such petition within 180 days of receipt of the petition or the petition shall be deemed denied, unless an extension of time is mutually agreed upon by the Secretary and the petitioner. 3. (C) The burden shall be on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health. 4. (D) A determination regarding a petition under this paragraph shall constitute final agency action.
Public information. Deadline.

5. (E) The Secretary shall promptly post to a public site all petitions received under this paragraph within 14 days of receipt and the Secretary shall promptly post the Secretary's response to each. 7. (7) 1. (A) A person need not file a petition under paragraph (6) to exempt a food ingredient described in section 201(qq)(2) from the allergen labeling requirements of this subsection, if the person files with the Secretary a notification containing-1. (i) scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where applicable) does not contain allergenic protein; or 2. (ii) a determination by the Secretary that the ingredient does not cause an allergic response that poses a risk to human health under a premarket approval or notification program under section 409.
2. Deadlines.

(B) The food ingredient may be introduced or delivered for introduction into interstate commerce as a food ingredient that is not a major food allergen 90 days after the date of receipt of the notification by the Secretary, unless the Secretary determines within the 90-day period that

the notification does not meet the requirements of this paragraph, or there is insufficient scientific evidence to determine that the food ingredient does not contain allergenic protein or does not cause an allergenic response that poses a risk to human health.
3. Public information. Deadline.

(C) The Secretary shall promptly post to a public site all notifications received under this subparagraph within 14 days of receipt and promptly post any objections thereto by the Secretary. (x) Notwithstanding subsection (g), (i), or (k), or any other law, a spice, flavoring, coloring, or incidental additive that is, or that bears or contains, a food allergen (other than a major food allergen), as determined by the Secretary by regulation, shall be disclosed in a manner specified by the Secretary by regulation.''.
2. 21 USC 343 note.

(b) Effect on Other Authority.--The amendments made by this section that require a label or labeling for major food allergens do not alter the authority of the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to require a label or labeling for other food allergens. 3. (c) Conforming Amendments.-1. (1) Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) (as amended by section 102(b)) is amended by adding at the end the following: (qq) The term `major food allergen' means any of the following: 1. (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. 2. (2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following: 1. (A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil. 2. (B) A food ingredient that is exempt under paragraph (6) or (7) of section 403(w).''. 2. (2) Section 403A(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1(a)(2)) is amended by striking or 403(i)(2) and inserting 403(i)(2), 403(w), or 403(x)
4. Applicability. 21 USC 321 note.

(d) Effective Date.--The amendments made by this section shall apply to any food that is labeled on or after January 1, 2006.

SEC. 204. REPORT ON FOOD ALLERGENS. Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the ``Secretary'') shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that-1. (1) 1. (A) analyzes-1. (i) the ways in which foods, during manufacturing and processing, are unintentionally contaminated with major food allergens, including contamination caused by the use by manufacturers of the same production line to produce both products for which major food allergens are intentional ingredients and products for which major food allergens are not intentional ingredients; and 2. (ii) the ways in which foods produced on dedicated production lines are unintentionally contaminated with major food allergens; and 2. (B) estimates how common the practices described in subparagraph (A) are in the food industry, with breakdowns by food type as appropriate; (2) advises whether good manufacturing practices or other methods can be used to reduce or eliminate cross-contact of foods with the major food allergens; (3) describes-1. (A) the various types of advisory labeling (such as labeling that uses the words ``may contain'') used by food producers; 2. (B) the conditions of manufacture of food that are associated with the various types of advisory labeling; and 3. (C) the extent to which advisory labels are being used on food products; (4) describes how consumers with food allergies or the caretakers of consumers would prefer that information about the risk of cross-contact be communicated on food labels as determined by using appropriate survey mechanisms; (5) states the number of inspections of food manufacturing and processing facilities conducted in the previous 2 years and describes-1. (A) the number of facilities and food labels that were found to be in compliance or out of compliance with respect to cross-contact of foods with residues of major food allergens and the proper labeling of major food allergens; 2. (B) the nature of the violations found; and 3. (C) the number of voluntary recalls, and their classifications, of foods containing undeclared major food allergens; and (6) assesses the extent to which the Secretary and the food industry have effectively addressed cross-contact issues.

2. 3.

4.

5.

6.

21 USC 374a.

SEC. 205. INSPECTIONS RELATING TO FOOD ALLERGENS.

The Secretary of Health and Human Services shall conduct inspections consistent with the authority under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) of facilities in which foods are manufactured, processed, packed, or held-1. (1) to ensure that the entities operating the facilities comply with practices to reduce or eliminate cross-contact of a food with residues of major food allergens that are not intentional ingredients of the food; and 2. (2) to ensure that major food allergens are properly labeled on foods.
Deadlines. Regulations. 21 USC 343 note.

SEC. 206. GLUTEN LABELING. Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, shall issue a proposed rule to define, and permit use of, the term ``gluten-free'' on the labeling of foods. Not later than 4 years after the date of enactment of this Act, the Secretary shall issue a final rule to define, and permit use of, the term ``gluten-free'' on the labeling of foods.
42 USC 242r.

SEC. 207. IMPROVEMENT AND PUBLICATION OF DATA ON FOOD-RELATED ALLERGIC RESPONSES. 1. (a) In General.--The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Commissioner of Food and Drugs, shall improve (including by educating physicians and other health care providers) the collection of, and publish as it becomes available, national data on-1. (1) the prevalence of food allergies; 2. (2) the incidence of clinically significant or serious adverse events related to food allergies; and 3. (3) the use of different modes of treatment for and prevention of allergic responses to foods. 2. (b) Authorization of Appropriations.--For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary.
42 USC 243 note.

SEC. 208. FOOD ALLERGIES RESEARCH.

1. Government organization.

(a) In General.--The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall convene an ad hoc panel of nationally recognized experts in allergy and immunology to review current basic and clinical research efforts related to food allergies.

2.

Deadline. Public information.

(b) Recommendations.--Not later than 1 year after the date of enactment of this Act, the panel shall make recommendations to the Secretary for enhancing and coordinating research activities concerning food allergies, which the Secretary shall make public. SEC. 209. FOOD ALLERGENS IN THE FOOD CODE. The Secretary of Health and Human Services shall, in the Conference for Food Protection, as part of its efforts to encourage cooperative activities between the States under section 311 of the Public Health Service Act (42 U.S.C. 243), pursue revision of the Food Code to provide guidelines for preparing allergen-free foods in food establishments, including in restaurants, grocery store delicatessens and bakeries, and elementary and secondary school cafeterias. The Secretary shall consider guidelines and recommendations developed by public and private entities for public and private food establishments for preparing allergen-free foods in pursuing this revision.
42 USC 300d-2 note.

SEC. 210. RECOMMENDATIONS REGARDING RESPONDING TO FOOD-RELATED ALLERGIC RESPONSES. The Secretary of Health and Human Services shall, in providing technical assistance relating to trauma care and emergency medical services to State and local agencies under section 1202(b)(3) of the Public Health Service Act (42 U.S.C. 300d-2(b)(3)), include technical assistance relating to the use of different modes of treatment for and prevention of allergic responses to foods. Approved August 2, 2004.

Page Last Updated: 08/21/2009

FDA Guidance on Labeling of Product Containing Lecithin from Soy

FDA Guidance on Labeling of Product Containing Lecithin from Soy

Guidance for Industry

Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act
Contains Nonbinding Recommendations April 2006 Comments and suggestions regarding this document may be submitted at any time. Submit comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this document contact Paul M. Kuznesof, Ph.D., at the Center for Food Safety and Applied Nutrition (CFSAN) at 301-436-1289 or at paul.kuznesof@fda.hhs.gov. Additional copies are available from: Office of Food Additive Safety (HFS-205) Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740

U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition Issued April 2006

Contains Nonbinding Recommendations

Table of Contents
I. II. Introduction Background A. Relevant Statutory Framework B. Food allergy to soy C. Lecithin derived from soy D. Allergic potential of lecithin derived from soy E. Labeling of certain uses of lecithin derived from soy Discussion Guidance

III. IV.

Contains Nonbinding Recommendations This guidance represents the current thinking of the Food and Drug Administration on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. If you wish to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this document.

I. Introduction
The purpose of this document is to provide guidance on the labeling, under section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 343(w), of certain uses in food of lecithin derived from soy.(1) In particular, as discussed in more detail below, FDA intends to consider the exercise of enforcement discretion for a food labeled on or after January 1, 2006, for which lecithin derived from soy is used solely as a component of a release agent(2) and the label for such food does not declare the presence of the lecithin consistent with the requirements of section 403(w). FDA intends to consider exercising such discretion when each of the factors discussed in section IV is present.

FDA guidance documents do not establish legally enforceable responsibilities. Instead, guidance documents describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in agency guidance documents means that something is suggested or recommended, but not required.

II. Background
A. Relevant statutory framework
Section 403(i) of the Act, 21 U.S.C. 343(i), requires that a food label bear the common or usual name of the food and, where fabricated from two or more ingredients, the common or usual name of each ingredient of the food, except that spices, flavorings, and certain colors are not required to be individually declared. The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) imposes new labeling requirements on certain foods. If a food is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains a major food allergen, that food must comply both with section 403(i) and section 403(w) of the Act, 21 U.S.C. 343(i), 343(w). Section 403(w)(1) requires that a food's label reveal the name of the food source from which the major food allergen is derived in a manner specified by that section. This source declaration requirement is extended by section 403(w)(4) to any incidental additive that is, or that bears or contains, a major food allergen, notwithstanding the regulatory exemption for incidental additives in 21 CFR 101.100(a)(3).(3) The requirements of section 403(w) apply to foods labeled on or after January 1, 2006. Section 201(qq) of the Act, 21 U.S.C. 321(qq), defines "major food allergen" as any one of eight foods or food groups (milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) or an ingredient that contains protein derived from one of the eight foods or food groups. The definition of "major food allergen" excludes any highly refined oil derived from one of the eight foods or food groups, and any ingredient derived from such an oil, as well as any ingredient exempt under the petition process specified in section 403(w)(6), 21 U.S.C. 343(w)(6), or the notification process specified in section 403(w)(7), 21 U.S.C. 343(w)(7).(4)

B. Food allergy to soy

FALCPA recognizes soy as one of the eight most common food allergens. Although definitive studies assessing the prevalence of soy allergy are lacking, it is currently estimated that 0.2% of children and adults in the U.S. are allergic to soy.(5) Based on this estimate, soy allergy appears to be less prevalent than allergies to other major food allergens. As with most common food allergens, allergic reactions to soy may result in lifethreatening symptoms, such as anaphylaxis. Furthermore, even low levels of soy protein

may cause adverse effects in some sensitive individuals. FDA considers an "adverse effect" to be any objective sign of an allergic reaction.(6) Currently, due to limited data, there is no consensus on the minimal dose of soy protein that will elicit an adverse effect (also referred to as the lowest observed adverse effect level or LOAEL). At least some researchers have suggested, however, that the LOAEL for soy protein appears to be higher than the LOAELs reported for other major allergens, such as milk, egg, and peanuts.

C. Lecithin derived from soy

Lecithin is a food ingredient that is derived from plant sources, including soy. Lecithin is isolated following hydration of solvent-extracted soy, sunflower, or corn oil. Lecithin is affirmed as generally recognized as safe (GRAS) with no limitation other than current good manufacturing practice. 21 CFR 184.1400.(7) Common food applications of lecithin include use as an emulsifier, a stabilizer, a dispersing aid, and an incidental additive, such as a release agent for baked goods. Regardless of its food application, lecithin is generally used in small amounts, with the result that it is, according to one lecithin manufacturer, present in finished foods at levels rarely exceeding 1% by weight of the final food product. During manufacture of lecithin derived from soy, most, but not all, of the soy protein is removed. Soy allergens, to the extent they are present in lecithin, would be found in the protein fraction of the ingredient. Accurately measuring lecithin's protein content presents challenges to current analytical methodology due to the ingredient's oily matrix and low levels of protein. The GRAS affirmation regulation specifies that the ingredient meet the specifications of the Food Chemicals Codex (FCC). The FCC monograph stipulates that food grade lecithin contain not more than 0.3% hexane-insoluble matter. Because the protein fraction of lecithin would reside in such insoluble material, this specification would limit the amount of protein in food grade lecithin to 0.3% or 300 mg/ 100 g lecithin. At least one major U.S. producer has stated that its manufacturing standard for lecithin derived from soy is set at 0.05% hexane-insoluble material or 50 mg/100g lecithin.

D. Allergic potential of lecithin derived from soy

As noted, lecithin derived from soy contains very small amounts of soy protein and it is generally used in small amounts, whether for a functional or technical effect in the finished food or as an incidental additive. The proteins in soy lecithin have been found, in some cases, to be soy allergens, and there are a few case reports in the medical literature of allergic reactions to lecithin derived from soy. However, allergy to lecithin derived from soy has been neither definitively established nor definitively negated by oral food challenge studies. Despite its widespread use in the food supply, FDA is aware of only a few allergen-related complaints about FDA-regulated products containing lecithin derived from soy.(8) Also, FDA is aware that some clinicians believe that foods containing lecithin derived from soy present little or no allergic risk to soy-sensitive

consumers, and these physicians do not advise their soy allergic patients to avoid lecithin derived from soy.

E. Labeling of lecithin derived from soy

Before the enactment of FALCPA, the declaration of lecithin derived from soy as a food ingredient was governed solely by 21 U.S.C. 343(i) and FDA's labeling regulations. Thus, when used as an ingredient that is intended to have a technical or functional effect in the finished food (for example, as an emulsifier), the ingredient was required to be declared only by its common or usual name, "lecithin." As noted, under 21 CFR 101.100(a)(3), an ingredient used in insignificant amounts with no technical or functional effect in the finished food (such as a release agent) is not required to be declared on the label. Thus, food manufacturers using lecithin derived from soy as a release agent may have concluded that they were not required to declare lecithin as an ingredient. FALCPA has altered the way in which lecithin derived from soy must be declared on the food label. Whether intended to have a technical or functional effect in the finished food or used as an incidental additive (such as a release agent), lecithin derived from soy must be declared as an ingredient, using its common or usual name, and with the food source ("soy," "soya", or "soybeans") declared as required by section 403(w) of the Act.

III. Discussion
FDA is committed to the full and prompt implementation of FALCPA and enforcement of the new legal authority that it provides. As noted, FALCPA defines as major food allergens eight foods or food groups or ingredients that contain protein derived from one of those eight, and requires that major food allergens be declared as set out in section 403(w) of the Act. Given the number of ingredients that meet the definition of a major food allergen, FALCPA will have an impact on an enormous number of food labels. It is well-recognized that various ingredients that are major food allergens present a range of risks to sensitive consumers. In light of the breadth of FALCPA's impact on food labels, the range of risks to sensitive consumers presented by various major food allergens, and the resources required to implement certain FALCPA provisions (such as the notification and petition processes for labeling exemptions), FDA intends to establish implementation and enforcement priorities. A major consideration in setting those priorities will be the public health impact of a particular implementation or enforcement effort. FDA acknowledges the widespread use of soy lecithin as a component of release agents prior to FALCPA. Although there are no data that establish the exact exposure to soy protein that would result from this use, based on the information available to FDA at this time, it is apparent that when lecithin derived from soy is used as a component of a release agent, the level of soy protein in the finished food is likely to be low. Also, the exposure to allergenic soy protein from such use would be expected to be considerably lower than exposures from other uses of soy lecithin or from soy-containing ingredients commonly used in food. This is due to the relatively low level of soy protein in lecithin derived from soy and the low level of use of the ingredient (lecithin derived from soy)

when used as a component of a release agent. In addition, when a substance is used as an incidental additive, the level of the substance in the food can be expected to be low. (9) There is currently no consensus on the minimal dose of soy protein that will elicit an adverse effect in sensitive consumers. At least some researchers have suggested, however, that the LOAEL for soy protein appears to be higher than the LOAELs reported for other major allergens, such as milk, egg, and peanuts. Absent a consensus on a LOAEL for soy protein and on levels of exposure to soy protein from the use of lecithin derived from soy as a component of a release agent, it is not possible to state unequivocally the risk, if any, that there may be to soy-allergic persons who consume foods for which lecithin derived from soy has been used as a component of a release agent. However, based on the foregoing, it appears that this risk is low compared to the aggregate risk to soy-sensitive individuals presented by the use of other ingredients containing soy protein, as well as the aggregate risk to allergic persons with non-soy sensitivities presented by ingredients that are, or contain protein derived from, one of the other major food allergens.

IV. Guidance
Consistent with the need to establish its enforcement priorities, FDA intends to consider the exercise of enforcement discretion for a food labeled on or after January 1, 2006, in which lecithin derived from soy is used as a component of a release agent and the label for such food does not declare the presence of lecithin consistent with the requirements of section 403(w) of the Act. The agency's intent to exercise its enforcement discretion for a limited period for the foregoing use of lecithin will help FDA to apply its increasingly limited resources to efforts associated with implementation and enforcement of FALCPA that are expected to have a more acute public health impact. The agency intends to reconsider its enforcement priorities with regard to the labeling of lecithin derived from soy used as a component of a release agent approximately 18 months after the issuance of this guidance. The agency expects that, during the period in which FDA intends to consider the exercise of its enforcement discretion as described above, manufacturers of foods that use lecithin derived from soy as a component of a release agent will revise as necessary the labels of their relevant food products to comply with FALCPA and begin to label their products using the FALCPA-compliant labels by the end of the enforcement discretion period. FDA intends to consider exercising such discretion when all of the following factors are present: 1. The food was labeled on or after January 1, 2006.(10) 2. The lecithin derived from soy used as a component of a release agent satisfies each of the specifications for lecithin in the Food Chemicals Codex, 5th Edition.(11) 3. The lecithin derived from soy is used solely as a component of a release agent as described in this guidance.

4. The release agent in which lecithin derived from soy is a component is used at the lowest level possible consistent with current good manufacturing practice. The agency emphasizes that this guidance does not apply if the lecithin derived from soy used as a component of a release agent does not comply with the Food Chemicals Codex specifications or if the lecithin derived from soy is used other than as a component of a release agent as described in this guidance.

Notes:
(1)

FDA has previously advised food manufacturers that the names "soy," "soya," and "soybeans" are all acceptable names for this legume. http://www.cfsan.fda.gov/~dms/alrguid.html (Updated web reference: Guidance for Industry:

Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4)). In this guidance document, FDA uses the

term "soy." In this document, the term "release agent" refers to an agent used to facilitate the release of foods (such as baked goods) from food contact surfaces, such as conveyor belts, molds, extrusion equipment, and baking pans, where the agent has been applied directly to the food contact surface, rather than incorporated into the food for such purpose. 21 CFR 101.100(a)(3) exempts from the ingredient declaration requirement any incidental additive that is present in a food at insignificant levels and has no functional or technical effect in the food.
(4) (3) (2)

Under the petition process, an ingredient may be exempt if the petitioner demonstrates that the ingredient does not cause an allergic response that poses a risk to human health. Under the notification process, an ingredient may be exempt if the notification contains scientific evidence that demonstrates that the ingredient does not contain allergenic protein, or if FDA previously has determined, under section 409 of the Act, that the food ingredient does not cause an allergic response that poses a risk to human health.

[Draft] Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition: Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food ([Draft] Threshold Report) at p. 11-12. See 70 Fed. Reg. 35258 (June 17, 2005), and http://www.cfsan.fda.gov/~dms/alrgn.html).
(6)

(5)

Draft Threshold Report at p. 51.

(7)

The lecithin affirmed as GRAS may be bleached with hydrogen peroxide or benzoyl peroxide. Also, enzyme-modified lecithin is affirmed as generally recognized as safe for

use as an emulsifier, 21 CFR 184.1063), and hydroxylated lecithin is an approved food additive for use as an emulsifier, 21 CFR 172.814. This information on the relatively low number of consumer complaints must, of course, be considered in the current regulatory context in which processing aid uses of lecithin derived from soy are not uniformly declared on food labels. In the absence of such declaration, a food allergic consumer who experiences an adverse reaction to a food product may not associate that reaction with soy because the label does not declare its presence in the food.
(9) (8)

FDA believes that at least some food manufacturers, relying on 21 CFR 101.100(a)(3) prior to FALCPA's enactment, did not consistently identify lecithin derived from soy in a food's ingredient statement when the substance was used as a component of a release agent. Thus, consumers, including soy-allergic consumers, were likely consuming these small amounts of lecithin derived from soy (with its low level of soy protein) when they consumed these foods.
(10)

Foods labeled prior to January 1, 2006, are not required to comply with FALCPA's labeling requirements so FDA need not consider the exercise of such discretion with respect to foods labeled before January 1, 2006.

FDA encourages lecithin producers to reduce, to the extent possible, the level of protein in their soy lecithin products and also encourages food manufacturers using lecithin derived from soy as a component of a release agent to reduce, to the extent possible, the level of soy lecithin in finished foods.

(11)

IDFA HACCP Forms

IDFA HACCP Forms

Plant Name: Address: City, State, Zip Code:

Product Description Form

Formal Product Name:

Food Safety Characteristics:

i.e. pH, water activity, etc. of Overall Product

Food Safety Characteristics: 1. i.e. pH, water activity, etc. of Each 2. Ingredient 3. 4. 5. 6. Packaging Used:

Ingredients on Package:

Labeling Requirements:

Storage and Distribution:

Intended Consumers:

Intended Use:

Shelf Life:

Approved by: ______________________________ Date:_____________________________________

Q1. Is the hazard identified at this step of sufficient likelihood of occurrence to warrant its control? N NO

MODIFIED DECISION TREE FOR HACCP

Not a CCP

YES Q3. Does the control measure for the hazard exist YES at this step?

Q2. Identify the Prerequisite Program or procedure step which reduces the likelihood of occurrence of the hazard to ensure that control at this step is not necessary.

NO YES
Is control at this step necessary?

YES

Modify this step, process, or product to eliminate this hazard or provide a control measure, then revisit the hazard analysis

NO
Proceed to the step where a control measure exists for this hazard and begin at Q4.

Q4. Does this step prevent, reduce or eliminate the likely occurrence of the hazard to an acceptable level?

YES

CCP

NO
Q5. Could contamination with the identified hazard occur in excess of the safe or acceptable level or could it increase to an unacceptable level? YES Q6. Will a subsequent step eliminate the identified hazard or reduce its likely occurrence to a safe level? NO This step is not a CCP

YES
Subsequent step is the CCP.

NO

CCP (Control at this step is necessary to prevent or reduce the risk of a hazard but may not eliminate it.)

Hazard Analysis Summary Table

Plant Name: ____________________________________________
Plant Address:________________________________________________

Product Name:_________________________________

Date:_____________________________________________

Process Step/ Ingredient or Input

Q1. Is the hazard identified at this step of sufficient Identify the specific likelihood of Potential Hazard occurrence to warrant its control? Biological (B) If "yes", then Chemical (C) proceed to Q3 Physical (P) If "no", stop and document at Q2 Q2. Identify the Prerequisite Program or procedure that manages the hazard to ensure that control at this step is not necessary.

Q3 Q6. Does a control measure exist at this step to prevent, reduce or eliminate the likely occurrence of a hazard to an acceptable level? If yes, document as a CCP If no, indicate where this will happen.

Process Step/ Ingredient or Input

Q1. Is the hazard identified at this step of sufficient Identify the specific likelihood of Potential Hazard occurrence to warrant its control? Biological (B) If "yes", then Chemical (C) proceed to Q3 Physical (P) If "no", stop and document at Q2 Q2. Identify the Prerequisite Program or procedure that manages the hazard to ensure that control at this step is not necessary.

Q3 Q6. Does a control measure exist at this step to prevent, reduce or eliminate the likely occurrence of a hazard to an acceptable level? If yes, document as a CCP If no, indicate where this will happen.

Process Step/ Ingredient or Input

Q1. Is the hazard identified at this step of sufficient Identify the specific likelihood of Potential Hazard occurrence to warrant its control? Biological (B) If "yes", then Chemical (C) proceed to Q3 Physical (P) If "no", stop and document at Q2 Q2. Identify the Prerequisite Program or procedure that manages the hazard to ensure that control at this step is not necessary.

Q3 Q6. Does a control measure exist at this step to prevent, reduce or eliminate the likely occurrence of a hazard to an acceptable level? If yes, document as a CCP If no, indicate where this will happen.

HACCP PLAN SUMMARY TABLE

(4) Monitoring (3) Critical Limits for each Critical Control Point What How Frequency Who (5) (6) (7) (8) Corrective Action(s) (9) Verification (10) Records

Product Name:

(1) Critical Control Point (CCP)

(2) Hazards

Firm Address:

Product Description: Firm Name: Method of Storage & Distribution: Intended Use & Consumer: Signature:

Date:

Plant Name: Address: City, State, Zip Code:

Product Description Form

Formal Product Name:

Food Safety Characteristics:

i.e. pH, water activity, etc. of Overall Product

Food Safety Characteristics: 1. i.e. pH, water activity, etc. of Each 2. Ingredient 3. 4. 5. 6. Packaging Used:

Ingredients on Package:

Labeling Requirements:

Storage and Distribution:

Intended Consumers:

Intended Use:

Shelf Life:

Approved by: ______________________________ Date:_____________________________________

HACCP PLAN SUMMARY TABLE FOR CCP ON PASTEURIZATION - IDFA

Product Name:

(4) Monitoring

(1) Critical Control Point (CCP)

(2) Hazards

(3) Critical Limits For each Critical Control Point

(5)

(6)

(7)

(8) Corrective Action(s)

(9) Verification

(10) Records

B - Vegetative Pathogens Isolate the affected product. Request evaluation by QA. Disposition the product. Document actions. Temperature (F) Isolate the affected product. Request evaluation by QA. Disposition the product. Document actions. Pasteurizer / Operator Manually divert flow of product.

What Temperature (F) Manually divert flow of product.

Who Pasteurizer / Operator

Temperature recording charts Corrective action records. CCP verification records. Equipment calibration records. Temperature recording charts Product flow charts Corrective action records. CCP verification records. Equipment calibration records.

Pasteurization (Properly functioning HTST without a magnetic flow meter system)

The temperature, as measured at the exit of the extended holding tube, must be at a minimum of 161F for 15 secs.

How Check and sign-off on temperature recording charts.

Frequency Monitoring is done by operator every 2 hours and after each product run.

Pasteurization (Properly functioning HTST with a magnetic flow meter system Flow Rate between low flow set point and high flow set point (gpm)

B Vegetative Pathogens

The temperature as measured at the exit of the extended holding tube, must be at a minimum of 161F for 15 secs. and ___ flow rate The flow rate through the holding tube must meet the following criteria: Low Flow_____gpm High Flow_____gpm Temperature (F) Time (Min) Pasteurizer / Operator

Check and sign-off on temperature and flow recording charts.

Monitoring is done by the operator after every 2 hours and after each product run.

1. Cut in - Cut out performed. 2. Indicating vs recording thermometer comparison 3. Pressure diff. checks 4. Supervisory review and sign-off on recording charts. 5. Equipment calibration. 6. Seal checks 1. Cut in - Cut out performed. 2. Indicating vs recording thermometer comparison 3. Pressure diff. checks 4. Supervisory review and sign-off on recording charts. 5. Equipment calibration. 6. Seal checks.

Vat Pasteurization (with continuous agitation)

B Vegetative Pathogens

Temperature charts Continue pasteurization until time / temperature criteria are met. If more than two hours has elapsed isolate the product and contact QA. Disposition the product. Document actions. Corrective action records. CCP verification records. Equipment calibration records.

The temperature as measured by the air space indicating thermometer must be at a minimum of 145F. The holding time must be a minimum of 30 minutes. The air space thermometer must indicate a minimum of 150F. Time (Min) Annotate the batch information for each batch on the recording chart. Record both air space and indicating thermometer temperatures.

Check and sign-off on recording charts.

Thermometer checks done at beginning and end of holding time.

1. Indicating vs recording thermometer comparison. 2. Supervisory review and sign-off on recording charts. 3. Equipment calibration. Calibration of thermometers. 4. Time calibration of chart controller. 5. Seal checks.

Product Description: Firm Name: Method of Storage & Distribution: Intended Use & Consumer: Signature: Firm Address: Date:

HACCP PLAN SUMMARY TABLE - MODEL CCP ON CONTINUOUS FLOW (HTST & HHST) PASTEURIZATION - NCIMS
Monitoring CCP Verification ** and *** Corrective Action(s)* Records

Critical Control Point (CCP) What Temperature at the exit of the holding tube Manually divert flow of product Record Review Pasteurizer Charts Isolate the affected product Pasteurizer charts verified Equipment Function Checks Operator performs required daily tests and record on the temperature charts Authorized plant person (supervised by regulatory when required) conducts checks listed in the Milk Plant Equipment Test Report (FDA Form 2359b) Seals: Verify required regulatory seals daily Evaluate and determine disposition of the product (reprocess or disposal) Residence time in the holding tube in continuous flow pasteurizers with magnetic flow meter based timing systems Continuous during Operation Document actions Flow Recorder Chart Pasteurizer Operator Corrective Action Records How Continuo us Temp. Recorder Chart Frequency At least once per shift by the operator Who Pasteurizer Operator

Hazard(s)

Critical Limits

Milk and Milk Products Pasteurization (HTST and HHST)

BiologicalVegetative Pathogens (non-spore formers)

Time & Temperature.

Note: Assuring that the minimum holding times are met in systems which use a sealed timing pump would be CCP verification, i.e. equipment calibration

CCP Verification - Records, including equipment testing records

* A properly operating HTST or HHST pasteurization system will divert raw product to the balance tank when predetermined set points are not met. ** Every particle of milk or milk is heated in a properly designed, calibrated and operated pasteurizer, to one of the temperature and time combinations specified in the current Grade A PMO. *** Pressure in the regenerator of continuous flow pasteurizers, and in the case of HHST pasteurizers as required in the holding tubes, across steam injectors and within infusion chambers, shall be addressed in the HACCP Plan and managed as CCP verification(s).

Product Description: Intended Use and Consumer: Signature:

Method of Storage and Distribution: Date:

HACCP PLAN SUMMARY TABLE FOR MODEL CCP ON VAT PASTEURIZATION - NCIMS
Critical Limits Monitoring Corrective Action(s) Records CCP Verification

Critical Control Point (CCP) What Record Review Pasteurizer charts verified Equipment Function Checks Operator performs required observation of indicating and airspace thermometers for each batch (air space checked at both the beginning and the end of the holding time) and recorded on the chart Authorized plant person (supervised by regulatory when required) conducts checks listed in the Milk Plant Equipment Test Report (FDA Form 2359b) Seals: Verify required regulatory seals daily if applicable After Pasteurization (i.e., during the record review): If the product is found not to have met the critical time/temperatur e, place all affected finished product on hold, and evaluate to determine product distribution, i.e., reprocess or destroy 145F with a holding time of a minimum of 30 minutes. Continuous during Operation Pasteurizer Operator The air space thermometer must indicate a minimum of 150F. Temp. Record er Chart Pasteurizer Charts How Frequency Who

Hazard(s)

Milk and Milk Products Pasteurization (Vat)

BiologicalVegetative Pathogens (non-spore formers)

Time and temperatures (in a vat that is continuously agitated to assure that there is no more than 1OF (0.5oC) difference between the warmest and the coldest product in the vat during processing) including minimum required time, product temperature and air space temperatures

During Pasteurization: Continue pasteurization until the time/temperatur e criteria have been met. If the time/temperatur e criteria cannot be met, in two (2) hours, an evaluation need sot be made as to the disposition of the product Corrective Action Records CCP Verification Records, including equipment testing records

Product Description: Intended Use and Consumer: Signature:

Method of Storage and Distribution: Date:

Company Name: Company Address:

Prerequisite Program #

Prerequisite Program Name: Date: Supersedes:

Prerequisite Work Sheet

1. Purpose (one to two sentences)

1. 2. 3. 4. 5. 6.

2.Identify Specific Tasks to accomplish Purpose brief description

Summary of Required Monitoring Documentation

Monitor (What & Who)

Frequency of Monitoring

Monitoring Document

Verification (Who & Frequency)

Retention (Where & How Long)

Procedure #1

Procedure #2

Procedure #3

Procedure #4

Monitor (What & Who)

Frequency of Monitoring

Monitoring Document

Verification (Who & Frequency)

Retention (Where & How Long)

Procedure #5

Procedure #6

Corrective Action:_________________________________________________________________________________________________ ________________________________________________________________________________________________________________

PREREQUISITE EXAMPLES AND FORMS

Prerequisite Program #1 Safety of the water that comes into contact with food or food contact surfaces including steam.

EXAMPLE
PURPOSE:

Plant Name: Issue Date: Supersedes: Approved by:

Water for milk plant purposes, including recirculated cooling water, shall be from a system that is properly constructed, protected and operated, and shall be accessible, adequate and of a safe sanitary quality. Whenever steam is used in contact with milk or milk products, it shall be of culinary quality with the use of acceptable additives, as necessary.

Note: The Grade A Pasteurized Milk Ordinance (PMO) provides guidance for water as well as steam. The administrative procedures will provide appropriate guidance for establishing specific procedures. The PMO also provides guidance for construction and operation of water systems, recirculated cooling water systems and systems used to generate culinary steam.

PROCEDURE SUMMARY: 1) Municipal Water a) Test back-flow preventers annually by approved outside service. b) Semi-annual testing for total coliform at corporate testing laboratory. c) Review of plant water distribution system on an annual basis or after major changes to the system. d) Quarterly testing for coliform of municipal water at source within the production environment. 2) Captive (Sweet) Water a) Semi-annual testing for total aerobic plate count and total coliform by state. b) Weekly testing for total aerobic plate count and total coliform by onsite laboratory. c) Weekly testing of chlorine level, additions as needed. d) Letter of continuous guarantee from supplier that captive water additives are of food grade quality. 3) Glycol a) Semi-annual testing for total aerobic plate count and total coliform by state. b) Monthly testing for total aerobic plate count and total coliform by onsite laboratory. c) Letter of continuous guarantee from supplier that glycol additives are of food grade quality. 4) Boiler / Steam a) Letter of continuous guarantee from supplier that boiler additives are of food grade quality. b) Chemical Additive monitoring by chemical supplier representative. 5) Central Sanitizer System a) Semi-annual testing for total aerobic plate count and total coliform at source. RECORDS: 1) Municipal Water a) Back-flow preventer inspection report located in Maintenance Engineers file. b) Testing report provided by corporate lab and located in Quality Assurance Managers file. c) Plant water distribution system review located in Quality Assurance Managers file. d) Testing results available within the electronic system under Plant Water category.

2) Captive (Sweet) Water a) State testing report located in onsite laboratory. b) Onsite microbiological testing results located within the electronic system under Plant Water category. c) Onsite chemical testing results located within the electronic system under Plant Water category. d) Letter of continuous guarantee located in Quality Assurance Managers file. 3) Glycol a) State testing report located in onsite laboratory. b) Onsite microbiological testing results located within the electronic system under Plant Water category. c) Letter of continuous guarantee located in Quality Assurance Managers file. 4) Boiler / Steam a) Letter of continuous guarantee located in Quality Assurance Managers file. b) Chemical Additive representative service report located in Maintenance Engineers file. 5) Central Sanitizer System a) Onsite microbiological testing results located within the electronic system under Plant Water category. CORRECTIONS: 1) Municipal Water a) Outside service to replace or repair back-flow preventer. b) Resample and retest, if 2nd test fails investigate possible sources of contamination and notify municipality. c) Make necessary changes. d) Clean and sanitize or replace sampled source, retest. 2) Captive (Sweet) Water a) Investigate source tank, review chemical concentrations and retest at onsite laboratory. Ensure timely regulatory resampling. b) Investigate source tank, review chemical concentrations and retest at onsite laboratory. c) Review chemical concentration and make necessary changes. d) Request letter from supplier. 3) Glycol a) Investigate source tank, review chemical concentrations and retest at onsite laboratory. Ensure timely regulatory resampling. b) Investigate source tank and retest at onsite laboratory. c) Request letter from supplier. 4) Boiler / Steam a) Request letter from supplier. b) Chemical representative makes changes as necessary.

5) Central Sanitizer System a) Investigate, clean and sanitize or replace sampled source, retest. Summary of Required Monitoring Documentation: Monitoring Frequency Monitoring Document VerificationRetentionWho & Where and Frequency How Long Maintenance Maintenance Engineer semi- Engineers File annually 2 years Quality Assurance Manager semiannually HACCP team annually Quality Assurance managers File 2 years Quality Assurance managers File 2 years Electronic System 2 years Laboratory File 2 years

Monitor-What Back-Flow Preventer

Monitor-Who Approved outside service

Municipal water Corporate total coliform testing lab testing Plant water distribution system review Plant water source testing HACCP team member, Maintenance Engineer Laboratory Technicians

Semi-annual Back-flow preventer inspection report Semi-annual Electronic System, RBOLI21 report Annual, or Plant water after major distribution changes system review Quarterly Electronic System

State captive water testing

State

Semi-annual State captive water testing report Weekly Electronic System

Onsite captive water microbiological testing Onsite captive water chemical testing Captive water additive letter of continuous guarantee State Glycol testing

Laboratory Technicians

Laboratory Technicians

Weekly

Electronic System

Quality Assurance Manager State

Annual, or after changes

Letter of continuous guarantee

Semi-annual State Glycol testing report

Quality Assurance Supervisor monthly Quality Assurance Manager semiannual Quality Assurance Supervisor monthly Quality Assurance Supervisor monthly Quality Assurance Supervisor annually Quality Assurance Manager semiannually

Electronic System 2 years Electronic System 2 years Quality Assurance managers File 2 years Laboratory File 2 years

Monitor-What

Monitor-Who

Monitoring Frequency Weekly

Monitoring Document Electronic System

Onsite glycol Laboratory microbiological Technicians testing Glycol additive letter of continuous guarantee Boiler additive letter of continuous guarantee Onsite boiler chemical testing Quality Assurance Manager Quality Assurance Manager Chemical Representative

Annual, or after changes Annual, or after changes

Letter of continuous guarantee Letter of continuous guarantee

Onsite central Laboratory sanitizer system Technicians microbiological testing

SemiService annually or Report more frequently if needed Semi-annual Electronic System

VerificationWho & Frequency Quality Assurance Supervisor monthly Quality Assurance Supervisor annually Quality Assurance Supervisor annually Maintenance Engineer annually

RetentionWhere and How Long Electronic System 2 years Quality Assurance managers File 2 years Quality Assurance managers File 2 years Maintenance Engineers File 2 years

Quality Assurance Supervisor semi-annually

Electronic System 2 years

Prerequisite Program #2 Condition and Cleanliness of Food Contact Surfaces.

EXAMPLE

Plant Name: Issue Date: Supersedes: Approved by:

PURPOSE:
All food contact surfaces shall be properly designed, constructed and maintained to facilitate proper sanitation. All food contact surfaces shall be adequately and routinely cleaned and sanitized with chemicals approved for food contact use.

Note: The Grade A Pasteurized Milk Ordinance (PMO) provides guidance for the condition and cleanliness of food contact surfaces. The administrative procedures will provide appropriate guidance for establishing specific procedures.

PROCEDURE SUMMARY: 6) Construction a) Process change control review of equipment prior to use or when a process change is made. b) Regulatory, third party and internal audits of equipment. 7) Cleanliness and Sanitation a) Cleaning procedures (SSOPs) for equipment b) Preoperational Cleaning Verification i) Fillers Preoperational inspection, CIP chart ii) HTST Start up check list, CIP chart iii) Tanks Preoperational inspection, CIP chart iv) Line Systems CIP chart, verification of time and temperature c) Cleaning Systems for Product Contact Surfaces i) Chemical concentration check of CIP systems ii) Periodic review of operation by chemical supplier representative iii) Chemical concentration, time and temperature check of COP system RECORDS: 6) Construction a) Process change control form located in Quality Assurance Managers office. b) Inspection reports and corrective action located in task keeper database, available on corporate computer network. 7) Cleanliness and Sanitation a) Daily cleaning checklist located in production office and SSOPs available in online SSOP system located on plant computer network b) Preoperational Cleaning Verification i) Preoperational inspection report located in production office. CIP charts located in production office. ii) HTST start-up checklist located in production office. CIP chart located in production office.

iii) Preoperational checklist located in production office. CIP chart located in production office. iv) CIP chart located in production office. c) Cleaning Systems for Product Contact Surfaces i) CIP System chemical concentration logs located in Sanitation Supervisors office. Current months records kept at CIP systems. ii) Chemical supplier representatives CIP Vessel Performance Report kept electronically on plant computer network. iii) Temperature recording chart and chemical concentration log located in production office. CORRECTIONS: 1) Construction a) Make necessary changes as determined by process control review. b) Make necessary changes as mandated by regulatory, third party and internal audits. 2) Cleanliness and Sanitation a) Supervisor verifies cleaning tasks were completed by the responsible operator. If unable to verify completion, unconfirmed tasks will be completed. b) Preoperational Cleaning Verification i) Fillers Failed preoperational inspection items cleaned until passes re-inspection. CIP Chart Investigate and take appropriate action, which may include rewashing of equipment, to verify equipment cleanliness. ii) HTST Failed start-up check list items (as relating to cleanliness of equipment) meets check list requirements. CIP Chart - Investigate and take appropriate action, which may include rewashing of equipment, to verify equipment cleanliness. iii) Tanks - Failed preoperational inspection items cleaned until passes re-inspection. CIP Chart Investigate and take appropriate action, which may include rewashing of equipment, to verify equipment cleanliness. iv) Line Systems - Investigate and take appropriate action, which may include rewashing of equipment, to verify equipment cleanliness. c) Cleaning Systems i) Adjust chemical concentration to desired range and take appropriate action, which may include rewashing of equipment, to verify equipment cleanliness. ii) Review report and take appropriate action to maintain cleaning effectiveness. iii) Investigate and take appropriate action, which may include rewashing of equipment, to verify equipment cleanliness.

Summary of Required Monitoring Documentation: Monitoring Frequency Prior to use or when a process change is made Regulatory Quarterly Third Party Annually Quality Assurance Monthly Every day of use Verification-Who Retention-Where & Frequency and How Long Quality Assurance Manager weekly Quality Assurance Manager quarterly for all available records Quality Assurance Managers office 2 years Task Keeper database 2 years

MonitorWhat Process Change Control

Monitor-Who Plant Operations Manager Regulatory, third party and quality assurance

Monitoring Document Process Change Control Form

Audits of equipment

Inspection reports, corrective action reports

Cleaning procedures for equipment Preoperational inspection Fillers

Production Employees

Daily cleaning checklist, SSOPs Preoperational inspection report, CIP chart HTST start-up checklist, CIP chart Preoperational inspection report, CIP chart CIP chart

Preoperational inspection HTST Preoperational inspection Tanks Preoperational inspection Line Systems Chemical concentration check of CIP systems Review of CIP system

Quality Assurance Department, Production Supervisor HTST Operator

Every day of use

Quality Assurance Department weekly Sanitation Supervisor weekly

Every day of use

Production Employees

Every day of use

Quality Assurance Manager weekly Sanitation Supervisor weekly Sanitation Supervisor weekly Sanitation Supervisor weekly Sanitation Supervisor annually

Production Office, Online SSOP system 2 years Sanitation Supervisors Office, Production Office 2 years Production Office 2 years

Production Office 2 years

Production Employees Production Employees

Every day of use Every day of use

Production Office 2 years CIP System, Production Office 2 years Stored electronically on network 2 years

Chemical Supplier Representative

Annually

CIP System chemical concentration log CIP Vessel Performance Report

MonitorWhat Chemical concentration, time and temperature check of COP system

Monitor-Who Production Employees

Monitoring Frequency Every day of use

Monitoring Document Temperature recording chart and chemical concentration log

Verification-Who Retention-Where & Frequency and How Long Sanitation Supervisorannually Production Office 2 years

Prerequisite Program #10 Product Temperature Management Program

EXAMPLE
Goal:

Plant Name: Issue Date: Supersedes: Approved by:

To have adequate means of establishing, maintaining and monitoring temperatures of: Raw materials/ingredients used in production. Finished product to ensure safe storage of the food. Distributed products.

Procedures: 1. Raw materials/ingredients temperature control. a. Monitoring Silo Storage Temperature Recording Charts b. Monitoring Incoming Milk Temperature Log 2. Finished Product Temperature Control a. Monitoring Finished Product Temperature Recording Charts. b. Monitoring Pasteurization Recording Charts c. Other documentation Daily Temperature Checks. 3. Pre-shipment Transport Requirements a. Monitoring Truck Inspection/Refrigeration Checks. Summary of Required Monitoring Documentation: Monitoring Frequency Daily Daily RetentionVerificationWhere and Who & How Long Frequency 1a. Silo Production Mgr Production Temp. Charts Weekly Dept. 1 year 1b. Milk Production Mgr. Production Receiving weekly Dept. 1 year Temp. Log 2a. Finished Warehouse Mgr. Warehouse Product Temp. Weekly Dept. 1 year Charts 2b. Production Mgr. Production Pasteurization weekly Dept. 1 year Temp. Charts 2c. Daily Warehouse Mgr. Warehouse Temp. Checks Weekly Dept. 1 year Monitoring Document 3a. Transportion Inspection & Temp. Log Warehouse Mgr. Warehouse Weekly Dept. 1 year

Monitor-What Monitor-Who Raw materials & Ingredients Raw materials & Ingredients Finished Products Finished Products inprocess Finished Products packaged Finished Products packaged Production Supervisor Milk Receiver

Warehouse Supervisor Production Supervisor Warehouse Supervisor Warehouse Supervisor

Weekly

Daily

Daily

Daily

Corrections: Corrections will be taken as needed at each step and noted on the monitoring form. Any correction that cannot be accomplished immediately will be reported to the appropriate supervisor to assess whether the non-conformity presents a significant weakness or has a potential impact on the ability to produce a safe product. In addition, the supervisor will assess whether immediate short term measures are needed to minimize the effect of the problem on our product or operation. Corrections that cannot be addressed immediately will be given a timeline for correction in the Scheduled Correction Log and will be reassessed on a weekly basis.

Signature:

Date:

Prerequisite program # 4: Maintenance of Hand Washing and Sanitizing, and Toilet Facilities Example

Page 1 of 2, September 8, 2008 Approved by___________________

PURPOSE: Toilet rooms shall not open directly into any room in which milk/milk products are processed. Toilet rooms shall be completely enclosed and shall have tight-fitting, self-closing doors. Dressing rooms, toilet rooms and fixtures shall be kept in a clean condition, in good repair and shall be well ventilated and well lighted. Sewage and other liquid wastes shall be disposed of in a sanitary manner (from PMO item 6p) Convenient hand washing facilities shall be provided, including hot and cold running water and or warm water, soap and individual sanitary towels. Hand washing facilities shall be kept clean and in good repair (from PMO Item 8p). (Note: This is an example of how the PMO can be used to provide guidance for the prerequisite program. In this situation, the PMO is referenced, but what we are interested in is the set of procedures we will put in place that will be monitored and documented in the prerequisite program.) PROCEDURE SUMMARY: 1. Restroom facilities and hand washing areas will be inspected and maintained by the last powder packer of the shift, at the close of each shift. 2. A contract cleaning service will clean and perform scheduled maintenance on restrooms weekly. 3. Monthly plant audits will assess repair, ventilation and lighting. 4. Annual verification will assess adequacy and convenience of hand washing facilities (Note: Prerequisite programs are broad areas of emphasis that need to have procedures established in order to identify specific actions that are to be taken. A program may have multiple procedures that fix responsibilities and assign frequencies.) WHAT TO MONITOR: 1. At least once per shift the designated employee will perform the inspection of all facilities and clean and/or maintain as needed using as a reference the checklist in PS#09951. 2. QC will check restrooms after contract cleaning before initialing the bill for payment. 3. The monthly plant audit walk-through team will assess repair, ventilation and lighting of restrooms. 4. The annual verification team will use a facilities inspection checklist and employee feedback to assess the adequacy and convenience of hand washing stations in the work areas. Need for hand sanitizing stations will also be assessed. (Note: In some programs, it is difficult to separate the procedures, what to monitor and documents and there is considerable redundancy when this format and these categories are used. RECORDS 1. Inspection log of hand washing, toilet and sanitizing facilities (PS # 09951) to kept in Plant Supervisors office when not in use. Completed documents are to be filed in Plant supervisors office and maintained for a year. 2. Contract cleaning bills are submitted to Accounts Payable after initialed by QC. These are stored in the Business Office and are maintained according to their policies.

3. The Monthly Plant Audit Form (PS#12345) includes section on restrooms-repair, ventilation, and lighting. Forms are filed in the lab for at least two years. 4. The Facilities Inspection Checklist for Annual Verification includes Are hand washing and hand sanitizing stations (if needed) adequate and convenient to the work areas? Checklists are maintained in the Plant Supervisors Office for two years.
(Note: The narrative nature of this section makes the identification and auditing of records somewhat less convenient than when this material is presented in chart form as on the PP#1 example.) Note from the above that procedures need be related to their monitoring and documentation directly in an easy to follow manner.

CORRECTIONS: 1. Corrections will be taken as needed at each monitoring step and noted on the monitoring form. 2. Any correction that cannot be accomplished immediately will be reported to the appropriate supervisor to assess whether the non-conformity presents a hazard, a potential impact on our ability to produce a quality product or a legal violation. In addition the supervisor will assess whether temporary measures are needed to minimize the effect of the non-conformity on our product or operation. 3. Corrections that cannot be addressed immediately will be given a timeline for correction in the Scheduled Correction Log and will be reassessed at weekly supervisors meetings until corrected. (Note: All corrections cannot be accomplished immediately, and some corrections have a higher urgency than others. No identified non-conformance should be noted without a carefully considered correction plan and a timeline to get it accomplished. Have a procedure to reassess the timeline regularly and adjust as necessary to make sure the due date does not pass without some action, if only to extend the timeline as necessary.) DATE: SIGNATURE: SUPERCEDES: 08/8/08

Plant HACCP Team

Experience HACCP Program Development Responsibilities
June 2006

Name

Job Title & Role on HACCP Team

FOR EXAMPLE - SEE BELOW B.S. Micro., 12 years in Oversee development & maintenance of various dairy plants plant HACCP program - Develop and finalize written Verification & Validation Program

Task Completion Date

Allen Smith

Quality Control Supervisor/HACCP Team Leader

Name of drafter: Date of Document:

Corrective Action Plan-Centralized Deviation Log

1. Segregate and hold the affected product 2. Perform or obtain a review to determine the acceptability of the affected product for distribution. 3. Take corrective action, when necessary, with respect to the affected product to ensure that no injurious or adulterated product enters commerce. 4. Correct the cause of the deviation 5. Perform or obtain timely validation as required by a qualified individual(s), to determine whether modification of the HACCP plan is required to reduce the risk of recurrence of the deviation. Modify the HACCP plan as necessary.

Identify CCP & Critical Limit

Description/Ca use of Deviation

Identity, Amount & Disposition of Affected Product

Description of Corrective Activities to Prevent Reoccurrence

Was HACCP Plan Re-Verification Conducted? If yes, summarize outcome

Was HACCP Plan Re-Validation Conducted? If yes, summarize outcome

Name of drafter: Date of Document:

CCP Records Plan

Location of Record Monitoring Employee Frequency of Record (daily, weekly, monthly) Comments

Name

Description of Record

Name of drafter: Date of Document:

VERIFICATION PLAN
Outcome and Follow-up
Need to update list for new HACCP Team Member Consumer mix unchanged, added Nebraska Break out past. into separate elements Eggnog not included Rework on Flow Diagram missed Identify specific biological hazards OK Did not address metal fragments May 4, 2008 May 6, 2008 " " Label CCPs with #1, #2, etc. OK " OK Temp for past. is operating limit

Reason for Review:

Specific Activity
Chris Bunch May 2, 2008

Name of Date Narrative of Specific Verifier Conducted Activity

Chris Bunch Jeanne Cochiarella " " May 4, 2008 " " May 4, 2008

HACCP Team Compare active HACCP Team Members members with Written list, frequency of meetings, etc. Consumer & Determine whether consumer mix & Distribution distribution have changed Hazard Flow Diagram for Each Product Analysis May 2, 2008

All products included

" All Flow Diagram Elements on H.A. " Jeanne Cochiarella

Hazards specifically identified

All hazards addressed by PP or CCP " " All hazards "reasonably likely to occur" addressed Jeanne CCPs properly identified Cochiarella Steve Janish HACCP Plan All CCPs from H.A. included

All CCPs have critial limits

HACCP Plan CCP monitoring records support C.L. "

Specific Activity
Steve Janish " " " Steve Janish " Hugh O'Hare May 10, 2008 Hugh O'Hare May 10, 2008 May 4, 2008 May 4, 2008 " " OK All tests run, seals in place at 3 month freq. Pump not calibrated for last 3 months " " " May 6, 2008 May 6, 2008 Missing records from 4/2-5/08 OK None for this period No deviations this period Select one name for past. seal record

Name of Date Narrative of Specific Verifier Conducted Activity Outcome and Follow-up

Monitoring records support critical limits

Responsible person identified Deviations documentation Corrective Action Plan followed CCP records consistently identified

Monitoring records signed & dated

Calibration of Past. Equipment check record CCP Monitoring Vitamin pump calibration & weekly Instruments use reconciliation Prerequisite All PPs identified in H.A. exist Programs All PPs identified in H.A. exist Craig Stevenson Craig Stevenson " " " Craig May 4, 2008 Stevenson Amy Rhodes May 2, 2008 " Poly Vander Wal " May 6, 2008

No documentation of Temp. Management PP MissingTemp. Man. PP See above. More detail needed on PP#3Equip. Cleaning Pest PP lack records for 3 months No date or sign. for ingredient COAs No summaries for March Taste complaint of April 2 with no info Yes

All PPs have written narrative

Consumer Complaints

All PP records exist & current All PP monitoring records signed & dated Weekly Summaries complete

Follow-up of all sensory & illness complaints Mock Recalls Written mock recall program exists with effectiveness criteria

Specific Activity
" " " No, only 90% of buyers contacted " Yes

Name of Date Narrative of Specific Verifier Conducted Activity Outcome and Follow-up

Mock recall conducted in last 6 months Effectiveness criteria met

VERIFICATION PLAN
Name of Verifier Frequency of Verification Activity Outcome and Action Items

Reason for Review:

Specific Activity, i.e. Narrative of Specific Activity

CCP records, corrective actions, equipment calibration, etc.

Name of drafter: Date of Document:

VALIDATION PLAN
Name of Validator
Kitty Smith April 15, 2008

Reason for Review: Name of drafter: Date of Document:

Specific Activity

Narrative of Specific Activity (example)

Date of Validation

Outcome and Action Items

No changes to the written HACCP program were necessary. It is recommended that training of substitutes and replacement staff on documenting the receipt of incoming packaging and ingredients be increased to once every three months.

1. Review of Plant History since _______

Kitty Smith

April 15, 2008

Recommend a weekly summary of all consumer complaints for product covered under the written HACCP program be circulated to plant QA and the plant manager.

No recalls or only one market withdrawal activity recorded for the products covered under this written HACCP Program during the last 12 months. Market withdrawal based on product packaging mix-up. Employee training and the preprequisite on incoming packaging and ingredients strengthened. 2. Review of All consumer complaints for Consumer the last 12 months addressed Complaint Files without the need to modify the since HACCP program other than ______________ one incident. See #1. 3. Identifying emerging hazards specific to products covered under the HACCP program. a. Experts i.e. contacted Allen Sayler, contacted IDFA; Steve Murphy, Cornell regarding University; Dr. Ron Schmidt, emerging new U. of Flordia; Dr. John hazards and dairy Rushing, NC State University; industry trends: Wisconsin Center for Dairy Sarah Jones April 12, 2008

All experts contacted did not identify any new hazards or change in the importance of existing hazards identified in the Hazard Analysis for the products covered in the written HACCP program.

Specific Activity

Narrative of Specific Activity (example)

Name of Validator

Date of Validation

Outcome and Action Items

b. Scientific Literature Search Conducted Jim Martin April 10 15, 2008

Located 35 scientific articles written over the last 12 months on the products covered under the written HACCP program with no new hazards identified.

c. Evaluated the Center for Disease Control's Morbidity & Mortality data for dairy products covered under HACCP program -

Kitty Smith

April 15, 2008

The trends of food borne outbreaks for calendar year 2007 did not identify any new pathogens of concern for dairy products and the number of outbreaks attributed to dairy products covered in the HACCP program dropped by 0.5%.

d. Reviewed FDA food recall data for the last 12 months for products covered under the written HACCP program 4. In-depth review of the written HACCP Team

Research; Dr. John Partridge, Michigan State University, Dr. Linda Harris, U. of Cal. Davis; etc. Completed an internet search on key words, xx, xxx, xxxx and xxxxx . Also did a library search of the following scientific journals and trade industry publications. XXXXXXXXXXXX XXXXXXXX XXXXXXXXXXXX Reviewed the CDC website (http://www.cdc.gov/ncidod/di seases/food/index.htm) and gathered information on food borne outbreaks related to dairy products and their causes. Review specific weekly CDC Morbidity & Mortality Weekly Reports at http://www.cdc.gov/mmwr/we ekcvol.html Reviewed the FDA website (http://www.fda.gov/oc/po/fir mrecalls/archive.html) on food recalls over the past 12 months Sarah Smith April 18, 2008

Of the 20 recalls of dairy products during the last 12 months, 17 were based on allergen concerns and lack of labeling with 2 based on microbial contamination with listeria or pathogenic ecoli, and eight based on comsumption of raw milk. All pathogens are included in the current Hazard Analysis. April 20 25, 2008 No changes made to the written hazard analysis for all 5 dairy products covered under the written HACCP

Did a step-by-step review of all 5 hazard analysis, based on

Specific Activity
program.

Narrative of Specific Activity (example)

Name of Validator

Date of Validation

Outcome and Action Items

information gathered from items 1, 2 & 3 a-d

Reviewed the written HACCP April 22 Made changes to strengthen the training of new and prerequisite sections, GMPS Team 27, 2008 replacement workers in reviewing incoming packaging, and SSOPS for all 5 dairy ingredient and other materials. Added an additional products based on the new supervisory requirement to review this new manual log information from items 1, 2 & within 48 hours. 3a-d. 7. Implementation Briefed plant management and HACCP April 30, Based on management and employee feedback, will of changes from conducted a HACCP training Team 2008 work to review COA and letters of guarantee program validation of the session for all production within the prerequisite on receiving/incoming written HACCP employees on HACCP and materials. program. outcome of the validation. Examples of Validation Activities: 1. In our example, pasteurization at >160F and > 6 seconds has been recommended and supported by scientific literature as a minimum criterion to achieve a 5-log reduction of vegetative and protozoan pathogens in juice. Proper process verification activities (i.e. commissioning equipment) must occur to ensure this recommended process is delivered. 2. When a processor uses a handheld computer and software system to record the monitoring activities, the system should be validated according to 21 CFR 11 to meet the processors and the computer manufacturers requirements. 3. It has been shown that a screen with a pore size of 2.0 millimeters eliminates foreign objects and restricts the particle size going into the pasteurizer resulting in compliance with FDA's CPG on Foreign Objects.

hazard analysis for each product covered by the HACCP program. 5. Based on outcome of #4, validation of the CCPs and critical limits. 6. Validate the written prerequisite sections, GMPS and SSOPS

Reviewed the HACCP Plan Summary Table for all 5 dairy products covered under the written HACCP program HACCP Team April 22 27, 2008

No changes made to the written HACCP Plan Summary table for all 5 products covered under the written HACCP program.

VALIDATION PLAN
Name of Validator Date of Validation Outcome and Action Items

Reason for Review: Name of drafter: Date of Document:

Specific Activity

Narrative of Specific Activity (example)

HACCP Program Records Summary

Date:
Frequency Every occurrence Responsible Monitor Responsible Verifier Comments

PP, CCP or Activity Name Employee Training & Hygiene

Record Name

HACCP Employee Training Log

GMP Employee Training Log

Information Collected Information will include employee name, date and time of training and brief description of training Information will include employee name, date and time of training and brief description of training Every occurrence

HACCP Team Meetings Product Safety Time between washings

Wash every 72 hours

2nd Shift Milk Receiver

Water Safety

Twice per week

Maintenance

Target level is 200 -300 ppm. Monthly Third shift maintenance

Concentrated Milk Tank Charts Pasteurization Records Water Log Sheet by Maintenance Dept. Monthly Water Results for Total Coliform Chlorine level Sanitizer Hose Stations Water and Sweet water coliform levels

PP, CCP or Activity Name Semi-annually On-file John

Record Name

Frequency

State Water Report Letter of Conformance

Responsible Monitor ODA

Responsible Verifier

Comments

Condition & Cleanliness of the Processing Equipment At the end of each day's use

CIP System #1 Chart

Information Collected Water and sweet water coliform Acceptability of sweet water and boiler water treatment with FDA requirements Date, time, plant name, identification of equipment being washed and operator responsible. Equipment could include???????? Continuous 12 hour temperature recording chart, computer gathered data on chemical concentrations, pH, flow rates, discharge pressure, etc. Manual Log 2nd Shift Manufacturing Employees

COP Tanks (2) Cleaning Log

At the end of each day's use

Vat Past. Record

Date, time, plant name, identification of equipment being washed, temperature of water, cleaning chemical (s) and amount used and operator responsible. Date, time, plant name,

At the end of each days use and for

Pasteurizer Operators

Continuous 12 hour recording

PP, CCP or Activity Name mid-day short washes. chart

Record Name

Frequency

Responsible Monitor

Responsible Verifier

Comments

Supervisor's Plant Inspection Record Weekly Supervisors

Manual Log

Metal Detector Log

Every hour during production

Manual Log

Equipment Preventative Maintenance Program

Information Collected identification of equipment being washed and operator responsible. Silo interior cracks, leaking valves, leaking agitator shafts, leaking motor oil seals, appropriate amount of grease used, shielding for equipment, conveyors, supports, lubricants, general facility cleanliness Accuracy of detection of 1.2 mm non-ferrous and 1.7 mm stainless steel. Date and time of repair request, origin of request, plant name, brief description of equipment to be repaired, identification of needed parts and FIFO Maintenance Staff Manual Log Build simple computerized tracking system.

PP, CCP or Activity Name

Record Name

Responsible Monitor

Responsible Verifier

Comments

Adulteration & Allergen Management Maintenance

CIP and product piping drawings

Maintenance

Freezing Units Cleaning

Product Check Log

Information Frequency Collected name of assigned employee. For equipment with scheduled periodic maintenance needs, also include the frequency of such maintenance. Current diagram Verify annually of all CIP and product piping PM Card for Semi-annually cleaning of all refrigeration units including radiator vanes Coliform, Every occurrence bacteria, yeast, molds, etc. Every raw milk tanker Continuous Milk Receiver

Temperature Control Temperature

Rework Log Concentrated Milk Temperature Receiving Log

Tank Temperature Charts

Milk Receiver

Below 45 degrees, no drug residues. Below 45 degrees and less than 72 hours on 7 day recording chart. Once per day in morning

Freezer Temperatures

Cooler temperature

PP, CCP or Activity Name

Record Name

Frequency

Responsible Monitor

Responsible Verifier

Comments

Every occurrence

On file for all covered products in Food Safety Manager office

Supplier

Update to be current.

Every shipment Supplier by Food Safety Manager Every shipment Dave Kramer by shipping/receiving employee Every raw milk tanker Milk Receiver

Return within 1 month after receipt Return within 1 month after receipt

Information Collected manually recorded from digital thermometer Employee Health Employee Information will & Hygiene Training Log include employee name, date and time of training and brief description of training Receiving/Storage/ Letters of Chemicals, Transport Guarantee or sodium chloride, Product Data hydrogen Sheets peroxide, ammonia hydroxide and phosphoric acid, packaging, salt COAs Bulk Starter Media, coagulant, cultures, color, Truck Inspection Records of Log damaged material, packaging integrity and condition of trailer Concentrated Milk Bacteria (DMS of Receiving Log 100,000 cfu/ml), drug residues (Charm SL), date and time, washing before leaving, if Below 45 degrees, no drug residues

PP, CCP or Activity Name Daily on Supervisors Audit Sheet Supervisors

Record Name

Non-dairy ingredients including Oat

Information Collected tanker was sealed, Temperatures of the whey powders

Frequency

Responsible Monitor

Responsible Verifier

Comments

Cookie, Wafer, Cone, Chocolate Chip Cookie, chocolate, peanuts, etc.

Recall Program

Pest Control

Market Identify affected Every occurrence Withdrawal/Recall product, amount, Log location, distribution, amount retained under plant control, basis for decision to withdraw from market or recall, date and time of notification of regulators, if applicable, etc. Mock Market Evaluate Semi-annually Withdrawal/Recall effectiveness of Exercise Market Withdrawal/Recall program and correct weaknesses Mouse Trap & Status of outside Monthly Bait Station Log and interior rodent Contractor

By outside Pest Control

PP, CCP or Activity Name Company Monthly Current file reviewed at least annually and updated as necessary Contractor Contractor

Record Name

Frequency

Responsible Monitor

Responsible Verifier

Comments

Insect Light Trap

Pesticide Label File

By plant employees Plant Food Safety Manager

Pesticide Application Log

For each separate application

Contractor

By plant employees or outside Pest Control Company

Facility Maintenance

Supervisor's Plant Inspection Record

Information Collected bait stations and glue boards Status of trap and dead insect load EPA Product Registration No., Pesticide ingredients, directions for use, cautionary statements, supplier, action to be taken if problem develops. Date, pesticide used, rate of application, location of application, EPA Registration number, targeted pest, amount used, method of application and identification of applicator. Door sanitizers, doors, walls, floors and ceiling construction, general interior and exterior Weekly Supervisors Manual Log

PP, CCP or Activity Name

Record Name

Frequency

Responsible Monitor

Responsible Verifier

Comments

Hand washing and Toilet Facility Maintenance Log Daily

Conducted by outside cleaning company

Environmental Swabbing Log

Alternate zones each week so entire plant covered every month.

Interior Air Sampling Log

Information Collected facility cleanliness and outside pallet protection. Cleaning of each hand washing, employee break room and toilet facility including stocking with soap, hand towels and toilet paper. Swabbing each of 4 interior plant zones on a rotating basis. Tested by outside lab for Salmonella and Listeria. In-plant analysis for yeast and molds from 4 separate zones. Use of RCS Air Sampler Alternate zones Jodi each week so entire plant covered every month. Every shipment Dave Kramer by shipping/receiving employee Return immediately if problems.

Toxic Chemical Use and Storage

Truck Inspection Log

Supervisor's Plant Inspection Record

Records of proper label, Bill of Lading, damaged material, packaging integrity and condition of trailer Proper labeling Weekly and storage of

Supervisors

PP, CCP or Activity Name

Record Name

Frequency

Responsible Monitor

Responsible Verifier

Comments

Air Filter Maintenance

Filter Log

Information Collected toxic chemicals in plant including bulk and employee-sized containers Raw milk receiving filter Whey filter (prior to RO)condition Monthly Air Filter Filter Log Maintenance

GMPs

Monthly Inspection Sheet Supervisor's Plant Inspection Record Compliance with 21 CFR 110 Maintenance Monthly and as needed by supervisors Daily Supervisors

Verification Records

Daily Shift Maintenance Log

Adjust as necessary

Lab thermometer calibration record

Semi-annually

Jodi

Vat Concentrated Milk Pasteurizer Equipment Checks

Quarterly and/or semi-annually

State Regulators

Conducted by state regulatory authority

HTST Whey Pasteurizer

Accuracy of raw milk and pasteurized cream silo temperature recorders Temperatures of plant operating thermometers Proper location and operation of public health control equipment, all necessary seals in place. See PMO Appendix I for details. Flow rate, proper inter wiring, Quarterly and/or semi-annually

State Regulators

Conducted by state

PP, CCP or Activity Name regulatory authority

Record Name

Responsible Monitor

Responsible Verifier

Comments

Equipment Checks

Heat-treated Starter Vat Equipment Checks

Information Frequency Collected proper FDV & LDV operation, proper holding tube slope, proper location and operation of public health control equipment, all necessary seals in place. See PMO Appendix I for details. Recording vs. Quarterly indicating thermometer, air space thermometer, outlet valve function Jodi Conducted by plant quality control because starter vats do not meet pasteurization construction standards

HACCP Program Validation

Current national illness data related to consumption of products cover under HACCP program, plant experience, recent scientific studies related to safety of products covered under HACCP

Once every 12 Chuck months and when new information becomes available specific to products covered under the HACCP program.

PP, CCP or Activity Name

Record Name

Frequency

Responsible Monitor

Responsible Verifier

Comments

HACCP Program Verification Allen

Information Collected program, regulatory recommendations or requirements Comparison of written HACCP program to implemented HACCP system to determine compliance. Critical limits on temperature of the Vat Pasteurizer Once every 12 months and when new products are added, new ingredients used or when processing steps are changed. Information is continuous and monitored by operator to assure proper functioning of equipment Daily Pasteurizer Operator at startup and chart change Supervisors Floor operator Supervisors

CCP - Raw Milk Pasteurization

Vat Past. Temperature Recording Chart

CCP Metal Detection

Metal Detection Log

Ability of metal detector to alarm if metal over specified size passed through

NCIMS HACCP Forms

NCIMS HACCP Forms

Department of Health and Human Services Food and Drug Administration DATE TYPE OF AUDIT STATE REGULATORY* FIRM NAME ADDRESS (Line 1) ADDRESS (Line 2) IMS LISTED PRODUCT(S) MANUFACTURED AND REVIEWED Hazard Analysis Issue Date(s) HACCP Plan Issue Date(s)

MILK PLANT, RECEIVING STATION OR TRANSFER STATION

NCIMS HACCP SYSTEM AUDIT REPORT

STATE REGULATORY FOLLOW-UP LICENSE/PERMIT NO. STATE LISTING FDA AUDIT OF LISTING

IMS PLANT NO.

CITY

STATE

ZIP CODE

Prerequisite Program(s) Issue Date(s)

ITEMS MARKED DID NOT MEET THE NCIMS HACCP PROGRAM CRITERIA DESCRIBED BELOW Starred Items are Critical Listing Elements
*NOTE: This regulatory NCIMS System Audit Report of your plant, receiving station, or transfer station serves as a notification of the intent to suspend your permit if items marked on this audit report are not in compliance at the time of the next regulatory audit or within established timelines. (Refer to PMO Sections 3 and 6, and Appendix K. for details.)

Section 1
A. B.

HAZARD ANALYSIS
Flow Diagram and Hazard Analysis conducted and written for each kind or group of milk or milk product processed.** Written Hazard Analysis identifies all potential milk or milk product safety hazards and determines those that are reasonably likely to occur (including hazards within and outside the processing plant environment). Written Hazard Analysis reassessed after changes in raw materials, formulations, processing methods/systems, distribution, intended use or consumers. Written Hazard Analysis signed and dated as required.

Section 6
A. B. C. D.

HACCP PLAN CORRECTIVE ACTION

Corrective actions when defined in the HACCP Plan were followed when deviations occurred. Predetermined corrective actions defined in the HACCP Plan ensure the cause of the deviation is corrected. Corrective action taken for products produced during a deviation from CL(s) defined in the HACCP Plan.** Affected milk or milk product produced during the deviation segregated and held, AND a review to determine product acceptability performed, AND corrective action taken to ensure that no adulterated milk and/or milk product that is injurious to health enters commerce. Cause of deviation was corrected. Reassessment of HACCP Plan performed and modified accordingly. Corrective actions documented.

C. D.

Section 2
A. B. C. D.

HACCP PLAN
Written HACCP Plan prepared for each kind or group of milk or milk product processed.** Written HACCP Plan implemented. Written HACCP Plan identifies all milk or milk product safety hazards that are reasonably likely to occur. Written HACCP Plan signed and dated as required. E. F. G.

Section 7
A. B. C.

HACCP PLAN VERIFICATION & VALIDATION

HACCP plan defines verification procedures, including frequency. Verification activities are conducted and comply with HACCP Plan. Reassessment of HACCP Plan conducted annually, OR 1. After changes that could affect the hazard analysis, OR 2. After significant changes in the operation including raw materials and/or source, product formulation, processing methods/systems, distribution intended use or intended consumer.

Section 3
A. B. C.

HACCP PLAN CRITICAL CONTROL POINTS (CCP)

HACCP Plan lists CCP(s) for each milk or milk product safety hazard identified as reasonably likely to occur. CCP(s) identified are adequate control measures for the milk or milk product safety hazard(s) identified. Control measures associated with CCP(s) listed are appropriate at the processing step identified.

Section 4
A. B. C. D.

HACCP PLAN CRITICAL LIMITS (CL)

HACCP Plan lists critical limits for each CCP. CL(s) are adequate to control the hazard identified.** CL(s) are achievable with existing monitoring instruments or procedures. CL(s) are met. E. F. G. H. D.

Calibration of CCP process monitoring instruments performed as required and at the frequency defined in the HACCP Plan.** CCP monitoring records reviewed and document that values are within CL(s) as required. Corrective action record reviewed as required. Calibration records and end product or in-process testing results defined in HACCP Plan reviewed as required. Records reviewed as required, including date and signature.

Section 5
A. B.

HACCP PLAN MONITORING

HACCP Plan defines monitoring procedures for each CCP. (what, how, frequency, whom, etc.) Monitoring procedures as defined in the HACCP Plan followed.

C. D.

Monitoring procedures as defined in the HACCP Plan adequately measure CL(s) at each CCP. Monitoring record data consistent with the actual value(s) observed during the audit.

Milk Plant, Receiving Station or Transfer Station NCIMS HACCP SYSTEM AUDIT REPORT ITEMS MARKED DID NOT MEET THE NCIMS HACCP PROGRAM CRITERIA DESCRIBED BELOW Starred Items are Critical Listing Elements

Section 8
A.

HACCP SYSTEM RECORDS

Required information included in the record, e.g., name/location of processor and/or date/time of activity and/or signature/initials of person performing operation and/or identity of product/product code. Processing/other information entered on record at time observed. Records retained as required, e.g., one year for refrigerated products and two years for preserved, shelf-stable or frozen products. Records relating to adequacy of equipment or processes retained for 2 years. HACCP records correct, complete and available for official review Information on HACCP records not falsified.**

Section 10
A. B. C. D. E. F. G. H. I.

OTHER NCIMS REQUIREMENTS

Incoming milk supply from NCIMS listed source(s) with sanitation scores of 90 or better or acceptable HACCP Listing.** Drug residue control program implemented.** Drug residue control program records complete. Labeling compliance as required. Prevention of adulteration of milk products. Regulatory samples comply with standards. Pasteurization Equipment design and construction. Approved Laboratory Utilized - (if not, Rating not conducted) Other items as noted.

B. C. D. E. F.

Section 9
A.

HACCP SYSTEM PREREQUISITE PROGRAMS (PPs)

Required PP written, implemented, and in substantial compliance by firm. 1. Safety of the water that comes into contact with milk or milk contact surfaces (including steam and ice); 2. Condition and cleanliness of equipment milk contact surfaces. 3. Prevention of cross contamination from unsanitary objects and/or practices to milk and milk products, packaging material and other milk contact surfaces, including utensils, gloves, outer garments, etc., and from raw product to processed product; 4. Maintenance of hand washing, hand sanitizing, and toilet facilities; 5. Protection of milk and milk product, milk packaging material, and milk contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and other chemical, physical and biological contaminants; 6. Proper labeling, storage, and use of toxic compounds. 7. Control of employee health conditions that could result in the microbiological contamination of milk and milk products, milk packaging materials, and milk contact surfaces; and

Section 11
A. B. C. D. E.

HACCP SYSTEM TRAINING (Individuals trained according to

Appendix K or alternatively, have equivalent job experience)

PPs developed by trained personnel. Hazard Analysis developed by trained personnel. HACCP Plan developed by trained personnel. HACCP Plan validation, modification or reassessment performed by trained personnel. HACCP Plan records review performed by trained personnel.

Section 12
A. B. C.

HACCP SYSTEM AUDIT FOLLOW-UP ACTION

Previous audit findings corrected. Previous audit findings remain corrected at time of this audit. A series of observations that lead to a finding of a potential HACCP System failure that is likely to result in a compromise to milk or milk product safety.**

B. C. D. E. F. G. H.

Additional PPs required or justified by the hazard analysis are written and implemented by firm. PP conditions and practices monitored as required PP monitoring performed at a frequency to ensure conformance. Corrections performed in a timely manner when PP monitoring records reflect deficiencies or non-conformities. PP audited by firm. PP monitoring records adequately reflect conditions observed. PP signed and dated as required.

Refer to attached Audit Discussion sheet(s) for details.

NAME OF AUDITOR(S) (Please Print SIGNATURE SIGNATURE DATE DATE

Department of Health and Human Services Food and Drug Administration STATE REGULATORY AGENCY FIRM NAME ADDRESS

NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT (To be included with all NCIMS HACCP Listings and FDA Audits)
DATE OF EVALUATION LICENSE/PERMIT NO. IMS PLANT NO.

NOTED RE1II$REGULATORY A OBLIGA1TJNDER THE NCIMS HACCP SYSTEM

(Ue additional sheets If necessaryj

A narrative description shall be provided as a part of all NCIMS HACCP Listings and FDA Audits. This report shall include an evaluation of the following requirements:

I Milk plant, receiving station or transfer station holds a valid permit.

.

2. Milk plant, receiving station or transfer station audited by the Regulatory Agency at the minimum required frequency.

3. Requirements interpreted in accordance with the Grade A PMO as indicated by past audits.

4. Pasteurization equipment tested at required frequency. (Not applicable to receiving and transfer stations.)

5. Individual and cooling water samples tested and reports on file as required.

6. Samples of milk plants milk and milk products collected at the required frequency and all necessary laboratory examinations made. (Not applicable to receiving and transfer stations.)

7. Sampling procedures approved by PHS/FDA evaluation methods.

8. Permit issuance, suspension, revocation, reinstatement, hearings, and/or court actions taken as required.

9. Records systematically maintained and current.

FORM FDA 2359n (10108)

PSCGraphics(301)443-1090

EF

SUBJECT

ISSUE DATE

PRODUCT

Product Description PLANT NAME

ADDRESS
SUPERSEDES PAGE

1 of 2
Alternate Acceptable Form to NACMCF Based Form

Formal Product Name: Product Description and Food Safety Characteristics: i.e. pH, water activity, etc. Packaging Used: Ingredients: Labeling Requirements: Storage and Distribution: Intended Consumers: Intended Use: Shelf Life:

EXAMPLE Product Description Form

Formal Product Name: Product Description and Food Safety Characteristics: Packaging Used:
Reduced Fat Milk (2%) Pasteurized and homogenized fluid, 2% milk fortified with vitamin A. Milk is filled in 1 gallon plastic bottles with tamper evident seal. Support growth of a number of pathogens. No natural protective characteristics. High Density Polyethylene gallon container with a polypropylene snap-on screw-off tamper evident cap. Labels are self adhesive and applied prior to filling. Code date is printed via coding equipment after capping Keep refrigerated, Grade A, Pasteurized, Homogenized, Vitamin A & D added, 30% less fat than regular milk Product is cased in standard milk cases four units per case. Temperature of storage is 45F. Distributed using refrigerated trucks ( 45F) to wholesale and retail outlets. Consumers of all ages consume this product. Ready to serve product. May also be used as an ingredient in preparing meals. 16 days under proper refrigeration.

Labeling Requirements: Storage and Distribution: Intended Consumers: Intended Use: Shelf Life:

SUBJECT SUPERSEDES PAGE

Hazard Analysis Worksheet

ISSUE DATE PRODUCT

PLANT NAME ADDRESS

(4) Justify your decision for column 3 (5) What control measure(s) can be applied to prevent, reduce, or eliminate the food safety hazards? YES NO

(1)

Ingredient/Processing Step YES YES YES YES YES YES Yes (Leave Blank) (Leave Blank) Likely to occur based on historical data NO Pasteurization (Leave Blank) (Leave Blank)
5

(2) Identify potential food safety hazards 1 introduced, controlled or enhanced at this step. (3) Are any potential food-safety hazards reasonably likely to occur? NO NO NO NO NO YES NO

(6) Is this step a critical Control point? (Yes/No)

Biological

Physical

Chemical

Biological

Physical

Chemical

Instructions and Example

None Animal drug residues No

Biological Vegetative Pathogens

No

Raw Milk Receiving

Physical

Chemical

Appendix N Testing in PP #5 Protection from Adulteration Date:

Approved By:

(Signature)

Do not carry the hazard through subsequent steps.

2 If a firm identifies a potential hazard in column 2 and yes is noted in column 3, justification is required in column 4 (This justification normally includes the scientific, regulatory, or historical reasons for the decision) and a control measure is required in column 5.

If a firm does not identify a potential hazard in column 2, then columns 3, 4 and 5 will be blank.

4 If a firm identifies a potential hazard in column 2 and No is noted in column 3, justification is required in column 4. This justification normally includes Prerequisite Programs or procedures that manage the hazard to ensure that control at this step is not necessary. Column 5 will be left blank.

Column 6 will be answered yes only if the step in column 1 is a critical control point (the control measure is applied at that step).

SUBJECT

ISSUE DATE

PRODUCT

CCP HACCP Plan Summary

SUPERSEDES PAGE

PLANT NAME ADDRESS

1 of 1
Critical Limits What How Frequency Who Monitoring Corrective Action(s) CCP Verification

Critical Control Point (CCP)

Hazard(s)

Records

Approved By:

(Signature)

Print Name:

Date:

SUBJECT Centralized Deviation Log

PLANT NAME ADDRESS Deviation #1

TODAYS DATE: DATE REPORTED: EXPLAIN CCP CRITICAL LIMIT DEVIATION: DATE OF INCIDENT: REPORTED BY:

PRODUCT / PROCESS INVOLVED

Product Name and Description: Code Date(s): Date(s) of Manufacture: Production Line #: ACTION TAKEN Yes Comments No Date:

CORRECTIVE ACTION:

1. Segregate and hold the affected product until 2. and 3. are completed

2.

Perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals qualified by training or experience to perform such a review; Take corrective action, when necessary, with respect to the affected product to ensure that no product is allowed to enter commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; Take corrective action, when necessary, to correct the cause of the deviation; and

Yes Comments Yes Comments Yes Comments

No

Date:

3.

No

Date:

4.

No

Date:

5. Perform or obtain timely validation by a qualified individual(s), as required in Appendix K, to determine whether modification of the HACCP Plan is required to reduce the risk of recurrence of the deviation, and modify the HACCP Plan as necessary.
DISPOSITION OF PRODUCT

Yes Comments

No

Date:

ROOT CAUSE OF DEVIATION

SUBJECT

ISSUE DATE

PRODUCT

HACCP Validation Checklist PLANT NAME ADDRESS

Validation Type (check one):
SUPERSEDES PAGE

1 of 2

Initial Validation (within 12 months of implementation)

Validation (Reassessment) due to changes made in raw materials or source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or intended consumers of the finished product and rate or type of consumer complaints.

Annual Validation (Reassessment) of the HACCP plan including Hazard Analysis Date Conducted: Conducted By:
Topic Yes No If Yes, Describe Food Safety Implication? Are modifications to the HACCP system required?

1. Evaluate product & process Product description changed, e.g. intended use, consumer? Formula changed? Ingredients / Packaging changed? Any new product consumption or storage methods? Any new suppliers? Process flow changed? Equipment / computer software changed? Finished Product Distribution changed? Other, e.g. production volume increased 2. Evaluate product / process history Repeat CCP deviations? Any recent industry recalls of similar product since the last annual validation? New or emerging hazards, e.g recent CDC Morbidity & Mortality problems identified with product? Regulatory agency recommendations, e.g. guidance documents, regulations? Any confirmed food safety consumer complaints? Other

SUBJECT

ISSUE DATE

Centralized List of HACCP Program Records

PLANT NAME ADDRESS
SUPERSEDES PAGE

1 of 2

The purpose of this checklist is to assist the plant HACCP team in demonstrating that those records normally required under the NCIMS HACCP voluntary alternative are current and available. This checklist may also serve as a tool for internal and external HACCP auditors. Record Available
( = yes)

Most Current Version

( = yes)

Comments

Required HACCP documents including forms are dated or identified with current version number. Each page is marked with a new date or version number whenever that page is updated. Most current versions used. Table of Contents Centralized List of HACCP Program Records

NA

Document Change Log

Process Flow Diagram (s) Product Description(s) Written Hazard Analysis(s) for each product CCP HACCP Plan Summary(s) for each product. CCP Monitoring Documents Centralized Deviation Log HACCP System Verification Documentation (including calibration of CCP monitoring equipment (i.e. past. equipment checks); review of CCP monitoring records, corrective action records, and calibration records; and plant signatures and date on these records) HACCP System Validation Documentation (Annually or when changes are made in raw materials or source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or intended consumers of the finished product and consumer complaints) Prerequisite Program #1 Safety of Water Monitoring Records related to this PP (list records by name) Nonconformity correction records related to this PP.

Prerequisite Program #2 Condition and Cleanliness of Food Contact Surfaces Monitoring Records related to this PP Nonconformity correction records related to this PP.

Prerequisite Program #3 Prevention of Cross-Contamination Monitoring Records related to this PP Nonconformity correction records related to this PP.

Prerequisite Program #4 Maintenance of Hand Washing and Sanitizing and Toilet Facilities Monitoring Records related to this PP Nonconformity correction records related to this PP.

Prerequisite Program #5 Protection from Adulteration

Record Available
( = yes)

Most Current Version

( = yes)

Comments

Monitoring Records related to this PP Nonconformity correction records related to this PP.

Prerequisite Program #6 Proper Labeling, Storage, and Use of Toxic Compounds Monitoring Records related to this PP Nonconformity correction records related to this PP.

Prerequisite Program #7 Control of Employee Health Condition Monitoring Records related to this PP Nonconformity correction records related to this PP.

Prerequisite Program #8 Exclusion of Pests Monitoring Records related to this PP Nonconformity correction records related to this PP.

Other Prerequisite Programs that are relied upon in the Hazard Analysis to reduce the likelihood of a potential hazard (List each separately, add rows as needed) Monitoring Records related to this PP Nonconformity correction records related to this PP.

Other Applicable NCIMS Requirements Appendix K (list each separately, add rows as needed) Monitoring Records related to these requirements Nonconformity correction records related to these requirements

Topic

Yes

No If No, Describe

Food Safety Implication?

Are modifications to the HACCP system required?

3. Evaluate adequacy of CCPs, critical limits, monitoring, corrective action, CCP verification, and record keeping procedures. Review current CCP documentation. Do the CCPs control the hazards? Are the CCP critical limits adequate? Do monitoring methods and frequency demonstrate control? Do corrective actions properly address affected product and correct deviations? Does validation include review of consumer complaints? Other, e.g. Prerequisite Programs or procedures may affect the hazard analysis

SUBJECT

ISSUE DATE

PRODUCT

HACCP Document Change Log

SUPERSEDES PAGE

PLANT NAME ADDRESS

1 of 1

The purpose of this form is to provide a history of revisions to HACCP program documents, e.g. Product Description, Flow Diagram, Hazard Analysis, CCP HACCP Plan Summary, Prerequisite Programs. Explain Change(s) Made Issue Date or Revision # of Changed Document(s)

Document(s) Changed1

Example Added liquid sugar strainer at receiving; removed air blow between pasteurized milk tank and filler Added liquid sugar strainer at receiving; removed air blow between pasteurized milk tank and filler Changed water supply from a municipal source to well water 11/09/04

Flow Diagram

Hazard Analysis

11/09/04

Prerequisite Program #1 Safety of Water

11/09/04

The name of document changed must be the same as it appears in the Table of Contents