FDA Food Safety Modernization Act: Marking a New Era in U.S.

Food Safety
A Silliker White Paper March 2011

Within the past decade, the number of food products recalled in the United States surged from a few hundred annually to thousands of products in 2009. Responding to persistent consumer concerns over the safety of imported foods and the growing complexity of the supply chain, the U.S. Food and Drug Administration sought expanded regulatory authority to ensure the safety of the U.S. food supply.
During the 111th U.S. Congress, more than 20 bills were introduced to address food safety concerns. Two comparable bills advanced in the House of Representatives and Senate. The Food Safety Enhancement Act (HR 2749) was passed by the U.S. House in July 2009, and the Senate approved the Food Safety Modernization Act (S. 510) in November 2010. After several weeks of debate over the competing bills, Congress agreed to pass an amended version of the comprehensive FDA Food Safety Modernization Act (HR 2751). On January 4, the FDA Food Safety Modernization Act (FSMA) was signed into law and marked the most significant change in U.S. food safety law since the passage of the FD&C Act in 1938. Since the FDA is responsible for ensuring the safety of 80% of the U.S. food supply, the new law will impact the daily operations of many food companies, both foreign and domestic, as well as the dietary supplement industry. Preventive controls, inspections, compliance and import monitoring are the major themes of the new law. Effective immediately, FDA has the authority to: access company records when a food safety risk is suspected ( 101); increase inspections of food facilities ( 201); and implement mandatory food recalls ( 206). During the next 18 to 24 months, FDA will begin to issue regulations to implement the remaining provisions of the law, including foreign supplier verification, mandatory food safety plans, fresh produce standards, and the accreditation of thirdparty auditors. As the FDA develops the new regulations, food companies and importers should act now to prepare for the upcoming regulations that will significantly impact the entire food supply chain. The FSMA ( 101) permits access to all records related to manufacturing, processing, packing, transportation, distribution, receipt, holding or importation of a food. Moreover, FDA inspectors can access records containing environmental monitoring results, product test results, supply chain monitoring and food safety plans. Under the Bioterrorism Act of 2002, all domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. were required to register with the FDA. The FSMA ( 102) mandates all food facilities must register with the FDA and update their registration every even-numbered year. If the FDA determines a serious health hazard is associated with food from a registered facility, the registration of the facility could be suspended. In effect, the FDA could shutter a facility if a serious hazard is discovered and block all shipments from the facility.

Food Safety Plans

One of the greatest challenges of the law will be the implementation of new requirements for FDA registered food facilities to conduct a hazard analysis and develop preventive control plans. Many food companies will be required to develop food safety plans (103) based on an evaluation of hazards related to food manufactured, processed, packed or held in all registered facilities. Following a hazard analysis, firms must identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards. Examples of preventive controls include: sanitation procedures for food contact surfaces; employee hygiene training; environmental monitoring to verify pathogen controls; a recall plan; supplier verification activities; and a food allergen control program. Firms will be required to reevaluate hazards and update food safety plans every three years or whenever a significant change occurs in activities conducted at the facility. A significant change has been defined as a change with potential to result in a new hazard or increase a previously identified hazard. To implement the requirements, FDA must issue regulations to establish standards for conducting a hazard analysis, as well as standards for implementing and documenting preventive controls. While many food facilities must implement hazard analysis and risk-based preventive controls, the FSMA provides exemptions for facilities subject to other food safety requirements, including: seafood, juice, dietary supplement, and low-acid canned food facilities.

FDA to Emphasize Prevention

Prevention is the cornerstone of the new law. In an effort to prevent food safety problems, the law requires the implementation of several measures to increase oversight of industry activities. Some of the key regulatory measures include: records inspection (101); biennial registration of food facilities (102); hazard analysis and risk-based preventive controls (103); performance standards (104); standards for produce safety (105); sanitary transportation of food (111); and new dietary ingredients (113).

Records and Registration

If inspectors have a reasonable belief that an article of food is adulterated, FDA inspectors are now authorized to have immediate access to all food facility records. 2

Lessons learned from existing FDA Hazard Analysis and Critical Control Point (HACCP) programs, including the seafood and juice programs, should support the development of new regulations for food safety plans. The FDA has defined HACCP as a systematic approach to the identification, evaluation, and control of food safety hazards, from raw material production through manufacturing, distribution and consumption. HACCP requirements for meat and poultry establishments were first announced in 1996, but the regulations were implemented between 1998 and 2000. The USDA Food Safety and Inspection Service (FSIS) developed the HACCP regulations based on the seven principles established by the U.S. National Advisory Committee on Microbiological Criteria for Foods, which include: (1) hazard analysis, (2) critical control point identification, (3) establishment of critical limits, (4) monitoring procedures, (5) corrective actions, (6) recordkeeping, and (7) verification, including validation. To improve the effectiveness of HACCP, FSIS combined the requirements with food safety performance standards to facilitate the control and reduction of pathogenic microorganisms. Since meat and poultry establishments are regulated by FSIS, the FSMA provisions for food safety plans are not applicable.

To develop the standards, FDA will consider naturallyoccurring hazards, unintentional hazards and intentional hazards (i.e. acts of terrorism). The standards will engage issues related to soil, hygiene, packaging, temperature controls, animals in the growing area, and water. In recent years, FDA has been actively developing fresh produce regulations. The regulations were expected to address quantitative limits for indicator microorganisms, environmental monitoring, and auditing requirements. Under the new law, the agency must issue regulations to establish standard practices and processes to prevent the introduction of biological, chemical and physical hazards. A final rule must be issued within one year after the comment period concludes for a proposed rule for fresh produce standards.

Sanitary Food Transportation Practices

Regulations to ensure sanitary food transportation practices have been on the FDA agenda for years. Under the new law ( 111), FDA must issue regulations for food transportation within 18 months. As part of a federal effort to focus on the prevention of food safety issues throughout the supply chain, the FDA issued guidance entitled, Sanitary Transportation of Food, and published an advance notice of proposed rulemaking (ANPR) in April 2010 for implementing the Sanitary Food Transportation Act of 2005. The ANPR requested industry insight regarding the occurrence of physical, chemical, biological or other contamination risks during the transportation of foods. The regulations will mandate sanitary transportation practices to be followed by shippers, carriers by motor vehicle or rail vehicle, receivers, and others involved in the transportation of food.

Performance Standards
Based on a review of significant foodborne contaminants, FDA might issue science-based guidance documents for contaminants related to specific products or food categories. Under Section 104 of the law, the FDA must evaluate significant foodborne contaminants every two years, which might result in guidance documents containing action levels for specific contaminants. The FDA approach to performance standards might follow the path forged by FSIS. When the FSIS implemented the Pathogen Reduction HACCP Final Rule, the first performance standards were established for the reduction of pathogenic microorganisms on raw meat. In May 2010, FSIS issued the long-awaited pathogen reduction performance standards for the control of Salmonella and Campylobacter in chilled carcasses at young chicken (broiler) and turkey slaughter establishments. Based on the results from the recent FSIS baseline sample collection programs for young chickens and turkeys, the agency set threshold standards for positive samples of pathogens that should be met by establishments. The 2010 performance standards have been called the most significant change in FSIS inspection policy since the implementation of HACCP.

New Dietary Ingredients

Due to concerns about the safety of dietary supplement ingredients, the law requires the FDA to develop guidance to clarify when a dietary supplement ingredient is a new dietary ingredient, the evidence required to affirm the safety of an ingredient, and appropriate methods to identify new dietary ingredients. In July, the FDA issued a draft guidance to advise the supplement industry about the need for pre-market safety notification for any product containing a new ingredient and related procedures for preparing notifications. FDA has described the guidance as an important preventive control to protect consumers from ingredients with unknown safety profiles.

Inspections, Detection and Response

Based on the foundation of prevention, the second tier of the legislation seeks to improve the detection of food safety problems and strengthen FDAs response. Riskbased food facility inspections, laboratory accreditation, enhanced traceability, and mandatory recall authority are some of the key components of Title II of the new law. 3

Fresh Produce Standards

Addressing persistent fresh produce safety concerns, the new law ( 105) requires the FDA to establish science-based minimum standards for the production and harvesting of certain types of fruits and vegetables.

Risk-based Inspections
Under the new law ( 201), FDA will increase inspection frequencies for any registered facility that manufactures, processes, packs or holds food. To maximize FDA resources, the agency must first identify high-risk foods, which will allow the agency to effectively allocate inspection resources according to the known food safety risks of the food and countries involved. Domestic highrisk facilities must be inspected at least once in the first five years following enactment and at least once every three years thereafter. In the case of domestic non-high risk facilities, inspections will be conducted at least once in the first seven years of the law and at least once every five years thereafter. The FDA should inspect at least 600 foreign facilities during the first year and double the number of foreign facility inspections every year. Overall, FDA would increase the frequency of inspection of all facilities, but focus on high-risk food facilities.

Department of Health and Human Services has suggested that a majority of food manufacturers and distributors are unable to effectively identify their suppliers or recipients. In coordination with the food industry, FSMA ( 204) requires the FDA to evaluate methods for the rapid identification of food recipients to prevent or mitigate a potential food safety incident. FDA will evaluate technologies to improve the tracking and tracing of food, which should result in the establishment of a formal system. To support the rapid and effective identification of food recipients, the FDA will develop a list of high-risk foods and related regulations for record-keeping requirements for high-risk foods. Food companies will be expected to maintain accurate supply and distribution records to improve the tracking and tracing of food.

Mandatory Recall Authority

Effective immediately, the FDA has the authority under FSMA ( 206) to impose a mandatory food recall if the responsible party declines to issue a voluntary product recall. The FDA can issue a recall if the agency suspects a product is adulterated, misbranded or a potential health risk. The new recall authority will impact registered facilities that manufacture, process, pack, distribute, receive, hold or import food.

Laboratory Testing and Accreditation

To ensure consistent quality in laboratory testing, food companies will be required to use accredited laboratories, both foreign and domestic, for all regulatory testing. The federal government will develop a laboratory accreditation program or recognize existing laboratory accreditation bodies that satisfy certain criteria for certifying laboratories. Under FSMA ( 202), all regulatory food testing must be conducted by laboratories accredited for the appropriate sampling and/or analytical testing methodologies. Under certain circumstances, laboratories might be expected to release test results that identify a food safety issue to FDA. The laboratory accreditation requirements would apply to the following types of regulatory testing: uu To support admission of imported food or removal of an Import Alert uu To comply with specific food testing requirement(s) under FDA regulations or the FD&C Act; uu FDA mandated testing to address an identified or suspected food safety problem. Under the law, the disclosure of test results would be required only in cases of regulatory testing as defined above, but the final FDA regulation will establish the specific requirements for disclosure. In the case of routine test results or non-pathogen microbiological testing for regulatory purposes, disclosure of the results is not mandated by FSMA. Moreover, the accredited laboratory requirement would be waived when a laboratory is not accredited to perform a new validated method and such method must be utilized in response to a potential or actual foodborne illness outbreak.

Administrative Detention
If the FDA has reason to believe a food is adulterated or misbranded, Section 207 of FSMA authorizes FDA to detain an article of food. Under previous authority from the Bioterrorism Act, credible evidence was necessary to confirm a potential health risk before FDA could detain a food. An interim final rule to implement the revised administrative detention requirements is expected in 2011.

Improving the Safety of Imported Food

With the globalization of the food supply chain, imported food now accounts for a substantial percentage of the U.S. food supply. As a result, the safety of imported foods has become a critical issue. While the FDA currently inspects only a small percentage of imported food shipments, the agency will now focus on ensuring safe food production practices are employed by foreign facilities. To address concerns about imported food safety, Title III of the legislation authorized a foreign supplier verification program, a voluntary qualified importer program, thirdparty certification for imported food or ingredients, and the accreditation of third-party auditors.

Foreign Supplier Verification Program

In order to verify that imported food is produced in compliance with U.S. laws and regulations, the law ( 301) requires that U.S. importers conduct risk-based foreign supplier verification activities. Verification requirements could delay shipments and impact foreign manufacturers,

Enhanced Tracking and Tracing

Traceability has been called a key element in federal investigations of foodborne illness outbreaks. The U.S. 4

processers, packers, holders and importers. Importer verification activities might include: monitoring shipment records, lot-by-lot certification, annual on-site inspections, evaluation of HACCP plans of foreign suppliers, and the sampling and testing of shipments. FDA is required to issue guidance and regulations within one year to implement the verification program.

when a food safety risk is suspected ( 101); increased inspections of food facilities ( 201); and the authority to implement mandatory food recalls ( 206). Within 18 to 24 months, FDA should implement additional FSMA components, including: uu Mandatory hazard analysis and preventive controls plan ( 103); uu Accreditation requirements for food testing laboratories ( 202); uu FDA access to test results from independent laboratories ( 202); uu Foreign supplier verification to ensure imported product is not adulterated ( 301); and the uu Accreditation of third-party auditors of foreign food establishments ( 307). Federal regulations or guidance are required to fully implement other key measures of FSMA, including the establishment of science-based standards for conducting a hazard analysis ( 103); performance standards ( 104); standards for fresh produce ( 105); administrative detention ( 207); sanitary food transportation practices ( 111); and new dietary ingredients ( 113). While food safety is the focal point of the new law, several regulatory measures could directly impact the dietary supplement industry. When the FDA issues guidance for establishing the safety of new dietary ingredients, manufacturers and distributors of dietary supplements must be prepared. Mandatory recall authority, facility registration, and foreign supplier verification are additional requirements of the FSMA that might require the attention of the supplement industry. During the legislative process, a controversial requirement for facility registration fees was eliminated, but other industry fees were approved in the final legislation. In particular, food companies could be required to pay fees to reimburse FDA for the expedited import program, export certificates, follow-up inspections, and mandatory recalls. As the FDA moves forward with the new regulations, the food industry must prepare now for the implementation of new requirements that could have a profound impact upon the daily activities of companies throughout the food supply chain.

Voluntary Qualified Importer Program

Importers will have the opportunity to expedite the movement of imported food shipments by participating in the Voluntary Quality Importer Program ( 302). Foreign food facilities must be certified by an accredited third-party auditor under the program. Before eligible U.S. importers can join the program, the FDA will evaluate the compliance history of the foreign supplier, known safety risks of a food, the importers Foreign Supplier Verification Program and food safety practices. Within 18 months, FDA will issue guidance to establish the program.

Third-party Certification
Under FSMA ( 303), FDA is authorized to permit thirdparty certification for imported foods or ingredients, but the requirements will depend on the known safety risks associated with a food, country, or region. For example, certification would be required if a food originated from a country or region with an inadequate food safety regulatory system or a history of food safety problems. Under this program, FDA may refuse admission of imported food due to the absence of certification. The import certification requirements will impact all foreign food manufacturers, processors, packers, holders and importers of foreign food.

Accreditation of Third-party Auditors

To facilitate the inspection of imported products and foreign food establishments, FSMA ( 307) mandates the accreditation of third-party auditors. A third-party auditor is defined as a foreign government, firm or individual. To establish the program, the FDA must develop model standards, including accreditation standards and audit report standards. Accredited auditors will be required to submit reports of regulatory audits to FDA and to report serious public health risks to FDA immediately. Records of voluntary consultative audits must be available to FDA upon request. In general, the FDA can revoke the accreditation of a third-party auditor if food or a facility certified by the auditor is linked to a foodborne illness outbreak involving serious health consequences.

Industry Should Prepare Now

After years of debate, the comprehensive food safety legislation has finally become law. Effective immediately, the FDA has new monitoring and enforcement responsibilities, including: access to all company records 5

About Silliker
In 2010, our brand evolution from Silliker Group Corporation to the Mrieux NutriSciences Corporation, enabled us to integrate a medical vision and health perspective into our scientific activities, giving nutrition a priority status. Our scientific leaders provide scientific expertise to food companies around the globe with analytical testing, consulting, auditing and contract research services, contributing to public health improvements through three divisions: Silliker, Inc., Biofortis and Bioagri. With locations worldwide, Silliker provide testing, consulting, auditing, research, clinical nutritional trials, sensory evaluation and training services that help assure food quality, safety and nutrition for food manufacturers, restaurants, caterers and retailers across our network. Our internationally recognized experts help clients develop new products, identify operational problems, anticipate areas of concern, and institute practical controls associated with food safety and quality risks. maintain a well-defined quality system and the necessary technical competencies to generate reliable test results. This respected benchmark bridges national boundaries, allowing us to provide harmonized services throughout our laboratory network. Our accredited laboratories also have specific internal quality requirements and performance programs in place to further assure the competency of our testing services. For over 40 years, Silliker has championed quality systems and results that are documentable and reproducible. Our unbending commitment to operational excellence helps our valued clients protect brand image, ensure timely delivery of products that match customer requirements, and meet exacting specifications for quality and safety. The success of your quality assurance program largely depends on your continuous commitment to quality. Across our network, we put our quality systems to the test so you can have the utmost confidence in your analytical results. Leading companies worldwide recognize Silliker as a trusted partner due to our ability to deliver accurate information in a timely manner, our reputation as a scientific leader, and our local and international presence.

Accreditations
All Silliker laboratories meet or exceed ISO 17025, an international standard that assures testing laboratories

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