Draft 3 as of 12 March 2020 ADMINISTRATIVE ORDER NO. i. SUBJECT: General Standard for Food Hygiene Repealing Administrative Order No. 153 _s. 2004 “Revised Guidelines on Current Good Manufacturing Practice in Manufacturing, Packing, Repacking, or Holding Food” RATIONALE The FDA is mandated by Republic Act (RA) 9711 (FDA Strengthening Act of 2009) and RA 10611 (Food Safety Act of the 2013) to issue authorizations in the form of License to Operate (LTO) and Certificate of Product Registration to food manufacturers, distributors, and traders. The compliance of Food Business Operators (FBOs) to Administrative Order No. 153 s, 2004 (Revised Guidelines on current Good Manufacturing Practice (GMP) in Manufacturing, Packing, Repacking, or Holding Food) is currently the basis for issuance of LTO. On May 2018, the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Inspection and Certification Systems on Food Hygiene for Prepared Foodstuff Products was approved. The Philippines, being a party to the ASEAN MRA, is mandated to comply with the ASEAN General Principles of Food Hygiene. Hence, the current FDA Administrative Order No. 153 s. 2004 (Revised Guidelines on current Good Manufacturing Practice (GMP) in Manufacturing, Packing, Repacking, or Holding Food) has to be rationalized and updated by identifying the hygiene requirement applicable in every stage of the food chain and applying the principle of Hazard Analysis and Critical Control Points (HACCP) in appropriate stages of the food chain to enhance food safety. Along with the Code on Sanitation of the Philippines (Presidential Decree No. 856 s. 1975), the Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods (FDA Circular 2013-010), The Food Safety Act of 2013 (Republic Act No. 10611), as well as respective codes of practice and standards for specific food commodities having pertinent provisions on hygiene and sanitation, this Order shall provide the working platform for FBOs to comply with safety and quality requirements for food businesses in accordance to the ASEAN General Principles of Food Hygiene. OBJECTIVES The main objective of this Order is to update the Guidelines for Good Manufacturing Practice in Manufacturing, Packing, Repacking, or Holding Page |Food to comply with the ASEAN General Principles of Food Hygiene. Specifically, this document aims to: 1. provide guidance on the application of food hygiene principles applicable throughout the food chain; 2. provide guidance to FBO on the application of HACCP principles to ensure food safety; and 3. present how HACCP principles are implemented. Il, SCOPE This guideline sets out the necessary hygiene conditions from manufacturing, preparation, packing, repacking, storage, distribution and transport of food ready for consumption. Primary production of food, which is under the jurisdiction of the Department of Agriculture, shall not be covered by FDA regulatory inspection. However, the general guidelines for primary production are provided herein for the FBO to ensure that sourcing of their raw materials comply with the basic principles of food hygiene as This is intended for use by FBOs and shall be utilized by FDA for assessing compliance of FBOs to the general principles of food hygiene in the manufacture, preparation, packing, repacking, storage distribution, and transport of food. IV. DEFINITION OF TERMS 1, Cleaning refers to the removal of soil, food residue, dirt, grease, or other ‘objectionable matter. Contaminant refers to any biological or chemical agent, foreign matter, or other substances not intentionally added to food which may compromise food safety or suitability. 3. Cross-contamination refers to the transfer of harmful micro-organisms from one item of food to another via a non-food surface such as human hands, equipment, or utensils. It may also be a direct transfer from a raw to a cooked food item. Contaminated water may be potential source of food contamination.’ 4. Disinfection refers to the reduction of the number of microorganisms in the environment by means of chemical agents and/or physical methods to a level that does not compromise food safety or suitability. World Health Organization South-East Asia Regional Office (2015, April 7). Food Safety: What You Should Know. Retrieved August 01, 2019 from: hitp:/www.searo.who.in¥entity world health _say/2015/whd-what-vou-shiould-know/en/repacking Page?9, 10. ML. 13. 14. 15. Establishment refers to any building or area in which food is handled and the surroundings under the control of the same management. Food refers to any substance or product whether processed, partially processed or unprocessed that is intended for human consumption. It includes drinks, and chewing gum, water and other substances which are intentionally incorporated into the food during its manufacture, preparation and treatment. Food business operator (FBO) refers to a person engaged in the food business including one’s agents and is responsible for ensuring that the food business under one’s control complies with government rules and regulations. Food handler refers to any person who directly handles packaged or unpacked food, food equipment and utensils, or food contact surfaces and is therefore expected to comply with food hygiene requirements. Food hygiene refers to all conditions and measures necessary to ensure the safety and suitability of food at all stages of the food chain, Food Safety refers to assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to intended use. Good Manufacturing Practices (GMP) refers to a quality assurance system aimed at ensuring that products are consistently manufactured, packed, repacked or held to quality standards appropriate for the intended use. It is thus concemed with both manufacturing and quality control procedure, Hazard refers to a biological, chemical, or physical agent in, or condition of, food with the potential to cause adverse health effect. Hazard Analysis and Critical Control Points (HACCP) refers to a system that identifies, evaluates, and controls hazards which are significant for food safety. Inspection refers to the examination of food, food production facilities or establishments, and the management and production systems of food businesses, including the examination of documents, finished product testing and registration, and of the origin and destination of production inputs and outputs to verify compliance with legal requirements by an agency mandated to perform food safety regulatory and/or enforcement function. Ingredient refers to any substance including food additive, used as a component in the manufacture or preparation of a food and present in the final product in its original or modified form. Pages16. cs 18. 19. 20. 21 23, 24, 25. Label refers to the display of written, printed or graphic matter upon the immediate container, tag, literature or other suitable material affixed thereto for the purpose of giving information as to identify components, ingredients, attributes, directions for use, specifications and such other information as may be required by law or regulator Licensing, refers to the process of approval of an application to operate or establish an establishment prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable the use, testing, promotion, advertisement, and/or sponsorship of processed and prepackaged health products. Philippine National Standard (PNS) refers to the minimum standard for a specific commodity established to help industries produce quality products, raise productivity, protect consumers and facilitate trade Premises refers to plant and grounds within the bounds of the industrial establishment. Prepackaged refers to processed food made up in advance, packed in a container, labeled and ready for sale to the consumer or for catering purposes, Primary production refers to production, rearing or growing of primary products including harvesting, milking and farmed animal production up to slaughter; and the rearing and growing of fish and other seafood in aquaculture ponds, It also includes fishing, and the hunting and catching of wild products. Recall refers to the method of withdrawing or correcting unsafe or hazardous health products from the distribution chain that may present a health hazard to the consumer or user. Repacking refers to the process of packaging or changing of container or wrapper, that may include or not a changing of label, in furtherance of distribution of food. Rework refers to the process of subjecting a clean and unadulterated food that has been removed from processing/packing, for reasons other than being unsanitary or unsafe, to all or specific part of process steps in order to attain safety, quality and suitability of food product. Water activity (a,) refers to the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature. It is an indication of the amount of free water in food that Page +supports microbial growth, and participates in and supports chemical and enzymatic reactions and spoilage processes. V. GENERAL GUIDELINES A. FBOs are responsible to ensure that sources of the raw materials at the primary production stage comply with the general principles of food hygiene. Regulatory inspections and audits shall be science- and risk-based approach as embodied in this guidance document. Issuance of appropriate FDA License to Operate (LTO) for FBOs specifically manufacturers, toll-manufacturers and repackers, shall be based on compliance to this guideline. Traders shall ensure that their toll- manufacturers comply with these guidelines. VI. SPECIFIC GUIDELINES AL PRIMARY PRODUCTION A system shall be in place to ensure that raw materials are free from contamination, and obtained from =— sources that will not contribute to contamination and deterioration of the raw ‘material. Compliance with this requirement shall be verified by any effective ‘means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification. A. Environmental Hygiene A.1.1 Primary food production shall not be done in areas with potentially hazardous substance that could lead to food spoilage. A.12 All possible sources of contamination from the environment shall be identified, and a system for controlling such contamination shall be in place A.1.3. The processing area for food products shall be physically separated from the processing area for non-food products, in such a way that all forms of contamination are prevented. A.2_ Hygienic Production of Food Sources A.2.1 Wastes and harmful substances shall be managed in a ‘manner that will not pose contamination to food and its sources. Page 5A22 There shall be measures in place for controlling health of plant and animal sources of raw materials so as not to cause threat to human health, A3 Handling, Storage and Transport AA ABl AB2 Raw materials and other ingredients shall be inspected, sorted out, segregated, and properly handled to ascertain that they are clean and suitable for processing into food. Postharvest handling or treatment, when necessary, shall ensure that the raw materials are safe for processing (i.e. not contain levels of microorganisms that may produce food poisoning or other disease in humans). Raw materials shall be stored and transported in containers or carriers, whichever is applicable, under conditions that will protect against contamination and minimize deterioration (ie. protected from contamination by pest chemicals, physical or microbiological contaminants, or other objectionable substances). Cleaning, Maintenance and Personnel Hygiene at Primary Production AAL AA2 Procedures for cleaning and maintenance of primary production facilities and maintaining personnel hygiene shall be enforced, particularly during harvesting, packing, and post-harvest treatment of raw materials intended for processing. Where applicable, guidelines on good personnel hygiene, as provided in the PNS/BAFS 49:2017 Code of Good Agricultural Practices (GAP) for Fruits and Vegetable Farming or PNS/BAFPS 60:2008 Code of Good Animal Husbandry Practices (GAHP), shall be applied. GMP ORGANIZATION There shall be an adequate number of personnel, as determined by the company. Food handlers shall have the knowledge, skill and capabilities relevant to their assigned functions, with good mental and physical health to handle food hygienically. B.1 Organization, Qu: BA.l ication, and Responsibilities The organizational structure of the company shall have clear delineation of the quality assurance/quality control and production unit. Each unit is headed by respective managers/heads, neither of whom shall be reporting to Page 6the other. B.1.2 The quality assurance/quality control and production manager/head shall be adequately trained and/or has obtained practical experience and managerial skill to judge potential risks and take the necessary action based on their respective functions B.1.3 The production manager shall have full authority and responsibility to manage production of food products, B.1.4 The quality assurance/quality control manager/head shall have full authority and responsibility in all quality assurance and quality control duties such as establishment, verification and implementation of all quality control procedures. B.1.5 The quality assurance/quality control unit shall be entrusted with the authority and responsibilities such as but not limited to: B.1.5.1 Approval/rejection of raw and packaging materials, labeling materials, bulk/ intermediate or finished products; B.1.5.3 Approval/rejection of procedures having impact on the product quality or product specifications; Review production records and quality control records; and Support monitoring and controlling the manufacturing environment, plant cleanliness production validation, calibration, training of personnel, approve supply of materials and contract parties, protect products and materials against spoilage and deterioration and the maintenance of records. B.1.6 When necessary, the quality assurance/quality control and production manager/head shall have shared responsibility in the following aspects: B.1.6.1 Establishing and authorizing written procedures; B.1.6.2 Collaboration with engineering/maintenance unit for equipment design, installation, repair, and maintenance; and Page?B2 B.1.6.3 Determination of training needs of personnel who come in direct or indirect contact with food, which when applicable, may be guided by the factors enumerated in B.2.2. B.1.7 Every employee shall be aware of their role and responsibility in protecting food from contamination ot deterioration. They shall have the necessary knowledge and skills to handle food hygienically. B.1.8 Personnel who are handling strong chemicals and other potentially hazardous substances shall be trained on safe handling techniques. B.1.9 Duties assigned to each employee shall be within the employce’s capacity to perform. Training B.2.1 All employees who are directly engaged in the manufacturing activities shall be trained in the particular operations they perform. B.2.2 To determine the level of training needed by personnel, the following factors may be considered: 1 nature of the, particularly the ability to sustain growth of pathogenic or __ spoilage microorganisms; B.2.2.2 manner in which the food is handled and packed, including the probability of contamination; extent and nature of processing or further preparation before final consumption; B.2.2.4 conditions under which the food will be stored; and B.2.2.5 expected length of time before consumption, B.2.3 Food handlers, maintenance and other concerned personnel shall be trained on Good Manufacturing Practices, Hazard Analysis Critical Control Points, and other Food Safety related trainings conducted by qualified individuals. B.2.5 Training in Good Manufacturing Practices shall be in Page 8accordance with written programs approved by the production and quality control managers/heads. B.2.6 Records of personnel training shall be maintained to enable periodic assessment of the effectiveness of training and instruction programmes; and determine further trainingneeds, B.2.7 Refresher trainings shall be conducted on a continuing basis to ensure awareness of all procedures necessary to maintain safety and suitability of food. PREMISES, Appropriate location, good hygienic design and construction, and provision of adequate facilities are important considerations to effectively control hazards C.1. Location Deciding for the location of food establishment should consider potential sources of contamination and possible measures that can be taken to protect food from contamination. Specifically, food establishment should be located away from areas that are: polluted; with industrial activities that may pose contamination; prone to flooding and/or pest infestation; and with solid or liquid wastes that cannot be removed effectively. C2 Grounds Grounds shall be constructed and maintained to protect against flood, seepage, and the access and/or harboring of pests (vermi rodents, birds, and insects), pet animals, or other animals. C3 Plant Design and Layout C.3.1 Food establishment shall be designed and laid out in a logical sequence that allows good hygiene practices including prevention of cross-contamination between and during production and maintenance operations. C.3.2 A master plan diagram or map shall be used to determine operational routes to avoid confusion and cross- contamination, enable smooth processing operation, and show designated plant areas such as, whenever applicable: gowning/changing rooms for all personnel; receiving of starting materials: incoming goods quarantine; sampling room for sampling of deliveries of starting materials; storage for approved materials Page 9C4 (ingredients, packaging & chemicals); storage of reject materials; preparation of materials and ingredients; processing operations; quality control facilities; packaging/labeling operations; staging/storage of bulk products; quarantine/storage for finished products; storage for approved finished products; equipment washing; storage of _cleaned/idle/non-functional equipment; major repair and maintenance activities; storage of cleaning tools and supplies; pantry/canteen; toilets and waste collection/treatment/ disposal. C.3.5 For manufacturing plants with prescribed hygiene zones, the master plan diagram shall also reflect the flow of air. 3.3 Locker/gowning room shall be directly connected to but separated from processing areas. ©.3.4 Hand washing and sanitizing facilities shall be at convenient proximity to areas where it is needed. €3.5 Toilets shall not be opened directly to production areas and shall have adequate supply of water, ventilation, and hand washing/sanitizing facility. C.3.6 The manufacturing area for human food shall not be used. for manufacturing non-human food, animal feed or inedible products. Internal Structures and Fittings C.4.1 Structures within the food establishment should be built with durable materials, easy to maintain, clean, and where appropriate, disinfect. 4.2 Working surfaces that come in direct contact with food shall be made of durable non-absorbent material, and inert to the food, detergents, disinfectant and other cleaning agents under normal operating conditions. They shall be maintained in sound condition, easy to clean and disinfect. C.4.3 Surfaces of walls, partitions, and ceiling should be smooth and without crevices, and shall be easy to clean, sealed, free of insects/pests, light colored, with height appropriate for the operation, with no possibility of shedding dirt or toxic substances, and where appropriate, water-proof or impervious materials Page 10C.4.5 Floor construction should be allow adequate drainage and cleaning, made of non-slip material, and without crevices, 4.6 Angles or juncture between walls, between wall and floor, and between wall and ceiling in food handling areas shall be sealed and coved to facilitate cleaning. 4.7 Windows shall be easy to clean, constructed to minimize dirt build-up, and where necessary, be fitted with removable and cleanable insect-proof screens, C.4.8 Doors shall have smooth, non-absorbent surfaces, easy to clean and/or disinfect, and where necessary, self-closing and elose-fitting. €.4.9 Stairs, lift cages and auxiliary structures such as platforms, ladders, chutes, shall be so situated and constructed as not to cause contamination of food. Chutes. shall be constructed with inspection and cleaning hatches C.5.1 Water supply 5.1.1 An adequate supply of potable water with facilities appropriate for storage, distribution control, and if needed, temperature control, shall be available for washing materials and hands to ensure safety and suitability of food. €.5.1.2 Potable water shall conform to the quality specification in the Philippine National Standards for Drinking Water 2017 (DOH-AO 2017-0010) or latest version. C.5.1.3 The water source shall be protected against contamination. 5.1.4 Non-potable water for use in non-food purposes such as, but not limited to, fire control, steam, refrigeration, and other similar purposes, shall have a designated, separate, and identifiable system. Non-potable water system shall not allow connection with or reflux into potable water system. C.5.2 Drainage and waste disposal Page 11C.5.2.1 Floors and drainage canals shall allow adequate draining, with no stagnant water. €.5.2.2 When waste disposal systems and facilities is necessary for operation, it shall be in conformance with relevant Department of Environment and Natural Resources (DENR) regulations, designed and constructed in an appropriate manner that does not constitute a source of contamination of food or potable water supply. C.5.3 Cleaning 5.3.1 Adequate facilities, suitably designated, should be provided for cleaning food, utensils and equipment. 5.3.2 Where necessary, cleaning facilities shall have adequate supply of hot and cold potable water. C.5.4 Personnel hygiene facilities and toilets 5.4.1 Personnel hygiene facilities shall be provided and suitably located and designed to ensure that an appropriate degree of personal hygiene can be maintained and contamination is avoided. €.5.4.2 Where appropriate, facilities should include: lavatories of appropriate hygienic design; hygienic hand washing and drying, with adequate supply of hot and cold water, hand soap and sanitizer, and adequate changing facilities for personnel. C.5.5 Temperature control 5.5.1 Depending on the nature of food operations, adequate facilities shall be provided for heating, drying, cooking, cooling, refrigerating, chilling, and freezing food. C.5.5.2 For storing/staging refrigerated or frozen food, the storage temperature, and when necessary ambient temperature, shall be controlled and monitored to ensure the safety and suitability of food. Page 12C.5.6 Air quality and ventilation C.5.6.1 Adequate means of natural or mechanical ventilation shall be provided for the purpose of minimizing air-borne contamination of food (c.g. from aerosols and condensation droplets), controlling ambient temperatures, controlling odors which might affect the suitability of food; and where necessary, controlling humidity, to ensure the safety and suitability of food. €.5.6.2 Ventilation systems should be so designed, constructed and maintained as not to allow flow of air from contaminated areas to clean areas. C.5.7 Lighting €.6.7.1 Natural or artificial lighting shall be adequately provided to enable hygienic operation. Where necessary, lighting should not result to misleading colors. C.6.7.2 The light intensity shall be adequate to. the nature of the operation. €.6.7.3 Where appropriate, light fixtures shall be protected (c.g. with shield or made of shatter proof material) to prevent contamination by breakages. C.5.8 Storage C.7.8.1 Where necessary, adequate facilities for storage of food, ingredients and non-food chemicals (e.g. cleaning materials, lubricants, fuels) shall be provided. C.7.8.2 Where appropriate, food storage facilities should be designed and constructed to allow cleaning and maintenance, avoid pest access and harborage, provide adequate protection to food, and where necessary, provide controlled environment to minimize food deterioration (e.g. by temperature and humidity control). C.5.9 Canteen / Eating facility Page 13D. C.5.9.1 A designated area for canteen or eating facility shall be provided in strategic location within the plant premises. €.5.9.2. Canteen or eating facility shall be so designed, constructed and maintained so as not to cause contamination to food and potable water system, and prevent access and harborage of pes EQUIPMENT ‘D.1 Location Equipment location and instalation shall eliminate. the possibility of cross contamination, allow for good hygienic practices, and facilitate cleaning, and if necessary, sanitizing. D.2 Food Control and Monitoring D.2.1 Equipment shall function according to intended use. D.2.2 All equipment shall allow adequate monitoring, sampling, and measuring of product quality. D.2.3 Equipment shall have no glass parts, no lacquer, paint or any coating that may chip off during operation, D.2.4 Seams of food contact surfaces shall be smoothly bonded, without any crevices, and maintained to minimize accumulation of food particles. D.2.5 Measuring equipment and devices shall be properly cleaned, maintained, and calibrated. D.2.5.1 Equipment for controlling and monitoring environment conditions such as but not limited to, temperature, pressure, and humidity. Equipment used for heat treatment, cooling, or freezing food shall be designed to achieve the required temperatures as rapidly as necessary for food safety and suitability, properly calibrated, and maintained in proper working condition. Such equipment shall allow for control and monitoring of temperature. D.2.6 Clean and sanitized portable equipment, utensils, and single-use containers shall be stored in a manner protected from splash, dust and other contamination, D.2.7 Holding, conveying and manufacturing systems, including, gravimetric, pneumatic, closed and automated systems, shall be designed and constructed to enable cleaning, disinfection, Page 14and pest control. D.2.8 Food-manufacturing areas and equipment used for ‘manufacturing human food should not be used to manufacture nonhuman food grade animal feed or inedible products, D.2.9 Other equipment in the processing area that does not come in direct contact with food shall likewise be constructed in a ‘manner that facilitates. their cleaning and maintenance. SANITATION AND HYGIE! E.1 Personal Hygiene E.1.1 Thereshall be established and documented procedures for disease control, personnel hygiene such as but not limited to the following: E.1.2.1 Any person known, appears, or suspected to have an illness or symptoms like jaundice, diarrhea, vomiting, fever, sore throat with fever, discharges from the eyes, ears nose, and visibly infected skin lesions (boils, cuts, ete.) shall be reported to the supervisor and excluded from any food handling/contact operations, E.1.3.2 All personnel working in direct contact with food, food contact surfaces, and food-packaging materials shall materials shall conform to hygienic practices while on duty to the extent necessary to maintain the safety and quality of food. E.1.3.3. Where necessary, wear outer garments, gloves, mask, hair restraint, including working shoes in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging. E.1.3.4 Wash hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand- washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, E.1.3.5 Remove all objects that might fall into or any substance that can cause contamination to food, equipment, or containers, such as but not limited to jewelry, watch, pin, nail polish/art, lotion or Page 15ointments applied to theskin. Store clothing or other personal belongings in designated areas, other than where food is exposed or equipment and utensils are washed. E.1.3.7 Food handlers shall not spit, cough, sneeze, eat, drink, chew, or use tobacco and other nicotine delivery device in areas where food is exposed or where equipment and utensils are washed. E.1.3.8 Equipment maintenance personnel, as well as visitors, shall practice proper personal hygiene while in areas where food is exposed or equipment and utensils are washed E.1.3.9 Other effective control measures shall be taken to prevent contamination of food, food-contact surfaces, or food-packaging materials with micro- organisms and other foreign substances. E.2 Sanitary Facilities E.2.1 Water shall be of quality necessary for the product, process or intended use. A designated circuit shall be provided for potable and non- potable water supply. E.2.1.1 Potable water can be used as a product, ingredient, direct cooling and heating food. There shall be adequate pressure and suitable temperature with adequate facilities for storage, where necessary, and distribution. There shall be adequate protection —_ against contamination of stored water. E2.1.2 Non-potable water shall not be used in food manufacture; and can be used for fire control, refrigeration, and other purposes not in direct contaet with food. F.2.2 Changing room/s shall strategically located to. prevent contamination of food, processing area, packaging materials and packing areas. E.2.4 Toilets shall be designed and constructed to ensure hygienic removal of waste matter, and hand-washing facilities with sufficient supply of potable water, hand cleaning preparation and with suitable hygienic means of drying ds installed adjacent to toilets, Page 16E.2.5 Hand washing facilities shall be provided with potable water and suitable hand cleaning preparation, sanitizers (when necessary) and a suitable hygienic means of drying hands, Where paper towels are used, a sufficient number of dispensers and receptacles should be provided adjacent to each washing facility. Taps that are non-hand operated are more appropriate. The facilities shall be furnished with properly trapped wastewater pipes leading to drains. E.2.3 Effluent and waste disposal facility shall be provided and maintained in good working condition according to applicable regulation of the Department of Environment and Natural Resources. All effluent lines (including sewer systems) shall be large enough to carry peak loads and shall be so constructed as to avoid contamination of potable water supplies and areas where food is exposed or stored. F.2.6 Solid wastes and inedible materials shall be placed in designated area until these are collected or removed from the processing plant. These facilities shall be designed to prevent access by pests and possible contamination of food, potable water, food-contact surfaces, processing and storage areas, and building premises. E.2.7 When applicable, a designated circuit for gas line shall be provided in a manner that prevents contamination of food, food contact surfaces, processing and storage areas. E.3 Maintenance, Cleaning, and Sanitation E,3.1 There shall be an established and documented procedure for maintenance, cleaning and sanitation of establishment and equipment in place. Buildings, fixtures and other facilities of the plant shall be kept in good repair and shall be regularly cleaned and maintained in a sanitary condition. E.3.3 Equipment shall be kept in an appropriate state of repair and condition to function as intended, facilitate cleaning and sanitation procedures; and prevent contamination. E.3.4 Cleaning should remove food residues and dirt, following a standard method appropriate with the nature of the food business, which includes, but not limited to, the use of detergents, alkalis or acids, heat, scrubbing, turbulent flow, vacuum or other established means of effective cleaning. Disinfection may be necessary after cleaning. Page 17F, E.3.6 Detergents, sanitizers and other chemicals shall be safe and effective for their intended use, Established procedure for safe use and handling shall be followed. E.4 Pest Control E41 E42 E43 Animals (including pets) shall not be allowed in any area of a food processing plant. Measures shall be taken to exclude pests and their breeding places from the processing areas and to protect food against the contamination by animals, birds, vermin, rodents and insects. Buildings should be kept in good repair and condition to prevent pest access. Holes, drains and other places where pests are likely to gain access should be kept sealed. When appropriate, wire screens may be installed on windows, doors and ventilators to prevent entry of pests. Potential food sources for pests (i.e. ingredients, raw materials, and packaging materials) shall be stored in pest proof containers and/or stacked above the ground away fiom walls. Product spills shall be cleaned up immediately so as not to attract pests E44 Areas both inside and outside food premises should be EAS E46 E47 kept clean, Where appropriate, refuse should be stored in covered and pest proof containers. Establishment and surrounding areas should be regularly examined for evidence of infestation. Eradicating pests through the use of chemical, physical or biological agents shall be done with utmost care following supplier instructions to avoid contamination and maintain safety and suitability of food. Effectiveness of pest control and eradication measure shall be monitored periodically. PRODUCTION AND PROCESS CONTROLS F.1 Incoming Material Requirements Fld Raw Materials and Ingredients F.1.1.1 Raw materials or ingredients shall be inspected, sorted, or otherwise properly handled to ascertain that they are clean and suitable for processing Page 18FA2 FALL2 FALI3 FAL FALLS F.L16 PALL? FALLS Where necessary, laboratory tests should be made to ensure that only sound, suitable raw materials or ingredients are used. Where appropriate, specifications for raw materials shall be identified and applied. Raw materials and ingredients shall be properly identified and subject to effective stock rotation. Materials for rework shall be held in appropriate containers and stored in conditions that will protect against contamination and deterioration. Only materials that pass the prescribed specifications shall be allowed for rework. Bulk materials for further processing shall be held in appropriate containers and stored in conditions that will protect against contamination and deterioration. Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents contamination and deterioration. Only potable water compliant with section C.5.1.2 of this Order shall be used for washing, soaking, or as ingredient. Ice and steam that come in direct contact with food shall be made from water that complies with section 5.1.2 of this. Packaging Materials F121 FAl22 FA23 F123 Packaging design and materials shall provide adequate protection for products to minimize contamination, prevent damage, and accommodate proper labelling. The food-contact surface of packaging material shall not pose migration of contaminant to the food. Where packaging material is made of breakable glass, there should be a procedure on how to deal with broken glass in food or adjacent areas in case of breakage Gases used for packing shall be non-toxic and not pose a threat to the safety and suitability of food. Page 19Where reusable packaging used, it shall be durable enough to withstand multiple use, easy to clean and sanitize. There shall be established effective means of ensuring reusable packaging will not pose a threat to safety and quality of food. F.2 Control of Operations F.2.1 Control of food hazard Fd F122 F123 Food hazard shall be controlled through application of HACCP-based system as follows: the i Identify any step in the operation which are critical to the safety of food; ii Establish and implement effective control procedures at cach critical step identified; iii Monitor control procedures to ensure continuing effectivene and iv Review control procedures periodically and whenever steps in operation change. The detailed logical sequence for application of HACCP is provided in Annex 2, while a sample HACCP Worksheet is provided in Annex 3. HACCP-based system applied throughout the food chain shall be used when deciding for appropriate product and process design. Control procedures may vary from simple stock rotation, equipment calibration, or proper loading of raw materials and finished products, to developing a new system based on expert advice, trial runs, and F.2.2 Time and temperature control F221 F.2.2.2 previous experience, which_—_involves documentation Time and temperature shall be established, controlled and monitored during processing such as but not limited to cooling, chilling, cooking, fermenting, drying, thermal processing, packing, and storage to ensure safety and suitability of food Acceptable and action limits shall be established for time and temperature variation Page 20F.2.23 F224 Establishing the temperature control system should consider the: nature of the food (i.e. water activity, pH, initial level and type of microorganisms); intended shelf-life of the product; method of packaging and processing: and intended use of the product (i.e. for further processing/cooking, ready- to-eat). ‘Temperature measuring and/or recording devices shall be checked at regular intervals and tested for accuracy. F.2.3 Specifications and other control parameters F.23.1 Where necessary, microbiological, physical, and chemical specifications and control parameters shall be established with scientific basis. Tolerable limits for microbiological, physical, or chemical specifications and control parameters shall be established with appropriate monitoring procedures, analytical methods, and action limits. F.2.4 Microbiological cross-contamination F241 Raw, unprocessed food shall be effectively separated from ready-to-eat either physically or by time, with cleaning in-between and, where appropriate, disinfection. Food contact surfaces, utensils, equipment fixtures and fittings shall be thoroughly cleaned and if necessary, disinfected, after a raw food has been handled or processed. When necessary, there shall be designated food-contact surfaces, utensils, equipment fittings and fixtures for raw or unprocessed food and processed food. For areas with high risk of microbiological contamination, access shall be restricted or controlled. Where necessary, access to such areas shall be only via a changing facility, where personnel may need to put on clean protective clothing including footwear and wash their hands before entering. F.2.5 Physical and chemical contamination F25.1 Procedures for preventing physical or chemical contamination (i.e. glass, metal shards, dust, fumes, Page 21and foul odor) of food shall be established and applied. F.2.5.2 Where necessary, suitable detection or screening devices shall be used. F.2.6 Product information and consumer awareness F.2.6.1 Lot identification shall aid in product recall and effective stock rotation. Each container of food shall be permanently marked to identify the producer and the lot. F.2.6.2 All in-process food and food products shall bear adequate product information to enable safe and correct handling, storage, display, and preparation the food products throughout the food chain. F.2.6.3 Prepackaged food products shall be labelled with clear instructions to enable safe and correct handling, display, storage, and use the food safely. F.2.6.4 Labelling of prepackaged food products shall be in accordance with the existing labeling requirements. F.2.6.5 Where appropriate, consumers shall be informed of the following, but not limited to: proper handling, storage, preparation, serving instruction, and product claims, which will enable consumers to understand the product and help them make informed choices. F.2.6.6 In particular, consumers shall be informed of the relationship between time/temperature control and foodborne illness G. QUALITY CONTROL G.1 Quality Management G.1.1 A quality control system shall be established to ensure that products contain the correct materials of specified quality and quantity and are manufactured under proper conditions following standard procedures to ensure the safety and suitability of food. G.1.2 The quality control involves sampling, inspecting and testing of starting materials, in process, intermediate, bulk and finished products. It also includes where applicable, review of batch documentation, sample retention program, Page 22stability studies, product complaints, product recalls, and maintaining correct specifications of materials and products. G.13 Acceptance criteria for starting materials, in-process materials, and finished products shall be established and applied G.1.4 A system shall be established to ensure that materials determined by quality control procedure to be rejects are effectively removed from the food chain. G.2 Rework G.2.1.When the food control system allows for rework, respective specifications for materials to be reworked shall be established and applied to ensure food safety and suitability. G.2.2 Finished product from rework materials shall be compliant with established specification and control parameters. G.2.3 Finished products from rework materials shall be properly identified, when necessary, be given a designated batch number. G.3 Product returns G.3.1 Returned products shall be identified and stored in designated location, G.3.2 For purposes of improving the food control system, the cause to product return shall be determined. When necessary, a review of batch manufacturing and distribution record shall be done to come up with a corrective action. G.3.3 Appropriate disposition for returned products shall be based on ensuring food safety and suitability throughout the food chain G.4 Laboratory facility and testing devices G.4.1 Should the food control system requires a laboratory, it shall be designed to suit the relevant operations. G.4.2 It shall be separated physically from the production areas or other areas which might get contaminated by the conduct laboratory procedures Page 23G.4,3 Laboratory instruments and testing devices shall be suitable to the established quality control system and specific control parameters employed. G.4.4 When necessary, the services of third-party laboratory shall be employed. DOCUMENTATIO! HLL Alll procedures and specification related to food manufacturing operations from sourcing of starting materials, through processing, packing, testing, cleaning, disinfection/sanitation, calibration, repair and maintenance, storage, and distribution shall be maintained and reviewed periodically. Revision of documents shall be done as necessary. H.2 Records relative sourcing of staring materials, receiving, testing, preparation, cleaning, disinfection/sanitation, calibration, repair and maintenance, processing, packing, storage, distribution, product recall, regulatory document, and other relevant data shall be maintained and reviewed for purposes of monitoring, traceability, and improvement of the establishment’s compliance to the general principles of food hygiene. QUALITY AUDITS 1.1 Quality audits consist of an examination and assessment of all or specific parts of the food control system with the specific purpose of improving compliance to the general principles of food hygiene as specified in this Order. 1.2. A quality audit may be conducted by independent/third-party specialists or internal audit team designated by the management for this purpose. 1.3 When necessary, such audits may also be extended to suppliers and contractors. 14 A report shall be made at the completion of each quality audit to serve as basis for instituting corrections or improvement of the food control system. WAREHOUSING AND DISTRIBUTION Jl Warehouses, storage areas, and delivery vehicles shall be maintained orderly, in good repair, clean, disinfected if necessary, and free from pests to prevent food deterioration and contamination. Page 241.2. No pesticides, disinfectants, toxic chemicals or other potentially contaminating materials shall be stored J3 Chemicals, defective stock, market returns, complaint good: potentially contaminated materials shall not be stored in close proximity to food materials. or J4 Designated storage facilities shall be secured enough to prevent theft, tampering, and other analogous incidences. J.5. First in - first out, or first expiry - first out system, and effective stock control shall be established and applied. PRODUCT COMPLAINTS AND RECALL K.1 All quality-related complaints, whether received verbally, in writing, or electronically shall be recorded and investigated according to a written procedure, Documented records of complaint shall be retained to evaluate trends, product-related frequencies, and severity with a view to taking additional and if appropriate, immediate corrective action, K.2 There shall be a written procedure that defines the circumstances under which a recall should be considered. ‘The recall procedure should designate who should be involved in evaluating the information, how a recall should be initiated, who should be informed about the recall, and how the recalled material should be treated, K.3 In the event of a serious or potentially life-threatening situation, all concerned local and national authorities shall be informed and sought for advice. If it is necessary to get in touch with concerned international authorities, communication should come from the national authority and not from the local companies. K4 The records of traceability of raw materials, packaging materials, processing data, laboratory test results and other relevant information shall be used as guide to analyze the effectiveness of the implementation of the procedure for product recall. K.5 The effectiveness of the established recall procedure shall be tested by conducting a mock recall or other means of measuring product recall effectiveness. K.6 Recall procedure shall be established in accordance with the FDA Circular No. 2016-012 Guidelines on Product Recall. Page 25vil. vil. Ix. L. RETENTION OF SAMPLES L.1 Samples of a batch product shall be used to investigate a product complaint and aids in traceability. L.2 A sufficient number of samples of the finished batch product shall be kept to serve as retained samples. Quantity of retained samples shall be enough for a complete testing, if and when necessary to do so. L.3 Retention samples shall be properly identified, recorded and stored in an area comparable with condition prevailing in the market. M. SUB-CONTRACTING OF MANUFACTURE M.1 The scope of sub-contracting and the list products to be manufactured shall be clearly stated in the contract. M.2 The conditions of contract manufacturing agreement shall be defined and agreed by parties for clarity and transparency. M.3 All aspects of contracted work shall be specified to obtain products conforming to agreed standards of safety, quality and suitability. M4 Both parties shall clearly state their respective duties and responsibilities to assure, protect, and maintain product safety, quality and suitability at all stages of the food chain REPEALING CLAUSE Administrative Order No. 153 s. 2004 and all other administrative issuances or parts thereof inconsistent with the provisions of this Order are hereby repealed and modified accordingly. TRASITORY PROVISION The approved implementation plan for this Order shall apply. EFFECTIVITY This Order shall take effect fifteen (15) days after its publication in a newspaper of general circulation FRANCISCO T. DUQUE III, MD, MSe Secretary of Health Page 26ANNEXES HACCP SYSTEM and GUIDELINES FOR ITS APPLICATION Annex { - Logical Sequence for Application of HACCP Annex 2 - Example of Decision Tree to Identify CCPs Annex 3 - Example of HACCP Worksheet Page 27Annex 1 LOGICAL SEQUENCE FOR APPLICATION OF HACCP? 1, Assemble HACCP Team 2. Describe Product 3. Indentify Intended Use 4. Construct Flow Diagram 5. On-site Confirmation of Flow Diagram 6. List all Potential Hazards Conduct Hazard Analysis Consider Control Measures 7. Determine CCPs (refer to Annex 2) 8, Establish Critical Limits for each CCP 9. Establish Monitoring Syssten for each CCP 10. Establish Corrective Actions 11. Establish Verification Procedure 12. Establish Documentation and Record Keeping CACIRCP 1-1969, Rev.4-2003, General Principles of Food Hygiene. Page 28Annex 2 EXAMPLE OF DECISION TREE TO IDENTIFY CCPs* (Answer questions in sequence) 02 Js the step specificalty designed to eliminate or reduce the likely ‘occurrence ofa hazard to an acceptable level? ** {03 Could contamination with identified hazards) occur in excess of ‘acceptable level(s, or could this merease to unacceptable level(s)? * &) HEL) Q4 Mita subsequent step eliminate identified hazard(s) or reduce likely oo a} + Proceed tothe next identified hazard inthe described process ** Acceptable and unacceptable levels need to be defined within the overall objectives in identifying the CCP: of HACCP Plan * CACIRCP 1-1969, Rev.4-2003, “eneral Principles of Food Hygiene. Page 29Annex 3 EXAMPLE OF HACCP WORKSHEET” {1 Describe Product Limite) | Procedur(s) | Actos) 4. Verification 7003, General Principles of Food Hygiene. Page 30