Fish and Fishery Products Hazards and Controls Guidance PDF June 2022 Edition

SGR 129 Fish and Fishery Products Hazards and Controls Guidance June 2022 Edition DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATI...

SGR 129 Fish and Fishery Products Hazards and Controls Guidance June 2022 Edition DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR FOOD SAFETY AND APPLIED NUTRITION OFFICE OF FOOD SAFETY  Fish and Fishery Products Hazards and Controls Guidance June 2022 Edition Additional copies may be purchased from: Florida Sea Grant IFAS - Extension Bookstore University of Florida P.O. Box 110011 Gainesville, FL 32611-0011 (800) 226-1764 www.ifasbooks.com Copies of this guidance document may be downloaded from: www.FDA.gov/Seafood U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (240) 402-2300 JUNE 2022  TABLE OF CONTENTS: FISH AND FISHERY PRODUCTS HAZARDS AND CONTROLS GUIDANCE - JUNE 2022 EDITION Section Page Guidance for Industry: Fish and Fishery Products Hazards and Control Guidance G-1 CHAPTER 1: General Information 19 CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 21 CHAPTER 3: Potential Species-Related and Process-Related Hazards 3–1 CHAPTER 4: Pathogens from the Harvest Area 75 CHAPTER 5: Parasites 91 CHAPTER 6: Natural Toxins 6–1 CHAPTER 7: Scombrotoxin (Histamine) Formation 113 CHAPTER 8: Other Decomposition-Related Hazards 153 CHAPTER 9: Environmental Chemical Contaminants Including Pesticides 9–1 CHAPTER 10: Methylmercury 181 CHAPTER 11: Aquaculture Drugs 11 – 1 CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other than Clostridium botulinum) 209 as a Result of Time and Temperature Abuse CHAPTER 13: Clostridium botulinum Toxin Formation 245 CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 293 CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 309 CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 315 CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product 331 Characteristics CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking 345 Processes CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Substances 19 – 1 CHAPTER 20: Metal Inclusion 385 CHAPTER 21: Glass Inclusion 395 APPENDIX 1: Forms A1 – 1 APPENDIX 2: Product Flow Diagram – Example A2 – 1 Table of Contents. 1 (June 2022). Section Page APPENDIX 3: Critical Control Point Decision Tree A3 – 1 APPENDIX 4: Bacterial Pathogen Growth and Inactivation 417 APPENDIX 5: FDA and EPA Safety Levels in Regulations and Guidance A5 – 1 APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw 443 APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing-Public Health 451 Impacts APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products A8 – 1 APPENDIX 9: Allergen Cross-Contact Prevention A9 – 1 APPENDIX 10: Allergen Cleaning and Sanitation for the Control of Allergens A10 – 1 APPENDIX 11: Approved Aquaculture Drugs A11 – 1 APPENDIX 12: Unapproved Aquaculture Drugs A12 – 1 ADDENDUM 1: Fish and Fishery Products (21 CFR 123) and Control of Communicable Diseases (21 AD1 – 1 CFR 1240.60) ADDENDUM 2: current Good Manufacturing Practices (cGMPs) AD2 – 1 Table of Contents. 2 (June 2022).  GUIDANCE FOR THE INDUSTRY: FISH AND FISHERY PRODUCTS HAZARDS AND CONTROLS GUIDANCE, JUNE 2022 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 telephone number listed on the title page of this guidance. I. INTRODUCTION II. DISCUSSION This guidance is intended to assist processors of A. Scope and Limitations fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) The control strategies and practices provided in plans. Processors of fish and fishery products will this guidance are recommendations to the fish find information in this guidance that will help and fishery products industry unless they are them identify hazards that are associated with required by regulation or statute. This guidance their products and help them formulate control provides information that would likely result in a strategies. The guidance will help consumers and HACCP plan that is acceptable to FDA. Processors the public generally to understand commercial may choose to use other control strategies, as seafood safety in terms of hazards and their long as they comply with the requirements of controls. The guidance does not specifically address the applicable food safety laws and regulations. safe handling practices by consumers or by retail However, processors that chose to use other control establishments, although many of the concepts strategies (e.g., critical limits) should scientifically contained in this guidance are applicable to both. establish their adequacy. This guidance is also intended to serve as a tool to be used by federal and state regulatory officials in The information contained in the tables in Chapter 3 the evaluation of HACCP plans for fish and fishery and in Chapters 4 through 21 provide guidance for products. determining which hazards are “reasonably likely to occur” in particular fish and fishery products FDA’s guidance documents, including this guidance, under ordinary circumstances. However, the tables do not establish legally enforceable responsibilities. should not be used separately for this purpose. The Instead, guidance describes the Agency’s current tables list potential hazards for specific species and thinking on a topic and should be viewed only as finished product types. This information should be recommendations, unless specific regulatory or combined with the information in the subsequent statutory requirements are cited. The use of the chapters to determine the likelihood of occurrence. word “should” in Agency guidance means that something is suggested or recommended, but not The guidance is not a substitute for the per- required. formance of a hazard analysis by a processor of fish and fishery products, as required by FDA’s This guidance has been prepared by the Division regulations. Hazards not covered by this guidance of Seafood Safety in the Center for Food Safety may be relevant to certain products under certain and Applied Nutrition at the U.S. Food and Drug circumstances. In particular, processors should Administration. be alert to new or emerging problems (e.g., the occurrence of natural toxins in fish not previously associated with that toxin). Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 1 (June 2022). FDA announced its adoption of final regulations recommendations for allergen cleaning and to ensure the safe and sanitary processing of fish sanitation, and allergen cross-contact through and fishery products in the Federal Register of two new appendixes (Appendix 9 and 10) since December 18, 1995 (60 FR 65096) (hereinafter normal cleaning and sanitation does not necessarily referred to as the Seafood HACCP Regulation). This address allergen residues. guidance, the Seafood HACCP Regulation (21 CFR 123), and the Control of Communicable Diseases This guidance does not describe corrective action regulation (21 CFR 1240) apply to all aquatic animal or verification records, because these records life, other than birds and mammals, used as food are not required to be listed in the HACCP plan. for human consumption. For example, in addition Nonetheless, such records must be maintained, to fresh and saltwater finfish and crustaceans, where applicable, as required in § 123.7 and § this guidance applies to echinoderms such as 123.8. Additionally, this guidance does not restate sea cucumbers and sea urchins; reptiles such as the general requirements for records that are set alligators and turtles; amphibians such as frogs; out in § 123.9(a). and to all mollusks, including land snails (escargot). It also applies to extracts and derivatives of fish, This guidance does not cover reassessment of the such as eggs (roe), oil, cartilage, and fish protein HACCP plan and/or the hazard analysis or review concentrate. In addition, this guidance applies to of consumer complaints, as mandated by § 123.8. products that are mixtures of fish and non-fish This guidance also does not provide specific ingredients, such as tuna sandwiches and soups. guidance to importers of fish and fishery products Addendum 1, § 123.3, lists the definitions for “fish” for the development of required importer verification and “fishery product” used in the Seafood HACCP procedures. However, the information contained in Regulation. the text, and, in particular, in Appendix 5 (“FDA and This guidance covers safety hazards associated EPA Safety Levels in Regulations and Guidance”), with fish and fishery products only. It does not should prove useful for this purpose. cover most hazards associated with non-fishery ingredients (e.g., Salmonella enteritidis in raw B. Chapter Modifications eggs). However, where such hazards are presented The following is a summary of the most significant by a fishery product that contains non-fishery changes made to this guidance. Moving forward, ingredients, control must be included in the FDA will publish this guidance as a living document HACCP plan (§ 123.6). Processors may use the on the FDA Seafood website (www.fda.gov/ principles included in this guidance for assistance in seafood). This guidance will now reference the developing appropriate controls for these hazards. date of publication as the edition of the document. This guidance does not cover the hazard associated Each chapter, appendix, and/or addendum will with the formation of Clostridium botulinum (C. also reference the date (month and year) the botulinum) toxin in low-acid canned foods (LACFs) most recent changes were made and published. or shelf-stable acidified foods. Mandatory controls Additionally, the “Guidance for Industry” section for this hazard are contained in the Thermally will identify the specific changes in the header Processed Low-Acid Foods Packaged in Hermetically with the date of publication. You should carefully Sealed Containers regulation (hereinafter referred review the chapters applicable to your product and to as the LACF Regulation, 21 CFR 113) and the process in addition to using this summarized list Acidified Foods regulation (21 CFR 114). Such of significant changes. controls may be, but are not required to be, included in HACCP plans for these products. This guidance does not cover all sanitation controls required by the Seafood HACCP Regulation. The maintenance of a sanitation monitoring program is an essential prerequisite to the development of a HACCP program. When sanitation controls are necessary for food safety, but are not included in a sanitation monitoring program, they must be included in the HACCP plan (21 CFR 123.6). However, this guidance document does contain Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 2 (June 2022). The following changes have been made throughout Chapter 3, Table 3-3: “Potential Invertebrate Species- this guidance document: Related Hazards” has been modified with the following recommendations as of June 2021: Chapter 1: “General Information” has been modified Barnacles, Gooseneck (Pollicipes polymerus) with the following recommendations as of April – Has been added with the hazards of natural 2011: toxins and environmental chemicals. Sea Cucumber – The following changes have Chapter 2: “Conducting a Hazard Analysis and been made: Developing a HACCP plan” has been modified o Aquacultured species have been identified with the following recommendations as of April with the hazards of environmental chemicals 2011: and aquaculture drugs; Chapter 3: “Potential Species-Related and Process- o Stichopus japonicus is synonymous with Apostichopus japonicus and has been Related Hazards” Introduction has been modified removed. with the following recommendations as of June Seabob (Xiphopenaeus kroyeri)– Shrimp has 2021: been added as a market name. The following notes were added: Shrimp – The following changes have been made: o For endangered and threatened species: refer to NOAA and the U.S. Fish and o Acetes japonicus has been added with the Wildlife Services to identify endangered hazard of environmental chemical. and threatened species with hyperlinks; Snail or Escargot – The following changes have been made: o Identifying “The Seafood List” as the reference to consult for naming of seafood o Cornu aspersa, Elona quimperiana, species; Helix lucorum, and Pila polita have been added with the hazards of parasites and o Identifying that the tables in Chapter 3 environmental chemicals. should be used in conjunction with Chapters Squid or Calamari – Nomenclature change from 4 – 21 in the development of a HACCP plan. Loligo opalescens to Doryteuthis opalescens. Chapter 3, Table 3-2: “Potential Vertebrate Species- Chapter 3, Table 3-4: “Potential Process-Related Related Hazards” has been modified with the Hazards” has been modified with the following following recommendations as of June 2021: recommendations as of August 2019: Crocodile – The following changes have been Footnote 2 has been removed. made: Footnotes 3, 4, 5, 6, and 7 have been o Wild and aquacultured species have been renumbered as a result of footnote 2 being identified; removed. o Associated hazards have been added. Header – Allergens and Food Intolerance Oreo Dory – Allocyttus spp., Neocyuttus spp., Substances – Chapter 19 – The following Oreosoma spp. and Pseudocyttus spp. have changes have been made: been added with the hazard of GFP. o Chapter title updated to remove “Prohibited Roughy, Orange – Hoplostethus atlanticus has Food and Color Additives;” been added with the hazard of GFP. o Footnote 5 has been added to the header. Scad (Selar crumenophthalmus) – The following Smoked Fish (Other than ROP) – New listing change has been made: for Chap 16 with Footnote 6 has been added. o Scombrotoxin (histamine) hazard has been Dried Fish (All) - Footnote 7 for Chapter 13 added. has been added. Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 3 (June 2022).  Battered or Breaded Finished Product Food – at least to some extent, the nature of the The following changes have been made: controls for this pathogen in HACCP plans; o “Package Type” has been divided into two The control strategy examples are restructured types; for improved clarity: one for source controls (e.g., tagging, labeling, source waters, harvester o New listing for Chapter 13 for the ROP licensure, and raw consumption advisory) and Package Type has been added. a second for time from harvest to refrigeration Raw oysters, clams, and mussels (ROP) – The controls. following changes have been made: o “Hot Fill” and “Steam Flush” has been Chapter 5: “Parasites” has been modified with the removed from the Package Type description; following recommendations as of April 2011: o The hazard of undeclared allergen has been It is now recognized that the parasite hazard removed. may be reasonably likely to occur in fish raised Raw oysters, clams, and mussels (other than in freshwater containing larvae of pathogenic ROP) – The following changes have been made: liver, lung and intestinal flukes because these parasites enter the fish through the skin rather o “Hot Fill” and “Steam Flush” has been than in the food. removed from the Package Type description; o The hazard of undeclared allergen has been Chapter 6: “Natural Toxins” has been modified with removed. the following recommendations as of August Footnotes – Footnotes 5, and 6 have been 2019: added. The information in the Chapter has been reorganized into two categories in each section. Chapter 4: “Pathogens from the Harvest Area” has been modified with the following o “Fish other than molluscan shellfish” and recommendations as of April 2011: o “Molluscan Shellfish.” Hydrostatic pressure, individual quick freezing Natural Toxin Detection Section was removed. (IQF) with extended storage, and irradiation are This information is utilized to confirm illnesses/ now identified as processes that are designed outbreaks, inform advisories for at risk harvest to retain raw product characteristics and that areas, and/or make a determination for harvest can be used to reduce Vibrio vulnificus (V. area closures. This information was never vulnificus) and Vibrio parahaemolyticus (V. intended for a processor to include in the HACCP parahaemolyticus) to non-detectable levels; plan as a control measure. The information has been relocated to Appendix 5. It is now recognized that a tag on a container of shellstock (in-shell molluscan shellfish) received Ciguatera Fish Poisoning (CFP) – The following from another dealer need not identify the changes have been made: harvester; o Additional locations were included based on Critical limits relating to control of pathogen scientific discovery of the toxin; growth prior to receipt of raw molluscan shellfish o Areas included are Florida, Hawaii, and by the primary processor are now linked to Puerto Rico; monitoring the time that the shellfish are exposed to air (i.e., by harvest or receding o Addition of finfish to contain CFP – lionfish, tide) rather than to the time that the shellfish mackerel and tang; are harvested; o Finfish previously listed in Chapter 3 are Reference is now made to the role of the Federal, now included in Chapter 6. state, tribal, territorial and foreign government Tetrodotoxin – Symptomology development has shellfish control authorities in determining been updated to align with the Bad Bug Book. whether the hazard of V. parahaemolyticus is reasonably likely to occur in raw molluscan shellfish and in the development of a V. parahaemolyticus control plan that will dictate, Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 4 (June 2022).  Natural Toxins addition – The following changes Control Strategy Example 1 – Source control have been made: for fish other than molluscan shellfish – The following changes have been made: o Clupeotoxin has been added as a natural toxin with associated information; o Critical Limit – “ASP for consumption advisory” was added; o Ichthyohemotoxin has been added as a natural toxin with associated information; o Establish Verification procedures – “Periodic verification of harvest locations” was added. o Seafood-associated rhabdomyolysis (some- times referred to as Haff disease) has been Control Strategy Example 2 – Harvest Area for added as a natural toxin with associated Molluscan Shellfish – The following changes information. have been made: A “Note” was added to the chapter regarding o Critical Limit – venomous fish. This was to correspond to the  Update made to align with the NSSP and Bad Bug Book’s new chapter to address the regulations for shellfish and HACCP, and potential concern and FDA’s thoughts.  A note was added regarding dockside Amnesic shellfish poisoning (ASP) – Additional screening to align with NSSP; species of lobster, sardine, white mullet, menhaden, and predatory species, such as o Monitoring Procedures – Florida pompano, Gulf Kingfish and spot, were  Update made to include information included. that would be required for monitoring Diarrhetic shellfish poisoning (DSP) – Addition as identified through the regulation locations for the toxin were included such as and NSSP; Puget Sound and the west coast of Canada, Bibliography was updated to reflect the additions Texas, Washington State, Alabama, Maryland, throughout the chapter. Massachusetts, and New York. Paralytic shellfish poisoning (PSP) – The Chapter 7: “Scombrotoxin (Histamine) Formation” following additions were made: has been modified with the following o Molluscan shellfish examples of clams, recommendations as of April 2011: cockles, mussels, oysters, and scallops; Information is now provided about the potential o Information regarding retention of the toxin for scombrotoxin (histamine) formation in and depuration; products like tuna salad that have been allowed to become recontaminated and then subjected o Expanded the information regarding to time and temperature abuse; gastropod accumulation of the toxin; The recommendations regarding on-board o Addition of finfish species where the toxin chilling of scombrotoxin-forming species of has been found in the viscera such as fish are now listed as follows: mackerel, Dungeness crab, tanner crab and red rock crab. o Fish exposed to air or water temperatures above 83°F (28.3°C) should be placed in Natural Toxin Control Section – The following ice, or in refrigerated seawater, ice slurry, changes have been made: in the Natural Toxin or brine of 40°F (4.4°C) or less, as soon as Control Section: possible during harvest, but not more than o ASP and PSP in fish other than molluscan 6 hours from the time of death, or shellfish – An example was added of o Fish exposed to air and water temperatures the adductor muscle from the scallop to of 83°F (28.3°C) or less should be placed in eliminate the toxin; ice, or in refrigerated seawater, ice slurry, o Molluscan Shellfish – The statement: “States or brine of 40°F (4.4°C) or less, as soon as must have a Biotoxin Contingency Plan” possible during harvest, but not more than was added. 9 hours from the time of death, or o Fish that are gilled and gutted before chilling should be placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 5 (June 2022).  or less, as soon as possible during harvest, The recommended level at which a lot should but not more than 12 hours from the time be rejected based on sensory examination when of death, or 118 fish are examined is now corrected to be no more than 2 fish to coincide with the goal o Fish that are harvested under conditions of less than 2.5% decomposition in the lot; that expose dead fish to harvest waters of 65°F (18.3°C) or less for 24 hours or It is now recommended that the number of fish less should be placed in ice, refrigerated subjected to sensory examination be increased seawater, ice slurry, or brine of 40°F (4.4°C) if there is likely to be greater than normal or less, as soon as possible after harvest, variability in the lot, and that only one species but not more than the time limits listed constitute a lot for sampling purposes; above, with the time period starting when When histamine analysis is performed as a the fish leave the 65°F (18.3°C) or less corrective action, it is now recommended environment; that any fish found to exceed the internal Cautions are now provided that handling temperature at receiving critical limit be practices and processing controls that are included in the sample; recommended as suitable for preventing the When the sensory critical limit has not been formation of scombrotoxin may not be sufficient met, it is now recommended that the processor to prevent fish from suffering quality or shelf-life perform histamine analysis of a minimum of 60 degradation (i.e., decomposition) in a way that fish, collected representatively from throughout may otherwise render it adulterated under the the lot, including all fish in the lot that show Federal Food, Drug, and Cosmetic Act; evidence of decomposition, and reject the lot The lower anterior portion of the loin is now if any fish are found with a histamine level identified as the best place to collect a sample greater than or equal to 50 ppm; from large fish for histamine analysis; Subdividing and retesting for histamine is no Fermenting, pickling, smoking, and drying are longer recommended after an initial failed now identified as likely critical control points histamine test; (CCPs) for this hazard; It is now recommended that employees who When fish are checked for internal temperature conduct sensory screening receive adequate at off-loading, it is now recommended that: training; o For fish held iced or refrigerated (not frozen) It is now recommended that for shipments onboard the vessel and off-loaded from the of scombrotoxin-forming species received vessel by the processor 24 or more hours under ice on open-bed trucks be checked for after death, the internal temperature should both sufficiency of ice and internal product be 40°F (4.4°C) or below, temperature; OR It is now recommended that shipments of scombrotoxin-forming species received under o For fish held iced or refrigerated (not frozen) gel packs be checked for both adequacy of gel onboard the vessel and off-loaded from the packs and internal product temperature; vessel by the processor from 15 to less than 24 hours after death, the internal It is now recommended that if only the internal temperature should be 50°F (10°C) or temperature of fish is checked at receipt by a below, secondary processor because the transit time is no more than 4 hours, calculation of transit OR time should include all time outside a controlled o For fish held iced or refrigerated (not frozen) temperature environment; onboard the vessel and off-loaded from the It is now recommended that if only the internal vessel by the processor from 12 to less temperature of fish is checked at receipt by a than 15 hours after death, the internal secondary processor because the transit time is temperature should be 60°F (15.6°C) or no more than 4 hours, a temperature-indicating below; device (e.g., a thermometer) should be used to determine internal product temperatures in a minimum of 12 fish, unless there are fewer Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 6 (June 2022).  than 12 fish in a lot, in which case all of the High-temperature alarms are no longer fish should be measured; recommended for monitoring temperatures in coolers or processing areas; When checks of the sufficiency of ice or chemical cooling media, such as gel packs, or internal When the adequacy of ice is established as the product temperatures are used at receipt of fish critical limit for refrigerated storage, it is now from another processor, it is now recommended recommended that monitoring be performed that the number of containers examined and with sufficient frequency to ensure control the number of containers in the lot be recorded; rather than at least twice per day. Control of scombrotoxin (histamine) formation during processing and storage are now provided Chapter 8: “Other Decomposition-Related as separate control strategy examples, and Hazards” has been modified with the following examples of HACCP plans are now provided recommendations as of April 2011: for both strategies; It is now noted that FDA has received consumer The extended exposure times during processing complaints concerning illnesses associated (more than 12 hours, cumulatively, if any with the consumption of decomposed salmon, portion of that time is at temperatures above attributable to the production in the fish of 70°F (21.1°C); or more than 24 hours, toxins other than histamine (e.g., biogenic cumulatively, as long as no portion of that amines, such as putrescine and cadaverine); time is at temperatures above 70°F (21.1°C)) It is now noted that there are also some previously recommended for fish that have been indications that chemicals formed when fats previously frozen are now also recommended and oils in foods oxidize may contribute to for fish that have been previously heat treated long-term detrimental health effects. sufficiently to destroy scombrotoxin-forming bacteria and are subsequently handled in a Chapter 9: “Environmental Chemical Contaminants manner where there is an opportunity for recontamination with scombrotoxin-forming Including Pesticides” has been modified with the bacteria; following recommendations as of June 2022: It is now acknowledged that it may be possible Title of the Chapter has changed from: “and to control scombrotoxin formation during Pesticides” to “Including Pesticides” since unrefrigerated processing using a critical pesticides are a subset of chemicals. limit that is time of exposure only (i.e., no Language in the chapter has been updated to temperature component), if it is developed with reflect the chapter title change. an assumption that worst-case temperatures (e.g., in excess of 70°F (21.1°C)) may occur; The following changes have been made to “Understand the Potential Hazard” section: Chemical coolants (e.g., gel packs) are no longer recommended for control of temperature o Added the explanation of sources of during in-plant storage; contamination with environmental chemicals including pesticides; For control of time and temperature during refrigerated storage, it is now noted that o Updated links; critical limits that specify a cumulative time o Added information on EPA requirements for and temperature of exposure to temperatures registered pesticides; above 40°F (4.4°C) are not ordinarily suitable o Explanation of regulatory approach to because of the difficulty in determining when environmental contaminates in fish specific products have entered and left the components utilized for other products cooler and the time and temperature exposures intended for human consumption has been to which they were subjected. However, there provided; and may be circumstances where this approach is suitable. It is also noted that minor variations o Removed Table 9-1 (action and tolerance in cooler temperature measurements can be levels) which has been included as a avoided by submerging the sensor for the reference in Appendix 5. temperature-recording device in a liquid that mimics the characteristics of the product; Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 7 (June 2022).  The following changes have been made to Chapter 11: “Aquaculture Drugs” has been modified “Determine Whether the Potential Hazard Is with the following recommendations as of June Significant” section: 2021: o Added the description of “residue”; and The following have been added to the o Added a paragraph on common food “Understand the Potential Hazard” section: processing activities and preparation o The explanation of residue and its techniques and their impact on the presence metabolite(s); of animal drug residues in the product. o A Note stating that aquaculture plants, The following changes have been made to the seaweed and algae are not covered by the “Identify Critical Control Points” section: Seafood HACCP regulation; o Add a description of on-farm visits o The explanation of the FFD&C Act conducted by the processor to review requirement for animal drug sell and use; farming conditions, land use practices, and pesticides utilization; o The reference to New Animal Drug Application Guidance; o Additional explanation for supplier’s certification or letter of guarantee control o Information regarding the use of medically strategy was provided; and important antimicrobials (Veterinary Feed Directive and prescriptions) and issue of o “Third-Party Farm Certification Program” antimicrobial resistance; has replaced “Quality Assurance Program” as control strategy 5. o Reference to CVM website for more information regarding judicious use of The following changes have been made to the therapeutic antimicrobials; “Develop a Control Strategy” section: o Hyperlink to the Drug Indexing; o Added examples of factors to be considered when determining the appropriate o Additional information regarding conditions preventative control and verification strategy of extra-label drug use (EDLU); by the processor; o A Note to foreign farmers to consult with o Add a recommendation for a secondary their country competent authority for processor; information on prescription requirements and technical support as well as provided o Revised paragraph regarding concentration OIE definition of veterinarian; of environmental contaminants including pesticides in pond water; and o Header “Unapproved Animal Drugs” with an explanation of unapproved drug; and o Control strategies 1 through 7 have been re-numbered and formatted. o Information regarding FDA import tolerances and listed animal drugs with established The following change has been made to the import tolerances. “Bibliography” section: The following have been added to the o Updated to reflect the changes in the guide “Determine Whether the Potential Hazard is with website links as deemed appropriate. Significant” section: Chapter 10: “Methylmercury” has been modified o Provided the overview of preventive with the following recommendations as of April measures for the hazard of aquaculture drugs used in aquaculture operations that 2011: can be employed by the processor; Has been rewritten to acknowledge that FDA o Information regarding aquaculture drug is receiving comments on a draft quantitative testing strategy and its importance as the risk assessment for methylmercury, which may verification of control limits established for result in a reassessment of its risk management aquaculture drug hazards; and strategies Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 8 (June 2022)).  o Paragraph regarding common food Chapter 12: “Pathogenic Bacteria Growth and processing activities and preparation Toxin Formation (Other than Clostridium techniques and their impact on the presence of animal drug residues in the product. botulinum) as a Result of Time and Temperature Abuse” has been modified with the following The following have been added and/or modified recommendations as of April 2011: in the “Identify Critical Control Points” section: It is now recognized that V. vulnificus, V. o Description of on-farm visit conducted by the parahaemolyticus, and Vibrio cholarae non-O1 processor to review farming conditions and and non-0139 are generally associated with the farm’s aquaculture drug use program; marine and estuarine species of fish and may o The “letter of guarantee” term to the not be reasonably likely to occur in freshwater “Supplier’s Certification” control strategy; species or non-fishery ingredients, unless they o The example of control strategy that have been cross-contaminated; includes “Processor’s Pre-Qualified Supplier It is now clarified that products that are partially Program” as example 3; cooked to set the batter or breading or stabilize o Control strategy “Farm’s Records of Drug the product shape (e.g., fish balls, shrimp Use” example 3 changed to example 4; egg rolls, and breaded fish portions) are not considered to be ready to eat; o Control strategy “Drug Residue testing by Processor” example 4 changed to example Information is now provided on the 5; determination of CCPs for products that are a combination of raw, ready-to-eat and cooked, o Control strategy “Quality Assurance ready-to-eat fishery ingredients; Program” replaced with “Third-Party Farm Certification Program” and is listed as Control of time and temperature abuse at example 6; and receipt, during cooling after cooking, during unrefrigerated processing, and during o Control strategy “Control During Holding or refrigerated storage and processing are now Transport” example 6 changed to example 7. provided as four separate control strategy The following have been added and/or modified examples. Examples of HACCP plans are now in the “Develop a Control Strategy” section: provided for all four strategies; o Examples of factors to be considered when For control of transit conditions at receipt of determining the appropriate preventative ready-to-eat fish or fishery products delivered control and verification strategy by the refrigerated (not frozen), it is now recommended processor; that all lots be accompanied by transportation records that show that the fish were held at or o Recommendation for a secondary processor; below an ambient or internal temperature of and 40°F (4.4°C) throughout transit or, for transit o Examples of control strategy 1-7 have been times of 4 hours or less, that the internal re-numbered and formatted. temperature of the fish at time of receipt was at or below 40°F (4.4°C); The following have been modified in the “Bibliography” section: For control of time and temperature during refrigerated storage and refrigerated processing, o Links have been updated. it is now noted that critical limits that specify a cumulative time and temperature of exposure to temperatures above 40°F (4.4°C) are not ordinarily suitable because of the difficulty in determining when specific products have entered and left the cooler and the time and temperature exposures to which they were subjected. However, there may be circumstances where this approach is suitable. It is also noted that minor variations in cooler temperature measurements can be avoided by submerging the sensor for the temperature- Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 9 (June 2022).  recording device in a liquid that mimics the should be limited to 5 hours (12 hours if S. characteristics of the product; aureus is the only pathogen of concern), It is now recommended that if only the internal OR temperature of the fishery product is checked o The product is held at internal temperatures at receipt, because the transit time is no more below 50°F (10°C), than 4 hours, calculation of transit time should include all time outside a controlled temperature OR environment; o Alternatively, the product is held at ambient It is now recommended that if only the internal air temperatures below 50°F (10°C) temperature of product is checked at receipt throughout processing; by a secondary processor because the transit For cooked, ready-to-eat products: time is no more than 4 hours, a temperature- indicating device (e.g., a thermometer) o If at any time the product is held at should be used to determine internal product internal temperatures above 80°F (27.2°C), temperatures in a minimum of 12 containers exposure time (i.e., time at internal (e.g., cartons and totes), unless there are fewer temperatures above 50°F (10°C) but below than 12 containers in a lot, in which case all of 135ºF (57.2ºC)) should be limited to 1 hour the containers should be measured; (3 hours if S. aureus is the only pathogen of concern), When checks of the sufficiency of ice or chemical cooling media, such as gel packs, or internal OR product temperatures are used at receipt of fish o Alternatively, if at any time the product is from another processor, it is now recommended held at internal temperatures above 80°F that the number of containers examined and (26.7°C), exposure time (i.e., time at the number of containers in the lot be recorded; internal temperatures above 50°F (10°C) Chemical coolants (e.g., gel packs) are no but below 135ºF (57.2ºC)) should be limited longer recommended for control of temperature to 4 hours, as long as no more than 1 of during in-plant storage; those hours is above 70°F (21.1°C), Recommended cumulative exposure times and OR temperatures (i.e., critical limits) are now listed o If at any time the product is held at internal as follows: temperatures above 70°F (21.1°C), but For raw, ready-to-eat products: never above 80°F (26.7°C), exposure time at internal temperatures above 50°F (10°C) o If at any time the product is held at should be limited to 2 hours (3 hours if S. internal temperatures above 70°F (21.1°C), aureus is the only pathogen of concern), exposure time (i.e., time at internal temperatures above 50°F (10°C) but below OR 135ºF (57.2ºC)) should be limited to 2 o Alternatively, if the product is never held at hours (3 hours if Staphylococcus aureus (S. internal temperatures above 80°F (26.7°C), aureus) is the only pathogen of concern), exposure times at internal temperatures OR above 50°F (10°C) should be limited to 4 hours, as long as no more than 2 of those o Alternatively, exposure time (i.e., time at hours are above 70°F (21.1°C), internal temperatures above 50°F (10°C) but below 135ºF (57.2ºC)) should be limited OR to 4 hours, as long as no more than 2 of o If the product is held at internal those hours are between 70°F (21.1°C) and temperatures above 50°F (10°C), but never 135ºF (57.2ºC), above 70°F (21.1°C), exposure time at OR internal temperatures above 50°F (10°C) should be limited to 5 hours (12 hours if S. o If the product is held at internal aureus is the only pathogen of concern), temperatures above 50°F (10°C), but never above 70°F (21.1°C), exposure time at OR internal temperatures above 50°F (10°C) Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 10 (June 2022).  o The product is held at internal temperatures High-temperature alarms are no longer below 50°F (10°C), recommended for monitoring temperatures in coolers or processing areas; OR Chemical coolants (e.g., gel packs) are no o Alternatively, the product is held at ambient longer recommended for control of temperature air temperatures below 50°F (10°C) during in-plant storage; throughout processing; When the adequacy of ice is established as the High-temperature alarms are no longer critical limit for refrigerated storage, it is now recommended for monitoring temperatures in recommended that monitoring be performed coolers or processing areas; with sufficient frequency to ensure control When the adequacy of ice is established as the rather than at least twice per day; critical limit for refrigerated storage, it is now It is now recommended that a water phase recommended that monitoring be performed salt level of 20% be achieved in shelf-stable, with sufficient frequency to ensure control reduced oxygen packaged products in which rather than at least twice per day; salt is the only barrier to pathogenic bacteria It is now recommended that monitoring growth and toxin formation; shipments received under gel packs include It is now recommended that monitoring both adequacy of gel packs and internal product shipments received under gel packs include temperature. both adequacy of gel packs and internal product temperature; Chapter 13: “Clostridium botulinum Toxin Formation” has been modified with the following It is now recommended that if only the internal temperature of the fishery product is checked recommendations as of April 2011: at receipt, because the transit time is no more Information is now provided on Time- than 4 hours, calculation of transit time should Temperature Indicator (TTI) performance and include all time outside a controlled temperature suitability; environment; A control strategy is now provided for application It is now recommended that if only the internal of TTIs on each of the smallest package units temperature of product is checked at receipt (i.e., the unit of packaging that will not be by a secondary processor because the transit distributed any further, usually consumer or time is no more than 4 hours, a temperature- end-user package), where refrigeration is the indicating device (e.g., a thermometer) sole barrier to prevent toxin formation; should be used to determine internal product It is no longer recommended that consideration temperatures in a minimum of 12 containers be given to whether the finished product will be (e.g., cartons and totes), unless there are fewer stored and distributed frozen when determining than 12 containers in a lot, in which case all of whether the hazard is significant. A control the containers should be measured; strategy is now provided to ensure that frozen A control strategy example is now provided for products are properly labeled when freezing receipt by a secondary processor of refrigerated is the sole barrier to prevent toxin formation; reduced oxygen packaged products that may Processors are now advised to take particular be stored and further distributed or used as an care in determining the safety of a packaging ingredient for further processing; material for a product in which (1) the spoilage It is now clarified that brining time should be organisms have been eliminated or significantly monitored during the processing of smoked fish; reduced by such processes as high-pressure It is now recommended that brine be treated processing and (2) refrigeration is the sole to minimize microbial contamination or be barrier to toxin formation. The generally periodically replaced as a good manufacturing recommended 10,000 cc/m2/24 hours at 24ºC practice control. oxygen transmission rates may not be suitable in this case; Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 11 (June 2022). Chapter 14: “Pathogenic Bacteria Growth and For surimi-based products, soups, or sauces, Toxin Formation as a Result of Inadequate the following pasteurization process is now recommended: a minimum cumulative, total Drying” has been modified with the following lethality of F194°F (F90°C) = 10 minutes, where z = recommendations as of April 2011: 12.6°F (7°C) for temperatures less than 194°F (90°C), and z = 18°F (10°C) for temperatures It is no longer recommended that consideration above 194°F (90°C); be given to whether the finished product will be stored and distributed frozen (in the case For Dungeness crabmeat, the following of reduced oxygen packaged products) or pasteurization process is now recommended: refrigerated (in the case of aerobically packaged a minimum cumulative total lethality of F194°F products) when determining whether the hazard (F90°C) = 57 minutes, where z = 15.5°F (8.6°C); is significant. A control strategy to ensure that Information concerning levels of Listeria refrigerated dried products are properly labeled monocytogenes (L. monocytogenes) in foods when refrigeration is the sole barrier to toxin is now updated based on the final FDA/U.S. formation is now provided. A control strategy Department of Agriculture L. monocytogenes to ensure that frozen products are properly risk assessment. labeled when freezing is the sole barrier to toxin formation is now provided in Chapter 13. Chapter 17: “Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Chapter 15: “Staphylococcus aureus Toxin Formation Characteristics” has been modified with the in Hydrated Batter Mixes” has been modified following recommendations as of April 2011: with the following recommendations as of April 2011: A new chapter that contains guidance for the The number of S. aureus organisms normally control of pathogen survival through processes needed to produce toxin is now listed as designed to retain raw product characteristics, 500,000 to 1,000,000 per gram; including high hydrostatic pressure processing, mild heat processing, IQF with extended frozen High-temperature alarms are no longer storage, and irradiation. At present, the recommended for monitoring temperatures in chapter applies exclusively to the processing processing areas. of molluscan shellfish products for which there is a desire to retain raw product characteristics. Chapter 16: “Pathogenic Bacteria Survival Through However, these technologies may have other Cooking or Pasteurization” has been modified applications. with the following recommendations as of April 2011: Chapter 18: “Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking The separate chapters that previously covered pathogen survival through cooking and Processes” has been modified with the following pathogen survival through pasteurization are recommendations as of April 2011: now combined; It is no longer recommended that consideration Pasteurization is now defined as a heat be given to whether the finished product will be treatment applied to eliminate the most stored and distributed frozen when determining resistant pathogen of public health concern whether the hazard is significant. A control that is reasonably likely to be present in food; strategy to ensure that frozen products are Information is now provided for an option to properly labeled when freezing is the sole monitor End-Point Internal Product Temperature, barrier to prevent C. botulinum toxin formation instead of continuous time and temperature is now provided in Chapter 13. monitoring during cooking or pasteurization, when a scientific study has been conducted to validate that it will provide a 6D process for the target pathogen; Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 12 (June 2022). Chapter 19: “Undeclared Major Food Allergens and detector or separated from the product stream Certain Food Intolerances Causing Substances” by magnets, screens, or other devices, the source of the fragment is located and corrected. has been modified with the following recommendations as of August 2019: Chapter 21: “Glass Inclusion” has been modified with the following recommendations as of April 2011: The language regarding allergen cross- contact has been enhanced; This chapter is no longer identified as a draft; The language regarding allergen sanitation The use of x-ray detection devices is no and cleaning has been enhanced; longer recommended as a reliable method for controlling glass inclusion; The examples have been consolidated for The recommended critical limit for the glass relevance; container cleaning and visual inspection Unnecessary examples have been removed; control strategy has been expanded to read, “All container pass through an operating glass “Prohibited additives” have been removed container inspection or cleaning process,” from the title and chapter since they are and “No detectable glass fragments in glass prohibited; containers passing the CCP.” As a result, the Label review for the appropriate identification recommended monitoring procedures are also of the allergen and being applied to the expanded so that they now are designed to appropriate product has been added; and also ensure that the processes are in place and operating; CFP and other regulatory references have The monitoring procedures for the glass been removed. container cleaning and visual inspection control strategy now include a recommendation that Chapter 20: “Metal Inclusion” has been modified a representative sample of the cleaned or with the following recommendations as of April inspected containers be examined at the start 2011: of processing, every 4 hours during processing, Foreign objects less than 0.3 inch (7 mm) are at the end of processing, and after any now identified as having a potential for causing breakdowns; trauma or serious injury to persons in special It is now recommended that monitoring for risk groups, such as infants, surgery patients, the presence of glass be performed at the and the elderly; start of each production day and after each Additional information on calibration and shift change. validation of electronic metal detectors is now It is now recommended that a representative provided; sample of cleaned or inspected glass containers Wire mesh baskets are no longer used as be examined daily, at the start of processing, an example of an unlikely source of metal every 4 hours during processing, at the end of fragments; processing, and after any breakdowns. The recommended critical limit for the metal Appendix 1: “Forms” has been modified with the detection or separation control strategy has following recommendations as of June 2021: been expanded to read, “All product passes through an operating metal detection or Updated for new page format and made 508 separation device,” and “No detectable metal compliance. fragments in a product passing through the metal detection or separation device.” As a Appendix 2: “Sample Product Flow Diagram” result, the recommended monitoring procedures has been modified with the following are also expanded so that they now are designed to also ensure that the processes are in place recommendations as of June 2021: and operating; Updated for new page number format and made It is now recommended that when metal 508 compliance. fragments are found in a product by a metal Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 13 (June 2022). Appendix 3: “Critical Control Point Decision Appendix 5: Table A-5, “FDA and EPA Safety Levels in Tree” has been modified with the following Regulations and Guidance,” has been modified recommendations as of June 2021: with the following recommendations as of June 2021: Updated for new page number format and made 508 compliance. Chemical Safety Levels – The following changes have been made: Appendix 4: “Bacterial Pathogen Growth and o Removal for lack of approved safety levels: Inactivation,” has been modified with the  Fluzapyroxad for freshwater finfish, following recommendations as of April 2011: shellfish, crustacean, and molluscs; Recommended summary cumulative exposure o Addition of the following: times and temperatures are now listed as described above for Chapter 12;  Bensulfuron methyl for use in crayfish; The maximum water phase salt level for growth  Chlorantraniliprole for use in crayfish; of Campylobacter jejuni is now listed as 1.7%;  Deltamethrin for use in freshwater The maximum level of acidity (pH) for growth finfish, farm raised finfish, saltwater of pathogenic strains of Escherichia coli (E. coli) finfish, tuna and other; is now listed as 10;  Imazethapyr for use in crayfish; The maximum recommended cumulative  Imidacloprid for use in fish, shellfish exposure times for Bacillus cereus are now listed and molluscs; as follows: 5 days at temperatures of 39.2 to  Pendimethalin for use in crayfish; 43°F (4 to 6°C); 1 day at temperatures of 44 to 59°F (7 to 15°C); 6 hours at temperatures  Propanil for use in crayfish; of 60 to 70°F (16 to 21°C); and 3 hours at  Quizalofop ethyl for use in shellfish and temperatures above 70°F (21°C); crustacean; The maximum cumulative exposure times for  Triclopyr and its metabolites for use in E. coli, Salmonella, and Shigella spp. are now fish and shellfish. listed as follows: 2 days for temperatures from their minimum growth temperature 41.4 to 50°F Appendix 6: “Japanese and Hawaiian Vernacular (10°C); 5 hours for temperatures of 51 to 70°F Names for Fish Eaten Raw” has been modified (11 to 21°C); and 2 hours for temperatures above 70°F (21°C); with the following recommendations as of April 2011: The maximum cumulative exposure times for Listeria monocytogenes are now listed as No longer lists food allergens. follows: 7 days for temperatures of 31.3 to It now contains a table of Japanese and Hawaiian 41ºF (-0.4 to 5ºC); 1 day for temperatures of 42 vernacular names and their corresponding U.S. to 50°F (6 to 10°C); 7 hours for temperatures market names. of 51 to 70°F (11 to 21°C); 3 hours for temperatures of 71 to 86°F (22 to 30°C); and Appendix 7: Bacterial and Viral Pathogens of 1 hour for temperatures above 86°F (30°C); Greatest Concern in Seafood Processing-Public The maximum cumulative exposure times Health Impacts” has been modified with the for Vibrio cholerae, V. vulnificus, and V. parahaemolyticus are now listed as follows: following recommendations as of April 2011: 21 days for temperatures from their minimum No longer lists the bibliography. growth temperature to 50°F (10°C); 6 hours It now contains information regarding the public for temperatures of 51 to 70°F (11 to 21°C); health impacts of bacterial and viral pathogens 2 hours at temperatures of 71 to 80°F (22 to of greatest concern in seafood processing 26.7°C); and 1 hour at temperatures above 80°F (26.7°C), with the last temperature range applying only to cooked, ready-to-eat products. Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 14 (June 2022). Appendix 8: “Procedures for Safe and Sanitary To ensure the regulations are maintained as Processing and Importing of Fish and Fishery the last sections of the Guide Products” has been modified with the following Addendum 2: “Current Good Manufacturing recommendations as of June 2021: Practices (cGMPs)” has been modified with the Moved information to Addendum 1 to ensure the following recommendations as of June 2021: regulations are maintained in the last sections of the Guide. New section Statement referring to Addendum 1 added Addition of 21 CFR 117 subpart B current Good Manufacturing Practices for quick reference. Appendix 9: “Allergen Cross-Contact Prevention” To ensure the regulations are maintained as has been modified with the following the last sections of the Guide. recommendations as of August 2019: New appendix with recommendations for establishing controls to prevent allergen cross- contact in a facility has been added. Appendix 10: “Cleaning and Sanitation for the Control of Allergens” has been modified with the following recommendations as of August 2019: New appendix with recommendations for establishing allergen cleaning and sanitation program has been added. Appendix 11: “Approved Aquaculture Drugs” has been modified with the following recommendations as of June 2021: New appendix with information on FDA approved animal drugs for aquaculture use. The approved drugs list has been formatted. Appendix 12: “Unapproved Aquaculture Drugs” has been modified with the following recommendations as of June 2021: New appendix with information on unapproved drugs including examples of FDA’s high enforcement priority drugs. Addendum 1: “Regulations: Fish and Fishery Products (21 CFR 123) and Control of Communicable Diseases (21 CFR 1240.60)” has been modified with the following recommendations as of June 2021: New section Movement of regulation out of Appendix 8 to Addendum Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 15 (June 2022).  NOTES: Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition. G - 16 (June 2022).  CHAPTER 1: General Information 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 telephone number listed on the title page of this guidance. THE GUIDANCE This is the fourth edition of the Food and Drug Copies of the training document may be Administration’s (FDA’s) “Fish and Fishery Products purchased from: Hazards and Controls Guidance.” This guidance Florida Sea Grant relates to FDA’s Fish and Fishery Products IFAS - Extension Bookstore regulation (called the Seafood HACCP Regulation, University of Florida 21 CFR 123, in this guidance document) and the P.O. Box 110011 Control of Communicable Diseases regulation, Gainesville, FL 32611-0011 21 CFR 1240, that require processors of fish (800) 226-1764 and fishery products to develop and implement HACCP systems for their operations. Those final Or regulations were published in the Federal Register www.ifasbooks.com on December 18, 1995, and became effective on December 18, 1997. The codified portion of the Or you may download a copy from: regulations is included in Appendix 8. http://www.fda.gov/FoodGuidances This guidance is being issued as a companion document to “HACCP: Hazard Analysis Critical Control Point Training Curriculum,” which was developed by the Seafood HACCP Alliance for Training and Education. The Alliance is an organization of federal and state regulators, including FDA, academia, and the seafood industry. FDA recommends that processors of fish and fishery products use the two documents together in the development of a HACCP system. This guidance document will be maintained on the FDA.GOV website, which should be consulted for subsequent updates. CHAPTER 1: General Information 19  NOTES: CHAPTER 1: General Information 20  CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 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 telephone number listed on the title page of this guidance. THE HACCP PLAN FORM THE HAZARD ANALYSIS WORKSHEET This guidance document is designed to walk In order to complete the HACCP Plan Form, you through a series of 18 steps that will yield a you will need to perform a process called completed Hazard Analysis Critical Control Point hazard analysis. The Seafood HACCP Regulation (HACCP) plan. A blank HACCP Plan Form is requires that all seafood processors conduct, contained in Appendix 1. Note that this is a two- or have conducted for them, a hazard analysis page form, with the second page to be used if to determine whether there are food safety your process has more critical control points than hazards that are reasonably likely to occur in can be listed on one page. The Procedures for their product and to the preventive measures that the Safe and Sanitary Processing and Importing a processor can apply to control those hazards of Fish and Fishery Products regulation, 21 CFR (21 CFR 123.6(a)). FDA has found that the use 123 (hereinafter, the Seafood HACCP Regulation), of a standardized Hazard Analysis Worksheet requires that you prepare a HACCP plan for fish assists with this process. A blank Hazard Analysis and fishery products that you process if there are Worksheet is contained in Appendix 1. Note that significant food safety hazards associated with the this is also a two-page form, with the second page products. The regulation does not require that you to be used if your process has more processing use the form included in Appendix 1. However, steps than can be listed on one page. The Seafood using this standardized form may help you develop HACCP Regulation does not require that the an acceptable plan and will expedite regulatory hazard analysis be kept in writing. However, review. A separate HACCP plan should be FDA expects that a written hazard analysis will developed for each location where fish and fishery be useful when you perform mandatory HACCP products are processed and for each kind of fish plan reassessments and when you are asked by and fishery product processed at that location. You regulators to justify why certain hazards were or may group products together in a single HACCP were not included in your HACCP plan. plan if the food safety hazards and controls are the same for all products in the group. CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 21 THE STEPS PRELIMINARY STEPS Following is a list of the steps that this guidance STEP 1: Provide general information. uses in HACCP plan development: Record the name and address of your processing Preliminary Steps facility in the spaces provided on the first page ° Provide general information; of both the Hazard Analysis Worksheet and the ° Describe the food; HACCP Plan Form (Appendix 1). ° Describe the method of distribution and STEP 2: Describe the food. storage; ° Identify the intended use and consumer; Identify the market name or Latin name (species) ° Develop a flow diagram. of the fishery component(s) of the product. Hazard Analysis Worksheet Examples: ° Set up the Hazard Analysis Worksheet; Tuna (Thunnus albacares); Shrimp (Pandals spp.); ° Identify potential species-related hazards; Jack mackerel (Trachurus spp.). ° Identify potential process-related hazards; ° Understand the potential hazard; Fully describe the finished product food. ° Determine whether the potential hazard Examples: is significant; Individually quick frozen, cooked, peeled ° Identify critical control points. shrimp; HACCP Plan Form Fresh tuna steaks; Frozen, surimi-based, imitation king crab ° Set up the HACCP Plan Form; legs; ° Set critical limits; Fresh, raw drum, in-the-round; ° Establish monitoring procedures: Raw shrimp, in-shell; What, Raw, shucked clams; How, Fresh seafood salad, with shrimp and blue Frequency, crabmeat; Frozen, breaded pollock sticks; Who; Frozen crab cakes. ° Establish corrective action procedures; Describe the packaging type. ° Establish a recordkeeping system; Examples: ° Establish verification procedures. Vacuum-packaged plastic bag; Aluminum can; Bulk, in wax-coated paperboard box; Plastic container with snap lid. Record this information in the space provided on the first page of both the Hazard Analysis Worksheet and the HACCP Plan Form. CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 22 STEP 3: Describe the method of distribution STEP 5: Develop a flow diagram. and storage. The purpose of the diagram is to provide a Identify how the product is distributed and stored clear, simple description of the steps involved in after distribution. the processing of your fishery product and its associated ingredients as they “flow” from receipt Examples: to distribution. The flow diagram should cover Stored and distributed frozen; all steps in the process that your firm performs. Distributed on ice and then stored under Receiving and storage steps for each of the refrigeration or on ice. ingredients, including non-fishery ingredients, Record this information in the space provided should be included. The flow diagram should be on the first page of both the Hazard Analysis verified on-site for accuracy. Worksheet and the HACCP Plan Form. Figure A-1 (Appendix 2) is an example of a flow diagram. STEP 4: Identify the intended use and consumer. HAZARD ANALYSIS WORKSHEET Identify how the product will be used by the end user or consumer. STEP 6: Set up the Hazard Analysis Examples: Worksheet. To be heated (but not fully cooked) and Record each of the processing steps (from served;