FDA《水产品HACCP指南》第四版-2022更新SeafoodHazardsGuide-CompleteDocument-June2022.pdf

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1、Fish and Fishery Products Hazards and Controls Guidance June 2022 EditionSGR 129DEPARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICEFOOD AND DRUG ADMINISTRATIONCENTER FOR FOOD SAFETY AND APPLIED NUTRITIONOFFICE OF FOOD SAFETYFish and Fishery Products Hazards and Controls GuidanceJune 2022 Ed

2、itionAdditional copies may be purchased from:Florida Sea Grant IFAS-Extension Bookstore University of Florida P.O.Box 110011 Gainesville,FL 32611-0011(800)226- Copies of this guidance document may be downloaded from:www.FDA.gov/Seafood U.S.Department of Health and Human ServicesFood and Drug Adminis

3、trationCenter for Food Safety and Applied Nutrition(240)402-2300JUNE 2022TABLE OF CONTENTS:FISH AND FISHERY PRODUCTS HAZARDS AND CONTROLS GUIDANCE-JUNE 2022 EDITIONSectionPageGuidance for Industry:Fish and Fishery Products Hazards and Control Guidance G-1CHAPTER 1:General Information 19CHAPTER 2:Con

4、ducting a Hazard Analysis and Developing a HACCP Plan 21CHAPTER 3:Potential Species-Related and Process-Related Hazards 3 1CHAPTER 4:Pathogens from the Harvest Area 75CHAPTER 5:Parasites 91CHAPTER 6:Natural Toxins 6 1CHAPTER 7:Scombrotoxin(Histamine)Formation 113CHAPTER 8:Other Decomposition-Related

5、 Hazards 153CHAPTER 9:Environmental Chemical Contaminants Including Pesticides 9 1CHAPTER 10:Methylmercury 181CHAPTER 11:Aquaculture Drugs 11 1CHAPTER 12:Pathogenic Bacteria Growth and Toxin Formation(Other than Clostridium botulinum)as a Result of Time and Temperature Abuse 209CHAPTER 13:Clostridiu

6、m botulinum Toxin Formation 245CHAPTER 14:Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 293CHAPTER 15:Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 309CHAPTER 16:Pathogenic Bacteria Survival Through Cooking or Pasteurization 315CHAPTER 17:Pathogenic

7、 Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 331CHAPTER 18:Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 345CHAPTER 19:Undeclared Major Food Allergens and Certain Food Intolerance Substances 19 1CHAPTER 20:Metal Incl

8、usion 385CHAPTER 21:Glass Inclusion 395APPENDIX 1:Forms A1 1APPENDIX 2:Product Flow Diagram Example A2 11(June 2022).Table of Contents.SectionPageAPPENDIX 3:Critical Control Point Decision Tree A3 1APPENDIX 4:Bacterial Pathogen Growth and Inactivation 417APPENDIX 5:FDA and EPA Safety Levels in Regul

9、ations and Guidance A5 1APPENDIX 6:Japanese and Hawaiian Vernacular Names for Fish Eaten Raw 443APPENDIX 7:Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing-Public Health Impacts 451APPENDIX 8:Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Product

10、s A8 1APPENDIX 9:Allergen Cross-Contact Prevention A9 1APPENDIX 10:Allergen Cleaning and Sanitation for the Control of AllergensA10 1 APPENDIX 11:Approved Aquaculture DrugsA11 1 APPENDIX 12:Unapproved Aquaculture DrugsA12 1ADDENDUM 1:Fish and Fishery Products(21 CFR 123)and Control of Communicable D

11、iseases(21 CFR 1240.60)AD1 1ADDENDUM 2:current Good Manufacturing Practices(cGMPs)AD2 1 2(June 2022).Table of Contents.GUIDANCE FOR THE INDUSTRY:FISH AND FISHERY PRODUCTS HAZARDS AND CONTROLS GUIDANCE,JUNE 2022 EDITIONThis guidance represents the Food and Drug Administrations(FDAs)current thinking o

12、n 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 th

13、e 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 This guidance is intended to assist processors of fish and fishery products in the development of their Hazard An

14、alysis Critical Control Point(HACCP)plans.Processors of fish and fishery products will find information in this guidance that will help them identify hazards that are associated with their products and help them formulate control strategies.The guidance will help consumers and the public generally t

15、o understand commercial seafood safety in terms of hazards and their controls.The guidance does not specifically address safe handling practices by consumers or by retail establishments,although many of the concepts contained in this guidance are applicable to both.This guidance is also intended to

16、serve as a tool to be used by federal and state regulatory officials in the evaluation of HACCP plans for fish and fishery products.FDAs guidance documents,including this guidance,do not establish legally enforceable responsibilities.Instead,guidance describes the Agencys current thinking on a topic

17、 and should be viewed only as recommendations,unless specific regulatory or statutory requirements are cited.The use of the word“should”in Agency guidance means that something is suggested or recommended,but not required.This guidance has been prepared by the Division of Seafood Safety in the Center

18、 for Food Safety and Applied Nutrition at the U.S.Food and Drug Administration.II.DISCUSSION A.Scope and Limitations The control strategies and practices provided in this guidance are recommendations to the fish and fishery products industry unless they are required by regulation or statute.This gui

19、dance provides information that would likely result in a HACCP plan that is acceptable to FDA.Processors may choose to use other control strategies,as long as they comply with the requirements of the applicable food safety laws and regulations.However,processors that chose to use other control strat

20、egies(e.g.,critical limits)should scientifically establish their adequacy.The information contained in the tables in Chapter 3 and in Chapters 4 through 21 provide guidance for determining which hazards are“reasonably likely to occur”in particular fish and fishery products under ordinary circumstanc

21、es.However,the tables should not be used separately for this purpose.The tables list potential hazards for specific species and finished product types.This information should be combined with the information in the subsequent chapters to determine the likelihood of occurrence.The guidance is not a s

22、ubstitute for the per-formance of a hazard analysis by a processor of fish and fishery products,as required by FDAs regulations.Hazards not covered by this guidance may be relevant to certain products under certain circumstances.In particular,processors should be alert to new or emerging problems(e.

23、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 to ensure the safe and sanitary processing of fish

24、 and fishery products in the Federal Register of December 18,1995(60 FR 65096)(hereinafter referred to as the Seafood HACCP Regulation).This guidance,the Seafood HACCP Regulation(21 CFR 123),and the Control of Communicable Diseases regulation(21 CFR 1240)apply to all aquatic animal life,other than b

25、irds and mammals,used as food for human consumption.For example,in addition to fresh and saltwater finfish and crustaceans,this guidance applies to echinoderms such as sea cucumbers and sea urchins;reptiles such as alligators and turtles;amphibians such as frogs;and to all mollusks,including land sn

26、ails(escargot).It also applies to extracts and derivatives of fish,such as eggs(roe),oil,cartilage,and fish protein concentrate.In addition,this guidance applies to products that are mixtures of fish and non-fish ingredients,such as tuna sandwiches and soups.Addendum 1,123.3,lists the definitions fo

27、r“fish”and“fishery product”used in the Seafood HACCP Regulation.This guidance covers safety hazards associated with fish and fishery products only.It does not cover most hazards associated with non-fishery ingredients(e.g.,Salmonella enteritidis in raw eggs).However,where such hazards are presented

28、by a fishery product that contains non-fishery ingredients,control must be included in the HACCP plan(123.6).Processors may use the principles included in this guidance for assistance in developing appropriate controls for these hazards.This guidance does not cover the hazard associated with the for

29、mation of Clostridium botulinum(C.botulinum)toxin in low-acid canned foods(LACFs)or shelf-stable acidified foods.Mandatory controls for this hazard are contained in the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation(hereinafter referred to as the LACF Regula

30、tion,21 CFR 113)and the Acidified Foods regulation(21 CFR 114).Such 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 i

31、s 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 recommendations for aller

32、gen cleaning and sanitation,and allergen cross-contact through two new appendixes(Appendix 9 and 10)since normal cleaning and sanitation does not necessarily address allergen residues.This guidance does not describe corrective action or verification records,because these records are not required to

33、be listed in the HACCP plan.Nonetheless,such records must be maintained,where applicable,as required in 123.7 and 123.8.Additionally,this guidance does not restate the general requirements for records that are set out in 123.9(a).This guidance does not cover reassessment of the HACCP plan and/or the

34、 hazard analysis or review of consumer complaints,as mandated by 123.8.This guidance also does not provide specific guidance to importers of fish and fishery products for the development of required importer verification procedures.However,the information contained in the text,and,in particular,in A

35、ppendix 5(“FDA and EPA Safety Levels in Regulations and Guidance”),should prove useful for this purpose.B.Chapter Modifications The following is a summary of the most significant changes made to this guidance.Moving forward,FDA will publish this guidance as a living document on the FDA Seafood websi

36、te(www.fda.gov/seafood).This guidance will now reference the date of publication as the edition of the document.Each chapter,appendix,and/or addendum will also reference the date(month and year)the most recent changes were made and published.Additionally,the“Guidance for Industry”section will identi

37、fy the specific changes in the header with the date of publication.You should carefully review the chapters applicable to your product and process in addition to using this summarized list of significant changes.G-2(June 2022).Guidance for the Industry:Fish and Fishery Products Hazards and Controls

38、Guidance,June 2022 Edition.The following changes have been made throughout this guidance document:Chapter 1:“General Information”has been modified with the following recommendations as of April 2011:Chapter 2:“Conducting a Hazard Analysis and Developing a HACCP plan”has been modified with the follow

39、ing recommendations as of April 2011:Chapter 3:“Potential Species-Related and Process-Related Hazards”Introduction has been modified with the following recommendations as of June 2021:The following notes were added:o For endangered and threatened species:refer to NOAA and the U.S.Fish and Wildlife S

40、ervices to identify endangered and threatened species with hyperlinks;o Identifying“The Seafood List”as the reference to consult for naming of seafood species;o Identifying that the tables in Chapter 3 should be used in conjunction with Chapters 4 21 in the development of a HACCP plan.Chapter 3,Tabl

41、e 3-2:“Potential Vertebrate Species-Related Hazards”has been modified with the following recommendations as of June 2021:Crocodile The following changes have been made:o Wild and aquacultured species have been identified;o Associated hazards have been added.Oreo Dory Allocyttus spp.,Neocyuttus spp.,

42、Oreosoma spp.and Pseudocyttus spp.have been added with the hazard of GFP.Roughy,Orange Hoplostethus atlanticus has been added with the hazard of GFP.Scad(Selar crumenophthalmus)The following change has been made:o Scombrotoxin(histamine)hazard has been added.Chapter 3,Table 3-3:“Potential Invertebra

43、te Species-Related Hazards”has been modified with the following recommendations as of June 2021:Barnacles,Gooseneck(Pollicipes polymerus)Has been added with the hazards of natural toxins and environmental chemicals.Sea Cucumber The following changes have been made:o Aquacultured species have been id

44、entified with the hazards of environmental chemicals and aquaculture drugs;o Stichopus japonicus is synonymous with Apostichopus japonicus and has been removed.Seabob(Xiphopenaeus kroyeri)Shrimp has been added as a market name.Shrimp The following changes have been made:o Acetes japonicus has been a

45、dded with the hazard of environmental chemical.Snail or Escargot The following changes have been made:o Cornu aspersa,Elona quimperiana,Helix lucorum,and Pila polita have been added with the hazards of parasites and environmental chemicals.Squid or Calamari Nomenclature change from Loligo opalescens

46、 to Doryteuthis opalescens.Chapter 3,Table 3-4:“Potential Process-Related Hazards”has been modified with the following recommendations as of August 2019:Footnote 2 has been removed.Footnotes 3,4,5,6,and 7 have been renumbered as a result of footnote 2 being removed.Header Allergens and Food Intolera

47、nce Substances Chapter 19 The following changes have been made:o Chapter title updated to remove“Prohibited Food and Color Additives;”o Footnote 5 has been added to the header.Smoked Fish(Other than ROP)New listing for Chap 16 with Footnote 6 has been added.Dried Fish(All)-Footnote 7 for Chapter 13

48、has been added.G-3(June 2022).Guidance for the Industry:Fish and Fishery Products Hazards and Controls Guidance,June 2022 Edition.Battered or Breaded Finished Product Food The following changes have been made:o“Package Type”has been divided into two types;o New listing for Chapter 13 for the ROP Pac

49、kage Type has been added.Raw oysters,clams,and mussels(ROP)The following changes have been made:o“Hot Fill”and“Steam Flush”has been removed from the Package Type description;o The hazard of undeclared allergen has been removed.Raw oysters,clams,and mussels(other than ROP)The following changes have b

50、een made:o“Hot Fill”and“Steam Flush”has been removed from the Package Type description;o The hazard of undeclared allergen has been removed.Footnotes Footnotes 5,and 6 have been added.Chapter 4:“Pathogens from the Harvest Area”has been modified with the following recommendations as of April 2011:Hyd