Fish and Fishery Products HACCP

8/3/2019 Fish and Fishery Products HACCP

1/475

Fish and Fishery ProductsHazards and Controls GuidanceFourth Edition APRIL 2011

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

OFFICE OF FOOD SAFETY


2/475


3/475

Fish and Fishery Products Hazards andControls GuidanceFourth Edition April 2011

Additional copies may be purchased rom:

Florida Sea GrantIFAS - Extension Bookstore

University o Florida

P.O. Box 110011

Gainesville, FL 32611-0011

(800) 226-1764

Or

www.iasbooks.com

Or you may download a copy rom:

http://www.da.gov/FoodGuidances

You may submit electronic or written commentsregarding this guidance at any time. Submitelectronic comments tohttp://www.regulations.gov. Submit written comments to the Divisiono Dockets Management (HFA-305), Food andDrug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852. All commentsshould be identied with the docket numberlisted in the notice o availability that publishes

in the Federal Register.

U.S. Department o Health and Human ServicesFood and Drug AdministrationCenter or Food Saety and Applied Nutrition(240) 402-2300

April 2011
http://www.ifasbooks.com/http://www.fda.gov/FoodGuidanceshttp://www.regulations.gov/http://www.regulations.gov/http://www.regulations.gov/http://www.regulations.gov/http://www.fda.gov/FoodGuidanceshttp://www.ifasbooks.com/


4/475


5/475

Table o Contents: Fish and Fishery Products Hazards and Controls Guidance

Guidance or the Industry: Fish and Fishery Products Hazards and Controls Guidance................................ 1

CHAPTER 1: General Inormation.......................................................................................................19CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan ..........................................21

CHAPTER 3: Potential Species-Related and Process-Related Hazards..................................................... 29

CHAPTER 4: Pathogens From the Harvest Area ...................................................................................75

CHAPTER 5: Parasites ......................................................................................................................91

CHAPTER 6: Natural Toxins ............................................................................................................ 99

CHAPTER 7: Scombrotoxin (Histamine) Formation ............................................................................. 113

CHAPTER 8: Other Decomposition-Related Hazards .........................................................................153

CHAPTER 9: Environmental Chemical Contaminants and Pesticides......................................................155

CHAPTER 10: Methylmercury ..........................................................................................................181

CHAPTER 11: Aquaculture Drugs .....................................................................................................183

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum)as a Result o Time and Temperature Abuse ................................................................. 209

CHAPTER 13: Clostridium botulinum Toxin Formation......................................................................... 245

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result o 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 RetainRaw Product Characteristics .......................................................................................331

CHAPTER 18: Introduction o Pathogenic Bacteria Ater Pasteurization andSpecialized Cooking Processes ................................................................................. 345

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substancesand Prohibited Food and Color Additives ....................................................................355

CHAPTER 20: Metal Inclusion..........................................................................................................385

CHAPTER 21: Glass Inclusion ..........................................................................................................395

APPENDIX 1: Forms....................................................................................................................... 405

APPENDIX 2: Sample Product Flow Diagram ..................................................................................... 411

APPENDIX 3: Critical Control Point Decision Tree ............................................................................... 413

APPENDIX 4: Bacterial Pathogen Growth and Inactivation .................................................................. 417

APPENDIX 5: FDA and EPA Saety Levels in Regulations and Guidance ................................................439

APPENDIX 6: Japanese and Hawaiian Vernacular Names or Fish Eaten Raw...................................... 443

APPENDIX 7: Bacterial and Viral Pathogens o Greatest Concern in Seaood Processing Public Health Impacts..................................................................................................451

APPENDIX 8: Procedures or Sae and Sanitary Processing and Importing o Fish and Fishery Products ... 455


6/475

NOTES:


7/475

Guidance or the Industry: Fish and Fishery Products Hazards and Controls GuidanceFourth Edition

This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create

or coner any rights or or on any person and does not operate to bind FDA or the public. You can use an alternative

approach i the approach satisfes the requirements o the applicable statutes and regulations. I you want to discuss

an alternative approach, contact the FDA sta responsible or implementing this guidance. I you cannot identiy the

appropriate FDA sta, call the telephone number listed on the title page o this guidance.

I. INTRODUCTION

This guidance is intended to assist processorso sh and shery products in the developmento their Hazard Analysis Critical Control Point(HACCP) plans. Processors o sh and shery

products will nd inormation in this guidancethat will help them identiy hazards that areassociated with their products, and help themormulate control strategies. The guidance willhelp consumers and the public generally tounderstand commercial seaood saety in termso hazards and their controls. The guidance doesnot specically address sae handling practices byconsumers or by retail establishments, althoughmany o the concepts contained in this guidanceare applicable to both. This guidance is also

intended to serve as a tool to be used by ederaland state regulatory ocials in the evaluation oHACCP plans or sh and shery products.

FDAs guidance documents, including thisguidance, do not establish legally enorceableresponsibilities. Instead, guidance describe theAgencys current thinking on a topic and shouldbe viewed only as recommendations, unless

specic regulatory or statutory requirements are

cited. The use o the wordshouldin Agency

guidance means that something is suggested orrecommended, but not required.

II. DISCUSSION

A. Scope and Limitations

The control strategies and practices provided inthis guidance are recommendations to the sh

and shery products industry unless they arerequired by regulation or statute. This guidanceprovides inormation that would likely result in aHACCP plan that is acceptable to FDA. Processorsmay choose to use other control strategies, aslong as they comply with the requirements othe applicable ood saety laws and regulations.However, processors that chose to use othercontrol strategies (e.g., critical limits) shouldscientically establish their adequacy.

The inormation contained in the tables in

Chapter 3 and in Chapters 4 through 21 provideguidance or determining which hazards arereasonably likely to occur in particular sh andshery products under ordinary circumstances.However, the tables should not be used separatelyor this purpose. The tables list potential hazardsor specic species and nished product types.This inormation should be combined withthe inormation in the subsequent chapters todetermine the likelihood o occurrence.

The guidance is not a substitute or theperormance o a hazard analysis by a processoro sh and shery products, as required by FDAsregulations. Hazards not covered by this guidancemay be relevant to certain products under certaincircumstances. In particular, processors shouldbe alert to new or emerging problems (e.g., theoccurrence o natural toxins in sh not previouslyassociated with that toxin).

Guidance or the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition

1


8/475

FDA announced its adoption o nal regulationsto ensure the sae and sanitary processing o shand shery products in theFederal RegisteroDecember 18, 1995 (60 FR 65096) (hereinaterreerred to as the Seaood HACCP Regulation).This guidance, the Seaood HACCP Regulation(21 CFR 123),and the Control o CommunicableDiseases regulation (21 CFR 1240) apply toall aquatic animal lie, other than birds andmammals, used as ood or human consumption.For example, in addition to resh and saltwaternsh and crustaceans, this guidance appliesto echinoderms such as sea cucumbers and seaurchins; reptiles such as alligators and turtles;amphibians such as rogs; and to all mollusks,including land snails (escargot). It also appliesto extracts and derivatives o sh, such as eggs(roe), oil, cartilage, and sh protein concentrate.In addition, this guidance applies to productsthat are mixtures o sh and non-sh ingredients,such as tuna sandwiches and soups. Appendix 8, 123.3, lists the denitions or sh and sheryproduct used in the Seaood HACCP Regulation.

This guidance covers saety hazards associatedwith sh and shery products only. It doesnot cover most hazards associated with non-shery ingredients (e.g., Salmonella enteritidis

in raw eggs). However, where such hazards arepresented by a shery product that contains non-shery ingredients, control must be includedin the HACCP plan ( 123.6). Processors mayuse the principles included in this guidance orassistance in developing appropriate controls orthese hazards.

This guidance does not cover the hazardassociated with the ormation oClostridiumbotulinum (C. botulinum) toxin in low-acidcanned oods (LACFs) or shel-stable acidiedoods. Mandatory controls or this hazard arecontained in the Thermally Processed Low-Acid Foods Packaged in Hermetically SealedContainers regulation (hereinater reerred toas the LACF Regulation, 21 CFR 113) and theAcidied Foods regulation (21 CFR 114). Suchcontrols may be, but are not required to be,included in HACCP plans or these products.

This guidance does not cover the sanitationcontrols required by the Seaood HACCPRegulation. However, the maintenance o asanitation monitoring program is an essentialprerequisite to the development o a HACCPprogram. When sanitation controls are necessaryor ood saety, but are not included in asanitation monitoring program, they must beincluded in the HACCP plan (21 CFR 123.6).

This guidance does not describe corrective actionor verication records, because these recordsare not required to 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 restatethe general requirements or records that are set

out in 123.9(a).

This guidance does not cover reassessment o theHACCP plan and/or the hazard analysis or reviewo consumer complaints, as mandated by 123.8.

This guidance also does not provide specicguidance to importers o sh and sheryproducts or the development o requiredimporter verication procedures. However,the inormation contained in the text, and, inparticular, in Appendix 5 (FDA and EPA Saety

Levels in Regulations and Guidance), shouldprove useul or this purpose.


2


9/475

B. Changes in This Edition

Following is a summary o the most signicantchanges in this edition o the guidancedocument. In addition to using this summary list,you should careully review the chapters that are

applicable to your product and process.

The inormation contained throughout this

guidance document is changed as ollows:

The elements o a control strategy (i.e., criticallimits, monitoring procedures, corrective actionprocedures, recordkeeping system, and vericationprocedures) are now consolidated or each controlstrategy. In most cases, an example o a HACCPplan ollows the discussion o each control strategy;

A bibliography is now located at the end omost chapters. Reerences have been addedand deleted or many o the chapters;

Inormation on the mechanics o completinga HACCP plan, previously repeated inChapters 4 through 21, is now contained inChapter 2;

Inormation on the potential public healthconsequences (i.e., illness or injury) oseaood saety hazards is now provided;

Recommendations or specic job positionsare no longer listed or Who should perormthe monitoring? in Chapters 4 through 21;

Additional inormation is now provided onthe perormance o accuracy checks andcalibration o temperature-indicating devices(e.g., thermometers) and temperature-recording devices (e.g., recordingthermometers); and

Reerence is no longer made to theintended issuance by FDA o guidance on

the development o Sanitation StandardOperating Procedures (SSOPs) and sanitationmonitoring or guidance on the developmento importer verication procedures.

The recommendations in Chapter 2 or

conducting a hazard analysis and developing a

HACCP plan are changed as ollows:

Additional inormation that is broadlyapplicable to these tasks, also contained inthe companion document to this guidance,HACCP: Hazard Analysis Critical ControlPoint Training Curriculum, developed by theSeaood HACCP Alliance or Training andEducation, is now included.

The inormation in Chapter 3 or identiying

potential species-related and process-related

hazards is changed as ollows:

Inormation is now provided on how illicitspecies substitution can impact on theidentication o potential species-relatedhazards.

The inormation contained in Table 3-2

(Potential Vertebrate Species-Related

Hazards) is changed as ollows:

There are several scientic name changes torefect changes in taxonomic conventions;

Aholehole (Kuhlia spp.) is no longer listed ashaving a potential ciguatera sh poisoning(CFP) hazard;

Amberjack or Yellowtail, Aquacultured(Seriola lalandi), is no longer listed as havinga potential CFP hazard;

Barramundi (Lates calcarier) is now listed asa species that is aquacultured;

Basa or Bocourti (Pangasius bocourti) is nowlisted as a species in U.S. commerce;

Bass, Sea (Dicentrarchus labrax) is nowlisted as a species that is aquacultured;

Bata (Labeo bata) is now listed as a speciesin U.S. commerce;

Bream (Abramis brama) is now listed as aspecies that is aquacultured;

Caparari (Pseudoplatystoma tigrinum) isnow listed as a market name or a speciespreviously reerred to as catsh;

Carp (Barbonymusspp., Hypophthalmichthysnobilis, and Carassius carassius) is nowlisted as a species in U.S. commerce;

Carp (Hypophthalmichthys nobilisandGuidance or the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition

3


10/475

Carassius carassius) is now listed as aspecies that is aquacultured;

Cascarudo (Callichthys callichthys) is nowlisted as a market name or a speciespreviously reerred to as catsh;

Characin (Leporinus obtusidens) is now listedas a species in U.S. commerce; Charal (Chirostoma jordani) is now listed as

a species in U.S. commerce;

Chiring (Apocryptes bato) is now listed as aspecies in U.S. commerce;

Clarias Fish, or Walking Clarias Fish (Clariasanguillarisand Clarias gariepinus), isnow listed as a market name or a speciespreviously reerred to as catsh, and is now

listed as a species that is aquacultured; Cobia (Rachycentron canadum) is now listed

as a species that is aquacultured;

Coroata (Platynematichthys notatus) isnow listed as a market name or a speciespreviously reerred to as catsh;

Curimbata or Guramata (Prochilodus lineatus)is now listed as a species in U.S. commerce;

Cusk-eel (Brotula clarkae) is now listed as aspecies in U.S. commerce;

Dace (Rhinichthys spp.) is now listed as aspecies that is aquacultured; Eel, Moray (Muraena retiera), is no longer

listed as having a potential CFP hazard;

Featherback (Notopterus notopterus) is nowlisted as a species in U.S. commerce;

Flathead (Platycephalus conatus) is nowlisted as a species in U.S. commerce;

Flatwhiskered Fish (Pinirampus pirinampu)is now listed as a market name or a species

previously reerred to as catsh; Frog (Rana spp.) is now listed as having a

parasite hazard;

Gillbacker, or Gilleybaka (Aspistor parkeri),is now listed as a market name or a speciespreviously reerred to as catsh;

Goatsh (Mulloidichthys vanicolenis) is nowlisted as a species in U.S. commerce;

Goatsh (Mulloidichthys spp., Pseudupeneusspp., and Upeneichthys lineatus) is no longerlisted as having a potential CFP hazard;

Goby (Neogobius melanostomus) is nowlisted as a species in U.S. commerce;

Grouper (Anyperodon spp., Caprodonschlegelii, andDiplectrum ormosum) isno longer listed as having a potential CFPhazard;

Grouper, or Coral Grouper (Plectropomusspp.), is now listed as a species in U.S.commerce;

Grouper, or Jewsh (Epinephelus itajara), isno longer listed as a having a potential CFPhazard;

Herring, or Sea Herring, or Sild (Clupeaspp.), is no longer listed as having a potentialscombrotoxin (histamine) hazard associatedwith its roe;

Hind (Epinephelus drummondhayi) is nolonger listed as having a potential CFPhazard;

Jack (Carangoides bartholomaei) is nowlisted as having a potential CFP hazard;

Jack (Selene spp., Urapsis secunda, andOligoplites saurus) is no longer listed ashaving a potential CFP hazard;

Jack or Crevalle (Alectis indicus) is no longerlisted as having a potential CFP hazard;

Jack or Roostersh (Nematistius pectoralis)is no longer listed as having a potential CFPhazard;

Jobsh (Aprion spp.) is now listed, andAprion virescensis deleted because it isincluded inAprion spp.;

Jobsh (Aphareus spp., Aprion spp., andPristipomoides spp.) is no longer listed ashaving a potential scombrotoxin (histamine)hazard;

Kahawai (Arripis spp.) is no longer listed ashaving a potential CFP hazard;

Loach (Somileptus gongota) is now listed as aspecies in U.S. commerce;


4


11/475

Mackerel, narrow-barred Spanish(Scomberomorus commerson), is now listedas having a potential CFP hazard;

Menhaden (Brevoortia spp. and Ethmidiummaculatum) is now listed as having

a potential scombrotoxin (histamine)hazard or products intended or directhuman consumption o the muscle andor aqueous components, such as shprotein concentrates, that are to be usedas ood additives. It is also listed ashaving a potential environmental chemicalcontaminant and pesticide hazard whenthe ood products are intended or humanconsumption, such as oil extracts used asdietary ingredients;

Oreo Dory (Neocyttus spp.)is now listed as aspecies in U.S. commerce;

Oreo Dory(Pseudocyttus spp.) is now listed,andPseudocyttus maculates is deletedbecause it is included inPseudocyttusspp;

Pangasius or Shortbarbel (Pangasiusmicronemus) is now listed as a market nameor a species previously reerred to as catsh;

Parrotsh (Bolbometopon spp.) is now listedas a species in U.S. commerce;

Piramutaba or Laulao Fish (Brachyplatystomavaillanti) is now listed as a market name ora species previously reerred to as catsh;

Puer (Fugu spp., now Takiugu spp.) is nowlisted as an aquacultured species;

Puer (Sphoeroides annulatus, Sphoeroidesnephelus, Sphoeroides spengleri, andSphoeroides testudineus, Tetraodon spp.) isnow listed as a species in U.S. commerce;

Puer (Fugu spp., now Takiugu spp.) is nowlisted as having a potential Paralytic ShellshPoisoning (PSP) hazard;

Rita (Rita rita) is now listed as a species inU.S. commerce;

Rohu (Labeo rohita) is now listed as aspecies in U.S. commerce;

Sailsh (Istiophorus platypterus) is now listedas a species in U.S. commerce;

Salmon and roe (wild) (reshwater)(Oncorhynchus spp. and Salmo salar) is nowlisted as having a potential parasite hazard;

Scad (Trachurus spp.) is now listed as havinga potential scombrotoxin (histamine) hazard;

Scad or Horse Mackerel (Trachurus trachurus)is now listed as a market name or a speciespreviously reerred to as only scad;

Shad (Alosa spp.) is no longer listed as havinga potential scombrotoxin (histamine) hazardassociated with its roe;

Shad, Hilsa (Tenualosa ilisha), is now listedas a species in U.S. commerce;

Snapper (Etelis spp. andPristipomoides spp.)is no longer listed as having a potential CFP

hazard; Snapper (Pristipomoides spp.) is no longer

listed as having a potential scombrotoxin(histamine) hazard;

Snapper (Symphorus nematophorus) is nowlisted as having a potential CFP hazard;

Sorubim, or Surubi (Pseudoplatystomacorruscans), is now listed as a market nameor a species previously reerred to as catsh;

Spearsh (Tetrapturus spp.) is now listed ashaving a potential scombrotoxin (histamine)hazard;

Squirrelsh (Holocentrus spp.) is no longerlisted as having a potential CFP hazard;

Sutchi or Swai (Pangasius hypophthalmus)are now listed as market names or a speciespreviously reerred to as catsh and are nowlisted as species that are aquacultured;

Tang (Naso spp.) is now listed as a species inU.S. commerce;

Tang (Tenthis spp.) is no longer listed.

Tang (Zebrasoma spp.) is no longer listed asa having a potential CFP hazard;

Tigersh (Datnioides microlepisandDatnioides polota) is now listed as a speciesin U.S. commerce;

Tinoil (Barbonymus altus) is now listed as aspecies in U.S. commerce;


5


12/475

Trahira (Hoplias malabaricus) is now listed

as a species in U.S. commerce;

Triggersh (Canthidermis suamen andMelichthys niger) is no longer listed as havinga potential CFP hazard;

Tuna (Thunnus spp.) is now listed as a genusthat is aquacultured; Turbot (Scophthalmus maximus, nowPsetta

maxima) is now listed as a species that isaquacultured;

Turtle (Malaclemys spp., Chelydra spp.,Apalone spp., and Trachemys spp.) is nowlisted as a species in U.S. commerce;

Turtle, Aquacultured (Malaclemys spp.,Chelydra spp., Apalone spp., and Trachemys

spp.), is now listed as a species in U.S.commerce;

Unicornsh (Naso unicornis) is now listed asa species in U.S. commerce;

Weaksh (Cynoscion spp.) is now listed ashaving a potential environmental chemicalcontaminant and pesticide hazard;

Weaksh, or Bangamary (Macrodon ancylodon),is now listed as a market name or a speciespreviously reerred to as only weaksh;

Whiskered Fish (Arius spp.) is now listedas a market name or a species previouslyreerred to as sea catsh;

Whiskered Fish, or Gatopsail Fish (Bagremarinus), is now listed as a market name ora species previously reerred to as sea catsh;

Whiskered Fish, or Hardhead WhiskeredFish (Ariopsis elis), is now listed as a marketname or a species previously reerred to assea catsh;

Wrasse (Cheilinus undulatus) is now listed asa species in U.S. commerce;

Yellowtail Amberjack (Seriola lalandi) is nowlisted as a species that is aquacultured andis no longer listed as having a potential CFPhazard;

Zander (Sander lucioperca) is now listed as aspecies that is aquacultured.


(Potential Invertebrate Species-Related

Hazards) is changed as ollows:

There are several scientic name changes torefect changes in taxonomic conventions;

Abalone (Haliotis spp.) is now listed ashaving a natural toxin hazard;

Conch (Lambis lambis) is now listed as aspecies in U.S. commerce;

Crab, all species are now listed as havinga potential environmental chemicalcontaminant and pesticide hazard;

Crab, Blue (Callinectes sapidus), is now listedas a species that is aquacultured;

Crab, Japanese Freshwater (Geothelphusadehaani), is now listed as a species in U.S.commerce;

Crab, Sheep ( Loxorhynchus grandis), is nowlisted as a species in U.S. commerce;

Crab, Swamp (Scylla serrata), is now listed asa species in U.S. commerce;

Murex, or Merex (Murex brandaris), is nowlisted as a species in U.S. commerce;

Oyster (Spondylus spp.) is now listed as aspecies in U.S. commerce;

Sea Squirt (Styela spp.) is now listed as aspecies in U.S. commerce;

Shrimp (Pleoticus muelleri) is now listed as aspecies in U.S. commerce;

Snail, Moon (Polinices spp.), is now listed asa species in U.S. commerce;

Whelk (Busycon spp.) is now listed as havinga potential natural toxin hazard.


(Potential Process-Related Hazards) is

changed as ollows:

Fish oil is now listed as a ood category; Changes have been made to be consistent

with changes in Chapters 13, 16, and 17.


6


13/475

The recommendations in Chapter 4 or the

control o pathogens rom the harvest area are

changed as ollows:


control o natural toxins are changed as ollows:

Hydrostatic pressure, individual quickreezing (IQF) with extended storage,

and irradiation are now identied asprocesses that are designed to retainraw product characteristics and that canbe used to reduce Vibrio vulnifcus(V.vulnifcus) and Vibrio parahaemolyticus(V.parahaemolyticus) to non-detectable levels;

It is now recognized that a tag on a containero shellstock (in-shell molluscan shellsh)received rom another dealer need notidentiy the harvester;

Critical limits relating to control o pathogengrowth prior to receipt o raw molluscanshellsh by the primary processor are nowlinked to monitoring the time that theshellsh are exposed to air (i.e., by harvestor receding tide) rather than to the time thatthe shellsh are harvested;

Reerence is now made to the role o theFederal, state, tribal, territorial and oreigngovernment shellsh control authoritiesin determining whether the hazard oV.parahaemolyticusis reasonably likely to occur inraw molluscan shellsh and in the developmento a V. parahaemolyticuscontrol plan that willdictate, at least to some extent, the nature o thecontrols or this pathogen in HACCP plans;

The control strategy examples arerestructured or improved clarity: one orsource controls (e.g., tagging, labeling,source waters, harvester licensure, and rawconsumption advisory) and a second or timerom harvest to rerigeration controls.

The recommendations in Chapter 5 or thecontrol o parasites are changed as ollows:

It is now recognized that the parasite hazardmay be reasonably likely to occur in shraised in reshwater containing larvae opathogenic liver, lung and intestinal fukesbecause these parasites enter the shthrough the skin rather than in the ood.

Azaspiracid Poisoning (AZP) is nowdescribed, and an action level o 0.16 mg/kgis now provided;

Inormation regarding potential molluscanshellsh toxins, pectenotoxins (PTXs)and yessotoxins (YTXs), is now provided,although FDA has no specic expectationsor control o YTXs;

An example o a HACCP plan is nowprovided or control o natural toxins inmolluscan shellsh;

The action level or Diarrhetic ShellshPoisoning (DSP) is now listed as 0.16 ppmtotal okadaic acid equivalents;

Action levels or CFP are now listed as 0.01ppb or Pacic ciguatoxin and 0.1 ppb orCaribbean ciguatoxin;

It is now noted that in 2008, FDA advisedagainst the consumption o lobster tomalleybecause unusually high levels o PSP toxinswere detected in that organ in lobsterscaught in the waters o New England duringa red tide event;

CFP is now described as being associatedwith consumption o toxin-contaminated shound in tropical or subtropical areas aroundthe world between 35 north latitude and 35south latitude, particularly the Caribbean Sea,Pacic Ocean, and Indian Ocean and in theFlower Garden Banks area in the northernGul o Mexico;

Gempylotoxin is now described as beingassociated with orange roughy (Hoplostethusatlanticus) and oreo dory (Allocyttus spp.,Pseudocyttus spp. and Neocyttus spp.)although in lesser amounts than escolar.


control o scombrotoxin (histamine) ormation

are changed as ollows:

Inormation is now provided about thepotential or scombrotoxin (histamine)


7


14/475

ormation in products like tuna saladthat have been allowed to becomerecontaminated and then subjected to timeand temperature abuse;

The recommendations regarding on-boardchilling o scombrotoxin-orming species osh are now listed as ollows:

Fish exposed to air or water temperaturesabove 83F (28.3C) should be placed inice, or in rerigerated seawater, ice slurry,or brine o 40F (4.4C) or less, as soonas possible during harvest, but not morethan 6 hours rom the time o death, or

Fish exposed to air and watertemperatures o 83F (28.3C) or lessshould be placed in ice, or in rerigeratedseawater, ice slurry, or brine o 40F(4.4C) or less, as soon as possibleduring harvest, but not more than 9hours rom the time o death, or

Fish that are gilled and gutted beorechilling should be placed in ice, orin rerigerated seawater, ice slurry, orbrine o 40F (4.4C) or less, as soon aspossible during harvest, but not morethan 12 hours rom the time o death, or

Fish that are harvested under conditionsthat expose dead sh to harvest waterso 65F (18.3C) or less or 24 hours orless should be placed in ice, rerigeratedseawater, ice slurry, or brine o 40F(4.4C) or less, as soon as possible aterharvest, but not more than the time limitslisted above, with the time period startingwhen the sh leave the 65F (18.3C) orless environment;

Cautions are now provided that handlingpractices and processing controls that arerecommended as suitable or preventingthe ormation o scombrotoxin may notbe sucient to prevent sh rom sueringquality or shel-lie degradation (i.e.,decomposition) in a way that may otherwiserender it adulterated under the Federal Food,Drug, and Cosmetic Act;

The lower anterior portion o the loin isnow identied as the best place to collect asample rom large sh or histamine analysis;

Fermenting, pickling, smoking, and dryingare now identied as likely critical control

points (CCPs) or this hazard; When sh are checked or internal

temperature at o-loading, it is nowrecommended that:

For sh held iced or rerigerated (notrozen) onboard the vessel and o-loaded rom the vessel by the processor24 or more hours ater death, the internaltemperature should be 40F (4.4C) orbelow,

ORFor sh held iced or rerigerated (notrozen) onboard the vessel and o-loaded rom the vessel by the processorrom 15 to less than 24 hours ater death,the internal temperature should be 50F(10C) or below,

OR

For sh held iced or rerigerated (notrozen) onboard the vessel and o-

loaded rom the vessel by the processorrom 12 to less than 15 hours ater death,the internal temperature should be 60F(15.6C) or below;

The recommended level at which a lotshould be rejected based on sensoryexamination when 118 sh are examinedis now corrected to be no more than 2 shto coincide with the goal o less than 2.5%decomposition in the lot;

It is now recommended that the number osh subjected to sensory examination beincreased i there is likely to be greater thannormal variability in the lot, and that onlyone species constitute a lot or samplingpurposes;

When histamine analysis is perormed as acorrective action, it is now recommendedthat any sh ound to exceed the internal


8


15/475

temperature at receiving critical limit beincluded in the sample;

When the sensory critical limit has notbeen met, it is now recommended thatthe processor perorm histamine analysis

o a minimum o 60 sh, collectedrepresentatively rom throughout the lot,including all sh in the lot that showevidence o decomposition, and reject the loti any sh are ound with a histamine levelgreater than or equal to 50 ppm;

Subdividing and retesting or histamine is nolonger recommended ater an initial ailedhistamine test;

It is now recommended that employees whoconduct sensory screening receive adequate

training;

It is now recommended that or shipmentso scombrotoxin-orming species receivedunder ice on open-bed trucks be checked orboth suciency o ice and internal producttemperature;

It is now recommended that shipments oscombrotoxin-orming species received undergel packs be checked or both adequacy ogel packs and internal product temperature;

It is now recommended that i only theinternal temperature o sh is checked atreceipt by a secondary processor becausethe transit time is no more than 4 hours,calculation o transit time should includeall time outside a controlled temperatureenvironment;

It is now recommended that i only theinternal temperature o sh is checked atreceipt by a secondary processor becausethe transit time is no more than 4 hours,

a temperature-indicating device (e.g., athermometer) should be used to determineinternal product temperatures in a minimumo 12 sh, unless there are ewer than 12 shin a lot, in which case all o the sh shouldbe measured;

When checks o the suciency o ice orchemical cooling media, such as gel packs,

or internal product temperatures are usedat receipt o sh rom another processor, itis now recommended that the number ocontainers examined and the number ocontainers in the lot be recorded;

Control o scombrotoxin (histamine)ormation during processing and storage arenow provided as separate control strategyexamples, and examples o HACCP plans arenow provided or both strategies;

The extended exposure times duringprocessing (more than 12 hours,cumulatively, i any portion o that time is attemperatures above 70F (21.1C); or morethan 24 hours, cumulatively, as long as noportion o that time is at temperatures above

70F (21.1C)) previously recommended orsh that have been previously rozen arenow also recommended or sh that havebeen previously heat treated sucientlyto destroy scombrotoxin-orming bacteriaand are subsequently handled in amanner where there is an opportunity orrecontamination with scombrotoxin-ormingbacteria;

It is now acknowledged that it may bepossible to control scombrotoxin ormation

during unrerigerated processing using acritical limit that is time o exposure only(i.e., no temperature component), i it isdeveloped with an assumption that worst-case temperatures (e.g., in excess o 70F(21.1C)) may occur;

Chemical coolants (e.g., gel packs) areno longer recommended or control otemperature during in-plant storage;

For control o time and temperature duringrerigerated storage, it is now noted thatcritical limits that speciy a cumulative timeand temperature o exposure to temperaturesabove 40F (4.4C) are not ordinarily suitablebecause o the diculty in determiningwhen specic products have entered andlet the cooler and the time and temperatureexposures to which they were subjected.However, there may be circumstances where


9


16/475

this approach is suitable. It is also notedthat minor variations in cooler temperaturemeasurements can be avoided bysubmerging the sensor or the temperature-recording device in a liquid that mimics thecharacteristics o the product;

High-temperature alarms are no longerrecommended or monitoring temperaturesin coolers or processing areas;

When the adequacy o ice is established asthe critical limit or rerigerated storage, itis now recommended that monitoring beperormed with sucient requency to ensurecontrol rather than at least twice per day.

The recommendations in Chapter 8 related

to other decomposition-related hazards are

changed as ollows:

It is now noted that FDA has receivedconsumer complaints concerning illnessesassociated with the consumption odecomposed salmon, attributable to theproduction in the sh o toxins other thanhistamine (e.g., biogenic amines, such asputrescine and cadaverine);

It is now noted that there are also someindications that chemicals ormed when ats

and oils in oods oxidize may contribute tolong-term detrimental health eects.


control o environmental chemical contaminants

and pesticides are changed as ollows:

Toxic element guidance levels or arsenic,cadmium, lead, and nickel are no longer listed;

Tolerance levels or endothall and itsmonomethyl ester in sh and carbaryl inoysters are now listed;

The collection o soil samples romaquaculture production sites is no longerlisted as a preventive measure;

An example o a HACCP plan is nowprovided or control o environmentalchemical contaminants in molluscanshellsh;

When testing or environmental chemicalcontaminants and pesticides is used as thecontrol measure, it is now recommendedthat the adequacy o the testing methodsand equipment be veried periodically (e.g.,by comparing results with those obtainedusing an Association o Ocial AnalyticalChemists (AOAC) or equivalent method, orby analyzing prociency samples).

Chapter 10, which covers the control o

methylmercury, has been rewritten to

acknowledge that FDA is receiving comments

on a drat quantitative risk assessment

or methylmercury, which may result in a

reassessment o its risk management strategies.

The recommendations in Chapter 11 or thecontrol o aquaculture drugs are changed as

ollows:

The potential or this hazard to occur duringtransportation o live sh is now recognized,and recommended controls are provided;

An explanation o extra-label use o drugs isnow provided, and a list o drugs prohibitedor extra-label use is now listed;

FDA high enorcement priority aquaculturedrugs are now listed;

Aquafor Type A Medicated Article(forenicol) is now listed as an approveddrug or catsh and salmonids;

Aquafor CA1 is now listed as an approveddrug or catsh or in ngerling to ood shas the sole ration or 10 consecutive days.

35% PEROX-AID (hydrogen peroxide)is now listed as an approved drug orreshwater-reared salmonids and reshwater-

reared cool water nsh and channel catsh; Terramycin 200 or Fish (oxytetracycline

dihydrate) Type C, is now listed as an approveddrug or catsh, salmonids; and lobster;

OxyMarine, Oxytetracycline HCl SolublePowder-343, Terramycin-343, TETROXY Aquaticis now listed as an approved drug or all nshry and ngerlings as an aid in identication;


10


17/475

Quarterly raw material, in-process,or nished product testing is nowrecommended as a verication step orcontrol strategies involving review osuppliers certicates at receipt o rawmaterials, review o records o drug use atreceipt o raw materials, and on-arm visits;

When testing or aquaculture drugs isused as the control measure, it is nowrecommended that the adequacy o thetesting methods and equipment be veriedperiodically (e.g., by comparing results withthose obtained using an AOAC or equivalentmethod, or by analyzing prociencysamples).


control o pathogenic bacteria growth and

toxin ormation (other than C. botulinum) as

a result o time and temperature abuse are

changed as ollows:

It is now recognized that V. vulnifcus, V.parahaemolyticus, and Vibrio cholaraenon-O1 and non-0139 are generallyassociated with marine and estuarine specieso sh and may not be reasonably likely tooccur in reshwater species or non-shery

ingredients, unless they have been cross-contaminated;

It is now claried that products that arepartially cooked to set the batter or breadingor stabilize the product shape (e.g., sh balls,shrimp egg rolls, and breaded sh portions)are not considered to be ready to eat;

Inormation is now provided on thedetermination o CCPs or products that are acombination o raw, ready-to-eat and cooked,ready-to-eat shery ingredients;

Control o time and temperature abuseat receipt, during cooling ater cooking,during unrerigerated processing, and duringrerigerated storage and processing are nowprovided as our separate control strategyexamples. Examples o HACCP plans arenow provided or all our strategies;

For control o transit conditions at receipto ready-to-eat sh or shery productsdelivered rerigerated (not rozen), it is nowrecommended that all lots be accompaniedby transportation records that show thatthe sh were held at or below an ambientor internal temperature o 40F (4.4C)throughout transit or, or transit times o 4hours or less, that the internal temperatureo the sh at time o receipt was at or below40F (4.4C);

For control o time and temperatureduring rerigerated storage and rerigeratedprocessing, it is now noted that criticallimits that speciy a cumulative time andtemperature o exposure to temperatures

above 40F (4.4C) are not ordinarily suitablebecause o the diculty in determiningwhen specic products have entered andlet the cooler and the time and temperatureexposures to which they were subjected.However, there may be circumstances wherethis approach is suitable. It is also notedthat minor variations in cooler temperaturemeasurements can be avoided bysubmerging the sensor or the temperature-recording device in a liquid that mimics the

characteristics o the product; It is now recommended that i only the

internal temperature o the shery productis checked at receipt, because the transittime is no more than 4 hours, calculation otransit time should include all time outside acontrolled temperature environment;

It is now recommended that i only theinternal temperature o product is checkedat receipt by a secondary processor becausethe transit time is no more than 4 hours,a temperature-indicating device (e.g., athermometer) should be used to determineinternal product temperatures in a minimumo 12 containers (e.g., cartons and totes),unless there are ewer than 12 containersin a lot, in which case all o the containersshould be measured;


11


18/475

Alternatively, exposure time (i.e., time atinternal temperatures above 50F (10C)but below 135F (57.2C)) should belimited to 4 hours, as long as no morethan 2 o those hours are between 70F(21.1C) and 135F (57.2C),

When checks o the suciency o ice orchemical cooling media, such as gel packs,or internal product temperatures are usedat receipt o sh rom another processor, itis now recommended that the number ocontainers examined and the number ocontainers in the lot be recorded;


Recommended cumulative exposure timesand temperatures (i.e., critical limits) are nowlisted as ollows:

For raw, ready-to-eat products:

I at any time the product is held atinternal temperatures above 70F(21.1C), exposure time (i.e., timeat internal temperatures above 50F(10C) but below 135F (57.2C))should be limited to 2 hours (3 hours iStaphylococcus aureus(S. aureus) is theonly pathogen o concern),

OR

OR

I the product is held at internaltemperatures above 50F (10C), but neverabove 70F (21.1C), exposure time atinternal temperatures above 50F (10C)should be limited to 5 hours (12 hours iS.

aureusis the only pathogen o concern),

OR

The product is held at internal temperatures below 50F (10C),

OR

Alternatively, the product is held atambient air temperatures below 50F(10C) throughout processing;

For cooked, ready-to-eat products:

I at any time the product is held atinternal temperatures above 80F(27.2C), exposure time (i.e., time atinternal temperatures above 50F (10C)but below 135F (57.2C)) should belimited to 1 hour (3 hours i S. aureus isthe only pathogen o concern),

OR

Alternatively, i at any time the productis held at internal temperatures above

80F (26.7C), exposure time (i.e., time atinternal temperatures above 50F (10C)but below 135F (57.2C)) should belimited to 4 hours, as long as no morethan 1 o those hours is above 70F(21.1C),

OR

I at any time the product is held atinternal temperatures above 70F(21.1C), but never above 80F (26.7C),

exposure time at internal temperaturesabove 50F (10C) should be limited to2 hours (3 hours iS. aureusis the onlypathogen o concern),

OR

Alternatively, i the product is never held atinternal temperatures above 80F (26.7C),exposure times at internal temperaturesabove 50F (10C) should be limited to 4hours, as long as no more than 2 o those

hours are above 70F (21.1C),OR

I the product is held at internaltemperatures above 50F (10C), but neverabove 70F (21.1C), exposure time atinternal temperatures above 50F (10C)should be limited to 5 hours (12 hours iS.aureusis the only pathogen o concern),


12


19/475

ORThe product is held at internal temperatures below 50F (10C),

OR

Alternatively, the product is held atambient air temperatures below 50F(10C) throughout processing;


When the adequacy o ice is established asthe critical limit or rerigerated storage, itis now recommended that monitoring beperormed with sucient requency to ensurecontrol rather than at least twice per day;

It is now recommended that monitoringshipments received under gel packs includeboth adequacy o gel packs and internalproduct temperature.


control oC. botulinum toxin ormation are

changed as ollows:

Inormation is now provided on Time-Temperature Indicator (TTI) perormanceand suitability;

A control strategy is now provided orapplication o TTIs on each o the smallestpackage units (i.e., the unit o packaging thatwill not be distributed any urther, usuallyconsumer or end-user package), wherererigeration is the sole barrier to preventtoxin ormation;

It is no longer recommended thatconsideration be given to whether thenished product will be stored and

distributed rozen when determining whetherthe hazard is signicant. A control strategy isnow provided to ensure that rozen productsare properly labeled when reezing is thesole barrier to prevent toxin ormation;

Processors are now advised to take particularcare in determining the saety o a packagingmaterial or a product in which (1) the

spoilage organisms have been eliminated orsignicantly reduced by such processes ashigh pressure processing and (2) rerigerationis the sole barrier to toxin ormation. Thegenerally recommended 10,000 cc/m2/24hours at 24C oxygen transmission rates maynot be suitable in this case;



When the adequacy o ice is establishedas the critical limit or rerigerated storage,it is now recommended that monitoring

be perormed with sucient requency toensure control rather than at least twice perday;

It is now recommended that a water phasesalt level o 20% be achieved in shel-stable,reduced oxygen packaged products in whichsalt is the only barrier to pathogenic bacteriagrowth and toxin ormation;

It is now recommended that monitoringshipments received under gel packs include

both adequacy o gel packs and internalproduct temperature;

It is now recommended that i only theinternal temperature o the shery productis checked at receipt, because the transittime is no more than 4 hours, calculation otransit time should include all time outside acontrolled temperature environment;

It is now recommended that i only theinternal temperature o product is checkedat receipt by a secondary processor because

the transit time is no more than 4 hours,a temperature-indicating device (e.g., athermometer) should be used to determineinternal product temperatures in a minimumo 12 containers (e.g., cartons and totes),unless there are ewer than 12 containersin a lot, in which case all o the containersshould be measured;


13


20/475

A control strategy example is now provided

or receipt by a secondary processor orerigerated reduced oxygen packagedproducts that may be stored and urtherdistributed or used as an ingredient orurther processing;

It is now claried that brining time should bemonitored during the processing o smokedsh;

It is now recommended that brine betreated to minimize microbial contaminationor be periodically replaced as a goodmanuacturing practice control.


control o pathogenic bacteria growth and

toxin ormation as a result o inadequatedrying are changed as ollows:

It is no longer recommended that considerationbe given to whether the nished productwill be stored and distributed rozen (in thecase o reduced oxygen packaged products)or rerigerated (in the case o aerobicallypackaged products) when determining whetherthe hazard is signicant. A control strategyto ensure that rerigerated dried products areproperly labeled when rerigeration is the sole

barrier to toxin ormation is now provided. Acontrol strategy to ensure that rozen productsare properly labeled when reezing is the solebarrier to toxin ormation is now provided inChapter 13.


control oS. aureustoxin ormation in hydrated

batter mixes are changed as ollows:

The number oS. aureusorganisms normallyneeded to produce toxin is now listed as

500,000 to 1,000,000 per gram; High-temperature alarms are no longer

recommended or monitoring temperaturesin processing areas.


control o pathogenic bacteria survival through

cooking are changed as ollows:

The separate chapters that previouslycovered pathogen survival through cookingand pathogen survival through pasteurizationare now combined;

Pasteurization is now dened as a heattreatment applied to eliminate the mostresistant pathogen o public health concernthat is reasonably likely to be present inood;

Inormation is now provided or an optionto monitor End-Point Internal ProductTemperature, instead o continuous timeand temperature monitoring during cookingor pasteurization, when a scientic studyhas been conducted to validate that it willprovide a 6D process or the target pathogen;

For surimi-based products, soups, or sauces,the ollowing pasteurization process is nowrecommended: a minimum cumulative,total lethality o F194F (F90C) = 10 minutes,where z = 12.6F (7C) or temperatures lessthan 194F (90C), and z = 18F (10C) ortemperatures above 194F (90C);

For dungeness crabmeat, the ollowingpasteurization process is now recommended:a minimum cumulative total lethality o F

194F

(F90C) = 57 minutes, where z = 15.5F (8.6C); Inormation concerning levels oListeria

monocytogenes(L. monocytogenes) in oodsis now updated based on the nal FDA/U.S.Department o AgricultureL. monocytogenesrisk assessment.

Chapter 17 is a new chapter that contains

guidance or the control o pathogen survival

through processes designed to retain raw

product characteristics, including high

hydrostatic pressure processing, mild heat

processing, IQF with extended rozen storage,

and irradiation. At present, the chapter applies

exclusively to the processing o molluscan

shellfsh products or which there is a desire

to retain raw product characteristics. However,

these technologies may have other applications

as well.


14


21/475


control o the introduction o pathogenic

bacteria ater pasteurization and specialized

cooking processes are changed as ollows:

It is no longer recommended that considerationbe given to whether the nished productwill be stored and distributed rozen whendetermining whether the hazard is signicant.A control strategy to ensure that rozenproducts are properly labeled when reezing isthe sole barrier to prevent C. botulinum toxinormation is now provided in Chapter 13.

The use o sulting agents in conch meat isnow identied as a reasonably likely hazard.


control o metal inclusion are changed as

ollows:


control o undeclared ood allergens and

intolerance substances and prohibited ood

and color additives are changed as ollows: Additional explanatory material on ood

allergens is now included, with inormationon the Food Allergen Labeling andConsumer Protection Act o 2004 and itsimpact on preventive controls or allergens;

Additional inormation is now provided onthe actors to be considered in judging whenthe presence o certain ood intolerancesubstances and prohibited ood and coloradditives is or is not reasonably likely tooccur, such as the historical use o thesubstance and the expected level o sultingagent in the ormulated nished ood;

Additional inormation is now provided onregulatory requirements or ood additives.

Corrective actions are now expanded toinclude steps that should be taken to regaincontrol over the operation ater a critical limitdeviation, or consistency with guidance inthe other chapters;

It is now recommended that nished productlabels be checked at time o labeling ratherthan at time o label receiving;

It is now recommended that nished producttesting be included as a verication stepwhen review o suppliers labeling is used asa monitoring procedure or the presence osulting agents;

Foreign objects less than 0.3 inch (7 mm)are now identied as having a potential orcausing trauma or serious injury to personsin special risk groups, such as inants,surgery patients, and the elderly;

Additional inormation on calibration andvalidation o electronic metal detectors isnow provided;

Wire mesh baskets are no longer used asan example o an unlikely source o metal

ragments; The recommended critical limit or the metal

detection or separation control strategy hasbeen expanded to read, All product passesthrough an operating metal detection orseparation device, and No detectable metalragments in a product passing throughthe metal detection or separation device.As a result, the recommended monitoringprocedures are also expanded so that theynow are designed to also ensure that theprocesses are in place and operating;

It is now recommended that when metalragments are ound in a product by a metaldetector or separated rom the product streamby magnets, screens, or other devices, thesource o the ragment is located and corrected.


control o glass inclusion are changed as ollows:

This chapter is no longer identied as a drat; The use o x-ray detection devices is no

longer recommended as a reliable method orcontrolling glass inclusion;

The recommended critical limit or the glasscontainer cleaning and visual inspectioncontrol strategy has been expanded to read,All container pass through an operatingglass container inspection or cleaning


15


22/475

process, and No detectable glass ragmentsin glass containers passing the CCP. Asa result, the recommended monitoringprocedures are also expanded so that theynow are designed to also ensure that theprocesses are in place and operating;

The monitoring procedures or theglass container cleaning and visualinspection control strategy now include arecommendation that a representative sampleo the cleaned or inspected containers beexamined at the start o processing, every4 hours during processing, at the end oprocessing, and ater any breakdowns;

It is now recommended that monitoring orthe presence o glass be perormed at the

start o each production day and ater eachshit change.

It is now recommended that arepresentative sample o cleaned orinspected glass containers be examineddaily, at the start o processing, every 4hours during processing, at the end oprocessing, and ater any breakdowns.

The Hazard Analysis Worksheet in Appendix

1 has been changed or consistency with the

worksheet in the HACCP: Hazard AnalysisCritical Control Point Training Curriculum,

developed by the Seaood HACCP Alliance or

Training and Education.

The recommendations in Appendix 4 or

bacterial pathogen growth and inactivation are

changed as ollows:

Recommended summary cumulativeexposure times and temperatures are nowlisted as described above or Chapter 12;

The maximum water phase salt level orgrowth oCampylobacter jejuniis now listedas 1.7%;

The maximum level o acidity (pH) orgrowth o pathogenic strains oEscherichiacoli(E. coli) is now listed as 10;

The maximum recommended cumulative

exposure times orBacillus cereusare nowlisted as ollows: 5 days at temperatures o39.2 to 43F (4 to 6C); 1 day at temperatureso 44 to 59F (7 to 15C); 6 hours attemperatures o 60 to 70F (16 to 21C); and3 hours at temperatures above 70F (21C);

The maximum cumulative exposure times orE. coli, Salmonella, and Shigella spp. are nowlisted as ollows: 2 days or temperaturesrom their minimum growth temperature41.4 to 50F (10C); 5 hours or temperatureso 51 to 70F (11 to 21C); and 2 hours ortemperatures above 70F (21C);

The maximum cumulative exposure timesorListeria monocytogenesare now listedas ollows: 7 days or temperatures o 31.3

to 41F (-0.4 to 5C); 1 day or temperatureso 42 to 50F (6 to 10C); 7 hours ortemperatures o 51 to 70F (11 to 21C); 3hours or temperatures o 71 to 86F (22 to30C); and 1 hour or temperatures above86F (30C);

The maximum cumulative exposure timesor Vibrio cholerae, V. vulnifcus, and V.parahaemolyticusare now listed as ollows:21 days or temperatures rom their minimum

growth temperature to 50F (10C); 6 hoursor temperatures o 51 to 70F (11 to 21C);2 hours at temperatures o 71 to 80F (22 to26.7C); and 1 hour at temperatures above80F (26.7C), with the last temperature rangeapplying only to cooked, ready-to-eat products.

The saety levels listed in Appendix 5, Table

A-5, FDA and EPA Saety Levels in Regulations

and Guidance, are changed as ollows:

Toxic element guidance levels or arsenic,cadmium, lead, and nickel are no longerlisted;

Tolerance levels or endothall and itsmonomethyl ester in sh and carbaryl inoysters are now listed;

A tolerance level or Florenicol in channelcatsh and reshwater-reared salmonids isnow listed;


16


23/475

The tolerance or oxytetracycline is nowcorrected to apply to all nsh and lobster;

The tolerance or sulamerazine is nowcorrected to apply to trout;

A list o drugs prohibited or extra-label useis now provided;

V. parahaemolyticusand V. vulnifcuslevelsare now listed or post-harvest processedmolluscan shellsh.

Appendix 6 no longer lists ood allergens. It

now contains a table o Japanese and Hawaiian

vernacular names and their corresponding U.S.

market names.

Appendix 7 no longer lists the bibliography. It

now contains inormation regarding the publichealth impacts o bacterial and viral pathogens

o greatest concern in seaood processing.


17


24/475

NOTES:


18


25/475

CHAPTER 1: General Information



approach i the approach satisfes the requirements o the applicable statutes and regulations. I you want to discuss

an alternative approach, contact the FDA sta responsible or implementing this guidance. I you cannot identiy the


THE GUIDANCE

This is the ourth edition o the Food and DrugAdministrations (FDAs) Fish and Fishery ProductsHazards and Controls Guidance. This guidancerelates to FDAs Fish and Fishery Productsregulation (called the Seaood HACCP Regulation,21 CFR 123, in this guidance document) and theControl o Communicable Diseases regulation,21 CFR 1240, that require processors o shand shery products to develop and implementHACCP systems or their operations. Those nalregulations were published in theFederal Registeron December 18, 1995, and became eective onDecember 18, 1997. The codied portion o theregulations is included in Appendix 8.

This guidance is being issued as a companion

document to HACCP: Hazard Analysis CriticalControl Point Training Curriculum, which wasdeveloped by the Seaood HACCP Allianceor Training and Education. The Alliance is anorganization o ederal and state regulators,including FDA, academia, and the seaoodindustry. FDA recommends that processors osh and shery products use the two documentstogether in the development o a HACCP system.

This guidance document will be maintained onthe FDA.GOV website, which should be consultedor subsequent updates.

Copies o the training document may bepurchased rom:

Florida Sea GrantIFAS - Extension Bookstore

University o FloridaP.O. Box 110011Gainesville, FL 32611-0011(800) 226-1764

Or

www.iasbooks.com

Or you may download a copy rom:

http://www.da.gov/FoodGuidances

CHAPTER 1: General Inormation

19
http://www.ifasbooks.com/http://www.fda.gov/FoodGuidanceshttp://www.fda.gov/FoodGuidanceshttp://www.ifasbooks.com/


26/475

NOTES:

CHAPTER 1: General Inormation

20


27/475

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan



approach i the approach satisfes the requirements o the applicable statutes and regulations. I you want to discussan alternative approach, contact the FDA sta responsible or implementing this guidance. I you cannot identiy the


THE HACCP PLAN FORM

This guidance document is designed to walkyou through a series o 18 steps that will yield acompleted Hazard Analysis Critical Control Point(HACCP) plan. A blank HACCP Plan Form is

contained in Appendix 1. Note that this is a two-page orm, with the second page to be used iyour process has more critical control points thancan be listed on one page. The Procedures orthe Sae and Sanitary Processing and Importingo Fish and Fishery Products regulation, 21 CFR123 (hereinater, the Seaood HACCP Regulation),requires that you prepare a HACCP plan or shand shery products that you process i there aresignicant ood saety hazards associated with theproducts. The regulation does not require that you

use the orm included in Appendix 1. However,using this standardized orm may help you developan acceptable plan and will expedite regulatoryreview. A separate HACCP plan should bedeveloped or each location where sh and sheryproducts are processed and or each kind o shand shery product processed at that location. Youmay group products together in a single HACCPplan i the ood saety hazards and controls are thesame or all products in the group.

THE HAZARD ANALYSIS WORKSHEET

In order to complete the HACCP Plan Form,you will need to perorm a process calledhazard analysis. The Seaood HACCP Regulationrequires that all seaood processors conduct,

or have conducted or them, a hazard analysisto determine whether there are ood saetyhazards that are reasonably likely to occur intheir product and to the preventive measures thata processor can apply to control those hazards(21 CFR 123.6(a)). FDA has ound that the useo a standardized Hazard Analysis Worksheetassists with this process. A blank Hazard AnalysisWorksheet is contained in Appendix 1. Note thatthis is also a two-page orm, with the second pageto be used i your process has more processing

steps than can be listed on one page. The SeaoodHACCP Regulation does not require that thehazard analysis be kept in writing. However,FDA expects that a written hazard analysis willbe useul when you perorm mandatory HACCPplan reassessments and when you are asked byregulators to justiy why certain hazards were orwere not included in your HACCP plan.


21


28/475

THE STEPS PRELIMINARY STEPS

Following is a list o the steps that this guidanceuses in HACCP plan development:

STEP 1: Provide general inormation.

Preliminary StepsProvide general inormation;Describe the ood;Describe the method o distribution andstorage;

Identiy the intended use and consumer;Develop a fow diagram.

Hazard Analysis WorksheetSet up the Hazard Analysis Worksheet;Identiy potential species-related hazards;

Identiy potential process-related hazards;Understand the potential hazard;Determine whether the potential hazardis signicant;

Identiy critical control points. HACCP Plan Form

Set up the HACCP Plan Form;Set critical limits;Establish monitoring procedures:

What, How, Frequency, Who;Establish corrective action procedures; Establish a recordkeeping system;Establish verication procedures.

Record the name and address o your processing

acility in the spaces provided on the rst pageo both the Hazard Analysis Worksheet and theHACCP Plan Form (Appendix 1).

STEP 2: Describe the ood.

Identiy the market name or Latin name (species)o the shery component(s) o the product.

Examples:

Tuna (Thunnus albacares); Shrimp (Pandals spp.); Jack mackerel (Trachurus spp.).

Fully describe the nished product ood.

Examples:

Individually quick rozen, cooked, peeledshrimp;

Fresh tuna steaks; Frozen, surimi-based, imitation king crab

legs;

Fresh, raw drum, in-the-round; Raw shrimp, in-shell; Raw, shucked clams; Fresh seaood salad, with shrimp and blue

crabmeat;

Frozen, breaded pollock sticks; Frozen crab cakes.

Describe the packaging type.

Examples:

Vacuum-packaged plastic bag;

Aluminum can; Bulk, in wax-coated paperboard box; Plastic container with snap lid.

Record this inormation in the space providedon the rst page o both the Hazard AnalysisWorksheet and the HACCP Plan Form.


22


29/475

STEP 3: Describe the method o distributionand storage.

Identiy how the product is distributed and storedater distribution.

Examples: Stored and distributed rozen; Distributed on ice and then stored under

rerigeration or on ice.


STEP 4: Identiy the intended use andconsumer.

Identiy how the product will be used by the enduser or consumer.

Examples:

To be heated (but not ully cooked) andserved;

To be eaten with or without urther cooking; To be eaten raw or lightly cooked; To be ully cooked beore consumption; To be urther processed into a heat and serve

product.

Identiy the intended consumer or user o theproduct. The intended consumer may be thegeneral public or a particular segment o thepopulation, such as inants or the elderly. Theintended user may also be another processor thatwill urther process the product.

Examples:

By the general public; By the general public, including some

distribution to hospitals and nursing homes; By another processing acility.


STEP 5: Develop a ow diagram.

The purpose o the diagram is to provide aclear, simple description o the steps involved inthe processing o your shery product and itsassociated ingredients as they fow rom receipt

to distribution. The fow diagram should coverall steps in the process that your rm perorms.Receiving and storage steps or each o theingredients, including non-shery ingredients,should be included. The fow diagram should beveried on-site or accuracy.

Figure A-1 (Appendix 2) is an example o a fowdiagram.

HAZARD ANALYSIS WORKSHEET

STEP 6: Set up the Hazard AnalysisWorksheet.

Record each o the processing steps (romthe fow diagram) in Column 1 o the HazardAnalysis Worksheet.

STEP 7: Identiy the potential species-relatedhazards.

Biological, chemical, and physical hazards canaect the saety o shery products. Some oodsaety hazards are associated with the product(e.g., the species o sh, the way in which thesh is raised or caught, and the region o theworld rom which the sh originates). Thesehazards are introduced outside the processingplant environment beore, during, or aterharvest. This guidance reers to these as speciesrelated hazards. Other ood saety hazards areassociated with the way in which the product

is processed (e.g., the type o packaging, themanuacturing steps, and the kind o storage).These hazards are introduced within theprocessing plant environment. This guidancereers to these as process-related hazards. Theyare covered in Step 8.

Find in Table 3-2 (Chapter 3) or Table 3-3(Chapter 3) the market name (Column 1) or


23


30/475

Latin name (Column 2) o the product that youidentied in Step 2. Use Table 3-2 or vertebrates(animals with backbones) such as nsh. UseTable 3-3 or invertebrates (animals withoutbackbones) such as shrimp, oysters, crabs, andlobsters. Determine whether the species has apotential species-related hazard by looking ora mark (or one- or three-letter codes or anatural toxin) in the right-hand columns o thetable. I it does, record the potential species-related hazard(s) in Column 2 o the HazardAnalysis Worksheet, at every processing step.

Tables 3-2 and 3-3 include the best inormationcurrently available to FDA concerning hazards thatare specic to each species o sh. You should useyour own expertise, or that o outside experts, as

necessary, to identiy any hazards that may notbe included in the table (e.g., those that may benew or unique to your region). You may alreadyhave eective controls in place or a number othese hazards as part o your routine or traditionalhandling practices. The presence o such controlsdoes not mean that the hazard is not signicant.The likelihood o a hazard occurring should bejudged in the absence o controls. For example, theact that scombrotoxin (histamine) developmentin a particular species o sh has not been noted

may be the result o (1) the inability o the sh toproduce histamine or (2) the existence o controlsthat are already in place to prevent its development(e.g., harvest vessel time and temperature controls).In the rst case, the hazard is not reasonablylikely to occur. In the second case, the hazard isreasonably likely to occur, and the controls shouldbe included in the HACCP plan.

STEP 8: Identiy potential process-relatedhazards.

Find in Table 3-4 (Chapter 3) the nished productood (Column 1) and package type (Column 2)that most closely match the inormation that youdeveloped in Steps 2 and 3. Record the potentialhazard(s) listed in the table or that product inColumn 2 o the Hazard Analysis Worksheet, atevery processing step.

You may need to include potential hazards ormore than one nished product ood categoryrom Table 3-4, which will happen when yourproduct ts more than one description. Forexample, i you cook shrimp and use it to preparea nished product salad, you should look at boththe cooked shrimp and the salads preparedrom ready-to-eat shery products categories inTable 3-4, Column 1. Potential hazards rom bothnished product ood categories apply to yourproduct and should be listed in Column 2 o theHazard Analysis Worksheet.

Table 3-4 includes the best inormation currentlyavailable to FDA concerning hazards that arerelated to specic processing techniques. Youshould use your own expertise, or that o outside

experts as necessary, to identiy any hazardsthat may not be included in the table (e.g., thosethat are new or unique to your physical plant,equipment, or process).

STEP 9: Understand the potential hazard.

Consult the hazards and controls chapters othis guidance document (Chapters 4 through 7,9, and 11 through 21) or each o the potentialhazards that you entered in Column 2 o the

Hazard Analysis Worksheet. These chapters oerguidance or completing your hazard analysisand developing your HACCP plan. Each chaptercontains a section, Understand the PotentialHazard, that provides inormation about thesignicance o the hazard, the conditions underwhich it may develop in a shery product, andmethods available to control the hazard.

STEP 10: Determine whether the potentialhazard is signifcant.

Narrow the list o potential hazards that youentered in Column 2 o the Hazard AnalysisWorksheet to those that are signicant or, inother words, reasonably likely to occur. TheSeaood HACCP Regulation denes a ood saetyhazard that is reasonably likely to occur as oneor which a prudent processor would establishcontrols because experience, illness data,


24


31/475

scientic reports, or other inormation providea basis to conclude that there is a reasonablepossibility that it will occur in the particular typeo sh or shery product being processed in theabsence o those controls.

The hazards and controls chapters o thisguidance (Chapters 4 through 7, 9, and 11through 21) each contain a section, DetermineWhether this Potential Hazard Is Signicant,that provides inormation about how to assessthe signicance o potential hazards. You shouldevaluate the signicance o a potential hazardindependently at each processing step. It maybe signicant at one step but not at another. Apotential hazard is signicant at the processingor handling step i (1) it is reasonably likely that

the hazard can be introduced at an unsae levelat that processing step; or (2) it is reasonablylikely that the hazard can increase to an unsaelevel at that processing step; or (3) it is signicantat another processing or handling step and itcan be prevented, eliminated, or reduced toan acceptable level at the current processing orhandling step. When evaluating the signicanceo a hazard at a processing step, you shouldconsider the method o distribution and storageand the intended use and consumer o the

product, which you developed in Steps 3 and 4.

I you determine that a potential hazard issignicant at a processing step, you shouldanswer Yes in Column 3 o the Hazard AnalysisWorksheet. I you determine that a potentialhazard is not signicant at a processing step, youshould answer No in that column. You shouldrecord the reason or your Yes or No answerin Column 4. You need not complete Steps 11through 18 or a hazard or those processing

steps where you have recorded a No.It is important to note that identiying a hazardas signicant at a processing step does not meanthat it must be controlled at that processing step.Step 11 will help you determine where in theprocess the critical control point is located.

STEP 11: Identiy critical control points.

For each processing step where a signicanthazard is identied in Column 3 o the HazardAnalysis Worksheet, determine whether itis necessary to exercise control at that step

in order to control the hazard. Figure A-2(Appendix 3) is a critical control point (CCP)decision tree that can be used to aid you inyour determination.

The hazards and controls chapters o thisguidance (Chapters 4 through 7, 9, and 11through 21) each contain a section, IdentiyCritical Control Points (CCPs), which providesinormation about where control should beexercised. Each chapter discusses one or more

control strategy example(s) or how the hazardcan be controlled, because there are oten moreways than one to control a hazard. CCP(s) orone control strategy example oten dier romthose o another example or the same hazard.The control strategies contain preventive measureinormation. Record the preventive measure(s) inColumn 5 o the Hazard Analysis Worksheet oreach Yes answer in Column 3.

For every signicant hazard, there must be atleast one CCP where the hazard is controlled(21 CFR 123.6(c)(2)). In some cases, control maybe necessary at more than one CCP or a singlehazard. In other cases, a processing step maybe a CCP or more than one hazard. CCPs arepoints in the process (i.e., processing steps)where the HACCP control activities will occur.Control activities at a CCP can eectively prevent,eliminate, or reduce the hazard to an acceptablelevel (21 CFR 123.3(b)).

I you determine that a processing step is a CCP

or a signicant hazard, you should enter Yes inColumn 6 o the Hazard Analysis Worksheet. Iyou determine that a processing step is not a CCPor a signicant hazard, you should enter Noin that column. You need not complete Steps 12through 18 or a hazard or those processing stepswhere you have recorded a No.


25


32/475

HACCP PLAN FORM

STEP 12: Set up the HACCP Plan Form.

Find the processing steps that you have identied

as CCPs in Column 6 o the Hazard AnalysisWorksheet. Record the names o these processingsteps in Column 1 o the HACCP Plan Form.Enter the hazard(s) or which these processingsteps were identied as CCPs in Column 2 othe HACCP Plan Form. This inormation canbe ound in Column 2 o the Hazard AnalysisWorksheet.

Complete Steps 13 through 18 or each o thesignicant hazards. These steps involve settingcritical limits, establishing monitoring procedures,

establishing corrective action procedures,establishing a recordkeeping system, andestablishing verication procedures.

STEP 13: Set critical limits.

For each processing step where a signicanthazard is identied on the HACCP Plan Form,identiy the maximum or minimum value towhich a parameter o the process must becontrolled in order to control the hazard. Each

control strategy example provided in the hazardsand controls chapters o this guidance (Chapters4 through 7, 9, and 11 through 21) each containa section, Set Critical Limits, that providesinormation about appropriate critical limits oreach o the control strategy example(s) discussed.

You should set a critical limit at such a value thati it is not met, the saety o the product may bequestionable. I you set a more restrictive criticallimit, you could, as a result, be required to takecorrective action when no saety concern actuallyexists. On the other hand, i you set a criticallimit that is too loose, you could, as a result,allow an unsae product to reach the consumer.

As a practical matter, it may also be advisableto set an operating limit that is more restrictivethan the critical limit. In this way, you can adjustthe process when the operating limit is not

met, but beore a critical limit deviation wouldrequire you to take corrective action. You shouldset operating limits based on your experiencewith the variability o your operation and withthe closeness o typical operating values to thecritical limit.

Consider that the critical limit should directlyrelate to the parameter that you will bemonitoring. For example, i you intend tomonitor the temperature o the water in thecooker and the speed o the belt that carries theproduct through the cooker (because you havedetermined that these actors result in the desiredinternal product temperature or the desiredtime), you should speciy water temperatureand belt speed as critical limits, not the internal

temperature o the product.

Enter the critical limit(s) in Column 3 o theHACCP Plan Form.

STEP 14: Establish monitoring procedures.

For each processing step where a signicanthazard is identied on the HACCP Plan Form,describe monitoring procedures that will ensurethat critical limits are consistently met (21 CFR123.6(c)(4)). The hazards and controls chapters

o this guidance document (Chapters 4 through7, 9, and 11 through 21) each contain a section,Establish Monitoring Procedures, that providesinormation about appropriate monitoringprocedures or each o the control strategyexample(s) discussed.

To ully describe your monitoring program, youshould answer our questions: (1) What will bemonitored? (2) How will monitoring be done? (3)How oten will monitoring be done (requency)?and (4) Who will do the monitoring?

It is important or you to keep in mind that themonitoring process should directly measurethe parameter or which you have establisheda critical limit. The necessary requency omonitoring is dependent upon the circumstances.Continuous monitoring is always desirable, andin some cases necessary. In other cases, it maynot be necessary or practical. You should monitor


26


33/475

oten enough that the normal variability in thevalues you are measuring will be detected. Thisis especially true i these values are typicallyclose to the critical limit. Additionally, the greaterthe time span between measurements, themore products you are putting at risk should ameasurement show a deviation rom a criticallimit has occurred, because you should assumethat the critical limit had not been met sincethe last good value. Even with continuousmonitoring, the paper or electronic record o thecontinuous monitoring should be periodicallychecked in order to determine whetherdeviations rom the critical limit have occurred.The requency o that check should be at leastdaily, and more requent i required in order to

implement an appropriate corrective action.Enter the What, How, Frequency, and Whomonitoring inormation in Columns 4, 5, 6, and 7,respectively, o the HACCP Plan Form.

STEP 15: Establish corrective actionprocedures.

A corrective action must be taken whenever thereis a deviation rom a critical limit at a CCP (21CFR 123.7((a)). For each processing step where

a signicant hazard is identied on the HACCPPlan Form, describe the procedures that youwill use when your monitoring indicates thatthe critical limit has not been met. Note that theSeaood HACCP Regulation does not requirethat you predetermine your corrective actions.You may instead elect to ollow the prescribedcorrective action procedures listed at 21 CFR123.7(c). However, a predetermined correctiveaction has the ollowing advantages: (1) Itprovides detailed instructions to the processing

employee that can be ollowed in the event o acritical limit deviation; (2) it can be prepared at atime when an emergency situation is not callingor an immediate decision; and (3) it removesthe obligation to reassess the HACCP plan inresponse to a critical limit deviation.

The hazards and controls chapters o thisguidance (Chapters 4 through 7, 9, and 11

through 21) each contain a section, EstablishCorrective Action Procedures, that providesinormation about appropriate corrective actionprocedures or each o the control strategyexample(s) discussed. An appropriate correctiveaction procedure must accomplish two goals: (1)ensure that an unsae product does not reachthe consumer and (2) correct the problem thatcaused the critical limit deviation (21 CFR 123.7).I the corrective action involves testing thenished product, the limitations o the samplingplan should be understood. Because o theselimitations, microbiological testing is oten not asuitable corrective action. The Seaood HACCPRegulation requires that c

Fish and Fishery Products HACCP

Documents

Transcript of Fish and Fishery Products HACCP