65096Federal Register /Vol. 60, No. 242/Monday, … · 65096Federal Register/Vol. 60, No. 242/Monday, December 18, 1995/Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN …

65096 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Parts 123 and 1240

[Docket No. 93N–0195]

RIN 0910–AA10

Procedures for the Safe and SanitaryProcessing and Importing of Fish andFishery Products

AGENCY: Food and Drug Administration,HHS.ACTION: Final rule.

SUMMARY: The Food and DrugAdministration (FDA) is adopting finalregulations to ensure the safe andsanitary processing of fish and fisheryproducts (hereinafter referred to asseafood), including imported seafood.The regulations mandate the applicationof Hazard Analysis Critical ControlPoint (HACCP) principles to theprocessing of seafood. HACCP is apreventive system of hazard control thatcan be used by processors to ensure thesafety of their products to consumers.FDA is issuing these regulations becausea system of preventive controls is themost effective and efficient way toensure that these products are safe.DATES: Effective December 18, 1997.Submit written comments on theinformation collection requirements byFebruary 16, 1996.ADDRESSES: Submit written commentson the information collectionrequirements to the DocketsManagement Branch (HFA–305), Foodand Drug Administration, 12420Parklawn Dr., rm. 1–23, Rockville, MD20857.FOR FURTHER INFORMATION CONTACT:Philip C. Spiller, Center for Food Safetyand Applied Nutrition (HFS–401), Foodand Drug Administration, 200 C St. SW.,Washington, DC 20204, 202–418–3133.

For further information concerningthe guidance entitled ‘‘Fish and FisheryProducts Hazards and Controls Guide,’’contact: Donald W. Kraemer (addressabove).SUPPLEMENTARY INFORMATION: Thecontents of this preamble are listed inthe following outline:

Table of ContentsI. Background

A. The ProposalB. Factual Basis for the Proposal—

SummaryII. The Comments

A. Legal Basis1. Introduction2. General Authority3. Insanitary Conditions

4. Records5. Relevance of Section 404 of the ActB. HACCP Pro and Con1. Overview2. The Significance of the Illness Data3. Exempt Specific Industry Segments?4. Would Voluntary HACCP be Superior?5. Other IssuesC. Should Some Types of Processors be

Exempt?1. Exempt Low Risk?2. Exempt Small Processors?D. Definitions1. General2. Cooked, Ready-to-Eat Fishery Product3. Critical Control Point (CCP)4. Critical Limit (CL)5. Fish6. Fishery Product7. Food Safety Hazard8. Harvester9. Importer10. Lot of Molluscan Shellfish11. Molluscan Shellfish12. Potable Water13. Preventive Measure14. Process Monitoring Instument15. Processing and Processora. Vessels, carriers, and retailb. Warehousesc. Other processing operations16. Scombroid Toxin Forming Species17. Shellfish Control Authority18. Smoked and Smoke-Flavored Fishery

ProductsE. The HACCP Plan1. Preliminary Steps2. Conducting a Hazard Analysis3. Types of Hazards4. When is a Hazard Reasonably Likely to

Occur?5. The Plan: Specific Considerations6. Positive Versus Negative Recordkeeping7. Signing the Plan8. Relationship to Parts 113 and 1149. Sanitation in the Plan10. Nonsafety Issues11. ‘‘Shall Render Adulterated’’F. Corrective Actions1. Should Corrective Actions be

Predetermined?2. Assessing the Product for Safety3. Documenting Corrective ActionsG. Verification1. Overview and Comments2. Need for Verification Requirement in

Regulations3. Verifying the HACCP Plan4. Verifying the Implementation of the Plan5. Product Testing6. Records Review7. Verifying the Hazard AnalysisH. Consumer Complaints1. Background2. Consumer Complaints as Verification

Tools3. Agency Access to Consumer ComplaintsI. Records1. Details and Signatures2. Retention and Storage3. Confidentiality of Records4. Agency Access to Records5. Agency Copying of RecordsJ. Training1. The Need for Mandatory Training2. Who Should Provide Training?

3. Should Training be ‘‘Grandfathered?’’4. Course Curriculum5. Do Importers Need Training?6. Testing and Retraining7. Gradations of Training8. Duties of the Trained IndividualK. Sanitation1. Background2. Should the Regulations Deal with

Sanitation?3. Why Isn’t Part 110 (21 CFR Part 110)

Adequate to Deal with SanitationConcerns?

4. Why Isn’t the Proposed ApproachAppropriate?

5. What is the Appropriate Approach toSanitation?

a. Inclusion of Sanitation Controls inHACCP Plans

b. SSOP6. Monitoring and Corrective Actions7. RecordsL. Imports1. Background2. Should Imports be Subject to These

Regulations?3. Should Importers be Subject to These

Regulations?4. Memoranda of Understanding (MOU’s)5. Importer Verification Procedures6. Affirmative Steps: General7. Foreign Processor HACCP Plans8. Other Affirmative Steps9. Importer Records10. Determination of ComplianceM. Guidelines or Regulations?1. Background2. Cooked, Ready-to-Eat Products and

Scombroid Species3. Smoked and Smoke-Flavored Fishery

ProductsN. Molluscan Shellfish1. Background2. Should There be Specific Requirements

for Raw Molluscan Shellfish?3. Cooked Versus Raw Molluscan Shellfish4. Shellfish Control Authorities5. Shellfish From Federal Waters6. Tagging and Recordkeeping

Requirements7. Other ConsiderationsO. Compliance and Effective Date1. Effective Date2. Public Meetings3. Penalties for Noncompliance4. Preapproval of HACCP Plans5. Filing Plans With FDA6. Third Party-Approval7. The First Inspection8. Role of the FDA Investigator9. Disagreements and Appeals10. Status of the ‘‘Guide’’11. Trade with the EU12. Measuring Program SuccessP. Other Issues1. Relationship to Other Programs2. ‘‘Whistleblower’’ Protection3. Separation of Quality Control (QC) and

Production4. Education5. Traceback Mechanisms6. Tribal Governments7. HACCP System ImprovementsIII. Paperwork Reduction Act of 1995IV. Economic ImpactA. Introduction

65097Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

B. Costs1. Alternative Model for Estimating the

Costsa. Small plant cost example 1i. Critical Control Points (CCP)ii. Corrective Actionsb. Small Plant Cost Example 22. Other Cost Reports3. Seafood PricesC. Benefits1. Safety Benefits2. Summary of Safety Benefits3. Nutrition Benefits from Mandatory

Seafood HACCP and IncreasedConsumer Confidence

4. Rent Seeking5. Export Benefits6. Reduce Enforcement Costsa. Seizuresb. Detentionsc. Automatic Detentionsd. Recallse. Injunctions7. Other BenefitsC. BenefitsD. Costs and Benefits of SanitationE. Costs and Benefits Attributable to

Foreign GovernmentsF. ConclusionG. Final Regulatory Flexibility AnalysisV. Environmental ImpactVI. ReferencesList of Subjects

I. Background

A. The ProposalIn the Federal Register of January 28,

1994 (59 FR 4142), FDA published aproposed rule to establish requirementsrelating to the processing and importingof seafood for commercial distributionin the United States. The requirementsinvolved the application of HACCPprinciples by processors and importersto ensure food safety to the maximumextent practicable. HACCP is a systemby which food processors evaluate thekinds of hazards that could affect theirproducts, institute controls to keepthese hazards from occurring or tosignificantly minimize their occurrence,monitor the performance of thosecontrols, and maintain records of thismonitoring as a matter of routinepractice.

In addition to publishing theproposed rule, FDA published in theFederal Register of April 7, 1994 (59 FR16655), a notice of availability of draftguidelines, primarily directed towardprocessors, on how to develop HACCPcontrols for specific types of processingoperations. The notice of availabilityrequested comments on the draft.Among other things, these draftguidelines, which were titled the ‘‘Fishand Fishery Products Hazards andControls Guide’’ (the Guide),inventoried known likely food safetyhazards associated with many species ofseafood and many processing methodsand made recommendations on ways to

control those hazards. Commentsreceived by FDA on the draft Guide areunder review. The agency intends topublish the first edition of the Guidebefore the effective date of theseregulations.

FDA established on the proposed rulea comment period of 90 days, to end onApril 28, 1994. The agency also askedfor comment on the draft guidelines bythe same date. During that commentperiod, FDA held public meetings innine cities to help ensure that the publicwas aware of the proposal, to answerquestions about its contents, and toencourage participation in therulemaking process through thesubmission of comments. In addition, atthese meetings, FDA staff explained tothe public how to use the draftguidelines to develop HACCP controlsin specific processing operations.

The agency received several writtenrequests for an extension of thecomment period. After consideringthese requests, FDA published a noticein the Federal Register on April 7, 1994(59 FR 16578), announcing a 30-dayextension of the comment period to May31, 1994, for both the proposed rule andthe draft guidelines.

B. Factual Basis for the Proposal—Summary

In the preamble to the proposed rule,FDA stated five principal reasons forthis initiative: (1) To create a moreeffective and efficient system forensuring the safety of seafood thancurrently exists; (2) to enhanceconsumer confidence; (3) to takeadvantage of the developmental work onthe application of HACCP-typepreventive controls for seafood that hadalready been undertaken by industry,academia, some States, and the Federalgovernment; (4) to respond to requestsby seafood industry representatives thatthe Federal government institute amandatory, HACCP-type inspectionsystem for their products; and (5) toprovide U.S. seafood with continuedaccess to world markets, where HACCP-type controls are increasingly becomingthe norm.

The preamble to the proposal citedthe conclusion of a 1991 study onseafood safety by the National Academyof Sciences’ (NAS) Institute of Medicinethat, while most seafoods on the marketare unlikely to cause illness to theconsumer, there are significant areas ofrisk and illnesses that do occur. Thestudy concluded that improvements inthe current system of regulatory controlare needed and repeatedlyrecommended the application ofHACCP controls where warranted.

Ensuring the safety of seafoodpresents special challenges to both theindustry and the regulator. Seafoodconsists of hundreds of edible speciesfrom around the world. Depending uponspecies and habitat, seafood can besubject to a wide range of hazards beforeharvest, including bacteria and viruses,toxic chemicals, natural toxins, andparasites. The harvesting of previouslyunderutilized species—a practice that isincreasing because of the depletion oftraditionally harvested species—can beexpected to create new source andprocess hazards that must be identifiedand controlled.

Unlike beef and poultry, seafood isstill predominately a wild-caught fleshfood that frequently must be harvestedunder difficult conditions and atvarying distances from processing,transport, and retail facilities. It is alsosubject to significant recreationalharvest, some of which finds its wayinto commercial channels. As fishfarming (aquaculture) increases, newproblems emerge as a result of habitat,husbandry, and drug use.

An additional complicating factor inensuring the safety of seafood is the factthat no other flesh food is imported inthe quantity, or from as many countries,as seafood. Over 55 percent of seafoodconsumed in this country is importedfrom approximately 135 countries.Several of these countries haveadvanced regulatory structures forseafood safety, but many others aredeveloping nations that lackinfrastructures capable of supportingnational programs for seafoodregulations comparable to those in moredeveloped nations.

To ensure safety, it is of utmostimportance that those who handle andprocess seafood commerciallyunderstand the hazards associated withthis type of food, know which hazardsare associated with the types ofproducts with which they are involved,and keep these hazards from occurringthrough a routine system of preventivecontrols. For the most part, however,seafood processors and importers arenot required, through licensure orexamination, to demonstrate anunderstanding of seafood hazards as aprerequisite to being able to dobusiness. In fact, there is evidence thatsuch an understanding does not exist ina significant portion of the industry. Asurvey conducted by FDA from 1992 to1993 of manufacturers of ready-to-eatseafood products revealed that, insignificant measure, firms have not beenemploying the types of preventiveprocessing controls necessary to ensurea safe product by design. FDA and Statesurveys have also revealed that many


processors of smoked and smoke-flavored fish are operating outside of theparameters that have been demonstratedthrough scientific research to benecessary to ensure that the hazard frombotulism is adequately controlled.

Because of seafood’s uniquecharacteristics (e.g., the fact that it ispredominantly wild caught and presentsa wide range of possible hazards), FDAbegan to question whether the currentFederal regulatory system, which wasdeveloped for the general food supply,is best suited for the seafood industry.Seafood processors are subject toperiodic, unannounced, mandatoryinspection by FDA. These inspectionsprovide the agency with a ‘‘snapshot’’ ofconditions at a facility at the moment ofinspection, but assumptions must bemade about conditions before and afterthat inspection. Concern about thereliability of these assumptions over theintervals between inspections createsquestions about the adequacy of thesystem.

Inspections today verify the industry’sknowledge of hazards and controlslargely by inference. Whether acompany produces products that areadulterated, or whether conditions in itsplant are consistent with current goodmanufacturing practice (CGMP), aremeasures of how well the companyunderstands what is necessary toproduce a safe and wholesome product.This system places a burden on theGovernment to find a problem and toprove that it exists, rather than on thefirm to establish for itself, for theregulator, and for consumers, that it hasadequate controls in place to ensuresafety.

Given the nature and frequency of thecurrent inspection system for seafood, ithas failed to produce a situation inwhich the public has full confidence inthe safety and wholesomeness of theseproducts. There has been a similarfailure with respect to imports.

Media and other public attention onseafood safety, and on the adequacy ofthe current regulatory program forseafood, has been substantial in recentyears. Many hearings on the sufficiencyand direction of the Federal seafoodsafety program have been held in bothHouses of Congress since the late1980’s, and numerous bills have beenconsidered for the stated purpose ofimproving seafood safety. This publicconcern has motivated representativesof the U.S. seafood industry to requestthat FDA develop a HACCP-basedprogram for these products.

Although not a public health issue,international trade is also a majorconsideration in determining theadvisability and benefits of a new

system of seafood regulation.Participation in the international tradein seafood is critical to U.S. consumersand to the U.S. seafood industry. TheUnited States is the world’s secondlargest seafood importing nation and thesecond largest exporter of fisheryproducts.

The international movement towardharmonization, coupled with the CodexAlimentarious Commission’s adoptionof HACCP for international use, clearlyargue for the adoption of this approachin the United States for seafood. Failureby the United States to adopt amandatory, HACCP-based system couldultimately undermine its export success,with considerable economicconsequences. Such failure also wouldundermine the United States ability tomeet growing international expectationsthat it enter into mutual recognition-type agreements with trading partnersbased on HACCP.

II. The Comments

FDA received over 250 submissionsfrom over 200 commentors on both theproposed regulations and the draftGuide. Individual companies, themajority of which are in the seafoodbusiness, submitted slightly over half ofthe comments. Nearly 40 tradeassociations submitted comments. Aswith the companies, the majority ofthese associations represent seafoodinterests, but a significant minority havememberships reflecting a range of foodproducts.

Comments were also received fromconsumer advocacy and similar groups,and coalitions of such groups. Alltotaled, the views of over 50organizations were represented in thesecomments.

Other commenters included Stateagencies, the Association of Food andDrug Officials (AFDO), the InterstateShellfish Sanitation Conference (ISSC),several scientific associations andbodies, departments of threeuniversities, foreign governments, andabout 25 individuals.

Overall, the comments coveredvirtually every aspect of the proposaland guidelines. FDA appreciates theeffort, interest, and thoughtfulnessreflected by these comments.

The following materials address thesignificant comments that were receivedon the proposed regulations, both on thespecific provisions of the proposal andon related matters. The materials on theprovisions of the proposed regulationsexplain, among other things, why theagency did or did not modify theprovisions based on the comments. Anyprovisions not addressed below were

not changed substantively or were notthe subject of significant comment.

FDA will respond to those commentsthat relate solely to the draft Guidewhen the first edition of that documentis completed and made available to thepublic. The agency intends to addressthose comments in a notice ofavailability to be published in theFederal Register.

A. Legal Basis

1. IntroductionAbout 25 comments addressed the

legal basis for these regulations. Nearlyhalf of these comments were eithercompanies that process foods other thanseafood or trade associations thatrepresent such companies, some of whoindicated that they were motivated tocomment, at least in part, by thepossible precedent that theseregulations could set for HACCPprograms beyond seafood. Some of thesecomments deferred comment on thelegal basis for the HACCP regulationsfor seafood but commented on whetherthe legal basis that FDA was proposingfor seafood would be appropriate formandatory HACCP programs for otherkinds of foods.

FDA is issuing these HACCPregulations for seafood under varioussections of the Federal Food, Drug, andCosmetic Act (the act), including, mostsignificantly, sections 402 (a)(1) and(a)(4) and 701(a) (21 U.S.C. 342 (a)(1)and (a)(4) and 371(a)). Section 402(a)(1)of the act states that a food isadulterated if it bears or contains anypoisonous or deleterious substance thatmay render the food injurious to health.Section 402(a)(4) of the act states that afood is adulterated if it has beenprepared, packed, or held underinsanitary conditions whereby it mayhave been contaminated with filth, orwhereby it may have been renderedinjurious to health. It is important torecognize that section 402(a)(4) of theact addresses conditions that mayrender a food injurious to health, ratherthan conditions that have actuallycaused the food to be injurious. SeeUnited States v. 1,200 Cans, PasteurizedWhole Eggs, Etc., 339 F. Supp. 131, 141(N.D. Ga. 1972). The question is thuswhether the conditions in a plant aresuch that it is reasonably possible thatthe food may be rendered injurious tohealth. The agency believes that, if aseafood processor does not incorporatecertain basic controls into its proceduresfor preparing, packing, and holdingfood, it is reasonably possible that thefood may be rendered injurious tohealth and, therefore, adulterated underthe act. Section 701(a) of the act


authorizes the agency to adoptregulations for the efficient enforcementof the act.

2. General Authority1. One comment stated that FDA had

not met its responsibility to present theshortcomings in the existing law whendemonstrating the need for theseregulations.

FDA believes that this comment ismisguided. The agency’s statutoryauthority is not deficient in this area.FDA does have a responsibility,however, to demonstrate that there is aneed for the regulations, and that theregulations are reasonably related to thepurposes of the act that they aredesigned to advance. FDA has fulfilledthis responsibility.

As outlined above, the act provides abroad statutory framework for Federalregulation to ensure human food willnot be injurious to health and to preventcommerce in adulterated foods. As therecord in this proceeding amplydemonstrates, there is a range ofcircumstances and conditions that haveraised concerns about how the safety ofseafood sold in this country is ensured.Given these concerns and itsresponsibility under the act, FDA hasconcluded that it is necessary to requirethat firms incorporate certain basicmeasures into how they processseafood. The agency also concludes thatfailure to incorporate these measuresinto a firm’s processing procedureswould mean that the firm would beproducing the product under insanitaryconditions whereby it may be renderedinjurious to health. (See United States v.Nova Scotia Food Products Corp., 568F.2d 240, 247 (2d Cir. 1977).)

2. A few comments took the view thatFDA lacked the authority to issue theseregulations because Congress hadconsidered legislation relating toseafood safety in recent years but hadnot enacted it. Much of this legislationcontained provisions authorizing theestablishment of a mandatory Federalinspection program based on HACCP-type principles. According to thecomments, Congress’ failure toauthorize this program after consideringdoing so indicated that the contents ofFDA’s seafood HACCP regulationsremain within the domain of Congressand have not been delegated to FDA toimplement.

FDA does not agree with thiscontention. Unquestionably, seafoodsafety has received considerableattention from Congress in recent years,most notably in the late 1980’s throughthe early 1990’s. Many hearings wereheld on the subject in both the House ofRepresentatives and the Senate during

this period, and several bills wereintroduced in both chambers. The highwater mark for this activity occurred atthe end of the 101st Congress whendiffering seafood safety bills passed bothchambers. These bills could not bereconciled before the end of the term,however, so nothing was enacted.Legislation introduced in the 102dCongress did not pass either chamber.

The fact that Congress has consideredthe issue of seafood safety, however,does not preclude FDA fromimplementing a mandatory seafoodHACCP program. The effect oflegislation that was never enacted on aFederal agency’s initiatives wasconsidered in National ConfectionersAssociation v. Califano, 569 F.2d 690,693 n.9 (D.C. Cir. 1978), a case involvinga challenge to FDA’s statutory authorityto issue good manufacturing practiceregulations for candy making. The courtrejected an argument that the existenceof legislation that was not enacted thatwould have given FDA expressauthority to require some of the thingsthat the agency included in itsregulations indicated that Congressintended to exclude such authority fromthe act as it was then written. Instead,as will be discussed below, inupholding the validity of theregulations, the court looked at whetherthe statutory scheme as a whole justifiedthe promulgation of the regulations.

It is true that a deliberate refusal byCongress to authorize a specific programwould at least be one factor to beweighed in determining the validity ofa regulation. See Toilet GoodsAssociation v. Gardner, 387 U.S. 158(1967). The expiration of the 101stCongress before competing seafood billscould be reconciled did not, however,amount to a refusal on the part ofCongress to authorize a mandatoryHACCP program, including HACCP-based inspections for seafood. Thus,FDA concludes that there is no merit tothe comments’ assertion.

3. Insanitary Conditions3. Several comments, most of whom

were trade associations or companiesinvolved in the processing of productsother than seafood, questioned whethersection 402(a)(4) of the act was anappropriate authority upon which tobase a mandatory HACCP program.Most of the concern hinged on whethera failure to have a HACCP plan, or tokeep HACCP records, could really beconsidered an ‘‘insanitary’’ conditionunder section 402(a)(4) of the act. Somequestioned whether safety issuesrelating to chemical or physical hazards,or to pesticides, unapproved additives,and drug residues, as included in the

proposed regulations, could be deemedto have been the result of insanitaryconditions. Two comments expressedthe view that section 402(a)(4) of the actdoes not concern food safety generallybut only safety problems caused byinsanitary conditions.

The relevant case law supports abroad reading of ‘‘insanitary.’’ In NovaScotia, supra, 568 F.2d at 247, the courtread ‘‘insanitary’’ to cover a wide set ofcircumstances necessary to ensure thatfood was not produced underconditions that may render it injuriousto health. Specifically, the courtconcluded that FDA’s regulationsmandating time-temperature-salinityrequirements for smoked fish productswere within the agency’s statutoryauthority under section 402(a)(4) of theact. The court rejected the argument that‘‘insanitary’’ limited coverage undersection 402(a)(4) of the act only tobacterial hazards that could enter theraw fish from equipment in theprocessing environment and not toproper processing to kill bacteria thatentered the processing facility in theraw fish itself.

Acceptance of a restrictive reading ofsection 402(a)(4) of the act, the court inNova Scotia noted, would probablyinvalidate several existing FDAregulations, including those relating tothe thermal processing of low-acidcanned foods in part 113 (21 CFR part113). When dealing with the publichealth, the court concluded, the statuteshould not be read too restrictively butconsistent with the act’s overall purposeto protect the public health. (See alsoUnited States v. Bacto-Unidisk, 394 U.S.784, 798 (1969); United States v.Dotterweich, 320 U.S. 277, 280 (1943).)

4. Notwithstanding these cases, onecomment cited the case of United Statesv. General Foods Corp, 446 F. Supp 740(1978), aff’d 591 F.2d 1332 (2d Cir.1978), for the proposition that a failureto have a HACCP plan could not alonebe a violation of section 402(a)(4) of theact because it would not constituteinsanitation.

FDA does not agree that the GeneralFoods case stands for this proposition.Rather, the court in General Foodsexplicitly recognized that ‘‘[b]ecause thepurpose of 402(a)(4) is to preventcontamination, or nip it in the bud,actual contamination of the finishedproduct need not be shown.’’ Id. at 752.Significantly, the court appeared to beimpressed with the preventive controlsthat were in place in the defendant’splant and took these into considerationin deciding that the agency had failed toprove that section 402(a)(4) of the acthad been violated. However, the courtdid not deal at all with the limits on


FDA’s authority to do rulemaking undersections 402(a)(4) and 701(a) of the actto establish standards for suchpreventive controls.

Thus, it is not inconsistent withGeneral Foods for FDA to adopt HACCPregulations that are designed to definethe minimum steps that a seafoodprocessor must take to ensure that thefood that it produces is not preparedunder conditions that may render itinjurious to health. Clearly, given therisks inherent in many seafoodoperations, if a processor does notidentify the critical control points in itsprocess, and does not monitor what goeson at those points, there is a reasonablepossibility that the food that it produceswill be injurious to health.

A primary objective of the seafoodHACCP regulations is to establish asystem of preventive controls for humanfood safety. The HACCP plan is afundamental step in the development ofthese controls. It is the step in which themanufacturer analyzes its process,identifies the points at which problemsmay occur, and establishes theparameters that must be met if thoseproblems are to be avoided. Thus,failure to have a HACCP plan would, infact, constitute an ‘‘insanitarycondition’’ as this term must beunderstood in light of the relevant caselaw.

Section 402(a)(4) was added to the actto ensure ‘‘the observance of thoseprecautions which consciousness of theobligation imposed upon producers ofperishable food products should requirein the preparation of food forconsumption by human beings.’’Hearings before the Senate Committeeon Commerce, S. 2800, 73d Cong., 2dSess., Mar. 1934, as cited in UnitedStates v. 1,200 Cans, Pasteurized WholeEggs, Etc., supra, 339 F. Supp. 140–141.Clearly, HACCP reflects the emerging,internationally recognizedunderstanding of the precautionsnecessary to produce safe food. Theseregulations embrace HACCP andprovide processors with directions forestablishing HACCP systems andoperating them as a matter of routinecustom and habit that will ensure thesafety of the food that they produce.Thus, FDA finds that operation underan effective HACCP system is necessaryto meet a processor’s obligation undersection 402(a)(4) of the act.

4. RecordsIn Confectioners, the court upheld

FDA’s authority to issue regulationsunder section 402(a)(4) of the act thatincluded recordkeeping requirements.The recordkeeping provisions of theregulations were challenged on the

grounds that they would permitprosecution where processingconditions were completely sanitary,but the records were deficient. Such anoutcome, it was argued, would bebeyond the scope of section 402(a)(4) ofthe act.

Citing Toilet Goods, the court rejectedthis argument and held that the primaryconsideration was whether the statutoryscheme as a whole, not just section402(a)(4) of the act, justified theagency’s regulations. The court pointedout that this consideration involved aninquiry into practicalities as well asstatutory purpose, i.e., enforcementproblems encountered by FDA and theneed for various forms of supervision inorder to accomplish the goals of the act.

5. Two comments expressed the viewthat the holding in Confectioners shouldbe limited to the specific facts in thatcase. One comment stated that the caseonly upheld FDA’s authority to imposerecordkeeping requirements on firms tofacilitate recalls of potentiallydangerous products. The other commentnoted that the case only granted FDAaccess to shipping records. Thecomment pointed out that FDA alreadyhas access to such records from carriersunder section 703 of the act.

While it is true that the records thatFDA was requiring, and to which theagency claimed access under theregulations involved in Confectioners,were source coding and distributionrecords in order to facilitate recalls, thecourt’s ruling involved broad principlesrelating to the validity of the regulationsgenerally and was not limited to recallsor shipping records. The court statedthat in light of the statutory scheme asa whole, ‘‘we find no basis for theAssociation’s distinction between theFDA’s role in preventing and remedyingcommerce in adulterated foods. Theagency believes that the Act imposes onthe FDA an equal duty to perform eachrole.’’ Id. at 694. This statement simplyis not consistent with the narrowreading suggested by the comment.Rather, it fully supports FDA’s authorityto adopt regulations to prevent theintroduction of adulterated foods intointerstate commerce. Clearly,compliance with FDA’s seafood HACCPregulations will help to achieve thatend.

It is also true, as one commentpointed out, that section 703 of the actexpressly grants FDA access to shippingrecords and not to the kinds ofprocessing records required in theseregulations. FDA cannot agree, however,that Confectioners stands for theproposition that FDA should haveaccess only to food manufacturers’shipping records because those are the

only kinds of records to which FDA hasaccess under section 703 of the act. Thecourt concluded that the narrow scopeof section 703 of the act is not alimitation on the right of the agency torequire recordkeeping and have accessto records that are outside the scope ofsection 703 of the act, so long as therecordkeeping requirement is limited,clearly assists the efficient enforcementof the act, and the burden ofrecordkeeping is not unreasonablyonerous (569 F.2d at 693 n.9).

The recordkeeping required underthese regulations passes theConfectioners test. First, therecordkeeping requirements are limited.The HACCP recordkeeping and recordaccess requirements in the final rule aretied specifically to the critical controlpoints (CCP’s) in the manufacturingprocess. In other words, therecordkeeping requirements are limitedto those points in the process at whichcontrol is essential if assurance that theresultant product will not be injuriousto health is to be achieved.

Second, the recordkeeping assists inthe efficient enforcement of the act. Therecordkeeping requirements, byfocusing on the CCP’s, ensure that theprocessor and the agency focus on thoseaspects of processing that mostjeopardize food safety. Unlike thecurrent inspection system,recordkeeping in a HACCP-type systemdocuments that preventive controls arebeing followed and enables the regulatorto verify this fact. Such a system,therefore, assists in effective andefficient enforcement of the act.

Finally, the HACCP-recordkeepingburden is not unduly onerous. It islimited to those aspects of processingthat are critical to food safety.Documentation that control is beingmaintained over these aspects ofprocessing need only be a minoradditional step in most instances. Thedocumentation required in the final ruleis narrowly tailored to ensure that onlyessential information needs to berecorded.

6. Several comments questionedwhether FDA may have access toHACCP records and plans on thegrounds that the act does not explicitlyauthorize such access. Some of thesecomments pointed to the lack ofauthorization in section 704 of the act(21 U.S.C. 74), the provision thatauthorizes the inspection of foodprocessors and other types ofestablishments. The comments pointedout that section 704 of the act authorizesagency access to certain records relatingto prescription drugs and medicaldevices during the course of thoseinspections but not to records relating to


foods. One comment felt that thespecific grant of records access for drugsand devices in section 704 of the actprecluded expansion of access torecords not specifically mentioned inthe act. Other comments felt that FDAwas barred from access simply becausethe act does not expressly grant it.

FDA does not agree, as the agency’sauthority under sections 402 and 701(a)of the act to issue these regulationsprovides ample authority for recordsaccess. The line of cases cited abovestands for the proposition that a lack ofexplicit delegated authority does notinvalidate agency regulations so long asthe regulations are consistent with theact’s overriding purpose. InConfectioners, the court upheld FDA’sauthority to adopt recordkeepingrequirements in the absence of anexplicit delegation of authority. In thatcase, moreover, the court found noevidence that Congress intended toimmunize food processors from limitedrecordkeeping (569 F.2d at 695).Similarly, the court in Nova Scotiaconcluded, in the absence of suchevidence, that there was no impedimentto a broad reading of the statute basedon the general purpose of the Congressin protecting public health (568 F.2d at248).

FDA has concluded, therefore, thatthese regulations are consistent withsection 704 of the act and with the actas a whole. Because the preventivecontrols required by HACCP areessential to the production of safe foodas a matter of design, the statutoryscheme is benefited by agency access torecords that demonstrate that thesecontrols are being systematicallyapplied. The case law supports FDA’sauthority to require such recordkeepingand to have access to such records.

Other countries, including Canada,the European Union (EU) Norway,Australia, and New Zealand, whichhave already implemented HACCP-typesystems, have deemed it necessary tothe success of their systems to providefor recordkeeping and record accessalong the lines of this regulation (foreither their entire seafood industries orseafood export industries). Thus, it iswidely accepted that recordkeeping andinspectional access are essentialcomponents of a HACCP-type seafoodsystem. In addition, in order to maintainother countries’ faith in the safetystandards of U.S. seafood exports, FDAneeds similar access to records showingHACCP implementation.

7. One comment expressed the viewthat the copying of records by FDA, asauthorized by these regulations, isbeyond the scope of section 704 of theact.

FDA points out that it is not actingunder section 704 of the act. Toeffectuate the broad purposes of the act,there may be some circumstances inwhich access to the records would bemeaningless without the opportunity tocopy them. While the agency does notanticipate that copying will benecessary in most instances, perhaps themost readily predictable circumstancein which copying would be necessary iswhen an investigator needs assistancefrom relevant experts in headquarters toevaluate the record. Without copying, itwould be necessary for the agency torely solely on the notations and reportof the investigator.

This reliance may not be adequate inmany circumstances. For example, theremay be a deviation from a critical limit(CL) that poses no health risks. Withoutthe ability to show a copy of the recordsto someone within the agency with thenecessary expertise in the area, aninvestigator would have to cite thecompany for a violation. If, however, anagency expert determined that thedeviation posed no safety risks, theagency could use its enforcementdiscretion not to pursue a violation.

8. One comment expressed the viewthat the act does not support amandatory HACCP program thatincludes access to records for the entireseafood industry. According to thecomment, the act permits FDA access torecords only under extreme conditionswhere there is a potential for injury, but,the comment noted, hazards are onlyassociated with a small percentage offish.

FDA cannot agree. While it is true thatthose seafood-related illnesses that arereported to public health authoritiestend to be associated with a limitednumber of species, potential hazards aremuch broader. As indicated above, the1991 NAS report on seafood safetyprovides an extensive inventory ofhazards.

For the benefit of the commentor it isworth noting that if a processor isinvolved with species and processes forwhich there are no food safety hazardsthat are reasonably likely to occur, aHACCP plan will not be necessaryunder these regulations. As will bediscussed later in this preamble, theagency anticipates a post-implementation dialog with firms onwhether they have hazards that must becontrolled in accordance with theseregulations and, if so, how many.

9. One comment expressed the viewthat the authority to inspect ordinaryfood records has not been assertedbefore. This statement was made insupport of the contention that there is

no statutory basis for FDA access toordinary food records.

The legal basis for FDA’s access torecords has already been fully addressedin this preamble. It is important to notethat the agency is not claiming a rightof access to food records coextensivewith that for drugs and devices undersection 704 of the act. Rather, FDA isasserting a right to access to records thatis narrowly tailored to advance thepurposes of the sections of the act thatit is implementing here, i.e., recordsrelating to the CCP’s in a firm’s process.

While the agency is not sure what thecomment meant by ‘‘ordinary’’ foodrecords, it is worth pointing out that theposition in this regulation on agencyaccess to records is a longstandinginterpretation for regulations of thistype. Agency access to processing andproduction records has been requiredsince the early 1970’s in FDA’sregulations for thermally processed low-acid foods packaged in hermeticallysealed containers (part 113) and foracidified foods part 114 (21 CFR 114).As discussed in the new section, theseregulations were issued primarily underthe authority of both sections 402(a)(4)and 404 of the act (21 U.S.C. 344),neither of which specifically mentionaccess to records.

5. Relevance of Section 404 of the Act

10. Several comments expressed theview that FDA should base HACCPregulations on section 404 of the actrather than on section 402(a)(4) of theact. Some of these comments werereferring to these seafood HACCPregulations, while others were primarilyconcerned with any HACCP regulationsthat FDA might issue for other foods.Other comments expressed the viewthat FDA’s existing low-acid cannedfood regulations should serve as amodel for new HACCP programs.Because some of the low-acid cannedfood regulations have been issued undersection 404 of the act, all of thesecomments may have been making thesame general point.

Most of those that advocated use ofsection 404 of the act as the legal basisexpressed concerns about theappropriateness of relying on section402(a)(4) of the act and the narrowgrants of access to records in the act,especially in section 704 of the act, andconcluded that the act only grants theagency access to records under extremesituations. One comment urged thatFDA issue the seafood HACCPregulations under the authority ofsection 404 of the act in order toenhance the agency’s ability to achievecompliance through the permit system.


Section 404 of the act is entitled‘‘Emergency Permit Control.’’ Itauthorizes FDA to establish a permitsystem for processors of food that maybe injurious to health when twoconditions are met: (1) Contamination iswith microorganisms, and (2) theinjurious nature of the product cannotbe adequately determined after theproduct enters interstate commerce.Section 404 of the act authorizes FDA toinspect firms that operate under thispermit system but does not mentionrecords or FDA access to records.

As indicated previously, FDA hasissued regulations under this authority.Regulations at part 108 (21 CFR part108) subpart A establish the permitsystem generally. Regulations at part108 subpart B establish that acidifiedfoods and thermally processed low-acidfoods in hermetically sealed containers(i.e., low-acid canned foods, or ‘‘LACF’’)meet the criteria in section 404 of theact and are therefore subject to thepermit system. Subpart B requiresprocessors of these foods to register withFDA and to submit detailed informationto FDA on their manufacturingprocesses.

As an adjunct to these regulations,FDA has also issued the regulations,referred to previously, at part 113 andpart 114 for these products. These latterregulations require the maintenance ofday-to-day processing records that areretained by the processor and are inaddition to the processing informationthat must be sent to FDA. FDAinvestigators have access to, and maycopy, these records (§§ 108.25(g) and108.35(h)).

While the permit system may havesome compliance advantages, as pointedout by one comment, there are otherconsiderations in this case that are moreimportant. The permit system is, as thetitle of section 404 of the act declares,an ‘‘emergency’’ system. Because it is anextreme remedy for extreme situations,FDA has used section 404 of the actrelatively sparingly.

In the case of seafood, although FDAstrongly believes that a HACCP systemwill correct deficiencies in the currentsystem and provide significant furtherassurance of safety, the agency cannotconclude that seafood is in an overallstate of emergency from a public healthstandpoint. This conclusion isconsistent with the position taken bythe NAS. The NAS’ Institute ofMedicine, in its 1991 report entitled‘‘Seafood Safety,’’ devoted hundreds ofpages to areas of risk and madenumerous recommendations aboutcontrol measures, including theapplication of HACCP whereappropriate. However, the NAS also

concluded that most seafood in the U.S.marketplace is unlikely to cause illness.

FDA believes that, for seafood at least,HACCP should be the norm rather thanan exceptional remedy for an extremesituation. A functioning HACCP systemreflects an understanding of the widerange of hazards to which seafood mayalways be subject and provides for asystematic application of the preventivecontrols necessary to minimize theoccurrence of those hazards. It is themost effective and efficient way knownof ensuring food safety as a matter ofdesign. In this regard, FDA hasconcluded that, for seafood, the efficientenforcement of the act should not haveto depend on a finding of an emergencyunder section 404 of the act.

It is also worth noting that section 404of the act would limit the application ofHACCP to hazards by reason ofcontamination from microorganisms.FDA is not aware of any HACCP expertor authoritative body, including theNational Advisory Committee forMicrobiological Criteria for Foods(NACMCF), which advocates limitingHACCP to these hazards only. A fulldiscussion of hazards to which seafoodHACCP should apply appears later inthis preamble.

FDA does not agree that section 404of the act is the only basis for theseseafood HACCP regulations, or that itwould be a more appropriate basis. It isnot clear, moreover, how section 404 ofthe act can be cited as supporting theproposition that the agency only hasaccess to records in extreme situations.As indicated earlier, section 404 of theact contains no express grant of accessto records. Again, FDA has concludedfrom the case law that, underappropriate circumstances, the agencyhas access to specific types of recordson foods and food processing forspecific purposes, where such access isnot expressly provided for in the act,but the agency cannot conclude that thisright is limited to extreme situations.Some of the comments providedexamples of extreme situations to whichHACCP regulations should be limitedfrom their standpoint. These examplesraise important issues that will beaddressed elsewhere in this preamble.

11. Two comments expressed theview that the LACF regulations shouldserve as a model for the types of recordsthat would be accessible under HACCPregulations.

FDA did in fact use the LACFregulations as a model in that regard.The HACCP plan required here issimilar to the scheduled processes thatprocessors must submit in the LACFregulations. Likewise, there is littledifference between the HACCP-

monitoring records required here andthe day-to-day processing records thatare required in LACF regulations.

B. HACCP Pro and Con

1. OverviewNearly half of the comments included

specific statements of support oropposition for the concept of amandatory HACCP program to ensurethe safety of seafood. The supportersoutnumbered the opponents by over 10to 1.

Nearly all of those who supported theapproach also had technical commentson various provisions in the proposal.Some conditioned their support on theavailability of additional enforcementauthorities or resources for FDA. Theseaspects of their comments will beresponded to elsewhere in thispreamble. A small number of thesecomments supported the concept of amandatory HACCP program for seafoodbut opposed the proposal as drafted.

The supporters of the conceptincluded most of the seafood tradeassociations that commented,businesses, consumer advocacyorganizations, Federal and Stateagencies, professional societies,academics, and a member of Congress.The reasons for this support included:Enhancement of consumer confidence,the superiority of HACCP-typepreventive controls over traditionalCGMP-type controls and end-productsampling, the view that HACCP is themost efficient and effective way toensure safety, and the view that amandatory HACCP system reflects anappropriate assigning of primaryresponsibility to industry for producingsafe food. Other reasons included aleveling of the competitive playing field,both domestically and internationally;the need for prompt adoption of amandatory HACCP program by FDA toenable the seafood industry to maintainits market position in Europe andelsewhere throughout the world; greaterproductivity; and increased industrycontrol over processing.

One large seafood trade associationstated:

[The association] strongly supports theadoption of a comprehensive regulatoryprogram by the FDA which is designed forfish and seafood using HACCP principles.HACCP systems have been appliedsuccessfully by individual firms in ourindustry, and they have been shown to be avery cost-effective way of controlling safetyhazards. Of equal importance, the adoptionof a HACCP-based regulatory program shouldlead to more effective and efficient use ofFDA resources, and less disruption of theprocessing and importing of seafood forconsumers.


A small number of commentsexpressed opposition to the mandatoryHACCP approach for seafood, however.One State comment expressed the viewthat HACCP would not have anysignificant effect on reducing illnessesfrom molluscan shellfish. Anothercomment stated that, overall, seafood-related illness data do not justifymandatory HACCP for seafood. (Severalother comments questioned the need forthese regulations in light of the NAS’conclusion that commercial seafood isgenerally safe. These comments eithergenerally opposed the proposedregulations as drafted, or opposed itsapplication to the comments’ segmentsof the seafood industry, but did notexpress opposition to mandatoryHACCP as a concept.) None of thesecomments supplied any new seafood-related illness data.

2. The Significance of the Illness Data

The preamble to the proposedregulations described broadly what isknown and not known about the extentof seafood-related illness in the UnitedStates. Foodborne illnesses tend to besignificantly underreported to publichealth authorities. Consequently,precise data on the numbers and causesof foodborne illness in this country donot exist. FDA does know, however, thatillness from seafood does occur, andthat a wide variety of hazards have beenidentified that could cause illness fromseafood (see Ref. 7, pp. 1–13). Theoverwhelming majority of these hazardsare amenable to preventive controls.FDA’s draft Guide addresses controls forover 20 specific types of safety hazards.

The primary purpose of theseregulations is to ensure that preventivecontrols are systematically applied inseafood processing as a matter of routinecustom and usage, and in a way that canbe verified by company management aswell as by regulatory authorities. Thus,while the reported illness data arehighly relevant to whether theseregulations should be issued, they arenot the sole basis for the regulations.

For molluscan shellfish in particular,FDA agrees with the commenters whobelieve that the principles of theNational Shellfish Sanitation Program(NSSP) should continue to form thebasis for the molluscan shellfish safetyprogram in this country. There is noclear alternative to proper waterclassification and patrol by Stateauthorities as the basis for molluscanshellfish safety. HACCP providesprocessors with an excellent system forensuring that these preventive-typecontrols are adhered to in a systematicway.

It may be argued—and somecomments made the point—that the bestway to reduce the overall number ofillnesses from raw molluscan shellfishis to provide additional resources to theStates to enhance their waterclassification and monitoring abilities.Classifying and patrolling shellfishharvesting waters are important meansof preventing molluscan shellfish thathave been contaminated from sewagefrom entering the marketplace.However, additional Federal resourceswill probably not be available for thispurpose in the foreseeable future. It isimperative, therefore, that the systemthat is in place be made as efficient aspossible.

It would be incongruous to exemptfrom a national system of preventivecontrols the processors of productsidentified by the NAS as the source ofthe greatest numbers of seafood-associated illnesses. FDA stronglybelieves that HACCP controls will helpshellfish processors and regulators aliketo better focus on potential safetyproblems and less on tangential mattersthan historically has been the case. Afull discussion of the application ofHACCP to raw molluscan shellfishappears later in this preamble.

3. Exempt Specific Industry Segments?12. Comments stating that HACCP

systems should not be mandated forspecific industry segments usuallyreferred to either the crab processing orthe catfish industries. These commentsgenerally expressed the view thatHACCP requirements for theseindustries were not necessary.

FDA advises that these regulations areflexible enough so that HACCP-typecontrols are not required where they arenot necessary, i.e., where it isreasonably likely that hazards do notexist. It is the agency’s experience,however, that there are reasonably likelyhazards associated with crabmeat as acooked, ready-to-eat product, includingthe growth of pathogens as a result oftime-temperature abuse of the productand the potential for pathogen survivalfrom inadequate pasteurization. Thereare reasonably likely hazards associatedwith the processing of catfish (e.g.,contamination from agriculturalchemicals, improperly used aquaculturedrugs, and a variety of hazards resultingfrom the in-plant processingoperations). It is incumbent onprocessors of these products to knowand control such hazards.

The agency recognizes that whetherreasonably likely hazards exist involvescase-by-case determinations. As will bediscussed in the ‘‘HACCP plan’’ sectionof this preamble, processors will be

given every opportunity to demonstratewhy no hazards exist in theiroperations.

4. Would Voluntary HACCP BeSuperior?

13. Some comments believed that avoluntary approach to HACCP forseafood would be preferable to amandatory approach. One reason givenfor this view was that, under amandatory system, the risk of regulatoryaction by FDA would compel processorsto design HACCP controls that were theminimum necessary to comply with therule. There would be a significantdisincentive for processors to designHACCP plans that have the greatestpractical impact on food safety out offear that occasional failure to meet thosehigher standards would trigger aregulatory response.

If voluntary HACCP systems werealready universal, or nearly so in theseafood industry, and they generallyapplied safety controls that were beyondthe minimum needed for safety, FDAwould see little reason to establish amandatory system. However, HACCP isnot the norm, and given the currentsituation in the seafood industry, FDAfinds that making HACCP mandatory isnecessary to ensure that safe,wholesome, and unadulterated productis produced. Thus, FDA is adopting part123 (21 CFR part 123).

The agency acknowledges thepossibility that, under a mandatorysystem, firms will perceive that they areon safer ground with FDA if theyestablish minimum acceptable controlsthat are more easily met, rather thanmore stringent controls that are beyondthe minimum necessary to ensure safetyand, therefore, are harder to meet. Forexample, in deciding what CCP’s toidentify in a HACCP plan, a processormight err on the side of inclusion undera voluntary plan but keep the number ofCCP’s down to the minimum acceptableto FDA if having a plan is mandatory.

It remains to be seen whetherprocessors will really choose to behavethis way under a mandatory system. Thechoices that processors will make maydepend, in part, on FDA policy towardHACCP plans that are beyond theminimum. The logic in favor of theagency initiating regulatory action whena processor fails to meet its own CL butsucceeds in meeting a minimum levelthat would have been an acceptable CLto FDA, would be that the firm is out ofcontrol vis a vis its own preventiveprocess. The logic against initiatingregulatory action would be that theprocessor is still in control in terms ofmeeting minimum necessary safetyparameters, and that the product is, in


FDA’s opinion, safe to eat. As anadditional factor, FDA does not want todiscourage firms from establishingpreventive controls for themselves thatare beyond the minimum necessary toensure safety.

In evaluating monitoring records,FDA will first determine whether therecorded values are within theprocessor’s critical limits as set out inits HACCP plan. Where values are foundthat are outside the CL’s, the agency willdetermine the cause and extent of suchoccurrences, and what corrective action,if any, the processor has taken. Whereproduct that was involved in a CLdeviation was distributed without firstbeing subjected to appropriatecorrective action, FDA will determinethe cause and extent of the controlfailure.

In determining the appropriate agencyregulatory response to CL deviations,FDA will assess the public health riskthat the product poses. This assessmentwill, in part, involve a determination ofwhether the minimum limit necessaryto ensure safety was breached. FDAacknowledges that this level and theprocessor’s CL may not always be thesame. The agency is not likely to takeaction against a product that it findsposes no significant public health risk,regardless of whether it has or has notmet the processor’s CL.

Nonetheless, processors mustestablish controls to ensure thatappropriate corrective actions are takenwhen their CL’s are breached. Wheresuch controls fail, FDA expectsprocessors to redesign their controlmechanisms as necessary. Chronicfailure to appropriately respond to CLdeviations demonstrates that aprocessor’s HACCP system isinadequate, and that fact could causeFDA to have some regulatory concern.

14. Another comment urged thatHACCP for seafood should be voluntaryon the grounds that FDA lacks theresources and statutory enforcementauthorities to operate a mandatorysystem. Other comments expressed thesame types of concerns about FDAresources and enforcement authoritieswithout concluding that a voluntarysystem would be preferable. Onecomment, from a consumer advocacyorganization representing several otherorganizations, supported the concept ofa mandatory HACCP system butexpressed reservations about FDA’sability to adequately perform HACCP-based inspections of processors withoutadditional resources. Other commentersexpressed the same kinds of concerns.The comment pointed out that becauseHACCP inspections will take longerthan current inspections, the intervals

between inspections will increasesignificantly, creating ‘‘an unenforcedindustry honor system.’’ Thecommenter, and some others, alsoadvocated additional enforcementauthorities.

The success of this program willdepend on a number of factors. One ofthese factors, unquestionably, will bethe ability of a regulatory authority, orauthorities, to adequately monitorprocessors’ HACCP systems throughinspections. If the frequency ofinspections is too low, safety may not beensured, consumer confidence may beeroded, and the accusation that theprogram is self-regulatory may havemerit, even though a HACCP-basedinspection allows the investigator toview a firm’s critical operations overtime, not just at the moment of theinspection.

The use of a HACCP-based systembears on the adequacy of FDA’sinspection resources in two importantrespects. The first is the effect of the useof HACCP-based inspections oninspection frequencies. The time neededto conduct a HACCP-based inspectionwill undoubtedly vary depending on thenumber of hazards, complexity of theoperation, and other factors. The firstround of HACCP inspections will likelytake longer—possibly as much as twiceas long in high-risk and complexoperations—as the CGMP-basedinspections FDA presently conducts,but the time-per-inspection is likely todrop significantly thereafter. It remainsto be seen whether inspection times willeventually shorten to current times, orwhether HACCP-based inspections willalways take longer on average. In anyevent, FDA finds some merit in thecomments’ basic concerns aboutinspection frequencies.

Second, as a countervailing matter, aHACCP-based inspection can be a moreefficient and effective inspection than aCGMP-based inspection, largely becauseit can be highly focused on matters thatare critical to safety, and because accessto key safety monitoring records allowsthe investigator to evaluate the processover time. Thus, some compensation forincreased intervals between inspectionswill be provided by the fact that theinvestigator gets not merely a snapshotof the operation of the plant in time buta broad view of how the plant has beenoperated over the preceding months oreven years, as reflected in the plant’srecords. Thus, FDA concludes that, onbalance, the somewhat longerinspection intervals that might occurunder a HACCP-based system would befully compensated for by the broaderview provided by a HACCP-basedinspection.

In addition, FDA intends to increasethe frequency and improve theconsistency of processor inspectionsthrough HACCP-based work sharingpartnerships with the States. One of theagency’s goals is for these regulations toserve as a basis for partnerships thatinvolves a pooling of resources.

While FDA acknowledges thecomments’ concerns about resources,the agency would not agree that theHACCP program should be abandonedbecause of resource constraints. Quitethe contrary, resource constraints makeit imperative that FDA seafoodinspections be based on the mosteffective and efficient system devised todate. HACCP is that system. Moreover,the agency believes that there is enoughflexibility in a HACCP-based inspectionsystem to permit gradations inimplementation (e.g., focusing on themost extreme hazards; selectivelyreviewing records) to accommodatewhatever resource situation exists at anygiven moment.

With regard to enforcementauthorities, as made clear above, the actprovides ample authority for theestablishment and implementation of aHACCP-based system by FDA.Regardless of whether additionalauthorities might be desirable, theresimply is no reason for FDA not toproceed to establish and implement aHACCP-based system forthwith.

15. Another comment expressedopposition to mandatory HACCP for theseafood industry on the grounds thatHACCP diverts the responsibility forensuring a safe product from thegovernment to the fish processors.

FDA’s intent is not to transfer itslegitimate responsibilities with regard tofood safety to the regulated industry. Inpoint of fact, the industry already hasresponsibility under the law to producea safe product. HACCP helps to clarify,however, how responsibility for humanfood safety is divided between industryand the regulator.

Industry, as stated above, must takeprimary responsibility for theproduction of safe food, while theregulator must be responsible for settingstandards (including programregulations such as these), verifying thatthe industry is doing its job, and takingremedial action when it is not. HACCPrequires that the industry be aware ofthe human food safety hazards that arereasonably likely to occur, and thatindustry operate under a system that isdesigned to ensure that those hazardsare not realized. Thus, HACCP enablesthe industry to demonstrate that it ismeeting its legitimate responsibilities.


5. Other Issues16. One comment supported the

concept of HACCP but expressed theview that the regulation drafting processshould be started over by forming acommittee consisting of representativesfrom various segments of the seafoodindustry, and appropriate governmentand university personnel. A few othercomments expressed the view that FDAhad acted too quickly in issuing theproposed regulations and also requestedthat FDA start over by engaging indiscussions with industry, foreignregulatory agencies, academia, andconsumers. These latter comments,which were mostly from companies notprimarily involved in the processing ofseafood, preferred a voluntary approachto HACCP, with mandatory applicationsonly in exceptional situations. FDA didnot act too quickly, or withoutappropriate consultation, in issuing theproposal in this proceeding. As thepreamble to the proposed ruledocumented at some length, theproposal was the culmination of anextensive process by FDA and others,including the seafood industry itself,that led major representatives of thatindustry to request the issuance of theproposal. Before that, industry tradeassociations testified repeatedly beforeCongress in the late 1980’s through theearly 1990’s in support of legislationthat would have required a mandatoryinspection system for seafood based onHACCP principles.

FDA participated in pilot programs inthe past such as the seafood HACCPpilot conducted jointly by FDA and theNational Marine Fisheries Service(NMFS) of the Department of Commerce(DOC) in 1990 to 1991. In addition, FDAran programs with seven othercountries. In developing theseregulations, the agency also tookadvantage of information from theModel Seafood Surveillance Project(MSSP). The MSSP was conducted bythe DOC at the request of Congress in1986 to design an inspection system forseafood consistent with HACCPprinciples. As part of the MSSP project,49 workshops were conducted involving1,200 industry, State, and universityparticipants. Canada currently has aHACCP system, and the EU has issueddirectives that move in that direction.The agency has concluded thatsufficient field trials have already takenplace to conclude that HACCP is aviable method of hazard control for theseafood industry.

Public input into the development ofthe HACCP approach contained in theseregulations has been substantial. Asdescribed earlier in this preamble, FDA

engaged in a series of ‘‘town meetings’’in nine cities across the country shortlyafter the proposal was published inorder to answer questions about theproposed regulations and encouragecomments. The public response toFDA’s proposal contributedsubstantially to the contents of the finalregulations.

C. Should Some Types of Processors BeExempt?

In the preamble to the proposedregulations FDA asked for comment onwhether either processors of ‘‘low-risk’’products or small processors, or both,should be exempted from therequirements of the final regulations.The agency asked for information onwhether the regulatory burden could bereduced without compromising thepublic health protection goals of theregulations, and whether there exists arational way to distinguish ‘‘high risk’’from ‘‘low risk,’’ and big processorsfrom little processors, for purposes ofHACCP.

1. Exempt Low Risk?The most obvious way of

distinguishing high-risk products fromlow-risk products would be on the basisof reported, confirmed, seafood-relatedillnesses. The preamble to the proposedregulations pointed out some problemswith this approach. First, the agencypointed out that the underreporting andskewed reporting that occurs withrespect to foodborne illness createssignificant concern as to whetherreported illnesses represent a reliableenough factor to serve as the basis foran exemption to these regulations.Second, FDA stated that it wasconcerned that there could be asignificant potential for harm that couldbe controlled by HACCP but that wouldnot have shown up in the data that isrelied on to establish risk. For example,while there may be no reported cases ofbotulism associated with some productsthat have the potential for Clostridiumbotulinum toxin, the severity of theconsequences of the hazard warrantpreventive controls. Likewise, whilethere may be no reported cases ofdomoic acid intoxication associatedwith shellfish from a particular area,preventive controls are warranted assoon as a such a case is made public.Thus, the preamble asked whetherpotential for harm might be a reasonableway to distinguish high-risk from low-risk products for purposes of anexemption. FDA was interested inwhether comments could provideusable criteria for such an exemption.

About 45 comments addressed thequestion of whether the regulations

should apply to high-risk products only.Roughly two-thirds of these commentspreferred a high-risk approach. For themost part, they either did not define‘‘high risk,’’ or defined it as includingessentially the top three reportedseafood- related illnesses (virus-relatedfrom raw molluscan shellfish,scombrotoxin, and ciguatoxin). For themost part, other hazards were assumedto represent a low risk.

17. One comment recommended thatthe regulations initially cover thehazards reported at the highest levels ofto the Centers for Disease Control andPrevention (CDC) because these hazardsare at least known to be causing illness,and that the agency should phase inother hazards as appropriate if thefoodborne-illness reporting system wereto reveal a need to do so.

Few comments were received onwhether there could be a basis fordistinguishing high risk from low riskother than reported illnesses. Somecomments suggested that the agencyshould consider severity of illness as acriterion. Some of these commentsspecifically cited smoked and smoke-flavored fish as products that should becovered on this basis because of thedevastating effects of botulism. A fewcomments expressed the view thatmandatory HACCP should be limited tohazards that can cause loss of life orirreversible injury.

Several comments objected to a ‘‘lowrisk’’ exemption in any form. Somepointed out that, given theunderreporting and skewed reportingthat exists, the CDC foodborne-illnessreporting system does not provide asuitable basis for making determinationsof comparative risk (i.e., high risk versuslow risk). These comments expressedconcern that linking the requirements ofthese regulations to illness reportingthat has already occurred would havethe effect of exempting emerginghazards, at least until they causedreported illness.

Other comments stated that there isno significant advantage to exemptinglow-risk products because processors ofthese products will have simplerHACCP plans than those who processproducts with more potential safetyhazards. One comment stated that ahigh risk-only approach made somesense but, as a practical matter, wouldnegate the added assurance toconsumers from HACCP that seafood issafe and processed under some form ofregulation. According to this comment,from a large seafood trade association, itis more important that the entire foodcategory be recognized as having beensubjected to modern safety assurance


procedures than that the regulationsexempt the low risk end of the industry.

FDA has considered these points ofview and has concluded that, at least fornow, there is no reasonable way todivide seafood products into high riskand low risk for purposes of theseregulations. The comments thatsuggested defining ‘‘high risk’’ in termsof the most frequently reported illnessesare correct that the volume of reportingtends to concentrate substantially in thethree hazard areas mentioned above.Because illnesses that are confirmed andreported tend to be those that are themost easily traced or diagnosed,however, the relative significance of thehigh level of reporting in these threeareas—as well as the drop-off inreporting in other areas—is not fullyknown. Moreover, illnesses associatedwith chronic hazards are virtuallyunreported because of the difficulties inassociating such illnesses to specificfood sources.

The comments did not include anynew data that would reveal whether therisks associated with the most reportedillnesses are actually the highest risks oronly the most apparent. No newinformation was provided to allow FDAto determine whether distinguishinghigh risk from low risk on the basis ofreported illnesses would constitute arational division for purposes of theseregulations. Nor has FDA been suppliedwith information that would allow it toconclude whether other valid criteriaexist.

FDA agrees with the comments thatpointed out that the requirements ofHACCP are less when risks are low.Moreover, as will be discussed later inthis preamble, FDA has revised the finalregulations to provide that HACCPplans are not required when there are noreasonably likely safety hazards tocontrol. Thus, HACCP inherently tendsto distinguish between high- and low-risk products without the need forexplicit exemptions.

FDA also agrees that broadexemptions would put at risk some ofthe principal objectives of theseregulations. Explicit exemptions makethe system less flexible and might notcover emerging situations for whichpreventive controls are necessary tokeep illnesses from occurring in the firstplace. A system that includes suchexemptions would likely not provide asmuch consumer confidence as would acomplete HACCP system. In addition,FDA notes that the benefits to theindustry in international trade fromadopting a HACCP system might beminimized if such exemptions wereadopted because the United States’

international trading partners are optingfor complete systems.

2. Exempt Small Processors?

18. Over 60 comments addressed thequestion of whether the regulationsshould exempt small businesses. Aboutfive out of six of these commentsopposed an exemption.

Those that supported an exemptionfor small businesses expressed concernabout the effect of the general costs ofimplementation, particularly the costsof training and recordkeeping. Onecomment observed that many smallbusinesses are economically-strapped,old, family enterprises that support anoften fragile local economy. Anothercomment expressed the view that smallbusinesses should be exempt becausethey are not involved in internationaltrade. One comment noted that thehighest volume producers (i.e., largebusinesses) are where a mistake affectsthe most consumers.

One comment recommended thatFDA develop exemption procedures torelieve small companies of paperworkand training requirements, especially ifthey produce low-risk products. A fewcomments suggested that smallbusinesses, or at least small businesseswith good records, be exempt from‘‘positive’’ recordkeeping, i.e., recordingthe results of each monitoring. Underthis kind of exemption, small businesseswould only record unusual occurrencesand corrective actions.

The majority of comments that arguedagainst exempting small businessesprovided a number of reasons. Onecomment pointed out that as much ashalf of seafood consumed in the UnitedStates is from small firms. Severalcomments stated that size is not relatedto risk. Small firms are the majorproducers of many high-risk products(e.g. cooked, ready-to-eat and rawmolluscan shellfish). Thus, according tothe comment, the final regulationswould represent a futile exercise ifsmall firms were not included. Onecomment observed that smallcompanies sometimes represent more ofa risk potential than large companiesdue to lack of enough trained qualitycontrol personnel. Other commentspointed out that small businesses withsimple operations would have simpleplans and a minimum of recordkeeping.

One comment pointed to difficultiesthat FDA would have in administeringexemptions to the regulations,particularly in distinguishing betweenfirms that were and were not entitled toan exemption. Another concernexpressed by comments was thepotential unfairness of exempting some

companies while requiring HACCP ofothers.

One State that has implementedmandatory HACCP for seafoodprocessors observed that HACCPrequirements had not proven to be anexcessive burden to small businesses inthat State.

Some comments that supportedincluding small businesses in thecoverage of the HACCP requirementrecommended, nonetheless, that FDAshould provide assistance to smallbusinesses through guidelines, modelplans, and technical and financialassistance. Some commentsacknowledged that small firms can workthrough trade groups on common plansand training.

Other comments felt that droppingsmall firms from the final regulationswould adversely affect consumerconfidence. One comment expressedfear that the international standing ofFDA’s seafood safety program would bein jeopardy if the regulations were toexempt some firms.

FDA does not know how to exemptsmall business without jeopardizing thepublic health objectives of theregulations. An exemption for smallprocessors of ‘‘low-risk’’ productswould run into the difficultiesexplained above in the discussion ofwhether these regulations should onlyapply to ‘‘high-risk’’ products. FDAagrees with the comments that, in theseafood industry, the size of theoperation often does not coincide withthe number or type of hazards that mustbe controlled in order to ensure a safeproduct (i.e., small size does notautomatically mean minimal hazards).For example, cooked, ready-to-eatseafood processing, a relatively complexmanufacturing operation, typicallyrequiring a larger than average numberof CCP’s, is concentrated in the smallbusiness portion of the seafoodindustry. Additionally, the processing ofraw molluscan shellfish, a productidentified by NAS as being associatedwith a disproportionately largepercentage of the seafood-borneillnesses, is most commonly performedby small firms. FDA also agrees that,because seafood businesses tend to besmall, an exemption for smallbusinesses could make HACCP theexception, rather than the rule, in thisindustry.

The concerns expressed in thecomments about the possible adverseconsequences of these regulations onsmall business, however, should not betaken lightly, and the agency has notdone so. FDA has no desire to establisha mandatory regime that cannot be metby otherwise responsible companies,


small or otherwise, that are producingsafe food. Indeed, these regulations arebased on the premises that: (1)Preventive controls for safety should bewithin the reach of anyone who isproducing seafood for commerce (i.e.,preventive controls should not beprohibitively burdensome, eitherfinancially or conceptually); and (2) it isin the public interest that everyone whois producing seafood for commerceshould practice preventive control forhuman food safety. The fundamentalquestion that the issue of whether toexempt small business raises is whetherthese premises are valid.

Having fully considered thecomments on this issue, FDA is notpersuaded that awareness of likely foodsafety hazards would cause financialhardship to small businesses, or thathaving reasonable, practical controls forthose hazards will cause undue harm.As will be discussed in the ‘‘Records’’section of this preamble, the costsassociated with the recordkeepingrequirements of HACCP are reallyincidental to the cost of monitoring andneed not place a significant burden onsmall businesses. For example, afterchecking the temperature of arefrigerator, the observer need only takean additional moment to document theresult of the observation. The agencycannot emphasize too strongly that, inmost instances, only very simplerecordkeeping is needed to adequatelyserve the purposes of the system. Thequestion from the agency’s standpoint,therefore, is whether the actualmonitoring of critical operations, atreasonable frequencies, would beprohibitively expensive to the smalloperator. FDA has not been providedwith a basis for such a conclusion.

This leaves plan development andtraining as costs. The guidelines thatFDA is making available on plandevelopment should help substantiallyto keep development costs down. FDAis also aware that trade associations andothers are interested in developingmodel plans that, when used in concertwith the guidelines, should furtherreduce the resources that a firm willneed for plan development. Thecreation of a HACCP plan does requiresome thought and effort by theprocessor to ensure that hazards andcontrols are understood and identified.Nonetheless, the guidelines and modelplans will enable small processors to beable to apply the thought and effortnecessary to create a HACCP plan withmaximum efficiency and minimum cost.

FDA is requiring that all processorseither employ at least one trainedindividual or contract for services fromat least one trained individual, as

needed. There are unavoidable costsassociated with this requirement. It isimperative that these costs be affordableto small business and be no greater thannecessary. As discussed at length in the‘‘Training’’ section of this preamble,FDA has been extensively involved witha consortium called the ‘‘SeafoodHACCP Alliance’’ (the Alliance)consisting of representatives fromFederal and State agencies, industry,and academia, to create a uniform, coretraining program that will meet therequirements of these regulations andwill cost very little. The agency is alsoaware of HACCP training that has beenprovided for years for members ofindustry by NMFS and others. As anadditional matter, FDA is allowing jobexperience to serve as a form of trainingin order to avoid the unnecessaryexpense to a processor of having to payfor a HACCP course when at least oneemployee already has knowledge that isequivalent to that provided by thecourse.

These efforts should alleviate theconcerns of those who believe that thetraining requirement will be tooburdensome on small business. Theagency will monitor the situationclosely once this training getsunderway. If costs turn out to besignificantly higher than FDAanticipates, the agency will considersome modification to the requirement.

While the agency regrets that grantmonies are not available to smallbusinesses from FDA, the effort that theagency is investing in guidelines andtraining development is a form ofsubsidy that should keep costs downgenerally.

D. Definitions

1. GeneralIn addition to relying on the

definitions contained in the act andthose in the umbrella goodmanufacturing practice regulations atpart 110 (21 CFR 110), FDA proposed at§ 123.3 (a) through (t) to define 20 termsthat are essential to the interpretation ofpart 123. Approximately 100 commentsaddressed various aspects of theproposed definitions at § 123.3.

The majority of the comments ondefinitions were concerned with themeanings that FDA proposed for‘‘processor’’ (§ 123.3(n)) and‘‘processing’’ (§ 123.3(m)). Thesecomments generally asked forclarification about the applicability ofthe definitions to a given commercialactivity, or contended that thedefinitions should be amended to eitherinclude or exclude certain activities.Most of the other comments that

addressed the definitions wereprimarily concerned with the meaningsproposed for ‘‘fish,’’ fishery product,’’‘‘critical control point,’’ ‘‘cooked ready-to-eat,’’ and ‘‘importer.’’ As a result ofthe comments as well as agencydecisions to modify other provisions inpart 123, FDA has deleted, revised, andadded definitions to those proposed at§ 123.3.

2. Cooked, Ready-To-Eat FisheryProduct

19. The proposed regulationscontained a definition for ‘‘cooked,ready-to-eat fishery product’’ at§ 123.3(b). The term was used atproposed § 123.10(a) and in theappendices to the proposed regulations.The final regulations no longer containthis term, and the appendices are notbeing codified. For these reasons, FDAhas eliminated the definition of‘‘cooked, ready-to-eat fishery product’’from the final regulations.

Nonetheless, a large number ofcomments expressed concerns about thedefinition as it was proposed. Ingeneral, the comments urged thatcertain products be excluded from thedefinition of ‘‘cooked, ready-to-eatfishery products;’’ those that are notfully cooked by the processor or thatwill be recooked by the consumer, andlow-acid canned foods subject to theprovisions of part 113.

FDA recognizes the significance of theuse of the term. Because the agency hasexcluded use of the term in these finalregulations, it will defer considerationof the comments until drafting of theGuide.

3. Critical Control Point (CCP)FDA proposed at § 123.3(c) to define

a critical control point as ‘‘a point in afood process where there is a highprobability that improper control maycause, allow, or contribute to a hazardin the final food.’’ The word ‘‘hazard’’in this definition was intended to referprimarily to food safety hazards. Itcould also have applied to quality andeconomic hazards, however, because theagency was proposing at § 123.6(c) toencourage processors to apply HACCPto these hazards as well.

20. A significant number of commentsurged the agency to modify thedefinition so that it clearly addressesonly food safety. These commentsrecommended that the word ‘‘hazard’’should be prefaced with either ‘‘foodsafety’’ or ‘‘health,’’ or that FDA shouldcodify the definition for ‘‘hazard’’ thathas been recommended by theNACMCF.

Several of the comments urged FDAto adopt the NACMCF definition for


‘‘critical control point’’ so that theagency’s regulations would beconsistent with nationally andinternationally agreed upon HACCPdefinitions. One objected to the phrases:‘‘high probability,’’ because of itsconnotation in statistical applications;‘‘improper control,’’ because of a lack ofa standard for proper control; and‘‘cause, allow, or contribute,’’ because itcould allow the elevation of trivialconcerns to critical control point status.

FDA is persuaded by those commentsthat urged consistency with theNACMCF definition for ‘‘critical controlpoint.’’ The agency has, therefore,modified proposed § 123.3(c)(redesignated as § 123.3(b)) to read,‘‘Critical control point means a point,step, or procedure in a food process atwhich control can be applied, and afood safety hazard can as a result beprevented, eliminated, or reduced toacceptable levels.’’ The modifiedlanguage is consistent with the agency’sdecision to limit the HACCP provisionsof part 123 to the avoidance of foodsafety hazards (see the ‘‘HACCP Plan’’section of this preamble for discussion).It is also compatible with modificationsdescribed elsewhere in this preambleaimed at greater consistency with theNACMCF recommendations. Thewording change will not have anypractical impact on the requirements ofthe regulations because the definitionstill reflects the agency’s intent torequire that seafood be processed in away that eliminates, to the extentpossible, the chance that it will berendered injurious to health byprocedures that are under the control ofthe processor.

The NACMCF definition does notcontain the phrases that were objectedto by one of the comments as describedabove. Thus, the concerns raised by thiscomment have been resolved.

21. A few comments, however, statedthat the definition should also apply tothe control of all decomposition becauseit is a major problem associated withseafood.

FDA acknowledges that, because ofthe highly perishable nature of fish,decomposition is probably the mostcommon problem associated withseafood. The agency furtheracknowledges the comments thatexpressed concern that failure to controlthis problem will continue to adverselyaffect consumer confidence. Theindustry especially should heed thisconcern and consider the application ofHACCP principles to decomposition, ifnecessary, to help maintain the qualityof its products.

Nonetheless, decomposition that isnot associated with safety is not

appropriately a part of these mandatoryHACCP regulations but should remainsubject to traditional goodmanufacturing practices controls (see,e.g., § 110.80(b) (21 CFR 110.80(b))). Asdiscussed earlier, these regulations arebeing issued, in part, under section402(a)(4) of the act. That sectionprovides that a food is adulterated if itis prepared, packed, or held underinsanitary conditions whereby it mayhave been rendered injurious to health.While decomposition in some speciescan be injurious to health and istherefore within the scope of section402(a)(4) of the act, most decompositionaffects the quality of seafood but not itssafety. Decomposition that affectsquality but not safety is subject tosection 402(a)(3) of the act. Therefore,FDA is not subjecting decompositionthat is not safety related to therequirements of these final regulationsbut will continue to regulatedecomposition under traditional CGMPcontrol.

FDA points out that it has defined‘‘food safety hazard,’’ a term that theagency uses in the definition of ‘‘criticalcontrol point,’’ in § 123.3(f). The agencydiscusses this definition, which isconsistent with the NACMCFrecommended definition, later in thissection.

4. Critical Limit (CL)FDA proposed in § 123.3(d) to define

a ‘‘critical limit’’ as ‘‘the maximum orminimum value to which a physical,biological, or chemical parameter mustbe controlled at a critical control pointto minimize the risk of occurrence of theidentified hazard.’’ In the preamble tothe proposed regulations, the agencyexplained that the proposed definitionwas intended to be consistent with theconcept of the NACMCF recommendeddefinition, which reads, ‘‘a criterion thatmust be met for each preventivemeasure associated with a criticalcontrol point.’’ However, the proposeddefinition was also intended to be moreexplanatory than is the NACMCFdefinition, especially as it relates to theassignment of a minimum or maximumvalue and in the relationship of thesevalues to a minimization of the risk,rather than to an absolute elimination ofrisk.

22. Several comments stated that theproposed definition of a ‘‘critical limit’’should be modified to be the definitionrecommended by the NACMCF. Thecomments asserted that the NACMCFdefinition is the internationallyaccepted standard, and that its use inthe regulations would avoid confusion.A few comments argued that FDA’s useof the phrase ‘‘minimize the risk’’

implies that the CL must be set to attainthe lowest possible risk, unlike the‘‘reduce to an acceptable level’’ standardin the NACMCF definition for CCP.

Although FDA agrees that thedefinitions in these regulations shouldclosely adhere to the NACMCF’srecommended definitions, the agencyconcludes that, in this instance, FDA’swording is more descriptive forregulatory purposes and more useful toprocessors. However, FDA has beenpersuaded that the phrase ‘‘minimizethe risk’’ may be misinterpreted asrequiring outcomes that are notrealistically achievable by a processor.To provide clarification and consistencywith the revised definition of ‘‘criticalcontrol point,’’ FDA has replaced thephrase ‘‘minimize the risk’’ with thephrase ‘‘prevent, eliminate, or reduce toan acceptable level’’ in the finalregulation (now codified as § 123.3(c)).As noted previously, this language alsoappears in the NACMCF definition of‘‘critical control point.’’ The newlanguage correctly provides for themaking of scientific judgments aboutappropriate degrees of hazard reduction,based on the nature of the hazard andthe availability of controls, and is moreconsistent than the proposed languagewith accepted HACCP convention.

23. One comment stated that the word‘‘identified’’ should be deleted from theproposed definition.

FDA is not persuaded to make anymodification to the definition inresponse to this comment. The‘‘identified hazard’’ refers to the hazardidentified in the HACCP plan.

24. One comment stated that thephrase ‘‘in the end product’’ should beadded following the word ‘‘hazard’’ inthe proposed definition.

FDA is not persuaded to make anymodification to the definition inresponse to this comment. Food safetyhazards are, by definition, those thatcause ‘‘a food to be unsafe for humanconsumption.’’ This definition implies aconsideration of the end product thatwill be offered for human consumption.

25. One comment objected to thephrase ‘‘the maximum or minimumvalue’’ in the definition, stating that, asin the case of certain food additives,there are situations where both amaximum and a minimum value exist,and a processor is required to maintainthe process between these values.

FDA is not persuaded to make anychanges to the proposed language inresponse to this comment. The word‘‘or,’’ which the agency uses in thedefinition, is inclusive. Thus, properlyread, § 123.3(c) states that a CL is themaximum value, the minimum value, orboth the maximum and minimum


values within which the parameter mustbe controlled to protect against theoccurrence of a food safety hazard.

For consistency with the definition of‘‘critical control point,’’ FDA has addedthe phrase ‘‘food safety’’ before the word‘‘hazard’’ in the text of § 123.3(c). Thelanguage in the final regulation nowreads, ‘‘Critical limit means themaximum or minimum value to whicha physical, biological, or chemicalparameter must be controlled at acritical control point to prevent,eliminate, or reduce to an acceptablelevel the occurrence of the identifiedfood safety hazard.’’

5. Fish

26. FDA proposed to define ‘‘fish’’ as‘‘fresh or saltwater finfish, molluscanshellfish, crustaceans, and other formsof aquatic animal life other than birds ormammals.’’ A significant number ofcomments suggested that FDA shouldmodify this definition to clarify whetherit includes species such as sea snails,abalone, frogs, alligators, turtles, otherreptiles, amphibians, sea cucumbers,plants, or algae.

FDA agrees that this type ofclarification would be helpful and hasmodified the definition at § 123.3(d) toread:

Fish means fresh or saltwater finfish,crustaceans, other forms of aquatic animallife (including, but not limited to, alligator,frog, aquatic turtle, jellyfish, sea cucumber,and sea urchin) other than birds or mammals,and all mollusks, where such animal life isintended for human consumption.

The term ‘‘mollusks’’ includesabalone, sea snails, and land snails (e.g.,escargot and any other terrestrialgastropods, such as the giant Africanland snail (Achatina fulica)). Theaddition of examples of aquatic animallife and the mention of mollusks areintended to make clear which speciesare covered by the term ‘‘fish.’’ Water-dwelling reptiles and amphibians otherthan alligators, turtles, and frogs havenot been specifically listed because theyare not significant commercial foodsources in the United States. Finally,FDA notes that, consistent with theproposed definition, aquatic plants(including algae) are excluded. Thisdefinition is consistent with thetraditional treatment of these productsby FDA.

The new language also serves toemphasize that these regulations applyonly to those products that are intendedfor human consumption. This point wasexplicit in the proposed definition for‘‘fishery product’’ but was inadvertentlynot mentioned in the proposeddefinition of ‘‘fish.’’

27. Two comments contended thatthere should be separate definitions forfinfish and shellfish, to differentiatebetween relative levels of safetyconcerns (e.g., high and low risk).

FDA disagrees with this comment.Such a differentiation would serve nopurpose in these regulations. Thepurpose of these regulations is to set upa unitary system that responds to aparticular product based on the risks itpresents, not to establish a system thatis divided up based on risk presented.The merits of differentiating betweenproducts on the basis of risk isaddressed in the section of the preambleentitled ‘‘Should Some Types ofProcessors be Exempt?’’

6. Fishery ProductFDA proposed to define ‘‘fishery

product’’ as ‘‘any edible human foodderived in whole or in part from fish,including fish that has been processedin any manner.’’ The preamble to theproposed regulations stated that theintent of the definition was to includeproducts that contain seafood as aningredient as well as those products thatare comprised of seafood alone, becausehazards derived from seafood arereasonably likely to occur in both typesof products.

28. A few comments urged that FDAexclude from the meaning of ‘‘fisheryproduct’’ any product that is made inwhole or in part from commerciallysterilized fishery products subject to therequirements of parts 113 and 114, (i.e.,thermally processed low-acid cannedfoods and acidified foods).

FDA disagrees with this comment.Although such foods are required to beproduced in accordance with certainHACCP-type control procedures toreduce the risk of the hazard of C.botulinum toxin production, thesecontrol measures do not address otherpotential hazards. For example, part 113provides no assurance that the rawmaterial used in the canning of tunawill be free from contamination withdangerous levels of histamine. Likewise,products made in part from low-acidcanned foods and acidified foods canalso present hazards that must beaddressed. For example, a salad made inpart from canned tuna can be subjectedto recontamination with pathogenicmicroorganisms and time-temperatureabuse during preparation.

Although FDA cannot exclude thoseproducts made in whole or in part fromlow acid canned foods or from acidifiedfoods from the definition of a ‘‘fisheryproduct,’’ it is worth noting that theagency has exempted processors whoare following the requirements of part113 or part 114 from having to include

controls for C. botulinum in theirHACCP plans. This hazard is alreadyaddressed by the requirements in thoseparts (see § 123.6(e) of these regulationsand the ‘‘HACCP Plan’’ section of thispreamble).

29. One comment suggested that thelanguage of the proposed definitioninappropriately excludes fish roe.

FDA points out that the phrase ‘‘anyedible human food product derived inwhole or in part from fish,’’ in theproposal was intended to cover theseproducts. FDA, however, has modifiedthe definition of ‘‘fishery product,’’ andit no longer includes this language.Therefore, to make clear that roe arecovered, FDA has made explicit in thedefinition of ‘‘fish’’ that the roe of thecovered animals are included.

30. A significant number of commentsurged that the definition excludeproducts that contain only a minimalamount of fish. These commentssuggested various standards that FDAshould apply to exclude such foodsfrom the definition. These included:Products that contain less than 50percent fish; products that contain lessthan 10 percent fish; products thatcontain 2 percent or less of cooked, or3 percent or less of raw, fish; productsin which fish is not a characterizingingredient; and products that containany nonfish ingredient unless a hazardanalysis identifies a significant hazardassociated with the fish ingredient. Thecomments provided no justification forthe percentages suggested.

FDA agrees that foods that containinconsequential amounts of fish, such asWorcestershire sauce, are not the typesof foods that should come under thepurview of these regulations. It isdoubtful that they pose reasonablylikely hazards associated with their fishcomponents. Moreover, these productsare neither represented nor perceived asbeing fish-based foods.

The comments provided FDA with nobasis, however, upon which to select aspecific minimum content of fishingredient for the definition of ‘‘fisheryproduct.’’ There is no obvious minimumpercentage of fish on which to exempta food that contains only a smallamount of fish from the provisions ofthese regulations.

Instead, the agency accepts thecomment that, to meet the definition ofa ‘‘fishery product,’’ a food should becharacterized by the qualities of the fishthat it contains. Thus, these regulationswill apply to those foods whose basicnature is defined by the fish that theycontain. Accordingly FDA has modifiedthe proposed definition (§ 123.3(e)) toread in part, ‘‘Fishery product meansany edible human food product in


which fish is a characterizingingredient.’’ This revision will serve toensure that mandatory HACCPrequirements do not apply to productsthat contain inconsequential amounts offish from a public health standpoint.

31. One comment stated that fish oilthat is intended for use in human foodshould not be subject to therequirements of these regulations untilit has been separated, through initialprocessing, from the oil that will beused for animal feeds and otherindustrial purposes. FDA does not findthat the comment provided sufficientjustification to treat this productdifferently from other human foodproducts processed from fish. Theagency acknowledges that the hazardsassociated with these products may beminimal. If that is the case, the fish oilprocessor’s burden will also be minimal,perhaps limited to training expensesand the performance of a hazardanalysis. Moreover, these regulations donot apply to products that are not forhuman consumption and fish oilprocessors that are confident that theirproduction will not be used for humanconsumption need not apply therequirements of these regulations.

7. Food Safety Hazard32. A number of the comments

recommended that FDA define ‘‘safetyhazard’’ or ‘‘food safety hazard.’’ Severalof these comments recommended thatFDA adopt a definition that is consistentwith the NACMCF recommendeddefinition for ‘‘hazard.’’ The commentswere primarily concerned with thecoverage of these regulations. Theyurged that the regulations be clear thatonly food safety hazards need beaddressed by the HACCP plan andargued that a definition would help toaccomplish that.

The NACMCF definition of ‘‘foodsafety hazard’’ reads, ‘‘A biological,chemical, or physical property that maycause a food to be unsafe forconsumption.’’ While FDA provided nodefinition of ‘‘food safety hazard’’ in theproposed regulations, it did raise theissue of the coverage of the regulationsin proposed § 123.6(b) (redesignated as§ 123.6(c)), which mandated coverage offood safety hazards only and listed ninetypes of food safety hazards posed bythe various types of fish and fisheryproducts. This list included examples ofbiological, chemical, and physicalhazards. Additionally, the preamble tothe proposed regulations discussed atlength the significance of a number ofthese types of hazards.

FDA agrees that the meaning ascribedby the agency to a food safety hazardshould be as clear as possible in these

regulations. The examples of hazards inthe proposed regulations—and codifiedin these final regulations—areconsistent with the NACMCF definitionfor a food safety hazard. Therefore, forthe sake of clarity, FDA has decided tocharacterize these examples in adefinition § 123.3(f), which reads, ‘‘Foodsafety hazard means any biological,chemical, or physical property that maycause a food to be unsafe for humanconsumption.’’ The only differencebetween this definition and theNACMCF recommendation is theaddition of the word ‘‘human.’’ FDA hasincluded this word to prevent confusionabout the application of theseregulations to pet or animal feed.

In keeping with the new definition,and to provide further clarificationabout the nature of the hazards that arerequired to be addressed by theseregulations, the term ‘‘hazard’’ has beenchanged to ‘‘food safety hazard’’ whereit appears throughout the codifiedportion of this document.

8. HarvesterFDA proposed to define ‘‘harvester’’

as ‘‘a person who has an identificationnumber issued by a shellfish controlauthority for commercially takingmolluscan shellfish by any means froma growing area.’’ After review, theagency has concluded that it was notnecessary to limit ‘‘harvesters’’ to thosepersons who have an identificationnumber, primarily because in somejurisdictions, identification numbersmay not be issued by a shellfish controlauthority. Without this limitation, FDAhas concluded that there is no need toestablish a particular meaning for thisterm for the purposes of theseregulations. Therefore, the agency hasremoved this definition from the finalregulations.

9. ImporterFDA proposed to define ‘‘importer’’ as

‘‘a person, or his representative in theUnited States, who is responsible forensuring that goods being offered forentry into the United States are incompliance with all laws affecting theimportation.’’ The preamble to theproposed regulations explained that theimporter is the owner of the importedgoods or the owner’s representative inthe United States. The preamble furthernoted that freight forwarders, foodbrokers, food jobbers, carriers, andsteamship representatives would notusually be considered to be the importerof the product for the purposes of theseregulations because they are not usuallyin a position to make decisions that canensure the safety of the product.However, the preamble did not

categorically rule out that theseindividuals could be the importerbecause sometimes they may be in aposition to make decisions relevant tosafety.

33. Several comments stated that FDAshould modify the definition of‘‘importer’’ to specifically excludeintermediary agents involved in theimporting process, such as freightforwarders, licensed U.S. customsbrokers, food brokers, food jobbers,carriers, and steamship representatives.These comments noted that, althoughimported products may enter the UnitedStates under the name of anintermediary, this practice is done forconvenience in handling the paperworkat the port of entry. The commentsstated that the intermediary has littleresponsibility for conducting thenegotiations with an overseas producerand rarely takes possession of theproducts. Therefore, the commentsstated, the intermediary has limitedinfluence on the safety of the importedgoods. Two comments pointed out, forexample, that customs brokers thatprovide their clients with the service ofusing the broker’s customs bond arelisted as the ‘‘importer of record’’ andmay thereby, unintentionally, beregarded as importers under theproposed definition, even though theydo not own or control the product beingimported.

Conversely, two comments arguedthat agents, such as food brokers, shouldbe included in the definition of an‘‘importer’’ because they bring productinto the United States and sell it. Thecomments argued that the brokersshould, therefore, be held responsiblefor ensuring that the foreign processorcomplies with the provisions of theseregulations, to avoid an unfairadvantage over domestic processors.

FDA concludes, based on theinformation provided in the comments,that these intermediaries can neither becategorically included or excluded.However, the agency recognizes that thenumber and type of comments on thisissue demonstrate that the language ofproposed § 123.3(h) was inadequate toconvey the agency’s intent, asarticulated in the preamble. For thisreason, FDA has clarified the definitionof ‘‘importer’’ in § 123.3(g) to read, inpart:

Importer means either the U.S. owner orconsignee at the time of entry into the UnitedStates, or the U.S. agent or representative ofthe foreign owner or consignee at the time ofentry into the United States, who isresponsible for ensuring that goods beingoffered for entry into the United States are incompliance with all laws affecting theimportation.


Reference to the owner or consignee ofthe imported goods parallels thelanguage in section 801 of the act (21U.S.C. 381).

Because the ownership of importedproducts can change many times in arelatively short period of time afterentry, the party who is the owner orconsignee at the time that theseproducts are offered for entry must beidentified as the importer. As the personthat has the ability to decide whether tooffer the product for entry, this personis in a position to ensure that theproduct is processed under appropriatecontrols and to demonstrate this fact toFDA.

FDA must be able to verify theexistence of the evidence of complianceby the foreign processor. This evidence,according to the provisions of § 123.12,is to be in the possession of the‘‘importer.’’ It must be available in theUnited States, however, if FDA is toconsider the information in decidingwhether to admit the products. Thus,where products are offered for entry bya U.S. owner or consignee, that owneror consignee will, for purposes of theseregulations, be considered the importerbecause it will have control of thisevidence. Where products are oftenoffered for entry without a U.S. owneror consignee, the U.S. agent of theforeign owner or consignee will beconsidered the ‘‘importer’’ for purposesof these regulations to make clear whowill be expected to have this evidencefor such products.

FDA recognizes that the U.S. owner orconsignee of the product, or the U.S.representative of the foreign owner orconsignee, at the time of entry into theUnited States may also serve otherfunctions. For example, it may also bea food broker for, or warehouser orprocessor of, the product. It may, insome instances, also be the freightforwarder, customhouse broker, orcarrier for the product. These otherfunctions will not matter, however, ifthe person is the U.S. owner orconsignee of the product, or the U.S.representative of the foreign owner orconsignee, at the time of entry into theUnited States. From FDA’s experience,while certainly not impossible, it is atleast unlikely that this qualification willbe met by the customhouse broker, thefreight forwarder, the carrier, or thesteamship representative.

The agency has attempted to clarifythis definition by including a sentencethat reads, ‘‘For the purposes of thisdefinition, ordinarily the importer is notthe custom house broker, the freightforwarder, the carrier, or the steamshiprepresentative.’’ Further, FDA does notintend to rely exclusively upon the

assignment of the ‘‘Importer of Record’’or the holder of the U.S. Customs SuretyBond in determining the ‘‘importer’’ forthe purposes of these regulations, as wassuggested in the preamble to theproposed regulations. In some instancesthe ‘‘Importer of Record’’ or the holderof the U.S. Customs Surety Bond willnot meet the qualifications of animporter that are set out in § 123.3(g).

10. Lot of Molluscan ShellfishFDA proposed to define a ‘‘lot of

molluscan shellfish’’ as ‘‘a collection ofshellstock or containers of shellstock ofno more than 1 day’s harvest from asingle, defined growing area harvestedby one or more harvesters.’’ Because oflanguage changes that FDA has made insubpart C of part 123, this term isnolonger used in the regulations.Consequently, FDA has decided thatthere is no need to define this term andhas eliminated the definition.

11. Molluscan Shellfish34. Comments from a number of State

agencies, trade associations, seafoodprocessors, and the ISSC objected to theuse of the term ‘‘fresh or frozen’’ in theproposed definition of ‘‘Molluscanshellfish.’’ The comments wereconcerned because this definitionwould have the effect of exemptingcanned and any other heat-processedmolluscan shellfish from the sourcecontrol, recordkeeping, and taggingprovisions of proposed subpart C of part123 and proposed § 1240.60(b).

The comments stated that limitingthese provisions to raw products wouldallow foreign firms to continue to heat-treat or can molluscan shellfish that areharvested from foreign waters that donot meet National Shellfish SanitationProgram (NSSP) standards and to exportthem to the United States. Thecomments stated that this situation wasnot in the best interest of the publichealth because of the potential for thepresence of heat-stable natural toxins,such as paralytic shellfish poison oramnesiac shellfish poison, as well aschemical contaminants. The commentsalso complained that, because Statelaws and regulations require that allmolluscan shellfish harvested in theUnited States come from watersapproved by a shellfish controlauthority regardless of whether they areto be consumed raw orcooked,continuing to allow foreignprocessors who export cooked shellfishto the United States to use molluscanshellfish from unapproved growingwaters places the domestic shellfishindustry at a competitive disadvantage.

FDA believes that these comments aregenerally valid but are beyond the scope

of this rulemaking. The point of thisrulemaking it to determine whetherFDA should require that HACCP befollowed in the processing of seafood.The question of whether cookedmolluscan shellfish that is being offeredfor import into this country is beingharvested in a manner that createspublic health concerns and unfaircompetitive advantages is a separatematter that the agency will address, ifnecessary, in the future.

Similar issues with respect to the useof the term ‘‘fresh or frozen’’ and theterm ‘‘raw’’ in proposed subpart C ofpart 123 of these regulations and inproposed part 1240 are discussed in the‘‘Molluscan Shellfish’’ section of thispreamble (see comment 144).

12. Potable Water

FDA proposed to define ‘‘potablewater’’ as ‘‘water which meets the U.S.Environmental Protection Agency’sPrimary Drinking Water Regulations asset forth in 40 CFR part 141.’’ Becauseof changes that the agency has made inproposed § 123.10 (redesignated as§ 123.11), the term is no longer used inthese regulations. Consequently, FDAhas eliminated the definition.

Nonetheless, a significant number ofcomments questioned when it would benecessary for processing water to meetthe definition of ‘‘potable water.’’Because it is likely that both terms (i.e.,processing water and potable water) willbe used in the first edition of the Guide,FDA will consider these commentsduring the redrafting of the Guide.

13. Preventive Measure

FDA has added a definition for theterm ‘‘preventive measure’’ at § 123.3(i).Although the term was not used in theproposal, the concept of preventivemeasures was a fundamental part of thehazard analysis that was implicit inproposed § 123.6(b). ‘‘Preventivemeasure’’ is used in the final regulationsin § 123.6(a) in the description of ahazard analysis.

FDA proposed to require that allprocessors create a HAACP plan. Basedon comments received, however, asexplained below, FDA has decided torequire that processors conduct hazardanalyses to determine whether theyneed to develop a HACCP plan. Thisdecision necessitates that FDA define‘‘preventive measure.’’ In accordancewith the recommendations of theNACMCF (see Ref. 34, p. 189), a hazardanalysis must identify both the foodsafety hazards that are reasonably likelyto occur and the preventive measuresthat are available to the processor tocontrol such hazards.


Identifying the preventive measures isnecessary in order to determine whethera processing step is a CCP for thathazard. A processing step cannot be aCCP for a hazard if no preventivemeasure is available at that step tocontrol the hazard. The definition of‘‘preventive measure’’ in theseregulations is essentially the same asthat recommended by the NACMCF.

14. Process Monitoring Instrument

The term ‘‘process controlinstrument’’ was used in the proposalfor consistency with the phrase ‘‘theprocedures * * * that will be used tocontrol and monitor each of the criticalcontrol points.’’ For consistency withthe NACMCF principles of HACCP,FDA has modified the language of§ 123.6(c)(4) to eliminate the word‘‘control.’’ In order to achieveconsistency within these regulations,the agency has concluded that theappropriate term for such instrumentsis, therefore, a ‘‘process monitoringinstrument.’’

15. Processing and Processor

Along with the term ‘‘importers,’’ theterms ‘‘processor’’ and ‘‘processing’’collectively define who is subject tothese regulations.

FDA proposed to define ‘‘processing’’ as:[W]ith respect to fish or fishery products,

handling, storing, preparing, heading,gutting, shucking, freezing, changing intodifferent market forms, manufacturing,preserving, packing, labeling, or holding.Practices such as heading or gutting intendedsolely to prepare a fish for holding on boarda harvest vessel are excluded. This regulationdoes not cover the operation of a retailestablishment.

FDA proposed to define ‘‘processor’’ as:[A]ny person engaged in commercial,

custom, or institutional processing of fish orfishery products, either in the United Statesor in a foreign country. Persons engaged inthe production of foods that are to be usedin market or consumer tests are alsoincluded. Persons who only harvest ortransport seafood, without otherwiseengaging in processing, are not covered bythese regulations.

a. Vessels, carriers, and retail. Asexplained in the preamble to theproposed regulations, the definitions of‘‘processor’’ and ‘‘processing’’ excludedfishing vessels that essentially onlyharvest, transportation companies thatcarry but do not otherwise process fishand fishery products, and retailestablishments. FDA invited commenton these exclusions.

In the preamble, FDA acknowledgedthat food safety hazards can beintroduced at these three points in thecommercial distribution chain.However, FDA tentatively decided to

exclude fishing vessels, carriers, andretailers from the definition of‘‘processor’’—and thus from directcoverage under these regulations—because of practical considerations,such as the fact that the large size of theU.S. fishing fleet and the large numbersof carriers and retailers wouldoverwhelm any rational Federalinspection system, and because theagency believed that the public healthgoals of the regulations could still bemet.

FDA expressed its tentative view thatthe HACCP regulations would affectfishing vessels and carriers indirectlythough the controls that processorsimpose to meet their obligations underHACCP. As for retail establishments, thepreamble explained that, historically,they have been the regulatoryresponsibility of State and localgovernments. FDA traditionally hasprovided support through training,technical assistance, and thedevelopment of model codes. Since theissuance of the proposal, FDA haspublished its retail and institutional‘‘Food Code,’’ with the recommendationthat it be adopted by State and localjurisdictions. The Food Code covershandling and receiving practices atretail, and its most recent versionincludes HACCP elements.

FDA’s approach to these issues isbased on agency discretion and does notderive from a lack of statutory authority.FDA has broad authority to regulateFood that is shipped in interstatecommerce. While carriers are exemptfrom most direct FDA regulation inaccordance with section 703 of the act(21 U.S.C. 373), the food beingtransported is not exempt. Moreover,FDA has authority under the PublicHealth Service Act (the PHS Act) (42U.S.C. 264) to take such measures as itdeems necessary to prevent theintroduction, transmission, or spread ofcommunicable disease from foreigncountries into the States or from oneState or possession into any other Stateor possession.

FDA received a significant volume ofcomment on the question of coverage bythese regulations of fishing vessels,carriers, and retail establishments. Themajority of comments strongly favoredinclusion of these entities within thescope of the these regulations.

35. The arguments relating to vesselsand carriers tended to overlap. Thosewho favored inclusion noted thathazards—particularly those associatedwith time-temperature abuse andinsanitation—can originate with fishingvessels and carriers. The commentsargued that not controlling theconditions under which seafood is

harvested and transported wouldamount to leaving CCP’s unregulated.One comment observed that carriershave an incentive to turn offrefrigeration units to save gas.

Several comments expressed the viewthat exclusion of vessels and carriersfrom the coverage of these regulationsunfairly makes processors responsiblefor these aspects of seafood production.One comment pointed out that vessels,especially those that harvest scombroidtoxin-forming species, should be legallyresponsible for any safety hazards thatthey cause through improper handling.Some comments asserted that HACCPcan be practiced on fishing vessels andby carriers, at least with regard totemperature controls.

One State agency expressed the viewthat holding processors responsible forthe behavior of fishing vessels has, in itsexperience, not worked, nor haseducation of fishing vessel owners orvoluntary compliance by owners. Thecomment did not document the basis forthese conclusions, however. Somecomments argued that, while it wouldbe difficult to include all vessels andcarriers, those involved with high-riskproducts should be included.

Comments in favor of excludingvessels and carriers from these HACCPregulations noted that FDA’s rationalefor exclusion was prudent given thenumber, location, and diversity of theU.S. fishing fleet and the complexity oftransport arrangements. For carriers, onecomment noted that partial loads thatare dropped off in different locationswould be especially difficult to control.Some comments asserted that directregulation of these entities was notnecessary because processors couldestablish minimum requirements as acondition of purchase, as part of theirHACCP systems. Some comments urged,however, that fishing vessels be subjectto HACCP requirements when theydeliver directly to an entity that is notsubject to these regulations (e.g., arestaurant). One comment argued thatreceiving firms should require thatproduct be in the same condition that itwas in when it left the previousprocessor.

Some comments questioned theability of fishing vessels and carriers tocomply with HACCP requirements. Anumber of comments favoredalternatives to HACCP, such asguidelines and standard operatingprocedures (SOP’s).

FDA is impressed by the strongsupport for inclusion, of fishing vesselsand carriers in the coverage of theseregulations. Some of this support wasbased on concern over the loss ofquality because of poor handling


practices (e.g., the effect of time-temperature abuse on shelf life andspoilage unrelated to safety) rather thanon food safety considerations.Nonetheless, members of these twoindustries should be aware thatsignificant concerns have beenexpressed with regard to their practices.

For some species and products, thepractices of fishing vessels andtransporters can have significant publichealth consequences. These practicescan put pressure on a processor who isreceiving these products to carefullyscrutinize the condition of incomingmaterials. The practices can also putpressure on a processor to determinewhether carriers are suitable to transporttheir finished products (e.g., thatcarriers have proper refrigeration).

The agency appreciates the argumentthat all entities that can affect safety inthe distribution chain should accept andshare this responsibility. These pointsnotwithstanding, FDA received nocomment that provided informationabout how the agency could operate aninspection program for carriers andharvest vessels with its currentresources. For this reason, the agencyconcludes that such a program isimpractical at this time.

When processors accept raw materialsfor processing, especially from vessels,they assume some responsibility for thecondition of the incoming materials,regardless of how others are regulated.This is true under both generalcommercial law and the lawsadministered by FDA. Carriers likewisehave responsibilities. If a carrier fails toexercise such controls as are necessary,food that it carries may be renderedadulterated and the owner of theproduct, i.e., the processor, could sufferproduct loss. Food handlers generallyshould exercise sufficient control overthe products in their custody to ensurethat any food safety hazards that arereasonably likely to occur during thatperiod are being addressed.

As an additional matter, FDA agreeswith those comments that advocated astep-wise regulatory approach to theseentities.

Mandatory HACCP for seafood is apioneering venture. While thegroundwork has been prepared for itthrough pilot projects and other effortsover the years, there is no substitute foractual experience once it is operating.The agency would prefer, therefore, toconstruct the system through a series ofmanageable steps if it needs to do so,rather than to risk overextending itselfand the system initially. While theseregulations exempt carriers and harvestvessels from direct coverage, experiencewith the application of a mandatory

HACCP program may, at some laterdate, cause the agency to reconsider itsapproach.

For fishing vessels, FDA intends, forthe time being, to issue good handlingpractice guidelines. To that end, theagency is studying those issued by theState of Alaska and by the CodexAlimentarius Commission of the Foodand Agriculture Organization/WorldHealth Organization, among other suchavailable guidance. FDA will evaluatethe effect of these guidelines, inaddition to any requirements that Stateshave or may adopt regarding fishingvessel practices, and reassess at a laterdate whether there is a need formandatory Federal controls. The agencyinvites continued correspondence andthe sharing of views on this matter.

The comments that recommendedthat vessels that sell directly to ‘‘non-HACCP’’ establishments (e.g.,restaurants) should be required to haveHACCP plans are advised that the FoodCode addresses the subject of sourcecontrol for retail establishments andrecommends the requirement of HACCPplans for retail establishments in somecircumstances. This matter relatesprincipally to State and local laws andis addressed below in the discussion ofretail establishments.

For carriers, the situation iscomplicated by the restriction in section703 of the act that was describedpreviously. As one commentrecommended, FDA has hadconversations with other Federalagencies on the subject of transportationof food and will continue to do so. Inthe meantime, FDA stronglyrecommends that processors review thematerial in the Guide on how they canexercise control over incoming rawmaterials as well as over shipments oftheir own products. One emerging areathat the agency is monitoring—andprocessors should consider also—is thedevelopment of inexpensive time-temperature sensors that indicatewhether proper temperatures have beenmaintained over a period of time.

36. The question of the inclusion ofretail establishments within themandatory seafood HACCP systeminvolves some different considerations.Processors have less influence, if any,over how their products are handled atretail than they do over how theirproducts are handled by vesseloperators or carriers. Some commentspointed out, for example, that aprocessor’s best efforts could be fornaught if the product is subsequentlymishandled at retail.

Several comments pointed out thatmany retail establishments carry outactivities that meet the definition of

‘‘processing.’’ According to thesecomments, such establishments shouldnot be exempt from HACCPrequirements.

Other comments took the view thatthese regulations should not apply toretail establishments, primarily for thereasons provided in the preamble to theproposal. Some recommended that retailestablishments should not be subject tothe regulations so long as the Food Codeapplies to them. Others suggested thatHACCP should apply if the retailestablishment buys directly from afishing vessel or from sport fishermen.Some suggested better consumereducation and voluntary HACCP-typeprograms.

FDA agrees that there are hazards thatoccur at the retail level that can rendermeaningless the controls that may havebeen in place elsewhere in the chain ofproduction and distribution. The NAShas cited retail and food serviceestablishments as sources of seafood-related illnesses (see Ref. 7, p. 27). FDAis convinced—and the commentssupport—that proper controls at theretail level are imperative to ensuring asafe product.

Nonetheless, FDA’s observation in thepreamble to the proposed regulationsremains valid that retail establishmentspose an inspection burden well beyondthe capacity of FDA. No comments haveprovided any basis for the agency toconclude otherwise or would justify thesignificant shift of resources that wouldbe necessary for FDA to even begin toaddress the retail sector in a meaningfulway. FDA notes that State and localgovernments provide significantregulation of the retail food sector. FDAhas committed the resources that it hasavailable for addressing retail problems,by providing training and technicalassistance to State and localgovernments. Most significantly, FDAhas provided guidance in the form ofthe Food Code, which provides thelatest and best scientifically basedadvice about preventing foodborneillness for adoption by thosejurisdictions that have regulatoryresponsibility for food service, retail,and vending operations.

It is worth noting that the Food Codesuggests the use of HACCP controls atretail in some circumstances wherecomments argued for such controls aspart of these regulations. Under theregulatory controls suggested in theFood Code, a retail establishment thatpurchases a scombroid toxin formingspecies of fish from a recreationalharvester, for example, would need aHACCP plan relating to how it willensure that fish had been handled so asto avoid time-temperature abuse. Under


the Food Code, fish caughtrecreationally generally require theapproval of a regulatory authority inorder to be sold to a retailestablishment. The States should beaware that the Food Code is responsiveto concerns raised by comments in theserespects. FDA urges the States toconsider adopting the Food Code forretail and institutional operations.

It is worth noting that the Food Codeapplies HACCP requirements to retailestablishments as an exception forextreme situations, rather than as therule. There is still much to be learnedabout the application of HACCP to retailestablishments. Also, it may not be wiseto single out seafood for the applicationof HACCP at retail. Retail operations canbe complex and involve the handling ofmany types of foods. Trying to operatea HACCP system solely for seafoodcould divert attention away fromimportant safety practices for high-riskproducts other than seafood.

For all these reasons, therefore, theagency concludes that FDA should notmandate HACCP systems for the seafoodcomponent of retail establishments atthis time. Also, the agency has not beenprovided with any information on howan FDA inspection program for suchestablishments would be feasible.Nonetheless, the agency will take allcomments on retail establishmentsunder advisement for futureconsideration as the system evolves.

It is important to note, however, thatwhere a processor engages in mixedoperations (i.e., some retail and somewholesale), as in the case of cash-and-carry warehouses noted by one of thecomments, the wholesale portion of theoperations will be subject to theprovisions of these regulations. As afurther point of clarification in responseto one comment, FDA has traditionally,and will continue to, classify centralkitchens that distribute product to retailoutlets that are owned by the same firmas a retail operation.

b. Warehouses. In the preamble to theproposed regulations FDA stated thatthe definition of ‘‘processor’’ includedwarehouses. Warehouses store fish andfishery products, one of the operationsincluded in the proposed definition of‘‘processing.’’ A ‘‘processor’’ is simplyan entity that engages in processing.

There are food safety hazards that canbe introduced while storing a product(e.g., in a warehouse). These hazardsinclude, among other things, pathogengrowth in cooked, ready-to-eat productsand histamine development inscombroid toxin-forming species, as aresult of improper storage temperatures.Nonetheless, the warehouseenvironment usually has few hazards

compared to complex processingoperations. Consequently, the preambleto the proposed regulations invitedcomment on whether warehousesshould be exempted from the definitionof ‘‘processor’’ and, by implication,whether ‘‘storing’’ should not beincluded in the definition of‘‘processing,’’ as one way of scaling theregulations back in terms of cost andburden.

37. The comments split about evenlyon this subject. Those that gave a reasonfor including warehouses cited the needto monitor storage temperatures forspecies that are prone to safety hazardsif they are temperature abused. Thosethat opposed and provided a reasontended to argue that storage aloneshould not subject an establishment tothe requirements of the regulations. Arelated concern was the view thatwarehouse operators do not have athorough knowledge of the productsthat they handle and only store productsthat are provided to them by others.This concern was expressed both bythose who objected to the inclusion ofwarehouses and those who simplyasked for clarification about the role ofwarehouses. Others who asked forclarification expressed the view thatwarehouses could be responsible forconditions during storage.

After consideration of thesecomments, FDA has decided to retainwarehouses (e.g., public storagewarehouses, foodservice distributionwarehouses, and wholesale grocers)within the definition of ‘‘processor’’ andto retain ‘‘storing’’ within the definitionof ‘‘processing.’’ It is important torecognize that section 402(a)(4) of theact covers storage along with otherforms of processing. It states that aproduct is adulterated if it is ‘‘prepared,packed, or held under unsanitaryconditions * * * whereby it may havebeen rendered injurious to health.’’These regulations are being issued forthe efficient enforcement of section402(a)(4) of the act. Moreover, asdescribed above, hazards can beintroduced as well as controlled duringstorage. HACCP is an appropriatesystem for the control of these hazards.

FDA believes that the burden onwarehouses will be minimal given thesimplicity of the operation and the factthat, in most cases, a warehouseman’sresponsibility under HACCP will onlyextend to conditions within thewarehouse that could cause a safetyhazard to occur.

For the most part, hazards derivingfrom the environment (pesticides, etc.)will be controlled during the initialprocessing of the product (i.e., by thefirst processor to take possession). As a

result, subsequent processors willreceive products that are generally freeof environmental hazards and thus willnot need to establish HACCP controlsfor them. More often than not, storingwill not be the first processingoperation. Thus, a warehouse will notusually be responsible forenvironmental hazards. The sameprinciple holds true for hazards arisingduring processing operations that occurbefore storage in a warehouse. Thosehazards must be controlled during theprior processing and generally notduring storage.

There may be occasions, however,when storage is the first processingoperation (e.g., when a warehouse willbe the first processor to receive rawmaterial fish from a fisherman oraquacultural producer). Under thesecircumstances, the warehouse, ratherthan a distant owner of the product,may be in the best position to obtaininformation that may be needed aboutharvest site, fishing practices, andtransportation to the dock that would begermane to safety. There should be somearrangement between the warehouseand the owner on this matter to ensurethat environmental hazards are properlyaddressed.

38. One comment objected to theinclusion of storage within thedefinition of processing on the groundsthat FDA should not dictate whereCCP’s should be.

The agency is not attempting to do so.FDA acknowledges that whether storageis a CCP will depend on thecircumstances. For example, refrigeratedstorage of a scombroid species willlikely be designated as a CCP, whereasdry storage of canned fish will not likelybe considered as such.

39. Another comment objected toincluding ‘‘airline warehousing’’ withinthese regulations.

If airlines hold product as part of theirusual course of business as carriers, theyare exempt from having HACCP plans inaccordance with section 703 of the act.

c. Other processing operations. 40. Afew comments requested clarification onwhether waterfront facilities that unloadvessels and pack the catch for shipmentto buyers are engaging in processing andthus meet the definition of ‘‘processor.’’

These firms perform activities such ashandling and storing that are includedin the definition of processing and fallwithin the purview of the ‘‘prepared,packed, or held’’ clause of section402(a)(4) of the act. Additionally, theseactivities warrant coverage under theseregulations because of their relationshipto reasonably likely hazards. Forexample, these firms are, by design,usually the first processors to receive


the product from the fisherman oraquacultural producer. As such, they areoften in the best position to controlenvironmental hazards, as waspreviously discussed. They also oftenstore the product, at least for shortperiods of time. In this capacity, theymay be responsible for ensuring that theproduct is not exposed to time-temperature abuse, a phenomenon thatcritically affects the safety of someproducts.

For these reasons, FDA has clarifiedthe definition of ‘‘processing’’ atproposed § 123.3(m) (redesignated as§ 123.3(k)) to specifically includedockside unloading.

41. One comment took the view thatonly processors who own the productsthat they are processing should besubject to these regulations andsuggested that the term ‘‘processor-owner’’ be substituted for ‘‘processor.’’Several other comments questionedwhether custom processors that do notown the product, should be subject tothe provisions of these regulations.

The definition of ‘‘processor’’ doesnot hinge on ownership. As indicatedearlier, whether a product is adulteratedunder section 402(a)(4) of the actdepends on the condition under whichit was ‘‘prepared, packed, or held.’’Ownership is not a relevant factor.Consistent with this principle, theseregulations define a processor as simplyan entity that engages in processing.‘‘Processing’’ is defined as including anumber of activities, such asmanufacturing and packing, that arenormally performed by a custom packer.

Like warehouses that store productsfor distant owners, custom packers areoften in the best position to exerciseHACCP controls for the products thatthey process. Because of the real-timenature of HACCP (i.e., becausemonitoring provides immediatefeedback as to whether a hazard is beingcontrolled), the processor can mosteffectively apply HACCP monitoringcontrols to a food being processed,regardless of whether the processor isthe actual owner of the food. FDArecognizes that it will often be beneficialfor the custom processor and the ownerof the product to fully discuss and agreeupon the HACCP controls that will beeffected by the custom processor whilethe product is in its possession.

42. One comment argued that custompackers should be included within thescope of these regulations because theseprocessors often can or smokerecreationally caught products and areoften the only commercial entity thatcan assure the safety of such products.While the definition of ‘‘processing’’clearly covers the kinds of activities

performed by custom packers, it is notthe intent of these regulations to addressarrangements between a recreationalfisherman and a custom packer for theprocessing of fish for the personal useof the fisherman. The regulations onlycover custom packing that is performedon behalf of an owner who intends tointroduce the fish into interstatecommerce. Nonetheless, the agencydoes not believe that clarification to theregulations is needed on this point.

43. One comment urged thataquacultural producers that alsoeviscerate the fish before delivery to aprocessing plant be required to complywith the requirements of theseregulations.

FDA agrees with the comment andfurther states that the process ofeviscerating is specifically included inthe definition of ‘‘processing.’’Eviscerating is excluded from thedefinition only when it occurs on aharvest vessel for the purpose ofpreparing the fish for holding en routeto the processor.

44. A few comments objected to FDAincluding labeling in the definition of‘‘processing.’’ The comments arguedthat labeling operations are unlikely tointroduce hazards to the product. FDAhas considered these comments butfinds that there is potential during somelabeling operations for the developmentof hazards. For example, improperlycontrolled labeling operations forscombroid species could result in time-temperature abuse of the product,increasing the risk of histaminecontamination. Cooked, ready-to-eatproducts could similarly be subjected totime-temperature abuse, resulting in thepotential for pathogen growth. Theinclusion of labeling in the list ofprocessing operations is not intended toimply that this step should always, oreven frequently, be considered a CCP.That can only be determined throughthe conduct of a hazard analysis.

FDA proposed to exempt ‘‘heading orgutting intended solely to prepare a fishfor holding on board a harvest vessel’’from the definition of ‘‘processing.’’ Indrafting the proposed regulations, FDAwas concerned that, in the absence ofsuch an exemption, harvest vessels thatare presently heading or gutting fishwould stop the practice to avoid beingsubject to the requirements of theseregulations. FDA did not want aninadvertent consequence of theseregulations to be a reduction in productquality. In addition, FDA tentativelyconcluded that safety hazardsintroduced by these operations aregenerally minimal.

45. One comment noted that FDAshould include the practice of freezing

fish on harvest vessels in the list ofexempted operations.

FDA agrees that freezing is anoperation that is routinely used onboarda harvest vessel in order to preserve thequality of the fish until it is landed forfurther processing (e.g., freezingperformed onboard tuna harvestingvessels). For this reason, the agency hasrevised the definition of ‘‘processing’’ toinclude an exemption for onboardfreezing.

46. One comment suggested that FDAalso exempt onboard scallop shuckingoperations.

Unlike shucking other molluscanshellfish, shucking scallops involveseviscerating, a procedure that fallswithin the exemption in § 123.3(k).Consequently, onboard shucking ofscallops does not constitute processingfor purposes of these regulations. Theagency does not believe that a change inthe definition is necessary in thisregard.

47. One comment suggested that, withrespect to molluscan shellfish,‘‘processors’’ should include shellfishshippers, reshippers, shucker-packers,repackers, and depurators.

The persons that perform all of thesetypes of operations are ‘‘processors’’under § 123.3(k)(1) and subject to theprovisions of these regulations. Thus,the agency has concluded that nochange in the definition is necessary.

16. Scombroid Toxin-Forming SpeciesThe term ‘‘scombroid toxin-forming

species’’ appears in § 123.6(c)(1)(vi) ofthis final rule. While FDA did notpropose to define this term in thecodified portion of the proposedregulations, it did propose to define itin part 123 appendix B as:

[T]una, bluefish, mahi mahi, mackerel,sardines, herring, kahawai, anchovies,marlin, and other species, whether or not ofthe family Scombridae, in which significantlevels of histamine may be produced in thefish flesh by decarboxylation of free histidineas a result of exposure of the fish aftercapture to temperatures that permit thegrowth of mesophilic bacteria.

Appendix B of part 123 is no longerincluded in these regulations, as isdiscussed elsewhere in this preamble.Consequently, FDA is transferring thedefinition from part 123 appendix B to§ 123.3(m) to clarify the meaning of§ 123.6(c)(1)(vi).

48. A number of comments objectedto the inclusion of herring in the list ofscombroid toxin-forming species,arguing that there has been noassociation between herring and cases ofhistamine poisoning.

In response to the comments, FDA hasmodified the definition of scombroid


toxin forming species to make specificreference to only tuna, bluefish, andmahi mahi, since the overwhelmingmajority of scombroid poisonings areassociated with these types of fish.Processors should assess the potential ofother species to product histamine. Thekey to the definition is whethersignificant levels of histamine may beproduced in the flesh of the fish.

17. Shellfish Control AuthorityFDA proposed to define ‘‘shellfish

control authority’’ as ‘‘a Federal or Statehealth authority, or foreign governmenthealth authority, legally responsible forthe administration of a program thatincludes classification of molluscanshellfish growing areas, enforcement ofharvesting controls, and certification ofmolluscan shellfish processors.’’

49. A few comments pointed out thatthe definition should not require that ashellfish control authority be a State‘‘health’’ authority because in someStates the responsibility is vested inother than a health agency, such as aresource management agency.

FDA recognizes that these commentsare correct. For this reason, the agencyhas modified the language in § 123.3(o)to read, in part, ‘‘State agency.’’ FDAbelieves that this term is sufficientlybroad to encompass any of the presentState arrangements. FDA has made aparallel change with respect to foreigngovernment authorities, in order toaccommodate the same kind ofvariations in regulatory arrangements.These final regulations similarly refer toa ‘‘foreign agency.’’

50. One comment, from a Stateregulatory agency, stated that within theUnited States, FDA should be theresponsible shellfish control authorityand should mandate that processorsregister with FDA, much as it has donewith low-acid canned foods andmedical devices. The comment furtherstated that a requirement in Federalregulations that State agencies performthis function may be unconstitutional.

The comment misconstrued theprovision. The provision is intended todefine the term ‘‘shellfish controlauthority’’ rather than to providesubstantive requirements. Furthermore,these regulations at no point mandatethat States perform certain functions.

51. Some comments expressedconcern that the proposed definition of‘‘shellfish control authority’’ was toonarrow in that it did not include anyentities that could serve the function ofa shellfish control authority for Federalwaters. The effect of the proposal, thecomments pointed out, would be toclose unnecessarily all molluscanshellfish harvesting in Federal waters.

It was never FDA’s intent to closeFederal waters to molluscan shellfishharvesting. These waters are beyond thejurisdiction of State shellfish controlauthorities, and no Federal agencyclassifies them in the same way thatStates classify their own waters. FDA isseeking a means to classify Federalwaters. An agreement with NMFSrelating to the classification of Federalwaters is one possible solution. For thisreason, FDA has modified proposed§ 123.3(o) to state that a shellfish controlauthority may be ‘‘a Federal agency.’’This subject is also discussed in the‘‘Molluscan Shellfish’’ section of thispreamble.

52. One comment urged that FDAprovide for the possibility of sovereigntribal governments serving as shellfishcontrol authorities.

FDA recognizes that the proposeddefinition was deficient because it failedto include tribal governments in the listof possible shellfish control authorities.The agency, the State of Washington,and 19 Indian tribes have recentlyentered into a settlement that will likelyresult in such an arrangement in theState of Washington (Ref. 202). Whensuch governments meet the necessarycriteria, it is the intent of the agency toformally recognize them for purposes ofclassifying shellfish growing waters andcertifying shellfish processing plants forinclusion on the Interstate CertifiedShellfish Shippers List. To provide forthis situation, FDA has modified thedefinition of ‘‘shellfish controlauthority’’ to include ‘‘sovereign tribalgovernments.’’

FDA has also recognized that in manycases the functions of ‘‘classification ofmolluscan shellfish growing areas,enforcement of harvesting controls, andcertification of molluscan shellfish,’’ aslisted in the proposed regulations, arenot carried out by a single agency. Toprovide for such a situation, FDA hasmodified the proposed language at§ 123.3(o) to read, ‘‘program thatincludes activities such as,’’ rather thansimply ‘‘program that includes.’’

18. Smoked and Smoke-FlavoredFishery Products

The terms such as ‘‘smoked fisheryproducts,’’ ‘‘smoked fish,’’ ‘‘smoked andsmoke-flavored fishery products’’ wereused in the proposed regulations andthroughout appendix 1 to the proposal.As a result of decisions discussedelsewhere in this preamble, reference to‘‘smoked and smoke-flavored fisheryproducts’’ has been eliminated in theseregulations except in part 123, subpartB.

While no definition of ‘‘smoked andsmoke-flavored fishery products’’ was

included in the definitions section ofthe proposed regulations, the terms‘‘smoke-flavored fish’’ and ‘‘smokedfish’’ were separately defined inappendix 1 to the proposal as:‘‘Smoked-flavored fish means fish thatis prepared by treating it with salt(sodium chloride) and then imparting toit the flavor of smoke by other than thedirect action of smoke, such asimmersing it in a solution of liquidsmoke,’’ and ‘‘Smoked fish means fishthat is prepared by treating it with salt(sodium chloride) and then subjecting itto the direct action of smoke fromburning wood, sawdust, or similarmaterial.’’ FDA solicited comment onthe materials in appendix 1. Because theterm is used in these final regulationsand FDA is concerned that there may beconfusion about its application, theagency has determined that a definitionof ‘‘smoked and smoke-flavored fisheryproducts’’ is needed in the codifiedportion of these regulations. FDA hasincluded one at § 123.3(s) that isconsistent with those proposed in theappendix 1 to the proposal. Section§ 123.3(s) reads:

Smoked or smoke-flavored fishery productsmeans the finished food prepared by: (1)Treating fish with salt (sodium chloride), and(2) subjecting it to the direct action of smokefrom burning wood, sawdust, or similarmaterial and/or imparting to it the flavor ofsmoke by a means such as immersing it ina solution of wood smoke.

FDA received numerous comments onthe regulatory treatment of smoked andsmoke-flavored fishery products, butnone that would affect this definition.

E. The HACCP PlanApproximately 100 comments

addressed one or more of the provisionsof proposed § 123.6. This section of theproposed regulations set out who mustwrite and implement a HACCP plan,and what the HACCP plan mustinclude.

1. Preliminary StepsFDA proposed in § 123.6 to require

that all processors of fish and fisheryproducts prepare and implement aHACCP plan that identifies the hazardsthat are reasonably likely to occur andthus that must be controlled for thatproduct. In the proposal, FDAacknowledged the processrecommended by the NACMCF fordeveloping a HACCP plan but did notpropose to require that processorsfollow it. The process recommended bythe NACMCF includes: Assembling aHACCP team, describing the food andits distribution, identifying the intendeduse and consumers of the food,developing a flow diagram, verifying the


flow diagram, and performing a hazardanalysis (Ref. 34, pp. 187–188). All butthe last of these have been identified byNACMCF as the ‘‘five preliminarysteps’’ of HACCP.

It was, and still is, the agency’s beliefthat processors would benefit from aprocess that included these five steps aswell as a hazard analysis in order tosuccessfully arrive at an appropriateHACCP plan. Nonetheless, the agencydid not propose to require adherence tothe ‘‘five preliminary steps,’’ orexplicitly propose to require that ahazard analysis be performed. So longas the processor had, in the end, aHACCP system that was appropriate forspecies and process, and was beingimplemented effectively, the agencytentatively concluded that theseregulations did not need to manage theprocess any further.

53. A number of the commentscontended that FDA should require thatfirms adhere to these procedures inpreparing a HACCP plan. Specifically, afew comments argued that the proposedrule significantly diminished thepotential effectiveness of HACCP by notrequiring that processors engage in the‘‘five preliminary steps.’’ The commentsargued that inclusion of the preliminarysteps would facilitate international tradeand reduce confusion on the part ofseafood importers and exporters throughconsistency with an internationallyrecognized standard for HACCP.

Several other comments urged thatthe NACMCF recommendation for thedevelopment of a process flow diagram,in particular, by a processor be mademandatory. These comments identifiedseveral benefits from such arequirement: To facilitate employeeimplementation of the plan, to facilitateprocessor verification activities, toreduce the time needed for regulators toreview the manufacturing process, andto enable the regulator to determinewhether the processor properlyconsidered the entire manufacturingprocess. One comment stated that FDA’sassumption that flow diagrams areburdensome or unnecessary is contraryto the 1992 NACMCF Report whichnotes that flow diagrams could besimple representations that accuratelydepict the steps in a process, rather thandetailed, technical drawings.

FDA acknowledges that, for thereasons stated in the comments, manyprocessors will find that thedevelopment of a flow diagram is auseful preliminary step to thepreparation of a HACCP plan. Otherprocessors may find, however, that,because of the simplicity of theiroperations, the preparation of a writtenflow diagram is an unnecessary step. In

either case, FDA is convinced that aprocessor’s decision to develop or not todevelop a flow diagram will be, andshould be, driven by its perception ofthe benefits of doing so. The commentsreceived on this subject were notsufficiently persuasive for the agency toconclude that a flow diagram should bemade mandatory. The commentsprovided no basis to find that in theabsence of a flow diagram, a processorcould not properly develop a HACCPplan, or that a plan, so developed,would likely cause the HACCP programto fail.

As some of the comments pointed out,there may be some benefit to theregulator to have access to a flowdiagram during an inspection, but thisconvenience is not a sufficient reason tomandate it. FDA investigators will likelydevelop their own flow diagrams duringtheir in-plant inspections and comparethem with the decisions reached by theprocessor in the development of theHACCP plan (e.g., the identification ofhazards and CCP’s). While it may bebeneficial for the investigator to be ableto compare his or her flow diagram withthat of the processor, it is not essentialto the conduct of the inspection.

FDA agrees with the comments thatstated that the other four elements of the‘‘five preliminary steps’’ are desirableattributes of the HACCP developmentprocess. However, the agency has notbeen persuaded that, in the absence ofa regulatory requirement that they befollowed, the HACCP program isunlikely to succeed. In order to write anappropriate plan some or all of thesesteps will likely have to be performed,even without a regulatory requirementto do so. However, if a processor canwrite a plan without these steps, thegoals of the regulations will still havebeen met. For FDA to require them tobe performed and documented in everycase would add burden and reduceflexibility unnecessarily. Moreover,FDA is unconvinced that any inhibitionto foreign trade is likely to occur ifadherence to these steps is not required.FDA believes that foreign tradingpartners will be satisfied by thepresence of a successful HACCP systemand will not reject U.S. exports becausesteps preliminary to HACCP were notdocumented.

Even without a requirementmandating specific preliminary steps,FDA believes that most processors willfollow the spirit, if not the exact letter,of the recommended procedures. Theseprocedures provide the processor with arecognized method of plan developmentthat will help lead to a successfuloutcome. FDA is primarily interested inthat outcome. The NACMCF

recommendation for the assembly of aHACCP team, in particular, could be asignificant burden for the many smallbusinesses operating in the seafoodindustry. For these reasons, the finalregulations do not mandate anypreliminary steps that processors mustperform as a prerequisite to conductinga hazard analysis or drafting a HACCPplan.

2. Conducting a Hazard Analysis54. A number of comments from trade

associations and processors objected tothe requirement in the proposal thatevery processor have and implement awritten HACCP plan. These commentscontended that FDA should revise thisprovision to require that a processorfirst conduct a hazard analysis todetermine whether any food safetyhazards exist that can be controlledthrough HACCP and then prepare andimplement a HACCP plan only whenthe hazard analysis identifies at leastone such food safety hazard. Onecomment stated that conducting ahazard analysis is the first step in a two-step process, with developing a HACCPplan being the second step. Thecomments urged consistency with theNACMCF recommendations in thisregard.

FDA agrees with the approachsuggested by the comments and believesthat it is essentially consistent withwhat the agency proposed. AlthoughFDA did not explicitly propose torequire that every processor conduct ahazard analysis, completion of such ananalysis by every processor was implicitin the requirement in proposed§ 123.6(b)(1) and (b)(2) that processorsidentify both the hazards that arereasonably likely to occur and the CCP’sfor each of these hazards.

In response to the comments, FDA hasdecided to clarify its regulations tomake the requirement that a hazardanalysis be conducted explicit ratherthan implicit in order to clarify the stepsthat are required as part of a HACCPsystem. Moreover, this change allowsthe agency to make clear thatconducting the analysis may or may notlead to the preparation of a HACCPplan.

Thus, FDA is providing in § 123.6(a)that processors shall conduct a hazardanalysis or have one conducted on theirbehalf. It is the agency’s expectation thatmost seafood processors will, afterperforming a hazard analysis, find itnecessary to control for at least onehazard and, therefore, be obligated toprepare a HACCP plan. However, whenno hazard is reasonably likely to occur,there is no reason to prepare a HACCPplan. Therefore, § 123.6(b) states, in


part, ‘‘(b) The HACCP plan. Everyprocessor shall have and implement awritten HACCP plan whenever a hazardanalysis reveals one or more food safetyhazards that are reasonably likely tooccur, as described in paragraph (a) ofthis section.’’

The agency does not believe that themethodology of conducting hazardanalyses is sufficiently standardized atthis time to justify mandating what theanalysis must include. FDA encouragesprocessors to utilize the NACMCFdocument as guidance in performingthis activity. In addition, the agencyrecognizes that the best way for it toverify a processor’s hazard analysis isindirectly, through its own evaluationsof whether a processor ought to have aHACCP plan, and whether a HACCPplan appropriately identifies the foodsafety hazards and CCP’s that arereasonably likely to occur. In otherwords, it is the end product of thehazard analysis, the HACCP plan and itsimplementation, that should be judgedby the regulator. For this reason, theagency is not requiring that hazardanalyses be performed according to astandardized regimen, or that they bedocumented in writing for FDA review.

Even though FDA is not requiring thatthe hazard analysis be available to theagency, there may be cases in which itwould be to the processor’s advantage tohave a carefully documented writtenhazard analysis to show to FDA. Suchdocumentation may prove useful inresolving differences between theprocessor and the agency about whethera HACCP plan is needed and about theselection of hazards, CCP’s, and CL’s.Written hazard analyses may also beuseful to processors in that they mayhelp provide the rationale for theestablishment of critical limits and otherplan components. Having the basis forthese decisions available may be helpfulwhen processors experience changes inpersonnel, especially those associatedwith the HACCP process, and inresponding to unanticipated CLdeviations.

3. Types of HazardsFDA received a number of comments

on the types of hazards that a mandatoryHACCP system should control, and thatthe hazard analysis should examine.The proposed regulations did notdistinguish among hazards but proposedto require that HACCP plans identify allfood safety hazards that are reasonablylikely to occur. The comments thataddressed the question of what types ofhazards mandatory HACCP shouldaddress generally preferred that its focusbe on some subset of hazards, ratherthan on the entire spectrum that could

cause seafood to be adulterated. Thecomments argued that the hazards thatwere not the focus of the HACCP regimeestablished by the regulations could becovered by more traditional food safetymechanisms. A review of thesecomments follows.

55. Several comments, fromprocessors and trade associations, statedthat the hazard analysis should only beused to identify those food safetyhazards that have the potential to cause‘‘serious adverse health consequences.’’These comments stated that suchconsequences included those thatwould trigger a ‘‘Class I’’ recall asdefined by FDA, particularly those thatinvolve contamination of the food withpathogenic microorganisms. A Class Irecall involves a situation in whichthere is a reasonable probability that theuse of, or exposure to, a violativeproduct will cause serious adversehealth consequences or death andwould not be used to respond tosituations in which the healthconsequences are temporary, medicallyreversible, or remote (21 CFR 7.3(m)(1)and (m)(2)). Other processor commentssuggested the use of the phrase‘‘significant food safety hazard’’ to limitthe scope of the HACCP regime withoutproposing a definition for the phrase.

One comment stated that focusing ontruly serious hazards is the only way tokeep the number of CCP’s to aminimum, so that a HACCP plan canrealistically be implemented. Thecomment also stated that having toomany CCP’s, or CCP’s that are notrelated to serious health risks, would soburden food processing personnel thateffective compliance with the HACCPplan would be undermined, and itwould be significantly more difficult tocontrol truly critical processes.

Several of these comments argued thathazards should have immediate, as wellas serious, health consequences beforebeing required to be identified in aHACCP plan. These and several otherprocessor comments generallyexpressed the view that hazards that cancause a food to be adulterated under theact, but that do not have the potentialto cause acute illness, should not berequired to be included in a HACCPplan. For example, two of the commentsstated that FDA should not use theHACCP regulations to ensureconformity with food additiveregulations, pesticide residuetolerances, or action levels forenvironmental contaminants. Onecomment stated that although processcontrols that are similar to HACCPcontrols are often used by foodmanufacturers to monitor these kinds ofcontaminants, the controls should not

be regarded as part of HACCP becausethey do not address acute healthhazards. A few comments suggested thatexisting regulatory programs areadequate to address these types ofhazards.

On the other hand, comments fromone trade association and a number ofindividuals acknowledged that drugresidues and pesticide residues shouldbe addressed by HACCP plans; wherethey are likely to occur at levels overtolerance. Comments from a number ofprocessors of aquaculture-raised finfishacknowledged that drug and pesticideresidues are food safety hazards thataffect their industry, but thesecomments questioned theappropriateness of the controlmechanisms provided in FDA’s draftGuide. Finally, comments from severalconsumer advocacy groups expressedcontinued concern for the hazardsposed by environmental contaminants.

Having considered these comments,FDA confirms its tentative view,reflected in the proposal, that HACCPshould be the norm, rather than theexception, for controlling safety relatedhazards in the seafood industry.Existing standards for suchcontaminants as drug residues,pesticides, and industrial contaminants,are established to ensure that theirpresence in foods does not render thefood unsafe. Processors of fish andfishery products are obliged to producefoods that meet these standards.

Processors are obliged to exercisecontrol over all food safety hazards thatare reasonably likely to occur. A failureto do so would mean that the food wasprepared under insanitary conditionswhereby it may have been renderedinjurious to health or is otherwiseadulterated. The criteria for including afood safety hazard in a processor’sHACCP plan should be the degree towhich the hazard is likely to develop inthat product (e.g., based on theprocessing technique, the harvestlocation, the species) and not the natureor immediacy of the illness or injurythat it is likely to cause.

FDA views as highly speculative theconcerns, expressed by a few commentsfrom the food industry, that inclusion inHACCP of those hazards that generallyrequire chronic exposure to producedisease will dilute HACCP systems tothe point of shifting industry resourcesaway from acute toxicity hazards. Noevidence was submitted to support suchclaims. The pilot HACCP programconducted jointly by FDA and NMFS,the current NMFS voluntary HACCPprogram, and the NMFS Model SeafoodSafety Program all included controls forfood additives, primarily a nonacute


food safety hazard, and there has beenno diminution of control of acutehazards as a result. Moreover, theagency is convinced that whendetermining, in accordance with§ 123.6(a), what contaminant hazardsare ‘‘reasonably likely’’ to occur in aparticular type of product, mostprocessors will have very few, if any, ofthese chronic exposure-type hazards tomanage through HACCP as opposed tothrough some other method of control.

FDA intends to monitor the progressof the seafood HACCP program to judge,among other things, whether theapplication of HACCP to food safetyhazards generally, rather than to themost extreme acute hazards, overloadsthe HACCP system and dilutes itseffectiveness for all hazards. Until suchan effect is actually found to occur, FDAis persuaded that the systematicapplication of preventive controls tofood safety hazards generally willprovide the American consumers withthe most effective and efficient foodsafety system that has been devised todate. If FDA were to determine thatHACCP needs to be scaled back in orderto make it work, the agency will takeappropriate steps to make such achange.

One other factor bears mention in thisregard. FDA has long been aware ofconsumer concern about environmentalcontaminants in fish and fisheryproducts. As previously mentioned, thisconcern was expressed in the commentsto the proposed regulations. The chancethat these regulations will increaseconsumer confidence in the safety ofseafood products would be greatlydiminished if these regulations did notrequire processors to consider the risksfrom these contaminants as part of theirhazard analysis.

56. A comment from a tradeassociation stated that, while there ispotential for an unapproved direct orindirect food or color additive to be ahealth hazard, the use of an additivethat has not been listed for use in fishbut is routinely used throughout thefood industry would not necessarily belikely to cause harm to human health.The comment said that a control for useof the additive should not be requiredto be included in a HACCP plan.

Under the act, certain products, suchas food additives, new animal drugs,including new animal drugs intendedfor use in aquaculture, and pesticides,require premarket approval before theymay be legally used. Moreover, thisapproval can be limited so that theproduct may only be used legally on orwith specific foods, or for specificpurposes, for which approval has beenobtained. This limitation reflects a

longstanding realization that the safetyof these types of products is variableand must be established on a use-by-usebasis. Whether an additive, drug, orpesticide is safe for a particular use, ina particular food, at a particular level,depends on factors such as the amountof the food that is consumed and, if theadditive, drug, or pesticide is ingestedin a living animal before capture, howthe product is metabolized in thatanimal.

Therefore, a food additive that hasbeen approved for use in some foods,but not fish and fishery products, isdeemed by the act to be unsafe for usewith fish and fishery products. FDA isnot in a position to change this aspectof the law through regulations.Consequently, the agency has notcreated an exemption from therequirement for HACCP controls forsafety hazards caused by the presence ofunapproved additives or other productsthat lack premarket approval for fish orfishery products.

The agency is aware that it is possiblethat some of these products may pose nomeaningful risk in fish and fisheryproducts at levels approved or allowedin other foods. It is the obligation of theproponent of the use of the substance tofollow applicable statutory procedure toestablish this fact to FDA’s satisfaction.

57. In the preamble to the proposedregulation, FDA specifically invitedcomment on whether, in order to reducethe burden of HACCP on the industry,as in the Canadian fishery productsHACCP regulation, the agency shouldlimit its HACCP approach to cover onlythose hazards that are introduced withinthe confines of the processing plant.This type of limitation would eliminatemandatory control of environmentalhazards such as pesticides, naturaltoxins, industrial contaminants, andaquaculture drugs through the HACCPsystem.

One comment contended that aprocessor of fishery products would bein a difficult position attempting toexercise control over problems thatoccur during harvesting. The commentstated that the purpose of HACCP is torequire that each processor beresponsible for minimizing thoseserious hazards that it is in the bestposition to control, but that theproposed regulations would force theprocessor to take responsibility forhazards that it may be poorly suited tocontrol. The comment argued thatFDA’s intent was to deploy HACCPsolely as a way of reducing the agency’sinspectional burden. The commentfurther stated that the focus should beon finding those few CCP’s within aspecific process where a serious hazard

can best be controlled. Several othercomments expressed confusion aboutthe application of HACCP toenvironmental hazards.

The preamble to the proposedregulations described the link betweenenvironmental hazards, such as naturaltoxins (e.g., ciguatera toxin, domoicacid, and saxitoxin), histamine, andvarious viral and bacterial pathogens,and human disease. The NAS’ ‘‘SeafoodSafety’’ report (Ref. 7, p. 1) suggestedthat the most significant reduction inillness from seafood would come fromthe control of environmental hazards.To eliminate coverage of such hazardsfrom these regulations would be toeliminate the greatest share ofanticipated benefits.

The preamble to the proposedregulations provided a number of waysin which the processor can exercisecontrol over environmental hazards.This control derives from the fact thatresponsible processors already exercisediscretion in obtaining their rawmaterials. Control is achieved bychecking tags on containers ofmolluscan shellfish to ensure that theyare harvested only from approvedwaters, checking with fishermen toensure that finfish do not originate fromharvest areas that are closed due to thepresence of excessive agricultural orindustrial contaminants, and physicallyexamining incoming histamine-formingspecies for evidence of decompositionand insisting that harvest vesselsexercise control over the time andtemperature of storage for these species.Similarly, processors of aquaculture-raised species can audit or otherwiseinsist on a producer controls over theuse of animal drugs or other hazardsresulting from inappropriate husbandrypractices. In a HACCP system, these areexamples of controls that can be appliedat the first CCP, i.e., at the receipt of rawmaterials.

FDA concludes that the measures thata processor takes to ensure that its rawmaterials are free of environmentalhazards are a critical part of a seafoodHACCP program. Responsibleprocessors already exercise the kind ofcontrol necessary to ensure that theirraw materials do not present such ahazard. If a likely hazard exists, itwould not be sufficient to use the priceoffered for raw materials to be the onlymeasure to protect against the hazard.

For these reasons, FDA has retainedenvironmental hazards in the list offood safety hazards that processorsshould consider in § 123.6(c)(1). Toclarify that there are hazards that occurbefore receipt of raw materials that canbe controlled nonetheless byexamination or discretion at the


receiving CCP, FDA has modified§ 123.6 by including the followingsentence in § 123.6(a), ‘‘Such food safetyhazards can be introduced both withinand outside the processing plantenvironment, including food safetyhazards that can occur before, during,and after harvest.’’

For consistency, § 123.6(c)(2) needs aspace here provides for both types ofCCP’s, and now reads:

(2) List the critical control points for eachof the identified food safety hazards,including, as appropriate: (i) Critical controlpoints designed to control food safetyhazards that could be introduced in theprocessing plant environment, and (ii)Critical control points designed to controlfood safety hazards introduced outside theprocessing plant environment, includingfood safety hazards that occur before, during,and after harvest.

Because most of the environmentalhazards to which fish are exposed willbe controlled by the first processor totake possession of the fish from thefisherman or aquacultural producer,whether that processor is located in theUnited States or in another country,subsequent processors need not focuson these hazards in their HACCP plans.For example, pesticide contamination ofinland and near shore finfish can beeffectively controlled by the firstprocessor by purchasing from fishermenwho do not harvest in areas that havebeen closed by regulatory authorities,and drug residue contamination can beeffectively controlled by the firstprocessor by purchasing fromaquaculture producers who use animaldrugs properly.

4. When Is a Hazard Reasonably LikelyTo Occur?

In the proposal, FDA identified ninecategories of safety hazards that mightoccur in fishery products. The agencytentatively concluded that a processormust establish HACCP controls whenone or more of the listed hazards isreasonably likely to occur.

58. A number of comments, fromprocessors and a trade association,questioned whether certain of thesenine hazard categories by themselvesjustify a HACCP plan. The commentschallenged the likelihood that some ofthese hazards would cause harm andasked for clarification on how aprocessor is to determine whether ahazard is ‘‘reasonably likely to occur.’’One comment held that, if the term‘‘reasonably likely to occur’’ is linked toactual incidents of illness caused by agiven hazard, it would be inappropriateto define some of the listed hazardcategories as reasonably likely to occur.This comment also requested that FDA

clarify whether the hazards identified inits draft Guide are those that the agencybelieves are reasonably likely to occurunder all conditions for the listedspecies and processing methods. Thecomment further noted that residues ofindustrial or agricultural chemicalspresent in seafood are usually notpresent at levels that are reasonablylikely to be a safety hazard, even inmany of those species that are listed inthe Guide as presenting that hazard.

As discussed in the preamble to theproposed regulations, FDA recognizesthat HACCP need not be used to controlevery theoretical hazard, no matter howremote the likelihood of its occurrence.Moreover, as discussed earlier in thispreamble, case law interpreting section402(a)(4) of the act has held thatconditions must be such as to create areasonable possibility that a hazard willoccur in order for product to beadulterated under that section of thelaw. (See United States v. 1,200 Cans,Pasteurized Whole Eggs, Etc., 339 F.Supp. 140–141.)

Unquestionably, historical occurrenceof reported illness is an appropriatestarting place for the identification offood safety hazards that are reasonablylikely to occur in the absence ofcontrols. For example, illness fromscombrotoxin in those species that formthe toxin if subjected to time andtemperature abuse after harvest is one ofthe most frequently reported illnessesfrom seafood. Moreover, therelationship between abuse after harvestand the formation of the toxin is wellestablished. FDA can say with comfort,therefore, that scombrotoxin poisoningis a hazard that is reasonably likely tooccur in the absence of appropriatecontrols for scombrotoxin-formingspecies of fish.

For some hazards, however, theincidence of reported illness is verylow. A good example is illness from theconsumption of raw fish species that areprone to parasites. The low number ofreported illnesses is probablyattributable to underreporting and to thefact that controls for this hazard (e.g.,commercial blast freezing that killsparasites) generally exist. However, it iswell established that in the absence ofcontrols, infection from parasites is ahazard that is reasonably likely to occurwhen a species that is prone to parasitesis consumed raw.

The incidence of reported illness thatis linked to a specific food is virtuallynonexistent when the illness is theresult of chronic exposure to a chemicalcontaminant. It is extremely difficult,for example, to link a specific case ofcancer to a specific contaminant in food.However, where public health officials

have determined that a contaminantrepresents a chronic health hazard, thestandard control strategy to beemployed by processors for suchcontaminants is to ensure that theirpresence in food remains below specificlevels.

Processors are advised of suchchronic health hazard determinationsthrough FDA action levels, publications(e.g., Federal Registers at 55 FR 14359,April 17, 1990; 58 FR 11609, February26, 1993; and 58 FR 48368, September15, 1993), or other similar guidancedocuments. If the contaminant ispresent in food in an amount that isabove that level, the food represents ahazard to health that the evidence fromthe chronic studies shows is reasonablylikely to occur. The question, then, iswhether the likelihood of finding a fishin which the contaminant is at a higherthan acceptable level is an event that isreasonably likely to occur. For openocean species of fish, for example, afinding of pesticide residues abovenationally established tolerances can bea very rare event. For near shore speciesin certain locations, however, a findingabove tolerance can occur often enoughso as to warrant controlling for it as amatter of reasonable prudence.

The incidence of reported illness fora particular hazard may also benonexistent or very low because thehazard may be too new to havegenerated reported illnesses. Theemergence of natural toxins harmful tohumans in species or in locales wherethe toxin has not been found before isa well known phenomenon in seafood.While FDA does not expect that HACCPcontrols should be in place to controlfor the possibility of such hazards—thehazard may or may not ever occur—theagency strongly believes that once ahazard does emerge and is identified,HACCP controls are highly appropriateto keep illnesses from occurring. For theduration of the a hazard, it must betreated as one that is reasonably likelyto occur.

To provide clarification on the abovepoints, FDA has modified § 123.6 byincluding the following sentence in new§ 123.6(a):

A food safety hazard that is reasonablylikely to occur is one for which a prudentprocessor would establish controls becauseexperience, illness data, scientific reports, orother information, provide a basis toconclude that there is a reasonable possibilitythat it will occur in the particular type of fishor fishery product being processed in theabsence of those controls.

To reinforce that it was not FDA’sintent to suggest that all of the ninehazard categories that it listed in§ 123.6(c)(1) are reasonably likely to


occur in all circumstances, the agencyhas modified the language in thisprovision to read in part,‘‘Consideration should be given towhether any food safety hazards arereasonably likely to occur as a result ofthe following:’’ (the list of ninecategories follows in the text).

The Guide is not intended as adefinitive list of the hazards that arereasonably likely to occur, under allconditions, for those species andprocessing methods listed.

HACCP is a operation-specificprocess. For this reason, the processormust decide on a case-by-case basiswhat hazards it needs to address; that is,what hazards are reasonably likely tooccur. The purpose of the hazardsportion of the Guide is to provide alisting of hazards, by fish species and byfinished product type, that FDA knowsto have a reasonable potential foroccurrence in the product.

FDA encourages processors to use theGuide, as well as any other availableinformation, to decide what hazardsneed to be addressed in any particularplan. Processors need to recognize thatthey need to use judgment in applyingthe Guide to their own particularcircumstances. For example, a processorof one species of fish may find thatpesticide contamination is listed as ahazard for the species, but may be awareof credible data that demonstrate thatthe water from which it obtains its fishis free of such contamination. In thatcase, the processor is free to deviatefrom the guidance. FDA intends toclarify the Guide on this point bydistinguishing between hazards that arereasonably likely to occur all of the time(e.g., histamine in species that are proneto it) and hazards that are reasonablylikely to occur under certaincircumstances (e.g., certain toxins whena ‘‘bloom’’ is occurring).

5. The Plan: Specific Considerations59. FDA proposed that HACCP plans

be specific to each processing locationand to each kind of fish and fisheryproduct processed by a processor,except that the plan may group kinds offish and fishery products together if thehazards, CCP’s, CL’s, and proceduresrequired to be included in the plan areidentical. A few comments fromprocessors and trade associationssuggested that production methodsshould also be allowed to be groupedtogether so long as the hazards and thecontrol procedures for the productionmethods are identical. The commentssuggested that grouping would reducethe paperwork burden on someprocessors without altering the benefitsattainable through HACCP.

FDA agrees with the suggestion forthe reason presented by the commentsand has modified § 123.6(b) accordingly,to read, in part:

A HACCP plan shall be specific to: (1) Eachlocation where fish and fishery products areprocessed by that processor; and (2) Eachkind of fish and fishery product processed bythe processor. The plan may group kinds offish and fishery products together, or groupkinds of production methods together, if thefood safety hazards, critical control points,critical limits, and procedures required to beidentified and performed in paragraph (c) ofthis section are identical for all fish andfishery products so grouped or for allproduction methods so grouped.

60. In the proposal, FDA specifiedthat a HACCP plan must identify: Theapplicable food safety hazards; theCCP’s; the CL’s; the control andmonitoring procedures; and therecordkeeping procedures. A fewcomments suggested that FDA use theword ‘‘list’’ or ‘‘include’’ rather than‘‘identify’’ to describe a requirement foran item to appear in the HACCP plan.The comments suggested that it is notclear from the word ‘‘identify’’ whetherthe regulations are intended to requirethat the plan contain or include theactual values (e.g., the temperature of arefrigerator) or a description of theprocedures, or whether it is permissiblesimply to make reference to theirexistence in a guideline or other source.

FDA’s intent is that a HACCP planexplicitly include the value or adescription of the procedures for each ofthe required HACCP elements. FDAagrees that a word such as ‘‘list’’ wouldbe less ambiguous. Therefore, FDA hasrevised § 123.6 (c)(1), (c)(2), (c)(3), and(c)(4) by substituting the word ‘‘list’’where the word ‘‘identify’’ appeared inthe proposed regulations.

FDA has also revised § 123.6(c) bymaking another clarifying change. Theagency has added the phrase ‘‘at aminimum’’ to the introductorystatement to make clear that therequired plan contents do not restrict aprocessor from including additionalinformation in the plan, where it may beappropriate.

61. Two comments requested thatFDA specify that decomposition, listedas one of the hazard categories in theproposal, is a hazard only in scombroidtoxin-forming species.

These comments stated thatdecomposition in other species is not asafety hazard but is an economic andaesthetic problem.

FDA agrees with the comments inpart. FDA’s intent was to require controlof decomposition in a HACCP plan onlywhen it represents a food safety hazard.As described in the preamble to the

proposed regulations, histamine(scombroid toxin) development as aresult of microbiological decompositionin certain species of fish is a wellrecognized food safety hazard (Ref. 5, p.24). There are some early indications,however, that the development ofputrescine and cadaverine, alsobyproducts of decomposition of fish,under certain circumstances, may alsorepresent food safety hazards (Ref. 203,p. 240). For this reason, FDA is hesitantto limit the safety concern associatedwith decomposition to the production ofhistamine. Accordingly, FDA hasmodified § 123.6(c)(1)(vi) to read,‘‘Decomposition in scombroid toxin-forming species or in any other specieswhere a food safety hazard has beenassociated with decomposition.’’

62. Comments from two Stategovernment agencies and a tradeassociation stated that FDA shouldeliminate parasites as a safety hazardthat must be considered for inclusion ina processor’s HACCP plan. Thecomments noted that, with respect topathogens, FDA makes the assumptionthat raw fish will be further processedby cooking, and that, therefore, that thepathogens will be destroyed and notpose a health hazard. The commentsurged that the same rationale be appliedto raw fish that may contain parasites.The comments further suggested thatthe retail level is appropriate point ofcontrol for parasites, and that theprovisions of the Food Code areadequate to address this issue.

The comments further argued thatparasites pose a hazard only in certainspecies that are consumed raw, and thatmandatory control procedures for allfish that are consumed raw would createan enormous economic hardship forsome segments of the industry. Inparticular, one of the commentscontended that parasites have neverbeen a problem in the large tunas thatare eaten raw, and that it should not benecessary to freeze such fish before theyare sold for raw consumption.

FDA’s intent is to require control ofparasites in a HACCP plan only in thoseinstances when parasites are reasonablylikely to occur in the portion of the fleshthat is consumed, and the presence ofthe parasites will present a food safetyhazard (e.g., where the fish is offered forraw consumption). To clarify this intent,FDA has modified § 123.6(c)(1)(vii) toread:

Parasites, where the processor hasknowledge or has reason to know that theparasite-containing fish or fishery productwill be consumed without a processsufficient to remove the hazard, or where theprocessor represents, labels, or intends forthe product to be so consumed.


With regard to the comparison madeby comments that FDA is requiringcontrol of parasites in raw fish but notpathogens in raw fish, thecharacterization of FDA’s policytowards pathogens is inaccurate. Thesanitation provisions of theseregulations are designed, in large part,to minimize the presence of pathogensin fish and fishery products, whetherthey are raw or further processed. Themajor opportunity for the introductionof enteric pathogens to processed fishand fishery products is from theprocessing environment as a result ofinsanitary practices rather than by thecarcass of the animal (Refs. 3, p. 267;and 7, p. 33). For this reason, sanitationcontrols designed to preventcontamination of fish flesh areimportant to minimize the levels ofenteric pathogens found on processedfish (Refs. 3, p. 10; 7, p. 27; 204; and205). The agency is convinced that, iffollowed, these controls will be effectivein minimizing the presence of suchpathogens. Moreover, FDA has longenforced a zero tolerance for thepresence of Salmonella on raw fish,based, in part, on the avoidability ofsuch contamination through theapplication of CGMP’s.

63. One comment stated that the term‘‘physical hazards’’ in the proposalcould be interpreted to includenonsafety related hazards.

In § 123.6(c), physical hazards are oneof nine listed causes of ‘‘food safetyhazards’’ that processors shouldconsider for listing in their HACCPplans (§ 123.6(c)(1)(ix)). Thus, theagency believes that the language of thissection clearly applies to food safetyhazards only, and no modification of theprovision is necessary in response tothis comment.

FDA proposed that HACCP plansinclude the CL’s that must be met ateach CCP. FDA received no significantcomment on this section (§ 123.6(c)(3))and has made no substantive changes toit.

FDA proposed to require that HACCPplans include the procedures for both‘‘monitoring’’ and ‘‘controlling’’ theCCP’s. FDA recognizes that monitoringand controlling serve different purposes,and that the appropriate HACCPprinciple is the monitoring of CCP’s toensure conformance with the CL (Ref.34, p. 197). How a processor exercisescontrol is not critical to product safetyso long as the CL is not exceeded. Thereare many ways to maintain control. Noone way or list of ways needs to bestated in the plan so long as monitoringis taking place at an appropriatefrequency to ensure that control isoccurring and to detect CL deviations

when they occur. For this reason, FDAhas modified § 123.6(c)(4) to read, ‘‘(4)List the procedures, and frequencythereof, that will be used to monitoreach of the critical control points toensure compliance with the criticallimits.’’

FDA has also eliminated the referencein § 123.6(c)(4) to consumer complaintsas a monitoring tool. As explained inmore detail in the ‘‘ConsumerComplaints’’ section of this preamble,FDA has concluded in response tocomments that consumer complaintsgenerally do not provide the processorwith the kind of immediate feedbackabout whether the process is undercontrol that monitoring should providein a HACCP system. Consumercomplaints may provide the processorwith information that would be usefulfor verification purposes, however.These regulations therefore requireprocessors to take consumer complaintsinto account as verification tools(§ 123.8(a)(2)(ii).

Likewise, FDA has moved thereference in the proposed regulations tothe calibration of process monitoringinstruments to the new ‘‘Verification’’section of these regulations (§ 123.8),and it has eliminated the specificreference to computer softwarevalidation. As explained in more detailin the ‘‘Verification’’ section of thispreamble, FDA has concluded inresponse to comments that calibration isa verification function that provides theprocessor with information aboutwhether its monitoring equipment isfunctioning properly. Computersoftware validation is a form ofcalibration and need not be addressedseparately in these regulations.

64. In the preamble to the proposedregulations, FDA asked for comment onwhether guarantees from suppliersshould be considered as an acceptableway of meeting the proposed monitoringrequirement. Comments from a numberof processors responded that acertificate from a producer that a lot ofraw material fish is free fromunacceptable levels of pesticide anddrug residues should be an acceptablemeans of monitoring the hazards ofanimal drug and pesticide residues inaquaculture-raised fish. The commentheld that reliance on suppliers’certificates may be necessary because ofthe logistical problems that could beassociated with analyzing raw materialsfor pesticides and drug residues. Ofparticular concern, the comments said,is the time necessary to analyze thesamples. The comments further statedthat the certificates should be based onparticipation in an industry-widequality assurance program designed to

ensure that the raw materials are freefrom these hazards.

FDA believes that caution iswarranted on the subject of supplierguarantees. Where more direct controlsare available, they should be used. Inthe case of aquaculture-raised fish, moredefinitive controls than the acceptanceof a certificate attesting to the absenceof unapproved drug residues alone areavailable to a processor, and thesecontrols are not unduly burdensome.They include the review of thesupplier’s animal drug control recordswhen the lot is offered for sale and asystem of onsite audits of the supplier,either by the processor or by a thirdparty. Such alternatives are alsoavailable for most raw material hazards(e.g., checking container tags andharvester licenses as a means ofcontrolling microbiologicalcontamination in molluscan shellfish,and checking vessel storage records as ameans of controlling histaminedevelopment in scombroid species).However, the agency recognizes thatthere may be some instances in whichsuch controls are not possible, andsuppliers’ certificates or guarantees arethe only available monitoring tool. Inthose cases, verification of theeffectiveness of the certificates may becritical. Thus, the extent to whichsuppliers’ guarantees can be relied uponwill have to be considered on a case-by-case basis. However, FDA has made nochange in § 123.6(c)(4) in response tothe comments.

FDA has added § 123.6(c)(5) thatdescribes requirements of the HACCPplan with regard to corrective actions.As explained in more detail in the‘‘Corrective Actions’’ section of thispreamble, FDA has concluded inresponse to comments that theseregulations should provide theprocessor with the option ofpredetermining corrective actions.Predetermined corrective actionprocedures have the potential to enablea processor to take faster action when adeviation occurs than would be possiblein the absence of such procedures, andto make a more timely response to thedeviation when trained or otherwisequalified individuals are not readilyavailable.

FDA has also added § 123.6(c)(6),which describes the requirements of theHACCP plan with regard to verification.As explained in more detail in the‘‘Verification’’ section of this preamble,FDA has concluded in response tocomments that a processor needs tospecifically include in its HACCP planthe verification procedures that it willuse and the frequency with which itwill use those procedures. FDA finds


that inclusion of this information in theplan is necessary to underscore that aprocessor has an ongoing obligation tobe sure that the verification steps that ithas determined are necessary are readilyascertainable by the processor and itsemployees as well as by regulatoryofficials.

FDA proposed to require that HACCPplans provide for a recordkeepingsystem that documents the monitoringof CCP’s. The proposed regulations alsoprovided that the records must includethe actual values obtained duringmonitoring and any consumercomplaints that relate to the operationof CCP’s or possible CL deviations. FDAhas removed the latter provision,relating to consumer complaints, from§ 123.6(c)(7). As explained above, thesefinal regulations treat consumercomplaints as verification tools ratherthan monitoring tools. Consequently,consumer complaints need not beincluded in a recordkeeping system thatdocuments the monitoring of CCP’s. Afull discussion of issues relating toconsumer complaints is presented in the‘‘Consumer Complaint’’ section of thispreamble.

6. Positive Versus NegativeRecordkeeping

The preamble to the proposedregulations invited comment onwhether it was necessary for the resultsof monitoring (i.e., the actual values) tobe recorded regardless of whether a CLwas met (positive recordkeeping), orwhether it was only necessary to recordinformation when a CL was not met(negative recordkeeping). The agencynoted that negative recordkeeping ispresumably less expensive than positiverecordkeeping.

65. A substantial number ofcomments addressed this issue.Approximately two-thirds of thesecomments, including those from tradeassociations, processors, Federal, State,and foreign government agencies,consumer advocacy groups, and aprofessional society, supportedrequiring positive records. Theremaining one-third of the commentsthat addressed this issue, from tradeassociations, processors, and Federaland State government agencies, arguedthat records should only be requiredwhen a CL deviation occurs, or thatpositive records should be required orencouraged, but that FDA should begranted access to only the negativerecords.

In general, the comments supportingthe need for positive records recognizedthat monitoring records serve two majorpurposes: To facilitate the identificationof trends that would lead to a loss of

control if not caught in time and todocument compliance with, ordeviations from, CL’s. Comments from alarge processor and a trade associationstated that, based on their extensiveexperience with HACCP, positivemonitoring records provide a pattern ofresults and values that is much moremeaningful than sporadic negativerecords alone. Several comments statedthat positive recordkeeping facilitatesthe taking of corrective action before theCL’s are exceeded.

Several comments stated that aprovision that required only negativerecords would penalize the firms thatalready maintain records of all CCPobservations. A few commentssuggested that neither firm managementnor FDA could verify that themonitoring procedures specified in aprocessor’s HACCP plan are beingcarried out if only records of deviationsfrom CL’s are kept, because there wouldbe no records to indicate that the otherchecks were actually being made. Acomment from a consumer group furtherargued that allowing the use of negativerecords alone could create theopportunity for processors to limit theirmonitoring, because no records wouldbe needed to demonstrate that suchmonitoring was performed.

Most comments that supported theuse of negative records alone stated thatpositive recordkeeping and the reviewof positive records was overlyburdensome for both the industry andthe regulator. A few comments statedthat positive records generate massivedatabases that disguise CL deviations,rather than illuminate them. Noexamples of this phenomenon wereprovided, however. One commentsuggested that since FDA inspects mostprocessors once a year or less, it isquestionable whether the agency wouldbe in a position to pick up trends in thedata from a review of all the positiverecords that would be retained. Anothercomment stated that it is just asunrealistic to expect FDA investigatorsto review all positive records as it is forFDA to inspect all fish. A few commentsargued that the sheer volume of thepaperwork produced with positiverecordkeeping would result in technicalor clerical errors by processors thatcould result in products being deemedby FDA to be adulterated.

Several comments suggested that asystem where CL deviations triggerremedial actions, which are properlydocumented, should be sufficient forFDA’s verification purposes. Onecomment suggested that becauseprocessors can falsify positive records aswell as negative records, FDA wasmistaken if its motive for proposing to

require positive records over negativerecords was to help preventunscrupulous processors fromcircumventing the system. Anadditional comment supported limitingmandatory HACCP recordkeeping tonegative records because FDA could notrule out the possibility that future courtdecisions or changes in FDA policymight permit the disclosure of HACCPrecords in FDA’s possession, andnegative recordkeeping would reduce acompany’s potential exposure.

FDA’s reasons for proposing positiverecords match those in the commentsthat support these kinds of records. Asthe preamble to the proposedregulations noted, recordkeeping is thekey to HACCP, enabling the processorand the regulator to see the operationthrough time. Negative records alone donot allow this assessment over time anddo not provide assurance that theappropriate monitoring was evenperformed.

FDA cannot conclude from thecomments that supported negativerecords that the burden of positiverecordkeeping is excessive or otherwiseoutweighs the benefits. The agencyacknowledges that a requirement forpositive records may be moreburdensome than one that only requiresnegative records. However, FDAreceived no new data on this issue.Positive recordkeeping can be extremelysimple and need not take much longerto perform than the monitoringnecessary to determine whether theprocess is in control (e.g., noting thetemperature of a refrigerator in alogbook located next to the refrigerator).The agency is convinced that thisminimal additional effort greatlyincreases the chances that a processor’sHACCP program will be successful.

Based largely on FDA’s experiencewith the positive recordkeepingrequirements in the low-acid cannedfood and the acidified food industries,FDA does not agree that the volume ofpositive records that a system willgenerate will defeat the system byhiding CL deviations or trends towardsuch deviations. FDA’s regulations atparts 113 and 114 require that theseindustries perform positiverecordkeeping at identified CCP’s. Theindustry itself requested thisrequirement.

FDA has found that these processorshave no trouble making positiverecords, and that both the processorsthemselves and the regulators becomeadept at reviewing them and derivingbenefits from them that would not havebeen available from negative records.These benefits have included being ableto pinpoint with confidence when a


deviation began and ended, being ableto react to trends toward a loss ofcontrol, and being able to prove thatCCP’s were actually being monitored asoften as necessary to ensure control. Therelative volume of records has notserved as a roadblock in this regard.

It is unlikely that FDA investigatorswill review all monitoring recordsduring routine inspections, except inhighly unusual circumstances. As hasbeen the case with FDA inspections oflow-acid canned foods and acidifiedfoods, the agency will, in most cases,select records to represent theproduction since the last inspection.This technique has proven to be botheffective and efficient.

As for the concern that the agencywill declare product adulterated on thebasis of technical or clerical errors inpositive-type records, the agencyadvises that it is not its intent to pursueregulatory action against product solelybecause of clerical or related errors inmandatory records. FDA does not takesuch actions against processors of low-acid canned foods or acidified foods,and it will not do so against seafoodprocessors. FDA will consider the entiresituation, and its potential for impact onhuman health, in formulating a responseto deviations from these regulations.

As for the comment that FDA mightas well mandate negative recordsbecause positive records can besuccessfully falsified, FDA advises thatthe possibility that records will befalsified—and that falsifiers will getaway with it—is an issue that involvesthe fundamental credibility of thesystem. From FDA’s standpoint, theagency’s decades-long experiencereviewing positive records on low-acidcanned foods and acidified foods givesit confidence that its investigators candetect falsifications. However, FDA didnot propose positive records for thepurpose of catching falsifiers. FDAproposed positive records because thisapproach confers benefits on both theindustry and the regulator that outweighthe additional work of maintainingthem. Aside from the view, to whichFDA strongly adheres, that mostprocessors are honest and will notfalsify records, the agency stronglybelieves that most processors willquickly see the benefits to themselves ofa properly operating HACCP systembased on positive records and will insistthat their records be accuratelycompleted.

One such benefit should be a moremotivated workforce. HACCPmonitoring and recordkeeping can andshould be done by the workers whooperate the system at the CCP’s, not byquality control personnel. To the extent

that these workers experience a sense ofresponsibility and pride associated withmaking accurate daily notations, theprocessor can expect to benefit.

Regarding public disclosure of recordsas mentioned by one of the comments,FDA continues to believe thatpossession of monitoring records by theagency will be more the exception thanthe rule, and that these kinds of recordsare protected from public disclosure inany event. The protection of records isaddressed in detail in the ‘‘Records’’section of this preamble.

FDA has therefore not modified therequirement that processors’ monitoringrecords include the actual valuesobtained during the monitoring.

7. Signing the Plan66. In the preamble to the proposed

regulations, FDA specifically invitedcomment on whether HACCP plansshould be required to be signed by arepresentative of the firm and, if so, bywhom. Approximately 30 commentsresponded to the inquiry. About two-thirds of these comments, fromprocessors, trade associations,professional associations, and Federal,State, and foreign national governmentalagencies, supported the need for asignature. The remaining comments,mostly from processors and tradeassociations, argued that a signature wasunnecessary.

Those that favored a requirement fora signature on HACCP plans stated thatthe signature does the following:Demonstrates formal adoption of theHACCP plan, solidifies responsibilityfor adherence to the plan, and fosters asense of management ownership. Thecomments made the followingsuggestions with regard to who shouldbe the signatory (in order of preference):Onsite manager, most responsibleindividual of the firm, any seniormanager, HACCP coordinator, and allHACCP team members. Thosecomments that argued against amandatory signature on the plan statedthat the existence of a HACCP plan itselfconstitutes management support for theplan.

FDA agrees with the comments thatrecommended a requirement for HACCPplans to be signed by a representative ofthe firm. As suggested by the comments,such a signature will provide directevidence of management’s acceptance ofthe plan for implementation. FDAcannot stress enough that for HACCP tosucceed, there must be a clearcommitment to it from the top of thefirm on down. Management must set astrong example in this regard. Asignature requirement will remindmanagement of this important

responsibility and will signal to allemployees that the firm regards theHACCP plan as a document to be takenseriously. Additionally, therepresentative’s signature, along withthe date of signing, would serve tominimize potential confusion over theauthenticity of any differing versions oreditions of the document that mightexist. FDA has concluded that theburden of such a requirement would beminimal, and has added a newparagraph at § 123.6(d), that reads:

(d) Signing and dating the HACCP plan. (1)The HACCP plan shall be signed and dated,either by the most responsible individualonsite at the processing facility or by a higherlevel official of the processor. This signatureshall signify that the plan has been acceptedfor implementation by the firm. (2) TheHACCP plan shall be dated and signed: (i)Upon initial acceptance; (ii) Upon anymodification; and (iii) upon verification ofthe plan * * *.’’

As will be discussed fully in the‘‘Verification’’ section of this preamble,the adequacy of the HACCP plan mustbe reassessed, and modified as needed,whenever significant changes in thefirm’s operations occur, but no less thanonce per year. These reassessments andmodifications are necessary to ensurethat the plan remains current and isresponsive to emerging problems. Thesignature of the firm representative willbe valuable in documenting that thesereassessments and modifications areperformed as required. Particularly if nomodification of the plan is needed,reassessment can be verified by FDAonly if documentation, such as asignature, is maintained by the firm.

8. Relationship to Parts 113 and 11467. A few comments urged that the

final regulations provide that if aprocessor of low-acid canned fisheryproducts is in compliance with FDA’sregulations for these products underpart 113, it would also be in compliancewith these HACCP regulations withrespect to the control of the hazard ofC. botulinum toxin production. Theregulations at part 113 establishHACCP-type controls for this hazard.

FDA agrees that there is no need fora processor to restate in its HACCP planthe requirements of part 113 or 114. Itis also not necessary for such aprocessor to institute controls inaddition to those specified in parts 113and 114 in order to control the hazardof C. botulinum toxin production.Consequently, processors who mustcomply with the requirements of part113 or 114 need not address this hazardat all in their HACCP plans. However,it is important to note that other hazardsmay be reasonably likely to occur in an


acidified or low-acid canned fisheryproduct. These hazards must beaddressed in the HACCP plan, asappropriate. For example, processors ofcanned tuna will likely need to identifyin their HACCP plans how they willcontrol the development of histaminebefore the canning process.Accordingly, to clarify what is requiredof processors of acidified and low-acidcanned fishery products, FDA hasadded § 123.6(e), which reads:

For fish and fishery products that aresubject to the requirements of part 113 or 114of this chapter, the HACCP plan need not listthe food safety hazard associated with theformation of Clostridium botulinum toxin inthe finished, hermetically sealed container,nor list the controls to prevent that foodsafety hazard. A HACCP plan for such fishand fishery products shall address any otherfood safety hazards that are reasonably likelyto occur.

9. Sanitation in the Plan

The question of the role of processingplant hygiene (i.e., traditional sanitationcontrols) in HACCP is addressed atlength in the ‘‘Sanitation’’ section of thispreamble. As explained in that section,FDA is requiring that processors addressplant sanitation by monitoring forcertain key sanitation conditions andpractices apart from critical controlpoint monitoring activities, or byincluding sanitation controls as part ofthe HACCP plan, or by adopting somecombination of these two approaches, atthe option of the processor. To reflectthis approach, in paragraph (f) in § 123.6on the inclusion of sanitation controlsin the HACCP plan FDA has stated: ‘‘(f)Sanitation controls may be included inthe HACCP plan. However, to the extentthat they are monitoring in accordancewith § 123.11(b), they need not beincluded in the HACCP plan and viceversa.’’

FDA recognizes that, in manyprocessing operations (e.g., cooked,ready-to-eat fishery products, smokedfishery products, and molluscanshellfish) sanitation controls, such ashand and equipment washing andsanitizing, are critical to the safety of thefood because they serve to minimize therisk of pathogen introduction intofinished products that may not befurther cooked before consumption (Ref.3, p. 267). For this reason, someprocessors may elect to include thecontrol of sanitation conditions andpractices in their HACCP plan inaddition to, or in place of, monitoringfor such conditions and practices apartfrom the HACCP plan. Based in part onexperience gained from the seafoodHACCP pilot project operated jointly byFDA and DOC, however, FDA also

recognizes that sanitation controls maybe difficult to fit in HACCP plans, withappropriate CL’s and corrective actionssometimes being elusive. For thisreason, some processors may elect torely exclusively on sanitation controlsthat are not part of the HACCP plan.FDA considers either approach to beacceptable, so long as whateverapproach is chosen is fullyimplemented and followed.

10. Nonsafety Issues

68. FDA proposed in § 123.6(c) torecommend, but not to require, thatHACCP plans include controls for suchnonsafety hazards as economicadulteration and decomposition that arenot related to safety. Additionally, FDAproposed to append to the regulations atAppendix D guidance on how aprocessor can use a HACCP-basedapproach to ensure that fish and fisheryproducts are in compliance with theeconomic adulteration and misbrandingprovisions of the act. Approximately 75comments addressed these proposedprovisions. The vast majority of thesecomments urged that proposed§ 123.6(c) and proposed Appendix D ofpart 123 be eliminated from theregulations. Some of these commentssuggested that it might be appropriatefor the contents of proposed AppendixD to be included in the Guide.

Those that argued for removal of therecommendation that HACCP be used tocontrol nonsafety hazards from theregulations stated that: (1) HACCP forsafety purposes will be a big enoughchallenge for both the industry andregulators, and that inclusion ofnonsafety hazards might beoverwhelming; (2) nonsafety hazards,such as economic fraud anddecomposition, are covered adequatelyby existing FDA regulations andstandards and by industry qualitycontrol programs; (3) inclusion ofnonsafety hazards deviates from theinternationally recognized NACMCFrecommendations; and (4) inclusion ofnonsafety hazards, even as arecommendation, would dilute andjeopardize a desirable industry focus onsafety. One comment stated thatprocessing plant personnel andsupervisors should be trained to expectserious consequences when CLdeviations occur because this heightenstheir attention to monitoring andcontrol. However, the comment furtherargued, the consequence of violating anonsafety CL is likely to be relativelyminor. The comment argued that, as aresult, plant personnel and supervisorswill become confused about thesignificance of CL deviations.

A significant minority of thecomments favored the treatment ofnonsafety hazards such as economicfraud and decomposition in the samemanner in which safety hazards aretreated in these regulations, withmandatory HACCP controls. Thesecomments argued that: the sameconditions of processing that affect theoccurrence of safety hazards affect theoccurrence of such nonsafety hazards asdecomposition and economic fraud,making the two control systemscompatible; an improvement inconsumer confidence in seafood cannotbe achieved without improvementsrelative to economic deception anddecomposition; decomposition is thenumber one cause of FDA legal actionwith respect to seafood; decompositionis a good indication of time andtemperature abuse, which has asignificant impact on the growth ofpathogens; the seafood industryconsiders economic fraud to be the mostsignificant hazard affecting themarketing of its products; speciessubstitution can be safety related, as inthe case of the substitution of ascombroid species for a nonscombroidspecies; HACCP controls would likelyenhance compliance with existingnonsafety standards; and inclusion ofcontrols for economic fraud anddecomposition would not significantlyincrease the costs to industry.

FDA concludes that the HACCPsystem will have to mature, and muchwill have to be learned, before it can bedetermined whether a mandatoryHACCP program should includenonsafety matters. Because theseregulations reflect a first step in termsof mandating HACCP, the agency iscomfortable as a matter of policy thatthey should initiate a system thatfocuses on food safety. Additionally, thestatutory provisions that form the basisfor these regulations are safetyprovisions. FDA’s application of HACCPis intended for the effective enforcementof sections 402(a) (1) and (a)(4) of theact, which apply to products thatcontain substances that may render theproduct injurious to health and toprocessing conditions that are insanitaryand that could render a productinjurious to health. Thus, the only realissue is whether the final regulationsshould retain the recommendationswith regard to the application of HACCPto nonsafety matters.

FDA is persuaded by the commentsthat the proposed recommendations forHACCP controls of nonsafety matters,coupled with the presence of proposedAppendix D of part 123, have thepotential for causing confusion aboutthe agency’s expectations and


enforcement policies. FDA recognizesthe point raised by a number ofcomments that advisory provisions areoften confused with or misapplied asrequirements. Given this fact and theemerging nature of HACCP, FDA hasdecided to eliminate proposed § 123.6(c)and Appendix D of part 123. FDA willconsider including the concepts thatunderlay these provisions in the firstedition of the Guide, however, becausethe Guide is understood as being therepository for recommendations relatingto seafood HACCP.

The agency’s decision to eliminatereference to nonsafety hazards fromthese regulations notwithstanding, suchhazards as economic adulteration,decomposition not normally associatedwith human illness, general unfitnessfor food, and misbranding constituteviolations of the act and are subject toregulatory action by FDA (see sections402(a)(3) and 403 of the act (21 U.S.C.343)). When inspections by FDAinvestigators reveal violations of theseprovisions of the act, FDA will takeenforcement action as it deemsappropriate. Processors who are able toaccommodate a HACCP system thatcovers both safety and nonsafetyhazards may find advantage in doing so,in order to better ensure compliancewith existing nonsafety regulations andstandards.

11. ‘‘Shall Render Adulterated’’

FDA proposed to provide that: Failure ofa processor or importer to have andimplement an HACCP plan that complieswith this section or to operate in accordancewith the requirements of this part, shallrender the products of that processor orimporter adulterated under section 402(a)(4)of the act.

The preamble to the proposedregulations explained that the proposedregulations set out those requirementsthat the agency had tentativelyconcluded are the minimum necessaryto ensure that the processing of fish andfishery products will not result inproduct that is injurious to health. FDAtentatively determined that suchminimum requirements include theestablishment of HACCP preventivecontrols. The preamble furtherexplained that section 402(a)(4) of theact, among other things, deems a food tobe adulterated if it is prepared, packed,or held under insanitary conditionswhereby it may have been renderedinjurious to health.

69. A significant number ofcomments, primarily from processorsand trade associations, opposed theproposed language of this provision.The comments urged that the word‘‘may’’ replace the word ‘‘shall’’ in order

to establish that instances ofnoncompliance with the regulations donot automatically constituteadulteration. They contended that,because FDA will not be preapprovingHACCP plans, a negative finding on thefirst FDA inspection could, under thelanguage that was proposed, cause theagency to consider all product producedto that point to be adulterated. Thecomments stated that each case ofnoncompliance should be evaluated onits own merits.

FDA fully agrees that each caseshould be judged on its merits but doesnot agree that it is necessary to changethe regulations in order to establish thisprinciple. The purpose of § 123.6(g),which sets out this language, is not tocreate a legal presumption that food isadulterated if there is not perfectadherence to these regulations but tomake clear that certain types ofpreventive controls are so fundamentalto ensuring the safety of seafood that ifthere is not adherence to them, the foodcannot be considered to have beenproduced in accordance with section402(a)(4) of the act.

As a practical matter, FDA expects toexercise broad regulatory discretion indeciding when violations of theseregulations warrant regulatory action,just as it does now for other situations.The agency will analyze each case on itsmerits, based at least in part on thepotential for harm that exists.

The agency’s primary concern is thatprocessors develop HACCP plans thataddress the hazards that are reasonablylikely to occur. When deficiencies inHACCP plans are detected during FDAinspections, the agency usually will firstattempt to seek voluntary correction ofthe situation. Only when such voluntarycorrection is not forthcoming is it likelythat FDA will elect to pursue regulatoryaction. It must be noted, however, that,where HACCP plan deficiencies resultin significant potential for consumerharm, the agency will evaluate the needfor corrective action with respect to theproduct that has been produced as wellas to the HACCP plan itself.

In this regard, FDA notes that achange from ‘‘shall’’ to ‘‘may’’ in theprovision would be more compatiblewith guidelines than with regulations.Consequently, the agency has retainedthe term ‘‘shall’’ in § 123.6(g). However,to clarify that a decision on whether totake regulatory action will involvediscretion based on the public healthsignificance of the violation, a sentencehas been added to indicate that when aviolation occurs, FDA will evaluate theprocessors overall implementation of itsHACCP plan in deciding how best toremedy the violation.

Consistent with the revisions to therequirements for imported productscontained in § 123.12, the word‘‘importers’’ has been eliminated from§ 123.6. As described in the ‘‘ImportedProducts’’ section of this preamble, theproposed requirement that an importerdevelop a HACCP plan (§ 123.11) hasbeen eliminated in favor of arequirement for importer verificationprocedures. This change eliminated therelevance of § 123.6 to importers.

Consistent with the revision to§ 123.6(a) and (b) that processors haveHACCP plans only when a hazardanalysis reveals one or more food safetyhazards that are reasonably likely tooccur, § 123.6(g) has been amended tostate that a processor’s failure to have aHACCP plan shall render the fish orfishery products adulterated only whena HACCP plan is necessary.

F. Corrective ActionsThe fifth HACCP principle, as

articulated by the NACMCF, is thatprocessors establish the correctiveactions that they will take shouldmonitoring show that a CL has beenexceeded. The NACMCF’s expectationis that these corrective actions should bepredetermined and written into theprocessor’s HACCP plan.

In the proposed regulations, FDAtentatively chose to incorporate theprinciple of corrective action withoutrequiring predetermined correctiveaction plans in the processor’s HACCPplan. Instead, FDA proposed minimum,generic corrective action procedures forprocessors to follow. In so doing, FDAwas trying to minimize the burden ofthe mandatory requirements of HACCP,especially for small processors. FDAtentatively concluded that theprocedures set out in proposed § 123.7represented the minimum requirementsnecessary to ensure that processorsrespond effectively to deviations thatcould affect safety, and that if thoseprocedures were followed, specificcorrective action plans, althoughdesirable, would not be necessary.

FDA proposed in § 123.7 to requirethat deviations from CL’s trigger a seriesof actions, including: Segregating andholding the product, making adetermination of the acceptability of theproduct for distribution, takingappropriate remedial action withrespect to the product and the cause ofthe deviation, and documenting theactions taken. In the preamble to theproposed regulations, FDA invitedcomment on the wisdom of thisapproach as opposed to requiring thatpredetermined corrective action plansbe made part of the HACCP plan. Alarge number of comments responded to


that request. Additional commentsaddressed the specifics of the proposedgeneric-type requirements in § 123.7.

1. Should Corrective Actions BePredetermined?

70. Approximately half of thecomments supported the correctiveaction system proposed by the agency ora variation of it, and the other halfcalled for mandatory predeterminedcorrective action plans. Many of thosethat supported mandatory correctiveaction plans urged consistency with theHACCP recommendations of theNACMCF. These comments noted thatthe NACMCF recommendations areconsistent with Codex AlimentariusCommission standards. They predictedthat compatibility of the finalregulations with such internationalstandards would minimize confusionfor processors and importers, smoothinternational adoption of HACCPprinciples, and facilitate trade. Thecomments stressed that predeterminingcorrective action is an essentialcomponent of a processor’s HACCPprogram, with the seven principlesbeing so closely intertwined that overallsuccess is probable only if all are intact.

A number of comments argued that aprocessor’s implementation of acorrective action plan would eliminateindecision and confusion about whatcorrective action should be taken in theevent of a deviation from a CL. Forexample, one comment pointed out thatcorrective actions written into theHACCP plan would eliminate the needfor employees to substantiate tomanagement the correctness of theirresponse to a deviation, because thecorrective action plan would providethe right actions to be taken for eachparticular deviation. A few commentsstated that, if the appropriate correctiveactions are detailed in the HACCP plan,responses by employees to CL failuresare more likely to be immediate(reducing product losses) and effective(reducing wasted effort). Thesecomments further noted that correctiveaction plans are particularly necessarywhen individuals qualified to makeproduct safety evaluations are notreadily available.

One comment asserted that thestrength of the HACCP system is that itis preventive, and that corrective actionplans are fundamental in preventing aproduct, for which there is a safetyconcern, from reaching the consumer.The comment further stated that writtencorrective action plans should providefor the documentation of the following:(1) The cause of the deviation, (2) theaction taken to ensure that the deviationdoes not reoccur, (3) the results of the

risk evaluation, and (4) productdisposition.

Many comments did not agree thatcorrective action plans should berequired. A few comments argued thatdeveloping a corrective action plan isimpractical and can be undulyrestrictive because of the diversity andcomplexity of seafood products and ofseafood processing operations. Onecomment noted that many situationsexist in which the appropriate responseto a CL failure is not apparent until thedetails of the particular situation areknown. Several stated that a correctiveaction plan is less preferable thanhaving responsible and knowledgeablepersonnel, adequately trained inHACCP, available to evaluate adeviation from a CL. If such personnelare available, one comment noted,deviations can be handled on a case-by-case basis, with appropriatedocumentation of the disposition of theaffected product.

Several comments argued that thelack of a corrective action plan is notsufficient evidence to demonstrate thata product is adulterated. The commentsargued that the proposed requirementthat a processor establish CL’s andperform and record appropriatecorrective actions when these limits areexceeded, provides sufficientdemonstration of hazard control.

A number of comments thatadvocated the concept of predeterminedcorrective action plans urged thatprocessors be given the option ofwriting such plans or of following aseries of minimum mandatory actions,like those proposed by FDA, when CLfailures occur. In the preamble to theproposed regulations the agency did, infact, encourage processors topredetermine corrective actions as partof the preparation of a HACCP plan.

On this issue, the merits of thevarious approaches tend to balance.Consequently, FDA agrees with thosecomments that urged that theregulations provide processors with theoption of developing their owncorrective action plans as part of theirHACCP plans or of following a genericmodel corrective action plan, providedin the regulations, should a deviationoccur.

The agency accepts the view thatpredetermined plans have the potentialto provide processors with benefits, aspointed out by the comments, such asfaster action when a deviation occurs,less need to justify to management theappropriateness of the corrective actionafter it has been taken, and a moretimely response to the deviation whentrained or otherwise qualifiedindividuals are not readily available to

make determinations. On the otherhand, FDA has not been provided withinformation on which it can concludethat these benefits—as desirable as theymay be—need to be mandated in orderto protect the public health. Processorscan build them into their HACCPsystems if they so choose, but the publichealth will be protected so long asshipment of the affected product intocommerce does not occur until thesignificance of the deviation has beenassessed and appropriately resolved.

This outcome is assured both withspecific predetermined corrective actionplans and with the minimum genericmodel that FDA is requiring as analternative. Without additional evidencefrom actual experience, which was notprovided by the comments, FDA cannotconclude that the overall success ofHACCP depends on whether processorshave specific predetermined plans forevents that might not necessarily occur.

Consequently, FDA has revised§ 123.7 to permit, but not to require,processors to include in their HACCPplans any written corrective actionplans that they develop. When adeviation from a CL occurs, § 123.7(a)requires that processors either: (1)Follow a corrective action plan that isappropriate for the particular deviation,or (2) follow the series of actionsprovided in § 123.7(c). The steps in§ 123.7(c) constitute a minimum genericmodel for corrective actions and, as willbe explained below, closely match thosethat were contained in the proposedregulations.

The final regulations at § 123.7(b)define an appropriate corrective actionplan as one that addresses both thesafety of the product that was beingprocessed when the CL failure occurredand the cause of the deviation. In thisrespect, the contents of the correctiveaction plan are consistent with theviews of the NACMCF (Ref. 34, pp. 199–200). The corrective action must ensurethat any unsafe product is notdistributed.

FDA advises that action necessary tocorrect the product may involve any oneor more of the following steps:Immediately reprocessing the product;diverting the product to another usewhere it can be used safely; segregatingthe product, holding it, and having itevaluated by a competent expert; ordestroying the product. In order toensure that subsequent product is notsubjected to the same deviation, thecorrective action must be sufficient tobring the process back under control(Ref. 34, pp. 199–200). FDA advises thatsuch action may involve, whereappropriate: adjustments to thoseprocess parameters that have an effect


on the relevant CL (e.g., flow rate,temperature, source of raw materials);temporarily diverting product around apoint in the process at which problemsare being encountered; or temporarilystopping production until the problemcan be corrected.

Section 123.7(c) describes the stepsthat a processor must take wheneverthere is a deviation from a CL but nocorrective action plan to follow. Asstated above, these steps constitute aminimum generic-type corrective actionplan. The objectives of these steps arethe same as those of a preconceivedplan: To ensure that adulterated productdoes not enter commerce and to correctthe cause of the deviation. Because it isa generic-type plan that is intended tobe applicable to any situation, some ofthe steps, such as segregating andholding the affected product(§ 123.7(c)(1)), might not be necessary ifthe corrective action had beenpredetermined. This aspect of thegeneric-type plan may provideprocessors with an incentive topredetermine corrective actionswhenever practical.

Another such incentive is therequirement, at § 123.7(c)(5), that theprocessor reassess the adequacy of itsHACCP plan when a deviation occurs.This requirement does not exist wherea corrective action plan exists. Thereason for the distinction is that, on onehand, if a processor has assessed itsprocess and decided that CL failures arelikely to occur from time to time atparticular points, those failures, whenthey occur, do not represent a failure ofthe plan but a foreseeable occurrence.On the other hand, if the processor hasnot made such an assessment, and afailure occurs, it is not possible to saywhat the failure means. The processormust assess whether the deviation is theresult of a system-wide problem that isnot being properly addressed by theplan or simply a failure that could beexpected to occur in the normal courseof things. The failure must be fullyassessed, and if it represents a failure ofthe plan, the plan must be modified toreduce the risk of reoccurrence.

The agency is convinced that thecorrective action approach contained inthe final regulations (i.e., predeterminedcorrective action plans at the option ofthe processor) adheres to the principlesof HACCP as recommended byNACMCF (Ref. 34, pp. 199–200) andwill not result in undue burden,confusion, or trade difficulties. At thesame time, these regulations willprovide the flexibility needed toaccommodate the varying levels ofHACCP sophistication within theindustry. FDA is satisfied that employee

indecision in responding to CLdeviations will not result in a publichealth problem in the absence ofcorrective action plans because the finalregulations contain a set of well definedactions that are to be followed if adeviation occurs and no predeterminedplan exists. The actions outlined in§ 123.7(d) ensure that no unsafe productwill enter commerce, and that anormalization of processing conditionswill be effected as quickly as possible.While the agency sees merit in theargument that predetermined correctiveaction plans will, in many cases, beeconomically beneficial to a processor(e.g., minimize product loss and wastedeffort), such economic factors will, inand of themselves, motivate processorsto predetermine appropriate correctiveactions, but they do not mean that theagency needs to require the adoption ofpredetermined plans.

71. A few comments recommendedthat FDA review corrective action plansfor adequacy during, or in advance of,the first regulatory visit. This review,the comments asserted, would help toavoid a situation in which the processortakes a corrective action in conformancewith its HACCP plan, but the agencylater determines that the action wasinadequate.

FDA agrees that these commentsreflect a desirable ideal but mustacknowledge that such a reviewordinarily will not be feasible. Ifprocessors complete their HACCP plans,including any corrective action plansthat they choose to develop, before theeffective date of these regulations, theymay be able to obtain a review of thoseplans as part of a routine FDAinspection.

In any event, the agency intends toreview corrective action plans that aprocessor includes as part of its HACCPplan during routine regulatoryinspections. Where the investigatorfinds a shortcoming in the correctiveaction plan, the investigator will discussit with the processor. As with a failureto meet any other provision of theseregulations, in determining its responseto such a shortcoming, the agency willconsider the totality of the situation andthe likelihood that the shortcoming willhave an adverse impact on the safety ofthe product. If a corrective action planhas not actually been used as of the timeof the investigator’s review, and as aconsequence of its review the agencyadvises the processor that the correctiveaction plan needs to be improved, it islikely that FDA will advise theprocessor to follow the alternativeprocedure in these regulations until theupgrade occurs.

2. Assessing the Product for Safety

72. FDA received comments onspecific aspects of the generic-typecorrective action plan provided inproposed § 123.7(a). A significantnumber of comments opposed theprovision that would have required an‘‘immediate’’ safety assessment when aCL deviation occurs. One commentstated that, because an appropriatelytrained individual may not beimmediately available to make adetermination of the acceptability of thelot, the provision should be modified torequire segregation and holding of theaffected product until either a timelysafety review by a properly trainedindividual has been completed, or adetermination has been made that theappropriate predetermined correctiveaction plan has been followed. Anumber of other comments alsosuggested that the phrase ‘‘immediatereview’’ be revised to ‘‘timely review.’’One comment recommended that FDAspecify a maximum amount of time inwhich to evaluate the product, forexample within 24 hours. Anothercomment advised that FDA permitprocessors to cook or freeze freshproduct involved in a CL deviation,until an evaluation can be completed.

FDA agrees that immediate review isnot necessary. As long as the reviewoccurs before the product is distributed,the public health will be sufficientlyprotected. Consequently, while§ 123.7(c)(2) requires a review todetermine the acceptability of theaffected product for distribution, it doesnot require that the review beimmediate, nor does it otherwise specifya timeframe for review. If there is achance that the product is still fit forcommerce, FDA expects that economicconsiderations will dictate the timing ofthe review. FDA agrees that, in manycases, it would be advantageous for aprocessor to cook or freeze a productpending results of a safety evaluation.The agency has no objection to such anaction as long as the processormaintains the identity of, and its controlover, the lot.

FDA has also modified § 123.7(c)(2)from the proposal to require that thereview of the product be conducted bysomeone with adequate training orexperience, although FDA is not tyingadequate training to training in HACCP(see § 123.10) as it did in the proposal.FDA made this change because, ascomments pointed out, a 3-day coursein HACCP would not necessarily qualifysomeone to make many public healthdeterminations of this nature. The basisfor this modification is more fully


described in the ‘‘Training’’ section ofthis preamble.

3. Documenting Corrective Actions

In § 123.7(d), FDA is retaining theproposed requirement that records ofcorrective actions be kept. As with theproposal, such records are subject to thegeneral recordkeeping requirements of§ 123.9. The records must document theactions taken in following either apredetermined corrective action plan orthe corrective action proceduresspecified in § 123.7(c).

73. One comment suggested that theabsence of written corrective actionplans would make it more difficult todocument a response to a deviation. Itwent on to explain that, with a plan, theprocessor could simply note, forexample, that ‘‘the product wasrecooked in accordance with ‘Section Bof the Plan.’’’ It pointed out that moreextensive documentation would benecessary if a processor did not have apredetermined plan.

FDA does not agree with thiscomment. Section § 123.7(d) requiresthat the corrective action taken by aprocessor be fully documented. It is theagency’s intent that such documentationprovide the specifics about the actionsthat were taken and not simply refer toa written procedure. In the examplegiven, records of the recookingoperation, equivalent to monitoringrecords for such an operation, i.e.,cooking, would be necessary todocument that the operation wasperformed in a manner that wouldrender the product safe. Thus, similardocumentation would be necessarywhether a plan exists or not.

It is worth noting that § 123.7(d) nowstates that corrective action records aresubject to verification in accordancewith § 123.8(a)(3)(ii). This requirementis not new but reflects the fact thatrecord review is deemed to be averification activity in the finalregulations but was not classified assuch in the proposal. A furtherdiscussion of this matter can be foundin the section of this preamble thatfollows.

G. Verification

1. Overview

Verification is one of the sevencommonly recognized principles ofHACCP. In the preamble to theproposed regulations, FDAacknowledged and discussed therecommendations of the NACMCF asthey relate to verification. According tothe NACMCF, verification essentiallyinvolves: (1) Verifying that the CL’s areadequate to control the hazards; (2)

ensuring that the HACCP plan isworking properly, e.g., that it is beingfollowed, and that appropriate decisionsare being made about corrective actions;and (3) ensuring that there isdocumented, periodic revalidation ofthe plan to make sure that it is stillrelevant to raw materials as well as toconditions and processes in the plant.

2. Need for Verification Requirement inRegulations

In the preamble to the proposedregulations, FDA encouraged processorsto adopt verification practices but didnot propose to require that a processor’sHACCP plan specify the verificationprocedures. Rather, the agencytentatively concluded that verificationof a HACCP plan would effectivelyoccur through: (1) Comparison of theplan to guidance documents such asFDA’s draft Guide; (2) technicalassistance provided through tradeassociations, universities, andgovernment agencies; (3) mandatoryreview of monitoring and correctiveaction records by trained individualsbefore product distribution; (4)mandatory reassessment of theadequacy of the HACCP plan as aconsequence of CL deviations; (5)reliance on the recommendations inFDA guidelines that processors ofcooked, ready-to-eat seafood productsuse the expertise of ‘‘processingauthorities,’’ i.e., third-party experts; (6)mandatory training; and (7) investigatorreview of the entire HACCP systemduring routine agency inspections. FDArequested comment on whether thisapproach is adequate to ensure that theverification principle was beingproperly addressed.

74. A large number of commentsresponded to this request.Approximately one-third of thesecomments stated that FDA’s proposedapproach to HACCP verification wasadequate. The other comments arguedthat verification should be specificallymandated as a part of a firm’s HACCPprogram.

A few of the comments favoring theproposed approach contended that aHACCP plan lacking verificationprocedures should not be grounds forFDA to consider a product to beadulterated. Several comments statedthat processors will engage inverification activities without arequirement, as a natural outgrowth ofa HACCP program, because withoutsuch activities, HACCP will not work.For this reason, they argued, it is notnecessary to mandate that verificationprocedures be included in processor’sHACCP plans.

Of the comments that supported theneed for specifically-mandatedverification activities, a significantnumber urged the agency to adopt sucha requirement to be consistent with theHACCP recommendations of theNACMCF. These comments noted thatthe NACMCF recommendations areconsistent with Codex AlimentariusCommission standards. They predictedthat compatibility of the finalregulations with such internationalstandards would minimize confusionfor processors and importers, smoothinternational adoption of HACCPprinciples, and facilitate trade. Thecomments stressed that verification isan essential component of a processor’sHACCP program, and that the sevenprinciples are so closely intertwinedthat overall success is probable only ifall are intact.

One of the comments stated thatverification should involve a continualreview and improvement of the HACCPsystem. The comment added thatverification is a primary responsibilityof processors, one that is equivalent inimportance to plan development.Several comments stated that thebenefits of HACCP verification include:Assurance that all CCP’s are identified,assurance that the plan is beingfollowed, a mechanism for third partyoversight of the plan developmentprocess, a means of measuring thesuccess of a HACCP system, andinformation on trends in the frequencyand reasons for CL deviations. Onecomment suggested that firms should berequired to perform verificationactivities at least annually.

A few comments stated that althoughthe proposed regulations included somerequired practices that could be deemedto be verification, such as the calibrationof process-monitoring instruments andplan reassessment and modification inresponse to a CL failure, the entireconcept of verification should beaddressed more fully in a separatesection of the final regulations. One ofthese comments suggested that thefollowing verification activities bespecifically mandated: Calibration ofprocess control instruments, validationof software for computer controlsystems, and daily review of monitoringrecords.

One comment stated that, without arequirement for specific verificationactivities, processors would rely strictlyon end-product testing to evaluate thesuccess of the HACCP plan, and thatsuch an approach would diminish theeffectiveness of the entire HACCPsystem. Several comments stated thatHACCP plan verification procedures


should include detailed government andindustry audits and product analyses.

One comment, from a consumeradvocacy organization, challengedwhether effective verification wouldreally occur through the measures citedin the preamble. The comment statedthat ‘‘third-party technical assistance’’ isnot a mandatory part of the HACCPprogram and, therefore, can not becounted on as a verification procedure.It added that such technical assistancewould tend to be performed during plandevelopment, and that verification mustbe an ongoing procedure. The commentstated that a ‘‘review of all HACCP-monitoring records by trainedindividuals before distribution ofproduct’’ is not verifiable by the agencybecause a firm can cut corners by havingtheir employees sign the recordswithout reviewing them. The commentargued that FDA auditing of consumercomplaints and mandatory in-processand end-product testing are importantverification procedures.

A few comments suggested that FDAshould include a requirement thatwritten verification procedures be inplace, but that the agency need notprescribe specific verification activities,or should do so only sparingly.

FDA notes that the proposedregulations contained specificprovisions identified by many of thecomments as appropriate verificationsteps. For example, the proposedrequirement that the HACCP planadequately address the food safetyhazards that are reasonably likely tooccur (§ 123.6(c) in this final rule) is acontinuing, rather than a one-timerequirement. Thus, to continually be incompliance with it, a responsibleprocessor would have to engage in someform of reassessment. Other provisionsin the proposal that commentsidentified as verification steps included:The required calibration of processmonitoring instruments; the requiredvalidation of computer software; therequirement that consumer complaintsbe reviewed to assess whether theyindicate a problem at a CCP; and therequirement that HACCP-monitoringand corrective action records bereviewed before distribution of theproduct. FDA now realizes, however,that by not specifically requiringverification as such, the proposalgenerated considerable confusion aboutwhether FDA intended to include orexclude the principle of verificationfrom processors’ HACCP programs. FDAhas concluded, therefore, thatverification is important enough to bean explicit part of the regulations. FDAhas made it such in the final rule at

§ 123.6(c)(6) and in a new section forverification, § 123.8.

Section 123.6(c)(6) requires thatprocessors include in their HACCPplans a list of the verificationprocedures that they will use and thefrequency of those procedures. Thisprovision is consistent with the view ofthe NACMCF that a processor’sverification procedures should beaddressed in the HACCP plan (Ref. 34,pp. 200–202). FDA does not expect thatthis requirement will be particularlyburdensome for the processor for tworeasons. First, the requirement thatverification procedures be listed in theHACCP plans is really only a variationof the proposal in that FDA proposed torequire a number of the activities that itis now designating as verificationactivities in § 123.6(b)(4) (e.g.,calibration of monitoring instrumentsand review of consumer complaints).Second, a list of the steps that aprocessor determines are appropriatelya part of the annual reassessment of theHACCP plan need not be extensive ordetailed. FDA recognizes that, at leastinitially, much of the annualverification procedure could take theform of meetings and discussion, andmay not lend itself well to a detailedlisting of steps. FDA believes that theannual verification procedure should beallowed to evolve, and that arequirement that the listing of steps inthe plan be detailed before an annualverification ever occurs could adverselyaffect that evolution.

The new section on verification,§ 123.8, describes the minimumcomponents of a processor verificationprogram. Among other things, theagency has consolidated there thoseaspects of the proposal that, accordingto comments, should be designated asverification activities. Section § 123.8contains little in the way of detail thatwas not included in the proposedregulations. In addition, it is designed tobe generally consistent with theverification concepts expressed by theNACMCF, as requested by comments,and at the same time, not undulyburdensome.

3. Verifying the HACCP PlanSection 123.8(a) requires that

processors with HACCP plans verifytwo aspects of their HACCP systems: (1)That their HACCP plans are adequate tocontrol food safety hazards that arereasonably likely to occur, and (2) thattheir plans are being effectivelyimplemented. Verifying these twoaspects is, essentially, what theNACMCF refers to as the first andsecond of the four processes ofverification (Ref. 34, p. 201).

Second, § 123.8(a)(1) requires that areassessment of the HACCP plan occurwhenever there are any changes of thetype listed in these regulations thatcould alter the plan, or at least annually.The NACMCF takes the view thatverification must occur on a periodic,regular basis (Ref. 34, p. 202), althoughno specific timeframes are suggested.FDA agrees with the NACMCF and thecomments that verification of theadequacy of the HACCP plan should beconducted on a regular basis, even inthe absence of a recognized change, toensure that the plan continues toaddress all of the reasonably likely foodsafety hazards with appropriate CL’sand monitoring procedures. It isessential that processors verify theadequacy of their plans and that thisverification occur on a periodic basis.Processors should conduct the review atintervals that are appropriate for theirprocesses. FDA agrees with one of thecomments, however, that this intervalbe no more than a year in order toensure that the plan remains adequate toaddress the hazards associated with thespecies and processes (Ref. 206, p.1084).

The regulations at § 123.8(a)(1)provide examples of changes that couldtrigger a reassessment. These includechanges in raw materials, productformulation, processing methods orsystems, finished product distributionsystems, or the intended use orconsumers of the finished product.These examples are derived from theNACMCF materials on the ‘‘fivepreliminary steps’’ that form the basisfor the HACCP plan (Ref. 34, pp. 188and 201). A change in any of these areascould necessitate a change in the planin order to respond to any new hazardsthat may have been introduced or tomaintain preventive control overexisting ones. It is important torecognize that this list is not allinclusive.

Section 123.8(a)(1) requires that theplan reassessment be performed by anindividual that has been trained inHACCP in accordance with § 123.10.This requirement is a logical outgrowthof the proposed requirement in § 123.9that a HACCP-trained individual beresponsible for the initial developmentof, and subsequent modifications to, theHACCP plan. These kinds of activitiesrequire an understanding of theprinciples of HACCP and plandevelopment as obtained throughtraining that is at least equivalent to thecourse required in § 123.10.

Section 123.8(a)(1) also requires that,where a reassessment reveals that theHACCP plan is inadequate, theprocessor shall immediately modify the


plan. Failure of a processor toimmediately modify its HACCP planafter it has determined that the plan isinadequate would result in theprocessor operating under a plan that isnot in conformance with theseregulations.

FDA recognizes that the methods thatprocessors will use to verify that theplan is still adequate will vary, based onindividual preferences and pastexperience. FDA agrees with commentsthat urged the agency to permitmaximum flexibility in the developmentof verification procedures that aretailored to individual operations.Nonetheless, the agency encouragesprocessors to consider the guidance inthe March 20, 1992, NACMCFpublication, ‘‘Hazard Analysis andCritical Control Point System.’’

Moreover, FDA believes that the bestway for the agency to judge the meritsof a processor’s annual verification willbe through its own continuingdeterminations of whether theprocessor’s overall HACCP systemremains appropriate for thecircumstances. These determinationswill occur as a product of the agency’songoing inspection program.

On this subject, FDA is sensitive tothe comment that the absence ofverification procedures from a HACCPplan should not, in and of itself, causea food to be deemed adulterated under402(a)(4) of the act. Nonetheless, theabsence of verification could jeopardizethe likelihood of success of the overallprogram. For example, monitoring acritical cooking step with a thermometerthat has not been calibrated provideslittle assurance that the CL is actuallybeing met, and failure to review recordsmay allow the absence of monitoring orimproper corrective action to gounnoticed for extended periods of time.Should the agency find itself in theposition of having to react to theabsence of adequate verificationprocedures in a processor’s HACCPplan, in deciding whether to bringregulatory action, the agency willconsider the totality of the situation,and the likelihood that it would have anadverse impact on the final food, as itwould in considering a processor’sfailure to meet any specific provision.

4. Verifying the Implementation of thePlan

The regulations at § 123.8(a)(2) and(a)(3) require ongoing verificationactivities in addition to the annualreassessment. These ongoing activitiesare in keeping with the NACMCF’s viewthat verification must also take the formof ‘‘frequent reviews’’ (Ref. 34, p. 201).Frequent reviews relate primarily to

whether the HACCP plan is functioningeffectively on a day-to-day basis. It isimportant to note that, for the most part,the requirements in these sections wereproposed in other parts of theregulations and are now being compiledin § 123.8(a)(2) and (a)(3). Severalcomments on these provisions pointedout that they were verification steps andshould be referred to as such. FDAagrees and has brought them together inthis new verification section of the finalregulations. Section 123.8(a)(2) requiresthat processors review consumercomplaints (proposed at § 123.6(b)(4)),calibrate process monitoringinstruments (proposed at § 123.6(b)(4)),and perform periodic end-product or in-process testing, as appropriate, inaccordance with written procedures forthese activities in the HACCP plan.

Section II H. of this preambleaddresses the review of consumercomplaints at some length.

The provision on the calibration ofmonitoring instruments(§ 123.8(a)(2)(ii)) is brought forwardwith no substantive change from theproposal. Calibration is an importantactivity and involves readily definedprocedures that can easily be providedin the plan.

Calibration can include the validationof computer hardware and software.FDA proposed to require that theHACCP plan detail the methods ofcomputer software validation to be usedby the processor. FDA received a smallnumber of comments both for andagainst computer software validation asa worthwhile part of verification. Twocomments supported the need forconsumer software verification. But twocomments suggested that computersoftware verification would be anunnecessary expense because it wouldresult in only marginally improvedreliability.

The agency has worked extensivelywith the low-acid canned food industryto verify computer hardware andsoftware that the industry is now usingto operate or control various processingfunctions. That experience hasdemonstrated to FDA both thedesirability and the feasibility ofverifying computer hardware andsoftware. For low-acid canned foods, theindustry is using computers to performseveral functions, including monitoringcompliance with CL’s, controlling theprocessing operations, taking correctiveactions, and recordkeeping (Ref. 221).

In a HACCP system such as that beingestablished for seafood by theseregulations, FDA is interested inensuring that hardware and software forcomputers that monitor compliancewith a CL be verified. However, when

computers are used as process-monitoring instruments, they must becalibrated in accordance with§ 123.8(a)(2)(ii). The other functions thata computer can perform, as listed above,can be verified through proceduresrequired elsewhere in these regulations(e.g., recordkeeping can be verifiedthrough the review of records by atrained individual in accordance with§ 123.8(a)(3)). Consequently, the agencyhas concluded that it is not necessaryfor these final regulations to include aspecific requirement for computervalidation.

Instead, the agency acknowledges thatthe proper frequency of equipmentcalibration is entirely dependent uponthe type of instrument and theconditions of its use. Therefore, FDA isnot being prescriptive in this regard.FDA has, however, provided guidanceon the subject in the draft Guide.Additional guidance should beobtainable from the manufacturer of theinstrument. The nature and frequency ofthe calibration effort should bedetermined at the time of HACCP plandevelopment and should be included inthe plan to ensure that it is regularlyand appropriately done. The agency isconvinced that without suchformalization, calibration, which, forsome instruments, may be done asinfrequently as once per year, may beoverlooked.

5. Product Testing

75. Section 123(8)(a)(2)(iii), whichlists the performing of end-product orin-process testing, is a new provision.FDA requested comment on what tests,including or in place of end-producttesting, should be used to measure thesuccess of the HACCP program, both interms of individual firms and thenational program as a whole, and howfrequently such tests should beadministered (Ref. 208 at 4183). A largenumber of respondents addressed FDA’srequest for comment. Approximatelyhalf of these comments supported theneed for an end-product testingrequirement. The other half objected tosuch a requirement or suggested that theneed should be determined on a case-by-case basis.

A number of consumer advocacyorganizations suggested that endproduct testing is essential because noother verification mechanism providespublic confidence that HACCP programsare actually resulting in a safer product.Several comments stated that regularmicrobiological testing would help aprocessor determine whether there aresources of contamination that are notbeing controlled.


A few comments suggested that suchtesting should be performed morefrequently during plan development andvalidation, and then reduced to somelower level as part of a firm’sverification efforts. Another commentsuggested that testing should beperformed quarterly by those processorswith a poor record of compliance andannually by those with a good record.

Several comments suggested that theneed for and frequency of productanalysis should be established as part ofthe HACCP plan development process.One of these comments noted that thefrequency of testing may fluctuatedepending, in part, upon changes inpersonnel, raw materials, equipment,and product formulation.

A number of comments stated thatend-product testing is a questionablemethod for measuring the success of aHACCP system. One of these commentsstated that end-product testing measuresthe effectiveness of the plan for a small,finite portion of production and haslimited value in measuring the successof the HACCP plan overall.

One comment stressed that finishedproduct testing is contrary to theconcept of HACCP, i.e., a reliance uponpreventive controls at critical pointsthroughout the system. Anothercomment contended that mandatorymicrobiological analysis of foods wouldbe inappropriate because: (1)Statistically valid sampling programs forpathogens are not economically feasiblebecause of the low incidence ofpathogens in most foods; (2) the use ofindicator organisms to predict thepresence of pathogens is not alwaysreliable and, where it is not, can becomemerely a test for aesthetics; and (3)microbiological analysis of foods isoften costly, imprecise, and slow, and,therefore, not suitable for real time datageneration.

The agency acknowledges theshortcomings of product testing,especially microbiological testing, usedfor process control as pointed out by thecomments. The NACMCF, in itscomments in response to FDA’squestions about product testing,reiterated its view that, whileverification is essential to the success ofHACCP, end-product testing has limitedvalue for measuring the success of aHACCP system. Comments also notedthat in-process or finished producttesting should not normally be aprerequisite for lot release under aHACCP program.

However, FDA recognizes that manyprocessors will find that product testinghas a role to play in the verification ofHACCP systems, and the agency wishesto encourage incorporation of testing

into HACCP plans, where appropriate.Consequently, the regulations at§ 123.8(a)(2)(iii) list end-product and in-process testing as a verification activityat the option of the processor.

The agency provided guidanceconcerning appropriate attributes forproduct testing in the draft Guide andintends to elaborate on it in the firstedition of the Guide.

6. Records ReviewSection § 123.8(a)(3) requires that a

trained individual review all recordsthat document monitoring of CCP’s, thetaking of corrective actions, thecalibrating of any process controlinstruments, and the performing of anyend-product or in-process testing. Thereview of HACCP records by a trainedindividual was included in theproposed regulations at § 123.8(b). Inresponse to comments that urgedconsistency with the recommendationsof the NACMCF, FDA has designatedthis review a verification function forpurposes of the final regulations and hasincluded it in the section onverification. Specifically, the proposedregulations provided that a HACCP-trained individual review themonitoring records, sanitation controlrecords, and corrective action recordsbefore distribution of the product towhich the records relate. Under theproposal, the individual’s review wouldinclude records of process monitoringinstrument calibration, because theagency characterized these records asmonitoring records.

The comments that FDA received onthese provisions focused on theproposed requirement that the reviewby the trained individual occur beforethe product could be shipped. Severalcomments objected, stating that such areview before shipment wasunnecessary, because under thecorrective action provisions of theproposed regulation, any CL deviationcaught by the observer/operator wouldnecessitate the segregation and holdingof the affected product before shipmentuntil the safety of the product could beassured. One comment further statedthat linking lot release to record reviewbefore shipment underestimates thelevel of control attainable through themonitoring and corrective actionprinciples of HACCP.

Comments from several processorsand trade associations stated that, forsome processors, it would beimpractical to withhold the shipment ofevery lot until HACCP records could beverified and signed. These commentsnoted that, with the use of today’s highspeed processing lines, it is normalpractice for some processors to begin

shipping products before the end of theshift (lot). Several comments also statedthat holding a product until the HACCPrecords could be reviewed could resultin a product being subjected tounfavorable conditions during storage,which could compromise both qualityand safety.

Several comments urged thatprocessors be permitted to review theHACCP records at the end of the day orat the end of the shift, even if thisreview occurred after distribution.Others suggested that record reviewshould be performed within a‘‘reasonable time’’ of production of therecord.

The agency remains convinced thatthe coupling of lot release withverification-type record review providesa valuable added level of safetyassurance. This kind of record reviewbefore shipment is a regulatoryrequirement for low-acid canned foodsand acidified foods. FDA’s experiencewith these industries is that recordreview before distribution has beeninstrumental in preventing theintroduction of potentially hazardousfoods into commerce (Ref. 221). Theagency encourages processors toinstitute such a program wheneverpossible.

However, FDA accepts from thecomments that the proposedrequirement would cause certainprocessors to delay shipping perishableproducts and thus present anunacceptable burden to them. Theagency therefore is not requiring thatrecord review occur before shipment.

Uncoupling record review from lotrelease leaves as the primary purposefor record review the periodicverification that the HACCP plan isappropriate and is being properlyimplemented. Record review needs tooccur with sufficient frequency so as toensure that any problems in the designand implementation of the HACCP planare uncovered promptly and to facilitateprompt modifications. The concept isroughly that of a ‘‘feedback loop,’’ withinformation coming out of the recordreview process in such a timely mannerthat it can have impact on theproduction of subsequent lots of theproduct.

FDA is convinced that a weeklyreview of HACCP monitoring andcorrective action records would providethe industry with the necessaryflexibility to handle highly perishablecommodities without interruption,while still facilitating speedy feedbackof information. FDA is reluctant toallow the level of flexibility provided bysuch language as ‘‘reasonable time,’’ outof concern for the confusion that it


would generate. FDA’s experience withlow-acid canned foods and acidifiedfoods has demonstrated that review ofthese kinds of records is a criticalverification tool. FDA is, therefore,adopting the proposed provision as§ 123.8(a)(3) with one revision. As setout in the final rule, it requires that theHACCP-trained individual review themonitoring records of CCP’s and therecords that document the taking ofcorrective actions within 1 week of themaking of the records, rather than beforeshipment, as a part of a processor’sverification activities (§ 123.8(a)(3) (i)and (ii)).

FDA agrees, on the other hand, thatthis principle need not apply to thereview of records of such verificationactivities as process control instrumentcalibration and product testing. Thefrequency of these activities will bevariable and dependent upon theHACCP plan development process.Consequently, setting a specific reviewfrequency for these records is notwarranted. Section 123.8(a)(3)(iii)reflects this conclusion. It requires thatthe HACCP-trained individual reviewthe calibration records within areasonable time after the records aremade, rather than before any additionalproducts are shipped. It also applies thesame ‘‘reasonable time’’ standard to anyend-product testing records that aremade.

The proposed regulations did notaddress the review of end-producttesting records by a trained individual.The requirement in these finalregulations for a review of such recordsreflects the principle contained in theproposal that there be a verification-typereview by a trained individual of theHACCP records that are being created bythe processor. In this respect, theresponsibilities of the trained individualare unchanged from those that werecontemplated in the proposal, althoughdetails relating to those responsibilitieshave been modified based on thecomments.

Section § 123.8(b) requires thatprocessors take appropriate correctiveaction whenever a review of a consumercomplaint, or any other verificationprocedure, reveals the need to do so.This provision is essentially arestatement of the proposal regardingconsumer complaints, expanded toinclude the results of verificationprocedures for purposes of emphasis.Verification was not specificallyincluded in the proposal. FDA isincluding a reference to it here toremind processors not to preclude thepossibility that information obtainedthrough verification could lead to thetaking of a corrective action. This

possibility exists even though, moreoften than not, verification will notprovide the kind of immediate feedbackthat the processor will receive frommonitoring. Corrective actions based oninformation received throughverification will be exceptions to therule. However, processors should bemindful of the possibility.

7. Verifying the Hazard Analysis

Section 123.8(c) requires that,whenever a processor does not have aHACCP plan because a hazard analysishas not revealed any food safety hazardsthat are reasonably likely to occur andthat can be controlled through HACCP,the processor must reassess the hazardanalysis whenever a change occurs thatcould reasonably affect whether such ahazard exists. FDA has includedexamples of such changes in § 123.8(c).The list is identical to that provided in§ 123.8(a)(1), for when a plan must bereassessed. Consequently, any change inthese factors should warrant areassessment to be certain that a plan isstill not needed.

FDA has concluded that, under amandatory HACCP system, the principleof verification applies equally to adecision that a HACCP plan is notnecessary as it does to a decision thatthe plan continues to be adequate.Circumstances change, and processorsmust be alert to whether the exemptionfrom the requirement to have a plancontinues to apply to them.

Section 123.8(d) requires thatprocessors document calibration andproduct testing in records that aresubject to the recordkeepingrequirements of the regulations at§ 123.9. The requirement that records bekept of process monitoring instrumentcalibration was included in theproposed regulations at § 123.6(b)(5).The requirement that records of end-product testing be kept is consistentwith the general recordkeepingprinciples of HACCP. The one exceptionis that FDA is not requiring records thatdocument the review of consumercomplaints. The agency is satisfied thatthe requirement for a processor toreview consumer complaints relating topotential safety concerns will besufficient for this kind of verificationactivity. Moreover, as explained in thediscussion of consumer complaintselsewhere in this preamble, FDA ispersuaded that most consumercomplaints will involve mattersunrelated to the mandatory HACCPsystem.

H. Consumer Complaints

1. BackgroundIn the proposed regulations, FDA

tentatively concluded that eachprocessor’s HACCP system had toutilize any consumer complaints thatthe processor receives that allege aproblem with product safety. Severalprovisions described how consumercomplaints were to be used. In one, FDAproposed to require that a processor’smonitoring efforts include the use ofconsumer complaints, and that itsHACCP plan reflect how they will beused. In a second provision, FDAproposed to require that, when aprocessor receives a consumercomplaint that may be related to theperformance of a CCP or that may reflecta CL deviation, the processor determinewhether a corrective action iswarranted, and, if so, take one inaccordance with the specified correctiveaction procedures. FDA also proposedto require that the taking of suchcorrective actions be fully documentedin records. Finally, FDA proposed torequire that consumer complaints thatrelate to the operation of a CCP or to apossible CL deviation be included aspart of the processor’s HACCP recordsand be available for agency review andcopying.

FDA’s rationale for proposing theserequirements was that consumercomplaints may be the first alert that aprocessor has that problems areoccurring that are not being detected orprevented by the processor’s HACCPcontrols. While the goal of a HACCPsystem is to prevent all likely hazardsfrom occurring, no system is foolproof.The agency tentativelyconcluded,therefore, that each HACCPsystem should take advantage ofconsumer complaints as they relate tothe operation of CCP’s. FDA alsotentatively concluded that it might benecessary for the agency to review thosecomplaints in order to be able to verifywhether a processor is taking necessarysteps to review its HACCP controls andtake corrective actions as necessary inresponse to consumer complaints. Theagency emphasized that it was referringsolely to complaints relating to theoperation of the HACCP CCP’s (i.e.,those that allege a problem with humanfood safety) and not to consumercomplaints generally.

2. Consumer Complaints as VerificationTools

76. FDA received a large number ofcomments on the advisability ofhandling consumer complaints in themanner that the agency proposed.Generally speaking, the comments


addressed two broad issues: Whetherconsumer complaints are relevant to aHACCP system, and if they are relevant,how they should be used. The questionof whether FDA should have access toconsumer complaints was a significantconcern that comments found germaneto both issues. Approximately one-fifthof the comments supported theproposed system or a variant of thesystem (i.e., they believed thatconsumer complaints are relevant to aHACCP system). Some of those whovoiced general support urged morecomprehensive agency access toconsumer complaints, and others urgedthat some restriction on agency accessbe put in place. The remainingapproximately four-fifths of thecomments, principally from seafood andother food processors and tradeassociations, argued that consumercomplaints have no place in a HACCPsystem.

Those comments that opposed themandatory use of consumer complaintsin a HACCP system provided a varietyof reasons. The comments argued thatconsumer complaints are generally: (1)Unrelated to the safety of the product;(2) not received in a timely manner thatwould facilitate control of the processand are, in this way, akin to finishedproduct testing; (3) erroneous andsometimes exaggerated or fraudulent; (4)vague; (5) subjective and nonscientific;(6) associated with hazards that developduring transportation, storage, and retailmarketing, rather than processing, ifthey identify food safety hazards of anykind; (7) not traceable to a specificprocessing plant or lot of product; and(8) not readily associated with a specificCCP or CL failure, even where it islikely that they are the result of aproblem during processing. Thesecomments asserted that, therefore,consumer complaints are not anappropriate monitoring tool.

A number of these commentssuggested that, given the problems listedabove, sorting through the large volumeof consumer complaints that arereceived by most large firms to identifythose few that might be able to be linkedto the performance of a specific CCPwould be a waste of both the processor’sand the agency’s time. These commentsstated that such a review of consumercomplaints would divert their effortsfrom more productive tasks.

Several comments raised additionalquestions about consumer complaints asa HACCP verification tool. Theysuggested that there are better, moreeffective means of verifying that theHACCP plan is working properly. Thesesuggestions are covered in the‘‘Verification’’ section of this preamble.

These comments further argued thatconsumer complaints are not identifiedin the NACMCF recommendations as auseful verification tool.

A relatively small, diverse group ofcomments, including those from aseafood processor, a seafood tradeassociation, a State regulatory agency,an individual, and a professionalorganization, supported the handling ofconsumer complaints as proposed. Oneof these comments suggested thatconsumer complaints could be useful inFDA’s efforts to verify that processors’HACCP programs are effective.

Another group of comments, fromconsumer advocacy organizations and aState regulatory agency, agreed thatconsumer complaints are an appropriatepart of HACCP. One of the commentsnoted that the consumer performs thefinal quality control check, and that ifa consumer finds a problem egregiousenough to take the time to write a letter,the information contained in that lettershould be considered in any evaluationof the adequacy of the relevant HACCPplan. The comment further argued thatconsumer complaints could bring tolight unidentified CCP’s. This benefit,the comment contended, would not bepossible under the proposed regulationsbecause the agency limited consumercomplaints in a HACCP system to thosethat may be related to a CL deviation atan existing CCP. Finally, one of thecomments noted that the inclusion ofconsumer complaint access in theproposed regulations is the one area inwhich the agency delivers on its ‘‘waterto table’’ commitment.

FDA is persuaded that consumercomplaints generally will not make aneffective monitoring tool in a HACCPsystem, primarily because they tend notto provide the kind of immediate,reliable feedback expected of a HACCP-monitoring system. FDA agrees with thecomments that suggested thatmonitoring procedures under HACCPmust provide the processor withimmediate feedback on whether theprocess is under control and bescientifically sound.

FDA is not persuaded, however, thatconsumer complaints are irrelevant toHACCP systems. The agency receivedno comments that were able todemonstrate that outside sources ofinformation should not, whereappropriate, supplement a processor’sown monitoring as a way of determiningwhether the process is in control.Moreover, a number of comments statedthat they go to some lengths to examinethe consumer complaints that theyreceive. The question, then, is whetherconsumer complaints can serve some

legitimate verification purpose in aHACCP system.

While consumer complaints are notspecifically addressed in the NACMCFHACCP recommendations, theverification portion of that documentstates, in part, that verificationinspections should be conducted,‘‘When foods produced have beenimplicated as a vehicle of foodbornedisease.’’ This statement is a recognitionthat information from sources outsidethe processing plant can and should beconsidered in the verification of aHACCP plan. In fact, it is FDA’sexperience that consumer injury orillness complaints to the agencyoccasionally point out problemstraceable to defective controls at thefood processing facility (Ref. 207).Where information that has potentialrelevance to food safety is available toa processor as a result of its ownconsumer complaint system, it isentirely appropriate for the processor toconsider that information in assessingthe adequacy of its HACCP program.FDA accepts the possibility that many,if not most, consumer complaints that aprocessor receives will not be germaneto safety, that many will turn out not tobe valid, and that others will relate toevents at retail or that are otherwisebeyond the ability of the processor tocontrol. Nonetheless, FDA stronglybelieves—and the comments supportthis view—that a responsible processorwill at least review consumercomplaints to determine their potentialvalue and take steps to correct theproduct or the process, when such stopsare warranted.

FDA has concluded, therefore, thatprocessors should evaluate theconsumer complaints that they receiveto determine whether the complaintsrelate to the performance of CCP’s, orreveal the existence of unidentifiedCCP’s, as part of their HACCPverification procedures. The agencyacknowledges that the absence ofconsumer complaints does not, by itself,verify the adequacy of a HACCP system.However, after taking into account allthe concerns raised by the comments,the agency is of the view that thoseconsumer complaints that a processordoes receive, and that allege a safetyproblem, can be of value as averification tool and should serve thatpurpose. This conclusion is reflected inthe requirements of § 123.8 of these finalregulations (see discussion in the‘‘Verification’’ section of this preamble),which lists the review of consumercomplaints as an appropriateverification activity (§ 123.8(a)(2)(i)).

As explained earlier in this preamble,because the agency regards consumer


complaints as a verification tool ratherthan a monitoring tool, FDA hasmodified § 123.6(c)(4) to eliminate theproposal requirement that the HACCPplan describe how consumer complaintswill be used in the monitoring of CCP’s.The agency has also modified§ 123.6(c)(7) to eliminate the proposedrequirement that consumer complaintsbe part of a processor’s HACCP-monitoring records.

FDA has concluded that when areview of a consumer complaint revealsa need for the processor to takecorrective action (e.g., recall,destruction, or reprocessing of theproduct or modification of the processto reduce the risk of reoccurrence of theproblem), such action must be taken inconformance with the applicablecorrective action procedures of theseregulations. This conclusion is reflectedin of § 123.8(b) which states thatprocessors shall immediately follow theprocedures in § 123.7 whenever areview of a consumer complaint, or anyother verification procedure, reveals theneed to take a corrective action. Thecorrective action provisions arediscussed in the ‘‘Corrective Actions’’section of this preamble.

As suggested by several of thecomments, records of corrective actionrelative to consumer complaints neednot include the original consumercomplaint. However, it is unlikely thata comprehensive record of thecorrective action taken could begenerated without at least the criticalinformation contained in the complaint,such as the nature of the complaint andidentification of the product inquestion. Identification of thecomplainant is not likely to be critical.

3. Agency Access to ConsumerComplaints

77. Many comments questionedwhether FDA should have access toconsumer complaints. Severalcomments argued that no other foodindustry is required to provide access toconsumer complaints. A fewspecifically cited the absence of such arequirement in the low-acid cannedfoods regulations (part 113).

One comment noted that FDA hasmethods other than access to acompany’s consumer complaint file toobtain information about productdefects that affect safety, includingdirect calls from consumers and healthprofessionals, MedWatch, and reportingto the Center for Disease Control andPrevention (CDC). Another commentsuggested that it would be more efficientto devise a system whereby consumersare encouraged to submit complaintsabout product safety directly to FDA

rather than to mandate access tocorporate files.

Several comments suggested thatconsumer complaint files should remaina private company matter, and that openaccess to these files is likely to result inregulatory abuse. A few commentsfurther argued that, by mandatingcomplaint file access, the agency wouldpenalize those firms with goodconsumer complaint gathering systemsand possibly deter others fromdeveloping such systems.

A relatively small, diverse group ofcomments, including seafoodprocessors, a seafood trade association,and a Federal government agency,submitted that, while it is appropriatefor FDA to mandate that processorsutilize consumer complaints inassessing the effectiveness of theirHACCP program, it is not necessary forthe agency to have direct access to thefirms’ complaint files. The commentssuggested two alternatives to providingdirect access to complaint files: (1)Allowing processors to prepare Noticesof Unusual Occurrence and CorrectiveAction (NUOCA) that described theaction taken in response to consumercomplaints that relate to product safety;or (2) allowing processors to prepare amatrix of complaints, as is currentlyused in the voluntary, fee-for-serviceHACCP program being operated byNMFS.

Others in this group suggested thatFDA have access only to writtencomplaints, or only to consumercomplaints, as opposed to tradecomplaints, which the comment arguedare often submitted for commercialadvantage only. One comment notedthat it would be impossible forprocessing vessels to retain consumercomplaints on board the vessel, and thatprovision should be made for these to bestored at the corporate office. Othercomments urged that FDA access toconsumer complaints not include theright to copy them, or that, in someother way, they be protected frompublic disclosure.

Another group of comments,composed of consumer advocacyorganizations and a State regulatoryagency, urged that all consumercomplaints, regardless of their potentialrelationship to product safety, beincluded in a processor’s HACCPrecords and be available for FDAreview. These comments suggested thatthe FDA investigator should make thedetermination of which complaints arerelevant for follow up rather than thefirm. They further suggested that theinvestigator can ignore any complaintsthat are not relevant to safety controls atthe processing facility.

Unquestionably, FDA has an essentialrole to play as a regulatory verifier ofHACCP. As described earlier, the agencyreceived a number of comments thatraised concerns about the veracity of amandatory HACCP system in theabsence of adequate regulatory review.Moreover, FDA has concluded that thisrole cannot be carried out without theability to review HACCP plans and anarrow category of processor’s records(i.e., those that relate to how a processoris controlling the critical safety aspectsof its operations). The agency is notinterested in expanding this accessbeyond those records that are theminimum necessary to carry out thisresponsibility.

With regard to consumer complaints,FDA is persuaded by the comments that,especially when used as HACCPverification records rather than HACCP-monitoring records as originallyproposed, the public health benefits thatmay accrue from agency access to thesekinds of records would probably beminimal and are outweighed by theconcerns that have been expressed.

FDA is satisfied that agency review ofa processor’s overall verificationscheme, plus access to records thatdocument any corrective actions thatwere taken as a result of informationobtained through consumer complaints,review of those complaints thatconsumers regularly send to the agency,the ability to conduct unannouncedinspections, and access to monitoringrecords and plans, should be enough forFDA to adequately verify processor’sHACCP systems.

FDA also accepts that the burden onprocessors if they had to segregatecomplaints that have a potentialrelationship to product safety fromthose that relate to product quality,economic issues, customer satisfaction,and other nonsafety issues, would begreat and is not warranted by anypotential gain in product safety. Manyfirms would have to take this step tomake safety-related complaints availableto FDA. Similarly, the agency recognizesthat a significant burden would beplaced upon its inspectional force if ithad to verify that a processor hadproperly categorized its complaints.

The alternative of FDA having accessto all consumer complaints and makingits own determinations about whichrelate to safety, as some commentssuggested, is simply not practicable. Inaddition, it is not the desire of FDA topenalize those firms that have large,expensive complaint gathering systems,by mandating that they provide allinformation so gathered for agencyreview, or to discourage others fromdeveloping such systems.


In the preamble to the proposedregulations, FDA stated that more thanhalf of the seafood-related consumercomplaints that it receives relate toproduct quality, filth, and economicdeception concerns. Access to allconsumer complaints is, therefore,unnecessary to ensure product safety.

FDA has, therefore, removed fromwhat is now § 123.9(c) the requirementthat consumer complaints relating tosafety be available to the agency. Theagency reiterates, however, thatprocessors should utilize all availableinformation as they evaluate theadequacy of their HACCP plans andtheir implementation. Consumercomplaints are one potential source ofinformation, and a significant group ofcomments recognized the value ofconsumer complaints in the verificationprocess.

I. RecordsFDA proposed that records required

by the regulations: (1) Contain certaininformation, (2) be completed at thetime of the activity, (3) be signed by theoperator or observer, (4) be reviewed forcompleteness and compliance with theHACCP plan and signed and dated bythe reviewer, (5) be retained forspecified periods of time, and (6) beavailable for review and copying byFDA.

FDA received a large number ofcomments that addressed theseproposed recordkeeping requirements.These comments were from a diversegroup of commenters, including largeand small processors, trade associations,individuals, Federal, State, and foreigngovernment agencies, consumeradvocacy groups, professional societies,and academics. Several commentsprovided arguments that support theneed in a mandatory HACCP programfor records in general, and nonespecifically argued in opposition to thatconcept. Most of the commentsaddressed specific issues that relate torecordkeeping.

Those comments that supported theneed for records stated thatrecordkeeping is a key component ofHACCP. One processor’s commentnoted that HACCP records must be keptin good order so that problems can beeasily tracked to their root cause. Onecomment stated that HACCP recordsfacilitate an evaluation of safetyconditions over time, rather thanthrough a ‘‘snap shot’’ inspection.Another processor noted that HACCPrecordkeeping is not overlyburdensome, and that the proposedregulations would not require it tomaintain any records in addition tothose that it already maintains.

1. Details and Signatures

78. FDA proposed that all HACCP-monitoring records (including records ofprocess-monitoring instrumentcalibration), sanitation control records,and corrective action records identifythe date of the activity that the recordreflects. One comment recommendedthat the final regulations should alsorequire that the time of each observationbe recorded, to make it easier to linkrecords to specific lots of product. Acomment from a trade associationrequested that the records be required toidentify the establishment where theactivity occurred to reduce the potentialfor confusion in firms with multipleprocessing facilities.

FDA agrees with both comments thatthe date and time on records will helpto connect information on the records tospecific lots of product, and that thename and location of the processor willhelp link information to a specificprocessing facility.

The agency has, therefore, modified§ 123.9(a)(1) and (a)(2) to state, in part,that the required records must include:‘‘(1) The name and location of theprocessor or importer; (2) The date andtime of the activity that the recordreflects.’’

79. FDA proposed to require thatHACCP-monitoring records (includingrecords of process-monitoringinstrument calibration) and sanitationcontrol records be signed by theobserver/operator. A few commentssupported the proposed requirement onthe grounds that it fosters accuracy andaccountability in the recordkeepingprocess. One comment opposed theproposed requirement, raising concernabout the legal liability that it imposedupon the workers that sign the records.A few comments suggested that theobserver/operator be allowed to initial,instead of sign, the records.

FDA agrees with the comments thatsuggested that a signature on monitoringand sanitation control records isnecessary to ensure accountability inthe recordkeeping process. FDA alsohopes that it will enhance workers’sense of responsibility and pride in theirparticipation in the HACCP system ofpreventive controls. Regarding workerliability, those that deliberately falsifyrecords are liable whether they sign therecords or not. In any event, thefalsification of records cannot becondoned and should not be toleratedby processors.

FDA further agrees that the purposefor the observer/ operator’s signature isachieved if the observer/operator eithersigns or initials the monitoring records.

FDA proposed to require the signatureof the observer/operator on all recordsinvolving observations or measurementsmade during processing or relatedactivities. This specification of the kindsof records in which signatures wererequired would have had the effect ofexempting consumer complaints, whichwere considered to be monitoringrecords in the proposal from thisrequirement. However, the use ofconsumer complaints as monitoringrecords has not been carried forward tothese final regulations. Consequently,limiting the records that must be signedto involving observations ormeasurements is no longer necessary,and FDA has deleted it for purposes ofclarification (see § 123.9(a)).

FDA has also deleted the proposedprovision that the observer/operatorneed not sign corrective action records.The agency proposed to require thatonly a trained individual sign theserecords. FDA is requiring the signatureor initials of the observer/operator oncorrective action records in order to beconsistent with the corrective actionprovisions of these regulations. In§ 123.7, for example, processors maynow predetermine their correctiveactions in ways that empower observer/operators to take corrective measures,especially in the absence of a trainedindividual. The likelihood that a trainedindividual might not be present at themoment when a corrective action mustbe initiated is enhanced by the fact thatsuch an individual need not be anemployee of the processor (see§ 123.10). Conversely, the presence of atrained individual during the initiationof a corrective action need not precludethe observer/operator from takingcorrective steps, as appropriate. Finally,the agency has concluded that theburden imposed by requiring thesignature or initials of the observer/operator whenever that individualparticipates in the making of acorrective action record isinconsequential.

80. Several comments questionedwhether the proposed requirement thatmonitoring records include the‘‘identity of the product, product code* * *,’’ meant that all fish and fisheryproducts were required to bear aproduct code.

It was not the intent of the agency torequire product codes on such products,only to require that they be listed onappropriate records when they are used.The purpose of the proposedrequirement was to facilitate linkagebetween records and product. To clarifythis point, FDA has modified what isnow § 123.9(a)(4) to read, ‘‘(4) Where


appropriate, the identity of the productand the production code, if any.’’

81. Several comments suggested thatFDA not specify the components ofrequired records. These commentsargued that many processors haveexisting forms that can appropriately beused as HACCP records.

It is not FDA’s intent in § 123.9(a) tospecify record format or content, beyondcertain minimum, essentialcomponents. Processor’s are encouragedto use existing records, makingmodifications only as necessary to meetthe previously described requirements.

2. Retention and StorageFDA proposed to require that

processors retain monitoring (includingprocess monitoring instrumentcalibration), sanitation control, andcorrective action records for 1 year afterthe date that they were prepared forrefrigerated products and for 2 years forfrozen or preserved products. FDA alsoproposed that records used tosubstantiate the adequacy of equipmentor processes be retained for 2 years afterthe date that they apply to productsbeing processed.

82. Several comments stated thatthese proposed retention times were toolong. Most of these comments suggestedrecord retention times of from 90 daysto 1 year for refrigerated products andfrom 6 months to 1 year for frozenproducts. One comment argued that 1year is a sufficient period for recordretention unless the records relate to aCL deviation, in which case they shouldbe held for 3 years. Another commenturged that the agency not mandaterecord retention times but requireprocessors to identify appropriateretention time requirements in theirHACCP plans.

FDA rejects those comments thatrequested a reduction in the proposedmandatory record retention period.While it may be true that mostrefrigerated products will be unusablewithin 90 days, as suggested by one ofthe comments, retention times of lessthan 1 year do not provide for sufficientaccess for the processor’s or FDA’sverification activities. (See revised§ 123.8(a)(1) and the accompanyingpreamble discussion of the minimum 1-year frequency of plan reassessment.)No new, substantive comment wasprovided relative to record retentiontimes for frozen or preserved productsthat would warrant a reduction for thoseproducts.

Thus, FDA has made no changes to§ 123.9(b).

83. FDA proposed that, in the case ofprocessing facilities that close betweenseasonal packs, records could be

transferred to another accessiblelocation between seasonal packs, as longas they were returned during the nextactive season. Comments from severalprocessors and trade associations urgedthe agency to modify the requirement to:(a) Allow for permanent transfer fromthe facility and (b) include both remoteprocessing sites and processing vesselsregardless of whether they closeseasonally. Comments from operators ofprocessing vessels and remoteprocessing sites and from a tradeassociation requested that FDA allowHACCP records to be kept on theprocessing vessel or remote site for aperiod of time and then be transferredpermanently to the processor’scorporate, or closest business office. Thecomments argued that the records inthose locations would be more easilystored, safer, and more readilyaccessible to regulators than they wouldbe at remote sites and on processingvessels. Additionally, they argued thatcorporate verification activities oftenwould be performed at the land-basedfacilities. Transfer of the records tothese facilities would promoteverification in these circumstances.Comments opposing the requirementthat the records be returned to aseasonally closed facility once thefacilities reopened expressed concernthat return of the records to thereopened locations could result in lostrecords.

FDA has been persuaded toaccommodate the difficulties associatedwith record storage on processingvessels and remote processing sites byallowing HACCP records to be movedfrom such facilities to anotherreasonably accessible location at the endof the seasonal pack without requiringthat the records all be returned for thefollowing season (§ 123.9(b)(3)).Additionally, the agency will, asproposed, allow HACCP records fromany facility that is closed betweenseasonal packs to be permanentlytransferred to another reasonablyaccessible location. However, FDApoints out that, in most instances, theagency will need to examine processingrecords onsite in order to conduct aneffective verification inspection. For thisreason, records must be so stored thatthey can be promptly returned to theprocessing facility upon demand byFDA. In order to maintain inspectionalefficiency, the time period between anFDA request for the records and theirarrival should not ordinarily exceed 24hours.

84. Several comments urged FDA toprovide for the use of computers tomaintain HACCP records.

It was not the intent of the agency topreclude such records. To make this factclear, FDA has added a new paragraph,§ 123.9(f), to the final regulation, whichreads, ‘‘(f) Records maintained oncomputers. The use of recordsmaintained on computers is acceptable,provided that appropriate controls areimplemented to ensure the integrity ofthe electronic data and signatures.’’

In the Federal Register of August 31,1994 (59 FR 45160), FDA proposedseparate regulations at 21 CFR 11 that,if adopted, will become the standard fordetermining what constitutesappropriate controls for electronicrecords, electronic signatures, andhandwritten signatures executed toelectronic records. In the interim,processors are encouraged to look toindustry standards for guidance.

3. Confidentiality of Records85. In the preamble to the proposed

regulation, FDA stated that, as apreliminary matter, HACCP plans andmonitoring records appear to fall withinthe bounds of trade secret orcommercial confidential informationand would, therefore, be protected frompublic disclosure by section 301(j) of theact (21 U.S.C. 331) and by the Freedomof Information Act (FOIA) and theDepartment of Health and HumanServices (DHHS) and FDA regulationspromulgated pursuant to these laws.FDA specifically invited comment onthe issue of public disclosure of HACCPrecords and on whether FDA has anydiscretion about the releasability of anyHACCP records that it may eventuallyhave in its possession. A large numberof comments responded to FDA’srequest for comment, especially in thecontext of the provision in theregulations (§ 123.9(c) in this final rule),that provides that all required recordsand plans must be available for reviewand copying.

A large number of comments, fromprocessors, trade associations,professional associations, State andFederal agencies, and individuals,contended that HACCP records andplans are trade secrets and should underno circumstances be released to thepublic. Comments from severalconsumer advocacy groups counteredthat in many cases HACCP records andplans will not contain trade secretinformation or will contain only limitedtrade secret information, and that thenonsecret parts (i.e., most of theircontents) should, therefore, be availableto the public.

Many of the comments that supportedprotection from public disclosure urgedthat the final regulations containcontrols over the agency’s access to, and


copying of, HACCP plans and records asthe only guaranteed way to ensureconfidentiality. The comments arguedthat the potential harm from exposure ofHACCP plans and records tocompetitors or to the public isconsiderable and carries the threat ofincreased costs, misuse, and damage tothe integrity of a firm and its products.

Several comments contended thatHACCP records will be trade secretbecause they will be process-specificand, therefore, will contain suchinformation as processing times andtemperatures. They stated that theseprocessing parameters may differ fromcompany to company based on productformulas.

A few comments argued that there isno precedent for public access toindustry-generated records. Some ofthese comments stated that processingrecords are regarded as trade secretunder the LACF regulations, and theynoted that § 108.35(d)(3)(ii) deemsprocessing information submitted toFDA to be trade secret within themeaning of 301(j) of the act and withinthe meaning of the FOIA. Othercomments asked that FDA protectHACCP plans and records in the sameway that the agency protects processingand quality control data that aresubmitted to FDA under cooperativequality assurance agreements (i.e.,manufacturing methods or processes,including quality control procedures,are deemed not to be releasable unlessthe information that they contain hasalready been released or is otherwise nolonger trade secret or confidentialcommercial per §§ 20.111(d)(2) and20.114 (21 CFR 20.111(d)(2) and20.114)).

Several comments suggested that FDAspecifically declare that: (1) HACCPplans and records are trade secrets; (2)section 301(j) of the act and the FOIAprohibit disclosure of trade secret orconfidential commercial informationand give the agency no discretionwhether to release these types ofrecords; and (3) § 20.81 provides fordisclosure of trade secret or confidentialcommercial information only if theinformation has been previouslydisclosed to the public.

One comment proposed that, if FDAfelt obliged to release some HACCP-related information pursuant to FOIArequests, reports of regular inspectionsbe released instead of HACCP plans andrecords, because such reports are likelyto contain less sensitive information.Another comment suggested that, toavoid releasing proprietary information,the agency should describe or explaininformation that is contained in HACCPplans and records in general terms

rather than release the recordsthemselves. The comment asserted thatthis step would serve to informconsumers about the relative safety ofthe product and the effectiveness of theHACCP system, while not divulgingspecific process parameters that aretrade secret or confidential commercial.

Conversely, comments from consumeradvocacy groups argued that, for themost part, HACCP plans and records arenot trade secret or confidentialcommercial. The comments assertedthat much of the information containedin these plans and records involves theapplication of basic sanitary engineeringand is already in the public domain, asevidenced by the draft FDA Guide.

The consumer advocacy groupsargued that, given the limited resourcesthat FDA can devote to monitoringHACCP compliance, public access toHACCP records should be as broad asallowed under the law, so thatconsumer confidence in, andunderstanding of, the seafood supplycan be fostered. One comment assertedthat the public’s right and need to knowabout matters involving public healthshould be the basis from which theagency formulates public access policy.Another comment stated that consumersare the intended beneficiaries of theHACCP seafood proposal and thereforeshould have the right to determinethrough record inspection whetherprocessors are properly implementingthe HACCP requirements. Thesecomments urged FDA to routinelycollect HACCP plans and records fromprocessors to facilitate agencyverification activities and public reviewof the effectiveness of the HACCPsystem. One comment from a consumeradvocacy group asserted that PublicCitizen Health Research Group v. FDA,704 F.2d 1280 (D.C. Cir. 1983) narrowlydefined trade secrets in such a way thatHACCP plans and the records at issuein this rulemaking could not beconsidered trade secret.

Unquestionably, adoption of amandatory HACCP system will placesignificant documentation requirementson seafood processors. As a result, theywill produce records that reflectprocessing designs and equipment andcertain types of day-to-day operations.They will be available to FDA. FDAstrongly believes that it is in the publicinterest to require that these records bemaintained, and that the agency haveaccess to them. Such records and accessare necessary to effectuate a mandatorysystem of preventive controls for safety.As stated in the preamble to theproposed regulations, FDA expects totake possession of records on a case-by-case basis, and only when there is a

specific need to do so. The agencycategorically rejects the view that FDAshould be a collection point for HACCPrecords and plans so that they may bemade publicly available. Nevertheless,the apprehension expressed by manycomments about the consequences ofpublic disclosure of these new types ofrecords is certainly understandable.

FDA agrees with the views expressedby consumer advocacy organizationsthat the public needs ways to be able tojudge how and whether it is benefitingfrom a HACCP system. Neither theagency nor the industry can reasonablyexpect that the public will simply takethe government’s word for it. It remainsto be seen, however, whether publicaccess to information about processorsthat processors have traditionally heldas protected is the only way, or the bestway, to provide the public withinformation about this system.

FDA is considering how meaningfuldata can be extracted from theinspectional process and prepared insuch a manner that it could be releasedwithout jeopardizing trade secret andconfidential commercial informationand yet be useful to both FDA and thepublic in evaluating this program. FDAis considering developing standardizedreports that would be completed byinvestigators at the conclusion ofroutine HACCP-based inspections andbecome part of agency files. Aspresently conceived, these reportswould contain a summary of the statusof the HACCP program in effect at thefirm, similar to the suggestion of two ofthe comments.

Nonetheless, the question is whether,as FDA preliminarily concluded, mostplans and records to be generated underthis program will be subject toprotection under existing law and FOIAregulations. FDA’s experience inseafood processing plants, itsexperience with HACCP, and itsunderstanding from the cost-benefitmodeling that has been done in thepreparation of these regulations is thatHACCP plans will take each processorsome time and money to develop. Thus,the agency concludes that HACCP plansgenerally will meet the definition oftrade secret, including the court’sdefinition in Public Citizen HealthResearch Group v. FDA, supra. Plansthat incorporate unique time-temperature regimens to achieveproduct safety, or other parameters thatare processor-specific and that are theresult of considerable research andeffort, will surely meet this definition.

Moreover, there is value in a plan toa company that produces it for no otherreason than that it took work to write.The equity in such a product is not


readily given away to competitors. FDAknows from its own experience thatplant configurations tend to be uniqueto individual processors, or at least haveunique features (Ref. 222). Whilegeneric plans will have great utility inmany circumstances, they serveprimarily as starting points forprocessors to develop their own plans.FDA expects that its Guide will helpserve that purpose, but firms will stillneed to expend time and money to tailorHACCP to their individualcircumstances.

Additionally, the agency has come tothe conclusion, as a matter of policy,that records and plans should beprotected to the extent possible in orderto promote the implementation ofHACCP across the seafood industry.FDA has concluded that the public willbenefit from the protection of recordsbecause it will actually strengthen theHACCP system. So long as thelegitimate public need to be able toevaluate the system can be met throughother means, the confidentiality ofHACCP records and plans generally willfoster the industry’s acceptance ofHACCP. Even though HACCP may bemandatory under these regulations, inorder for it to succeed, processors mustbe committed to it because they seevalue in it for themselves. Fear of publicdisclosure of matters that have longbeen regarded as confidential businessmatters could significantly underminethat commitment. FDA concludes,therefore, that it is in the public interestto foster tailored HACCP plans thatdemonstrate understanding andthought, rather than promote the use ofrote plans and minimally acceptablestandards due to fear of publicdisclosure.

FDA understands that it cannot makepromises of confidentiality that exceedthe permissible boundaries establishedunder FOIA, nor does the agency wishto do so in this case. The agency stilldoes not expect that it will be inpossession of a large volume of plansand records at any given moment.However, given the significant interestin this subject as conveyed by thecomments, FDA has concluded that thefinal regulations should reflect the factthat the HACCP plans and records thatdo come into FDA’s possession willgenerally meet the definition of eithertrade secret or commercial confidentialmaterials. A statement to this effect inthe final regulations will help to makethis fact as widely understood aspossible and will clarify the agency’sposition on this matter. This fact iscodified at § 123.9(d)(1), which reads asfollows:

(d) Public disclosure. (1) Subject to thelimitations in paragraph (d)(2) of this section,all plans and records required by this part arenot available for public disclosure unlessthey have been previously disclosed to thepublic as defined in § 20.81 of this chapter,or they relate to a product or ingredient thathas been abandoned and they no longerrepresent a trade secret or confidentialcommercial or financial information asdefined in § 20.61 of this chapter.

The agency acknowledges that therecould be exceptions to this general rule.The nature of information in HACCPplans and records varies. Some of itcould be generally available processingmethodology or procedures, based ongeneric or model HACCP plans orguidelines developed by the agency orsome other public source, that issufficiently reflective of an industrystandard that it has little if anyproprietary value. In such a case, inresponse to an FOIA request, there maynot be a valid reason for protecting thisinformation. The agency has concludedthat there should be a provision thatmakes clear that it will makeinformation available in appropriatecircumstances. Consequently, the finalregulations in § 123.9(d)(2), state:

(2) However, these records and plans maybe subject to disclosure to the extent thatthey involve materials that are otherwisepublicly available, or that disclosure couldnot reasonably be expected to cause acompetitive hardship, such as generic-typeHACCP plans that reflect standard industrypractices.

There is precedent for describing inregulations the records that haveprotected status. The low-acid cannedfood regulations at § 108.35(l) providethat, except under certain limitedsituations, filed scheduled processessubmitted to FDA are not available forpublic disclosure. Additionally,§ 108.35(d) provides that data submittedto the agency to support these processesare to be treated as trade secret. Thesematerials are analogous to HACCPplans, and their treatment is consistentwith the agency’s views relative to theprotected status of HACCP plans. Thecomments that suggested that the low-acid canned foods regulations granttrade secret status to the monitoringrecords that are required to be kept bypart 113 are incorrect. These records arenot provided any special status in thoseregulations.

4. Agency Access to Records

86. Several comments suggested thatthe final regulations should requireprocessors to provide access by FDA toHACCP records only after thesubmission by the agency of a writtenrequest for specific records it deems

necessary to review. The commentsnoted that this approach would besimilar to § 108.35(h) in the LACFregulations, because processors arefamiliar and satisfied with suchprocedures.

FDA remains convinced that access toHACCP documents is essential to theagency’s verification of a firm’s HACCPsystem. A key feature of the HACCPverification process is access bygovernment investigators to the HACCPplan, to monitoring records keptaccording to the plan, and to records ofcorrective actions that were taken inresponse to CL deviations. Examinationof HACCP records enables aninvestigator to see how the processingfacility or the importer operates overtime rather than how it is functioning atone particular moment in time.Additionally, it will enable the regulatorto review the adequacy of theprocessor’s or the importer’s preventivecontrol system itself.

FDA rejects the idea of being requiredto request in writing access to HACCPplans and records. The agency isconvinced that it has sufficientlylimited its access to those records andplans that are minimally necessary toadequately evaluate the adequacy of afirm’s HACCP system. Section 123.9(c)has been modified slightly to clarify towhich records FDA is required to begranted access.

The comments are correct that theemergency permit regulations for low-acid canned foods at § 108.35 requirethat FDA issue a written request foraccess to monitoring records. However,the written request has proven to bemerely a mechanical exercise. It has notin any way served to affect the outcomeof FDA access to records, nor is itassociated with any managerial controlover the activities of FDA investigators,with respect to the kind or numbers ofrecords to which they seek access.Moreover, the bottled water regulationsat § 129.80(h), promulgated subsequentto the low-acid canned food regulations,do not contain a requirement for theissuance of a written request for records.FDA is not aware of any undue concernsexpressed by the bottled water industryrelative to agency abuse of its recordsaccess authority as a result of the lackof a written request requirement inthose regulations. FDA further notesthat its investigators are required topresent a written notice of inspection tomanagement of the firm at the start ofeach inspection. The notice explains theauthority of the investigator to conductan inspection of the facility. The agencyhas concluded that there is no need tofurther encumber the efficientenforcement of these regulations with a


written request for those records towhich it is entitled to have access. It haschosen to use the more recentregulations, bottled water, as the modelfor these regulations with respect torecords access.

5. Agency Copying of Records87. A large number of comments

opposed the provision in the proposalthat provided for FDA copying ofHACCP plans and records, mostlybecause of concern about publicdisclosure. Several comments statedthat the agency should be permitted toobtain copies only to support aregulatory action and only after FDA hasobtained a subpoena. Several othercomments suggested that FDA bepermitted to copy only those recordsthat relate to a CL failure.

Several comments requested that FDAprovide safeguards to control potentiallyabusive regulatory practices byestablishing rules to be followed whencopying records. The comments statedthat the rules should accomplish thefollowing: Identify investigatorsauthorized to copy records, limitcopying to records pertaining directly toCCP’s, require prior writtenauthorization for copying from theinvestigator’s supervisor, require thatthe authorization identify the specificrecords to be copied and the reason thatthey are needed, require that aresponsible company executive receiveeach request before any copying ispermitted, and permit the company toquestion the purpose for the requestbefore records are copied.

Comments from several consumeradvocacy groups, on the other hand,supported the agency’s need to copyrecords.

There are two primary reasons for theagency to copy HACCP plans andrecords: (1) To facilitate expert review ofsuch issues as the identification ofappropriate hazards and CL’s in HACCPplans and the evaluation of theadequacy of corrective actions taken inresponse to CL failures; and (2) todocument suspected inadequacies of theHACCP plan or the firm’simplementation of the plan for possibleregulatory followup.

Limiting the copying of records tothose situations in which regulatoryaction is contemplated or in which asubpoena could be obtained wouldserve neither the needs of the industrynor the agency. Resolution ofdifferences in food safety controlstrategies through scientific review anddialog, where possible, is superior toreliance solely upon the legal system forsuch resolution. Similarly, limiting thecopying of records to instances

involving CL deviations wouldinappropriately restrict the agency’sability to evaluate potential problems inthe identification of CCP’s, theestablishment of CL’s, and otherscientific issues, which, in some cases,may be beyond the expertise of agencyinvestigators.

Industry comments have expressedconsiderable concern, as discussed inthe ‘‘Compliance’’ section of thispreamble, that there will be nomechanism for dialog with the agency ifa firm disagrees with an investigator’sfindings with regard to the sufficiencyof HACCP plans and records. Theagency is strongly committed to dialogwhenever possible. Provision of a meansby which senior reviewers at agencyheadquarters will have access to HACCPplans and records will facilitate thatprocess.

FDA has concluded that therestrictions on copying of recordssuggested by the comments wouldsignificantly interfere with that access.It would be highly inefficient for FDAto identify a special class ofinvestigators that are permitted to copyHACCP records and plans. FDAinvestigators are responsible forconducting inspections andinvestigations to enforce a wide array ofregulations, and FDA field managersneed the flexibility to assign work in anefficient and effective manner. Copying,like record access, is limited to therecords specified in § 123.9(c). It wouldbe highly impractical for supervisorypreapproval to be accorded to aninvestigator for the copying of specificrecords. Until an investigator hasevaluated a HACCP plan and validatedthe operations of the plant, it is notlikely that the investigator will knowwith any certainty what HACCP recordsare appropriate for review. Additionally,inspections are often done in remotelocations and under highly flexibleitineraries that preclude close contactbetween the investigator and particularsupervisor. Certainly, FDA investigatorswill make every effort to obtain HACCPplans and records from responsibleindividuals of the firm and will, ifnecessary, explain the relevance of therequested records to the recordkeepingrequirements of these regulations.

The agency is unconvinced of theneed to modify § 123.9(c) in response tothe aforementioned comments, exceptthat reference to consumer complaintsin this section has been eliminated asdiscussed in the ‘‘ConsumerComplaints’’ section of this preamble.

88. Several comments questioned thephrase ‘‘duly authorized officers andemployees’’ used in this section. Somefelt that it referred, at least in part, to

employees of the firm, and others feltthat it excluded officials of Stateregulatory agencies that may adopt theseregulations by reference.

The intent of the proposed regulationswas to grant records access to regulatoryagency officers and employees, notofficers or employees of a firm. Thelanguage was intended to be flexibleenough to cover State officials if theiragency adopted the regulations byreference. FDA has changed the wordingof the regulations to address theseconcerns.

The modified paragraph in § 123.9(c)reads:

(c) Official review. All records required bythis part and all plans and proceduresrequired by this part shall be available forofficial review and copying at reasonabletimes.

J. TrainingA large number of comments

addressed the proposed trainingrequirements. FDA proposed to requirethat each processor and importeremploy at least one individual who hassuccessfully completed a training coursethat has been approved by FDA on theapplication of HACCP to fish andfishery products processing. FDA alsoproposed that the trained person orpersons be responsible for, at aminimum, developing and modifyingthe HACCP plan, evaluating theadequacy of corrective actions taken inresponse to CL deviations, andreviewing monitoring records beforeshipment.

In the preamble to the proposedregulations, FDA specifically requestedcomment on: (1) Whether the need fortraining could be satisfied by differentgradations of training (e.g., based oncomplexity or size of operation or on thedegree of risk posed by the productsbeing produced); (2) whether othertraining formats, such as video tapes,might be effective, at least under somecircumstances (e.g., a small businesswhose processing involved fewhazards); (3) whether, assuming theregulations are adopted by FDA,training in HACCP received before theyare effective should be ‘‘grandfathered’’as fulfilling the training requirement;and (4) whether some or all of thetraining requirements should be deletedor modified as a means of reducing theburden on the industry.

1. The Need for Mandatory Training89. Most of the comments that

addressed the question of whether thereshould be a mandatory trainingrequirement expressed support for it. Asignificant portion of these commentsacknowledged the need for at least one


trained individual at each processingfacility. Those that provided reasons fortheir support contended that properlytrained personnel are essential to thedevelopment and effectiveness ofHACCP controls, and that training isnecessary to ensure consistency ofapproach.

Those few comments that expressedreservations about the overall HACCPtraining requirement generallyacknowledged the need for a trainedindividual in the plant but opposed acompulsory training program. Twocomments, from State governments,expressed concerns about the financialburden of training on small businessesand questioned the need for makingsuch a provision mandatory.

The overwhelming support in thecomments for HACCP training isindicative of the nearly universal viewthat training is essential to the effectiveimplementation of a HACCP system. Asstated in the preamble to the proposedregulations, this view is shared by theNAS based on the success of thetraining requirement in FDA’s HACCP-based regulations for low-acid cannedfoods at part 113 (Ref. 54). The primaryconcern expressed about mandatorytraining is the cost.

The agency is convinced that itsefforts with the Alliance will facilitatethe development and implementation ofa low cost training program. Asmentioned above, the Alliance is acooperative effort between Federal andState food regulatory agencies,academia, and the fish and fisheryproducts industry to provide support tothe industry in meeting its needsrelative to HACCP training, technicalassistance, and research. Presently, theAlliance Steering Committee iscomprised of representatives of FDA,the U.S. Department of Agriculture(USDA), NMFS, AFDO and its sixregional affiliates, the Sea GrantColleges, the ISSC, the NationalFisheries Institute, and the NationalFood Processors Association (NFPA).

The goals of the Alliance are todevelop: a HACCP training course thatwill meet the requirements of theseregulations, a mechanism for deliveringthe training to the fish and fisheryproducts industry, a compendium ofestablished methods for controllinghazards in the fish and fishery productsindustry, and a mechanism forcoordinating the research efforts of theparticipating agencies to facilitate thedevelopment of improved methods ofhazard identification and control.

The training course materials are inan advanced stage of development andare expected to be publicly availableshortly after the publication of these

regulations. The AFDO regionalaffiliates have agreed to work withintheir regions to identify regulatory andindustry training needs and qualifiedtrainers who are interested inparticipating in the Alliance-sponsoredtraining. They have also agreed to serveas the course coordinators for theAlliance-sponsored training, which willbe conducted on a cost-recovery basis.

The Alliance is developing a 3-daycourse, divided about equally among:(1) The fundamentals of HACCP, basedon the recommendations of theNACMCF; (2) the requirements of theseregulations and the recommendations ofthe Guide; and (3) a practical exercise inHACCP plan development.

FDA is sensitive to the concernsexpressed about the cost of training butis optimistic that training will not beunnecessarily burdensome on smallbusiness, either in actual outof-pocketexpenses or in lost productivity. As waspreviously mentioned, FDA is workingwith the Alliance to produce a low cost,3-day HACCP-training course for theseafood industry, that is intended tomeet the requirements of theseregulations. Current plans are for thecourse to be offered through a variety ofpublic institutions, including Sea Grantcolleges. As indicated earlier, in thissetting the course is expected to beoffered on a cost recovery basis. It islikely that the course will also beoffered by private institutions, usingtheir own fee structure.

The other cost associated with thetraining requirement is the lostproductivity for the duration of thecourse. FDA is convinced that, with theflexibility in course structure, describedelsewhere in this section, training canbe taken at times when it would leastaffect the operations of the firm (e.g.,during an off-season, at night).Moreover, FDA is convinced by thecomments that, as a general rule, thebenefits of training will significantlyoutweigh the burden. The agency hasconcluded that with certainmodifications from the proposal asdescribed below, training should remaina feature of these regulations.

The agency has made onemodification in response to requeststhat it modify the training requirementto reduce financial burden, especiallyon smaller processors. FDAacknowledges that a short course inHACCP has its limitations. For example,a 3-day course might not have anythingimportant to offer to an individual whohas significant job experience workingwith or for an individual who is well-versed in HACCP. In such a situation, ifthe processor loses the trainedindividual, it should be able to replace

him or her with the individual who has,in effect, apprenticed with the trainedindividual without having to send theapprentice to a course in HACCPtraining, assuming, of course, that theapprenticeship has imparted a level ofknowledge at least equivalent to thatthat could be provided by the training.The agency has modified the regulationsto provide for this kind of situation bypermitting adequate job experience toqualify and individual to perform thefunctions of the trained individual.

Note that all references in thispreamble to a trained individual meanan individual who meets therequirements of § 123.10 through eithercompletion of a course or job experiencethat provides an equivalent level ofknowledge.

2. Who Should Provide Training?90. A significant number of comments

identified organizations or individualsthat they considered to be qualified toconduct or develop HACCP-trainingcourses. The majority of the comments,which included remarks fromprocessors, trade associations, and Stategovernments, suggested that FDAshould either conduct such training orat least approve the relevant coursematerial. A few of the comments thatrecommended that FDA conduct thecourses also recommended that FDAprovide the courses at no cost orfinancially support the training. Thecomments that endorsed FDA approvedcourses asserted that this approachwould result in a standardized,comprehensive training program thatemphasizes the minimum acceptableHACCP requirements.

Other comments recommended thattraining programs could be conductedby NFPA or other trade associations,ISSC, Sea Grant colleges and otheracademic institutions, consultants, andState and local regulatory agencies. Thecomments acknowledged the costsavings that could be realized with tradeassociation- provided training andthrough the HACCP training experiencealready possessed by the NFPA. Onecomment suggested that allowing manytraining programs would offer hundredsof professionals the opportunity tocontribute to the development ofHACCP. A few comments suggested thatFDA publish a listing of approvedtraining courses.

A comment from the ISSC cautionedthat organization does not support theshifting of public health training in thearea of molluscan shellfish away fromitself. The comment further stated thatthe organization would workcooperatively with the Alliance in thedevelopment of a HACCP-training


course, which it suggested should beFederally subsidized and ISSCendorsed.

A few comments suggested that theAlliance be permitted to develop thestandard for HACCP training, and thatthe results be shared with allprospective trainers. A few additionalcomments urged that HACCP training bebased on the recommendations ofNACMCF, because such efforts wouldresult in a training program that waswell defined.

FDA generally agrees with thesecomments. The agency does not intendto run HACCP-training courses for theindustry. Rather, FDA must, ofnecessity, focus its HACCP training ongovernment investigators. The agencyanticipates that industry training will beconducted privately and throughacademia. This division of labor isbased on the model that has workedwell for the training requirement forlow-acid canned foods.

FDA agrees, moreover, that thereshould be widespread opportunity forconducting HACCP training. It is not theagency’s intent to specify or limit thefield of qualified trainers.

The training course that is underdevelopment by the Alliance is based onthe recommendations of the NACMCF.After reviewing the final draft of theAlliance training materials, FDA intendsto publish a notice of availability of thedocuments in the Federal Register. It isthe agency’s intent to utilize theAlliance materials as the standardagainst which other course materialsmay be judged.

The agency strongly encouragestrainers to evaluate their courses, past,present, and future, against the Alliancematerials when they become availableand to modify or adapt curricula, wherenecessary, to ensure that they areconsistent with, and provide at least anequivalent level of instruction to, theAlliance course. Where previouslyconducted training fails to meet thisstandard, it may suffice to providesupplemental materials or instruction sothat the cumulative training is at leastequivalent to the Alliance course. FDAalso encourages the fish and fisheryproducts industry to confirm with pastor prospective trainers that a particularcourse is equivalent to and consistentwith the Alliance materials. The agencyhas no plans to publish a list of‘‘approved’’ courses other than theAlliance course materials.

Finally, it should be noted that FDAresources will not be sufficient to fundthe training of all appropriate regulators(i.e., State or local regulators). Theagency is confident, however, thatAlliance training will provide a low cost

opportunity for high quality HACCPtraining for State or local regulators aswell as for processors.

Because FDA will not be approving inadvance specific courses other than theAlliance curriculum, and in response tocomments, the final regulations havebeen modified at § 123.10 to require thattraining courses be ‘‘at least equivalentto the standardized curriculumrecognized as adequate by the U.S. Foodand Drug Administration.’’ FDA hadproposed to require that training coursesbe ‘‘approved by the Food and DrugAdministration.’’

3. Should Training Be ‘‘Grandfathered?’’91. A large number of comments

addressed the question of whethertraining in HACCP received before theeffective date of these regulationsshould be ‘‘grandfathered’’ as fulfillingthe training requirement. All of thesecomments supported the grandfatheringof such training. Many of the thesecomments recommended specifictraining courses that FDA shouldgrandfather. Approximately half of thesecomments requested that those trainedunder NMFS’ HACCP training programbe grandfathered. Those that providedreasons referenced the large number thathad been trained at the time of thewriting of the comment (1,310domestically and 394 overseas) andstressed that NMFS’ training was morecomprehensive than that which wouldbe necessary under FDA’s HACCPapproach, especially because the NMFSprogram covers nonsafety hazards inaddition to safety hazards.

Other comments supportedgrandfathering HACCP coursesconducted by NFPA, Sea Grant colleges,State regulatory agencies and thoseorganizations sanctioned by suchagencies to provide HACCP training,and Pacific Fisheries Services. Onecomment suggested that graduationfrom a Better Process Control School, asrequired by parts 113 and 114 forprocessors of acidified and low-acidcanned foods, should be considered tomeet the requirements of theseregulations. Another comment urgedthat any training program based on theHACCP principles recommended by theNACMCF should be grandfathered.

One comment suggested that, in orderto grandfather courses, FDA would needto develop a system to determine theeffectiveness of the training that hasbeen conducted. The commentrecommended the use of testing orcurriculum review as evaluation tools.The comment further encouraged thedevelopment of a formal approvalprocess for previously conductedtraining.

FDA has concluded that it is not in aposition to grandfather HACCP trainingreceived before the issuance of theseregulations. Blanket grandfatheringwould pose the risk of sanctioningtraining that does not fully prepareprocessors for operating under theseregulations, and case-by-casegrandfathering would be undulydemanding on agency resources.

On the other hand, the agency willnot presume that HACCP trainingreceived prior to the issuance of theseregulations will have to be repeated.FDA will challenge the adequacy ofprior training only when a processor’sperformance demonstrates a lack ofunderstanding of HACCP principles.

Nonetheless, FDA encouragesprocessors to update any prior trainingto ensure that they have a thoroughunderstanding of the requirements ofthese regulations. It may well be thatmany traditional HACCP courses willneed only minimal supplementation toaccommodate them to the provisions ofthese regulations, and that there will beno need for a processor to repeat anentire course. As mentioned above,partial, supplemental courses may beoffered, or reading materials developedby the course offerer and sent to theprocessor may suffice. There arenumerous possibilities.

FDA is also not in a position to makedeterminations in advance about theacceptability of courses that will beoffered after the issuance of theseregulations. FDA agrees with thecomment that, in order to do so, theagency would have to develop a systemfor course evaluation. Review of coursematerials, auditing of coursepresentations, testing, and otherevaluation tools that FDA might have toemploy are labor intensive and are notthe most efficient use of agencyresources. Rather, the adequacy ofcourses will have to be evaluated byFDA on a case-by-case basis, wheninspectional or other evidence causesthe agency to question whether thecourse meets the requirements of§ 123.10.

The ultimate determination of thesuccess of training is whetherprocessors are operating effectiveHACCP systems. In the initial stages ofthe program, at least, FDA’s primaryfocus will have to be on whetherHACCP plans are adequate, and thesystems are being effectivelyimplemented. FDA’s interest in theadequacy of training will increase whenplans and systems fail to demonstrate anadequate understanding of HACCP andits application to seafood.

Nonetheless, FDA can state that theBetter Processing School curriculum for


acidified and low-acid canned foodswill not be adequate to meet the trainingrequirement of these regulations. TheBetter Processing School was developedto instruct acidified and low-acidcanned food processors in how to safelyprocess such products to control thehazard of the development of botulinaltoxin in accordance with therequirements of parts 113 and 114. Thecourse does not provide instruction inthe principles of HACCP or addressother hazards (e.g., histaminedevelopment) to which these productsmight also be exposed.

4. Course Curriculum92. A few comments suggested that

the training be divided into a basicHACCP core and interchangeablesegments based on the portions of theindustry of interest to the students (e.g.,vessels, cooked, ready-to-eat fisheryproducts, molluscan shellfish, andsmoked fish).

As mentioned previously, theAlliance course includes threesegments: A basic HACCP core, therequirements of these regulations, andthe development of a HACCP plan. Thefirst two segments are applicable to theentire fish and fishery productsindustry. The Alliance hasacknowledged the need to developindustry-specific features for the thirdsegment. The agency is in agreementwith the Alliance and with the commentin this regard and would encourage thedevelopment of such directed courses.

93. In response to FDA’s invitation tocomment on the advisability of alternatetraining formats, several commentsexpressed support for the use of videotapes by small processors of low-riskproducts. A few additional commentsdid not specifically address video tapedtraining but stated that, while it isdesirable to have uniform training,ultimately training should involve‘‘whatever it takes.’’ One commentsuggested that home study courses andeducation via television might beacceptable alternatives to more formal,for-fee training mechanisms. A fewcomments opposed courses that consistexclusively of video tapes, based onconcern for a potential limitation in thelevel of understanding that could resultfrom this type of noninteractive trainingmethod.

FDA agrees with the comments thatexpressed concern with teachingmethods, such as video tapes, that lackinstructor/student interaction. However,in the interest of providing flexibility inmeeting the training requirement ofthese regulations, the agency hasconcluded that any teaching format isacceptable so long as it provides a level

of understanding at least equivalent tothat provided by the Alliance trainingprogram. FDA is aware that video tapetraining is widely used for a variety ofpurposes. The agency cannot concludethat video-based HACCP training willnot accomplish the purposes of thetraining requirement. For remote siteprocessors, video-based training may bethe only practical method available.

It is unlikely, however, that two orthree 2-hour video tapes, as onecomment suggested, will provide anequivalent level of training to the 3-dayAlliance course under development. Onthe other hand, a series of videopresentations, perhaps in conjunctionwith a 1-day workshop, may beadequate.

94. A few comments addressed thelength of the training course. Onesuggested that 3 days would be overlyburdensome on small businessesbecause of the loss of manpower duringthe course. Another suggested that 3days was not long enough to furnish theneeded information. One commentsuggested that the length of trainingshould be based on the level ofexperience of the student and the levelof complexity of the processingoperation.

FDA has concluded, based, in part, onits participation in the Alliance, that the3-day Alliance curriculum is theminimum necessary to develop anadequate understanding of HACCPprinciples and essentials of HACCP plandevelopment. If the curriculum werereduced any further, processors wouldrisk having to take more time later toimplement their HACCP systems as aresult of trial and error, and as a result,the quality of their HACCP programswould be jeopardized.

Nonetheless, FDA is not specifying inthe regulations how long the coursemust take, only that it be equivalent interms of curriculum to the standardizedcurriculum recognized as adequate bythe agency. If true equivalency can beachieved in less time, FDA would haveno objection. Moreover, dependingupon the circumstances, FDA wouldhave no objection to training that can beimparted in segments at convenienttimes so as to cause only a minimaldisruption to the work schedule.

Section 123.10, therefore, states thatthe training must be ‘‘at least equivalentto the standardized curriculumrecognized as adequate by the U.S. Foodand Drug Administration.’’ Thisprovision will also accommodate theuse of food processing experts, whohave received training in HACCP that isfar more extensive than that planned bythe Alliance. FDA recognizes that itwould be inappropriate to limit the

universe of experts to those who havetaken a course based on the Alliance 3-day curriculum. The issue of the use ofconsultants and other experts will befurther discussed later in this section.

5. Do Importers Need Training?

95. A few comments suggested thatFDA should provide separate orspecialized training aids for importers.Two of these comments noted thatimporters have not, historically, beeninvolved with the processing of seafoodcommodities. The comments requestedthat FDA work with trade associationsthat represent importers in setting upworkshops, developing specializedtraining materials for importers, andrecognizing training provided by foreigninstitutions.

FDA has reassessed the need fortraining to accomplish the HACCPfunctions assigned to importers,especially in light of changes in theimports provisions of these finalregulations. These changes are fullydiscussed in the ‘‘Imports’’ section ofthis preamble. In summary, importersare now required to conduct verificationactivities but are no longer required tohave full HACCP plans of their ownunless they also meet the definition ofa ‘‘processor.’’ FDA has concluded thatHACCP training, while desirable, is notessential to the preparation of importers’verification procedures, as specified at§ 123.12(a)(2). For this reason, trainingis not required for importers, and allreference to required training forimporter functions has been droppedfrom § 123.10.

Nonetheless, the agency is aware thatimporters may be unfamiliar with thetechnical aspects of fish and fisheryproduct processing and HACCP controlprocedures. Knowledge about thesematters would be helpful for purposesof verification. To meet this need, FDAplans to include in the Guide specificmaterials relating to importers’verification procedures. In addition, ashas traditionally been the case, theagency intends to continue to interactwith, and provide information to, theimport industry through tradeassociations and other forums, withinthe limits of budget constraints.Moreover, importers may want toparticipate in the training courses thatare offered by the Alliance.

Finally, the agency agrees with thecomment that suggested that trainingoverseas should be conducted by foreigninstitutions recognized for theirexpertise in seafood processing andHACCP control. This issue will befurther discussed in the ‘‘Imports’’section of this preamble.


6. Testing and Retraining

96. Several comments supported themandatory use of testing to assesswhether an individual has successfullycompleted HACCP training. Twocomments further recommended thatthe agency could consider the trainingrequirement to be met if a personsuccessfully passes an examination.

The agency is not opposed to testingat the end of a course but prefers not tomandate that courses include tests.Trainers will be free to include or notinclude testing as part of their trainingefforts. The issue of student evaluationis one that is still being debated in theAlliance relative to Alliance-sponsoredtraining courses.

However, testing alone does notprovide the kind of exposure to theconcepts of HACCP that is necessary toresult in company understanding andcommitment. The function of training isto prepare industry to meet therequirements of the regulations, not totest competency. The true test will bewhether processors are able toimplement their HACCP systems.Processors will be judged as plans arereviewed, and plant operations areevaluated, during inspections.

97. A few comments recommendedmandatory retraining or continuingeducation. The comments stated that asnew information about the science offish and fishery products hazards andthe technology of their control becomesavailable, there will need to be somemethod for introducing this informationto previously trained individuals. Onecomment, on the other hand, urged thattraining be limited to a single event andnot be subject to periodic renewal.

The primary purpose of the training isto teach the fundamentals of HACCP.These are unlikely to change over time.A comprehensive discussion of seafoodhazards and controls is far too extensivefor inclusion in a 3-day training session.The agency has concluded thatinformation about the technology that isavailable to control hazards should bemade available to the industry throughthe Guide, the Alliance Compendium ofEstablished Processes, and other modesof technical assistance. FDA supportsthe idea of continuing education andwill encourage it, but the agency is notprepared to mandate it in these finalregulations.

98. A comment suggested that theregulations mandate remedial orenhanced training for a first timeviolator whose infractions have resultedfrom a misunderstanding of HACCPprinciples.

Whenever an infraction occurs, thenature of the remedy that is warranted

depends on factors such as the publichealth significance of the infraction. Theagency has administrative warningsand, when necessary, a range ofregulatory actions available to it. (Seethe ‘‘Compliance’’ section of thispreamble for a more thoroughdiscussion of compliance philosophyunder HACCP and available remedies.)Ultimately, however, it will be theprocessor who will be responsible forcorrecting the deficiencies in its HACCPsystem. Part of that responsibility willbe determining the most appropriatemethod of resolving any failure to fullyunderstand HACCP principles, whetherthrough remedial training, hiring aconsultant, or taking some other step. Solong as an appropriate outcome can beobtained, FDA would prefer not tomandate any particular method ofremediation in these regulations.Processors certainly may wish toconsider additional education as anoption, however.

7. Gradations of Training

99. Several comments addressedwhether the HACCP trainingrequirement could be satisfied bydifferent gradations of training,depending on the complexity or size ofthe operation or on the degree of risksposed by the product being produced.The majority of these commentssupported the concept of variable levelsof HACCP training. Most did notprovide the basis of their support. Thosethat did suggested that small or largescale processing of low-risk productswould not likely require any specialtraining, and that small scale processingof even high-risk products would allowfor individual examination of every fish,an option that is not possible in largescale processing. One comment furthersuggested the use of variances toexclude certain industry members fromthe training requirement, rather thanproviding a blanket exemption for asegment of the industry.

A minority of the comments on thissubject opposed any variations in thelevel of training. Several of thesecomments stated that the necessity forHACCP education and training does notvary based on the size of a company,and that a standard training curriculumshould be developed for all companies,regardless of their size. Some of thesecomments stated that smaller processingoperations may be inherently less safe,and that, cumulatively, they represent alarge amount of the seafood making itsway to the consumer. One commentstated that smaller processingoperations may actually have a greaterneed for employee training, compared to

some larger processing operations thatmay already have trained staff.

The agency agrees with the commentsthat suggested that the need for HACCPtraining does not vary solely by the sizeof the processor. An understanding ofthe principles of HACCP is essential forthe successful implementation of aHACCP program, regardless ofestablishment size. The agency agreeswith the assertion that, in many cases,the training needs of small businessesmay, in fact, be greater than those oflarge firms, because they frequently lackthe trained quality control and researchand development staffs that are commonin large firms. Moreover, smallbusinesses comprise a significantportion of certain high-risk segments ofthe fish and fishery products industry,such as processors of molluscanshellfish and cooked, ready-to-eatproducts. Training will be critical toensure the success of HACCP in thesesegments.

Although the agency expects that thecomplexity of HACCP plans will varywith the number and type of hazardsassociated with a processing operation,an understanding of the basic principlesof HACCP, and how to apply thoseprinciples to the processor’s operations,will remain essential. The curriculumunder development by the Alliance isdesigned to provide a very basicgrounding in these matters. As statedearlier, the Alliance has acknowledgeda need to tailor part of the course so thatit can be directed toward specificindustry segments. This approach maybe the best way to provide flexibility inthe program, so that training can matchthe degree of complexity and risk thatis encountered by the processor. FDAwill continue to encourage thedevelopment of industry-specifictraining features.

The agency is not persuaded that theability of a processor to individuallyexamine all fish because of the smallscale of operations will reduce theprocessor’s need to understand thehazards associated with seafood and thespecifics of a systematic approach forcontrolling them. FDA has long takenthe position that observing each fish onan assembly line is an inappropriateway to ensure seafood safety (Ref. 208,p. 4146). While matters relating to thequality of the fish can be observed inthis manner, safety matters often cannot.

8. Duties of the Trained Individual100. Several comments suggested that

a firm be permitted to hire a consultant,or an outside expert, who is not anemployee of the firm, to perform thefunctions required of a trainedindividual. Two trade associations


argued that contracting for thedevelopment of a HACCP plan by aprofessional consultant could be moreefficient and cost effective, especiallyfor many small companies. Relatedcomments pointed out that some of theproposed functions of the trainedindividual either did not require aperson to be onsite continually (e.g.,plan development) or required expertisethat could not realistically be obtainedin a 3-day course (e.g., making decisionsabout whether product that has beensubject to a deviation is safe to releaseinto commerce).

While the agency considers trainingemployees to be preferable to hiringoutside consultants in terms of fosteringthe appropriate corporate culture andcommitment to HACCP, FDA recognizesthe importance of ensuring theflexibility that firms, especially smallbusinesses, may need to comply withthe regulations in a cost-effectivemanner. The agency also accepts that forsome processors, the expertise that maybe needed from time to time could bestbe provided by an expert consultant.Consequently, the agency is modifying§ 123.10 to read as follows: ‘‘* * * thefollowing functions shall be performedby an individual who has successfullycompleted a course of instruction* * *.’’ The requirement thatprocessors employ a trained individualhas been eliminated. Moreover, FDA hasmodified § 123.10(c) to state, ‘‘Thetrained individual need not be anemployee of the processor.’’

101. A number of comments askedwhether the regulations would require aseparate trained individual for eachprocessing location of each company orjust one per company.

FDA intends that the functionsenumerated in § 123.10 be performed bya trained individual. The number ofemployees a processor must train, or theconsultants that must be hired, in orderto ensure that trained individualsperform these functions is left to thejudgment of the processor. For somefirms, one individual will be sufficient.Others will need to secure the servicesof more than one such individual, eitheras employees or as consultants. Whetherthese individuals are located at eachfacility, at a corporate headquarters, ata consulting firm, or at somecombination of these arrangements is tobe determined by each individualprocessor.

102. A few comments were concernedabout the logistics of the routinefunctions that the agency proposed mustbe performed by someone with HACCPtraining (i.e., record review anddeviation handling). Specifically, theyargued that the proposed requirements

would actually require each firm to havemore than one trained individualbecause of work weeks that routinelyexceed 40 hours, vacations, illnesses,and employee turnover. Theconsequence, the comments suggested,would drive up the cost of training.

FDA acknowledges that, for certainsituations, these comments may becorrect. However, the agency has madethree changes in the final regulations tominimize this possibility. First, as statedabove, a processor may hire trainedconsultants on an as-needed basis.Second, as discussed in the‘‘Verification’’ section of the preamble,the regulations do not include theproposed requirement that a trainedindividual review monitoring recordsbefore the product to which the recordsrelate is shipped. These final regulationsrequire only a weekly review. As aresult, the need to have a trainedindividual onsite every day has becomesubstantially reduced. Third, asdescribed below, FDA has decided notto require that the trained individualevaluate CL deviations and correctiveactions. This modification reduces stillfurther the need to have a trainedindividual onsite at all times. Inaddition, as described previously, theagency is allowing processors to employindividuals whose training has beenobtained through on-the-job experience.Thus, for example, a processor thatneeds the services of two trainedindividuals could satisfy therequirements of these regulations byemploying an individual who has beentrained in an adequate course and asecond individual who has apprenticedsufficiently with the first individual tohave mastered the subject.

As a related matter, the provision inthe final regulations that provides forthe development of corrective actionplans (see the ‘‘Corrective Actions’’section of this preamble) couldeliminate the need to bring an expertonto the scene in many instances inwhich corrective action is necessary.The processor may be able to follow thecorrective action plan without having torely on an expert or trained individual.This procedure could permit furthersavings.

103. Some comments suggested thatthere should be different categories oftrained individuals, with differentresponsibilities. These comments, fromindividuals, processors, and tradeassociations, asserted that a firm shouldhave one HACCP trained person capableof conducting or overseeing the routineoperation of the HACCP program, butthat this individual should notnecessarily be responsible for designing

a firm’s HACCP plan or making complexscientific evaluations.

Another comment suggested that itwas unrealistic to expect that a trainingprogram would provide the level ofexpertise necessary for a person to makea determination on whether a deviationmay have rendered a product injuriousto health or otherwise adulterated.

FDA generally agrees with thesecomments. It was never the agency’sintent to limit the processor’s use ofexperts to employees whose trainingincluded the course prescribed by theseregulations, especially in the areas ofHACCP plan development and theevaluation of CL deviations andcorrective actions (i.e., makingevaluations about whether product thathas been subject to a deviation is safe toship). While FDA is convinced that ashort course in HACCP principles isimportant to the success of the overallprogram, the agency also recognizes thatsuch a course has its limitations.

FDA has deleted the proposedrequirement that the HACCP-trainedindividual be required to evaluate CLdeviations and corrective actions toallow for the use of experts in otherappropriate scientific disciplines thathave not been trained in accordancewith these regulations. For example, theagency does not expect that a processorwill be able to determine the publichealth consequences of every possibledeviation without the assistance ofexperts. The kind of expertise necessarywould likely involve disciplines otherthan HACCP. Moreover, the agencyagrees that it is unreasonable to expectthat successful completion of a 3-dayHACCP course alone would qualify anindividual to make determinationsabout the safety of products involved ina CL failure. HACCP training in such asituation could only reasonably beexpected to help ensure that appropriatecorrective action measures are taken andrecorded from a HACCP perspective.Consistent with this change, FDA hasmodified § 123.7(c)(2) to state that adetermination of acceptability fordistribution into commerce of productsthat may have been affected by adeviation must be made by individualswith the expertise to make such adetermination, and that suchindividuals need not be those who meetthe requirements of § 123.10.

Nonetheless, FDA expects that, at aminimum, an individual trained inaccordance with these regulations willperform the verification function ofreviewing records of corrective actionsto ensure that they are complete, andthat an appropriate corrective actionwas taken (i.e., one that waspredetermined in the HACCP plan, or


one that was determined by a qualifiedexpert to be sufficient to render theproduct safe). Section 123.10(c) requiresthat the trained individual performcertain record reviews associated withthe verification principle of HACCP,including reviews of corrective actionrecords (see § 123.8(a)(3)(ii)).

FDA has modified § 123.10 from theproposal to clarify and to conform thissection to other features of theregulations. A summary of thesemodifications follows.

FDA has revised § 123.10(a) to clarifythat when a trained individual developsan HACCP plan for a processor, thiseffort may involve adapting a model orgeneric-type plan for use by thatprocessor. FDA received a significantnumber of comments on the pros andcons of model or generic-type HACCPplans. This subject is addressed invarious places in the preamble, mostnotably in the section entitled ‘‘OtherIssues.’’ In summary, the developmentof model plans can be of great benefitto the industry, especially smallbusinesses, so long as the model plansare tailored by processors to meet theirindividual situations and are not simplycopied verbatim. The agency isconvinced that, in most cases, generic ormodel plans will need to be modified tosome extent to fully accommodate thespecifics of the processor’s operations.

Section 123.10(b) provides, in part,that the trained individual isresponsible for reassessing andmodifying the HACCP plan inaccordance with corrective actionprocedures specified in § 123.7(c)(5).This requirement is not new. It shouldbe noted, however, that, unlike theproposal, the final rule requires thetrained individual to perform thesefunctions only when the processor doesnot have a predetermined correctiveaction plan that addresses the specificdeviation. As explained in the‘‘Corrective Action’’ section of thispreamble, a review and reassessment ofthe plan should not ordinarily benecessary when a corrective action wasanticipated, as reflected by the existenceof a predetermined corrective actionplan.

Section 123.10(b) also requires that atrained individual perform the annualreassessment of the processor’s HACCPplan as required by § 123.8(a)(1). A newfeature of the regulations, thisrequirement parallels the mandate thateach processor engage in verificationactivities (see § 123.8(a)). It is a logicaloutgrowth of the principle, central toboth the proposal and this final rule,that plan development be performed byindividuals who possess the knowledge

and skills that are obtained throughtraining in HACCP.

Section 123.10(c) requires that atrained individual perform certainrecord reviews as enumerated in§ 123.8(a)(3). This requirement is notnew except for the review of records ofend-product testing, if any. End-producttesting was not addressed in theproposal but, as explained in the‘‘Verification’’ section of the preamble,has been added as an optionalverification activity. The review of end-product testing records by a trainedindividual is a logical outgrowth of theprinciple that was reflected in theproposal in § 123.8(b) that a trainedindividual review all HACCP records forcompleteness and consistency withwritten HACCP procedures.

Finally, it should be noted that therequirement in the proposed regulationsthat trained individuals perform certainfunctions for importers has beendropped entirely. This deletion isconsistent with the changes that FDA ismaking in the provisions that applied toimporters in this final rule. Theserevisions are described elsewhere in thispreamble. In summary, importers aregiven alternatives to having HACCPplans and are not required to take thekinds of actions for which a trainedindividual has been determined to beessential.

K. Sanitation

1. BackgroundFDA proposed to require that

processors conduct sanitationinspections at specified frequencies toensure that each of up to 18 specifiedsanitation conditions are maintained inthe processing facility where they arerelevant to the type of processing beingperformed. The agency also proposed torequire that processors maintainsanitation control records, and that theytake and document corrective actionswhen the specified conditions were notmet. In addition, FDA encouraged, butdid not propose to require, processors tomake use of written SSOP’s to ensurethat the necessary sanitation measureswere implemented.

FDA tentatively concluded thatsanitation controls are necessary inthese regulations because: (1) Sanitationpractices directly affect themicrobiological safety of seafoodproducts that are not further cooked bythe consumer, such as cooked, ready-to-eat products, smoked products, rawmolluscan shellfish, and other fish thatare consumed raw; (2) sanitationpractices are relevant to themicrobiological safety of seafoodproducts even where these products are

to be cooked by the consumer; (3)sanitation practices directly affect thechemical and physical safety of seafoodproducts; (4) nearly half the consumercomplaints relating to seafood that FDAreceives in a typical year are related toplant or food hygiene; and (5)inspections conducted by FDA andNMFS demonstrate that a significantportion of seafood processors operateunder poor sanitation conditions.

The MSSP, conducted by NMFS,concluded that sanitation controls couldbe included in HACCP plans withoutoverloading HACCP. Moreover, theFDA/NMFS HACCP-based seafood pilotprogram included sanitation CCP’s.Nonetheless, FDA tentatively concludedthat monitoring and recordkeeping forthe 18 specific sanitation conditionsspecified in the proposal should bepermitted to occur outside of aprocessor’s HACCP plan so as not tooverload it. Because these sanitationcontrols relate to an entire facility, notjust to a limited number of CCP’s, FDAfelt that they would not all fit wellwithin an HACCP plan.

FDA took this prescriptive approachto sanitation to assist processors so thatthey would not have to figure out how,or whether, to include sanitation intheir HACCP plans and to help themresolve the sanitation problems that theseafood industry has chronicallyexperienced. By requiring a specific,daily sanitation regime that incorporatesHACCP-type features (i.e., monitoringand recordkeeping) to help theprocessor track sanitation in its plant,FDA hoped to foster a culture of, andcommitment to, good sanitationpractices that has been lacking in asignificant portion of the industry.

2. Should the Regulations Deal WithSanitation?

FDA requested comment on whethersanitation control measures should beaddressed by processors in accordancewith the proposed approach, or whetherthe regulations should require thatprocessors address sanitation in theirHACCP plans.

More than 250 comments addressedvarious aspects of the proposedsanitation requirements, morecomments than addressed any otheraspect of the proposed regulations.Approximately 100 of these commentsaddressed FDA’s questions about theapproach to sanitation control in theseregulations. The remaining commentsfocused on specific sanitationprovisions.

104. Approximately 10 percent ofthose that responded to the requestssupported the proposed approach.These comments were from processors,


consumer advocacy groups, State,Federal, and foreign governmentagencies, and a trade association.Approximately five percent of thecomments, from processors, tradeassociations, and State governmentagencies, objected to the inclusion ofany explicit sanitation controls in theseregulations. It is not clear, however,whether the latter comments wereobjecting to sanitation controls as part ofHACCP where appropriate for safety orto any sanitation approach beyondHACCP. The remaining approximately85 percent of the comments, principallyfrom processors, trade associations, andState and Federal government agencies,generally acknowledged the need forthese regulations to address sanitationin seafood processing plants butobjected to one or more of the specificsof the proposal.

Those that supported the proposedapproach argued that sanitation controlsare a critical component of theregulations because: (1) Addressing theinsanitary practices in the seafoodprocessing industry is essential toimproved consumer confidence; (2)effective sanitation controls are aprerequisite to the proper functioning ofa HACCP system; and (3) sanitationcontrols are critical to the managementof microbiological hazards in bothproducts that will not be cooked by theconsumer and those that will be cooked,the latter because of the potential forcross-contamination in the kitchen. Thecomments suggested that a prescriptiveapproach to sanitation is warrantedbecause the FDA and NMFS inspectionresults cited in the preamble to theproposal documented the failure of asignificant percentage of the industry tocontrol key sanitation conditions andpractices. Moreover, these commentscontinued, the enumeration of specificcontrols relieves the industry of theburden of identifying the mostsignificant areas of concern.

Several comments stated thatsanitation requirements for seafoodprocessors are necessary becauseguidelines do not have the force ofregulation and therefore are moredifficult to enforce. One comment statedthat including sanitation requirementsin these regulations would simplifycompliance for seafood processorsbecause the HACCP and sanitationrequirements would be in one place.One comment stated that someprocessors would be more inclined toimplement sanitation control measuresif all processors were subject to thesame mandatory requirements.

Many of the comments that objectedto the manner in which FDA proposedto treat sanitation acknowledged that

effective sanitation controls are essentialto the proper functioning of a HACCPsystem. As with comments thatsupported the proposed approach, a fewof these comments identified sanitationas a prerequisite to HACCP.

The comments that objected to theinclusion of any sanitation requirementsin these regulations provided reasonsthat the agency believes are morerelevant to the question of how theseregulations should address sanitationthan to whether they should address theissue. For this reason, the argumentspresented in these comments areaddressed later in this section.

FDA accepts the view expressed bythe overwhelming majority of comments(i.e., those that advocated the proposedapproach and those that advocated othersanitation control mechanisms) thatsanitation is relevant to the goals ofthese regulations and should beaddressed in them. The primary sourceof pathogenic microorganisms for mostfish (i.e., wild-caught fish) is theprocessing plant environment (Ref. 3, p.267). The control of sanitation in theplant is the most effective way tominimize pathogens, and, for productsthat are not given a final heat treatmentafter packaging, it is the only way tominimize them at that stage in the chainof distribution (Refs. 3, p. 10; 7, p. 27;204; and 205). This situation is nearlythe reverse of that for red meat andpoultry, where pathogens are likely tohave originated from the raw materialsbefore they enter the plant (Refs. 36, p.197; 209; and 210, p. 1).

A significant body of opinion holds,moreover, that good sanitation is anecessary foundation for HACCP. Thisview was articulated in comments tothis rulemaking and in the proposedrule to establish HACCP and otherrequirements for the beef and poultryindustries issued by USDA (Ref. 211).USDA proposed both SOPs forsanitation as a prerequisite to a HACCPplan and sanitation as part of HACCPwhere critical for safety (Ref. 211, p.6789).

FDA concludes, therefore, that theseregulations cannot fully address allmatters relevant to safety, orsignificantly contribute to therestoration of consumer confidence inseafood without providing for majorimprovements in sanitation. Therefore,these regulations address sanitation.

3. Why Isn’t Part 110 (21 CFR Part 110)Adequate To Deal With SanitationConcerns?

105. Some comments asserted that itwould be adequate to rely on theexisting CGMP’s in part 110, whichprovide guidance of general

applicability to all foods. A variation onthat concern was the view that thesanitation standards in part 110 neednot be codified in these regulationsbecause they are adequately expressedin that part. The NACMCF pointed outthat the CGMP’s have proven adequatefor a wide variety of processed foodsunder FDA’s jurisdiction. Somecomments stated that part 110 should bemade mandatory for seafood and fullyenforced.

Good sanitation is already mandatoryfor all foods. Section 402(a)(4) of the actdeems food to be adulterated ifprocessed under insanitary conditions.The CGMP’s in part 110 articulate thekinds of conditions and practices thatneed to be followed in order to avoidproducing an adulterated product undersection 402(a)(4) of the act.

Nevertheless, while FDA has beenenforcing the sanitation standardscontained in part 110 for many years, asindicated earlier, it has not succeeded indeveloping a culture throughout theseafood industry in which processorsassume an operative role in controllingsanitation in their plants. The statisticsrelating to the incidence of insanitationcited in the preamble to the proposedregulations (Ref. 208 at 4161–4162)clearly demonstrate that such a cultureis not adequately in place. Thefollowing observation about culture inthe preamble to USDA’s proposedHACCP rules for beef and poultry isapplicable here as well:

* * * Identification of sanitationrequirements has been viewed by someestablishment owners and personnel as theinspector’s responsibility. Suchestablishments often fail to take the initiativeto find and remedy insanitary conditions,relying instead on the inspector to finddeficiencies. (Ref. 211, p. 6788)

Moreover, FDA points out that whilethe CGMP’s state that sanitation controlsshould occur as frequently as necessary,they are silent with regard to monitoringby the processor to ensure for itself thatsanitation controls are being followed.

For these reasons, FDA concludes thatpart 110 alone has not proven to beadequate for the seafood industry. Inorder to ensure that firms take fullresponsibility for sanitation in theirplants, which is strongly related to theproduction of safe and wholesomeseafood, FDA has concluded that it isnecessary to include sanitationrequirements in these regulations.

4. Why Isn’t the Proposed ApproachAppropriate?

106. Many comments that agreed thatsanitation should be addressed in theregulations, as well as some thatopposed addressing it, objected that the


proposal was too prescriptive. Thesecomments asserted that: (1) Theproposed 18 sanitation controls areoverly prescriptive and inflexible andare not appropriate for all processors; (2)the codification of prescriptivesanitation requirements as regulationslimits the ability of processors to keeppace with advances in science andtechnology; (3) the proposed sanitationcontrols have the effect of establishingeighteen CCP’s, which are not alwaysappropriate; and (4) the proposedsanitation provisions duplicate orcontradict existing State or NSSPrequirements. FDA will respond to thesecriticisms.

Many comments that argued that the18 specific sanitation controls that FDAproposed were too prescriptiveprovided examples of how thisapproach could deny processors theflexibility necessary to develop andimplement sanitation programs that areeffective for the specific conditions inwhich they are to be used. Some ofthese examples are as follows:

(1) A few comments challenged theproposed ‘‘easily cleanable’’ standardfor equipment, suggesting that in someapplications (e.g., at sea processing andold equipment) this standard may not beattainable and may not be necessary aslong as the equipment is, in fact,cleaned;

(2) A large number of commentschallenged the proposed 4-hourequipment cleaning frequency,suggesting that it is unwarranted insome situations (e.g., refrigeratedprocessing facilities) because it isinconsistent with actual microbiologicalgrowth rates. It is unduly burdensomein other situations (e.g., surimiprocessing facilities), according to thecomments, because it would limit shiftsto 4 hours, would interrupt production,and would require hours of equipmentbreakdown time;

(3) A few comments challenged theproposed ‘‘impermeable’’ standard forgloves and outer garments that contactfood or food contact surfaces, suggestingthat in some instances it wasimpractical (e.g., filleting fish);

(4) A significant number of commentschallenged the proposed 4-hour handsanitizer strength test frequency,suggesting that replacement of dipsrather than checking concentration maybe appropriate, as may be the use ofautomated hand washing and sanitizingsystems; and,

(5) A number of comments challengedthe proposed requirement that handwashing and sanitizing stations belocated in processing areas, suggestingthat they need only be easily accessible.

These comments have general meritand have persuaded the agency that aless prescriptive approach isappropriate to ensure that theregulations do not impose impractical,unduly burdensome, or excessivelyrigid requirements.

107. Another concern with FDA’sapproach was that codifying specificsanitation control procedures would notenable processors to keep theirsanitation programs updated withadvances in science and technology. Asan example, the NACMCF commentcited recent industry experience withother foods that has shown that theproposed requirement of midshiftcleaning and sanitizing in packagingrooms for ready-to-eat foods, may withmany current sanitation practicesactually be counterproductive to thecontrol of Listeria monocytogenes. TheNACMCF advised that codification of amidshift cleaning requirement wouldhave prevented these industries frommodifying their cleaning procedures toadjust to the new information.

FDA agrees that sanitationrequirements should be sufficientlyflexible to permit the incorporation ofnew information and better procedures.

108. A number of the comments,including more than half of those thatopposed any new form of sanitationcontrols, argued that the sanitationcontrol approach proposed by FDAwould effectively establish eighteenmandatory sanitation CCP’s that maynot always be appropriate.

These comments may have been theresult of a misunderstanding of therelationship between processor HACCPplans and the proposed sanitationcontrols. While the proposed controlsinvolved monitoring and recordkeeping,they were not proposed as part of aprocessor’s HACCP system. FDA did notintend to designate them as CCP’s. FDAbelieves that the provisions of thesefinal rules make clear that the necessarysanitary controls need not be consideredto be CCP’s.

109. A large number of the commentsthat objected to the manner in whichFDA proposed to handle sanitationargued that the proposed sanitationprovisions are redundant with State andlocal regulations and, with respect tomolluscan shellfish, with the NSSP.

FDA acknowledges that the NSSP andmost State seafood control programsinclude provisions, much like FDA’sCGMP’s, that are designed to controlprocessing plant sanitation. These otherprovisions, like the CGMP’s, serve asbaseline standards for sanitation.However, the rates of noncompliancewith existing CGMP standards, asdetailed in the preamble to the proposed

regulations (Ref. 208 at 4161–4162),demonstrate a need for a system inwhich processors are responsible for notonly meeting these baseline standardsbut also routinely auditing theirfacilities and operations to ensure thatthey are meeting them. In this way, thesanitation requirements of theseregulations build upon existingsanitation requirements, at the Federal,State, and local levels.

The more generalized nature of thesefinal regulations with respect tosanitation should mitigate the concernsof the comments that complained aboutthe conflict between, and duplicationwith, existing sanitation standards.

As discussed elsewhere in thispreamble, FDA encourages adoption ofthese regulations by State and localregulatory agencies. FDA is convincedthat, in many cases, the regulations canbe quite easily overlaid on existingState, local, and NSSP requirements.

5. What Is the Appropriate Approach toSanitation?

Based on its review of the comments,FDA has been convinced that amodification of its approach tosanitation is appropriate. FDAconcludes that its approach in theproposal was too inflexible and couldhave made it more difficult in certaincircumstances to incorporate newtechnologies and information.

The comments argued for one or moreof several approaches that theyidentified as being more appropriatethan FDA’s proposed approach: (1)Requiring that each processor developand follow a SSOP that is specificallytailored to a processing operation; (2)including sanitation controls in theHACCP plan where they are critical toproduct safety; and (3) retaining thegeneral approach of the proposedregulations but somehow reducing thenumber of specific requirements.Approximately 85 percent of those thatopposed the way that sanitation wastreated in the proposal advocated one ora combination of the first two of theapproaches, with the recommendationsevenly split between the two. The smallnumber of comments that objected toincluding any specific sanitationrequirements in the regulations mayalso have been arguing that sanitationshould not be part of HACCP but shouldbe controlled solely through CGMP’s.

a. Inclusion of sanitation controls inHACCP plans.

110. There was strong support in thecomments for the inclusion of sanitationcontrols in HACCP plans, particularlywhere the controls are necessary toprotect the safety of the product. Thecomments stated that a processor’s


hazard analysis may reveal the need tocontrol certain aspects of sanitation inthe HACCP plan, especially to controlhazards involving microbiologicalcontamination. One comment noted thatsanitation controls are likely to becomponents of the HACCP plans ofmolluscan shellfish processors.

Given the strong support thatsanitation controls should be includedin HACCP plans where they are criticalto safety, FDA has no objection toprocessors including sanitation controlsin their HACCP plans. Consequently,these final regulations state in § 123.6(f)and § 123.11(d) that sanitation controlsfor safety may be included in HACCPplans.

The agency has concerns, however, asto whether including sanitation controlsin a HACCP plan will be adequate toensure that appropriate conditions existin a plant. The conditions that would beaddressed in the HACCP plan will likelybe those that are most critically anddirectly related to product safety. Othersituations that are relevant to safety, butin a less direct way, would probably notbe controlled through HACCP. Forexample, following the NACMCFrecommendations for hazard analysisand HACCP plan development wouldlikely result in the identification of anumber of equipment and hand washingcontrols at CCP’s in the HACCP plan forthe processing of a cooked, ready-to-eatproduct to minimize the risk ofmicrobiological contamination but notin the identification of these samecontrols in the HACCP plan for a rawfinished product that would normallybe cooked before consumption. In thelatter case, however, attention tosanitation would still be important inthe processing plant to preventcontamination of the product, given thatthe ultimate consumer cook may beinadequate, or that the product, oncecontaminated, could be a source ofcross-contamination to other foods.

Likewise, the potential forcontamination of either a cooked, ready-to-eat product or a raw product as aresult of rodent activity in a processingplant, or as a result of improper use ofpesticides on or near the product, wouldnot likely be identified in a HACCPplan. All of these conditions arerelevant to the safety of the product andshould be addressed by processors. It isnot clear whether HACCP can fullysucceed in plants that are not in controlof general sanitation practices.The inclusion of sanitation in HACCP—as desirable as it may be—will not fullyresolve this problem.

b. SSOP.111. As indicated above, a significant

number of comments that addressed

alternatives to the prescriptive approachto sanitation in the proposal preferred aSSOP, either alone or in combinationwith critical sanitation controls inHACCP. Significantly, the NACMCFwas among those that made thissuggestion. NMFS’ comment stated that,in its experience, the development ofSSOP’s by processors in its voluntaryprogram has been associated withmarked improvement in sanitation.Many comments stated that much of theseafood processing industry already hasSSOP’s, and that those that do notshould develop them.

FDA agrees that the development byprocessors of an SSOP would be abeneficial step. FDA therefore isrecommending in § 123.11(a) that:

Each processor should have andimplement a written sanitation standardoperating procedure (herein referred to asSSOP) or similar document that is specific toeach location where fish and fishery productsare produced.

An SSOP places the primary burdenfor identifying relevant controls on thefood processor. To meet this burden, itwill be necessary for the processor tothink through each operation andidentify where, and how frequently,appropriate sanitation measures arenecessary. The process of doing so willfoster the type of culture that FDA istrying to promote, in which processorsassume an operative role in controllingsanitation in their plants.

FDA is adopting § 123.11 pursuant tosections 402(a)(4) and 701(a) of the actto ensure that seafood is not producedunder insanitary conditions whereby itmay be rendered injurious to health. Itgrows directly out of proposed § 123.10,but, as stated above, it reflects theagency’s efforts to make the sanitationrequirements more flexible.

FDA has not elected to make thedevelopment of an SSOP mandatorybecause it recognizes that someprocessors may be able to achievesatisfactory sanitation conditions andpractices without having to committheir sanitation control procedures towriting. The agency remains convincedhowever, that such satisfactoryconditions are unlikely to be achievedwithout periodic monitoring of theoperations. For this reason the agencyhas retained at § 123.11(b) themandatory sanitation monitoringrequirements proposed at § 123.10(c).Sanitation monitoring will be furtherdiscussed in the next section of thispreamble.

Where a processor elects to developan SSOP it should specify how it willmeet those sanitation conditions andpractices that are to be monitored in

accordance with § 123.11(b). Theseconditions and practices will also bediscussed in the next section.

Both § 123.11(d) and § 123.6(f)provide that sanitation controls that aremonitored in accordance with§ 123.11(b) need not be included in theHACCP plan and vice versa. Thepurpose of these provisions is to allowprocessors to incorporate thosesanitation controls into their HACCPplans that they believe are appropriatelyaddressed through HACCP, withouthaving to duplicate those controls in aseparate sanitation program.

6. Monitoring and Corrective ActionsThe regulations no longer contain

specific monitoring frequencies toensure that proper sanitation conditionsare being met, as was proposed at§ 123.10(c). In keeping with the agency’sdecision to reduce the prescriptivenature of the sanitation requirements,§ 123.11(b) now requires that eachprocessor monitor the conditions andpractices during processing withsufficient frequency to ensure, at aminimum, conformance with certainkey sanitation conditions and practicesas specified in part 110.

112. The agency arrived at thisapproach in response to the comments.As part of the agency’s efforts to achieveflexibility, it examined the 18 sanitationcontrols that it proposed at § 123.10(a)in light of the comments that arguedthat they were overly prescriptive. FDAproposed the 18 sanitation controls toensure that, where relevant to theprocessing operation, important areas ofconcern were addressed in each plant.The preamble addressed at some lengthwhy each of them was significant andrelevant to safety. Moreover, althoughconsiderable comment was received thatchallenged the manner in which aparticular processor should addressthese sanitation conditions and thesituations in which they should beconsidered applicable, only twocomments challenged the significance ofthese conditions or the need for them tobe controlled when they are determinedto be germane, and neither commentprovided a basis for doubting thesignificance of these controls.

FDA concludes that, where relevant toa processor’s operation, the processorshould monitor sanitation conditionsand practices relating to the generalsubject areas reflected by the 18 specificsanitation controls because they areimportant for ensuring the safety of theproduct. As in the proposal, eachprocessor will be responsible fordetermining which of the subject areasare relevant to its plant and process.However, unlike the proposal, the


processor will be free to tailor thesanitation controls to the circumstancesof its operation, as long as it does so ina manner that ensures the effectivenessof those controls. The regulations do notspecify the manner in which controlmust be achieved. FDA will provideguidance on how to ensure appropriatesanitation control in the Guide. FDA isdeferring consideration of the commentsthat it received on the specificsanitation control measures that itdescribed in the proposal until itprepares the Guide.

In order to ensure that processorsmonitor the general subject areasreflected by the 18 specific sanitationcontrols listed in the proposal, FDA hasconcluded that it is appropriate to listin the regulations the sanitation controlsthat should be considered. This list willensure that the most significantsanitation controls are considered by theprocessor in formulating the measuresthat it will institute in its plant.

The controls that FDA is listing in§ 123.11(b) no longer contain sanitationstandards that are beyond part 110 orrepeat specific standards that arecontained in that part. Instead,§ 123.11(b) now states that the processorshall ensure that actions are taken toensure that those sanitary conditionsthat are contained in part 110 and thatare relevant to the plant are maintainedin eight general areas:

(1) The safety of the water that comesinto contact with food or food contactsurfaces or is used in the manufactureof ice (§ 123.11(b)(1)). This controlderives from proposed § 123.10 (a)(1)and (a)(2) relating to water quality andtreatment and to cross connectionsbetween potable and nonpotable watersystems.

Water is used in virtually all seafoodprocessing facilities for washingproduct, equipment, and employees’hands, for transporting fish in flumes,and as an ingredient. Contaminatedwater can serve as a vehicle forcontamination of the product, bothdirectly and indirectly (Refs. 63; 64; 65,p. 49; 66; 67; and 68, pp. 1 and 2). Crossconnections, which include situationsthat allow for back siphonage into apotable system from a nonpotablesystem under negative pressureconditions, can result in the chemical ormicrobiological contamination of thepotable water system (Refs. 64; 65, pp.50 and 51; 68; 71; and 72).

This matter was one of the two, asindicated above, about which FDAreceived a comment that challenged theneed for a sanitation control. Acomment suggested that the safety of thewater supply is within the jurisdictionof local health authorities, and that a

processor should not have to deal withthat issue.

FDA acknowledges that many Stateand local jurisdictions exercise controlover both public and private watersupplies. In the case of private wells,they often permit and inspect theconstruction of the well and collectperiodic water samples formicrobiological and chemical attributes.Where such is the case, it may bereasonable for the processor to relyupon these measures. However, in theabsence of appropriate controls by apublic authority, FDA has concludedthat the processor must exercisewhatever control is necessary to ensurethat the water supply is safe. To dootherwise would be to subject theproduct to an unacceptable safety riskfrom the contaminants that may beintroduced by the water.

(2) The condition and cleanliness offood contact surfaces, includingutensils, gloves, and outer garments(§ 123.11(b)(2)). This control derivesfrom proposed § 123.10 (a)(3) through(a)(5) relating to the design,workmanship, materials, andmaintenance of food contact surfaces;the cleaning and sanitizing of thesesurfaces, including the frequency ofcleaning and sanitizing; theimpermeability of gloves and outergarments that contact food; and themaintenance of gloves and outergarments.

Utensils, equipment, aprons, gloves,outer garments, and other food contactsurfaces can be vehicles for microbialcontamination of both the raw andfinished products. Food contact surfacesthat contain breaks, pits, cuts, orgrooves, or that are porous or corroded,may harbor pathogenic microorganismsthat can migrate to the product andcontaminate it. These kinds of surfacesare difficult to clean (Refs. 65, pp. 20,and 36–48; 72, pp. 166–167; 73; and 83).Where food contact surfaces areconstructed of toxic materials, theproduct may be directly contaminated(Ref. 74). Inadequately cleaned foodcontact surfaces can serve as a reservoirfor pathogenic microorganisms,especially if biofilms are allowed toform, in which microorganisms can beentrapped and shielded from the actionof cleaning and sanitizing compounds.

(3) The prevention of cross-contamination from insanitary objects tofood, food packaging material, and otherfood contact surfaces, includingutensils, gloves, and outer garments,and from raw product to cooked product(§ 123.11(b)(3)). This control derivesfrom proposed § 123.10 (a)(6), (a)(7),(a)(13), and (a)(18), relating to employeepractices to prevent contamination, to

physical separation of raw and cookedproduct, and to plant design to preventcontamination.

Employees and food contact surfacescan serve as vectors in the transmissionof pathogenic microorganisms to thefood. These microorganisms can beintroduced to the product from outsideareas, rest rooms, contaminated rawmaterials, waste or waste receptacles,floors, and other insanitary objects. Inthe processing of cooked products, theraw material may also serve as areservoir of pathogenic microorganisms.Employees or equipment that touch theraw material can transmit thesemicroorganisms to the cooked product(Refs. 7, 63, 64, 73, 74, 84, and 85).Finally, proper construction of theprocessing plant is essential if othersanitary measures are to be successful.For example, incompatible operations,such as handling of raw materials andhandling of cooked product, should beisolated (Refs. 71, 74, 87, and 88).

(4) The maintenance of hand washing,hand sanitizing, and toilet facilities(§ 123.11(b)(4)). This control derivesfrom proposed § 123.10 (a)(8) and(a)(16), relating to the location andmaintenance of hand washing andsanitizing facilities, and toilet facilities.

Employee’s hands can serve as avector for the transmission ofpathogenic microorganisms to the food.Hand washing and sanitizing, whenperformed using suitable preparationsare effective means of preventing suchtransmission. Toilet facilities eliminatefrom the processing environmentpathogenic microorganisms shed infecal material (Refs. 63, 64, 73, 74, 84,and 85).

(5) The protection of food, foodpackaging material, and food contactsurfaces from adulteration withlubricants, fuel, pesticides, cleaningcompounds, sanitizing agents,condensate, and other chemical,physical, and biological contaminants(§ 123.11(b)(5)). This control derivesfrom proposed § 123.10(a)(9), (a)(11),and (a)(12), relating to the protection offood from various microbiological,chemical, and physical contaminants.

The use of toxic compounds (e.g.,pesticides, cleaning and sanitizingagents, and lubricants) is frequentlynecessary in the processingenvironment. Food and food packagingmaterials should be protected orremoved from areas where pesticidesare used, and caustic cleaningcompounds should be thoroughlyremoved from food contact surfacesbefore processing begins (Ref. 74).Condensate which forms on aninsanitary surface and then falls on the


product may carry with it pathogenicmicroorganisms (Ref. 65, pp. 24–25).

This measure is the second aboutwhich FDA received a comment thatchallenged the value of having asanitation control. A commentsuggested that preventing the formationof condensate on ceilings aboveprocessing is, in some situations,physically impossible. The commentdid not suggest that condensate isirrelevant to safety.

FDA reasserts that condensate isrelevant but acknowledges that there areinstances in which it may be impracticalfor it to be fully eliminated. In theseinstances, after taking all reasonablemeasures to minimize the developmentof condensate, the processor will needto take steps to protect the product fromthe dripping condensate or to ensurethat the surface from which it isdripping is sanitary. The developmentof a written SSOP processor shouldtailor its sanitation controls to itsparticular situation in order toaccomplish this objective.

(6) The proper labeling, storage, anduse of toxic compounds (§ 123.11(b)(6)).This control derives from proposed§ 123.10(a)(10), relating to the overallhandling of toxic compounds to protectagainst contamination of food. Improperuse of toxic compounds is a frequentcause of product adulterationthroughout the food industry. Properlabeling, storage, and use of thecompounds is necessary to minimizethe risk of occurrence of such incidents(Ref. 74).

(7) The control of employee healthconditions that could result in themicrobiological contamination of food,food packaging materials, and foodcontact surfaces (§ 123.11(a)(7)). Thiscontrol derives from proposed§ 123.10(a)(15), relating to the exclusionof persons who appear to have anillness, wound, or other affliction thatcould be a source of microbialcontamination.

Employees can serve as a reservoir ofdiseases, such as salmonellosis,shigellosis, and hepatitis, that can betransmitted to consumers by foods.Additionally, open sores, boils, orinfected wounds present the potentialfor contamination of the food with suchpathogenic microorganisms asStaphylococcus aureus (Refs. 22, 74,and 84).

(8) Exclusion of pests from the foodplant (§ 123.11(b)(8)). This controlderives from the proposed requirementsat § 123.10(a)(17). Pests, such as rodents,birds, and insects carry a variety ofhuman disease agents, which they canintroduce to the processing environment(Refs. 63, 64, 73, and 84).

113. FDA proposed at § 123.10(a)(14)that, ‘‘Refrigeration units that store rawmaterials, in-process, or finished fish orfishery products that are cooked, ready-to-eat, smoked, or made in whole or inpart from scombroid toxin formingspecies shall be operated at atemperature of 40 °F (4.4 °C) or below.’’The purpose of the proposedrequirement was to ensure thatprocessors control the microbiologicalhazards associated with refrigeratedstorage for these particularly susceptibleproducts. A significant number ofcomments argued the control oftemperature in refrigerated storage is aprocessing hazard rather than asanitation issue, and should be coveredby a firm’s HACCP plan.

FDA agrees with these comments andhas not included a provision onrefrigeration in the sanitation section ofthese regulations. A large number ofcomments were received relative to theappropriateness of a 40 °F (4.4 °C) limit.These comments are no longer relevantto these regulations but will beaddressed in the redrafting of the Guide.

FDA has also incorporated thecorrective action requirement relative tosanitation conditions proposed at§ 123.10(d) in § 123.11(b). Section123.11(b) the processor shall, correct ina timely manner those sanitationconditions and practices that are notmet. The phrase ‘‘in a timely manner’’did not appear in the language ofproposed § 123.10(d). However, it wasimplicit that corrections should be madeas quickly as possible so as not tosubject subsequently processed productto conditions that could both jeopardizetheir safety and render themadulterated. FDA has added the phrasefor clarity.

Note that the other corrective actionrequirements in these regulations, i.e.,those in § 123.7, do not apply tosanitation controls that are exclusivelyaddressed in § 123.11. The controls in§ 123.7 apply to a processor’s HACCPsystem only.

7. Records114. FDA received approximately 20

comments that addressed the issue ofsanitation records. Many othersdiscussed recordkeeping in general butdid not specifically mention records ofsanitation controls. These lattercomments have already been addressedin the ‘‘Records’’ section of thispreamble.

Of those that commented specificallyon sanitation records, approximatelythree-fifths, from processors and tradeassociations, objected to the proposedrequirement that processors maintainrecords that demonstrate compliance

with the appropriate sanitationstandards. In fact, a number ofcomments listed this issue as asignificant reason for their objection tothe overall proposed approach tosanitation control. The commentssuggested that sanitation recordkeepingis costly and has not been demonstratedto be effective. None of these commentsprovided any data in support of theirstatements. Some argued that, whilethey accepted the notion of records forCCP monitoring, they opposed recordsof sanitation monitoring.

The remaining comments thataddressed the issue of sanitationrecords, from consumer advocacygroups, an individual, a Federalgovernment agency, a trade association,and a seafood broker, supported theneed for such records. These commentsargued that sanitation records areessential to ensure that processorsadhere to established sanitary standards,and that they need not be extensive.

FDA does not find the argumentsagainst the requirement for sanitationcontrol records to be compelling. Theagency concludes that the burden willbe minimal. Checklist type or simplenotation records will suffice in mostinstances. Creating them should beincidental to monitoring. Monitoring toensure that sanitation is under control isthe responsibility of all processors.

Monitoring and recording ofsanitation conditions is as much a keyto the success in improving thoseconditions, and, hence, to increasingconsumer confidence in the seafoodprocessing industry, as is thedevelopment by a processor of an SSOP.As in the case of HACCP records,sanitation records require thatprocessors engage in systematicmonitoring of their own sanitationpractices and conditions. It enablesthem to see trends. Moreover,participation in recordkeeping helpsempower the work force and fosterresponsibility. It also allows theregulator to assess a processor’scompliance over a period of time, notjust at the time of an inspection.

FDA believes that the records bearingon the monitoring of relevant sanitationconditions and practices and FDA’saccess to such records are all essentialif § 123.11 is to be an effectiveregulatory strategy. Therefore, FDA hasconcluded that the recordkeepingrequirement proposed at § 123.10(b) willbe retained. To reflect othermodifications in this section, § 123.11(c)has been modified to read, ‘‘Eachprocessor shall maintain sanitationcontrol records that, at a minimum,document the monitoring andcorrections prescribed by paragraph (b)


of this section. These records are subjectto the requirements of § 123.9.’’

Additionally, FDA has moved therequirement that sanitation correctionsbe documented from proposed § 123.10(d) to § 123.11 (b).

Finally, FDA notes that § 123.11 doesnot contain any mention of importers.The lack of a mention of importers inthis section reflects the position that theagency is taking in these regulationsthat, to the extent that importers are alsoprocessors, they would be subject to thesanitation requirements in this section.To the extent that they serve asimporters only, the sanitationprovisions are not relevant to theiroperations.

L. Imports

1. Background

The majority of seafood consumed inthe United States is imported. FDA’ssurveillance system for imports largelyconsists of reviewing the customsentries for fish and fishery productsbeing offered for entry into the UnitedStates, engaging in wharf examinationsand sample collections for laboratoryanalysis, and placing products with ahistory of problems on automaticdetention. As with domesticinspections, this method is basically a‘‘snapshot’’ approach that places asignificant burden on the government touncover problems. It has failed to resultin full compliance or consumerconfidence in the safety of importedseafood. Consequently, the agencytentatively concluded that HACCPcontrols should apply to imported fishand fishery products as well as todomestic products. Among other things,FDA proposed that the definition of‘‘processor’’ explicitly include thosewho process seafood in foreigncountries.

In addition, FDA tentativelyconcluded that the importer shouldshare some responsibility with theforeign processor for safety. More oftenthan not, it is an U.S. importer, ratherthan the foreign processor, who actuallyoffers imported fish and fisheryproducts for entry into the UnitedStates. The preamble noted that, whilemany importers are conscientious aboutthe safety of the products that theyimport, others have little understandingof the potential hazards associated withtheir products. Thus, the agencytentatively concluded that the existingsystem of import controls had notpromoted a sense of responsibility inthe import industry.

Therefore, in addition to proposing torequire that foreign processors thatexport to the United States comply with

part 123, FDA proposed that importersof fish and fishery products take stepsto ensure that their shipments areobtained from such processors.Specifically, FDA proposed thatimporters: (1) Have and implement aHACCP plan that describes how theproduct will be processed while undertheir control; (2) maintain a copy of theforeign processor’s HACCP plan; and (3)take affirmative steps to ensure that theimported fish or fishery product wasproduced in conformance with theforeign processor’s HACCP plan andwith the proposed sanitationrequirements. The agency also proposedthat importers need not take affirmativesteps if the fish or fishery product wasimported from a country with whichFDA has a MOU documenting theequivalency of the foreign inspectionsystem with the U.S. system.

2. Should Imports Be Subject to TheseRegulations?

115. Approximately 70 commentsaddressed various aspects of theproposed requirements for imports.Approximately half of the commentsthat addressed the import provisionsargued that it is necessary to subjectimported products to the sameregulatory requirements as domesticallyprocessed products. These commentswere submitted by processors, tradeassociations, State and foreigngovernment agencies, professionalassociations, and individuals. Many ofthese comments argued that exemptingforeign processors from therequirements of these regulations wouldput the domestic industry at an unfaireconomic disadvantage. Othercomments stated that the importrequirements would increase consumerconfidence in seafood because theywould ensure that imported fisheryproducts have been produced under thesame HACCP requirements and held tothe same sanitation standards asdomestically produced product. A fewcomments suggested that importedproducts are more likely to presentsafety hazards than domestically-produced products because of a lack ofunderstanding of CGMP’s on the part offoreign processors. One commentasserted that a number of countries,including Canada, the EU, Iceland, andThailand are in varying stages ofestablishing HACCP programs for theirown domestic seafood processors.

Most of the remaining comments(approximately one-half) did notcomment on whether HACCP controlsshould be required for imported fishand fishery products but discussedaspects of the agency’s proposed

approach. These comments will beaddressed later in this section.

FDA did not receive any commentsthat persuaded it that imports should beexempt from the requirements of theseregulations. On the contrary, thecomments reflect a nearly universalrecognition that the safety of seafoodcannot be adequately ensured if themajority of products (that is, imports)are not subject to the same controls asdomestic products.

Therefore, the agency has notmodified the regulations’ basicapproach for imports.

116. Only two comments objected tothe concept that imported fish or fisheryproducts should meet the samerequirements as those for domesticproducts. One of these commentsargued that FDA should be tolerant of aforeign processor that may not have theknowledge or time to develop a HACCPplan before its product is ready forexport and urged the agency to developa temporary waiver system toaccommodate such firms.

FDA is convinced that a 2-yearimplementation period, as discussed inthe ‘‘Effective Date and Compliance’’section of this preamble, will providesufficient time for processors, bothwithin and outside the United States, todevelop and implement HACCP plansand otherwise come into compliancewith the provisions of these regulations.The comment provided no basis fortreating foreign processors anydifferently than domestic processors inthis regard.

117. Another comment suggested thatraw material fish and fishery productsimported for further processing in theUnited States should be exempt fromthe requirements of the regulations butprovided no reason to support thatposition.

The exemption requested by thecomment would make it difficult, if notimpossible, to control environmentalhazards that may be associated withthese products. This preamble and thepreamble to the proposed regulationsfully discuss the conclusions of theNAS, which identified raw materialhazards, such as microbiologicalcontamination in molluscan shellfishand natural toxins in both shellfish andfinfish, as among the most pressingproblems that must be addressed toensure seafood safety. For the most part,these hazards are best addressed at thetime of harvest and by primaryprocessors, through HACCP, at the timeof receipt. In many cases, there is littleopportunity for control beyond the latterpoint. Raw material fish and fisheryproducts for further processingcomprise a substantial portion of fish


and fishery products imported into theUnited States (Ref. 212, p. 49). Thus, toexempt foreign processing of suchproducts from the requirements of theseregulations would be to greatly diminishthe scope and, therefore, the overalleffectiveness of these regulations.

118. One comment that supported theneed for equitable treatment of importedand domestically produced productsurged the agency to provide the sameopportunities for processors abroad tofamiliarize themselves with therequirements of these regulations as itdoes the domestic industry. Thecomment argued that just printing theregulations in the Federal Registerwould not fulfill that responsibility. Thecomment further suggested that FDAsend copies of guidance materials to allknown foreign seafood processors,preferably in their native language.

FDA acknowledges the difficulty inreaching foreign processors withinformation about the requirements ofthese regulations. However, massmailings to, and multiple translationsof, these regulations and the Guide forall foreign seafood processors thatexport to the United States would not bepracticable for FDA.

The agency intends to reach foreignprocessors primarily by briefing foreignembassy staffs and by communicatingwith U.S. importers during public andtrade association meetings. Based onexperience in disseminating informationabout U.S. requirements to the importcommunity, the agency expects thatthese two groups will provide thenecessary information and guidancematerials (in the appropriate languages)to the foreign processors that theyrepresent. This same approach was usedin disseminating information about theproposed regulations. In fact, FDAbecame aware of a Japanese translationof the proposal shortly after it issued.

In addition, FDA traditionally hasprovided training and technicalassistance for foreign processors andgovernment officials on a variety of foodcontrol topics, within the constraints ofbudget and manpower. These projectshave principally been conducted indeveloping countries, often those inwhich the agency has become aware ofa particular problem that threatens thesafety of products offered for entry intothe United States. FDA anticipates thatthese kinds of projects will continue,and that they will focus more closely onHACCP. FDA also expects that HACCPtraining, performed in accordance withthe standardized training materialsunder development by the Alliance (seethe ‘‘Training’’ section of this preamble),will provide further opportunity for

foreign processors to be exposed to therequirements of these regulations.

3. Should Importers Be Subject to TheseRegulations?

119. Approximately half of those whocommented on the import provisionsaddressed whether the importer shouldbe required to take steps to ensure thatits shipment originates from a foreignprocessor that operates under HACCP.Approximately half of these commentsfavored the concept and half opposed it,with both groups being diverse in theirrepresentation.

Of those who opposed it, manyargued that these requirements shouldbe the responsibility of the government,and that FDA should not require thatimporters enforce them. A number ofthese comments further argued thatequivalent foreign governmentinspection systems cannot be presumedto be in place, and that the only way toachieve a ‘‘level playing field’’ is forFDA to perform inspections of foreignprocessors at the same frequency, andusing the same standards, that theagency applies to domestic processors.One comment suggested that it may benecessary to obtain legislative authorityto perform foreign inspections, as acondition of importation. Anothercomment suggested that FDA auditingof foreign processor compliance wouldgive importers assurance that theproducts that they obtain from suchsources had been produced inaccordance with appropriate U.S.standards.

One comment, while not opposed tomandatory importer responsibilities,nonetheless argued that FDA shouldspend as much time and effortinspecting foreign processors as it doeson domestic processors because over 50percent of the seafood consumed in theUnited States is imported. The commentcontinued that, ‘‘to do any less would bean unfair burden to domestic processorsand would not accomplish the statedgoal to significantly improve the safetyof seafood consumed in the U.S.’’

One comment argued that there is noreal cost savings in assigning importersthe responsibility of verifying foreignprocessor compliance rather thanassigning that responsibility to FDA,because importers will merely passalong the additional costs to theconsumer. Another comment noted thatmany small importers obtain productsfrom over 25 countries, and that theycannot afford to provide thesurveillance necessary to ensurecompliance.

Another comment argued that manyimporters function simply as brokers,connecting a buyer with a seller, and

that they lack the expertise, manpower,and facilities to evaluate the adequacyof a processor’s HACCP controls. Onecomment stated, ‘‘Many of the peopleinvolved in importing never see theproduct and know nothing about fish—these are people in a small room witha battery of phones!’’ Another commentargued against placing reliance forassuring the safety of imported seafoodon persons who have a financial interestin the product but lack the requiredknowledge about seafood safety.

One comment argued that requiringimporters to exercise control over theirsuppliers has no parallel in theproposed domestic HACCP scheme. Thecomment stated that domesticprocessors must control the hazards thatare introduced during their processingoperations but need not be involved inverifying the control of those hazardsassociated with their supplier’soperations. Some comments argued thatthe responsibility for controllinghazards that are reasonably likely tooccur should be assigned to the foreignprocessor, while others argued that itshould be assigned to the U.S. processorto whom the importer sells the product.One comment asserted that importersare not in a position to exercise controlover the processing of products inforeign plants any more than they are ina position to exercise control over howthe products are handled by theircustomers.

Most of those comments thatsupported the concept of importerresponsibility provided no reason.However, one comment stated thatrequirements on importers wouldensure that someone in the UnitedStates would be legally responsible forthe safety and wholesomeness of eachimported product.

FDA recognizes that requiringimporters to take steps to ensure thatforeign processors from whom theypurchase seafood products are incompliance with these regulations couldnecessitate significant changes in theoperations of importers who havelimited their activities to matchingbuyers with sellers based on productspecifications that may have had little todo with safety. However, for tworeasons, FDA cannot agree thatresponsibility with regard to safety isinappropriate for importers.

First, it has always been theimporter’s responsibility to offer forentry into this country products that arenot adulterated under U.S. law. It is aprohibited act, under section 301(a) ofthe act, to introduce into interstatecommerce an adulterated food. Thus, animporter would be committing aprohibited act if it failed to ensure that


the food that it is offering for importinto the United States is not adulteratedunder section 402 of the act, includingsection 402(a)(4), one of the principalprovisions on which these regulationsare based.

Currently, however, the importer isnot required to operate in a proactivemanner to ensure that it is meeting thisresponsibility. Rather, the importer needonly offer products for entry intocommerce and thereby place the burdenon the government to find a problem.Many importers traditionally havepurchased ‘‘FDA rejection insurance’’ tohedge against that possibility. Thegovernment can shift the burden to theimporter by placing the importer’sproducts on automatic detention if itfinds problems that warrant such a step,but in most instances the burdenremains on the government.

Second, responsible importersunderstand the issues related to thesafety of the seafood products that theyimport and customarily require thatforeign suppliers conform to theirproduct specifications and applicableU.S. regulations relating to safety. Theseimporters take various measures toensure that a foreign processor cancomply with their specifications andsafety requirements before they agree topurchase products from the foreignprocessor.

Thus, it is feasible for importers totake steps to ensure that they are notoffering adulterated products for entryinto U.S. commerce. Requiring suchmeasures will not be a significant addedburden for many importers, particularlyas HACCP principles become morewidely used and understood ininternational commerce. Foreignprocessors that want to participate inthe export market, not only to theUnited States but to the EU, Canada,and an increasing number of othercountries, will implement HACCP andsanitation control programs and will beprepared to address an importer’s needsfor verification.

FDA does not agree that there is noparallel in the domestic scheme to theimporter’s responsibility to ensure thatthe goods it is offering were producedunder HACCP. Domestic processors,like importers must work with theirsuppliers (e.g., fishermen) to ensure thatall reasonably likely hazards (e.g.natural toxins and agricultural andindustrial chemical contaminants) arecontrolled. FDA is confident thatimporters, like processors, will realizethat ensuring that foreign processorsinstitute preventive control systems is acost effective means of ensuring that theproducts that they offer for entry intothe United States will consistently meet

FDA’s entry requirements and will besafe for consumption. FDA alsodisagrees with those comments thatsuggested that a requirement thatimporters take steps to ensure that theproducts they offer for entry have beenproduced under a HACCP plan is anabrogation of FDA’s responsibilities. Asstated previously, the industry has aresponsibility to ensure that the foodthat it introduces into interstatecommerce is not adulterated. FDA has aresponsibility to verify that industry ismeeting its obligation and to takeremedial action if industry fails to do so.Importers, who are usually the ownersof the products that they are offeringinto commerce, are a part of thatindustry. FDA cannot accept thatimporters have no responsibility toensure that their products are notadulterated.

The agency recognizes that probablythe most effective way for a regulatoryagency to evaluate a processor’scompliance with the HACCP andsanitation requirements is throughonsite inspection of facilities, practices,and records. FDA has performed alimited number of inspections of foreignprocessors and, within its budgetarylimitations, will continue to do so toenforce these regulations. However,such inspections are costly, and anyattempt to significantly increase theirnumber would require additionalresources.

FDA will continue its traditionalimport surveillance role, utilizing entrydocument review, wharf examinations,sample collections, and automaticdetentions as screening tools. Thesetools indirectly evaluate the adequacy ofHACCP and sanitation controls and willcontinue to be useful in detectingsignificant problems. While end-producttesting and evaluation are not adequatesubstitutes for preventive controls inensuring the safety of a product, theycan provide verification whereappropriate (Ref. 34, pp. 201–202).

FDA has concluded that requiringHACCP controls, together with importsurveillance and periodic inspections ofimporters to ensure their compliancewith the requirements of § 123.12, willbetter ensure the safety of imports thanthe current system.

In a related matter, § 123.3(g) makesclear that, under ordinarycircumstances, freight forwarders,custom house brokers, carriers, orsteamship representatives will not berequired to fulfill the obligations of animporter. It is possible, although FDAhas no way to know with any certainty,that some of those that objected to beingrequired to fulfill those obligationswould, as a result of these clarifications,

find that they would not be expected todo so.

4. Memoranda of Understanding(MOU’s)

120. Many of the comments thatobjected to the importer responsibilityprovisions of the proposal on thegrounds that the government is theappropriate entity to ensure foreignprocessor compliance, stated that themost effective means of ensuring suchcompliance would be for FDA to enterinto MOU’s with the governments ofexporting nations. Approximately one-third of those that commented in anyway on the importer provisions urgedFDA make the negotiation of MOU’s ahigh priority. Only one commentobjected to the development of MOU’s.

Several comments argued that FDAshould develop MOU’s with allcountries from which seafood isimported. One of these commentspointed out that to do otherwise wouldunfairly cause the obligations ofimporters to vary considerably. A fewcomments argued that the existence ofan MOU should be a prerequisite for theimportation of seafood products from acountry. One of these comments statedthat mandatory MOU’s would reducethe complexity of the present importsurveillance situation, reduce thenumber of countries exporting seafoodto the United States, and encourage thedevelopment of improved food safetyprograms in exporting countries.Another comment asserted that MOUdevelopment is appropriate becausegovernment-to-governmentrelationships and audits can be free ofinfluence from packers and importers,whereas foreign suppliers may be proneto provide false assurances about theirprograms to prospective importers.

One comment urged FDA to fullydescribe the process and criteria fordeveloping and evaluating MOU’s andexpressed concern about the processbecause of the varying level ofsophistication of foreign seafood controlprograms. One comment stated that theforeign government should beresponsible for evaluating the foreignprocessor’s HACCP plan, inspecting theforeign processor, periodicallyanalyzing products produced by theforeign processor, and issuing healthcertificates. A few comments stated thatFDA should monitor the effectiveness ofthe foreign government’s controlprogram in a manner that is authorizedin the MOU. These comments statedthat, under the MOU’s, the foreigngovernment should provide FDA withperiodic lists of processors that meet therequirements of these regulations, or,alternately, that all seafood processors


in the country would be required tomeet the requirements.

One comment urged FDA to publishperiodic reports on the status of MOU’son seafood products and to make themavailable to all importers. This commentand others argued that it should beFDA’s responsibility to notify importersabout changes in the status of MOU’s,rather than be the responsibility of theimporter to find out about any changes.One of these comments noted that,because a change in the status of anMOU could be very detrimental toimporters, there must be sufficient leadtime to allow importers to developalternate verification procedures whenchanges do occur.

Another comment urged FDA tocoordinate with U.S. importers andexporters in developing a schedule forMOU development. The same commenturged FDA to assign more resources tothe development of MOU’s.

On the other hand, one commentstated that the MOU developmentprocess is overly open-ended and couldresult in inconsistencies betweendomestic and foreign requirements. Thecomment argued that this inconsistencycould result in an economicdisadvantage for domestic processors.

FDA agrees with those comments thaturged that the agency give high priorityto the establishment of MOU’s with U.S.seafood trading partners. In the absenceof significant numbers of agencyinspections of foreign processingfacilities, FDA acknowledges that anMOU can be the most efficient andeffective mechanism for ensuring thatforeign processing plants are operatingin compliance with the requirements ofthese regulations. FDA also agrees thatthe potential for signing an MOU withFDA is likely to serve as an incentive forthe improvement of regulatory foodcontrol programs and processingconditions in seafood exportingcountries, especially where theexistence of an MOU serves to excusethe importer of products from thatcountry from certain verificationactivities.

FDA has concluded that thedevelopment of MOU’s or similaragreements with foreign regulatoryagencies is an appropriate method forensuring that foreign processors thatexport to the United States are incompliance with the requirements ofthese regulations. Moreover, assuggested by several comments, theagency has determined that, where anMOU exists, there is no need for theimporter to perform any independentverification procedures for purposes ofthese regulations. In this situation, theimporter should be able to rely upon the

foreign regulatory authority to ensurecompliance by foreign processors.

FDA is therefore retaining theprovision on MOU’s from the proposalbut modifying it to provide that, wherean importer elects to obtain a fish orfishery product from a country withwhich FDA has an active MOU or othersimilar agreement, the importer neednot engage in any independentverification activities.

The agency has developed an internalprotocol for developing MOU’s and isnegotiating agreements with severalcountries. FDA is committed tonegotiating as many MOU’s as possible.Also in the Federal Register of June 15,1995 (60 FR 31485), FDA published thenotice of availability of a newCompliance Policy Guide on MOU’s.

However, it is not reasonable toexpect that an agreement could bereached with all countries from whichseafood is imported into the UnitedStates. The barriers to achieving such aresult include the inadequacy of foreignregulatory programs and the lack ofinterest on the part of some foreigngovernments in entering into anagreement. The availability of FDAresources also can affect at least howlong it takes FDA to enter into aparticular MOU.

For these reasons, the existence of anMOU or similar agreement as arequirement of entry of fish or fisheryproducts into the United States wouldresult in an enormous negativeeconomic impact to a major segment ofthe U.S. seafood industry. Moreover,such a restriction is not warranted froma public health perspective given thealternative means of verifying theexistence of HACCP controls that areprovided in these regulations.

Experience obtained in part in theinternational portion of the FDA/NMFSseafood HACCP pilot project hasdemonstrated that foreign seafoodregulatory programs vary considerably,both in their capabilities and in theirstructures. Likewise, foreign seafoodprocessing conditions are highlyvariable. Thus, FDA cannot simplyfollow a boiler plate format innegotiating MOU’s. Rather, they must betailored to the specifics of the situationpresented by a particular country. It ispossible that some agreements canprovide simply for the submission oflists of approved processors to FDA atregular intervals; others may requiremuch more extensive FDA involvementbefore and after goods flow under theagreement. Some agreements may coverall of a country’s seafood processors,while others may be targeted to specificspecies or product forms, depending on

factors such as the capability of theforeign regulatory authority.

In any case, all agreements can beexpected to provide for FDA verificationof the effectiveness of the foreignprograms, including onsite visits. FDAis principally interested in two- wayagreements, that is, agreements thatacknowledge the acceptability of theU.S. regulatory system to the foreigngovernment as well as the acceptabilityof the foreign regulatory system to theU.S. government.

The agency will make everyreasonable effort to communicate withthe industry about changes in the statusof MOU’s through Federal Registernotifications and other means. FDA isopen to suggestions about the best waysto communicate in this regard.

Nevertheless, it will ultimately be theimporter’s responsibility to keepappraised of any changes in the statusof MOU’s.

The agency is also receptive to theviews of the seafood industry and othersabout how countries should beprioritized for the purpose ofnegotiating MOU’s. Any informationthat the agency receives on this topicwill be coupled with existinginformation concerning the likelihoodof negotiation success and the types andquantity of products typically offeredfor entry from the country in question.

5. Importer Verification Procedures121. The remaining comments

discussed specific aspects of theproposed importer requirements. Someof these comments argued that theresponsibilities that were proposed forimporters are onerous, unworkable, andinefficient but offered nothing insupport of these assertions.

A number of comments objected tothe proposed requirement that allimporters have and implement aHACCP plan. Several of these commentscontended that an importer’s plan canonly address the hazards that occurduring the time that products are underthe importer’s control (i.e., from thetime the importer takes possession ofthe product until it is shipped to itscustomer), and that requiring that theplan cover this point is inconsistentwith the principles of HACCP. Onecomment agreed that an importershould be required to develop a plan ifit also processes the product, as in thecase of an importer who stores theproduct. The comment asserted that, insuch a case, however, the importer’sHACCP plan would be minimal. Thecomment further asserted that theforeign processor should be the partyresponsible for developing a HACCPplan that addresses the hazards


introduced during processing in theforeign plant. The commentrecommended that, as an alternative tohaving a HACCP plan, an importershould be able to develop SOP’s thatoutline the steps that it will take todetermine whether to purchase theproduct from a foreign supplier.

A number of comments supported theproposed requirement for importerHACCP plans but provided no reasonsfor their support.

The agency agrees that it would beinappropriate to require that importershave and implement a HACCP planregardless of whether they process theproducts they import. As statedelsewhere in this preamble, HACCP is asystem that provides immediatefeedback, through the monitoring ofCCP’s, as to whether a process is undercontrol. Unless an importer is also aprocessor, there are no CCP’s in theclassic sense for the importer tomonitor, and from which to obtain real-time feedback. Consequently, onlywhere importers also process inaccordance with the definition of thatterm at § 123.3(k) will they be requiredto have and implement a HACCP planthat meets the requirements of § 123.6.Those food safety hazards that can becontrolled by the foreign processor mustbe addressed in the foreign processor’sHACCP plan in accordance with § 123.6.

Consequently, FDA has revised theregulations to limit the responsibilitiesof importers. Instead of having tomaintain their own HACCP plan, under§ 123.12(a), in the absence of an MOUor similar agreement, importers onlyneed to maintain and implement writtenverification procedures for ensuring thatthe fish and fishery products that theyoffer for import into the United Stateshave been processed in accordance withthe requirements of these regulations.The only exception to this rule wouldbe if the importer itself engages inprocessing, such as holding food, inwhich case the importer would, asstated above, also be a processor andsubject to § 123.6.

122. In determining the nature of theverification procedures that an importermust have and implement, FDAconsidered the comments thataddressed the appropriate functions andexisting procedures of importers.Several comments noted that importersroutinely purchase products accordingto specifications and observed that thesespecifications could be the basis forreasonable control measures forimporters. The NACMCF recommendedthat importers be required to maintainproduct specifications that are relevantto product safety for fish and fisheryproducts that they import. The

NACMCF listed water activity, pH,histamine content, and, perhaps,pathogen limits as examples ofspecifications that importers might setin an effort to ensure product safety.

The agency agrees with the commentsthat product specifications can be usefultools with which importers can exercisesome control over the products that theypurchase and offer for entry into theUnited States. In fact, FDA stated in thepreamble to the proposed regulationsthat the purpose of an importer’s planwas, in part, to include criteria for howthe importer will decide to purchaseseafood. FDA is also encouraged by thefact that the comments generally agreedthat having product specificationswould not constitute a new burden formany importers.

For these reasons, the agency in§ 123.12(a)(2)(i), is requiring that theimporter’s written verificationprocedures include productspecifications that are designed toensure that the product is notadulterated under section 402 of theFederal Food, Drug, and Cosmetic Actbecause it may be injurious to health orhave been processed under insanitaryconditions. These are the adulterationsections that relate to the safety of fish.

In many cases, importers will findexisting Federal food safety standards,including tolerances and guidelines, tobe useful specifications. In other cases,specifications may need to be tailored tothe circumstances. For example, theimporter might need to ensure that thetemperature of a modified atmospherepackaged product, when it comes off aship, is 38 °F (in such foods there is arisk of C. botulinum type E growth andtoxin development which can occur attemperatures as low as 38 °F), althoughthe CGMP’s at § 110.80(b)(3)(i) stateonly that refrigerated foods should bestored at 45 °F or below. The importeris encouraged to seek the advice ofqualified experts, as needed, in settingspecifications. The same resourcesavailable to help domestic processors insetting CL’s are available to importers,including the Guide; Sea GrantInstitution and other academics;Federal, State, and local food safetyregulatory agencies; consultants; theAlliance and other training courses; andpublished literature.

6. Affirmative Steps: GeneralAs a second part of the importer’s

verification procedure, FDA isessentially retaining from the proposal,in § 123.12(a)(2)(ii), the requirement thatthe importer take affirmative steps toensure that the products being offeredfor entry are actually being producedunder controls that meet the

requirements of these regulations. Inorder for product specifications to bemeaningful, importers must take stepsto establish that their suppliers are infact operating in a manner that canreasonably be expected to produce aproduct that meets those specifications.Effective verification involvesscrutinizing the standard, much likeevaluating whether the HACCP plancontinues to be appropriate, andscrutinizing performance to determinewhether the standard is consistentlyreached, much like reviewingmonitoring records (Ref. 34, p. 201).FDA is adopting this approach in§ 123.12(a)(2)(ii).

Among the affirmative steps that FDAproposed that a processor take were: (1)Obtaining the foreign processor’sHACCP-monitoring records; (2)obtaining a certificate from a foreigngovernment inspection authoritycertifying that the firm is operatingunder a valid HACCP plan orcertification on a lot-by-lot basis; (3)regularly inspecting a supplier’sfacilities; (4) periodic end-producttesting by the importer or a privatelaboratory hired by the importer; or (5)other such verification measures asappropriate. FDA listed theseaffirmative steps as examples of thetypes of measures that would beacceptable to the agency. FDA does notwish to predetermine all the possibleways that an importer could performaffirmative steps.

123. A number of comments objectedto each of the affirmative steps that FDAlisted in the proposed regulations, anda few expressed support for each.However, few of the comments providedany reasons for their positions.

One comment suggested that the bestmeans by which an importer can ensurethat the conditions at a foreignprocessing facility are at least equivalentto those required of domestic processorsis for the importer to verify theadequacy and implementation of theforeign processor’s HACCP plan duringa visit to the facility. Another commentstated that, ‘‘without both audits andHACCP records, foreign plants (possiblydomestic facilities too) will not adhereto the letter of the FDA regulation andassure safe product in the market.’’

Conversely, a number of commentsargued that it would be unworkable forimporters to conduct inspections offoreign processors. One of thesecomments stated that to justify theexpense of such an undertaking wouldnecessitate that a highly trained,competent individual perform thefunction.

As stated earlier, FDA remainsconvinced that importers must exercise


sufficient control over the fish andfishery products that they offer for entryinto their country to ensure that theproducts are produced pursuant to therequirements of these regulations. Theagency recognizes that any one of theaffirmative steps may not be appropriateor feasible for a particular importer orforeign processor. The regulations allowimporters to select an affirmative stepthat is workable for their circumstancesand to develop appropriate affirmativesteps other than those listed in theregulations (see § 123.12(a)(2)(ii)(F)).However, such measures must provideat least an equivalent level of assuranceof foreign processor compliance as thatprovided by the listed affirmative steps.

Additionally, FDA has modified theimporter requirements to allow for theperformance of any of the affirmativesteps by a competent third party(§ 123.12(b)). This provision provideseven greater flexibility to importers inmeeting the requirements of theseregulations.

Thus, FDA is not persuaded that theaffirmative steps are not feasible orappropriate and has included them inthese final regulations.

124. A comment argued thatgovernment certificates should not beacceptable unless they are issued bycountries with which FDA has signedan MOU or similar agreement. Thecomment asserted that, especially indeveloping countries, there may bedifferent interpretations of theregulations, and differences incompetency, credibility, infrastructure,intent, and uniformity that might bringthe utility of such certificates intoquestion.

FDA acknowledges that it is likely tohave a higher level of confidence incertificates received from a governmententity with which it has signed anagreement than with one with which noagreement exists. However, as discussedabove, it is unlikely that the agency willbe able to negotiate an MOU with everycountry that exports seafood to theUnited States. Thus, there may becountries that have excellentcertification programs with which FDA,for a variety of reasons, simply does nothave an opportunity to enter into anagreement. Moreover, if the agencylearns, either through its own routinesurveillance activities, consumercomplaints, or other means, that there isevidence that a country is routinelyissuing certificates inappropriately, theagency will try to inform firms thatimport fish or fishery products from thatcountry that it will expect them to useother means of verification if they wantto avoid the appearance that those

products are adulterated under section402(a)(4) of the act (see § 123.12(d)).

125. One comment urged thatcertification be permitted on acontinuing basis rather than requiringlot-by-lot certification.

FDA agrees that continuingcertification is appropriate and notesthat the language and intent of theproposed regulations would haveallowed for it. Nonetheless, in an effortto further clarify this situation, theagency provided in § 123.12(a)(2)(ii)(B)that: ‘‘Obtaining either a continuing orlot-by-lot certificate * * *’’ will be oneway to satisfy the requirement that animporter take affirmative steps to ensurethat the product is produced inaccordance with the requirements ofthis part.

7. Foreign Processor HACCP Plans126. Approximately 15 comments

addressed whether importers should berequired to have on file copies of theHACCP plans of each of their foreignprocessors. Approximately half of thesecomments supported such arequirement, although for the most partthey provided no reasons for theirsupport. The other half objected to therequirement. One of these commentsargued that possession of a foreignprocessor’s HACCP plan would becumbersome for the importer and wouldprovide no assurance that productshipped by that processor wasprocessed in accordance with the plan.One comment cautioned that it wouldbe unrealistic to expect that importerscould make any but a rudimentaryjudgment as to the adequacy of foreignprocessors’ HACCP plans. Suchjudgments, these comments asserted,should be reserved for the regulatorwhen the plans are assessed duringinspections of importers’ records.

One comment cited the possibility ofbreaches in confidentiality becausecommercially sensitive material wouldbe supplied to importers. A relatedcomment suggested that, to solve theconfidentiality problem, the foreignprocessors’ HACCP plans should befiled directly with FDA rather than withimporters.

Although the agency continues tobelieve that a foreign processor’sHACCP plan provides a useful basis forverification, FDA is persuaded by thecomments that there are logistical andother issues that could render theretention of HACCP plans by importersunmanageable in some cases. FDA hasalso concluded that, in most cases,affirmative steps such as those listed in§ 123.12(a)(2)(ii) (e.g., onsite inspectionby the importer and certification by aforeign government agency) will be

adequate to enable an importer to verifythat the products being imported aresafe in accordance with therequirements of these regulations.

As described previously, theNACMCF recommendations describetwo primary goals of verification: (1)Ensure that the plan is adequate toaddress the hazards that are likely toaffect the product; and (2) ensure thatthe plan is being consistentlyimplemented. The affirmative stepslisted in § 123.12(a)(2)(ii) are designedto address both of these functions. Forexample, obtaining HACCP andsanitation monitoring records from theforeign processor (§ 123.12(a)(2)(ii)(A))enables the importer to confirm that theforeign processor has addressed therelevant hazards and sanitationconcerns (i.e., those for which there aremonitoring records), and that it ismonitoring to ensure that theseconcerns are under control during theproduction of lots that are shipped tothe importer. Similarly, obtaininggovernmental or third party certificationof foreign processor compliance withthe requirements of these regulations(§ 123.12(a)(2)(ii)(B)) or inspecting theforeign processor directly(§ 123.12(a)(2)(ii)(C)) enables theimporter to confirm that the foreignprocessor has an adequate HACCP planand SSOP, and that the relevantsanitation and safety concerns are beingcontrolled for those lots that are shippedto the importer. The affirmative stepoptions provided for by§ 123.12(a)(2)(ii)(D) and (a)(2)(ii)(E) arediscussed later in this section.

Consequently, FDA has not includeda requirement that importers of fish andfishery products have on file the HACCPplans of each of their foreign suppliersin these final regulations.

Nonetheless, FDA points out thatmaintaining copies of these plans couldbe one of several measures that animporter could incorporate into itsaffirmative steps. Therefore, these finalregulations in § 123.12(a)(2)(ii)(D)incorporate the concept as one of theaffirmative steps that an importer maychoose to use for verification purposes.

127. One comment noted that theplans of foreign processors wouldnormally be prepared in the nativelanguage of the country of origin andasked whether FDA would require thatthese documents be translated intoEnglish. On the other hand, anothercomment recommended that HACCPplans be maintained in both thelanguage of the native country and inEnglish.

FDA agrees with the comment thatargued that a copy of a processor’sHACCP plan would not, by itself,


provide adequate assurance that a givenshipment of imported product wasprocessed in compliance with thatHACCP plan or that the sanitationrequirements of § 123.11 were met. Oneadditional thing is needed to providesuch assurance: a written guaranteefrom the foreign processor that theproducts shipped to the importer areprocessed in accordance with theseregulations. The guarantee is necessaryto demonstrate that the HACCP andsanitation control systems are beingimplemented for products shipped tothe importer. An importer should beable to make a reasonable judgementabout the validity of the guaranteethrough a rudimentary review of theplan, as described below. Therefore,FDA is including these requirements in§ 123.12(a)(2)(ii)(D).

FDA is also providing in§ 123.12(a)(2)(ii)(D) that the foreignprocessors’ HACCP plans that aremaintained by importers be written inEnglish, so that they will be meaningfulto the importer and will allow forregulatory review.

128. As stated above, one commentcautioned the agency about the ability ofmany importers to evaluate theadequacy of HACCP plans that theymight retain.

FDA acknowledges that manyimporters may not have the technicalexpertise to evaluate the adequacy ofseafood HACCP plans. However, theagency is convinced that, as a result ofthe importers’ assessment of the foodsafety hazards that are reasonably likelyto be presented by the product, theimporter should have developed somegeneral expectations about the contentof the HACCP plan (e.g., which hazardsshould be addressed). The importershould be able to spot any obviousshortcomings and to discuss them withthe foreign processor. It is not enoughthat importers simply file away thedocuments upon receipt. Importers mayfind it advantageous to make a judgmentabout the likelihood that their productspecifications will be met and to insistthat they be given a guarantee thatcontains assurances that thespecifications will be met.

129. Regarding the comment thatcomplained about the potential loss ofconfidentiality of foreign processorHACCP plans that are provided toimporters, since the agency haseliminated the requirement that allimporters retain copies of foreignprocessor plans, the significance of thisissue has been minimized. In the casewhere a foreign processor does not wishto share its plan with the importer, theprocessor and the importer would need

to agree upon another means ofproviding for importer verification.

130. Regarding the comment thatsuggested that all foreign processors filetheir plans with FDA, the resourcedemands on the agency that wouldcome with such an undertaking wouldbe prohibitive. FDA cannot accept thissuggestion.

8. Other Affirmative StepsAs a related matter, FDA has

determined that, in the absence of arequirement that importers maintain acopy of the foreign processor’s HACCPplan, finished product tests alone areinsufficient as an importer affirmativestep to ensure that the foreign processoris operating in accordance with theseregulations. Finished product testingalone has a small statistical likelihoodof detecting defects in a product,especially when the occurrence of sucha defect is an uncommon event, as is thecase with most seafood hazards (Ref.213). The proposed requirement for theimporter to obtain a copy of the foreignprocessor’s HACCP plan, in addition toperforming finished product testing,would have provided indirect evidencethat HACCP controls are in place andwould have lent support to aconclusion, based upon the analyticalfindings, that the relevant hazards areunder control. In the absence of suchevidence, the importer cannotreasonably conclude that the hazardsare being controlled based solely on anegative analytical finding. For thisreason FDA has required in§ 123.12(a)(2)(ii)(E) that such samplingbe accompanied by a written guaranteefrom the foreign processor that productsbeing shipped to the importer areprocessed in a manner consistent withthe requirements of these regulations.The guarantee provides the importerwith reasonable assurance that HACCPand sanitation controls are in place andare being implemented, in a mannersimilar to the way that the foreignprocessor’s HACCP plan would haveunder the requirements of the proposedregulations. Under this alternative, theimporter would not have to maintain acopy of the HACCP plan.

For clarification and consistencywithin the document, FDA has revisedthe language of two of the affirmativesteps to include reference to thesanitation provisions of the regulations.In both the proposed regulations andthese final regulations the statedpurpose of the affirmative steps is toenable the importer to verify that thefish or fishery product was processedunder conditions that meet both theHACCP and sanitation requirements ofthese regulations. However, the

formulations of two of the affirmativesteps in the proposal did not makespecific reference to sanitation. To avoidconfusion over what the affirmativesteps should cover, § 123.12(a)(2)(ii)(A)now reads ‘‘Obtaining from the foreignprocessor the HACCP and sanitationmonitoring records * * *’’ and§ 123.12(a)(2)(ii)(B) reads ‘‘* * *certifying that the imported fish orfishery product is or was processed inaccordance with the requirements ofthis part.’’

131. Several comments asked theagency to specify the frequency withwhich the importer affirmative stepsmust be taken. A few commentssuggested that the frequency should beno greater than the frequency ofequivalent FDA verification activities.

It would not be practical for theagency to specify frequencies foraffirmative steps that would beappropriate in all circumstances.Consistent with the frequency ofmonitoring by processors, importersshould take affirmative steps to monitortheir suppliers with sufficient frequencyto accomplish its purpose—that is, toprovide the importer with reasonableassurance that the foreign processor isoperating in compliance with theseregulations.

It would be inappropriate to tieimporter affirmative step frequencies toaverage FDA sampling and inspectionfrequencies. FDA sample collection andinspection frequencies are determined,in part, by the compliance history ofindividual firms, agency priorities, andoverall agency resources, not simply ona desired average minimum rate ofverification. Thus, FDA’s rate ofinspection has no bearing on howfrequently an importer should monitor asupplier.

132. A number of comments urgedthat the agency permit importers tocontract with third parties to performverification activities on their behalf.Two comments opposed such aprovision but did not provide reasonsfor their position.

Several comments urged thatcertificates by nongovernmental thirdparties be accepted as an affirmativestep. One of these comments, from atrade association, suggested that anequivalent arrangement has beenaccepted by FDA in controlling theimportation of canned mushrooms fromthe Peoples Republic of China. Thissame comment argued that a systemwhere individual importers inspect eachof their suppliers is highly inefficient.The comment suggested that a single,technically competent party shouldperform the inspections. The tradeassociation offered to serve as a


clearinghouse for the reports of suchinspections. Likewise, the associationoffered to serve as a clearinghouse forfinished product sample results forimported products, reducing thenumber of samples needed when thesame product is imported by a numberof importers. The comment furthersuggested that the association bepermitted to hold foreign processorHACCP plans for its members, andperhaps for nonmembers. The commentargued that acceptance of thissuggestion would reduce the number ofduplicate records for the same productstored by various importers.

The agency accepts that third partyverification can be an appropriate andefficient control mechanism. Such asystem is consistent with the use ofthird parties by processors for plandevelopment, record review, and CLdeviation evaluation. Therefore, FDAhas added a new provision at§ 123.12(b), that reads, ‘‘An importermay hire a competent third party toassist with or perform any or all of theverification activities specified inparagraph (a)(2) of this section,including writing the importer’sverification procedures on theimporter’s behalf.’’ It is worth pointingout that where an importer uses theservices of a third party, the importerremains responsible for the verificationprocedures that are performed. Theimporters must be able to demonstratethat appropriate verification measureshave been performed. This step mayinvolve providing an FDA investigatorwith a copy of the foreign processor’sHACCP plan, results of end-productsampling, results of an onsiteinspection, the foreign processor’smonitoring records, or the foreignprocessor’s written guarantee. Thirdparties must, of course, be competent toperform the duties in question, and FDAreserves the right to challenge suchcompetency. The agency has noobjection to the use of clearinghousesfor importer verification activities, aslong as the forgoing requirements aremet.

9. Importer RecordsAs previously mentioned, the

proposed regulations would haverequired that importers develop andimplement a HACCP plan. One effect ofsuch a requirement would have beenthat importers would have had tomaintain appropriate records. As hasbeen explained, FDA is adopting onlythose essential components of theproposed approach that the agencyconsiders to be practicable forimporters. One such component isrecordkeeping. Recordkeeping is

essential in documenting for the benefitof importers and the agency theaffirmative steps of importers, in thesame way that it is essential indocumenting the monitoring, correctiveaction, and verification activities ofprocessors. For this reason, the agencyhas retained the recordkeeping aspect ofthe proposal for importers, in a mannerthat is consistent with the overallapproach for importers in these finalregulations. Section 123.12(c), whichtreats importer records identically toprocessor records, reads, ‘‘The importershall maintain records, in English, thatdocument the performance and resultsof the affirmative steps specified inparagraph (a)(2)(ii) of this section. Theserecords shall be subject to the applicableprovisions of § 123.9.’’

133. FDA proposed that importersencourage foreign processors to obtainHACCP training. A few comments urgedthe agency to make it clear that foreignprocessors must comply with the sametraining requirements as are applicableto domestic processors. One commenturged the agency to permit HACCP-training courses for foreign processors tobe conducted in the country of origin by‘‘an official agency.’’

FDA agrees that the need for trainingis the same for foreign processors as itis for domestic processors. The intendedbenefits of the training requirements arefully discussed in the ‘‘Training’’section of this preamble. Nonetheless,the agency finds that the proposedrequirement that importers encourageforeign processors to obtain training isunnecessary. Foreign processors thatship seafood products to the UnitedStates are advised of the trainingrequirement of these regulations in thesame way that they are advised of theother requirements of these regulations,through publication of the regulations.In addition, as mentioned elsewhere inthis preamble, FDA intends to providethe embassies of seafood exportingcountries with information concerningthese regulations in order that they mayin turn provide it to the processors intheir countries. Consequently, FDA isnot adopting this provision.

FDA has no objection to HACCPtraining being performed in the countryof origin by ‘‘an official agency’’ or otherentity, as long as the course ofinstruction is at least equivalent to thatprovided by the standardized courseunder development by the Alliance.

10. Determination of ComplianceFDA proposed to require that there be

evidence that imported fish and fisheryproducts were processed underconditions that comply with therequirements of these regulations, and

that if assurances that this was the casedid not exist, the product would appearto be adulterated and would be deniedentry. This section of the proposedregulations provided five types ofevidence that the agency wouldconsider as adequate to provide suchassurance.

134. A few comments supported theseprovisions. However, a few commentssuggested that, if the importer is unableto provide assurance that a HACCPsystem is in place, the importer shouldbe permitted to conduct finishedproduct testing rather than having theproduct denied entry. One commenturged that importers be held only to a‘‘best efforts’’ standard in determiningwhether their suppliers are incompliance with these regulations. Thiscomment suggested that if an importercannot determine that such complianceexists after using its best efforts, theimporter’s product should not bebanned from the United States.

The purpose of these regulations is tocause processors of fish and fisheryproducts, both domestic and foreign, todevelop and implement HACCP systemsof preventive controls to ensure thesafety of their products. The importerrequirements are designed to impose anobligation on importers to ensure that,like domestic products, the productsthat they are importing are notadulterated within the meaning ofsection 402(a)(4) of the act. Thisrequirement means that importers mustbe able to satisfy themselves, andultimately FDA, that the fish and fisheryproducts that they are offering forimport were produced subject to aHACCP system and sanitation controlsdesigned to prevent insanitaryprocessing conditions that may renderthe food injurious to health. If animporter does not have evidence thatshows that the products were producedsubject to such controls, it should notoffer the product for import into thiscountry. The lack of such evidencecreates the appearance of adulterationthat cannot be overcome by thecollection and analysis of a finishedproduct sample by an importer. Giventhe problems that can arise in seafoodprocessing if HACCP and sanitationcontrols are not in place, under sections402(a)(4), 701(a), and 801(a) of the act,FDA is adopting § 123.12(d), whichprovides that if evidence does not existthat an imported fish or fishery producthas been processed under conditionsthat are equivalent to those required ofdomestic processors, the product willappear to be adulterated.

Section 123.12(d) derives fromproposed § 123.12 (a) and (b). FDA hascombined these provisions and, as


suggested by a comment, has usedterminology consistent with the rest ofthe regulation in § 123.12(d). Whileproposed § 123.12 (a)(1) through (a)(5),which described the types of evidencethat could be used to demonstratecompliance with the proposedregulations, reflected importantprinciples for the importation of fish,based on the comments, FDA finds thatthese provisions were causingconfusion, and that the statute canappropriately be implemented withoutincluding them in the final rule. For thisreason, FDA has not adopted theseprovisions.

135. One comment asked whatdocuments, if any, would have to bepresented to FDA at the time of entryconcerning the status of the foreignprocessor. Another comment suggestedthat importers should note on the entrydocuments that a HACCP plan isavailable for the foreign processor. Thiscomment stated that FDA would havean opportunity to review the plan aspart of its determination of whether toallow entry of the product.

FDA is not requiring that evidence ofthe importers’ affirmative steps bepresented along with the existing U.S.Customs Service entry documents as amatter of routine practice. It is possiblethat, in some circumstances, such a stepwill be necessary (e.g., where the agencyhas reason to believe that inappropriateconditions exist in the foreignprocessing facility). However, typically,the importer will be able to retain suchevidence in its files and to make itavailable to the agency when FDAperforms an inspection at the importer’splace of business. Such a system isnecessary because of the time that isnecessary for the agency to properlyreview the importer’s documentation ofits affirmative steps and of the foreignprocessors’ HACCP plans. Nonetheless,the agency is willing to explore alternatemethods of implementing the importrequirements of these regulations, suchas that suggested by the comment. FDAwelcomes a continuing public dialogabout this matter.

136. One comment asked whetherFDA would maintain an approved list offoreign processors.

The agency has no plans to maintainsuch a list, nor is it apparent upon whatbasis such a list would be prepared. Apossible exception would be as part ofan MOU arrangement, where the foreigncountry would agree to provide a list of‘‘approved’’ firms to FDA. In such asituation, FDA would use reasonablemeans to inform the import industry ofthe purpose and contents of the list andupdate them as rapidly as possiblewhen changes are made.

137. One comment expressed concernthat the same foreign processor HACCPplan might be reviewed by differentFDA investigators in different ports ofentry, and that these investigators mightreach different conclusions as to itsadequacy. The comment urged that theagency coordinate such reviews, as wellas reviews of importers’ affirmativesteps, in a way that would minimizeinconsistencies.

FDA acknowledges that the situationmight well arise where differentinvestigators review the same foreignprocessor HACCP plan as a part ofdifferent importer inspections. Tominimize inconsistencies in suchreviews, the agency intends to train itsinspectional staff in the requirements ofthese regulations and the application ofHACCP principles to seafoodprocessing, including training on theGuide. The agency also intends todevelop guidance relative to importerverification activities.

M. Guidelines or Regulations?

1. Background

FDA recognizes that many processorswill need guidance in the preparation ofHACCP plans, and that HACCP planswill vary in complexity. The agency iscommitted to providing the industrywith technical assistance that includesgeneral guidelines for HACCP plans andthe contents of plans for specific typesof products and processes.

As part of FDA’s seafood HACCPproposal, the agency includedguidelines, in the form of appendices,on how processors of cooked, ready-to-eat products and products involvingscombrotoxin-forming species couldmeet various provisions of the proposedregulations relating to the developmentand implementation of HACCP plans.FDA regards these products as beinghigh-risk relative to other seafoods.They involve special considerations orspecial hazards for which additionalguidance would likely be useful.

Cooked, ready-to-eat fishery productspresent an elevated risk of amicrobiological hazard compared tomost other seafood products. They arecooked as part of processing and mightnot receive additional cooking byconsumers before consumption.Consequently, to be safe, these productsmust not contain pathogens at a levelthat will cause disease and must not besubjected to time-temperature abuse thatwould allow any existing pathogens togrow to unacceptable levels.

Scombrotoxin-forming species are fishthat can form a toxin if exposed afterdeath for significant periods totemperatures that permit the growth of

certain bacteria. Scombrotoxin canresult in a mild to severe allergicresponse in humans.

The guidelines for these productscontained advice about hazards that arereasonably likely to occur and on detailsfor HACCP plans for the control of thesehazards. In addition to asking forcomments on the substance of theguidelines, the agency asked forcomment on whether these guidelinesshould remain as guidelines, or whethersome or all of them should be adoptedas regulations. As regulations, theywould, essentially, tell processors thatcertain hazards must be controlled intheir HACCP plans, identify in advancecritical points in the processing of theseproducts that processors must control tominimize these hazards, and tellprocessors what they would have to do,at a minimum, to maintain propercontrol of those critical points.

In another appendix to the proposedregulations, FDA published excerptsfrom the draft Guide, mentioned earlierin this preamble, for the stated purposesof publicizing the existence of that draftGuide and of providing processors withinformation about the types of guidancethat the agency expected would beavailable in it.

One of the excerpts that FDApublished was guidance on theprocessing of smoked and smoke-flavored fish. These products representa significant hazard relative tocontamination with C. botulinum,especially when packaged in reducedoxygen atmosphere packaging. FDArequested comment on whether thisguidance should remain solely withinthe Guide, whether it should beprovided an appendix to theregulations, or whether it should beadopted as regulations. The effect ofadopting these materials as regulationswould be the same as for the appendicesdescribed above.

If these materials remained in theform of guidelines, processors would befree to adopt them or not, so long asmeasures that provide an equivalent orsuperior degree of safety areimplemented.

138. Approximately 55 commentsresponded to FDA’s request forcomment on whether these materialsshould remain as guidelines or beadopted as regulations. The majority ofcomments preferred guidelines. A fewcomments suggested that FDA initiallyissue guidelines, then possibly convertthem to regulations after gainingexperience with them as adjuncts to afunctioning HACCP system or after pilottesting them. A few comments preferredto retain some of the materials as


guidelines and convert others toregulations.

Over one-third of those whocommented on this subject supportedguidelines in general, withoutdistinguishing among the threeguidelines. They argued that guidelinesare in keeping with the generalphilosophy of HACCP that processorsassume responsibility for the safety oftheir products. Some stated that detailedregulations for processors to followwould not provide an adequateincentive to processors to develop a fullunderstanding of the hazards associatedwith their products or processes. Theresult could be the development of roteHACCP plans that might be inadequatefor safety in specific situations.

Some comments pointed out that,while guidelines can assist processors toidentify controls, guidelines probablycould never properly identify the CCP’sand limits for all processors given theuniqueness of individual processingmethods. In the case of regulations,processors would be obliged to adhereto the presented limits regardless oftheir appropriateness to the operation.Many of these comments preferred theflexibility that guidelines provide inpermitting HACCP controls to evolvewith a changing knowledge base andnew technologies. Some expressedconcern that if the guidelines wereadopted as regulations, the industrywould bear an unnecessary burden ofhaving to petition FDA for amendmentsin order to accommodate new productsor processes. Modifications to theregulations could take considerabletime.

Several comments specificallyobjected to adopting either theguidelines for cooked, ready-to-eatproducts or the guidelines forscombroid toxin-forming species, orboth, as regulations. The reasons weregenerally the same as those given bythose comments that supported the useof guidelines generally.

One comment did express the concernthat adopting the scombroid guidelineas regulations would have the effect ofadopting a policy action level forhistamine as a defacto regulationwithout a formal notice and commentrulemaking.

Several comments requested thatguidelines only appear in the Guide,and not in appendices to theregulations, to alleviate confusion.

However, FDA did receive a numberof comments that urged the agency toadopt these guidelines as regulations.These comments cited a need forminimum enforceable standards forthese products to ensure the protectionof the public health. The comments

argued that minimum standards wouldavoid confusion about what isenforceable, and what is not. Theypointed out that as regulations, theseprovisions could be more readilyenforced.

FDA believes that all of thesecomments have merit. Guidelines canprovide flexibility that regulationssometimes lack. Moreover, because theyare advisory in nature, guidelines areless likely to be followed by rote.

FDA thus agrees that, ideally, HACCPshould serve as a catalyst for processorsto develop a full understanding of therelationships between their productsand processes and human food safetyand to devise controls for ensuringsafety. There may well be more than oneway to reach an appropriate safetyendpoint. Regulations might not alwaystake such alternatives into account.

On the other hand, in those casesinvolving high-risk products whereadherence to scientifically establishedminimum standards or procedures isnecessary to ensure a safe product bydesign, and those minimums are notlikely to change, there is good reason tomake those minimums something morethan advisories. In those types ofsituations, it makes no sense to act as ifthe work that scientifically establishedthe minimum processing conditions hadnot been done.

2. Cooked, Ready-To-Eat Products andScombroid Species

These, then, are the considerationsthat FDA has weighed. In the case ofcooked, ready-to-eat products andproducts made in whole or in part fromscombroid toxin-forming species, FDAis persuaded that the guidelines shouldremain as guidelines, at least until thereis enough experience with them todetermine whether a change toregulations is warranted. The agencyhas concluded that processors should begiven maximum flexibility, at leastinitially, to identify the reasonablylikely hazards and the CCP’s and CL’sfor those hazards that are mostappropriate for their manufacturingprocesses. FDA will examine over timewhether processors are achieving anadequate degree of preventive controlfor these products under the guidelines,and whether they are doing so byfollowing the guidelines exactly orpartially or by relying on alternativeapproaches.

FDA acknowledges that manycomments objected to the details of theappendices. These comments will beaddressed when the first edition of theGuide is published. FDA recognizes thatthese materials will be more easily

modified and improved if they remainas guidelines, at least for the time being.

FDA agrees that all of these guidelinesshould appear solely in the Guide.There are no appendices to these finalregulations.

3. Smoked and Smoke-Flavored FisheryProducts

The guidance for smoked and smoke-flavored fish contained specificprocessing parameters (i.e., time andtemperature of smoking and finishedproduct salt and nitrite concentrations)to be met in the processing of suchproducts, and control mechanisms forensuring that they are met. C. botulinumtoxin production is prevented insmoked and smoke-flavored fish bycontrolling these interrelated variables,as well as by controlling thetemperature of the product throughoutthe chain of distribution.

139. Approximately 25 commentsaddressed whether these materialsshould be regulations or guidelines.About half of the comments,representing State and Federalregulatory agencies, professionalassociations, and others, urged that thematerials be codified as regulations. Theremainder, representing processors andtrade associations, requested that theguidelines remain as guidelines.

A number of the comments that urgedthat the smoked and smoke-flavored fishguidelines be issued as regulationsasserted that regulations are more easilyenforceable, would provide cleardirection to the industry, and wouldprovide much needed nationwideuniformity in the processing of smokedfish. One comment from a Stateregulatory agency observed thatprocessors are not adhering to existingguidelines, such as the 1991recommendations for these products byAFDO, and are unlikely to change theiroperations in response to anotherguideline. Several comments arguedthat the States need Federal regulationsto support their own efforts to regulatethe industry and to foster uniformityamong the various existing Staterequirements. One of these commentsalso stated that such regulations areneeded to ensure the safety of smokedfish, because the product has a historyof involvement in botulism outbreaks, ishandled more than most other products,increasing the risk of microbiologicalcontamination, and is frequently notcooked prior to consumption. Onecomment suggested that the guidelinesbe tested in pilot programs beforemaking them mandatory, and thatresearch information on smoked fish bedisseminated to industry through


technical bulletins, workshops, andmeetings.

Several of the comments thatsuggested that the proposed guidelinesremain as guidelines argued that FDAhas not demonstrated that presentpractices in the smoked fish industryare causing risks that would justifyregulations, and that there have been norecent incidents of botulism attributableto smoked fish. Several comments statedthat most of the problems with smokedfish in the past have resulted from abuseof the product at retail or by theconsumer.

A few comments objected to FDA’scontention that large portions of theindustry do not conduct final producttesting and to the inference that allsmoked fish processors do not monitorthe composition of their products. Thecomments stated that responsiblecompanies do conduct product testingon a regular and routine schedule, havescheduled processes, and are aware ofwhat they are doing.

Other comments recommended thatFDA enforcement of the currentCGMP’s, coupled with State and localenforcement of the Food Code forsmoked products that are produced inrestaurants, retail, and food serviceestablishments, would make itunnecessary to treat smoked fishproducts any differently than otherproducts under these HACCPregulations. One comment suggestedthat guidelines would have the sameimpact as regulations because HACCPplans would be rejected by FDA if theydo not contain the recommendedcontrols, and because States wouldadopt the guidelines as regulations.

One comment argued that theissuance of prescriptive regulationswould eliminate the diversity in thetypes of smoked fish products availableand result in a ‘‘homogeneous’’ market.Another comment counseled that theissuance of a regulation would causeAlaskan native salmon processors toabandon their traditional trade.

The agency remains convinced thatsmoked and smoke-flavored fish is apotentially hazardous food. While casesof botulism have not been attributed tocommercially prepared smoked orsmoke-flavored fish in over 30 years, theoutbreaks of the 1960’s clearlydemonstrate the potential for suchoccurrence. Virtually all the researchthat has been conducted establish thatprocessors need to control time,temperature, and salinity (T-T-S)parameters and other matters for theseproducts in order to provide adequatebarriers to toxin production (Ref. 214).

As the preamble to the proposedregulations pointed out, FDA and a

number of States have longstandingconcerns that the actions of a significantportion of the smoked fish industry donot demonstrate a full appreciation forthe nature of the risks. FDA and NewYork State surveys of the smoked fishindustry in the late 1980’s, for example,showed that many processors did notroutinely control their T-T-Sparameters.

The comments have not persuadedFDA that, even without regulations,processors will employ preventivecontrols to ensure the safety of theseproducts as a matter of design and notof chance. Botulism derives from one ofthe most dangerous toxins known toexist. Controls to prevent the formationof this toxin cannot be left to chance.HACCP controls for this hazard arehighly appropriate because HACCPrequires that the processor analyze itsoperation to determine how hazardsaffecting its product can arise, and thatit institute specific controls to preventthose hazards. The majority ofcomments that addressed smoked andsmoke flavored fish products eithersupported the concept of HACCPcontrols or did not argue against them.

140. The question, therefore, iswhether, in addition to requiringHACCP plans for these products, FDAshould mandate specific CCP’s,minimum CL’s, monitoring frequencies,and other matters that processors wouldhave to include in their HACCP plans.If the agency were to codify draftguidelines as regulations, the agencywould be answering that question in theaffirmative. The preamble to theproposed regulations identified the T-T-S parameters in the draft guidelines asbeing scientifically establishedminimums for ensuring that toxinproduced by C. botulinum will not beproduced over the shelf life of theproduct under refrigerated conditionsand under conditions of moderatetemperature abuse. FDA has been urgedfor years to mandate such T-T-Sparameters for these products. In 1988and 1989, for example, AFDO passedresolutions asking FDA to expedite thedevelopment of regulations for the safeprocessing of smoked fish. Thecomments to this rulemaking thatsupported regulations over guidelinessupport the mandating of specific T-T-S parameters.

However, a significant number ofother comments challenged whethersome of the parameters in the guidelineswere actually minimums, as FDA hadcontended. They specifically objected tothe minimum water-phase salt levels inthe draft guidelines for air packagedsmoked and smoke-flavored fish.Generally, these comments stated that

there is little safety concern with air-packaged smoked or smoke-flavored fish(hot or cold smoked) containing as littleas 2.5 percent water phase salt (less thanthe minimum stated in the guidelines),and requested that FDA reexamine theexisting scientific data. A few commentsstated that air-packaged smoked fish hasa limited shelf life in the refrigeratedstate and that NMFS research has shownthat spoilage occurs before toxinproduction. One comment stated thatNMFS, New York State Department ofAgriculture and Markets, and AFDO allconsider a minimum water-phase saltcontent of 2.5 percent to be acceptablefor air-packaged products.

A few comments suggested that analternative to specifying T-T-Sparameters would be to require that allprocessors have a scheduled process forair-packaged products. The commentstated that this requirement has beensuccessful in the State of New York andhas enabled industry to produceproducts with water-phase saltconcentrations that are lower than thoseproposed by FDA. A few commentssuggested that the high salt levelsproposed by FDA for smoked andsmoke-flavored products would becounterproductive to those governmentprograms aimed at reducing salt in thehuman diet and would be unacceptable,or only marginally acceptable, toconsumers. Other comments suggestedthat the necessary minimum salt levelsfor smoked and smoke-flavored fishmight be reduced by shortening theshelf life of the product or by storingand distributing the product frozen.

The comments have persuaded FDAthat it may be possible for processors touse parameters other than those inFDA’s draft guidelines and still producea safe product. Moreover, the NACMCFhas recently endorsed AFDO’srecommended parameters for smokedand smoke-flavored fish. Most notably,these recommendations differ fromthose in FDA’s draft guidelines in thatthey provide for a minimum finishedproduct water phase salt content in air-packed product of 2.5 percent, whereasthe FDA proposal provided for a rangeof minimum values of from 2.5 percentto 3.5 percent, depending upon otherprocessing parameters.

The agency acknowledges, therefore,that some recommended T-T-Sparameters differ from those in FDA’sdraft guidelines. FDA acknowledges thepossibility that other safe T-T-Sparameters exist as well. It is reasonableto suppose that there is more to belearned about how the development ofC. botulinum toxin is controlled in theseproducts, given the lack of reportedillnesses in recent years. Thus, while


FDA strongly believes that the T-T-Sparameters in its draft guidelinesprovide effective controls for botulism,the agency accepts that they are notnecessarily the only effective controls,or that all effective controls have beenidentified.

Consequently, the agency hasconcluded that, at least for now, themost appropriate place for suchguidance on T-T-S parameters andrelated matters is the Guide, and that itwould not be appropriate to adoptspecific parameters for the processing ofsmoked fish by regulation. However,because of the extreme nature of thehazard, and in response to comments,FDA has chosen to codify a rudimentaryperformance standard for the control ofbotulism in these products from thedraft guidelines (item number 11). Asincorporated at subpart B, § 123.16, theperformance standard reads:

In order to meet the requirements ofsubpart A of this part, processors of smokedand smoke-flavored fishery products, exceptthose subject to the requirements of part 113or 114 of this chapter, shall include in theirHACCP plans how they are controlling thefood safety hazard associated with theformation of toxin by C. botulinum for atleast as long as the shelf life of the productunder normal and moderate abuseconditions.

This requirement responds in part tothe comments that proposed that FDArequire that all processors scientificallyestablish scheduled processes forsmoked and smoke-flavored fish, ratherthat mandate specific T-T-S parametersand other matters. It requires processorsto establish CL’s that are bothappropriate to their operation andscientifically sound. Because botulismis undoubtedly a hazard that must becontrolled in the production of theseproducts, subpart B of part 123 does notimpose a requirement that would notexist in its absence. It has been includedfor emphasis and as a reminder toprocessors. The Guide will provideprocessors with assistance with regardto specific T-T-S parameters and relatedmatters.

141. FDA proposed that, with certainexceptions, fish to be smoked or saltedbe eviscerated and free of residualviscera. The preamble to the proposedregulations explained that salted orsmoked uneviscerated fish present apotential hazard for the development ofC. botulinum toxin production. Theviscera of fish contain the majority of C.botulinum normally present.

One comment argued that the entireevisceration provision should be movedto the Guide. Another commentsuggested that specific evisceration

requirements be codified but not as partof sanitation.

These regulations require in subpart Bof part 123 that the processors ofsmoked and smoke-flavored fishdescribe in their HACCP plans how theyare controlling the food safety hazardassociated with the formation of toxinby C. botulinum. Specific types ofcontrols will be provided in the Guide.Because evisceration is one form ofcontrol for this toxin, it will be coveredin the Guide as well and need not beincluded in the regulations.Consequently, FDA has not includedthis proposed provision in these finalregulations.

N. Molluscan Shellfish

1. BackgroundIn addition to the general HACCP

provisions in subpart A of part 123,FDA proposed subpart C of part 123—‘‘Raw Molluscan Shellfish,’’ which setforth specific requirements for theprocessing of fresh or frozen molluscanshellfish. Proposed subpart C of part 123described certain types of controls thatprocessors of these products mustinclude in their HACCP plans in orderto meet the requirements of subpart Aof part 123.

Specifically, FDA proposed to requirethat processors of raw molluscanshellfish identify in their HACCP planshow they are controlling the origin ofthe molluscan shellfish that theyprocess. FDA proposed to require thatthese controls include accepting onlymolluscan shellfish that originated fromgrowing waters that are approved by ashellfish control authority, that are fromharvesters that are licensed or fromprocessors that are certified by ashellfish control authority, and that areproperly tagged or labeled. In addition,FDA proposed to require that processorsmaintain records to document that eachlot of raw molluscan shellfish meetsthese requirements. FDA also proposedto amend § 1240.60 (21 CFR 1240.60) toprovide for a system of tagging forshellstock and labeling for shuckedmolluscan shellfish as a means of sourceidentification.

It is important to note that shellfishcontrol authorities in the United Statesare generally agencies of Stategovernments, and that the tagging ofmolluscan shellfish is an importantaspect of State shellfish controlprograms. As discussed below, referenceto aspects of existing State programs inthese Federal regulations is notintended to supplant or override theState programs in any way. Rather, theseprovisions are intended to strengthenthe Federal system in ways that will

complement, and thereby bettersupport, State programs.

Molluscan shellfish consumed raw orpartially cooked pose unique publichealth risks. As the preamble to theproposed regulations noted, theyprobably cause the majority of allseafood-related illnesses in the UnitedStates. This situation is not unexpected,given the nature of the product and theway that it is consumed. The preambledocumented a relationship between themicrobiological quality of molluscanshellfish growing waters and theincidence of molluscan shellfish-bornedisease. It also noted that naturallyoccurring toxins may accumulate inmolluscan shellfish because they arefilter-feeding animals.

The NSSP was established as acooperative program among FDA, Stateregulatory agencies, and the molluscanshellfish industry, relying on section361 of the PHS Act (42 U.S.C. 264), toprovide for the classification and patrolof shellfish growing waters and theinspection and certification of shellfishprocessors. The preamble to theproposal reaffirmed FDA’s support forthe NSSP but noted the difficulties thatare associated with ensuring the safetyof these uncooked products. As thepreamble stated, FDA tentativelydetermined that it could strengthen andprovide additional support for thecooperative program through theseregulations.

2. Should There Be SpecificRequirements for Raw MolluscanShellfish?

FDA received approximately 45comments about the proposedrequirements for raw molluscanshellfish. The responses were fromprocessors, trade associations, State andFederal government agencies,individuals, consumer advocacy groups,and a foreign country. Approximatelyhalf of these comments urged FDA toeliminate proposed subpart C of part123 and the proposed amendment to§ 1240.60, while the other halfacknowledged the advisability ofincluding these kinds of provisions butcommented on, or questioned, variousspecifics of them.

The comments that generallysupported the need for specificrequirements for raw molluscanshellfish were from trade associations,molluscan shellfish industry members,consumer advocacy groups, Federal andState government agencies, individuals,and a professional organization. Anumber of comments noted that specialrequirements for molluscan shellfish arewarranted because of the association ofthese products with illness. One


comment in particular stated that, withrespect to seafood, molluscan shellfish‘‘serve as the primary source of illnessdue to ingestion.’’ One comment notedthat Federal regulations relating tosource of origin controls for rawmolluscan shellfish would enable FDAto lend support to the States in theadministration of the NSSP. Anothercomment suggested that the proposedregulations would improve FDA’sregulatory effectiveness with regard tomolluscan shellfish control. Thecomment from the ISSC stated that ‘‘TheConference has long recognized andsupported expansion of FDA authorityto assist States in assuring the safety ofmolluscan shellfish.’’

The comments that suggested thatsubpart C of part 123 and theamendment to § 1240.60 be deletedwere from State government agenciesand seafood processors. A number of thecomments that suggested deletion of theproposed provisions stated that thetagging and labeling requirements of theNSSP are designed not to serve as acontrol to prevent harvesting fromclosed areas but to assist States intracing shellfish that are implicated inillness outbreaks back to the harvestarea. The comments went on to statethat harvesters who illegally harvestfrom closed waters do not identify theshellfish as originating from the closedarea. The comments maintained thatpreventing illegal harvesting is the keyto reducing the incidence of illness, andthat the only known method to achievethis goal is through effective lawenforcement, including the patrol ofclosed waters.

A number of these comments arguedthat increased FDA funding and supportfor State molluscan shellfish control andpatrol efforts would do more than theproposed rule to deter illegal harvesting,to increase States’ compliance with theNSSP, and reduce the number ofillnesses caused by molluscan shellfish.The comments went on to state that theproposed regulations unnecessarilyduplicate the requirements now in placein the Manual of Operations for theNSSP. They contended that formaladoption of NSSP requirements intoFederal regulations would release Stateagencies from their cooperativerelationship with FDA under the NSSP.

One comment noted that theweaknesses in State molluscan shellfishcontrol programs are in areas notaddressed by the proposed regulations,such as improperly classified growingwaters; the ability of State growingwater classification programs to respondto breakdowns at waste water treatmentfacilities or unexpected climatic eventsthat affect the quality of molluscan

shellfish growing waters; and improperhandling by caterers and consumers.The comment concluded that theproposed HACCP provisions formolluscan shellfish will, therefore, notreduce the incidence of illnessattributable to such products.

As previously mentioned, FDA is apartner with State and foreignregulatory authorities and with industryin the NSSP. The NSSP Manual ofOperations provides the standards forState and foreign molluscan shellfishregulatory programs that belong to thecooperative program, as well as forprocessors. The participating Statesroutinely adopt those standards as lawor regulations, but the NSSP itself hasneither Federal nor State regulatorystature.

Each participating State and foreignnation classifies and monitors itsmolluscan shellfish growing waters,controls harvesting, inspects molluscanshellfish processors, and issuescertificates for those that meet theshellfish control authority’s criteria.FDA evaluates State and foreignmolluscan shellfish control programsand publishes monthly the ‘‘InterstateCertified Shellfish Shippers List,’’which lists the molluscan shellfishprocessors that are certified under thecooperative program. States that are inthe program are not willing to receiveshellfish from noncertified shippers.

FDA disagrees with the commentsthat suggest that establishment of theproposed source controls in Federalregulations would supplant the similarand, in some cases more stringent,requirements of participating States andforeign nations or the standards set forthin the NSSP. Rather, the agency isconvinced that they will reinforce andsupport these requirements andstandards.

The molluscan shellfish industry issubject to significant regulatoryoversight in those States that participatein the NSSP. However, the quality andeffectiveness of State laws andenforcement activities can varyconsiderably as a function of thefinancial and administrative supportavailable to the responsible State units(Ref. 7, p. 15). For example, FDAdocumented discrepancies in Stateenforcement practices during its 1994evaluation of State programs todetermine compliance with the NSSPstandards (Ref. 215). Moreover, althoughall harvesting States participate in theNSSP, many other States do not.

Based on these factors, FDA proposed,and is now adopting, subpart C of part123 and amendments to § 1240.60 tosupport and strengthen the shellfishprogram in two ways. First, these

provisions will complement the effortsof the States. FDA recognizes that whileStates are making significant andimportant efforts to ensure that allshellfish harvested in their jurisdictionare taken only from open waters andthen properly tagged, some shellfishthat do not meet these requirementsinevitably escape State control. The newprovisions will allow FDA to take actionagainst shellfish that are not harvestedfrom open waters or that are notproperly tagged if it encounters suchshellfish in interstate commerce andmake the gravamen of such action theorigination from unopen waters or thelack of proper tagging itself, rather thanevidence that the shellfish are injuriousto health.

Second, the regulations require thatprocessors only use shellfish thatoriginate from growing waters that havebeen approved for harvesting and thathave been properly tagged. Failure to doso can result in Federal regulatoryaction against the product or against theprocessor itself. This fact shouldprovide a significant incentive toprocessors to ensure that they are notreceiving shellfish that do not meetthese requirements.

Taken as a whole, rather thandiminishing in any way the importanceof State programs, FDA’s regulationselevate the importance of thoseprograms. These regulations makeproper origin and tagging—conceptsthat derive directly from the NSSP—keys to the unimpeded movement ofshellfish in interstate, as well asintrastate, commerce.

Moreover, these requirements extendthese control measures to importedproducts, enabling FDA to moreefficiently and effectively ensure thesafety of imported raw molluscanshellfish. At present, the agency mustresort to advising State regulatoryauthorities of the prospective entry ofraw molluscan shellfish from anuncertified source (Ref. 216, part V, p.5). While States normally take actionagainst uncertified imported rawmolluscan shellfish, FDA is aware thatuncertified imports enter interstatecommerce (Ref. 107).

FDA acknowledges that uniformFederal tagging and record-keepingrequirements will not completelyeliminate illegal harvesting. The agencyagrees with the comments that rigorousenforcement of closed area restrictionsby State regulatory agencies will alwaysbe needed. Unquestionably, increasedfunding would help State efforts toclassify and patrol growing areas.However, FDA does not have resourcesfor this purpose. Nonetheless, theagency remains convinced that there are


significant, positive steps that can betaken to strengthen source controls aspart of HACCP, and thereby to supportthe cooperative program.

A processor’s most significant safetycontrol for raw molluscan shellfish is atthe point of receipt. If processors refuseto accept molluscan shellfish for whichthere is no assurance that they havebeen legally harvested, the incentive forillegal harvesting would be eliminated.FDA participation in a number of covertinvestigations into illegal molluscanshellfish harvesting in recent years hasconvinced the agency that, in manycases, processors are aware of the illegalharvesting activity of their suppliers(Ref. 217). If the provisions of theseregulations can help foster a culturechange in that respect, shellfish safetywill be significantly enhanced.

Based on these considerations, theagency proposed that, as a universalaspect of the HACCP plans for theseproducts, molluscan shellfishprocessors engage in certain activities toensure that the products that theyreceive originate only from waters thathave been approved by a shellfishcontrol authority (e.g., checking tags oncontainers of shellstock, licenses offishermen, and certification ofsuppliers). Molluscan shellfish that areclearly improperly tagged or fromquestionable sources must be rejectedby processors as a requirement of theirHACCP plans. It is reasonable toconclude that, as more processors adoptHACCP and exercise greater controlover their suppliers, the amount ofillegally harvested shellfish offered forsale will decrease, because the marketfor such product will decline.

While it is true that the taggingrequirements of the NSSP wereprimarily designed as a means of tracingback molluscan shellfish involved inincidences of illness to their harvestarea, they have also served as a keycomponent in efforts by FDA and Stateregulators and industry to ensure thatmolluscan shellfish that are placed incommerce originate from areas that areapproved by a shellfish controlauthority. It is certainly true that thetags on containers of molluscanshellfish that are harvested from closedwaters are often falsified to disguisetheir true origin. However, suchfalsification carries potential Federaland State penalties and is a focus ofcurrent molluscan shellfish controlprograms.

Regarding the comments that pointedto weaknesses in State programs, atretail, in the classification of molluscanshellfish growing waters, and elsewhere,which are not directly addressed bythese regulations, the agency

acknowledges that HACCP plans andspecific source control requirementscannot serve as a substitute forimprovements in the food safety systemthat directly address these weaknesses.Regulatory systems will always havetheir strengths and weaknesses, andresearch to better understand andcontrol hazards will always be needed.Nonetheless, these comments provideno reason for FDA to abandon its effortsto remedy existing agency weaknessesand, in particular, to lend support to theStates in those areas to which theseregulations do relate.

141. One comment stated thatreferences cited in the preamble to theproposed regulations in support of thetagging requirements (Refs. 102 through109) do not provide convincingevidence of a need for such a measure.The comment stated that, for the mostpart, the references that FDA citeddocument corrective actions taken byState regulatory agencies that wouldlikely be the same measures that FDAofficials would take under the proposedregulations. In addition, the commentstated that a failure to have properlytagged shellfish does not always meanthat the shellfish were harvestedillegally. The comment pointed out thatthe absence of a tag could mean simplythat the tag was lost.

The references in the question containexamples of problems associated withmolluscan shellfish tagging,recordkeeping, and harvesting. FDAcited these references to demonstratethat, in some cases, the deterrent effectof existing State tagging requirementsand sanctions is inadequate to preventproblems from arising (Refs. 102, 103,and 109). The problems documented inthe references helped persuade FDA topropose Federal source controlrequirements to help deter the interstateshipment of shellfish from unapprovedharvest areas. FDA did not intend toimply that the State actions that weredocumented in these references wereincorrect, or that FDA would haveresponded in a different manner. FDAcontinues to believe that the referencesare relevant and supportive to itsintended assertion.

A few comments maintained that abetter strategy for decreasing illnessfrom the consumption of molluscanshellfish would be to increase theeducation efforts of FDA and of the ISSCthat are directed toward consumers andthe medical community to alertsusceptible individuals to the risksassociated with the consumption of rawmolluscan shellfish.

The agency agrees that consumereducation can play a vital role inreducing illnesses associated with the

consumption of raw molluscanshellfish, particularly in medicallycompromised individuals. During theperiod of 1984 through 1994, the agencyexpended nearly $1 million to alert thepublic to the risks of raw molluscanshellfish consumption by distributingbrochures to consumer groups, groupsthat represent those with specialmedical conditions, and consumers;developing a video news release; issuingpress releases; and establishing the toll-free, FDA Seafood Hotline. Included inthis expenditure is the agency’s effortsto inform the medical community aboutthe illnesses associated with theconsumption of raw molluscan shellfishby providing informative articles tomedical bulletins and journals and bymailing brochures and news articles totarget professional groups. The agencywill continue its consumer educationefforts, but such efforts alone will beinsufficient to address the hazardsposed by the consumption of rawmolluscan shellfish harvested fromunapproved growing waters. Theexisting and planned consumereducation efforts are geared towardindividuals in high-risk consumergroups, advising them to avoidmolluscan shellfish that have not beenfully cooked. The risks posed byviruses, toxins, and many bacteria are tothe population as a whole. There is littleadvice that the agency could providethat would enable consumers to protectthemselves from these kinds of hazardsin molluscan shellfish.

143. Several comments questioned thevalidity of FDA’s statement thatmolluscan shellfish consumed raw orpartially cooked pose unique publichealth risks and probably cause themajority of all seafood-related illnessesin the United States.

The comments provided no data uponwhich to conclude that either the NASor FDA is wrong in this regard. FDAremains convinced that the statementsmade in the preamble to the proposedregulations are valid, and that thereferences support these statements.

3. Cooked Versus Raw MolluscanShellfish

144. Comments from a number ofState agencies, trade associations,seafood processors, and the ISSCobjected to the use of the terms ‘‘raw’’and ‘‘fresh or frozen’’ in the title of part123 subpart C and the text of theproposed regulations on shellfish. Thesecomments were concerned becausethese terms would have the effect ofexempting canned and any other heat-processed molluscan shellfish from thesource control, recordkeeping, and


tagging provisions of subpart C of part123 and § 1240.60(b).

The comments stated that limitingthese provisions to raw products wouldallow foreign firms to continue to heat-treat or can molluscan shellfish that areharvested from foreign waters that donot meet NSSP standards and to exportthem to the United States. Thecomments stated that this situation wasnot in the best interest of the publichealth because of the potential for thepresence of heat-stable natural toxins,such as paralytic shellfish poison oramnesiac shellfish poison, as well aschemical contaminants. The commentsalso complained that, because Statelaws and regulations require that allmolluscan shellfish harvested in theUnited States come from watersapproved by a shellfish controlauthority regardless of whether they areto be consumed raw or cooked,continuing to allow foreign processorswho export cooked shellfish to theUnited States to use molluscan shellfishfrom unapproved growing waters placesthe domestic shellfish industry at acompetitive disadvantage. Othercomments requested that FDA clarifywhether canned shellfish were includedin subpart C of part 123 but did notsuggest that canned and other heat-processed shellfish be included.

FDA has responded to thesecomments generally in response tocomment 34, supra. The agency addsthe following points:

It is important to recognize thatforeign processors who export cookedmolluscan shellfish to the United Statesnow will have to have HACCP systemsthrough which they identify and controlhazards that are reasonably likely tooccur. These hazards include heat stabletoxins and chemical contaminants thatwould cause these products to beadulterated under U.S. law.

To further clarify that therequirements of subpart C of part 123apply only to the processing ofmolluscan shellfish that are not heattreated or treated in some other mannerby the processor to eliminatemicroorganisms of public healthconcern, FDA has modified the languageat § 123.20 to read, ‘‘This subpartaugments subpart A of this part bysetting forth specific requirements forprocessing fresh or frozen molluscanshellfish, where such processing doesnot include a treatment that ensures thedestruction of vegetative cells ofmicroorganisms of public healthconcern.’’

4. Shellfish Control AuthoritiesFDA proposed to require that

processors only process molluscan

shellfish that originate from watersapproved for harvesting by a shellfishcontrol authority. The term ‘‘shellfishcontrol authority’’ is defined at§ 123.3(o) to include foreign governmenthealth authorities that are legallyresponsible for the administration of aprogram that includes classification ofmolluscan shellfish growing areas.

145. Two trade associationsquestioned how a processor couldevaluate the competency of a foreignshellfish control authority. They statedthat FDA should require that a foreigncountry that exports shellfish to theUnited States have an agreement withthe agency that establishes that acompetent shellfish control authorityexists in that country, and that theforeign shellfish program meets NSSPstandards. One comment from a seafoodprocessor argued that it would beunreasonable to require processors toverify that molluscan shellfish from allover the world are caught or cultivatedin waters that meet NSSP standards.The comment stated, moreover, that aprocessor could not keep abreast ofwhich countries have current shellfishagreements with FDA and whichcountries do not.

FDA acknowledges the merits ofrequiring that a foreign country thatexports shellfish to the United Stateshave an agreement with the agency buthas concluded that, given thesignificance of such a requirement andthe agency’s failure to raise thepossibility of imposing it in theproposal, it is beyond the scope of thisrulemaking. Even though FDA is notimposing such a requirement, it is thecase that the only means by which aprocessor can ensure that the molluscanshellfish of foreign origin that it receivesare in compliance with the requirementsof subpart C of part 123 of theseregulations is by determining whetherthe foreign shellfish control authority isformally recognized by FDA. It is notlikely that the processor could employany other process that would give itassurance that molluscan shellfishharvesting waters that are approved bythe shellfish control authority areproperly classified. Such adetermination is appropriatelyperformed through government togovernment audit.

5. Shellfish From Federal Waters146. Comments from a significant

number of trade associations andseafood processors stated that arequirement that shellfish originate onlyin waters ‘‘approved for harvesting by ashellfish control authority’’ wouldpreclude harvesting in Federal watersunless the Federal government

introduced a formal approval processfor waters under its purview through aFederal shellfish control authority.

Under the current system, Stateagencies are responsible for approvingmolluscan shellfish growing waters.However, State jurisdiction extendsonly to waters that are within threemiles of the shore. Waters beyond thatpoint but up to 200 miles offshore areunder the jurisdiction of the Federalgovernment. The comments pointed outthat the harvesting of molluscanshellfish is permitted in all of theoceanic waters under Federal controlunless there is a specific Federal actionto declare an area unsafe under theprovisions of the Magnuson FisheryConservation and Management Act. Thecomments further noted that largevolumes of molluscan shellfish areharvested in Federal waters.

How Federal waters will be classified,and by whom, has not been fullyresolved. The comments are correct thatthe proposed requirement, ifincorporated into the final rule, wouldpose significant problems for molluscanshellfish processors who receiveproduct harvested from Federal waters.Therefore, FDA has modified § 123.28(b)to allow for the receipt of molluscanshellfish that are harvested in U.S.Federal waters except where suchwaters are specifically closed toharvesting by an agency of the Federalgovernment. This provision isconsistent with the provisions of theMagnuson Act.

It is worth noting that, by allowingFederal waters to be open unless theyare specifically closed, this system is theopposite of the State system, underwhich waters are closed unless they areaffirmatively classified so as to be open.This difference is reasonable from apublic health standpoint because thereis less likelihood that Federal waterswill be affected by pollution than willnear shore State waters.

Furthermore, because there is noFederal authority to license shellfishharvesters who fish in Federal waters,FDA has modified § 123.28(c) to requireonly that a harvester be in compliancewith such licensure requirements asmay apply to the harvesting ofmolluscan shellfish, rather thanspecifically requiring licensure.

6. Tagging and RecordkeepingRequirements

147. FDA proposed recordkeepingrequirements for processors to followwith respect to shellstock and shuckedmolluscan shellfish in § 123.28 andrequirements for the information to beincluded on the shellstock tag in§ 1240.60. A few comments stated that


the proposed molluscan shellfish tagand record requirements were toospecific, and that placing suchrequirements in the form of regulationswould make it difficult to make timelychanges to these requirements as futureneeds may dictate. The commentsasserted that FDA or the ISSC may wishto modify the content or form ofmolluscan shellfish tags or records toimprove product traceability. Theysuggested that FDA write the taggingand recordkeeping requirements at§ 123.28 and § 1240.60 in general termsand allow the specific form andinformation required on the tags to beaddressed by the NSSP. The commentswent on to urge that, if the agency weredetermined to include specific taggingand recordkeeping requirements as partof the final regulations, they should befully consistent with current NSSPguidelines.

It is not the agency’s intent that theprovisions of § 123.28 and § 1240.60would preclude the ISSC or Stateagencies from adopting additionalrecordkeeping or tagging requirements.The recordkeeping and taggingrequirements in these regulations arethe minimum necessary to ensure thatshellfish can be traced throughdistribution channels, back to theharvest source. FDA explained whyeach of the specific requirements isnecessary in the preamble to theproposed regulations, and the commentsdid not take issue with the agency’sexplanation with respect to any of theparticulars. Therefore, FDA disagreeswith the comments that therecordkeeping or tagging requirementsare more restrictive than they need tobe, or that they would interfere with theNSSP tagging program.

Moreover, as stated previously, theagency has drafted the regulationsbroadly enough so as not to conflictwith any improvements that the ISSCmay wish to make in the form that a tagmay take or in how information on tagsis to be stored. The definition of theword ‘‘tag’’ at § 123.3(t) (added at§ 1240.3(u) for consistency) reads, inpart, ‘‘a record of harvesting informationattached to a container of shellstock* * *.’’ This definition is sufficientlybroad to include such systems as barcodes, embossed plastic, or othernontraditional methods of identificationthat may be used by the industry in thefuture. The agency is supportive ofefforts to improve the existing methodsof recording harvesting information.

Nonetheless, it is important for theregulations to identify the minimumspecific information that must appearon a tag. During past illness outbreaks,FDA, State regulatory agencies, and

industry have had difficulty tracing theimplicated shellfish to their sources,especially after they have been in thepossession of several differentprocessors (Refs. 99; 100; 102–106; 109;218; and 219, pp. 37–39). Thesedifficulties in tracing the shellfish haveoccurred because the shellfish were notin compliance with the tagging andrecordkeeping provisions of the NSSP.The requirements at § 123.28 will enableFDA to help the States to enforceminimum tagging and recordkeepingrequirements for imported and domesticproducts. Moreover, the agency believesthat placing the tagging andrecordkeeping requirements in Federalregulations will emphasize thenationwide importance of thisinformation in protecting the publichealth, as described earlier.

148. One comment noted that theNSSP does not specify that the name ofthe harvester must be on a molluscanshellfish tag, but that the proposedregulations would require thisinformation.

The NSSP specifies that the numberassigned to the harvester by the shellfishcontrol authority must be listed on thetag. The agency recognizes that theremay be a variety of effective ways toidentify the harvester of the molluscanshellfish, depending on the method ofharvest, State requirements, and localtradition. For this reason, the agency hasmodified § 1240.60(b) to read that thetag shall disclose:

* * * by whom they were harvested (i.e., theidentification number assigned to theharvester by the shellfish control authorityor, if such identification numbers are notassigned, the name of the harvester or thename or registration number of theharvester’s vessel).

For consistency, FDA has made asimilar change in § 123.28(c)(5).

149. A significant number ofcomments recommended that FDAmodify § 1240.60(b) to allow bills oflading or other shipping documents toaccompany bulk shipments of shellstockin lieu of tags, as long as they providethe same information. A few commentssuggested that bills of lading or othershipping documents be used in lieu oftags on individual containers ofshellstock when a shipment consists ofa large volume of shellstock in sacks orboxes. Several comments asked forclarification of the impact of theproposed requirements on currentrepacking operations that commingleshellstock from various harvesters intoone container.

FDA recognizes that an inconsistencyexisted between proposed § 123.28 andproposed § 1240.60 because the former

would have allowed shippingdocuments to provide the requiredinformation for bulk shipment, and thelatter would not. FDA agrees with thecomments that recommended providingfor the use of shipping documents andhas modified § 1240.60(b) to provide theneeded consistency. Under existingindustry practice the truck, cage, orvessel hold serve the same purpose asa container for the shellstock, makingtagging impractical. In that case, theshipping document serves the samefunction as the tag.

However, the agency does not agreewith the suggestion that containers ofshellstock in large shipments be allowedto be covered by shipping documents inlieu of tags. FDA cannot justify treatingshellstock in large shipments differentlythan shellstock in smaller shipments,nor could the terms ‘‘large’’ or ‘‘small’’be readily defined. Large shipments canbe subdivided, perhaps many times, orcommingled with other lots ofmolluscan shellfish. The sourceinformation would, therefore, benecessary on each container to ensureproper identification. Without tags, theidentity of individual containers couldbe lost. FDA is requiring that allshellstock, even after repacking, bear atag that identifies the prescribedinformation, including the identificationof the harvesters to ensure that allshellstock is readily traceable(§ 1240.60).

7. Other Considerations150. Comments from a few trade

associations and from seafoodprocessors stated that FDA shouldrequire a production code on eachcontainer of shucked molluscanshellfish. The comments suggested thatthe code consist of an identifying markthat allows the processor to determinewhere the remainder of the lot wasshipped, and where and when therelevant shellstock was harvested.

FDA agrees that production codes canbe useful on containers of shuckedmolluscan shellfish to facilitate traceback of questionable product. Theagency encourages the use of codes bymolluscan shellfish processors.However, such a requirement is notwithin the scope of the proposedregulations. The agency will considerwhether such a requirement should bepursued in a separate rulemaking.

151. Comments from severalconsumer groups stated that if awarning label is not mandated by FDAon raw molluscan shellfish to alert at-risk consumers of the danger to healthposed by the product, FDA shouldrequire that Gulf Coast oyster processorsadequately cook the product to


eliminate risks from Vibrio vulnificusduring periods when shellfish cannot beharvested free from this bacterium. Theyfurther stated that cooking should not berequired when the shellfish are freefrom this bacterium.

FDA agrees that effective controls areneeded to protect consumers from thehazard posed by V. vulnificus in GulfCoast oysters during certain times of theyear. The agency is evaluating thepotential effectiveness of a variety ofcontrol mechanisms. Mandating specificmechanisms, however, would beoutside the scope of this rulemaking.FDA is therefore taking these commentsunder advisement.

152. A few comments urged that theword ‘‘processor’’ be changed to‘‘certified dealer and licensed harvester’’throughout § 123.28 to make theterminology consistent with the NSSPand to clarify that these requirementsapply to everyone who buys and sellsshellfish before the shellfish reach theretail marketplace. The comments alsorecommended changing the word‘‘shipper’’ to ‘‘processor or packer’’ inthe provision that is codified at§ 123.28(d)(3) in these final regulationsto include the shucker, repacker,shipper, reshipper, or depurator.

As mentioned in the ‘‘Definitions’’section of this preamble, the agency hasconcluded that the definition for‘‘processor’’ covers all NSSPclassifications of shellfish dealers,without specifically naming each one.For consistency throughout theregulations, use of the term will remainunchanged.

FDA agrees, however, that the word‘‘shipper,’’ as the agency used it in theproposed regulations, could causeconfusion because that term has adifferent meaning in the NSSP Manualof Operations. Therefore, FDA haschanged the language of the finalregulations to read ‘‘packer orrepacker.’’ The certification number ofthe packer or repacker is readilyavailable to the processor since it isrequired, under the NSSP standards, oneach label of shucked product. Forconsistency, FDA has modified§ 1240.60(c) to also read ‘‘packer orrepacker’’ where it had previously read‘‘processor.’’

153. A few comments stated thatproposed § 123.28(b), which referred tomolluscan shellfish that ‘‘originate fromgrowing areas that are approved forharvesting,’’ appears to prohibitprocessors from using products fromharvest waters classified under theNSSP as ‘‘conditionally restricted.’’Under the NSSP, shellstock taken fromsuch waters cannot be directly marketedfor human consumption but can be

‘‘relayed’’ to an open growing area forharvest at a later date. In addition, thecomments pointed out that the word‘‘approved’’ is a formal classificationdesignation used in the NSSP. Thesecomments said that harvesting ispermitted from areas with other than‘‘approved’’ classifications but wouldappear to be prohibited under theprovisions of proposed § 123.28(b). Thecomments suggested use of the term‘‘open’’ growing waters, which wouldapply to several different NSSP harvestarea classifications.

FDA agrees that the word ‘‘originate’’,as used in proposed § 123.28(b), is toorestrictive and has revised this sectionto say ‘‘harvested from.’’ With regard tothe word ‘‘approved,’’ FDA concludesthat no change is warranted. Theproposal neither adopted nor referencedthe NSSP growing water classificationsystem. The phrase ‘‘approved forharvesting’’ should not be construed tobe limited to those waters classified bya State under the NSSP as ‘‘approved’’areas. The phrase ‘‘approved forharvesting’’ is used in the finalregulations for its common sensemeaning (i.e., those areas from whichharvesting is allowed), which FDAbelieves is appropriate.

154. For clarification purposes,definitions for the terms ‘‘certificationnumber’’, ‘‘shellfish control authority’’,and ‘‘tag’’ have been added at§ 1240.3(s), (t), and (u), respectively.These definitions are taken directlyfrom § 123.3.

155. One comment urged that theregulations be modified to specificallystate that a HACCP plan for rawmolluscan shellfish that contains thecontrols specified in subpart C of part123 is deemed to meet the requirementsof § 123.6.

The agency disagrees with thiscomment. The requirements of subpartC of part 123 are designed to control theenvironmental hazards associated withthe harvest waters from whichmolluscan shellfish are taken,particularly those relating to sewage-related pathogens, chemicalcontaminants, and natural toxins. Forthis reason, they must be included inthe HACCP plans of all raw molluscanshellfish processors. However, they arenot intended to control process-relatedhazards resulting from, for example,time-temperature abuse of the product,improper use of food additives, or metalfragments. To control these hazards, theprocessor needs to follow the generalapproach set out in subpart A of part123. The agency has developed the twosubparts to be complementary and hasstrived to eliminate any redundancy intheir provisions. Thus, it is theoretically

possible that a HACCP plan thatcontains the controls specified insubpart C alone of part 123 still mightnot meet all the requirements of § 123.6.

FDA has made two modifications in§ 1240.60(b) for clarity only. Where theproposed regulations required that thetag identify the ‘‘* * * place whereharvested * * *,’’ FDA has added, ‘‘(byState and site).’’ This change makes§ 1240.60(b) consistent with§ 123.28(c)(2). Additionally, where theproposed regulations stated thatimproperly tagged or labeled productwould be ‘‘subject to seizure anddestruction,’’ FDA has amended thelanguage to read, ‘‘subject to seizure orrefusal of entry, and destruction.’’ Thischange is to make clear that, forimported products, the appropriateregulatory procedure is refusal of entry,rather than seizure.

O. Compliance and Effective Date

1. Effective Date

FDA proposed that these finalregulations be effective and enforced 1year after the date that they arepublished in the Federal Register. Thepurpose of this proposed effective datewas to provide processors with enoughtime to develop and implement HACCPplans. The agency invited comment onwhether 1 year would be adequate.

156. FDA received more than 60comments about the proposed effectivedate. Virtually all comments agreed thatthe agency should provide some periodbefore the regulations become effective.The comments either agreed with a 1-year implementation period orrequested a longer period of 2 years ormore. There were also a number ofcomments that responded to theagency’s question about whetherimplementation dates should bestaggered based on such factors as sizeof firm and level of risk.

A minority of comments stated that 1year for implementation is adequate.These comments argued that after 1year, the industry would have had 3-years notice of the requirements. Thecomments argued that 3 years wassufficient total time to be informedabout impending regulations. Anothercomment stated that one year might besufficient for the seafood industry, butother food industries could needconsiderably more time.

Several comments recommended thatFDA provide an implementation periodof longer than 1 year but did notrecommend a specific alternative. Thesecomments were concerned that HACCPtraining would not be completed in timefor a 1-year implementation date; thatforeign processors would need more


time to implement HACCP; and that 1year after Canada required HACCP forits seafood industry, only half of itsfirms had complied.

The largest number of comments onthis topic recommended that FDA makethe regulations effective 2 years afterpublication. The reason most often citedwas that it will be more than 1 yearbefore most of the affected firms cancomplete HACCP training. The nextmost frequently cited reason was thatfirms and trade associations neededmore time for HACCP plandevelopment. Several comments alsodiscussed the time required to modifyequipment and raise capital; to respondto initial, voluntary reviews of HACCPplans by regulatory agencies; and forFederal, State, and local officials tounderstand HACCP and how to enforceit and to arrange for cooperativeenforcement. A few comments statedthat FDA needs sufficient time todevelop agreements with foreigncountries.

Several comments contended thatmore than 2 years should be allowed toimplement the regulation. Thesecomments mentioned the culturalchange that HACCP will require andconcern about the impact that theregulations will have on small firms aswell as on large firms with multipleproducts and lines. They alsomentioned the time needed for training.

Over 20 comments recommended thatFDA stagger effective dates. A majorityof these comments stated that such aphased-in start-up should be based onproduct risk. The remainder of thecomments split in favor of eitherconsidering both the size of a firm andthe risk from the products it makes orjust the size of a firm.

A smaller number of commentsargued against a staggered start. Thesecomments expressed the view that smallfirms and foreign products should notbe treated differently and pointed outthat all firms will already have had 3years of notice. Some of these commentsstated that it would be hard to justifystaggering implementation based on riskwhen the illness data are so incomplete.Others expressed the view thatadministering a staggered start woulduse up valuable resources and onlyresult in confusion; that staggeringwould put some firms at a competitivedisadvantage; and that it mightencourage procrastination.

After fully considering all of thesecomments, FDA agrees with thecomments that suggested that a 2-yeareffective date is appropriate. Based onFDA’s participation with the Alliancethat is developing training materials forthis program, FDA has come to realize

that 2 years must be provided toestablish training programs and to giveparticipants enough time to take them.Two years is also the minimum timenecessary to train regulatory personnel.The additional time is also necessary sothat the States will have a fullopportunity to understand and respondto the effects of these regulations. It willalso increase the likelihood that moreagreements with other countries willexist.

The additional year will also increasethe opportunity for processors to engagein ‘‘voluntary’’ HACCP inspections inadvance of the effective date in order toobtain preliminary, nonregulatoryfeedback from the agency on theirprogress.

The agency acknowledges that it hasurged the industry to begin preparingfor HACCP well before the issuance ofthese final regulations. However, as thispreamble amply demonstrates, asignificant number of questions wereraised as a result of the proposal thatcould not be answered until now.Moreover, the entire support structurefor HACCP, including the issuance ofthe first edition of the Guide and thedevelopment of training courses, modelplans, and other forms of technicalassistance that will be useful to theindustry, and especially to smallbusinesses, will not be in place in timeto permit a 1-year effective date.

On the other hand, more than 2 yearsdoes not appear at this time to bewarranted. The agency is concerned thatadditional time would adversely affectthe momentum for this program withoutadding significantly to the likelihoodthat it will succeed.

On the other hand, FDA is sensitiveto the need to ensure that smallbusinesses will not incur anunreasonable threat to their survival byan effective date that is too short. Theagency intends to monitor the progressof the industry after the regulations arepublished and invites feedback on thissubject. If FDA determines that theeffective date is placing a significantand unreasonable burden on theindustry, particularly on smallbusinesses, the agency would be willingto consider an extension for as much asone additional year or some form ofadditional technical assistance. Theagency would consider whether thedelay is needed for training, draftingplans, or taking other measures thatdirectly relate to the installation of aHACCP system, or whether the time isneeded to comply with existingCGMP’s, which are a prerequisite forHACCP. FDA will likely be reluctant togive firms an extended period of time to

achieve compliance with existingrequirements.

FDA also finds that there is not anadequate basis at this time for staggeringthe starts based on size or risk. Thearguments for and against staggeringgenerally parallel those for and againstexempting firms from these regulationsaltogether on the basis of either size orrisk. These arguments are discussed inthe section of this preamble entitled‘‘Should Some Types of Processors BeExempt?’’ In summary, a good case canbe made that implementation by smallfirms should not be delayed becausesuch firms account for much of theproducts with significant potential forrisk, such as cooked, ready-to-eatproducts. Moreover, most seafoodprocessors are small firms. Risk-based,as opposed to size-based, criteria forstaggering firms would inevitably bearbitrary to some degree because datafrom foodborne illness reportingsystems tend to skew the reports towardmore easily diagnosable illnesses.

The comments received on the subjectof staggering do not provide a ready wayto overcome these problems. Moreover,the 2-year effective date (rather than 1year as proposed), guidance, technicalassistance, and training that will beavailable to all processors should makestaggering much less necessary than itotherwise might have been.

As stated above, however, the agencywelcomes feedback on the progress thatprocessors are making to implementHACCP that could have a bearing onwhether staggering or an extension ofthe effective date would be appropriate,especially for small businesses.

157. Several comments asked for aform of staggering based on when aninspection occurs before the effectivedate. These comments stated thatprocessors who voluntarily submit toinspection under the regulations beforethe effective date and are advised thattheir HACCP systems are not yet incompliance with the regulations shouldhave at least a 6-month grace period tocorrect the problems. The examplegiven in these comments was that of aprocessor who is so advised 1 daybefore the effective date and thus isinevitably out of compliance on theeffective date.

As reflected in the comments,inspections of HACCP systems beforethe effective date will occur because afirm desires feedback and volunteers forit when an FDA investigator arrives foran inspection. That feedback willconstitute informal advice only and willprovide training for the investigator aswell as for the processor. There may besome advantage to a processor to obtainfeedback and training sooner rather than


later, but the results will have no formalstatus with the agency and would notwarrant an extension of the effectivedate.

The agency has heard considerableconcern that it will automatically seekto seize or otherwise remove fromcommerce all products being producedunder a HACCP system that isdetermined to be deficient in anyrespect. That concern is unfounded. Theconsequence of being out of compliancewith HACCP requirements, on the firstinspection after implementation orotherwise, is addressed throughout thissection. In summary, FDA’s reactionwill depend, as it does today, on theoverall public health significance of thedeficiency.

2. Public Meetings158. One comment suggested that

FDA conduct public meetings to explainthe requirements of these regulations tothe seafood processing industry betweenthe publication date and effective dateof these regulations. The comment alsoencouraged a coordination of research,training, and educational effortsbetween industry and FDA in order tofacilitate the implementation of thisHACCP program.

FDA fully agrees with the comment.It is the intent of the agency to engagein a dialog with industry, through acombination of public meetings anddiscussions at trade associationmeetings, to facilitate a thoroughunderstanding of the regulations. FDA’saffiliation with the Alliance reflects theagency’s commitment to a cooperativerelationship among industry,government (Federal and State), andacademia in the areas of research,training, and technical assistance.

3. Penalties for Noncompliance159. A significant number of

comments, from processors and tradeassociations, requested that FDAaddress how noncompliance with themandatory sanitation controlprocedures will be handled. Several ofthese comments also requested that FDAdescribe the penalties that can beimposed upon a processor and itsofficers for: Failure of a processor tohave and implement a HACCP plan;noncompliance with sanitation controlprocedures; and failure to meet minorrequirements of the regulations, such asthe lack of a signature on a document.One comment stated that FDA’s legalauthorities and enforcement proceduresdo not provide a means for the agencyto respond in a manner that is relatedto the severity of deficiencies—that is, aless severe response to a less significantdeficiency.

FDA has a longstanding practice oftailoring its regulatory response to thefacts. A deviation from any of theprovisions of these regulations,including those involving the control ofsanitation, carries the potential forregulatory action pursuant to section402(a)(4) of the act. However, FDAintends to enforce these regulations in amanner that focuses on those deviationsthat have the greatest potential forcausing harm. It is not FDA’s intent topursue regulatory action against aproduct or a processor exclusively forclerical errors or minor errors ofomission. To do so would certainly notbe an efficient use of agency resources,nor would it be in the best interests ofthe consuming public.

The penalty provisions for food foundto be adulterated are described at‘‘Prohibited Acts and Penalties,’’ inchapter III of the act. The statutorysanctions that FDA may seek includeseizure and condemnation of a food andinjunction and criminal penaltiesagainst a person (i.e., a firm and itsresponsible management).

FDA may also use existingadministrative procedures, such aswarning letters and conferences with aprocessor, to bring instances ofnoncompliance to the processor’sattention as it frequently does under itscurrent inspection programs.

The agency cannot state preciselywhat type of action it will take when itdetects a deficiency because FDAevaluates each deficiency on a case-by-case basis to determine the publichealth significance of the violation andthe appropriate response.

4. Preapproval of HACCP PlansIn the preamble to the proposed

regulations, FDA tentatively concludedthat HACCP plans would not have to besubmitted to the agency or otherwisepreapproved before theirimplementation by processors. Thereasons for the agency’s tentativeconclusion included: (1) HACCP plansshould be judged in the context of theprocessing plant, a process bestaccomplished during routine FDAinspections of processing facilities; and(2) the agency does not have sufficientresources to review HACCP plans fromall domestic and foreign seafoodprocessors in advance of either HACCPimplementation by the processor or theconduct of HACCP-based inspections byFDA.

160. Approximately 20 commentsaddressed this issue. About two-thirdsof these comments, from consumeradvocacy groups, processors, tradeassociations, and State governmentagencies, contended that a processor

should be required to file a HACCP planand obtain approval from FDA beforeimplementing the plan. The remainingcomments, from processors, tradeassociations, and a foreign government,agreed with FDA’s tentative conclusionthat HACCP plans need not besubmitted to the agency or preapprovedbefore they are implemented.

Some of the comments favoringpreapproval argued that FDA shouldhave control over the design of eachplan before it is implemented to ensurethat all of the CCP’s are identified, andthat appropriate records will be kept.Other comments contended that, in theabsence of a preapproved plan, aprocessor may implement a plan thatFDA would later judge to be inadequate,possibly raising concerns about theproduct already produced under theplan.

Several comments in opposition topreapproval argued that it would be tooexpensive and difficult for both FDAand the processors (the latter becauseimplementation would be delayed whileprocessors waited for FDA topreapprove the plan and everysubsequent change to the plan). Onecomment expressed concern that, informally approving a HACCP plan,regulatory authorities would assumesome responsibility for the HACCPsystem of an individual processor.

A few comments stated that HACCPplans will evolve as operations areadjusted, based on the processor’sverification activities. These commentsargued that a requirement for thepreapproval of HACCP plans wouldencumber a processor’s ability to updateits HACCP plan.

The resource situation since theproposal was issued in January, 1994,has not changed in any way that wouldmake the preapproval of HACCP plansby FDA practicable. Thus, FDA’sanalysis of the comments has focusedon whether a lack of preapproval raisessignificant implementation problemsthat the agency must address. Thecomments have not convinced theagency that it does. FDA finds that apreapproval system would undulyburden the agency’s resources, withoutproviding significant advantages to thepublic health. The effectiveness of aHACCP plan, including monitoring,recordkeeping, and verification, can bestbe evaluated under actual operatingconditions.

The preapproval of HACCP plans isdistinguishable from the situation forlow acid canned foods, where FDAreviews submissions of scheduledprocesses and revisions to theseprocesses without hinging that reviewon a visual inspection of the facility. For


low-acid canned foods, the submissionrelates solely to the adequacy of thecooking process to control one hazard(C. botulinum). This process lends itselfto a paper evaluation.

FDA agrees with the comments thatsuggested that a requirement for agencyapproval of a processor’s changes to anexisting HACCP plan wouldunnecessarily slow the process of planimprovement. The ability to modify theplan quickly based on feedback fromverification activities is an importantaspect of HACCP that could be degradedby a preapproval requirement.

With regard to the concern that thelack of plan preapproval will expose aprocessor to risk of product loss if aHACCP plan, under which it had beenoperating, is deemed by FDA to beinadequate, the agency advises thatthere are several issues that shouldmitigate this concern. First, the agencyis committed to providing guidance, inthe form of the Guide, to assistprocessors in the development ofHACCP plans that are likely to beacceptable to the agency. The Guide willbe further discussed later in this section.

Second, FDA is convinced that thetraining requirements of theseregulations will serve to inform theregulated industry about theexpectations of the agency with respectto HACCP plan content. FDA is workingclosely with the Alliance to ensure thattraining reflects FDA policy.

Third, FDA recognizes and acceptsthat, for HACCP plans to be effectiveand efficient, they must be tailored tothe operating conditions of theindividual processor. Of necessity, thisfact means that there may be multipleways to control an individual hazard.Consequently, FDA investigators will betrained to objectively evaluate theprocessor’s HACCP plan from thestandpoint of whether it accomplishesits intended function (i.e., hazardcontrol), rather than whether it followsany preconceived model.

Finally, as described earlier, for theHACCP program, FDA intends torespond proportionally to deficienciesthat it finds during inspections. Thenature of the agency’s response willdepend on the totality of the situationand on the public health implications ofthe deficiency. When circumstancespermit, the processor will be given theopportunity to make appropriatecorrections.

5. Filing Plans With FDA161. A few comments stated that FDA

should require processors to file HACCPplans with the agency, not necessarily toobtain preapproval, but to allow FDA tocompile HACCP plans from all seafood

processors. The comments suggestedthat FDA selectively audit a sample ofprocessor HACCP plans from the filecopies, perhaps based on product risk,the presence or absence of certainCCP’s, or other relevant factors. Some ofthese comments recommended that FDArequest voluntary submission of plansprior to the implementation deadline.

A file, or library, of HACCP plans ofall seafood processors would likelypresent various benefits from thestandpoint of trend analysis andprogram evaluation. The agency finds,however, that the burdens wouldoutweigh the benefits, largely for thesame reasons that rule out thepreapproval of plans by FDA. Forexample, the library would have to beupdated every time that any processorupdated its plan. Therefore, FDA is notrequiring that processors file their planswith the agency.

6. Third Party-Approval162. Several comments urged FDA to

include a provision requiring third-party approval of processors’ HACCPplans, especially if preapproval by FDAis not required. The commentssuggested that the lack of a requirementfor a processor to use a disciplinaryteam approach to develop a HACCPplan, as suggested by the NACMCF,coupled with infrequent FDAinspections, could mean that aprocessor might operate for yearswithout an appropriate plan. Thecomments noted that competentprocessing authorities are available toprovide third-party plan approvals andaudits.

On the other hand, one commentargued that a requirement for third partyHACCP plan approval is not necessary.This comment stated that anonregulatory first inspection wouldobviate any form of preapproval.

FDA recognizes that some processorsmay benefit from obtaining third-partyassistance in developing their HACCPplans and in evaluating theirimplementation. An independent auditis often helpful in locating problems ina system and offers the benefit ofbringing in expertise not alwayspossessed by many seafood processors.FDA is aware that some processors haveengaged in these kinds of arrangementsin the past and encourages their use.

However, the agency cannot agree thatthird party assistance should serve as an‘‘approval’’ for regulatory purposes.First, to maximize consistency and fairtreatment, the responsibility for theinitial HACCP plan evaluation (outsideof the processor’s own verificationactivities) belongs to FDA, throughroutine inspections of processing plants.

Second, establishing, certifying, andauditing a network of third partieswhose approvals FDA wouldautomatically accept would imposesignificant burdens on the agency thatFDA could not accommodate.

As discussed above, FDA is engagingin significant efforts to facilitate thedevelopment of appropriate HACCPplans. The overall high level of policyguidance and technical assistance thatwill be available to processors from FDAand a variety of other sources shouldminimize the incidence of processorsdeveloping and implementing plans thatdo not address those hazards that arereasonably likely to occur. Therefore,FDA is not providing for third-partyapproval of HACCP plans.

7. The First InspectionIn the preamble to the proposed

regulations, FDA tentatively concludedthat, after the effective date of theseregulations, FDA’s review of processors’HACCP plans and procedures wouldoccur at the time of the routineestablishment inspection. FDArequested comment on whether the firstHACCP review should be nonregulatory,even though the inspection of theprocessor would otherwise beregulatory.

163. Approximately 30 comments,mostly representing processors andtrade associations, addressed this issue.All but one of the comments asked thatthe first review of a processor’s HACCPplan and procedures be nonregulatory.Approximately one-fourth of thesecomments further asked that the secondsuch evaluation also be nonregulatory.

The comments stated that anonregulatory visit by FDA would assistthe processor in determiningdeficiencies in its plan without fear ofenforcement action and would provideFDA investigators with hands-onexperience in a HACCP-basedinspection. The comments suggestedthat this arrangement would foster acooperative spirit between the agencyand the industry and would provide thetime necessary for the investigator todiscuss with the processor how the planshould be tailored to address the detailsof the processor’s operation.

One comment stated that theinitiation of a sweeping, new programwill generate many questions and willnecessitate innumerable judgments onthe part of both processors andinvestigators. The comment suggestedthat it would be preferable for thesequestions and judgments to occurduring nonregulatory visits.

On the other hand, one commentsuggested that the first review of aprocessor’s HACCP plan should be


regulatory, because once the effectivedate has been reached, compliance withthe regulations should be enforced.

FDA agrees with the comments thatsuggested that a smooth transition to amandatory HACCP system of preventivecontrols is more likely the result ofdialogue than regulatory action. ForHACCP to succeed, processors must becommitted to it because they perceivebenefits to themselves from its use otherthan simply the avoidance of regulatorysanctions.

FDA has concluded that a 2-yeareffective date, rather than the 1-yeardate that was proposed, will providesubstantial opportunity for dialogue.Moreover, the proportional response toproblems that FDA intends to employ,taking into account the newness of thesystem, should obviate many of thecomments’ concerns about excessiveregulatory sanctions early in theprocess. Consequently, FDA concludesthat an officially designated,nonregulatory first inspection is notnecessary.

FDA has concluded that 2 years issufficient time for a processor to trainemployees or secure properly trainedconsultants, perform a hazard analysis,develop a HACCP plan, and implementand evaluate HACCP control proceduresthat will comply with these regulations.The additional year will enable theagency’s field investigative force and theindustry to begin sorting out many ofthe issues that are likely to developduring implementation.

As stated earlier, the agency intendsto perform informal HACCP evaluationsof willing processors during routineinspections conducted during the 2-yearimplementation period. Theseevaluations should serve to aid thedevelopment of both the industry’sHACCP programs and the agency’sHACCP inspectional skills. They willalso largely take the place of theproposed type of nonregulatoryinspections.

FDA agrees with the comment thatpointed out that the initiation of thisprogram will generate many questionsand issues that will have to be workedout between processors and the agency.Moreover, FDA accepts that, despite theyears of groundwork and the pilotprograms that have been the basis foragency policy decisions to date, therewill be details that will have to evolveover time as the program isimplemented. It is highly likely that thisevolution will continue well after theeffective date of these regulations. FDAwill take this factor into account in itsinitial interactions with processors afterthe effective date. The agency may findit appropriate to use its regulatory

discretion when it finds a basis forconcern about a processor’s HACCPplan or procedures that relate to amatter about which policy is still beingformulated.

However, the agency is concernedthat there could be significant problemsif it officially designated its HACCPreview during the first inspection asbeing nonregulatory. First, such a stepcould create unfair situations. Forexample, FDA could find itself in theposition of pursuing regulatory actionagainst one processor for failure toadequately control a particular hazardwhile, at the same time, treating asimilar deficiency by another processoras ‘‘nonregulatory.’’ Second, it couldfoster actions by firms to avoidapplication of the regulations, such asname changes or reorganizations tocreate the argument that the ‘‘new firm’’is entitled to a nonregulatory inspection.Third, it is not clear how long such apolicy should last. Arguably, thereasons in support of a nonregulatoryfirst inspection become much weaker inthe case of a firm that goes into businessfor the first time a number of years afterthe effective date of the program.

For all of the foregoing reasons, FDAhas concluded that it can accomplishthe things that led it to inquire about thepossibility of, and the comments tosupport, designating the first HACCPinspection as a nonregulatory inspectionwithout making such a designation andcreating the problems that such adesignation could cause.

8. Role of the FDA Investigator164. In the preamble to the proposal,

FDA stated its tentative conclusion thatits investigators would, among otherthings, evaluate the adequacy ofprocessors’ HACCP plans during routineinspections. A few comments objectedto this role for the investigators. Thesecomments stated that investigatorsshould be responsible for verifying thatthe processor has performed a hazardanalysis; developed a HACCP planwhere warranted; implemented theHACCP plan; and recognized, corrected,and recorded deviations from theHACCP plan. The comments furtherstated that investigators should not be ina position to challenge the adequacy ordesign of a HACCP plan.

The comments pointed out thatHACCP plans are tailored for eachoperation, designed by either a companyteam or a knowledgeable individualthoroughly familiar with the operation.They questioned whether an FDAinvestigator would have the expertise todetermine the acceptability of the plan.

Many FDA investigators already haveconsiderable training in HACCP and

food science, and most have anacademic background in the sciences.They will also receive training duringthe implementation period that focuseson compliance with these regulations.The investigators will be exposed to theGuide, among other sources, forinformation about potential hazards tobe considered for particular productsand processes. This exposure, coupledwith investigators’ experience with theindustries with which they work, willgive them a sound basis for makingscreening determinations about theadequacy of processors’ HACCP plans.There is little doubt that the caliber ofinvestigator screening decisions willimprove with experience with theseregulations and with exposure to moreand varied processor HACCP programs.FDA is confident that its fieldinvestigative staff will quickly adjust tothe task of fostering compliance withthese regulations, as they have to pastinitiatives.

Where investigators are unsure aboutthe adequacy of a processor’s HACCPplan, they will have ready access to, andwill be encouraged to consult with,district, regional, and headquartersexperts. Investigators will also beinstructed to discuss with plantmanagement the reasons and scientificsupport for hazard analysis and HACCPplan decisions that are in question.Where, because of the complexity of aparticular situation, the investigatorcannot reach a decision about theadequacy of a particular aspect of aprocessor’s HACCP plan, theinvestigator will be instructed to collectas much information, includingsupporting data, as is necessary in orderto facilitate further agency review.

Therefore, FDA concludes that theexisting system adequately addressesthe concerns of the comments.

9. Disagreements and Appeals165. A significant number of

comments, primarily from processorsand trade associations, stated that FDAshould have a mechanism to resolvedifferences between an FDA investigatorand a processor regarding the adequacyof the processor’s HACCP plan,especially given the subjective nature ofthe determination as to what thehazards are that are reasonably likely tooccur and that therefore must becontrolled through HACCP. Thecomments contended that a cooperativediscussion between FDA and theprocessor’s HACCP experts would bepreferable to an enforcementconfrontation, and that this discussionwould allow a processor to explain itsdecisions and procedures. Othercomments urged FDA to formalize an


appeal process in the regulations thatwould establish a processor’s rights tocontest any HACCP compliance actionby FDA. Moreover, these commentsstated that FDA should not takeenforcement action based on adisagreement in the field between aninvestigator and the developers of theplan.

As previously mentioned, agencyinvestigators will be instructed todiscuss their concerns about potentialinadequacies in processor HACCP planswith the management of the firm in aneffort to learn the basis of the firm’sdecisions. If the investigator retainsconcern that a plan is inadequate insome regard even after discussing itwith the firm, the investigator will listfindings on the report that is providedto the management of the firm at theconclusion of the inspection(Inspectional Observations, FDA483).The FDA483 only represents theopinion of the investigator and is notnecessarily the final opinion of theagency. The investigator will documentthe processor’s response to, orexplanation of, the findings listed on theFDA483 report.

It has been longstanding FDA policyto conduct an internal review ofinvestigators’ inspectional findingsbefore initiating regulatory action. Thereis an opportunity at each stage fordiscussion between the firm and theagency. These FDA review practiceswill not change under a HACCP-basedsystem.

Based on the foregoing, the agencyconcludes that the concern expressed inthe comments about possibleprecipitous compliance action as aresult of the findings of FDAinvestigators is unwarranted. It is worthrepeating that the agency intends toengage in conflict resolution throughdialogue wherever possible andappropriate. Given these facts, FDA hasconcluded that a provision for a specialappeals process for matters concerningthese regulations is not necessary.

10. Status of the ‘‘Guide’’In the preamble to the proposed

regulations, FDA discussed the ‘‘fivepreliminary steps’’ to HACCPrecommended by the NACMCF. Thesesteps lead a processor through a logicalprocess for identifying hazards that arelikely to occur in a product and fordeveloping a HACCP plan. In an effortto facilitate this process, especially forthe many small businesses involved inseafood processing, FDA is developingthe Guide, a draft of which was madeavailable shortly after publication of theproposed regulations. The draft Guideprovides information on hazards and

appropriate controls by species and byproduct type. The preamble said thatthe information contained in the draftGuide is the kind of information thatwould likely result in a HACCP planthat is acceptable to the agency. FDAreceived considerable comment on thecontents of the draft Guide and intendsto publish a redrafted first editionshortly after the publication of theseregulations.

166. A number of commentsexpressed concern about how the Guidewould be used by FDA investigatorswhen evaluating a processor’s HACCPplan. The commenters were troubled bythe prospect that FDA investigatorswould not be trained to evaluate HACCPplans that differ from the Guide, andthat, therefore, they would takeexception to a HACCP plan that deviatesfrom the Guide. The comments statedthat industry experience with HACCPdemonstrates the need to provideflexibility so that HACCP plans can betailored to the specific operatingconditions of a processor.

Other comments stated that the Guidedid not provide express guidance on themeaning of the key phrase ‘‘reasonablylikely to occur.’’ The comments statedthat the Guide should clarify whether itis FDA’s intention that the hazardsidentified in the Guide are the‘‘reasonably likely’’ hazards under allconditions for the specific species andprocessing operations that are listed.

Several comments cautioned that theGuide should not be characterized as a‘‘safe harbor,’’ i.e., that FDA should notpromote strict adherence to the Guideregardless of the circumstances. Such acharacterization, they argued, couldcause processors to omit the criticalhazard analysis step in HACCP plandevelopment and risk developing plansthat do not fit the conditions of theirprocesses.

The Guide is, in the agency’s opinion,a compilation of the best availableinformation on the subject of hazardsand controls in seafood processing. Itcontains FDA’s recommendations as tothe hazards that it believes are‘‘reasonably likely’’ to occur in specificspecies and finished product formsunder ordinary circumstances, but italso provides information on rarerhazards as well. FDA recognizes that thefirst edition of the Guide must clearlydistinguish between the two.

The term ‘‘reasonably likely’’ is noweffectively defined in § 123.6(a). It isworth noting that, under § 123.6(a),whether a hazard is ‘‘reasonably likely’’will depend, at least in part, on thecircumstances that exist at the time thatthe hazard analysis is conducted. Forexample, a certain toxin might be rare,

but if it starts presenting itself in fishand becomes known, it may warrant anew hazard analysis that may identify itas ‘‘reasonably likely’’ for a period oftime.

FDA also recognizes thatcircumstances may occur in whichhazards will exist that are not identifiedin the Guide. These hazards may be theresult of a previously unidentifiedphenomenon (e.g., the identification ofa natural toxin in a species previouslynot associated with that toxin) or ofunique conditions in the way that theproduct is handled by a particularprocessor (e.g., unusual equipment orprocessing methods). Thus, a definitivedetermination of ‘‘reasonably likely tooccur’’ can come only as a result of acarefully conducted hazard analysisperformed for a specific product underspecific processing conditions.

FDA recognizes that a HACCPapproach requires flexibility and willendeavor to make the Guide consistentwith such flexibility. FDA will providetraining to its investigators so that theywill be prepared to evaluate a HACCPplan that is not consistent with theGuide and to evaluate the effectivenessof controls that differ from thosesuggested in the Guide. The agencyagrees that the Guide is not a ‘‘safeharbor’’ for all situations. Processorswho utilize the Guide should compareit to their own circumstances and makewhatever adjustments in the approachsuggested in the Guide that arenecessary.

11. Trade With the EU167. One comment suggested that,

because of directives issued by the EU,many processors may need earlyrecognition of their HACCP programs byFDA. The comment further suggestedthat early recognition could be used bythe agency as a means of training FDAinspectional personnel.

FDA is aware of the directives of theEU. The agency intends to consider howit can best help processors respond tothose directives, among other factors, asit formulates its plans forimplementation of these regulations.

12. Measuring Program SuccessIn the preamble to the proposed

regulations, FDA asked for comment onwhat tests should be used to measurethe success of the HACCP program as awhole, and how often those tests shouldbe conducted.

168. A significant number ofcomments stated that indicators of thesuccess of the seafood HACCP programcould include: A reduction in thenumber of seafood-borne illnesses;improved consumer confidence in


seafood consumption; and a reductionin the number of violative products thatenter the marketplace. Severalcomments stated that periodicinspections of, and sampling at,processors and importers by FDA, State,and foreign officials, coupled withillness reporting from a strengthenedCDC program, would provide adequateverification of the effectiveness of theprogram. However, two other commentsstated that the success of the seafoodHACCP program cannot be measuredsolely by a decrease in illnesses,because many food-borne illnesses arethe result of problems in the retailsector, which is neither covered bythese regulations nor adequatelyregulated by the States.

The agency agrees with thosecomments that suggested that theultimate goal of these regulations shouldbe the improved safety of fish andfishery products—a reduction in theactual number of seafood-relatedillnesses. FDA will continue to closelymonitor the CDC system, as well asreports of illness and death attributableto the consumption of seafood that itreceives from other sources, for trendsthat may indicate an emerging problemor the intensification or modification ofan existing problem. However, theagency also agrees with those commentsthat suggested that, because many of theseafood-related illnesses are attributableto recreational or subsistence fishing orto problems in the retail and food-service sectors (Ref. 7, pp. 2; 15; 27; and28), improvements in process controlsthat result from the implementation ofHACCP may not be fully reflected by areduction in the number of illnesses.Additionally, as has been previouslydiscussed, the CDC system encompassesonly reported illnesses and is animperfect means of judging reductionsin actual numbers of illnesses. FDA issupportive of a strengthening of the CDCreporting system.

Based in part on the commentsreceived, the agency will be looking atways to assess a relationship betweensuccess of the HACCP program andlevels of consumer confidence, levels ofviolative product in the marketplace,improvements in the quality andquantity of preventive controlsthroughout the industry; and the resultsof FDA and cooperating State andforeign inspections. As indicated in thesummary of the Regulatory ImpactAnalysis elsewhere in this preamble,FDA is planning to evaluate key featuresof this program within the first severalyears of implementation. Thisevaluation will include an assessment ofits effectiveness.

169. One comment suggested thatend-product testing should be used byFDA for program surveillance purposes,particularly for imports. This commentencouraged FDA to conduct statisticallyreliable baseline and monitoringsurveys, modeled after those used in theMSSP, conducted by NMFS, to: (1)Determine how often consumer hazardsoccur; (2) set specific goals, objectives,and operational strategies for theHACCP program; and (3) provide ameans by which the program’s successcan be measured.

FDA has historically collected andanalyzed surveillance samples duringand outside the course of its routineinspections. The purposes for thesesample collections, in many ways, alignwith those suggested by the comment.The agency is committed to continuedsurveillance sampling and intends touse such sampling in an assessment ofthe HACCP program.

170. Another comment suggested thatHACCP will only be successful inimproving confidence in seafood if theprogram is accompanied by a consumereducation effort that explains thebenefits of HACCP. The commentencouraged FDA to perform a baselinestudy that assesses the level ofconsumer anxiety with respect toseafood consumption and compare it tothe results of a study that it performssometime in the future.

FDA agrees that another major goal ofthese regulations is to increaseconsumer confidence in the safety ofseafood. The agency recognizes thatpublication and enforcement ofregulations aimed at improving seafoodsafety alone will not achieve that goal.Consumers must be informed of thebenefits of producing products underHACCP preventive controls. Within itsbudgetary constraints, the agencyintends to engage in a program ofconsumer education for that purpose.The prospect of baseline and followupstudies of consumer confidence (oranxiety) will also be considered.

P. Other IssuesFDA received a number of additional

comments that did not address anyspecific provision of the proposal,although some of them were in responseto invitations in the preamble tocomment on various subjects.

1. Relationship to Other ProgramsIn the preamble to the proposed

regulations, FDA invited comment onhow FDA’s HACCP program for seafoodprocessors should mesh with existingState HACCP programs for seafood, inorder to avoid imposing inconsistentFederal and State HACCP requirements.

In the preamble, FDA acknowledgedthat many States are under considerablepressure to cut back on programs wherethere is an overlapping Federal program.Nonetheless, the agency urged States tomaintain, if not strengthen, theirseafood programs and to work with FDAto develop an integrated Federal/State,HACCP-based seafood control program.

171. Approximately 12 comments,representing processors, tradeassociations, and State governmentagencies, recommended that FDAcoordinate its HACCP program withexisting State and Federal seafoodcontrol programs. Several commentsemphasized that a coordinated effortwould ensure uniform application andinterpretation of HACCP principles,while preventing duplication of effortthat wastes limited enforcementresources. One comment stated thatsuch a coordinated effort would befacilitated if only a single HACCP planwere required for each processingfacility, rather than one that wasdesigned to meet FDA requirements andanother that would meet Staterequirements. Another comment notedthat a multitude of differing HACCPregulations would only serve to confuseprocessors and dilute the effectivenessof the Federal program. The commentfurther recommended that FDA workwith AFDO to promote State laws andregulations that are compatible withFDA’s HACCP program.

One comment suggested the formationof a task force representing the foodindustry, FDA, USDA, and DOC to worktowards the goal of reducing regulatoryduplication.

The agency agrees that there is a needfor Federal/State partnership tofacilitate the efficient implementation ofHACCP programs. FDA believes thatcoordination with the States wouldpermit both the agency and the States toleverage their inspectional resources.FDA, as well as the States, wouldbenefit by dividing the workload andsharing data and other information.Such coordination would also benefitindustry through consistent inspectionsand regulatory requirements.

The agency has already begun tocoordinate its efforts with the States onseafood. The formation of the Alliance,to which AFDO is a member, is onesuch endeavor. The Alliance isdescribed in detail in the ‘‘Training’’section of this preamble.

With FDA’s support, AFDO passed aresolution supporting the developmentof FDA/State partnership agreements atits 1994 meeting in Portland, ME (Ref.220). The resolution specificallyrecommended that HACCP be the basisof such partnerships and noted the


shared roles of FDA and State regulatorsin seafood safety, the limited resourcesof both levels of government, and theexistence and the potential impact ofthe Alliance.

Meanwhile, FDA is increasing its useof partnership agreements with Stateenforcement agencies. For instance, theNortheast Region of FDA has enteredinto a threeway partnership agreementwith the Northeast Food and DrugOfficials Association and individualStates to provide industry with HACCPtraining at the retail level. FDA alsoexpects to enter into partnershipagreements with States to implementHACCP pilot programs for foods otherthan seafood. FDA’s Northeast Regionhas already signed such an agreementwith the Commonwealth ofMassachusetts, and more areanticipated.

These initiatives demonstrate theagency’s desire to coordinate its effortswith the States. The agency’scooperative efforts in the area of HACCPreflect a trend. The agency has usedcooperative efforts in other areas, suchas pesticide sampling and workplansharing. FDA will continue to exploreways to coordinate the Federal and Staterole in the regulation of seafood.

172. A number of commentsrecommended that States act as theprimary enforcement agencies for theseHACCP regulations, while FDA’sresponsibility would be to evaluate theStates’ compliance with HACCPinspection protocols. Some of thesecomments suggested that such aprogram could be patterned after theNSSP.

FDA is adopting these HACCPregulations to implement and enforcethe act. While FDA plans to workcooperatively with the States in all wayspossible, the agency cannot delegate itsauthority under the act. It is possiblethat in some aspects of seafoodprocessing, the States will serve as theprimary enforcement agencies, withFDA serving primarily an auditingfunction. However, responsibility forenforcing the act and these regulationsmust remain with FDA.

173. A number of comments, fromprocessors, trade associations, and oneconsumer advocacy group, maintainedthat FDA’s HACCP regulations shouldpreempt any existing State HACCPprograms. The comments contendedthat Federal preemption wouldultimately reduce confusion caused byconflicting State programs, reduce costs,and promote uniformity. Examples ofthe specific areas of conflict were notprovided by the comments.

As was previously stated, FDAintends to work through AFDO and

through Federal/State partnerships toseek consistency in State regulatoryapproaches to HACCP for seafoodinspection and through the NSSPprocess and the ISSC to attain this goalspecifically for molluscan shellfish.Moreover, processors in each State mustcomply with Federal HACCPrequirements if their product moves ininterstate commerce. For these reasons,the agency has concluded that there isno need for Federal preemption of Stateregulatory requirements.

174. Several comments encouragedFDA to work closely with NMFS tocoordinate FDA’s program with theexisting NMFS’ HACCP program. Thecomments noted that cooperation withNMFS would help the two agenciesavoid wasteful duplication of effort andwould reduce the burden on those firmsalready operating under the NMFSprogram.

FDA agrees with these comments andnotes that FDA and NMFS arecoordinating their HACCP programs toensure compatibility. Nonetheless, FDAadvises that the NMFS program is avoluntary, fee-for-service program and islikely to continue to include featuresthat go beyond the requirements of theseregulations, especially in the area ofpreventive controls for economic fraudand plant and food hygiene.

A 1974 MOU between FDA andNMFS recognizes the respective roles ofthe two agencies and commits the twoagencies to consistency andcooperation. FDA will continue to workwith NMFS to maintain a coordinatedFederal effort.

2. ‘‘Whistleblower’’ Protection

175. A few comments urged that theseregulations include ‘‘whistleblower’’protection for employees of seafoodprocessors. Whistleblower protection isdesigned to protect workers from beingfired or otherwise discriminated againstfor revealing wrongdoing by theiremployers. The wrongdoing in this case,presumably, would likely involve thefalsification of HACCP records. Thecomments argued that: ‘‘Whistleblowersare iispensable as the eyes and ears foroverextended FDA personnel makinglimited spot checks. The public’s line ofdefense will be no stronger than theshield protecting industry worker’srights to obey and help enforce thislaw.’’

One concern that FDA has heardabout the credibility of a HACCP systemis that important records can befalsified. It is alleged that, withoutwhistleblower protection, it is muchless likely that the agency will knowabout falsifications.

While the agency is confident, basedin part on its experience reviewingrecords in the low-acid canned foodprogram, that it can detect falsification,FDA also expects from experience thatit will be alerted to possible wrongdoingfrom time to time by employees ofprocessors even in the absence ofwhistleblower protection. FDA hasreceived, and acted upon, confidentialinformation from employees ofregulated firms for decades. Thisassistance has proven invaluable onmany occasions. The only protection tothese employees available from FDA hasbeen confidentiality.

The question raised by the commentsis whether, in addition to the actionsagainst the product or the processor thatwould be available to FDA as a result ofviolations of the requirements of the actand these regulations, there must bespecific protection for employees inorder for the program to succeed. Theagency has concluded that, like otherFDA programs, this program can besuccessful in the absence of specificwhistleblower protection, and thatcongressional action would be necessaryto provide protection other thanconfidentiality.

FDA cannot provide whistleblowerprotection in these regulations. FDAbelieves—and case law bears out—thatthere must be a nexus between theconduct being required by regulationsand the focus of the underlying statute,in this case primarily section 402(a)(4)of the act. An analysis of the applicationof section 402(a)(4) of the act to theseregulations can be found in the ‘‘LegalBasis’’ section of this preamble.

While FDA has determined that anassessment of processing risks and aplan that ensures that these risks areminimized has the requisite nexus tosection 402(a)(4) of the act, and that thisnexus justifies adopting theseregulations, the agency does not see asufficient nexus between whistleblowerprotection and the prevention ofadulteration of food. If a firm retaliatesagainst an employee who bringscomplaints or other information aboutthe firm to FDA, the implication of suchan action is that there is a condition atthe firm that may need investigation,not that the products produced by thefirm are necessarily adulterated. It maybe the case that the products areadulterated, but such a conclusion doesnot flow as directly from section402(a)(4) of the act as does theconclusion that seafood products notproduced under a HACCP plan havebeen produced under insanitaryconditions whereby they may have beenrendered injurious to health. For thisreason, FDA concludes that it lacks


clearcut authority to providewhistleblower protection in theseregulations.

3. Separation of Quality Control (QC)and Production

176. A few comments requested thatthe regulations mandate structuralindependence within a processing firmbetween ‘‘HACCP QC [quality control]personnel’’ and ‘‘production’’personnel. Otherwise, according to thecomments, ‘‘HACCP QC personnelcould still be hired and fired by aproduction supervisor.’’

FDA does not believe that a change inthe regulations would be beneficial inthis regard. It is important to recognizethat, under HACCP, productionpersonnel are the observer/operatorswho perform the initial monitoring ofCCP’s as well as the recordkeeping thatdocuments the results of thismonitoring. The operation of theHACCP system must involve the wholeorganization, not just QC personnel.

However, it is reasonable to expectthat, where practical, verificationactivities should be performed byindividuals other than those who madethe records in the first place. Forverification, the agency encourages thekind of organizational separation that isbeing urged in the comments.

The agency recognizes, however, thatmany seafood companies will not belarge enough to have distinct,independent organizational units thatcan verify each other’s work. Theseafood industry is characterized bysmall businesses. FDA has concludedthat such a requirement is not practicalfor this industry.

It is worth noting that the regulationsat parts 113 and 114 for low-acidcanned foods and acidified foodscontain recordkeeping requirements andsome verification requirements that aresimilar to the provisions of theseregulations. In certain respects, parts113 and 114 served as models for theseafood HACCP program. Thoseregulations have succeeded even thoughthey do not require a separationbetween QC personnel and productionpersonnel. Given this history, theagency is reluctant to mandate theinternal structure of seafood processors.

4. Education177. FDA received a number of

comments on the subject of seafoodsafety education. These comments werein response to an invitation in thepreamble to the proposed regulations forcomments on risk reduction activitiesthat could be regarded ascomplementary to HACCP, primarilydirected toward postprocessing

handling. In addition, FDA asked forcomment on appropriate education andinformation that should be directedtoward consumers and recreationalfishermen, even though educationaimed at these groups is actually outsidethe scope of this rulemaking. FDA madethis request based on a recognition thatHACCP cannot reasonably be expectedto solve every problem. The agencyrecognizes that HACCP must beintegrated into a comprehensiveprogram for seafood safety. Education isanother important component of thatprogram. As one comment noted:

* * * the responsibility for seafood safetyshould be met at every level of seafooddistribution, from harvesters to processors toretailers, restaurants and, finally, theconsumers themselves. Regulations are not asubstitute for informed and responsiblebehavior and it is impractical to extend thescope of the proposed regulations toeveryone involved in handling andconsuming seafood.

The comments overwhelminglyendorsed the value of education. Theystrongly supported education for: (1)Consumers on the handling andpurchasing of seafood, especiallythrough brochures at the point ofpurchase and information available atpharmacies, and on the significance ofHACCP, especially with regard to thegovernment’s verification role; (2)recreational fishermen, provided by theState during licensure (with guidancefrom the Federal government) andthrough articles in popular fishing andoutdoors magazines; (3) subsistencefishermen; (4) retailers, including foodservice and restaurants.

FDA greatly appreciates thesecomments. The agency agrees thateducation is an essentialcomplementary activity to HACCP aswell as to other aspects of FDA’s overallseafood program. The comments will betaken into account as the agencydevelops its educational program.

178. FDA also invited comment onwhether the agency should considerproposing to require handlinginstructions for consumers on thelabeling of seafood. Any action that FDAwere to take along these lines would beas part of a separate rulemaking.

The agency received about 20comments on this issue. Approximatelyhalf of those comments supported thenotion of mandatory safe handlinginstructions. One business noted thatsafe handling instructions would help toensure the safety of a product throughthe distribution chain, while anotherbusiness said that such instructions hada real potential to decrease seafood-related illness. One individualcommented that safe handling

instructions would increase consumerconfidence in these products. Oneindustry comment noted that a taskforce composed of industry, Federal andState agencies, and consumers shouldagree on the appropriate statement.Some comments indicated that safehandling instructions might beappropriate for high-risk products.

The remainder of the comments onthis issue disagreed that safe handlinginstructions for seafood should berequired by FDA. Many of thesecomments noted that most seafoodproducts include such instructionsvoluntarily. One trade associationcommented that such a requirementwould limit retailers’ flexibility andcreativity and impose significant newcosts on retailers and consumers. Mostof those comments noted that requiringnew information would detract fromother labeling requirements.

FDA appreciates these comments andthe different points of view that theyrepresent. The agency will use thecomments in its deliberations on thisissue.

179. Finally, FDA described some ofits educational efforts aimed atmedically compromised individualsabout avoiding raw molluscan shellfishand invited comment on types ofeducation and information activitiesthat might be useful in this regard. Theagency received about a dozencomments on this subject.

Most of these comments addressedwhether there should be mandatorywarning labeling for raw molluscanshellfish. A majority of the commentsstated that the agency should requirewarning labeling. Three comments fromconsumer groups stressed the need toprotect high-risk individuals. One Stategovernment commented that warningsfor raw molluscan shellfish should betied to specific locations and times ofyear. One professional associationrequested that the warning state that theshellfish should only be eaten if it iscertified and tagged.

Three comments stated that warninglabels would be inappropriate. Onecomment noted that shellfish are notconsumed in enough quantity to be aproblem. Another comment stated thatwarning labels would unduly alarmthose not at risk and that better channelsexist for educating those at risk.

A few comments did not specificallyaddress warning labels butrecommended that FDA target advicedirectly to compromised individuals.Those comments suggested that FDAdirect information to the medicalcommunity involved in the treatment ofthose individuals.


Again, FDA thanks the comments forproviding views on a matter that isoutside the scope of this rulemaking.FDA is working to provide informationto at-risk populations and its strategy onhow best to do so is evolving. Theagency will take the comments intoaccount as it develops policy in thisarea.

In summary, the agency agrees thateducation is an essentialcomplementary activity to HACCP aswell as to other aspects of FDA’s overallseafood program. The commentsrelating to education will be useful tothe agency as it develops its educationprograms.

5. Traceback Mechanisms180. One comment recommended that

FDA develop and incorporate methodsto trace back fish and mandate suchtraceback in these regulations. Thecomment described the use of bar codesand computer-based tracking numbersby a meat products company that enableit to trace a specific cut of meat from astore or restaurant to its source.

The agency acknowledges thattraceback to the water would be usefulfor certain species of fish associatedwith certain hazards, e.g., ciguatoxin.On the other hand, traceback to thewater for scombrotoxin would not beparticularly useful, although tracebackthrough the distribution chain to findout the source of mishandling would beuseful. The agency urges the industry toconsider this comment. FDA advisesthat it is willing to explore this ideafurther, although not as part of thisrulemaking.

6. Tribal Governments181. FDA received a few comments on

the effect of these regulations on tribalgovernments. The preamble to theproposed regulations noted thatExecutive Order 12875 of October 26,1993, requires, among other things,consultation with tribal governmentsbefore the formal promulgation ofregulations containing unfundedFederal mandates. While FDA does notbelieve that these regulations impose anunfunded Federal mandate, the agencywishes to foster consultation on mattersthat might significantly affect tribalcommunities. Consequently, FDArequested comment on the economiceffect of the regulations on tribalgovernments.

FDA received no comments fromtribal governments. One comment, froma tribal business, stated that the impactof the regulations on tribal governmentswill be beneficial because they willresult in safe products, positiveconsumer perceptions, and positive

market impacts. The other comment thatmentioned this subject was from anacademic, who expressed the view thatthe regulations will have a major impacton tribal groups involved in fisheriesand contains unfunded Federalmandates. The comment did notelaborate. Neither of these commentsjustifies any change in these regulations.

The agency remains interested infostering consultation with tribalcommunities as they see fit andencourages correspondence from tribalgovernments.

7. HACCP System Improvements182. A comment urged that there be

a process to continually amend orupdate these regulations.

FDA points out that such amechanism exists in its regulations.Under § 10.30 (21 CFR 10.30), interestedpersons are provided with a process bywhich they can petition the agency toamend and update these regulations.

From a less mechanistic viewpoint,the agency recognizes that theseregulations represent a pioneeringprogram that has not been attemptedbefore. While the agency believes thatsufficient groundwork has been laid toadopt these regulations and to begin toimplement them, FDA alsoacknowledges that full scaleimplementation will revealmodifications that may be necessary,both in the short and long terms.Consequently, the agency will be highlyreceptive to feedback from all partieswho are affected by these regulationsand will remain open to changes thatare necessary in the regulations. The‘‘Verification’’ section of this preamblereflects the agency’s interest inevaluating this program.

183. A number of comments asked forimprovements in the foodborne-illnessreporting system operated by CDC.Some comments urged collaborationbetween FDA and CDC. One commentadvocated the creation of an activereporting system.

These comments are essentiallyoutside the scope of this rulemaking.Nonetheless, the agency recognizes thatthe strength of the foodborne-illnessreporting system bears directly on theability of the agency to measure thepublic health impact of HACCP. BothFDA and CDC agree that underreportingis an undesirable feature of the currentsystem. FDA and CDC have beencollaborating on an active-type reportingsystem. The limiting factor, however,will always be resources. Significantimprovements in the current systemwill involve considerable expense.

184. One comment provided views onfactors that would limit the

effectiveness of HACCP. The commentcited:

[P]oor commitment by companymanagement and lack of allocation ofnecessary resources; improper training; lackof understanding and planning in all stagesof implementation of a plan[,] and failure torecognize the need to understand thecorporate culture change which mustaccompany an effective HACCP program.

FDA agrees with this comment buthopes that company management willembrace HACCP and recognize thebenefits that it offers to the firm.

III. Paperwork Reduction Act of 1995This final rule contains collections of

information that are subject to review bythe Office of Management and Budget(OMB) under the Paperwork ReductionAct of 1995 (Pub. L. 104–13). The title,description, and respondent descriptionof the information collections are shownbelow along with an estimate of theannual recordkeeping and periodicreporting burden. Included in theestimate is the time for reviewinginstructions, searching existing datasources, gathering and maintaining thedata needed, and completing andreviewing the collection of information.

Title: Reporting and recordkeepingrequirements for processors andimporters of fish and fishery productsunder the provisions of 21 CFR parts123 and 1240. Procedures for the Safeand Sanitary Processing and Importingof Fish and Fishery Products.

Description: This regulationimplements the use of Hazard Analysisand Critical Control Point (HACCP)methodology to ensure that processedand imported fish and fishery productsare safe within the meaning of sections402(a)(1) and 402(a)(4) of the FederalFood, Drug, and Cosmetic Act (21 U.S.C.342(a)(1) and 342(a)(4)).

Description of Respondents:Businesses or other for profitorganizations.

Although the January 28, 1994,proposed rule provided a 60 daycomment period (extended to 90 days inthe April 7, 1994, Federal Register, 59FR 16578) under the PaperworkReduction Act of 1980, and this finalrule incorporates the commentsreceived, as required by 44 U.S.C.section 3507(d), FDA is providingadditional opportunities for publiccomment under the PaperworkReduction Act of 1995, which applies tothis final rule and was enacted after theexpiration of the comment period.

Therefore, the agency solicits publiccomment on the information collectionrequirements in order to: (1) Evaluatewhether the proposed collection ofinformation is necessary for the proper


performance of the functions of theagency, including whether theinformation will have practical utility;(2) evaluate the accuracy of the agency’sestimate of the burden of the proposedcollection of information, including thevalidity of the methodology andassumptions used; (3) enhance thequality, utility, and clarity of theinformation to be collected; and (4)minimize the burden of the collection ofinformation on those who are torespond, including through the use ofappropriate automated, electronic,mechanical, or other technological

collection techniques or other forms ofinformation technology, e.g., permittingelectronic submission of responses.

Individuals and organizations maysubmit comments on the informationcollection requirements by February 16,1996, and should direct comments toFDA’s Dockets Management Branch(address above).

Prior to the effective date of this finalrule, FDA will publish a notice in theFederal Register when the informationcollection requirements in this rule aresubmitted for OMB approval, and againwhen OMB makes a decision to

approve, modify or disapprove theinformation collection requirements.

Sections of this final rule require thatcertain businesses collect informationand keep records. Under Public Law104–13 Federal agencies are required toestimate the hours and costs attributableto collections of information, as definedin 44 U.S.C. 3502(3), that are requiredby Federal regulation. Table 1 sets forthan estimate of the hours that arerequired annually for compliance witheach section in part 123 that requiresregulated entities to collect or recordinformation.

TABLE 1.—ESTIMATED AVERAGE ANNUAL INFORMATION COLLECTION AND RECORDKEEPING BURDEN

21 CFRNo. of re-

spond-ents

No. of re-sponsesper re-spond-ent 1

Hours perre-

sponse 2

Totalhours

123.6(a),(b),(d) ................................................................................................................................. 4,850 1 16 77,600 3

123.6(c)(5) ........................................................................................................................................ 4,850 4 0.3 5,280123.8(a)(1),(c) .................................................................................................................................. 4,850 1 4 19,400123.12(a)(2)(ii) .................................................................................................................................. 1,000 80 0.2 16,000123.6(c)(7) ........................................................................................................................................ 4,850 280 0.3 470,400123.7(d) ............................................................................................................................................ 1,940 4 0.1 1,940123.8(d) ............................................................................................................................................ 4,850 47 0.1 22,795123.11(c) .......................................................................................................................................... 4,850 280 0.1 135,800123.12(c) .......................................................................................................................................... 1,000 80 0.1 8,000123.12(a)(2) ...................................................................................................................................... 20 1 20 4,000 3

123.10 .............................................................................................................................................. 24 1 24 116,400 3

First year total burden hours .................................................................................................... ................ ................ ................ 877,615Annual recurring total hours ..................................................................................................... ................ ................ ................ 679,615

1 Based on an estimated average of 280 working days per year.2 Estimated average time per 8 hour work day unless one time response.3 Nonrecurring burdens.The above estimates include the information collection requirements in the following sections:123.16 Smoked Fish—process controls (see 123.6(b))123.28(a) Source Controls—Molluscan Shellfish (see 123.6(b))123.28(c),(d) Records—molluscan shellfish (see 123.6(c)(7))123.9 Records control general (see recording and records)

The time and costs of these activitieswill vary considerably amongprocessors and importers of fish andfishery products, depending on the typeand number of products involved, andthe nature of the equipment orinstruments required to monitor criticalcontrol points. The burdens have beenestimated using the typical smallseafood processing firm as a modelbecause these firms represent asignificant proportion of the industry.

The burden estimate in Table 1includes only those collections ofinformation under this rule that are notalready required under current statutesand regulations and are being added bythis rule. For example, the current goodmanufacturing practices provisions in21 CFR part 110 already require that allfood processors ensure good sanitarypractices and conditions, monitor thequality of incoming materials, monitorand control food temperatures toprevent bacterial growth, and perform

certain corrective actions andverification procedures.

In addition, the estimate does notinclude collections of information thatare a usual and customary part ofbusinesses’ normal activities. Forexample, the tagging and labelling ofmolluscan shellfish (§ 1240.60) is acustomary and usual practice amongseafood processors. Consequently, theestimates in Table 1 accounts only fornew information collection andrecording requirements attributable topart 123.

There are no additional capital costsassociated with this regulation that arenot also attributable to the preexistingrequirements of part 110.

FDA estimated in the proposal thatthe total burden to all respondentswould be 2,826,850 hours. Thatestimate, however, significantlyoverestimated the burden because itincluded activities performed bydomestic processors that are not related

to information collection andrecordkeeping, and, more significantly,did not account for existing regulatoryrequirements and usual and customarybusiness practices, as described above.

The agency has recalculated therecordkeeping burden in a manner thatis more consistent with the intent ofPublic Law 104–13. Therefore, theburdens presented in Table 1 are thoseactually associated with collecting andrecording the pertinent HACCPinformation. The burdens for HACCPplan development, plan reassessment,and record review are also included inthe recalculated burden. In estimatingthe time for the preparation of a HACCPplan, the agency believes that asignificant portion of the training hourscan also be characterized as time spenton preparation of the plan.

Additionally, the agency recognizesthat the regulations will place a burdenon seafood importers. For this reason,FDA has included in the burden


estimate the time necessary forimporters to develop a writtenverification plan, verify compliance ofimports, and keep records of theirverification activities.

Few comments provided informationon the number of hours that a processorwould expend on information collectionand recordkeeping, as described in thepreamble to the proposed regulation.One comment estimated that the annualburden would vary from 200 to over 700hours, depending on the type ofproduct, and another commentsuggested that one hour per day, or 365hours per year, would be required. Onecomment stated that the agency’sestimate of 650 hours per year wasreasonable. Another comment estimatedfour to five hours per day, or 1,820hours per year as the likely burden.None of these comments providedinformation to support how thecommenters arrived at their estimates.

It seems likely that the estimatessuggested by the comments werecalculated based on the same errors thatthe agency made in the proposal, that is,by combining the burdens associatedwith HACCP data collection andrecordkeeping with other HACCPactivities unrelated to informationcollection and recordkeeping, withusual and customary informationcollection and recordkeeping practices,and with collections of informationrequired by the provisions of theFederal Food, Drug, and Cosmetic Actand implementing regulations. Thisconclusion is supported by the fact thatsome of the comments expressedagreement with the agency’scalculations. For these reasons, FDAconcludes that no changes in itscorrected calculations are necessary torespond to the comments.

IV. Economic Impact

A. IntroductionIn accordance with Executive Order

12866 and the Regulatory FlexibilityAct, FDA has examined the impacts ofthe final rule. Executive Order 12866

directs agencies to assess all costs andbenefits of available regulatoryalternatives and, when regulation isnecessary, to select regulatoryapproaches that maximize net benefits(including potential economic,environmental, public health and safetyeffects; distributive impacts; andequity). The Regulatory Flexibility Act(Pub. L. 96–354) requires analyzingoptions for regulatory relief for smallbusinesses.

The Unfunded Mandates Reform Act(Pub. L. 104–4) requires (in section 202)that agencies prepare an assessment ofanticipated costs and benefits beforeproposing any rule that may result in anannual expenditure by State, local andtribal governments, in the aggregate, orby the private sector, of $100,000,000(adjusted annually for inflation). TheUnfunded Mandates Reform Act alsorequires (in section 205) that the agencyidentify and consider a reasonablenumber of regulatory alternatives and,from these alternatives, select the leastcostly, most cost-effective, or leastburdensome alternative that achievesthe objective of the rule. Even thoughFDA finds that the costs of this finalrule may be below $100 million a year,estimating these costs is a difficult taskinvolving uncertainties. This analysis,together with the preamble published inthe Federal Register and supportinganalysis and materials, constitutes afinal RIA. Therefore, FDA has treatedthe final rule as an economicallysignificant regulatory action underExecutive Order 12866. Consequently,the agency has completed this full RIAwhich demonstrates that this rule isconsistent with the principles set forthin the Executive Order and in these twostatutes. In addition, this document hasbeen reviewed by the Office ofManagement and Budget as aneconomically significant regulatoryaction under Executive Order 12866.FDA has concluded that the net benefitsof this rule (benefits minus costs) arelargest for the regulatory option selectedas specified by Executive Order 12866.

FDA has also concluded that, pursuantto the Unfunded Mandates Act, theregulatory option selected is the leastburdensome option to accomplish thegoal of controlling all physical,chemical, and microbiological hazardsreasonably likely to be present inseafood.

As a part of the preamble to theproposed regulation, FDA published asummary of the Preliminary RegulatoryImpact Analysis (PRIA) and placed onfile with FDA’s Docket ManagementsBranch the complete PRIA. In addition,FDA has placed the full final RegulatoryImpact analysis on file at DocketsManagement Branch (address above).

FDA has fully reviewed theinformation on which the PRIA wasbased, the comments on the PRIA, andother available information on the costsand benefits of HACCP for the seafoodindustry. Based on this review, FDA hasarrived at two estimates of the costs inthis final rule as well as upper andlower estimates of benefits. As can beseen in the agency’s summary of costsand benefits are summarized in Table 2,FDA believes that the costs of the finalrule will range from $677 million to$1.488 while the benefits will rangefrom $1.435 to $2.561 billion. In its finalanalysis, the agency maintains that thetotal benefits of this mandatory seafoodHACCP rule will exceed the total costs.

Regulatory Options

The agency raised and receivedcomment on a number of regulatoryoptions in the PRIA. The mostsignificant two options raised wereregulating only high risk products or themost serious hazards and providingregulatory relief for small businesses.The first option is inconsistent with theobjective of this regulation, to control allphysical, chemical or microbiologicalhazards reasonably likely to be found inseafood products. Although FDA hasnot granted relief only for smallbusiness, the agency has extended thecompliance date for all firms from 1year to 2 years.

TABLE 2.—SUMMARY OF TOTAL COSTS AND BENEFITS

YearCosts from

FDA models(millions)

Costs adjustedfrom NMFSmodel (mil-

lions)

Benefits lower(millions)

Benefits upper(millions)

1 ....................................................................................................................... $69 $162 $73 $1082 ....................................................................................................................... 42 9173 1083 ....................................................................................................................... 41 83 85 1564 ....................................................................................................................... 38 80 87 158

Total1 ..................................................................................................... 677 1,482 1,435 2,561

1The total defines the total discounted costs and benefits beyond the 4th year and discounted at 6 percent.


B. Costs

In the PRIA, FDA was reluctant to relyonly on results of the limited experiencewith HACCP in the seafood industry.FDA balanced the reports of someseafood firms, which showed that thecosts of HACCP were low, with a studyof the costs of HACCP that had beendone under contract with NMFS by A.T. Kearney, Inc. (Contract No.NA88AA–H–SK006). This studyshowed significantly higher costs (asreflected in the range of cost estimatessummarized above) but had severalflaws that engender skepticism about itsresults as well. For example, none of theplants that were the subjects of thestudy had actually implementedHACCP, and the system whose costswere studied was significantly moredemanding than the system embodiedin the 21 CFR part 123. Despite thesefacts, the cost estimates in the PRIAwere based on the results of the NMFSstudy because FDA considered it torepresent the best evidence available atthat time.

As explained more fully below, FDAused modeling technique and theexperience reported about seafood firmsto produce estimates that are in generalagreement and that are approximatelyone-fourth of those estimated in theNMFS study reported in the PRIA.

In estimating the costs in this PRIA,there are three checks that have helpedensure the accuracy of the costs thatwould be imposed by adoption of thisregulation. The first is the costcomments, but these, the agency’sanalysis revealed, were in most casesrather general, not well supported, andof only marginal assistance. The secondis modeling by FDA experts based ontheir experience with the use of HACCPin the seafood industry; working withaquatic species and the public healthproblems that they present; inspectingand studying both seafood plants andlow acid canned food plants (whichhave operated under HACCP principlesfor almost two decades); andparticipating in the FDA–NMFS seafoodpilot. The results of this modeling aredetailed below. The third source isinformation that FDA received fromfirms that have actually implementedHACCP. Even though FDA finds that thecosts of this final rule may be below$100 million, estimating these costs is adifficult task involving someuncertainties. The agency recognizesthat the rule may affect in a materialway a sector of the economy. Therefore,FDA has treated the final rule as asignificant regulatory action underExecutive Order 12866. Consequently,

the agency has completed a fullRegulatory Impact Analysis.

The agency received approximately230 comments on issues involving thePRIA. These comments are fullysummarized and addressed in the fullRIA which is included in the record asReference 229. However, because of theproblems with these comments notedabove, FDA did not generally use themin the revised estimates reported hereand in the full RIA. The reasons for thisare more fully explained in the full RIA.

These adjusted NMFS model costestimates result in per plant costs fordomestic manufacturers of $23,000 inthe first year and $13,000 in subsequentyears. Total costs for compliance withthese regulations using the adjustedNMFS data are shown in Table 3. FDAhas also concluded that the PRIArepresents a reasonable upper estimateof the costs of HACCP. Table 3 alsosummarizes the specific cost estimatesthat FDA arrived at using data from theNMFS model with cost refinementsreceived from commenters and FDAseafood industry experts.

TABLE 3.—DISAGGREGATED COSTSFROM ADJUSTED NMFS MODEL

Million

1st Year:Domestic manufacturers and Im-

porters ..................................... $112Major plant repair and renovation 13Sea Grant expertise .................... 1Repackers and warehouses ....... 14Harvesters for rejected raw prod-

uct ............................................ 1Shellfish vessels ......................... 3Foreign processors ..................... 18

Total ..................................... 162

2d Year:Domestic manufacturers ............. 65Sea Grant expertise .................... 1Repackers and warehouses ....... 14Shellfish vessels ......................... 1Foreign processors ..................... 10

Total ..................................... 91

3d Year:Domestic manufacturers ............. 65Sea Grant expertise .................... 1Repackers and warehouses ....... 14IQF Shellfish plants ..................... 3

Total ..................................... 83

4th Year:Domestic manufacturers ............. 65Sea Grant expertise .................... 1Repackers and warehouses ....... 14

TABLE 3.—DISAGGREGATED COSTSFROM ADJUSTED NMFS MODEL—Continued

Million

Total ..................................... 80Total discounted costs beyond the 4th year

and discounted at 6 percent, the costs are$1,482 million.

1. Alternative Model for Estimating theCosts

In addition to the cost estimate basedon the NMFS modeling, FDA ispresenting a second cost estimate forthese regulations. The uncertaintiesassociated with the choices made byseafood processors to control hazardsjustify providing a range of potentialcosts based on more than one model.

In examples created by seafoodexperts within FDA, the cost ofcompliance with these regulations wasestimated for two small hypotheticalseafood processors that the agencybelieves to be representative of asignificant portion of the seafoodindustry. One of the plants is assumedto be in substantial compliance withexisting CGMP requirements. Therefore,the costs experienced by that plant areattributable exclusively to theestablishment and maintenance of aHACCP system. The other plant hassome CGMP deficiencies that the agencybelieves are typical of those displayedby seafood processors. This plant isidentical to the first plant except for theCGMP deviations. The costs calculatedfor this second plant represent the costassociated with the establishment andmaintenance of HACCP as well as costsassociated with the correction andmonitoring of sanitation conditions.

The models concern two plants thatcut and package tuna which is receivedfrozen and that also distribute orangeroughy fillets. The complexity of theprocessing operations, and the natureand number of hazards, are assumed tobe roughly equivalent to that of theother types of operations. FDArecognizes the difficulty in validatingthese assumptions. Nonetheless, theresults demonstrate that processors mayhave costs that are significantly belowthe averages estimated by means of theNMFS report. As discussed later, datareceived from firms that haveimplemented HACCP are generallysupportive of the results of thismodeling.

a. Small plant cost example 1. This isthe example of a firm that is a processorof frozen tuna steaks and distributor ofimported orange roughy fillets whoreceives all fish frozen. This plant is


located in a major seafood processingregion, so there is no need for plantpersonnel to travel to other cities toreceive training as it would be availablelocally. This processor operates 280days per year. The plant manager is paid$15 per hour and production workersare paid $8.50 per hour. No food safetyhazards are reasonably likely to occur inorange roughy, so a written hazardanalysis shows hazards for tuna only.This processor has no need to makeCGMP improvements so the plant costsare limited to the following:

(1) Training—($760). This iscalculated as follows: $400 tuition plusthe opportunity cost of training time($24 hours x $15 per hour). Theprocessor is expected to do most of thehazard analysis during the class.

(2) HACCP Plan Refinement—($240).This is calculated by taking 16 hoursbilled at $15 per hour using the FDAFish and Fishery Products Hazards andControls Guide.

(3) Plant Sanitation Audit—($0). Thisis done 3 times daily for 20 minuteseach time. However, because the firm ismodeled as being in compliance withexisting CGMP’s, it is assumed thatthese audits are already being done. Itis assumed that there is a negligible costfor recordkeeping.

i. Critical Control Points (CCP). (4)Receiving CCP (histamine)—($3,200).This processor gets a freezing log fromthe tuna harvester and makes a visualcheck of the fish to see that they arefrozen. The processor keeps a copy ofthe freezing log and makes a note of thevisual check. The fish are thentransferred to a plant freezer. Themonitoring takes 15 minutes per lot for4 lots per day. Similar monitoring is

already occurring and the marginal costfor the recordkeeping is negligible.

The processor drills a representativesample of each lot and performs anorganoleptic examination fordecomposition of the tuna. It is assumedthat this monitoring is not being doneprevious to this regulation and takes 20minutes per lot for 4 lots per day.Monitoring is billed at $8.50 per hour.Also, there is a cost for a new drill ($50)and it is assumed that recordkeepingcosts are negligible.

(5) Cutting CCP (metal fragments)—($0). A worker checks the saw blade atevery break to look for broken saw teethand keeps a log of checking on the teeth.Monitoring takes a few minutes perbreak. It is assumed that there is anegligible marginal cost for themonitoring and recordkeeping. Fish isweighed, packed, labeled and returnedto the freezer.

ii. Corrective actions. (6) Problemswith incoming product—($0). It isexpected that product rejects in the firstyear would be higher but they wouldreturn to current levels in the secondyear as harvesters became aware of theprocessor’s new requirements. The totalcost for the industry is $1 million for thefirst year and zero in the followingyears. Because harvesters and notprocessors bear the cost of rejected rawproduct, this cost is included in Table4 as a separate line item and not inTable 3 which includes only costs borneby processors.

(7) A saw tooth breaks every twoyears—($20). A worker needs toexamine potentially affected productevery 2 years. This is expected to take4 hours billed at $8.50 to check twohours worth of cutting.

iii. Verification. (8) Record review—($400). This involves a review of fivesanitation records, five receivingrecords, and a log book for the cuttingoperation. These are expected to be verysimple (e.g., check mark records).Consequently, this review is expected totake 30 minutes per week billed at $15per hour.

(9) Review hazard analysis & HACCPplan—($60). This is expected to take 4hours per year at $15 per hour.

(10) Administrative changes—20percent of all of the other costs in thefirst year and 10 percent in the secondyear.

b. Small plant cost example 2. Thecategories of costs that are different fromExample 1 are explained below.

(1) Plant Sanitation Audit—($2,800).This will need to be done 3 times dailytaking approximately 20 minutes foreach audit. It is assumed that someminimal sanitation assessment isalready being done once per day, but anadditional 40 minutes would berequired to perform three adequateaudits. Again, it is assumed that there isa negligible cost for recordkeeping.

(2) Extra Equipment Cleaning andSanitizing—($2,480). This is assumed totake 1 hour per day billed at $8.50 perhour. Also, additional water, andcleaning and sanitizing materials areassumed to cost $100.

(3) Eliminate Fly Infestation—($330).Torn screens need to be repaired taking2 hours billed at $8.50 per hour. Also,screening materials assumed to cost $15are needed. An exterminator to applypesticides costs $300.

Table 4 represents the modelsdescribed above in tabular form.

TABLE 4.—FDA MODELS OF SMALL PLANTS

Category

Small plant 1 (no GMPcosts)

Small plant 2 (GMPcosts)

Year 1 Year 2— Year 1 Year 2—

Training ............................................................................................................................ 760 0 760 0HACCP plan refinement ................................................................................................... 240 0 240 0Sanitation audit ................................................................................................................ 0 0 2,800 2,800Receiving CCP ................................................................................................................. 3,200 3,200 3,200 3,200Cutting CCP ..................................................................................................................... 0 0 0 0Sawtooth monitoring ........................................................................................................ 20 20 20 20Record review .................................................................................................................. 400 400 400 400HACCP plan review ......................................................................................................... 60 60 60 60Equipment cleaning .......................................................................................................... 0 0 2,500 2,500Eliminate pests ................................................................................................................. 0 0 330 0Administration ................................................................................................................... 940 370 2,100 900

Per plant costs .......................................................................................................... $5,600 $4,000 $12,400 $9,900

In order to estimate an average plantcost from these FDA model plants, FDAassumed that, based on the results of theagency’s 1990/1991 survey of the

seafood industry, 20 percent of smallfirms are similar to the model plant thatrequires some GMP improvements(Small Plant 2) and that 80 percent of

the small firms are similar to the modelplant that is in compliance with currentCGMP’s (Small Plant 1). The agency hasalso assumed that the cost of


compliance for large firms is the sameas that of small firms. There areoffsetting considerations that have ledthe agency to make this assumption inthis model. For example, agencyexperience suggests that it is likely thatsmall firms will, on average, have largersanitation costs and thus incur greaterexpenses to rectify existing CGMPdeviations. Large firms, on the otherhand, are more likely to have a greaternumber of products and processinglines, resulting in greater costs of plandevelopment and monitoring. However,the agency believes that large firms aremore likely to already have preventive

controls, formalized sanitationprograms, and record keeping systemsin place than small firms. Additionally,large firms are more likely to take onnew monitoring regimes with theirexisting quality control and productionstaffs than are small firms. The agencybelieves that these considerations wouldcounteract each other and should resultin fairly equal costs for large and smallfirms.

To complete the FDA model, FDAassumed that exporters (one- half of the1,000 large firms) would only need tospend $1,000 in order to comply withthis rule. Combining the two plant totalcosts as reported in Table 4 and

weighting the proportion of the industrythey are assumed to represent, averageplant costs are estimated to be $6,400 inthe first year and $4,800 in subsequentyears.

The foreign processor costs associatedwith this rule and passed on to U.S.consumers are estimated to be 13percent of the average domestic plantcosts. The total cost of this regulationusing this method of cost modeling is$71 million in the first year and $38million in the fourth year and beyond.

Total costs for compliance with theseregulations using the FDA model areshown in Table 5.

TABLE 5.—DISAGGREAGATED COSTS FROM FDA MODEL

1st Year Costs:Domestic manufacturers and importers ............................................................................................................................................. $32 million.Major plant repair and renovation ...................................................................................................................................................... 13 million.Sea Grant expertise ........................................................................................................................................................................... 1 million.Repackers and warehouses ............................................................................................................................................................... 14 million.Harvesters for rejected raw product ................................................................................................................................................... 1 million.Shellfish vessels ................................................................................................................................................................................. 3 million.Foreign processors ............................................................................................................................................................................. 5 million.Total .................................................................................................................................................................................................... 69 million.2d Year CostsDomestic manufacturers ..................................................................................................................................................................... $ 23 million.Sea Grant expertise ........................................................................................................................................................................... 1 million.Repackers and warehouses ............................................................................................................................................................... 14 million.Shellfish vessels ................................................................................................................................................................................. 1 million.Foreign processors ............................................................................................................................................................................. 3 million.

Total ............................................................................................................................................................................................. 42 million.3d Year Costs:Domestic manufacturers ..................................................................................................................................................................... 23 million.Sea a grant expertise ......................................................................................................................................................................... 1 million.Repackers and warehouses ............................................................................................................................................................... 14 million.IQF Shellfish plants ............................................................................................................................................................................ 3 million.

Total ............................................................................................................................................................................................. 41 million.4th Year (and subsequent years) CostsDomestic manufactures ...................................................................................................................................................................... 23 million.Sea Grant expertise ........................................................................................................................................................................... 1 million.Repackers and warehouses ............................................................................................................................................................... 14 million.

Total ............................................................................................................................................................................................. 38 million.Total Discounted Costs:Beyond the 4th year and discounted at 6 percent, the costs are $677 million.

There are a number of explanationsthat would account for the uncertaintybetween the FDA and NMFS models.Virtually all of the difference can beexplained by the two different estimatesof what it would take to come intocompliance with 21 CFR part 110(FDA’s CGMP regulations). In the caseof the NMFS study, the contractorsestimated the cost of coming into fullcompliance with all CGMPs. Using thismethodology, they found thatapproximately 80 percent of the plantswere out of compliance. On the otherhand, the FDA model uses the results ofFDA’s own survey of the industry,which only listed plants as being out ofcompliance if the CGMP violations wererelated to potential contamination of theseafood product. In this case, FDA

found that only about 20 percent of thefirms were out of compliance. Inaddition, the FDA cost model assumesthe simplest, least expensive correctiveaction to solve the CGMP violation. TheNMFS model did not use the sameapproach in all cases.

2. Other Cost Reports

Reports received by FDA on the costof implementing HACCP discussedbelow appear generally to support theresults of FDA modeling across theseafood industry. While the modelingwas limited to certain types of smalloperations, the firms for which FDA hasinformation on reported costs representa cross section of processing operationtypes, including canned, fresh, frozen,smoked/salted, molluscan shellfish, and

cooked, ready-to-eat products as well aswarehouses and repacking operations. Itshould be noted that these costs arereported only as an additional source ofinformation. They were not used togenerate FDA’s model plants.

The cost information obtained fromindustry includes responses to a 1991evaluation questionnaire from four firmsthat participated in the FDA/NOAAseafood HACCP pilot in 1990–1991. Italso includes information provided toFDA from seven firms through theassistance of the National FoodProcessors Association. (These 7 firmsoperate a total of 44 processing plants.)It further includes information from twoseafood trade associations, the NationalFisheries Institute and the New EnglandFisheries Development Association


11 The costs referred to here are those estimatedfor NMFS for the type of HACCP system it wasstudying. For the purposes of the PRIA and RIA,FDA made adjustments to the costs estimated forNMFS so as to be consistent with FDA’s ownregulation. These adjusted costs from the NMFSmodels are the estimates presented earlier in thisdocument.

(NEFDA), which provided FDA withsummary information about memberfirms that had implemented HACCPsystems. The 2 seafood tradeassociations provided information on 16firms. NEFDA operated a HACCP pilotwith member firms through a Federalgrant. All of this information wasreceived by FDA before the publicationof the proposed regulations and wasreported in the PRIA. After thepublication of the proposal, FDAreceived information from a largeprocessor-exporter on its HACCP start-up costs. This processor reported startup costs of $1,000 per plant. In total,FDA has information on 86 plants (Refs.129 and 223).

Many of these firms haveimplemented HACCP as participants ineither pilot programs, the NOAA fee-for-service program, or the State of Alaskaprogram, and therefore their HACCPsystems have been subject to some formof third party verification. Virtually allof these plants have developed HACCPplans, many of which included criticalcontrol points for quality or economicfraud or both in addition to safety. Inthis respect, many firms implemented amore extensive form of HACCP than isbeing mandated by FDA.

More complete information on start-up costs received from 22 firms whohave implemented HACCP issummarized in Table 6. Some of thesecosts are for multi-plant firms and somefor firms operating only one plant.

TABLE 6.—START-UP COSTS

No. of firms Start-up costs ($)

4 <1,00015 1,000–5,0001 5,000–10,0001 10,000–15,0001 >20,000

FDA notes that there are severaluncertainties with these data. Theagency does not have sufficientinformation to extrapolate the costsobserved by these firms to the entireindustry. FDA also does not know theextent of previous HACCP-typeactivities in these firms so that they mayhave different incremental costs thanthe industry average. Additionally, forsubsequent year costs, some of the firmsreported costs that exceeded the start-upcosts shown in the table although somewere below, and it is not clear if coststhat might be incurred in order tocomply with CGMP’s are represented.

Nevertheless, the range of reportedcosts, are consistent with the FDAmodel for a processing operation thatdoes not incur such costs. Notably, the

estimates developed for NMFS of thecosts of operating HACCP systems forsmall businesses are consistent with theFDA model and with the reports to FDAby trade associations discussed above.1Thus, three independent sources ofinformation suggest that annual HACCPcosts, at least for small businesses, arewithin a range of $3,000 to $6,000 perplant if sanitation costs are notincluded. Although the HACCP costestimates made for NMFS did notinclude certain aspects of a HACCPsystem such as HACCP plandevelopment, plan verification, andtaking corrective actions, the estimatesdid include the costs of operatingHACCP systems for quality andeconomic adulteration in addition tosafety. These costs were not included inthe NMFS cost estimates reported here.The FDA HACCP system involves safetyonly and is therefore less expensive.

It is also worth noting that threeindependent sources (FDA’s owninspection experience, NMFSinspection experience with plantspurchasing its voluntary inspectionservices, and the contractor’s report forNMFS) confirm the existence ofsanitation deficiencies in some seafoodplants. Because FDA holds that theseconditions must be corrected underexisting requirements, the costsassociated with these corrections will beborne by processors regardless ofwhether sanitation provisions areincluded in the seafood HACCPregulations or somewhere else.Sanitation controls for processors mayaddress a number of enteric pathogensdiscussed elsewhere in this analysisincluding Salmonella, Shigella,hepatitis A, L. monocytogenes,campylobacter, and C. botulinum.Contamination may come from eitherthe raw product or from poor hygienepractices such as insufficient control ofvermin (flies and rodents) or insanitarywater. In addition, poor sanitation maycause contamination of the product withpesticides, lubricants, cleaningcompounds, or other toxic substancesbecause of improper labeling, storage oruse. The system in the seafood HACCPregulations is based on the monitoringof sanitation conditions by processors.FDA is not aware of any method forprocessors to take control of thesanitation conditions within their plantsother than by a method that involves

routine monitoring. Recording theresults of these observations, as requiredby the regulations, need involve onlyminimal additional cost.

3. Seafood PricesA number of comments referred to the

effect that the regulation will have onthe price of seafood that consumersexperience at the retail level. In thePRIA, it was presumed that most of thecost of compliance of the proposedregulations would be passed on toconsumers. In the PRIA, it wascalculated that if the domestic industrypassed on to consumers all of the costsestimated in the PRIA, prices fordomestically produced seafood wouldincrease by less than 1 percent in thefirst year and less than one-half of 1percent in succeeding years. It wasnoted in the PRIA that price changes ofsuch magnitude are unlikely to have asignificant impact on general seafoodpurchases.

Some commenters claimed that all ofthe cost of the regulation would be bornby processors, and that none of theincrease in cost would be passed on toconsumers. These commentersexplained that seafood is currently at adisadvantage compared to other fleshfoods for consumers’ food dollarsbecause seafood has a higher price perpound. If the relative price of seafoodwere to increase further, consumerswould eat less seafood. The commenteralso explained that domestic seafoodprocessors are at a competitivedisadvantage compared with seafoodthat can be imported at low cost (i.e.,lower wages). If domestic processorswere to raise their prices, seafoodimports would take an even larger partof the seafood market away fromdomestically produced seafood.

Other comments said that processorswill pass on all of the cost of theregulation, and that the regulation willcause the consumer price of seafood torise. Some said that the price increasewould be large enough to cause adecrease in seafood consumption.

Both theories have some merit,although neither is completely correct.The agency agrees that, all other thingsremaining the same, an increase in theprice of seafood will decrease seafoodconsumption and increase theconsumption of other fresh foods.However, the decision of a consumer topurchase a product depends on anumber of factors.

Seafood includes many invertebrateand vertebrate species which vary inprice per pound, often by over 100percent, for a particular species(depending, in part, on seasonalsupply). Such diversity, compared with


meat and poultry, makes it clear thatthere is not perfect substitution amongthe flesh foods. Nevertheless, data baseson food consumption are equally clearat showing that as people haveincreased their consumption of variousseafood products, they have reducedtheir consumption of meat and poultry.

There are other nonprice factors in theconsumption decision. A consumersurvey found that taste, quality, andfreshness were rated above price(‘‘moderately important’’) in decisionsto order seafood in a restaurant or topurchase for preparation at home. In asurvey of retailers’ experiences,consumers ranked quality ahead of pricein making seafood selections and ratedthe need for information on cooking asa concern equal to price (Refs. 244 and225).

Another relevant consideration is thefact that a disproportionate percentageof seafood is consumed in restaurants asa luxury item where the cost of the rawmaterial is not as important a factor inthe purchasing decisions made by theseconsumers.

All of this information is consistentwith other data in this analysis thatsuggests that a 1 percent change in priceresults in less than one-half of onepercent change in seafood consumption.

Another major factor that lessens anycompetitive cost advantage meat andpoultry products might experience froman increase in seafood cost is that USDAis proposing similar HACCP regulationsfor meat and poultry. USDA’s proposal,if finalized for meat and poultryproducts, suggests that all segments ofthe flesh food market may face costincreases in the near future. It is entirelypossible that the price of seafoodrelative to meat and poultry will notchange. The agency agrees that someseafood imports have a cost advantageover domestically produced seafood,primarily due to lower labor and capitalcosts of production. However, becausethe regulation applies to imports as wellas domestic products and becauseimporters from EU member nations willsoon be under HACCP requirements andexperiencing increased costs, it isreasonable to assume that the price ofimported seafood relative to domesticseafood will not change.

In the short run, the ability ofproducers to pass on cost increases islargely determined by the elasticity ofdemand (the degree to which consumersreduce their consumption of a good inresponse to a given increase in price)and the elasticity of supply (the degreeto which producers increase theirproduction of a good in response to agiven increase in price). The elasticity ofdemand is determined in turn by,

among other things, the presence orabsence of close substitutes. Thus, forexample, if there are close substitutesand the price of a good goes up,consumers will not continue toconsume the higher priced good butswitch to one of the substitutes.

If manufacturers know that consumerswill not switch to a substitute whenthere is a price increase, then they arefree to pass along all of the increasedcosts (from complying with theregulation) in the form of priceincreases. However, where there areclose substitutes for seafood, such asother flesh foods, consumers respond toprice increases by reducing theirconsumption of the high priced good.Rather than attempting to pass on all ofthe costs of the regulation in the formof higher prices, producers must acceptreduced profits and bear some, if not all,of the burden of the cost increase.

In very competitive markets, such asthe market for flesh food, where meat,fish, and poultry are consideredsubstitutes, producers bear the entireburden of any increases in fixed costs.Fixed costs are costs that do not change,despite the size of the firm and changesin the level of output. Examples of fixedcosts are costs of plant, equipment, andmanagement; much of these costs areexpected to be borne by processors.Because large firms spread fixed costsover larger output, they may be able topass on these costs when smaller firmscannot.

In addition, also in the short run,producers may bear some portion of thevariable costs that cannot be profitablypassed on to consumers. Variable costsare costs that vary with changes in theamount of output. Examples of variablecosts are costs of raw materials andhourly labor. However, it is likely thatmuch of the variable costs will bepassed on to consumers.

When firms in a competitive marketcannot pass on all of a cost increase inthe short run, profits decline. Beyondsome point profits become either so lowor negative that the firm is forced toclose (discussed more fully in theRegulatory Flexibility Analysis below).In the long run, the exit of thesemarginal firms reduces the industrysupply (of seafood) and permits theremaining firms to raise prices to coverthe full costs of production, bothvariable and fixed costs. Thus, in thelong run, seafood prices will rise by thefull cost of the regulation.

A few comments requested a betteranalysis of price changes. Thesecommenters criticized the approachused to estimate price increases in theExecutive Summary of the PRIA. Ratherthan dividing the estimated domestic

cost of the regulation by the totaldomestic production, the commenterssuggested estimating price changes foreach market segment. The advantages ofthis approach are that different types ofseafood are treated separately (thechange in the price of raw tuna mightbe very different from the change in theprice of ready-to-eat shrimp cocktail)and that different sized firms are treatedseparately (small firms may be forced toraise prices more than large firms).

FDA agrees that this method ofdetermining price changes is morelegitimate than the method employed inthe PRIA. However, FDA did not receiveany information from commenters thatwould enable the agency to calculateprices in this manner. It is worth noting,however, that the contractor thatperformed the study upon which manyof the estimated costs in this RIA arebased did take product type intoaccount when estimating cost increases.That contractor estimated a range of costincreases from negligible to 1.3 percent,depending on the product. Again, it isimportant to note that that studyincluded costs for the control of typesof hazards not covered by this finalregulation.

Finally, while the methodology usedin the PRIA might not produce accurateprice changes, it suggests that overallprice increases due to this regulationcould well have a negligible effect ondemand.

C. BenefitsIn the PRIA, FDA estimated that the

proposed option, which is beingadopted in this final rule, would: (1)Reduce the amount of foodborne illnessthat results from consumption ofseafood and; (2) generate significantnutrition benefits as a result of theincreased consumption of seafood(brought about by a decrease inconsumer anxiety) with a concomitantdecrease in the consumption of meatand poultry; (3) reduce the amount ofrent seeking (rent seeking is a termeconomists have applied to activitieswhich do not contribute to societalwelfare but only seek to transferresources from one party to another);and (4) generate export benefits byallowing U.S. exporters to continue toexport to countries requiring HACCP.

The last benefit, the export benefit, ischaracterized as the benefit to firmsexporting to countries that requirefederal oversight and certification ofHACCP programs. In addition to thebenefits cited in the PRIA, the agency isaddressing benefits derived fromreduced enforcement costs, and isdiscussing other unquantified benefitsof adopting the seafood HACCP


regulations. The agency has fullyconsidered all of the comments onbenefits. These estimates are more fullyexplained in the full RIA. What followsis FDA’s conclusion as to how thesebenefits should be valued.

1. Safety Benefits

In the tables below, FDA presentsrevised estimates of the benefits ofmandatory HACCP for seafoodprocessors. Several changes from thepreamble to the proposal arenoteworthy. First, based on thecomment that said that FDA hadunderestimated the number of cases,FDA has reestimated the baselinenumbers of cases for certain illnesses(Ref. 226). Next, some changes weremade to the valuations of particularcases, as better information wasobtained concerning the probabilities ofdeath per type of illness. Finally, asmentioned above, some changes havebeen made to the estimates of thepercentages of the illnesses reduced.

Although Canada, for example, hasmandatory HACCP for its seafoodprocessors, no data exist on the efficacyof HACCP. Therefore, for thepercentages of the illnesses reduced,FDA used three different types of itsexperts (seafood experts,epidemiologists familiar with microbialhazards, and microbiologists) to addressthe efficacy of seafood HACCP. Each ofthese experts reviewed the literature oneach type of hazard as well as therequirements of HACCP. The rangesreflect likely upper and lower boundson how effective HACCP will be atcontrolling production deficiencies byprocessors, including indirect controlsexerted by processors on the owners ofharvesting vessels. In addition, thetables reflect the fact that some of thecases of illness are not addressable bythis rule as they are caused by eitherconsumer or restaurant mishandling or

poor fishing practices by recreationalfishermen.

In order to calculate the number ofcases (annual cases resulting fromexposure to hazards associated withseafood consumption) that would bereduced by HACCP, each of the fourexperts followed a series of methodicalsteps. The first was to determine thetypes of seafood associated with eachhazard. The second step consisted ofreviewing the various aspects of the ruleto determine the areas of seafoodharvesting and processing that the rulecould affect. The third step was toeliminate those cases that could not beaffected by the rule.

These would be cases that seafoodprocessors could neither eliminatethrough processing nor prevent frombeing introduced, either by their ownstaff or by control over raw materials.Cases caused or controlled by factorsoutside of the HACCP system includerecreational harvest (approximately 20percent of all seafood harvested) thatdoes not pass through processing plantsand problems caused by restaurant,supermarket or consumer impropercooking or mishandling. In addition,there will be some types of hazards thatwill not, for the foreseeable future, becontrollable by means other thanavoiding contaminated waters, whichwill not be 100 percent effective(ciguatera, for example). Until rapid,inexpensive tests are developed, HACCPcannot be 100% effective at controllingthese hazards.

Once each expert had accounted forthose cases that could not potentially bereached by this rule, the experts thenassessed the likely effectiveness ofcontrol steps associated with broadsanitation improvements and mandatorycontrols on specific hazards and specificspecies.

Ciguatera: Both the lower and upperbound reductions in illness are

relatively small in the near term becausethere does not yet exist a rapid,inexpensive test for this toxin.Processors and commercial fishermenmust rely on information about whethergeographic areas are ciguatoxic.Moreover, many illnesses areattributable to recreational harvest.

Hepatitis A virus: This illness derivesmostly from molluscan shellfish. Formolluscan shellfish, the controls areharvesting from approved waters andgood sanitation in the plant. Theseregulations specifically involve bothtypes of controls. The upper boundnumber is 50 percent of the totalestimated number of illnesses largelybecause of the problems that states havein patrolling and controlling illegallyharvested molluscan shellfish.

Norwalk virus: This illness derivesfrom raw molluscan shellfish that arecontaminated from human pollution inharvesting areas. Control involvesharvesting from approve waters. Theseregulations include this kind of control.The upper bound number is 50 percentof the total estimated number ofillnesses largely because of the problemsthat states have in patrolling andcontrolling illegally harvestedmolluscan shellfish and because of theuncertainty of the control of sewagefrom harvesting and recreationalvessels.

Vibrio vulnificus: This illnessessentially derives from eating rawmolluscan shellfish from the Gulf ofMexico. Vibrio vulnificus is a naturallyoccurring, ubiquitous, marine organism.The lower and upper bound numbersreflect the fact that controls are newlyemerging for this organism and stillhave uncertainties associated withthem.

Table 6a sets out the new estimates ofbaseline cases of foodborne diseaserelated to HACCP and the range of casesaverted by HACCP.

TABLE 6a.—ESTIMATE OF ANNUAL CASES AVERTED

HazardEstimatednumber of

cases 1

Number ofcases avert-ed (lower) 2

Number ofcases avert-ed (upper) 1

Anasakis ................................................................................................................................................... 100 25 60Campylobacter jejuni ............................................................................................................................... 200 100 150Ciguatera .................................................................................................................................................. 1,600 96 200Clostridium botulinum .............................................................................................................................. 10 3 5Clostridium perfringens ............................................................................................................................ 200 100 150Diphyllobothrum latum ............................................................................................................................. 1,000 250 600Giardia ...................................................................................................................................................... 30 15 23Hepatitis A Virus ...................................................................................................................................... 1,000 150 500Other Marine Toxins ................................................................................................................................ 20 .................... 1Norwalk Virus ........................................................................................................................................... 100,000 15,000 50,000Other Vibrio’s ........................................................................................................................................... 1,000 200 500Paralytic Shellfish Poisoning .................................................................................................................... 10 .................... 1Salmonella non typhi ............................................................................................................................... 200 100 150Scombrotoxin ........................................................................................................................................... 8,000 4,000 6,000


TABLE 6a.—ESTIMATE OF ANNUAL CASES AVERTED—Continued

HazardEstimatednumber of

cases 1

Number ofcases avert-ed (lower) 2

Number ofcases avert-ed (upper) 1

Shigella .................................................................................................................................................... 200 100 150Vibrio vulnificus (3d year) ........................................................................................................................ 60 12 30

Total .............................................................................................................................................. 113,630 20,151 58,520

1 These numbers were determined in consultation with representatives from the Centers for Disease Control and Prevention.2 The upper and lower bounds were determined by a panel of scientists at CFSAN (Dr. George P. Hoskin, Dr. Karl C. Klontz, Dr. Kaye I

Wachsmuth and Dr. Thomas C. Wilcox.

Table 7 reflects revised estimates of the total cost of seafood illness.

TABLE 7.—ANNUAL COST OF SEAFOOD ILLNESS

Hazard Value percase

Total cost ofseafood illness

Anasakis .................................................................................................................................................................. $1,703 $170,332Campylobacter jejuni ............................................................................................................................................... 9,390 1,877,924Ciguatera ................................................................................................................................................................. 15,247 24,395,438Clostridium botuli num ............................................................................................................................................. 223,252 2,232,524Clostridium perfrin gens ........................................................................................................................................... 6,551 1,310,164Diphyllobothrum latum ............................................................................................................................................. 2,753 2,752,617Giardia ..................................................................................................................................................................... 6,104 183,112Hepatitis A Virus ...................................................................................................................................................... 22,669 22,668,870Other Marine Toxins ................................................................................................................................................ 269 5,380Norwalk Virus ........................................................................................................................................................... 575 57,500,000Other Vibrio’s ........................................................................................................................................................... 2,955 2,954,842Paralytic shellfish poisoning .................................................................................................................................... 92,356 1,200,628Salmonella non-typhi ............................................................................................................................................... 8,199 1,639,756Scombrotoxin ........................................................................................................................................................... 339 2,708,755Shigella .................................................................................................................................................................... 16,750 3,349,961Vibrio vulnificus ........................................................................................................................................................ 2,008,917 120,535,039

Total .............................................................................................................................................................. ........................ 245,485,342

Table 8 shows the estimates of the efficacy of mandatory seafood HACCP at reducing foodborne disease in thethird year following the date of implementation (undiscounted).

TABLE 8.—ESTIMATE OF THE EFFICACY OF MANDATORY HACCP AT REDUCING FOODBORNE DISEASE IN THE THIRD YEAR

HazardsLower boundestimate (3d

year)

Upper boundestimate (3d

year)

Anasakis .................................................................................................................................................................. $42,583 $102,199Campylobacter jejuni ............................................................................................................................................... 938,962 1,408,443Ciguatera ................................................................................................................................................................. 1,463,726 3,049,430Clostridium botulinum .............................................................................................................................................. 558,131 1,116,262Clostridium perfringens ............................................................................................................................................ 655,082 982,623Diphyllobothrum latum ............................................................................................................................................. 688,154 1,651,570Giardia ..................................................................................................................................................................... 91,556 137,334Hepatitis A Virus ...................................................................................................................................................... 3,400,331 11,334,435Other Marine Toxins ................................................................................................................................................ ........................ 269Norwalk Virus ........................................................................................................................................................... 8,625,000 28,750,000Other Vibrio’s ........................................................................................................................................................... 590,968 1,477,421Paralytic Shellfish Poisoning ................................................................................................................................... ........................ 46,178Salmonella non-typhi ............................................................................................................................................... 819,878 1,229,817Scombrotoxin ........................................................................................................................................................... 1,354,377 2,031,566Shigella .................................................................................................................................................................... 1,674,981 2,512,471Vibrio vulnificus (3d year) ........................................................................................................................................ 24,107,004 60,267,519

Total .............................................................................................................................................................. 45,010,733 116,097,537

Finally, in response to the comments, FDA has attempted in Table 9 to associate particular hazards with categoriesof seafood (to the extent the data allow).


TABLE 9.—ASSOCIATION OF PARTICULAR HAZARDS WITH CATEGORIES OF SEAFOOD

HazardsEstimatednumber of

casesAffected species

Anasakis ........................................................................................ 100 Raw Finfish.Campylobacter jejuni ..................................................................... 200 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.Ciguatera ....................................................................................... 1600 Tropical, reef associated species of finfish.Clostridium botulinum .................................................................... 10 Vacuum Packaged Fish, Smoked and Salted Fish.Clostridium perfringens ................................................................. 200 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.Diphyllobothrum latum ................................................................... 1000 Raw Finfish.Giardia ........................................................................................... 30 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.Hepatitis A Virus ............................................................................ 1000 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.Other Marine Toxins ...................................................................... 20 Molluscan Shellfish.Norwalk Virus ................................................................................ 100,000 Molluscan Shellfish.Other Vibrio’s ................................................................................. 1,000 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.Salmonella non-typhi ..................................................................... 200 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.Scombrotoxin ................................................................................. 8,000 Scombroid Species of Finfish.Paralytic Shellfish Poisoning ......................................................... 10 Molluscan Shellfish.Shigella .......................................................................................... 200 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.Vibrio vulnificus ............................................................................. 60 Molluscan Shellfish.

Total .................................................................................... 113,630

2. Summary of Safety Benefits

The safety benefits are shown by yearin Table 10 (undiscounted).

TABLE 10.—SAFETY BENEFITS

Year Lower boundbenefits

Upper boundbenefits

1 .................... 32,957,233 67,897,7512 .................... 32,957,233 67,897,7513 .................... 45,010,733 116,097,5374 and beyond 45,010,733 116,097,537

3. Nutrition Benefits From MandatorySeafood HACCP and IncreasedConsumer Confidence

In the PRIA, FDA estimated what thepotential nutrition benefits might be ifreduced consumer anxiety over seafoodsafety led to increased sales. FDAhypothesized that this might lead toconsumers eating lower fat meals (onaverage) as they replaced higher fat meatand poultry with lower fat seafood.

The agency has considered this issuein greater detail in the full RIA. FDAacknowledged in the PRIA that theentire estimate of nutrition benefitsresulting from increased sales of seafoodat the expense of meat and poultry salesis speculative. Although the agencybelieves that increased consumerconfidence would result from having astate-of-the-art HACCP system in placefor the seafood industry, no data werereceived to confidently predict theultimate increase in the quantity ofseafood sold as a result of thisregulation. Sales data of this type werealso not available before or after theagency initiated its low acid cannedfood regulations. Finally, the agencywas unable to determine if any increase

in consumer confidence would offset aprice increase resulting from HACCPcosts.

The agency was equally concernedabout possible nutrition benefits as towhether there would be an exactexchange in the nutrient profile betweenfish as prepared and meat and poultry.The agency finds that some fish dishesas consumed are eaten fried or servedwith heavy sauces, and that differentspecies of fish have different fat profiles.Thus, for some consumers who makesubstitutions of fish meals for meat andpoultry, it is not totally clear if therewill be a favorable decrease in fatintake. Because there are too manyunknown variables surrounding thesesubstitutes and the lack of sales data,the agency is unable to quantify thisbenefit.

4. Rent SeekingRent seeking activities were

characterized in the proposal as ‘‘publicand private resources (which) have beenexpended in attempts to alter the levelof regulatory effort toward seafoodsafety, as well as alter which Federalagency should oversee the industry.’’‘‘Rent seeking’’ is a term economistshave applied to activities that do notcontribute to societal welfare but onlyseek to transfer resources from one partyto another. An example often given islobbying to change the ownership of agovernment granted special privilege sothat profits change hands. In manycases, however, it is difficult todistinguish between activities thatultimately indirectly benefit societyfrom those that only transfer profits. Theproposal hypothesized that one benefitof the regulation was to reduce thesocial costs of rent seeking.

One commenter noted that the reasonlarge firms support HACCP is becausethey must have HACCP to export toEurope. The commenter noted thatmandated HACCP would ‘‘ensure thatall domestic processing firms face thesame costs, thereby reducing anycompetitive disadvantage.’’

FDA does not agree that this is ajustification for HACCP. The reason forimplementing HACCP is to reduce theincidence of foodborne disease.However, FDA agrees that this ‘‘rent-seeking’’ argument may explain somesupport for HACCP by larger exportingfirms. It is important to note, however,that there are small firms who export toEurope as well.

5. Export BenefitsIn the PRIA, FDA asserted that one

benefit (unquantified) of the rule was toallow firms now exporting to the EU tocontinue to do so because of the EUrequirement for a federally overseenvoluntary HACCP program. Severalcommenters noted that some countriesthat import seafood from the UnitedStates are beginning to require HACCP.One commenter noted that more than 30percent of seafood produced in theUnited States is exported. The samecommenter noted the disruption intrade when French authorities did notcoordinate their seafood safetyrequirements with ‘‘other officials.’’Several commenters noted the need formore Memoranda of Understandings(MOU’s) between the United States andother countries for seafood. Onesuggested that such MOU’s be basedupon HACCP as defined by variousinternational bodies. Finally, onecommenter noted that FDA ‘‘should takeinto account how the international


community is implementing HACCPbefore the agency imposes regulationsthat may create unnecessary tradebarriers.’’

As discussed in the PRIA, thisprogram will benefit those seafoodprocessors who are exporting to nationsrequiring HACCP. However, as alsonoted in the PRIA, there is in place afederally overseen HACCP program,specifically, the program being offeredto processors by the National MarineFisheries Service (NMFS).

FDA has made an estimate of the costsavings to exporting firms of being inFDA’s mandatory program in lieu of theNMFS program. The alternative toNMFS review (if FDA were not to adopt

this regulation) would be inspection ofproduct that is offered for entry into theEU on an entry-by-entry basis and thepayment of a significant fee for theseinspection services. With approximately2 billion pounds being exported eachyear, this savings of resources amountsto, at a minimum, $20 million per year.

In addition, although the EU hasannounced the requirement that HACCPbe in place by January 1, 1996, adoptionof a U.S. plan reduces some of theuncertainty for U.S. firms and firmsexporting to the United Statesconcerning the ultimate form of aninternationally agreed upon HACCPrequirement.

6. Reduced Enforcement Costs

Comments qualitatively mentionedother benefits including fewer productrecalls and other enforcement actions.FDA agrees that there will be fewerproduct recalls, seizures, injunctionsand detentions of seafood and seafoodproducts. As examples of what benefitscould have accrued in 1994, the agencyhas calculated the value of each of theseactions and addressed them below.

a. Seizures. A seizure is a civil actiondesigned to remove violative goods fromconsumer channels. Table 11 shows theactions and their associated costs thatfollow a determination that a violationexists and that goods should be seized.

TABLE 11.—SEIZURE STEPS

Action Hours/Other Cost

Federal personnel collect and analyze samples, write up recommendations (programand general counsel), review the case and make recommendations to the U.S. attor-ney.

120 .............................................................. $12,840

U.S. attorney files complaint and Court orders goods arrested ........................................ 16 ................................................................ 1,712U.S. Marshal and other federal official seizes goods at location ...................................... 8 ..................................................................

Travel ..........................................................856200

Firm hires attorney to contest/accept action ..................................................................... 16 ................................................................ 1,712Food is reconditioned by firm ............................................................................................ 16 firm .........................................................

16 Federal lower valued food 2 ...................1,7121,712

Food is denatured (converted to a non-food use) or; ....................................................... 16 firm .........................................................8 Federal lower valued food 2 .....................

1,712856

Food is destroyed .............................................................................................................. 8 firm ...........................................................8 Federal lost food 1 ....................................

856856

1 The rate of $107 per hour represents the cost of a loaded (including equipment and benefits) employee plus headquarters support of approxi-mately 70 percent.

2 Total seizure costs are calculated in Table 12.

Table 12 shows the seizures in 1994. Assuming that half of all seizures are prevented each year, the benefitsare expected to be approximately $290,000 each year.

TABLE 12.—SEIZURES IN 1994

Problem No. Administra-tive costs 1 Action 2 Total

Decomposition (Destroy) .............................................................................................................. 5 $17,320 $46,565 $320,925Filth (Denature) ............................................................................................................................ 3 17,320 8,709 78,087Chemicals (Destroy) ..................................................................................................................... 2 17,320 10,108 54,856Other (Destroyed) ........................................................................................................................ 4 17,320 14,212 126,128

Total ................................................................................................................................... 14 .................... .................... 3 579,996

1 Costs of items (1) through (4) in the preceding Table totaled are $17,320.2 The actions that are typically taken for each type of hazard are listed in the PROBLEM column. Costs include the value of destroyed food

multiplied by the number of actions or, in the case of denaturing, it is assumed that 10 percent of the value of the product is retained. No foodwas reconditioned.

3 This number may well underestimate the benefit. FDA recently completed a seizure proceeding (not filed in 1994) in which $5 million of prod-uct was condemned. Thus, preventing seizure can have a significantly higher value than that reflected in this table.

b. Detentions. A detention is a procedure for preventing violative products from entering the United States. Table13 shows the actions and their associated costs that follow a determination that a sample is violative, the followingactions take place.

TABLE 13.—DETENTION STEPS

Action Hours/other Cost 2

Federal personnel send a detention notice to the importer with an opportunity to introduce testimony ......... 2 ....................................... $214Importer hires attorney and introduces evidence. Submits response application ........................................... 16 ..................................... 1,712Determination of action to take ......................................................................................................................... 24 ..................................... 2,568Reshipment allowed, or .................................................................................................................................... 10 .....................................

Travel, Cost to Reship .....1,070

200


TABLE 13.—DETENTION STEPS—Continued

Action Hours/other Cost 2

Product is denatured, or ................................................................................................................................... 8, Loss of value,2 Cost ofdenaturing,2, Resellingcosts 2.

856

Goods are destroyed under Federal supervision ............................................................................................. 16, Loss of product 1.

1 These costs are calculated in table 14 which gives estimates of the numbers and estimated costs for detentions in 1994.2 Seizure can have a significantly higher value than that reflected in this table.

TABLE 14.—DETENTIONS IN 1994

Reason Number ofdetentions Quantity 1 Dollars 1 Detention

disposition 2Detentionadmin 3

Borates ........................................................................................... 25 21,484 1,827,173 183,017 112,350C. botulinum ................................................................................... 1 113,790 363,434 363,434 4,494E.coli/coliforms ............................................................................... 14 254,774 742,786 149,413 62,916Histamines ...................................................................................... 2 98,023,014 1,361,714 273,199 8,988Lead ............................................................................................... 2 102,188 87,440 9,044 8,988Listeria/Other Pathogens ............................................................... 51 2,792,808 21,369,692 4,274,794 229,194Mercury .......................................................................................... 11 7,338,900 12,720,272 1,272,327 49,434Poisonous/Deleterious sub-nec ..................................................... 7 180,000 446,025 446,025 31,458Salmonella/arizona ......................................................................... 129 221,543,300 76,137,973 15,228,451 579,726Staphylocci ..................................................................................... 6 55,810 199,550 40,766 26,964Sulfites ............................................................................................ 23 713,653 8,100,620 810,362 103,362Unsafe food additives—NEC ......................................................... 5 67,160 540,201 540,201 22,470

Total ..................................................................................... 276 ...................... ...................... 23,591,033 1,240,344

1 Quantity and dollars include the total amount of both detentions and automatic detentions and are shown to illustrate how detentions werecalculated.

2 Disposition included reshipping which was estimated to be 10 percent times the number of shipments (quantity) times the value per shipment(dollars/quantity); reconditioning which was estimated to be 20 percent of the value of the shipment (dollars) or destruction which was estimatedto be 100 percent of the value of the shipment.

3 Administrative costs are estimated to be $4,494 per detention, the sum of the first three rows of the previous table.

Assuming just half of these detentions are prevented by HACCP, benefits to the federal government and industrywould be approximately $12 million per year.

c. Automatic detentions. Automatic detentions place each lot of imported products on detention upon arrival atthe border until the importer has demonstrated that the products do not violate the Federal Food, Drug, and CosmeticAct. This is normally done by the importer hiring independent labs to sample each lot. Table 15 shows the numberand types of relevant automatic detentions that took place in 1994.

TABLE 15.—AUTOMATIC DETENTIONS IN 1994

ReasonNumber of

automatic de-tentions

Sample cost1 Storage cost2

Borates ............................................................................................................................................... 53 $132,500 $182,717C. botulinum ....................................................................................................................................... 104 260,000 36,343E.coli/coliforms ................................................................................................................................... 8 20,000 74,279Histamines ......................................................................................................................................... 63 157,500 136,171Lead ................................................................................................................................................... 1 2,500 8,744Listeria/Other Pathogens ................................................................................................................... 236 590,000 2,136,969Mercury .............................................................................................................................................. 397 992,500 1,272,027Pesticide chlorothalanil ...................................................................................................................... 1 2,500 50Poisonous and Deleterious sub-nec .................................................................................................. 4 10,000 44,603Salmonella/arizona ............................................................................................................................. 759 1,897,500 7,613,797Staphylocci ......................................................................................................................................... 0 0 19,955Sulfites ............................................................................................................................................... 12 30,000 810,062Underprocessed ................................................................................................................................. 3 7,500 15,454Unsafe food additives—NEC ............................................................................................................. 3 7,500 54,020

Total ........................................................................................................................................ 1,644 4,110,000 12,405,191

1 1 Calculation of costs assumes that, for each product placed on automatic detention, 10 lots per year will be analyzed with 1 sample each ata cost of $250 per sample.

2 Assumes storage costs equals 10 percent of the stated value of the goods.

Again assuming that half of the aboveautomatic detentions are eliminated

each year, then the benefits will beapproximately $6 million per year.

d. Recalls. The costs of recalls to afirm vary from inexpensive notification


of consignees to several million dollars,depending on the nature of the hazard,the type of seafood, the cost and amountof product involved, and thedistribution chain of the product. Thecosts of a recall include searching forthe recalled products, removing themfrom retail and wholesale outlets,replacing the adulterated product,effectiveness checks, and disposal orreconditioning. In some cases recallscause marketing disruptions, loss ofshelf space, and subsequent losses insales via publicity.

FDA costs include investigative andanalytical time and expenses,administrative costs, cost of samples,and auditing time.

FDA assumes that the costs of recallsborne by firms are directly related to thedistribution costs associated with theproducts and to the size of thecontaminated lots. Distribution costsaccount for about one-third of the finalvalue of seafood. FDA assumes that thefirm must bear the full amount of thedistribution costs of the recall. Inaddition, the other costs listed aboveraise the total cost of recalls borne byfirms to one-half the value of theproduct. FDA uses one-half the value ofthe product as the base for the estimateof total recall costs. The total recall costof seafood processing firms in 1994 isestimated to be $2,461,906, as shown in

table 16. FDA audit checks for seafoodtook 474 hours in 1994. FDA assumesthat total FDA costs per recall wereproportional to audit hours. The costper hour of an audit check is $107,giving an FDA audit cost of $50,718(474 x 107). FDA collected 72 samplesat $250 per sample, giving sample costsof $18,000 (72 x 250). FDA thusestimates additional costs due to recallsto be $68,718 ($50,718 + $18,000). Thetotal recall cost is estimated to be$2,530,624 ($2,461,906 + $68,718).Again, the estimate for the purpose ofthis benefits analysis assumes that halfof all recalls will be prevented or about$1,250,000.

TABLE 16.—RECALLS IN 1994

Fish Hazards Amount Total

Canned tuna ......................................................... Filth, decomposed, punctured cans, shortweight.

6,599 cases .................. $150,687

Crab ...................................................................... L. monocytogenes ............................................... 16,156 lbs ..................... 64,624Escolar fish ........................................................... Decomposed, sc ombroid, illness ....................... 1,719 lbs ....................... 1,614Herring, salted Schmaltz ...................................... L. monocytogenes ............................................... 1,200 lbs ....................... 1,740Hilsha fish ............................................................. Salmonella ........................................................... 2,000 lbs ....................... 2,100Lobster .................................................................. L. monocytogenes, salmonella ............................ 25,920 lbs ..................... 243,648Mahi mahi, fresh ................................................... Decomposed ....................................................... 575 lbs .......................... 834Nova chips ............................................................ L. monocytogenes ............................................... 54 lbs ............................ 157Oysters, shellstock ............................................... V. vulnificus ......................................................... 9,219,430 lbs ................ 1,843,886Oysters, shucked .................................................. V. vulnificus ......................................................... 21,944 lbs ..................... 87,776Sardines, flat fillets ............................................... Rusty, leaky, decomposed .................................. 33,600, 13 oz cans ...... 50,400Smoked catfish, salmon, sturgeon, tuna .............. L. monocytogenes ............................................... 1,060 lbs ....................... 2,963Tuna steaks .......................................................... Decomposed ....................................................... 7,110 lbs ....................... 11,477

Total ........................................................... .............................................................................. ....................................... 2,461,906.00

e. Injunctions. Injunctions are themost severe form of domestic penaltieswhereby a firm is enjoined fromproducing/distributing a product until aviolation is remedied. There areapproximately 5 injunctions by FDAagainst seafood products each yearcosting the firm an average of about$70,000 and FDA an average of about$30,000 each or about $500,000 peryear. These costs include court costs,analytical testing costs, inspectionscosts, and lost production costs. Again,if this rule reduced injunctions by half,societal savings would be $250,000.

Total enforcement benefits are thesum of all of the reduced enforcementcosts estimated to be approximately $20million per year.

7. Other Benefits

Commenters also mentioned benefitsincluding better process control(resulting in lower production costs)and improved employee morale.

FDA believes that there may be ‘‘re-engineering’’ types of benefitsassociated with these regulations. Forboth seafood and other foods for which

HACCP has been implemented, FDA hasreceived information that firms havefound cost-saving innovations in otherareas as they implement HACCP. Theseinnovations are considered trade secretsby firms and thus, their description(actual process innovations) andquantification is impossible as firmshave not released this data into thepublic domain. This phenomenoninvolves unexpected savings andefficiencies as a result of establishing anew system in a processing operation.The majority of firms that havepreviously instituted HACCP reportedthat they believed that the advantagesthey derived from HACCP were worththe costs to them in terms of bettercontrol over their operations, bettersanitation, and greater efficiencies, suchas reduced waste. Virtually all foresawlong-term benefits from operating underHACCP.

Improved employee morale dependson how HACCP is implemented. If, forexample, employees are (1) participatingin day-to-day monitoring of criticalcontrol points, (2) allowed throughcorrective action plans to participate in

corrective actions including shuttingdown a line when a critical limit hasbeen exceeded, and (3) are rewarded forthis decision rather than penalized orforced to rigorously defend theiractions, then employee morale mayincrease. Such an increase in morale, ifvalid, may lead to greater productivity.However, it is in the direct financialinterest of every company to maintainemployee morale such that anyadditional benefit from this regulation islikely to be small.

A final benefit will be realized forfinfish where processing plants andvessels, in an effort to control forhistamine formation, keep fish cooledfrom harvest to retail. This willsimultaneously decrease thedecomposition rate that causes seafoodto be thrown out because of organolepticproblems. The same situation existsrelative to cooked, ready-to-eat productsand smoked fish. One retailer citedlosses of 4 percent to 8 percent of allseafood because of decomposition. Ifsome of this decomposition begins priorto arrival at the retail level and isreduced in any degree by this


regulation, benefits could potentially belarge.

However, FDA recognizes that there isalso a short term cost (e.g., as molluscanshellfish harvesters attempt to supplyprocessors with untagged shellfish orfrom vessels without sanitary facilitiesaboard and find the harvest rejected).The same will also be true for finfishwhich have not been properlytemperature controlled from harvest toprocessor. These harvests will bediscarded although this behavior is notexpected to occur often, or more thanonce in any instance.

D. Costs and Benefits of SanitationA portion of the costs and benefits of

this rule derive from the improvementsin the facilities and CGMP’s in seafoodplants. Although all food manufacturingplants are required to produce foodunder sanitary conditions now, FDA’sexperience, and that of others, indicatethat many seafood processors are notproducing seafood under thoseconditions. The sanitation, monitoring,and recordkeeping provisions of thisrule are expected to drive processors toimprove their sanitation conditions andthus reduce the need for FDA to enforceCGMP’s through regulatory actions.These provisions will produce netincreases in societal welfare withaccompanying costs and benefits.

Current goods manufacturingpractices include such things ascleanliness and habits of personnel, theconditions of buildings and facilities,equipment, production and processcontrols, and conditions of warehousingand distribution of the product. It isdifficult to differentiate between costsand benefits that are HACCP-related andthose that are sanitation-related. Forexample, processors are required underHACCP to keep records that show thatCGMP’s such as ‘‘Measures such assterilizing, irradiating, pasteurizing,freezing, refrigerating, controlling pH orcontrolling aw that are taken to destroyor prevent the growth of undesirablemicroorganisms, particularly those ofpublic health significance, shall beadequate under the conditions ofmanufacture, handling, and distributionto prevent food from being adulteratedwithin the meaning of the act’’ are beingfollowed (see 21 CFR 110.80(a) (2) and(4)). However, the benefits derive frommaking plant and processing changes,uncovering problems in processing dueto recordkeeping and taking correctiveaction which prevents hazardousseafood from being sold. Thus, HACCPand CGMP’s are inextricablyintertwined and it is difficult tocalculate the marginal benefits andmarginal costs of each.

E. Costs and Benefits Attributable toForeign Governments

FDA has reported the portion of theincreased costs that are expected to bepassed on to U.S. consumers by foreignprocessors. The justification for thisaction is that FDA has not includedsafety benefits that foreign consumersmay enjoy when foreign firms thatexport to the United States introduceHACCP into their plants. FDA has alsoincluded, as a benefit of this regulation,reduced enforcement actions towardproducts produced by foreign firms andreduced illnesses that U.S. consumerssuffer from imported seafood.

In a benefit-cost analysis, costs andbenefits are attributable to choices madeamong competing options. However, inthis rule, there are difficulties inassigning the costs and benefits tochoices made by FDA to require HACCPof domestic and foreign seafoodprocessors. This difficulty arisesbecause other countries either alreadyrequire HACCP or have indicated thatthey will do so in the near future—forboth their domestic and importedseafood products. No costs or benefitsshould be ascribed to choices made bythe U.S. Government in this rule thataffect firms already complying withforeign regulations, if the regulations arethe same and no changes need to bemade to be in compliance with the U.S.regulation.

Thus, foreign firms in those countrieswho export to the United States may berequired to comply first with the U.S.plan or first with their own country’splan; the timing is impossible to predict.However, FDA does have evidence fromthe European Union that the seafoodproduced by the following countries (atleast seafood for export) have met theEU standard for HACCP— Albania,Australia, Austria, Belgium, Brazil,Canada, Chile, Columbia, Denmark,Ecuador, England, Faro Is., Finland,France, Germany, Greece, Holland,Iceland, Indonesia, Ireland, Italy, Japan,Luxembourg, Mexico, Morocco, NewZealand, Norway, Peru, Philippines,Sweden, Taiwan, Thailand, and Turkey.

F. Conclusion

As the above analysis demonstrates,FDA finds that the estimated benefitsexceed the estimated costs. Theestimated costs are approximately onethird of those in the PRIA, ranging from$677 million to $1.488 billion. Theseestimated costs were based primarily onthe reports of some seafood firms andmodeling done by FDA experts based ontheir experience with HACCP but alsoconsidered the study done undercontract with NMFS. The benefits range

from $1.435 billion to $2.561 billion andinclude benefits from safety, nutrition,increased consumer confidence, rentseeking activities, exports, and reducedenforcement costs.

G. Final Regulatory Flexibility AnalysisThe Regulatory Flexibility Act (Pub.

L. 96–354) requires analyzing optionsfor regulatory relief for small businesses.In the PRIA, FDA listed for comment aseries of regulatory options on how togrant regulatory relief for small firms. Inthat document, FDA defined small firmsas having less than $1 million in annualgross revenue (for non-shrimpprocessors) and less than $2 million forshrimp processors. In the PRIA,regulatory options for small businessrelief included:

(1) Requiring HACCP-type controls forthose critical control points inindividual plants that have a history offailure.

(2) Exempting very small processorsfrom the requirements in the proposedregulatory option.

(3) Allowing a longer implementationperiod such that HACCP requirementsmay be phased in over a longer periodof time.

(4) Providing generic HACCP plans(without mandatory control points) forcertain types of operations, providingfederal verification, or less frequentmonitoring of critical control points.

FDA received a large number ofcomments on these options and on thecosts that small businesses would incuras a result of the proposed option.

The agency has fully considered all ofthe comments received on its regulatoryflexibility analysis and has responded tothese comments in the full RIA. Whatfollows is a summary of FDA’s majorconclusions from the analysis.

FDA received comments on whetherthere should be exemptions forprocessors based on either the size ofthe processor or the degree of riskassociated with the product or process.For example, one commenter supportedthe exemption of small firms on thebasis that small firms that represent 75percent of the industry in terms of thenumber of plants, produce less than 10percent of the seafood consumed.

FDA has concluded that there shouldbe no exemptions for small firms. Smallprocessors often engage in relativelyhigh risk seafood processing, and anexemption based on size couldinappropriately exempt high riskoperations. An exemption based on riskmight entail knowing which seafoodmight be responsible for a reported andconfirmed illness. The agency findshowever that because underreportingand skewed reporting of foodborne


illnesses occurs it is not always directlypossible to relate the reported illnessesto risk. This subject is also discussed atlength in the preambles to both theproposed and final rule.

One comment recommended that nofirms be completely exempt, but thatsome firms be subject to differentHACCP requirements depending onsize. The smaller the firm, the less strictthe record-keeping, testing, andmonitoring requirements. The use of ashort form for recordkeeping andinformal monitoring was supported insome comments.

Again, this is a topic that isextensively covered in the preamble tothe final rule. FDA notes that HACCPdepends on the degree of risk andcomplexity of processing and thatHACCP requirements for each plant arecalibrated based on these factors.Whether the plant is large or small, ifthere are few hazards and simpleprocesses, HACCP requirements areinherently minimal. If there are nohazards, no HACCP plan is required.Overall, however the agency believesthat many smaller firms are associatedwith simpler processes and that theHACCP system already accommodatesthe commenter’s concern.

In the long run, as processors adoptHACCP and attempt to pass costs on toconsumers, the retail price of seafoodwill rise by less than 1 percent. In theabsence of an increase in consumerdemand that may result from thisregulation, as the price of seafood rises,consumers will purchase less seafood.As producers fail to sell all of theseafood offered at the higher price,output must fall. Moreover, output mustdecrease in the highest cost sector of theindustry, generally small processors.Although it is possible that smallprocessors will cut back production butstay in business, the small profitmargins of some small seafoodproducers strongly imply that thereduction in output will come aboutbecause small processors go out ofbusiness. For every one percent increasein the price of seafood, approximately140 small processors could go out ofbusiness. The estimated number comesfrom the following calculation. FDA hasestimated that as costs are passed on,HACCP will raise the price of seafood toconsumers. The price elasticity ofdemand, which is the percentage changein quantity purchased divided by thepercentage change in price, is estimatedto be ¥0.37 for seafood (Ref. 227). Aone percent increase in the priceconsumers pay for seafood shouldtherefore reduce the quantity purchasedby 0.37 percent (1 percent times ¥0.37).FDA believes that the entire reduction

in output attributable to HACCP will beborne by small processors who go out ofbusiness. Although close to 80 percentof seafood processors are classified assmall, small processors account for only10 percent of total industry output (Ref.228). In the case of a 0.37 percentdecline in total processing outputrepresents a decline in the output ofsmall processors of 3.7 percent (0.37percent divided by 0.10). If the declinein the number of processors wereproportional to the decline in the outputof small processors, the reduction in thenumber of processors would be 3.7percent in the case of a 1 percent priceincrease. FDA is uncertain as to whatprice increase will actually occur.

The agency finds that the number ofsmall seafood processors that go out ofbusiness will be determined by the costper unit (or per plant) of implementingHACCP, the effect of HACCP on seafoodprices, the ability of small plants to passcosts on to consumers, the currentpractices of the plants and theimplementation time. The analysis hasassumed that the regulation will haveno positive effect on the demand forseafood. If the regulation in factincreases consumer confidence inseafood sufficiently to increase thedemand for seafood, then the effect onsmall business would be less.

Although the economic impact onsmall firms is difficult to predict, manysmall firms should be able to implementHACCP at low cost, as they have alreadyfulfilled many of its basic requirements.The closer a firm’s current practices areto HACCP, the lower the cost of HACCPand the more likely is firm survival.Some small firms occupy market nichesthat allow them to pass on more of theircosts than the industry average,increasing their likelihood of survival.

The effect of HACCP on small seafoodprocessors depends on their costs ofcompliance and on the changes in therelative price of seafood. FDA expectsthe relative price increase attributable toHACCP to be small. For many smallfirms, the flexibility built into theregulation strongly implies that HACCPcosts will be low. In consideration ofsmall firms, the agency has extended theeffective date to 2 years frompublication. FDA will also bepublishing a Guide that will providesmall processors with valuableinformation for developing andimplementing HACCP. Additionally, theagency, in cooperation with Sea GrantUniversities and others through theSeafood HACCP Alliance, will beproviding to small firms assistance ontraining and other needs.

FDA recognizes that HACCP is aninnovative regulatory system that has

not been applied on a large scale toongoing commercial enterprises in theUnited States. For this reason all of theagency’s estimates of firm behavior,costs and benefits necessarily involvesubstantial uncertainty. As explained inthis Regulatory Impact Analysis, FDAhas used modeling techniques andinformed judgements rather than firmempirical data to estimate many effects.In order to determine the accuracy ofthese estimates, and also to assist inpossible mid-course corrections, FDAand HHS plan to conduct an evaluationstudy during the first few years after theeffective date of these regulations. Thisstudy could focus on each major type ofone-time or continuing compliance cost,on different types of firms, on differentsizes of firms (with particular attentionto the smallest firms), and on both costsrequired by the regulation and on coststhat firms may incur unnecessarily. Itcould also address the ability of firms tounderstand and implement HACCPproperly, and any other problems thatmay impede rapid and inexpensiveimplementation. This study could alsoinclude an exploratory analysis ofbenefits, addressing both improvementsin processing as measured byelimination of hazards and, to the extentpermitted by existing data systems,early trends in reported incidence ofillness caused by seafood.

V. Environmental Impact

The agency has previously consideredthe environmental effects of this rule asannounced in the proposed rule (59 FR4142, January 28, 1994). No newinformation or comments have beenreceived that would affect the agency’sprevious determination that there is nosignificant impact on the humanenvironment, and that an environmentalimpact statement is not required.

VI. References

The following references have beenplaced on display in the DocketsManagement Branch (address above)and may be seen by interested personsbetween 9 a.m. and 4 p.m., Mondaythrough Friday.

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List of Subjects

21 CFR Part 123

Fish, Fishery products, Imports,Reporting and recordkeepingrequirements, Seafood.

21 CFR Part 1240

Communicable diseases, Publichealth, Travel restrictions, Watersupply.

Therefore, under the Federal Food,Drug, and Cosmetic Act and underauthority delegated to the Commissionerof Food and Drugs, title 21 CFR chapterI is amended as follows:

1. New part 123 is added to read asfollows:

PART 123—FISH AND FISHERYPRODUCTS

Subpart A—General Provisions

Sec.123.3 Definitions.123.5 Current good manufacturing practice.123.6 Hazard Analysis and Hazard Analysis

Critical Control Point (HACCP) plan.123.7 Corrective actions.123.8 Verification.

123.9 Records.123.10 Training.123.11 Sanitation control procedures.123.12 Special requirements for imported

products.

Subpart B—Smoked and Smoke-FlavoredFishery Products

123.15 General.123.16 Process controls.

Subpart C—Raw Molluscan Shellfish

123.20 General.123.28 Source controls.

Authority: Secs. 201, 402, 403, 406, 409,701, 704, 721, 801, 903 of the Federal Food,Drug, and Cosmetic Act (21 U.S.C. 321, 342,343, 346, 348, 371, 374, 379e, 381, 393); secs.301, 307, 361 of the Public Health ServiceAct (42 U.S.C. 241, 242l, 264).

Subpart A—General Provisions

§ 123.3 Definitions.The definitions and interpretations of

terms in section 201 of the FederalFood, Drug, and Cosmetic Act (the act)and in part 110 of this chapter areapplicable to such terms when used inthis part, except where they are hereinredefined. The following definitionsshall also apply:

(a) Certification number means aunique combination of letters andnumbers assigned by a shellfish controlauthority to a molluscan shellfishprocessor.

(b) Critical control point means apoint, step, or procedure in a foodprocess at which control can be applied,and a food safety hazard can as a resultbe prevented, eliminated, or reduced toacceptable levels.

(c) Critical limit means the maximumor minimum value to which a physical,biological, or chemical parameter mustbe controlled at a critical control pointto prevent, eliminate, or reduce to anacceptable level the occurrence of theidentified food safety hazard.

(d) Fish means fresh or saltwaterfinfish, crustaceans, other forms ofaquatic animal life (including, but notlimited to, alligator, frog, aquatic turtle,jellyfish, sea cucumber, and sea urchinand the roe of such animals) other thanbirds or mammals, and all mollusks,where such animal life is intended forhuman consumption.

(e) Fishery product means any humanfood product in which fish is acharacterizing ingredient.

(f) Food safety hazard means anybiological, chemical, or physicalproperty that may cause a food to beunsafe for human consumption.

(g) Importer means either the U.S.owner or consignee at the time of entryinto the United States, or the U.S. agentor representative of the foreign owner orconsignee at the time of entry into the

United States, who is responsible forensuring that goods being offered forentry into the United States are incompliance with all laws affecting theimportation. For the purposes of thisdefinition, ordinarily the importer is notthe custom house broker, the freightforwarder, the carrier, or the steamshiprepresentative.

(h) Molluscan shellfish means anyedible species of fresh or frozen oysters,clams, mussels, or scallops, or edibleportions of such species, except whenthe product consists entirely of theshucked adductor muscle.

(i) Preventive measure meansphysical, chemical, or other factors thatcan be used to control an identified foodsafety hazard.

(j) Process-monitoring instrumentmeans an instrument or device used toindicate conditions during processing ata critical control point.

(k)(1) Processing means, with respectto fish or fishery products: Handling,storing, preparing, heading,eviscerating, shucking, freezing,changing into different market forms,manufacturing, preserving, packing,labeling, dockside unloading, orholding.

(2) The regulations in this part do notapply to:

(i) Harvesting or transporting fish orfishery products, without otherwiseengaging in processing.

(ii) Practices such as heading,eviscerating, or freezing intended solelyto prepare a fish for holding on boarda harvest vessel.

(iii) The operation of a retailestablishment.

(l) Processor means any personengaged in commercial, custom, orinstitutional processing of fish or fisheryproducts, either in the United States orin a foreign country. A processingincludes any person engaged in theproduction of foods that are to be usedin market or consumer tests.

(m) Scombroid toxin-forming speciesmeans tuna, bluefish, mahi mahi, andother species, whether or not in thefamily Scombridae, in which significantlevels of histamine may be produced inthe fish flesh by decarboxylation of freehistidine as a result of exposure of thefish after capture to temperatures thatpermit the growth of mesophilicbacteria.

(n) Shall is used to state mandatoryrequirements.

(o) Shellfish control authority meansa Federal, State, or foreign agency, orsovereign tribal government, legallyresponsible for the administration of aprogram that includes activities such asclassification of molluscan shellfishgrowing areas, enforcement of


molluscan shellfish harvesting controls,and certification of molluscan shellfishprocessors.

(p) Shellstock means raw, in-shellmolluscan shellfish.

(q) Should is used to staterecommended or advisory procedures orto identify recommended equipment.

(r) Shucked shellfish meansmolluscan shellfish that have one orboth shells removed.

(s) Smoked or smoke-flavored fisheryproducts means the finished foodprepared by:

(1) Treating fish with salt (sodiumchloride), and

(2) Subjecting it to the direct action ofsmoke from burning wood, sawdust, orsimilar material and/or imparting to itthe flavor of smoke by a means such asimmersing it in a solution of woodsmoke.

(t) Tag means a record of harvestinginformation attached to a container ofshellstock by the harvester or processor.

§ 123.5 Current good manufacturingpractice.

(a) Part 110 of this chapter applies indetermining whether the facilities,methods, practices, and controls used toprocess fish and fishery products aresafe, and whether these products havebeen processed under sanitaryconditions.

(b) The purpose of this part is to setforth requirements specific to theprocessing of fish and fishery products.

§ 123.6 Hazard Analysis and HazardAnalysis Critical Control Point (HACCP)Plan.

(a) Hazard analysis. Every processorshall conduct, or have conducted for it,a hazard analysis to determine whetherthere are food safety hazards that arereasonably likely to occur for each kindof fish and fishery product processed bythat processor and to identify thepreventive measures that the processorcan apply to control those hazards. Suchfood safety hazards can be introducedboth within and outside the processingplant environment, including foodsafety hazards that can occur before,during, and after harvest. A food safetyhazard that is reasonably likely to occuris one for which a prudent processorwould establish controls becauseexperience, illness data, scientificreports, or other information provide abasis to conclude that there is areasonable possibility that it will occurin the particular type of fish or fisheryproduct being processed in the absenceof those controls.

(b) The HACCP plan. Every processorshall have and implement a writtenHACCP plan whenever a hazard

analysis reveals one or more food safetyhazards that are reasonably likely tooccur, as described in paragraph (a) ofthis section. A HACCP plan shall bespecific to:

(1) Each location where fish andfishery products are processed by thatprocessor; and

(2) Each kind of fish and fisheryproduct processed by the processor. Theplan may group kinds of fish and fisheryproducts together, or group kinds ofproduction methods together, if the foodsafety hazards, critical control points,critical limits, and procedures requiredto be identified and performed inparagraph (c) of this section areidentical for all fish and fisheryproducts so grouped or for allproduction methods so grouped.

(c) The contents of the HACCP plan.The HACCP plan shall, at a minimum:

(1) List the food safety hazards thatare reasonably likely to occur, asidentified in accordance with paragraph(a) of this section, and that thus must becontrolled for each fish and fisheryproduct. Consideration should be givento whether any food safety hazards arereasonably likely to occur as a result ofthe following:

(i) Natural toxins;(ii) Microbiological contamination;(iii) Chemical contamination;(iv) Pesticides;(v) Drug residues;(vi) Decomposition in scombroid

toxin-forming species or in any otherspecies where a food safety hazard hasbeen associated with decomposition;

(vii) Parasites, where the processorhas knowledge or has reason to knowthat the parasite-containing fish orfishery product will be consumedwithout a process sufficient to kill theparasites, or where the processorrepresents, labels, or intends for theproduct to be so consumed;

(viii) Unapproved use of direct orindirect food or color additives; and

(ix) Physical hazards;(2) List the critical control points for

each of the identified food safetyhazards, including as appropriate:

(i) Critical control points designed tocontrol food safety hazards that could beintroduced in the processing plantenvironment; and

(ii) Critical control points designed tocontrol food safety hazards introducedoutside the processing plantenvironment, including food safetyhazards that occur before, during, andafter harvest;

(3) List the critical limits that must bemet at each of the critical control points;

(4) List the procedures, and frequencythereof, that will be used to monitoreach of the critical control points to

ensure compliance with the criticallimits;

(5) Include any corrective action plansthat have been developed in accordancewith § 123.7(b), to be followed inresponse to deviations from criticallimits at critical control points;

(6) List the verification procedures,and frequency thereof, that theprocessor will use in accordance with§ 123.8(a);

(7) Provide for a recordkeeping systemthat documents the monitoring of thecritical control points. The records shallcontain the actual values andobservations obtained duringmonitoring.

(d) Signing and dating the HACCPplan. (1) The HACCP plan shall besigned and dated, either by the mostresponsible individual onsite at theprocessing facility or by a higher levelofficial of the processor. This signatureshall signify that the HACCP plan hasbeen accepted for implementation bythe firm.

(2) The HACCP plan shall be datedand signed:

(i) Upon initial acceptance;(ii) Upon any modification; and(iii) Upon verification of the plan in

accordance with § 123.8(a)(1).(e) Products subject to other

regulations. For fish and fisheryproducts that are subject to therequirements of part 113 or 114 of thischapter, the HACCP plan need not listthe food safety hazard associated withthe formation of Clostridium botulinumtoxin in the finished, hermeticallysealed container, nor list the controls toprevent that food safety hazard. AHACCP plan for such fish and fisheryproducts shall address any other foodsafety hazards that are reasonably likelyto occur.

(f) Sanitation. Sanitation controls maybe included in the HACCP plan.However, to the extent that they aremonitored in accordance with§ 123.11(b) they need not be included inthe HACCP plan, and vice versa.

(g) Legal basis. Failure of a processorto have and implement a HACCP planthat complies with this sectionwhenever a HACCP plan is necessary,otherwise operate in accordance withthe requirements of this part, shallrender the fish or fishery products ofthat processor adulterated under section402(a)(4) of the act. Whether aprocessor’s actions are consistent withensuring the safety of food will bedetermined through an evaluation of theprocessors overall implementation of itsHACCP plan, if one is required.


§ 123.7 Corrective actions.

(a) Whenever a deviation from acritical limit occurs, a processor shalltake corrective action either by:

(1) Following a corrective action planthat is appropriate for the particulardeviation, or

(2) Following the procedures inparagraph (c) of this section.

(b) Processors may develop writtencorrective action plans, which becomepart of their HACCP plans in accordancewith § 123.6(c)(5), by which theypredetermine the corrective actions thatthey will take whenever there is adeviation from a critical limit. Acorrective action plan that isappropriate for a particular deviation isone that describes the steps to be takenand assigns responsibility for takingthose steps, to ensure that:

(1) No product enters commerce thatis either injurious to health or isotherwise adulterated as a result of thedeviation; and

(2) The cause of the deviation iscorrected.

(c) When a deviation from a criticallimit occurs and the processor does nothave a corrective action plan that isappropriate for that deviation, theprocessor shall:

(1) Segregate and hold the affectedproduct, at least until the requirementsof paragraphs (c)(2) and (c)(3) of thissection are met;

(2) Perform or obtain a review todetermine the acceptability of theaffected product for distribution. Thereview shall be performed by anindividual or individuals who haveadequate training or experience toperform such a review. Adequatetraining may or may not includetraining in accordance with § 123.10;

(3) Take corrective action, whennecessary, with respect to the affectedproduct to ensure that no product enterscommerce that is either injurious tohealth or is otherwise adulterated as aresult of the deviation;

(4) Take corrective action, whennecessary, to correct the cause of thedeviation;

(5) Perform or obtain timelyreassessment by an individual orindividuals who have been trained inaccordance with § 123.10, to determinewhether the HACCP plan needs to bemodified to reduce the risk ofrecurrence of the deviation, and modifythe HACCP plan as necessary.

(d) All corrective actions taken inaccordance with this section shall befully documented in records that aresubject to verification in accordancewith § 123.8(a)(3)(ii) and therecordkeeping requirements of § 123.9.

§ 123.8 Verification.(a) Overall verification. Every

processor shall verify that the HACCPplan is adequate to control food safetyhazards that are reasonably likely tooccur, and that the plan is beingeffectively implemented. Verificationshall include, at a minimum:

(1) Reassessment of the HACCP plan.A reassessment of the adequacy of theHACCP plan whenever any changesoccur that could affect the hazardanalysis or alter the HACCP plan in anyway or at least annually. Such changesmay include changes in the following:Raw materials or source of rawmaterials, product formulation,processing methods or systems, finishedproduct distribution systems, or theintended use or consumers of thefinished product. The reassessmentshall be performed by an individual orindividuals who have been trained inaccordance with § 123.10. The HACCPplan shall be modified immediatelywhenever a reassessment reveals thatthe plan is no longer adequate to fullymeet the requirements of § 123.6(c).

(2) Ongoing verification activities.Ongoing verification activitiesincluding:

(i) A review of any consumercomplaints that have been received bythe processor to determine whether theyrelate to the performance of criticalcontrol points or reveal the existence ofunidentified critical control points;

(ii) The calibration of process-monitoring instruments; and,

(iii) At the option of the processor, theperforming of periodic end-product orin-process testing.

(3) Records review. A review,including signing and dating, by anindividual who has been trained inaccordance with § 123.10, of the recordsthat document:

(i) The monitoring of critical controlpoints. The purpose of this review shallbe, at a minimum, to ensure that therecords are complete and to verify thatthey document values that are withinthe critical limits. This review shalloccur within 1 week of the day that therecords are made;

(ii) The taking of corrective actions.The purpose of this review shall be, ata minimum, to ensure that the recordsare complete and to verify thatappropriate corrective actions weretaken in accordance with § 123.7. Thisreview shall occur within 1 week of theday that the records are made; and

(iii) The calibrating of any processcontrol instruments used at criticalcontrol points and the performing of anyperiodic end-product or in-processtesting that is part of the processor’sverification activities. The purpose of

these reviews shall be, at a minimum, toensure that the records are complete,and that these activities occurred inaccordance with the processor’s writtenprocedures. These reviews shall occurwithin a reasonable time after therecords are made.

(b) Corrective actions. Processors shallimmediately follow the procedures in§ 123.7 whenever any verificationprocedure, including the review of aconsumer complaint, reveals the need totake a corrective action.

(c) Reassessment of the hazardanalysis. Whenever a processor does nothave a HACCP plan because a hazardanalysis has revealed no food safetyhazards that are reasonably likely tooccur, the processor shall reassess theadequacy of that hazard analysiswhenever there are any changes thatcould reasonably affect whether a foodsafety hazard now exists. Such changesmay include, but are not limited tochanges in: Raw materials or source ofraw materials, product formulation,processing methods or systems, finishedproduct distribution systems, or theintended use or consumers of thefinished product. The reassessmentshall be performed by an individual orindividuals who have been trained inaccordance with § 123.10.

(d) Recordkeeping. The calibration ofprocess-monitoring instruments, and theperforming of any periodic end-productand in-process testing, in accordancewith paragraphs (a)(2)(ii) through (iii) ofthis section shall be documented inrecords that are subject to therecordkeeping requirements of § 123.9.

§ 123.9 Records.(a) General requirements. All records

required by this part shall include:(1) The name and location of the

processor or importer;(2) The date and time of the activity

that the record reflects;(3) The signature or initials of the

person performing the operation; and(4) Where appropriate, the identity of

the product and the production code, ifany. Processing and other informationshall be entered on records at the timethat it is observed.

(b) Record retention. (1) All recordsrequired by this part shall be retained atthe processing facility or importer’splace of business in the United Statesfor at least 1 year after the date theywere prepared in the case of refrigeratedproducts and for at least 2 years after thedate they were prepared in the case offrozen, preserved, or shelf-stableproducts.

(2) Records that relate to the generaladequacy of equipment or processesbeing used by a processor, including the


results of scientific studies andevaluations, shall be retained at theprocessing facility or the importer’splace of business in the United Statesfor at least 2 years after theirapplicability to the product beingproduced at the facility.

(3) If the processing facility is closedfor a prolonged period between seasonalpacks, or if record storage capacity islimited on a processing vessel or at aremote processing site, the records maybe transferred to some other reasonablyaccessible location at the end of theseasonal pack but shall be immediatelyreturned for official review upondemand.

(c) Official review. All recordsrequired by this part and all plans andprocedures required by this part shall beavailable for official review and copyingat reasonable times.

(d) Public disclosure. (1) Subject tothe limitations in paragraph (d)(2) ofthis section, all plans and recordsrequired by this part are not availablefor public disclosure unless they havebeen previously disclosed to the publicas defined in § 20.81 of this chapter orthey relate to a product or ingredientthat has been abandoned and they nolonger represent a trade secret orconfidential commercial or financialinformation as defined in § 20.61 of thischapter.

(2) However, these records and plansmay be subject to disclosure to theextent that they are otherwise publiclyavailable, or that disclosure could notreasonably be expected to cause acompetitive hardship, such as generic-type HACCP plans that reflect standardindustry practices.

(e) Tags. Tags as defined in § 123.3(t)are not subject to the requirements ofthis section unless they are used tofulfill the requirements of § 123.28(c).

(f) Records maintained on computers.The maintenance of records oncomputers is acceptable, provided thatappropriate controls are implemented toensure the integrity of the electronicdata and signatures.

§ 123.10 Training.At a minimum, the following

functions shall be performed by anindividual who has successfullycompleted training in the application ofHACCP principles to fish and fisheryproduct processing at least equivalent tothat received under standardizedcurriculum recognized as adequate bythe U.S. Food and Drug Administrationor who is otherwise qualified throughjob experience to perform thesefunctions. Job experience will qualify anindividual to perform these functions ifit has provided knowledge at least

equivalent to that provided through thestandardized curriculum.

(a) Developing a HACCP plan, whichcould include adapting a model orgeneric-type HACCP plan, that isappropriate for a specific processor, inorder to meet the requirements of§ 123.6(b);

(b) Reassessing and modifying theHACCP plan in accordance with thecorrective action procedures specifiedin § 123.7(c)(5), the HACCP plan inaccordance with the verificationactivities specified in § 123.8(a)(1), andthe hazard analysis in accordance withthe verification activities specified in§ 123.8(c); and

(c) Performing the record reviewrequired by § 123.8(a)(3); The trainedindividual need not be an employee ofthe processor.

§ 123.11 Sanitation control procedures.

(a) Sanitation SOP. Each processorshould have and implement a writtensanitation standard operating procedure(herein referred to as SSOP) or similardocument that is specific to eachlocation where fish and fishery productsare produced. The SSOP should specifyhow the processor will meet thosesanitation conditions and practices thatare to be monitored in accordance withparagraph (b) of this section.

(b) Sanitation monitoring. Eachprocessor shall monitor the conditionsand practices during processing withsufficient frequency to ensure, at aminimum, conformance with thoseconditions and practices specified inpart 110 of this chapter that are bothappropriate to the plant and the foodbeing processed and relate to thefollowing:

(1) Safety of the water that comes intocontact with food or food contactsurfaces, or is used in the manufactureof ice;

(2) Condition and cleanliness of foodcontact surfaces, including utensils,gloves, and outer garments;

(3) Prevention of cross-contaminationfrom insanitary objects to food, foodpackaging material, and other foodcontact surfaces, including utensils,gloves, and outer garments, and fromraw product to cooked product;

(4) Maintenance of hand washing,hand sanitizing, and toilet facilities;

(5) Protection of food, food packagingmaterial, and food contact surfaces fromadulteration with lubricants, fuel,pesticides, cleaning compounds,sanitizing agents, condensate, and otherchemical, physical, and biologicalcontaminants;

(6) Proper labeling, storage, and use oftoxic compounds;

(7) Control of employee healthconditions that could result in themicrobiological contamination of food,food packaging materials, and foodcontact surfaces; and

(8) Exclusion of pests from the foodplant.

The processor shall correct in a timelymanner, those conditions and practicesthat are not met.

(c) Sanitation control records. Eachprocessor shall maintain sanitationcontrol records that, at a minimum,document the monitoring andcorrections prescribed by paragraph (b)of this section. These records are subjectto the requirements of § 123.9.

(d) Relationship to HACCP plan.Sanitation controls may be included inthe HACCP plan, required by § 123.6(b).However, to the extent that they aremonitored in accordance withparagraph (b) of this section they neednot be included in the HACCP plan, andvice versa.

§ 123.12 Special requirements forimported products.

This section sets forth specificrequirements for imported fish andfishery products.

(a) Importer verification. Everyimporter of fish or fishery products shalleither:

(1) Obtain the fish or fishery productfrom a country that has an activememorandum of understanding (MOU)or similar agreement with the Food andDrug Administration, that covers thefish or fishery product and documentsthe equivalency or compliance of theinspection system of the foreign countrywith the U.S. system, accurately reflectsthe current situation between thesigning parties, and is functioning andenforceable in its entirety; or

(2) Have and implement writtenverification procedures for ensuring thatthe fish and fishery products that theyoffer for import into the United Stateswere processed in accordance with therequirements of this part. Theprocedures shall list at a minimum:

(i) Product specifications that aredesigned to ensure that the product isnot adulterated under section 402 of theFederal Food, Drug, and Cosmetic Actbecause it may be injurious to health orhave been processed under insanitaryconditions, and,

(ii) Affirmative steps that may includeany of the following:

(A) Obtaining from the foreignprocessor the HACCP and sanitationmonitoring records required by this partthat relate to the specific lot of fish orfishery products being offered forimport;

(B) Obtaining either a continuing orlot-by-lot certificate from an appropriate


foreign government inspection authorityor competent third party certifying thatthe imported fish or fishery product isor was processed in accordance with therequirements of this part;

(C) Regularly inspecting the foreignprocessor’s facilities to ensure that theimported fish or fishery product is beingprocessed in accordance with therequirements of this part;

(D) Maintaining on file a copy, inEnglish, of the foreign processor’sHACCP plan, and a written guaranteefrom the foreign processor that theimported fish or fishery product isprocessed in accordance with therequirements of the part;

(E) Periodically testing the importedfish or fishery product, and maintainingon file a copy, in English, of a writtenguarantee from the foreign processorthat the imported fish or fishery productis processed in accordance with therequirements of this part or,

(F) Other such verification measuresas appropriate that provide anequivalent level of assurance ofcompliance with the requirements ofthis part.

(b) Competent third party. Animporter may hire a competent thirdparty to assist with or perform any or allof the verification activities specified inparagraph (a)(2) of this section,including writing the importer’sverification procedures on theimporter’s behalf.

(c) Records. The importer shallmaintain records, in English, thatdocument the performance and resultsof the affirmative steps specified inparagraph (a)(2)(ii) of this section. Theserecords shall be subject to the applicableprovisions of § 123.9.

(d) Determination of compliance.There must be evidence that all fish andfishery products offered for entry intothe United States have been processedunder conditions that comply with thispart. If assurances do not exist that theimported fish or fishery product hasbeen processed under conditions thatare equivalent to those required ofdomestic processors under this part, theproduct will appear to be adulteratedand will be denied entry.

Subpart B—Smoked and Smoke-flavored Fishery Products

§ 123.15 General.This subpart augments subpart A of

this part by setting forth specificrequirements for processing smoked andsmoke-flavored fishery products.

§ 123.16 Process controls.In order to meet the requirements of

subpart A of this part, processors of

smoked and smoke-flavored fisheryproducts, except those subject to therequirements of part 113 or 114 of thischapter, shall include in their HACCPplans how they are controlling the foodsafety hazard associated with theformation of toxin by Clostridiumbotulinum for at least as long as theshelf life of the product under normaland moderate abuse conditions.

Subpart C—Raw Molluscan Shellfish

§ 123.20 General.This subpart augments subpart A of

this part by setting forth specificrequirements for processing fresh orfrozen molluscan shellfish, where suchprocessing does not include a treatmentthat ensures the destruction ofvegetative cells of microorganisms ofpublic health concern.

§ 123.28 Source controls.(a) In order to meet the requirements

of subpart A of this part as they applyto microbiological contamination,chemical contamination, natural toxins,and related food safety hazards,processors shall include in their HACCPplans how they are controlling theorigin of the molluscan shellfish theyprocess to ensure that the conditions ofparagraphs (b), (c), and (d) of thissection are met.

(b) Processors shall only processmolluscan shellfish harvested fromgrowing waters approved for harvestingby a shellfish control authority. In thecase of molluscan shellfish harvestedfrom U.S. Federal waters, therequirements of this paragraph will bemet so long as the shellfish have notbeen harvested from waters that havebeen closed to harvesting by an agencyof the Federal government.

(c) To meet the requirements ofparagraph (b) of this section, processorswho receive shellstock shall accept onlyshellstock from a harvester that is incompliance with such licensurerequirements as may apply to theharvesting of molluscan shellfish orfrom a processor that is certified by ashellfish control authority, and that hasa tag affixed to each container ofshellstock. The tag shall bear, at aminimum, the information required in§ 1240.60(b) of this chapter. In place ofthe tag, bulk shellstock shipments maybe accompanied by a bill of lading orsimilar shipping document that containsthe information required in § 1240.60(b)of this chapter. Processors shallmaintain records that document that allshellstock have met the requirements ofthis section. These records shalldocument:

(1) The date of harvest;

(2) The location of harvest by Stateand site;

(3) The quantity and type of shellfish;(4) The date of receipt by the

processor; and(5) The name of the harvester, the

name or registration number of theharvester’s vessel, or an identificationnumber issued to the harvester by theshellfish control authority.

(d) To meet the requirements ofparagraph (b) of this section, processorswho receive shucked molluscanshellfish shall accept only containers ofshucked molluscan shellfish that bear alabel that complies with § 1240.60(c) ofthis chapter. Processors shall maintainrecords that document that all shuckedmolluscan shellfish have met therequirements of this section. Theserecords shall document:

(1) The date of receipt;(2) The quantity and type of shellfish;

and(3) The name and certification

number of the packer or repacker of theproduct.

PART 1240—CONTROL OFCOMMUNICABLE DISEASES

2. The authority citation for 21 CFRpart 1240 continues to read as follows:

Authority: Secs. 215, 311, 361, 368 of thePublic Health Service Act (42 U.S.C. 216,243, 264, 271).

3. Section 1240.3 is amended byrevising paragraph (r), and by addingnew paragraphs (s), (t), and (u) to readas follows:

§ 1240.3 General definitions.

* * * * *(r) Molluscan shellfish. Any edible

species of fresh or frozen oysters, clams,mussels, and scallops or edible portionsthereof, except when the productconsists entirely of the shuckedadductor muscle.

(s) Certification number means aunique combination of letters andnumbers assigned by a shellfish controlauthority to a molluscan shellfishprocessor.

(t) Shellfish control authority means aFederal, State, or foreign agency, orsovereign tribal government, legallyresponsible for the administration of aprogram that includes activities such asclassification of molluscan shellfishgrowing areas, enforcement ofmolluscan shellfish harvesting controls,and certification of molluscan shellfishprocessors.

(u) Tag means a record of harvestinginformation attached to a container ofshellstock by the harvester or processor.

4. Section 1240.60 is amended byrevising the section heading, by


redesignating the existing text asparagraph (a) and adding the word‘‘molluscan’’ before the word‘‘shellfish’’ the two times that it appears,and by adding new paragraphs (b), (c),and (d) to read as follows:

§ 1240.60 Molluscan shellfish.

* * * * *(b) All shellstock shall bear a tag that

discloses the date and place they wereharvested (by State and site), type andquantity of shellfish, and by whom theywere harvested (i.e., the identificationnumber assigned to the harvester by theshellfish control authority, where

applicable or, if such identificationnumbers are not assigned, the name ofthe harvester or the name or registrationnumber of the harvester’s vessel). Inplace of the tag, bulk shellstockshipments may be accompanied by abill of lading or similar shippingdocument that contains the sameinformation.

(c) All containers of shuckedmolluscan shellfish shall bear a labelthat identifies the name, address, andcertification number of the packer orrepacker of the molluscan shellfish.

(d) Any molluscan shellfish withoutsuch a tag, shipping document, or label,

or with a tag, shipping document, orlabel that does not bear all theinformation required by paragraphs (b)and (c) of this section, shall be subjectto seizure or refusal of entry, anddestruction.

Dated: October 3, 1995.David A. Kessler,Commissioner of Food and Drugs.Donna E. Shalala,Secretary of Health and Human Services.[FR Doc 95–30332 Filed 12–11–95; 10:40 am]BILLING CODE 4160–01–P

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65096Federal Register /Vol. 60, No. 242/Monday, … · 65096Federal Register/Vol. 60, No. 242/Monday, December 18, 1995/Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN …