[Federal Register Volume 60, Number 242 (Monday, December 18, 1995)]
[Rules and Regulations]
[Pages 65096-65202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30332]




[[Page 65095]]

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Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Parts 123 and 1240



Procedures for the Safe and Sanitary Processing and Importing of Fish 
and Fishery Products; Final Rule

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

[[Page 65096]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 123 and 1240

[Docket No. 93N-0195]
RIN 0910-AA10


Procedures for the Safe and Sanitary Processing and Importing of 
Fish and Fishery Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is adopting final 
regulations to ensure the safe and sanitary processing of fish and 
fishery products (hereinafter referred to as seafood), including 
imported seafood. The regulations mandate the application of Hazard 
Analysis Critical Control Point (HACCP) principles to the processing of 
seafood. HACCP is a preventive system of hazard control that can be 
used by processors to ensure the safety of their products to consumers. 
FDA is issuing these regulations because a system of preventive 
controls is the most effective and efficient way to ensure that these 
products are safe.

DATES: Effective December 18, 1997. Submit written comments on the 
information collection requirements by February 16, 1996.

ADDRESSES: Submit written comments on the information collection 
requirements to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Philip C. Spiller, Center for Food 
Safety and Applied Nutrition (HFS-401), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3133.
    For further information concerning the guidance entitled ``Fish and 
Fishery Products Hazards and Controls Guide,'' contact: Donald W. 
Kraemer (address above).

SUPPLEMENTARY INFORMATION: The contents of this preamble are listed in 
the following outline:

Table of Contents

I. Background
    A. The Proposal
    B. Factual Basis for the Proposal--Summary
II. The Comments
    A. Legal Basis
    1. Introduction
    2. General Authority
    3. Insanitary Conditions
    4. Records
    5. Relevance of Section 404 of the Act
    B. HACCP Pro and Con
    1. Overview
    2. The Significance of the Illness Data
    3. Exempt Specific Industry Segments?
    4. Would Voluntary HACCP be Superior?
    5. Other Issues
    C. Should Some Types of Processors be Exempt?
    1. Exempt Low Risk?
    2. Exempt Small Processors?
    D. Definitions
    1. General
    2. Cooked, Ready-to-Eat Fishery Product
    3. Critical Control Point (CCP)
    4. Critical Limit (CL)
    5. Fish
    6. Fishery Product
    7. Food Safety Hazard
    8. Harvester
    9. Importer
    10. Lot of Molluscan Shellfish
    11. Molluscan Shellfish
    12. Potable Water
    13. Preventive Measure
    14. Process Monitoring Instument
    15. Processing and Processor
    a. Vessels, carriers, and retail
    b. Warehouses
    c. Other processing operations
    16. Scombroid Toxin Forming Species
    17. Shellfish Control Authority
    18. Smoked and Smoke-Flavored Fishery Products
    E. The HACCP Plan
    1. Preliminary Steps
    2. Conducting a Hazard Analysis
    3. Types of Hazards
    4. When is a Hazard Reasonably Likely to Occur?
    5. The Plan: Specific Considerations
    6. Positive Versus Negative Recordkeeping
    7. Signing the Plan
    8. Relationship to Parts 113 and 114
    9. Sanitation in the Plan
    10. Nonsafety Issues
    11. ``Shall Render Adulterated''
    F. Corrective Actions
    1. Should Corrective Actions be Predetermined?
    2. Assessing the Product for Safety
    3. Documenting Corrective Actions
    G. Verification
    1. Overview and Comments
    2. Need for Verification Requirement in Regulations
    3. Verifying the HACCP Plan
    4. Verifying the Implementation of the Plan
    5. Product Testing
    6. Records Review
    7. Verifying the Hazard Analysis
    H. Consumer Complaints
    1. Background
    2. Consumer Complaints as Verification Tools
    3. Agency Access to Consumer Complaints
    I. Records
    1. Details and Signatures
    2. Retention and Storage
    3. Confidentiality of Records
    4. Agency Access to Records
    5. Agency Copying of Records
    J. Training
    1. The Need for Mandatory Training
    2. Who Should Provide Training?
    3. Should Training be ``Grandfathered?''
    4. Course Curriculum
    5. Do Importers Need Training?
    6. Testing and Retraining
    7. Gradations of Training
    8. Duties of the Trained Individual
    K. Sanitation
    1. Background
    2. Should the Regulations Deal with Sanitation?
    3. Why Isn't Part 110 (21 CFR Part 110) Adequate to Deal with 
Sanitation Concerns?
    4. Why Isn't the Proposed Approach Appropriate?
    5. What is the Appropriate Approach to Sanitation?
    a. Inclusion of Sanitation Controls in HACCP Plans
    b. SSOP
    6. Monitoring and Corrective Actions
    7. Records
    L. Imports
    1. Background
    2. Should Imports be Subject to These Regulations?
    3. Should Importers be Subject to These Regulations?
    4. Memoranda of Understanding (MOU's)
    5. Importer Verification Procedures
    6. Affirmative Steps: General
    7. Foreign Processor HACCP Plans
    8. Other Affirmative Steps
    9. Importer Records
    10. Determination of Compliance
    M. Guidelines or Regulations?
    1. Background
    2. Cooked, Ready-to-Eat Products and Scombroid Species
    3. Smoked and Smoke-Flavored Fishery Products
    N. Molluscan Shellfish
    1. Background
    2. Should There be Specific Requirements for Raw Molluscan 
Shellfish?
    3. Cooked Versus Raw Molluscan Shellfish
    4. Shellfish Control Authorities
    5. Shellfish From Federal Waters
    6. Tagging and Recordkeeping Requirements
    7. Other Considerations
    O. Compliance and Effective Date
    1. Effective Date
    2. Public Meetings
    3. Penalties for Noncompliance
    4. Preapproval of HACCP Plans
    5. Filing Plans With FDA
    6. Third Party-Approval
    7. The First Inspection
    8. Role of the FDA Investigator
    9. Disagreements and Appeals
    10. Status of the ``Guide''
    11. Trade with the EU
    12. Measuring Program Success
    P. Other Issues
    1. Relationship to Other Programs
    2. ``Whistleblower'' Protection
    3. Separation of Quality Control (QC) and Production
    4. Education
    5. Traceback Mechanisms
    6. Tribal Governments
    7. HACCP System Improvements
    III. Paperwork Reduction Act of 1995
    IV. Economic Impact
    A. Introduction 
    
[[Page 65097]]

    B. Costs
    1. Alternative Model for Estimating the Costs
    a. Small plant cost example 1
    i. Critical Control Points (CCP)
    ii. Corrective Actions
    b. Small Plant Cost Example 2
    2. Other Cost Reports
    3. Seafood Prices
    C. Benefits
    1. Safety Benefits
    2. Summary of Safety Benefits
    3. Nutrition Benefits from Mandatory Seafood HACCP and Increased 
Consumer Confidence
    4. Rent Seeking
    5. Export Benefits
    6. Reduce Enforcement Costs
    a. Seizures
    b. Detentions
    c. Automatic Detentions
    d. Recalls
    e. Injunctions
    7. Other Benefits
    C. Benefits
    D. Costs and Benefits of Sanitation
    E. Costs and Benefits Attributable to Foreign Governments
    F. Conclusion
    G. Final Regulatory Flexibility Analysis
    V. Environmental Impact
    VI. References
    List of Subjects

I. Background

A. The Proposal

    In the Federal Register of January 28, 1994 (59 FR 4142), FDA 
published a proposed rule to establish requirements relating to the 
processing and importing of seafood for commercial distribution in the 
United States. The requirements involved the application of HACCP 
principles by processors and importers to ensure food safety to the 
maximum extent practicable. HACCP is a system by which food processors 
evaluate the kinds of hazards that could affect their products, 
institute controls to keep these hazards from occurring or to 
significantly minimize their occurrence, monitor the performance of 
those controls, and maintain records of this monitoring as a matter of 
routine practice.
    In addition to publishing the proposed rule, FDA published in the 
Federal Register of April 7, 1994 (59 FR 16655), a notice of 
availability of draft guidelines, primarily directed toward processors, 
on how to develop HACCP controls for specific types of processing 
operations. The notice of availability requested comments on the draft. 
Among other things, these draft guidelines, which were titled the 
``Fish and Fishery Products Hazards and Controls Guide'' (the Guide), 
inventoried known likely food safety hazards associated with many 
species of seafood and many processing methods and made recommendations 
on ways to control those hazards. Comments received by FDA on the draft 
Guide are under review. The agency intends to publish the first edition 
of the Guide before the effective date of these regulations.
    FDA established on the proposed rule a comment period of 90 days, 
to end on April 28, 1994. The agency also asked for comment on the 
draft guidelines by the same date. During that comment period, FDA held 
public meetings in nine cities to help ensure that the public was aware 
of the proposal, to answer questions about its contents, and to 
encourage participation in the rulemaking process through the 
submission of comments. In addition, at these meetings, FDA staff 
explained to the public how to use the draft guidelines to develop 
HACCP controls in specific processing operations.
    The agency received several written requests for an extension of 
the comment period. After considering these requests, FDA published a 
notice in the Federal Register on April 7, 1994 (59 FR 16578), 
announcing a 30-day extension of the comment period to May 31, 1994, 
for both the proposed rule and the draft guidelines.

B. Factual Basis for the Proposal--Summary

    In the preamble to the proposed rule, FDA stated five principal 
reasons for this initiative: (1) To create a more effective and 
efficient system for ensuring the safety of seafood than currently 
exists; (2) to enhance consumer confidence; (3) to take advantage of 
the developmental work on the application of HACCP-type preventive 
controls for seafood that had already been undertaken by industry, 
academia, some States, and the Federal government; (4) to respond to 
requests by seafood industry representatives that the Federal 
government institute a mandatory, HACCP-type inspection system for 
their products; and (5) to provide U.S. seafood with continued access 
to world markets, where HACCP-type controls are increasingly becoming 
the norm.
    The preamble to the proposal cited the conclusion of a 1991 study 
on seafood safety by the National Academy of Sciences' (NAS) Institute 
of Medicine that, while most seafoods on the market are unlikely to 
cause illness to the consumer, there are significant areas of risk and 
illnesses that do occur. The study concluded that improvements in the 
current system of regulatory control are needed and repeatedly 
recommended the application of HACCP controls where warranted.
    Ensuring the safety of seafood presents special challenges to both 
the industry and the regulator. Seafood consists of hundreds of edible 
species from around the world. Depending upon species and habitat, 
seafood can be subject to a wide range of hazards before harvest, 
including bacteria and viruses, toxic chemicals, natural toxins, and 
parasites. The harvesting of previously underutilized species--a 
practice that is increasing because of the depletion of traditionally 
harvested species--can be expected to create new source and process 
hazards that must be identified and controlled.
    Unlike beef and poultry, seafood is still predominately a wild-
caught flesh food that frequently must be harvested under difficult 
conditions and at varying distances from processing, transport, and 
retail facilities. It is also subject to significant recreational 
harvest, some of which finds its way into commercial channels. As fish 
farming (aquaculture) increases, new problems emerge as a result of 
habitat, husbandry, and drug use.
    An additional complicating factor in ensuring the safety of seafood 
is the fact that no other flesh food is imported in the quantity, or 
from as many countries, as seafood. Over 55 percent of seafood consumed 
in this country is imported from approximately 135 countries. Several 
of these countries have advanced regulatory structures for seafood 
safety, but many others are developing nations that lack 
infrastructures capable of supporting national programs for seafood 
regulations comparable to those in more developed nations.
    To ensure safety, it is of utmost importance that those who handle 
and process seafood commercially understand the hazards associated with 
this type of food, know which hazards are associated with the types of 
products with which they are involved, and keep these hazards from 
occurring through a routine system of preventive controls. For the most 
part, however, seafood processors and importers are not required, 
through licensure or examination, to demonstrate an understanding of 
seafood hazards as a prerequisite to being able to do business. In 
fact, there is evidence that such an understanding does not exist in a 
significant portion of the industry. A survey conducted by FDA from 
1992 to 1993 of manufacturers of ready-to-eat seafood products revealed 
that, in significant measure, firms have not been employing the types 
of preventive processing controls necessary to ensure a safe product by 
design. FDA and State surveys have also revealed that many 

[[Page 65098]]
processors of smoked and smoke-flavored fish are operating outside of 
the parameters that have been demonstrated through scientific research 
to be necessary to ensure that the hazard from botulism is adequately 
controlled.
    Because of seafood's unique characteristics (e.g., the fact that it 
is predominantly wild caught and presents a wide range of possible 
hazards), FDA began to question whether the current Federal regulatory 
system, which was developed for the general food supply, is best suited 
for the seafood industry. Seafood processors are subject to periodic, 
unannounced, mandatory inspection by FDA. These inspections provide the 
agency with a ``snapshot'' of conditions at a facility at the moment of 
inspection, but assumptions must be made about conditions before and 
after that inspection. Concern about the reliability of these 
assumptions over the intervals between inspections creates questions 
about the adequacy of the system.
    Inspections today verify the industry's knowledge of hazards and 
controls largely by inference. Whether a company produces products that 
are adulterated, or whether conditions in its plant are consistent with 
current good manufacturing practice (CGMP), are measures of how well 
the company understands what is necessary to produce a safe and 
wholesome product. This system places a burden on the Government to 
find a problem and to prove that it exists, rather than on the firm to 
establish for itself, for the regulator, and for consumers, that it has 
adequate controls in place to ensure safety.
    Given the nature and frequency of the current inspection system for 
seafood, it has failed to produce a situation in which the public has 
full confidence in the safety and wholesomeness of these products. 
There has been a similar failure with respect to imports.
    Media and other public attention on seafood safety, and on the 
adequacy of the current regulatory program for seafood, has been 
substantial in recent years. Many hearings on the sufficiency and 
direction of the Federal seafood safety program have been held in both 
Houses of Congress since the late 1980's, and numerous bills have been 
considered for the stated purpose of improving seafood safety. This 
public concern has motivated representatives of the U.S. seafood 
industry to request that FDA develop a HACCP-based program for these 
products.
    Although not a public health issue, international trade is also a 
major consideration in determining the advisability and benefits of a 
new system of seafood regulation. Participation in the international 
trade in seafood is critical to U.S. consumers and to the U.S. seafood 
industry. The United States is the world's second largest seafood 
importing nation and the second largest exporter of fishery products.
    The international movement toward harmonization, coupled with the 
Codex Alimentarious Commission's adoption of HACCP for international 
use, clearly argue for the adoption of this approach in the United 
States for seafood. Failure by the United States to adopt a mandatory, 
HACCP-based system could ultimately undermine its export success, with 
considerable economic consequences. Such failure also would undermine 
the United States ability to meet growing international expectations 
that it enter into mutual recognition-type agreements with trading 
partners based on HACCP.

II. The Comments

    FDA received over 250 submissions from over 200 commentors on both 
the proposed regulations and the draft Guide. Individual companies, the 
majority of which are in the seafood business, submitted slightly over 
half of the comments. Nearly 40 trade associations submitted comments. 
As with the companies, the majority of these associations represent 
seafood interests, but a significant minority have memberships 
reflecting a range of food products.
    Comments were also received from consumer advocacy and similar 
groups, and coalitions of such groups. All totaled, the views of over 
50 organizations were represented in these comments.
    Other commenters included State agencies, the Association of Food 
and Drug Officials (AFDO), the Interstate Shellfish Sanitation 
Conference (ISSC), several scientific associations and bodies, 
departments of three universities, foreign governments, and about 25 
individuals.
    Overall, the comments covered virtually every aspect of the 
proposal and guidelines. FDA appreciates the effort, interest, and 
thoughtfulness reflected by these comments.
    The following materials address the significant comments that were 
received on the proposed regulations, both on the specific provisions 
of the proposal and on related matters. The materials on the provisions 
of the proposed regulations explain, among other things, why the agency 
did or did not modify the provisions based on the comments. Any 
provisions not addressed below were not changed substantively or were 
not the subject of significant comment.
    FDA will respond to those comments that relate solely to the draft 
Guide when the first edition of that document is completed and made 
available to the public. The agency intends to address those comments 
in a notice of availability to be published in the Federal Register.

A. Legal Basis

1. Introduction
    About 25 comments addressed the legal basis for these regulations. 
Nearly half of these comments were either companies that process foods 
other than seafood or trade associations that represent such companies, 
some of who indicated that they were motivated to comment, at least in 
part, by the possible precedent that these regulations could set for 
HACCP programs beyond seafood. Some of these comments deferred comment 
on the legal basis for the HACCP regulations for seafood but commented 
on whether the legal basis that FDA was proposing for seafood would be 
appropriate for mandatory HACCP programs for other kinds of foods.
    FDA is issuing these HACCP regulations for seafood under various 
sections of the Federal Food, Drug, and Cosmetic Act (the act), 
including, most significantly, 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 is adulterated if it bears or contains 
any poisonous or deleterious substance that may render the food 
injurious to health. Section 402(a)(4) of the act states that a food is 
adulterated if it has been prepared, packed, or held under insanitary 
conditions whereby it may have been contaminated with filth, or whereby 
it may have been rendered injurious to health. It is important to 
recognize that section 402(a)(4) of the act addresses conditions that 
may render a food injurious to health, rather than conditions that have 
actually caused the food to be injurious. See United States v. 1,200 
Cans, Pasteurized Whole Eggs, Etc., 339 F. Supp. 131, 141 (N.D. Ga. 
1972). The question is thus whether the conditions in a plant are such 
that it is reasonably possible that the food may be rendered injurious 
to health. The agency believes that, if a seafood processor does not 
incorporate certain basic controls into its procedures for preparing, 
packing, and holding food, it is reasonably possible that the food may 
be rendered injurious to health and, therefore, adulterated under the 
act. Section 701(a) of the act 

[[Page 65099]]
authorizes the agency to adopt regulations for the efficient 
enforcement of the act.
2. General Authority
    1. One comment stated that FDA had not met its responsibility to 
present the shortcomings in the existing law when demonstrating the 
need for these regulations.
    FDA believes that this comment is misguided. The agency's statutory 
authority is not deficient in this area. FDA does have a 
responsibility, however, to demonstrate that there is a need for the 
regulations, and that the regulations are reasonably related to the 
purposes of the act that they are designed to advance. FDA has 
fulfilled this responsibility.
    As outlined above, the act provides a broad statutory framework for 
Federal regulation to ensure human food will not be injurious to health 
and to prevent commerce in adulterated foods. As the record in this 
proceeding amply demonstrates, there is a range of circumstances and 
conditions that have raised concerns about how the safety of seafood 
sold in this country is ensured. Given these concerns and its 
responsibility under the act, FDA has concluded that it is necessary to 
require that firms incorporate certain basic measures into how they 
process seafood. The agency also concludes that failure to incorporate 
these measures into a firm's processing procedures would mean that the 
firm would be producing the product under insanitary conditions whereby 
it may be rendered injurious to health. (See United States v. Nova 
Scotia Food Products Corp., 568 F.2d 240, 247 (2d Cir. 1977).)
    2. A few comments took the view that FDA lacked the authority to 
issue these regulations because Congress had considered legislation 
relating to seafood safety in recent years but had not enacted it. Much 
of this legislation contained provisions authorizing the establishment 
of a mandatory Federal inspection program based on HACCP-type 
principles. According to the comments, Congress' failure to authorize 
this program after considering doing so indicated that the contents of 
FDA's seafood HACCP regulations remain within the domain of Congress 
and have not been delegated to FDA to implement.
    FDA does not agree with this contention. Unquestionably, seafood 
safety has received considerable attention from Congress in recent 
years, most notably in the late 1980's through the early 1990's. Many 
hearings were held on the subject in both the House of Representatives 
and the Senate during this period, and several bills were introduced in 
both chambers. The high water mark for this activity occurred at the 
end of the 101st Congress when differing seafood safety bills passed 
both chambers. These bills could not be reconciled before the end of 
the term, however, so nothing was enacted. Legislation introduced in 
the 102d Congress did not pass either chamber.
    The fact that Congress has considered the issue of seafood safety, 
however, does not preclude FDA from implementing a mandatory seafood 
HACCP program. The effect of legislation that was never enacted on a 
Federal agency's initiatives was considered in National Confectioners 
Association v. Califano, 569 F.2d 690, 693 n.9 (D.C. Cir. 1978), a case 
involving a challenge to FDA's statutory authority to issue good 
manufacturing practice regulations for candy making. The court rejected 
an argument that the existence of legislation that was not enacted that 
would have given FDA express authority to require some of the things 
that the agency included in its regulations indicated that Congress 
intended to exclude such authority from the act as it was then written. 
Instead, as will be discussed below, in upholding the validity of the 
regulations, the court looked at whether the statutory scheme as a 
whole justified the promulgation of the regulations.
    It is true that a deliberate refusal by Congress to authorize a 
specific program would at least be one factor to be weighed in 
determining the validity of a regulation. See Toilet Goods Association 
v. Gardner, 387 U.S. 158 (1967). The expiration of the 101st Congress 
before competing seafood bills could be reconciled did not, however, 
amount to a refusal on the part of Congress to authorize a mandatory 
HACCP program, including HACCP-based inspections for seafood. Thus, FDA 
concludes that there is no merit to the comments' assertion.
3. Insanitary Conditions
    3. Several comments, most of whom were trade associations or 
companies involved in the processing of products other than seafood, 
questioned whether section 402(a)(4) of the act was an appropriate 
authority upon which to base a mandatory HACCP program. Most of the 
concern hinged on whether a failure to have a HACCP plan, or to keep 
HACCP records, could really be considered an ``insanitary'' condition 
under section 402(a)(4) of the act. Some questioned whether safety 
issues relating to chemical or physical hazards, or to pesticides, 
unapproved additives, and drug residues, as included in the proposed 
regulations, could be deemed to have been the result of insanitary 
conditions. Two comments expressed the view that section 402(a)(4) of 
the act does not concern food safety generally but only safety problems 
caused by insanitary conditions.
    The relevant case law supports a broad reading of ``insanitary.'' 
In Nova Scotia, supra, 568 F.2d at 247, the court read ``insanitary'' 
to cover a wide set of circumstances necessary to ensure that food was 
not produced under conditions that may render it injurious to health. 
Specifically, the court concluded that FDA's regulations mandating 
time-temperature-salinity requirements for smoked fish products were 
within the agency's statutory authority under section 402(a)(4) of the 
act. The court rejected the argument that ``insanitary'' limited 
coverage under section 402(a)(4) of the act only to bacterial hazards 
that could enter the raw fish from equipment in the processing 
environment and not to proper processing to kill bacteria that entered 
the processing facility in the raw fish itself.
    Acceptance of a restrictive reading of section 402(a)(4) of the 
act, the court in Nova Scotia noted, would probably invalidate several 
existing FDA regulations, including those relating to the thermal 
processing of low-acid canned foods in part 113 (21 CFR part 113). When 
dealing with the public health, the court concluded, the statute should 
not be read too restrictively but consistent with the act's overall 
purpose to protect the public health. (See also United States v. Bacto-
Unidisk, 394 U.S. 784, 798 (1969); United States v. Dotterweich, 320 
U.S. 277, 280 (1943).)
    4. Notwithstanding these cases, one comment cited the case of 
United States v. General Foods Corp, 446 F. Supp 740 (1978), aff'd 591 
F.2d 1332 (2d Cir. 1978), for the proposition that a failure to have a 
HACCP plan could not alone be a violation of section 402(a)(4) of the 
act because it would not constitute insanitation.
    FDA does not agree that the General Foods case stands for this 
proposition. Rather, the court in General Foods explicitly recognized 
that ``[b]ecause the purpose of 402(a)(4) is to prevent contamination, 
or nip it in the bud, actual contamination of the finished product need 
not be shown.'' Id. at 752. Significantly, the court appeared to be 
impressed with the preventive controls that were in place in the 
defendant's plant and took these into consideration in deciding that 
the agency had failed to prove that section 402(a)(4) of the act had 
been violated. However, the court did not deal at all with the limits 
on 

[[Page 65100]]
FDA's authority to do rulemaking under sections 402(a)(4) and 701(a) of 
the act to establish standards for such preventive controls.
    Thus, it is not inconsistent with General Foods for FDA to adopt 
HACCP regulations that are designed to define the minimum steps that a 
seafood processor must take to ensure that the food that it produces is 
not prepared under conditions that may render it injurious to health. 
Clearly, given the risks inherent in many seafood operations, if a 
processor does not identify the critical control points in its process, 
and does not monitor what goes on at those points, there is a 
reasonable possibility that the food that it produces will be injurious 
to health.
    A primary objective of the seafood HACCP regulations is to 
establish a system of preventive controls for human food safety. The 
HACCP plan is a fundamental step in the development of these controls. 
It is the step in which the manufacturer analyzes its process, 
identifies the points at which problems may occur, and establishes the 
parameters that must be met if those problems are to be avoided. Thus, 
failure to have a HACCP plan would, in fact, constitute an ``insanitary 
condition'' as this term must be understood in light of the relevant 
case law.
    Section 402(a)(4) was added to the act to ensure ``the observance 
of those precautions which consciousness of the obligation imposed upon 
producers of perishable food products should require in the preparation 
of food for consumption by human beings.'' Hearings before the Senate 
Committee on Commerce, S. 2800, 73d Cong., 2d Sess., Mar. 1934, as 
cited in United States v. 1,200 Cans, Pasteurized Whole Eggs, Etc., 
supra, 339 F. Supp. 140-141. Clearly, HACCP reflects the emerging, 
internationally recognized understanding of the precautions necessary 
to produce safe food. These regulations embrace HACCP and provide 
processors with directions for establishing HACCP systems and operating 
them as a matter of routine custom and habit that will ensure the 
safety of the food that they produce. Thus, FDA finds that operation 
under an effective HACCP system is necessary to meet a processor's 
obligation under section 402(a)(4) of the act.
4. Records
    In Confectioners, the court upheld FDA's authority to issue 
regulations under section 402(a)(4) of the act that included 
recordkeeping requirements. The recordkeeping provisions of the 
regulations were challenged on the grounds that they would permit 
prosecution where processing conditions were completely sanitary, but 
the records were deficient. Such an outcome, it was argued, would be 
beyond the scope of section 402(a)(4) of the act.
    Citing Toilet Goods, the court rejected this argument and held that 
the primary consideration was whether the statutory scheme as a whole, 
not just section 402(a)(4) of the act, justified the agency's 
regulations. The court pointed out that this consideration involved an 
inquiry into practicalities as well as statutory purpose, i.e., 
enforcement problems encountered by FDA and the need for various forms 
of supervision in order to accomplish the goals of the act.
    5. Two comments expressed the view that the holding in 
Confectioners should be limited to the specific facts in that case. One 
comment stated that the case only upheld FDA's authority to impose 
recordkeeping requirements on firms to facilitate recalls of 
potentially dangerous products. The other comment noted that the case 
only granted FDA access to shipping records. The comment pointed out 
that FDA already has access to such records from carriers under section 
703 of the act.
    While it is true that the records that FDA was requiring, and to 
which the agency claimed access under the regulations involved in 
Confectioners, were source coding and distribution records in order to 
facilitate recalls, the court's ruling involved broad principles 
relating to the validity of the regulations generally and was not 
limited to recalls or shipping records. The court stated that in light 
of the statutory scheme as a whole, ``we find no basis for the 
Association's distinction between the FDA's role in preventing and 
remedying commerce in adulterated foods. The agency believes that the 
Act imposes on the FDA an equal duty to perform each role.'' Id. at 
694. This statement simply is not consistent with the narrow reading 
suggested by the comment. Rather, it fully supports FDA's authority to 
adopt regulations to prevent the introduction of adulterated foods into 
interstate commerce. Clearly, compliance with FDA's seafood HACCP 
regulations will help to achieve that end.
    It is also true, as one comment pointed out, that section 703 of 
the act expressly grants FDA access to shipping records and not to the 
kinds of processing records required in these regulations. FDA cannot 
agree, however, that Confectioners stands for the proposition that FDA 
should have access only to food manufacturers' shipping records because 
those are the only kinds of records to which FDA has access under 
section 703 of the act. The court concluded that the narrow scope of 
section 703 of the act is not a limitation on the right of the agency 
to require recordkeeping and have access to records that are outside 
the scope of section 703 of the act, so long as the recordkeeping 
requirement is limited, clearly assists the efficient enforcement of 
the act, and the burden of recordkeeping is not unreasonably onerous 
(569 F.2d at 693 n.9).
    The recordkeeping required under these regulations passes the 
Confectioners test. First, the recordkeeping requirements are limited. 
The HACCP recordkeeping and record access requirements in the final 
rule are tied specifically to the critical control points (CCP's) in 
the manufacturing process. In other words, the recordkeeping 
requirements are limited to those points in the process at which 
control is essential if assurance that the resultant product will not 
be injurious to health is to be achieved.
    Second, the recordkeeping assists in the efficient enforcement of 
the act. The recordkeeping requirements, by focusing on the CCP's, 
ensure that the processor and the agency focus on those aspects of 
processing that most jeopardize food safety. Unlike the current 
inspection system, recordkeeping in a HACCP-type system documents that 
preventive controls are being followed and enables the regulator to 
verify this fact. Such a system, therefore, assists in effective and 
efficient enforcement of the act.
    Finally, the HACCP-recordkeeping burden is not unduly onerous. It 
is limited to those aspects of processing that are critical to food 
safety. Documentation that control is being maintained over these 
aspects of processing need only be a minor additional step in most 
instances. The documentation required in the final rule is narrowly 
tailored to ensure that only essential information needs to be 
recorded.
    6. Several comments questioned whether FDA may have access to HACCP 
records and plans on the grounds that the act does not explicitly 
authorize such access. Some of these comments pointed to the lack of 
authorization in section 704 of the act (21 U.S.C. 74), the provision 
that authorizes the inspection of food processors and other types of 
establishments. The comments pointed out that section 704 of the act 
authorizes agency access to certain records relating to prescription 
drugs and medical devices during the course of those inspections but 
not to records relating to 

[[Page 65101]]
foods. One comment felt that the specific grant of records access for 
drugs and devices in section 704 of the act precluded expansion of 
access to records not specifically mentioned in the act. Other comments 
felt that FDA was barred from access simply because the act does not 
expressly grant it.
    FDA does not agree, as the agency's authority under sections 402 
and 701(a) of the act to issue these regulations provides ample 
authority for records access. The line of cases cited above stands for 
the proposition that a lack of explicit delegated authority does not 
invalidate agency regulations so long as the regulations are consistent 
with the act's overriding purpose. In Confectioners, the court upheld 
FDA's authority to adopt recordkeeping requirements in the absence of 
an explicit delegation of authority. In that case, moreover, the court 
found no evidence that Congress intended to immunize food processors 
from limited recordkeeping (569 F.2d at 695). Similarly, the court in 
Nova Scotia concluded, in the absence of such evidence, that there was 
no impediment to a broad reading of the statute based on the general 
purpose of the Congress in protecting public health (568 F.2d at 248).
    FDA has concluded, therefore, that these regulations are consistent 
with section 704 of the act and with the act as a whole. Because the 
preventive controls required by HACCP are essential to the production 
of safe food as a matter of design, the statutory scheme is benefited 
by agency access to records that demonstrate that these controls are 
being systematically applied. The case law supports FDA's authority to 
require such recordkeeping and to have access to such records.
    Other countries, including Canada, the European Union (EU) Norway, 
Australia, and New Zealand, which have already implemented HACCP-type 
systems, have deemed it necessary to the success of their systems to 
provide for recordkeeping and record access along the lines of this 
regulation (for either their entire seafood industries or seafood 
export industries). Thus, it is widely accepted that recordkeeping and 
inspectional access are essential components of a HACCP-type seafood 
system. In addition, in order to maintain other countries' faith in the 
safety standards of U.S. seafood exports, FDA needs similar access to 
records showing HACCP implementation.
    7. One comment expressed the view that the copying of records by 
FDA, as authorized by these regulations, is beyond the scope of section 
704 of the act.
    FDA points out that it is not acting under section 704 of the act. 
To effectuate the broad purposes of the act, there may be some 
circumstances in which access to the records would be meaningless 
without the opportunity to copy them. While the agency does not 
anticipate that copying will be necessary in most instances, perhaps 
the most readily predictable circumstance in which copying would be 
necessary is when an investigator needs assistance from relevant 
experts in headquarters to evaluate the record. Without copying, it 
would be necessary for the agency to rely solely on the notations and 
report of the investigator.
    This reliance may not be adequate in many circumstances. For 
example, there may be a deviation from a critical limit (CL) that poses 
no health risks. Without the ability to show a copy of the records to 
someone within the agency with the necessary expertise in the area, an 
investigator would have to cite the company for a violation. If, 
however, an agency expert determined that the deviation posed no safety 
risks, the agency could use its enforcement discretion not to pursue a 
violation.
    8. One comment expressed the view that the act does not support a 
mandatory HACCP program that includes access to records for the entire 
seafood industry. According to the comment, the act permits FDA access 
to records only under extreme conditions where there is a potential for 
injury, but, the comment noted, hazards are only associated with a 
small percentage of fish.
    FDA cannot agree. While it is true that those seafood-related 
illnesses that are reported to public health authorities tend to be 
associated with a limited number of species, potential hazards are much 
broader. As indicated above, the 1991 NAS report on seafood safety 
provides an extensive inventory of hazards.
    For the benefit of the commentor it is worth noting that if a 
processor is involved with species and processes for which there are no 
food safety hazards that are reasonably likely to occur, a HACCP plan 
will not be necessary under these regulations. As will be discussed 
later in this preamble, the agency anticipates a post-implementation 
dialog with firms on whether they have hazards that must be controlled 
in accordance with these regulations and, if so, how many.
    9. One comment expressed the view that the authority to inspect 
ordinary food records has not been asserted before. This statement was 
made in support of the contention that there is no statutory basis for 
FDA access to ordinary food records.
    The legal basis for FDA's access to records has already been fully 
addressed in this preamble. It is important to note that the agency is 
not claiming a right of access to food records coextensive with that 
for drugs and devices under section 704 of the act. Rather, FDA is 
asserting a right to access to records that is narrowly tailored to 
advance the purposes of the sections of the act that it is implementing 
here, i.e., records relating to the CCP's in a firm's process.
    While the agency is not sure what the comment meant by ``ordinary'' 
food records, it is worth pointing out that the position in this 
regulation on agency access to records is a longstanding interpretation 
for regulations of this type. Agency access to processing and 
production records has been required since the early 1970's in FDA's 
regulations for thermally processed low-acid foods packaged in 
hermetically sealed containers (part 113) and for acidified foods part 
114 (21 CFR 114). As discussed in the new section, these regulations 
were issued primarily under the authority of both sections 402(a)(4) 
and 404 of the act (21 U.S.C. 344), neither of which specifically 
mention access to records.
5. Relevance of Section 404 of the Act
    10. Several comments expressed the view that FDA should base HACCP 
regulations on section 404 of the act rather than on section 402(a)(4) 
of the act. Some of these comments were referring to these seafood 
HACCP regulations, while others were primarily concerned with any HACCP 
regulations that FDA might issue for other foods. Other comments 
expressed the view that FDA's existing low-acid canned food regulations 
should serve as a model for new HACCP programs. Because some of the 
low-acid canned food regulations have been issued under section 404 of 
the act, all of these comments may have been making the same general 
point.
    Most of those that advocated use of section 404 of the act as the 
legal basis expressed concerns about the appropriateness of relying on 
section 402(a)(4) of the act and the narrow grants of access to records 
in the act, especially in section 704 of the act, and concluded that 
the act only grants the agency access to records under extreme 
situations. One comment urged that FDA issue the seafood HACCP 
regulations under the authority of section 404 of the act in order to 
enhance the agency's ability to achieve compliance through the permit 
system. 

[[Page 65102]]

    Section 404 of the act is entitled ``Emergency Permit Control.'' It 
authorizes FDA to establish a permit system for processors of food that 
may be injurious to health when two conditions are met: (1) 
Contamination is with microorganisms, and (2) the injurious nature of 
the product cannot be adequately determined after the product enters 
interstate commerce. Section 404 of the act authorizes FDA to inspect 
firms that operate under this permit system but does not mention 
records or FDA access to records.
    As indicated previously, FDA has issued regulations under this 
authority. Regulations at part 108 (21 CFR part 108) subpart A 
establish the permit system generally. Regulations at part 108 subpart 
B establish that acidified foods and thermally processed low-acid foods 
in hermetically sealed containers (i.e., low-acid canned foods, or 
``LACF'') meet the criteria in section 404 of the act and are therefore 
subject to the permit system. Subpart B requires processors of these 
foods to register with FDA and to submit detailed information to FDA on 
their manufacturing processes.
    As an adjunct to these regulations, FDA has also issued the 
regulations, referred to previously, at part 113 and part 114 for these 
products. These latter regulations require the maintenance of day-to-
day processing records that are retained by the processor and are in 
addition to the processing information that must be sent to FDA. FDA 
investigators have access to, and may copy, these records 
(Secs. 108.25(g) and 108.35(h)).
    While the permit system may have some compliance advantages, as 
pointed out by one comment, there are other considerations in this case 
that are more important. The permit system is, as the title of section 
404 of the act declares, an ``emergency'' system. Because it is an 
extreme remedy for extreme situations, FDA has used section 404 of the 
act relatively sparingly.
    In the case of seafood, although FDA strongly believes that a HACCP 
system will correct deficiencies in the current system and provide 
significant further assurance of safety, the agency cannot conclude 
that seafood is in an overall state of emergency from a public health 
standpoint. This conclusion is consistent with the position taken by 
the NAS. The NAS' Institute of Medicine, in its 1991 report entitled 
``Seafood Safety,'' devoted hundreds of pages to areas of risk and made 
numerous recommendations about control measures, including the 
application of HACCP where appropriate. 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 than an exceptional remedy for an extreme situation. A 
functioning HACCP system reflects an understanding of the wide range of 
hazards to which seafood may always be subject and provides for a 
systematic application of the preventive controls necessary to minimize 
the occurrence of those hazards. It is the most effective and efficient 
way known of ensuring food safety as a matter of design. In this 
regard, FDA has concluded that, for seafood, the efficient enforcement 
of the act should not have to depend on a finding of an emergency under 
section 404 of the act.
    It is also worth noting that section 404 of the act would limit the 
application of HACCP to hazards by reason of contamination from 
microorganisms. FDA is not aware of any HACCP expert or authoritative 
body, including the National Advisory Committee for Microbiological 
Criteria for Foods (NACMCF), which advocates limiting HACCP to these 
hazards only. A full discussion of hazards to which seafood HACCP 
should apply appears later in this preamble.
    FDA does not agree that section 404 of the act is the only basis 
for these seafood HACCP regulations, or that it would be a more 
appropriate basis. It is not clear, moreover, how section 404 of the 
act can be cited as supporting the proposition that the agency only has 
access to records in extreme situations. As indicated earlier, section 
404 of the act contains no express grant of access to records. Again, 
FDA has concluded from the case law that, under appropriate 
circumstances, the agency has access to specific types of records on 
foods and food processing for specific purposes, where such access is 
not expressly provided for in the act, but the agency cannot conclude 
that this right is limited to extreme situations. Some of the comments 
provided examples of extreme situations to which HACCP regulations 
should be limited from their standpoint. These examples raise important 
issues that will be addressed elsewhere in this preamble.
    11. Two comments expressed the view that the LACF regulations 
should serve as a model for the types of records that would be 
accessible under HACCP regulations.
    FDA did in fact use the LACF regulations as a model in that regard. 
The HACCP plan required here is similar to the scheduled processes that 
processors must submit in the LACF regulations. Likewise, there is 
little difference between the HACCP-monitoring records required here 
and the day-to-day processing records that are required in LACF 
regulations.

B. HACCP Pro and Con

1. Overview
    Nearly half of the comments included specific statements of support 
or opposition for the concept of a mandatory HACCP program to ensure 
the safety of seafood. The supporters outnumbered the opponents by over 
10 to 1.
    Nearly all of those who supported the approach also had technical 
comments on various provisions in the proposal. Some conditioned their 
support on the availability of additional enforcement authorities or 
resources for FDA. These aspects of their comments will be responded to 
elsewhere in this preamble. A small number of these comments supported 
the concept of a mandatory HACCP program for seafood but opposed the 
proposal as drafted.
    The supporters of the concept included most of the seafood trade 
associations that commented, businesses, consumer advocacy 
organizations, Federal and State agencies, professional societies, 
academics, and a member of Congress. The reasons for this support 
included: Enhancement of consumer confidence, the superiority of HACCP-
type preventive controls over traditional CGMP-type controls and end-
product sampling, the view that HACCP is the most efficient and 
effective way to ensure safety, and the view that a mandatory HACCP 
system reflects an appropriate assigning of primary responsibility to 
industry for producing safe food. Other reasons included a leveling of 
the competitive playing field, both domestically and internationally; 
the need for prompt adoption of a mandatory HACCP program by FDA to 
enable the seafood industry to maintain its market position in Europe 
and elsewhere throughout the world; greater productivity; and increased 
industry control over processing.
    One large seafood trade association stated:

    [The association] strongly supports the adoption of a 
comprehensive regulatory program by the FDA which is designed for 
fish and seafood using HACCP principles. HACCP systems have been 
applied successfully by individual firms in our industry, and they 
have been shown to be a very cost-effective way of controlling 
safety hazards. Of equal importance, the adoption of a HACCP-based 
regulatory program should lead to more effective and efficient use 
of FDA resources, and less disruption of the processing and 
importing of seafood for consumers.


[[Page 65103]]

    A small number of comments expressed opposition to the mandatory 
HACCP approach for seafood, however. One State comment expressed the 
view that HACCP would not have any significant effect on reducing 
illnesses from molluscan shellfish. Another comment stated that, 
overall, seafood-related illness data do not justify mandatory HACCP 
for seafood. (Several other comments questioned the need for these 
regulations in light of the NAS' conclusion that commercial seafood is 
generally safe. These comments either generally opposed the proposed 
regulations as drafted, or opposed its application to the comments' 
segments of the seafood industry, but did not express opposition to 
mandatory HACCP as a concept.) None of these comments supplied any new 
seafood-related illness data.
2. The Significance of the Illness Data
    The preamble to the proposed regulations described broadly what is 
known and not known about the extent of seafood-related illness in the 
United States. Foodborne illnesses tend to be significantly 
underreported to public health authorities. Consequently, precise data 
on the numbers and causes of foodborne illness in this country do not 
exist. FDA does know, however, that illness from seafood does occur, 
and that a wide variety of hazards have been identified that could 
cause illness from seafood (see Ref. 7, pp. 1-13). The overwhelming 
majority of these hazards are amenable to preventive controls. FDA's 
draft Guide addresses controls for over 20 specific types of safety 
hazards.
    The primary purpose of these regulations is to ensure that 
preventive controls are systematically applied in seafood processing as 
a matter of routine custom and usage, and in a way that can be verified 
by company management as well as by regulatory authorities. Thus, while 
the reported illness data are highly relevant to whether these 
regulations should be issued, they are not the sole basis for the 
regulations.
    For molluscan shellfish in particular, FDA agrees with the 
commenters who believe that the principles of the National Shellfish 
Sanitation Program (NSSP) should continue to form the basis for the 
molluscan shellfish safety program in this country. There is no clear 
alternative to proper water classification and patrol by State 
authorities as the basis for molluscan shellfish safety. HACCP provides 
processors with an excellent system for ensuring that these preventive-
type controls are adhered to in a systematic way.
    It may be argued--and some comments made the point--that the best 
way to reduce the overall number of illnesses from raw molluscan 
shellfish is to provide additional resources to the States to enhance 
their water classification and monitoring abilities. Classifying and 
patrolling shellfish harvesting waters are important means of 
preventing molluscan shellfish that have been contaminated from sewage 
from entering the marketplace. However, additional Federal resources 
will probably not be available for this purpose in the foreseeable 
future. It is imperative, therefore, that the system that is in place 
be made as efficient as possible.
    It would be incongruous to exempt from a national system of 
preventive controls the processors of products identified by the NAS as 
the source of the greatest numbers of seafood-associated illnesses. FDA 
strongly believes that HACCP controls will help shellfish processors 
and regulators alike to better focus on potential safety problems and 
less on tangential matters than historically has been the case. A full 
discussion of the application of HACCP to raw molluscan shellfish 
appears later in this preamble.
3. Exempt Specific Industry Segments?
    12. Comments stating that HACCP systems should not be mandated for 
specific industry segments usually referred to either the crab 
processing or the catfish industries. These comments generally 
expressed the view that HACCP requirements for these industries were 
not necessary.
    FDA advises that these regulations are flexible enough so that 
HACCP-type controls are not required where they are not necessary, 
i.e., where it is reasonably likely that hazards do not exist. It is 
the agency's experience, however, that there are reasonably likely 
hazards associated with crabmeat as a cooked, ready-to-eat product, 
including the growth of pathogens as a result of time-temperature abuse 
of the product and the potential for pathogen survival from inadequate 
pasteurization. There are reasonably likely hazards associated with the 
processing of catfish (e.g., contamination from agricultural chemicals, 
improperly used aquaculture drugs, and a variety of hazards resulting 
from the in-plant processing operations). It is incumbent on processors 
of these products to know and control such hazards.
    The agency recognizes that whether reasonably likely hazards exist 
involves case-by-case determinations. As will be discussed in the 
``HACCP plan'' section of this preamble, processors will be given every 
opportunity to demonstrate why no hazards exist in their operations.
4. Would Voluntary HACCP Be Superior?
    13. Some comments believed that a voluntary approach to HACCP for 
seafood would be preferable to a mandatory approach. One reason given 
for this view was that, under a mandatory system, the risk of 
regulatory action by FDA would compel processors to design HACCP 
controls that were the minimum necessary to comply with the rule. There 
would be a significant disincentive for processors to design HACCP 
plans that have the greatest practical impact on food safety out of 
fear that occasional failure to meet those higher standards would 
trigger a regulatory response.
    If voluntary HACCP systems were already universal, or nearly so in 
the seafood industry, and they generally applied safety controls that 
were beyond the minimum needed for safety, FDA would see little reason 
to establish a mandatory system. However, HACCP is not the norm, and 
given the current situation in the seafood industry, FDA finds that 
making HACCP mandatory is necessary to ensure that safe, wholesome, and 
unadulterated product is produced. Thus, FDA is adopting part 123 (21 
CFR part 123).
    The agency acknowledges the possibility that, under a mandatory 
system, firms will perceive that they are on safer ground with FDA if 
they establish minimum acceptable controls that are more easily met, 
rather than more stringent controls that are beyond the minimum 
necessary to ensure safety and, therefore, are harder to meet. For 
example, in deciding what CCP's to identify in a HACCP plan, a 
processor might err on the side of inclusion under a voluntary plan but 
keep the number of CCP's down to the minimum acceptable to FDA if 
having a plan is mandatory.
    It remains to be seen whether processors will really choose to 
behave this way under a mandatory system. The choices that processors 
will make may depend, in part, on FDA policy toward HACCP plans that 
are beyond the minimum. The logic in favor of the agency initiating 
regulatory action when a processor fails to meet its own CL but 
succeeds in meeting a minimum level that would have been an acceptable 
CL to FDA, would be that the firm is out of control vis a vis its own 
preventive process. The logic against initiating regulatory action 
would be that the processor is still in control in terms of meeting 
minimum necessary safety parameters, and that the product is, in 

[[Page 65104]]
FDA's opinion, safe to eat. As an additional factor, FDA does not want 
to discourage firms from establishing preventive controls for 
themselves that are beyond the minimum necessary to ensure safety.
    In evaluating monitoring records, FDA will first determine whether 
the recorded values are within the processor's critical limits as set 
out in its HACCP plan. Where values are found that are outside the 
CL's, the agency will determine the cause and extent of such 
occurrences, and what corrective action, if any, the processor has 
taken. Where product that was involved in a CL deviation was 
distributed without first being subjected to appropriate corrective 
action, FDA will determine the cause and extent of the control failure.
    In determining the appropriate agency regulatory response to CL 
deviations, FDA will assess the public health risk that the product 
poses. This assessment will, in part, involve a determination of 
whether the minimum limit necessary to ensure safety was breached. FDA 
acknowledges that this level and the processor's CL may not always be 
the same. The agency is not likely to take action against a product 
that it finds poses no significant public health risk, regardless of 
whether it has or has not met the processor's CL.
    Nonetheless, processors must establish controls to ensure that 
appropriate corrective actions are taken when their CL's are breached. 
Where such controls fail, FDA expects processors to redesign their 
control mechanisms as necessary. Chronic failure to appropriately 
respond to CL deviations demonstrates that a processor's HACCP system 
is inadequate, and that fact could cause FDA to have some regulatory 
concern.
    14. Another comment urged that HACCP for seafood should be 
voluntary on the grounds that FDA lacks the resources and statutory 
enforcement authorities to operate a mandatory system. Other comments 
expressed the same types of concerns about FDA resources and 
enforcement authorities without concluding that a voluntary system 
would be preferable. One comment, from a consumer advocacy organization 
representing several other organizations, supported the concept of a 
mandatory HACCP system but expressed reservations about FDA's ability 
to adequately perform HACCP-based inspections of processors without 
additional resources. Other commenters expressed the same kinds of 
concerns. The comment pointed out that because HACCP inspections will 
take longer than current inspections, the intervals between inspections 
will increase significantly, creating ``an unenforced industry honor 
system.'' The commenter, and some others, also advocated additional 
enforcement authorities.
    The success of this program will depend on a number of factors. One 
of these factors, unquestionably, will be the ability of a regulatory 
authority, or authorities, to adequately monitor processors' HACCP 
systems through inspections. If the frequency of inspections is too 
low, safety may not be ensured, consumer confidence may be eroded, and 
the accusation that the program is self-regulatory may have merit, even 
though a HACCP-based inspection allows the investigator to view a 
firm's critical operations over time, not just at the moment of the 
inspection.
    The use of a HACCP-based system bears on the adequacy of FDA's 
inspection resources in two important respects. The first is the effect 
of the use of HACCP-based inspections on inspection frequencies. The 
time needed to conduct a HACCP-based inspection will undoubtedly vary 
depending on the number of hazards, complexity of the operation, and 
other factors. The first round of HACCP inspections will likely take 
longer--possibly as much as twice as long in high-risk and complex 
operations--as the CGMP-based inspections FDA presently conducts, but 
the time-per-inspection is likely to drop significantly thereafter. It 
remains to be seen whether inspection times will eventually shorten to 
current times, or whether HACCP-based inspections will always take 
longer on average. In any event, FDA finds some merit in the comments' 
basic concerns about inspection frequencies.
    Second, as a countervailing matter, a HACCP-based inspection can be 
a more efficient and effective inspection than a CGMP-based inspection, 
largely because it can be highly focused on matters that are critical 
to safety, and because access to key safety monitoring records allows 
the investigator to evaluate the process over time. Thus, some 
compensation for increased intervals between inspections will be 
provided by the fact that the investigator gets not merely a snapshot 
of the operation of the plant in time but a broad view of how the plant 
has been operated over the preceding months or even years, as reflected 
in the plant's records. Thus, FDA concludes that, on balance, the 
somewhat longer inspection intervals that might occur under a HACCP-
based system would be fully compensated for by the broader view 
provided by a HACCP-based inspection.
    In addition, FDA intends to increase the frequency and improve the 
consistency of processor inspections through HACCP-based work sharing 
partnerships with the States. One of the agency's goals is for these 
regulations to serve as a basis for partnerships that involves a 
pooling of resources.
    While FDA acknowledges the comments' concerns about resources, the 
agency would not agree that the HACCP program should be abandoned 
because of resource constraints. Quite the contrary, resource 
constraints make it imperative that FDA seafood inspections be based on 
the most effective and efficient system devised to date. HACCP is that 
system. Moreover, the agency believes that there is enough flexibility 
in a HACCP-based inspection system to permit gradations in 
implementation (e.g., focusing on the most extreme hazards; selectively 
reviewing records) to accommodate whatever resource situation exists at 
any given moment.
    With regard to enforcement authorities, as made clear above, the 
act provides ample authority for the establishment and implementation 
of a HACCP-based system by FDA. Regardless of whether additional 
authorities might be desirable, there simply is no reason for FDA not 
to proceed to establish and implement a HACCP-based system forthwith.
    15. Another comment expressed opposition to mandatory HACCP for the 
seafood industry on the grounds that HACCP diverts the responsibility 
for ensuring a safe product from the government to the fish processors.
    FDA's intent is not to transfer its legitimate responsibilities 
with regard to food safety to the regulated industry. In point of fact, 
the industry already has responsibility under the law to produce a safe 
product. HACCP helps to clarify, however, how responsibility for human 
food safety is divided between industry and the regulator.
    Industry, as stated above, must take primary responsibility for the 
production of safe food, while the regulator must be responsible for 
setting standards (including program regulations such as these), 
verifying that the industry is doing its job, and taking remedial 
action when it is not. HACCP requires that the industry be aware of the 
human food safety hazards that are reasonably likely to occur, and that 
industry operate under a system that is designed to ensure that those 
hazards are not realized. Thus, HACCP enables the industry to 
demonstrate that it is meeting its legitimate responsibilities. 

[[Page 65105]]

5. Other Issues
    16. One comment supported the concept of HACCP but expressed the 
view that the regulation drafting process should be started over by 
forming a committee consisting of representatives from various segments 
of the seafood industry, and appropriate government and university 
personnel. A few other comments expressed the view that FDA had acted 
too quickly in issuing the proposed regulations and also requested that 
FDA start over by engaging in discussions with industry, foreign 
regulatory agencies, academia, and consumers. These latter comments, 
which were mostly from companies not primarily involved in the 
processing of seafood, preferred a voluntary approach to HACCP, with 
mandatory applications only in exceptional situations. FDA did not act 
too quickly, or without appropriate consultation, in issuing the 
proposal in this proceeding. As the preamble to the proposed rule 
documented at some length, the proposal was the culmination of an 
extensive process by FDA and others, including the seafood industry 
itself, that led major representatives of that industry to request the 
issuance of the proposal. Before that, industry trade associations 
testified repeatedly before Congress in the late 1980's through the 
early 1990's in support of legislation that would have required a 
mandatory inspection system for seafood based on HACCP principles.
    FDA participated in pilot programs in the past such as the seafood 
HACCP pilot conducted jointly by FDA and the National Marine Fisheries 
Service (NMFS) of the Department of Commerce (DOC) in 1990 to 1991. In 
addition, FDA ran programs with seven other countries. In developing 
these regulations, the agency also took advantage of information from 
the Model Seafood Surveillance Project (MSSP). The MSSP was conducted 
by the DOC at the request of Congress in 1986 to design an inspection 
system for seafood consistent with HACCP principles. As part of the 
MSSP project, 49 workshops were conducted involving 1,200 industry, 
State, and university participants. Canada currently has a HACCP 
system, and the EU has issued directives that move in that direction. 
The agency has concluded that sufficient field trials have already 
taken place to conclude that HACCP is a viable method of hazard control 
for the seafood industry.
    Public input into the development of the HACCP approach contained 
in these regulations has been substantial. As described earlier in this 
preamble, FDA engaged in a series of ``town meetings'' in nine cities 
across the country shortly after the proposal was published in order to 
answer questions about the proposed regulations and encourage comments. 
The public response to FDA's proposal contributed substantially to the 
contents of the final regulations.

C. Should Some Types of Processors Be Exempt?

    In the preamble to the proposed regulations FDA asked for comment 
on whether either processors of ``low-risk'' products or small 
processors, or both, should be exempted from the requirements of the 
final regulations. The agency asked for information on whether the 
regulatory burden could be reduced without compromising the public 
health protection goals of the regulations, and whether there exists a 
rational way to distinguish ``high risk'' from ``low risk,'' and big 
processors from little processors, for purposes of HACCP.
1. Exempt Low Risk?
    The most obvious way of distinguishing high-risk products from low-
risk products would be on the basis of reported, confirmed, seafood-
related illnesses. The preamble to the proposed regulations pointed out 
some problems with this approach. First, the agency pointed out that 
the underreporting and skewed reporting that occurs with respect to 
foodborne illness creates significant concern as to whether reported 
illnesses represent a reliable enough factor to serve as the basis for 
an exemption to these regulations. Second, FDA stated that it was 
concerned that there could be a significant potential for harm that 
could be controlled by HACCP but that would not have shown up in the 
data that is relied on to establish risk. For example, while there may 
be no reported cases of botulism associated with some products that 
have the potential for Clostridium botulinum toxin, the severity of the 
consequences of the hazard warrant preventive controls. Likewise, while 
there may be no reported cases of domoic acid intoxication associated 
with shellfish from a particular area, preventive controls are 
warranted as soon as a such a case is made public. Thus, the preamble 
asked whether potential for harm might be a reasonable way to 
distinguish high-risk from low-risk products for purposes of an 
exemption. FDA was interested in whether comments could provide usable 
criteria for such an exemption.
    About 45 comments addressed the question of whether the regulations 
should apply to high-risk products only. Roughly two-thirds of these 
comments preferred a high-risk approach. For the most part, they either 
did not define ``high risk,'' or defined it as including essentially 
the top three reported seafood- related illnesses (virus-related from 
raw molluscan shellfish, scombrotoxin, and ciguatoxin). For the most 
part, other hazards were assumed to represent a low risk.
    17. One comment recommended that the regulations initially cover 
the hazards reported at the highest levels of to the Centers for 
Disease Control and Prevention (CDC) because these hazards are at least 
known to be causing illness, and that the agency should phase in other 
hazards as appropriate if the foodborne-illness reporting system were 
to reveal a need to do so.
    Few comments were received on whether there could be a basis for 
distinguishing high risk from low risk other than reported illnesses. 
Some comments suggested that the agency should consider severity of 
illness as a criterion. Some of these comments specifically cited 
smoked and smoke-flavored fish as products that should be covered on 
this basis because of the devastating effects of botulism. A few 
comments expressed the view that mandatory HACCP should be limited to 
hazards that can cause loss of life or irreversible injury.
    Several comments objected to a ``low risk'' exemption in any form. 
Some pointed out that, given the underreporting and skewed reporting 
that exists, the CDC foodborne-illness reporting system does not 
provide a suitable basis for making determinations of comparative risk 
(i.e., high risk versus low risk). These comments expressed concern 
that linking the requirements of these regulations to illness reporting 
that has already occurred would have the effect of exempting emerging 
hazards, at least until they caused reported illness.
    Other comments stated that there is no significant advantage to 
exempting low-risk products because processors of these products will 
have simpler HACCP plans than those who process products with more 
potential safety hazards. One comment stated that a high risk-only 
approach made some sense but, as a practical matter, would negate the 
added assurance to consumers from HACCP that seafood is safe and 
processed under some form of regulation. According to this comment, 
from a large seafood trade association, it is more important that the 
entire food category be recognized as having been subjected to modern 
safety assurance 

[[Page 65106]]
procedures than that the regulations exempt the low risk end of the 
industry.
    FDA has considered these points of view and has concluded that, at 
least for now, there is no reasonable way to divide seafood products 
into high risk and low risk for purposes of these regulations. The 
comments that suggested defining ``high risk'' in terms of the most 
frequently reported illnesses are correct that the volume of reporting 
tends to concentrate substantially in the three hazard areas mentioned 
above. Because illnesses that are confirmed and reported tend to be 
those that are the most easily traced or diagnosed, however, the 
relative significance of the high level of reporting in these three 
areas--as well as the drop-off in reporting in other areas--is not 
fully known. Moreover, illnesses associated with chronic hazards are 
virtually unreported because of the difficulties in associating such 
illnesses to specific food sources.
    The comments did not include any new data that would reveal whether 
the risks associated with the most reported illnesses are actually the 
highest risks or only the most apparent. No new information was 
provided to allow FDA to determine whether distinguishing high risk 
from low risk on the basis of reported illnesses would constitute a 
rational division for purposes of these regulations. Nor has FDA been 
supplied with information that would allow it to conclude whether other 
valid criteria exist.
    FDA agrees with the comments that pointed out that the requirements 
of HACCP are less when risks are low. Moreover, as will be discussed 
later in this preamble, FDA has revised the final regulations to 
provide that HACCP plans are not required when there are no reasonably 
likely safety hazards to control. Thus, HACCP inherently tends to 
distinguish between high- and low-risk products without the need for 
explicit exemptions.
    FDA also agrees that broad exemptions would put at risk some of the 
principal objectives of these regulations. Explicit exemptions make the 
system less flexible and might not cover emerging situations for which 
preventive controls are necessary to keep illnesses from occurring in 
the first place. A system that includes such exemptions would likely 
not provide as much consumer confidence as would a complete HACCP 
system. In addition, FDA notes that the benefits to the industry in 
international trade from adopting a HACCP system might be minimized if 
such exemptions were adopted because the United States' international 
trading partners are opting for complete systems.
2. Exempt Small Processors?
    18. Over 60 comments addressed the question of whether the 
regulations should exempt small businesses. About five out of six of 
these comments opposed an exemption.
    Those that supported an exemption for small businesses expressed 
concern about the effect of the general costs of implementation, 
particularly the costs of training and recordkeeping. One comment 
observed that many small businesses are economically-strapped, old, 
family enterprises that support an often fragile local economy. Another 
comment expressed the view that small businesses should be exempt 
because they are not involved in international trade. One comment noted 
that the highest volume producers (i.e., large businesses) are where a 
mistake affects the most consumers.
    One comment recommended that FDA develop exemption procedures to 
relieve small companies of paperwork and training requirements, 
especially if they produce low-risk products. A few comments suggested 
that small businesses, or at least small businesses with good records, 
be exempt from ``positive'' recordkeeping, i.e., recording the results 
of each monitoring. Under this kind of exemption, small businesses 
would only record unusual occurrences and corrective actions.
    The majority of comments that argued against exempting small 
businesses provided a number of reasons. One comment pointed out that 
as much as half of seafood consumed in the United States is from small 
firms. Several comments stated that size is not related to risk. Small 
firms are the major producers of many high-risk products (e.g. cooked, 
ready-to-eat and raw molluscan shellfish). Thus, according to the 
comment, the final regulations would represent a futile exercise if 
small firms were not included. One comment observed that small 
companies sometimes represent more of a risk potential than large 
companies due to lack of enough trained quality control personnel. 
Other comments pointed out that small businesses with simple operations 
would have simple plans and a minimum of recordkeeping.
    One comment pointed to difficulties that FDA would have in 
administering exemptions to the regulations, particularly in 
distinguishing between firms that were and were not entitled to an 
exemption. Another concern expressed by comments was the potential 
unfairness of exempting some companies while requiring HACCP of others.
    One State that has implemented mandatory HACCP for seafood 
processors observed that HACCP requirements had not proven to be an 
excessive burden to small businesses in that State.
    Some comments that supported including small businesses in the 
coverage of the HACCP requirement recommended, nonetheless, that FDA 
should provide assistance to small businesses through guidelines, model 
plans, and technical and financial assistance. Some comments 
acknowledged that small firms can work through trade groups on common 
plans and training.
    Other comments felt that dropping small firms from the final 
regulations would adversely affect consumer confidence. One comment 
expressed fear that the international standing of FDA's seafood safety 
program would be in jeopardy if the regulations were to exempt some 
firms.
    FDA does not know how to exempt small business without jeopardizing 
the public health objectives of the regulations. An exemption for small 
processors of ``low-risk'' products would run into the difficulties 
explained above in the discussion of whether these regulations should 
only apply to ``high-risk'' products. FDA agrees with the comments 
that, in the seafood industry, the size of the operation often does not 
coincide with the number or type of hazards that must be controlled in 
order to ensure a safe product (i.e., small size does not automatically 
mean minimal hazards). For example, cooked, ready-to-eat seafood 
processing, a relatively complex manufacturing operation, typically 
requiring a larger than average number of CCP's, is concentrated in the 
small business portion of the seafood industry. Additionally, the 
processing of raw molluscan shellfish, a product identified by NAS as 
being associated with a disproportionately large percentage of the 
seafood-borne illnesses, is most commonly performed by small firms. FDA 
also agrees that, because seafood businesses tend to be small, an 
exemption for small businesses could make HACCP the exception, rather 
than the rule, in this industry.
    The concerns expressed in the comments about the possible adverse 
consequences of these regulations on small business, however, should 
not be taken lightly, and the agency has not done so. FDA has no desire 
to establish a mandatory regime that cannot be met by otherwise 
responsible companies, 

[[Page 65107]]
small or otherwise, that are producing safe food. Indeed, these 
regulations are based on the premises that: (1) Preventive controls for 
safety should be within the reach of anyone who is producing seafood 
for commerce (i.e., preventive controls should not be prohibitively 
burdensome, either financially or conceptually); and (2) it is in the 
public interest that everyone who is producing seafood for commerce 
should practice preventive control for human food safety. The 
fundamental question that the issue of whether to exempt small business 
raises is whether these premises are valid.
    Having fully considered the comments on this issue, FDA is not 
persuaded that awareness of likely food safety hazards would cause 
financial hardship to small businesses, or that having reasonable, 
practical controls for those hazards will cause undue harm. As will be 
discussed in the ``Records'' section of this preamble, the costs 
associated with the recordkeeping requirements of HACCP are really 
incidental to the cost of monitoring and need not place a significant 
burden on small businesses. For example, after checking the temperature 
of a refrigerator, the observer need only take an additional moment to 
document the result of the observation. The agency cannot emphasize too 
strongly that, in most instances, only very simple recordkeeping is 
needed to adequately serve the purposes of the system. The question 
from the agency's standpoint, therefore, is whether the actual 
monitoring of critical operations, at reasonable frequencies, would be 
prohibitively expensive to the small operator. FDA has not been 
provided with a basis for such a conclusion.
    This leaves plan development and training as costs. The guidelines 
that FDA is making available on plan development should help 
substantially to keep development costs down. FDA is also aware that 
trade associations and others are interested in developing model plans 
that, when used in concert with the guidelines, should further reduce 
the resources that a firm will need for plan development. The creation 
of a HACCP plan does require some thought and effort by the processor 
to ensure that hazards and controls are understood and identified. 
Nonetheless, the guidelines and model plans will enable small 
processors to be able to apply the thought and effort necessary to 
create a HACCP plan with maximum efficiency and minimum cost.
    FDA is requiring that all processors either employ at least one 
trained individual or contract for services from at least one trained 
individual, as needed. There are unavoidable costs associated with this 
requirement. It is imperative that these costs be affordable to small 
business and be no greater than necessary. As discussed at length in 
the ``Training'' section of this preamble, FDA has been extensively 
involved with a consortium called the ``Seafood HACCP Alliance'' (the 
Alliance) consisting of representatives from Federal and State 
agencies, industry, and academia, to create a uniform, core training 
program that will meet the requirements of these regulations and will 
cost very little. The agency is also aware of HACCP training that has 
been provided for years for members of industry by NMFS and others. As 
an additional matter, FDA is allowing job experience to serve as a form 
of training in order to avoid the unnecessary expense to a processor of 
having to pay for a HACCP course when at least one employee already has 
knowledge that is equivalent to that provided by the course.
    These efforts should alleviate the concerns of those who believe 
that the training requirement will be too burdensome on small business. 
The agency will monitor the situation closely once this training gets 
underway. If costs turn out to be significantly higher than FDA 
anticipates, the agency will consider some modification to the 
requirement.
    While the agency regrets that grant monies are not available to 
small businesses from FDA, the effort that the agency is investing in 
guidelines and training development is a form of subsidy that should 
keep costs down generally.

D. Definitions

1. General
    In addition to relying on the definitions contained in the act and 
those in the umbrella good manufacturing practice regulations at part 
110 (21 CFR 110), FDA proposed at Sec. 123.3 (a) through (t) to define 
20 terms that are essential to the interpretation of part 123. 
Approximately 100 comments addressed various aspects of the proposed 
definitions at Sec. 123.3.
    The majority of the comments on definitions were concerned with the 
meanings that FDA proposed for ``processor'' (Sec. 123.3(n)) and 
``processing'' (Sec. 123.3(m)). These comments generally asked for 
clarification about the applicability of the definitions to a given 
commercial activity, or contended that the definitions should be 
amended to either include or exclude certain activities. Most of the 
other comments that addressed the definitions were primarily concerned 
with the meanings proposed for ``fish,'' fishery product,'' ``critical 
control point,'' ``cooked ready-to-eat,'' and ``importer.'' As a result 
of the comments as well as agency decisions to modify other provisions 
in part 123, FDA has deleted, revised, and added definitions to those 
proposed at Sec. 123.3.
2. Cooked, Ready-To-Eat Fishery Product
    19. The proposed regulations contained a definition for ``cooked, 
ready-to-eat fishery product'' at Sec. 123.3(b). The term was used at 
proposed Sec. 123.10(a) and in the appendices to the proposed 
regulations. The final regulations no longer contain this term, and the 
appendices are not being codified. For these reasons, FDA has 
eliminated the definition of ``cooked, ready-to-eat fishery product'' 
from the final regulations.
    Nonetheless, a large number of comments expressed concerns about 
the definition as it was proposed. In general, the comments urged that 
certain products be excluded from the definition of ``cooked, ready-to-
eat fishery products;'' those that are not fully cooked by the 
processor or that will be recooked by the consumer, and low-acid canned 
foods subject to the provisions of part 113.
    FDA recognizes the significance of the use of the term. Because the 
agency has excluded use of the term in these final regulations, it will 
defer consideration of the comments until drafting of the Guide.
3. Critical Control Point (CCP)
    FDA proposed at Sec. 123.3(c) to define a critical control point as 
``a point in a food process where there is a high probability that 
improper control may cause, allow, or contribute to a hazard in the 
final food.'' The word ``hazard'' in this definition was intended to 
refer primarily to food safety hazards. It could also have applied to 
quality and economic hazards, however, because the agency was proposing 
at Sec. 123.6(c) to encourage processors to apply HACCP to these 
hazards as well.
    20. A significant number of comments urged the agency to modify the 
definition so that it clearly addresses only food safety. These 
comments recommended that the word ``hazard'' should be prefaced with 
either ``food safety'' or ``health,'' or that FDA should codify the 
definition for ``hazard'' that has been recommended by the NACMCF.
    Several of the comments urged FDA to adopt the NACMCF definition 
for 

[[Page 65108]]
``critical control point'' so that the agency's regulations would be 
consistent with nationally and internationally agreed upon HACCP 
definitions. One objected to the phrases: ``high probability,'' because 
of its connotation in statistical applications; ``improper control,'' 
because of a lack of a standard for proper control; and ``cause, allow, 
or contribute,'' because it could allow the elevation of trivial 
concerns to critical control point status.
    FDA is persuaded by those comments that urged consistency with the 
NACMCF definition for ``critical control point.'' The agency has, 
therefore, modified proposed Sec. 123.3(c) (redesignated as 
Sec. 123.3(b)) to read, ``Critical control point means a point, step, 
or procedure in a food process at which control can be applied, and a 
food safety hazard can as a result be prevented, eliminated, or reduced 
to acceptable levels.'' The modified language is consistent with the 
agency's decision to limit the HACCP provisions of part 123 to the 
avoidance of food safety hazards (see the ``HACCP Plan'' section of 
this preamble for discussion). It is also compatible with modifications 
described elsewhere in this preamble aimed at greater consistency with 
the NACMCF recommendations. The wording change will not have any 
practical impact on the requirements of the regulations because the 
definition still reflects the agency's intent to require that seafood 
be processed in a way that eliminates, to the extent possible, the 
chance that it will be rendered injurious to health by procedures that 
are under the control of the processor.
    The NACMCF definition does not contain the phrases that were 
objected to by one of the comments as described above. Thus, the 
concerns raised by this comment have been resolved.
    21. A few comments, however, stated that the definition should also 
apply to the control of all decomposition because it is a major problem 
associated with seafood.
    FDA acknowledges that, because of the highly perishable nature of 
fish, decomposition is probably the most common problem associated with 
seafood. The agency further acknowledges the comments that expressed 
concern that failure to control this problem will continue to adversely 
affect consumer confidence. The industry especially should heed this 
concern and consider the application of HACCP principles to 
decomposition, if necessary, to help maintain the quality of its 
products.
    Nonetheless, decomposition that is not associated with safety is 
not appropriately a part of these mandatory HACCP regulations but 
should remain subject to traditional good manufacturing practices 
controls (see, e.g., Sec. 110.80(b) (21 CFR 110.80(b))). As discussed 
earlier, these regulations are being issued, in part, under section 
402(a)(4) of the act. That section provides that a food is adulterated 
if it is prepared, packed, or held under insanitary conditions whereby 
it may have been rendered injurious to health. While decomposition in 
some species can be injurious to health and is therefore within the 
scope of section 402(a)(4) of the act, most decomposition affects the 
quality of seafood but not its safety. Decomposition that affects 
quality but not safety is subject to section 402(a)(3) of the act. 
Therefore, FDA is not subjecting decomposition that is not safety 
related to the requirements of these final regulations but will 
continue to regulate decomposition under traditional CGMP control.
    FDA points out that it has defined ``food safety hazard,'' a term 
that the agency uses in the definition of ``critical control point,'' 
in Sec. 123.3(f). The agency discusses this definition, which is 
consistent with the NACMCF recommended definition, later in this 
section.
4. Critical Limit (CL)
    FDA proposed in Sec. 123.3(d) to define a ``critical limit'' as 
``the maximum or minimum value to which a physical, biological, or 
chemical parameter must be controlled at a critical control point to 
minimize the risk of occurrence of the identified hazard.'' In the 
preamble to the proposed regulations, the agency explained that the 
proposed definition was intended to be consistent with the concept of 
the NACMCF recommended definition, which reads, ``a criterion that must 
be met for each preventive measure associated with a critical control 
point.'' However, the proposed definition was also intended to be more 
explanatory than is the NACMCF definition, especially as it relates to 
the assignment of a minimum or maximum value and in the relationship of 
these values to a minimization of the risk, rather than to an absolute 
elimination of risk.
    22. Several comments stated that the proposed definition of a 
``critical limit'' should be modified to be the definition recommended 
by the NACMCF. The comments asserted that the NACMCF definition is the 
internationally accepted standard, and that its use in the regulations 
would avoid confusion. A few comments argued that FDA's use of the 
phrase ``minimize the risk'' implies that the CL must be set to attain 
the lowest possible risk, unlike the ``reduce to an acceptable level'' 
standard in the NACMCF definition for CCP.
    Although FDA agrees that the definitions in these regulations 
should closely adhere to the NACMCF's recommended definitions, the 
agency concludes that, in this instance, FDA's wording is more 
descriptive for regulatory purposes and more useful to processors. 
However, FDA has been persuaded that the phrase ``minimize the risk'' 
may be misinterpreted as requiring outcomes that are not realistically 
achievable by a processor. To provide clarification and consistency 
with the revised definition of ``critical control point,'' FDA has 
replaced the phrase ``minimize the risk'' with the phrase ``prevent, 
eliminate, or reduce to an acceptable level'' in the final regulation 
(now codified as Sec. 123.3(c)). As noted previously, this language 
also appears in the NACMCF definition of ``critical control point.'' 
The new language correctly provides for the making of scientific 
judgments about appropriate degrees of hazard reduction, based on the 
nature of the hazard and the availability of controls, and is more 
consistent than the proposed language with accepted HACCP convention.
    23. One comment stated that the word ``identified'' should be 
deleted from the proposed definition.
    FDA is not persuaded to make any modification to the definition in 
response to this comment. The ``identified hazard'' refers to the 
hazard identified in the HACCP plan.
    24. One comment stated that the phrase ``in the end product'' 
should be added following the word ``hazard'' in the proposed 
definition.
    FDA is not persuaded to make any modification to the definition in 
response to this comment. Food safety hazards are, by definition, those 
that cause ``a food to be unsafe for human consumption.'' This 
definition implies a consideration of the end product that will be 
offered for human consumption.
    25. One comment objected to the phrase ``the maximum or minimum 
value'' in the definition, stating that, as in the case of certain food 
additives, there are situations where both a maximum and a minimum 
value exist, and a processor is required to maintain the process 
between these values.
    FDA is not persuaded to make any changes to the proposed language 
in response to this comment. The word ``or,'' which the agency uses in 
the definition, is inclusive. Thus, properly read, Sec. 123.3(c) states 
that a CL is the maximum value, the minimum value, or both the maximum 
and minimum 

[[Page 65109]]
values within which the parameter must be controlled to protect against 
the occurrence of a food safety hazard.
    For consistency with the definition of ``critical control point,'' 
FDA has added the phrase ``food safety'' before the word ``hazard'' in 
the text of Sec. 123.3(c). The language in the final regulation now 
reads, ``Critical limit means the maximum or minimum value to which a 
physical, biological, or chemical parameter must be controlled at a 
critical control point to prevent, eliminate, or reduce to an 
acceptable level the occurrence of the identified food safety hazard.''
5. Fish
    26. FDA proposed to define ``fish'' as ``fresh or saltwater 
finfish, molluscan shellfish, crustaceans, and other forms of aquatic 
animal life other than birds or mammals.'' A significant number of 
comments suggested that FDA should modify this definition to clarify 
whether it includes species such as sea snails, abalone, frogs, 
alligators, turtles, other reptiles, amphibians, sea cucumbers, plants, 
or algae.
    FDA agrees that this type of clarification would be helpful and has 
modified the definition at Sec. 123.3(d) to read:

    Fish means fresh or saltwater finfish, crustaceans, other forms 
of aquatic animal life (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 is 
intended for human consumption.

    The term ``mollusks'' includes abalone, sea snails, and land snails 
(e.g., escargot and any other terrestrial gastropods, such as the giant 
African land snail (Achatina fulica)). The addition of examples of 
aquatic animal life and the mention of mollusks are intended to make 
clear which species are covered by the term ``fish.'' Water-dwelling 
reptiles and amphibians other than alligators, turtles, and frogs have 
not been specifically listed because they are not significant 
commercial food sources in the United States. Finally, FDA notes that, 
consistent with the proposed definition, aquatic plants (including 
algae) are excluded. This definition is consistent with the traditional 
treatment of these products by FDA.
    The new language also serves to emphasize that these regulations 
apply only to those products that are intended for human consumption. 
This point was explicit in the proposed definition for ``fishery 
product'' but was inadvertently not mentioned in the proposed 
definition of ``fish.''
    27. Two comments contended that there should be separate 
definitions for finfish and shellfish, to differentiate between 
relative levels of safety concerns (e.g., high and low risk).
    FDA disagrees with this comment. Such a differentiation would serve 
no purpose in these regulations. The purpose of these regulations is to 
set up a unitary system that responds to a particular product based on 
the risks it presents, not to establish a system that is divided up 
based on risk presented. The merits of differentiating between products 
on the basis of risk is addressed in the section of the preamble 
entitled ``Should Some Types of Processors be Exempt?''
6. Fishery Product
    FDA proposed to define ``fishery product'' as ``any edible human 
food derived in whole or in part from fish, including fish that has 
been processed in any manner.'' The preamble to the proposed 
regulations stated that the intent of the definition was to include 
products that contain seafood as an ingredient as well as those 
products that are comprised of seafood alone, because hazards derived 
from seafood are reasonably likely to occur in both types of products.
    28. A few comments urged that FDA exclude from the meaning of 
``fishery product'' any product that is made in whole or in part from 
commercially sterilized fishery products subject to the requirements of 
parts 113 and 114, (i.e., thermally processed low-acid canned foods and 
acidified foods).
    FDA disagrees with this comment. Although such foods are required 
to be produced in accordance with certain HACCP-type control procedures 
to reduce the risk of the hazard of C. botulinum toxin production, 
these control measures do not address other potential hazards. For 
example, part 113 provides no assurance that the raw material used in 
the canning of tuna will be free from contamination with dangerous 
levels of histamine. Likewise, products made in part from low-acid 
canned foods and acidified foods can also present hazards that must be 
addressed. For example, a salad made in part from canned tuna can be 
subjected to recontamination with pathogenic microorganisms and time-
temperature abuse during preparation.
    Although FDA cannot exclude those products made in whole or in part 
from low acid canned foods or from acidified foods from the definition 
of a ``fishery product,'' it is worth noting that the agency has 
exempted processors who are following the requirements of part 113 or 
part 114 from having to include controls for C. botulinum in their 
HACCP plans. This hazard is already addressed by the requirements in 
those parts (see Sec. 123.6(e) of these regulations and the ``HACCP 
Plan'' section of this preamble).
    29. One comment suggested that the language of the proposed 
definition inappropriately excludes fish roe.
    FDA points out that the phrase ``any edible human food product 
derived in whole or in part from fish,'' in the proposal was intended 
to cover these products. FDA, however, has modified the definition of 
``fishery product,'' and it no longer includes this language. 
Therefore, to make clear that roe are covered, FDA has made explicit in 
the definition of ``fish'' that the roe of the covered animals are 
included.
    30. A significant number of comments urged that the definition 
exclude products that contain only a minimal amount of fish. These 
comments suggested various standards that FDA should apply to exclude 
such foods from the definition. These included: Products that contain 
less than 50 percent fish; products that contain less than 10 percent 
fish; products that contain 2 percent or less of cooked, or 3 percent 
or less of raw, fish; products in which fish is not a characterizing 
ingredient; and products that contain any nonfish ingredient unless a 
hazard analysis identifies a significant hazard associated with the 
fish ingredient. The comments provided no justification for the 
percentages suggested.
    FDA agrees that foods that contain inconsequential amounts of fish, 
such as Worcestershire sauce, are not the types of foods that should 
come under the purview of these regulations. It is doubtful that they 
pose reasonably likely hazards associated with their fish components. 
Moreover, these products are neither represented nor perceived as being 
fish-based foods.
    The comments provided FDA with no basis, however, upon which to 
select a specific minimum content of fish ingredient for the definition 
of ``fishery product.'' There is no obvious minimum percentage of fish 
on which to exempt a food that contains only a small amount of fish 
from the provisions of these regulations.
    Instead, the agency accepts the comment that, to meet the 
definition of a ``fishery product,'' a food should be characterized by 
the qualities of the fish that it contains. Thus, these regulations 
will apply to those foods whose basic nature is defined by the fish 
that they contain. Accordingly FDA has modified the proposed definition 
(Sec. 123.3(e)) to read in part, ``Fishery product means any edible 
human food product in 

[[Page 65110]]
which fish is a characterizing ingredient.'' This revision will serve 
to ensure that mandatory HACCP requirements do not apply to products 
that contain inconsequential amounts of fish from a public health 
standpoint.
    31. One comment stated that fish oil that is intended for use in 
human food should not be subject to the requirements of these 
regulations until it has been separated, through initial processing, 
from the oil that will be used for animal feeds and other industrial 
purposes. FDA does not find that the comment provided sufficient 
justification to treat this product differently from other human food 
products processed from fish. The agency acknowledges that the hazards 
associated with these products may be minimal. If that is the case, the 
fish oil processor's burden will also be minimal, perhaps limited to 
training expenses and the performance of a hazard analysis. Moreover, 
these regulations do not apply to products that are not for human 
consumption and fish oil processors that are confident that their 
production will not be used for human consumption need not apply the 
requirements of these regulations.
7. Food Safety Hazard
    32. A number of the comments recommended that FDA define ``safety 
hazard'' or ``food safety hazard.'' Several of these comments 
recommended that FDA adopt a definition that is consistent with the 
NACMCF recommended definition for ``hazard.'' The comments were 
primarily concerned with the coverage of these regulations. They urged 
that the regulations be clear that only food safety hazards need be 
addressed by the HACCP plan and argued that a definition would help to 
accomplish that.
    The NACMCF definition of ``food safety hazard'' reads, ``A 
biological, chemical, or physical property that may cause a food to be 
unsafe for consumption.'' While FDA provided no definition of ``food 
safety hazard'' in the proposed regulations, it did raise the issue of 
the coverage of the regulations in proposed Sec. 123.6(b) (redesignated 
as Sec. 123.6(c)), which mandated coverage of food safety hazards only 
and listed nine types of food safety hazards posed by the various types 
of fish and fishery products. This list included examples of 
biological, chemical, and physical hazards. Additionally, the preamble 
to the proposed regulations discussed at length the significance of a 
number of these types of hazards.
    FDA agrees that the meaning ascribed by the agency to a food safety 
hazard should be as clear as possible in these regulations. The 
examples of hazards in the proposed regulations--and codified in these 
final regulations--are consistent with the NACMCF definition for a food 
safety hazard. Therefore, for the sake of clarity, FDA has decided to 
characterize these examples in a definition Sec. 123.3(f), which reads, 
``Food safety hazard means any biological, chemical, or physical 
property that may cause a food to be unsafe for human consumption.'' 
The only difference between this definition and the NACMCF 
recommendation is the addition of the word ``human.'' FDA has included 
this word to prevent confusion about the application of these 
regulations to pet or animal feed.
    In keeping with the new definition, and to provide further 
clarification about the nature of the hazards that are required to be 
addressed by these regulations, the term ``hazard'' has been changed to 
``food safety hazard'' where it appears throughout the codified portion 
of this document.
8. Harvester
    FDA proposed to define ``harvester'' as ``a person who has an 
identification number issued by a shellfish control authority for 
commercially taking molluscan shellfish by any means from a growing 
area.'' After review, the agency has concluded that it was not 
necessary to limit ``harvesters'' to those persons who have an 
identification number, primarily because in some jurisdictions, 
identification numbers may not be issued by a shellfish control 
authority. Without this limitation, FDA has concluded that there is no 
need to establish a particular meaning for this term for the purposes 
of these regulations. Therefore, the agency has removed this definition 
from the final regulations.
9. Importer
    FDA proposed to define ``importer'' as ``a person, or his 
representative in the United States, who is responsible for ensuring 
that goods being offered for entry into the United States are in 
compliance with all laws affecting the importation.'' The preamble to 
the proposed regulations explained that the importer is the owner of 
the imported goods or the owner's representative in the United States. 
The preamble further noted that freight forwarders, food brokers, food 
jobbers, carriers, and steamship representatives would not usually be 
considered to be the importer of the product for the purposes of these 
regulations because they are not usually in a position to make 
decisions that can ensure the safety of the product. However, the 
preamble did not categorically rule out that these individuals could be 
the importer because sometimes they may be in a position to make 
decisions relevant to safety.
    33. Several comments stated that FDA should modify the definition 
of ``importer'' to specifically exclude intermediary agents involved in 
the importing process, such as freight forwarders, licensed U.S. 
customs brokers, food brokers, food jobbers, carriers, and steamship 
representatives. These comments noted that, although imported products 
may enter the United States under the name of an intermediary, this 
practice is done for convenience in handling the paperwork at the port 
of entry. The comments stated that the intermediary has little 
responsibility for conducting the negotiations with an overseas 
producer and rarely takes possession of the products. Therefore, the 
comments stated, the intermediary has limited influence on the safety 
of the imported goods. Two comments pointed out, for example, that 
customs brokers that provide their clients with the service of using 
the broker's customs bond are listed as the ``importer of record'' and 
may thereby, unintentionally, be regarded as importers under the 
proposed definition, even though they do not own or control the product 
being imported.
    Conversely, two comments argued that agents, such as food brokers, 
should be included in the definition of an ``importer'' because they 
bring product into the United States and sell it. The comments argued 
that the brokers should, therefore, be held responsible for ensuring 
that the foreign processor complies with the provisions of these 
regulations, to avoid an unfair advantage over domestic processors.
    FDA concludes, based on the information provided in the comments, 
that these intermediaries can neither be categorically included or 
excluded. However, the agency recognizes that the number and type of 
comments on this issue demonstrate that the language of proposed 
Sec. 123.3(h) was inadequate to convey the agency's intent, as 
articulated in the preamble. For this reason, FDA has clarified the 
definition of ``importer'' in Sec. 123.3(g) to read, in part:

    Importer means either the U.S. owner or consignee at the time of 
entry into the United States, or the U.S. agent or representative of 
the foreign owner or consignee at the time of entry into the United 
States, who is responsible for ensuring that goods being offered for 
entry into the United States are in compliance with all laws 
affecting the importation.


[[Page 65111]]

Reference to the owner or consignee of the imported goods parallels the 
language in section 801 of the act (21 U.S.C. 381).
    Because the ownership of imported products can change many times in 
a relatively short period of time after entry, the party who is the 
owner or consignee at the time that these products are offered for 
entry must be identified as the importer. As the person that has the 
ability to decide whether to offer the product for entry, this person 
is in a position to ensure that the product is processed under 
appropriate controls and to demonstrate this fact to FDA.
    FDA must be able to verify the existence of the evidence of 
compliance by the foreign processor. This evidence, according to the 
provisions of Sec. 123.12, is to be in the possession of the 
``importer.'' It must be available in the United States, however, if 
FDA is to consider the information in deciding whether to admit the 
products. Thus, where products are offered for entry by a U.S. owner or 
consignee, that owner or consignee will, for purposes of these 
regulations, be considered the importer because it will have control of 
this evidence. Where products are often offered for entry without a 
U.S. owner or consignee, the U.S. agent of the foreign owner or 
consignee will be considered the ``importer'' for purposes of these 
regulations to make clear who will be expected to have this evidence 
for such products.
    FDA recognizes that the U.S. owner or consignee of the product, or 
the U.S. representative of the foreign owner or consignee, at the time 
of entry into the United States may also serve other functions. For 
example, it may also be a food broker for, or warehouser or processor 
of, the product. It may, in some instances, also be the freight 
forwarder, customhouse broker, or carrier for the product. These other 
functions will not matter, however, if the person is the U.S. owner or 
consignee of the product, or the U.S. representative of the foreign 
owner or consignee, at the time of entry into the United States. From 
FDA's experience, while certainly not impossible, it is at least 
unlikely that this qualification will be met by the customhouse broker, 
the freight forwarder, the carrier, or the steamship representative.
    The agency has attempted to clarify this definition by including a 
sentence that reads, ``For the purposes of this definition, ordinarily 
the importer is not the custom house broker, the freight forwarder, the 
carrier, or the steamship representative.'' Further, FDA does not 
intend to rely exclusively upon the assignment of the ``Importer of 
Record'' or the holder of the U.S. Customs Surety Bond in determining 
the ``importer'' for the purposes of these regulations, as was 
suggested in the preamble to the proposed regulations. In some 
instances the ``Importer of Record'' or the holder of the U.S. Customs 
Surety Bond will not meet the qualifications of an importer that are 
set out in Sec. 123.3(g).
10. Lot of Molluscan Shellfish
    FDA proposed to define a ``lot of molluscan shellfish'' as ``a 
collection of shellstock or containers of shellstock of no more than 1 
day's harvest from a single, defined growing area harvested by one or 
more harvesters.'' Because of language changes that FDA has made in 
subpart C of part 123, this term isno longer used in the regulations. 
Consequently, FDA has decided that there is no need to define this term 
and has eliminated the definition.
11. Molluscan Shellfish
    34. Comments from a number of State agencies, trade associations, 
seafood processors, and the ISSC objected to the use of the term 
``fresh or frozen'' in the proposed definition of ``Molluscan 
shellfish.'' The comments were concerned because this definition would 
have the effect of exempting canned and any other heat-processed 
molluscan shellfish from the source control, recordkeeping, and tagging 
provisions of proposed subpart C of part 123 and proposed 
Sec. 1240.60(b).
    The comments stated that limiting these provisions to raw products 
would allow foreign firms to continue to heat-treat or can molluscan 
shellfish that are harvested from foreign waters that do not meet 
National Shellfish Sanitation Program (NSSP) standards and to export 
them to the United States. The comments stated that this situation was 
not in the best interest of the public health because of the potential 
for the presence of heat-stable natural toxins, such as paralytic 
shellfish poison or amnesiac shellfish poison, as well as chemical 
contaminants. The comments also complained that, because State laws and 
regulations require that all molluscan shellfish harvested in the 
United States come from waters approved by a shellfish control 
authority regardless of whether they are to be consumed raw or 
cooked,continuing to allow foreign processors who export cooked 
shellfish to the United States to use molluscan shellfish from 
unapproved growing waters places the domestic shellfish industry at a 
competitive disadvantage.
    FDA believes that these comments are generally valid but are beyond 
the scope of this rulemaking. The point of this rulemaking it to 
determine whether FDA should require that HACCP be followed in the 
processing of seafood. The question of whether cooked molluscan 
shellfish that is being offered for import into this country is being 
harvested in a manner that creates public health concerns and unfair 
competitive advantages is a separate matter that the agency will 
address, if necessary, in the future.
    Similar issues with respect to the use of the term ``fresh or 
frozen'' and the term ``raw'' in proposed subpart C of part 123 of 
these regulations and in proposed part 1240 are discussed in the 
``Molluscan Shellfish'' section of this preamble (see comment 144).
12. Potable Water
    FDA proposed to define ``potable water'' as ``water which meets the 
U.S. Environmental Protection Agency's Primary Drinking Water 
Regulations as set forth in 40 CFR part 141.'' Because of changes that 
the agency has made in proposed Sec. 123.10 (redesignated as 
Sec. 123.11), the term is no longer used in these regulations. 
Consequently, FDA has eliminated the definition.
    Nonetheless, a significant number of comments questioned when it 
would be necessary for processing water to meet the definition of 
``potable water.'' Because it is likely that both terms (i.e., 
processing water and potable water) will be used in the first edition 
of the Guide, FDA will consider these comments during the redrafting of 
the Guide.
13. Preventive Measure
    FDA has added a definition for the term ``preventive measure'' at 
Sec. 123.3(i). Although the term was not used in the proposal, the 
concept of preventive measures was a fundamental part of the hazard 
analysis that was implicit in proposed Sec. 123.6(b). ``Preventive 
measure'' is used in the final regulations in Sec. 123.6(a) in the 
description of a hazard analysis.
    FDA proposed to require that all processors create a HAACP plan. 
Based on comments received, however, as explained below, FDA has 
decided to require that processors conduct hazard analyses to determine 
whether they need to develop a HACCP plan. This decision necessitates 
that FDA define ``preventive measure.'' In accordance with the 
recommendations of the NACMCF (see Ref. 34, p. 189), a hazard analysis 
must identify both the food safety hazards that are reasonably likely 
to occur and the preventive measures that are available to the 
processor to control such hazards. 

[[Page 65112]]

    Identifying the preventive measures is necessary in order to 
determine whether a processing step is a CCP for that hazard. A 
processing step cannot be a CCP for a hazard if no preventive measure 
is available at that step to control the hazard. The definition of 
``preventive measure'' in these regulations is essentially the same as 
that recommended by the NACMCF.
14. Process Monitoring Instrument
    The term ``process control instrument'' was used in the proposal 
for consistency with the phrase ``the procedures * * * that will be 
used to control and monitor each of the critical control points.'' For 
consistency with the NACMCF principles of HACCP, FDA has modified the 
language of Sec. 123.6(c)(4) to eliminate the word ``control.'' In 
order to achieve consistency within these regulations, the agency has 
concluded that the appropriate term for such instruments is, therefore, 
a ``process monitoring instrument.''
15. Processing and Processor
    Along with the term ``importers,'' the terms ``processor'' and 
``processing'' collectively define who is subject to these regulations.

    FDA proposed to define ``processing'' as:
    [W]ith respect to fish or fishery products, handling, storing, 
preparing, heading, gutting, shucking, freezing, changing into 
different market forms, manufacturing, preserving, packing, 
labeling, or holding. Practices such as heading or gutting intended 
solely to prepare a fish for holding on board a harvest vessel are 
excluded. This regulation does not cover the operation of a retail 
establishment.
    FDA proposed to define ``processor'' as:
    [A]ny person engaged in commercial, custom, or institutional 
processing of fish or fishery products, either in the United States 
or in a foreign country. Persons engaged in the production of foods 
that are to be used in market or consumer tests are also included. 
Persons who only harvest or transport seafood, without otherwise 
engaging in processing, are not covered by these regulations.

    a. Vessels, carriers, and retail. As explained in the preamble to 
the proposed regulations, the definitions of ``processor'' and 
``processing'' excluded fishing vessels that essentially only harvest, 
transportation companies that carry but do not otherwise process fish 
and fishery products, and retail establishments. FDA invited comment on 
these exclusions.
    In the preamble, FDA acknowledged that food safety hazards can be 
introduced at these three points in the commercial distribution chain. 
However, FDA tentatively decided to exclude fishing vessels, carriers, 
and retailers from the definition of ``processor''--and thus from 
direct coverage under these regulations--because of practical 
considerations, such as the fact that the large size of the U.S. 
fishing fleet and the large numbers of carriers and retailers would 
overwhelm any rational Federal inspection system, and because the 
agency believed that the public health goals of the regulations could 
still be met.
    FDA expressed its tentative view that the HACCP regulations would 
affect fishing vessels and carriers indirectly though the controls that 
processors impose to meet their obligations under HACCP. As for retail 
establishments, the preamble explained that, historically, they have 
been the regulatory responsibility of State and local governments. FDA 
traditionally has provided support through training, technical 
assistance, and the development of model codes. Since the issuance of 
the proposal, FDA has published its retail and institutional ``Food 
Code,'' with the recommendation that it be adopted by State and local 
jurisdictions. The Food Code covers handling and receiving practices at 
retail, and its most recent version includes HACCP elements.
    FDA's approach to these issues is based on agency discretion and 
does not derive from a lack of statutory authority. FDA has broad 
authority to regulate Food that is shipped in interstate commerce. 
While carriers are exempt from most direct FDA regulation in accordance 
with section 703 of the act (21 U.S.C. 373), the food being transported 
is not exempt. Moreover, FDA has authority under the Public Health 
Service Act (the PHS Act) (42 U.S.C. 264) to take such measures as it 
deems necessary to prevent the introduction, transmission, or spread of 
communicable disease from foreign countries into the States or from one 
State or possession into any other State or possession.
    FDA received a significant volume of comment on the question of 
coverage by these regulations of fishing vessels, carriers, and retail 
establishments. The majority of comments strongly favored inclusion of 
these entities within the scope of the these regulations.
    35. The arguments relating to vessels and carriers tended to 
overlap. Those who favored inclusion noted that hazards--particularly 
those associated with time-temperature abuse and insanitation--can 
originate with fishing vessels and carriers. The comments argued that 
not controlling the conditions under which seafood is harvested and 
transported would amount to leaving CCP's unregulated. One comment 
observed that carriers have an incentive to turn off refrigeration 
units to save gas.
    Several comments expressed the view that exclusion of vessels and 
carriers from the coverage of these regulations unfairly makes 
processors responsible for these aspects of seafood production. One 
comment pointed out that vessels, especially those that harvest 
scombroid toxin-forming species, should be legally responsible for any 
safety hazards that they cause through improper handling. Some comments 
asserted that HACCP can be practiced on fishing vessels and by 
carriers, at least with regard to temperature controls.
    One State agency expressed the view that holding processors 
responsible for the behavior of fishing vessels has, in its experience, 
not worked, nor has education of fishing vessel owners or voluntary 
compliance by owners. The comment did not document the basis for these 
conclusions, however. Some comments argued that, while it would be 
difficult to include all vessels and carriers, those involved with 
high-risk products should be included.
    Comments in favor of excluding vessels and carriers from these 
HACCP regulations noted that FDA's rationale for exclusion was prudent 
given the number, location, and diversity of the U.S. fishing fleet and 
the complexity of transport arrangements. For carriers, one comment 
noted that partial loads that are dropped off in different locations 
would be especially difficult to control. Some comments asserted that 
direct regulation of these entities was not necessary because 
processors could establish minimum requirements as a condition of 
purchase, as part of their HACCP systems. Some comments urged, however, 
that fishing vessels be subject to HACCP requirements when they deliver 
directly to an entity that is not subject to these regulations (e.g., a 
restaurant). One comment argued that receiving firms should require 
that product be in the same condition that it was in when it left the 
previous processor.
    Some comments questioned the ability of fishing vessels and 
carriers to comply with HACCP requirements. A number of comments 
favored alternatives to HACCP, such as guidelines and standard 
operating procedures (SOP's).
    FDA is impressed by the strong support for inclusion, of fishing 
vessels and carriers in the coverage of these regulations. Some of this 
support was based on concern over the loss of quality because of poor 
handling 

[[Page 65113]]
practices (e.g., the effect of time-temperature abuse on shelf life and 
spoilage unrelated to safety) rather than on food safety 
considerations. Nonetheless, members of these two industries should be 
aware that significant concerns have been expressed with regard to 
their practices.
    For some species and products, the practices of fishing vessels and 
transporters can have significant public health consequences. These 
practices can put pressure on a processor who is receiving these 
products to carefully scrutinize the condition of incoming materials. 
The practices can also put pressure on a processor to determine whether 
carriers are suitable to transport their finished products (e.g., that 
carriers have proper refrigeration).
    The agency appreciates the argument that all entities that can 
affect safety in the distribution chain should accept and share this 
responsibility. These points notwithstanding, FDA received no comment 
that provided information about how the agency could operate an 
inspection program for carriers and harvest vessels with its current 
resources. For this reason, the agency concludes that such a program is 
impractical at this time.
    When processors accept raw materials for processing, especially 
from vessels, they assume some responsibility for the condition of the 
incoming materials, regardless of how others are regulated. This is 
true under both general commercial law and the laws administered by 
FDA. Carriers likewise have responsibilities. If a carrier fails to 
exercise such controls as are necessary, food that it carries may be 
rendered adulterated and the owner of the product, i.e., the processor, 
could suffer product loss. Food handlers generally should exercise 
sufficient control over the products in their custody to ensure that 
any food safety hazards that are reasonably likely to occur during that 
period are being addressed.
    As an additional matter, FDA agrees with those comments that 
advocated a step-wise regulatory approach to these entities.
    Mandatory HACCP for seafood is a pioneering venture. While the 
groundwork has been prepared for it through pilot projects and other 
efforts over the years, there is no substitute for actual experience 
once it is operating. The agency would prefer, therefore, to construct 
the system through a series of manageable steps if it needs to do so, 
rather than to risk overextending itself and the system initially. 
While these regulations exempt carriers and harvest vessels from direct 
coverage, experience with the application of a mandatory HACCP program 
may, at some later date, cause the agency to reconsider its approach.
    For fishing vessels, FDA intends, for the time being, to issue good 
handling practice guidelines. To that end, the agency is studying those 
issued by the State of Alaska and by the Codex Alimentarius Commission 
of the Food and Agriculture Organization/World Health Organization, 
among other such available guidance. FDA will evaluate the effect of 
these guidelines, in addition to any requirements that States have or 
may adopt regarding fishing vessel practices, and reassess at a later 
date whether there is a need for mandatory Federal controls. The agency 
invites continued correspondence and the sharing of views on this 
matter.
    The comments that recommended that vessels that sell directly to 
``non-HACCP'' establishments (e.g., restaurants) should be required to 
have HACCP plans are advised that the Food Code addresses the subject 
of source control for retail establishments and recommends the 
requirement of HACCP plans for retail establishments in some 
circumstances. This matter relates principally to State and local laws 
and is addressed below in the discussion of retail establishments.
    For carriers, the situation is complicated by the restriction in 
section 703 of the act that was described previously. As one comment 
recommended, FDA has had conversations with other Federal agencies on 
the subject of transportation of food and will continue to do so. In 
the meantime, FDA strongly recommends that processors review the 
material in the Guide on how they can exercise control over incoming 
raw materials as well as over shipments of their own products. One 
emerging area that the agency is monitoring--and processors should 
consider also--is the development of inexpensive time-temperature 
sensors that indicate whether proper temperatures have been maintained 
over a period of time.
    36. The question of the inclusion of retail establishments within 
the mandatory seafood HACCP system involves some different 
considerations. Processors have less influence, if any, over how their 
products are handled at retail than they do over how their products are 
handled by vessel operators or carriers. Some comments pointed out, for 
example, that a processor's best efforts could be for naught if the 
product is subsequently mishandled at retail.
    Several comments pointed out that many retail establishments carry 
out activities that meet the definition of ``processing.'' According to 
these comments, such establishments should not be exempt from HACCP 
requirements.
    Other comments took the view that these regulations should not 
apply to retail establishments, primarily for the reasons provided in 
the preamble to the proposal. Some recommended that retail 
establishments should not be subject to the regulations so long as the 
Food Code applies to them. Others suggested that HACCP should apply if 
the retail establishment buys directly from a fishing vessel or from 
sport fishermen. Some suggested better consumer education and voluntary 
HACCP-type programs.
    FDA agrees that there are hazards that occur at the retail level 
that can render meaningless the controls that may have been in place 
elsewhere in the chain of production and distribution. The NAS has 
cited retail and food service establishments as sources of seafood-
related illnesses (see Ref. 7, p. 27). FDA is convinced--and the 
comments support--that proper controls at the retail level are 
imperative to ensuring a safe product.
    Nonetheless, FDA's observation in the preamble to the proposed 
regulations remains valid that retail establishments pose an inspection 
burden well beyond the capacity of FDA. No comments have provided any 
basis for the agency to conclude otherwise or would justify the 
significant shift of resources that would be necessary for FDA to even 
begin to address the retail sector in a meaningful way. FDA notes that 
State and local governments provide significant regulation of the 
retail food sector. FDA has committed the resources that it has 
available for addressing retail problems, by providing training and 
technical assistance to State and local governments. Most 
significantly, FDA has provided guidance in the form of the Food Code, 
which provides the latest and best scientifically based advice about 
preventing foodborne illness for adoption by those jurisdictions that 
have regulatory responsibility for food service, retail, and vending 
operations.
    It is worth noting that the Food Code suggests the use of HACCP 
controls at retail in some circumstances where comments argued for such 
controls as part of these regulations. Under the regulatory controls 
suggested in the Food Code, a retail establishment that purchases a 
scombroid toxin forming species of fish from a recreational harvester, 
for example, would need a HACCP plan relating to how it will ensure 
that fish had been handled so as to avoid time-temperature abuse. Under 


[[Page 65114]]
the Food Code, fish caught recreationally generally require the 
approval of a regulatory authority in order to be sold to a retail 
establishment. The States should be aware that the Food Code is 
responsive to concerns raised by comments in these respects. FDA urges 
the States to consider adopting the Food Code for retail and 
institutional operations.
    It is worth noting that the Food Code applies HACCP requirements to 
retail establishments as an exception for extreme situations, rather 
than as the rule. There is still much to be learned about the 
application of HACCP to retail establishments. Also, it may not be wise 
to single out seafood for the application of HACCP at retail. Retail 
operations can be complex and involve the handling of many types of 
foods. Trying to operate a HACCP system solely for seafood could divert 
attention away from important safety practices for high-risk products 
other than seafood.
    For all these reasons, therefore, the agency concludes that FDA 
should not mandate HACCP systems for the seafood component of retail 
establishments at this time. Also, the agency has not been provided 
with any information on how an FDA inspection program for such 
establishments would be feasible. Nonetheless, the agency will take all 
comments on retail establishments under advisement for future 
consideration as the system evolves.
    It is important to note, however, that where a processor engages in 
mixed operations (i.e., some retail and some wholesale), as in the case 
of cash-and-carry warehouses noted by one of the comments, the 
wholesale portion of the operations will be subject to the provisions 
of these regulations. As a further point of clarification in response 
to one comment, FDA has traditionally, and will continue to, classify 
central kitchens that distribute product to retail outlets that are 
owned by the same firm as a retail operation.
    b. Warehouses. In the preamble to the proposed regulations FDA 
stated that the definition of ``processor'' included warehouses. 
Warehouses store fish and fishery products, one of the operations 
included in the proposed definition of ``processing.'' A ``processor'' 
is simply an entity that engages in processing.
    There are food safety hazards that can be introduced while storing 
a product (e.g., in a warehouse). These hazards include, among other 
things, pathogen growth in cooked, ready-to-eat products and histamine 
development in scombroid toxin-forming species, as a result of improper 
storage temperatures. Nonetheless, the warehouse environment usually 
has few hazards compared to complex processing operations. 
Consequently, the preamble to the proposed regulations invited comment 
on whether warehouses should be exempted from the definition of 
``processor'' and, by implication, whether ``storing'' should not be 
included in the definition of ``processing,'' as one way of scaling the 
regulations back in terms of cost and burden.
    37. The comments split about evenly on this subject. Those that 
gave a reason for including warehouses cited the need to monitor 
storage temperatures for species that are prone to safety hazards if 
they are temperature abused. Those that opposed and provided a reason 
tended to argue that storage alone should not subject an establishment 
to the requirements of the regulations. A related concern was the view 
that warehouse operators do not have a thorough knowledge of the 
products that they handle and only store products that are provided to 
them by others. This concern was expressed both by those who objected 
to the inclusion of warehouses and those who simply asked for 
clarification about the role of warehouses. Others who asked for 
clarification expressed the view that warehouses could be responsible 
for conditions during storage.
    After consideration of these comments, FDA has decided to retain 
warehouses (e.g., public storage warehouses, foodservice distribution 
warehouses, and wholesale grocers) within the definition of 
``processor'' and to retain ``storing'' within the definition of 
``processing.'' It is important to recognize that section 402(a)(4) of 
the act covers storage along with other forms of processing. It states 
that a product is adulterated if it is ``prepared, packed, or held 
under unsanitary conditions * * * whereby it may have been rendered 
injurious to health.'' These regulations are being issued for the 
efficient enforcement of section 402(a)(4) of the act. Moreover, as 
described above, hazards can be introduced as well as controlled during 
storage. HACCP is an appropriate system for the control of these 
hazards.
    FDA believes that the burden on warehouses will be minimal given 
the simplicity of the operation and the fact that, in most cases, a 
warehouseman's responsibility under HACCP will only extend to 
conditions within the warehouse that could cause a safety hazard to 
occur.
    For the most part, hazards deriving from the environment 
(pesticides, etc.) will be controlled during the initial processing of 
the product (i.e., by the first processor to take possession). As a 
result, subsequent processors will receive products that are generally 
free of environmental hazards and thus will not need to establish HACCP 
controls for them. More often than not, storing will not be the first 
processing operation. Thus, a warehouse will not usually be responsible 
for environmental hazards. The same principle holds true for hazards 
arising during processing operations that occur before storage in a 
warehouse. Those hazards must be controlled during the prior processing 
and generally not during storage.
    There may be occasions, however, when storage is the first 
processing operation (e.g., when a warehouse will be the first 
processor to receive raw material fish from a fisherman or aquacultural 
producer). Under these circumstances, the warehouse, rather than a 
distant owner of the product, may be in the best position to obtain 
information that may be needed about harvest site, fishing practices, 
and transportation to the dock that would be germane to safety. There 
should be some arrangement between the warehouse and the owner on this 
matter to ensure that environmental hazards are properly addressed.
    38. One comment objected to the inclusion of storage within the 
definition of processing on the grounds that FDA should not dictate 
where CCP's should be.
    The agency is not attempting to do so. FDA acknowledges that 
whether storage is a CCP will depend on the circumstances. For example, 
refrigerated storage of a scombroid species will likely be designated 
as a CCP, whereas dry storage of canned fish will not likely be 
considered as such.
    39. Another comment objected to including ``airline warehousing'' 
within these regulations.
    If airlines hold product as part of their usual course of business 
as carriers, they are exempt from having HACCP plans in accordance with 
section 703 of the act.
    c. Other processing operations. 40. A few comments requested 
clarification on whether waterfront facilities that unload vessels and 
pack the catch for shipment to buyers are engaging in processing and 
thus meet the definition of ``processor.''
    These firms perform activities such as handling and storing that 
are included in the definition of processing and fall within the 
purview of the ``prepared, packed, or held'' clause of section 
402(a)(4) of the act. Additionally, these activities warrant coverage 
under these regulations because of their relationship to reasonably 
likely hazards. For example, these firms are, by design, usually the 
first processors to receive 

[[Page 65115]]
the product from the fisherman or aquacultural producer. As such, they 
are often in the best position to control environmental hazards, as was 
previously discussed. They also often store the product, at least for 
short periods of time. In this capacity, they may be responsible for 
ensuring that the product is not exposed to time- temperature abuse, a 
phenomenon that critically affects the safety of some products.
    For these reasons, FDA has clarified the definition of 
``processing'' at proposed Sec. 123.3(m) (redesignated as 
Sec. 123.3(k)) to specifically include dockside unloading.
    41. One comment took the view that only processors who own the 
products that they are processing should be subject to these 
regulations and suggested that the term ``processor-owner'' be 
substituted for ``processor.'' Several other comments questioned 
whether custom processors that do not own the product, should be 
subject to the provisions of these regulations.
    The definition of ``processor'' does not hinge on ownership. As 
indicated earlier, whether a product is adulterated under section 
402(a)(4) of the act depends on the condition under which it was 
``prepared, packed, or held.'' Ownership is not a relevant factor. 
Consistent with this principle, these regulations define a processor as 
simply an entity that engages in processing. ``Processing'' is defined 
as including a number of activities, such as manufacturing and packing, 
that are normally performed by a custom packer.
    Like warehouses that store products for distant owners, custom 
packers are often in the best position to exercise HACCP controls for 
the products that they process. Because of the real-time nature of 
HACCP (i.e., because monitoring provides immediate feedback as to 
whether a hazard is being controlled), the processor can most 
effectively apply HACCP monitoring controls to a food being processed, 
regardless of whether the processor is the actual owner of the food. 
FDA recognizes that it will often be beneficial for the custom 
processor and the owner of the product to fully discuss and agree upon 
the HACCP controls that will be effected by the custom processor while 
the product is in its possession.
    42. One comment argued that custom packers should be included 
within the scope of these regulations because these processors often 
can or smoke recreationally caught products and are often the only 
commercial entity that can assure the safety of such products. While 
the definition of ``processing'' clearly covers the kinds of activities 
performed by custom packers, it is not the intent of these regulations 
to address arrangements between a recreational fisherman and a custom 
packer for the processing of fish for the personal use of the 
fisherman. The regulations only cover custom packing that is performed 
on behalf of an owner who intends to introduce the fish into interstate 
commerce. Nonetheless, the agency does not believe that clarification 
to the regulations is needed on this point.
    43. One comment urged that aquacultural producers that also 
eviscerate the fish before delivery to a processing plant be required 
to comply with the requirements of these regulations.
    FDA agrees with the comment and further states that the process of 
eviscerating is specifically included in the definition of 
``processing.'' Eviscerating is excluded from the definition only when 
it occurs on a harvest vessel for the purpose of preparing the fish for 
holding en route to the processor.
    44. A few comments objected to FDA including labeling in the 
definition of ``processing.'' The comments argued that labeling 
operations are unlikely to introduce hazards to the product. FDA has 
considered these comments but finds that there is potential during some 
labeling operations for the development of hazards. For example, 
improperly controlled labeling operations for scombroid species could 
result in time-temperature abuse of the product, increasing the risk of 
histamine contamination. Cooked, ready-to-eat products could similarly 
be subjected to time-temperature abuse, resulting in the potential for 
pathogen growth. The inclusion of labeling in the list of processing 
operations is not intended to imply that this step should always, or 
even frequently, be considered a CCP. That can only be determined 
through the conduct of a hazard analysis.
    FDA proposed to exempt ``heading or gutting intended solely to 
prepare a fish for holding on board a harvest vessel'' from the 
definition of ``processing.'' In drafting the proposed regulations, FDA 
was concerned that, in the absence of such an exemption, harvest 
vessels that are presently heading or gutting fish would stop the 
practice to avoid being subject to the requirements of these 
regulations. FDA did not want an inadvertent consequence of these 
regulations to be a reduction in product quality. In addition, FDA 
tentatively concluded that safety hazards introduced by these 
operations are generally minimal.
    45. One comment noted that FDA should include the practice of 
freezing fish on harvest vessels in the list of exempted operations.
    FDA agrees that freezing is an operation that is routinely used 
onboard a harvest vessel in order to preserve the quality of the fish 
until it is landed for further processing (e.g., freezing performed 
onboard tuna harvesting vessels). For this reason, the agency has 
revised the definition of ``processing'' to include an exemption for 
onboard freezing.
    46. One comment suggested that FDA also exempt onboard scallop 
shucking operations.
    Unlike shucking other molluscan shellfish, shucking scallops 
involves eviscerating, a procedure that falls within the exemption in 
Sec. 123.3(k). Consequently, onboard shucking of scallops does not 
constitute processing for purposes of these regulations. The agency 
does not believe that a change in the definition is necessary in this 
regard.
    47. One comment suggested that, with respect to molluscan 
shellfish, ``processors'' should include shellfish shippers, 
reshippers, shucker-packers, repackers, and depurators.
    The persons that perform all of these types of operations are 
``processors'' under Sec. 123.3(k)(1) and subject to the provisions of 
these regulations. Thus, the agency has concluded that no change in the 
definition is necessary.
16. Scombroid Toxin-Forming Species
    The term ``scombroid toxin-forming species'' appears in 
Sec. 123.6(c)(1)(vi) of this final rule. While FDA did not propose to 
define this term in the codified portion of the proposed regulations, 
it did propose to define it in part 123 appendix B as:

    [T]una, bluefish, mahi mahi, mackerel, sardines, herring, 
kahawai, anchovies, marlin, and other species, whether or not of the 
family Scombridae, in which significant levels of histamine may be 
produced in the fish flesh by decarboxylation of free histidine as a 
result of exposure of the fish after capture to temperatures that 
permit the growth of mesophilic bacteria.

Appendix B of part 123 is no longer included in these regulations, as 
is discussed elsewhere in this preamble. Consequently, FDA is 
transferring the definition from part 123 appendix B to Sec. 123.3(m) 
to clarify the meaning of Sec. 123.6(c)(1)(vi).
    48. A number of comments objected to the inclusion of herring in 
the list of scombroid toxin-forming species, arguing that there has 
been no association between herring and cases of histamine poisoning.
    In response to the comments, FDA has modified the definition of 
scombroid 

[[Page 65116]]
toxin forming species to make specific reference to only tuna, 
bluefish, and mahi mahi, since the overwhelming majority of scombroid 
poisonings are associated with these types of fish. Processors should 
assess the potential of other species to product histamine. The key to 
the definition is whether significant levels of histamine may be 
produced in the flesh of the fish.
17. Shellfish Control Authority
    FDA proposed to define ``shellfish control authority'' as ``a 
Federal or State health authority, or foreign government health 
authority, legally responsible for the administration of a program that 
includes classification of molluscan shellfish growing areas, 
enforcement of harvesting controls, and certification of molluscan 
shellfish processors.''
    49. A few comments pointed out that the definition should not 
require that a shellfish control authority be a State ``health'' 
authority because in some States the responsibility is vested in other 
than a health agency, such as a resource management agency.
    FDA recognizes that these comments are correct. For this reason, 
the agency has modified the language in Sec. 123.3(o) to read, in part, 
``State agency.'' FDA believes that this term is sufficiently broad to 
encompass any of the present State arrangements. FDA has made a 
parallel change with respect to foreign government authorities, in 
order to accommodate the same kind of variations in regulatory 
arrangements. These final regulations similarly refer to a ``foreign 
agency.''
    50. One comment, from a State regulatory agency, stated that within 
the United States, FDA should be the responsible shellfish control 
authority and should mandate that processors register with FDA, much as 
it has done with low-acid canned foods and medical devices. The comment 
further stated that a requirement in Federal regulations that State 
agencies perform this function may be unconstitutional.
    The comment misconstrued the provision. The provision is intended 
to define the term ``shellfish control authority'' rather than to 
provide substantive requirements. Furthermore, these regulations at no 
point mandate that States perform certain functions.
    51. Some comments expressed concern that the proposed definition of 
``shellfish control authority'' was too narrow in that it did not 
include any entities that could serve the function of a shellfish 
control authority for Federal waters. The effect of the proposal, the 
comments pointed out, would be to close unnecessarily all molluscan 
shellfish harvesting in Federal waters.
    It was never FDA's intent to close Federal waters to molluscan 
shellfish harvesting. These waters are beyond the jurisdiction of State 
shellfish control authorities, and no Federal agency classifies them in 
the same way that States classify their own waters. FDA is seeking a 
means to classify Federal waters. An agreement with NMFS relating to 
the classification of Federal waters is one possible solution. For this 
reason, FDA has modified proposed Sec. 123.3(o) to state that a 
shellfish control authority may be ``a Federal agency.'' This subject 
is also discussed in the ``Molluscan Shellfish'' section of this 
preamble.
    52. One comment urged that FDA provide for the possibility of 
sovereign tribal governments serving as shellfish control authorities.
    FDA recognizes that the proposed definition was deficient because 
it failed to include tribal governments in the list of possible 
shellfish control authorities. The agency, the State of Washington, and 
19 Indian tribes have recently entered into a settlement that will 
likely result in such an arrangement in the State of Washington (Ref. 
202). When such governments meet the necessary criteria, it is the 
intent of the agency to formally recognize them for purposes of 
classifying shellfish growing waters and certifying shellfish 
processing plants for inclusion on the Interstate Certified Shellfish 
Shippers List. To provide for this situation, FDA has modified the 
definition of ``shellfish control authority'' to include ``sovereign 
tribal governments.''
    FDA has also recognized that in many cases the functions of 
``classification of molluscan shellfish growing areas, enforcement of 
harvesting controls, and certification of molluscan shellfish,'' as 
listed in the proposed regulations, are not carried out by a single 
agency. To provide for such a situation, FDA has modified the proposed 
language at Sec. 123.3(o) to read, ``program that includes activities 
such as,'' rather than simply ``program that includes.''
18. Smoked and Smoke-Flavored Fishery Products
    The terms such as ``smoked fishery products,'' ``smoked fish,'' 
``smoked and smoke-flavored fishery products'' were used in the 
proposed regulations and throughout appendix 1 to the proposal. As a 
result of decisions discussed elsewhere in this preamble, reference to 
``smoked and smoke-flavored fishery products'' has been eliminated in 
these regulations except in part 123, subpart B.
    While no definition of ``smoked and smoke-flavored fishery 
products'' was included in the definitions section of the proposed 
regulations, the terms ``smoke-flavored fish'' and ``smoked fish'' were 
separately defined in appendix 1 to the proposal as: ``Smoked-flavored 
fish means fish that is prepared by treating it with salt (sodium 
chloride) and then imparting to it the flavor of smoke by other than 
the direct action of smoke, such as immersing it in a solution of 
liquid smoke,'' and ``Smoked fish means fish that is prepared by 
treating it with salt (sodium chloride) and then subjecting it to the 
direct action of smoke from burning wood, sawdust, or similar 
material.'' FDA solicited comment on the materials in appendix 1. 
Because the term is used in these final regulations and FDA is 
concerned that there may be confusion about its application, the agency 
has determined that a definition of ``smoked and smoke-flavored fishery 
products'' is needed in the codified portion of these regulations. FDA 
has included one at Sec. 123.3(s) that is consistent with those 
proposed in the appendix 1 to the proposal. Section Sec. 123.3(s) 
reads:

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

FDA received numerous comments on the regulatory treatment of smoked 
and smoke-flavored fishery products, but none that would affect this 
definition.

E. The HACCP Plan

    Approximately 100 comments addressed one or more of the provisions 
of proposed Sec. 123.6. This section of the proposed regulations set 
out who must write and implement a HACCP plan, and what the HACCP plan 
must include.
1. Preliminary Steps
    FDA proposed in Sec. 123.6 to require that all processors of fish 
and fishery products prepare and implement a HACCP plan that identifies 
the hazards that are reasonably likely to occur and thus that must be 
controlled for that product. In the proposal, FDA acknowledged the 
process recommended by the NACMCF for developing a HACCP plan but did 
not propose to require that processors follow it. The process 
recommended by the NACMCF includes: Assembling a HACCP team, describing 
the food and its distribution, identifying the intended use and 
consumers of the food, developing a flow diagram, verifying the 

[[Page 65117]]
flow diagram, and performing a hazard analysis (Ref. 34, pp. 187-188). 
All but the last of these have been identified by NACMCF as the ``five 
preliminary steps'' of HACCP.
    It was, and still is, the agency's belief that processors would 
benefit from a process that included these five steps as well as a 
hazard analysis in order to successfully arrive at an appropriate HACCP 
plan. Nonetheless, the agency did not propose to require adherence to 
the ``five preliminary steps,'' or explicitly propose to require that a 
hazard analysis be performed. So long as the processor had, in the end, 
a HACCP system that was appropriate for species and process, and was 
being implemented effectively, the agency tentatively concluded that 
these regulations did not need to manage the process any further.
    53. A number of the comments contended that FDA should require that 
firms adhere to these procedures in preparing a HACCP plan. 
Specifically, a few comments argued that the proposed rule 
significantly diminished the potential effectiveness of HACCP by not 
requiring that processors engage in the ``five preliminary steps.'' The 
comments argued that inclusion of the preliminary steps would 
facilitate international trade and reduce confusion on the part of 
seafood importers and exporters through consistency with an 
internationally recognized standard for HACCP.
    Several other comments urged that the NACMCF recommendation for the 
development of a process flow diagram, in particular, by a processor be 
made mandatory. These comments identified several benefits from such a 
requirement: To facilitate employee implementation of the plan, to 
facilitate processor verification activities, to reduce the time needed 
for regulators to review the manufacturing process, and to enable the 
regulator to determine whether the processor properly considered the 
entire manufacturing process. One comment stated that FDA's assumption 
that flow diagrams are burdensome or unnecessary is contrary to the 
1992 NACMCF Report which notes that flow diagrams could be simple 
representations that accurately depict the steps in a process, rather 
than detailed, technical drawings.
    FDA acknowledges that, for the reasons stated in the comments, many 
processors will find that the development of a flow diagram is a useful 
preliminary step to the preparation of a HACCP plan. Other processors 
may find, however, that, because of the simplicity of their operations, 
the preparation of a written flow diagram is an unnecessary step. In 
either case, FDA is convinced that a processor's decision to develop or 
not to develop a flow diagram will be, and should be, driven by its 
perception of the benefits of doing so. The comments received on this 
subject were not sufficiently persuasive for the agency to conclude 
that a flow diagram should be made mandatory. The comments provided no 
basis to find that in the absence of a flow diagram, a processor could 
not properly develop a HACCP plan, or that a plan, so developed, would 
likely cause the HACCP program to fail.
    As some of the comments pointed out, there may be some benefit to 
the regulator to have access to a flow diagram during an inspection, 
but this convenience is not a sufficient reason to mandate it. FDA 
investigators will likely develop their own flow diagrams during their 
in-plant inspections and compare them with the decisions reached by the 
processor in the development of the HACCP plan (e.g., the 
identification of hazards and CCP's). While it may be beneficial for 
the investigator to be able to compare his or her flow diagram with 
that of the processor, it is not essential to the conduct of the 
inspection.
    FDA agrees with the comments that stated that the other four 
elements of the ``five preliminary steps'' are desirable attributes of 
the HACCP development process. However, the agency has not been 
persuaded that, in the absence of a regulatory requirement that they be 
followed, the HACCP program is unlikely to succeed. In order to write 
an appropriate plan some or all of these steps will likely have to be 
performed, even without a regulatory requirement to do so. However, if 
a processor can write a plan without these steps, the goals of the 
regulations will still have been met. For FDA to require them to be 
performed and documented in every case would add burden and reduce 
flexibility unnecessarily. Moreover, FDA is unconvinced that any 
inhibition to foreign trade is likely to occur if adherence to these 
steps is not required. FDA believes that foreign trading partners will 
be satisfied by the presence of a successful HACCP system and will not 
reject U.S. exports because steps preliminary to HACCP were not 
documented.
    Even without a requirement mandating specific preliminary steps, 
FDA believes that most processors will follow the spirit, if not the 
exact letter, of the recommended procedures. These procedures provide 
the processor with a recognized method of plan development that will 
help lead to a successful outcome. FDA is primarily interested in that 
outcome. The NACMCF recommendation for the assembly of a HACCP team, in 
particular, could be a significant burden for the many small businesses 
operating in the seafood industry. For these reasons, the final 
regulations do not mandate any preliminary steps that processors must 
perform as a prerequisite to conducting a hazard analysis or drafting a 
HACCP plan.
2. Conducting a Hazard Analysis
    54. A number of comments from trade associations and processors 
objected to the requirement in the proposal that every processor have 
and implement a written HACCP plan. These comments contended that FDA 
should revise this provision to require that a processor first conduct 
a hazard analysis to determine whether any food safety hazards exist 
that can be controlled through HACCP and then prepare and implement a 
HACCP plan only when the hazard analysis identifies at least one such 
food safety hazard. One comment stated that conducting a hazard 
analysis is the first step in a two-step process, with developing a 
HACCP plan being the second step. The comments urged consistency with 
the NACMCF recommendations in this regard.
    FDA agrees with the approach suggested by the comments and believes 
that it is essentially consistent with what the agency proposed. 
Although FDA did not explicitly propose to require that every processor 
conduct a hazard analysis, completion of such an analysis by every 
processor was implicit in the requirement in proposed Sec. 123.6(b)(1) 
and (b)(2) that processors identify both the hazards that are 
reasonably likely to occur and the CCP's for each of these hazards.
    In response to the comments, FDA has decided to clarify its 
regulations to make the requirement that a hazard analysis be conducted 
explicit rather than implicit in order to clarify the steps that are 
required as part of a HACCP system. Moreover, this change allows the 
agency to make clear that conducting the analysis may or may not lead 
to the preparation of a HACCP plan.
    Thus, FDA is providing in Sec. 123.6(a) that processors shall 
conduct a hazard analysis or have one conducted on their behalf. It is 
the agency's expectation that most seafood processors will, after 
performing a hazard analysis, find it necessary to control for at least 
one hazard and, therefore, be obligated to prepare a HACCP plan. 
However, when no hazard is reasonably likely to occur, there is no 
reason to prepare a HACCP plan. Therefore, Sec. 123.6(b) states, in 

[[Page 65118]]
part, ``(b) The HACCP plan. Every processor shall have and implement a 
written HACCP plan whenever a hazard analysis reveals one or more food 
safety hazards that are reasonably likely to occur, as described in 
paragraph (a) of this section.''
    The agency does not believe that the methodology of conducting 
hazard analyses is sufficiently standardized at this time to justify 
mandating what the analysis must include. FDA encourages processors to 
utilize the NACMCF document as guidance in performing this activity. In 
addition, the agency recognizes that the best way for it to verify a 
processor's hazard analysis is indirectly, through its own evaluations 
of whether a processor ought to have a HACCP plan, and whether a HACCP 
plan appropriately identifies the food safety hazards and CCP's that 
are reasonably likely to occur. In other words, it is the end product 
of the hazard analysis, the HACCP plan and its implementation, that 
should be judged by the regulator. For this reason, the agency is not 
requiring that hazard analyses be performed according to a standardized 
regimen, or that they be documented in writing for FDA review.
    Even though FDA is not requiring that the hazard analysis be 
available to the agency, there may be cases in which it would be to the 
processor's advantage to have a carefully documented written hazard 
analysis to show to FDA. Such documentation may prove useful in 
resolving differences between the processor and the agency about 
whether a HACCP plan is needed and about the selection of hazards, 
CCP's, and CL's. Written hazard analyses may also be useful to 
processors in that they may help provide the rationale for the 
establishment of critical limits and other plan components. Having the 
basis for these decisions available may be helpful when processors 
experience changes in personnel, especially those associated with the 
HACCP process, and in responding to unanticipated CL deviations.
3. Types of Hazards
    FDA received a number of comments on the types of hazards that a 
mandatory HACCP system should control, and that the hazard analysis 
should examine. The proposed regulations did not distinguish among 
hazards but proposed to require that HACCP plans identify all food 
safety hazards that are reasonably likely to occur. The comments that 
addressed the question of what types of hazards mandatory HACCP should 
address generally preferred that its focus be on some subset of 
hazards, rather than on the entire spectrum that could cause seafood to 
be adulterated. The comments argued that the hazards that were not the 
focus of the HACCP regime established by the regulations could be 
covered by more traditional food safety mechanisms. A review of these 
comments follows.
    55. Several comments, from processors and trade associations, 
stated that the hazard analysis should only be used to identify those 
food safety hazards that have the potential to cause ``serious adverse 
health consequences.'' These comments stated that such consequences 
included those that would trigger a ``Class I'' recall as defined by 
FDA, particularly those that involve contamination of the food with 
pathogenic microorganisms. A Class I recall involves a situation in 
which there is a reasonable probability that the use of, or exposure 
to, a violative product will cause serious adverse health consequences 
or death and would not be used to respond to situations in which the 
health consequences are temporary, medically reversible, or remote (21 
CFR 7.3(m)(1) and (m)(2)). Other processor comments suggested the use 
of the phrase ``significant food safety hazard'' to limit the scope of 
the HACCP regime without proposing a definition for the phrase.
    One comment stated that focusing on truly serious hazards is the 
only way to keep the number of CCP's to a minimum, so that a HACCP plan 
can realistically be implemented. The comment also stated that having 
too many CCP's, or CCP's that are not related to serious health risks, 
would so burden food processing personnel that effective compliance 
with the HACCP plan would be undermined, and it would be significantly 
more difficult to control truly critical processes.
    Several of these comments argued that hazards should have 
immediate, as well as serious, health consequences before being 
required to be identified in a HACCP plan. These and several other 
processor comments generally expressed the view that hazards that can 
cause a food to be adulterated under the act, but that do not have the 
potential to cause acute illness, should not be required to be included 
in a HACCP plan. For example, two of the comments stated that FDA 
should not use the HACCP regulations to ensure conformity with food 
additive regulations, pesticide residue tolerances, or action levels 
for environmental contaminants. One comment stated that although 
process controls that are similar to HACCP controls are often used by 
food manufacturers to monitor these kinds of contaminants, the controls 
should not be regarded as part of HACCP because they do not address 
acute health hazards. A few comments suggested that existing regulatory 
programs are adequate to address these types of hazards.
    On the other hand, comments from one trade association and a number 
of individuals acknowledged that drug residues and pesticide residues 
should be addressed by HACCP plans; where they are likely to occur at 
levels over tolerance. Comments from a number of processors of 
aquaculture-raised finfish acknowledged that drug and pesticide 
residues are food safety hazards that affect their industry, but these 
comments questioned the appropriateness of the control mechanisms 
provided in FDA's draft Guide. Finally, comments from several consumer 
advocacy groups expressed continued concern for the hazards posed by 
environmental contaminants.
    Having considered these comments, FDA confirms its tentative view, 
reflected in the proposal, that HACCP should be the norm, rather than 
the exception, for controlling safety related hazards in the seafood 
industry. Existing standards for such contaminants as drug residues, 
pesticides, and industrial contaminants, are established to ensure that 
their presence in foods does not render the food unsafe. Processors of 
fish and fishery products are obliged to produce foods that meet these 
standards.
    Processors are obliged to exercise control over all food safety 
hazards that are reasonably likely to occur. A failure to do so would 
mean that the food was prepared under insanitary conditions whereby it 
may have been rendered injurious to health or is otherwise adulterated. 
The criteria for including a food safety hazard in a processor's HACCP 
plan should be the degree to which the hazard is likely to develop in 
that product (e.g., based on the processing technique, the harvest 
location, the species) and not the nature or immediacy of the illness 
or injury that it is likely to cause.
    FDA views as highly speculative the concerns, expressed by a few 
comments from the food industry, that inclusion in HACCP of those 
hazards that generally require chronic exposure to produce disease will 
dilute HACCP systems to the point of shifting industry resources away 
from acute toxicity hazards. No evidence was submitted to support such 
claims. The pilot HACCP program conducted jointly by FDA and NMFS, the 
current NMFS voluntary HACCP program, and the NMFS Model Seafood Safety 
Program all included controls for food additives, primarily a nonacute 

[[Page 65119]]
food safety hazard, and there has been no diminution of control of 
acute hazards as a result. Moreover, the agency is convinced that when 
determining, in accordance with Sec. 123.6(a), what contaminant hazards 
are ``reasonably likely'' to occur in a particular type of product, 
most processors will have very few, if any, of these chronic exposure-
type hazards to manage through HACCP as opposed to through some other 
method of control.
    FDA intends to monitor the progress of the seafood HACCP program to 
judge, among other things, whether the application of HACCP to food 
safety hazards generally, rather than to the most extreme acute 
hazards, overloads the HACCP system and dilutes its effectiveness for 
all hazards. Until such an effect is actually found to occur, FDA is 
persuaded that the systematic application of preventive controls to 
food safety hazards generally will provide the American consumers with 
the most effective and efficient food safety system that has been 
devised to date. If FDA were to determine that HACCP needs to be scaled 
back in order to make it work, the agency will take appropriate steps 
to make such a change.
    One other factor bears mention in this regard. FDA has long been 
aware of consumer concern about environmental contaminants in fish and 
fishery products. As previously mentioned, this concern was expressed 
in the comments to the proposed regulations. The chance that these 
regulations will increase consumer confidence in the safety of seafood 
products would be greatly diminished if these regulations did not 
require processors to consider the risks from these contaminants as 
part of their hazard analysis.
    56. A comment from a trade association stated that, while there is 
potential for an unapproved direct or indirect food or color additive 
to be a health hazard, the use of an additive that has not been listed 
for use in fish but is routinely used throughout the food industry 
would not necessarily be likely to cause harm to human health. The 
comment said that a control for use of the additive should not be 
required to be included in a HACCP plan.
    Under the act, certain products, such as food additives, new animal 
drugs, including new animal drugs intended for use in aquaculture, and 
pesticides, require premarket approval before they may be legally used. 
Moreover, this approval can be limited so that the product may only be 
used legally on or with specific foods, or for specific purposes, for 
which approval has been obtained. This limitation reflects a 
longstanding realization that the safety of these types of products is 
variable and must be established on a use-by-use basis. Whether an 
additive, drug, or pesticide is safe for a particular use, in a 
particular food, at a particular level, depends on factors such as the 
amount of the food that is consumed and, if the additive, drug, or 
pesticide is ingested in a living animal before capture, how the 
product is metabolized in that animal.
    Therefore, a food additive that has been approved for use in some 
foods, but not fish and fishery products, is deemed by the act to be 
unsafe for use with fish and fishery products. FDA is not in a position 
to change this aspect of the law through regulations. Consequently, the 
agency has not created an exemption from the requirement for HACCP 
controls for safety hazards caused by the presence of unapproved 
additives or other products that lack premarket approval for fish or 
fishery products.
    The agency is aware that it is possible that some of these products 
may pose no meaningful risk in fish and fishery products at levels 
approved or allowed in other foods. It is the obligation of the 
proponent of the use of the substance to follow applicable statutory 
procedure to establish this fact to FDA's satisfaction.
    57. In the preamble to the proposed regulation, FDA specifically 
invited comment on whether, in order to reduce the burden of HACCP on 
the industry, as in the Canadian fishery products HACCP regulation, the 
agency should limit its HACCP approach to cover only those hazards that 
are introduced within the confines of the processing plant. This type 
of limitation would eliminate mandatory control of environmental 
hazards such as pesticides, natural toxins, industrial contaminants, 
and aquaculture drugs through the HACCP system.
    One comment contended that a processor of fishery products would be 
in a difficult position attempting to exercise control over problems 
that occur during harvesting. The comment stated that the purpose of 
HACCP is to require that each processor be responsible for minimizing 
those serious hazards that it is in the best position to control, but 
that the proposed regulations would force the processor to take 
responsibility for hazards that it may be poorly suited to control. The 
comment argued that FDA's intent was to deploy HACCP solely as a way of 
reducing the agency's inspectional burden. The comment further stated 
that the focus should be on finding those few CCP's within a specific 
process where a serious hazard can best be controlled. Several other 
comments expressed confusion about the application of HACCP to 
environmental hazards.
    The preamble to the proposed regulations described the link between 
environmental hazards, such as natural toxins (e.g., ciguatera toxin, 
domoic acid, and saxitoxin), histamine, and various viral and bacterial 
pathogens, and human disease. The NAS' ``Seafood Safety'' report (Ref. 
7, p. 1) suggested that the most significant reduction in illness from 
seafood would come from the control of environmental hazards. To 
eliminate coverage of such hazards from these regulations would be to 
eliminate the greatest share of anticipated benefits.
    The preamble to the proposed regulations provided a number of ways 
in which the processor can exercise control over environmental hazards. 
This control derives from the fact that responsible processors already 
exercise discretion in obtaining their raw materials. Control is 
achieved by checking tags on containers of molluscan shellfish to 
ensure that they are harvested only from approved waters, checking with 
fishermen to ensure that finfish do not originate from harvest areas 
that are closed due to the presence of excessive agricultural or 
industrial contaminants, and physically examining incoming histamine-
forming species for evidence of decomposition and insisting that 
harvest vessels exercise control over the time and temperature of 
storage for these species. Similarly, processors of aquaculture-raised 
species can audit or otherwise insist on a producer controls over the 
use of animal drugs or other hazards resulting from inappropriate 
husbandry practices. In a HACCP system, these are examples of controls 
that can be applied at the first CCP, i.e., at the receipt of raw 
materials.
    FDA concludes that the measures that a processor takes to ensure 
that its raw materials are free of environmental hazards are a critical 
part of a seafood HACCP program. Responsible processors already 
exercise the kind of control necessary to ensure that their raw 
materials do not present such a hazard. If a likely hazard exists, it 
would not be sufficient to use the price offered for raw materials to 
be the only measure to protect against the hazard.
    For these reasons, FDA has retained environmental hazards in the 
list of food safety hazards that processors should consider in 
Sec. 123.6(c)(1). To clarify that there are hazards that occur before 
receipt of raw materials that can be controlled nonetheless by 
examination or discretion at the 

[[Page 65120]]
receiving CCP, FDA has modified Sec. 123.6 by including the following 
sentence in Sec. 123.6(a), ``Such food safety hazards can be introduced 
both within and outside the processing plant environment, including 
food safety hazards that can occur before, during, and after harvest.''
    For consistency, Sec. 123.6(c)(2) needs a space here provides for 
both types of CCP's, and now reads:

    (2) List the critical control points for each of the identified 
food safety hazards, including, as appropriate: (i) Critical control 
points designed to control food safety hazards that could be 
introduced in the processing plant environment, and (ii) Critical 
control points designed to control food safety hazards introduced 
outside the processing plant environment, including food safety 
hazards that occur before, during, and after harvest.
    Because most of the environmental hazards to which fish are exposed 
will be controlled by the first processor to take possession of the 
fish from the fisherman or aquacultural producer, whether that 
processor is located in the United States or in another country, 
subsequent processors need not focus on these hazards in their HACCP 
plans. For example, pesticide contamination of inland and near shore 
finfish can be effectively controlled by the first processor by 
purchasing from fishermen who do not harvest in areas that have been 
closed by regulatory authorities, and drug residue contamination can be 
effectively controlled by the first processor by purchasing from 
aquaculture producers who use animal drugs properly.
4. When Is a Hazard Reasonably Likely To Occur?
    In the proposal, FDA identified nine categories of safety hazards 
that might occur in fishery products. The agency tentatively concluded 
that a processor must establish HACCP controls when one or more of the 
listed hazards is reasonably likely to occur.
    58. A number of comments, from processors and a trade association, 
questioned whether certain of these nine hazard categories by 
themselves justify a HACCP plan. The comments challenged the likelihood 
that some of these hazards would cause harm and asked for clarification 
on how a processor is to determine whether a hazard is ``reasonably 
likely to occur.'' One comment held that, if the term ``reasonably 
likely to occur'' is linked to actual incidents of illness caused by a 
given hazard, it would be inappropriate to define some of the listed 
hazard categories as reasonably likely to occur. This comment also 
requested that FDA clarify whether the hazards identified in its draft 
Guide are those that the agency believes are reasonably likely to occur 
under all conditions for the listed species and processing methods. The 
comment further noted that residues of industrial or agricultural 
chemicals present in seafood are usually not present at levels that are 
reasonably likely to be a safety hazard, even in many of those species 
that are listed in the Guide as presenting that hazard.
    As discussed in the preamble to the proposed regulations, FDA 
recognizes that HACCP need not be used to control every theoretical 
hazard, no matter how remote the likelihood of its occurrence. 
Moreover, as discussed earlier in this preamble, case law interpreting 
section 402(a)(4) of the act has held that conditions must be such as 
to create a reasonable possibility that a hazard will occur in order 
for product to be adulterated under that section of the law. (See 
United States v. 1,200 Cans, Pasteurized Whole Eggs, Etc., 339 F. Supp. 
140-141.)
    Unquestionably, historical occurrence of reported illness is an 
appropriate starting place for the identification of food safety 
hazards that are reasonably likely to occur in the absence of controls. 
For example, illness from scombrotoxin in those species that form the 
toxin if subjected to time and temperature abuse after harvest is one 
of the most frequently reported illnesses from seafood. Moreover, the 
relationship between abuse after harvest and the formation of the toxin 
is well established. FDA can say with comfort, therefore, that 
scombrotoxin poisoning is a hazard that is reasonably likely to occur 
in the absence of appropriate controls for scombrotoxin-forming species 
of fish.
    For some hazards, however, the incidence of reported illness is 
very low. A good example is illness from the consumption of raw fish 
species that are prone to parasites. The low number of reported 
illnesses is probably attributable to underreporting and to the fact 
that controls for this hazard (e.g., commercial blast freezing that 
kills parasites) generally exist. However, it is well established that 
in the absence of controls, infection from parasites is a hazard that 
is reasonably likely to occur when a species that is prone to parasites 
is consumed raw.
    The incidence of reported illness that is linked to a specific food 
is virtually nonexistent when the illness is the result of chronic 
exposure to a chemical contaminant. It is extremely difficult, for 
example, to link a specific case of cancer to a specific contaminant in 
food. However, where public health officials have determined that a 
contaminant represents a chronic health hazard, the standard control 
strategy to be employed by processors for such contaminants is to 
ensure that their presence in food remains below specific levels.
    Processors are advised of such chronic health hazard determinations 
through FDA action levels, publications (e.g., Federal Registers at 55 
FR 14359, April 17, 1990; 58 FR 11609, February 26, 1993; and 58 FR 
48368, September 15, 1993), or other similar guidance documents. If the 
contaminant is present in food in an amount that is above that level, 
the food represents a hazard to health that the evidence from the 
chronic studies shows is reasonably likely to occur. The question, 
then, is whether the likelihood of finding a fish in which the 
contaminant is at a higher than acceptable level is an event that is 
reasonably likely to occur. For open ocean species of fish, for 
example, a finding of pesticide residues above nationally established 
tolerances can be a very rare event. For near shore species in certain 
locations, however, a finding above tolerance can occur often enough so 
as to warrant controlling for it as a matter of reasonable prudence.
    The incidence of reported illness for a particular hazard may also 
be nonexistent or very low because the hazard may be too new to have 
generated reported illnesses. The emergence of natural toxins harmful 
to humans in species or in locales where the toxin has not been found 
before is a well known phenomenon in seafood. While FDA does not expect 
that HACCP controls should be in place to control for the possibility 
of such hazards--the hazard may or may not ever occur--the agency 
strongly believes that once a hazard does emerge and is identified, 
HACCP controls are highly appropriate to keep illnesses from occurring. 
For the duration of the a hazard, it must be treated as one that is 
reasonably likely to occur.
    To provide clarification on the above points, FDA has modified 
Sec. 123.6 by including the following sentence in new Sec. 123.6(a):

    A food safety hazard that is reasonably likely to occur is one 
for which a prudent processor would establish controls because 
experience, illness data, scientific reports, or other information, 
provide a basis to conclude that there is a reasonable possibility 
that it will occur in the particular type of fish or fishery product 
being processed in the absence of those controls.

    To reinforce that it was not FDA's intent to suggest that all of 
the nine hazard categories that it listed in Sec. 123.6(c)(1) are 
reasonably likely to 

[[Page 65121]]
occur in all circumstances, the agency has modified the language in 
this provision to read in part, ``Consideration should be given to 
whether any food safety hazards are reasonably likely to occur as a 
result of the following:'' (the list of nine categories follows in the 
text).
    The Guide is not intended as a definitive list of the hazards that 
are reasonably likely to occur, under all conditions, for those species 
and processing methods listed.
    HACCP is a operation-specific process. For this reason, the 
processor must decide on a case-by-case basis what hazards it needs to 
address; that is, what hazards are reasonably likely to occur. The 
purpose of the hazards portion of the Guide is to provide a listing of 
hazards, by fish species and by finished product type, that FDA knows 
to have a reasonable potential for occurrence in the product.
    FDA encourages processors to use the Guide, as well as any other 
available information, to decide what hazards need to be addressed in 
any particular plan. Processors need to recognize that they need to use 
judgment in applying the Guide to their own particular circumstances. 
For example, a processor of one species of fish may find that pesticide 
contamination is listed as a hazard for the species, but may be aware 
of credible data that demonstrate that the water from which it obtains 
its fish is free of such contamination. In that case, the processor is 
free to deviate from the guidance. FDA intends to clarify the Guide on 
this point by distinguishing between hazards that are reasonably likely 
to occur all of the time (e.g., histamine in species that are prone to 
it) and hazards that are reasonably likely to occur under certain 
circumstances (e.g., certain toxins when a ``bloom'' is occurring).
5. The Plan: Specific Considerations
    59. FDA proposed that HACCP plans be specific to each processing 
location and to each kind of fish and fishery product processed by a 
processor, except that the plan may group kinds of fish and fishery 
products together if the hazards, CCP's, CL's, and procedures required 
to be included in the plan are identical. A few comments from 
processors and trade associations suggested that production methods 
should also be allowed to be grouped together so long as the hazards 
and the control procedures for the production methods are identical. 
The comments suggested that grouping would reduce the paperwork burden 
on some processors without altering the benefits attainable through 
HACCP.
    FDA agrees with the suggestion for the reason presented by the 
comments and has modified Sec. 123.6(b) accordingly, to read, in part:

    A HACCP plan shall be specific to: (1) Each location where fish 
and fishery products are processed by that processor; and (2) Each 
kind of fish and fishery product processed by the processor. The 
plan may group kinds of fish and fishery products together, or group 
kinds of production methods together, if the food safety hazards, 
critical control points, critical limits, and procedures required to 
be identified and performed in paragraph (c) of this section are 
identical for all fish and fishery products so grouped or for all 
production methods so grouped.

    60. In the proposal, FDA specified that a HACCP plan must identify: 
The applicable food safety hazards; the CCP's; the CL's; the control 
and monitoring procedures; and the recordkeeping procedures. A few 
comments suggested that FDA use the word ``list'' or ``include'' rather 
than ``identify'' to describe a requirement for an item to appear in 
the HACCP plan. The comments suggested that it is not clear from the 
word ``identify'' whether the regulations are intended to require that 
the plan contain or include the actual values (e.g., the temperature of 
a refrigerator) or a description of the procedures, or whether it is 
permissible simply to make reference to their existence in a guideline 
or other source.
    FDA's intent is that a HACCP plan explicitly include the value or a 
description of the procedures for each of the required HACCP elements. 
FDA agrees that a word such as ``list'' would be less ambiguous. 
Therefore, FDA has revised Sec. 123.6 (c)(1), (c)(2), (c)(3), and 
(c)(4) by substituting the word ``list'' where the word ``identify'' 
appeared in the proposed regulations.
    FDA has also revised Sec. 123.6(c) by making another clarifying 
change. The agency has added the phrase ``at a minimum'' to the 
introductory statement to make clear that the required plan contents do 
not restrict a processor from including additional information in the 
plan, where it may be appropriate.
    61. Two comments requested that FDA specify that decomposition, 
listed as one of the hazard categories in the proposal, is a hazard 
only in scombroid toxin-forming species.
    These comments stated that decomposition in other species is not a 
safety hazard but is an economic and aesthetic problem.
    FDA agrees with the comments in part. FDA's intent was to require 
control of decomposition in a HACCP plan only when it represents a food 
safety hazard. As described in the preamble to the proposed 
regulations, histamine (scombroid toxin) development as a result of 
microbiological decomposition in certain species of fish is a well 
recognized food safety hazard (Ref. 5, p. 24). There are some early 
indications, however, that the development of putrescine and 
cadaverine, also byproducts of decomposition of fish, under certain 
circumstances, may also represent food safety hazards (Ref. 203, p. 
240). For this reason, FDA is hesitant to limit the safety concern 
associated with decomposition to the production of histamine. 
Accordingly, FDA has modified Sec. 123.6(c)(1)(vi) to read, 
``Decomposition in scombroid toxin- forming species or in any other 
species where a food safety hazard has been associated with 
decomposition.''
    62. Comments from two State government agencies and a trade 
association stated that FDA should eliminate parasites as a safety 
hazard that must be considered for inclusion in a processor's HACCP 
plan. The comments noted that, with respect to pathogens, FDA makes the 
assumption that raw fish will be further processed by cooking, and 
that, therefore, that the pathogens will be destroyed and not pose a 
health hazard. The comments urged that the same rationale be applied to 
raw fish that may contain parasites. The comments further suggested 
that the retail level is appropriate point of control for parasites, 
and that the provisions of the Food Code are adequate to address this 
issue.
    The comments further argued that parasites pose a hazard only in 
certain species that are consumed raw, and that mandatory control 
procedures for all fish that are consumed raw would create an enormous 
economic hardship for some segments of the industry. In particular, one 
of the comments contended that parasites have never been a problem in 
the large tunas that are eaten raw, and that it should not be necessary 
to freeze such fish before they are sold for raw consumption.
    FDA's intent is to require control of parasites in a HACCP plan 
only in those instances when parasites are reasonably likely to occur 
in the portion of the flesh that is consumed, and the presence of the 
parasites will present a food safety hazard (e.g., where the fish is 
offered for raw consumption). To clarify this intent, FDA has modified 
Sec. 123.6(c)(1)(vii) to read:

    Parasites, where the processor has knowledge or has reason to 
know that the parasite-containing fish or fishery product will be 
consumed without a process sufficient to remove the hazard, or where 
the processor represents, labels, or intends for the product to be 
so consumed.


[[Page 65122]]

    With regard to the comparison made by comments that FDA is 
requiring control of parasites in raw fish but not pathogens in raw 
fish, the characterization of FDA's policy towards pathogens is 
inaccurate. The sanitation provisions of these regulations are 
designed, in large part, to minimize the presence of pathogens in fish 
and fishery products, whether they are raw or further processed. The 
major opportunity for the introduction of enteric pathogens to 
processed fish and fishery products is from the processing environment 
as a result of insanitary practices rather than by the carcass of the 
animal (Refs. 3, p. 267; and 7, p. 33). For this reason, sanitation 
controls designed to prevent contamination of fish flesh are important 
to minimize the levels of enteric pathogens found on processed fish 
(Refs. 3, p. 10; 7, p. 27; 204; and 205). The agency is convinced that, 
if followed, these controls will be effective in minimizing the 
presence of such pathogens. Moreover, FDA has long enforced a zero 
tolerance for the presence of Salmonella on raw fish, based, in part, 
on the avoidability of such contamination through the application of 
CGMP's.
    63. One comment stated that the term ``physical hazards'' in the 
proposal could be interpreted to include nonsafety related hazards.
    In Sec. 123.6(c), physical hazards are one of nine listed causes of 
``food safety hazards'' that processors should consider for listing in 
their HACCP plans (Sec. 123.6(c)(1)(ix)). Thus, the agency believes 
that the language of this section clearly applies to food safety 
hazards only, and no modification of the provision is necessary in 
response to this comment.
    FDA proposed that HACCP plans include the CL's that must be met at 
each CCP. FDA received no significant comment on this section 
(Sec. 123.6(c)(3)) and has made no substantive changes to it.
    FDA proposed to require that HACCP plans include the procedures for 
both ``monitoring'' and ``controlling'' the CCP's. FDA recognizes that 
monitoring and controlling serve different purposes, and that the 
appropriate HACCP principle is the monitoring of CCP's to ensure 
conformance with the CL (Ref. 34, p. 197). How a processor exercises 
control is not critical to product safety so long as the CL is not 
exceeded. There are many ways to maintain control. No one way or list 
of ways needs to be stated in the plan so long as monitoring is taking 
place at an appropriate frequency to ensure that control is occurring 
and to detect CL deviations when they occur. For this reason, FDA has 
modified Sec. 123.6(c)(4) to read, ``(4) List the procedures, and 
frequency thereof, that will be used to monitor each of the critical 
control points to ensure compliance with the critical limits.''
    FDA has also eliminated the reference in Sec. 123.6(c)(4) to 
consumer complaints as a monitoring tool. As explained in more detail 
in the ``Consumer Complaints'' section of this preamble, FDA has 
concluded in response to comments that consumer complaints generally do 
not provide the processor with the kind of immediate feedback about 
whether the process is under control that monitoring should provide in 
a HACCP system. Consumer complaints may provide the processor with 
information that would be useful for verification purposes, however. 
These regulations therefore require processors to take consumer 
complaints into account as verification tools (Sec. 123.8(a)(2)(ii).
    Likewise, FDA has moved the reference in the proposed regulations 
to the calibration of process monitoring instruments to the new 
``Verification'' section of these regulations (Sec. 123.8), and it has 
eliminated the specific reference to computer software validation. As 
explained in more detail in the ``Verification'' section of this 
preamble, FDA has concluded in response to comments that calibration is 
a verification function that provides the processor with information 
about whether its monitoring equipment is functioning properly. 
Computer software validation is a form of calibration and need not be 
addressed separately in these regulations.
    64. In the preamble to the proposed regulations, FDA asked for 
comment on whether guarantees from suppliers should be considered as an 
acceptable way of meeting the proposed monitoring requirement. Comments 
from a number of processors responded that a certificate from a 
producer that a lot of raw material fish is free from unacceptable 
levels of pesticide and drug residues should be an acceptable means of 
monitoring the hazards of animal drug and pesticide residues in 
aquaculture-raised fish. The comment held that reliance on suppliers' 
certificates may be necessary because of the logistical problems that 
could be associated with analyzing raw materials for pesticides and 
drug residues. Of particular concern, the comments said, is the time 
necessary to analyze the samples. The comments further stated that the 
certificates should be based on participation in an industry-wide 
quality assurance program designed to ensure that the raw materials are 
free from these hazards.
    FDA believes that caution is warranted on the subject of supplier 
guarantees. Where more direct controls are available, they should be 
used. In the case of aquaculture-raised fish, more definitive controls 
than the acceptance of a certificate attesting to the absence of 
unapproved drug residues alone are available to a processor, and these 
controls are not unduly burdensome. They include the review of the 
supplier's animal drug control records when the lot is offered for sale 
and a system of onsite audits of the supplier, either by the processor 
or by a third party. Such alternatives are also available for most raw 
material hazards (e.g., checking container tags and harvester licenses 
as a means of controlling microbiological contamination in molluscan 
shellfish, and checking vessel storage records as a means of 
controlling histamine development in scombroid species). However, the 
agency recognizes that there may be some instances in which such 
controls are not possible, and suppliers' certificates or guarantees 
are the only available monitoring tool. In those cases, verification of 
the effectiveness of the certificates may be critical. Thus, the extent 
to which suppliers' guarantees can be relied upon will have to be 
considered on a case-by-case basis. However, FDA has made no change in 
Sec. 123.6(c)(4) in response to the comments.
    FDA has added Sec. 123.6(c)(5) that describes requirements of the 
HACCP plan with regard to corrective actions. As explained in more 
detail in the ``Corrective Actions'' section of this preamble, FDA has 
concluded in response to comments that these regulations should provide 
the processor with the option of predetermining corrective actions. 
Predetermined corrective action procedures have the potential to enable 
a processor to take faster action when a deviation occurs than would be 
possible in the absence of such procedures, and to make a more timely 
response to the deviation when trained or otherwise qualified 
individuals are not readily available.
    FDA has also added Sec. 123.6(c)(6), which describes the 
requirements of the HACCP plan with regard to verification. As 
explained in more detail in the ``Verification'' section of this 
preamble, FDA has concluded in response to comments that a processor 
needs to specifically include in its HACCP plan the verification 
procedures that it will use and the frequency with which it will use 
those procedures. FDA finds 

[[Page 65123]]
that inclusion of this information in the plan is necessary to 
underscore that a processor has an ongoing obligation to be sure that 
the verification steps that it has determined are necessary are readily 
ascertainable by the processor and its employees as well as by 
regulatory officials.
    FDA proposed to require that HACCP plans provide for a 
recordkeeping system that documents the monitoring of CCP's. The 
proposed regulations also provided that the records must include the 
actual values obtained during monitoring and any consumer complaints 
that relate to the operation of CCP's or possible CL deviations. FDA 
has removed the latter provision, relating to consumer complaints, from 
Sec. 123.6(c)(7). As explained above, these final regulations treat 
consumer complaints as verification tools rather than monitoring tools. 
Consequently, consumer complaints need not be included in a 
recordkeeping system that documents the monitoring of CCP's. A full 
discussion of issues relating to consumer complaints is presented in 
the ``Consumer Complaint'' section of this preamble.
6. Positive Versus Negative Recordkeeping
    The preamble to the proposed regulations invited comment on whether 
it was necessary for the results of monitoring (i.e., the actual 
values) to be recorded regardless of whether a CL was met (positive 
recordkeeping), or whether it was only necessary to record information 
when a CL was not met (negative recordkeeping). The agency noted that 
negative recordkeeping is presumably less expensive than positive 
recordkeeping.
    65. A substantial number of comments addressed this issue. 
Approximately two-thirds of these comments, including those from trade 
associations, processors, Federal, State, and foreign government 
agencies, consumer advocacy groups, and a professional society, 
supported requiring positive records. The remaining one-third of the 
comments that addressed this issue, from trade associations, 
processors, and Federal and State government agencies, argued that 
records should only be required when a CL deviation occurs, or that 
positive records should be required or encouraged, but that FDA should 
be granted access to only the negative records.
    In general, the comments supporting the need for positive records 
recognized that monitoring records serve two major purposes: To 
facilitate the identification of trends that would lead to a loss of 
control if not caught in time and to document compliance with, or 
deviations from, CL's. Comments from a large processor and a trade 
association stated that, based on their extensive experience with 
HACCP, positive monitoring records provide a pattern of results and 
values that is much more meaningful than sporadic negative records 
alone. Several comments stated that positive recordkeeping facilitates 
the taking of corrective action before the CL's are exceeded.
     Several comments stated that a provision that required only 
negative records would penalize the firms that already maintain records 
of all CCP observations. A few comments suggested that neither firm 
management nor FDA could verify that the monitoring procedures 
specified in a processor's HACCP plan are being carried out if only 
records of deviations from CL's are kept, because there would be no 
records to indicate that the other checks were actually being made. A 
comment from a consumer group further argued that allowing the use of 
negative records alone could create the opportunity for processors to 
limit their monitoring, because no records would be needed to 
demonstrate that such monitoring was performed.
    Most comments that supported the use of negative records alone 
stated that positive recordkeeping and the review of positive records 
was overly burdensome for both the industry and the regulator. A few 
comments stated that positive records generate massive databases that 
disguise CL deviations, rather than illuminate them. No examples of 
this phenomenon were provided, however. One comment suggested that 
since FDA inspects most processors once a year or less, it is 
questionable whether the agency would be in a position to pick up 
trends in the data from a review of all the positive records that would 
be retained. Another comment stated that it is just as unrealistic to 
expect FDA investigators to review all positive records as it is for 
FDA to inspect all fish. A few comments argued that the sheer volume of 
the paperwork produced with positive recordkeeping would result in 
technical or clerical errors by processors that could result in 
products being deemed by FDA to be adulterated.
    Several comments suggested that a system where CL deviations 
trigger remedial actions, which are properly documented, should be 
sufficient for FDA's verification purposes. One comment suggested that 
because processors can falsify positive records as well as negative 
records, FDA was mistaken if its motive for proposing to require 
positive records over negative records was to help prevent unscrupulous 
processors from circumventing the system. An additional comment 
supported limiting mandatory HACCP recordkeeping to negative records 
because FDA could not rule out the possibility that future court 
decisions or changes in FDA policy might permit the disclosure of HACCP 
records in FDA's possession, and negative recordkeeping would reduce a 
company's potential exposure.
    FDA's reasons for proposing positive records match those in the 
comments that support these kinds of records. As the preamble to the 
proposed regulations noted, recordkeeping is the key to HACCP, enabling 
the processor and the regulator to see the operation through time. 
Negative records alone do not allow this assessment over time and do 
not provide assurance that the appropriate monitoring was even 
performed.
    FDA cannot conclude from the comments that supported negative 
records that the burden of positive recordkeeping is excessive or 
otherwise outweighs the benefits. The agency acknowledges that a 
requirement for positive records may be more burdensome than one that 
only requires negative records. However, FDA received no new data on 
this issue. Positive recordkeeping can be extremely simple and need not 
take much longer to perform than the monitoring necessary to determine 
whether the process is in control (e.g., noting the temperature of a 
refrigerator in a logbook located next to the refrigerator). The agency 
is convinced that this minimal additional effort greatly increases the 
chances that a processor's HACCP program will be successful.
    Based largely on FDA's experience with the positive recordkeeping 
requirements in the low-acid canned food and the acidified food 
industries, FDA does not agree that the volume of positive records that 
a system will generate will defeat the system by hiding CL deviations 
or trends toward such deviations. FDA's regulations at parts 113 and 
114 require that these industries perform positive recordkeeping at 
identified CCP's. The industry itself requested this requirement.
    FDA has found that these processors have no trouble making positive 
records, and that both the processors themselves and the regulators 
become adept at reviewing them and deriving benefits from them that 
would not have been available from negative records. These benefits 
have included being able to pinpoint with confidence when a 

[[Page 65124]]
deviation began and ended, being able to react to trends toward a loss 
of control, and being able to prove that CCP's were actually being 
monitored as often as necessary to ensure control. The relative volume 
of records has not served as a roadblock in this regard.
    It is unlikely that FDA investigators will review all monitoring 
records during routine inspections, except in highly unusual 
circumstances. As has been the case with FDA inspections of low-acid 
canned foods and acidified foods, the agency will, in most cases, 
select records to represent the production since the last inspection. 
This technique has proven to be both effective and efficient.
    As for the concern that the agency will declare product adulterated 
on the basis of technical or clerical errors in positive-type records, 
the agency advises that it is not its intent to pursue regulatory 
action against product solely because of clerical or related errors in 
mandatory records. FDA does not take such actions against processors of 
low-acid canned foods or acidified foods, and it will not do so against 
seafood processors. FDA will consider the entire situation, and its 
potential for impact on human health, in formulating a response to 
deviations from these regulations.
    As for the comment that FDA might as well mandate negative records 
because positive records can be successfully falsified, FDA advises 
that the possibility that records will be falsified--and that 
falsifiers will get away with it--is an issue that involves the 
fundamental credibility of the system. From FDA's standpoint, the 
agency's decades-long experience reviewing positive records on low-acid 
canned foods and acidified foods gives it confidence that its 
investigators can detect falsifications. However, FDA did not propose 
positive records for the purpose of catching falsifiers. FDA proposed 
positive records because this approach confers benefits on both the 
industry and the regulator that outweigh the additional work of 
maintaining them. Aside from the view, to which FDA strongly adheres, 
that most processors are honest and will not falsify records, the 
agency strongly believes that most processors will quickly see the 
benefits to themselves of a properly operating HACCP system based on 
positive records and will insist that their records be accurately 
completed.
    One such benefit should be a more motivated workforce. HACCP 
monitoring and recordkeeping can and should be done by the workers who 
operate the system at the CCP's, not by quality control personnel. To 
the extent that these workers experience a sense of responsibility and 
pride associated with making accurate daily notations, the processor 
can expect to benefit.
    Regarding public disclosure of records as mentioned by one of the 
comments, FDA continues to believe that possession of monitoring 
records by the agency will be more the exception than the rule, and 
that these kinds of records are protected from public disclosure in any 
event. The protection of records is addressed in detail in the 
``Records'' section of this preamble.
    FDA has therefore not modified the requirement that processors' 
monitoring records include the actual values obtained during the 
monitoring.
7. Signing the Plan
    66. In the preamble to the proposed regulations, FDA specifically 
invited comment on whether HACCP plans should be required to be signed 
by a representative of the firm and, if so, by whom. Approximately 30 
comments responded to the inquiry. About two-thirds of these comments, 
from processors, trade associations, professional associations, and 
Federal, State, and foreign national governmental agencies, supported 
the need for a signature. The remaining comments, mostly from 
processors and trade associations, argued that a signature was 
unnecessary.
    Those that favored a requirement for a signature on HACCP plans 
stated that the signature does the following: Demonstrates formal 
adoption of the HACCP plan, solidifies responsibility for adherence to 
the plan, and fosters a sense of management ownership. The comments 
made the following suggestions with regard to who should be the 
signatory (in order of preference): Onsite manager, most responsible 
individual of the firm, any senior manager, HACCP coordinator, and all 
HACCP team members. Those comments that argued against a mandatory 
signature on the plan stated that the existence of a HACCP plan itself 
constitutes management support for the plan.
    FDA agrees with the comments that recommended a requirement for 
HACCP plans to be signed by a representative of the firm. As suggested 
by the comments, such a signature will provide direct evidence of 
management's acceptance of the plan for implementation. FDA cannot 
stress enough that for HACCP to succeed, there must be a clear 
commitment to it from the top of the firm on down. Management must set 
a strong example in this regard. A signature requirement will remind 
management of this important responsibility and will signal to all 
employees that the firm regards the HACCP plan as a document to be 
taken seriously. Additionally, the representative's signature, along 
with the date of signing, would serve to minimize potential confusion 
over the authenticity of any differing versions or editions of the 
document that might exist. FDA has concluded that the burden of such a 
requirement would be minimal, and has added a new paragraph at 
Sec. 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 individual 
onsite at the processing facility or by a higher level official of 
the processor. This signature shall signify that the plan has been 
accepted for implementation by the firm. (2) The HACCP plan shall be 
dated and signed: (i) Upon initial acceptance; (ii) Upon any 
modification; and (iii) upon verification of the plan * * *.''

    As will be discussed fully in the ``Verification'' section of this 
preamble, the adequacy of the HACCP plan must be reassessed, and 
modified as needed, whenever significant changes in the firm's 
operations occur, but no less than once per year. These reassessments 
and modifications are necessary to ensure that the plan remains current 
and is responsive to emerging problems. The signature of the firm 
representative will be valuable in documenting that these reassessments 
and modifications are performed as required. Particularly if no 
modification of the plan is needed, reassessment can be verified by FDA 
only if documentation, such as a signature, is maintained by the firm.
8. Relationship to Parts 113 and 114
    67. A few comments urged that the final regulations provide that if 
a processor of low-acid canned fishery products is in compliance with 
FDA's regulations for these products under part 113, it would also be 
in compliance with these HACCP regulations with respect to the control 
of the hazard of C. botulinum toxin production. The regulations at part 
113 establish HACCP-type controls for this hazard.
    FDA agrees that there is no need for a processor to restate in its 
HACCP plan the requirements of part 113 or 114. It is also not 
necessary for such a processor to institute controls in addition to 
those specified in parts 113 and 114 in order to control the hazard of 
C. botulinum toxin production. Consequently, processors who must comply 
with the requirements of part 113 or 114 need not address this hazard 
at all in their HACCP plans. However, it is important to note that 
other hazards may be reasonably likely to occur in an 

[[Page 65125]]
acidified or low-acid canned fishery product. These hazards must be 
addressed in the HACCP plan, as appropriate. For example, processors of 
canned tuna will likely need to identify in their HACCP plans how they 
will control the development of histamine before the canning process. 
Accordingly, to clarify what is required of processors of acidified and 
low-acid canned fishery products, FDA has added Sec. 123.6(e), which 
reads:

    For fish and fishery products that are subject to the 
requirements of part 113 or 114 of this chapter, the HACCP plan need 
not list the food safety hazard associated with the formation of 
Clostridium botulinum toxin in the finished, hermetically sealed 
container, nor list the controls to prevent that food safety hazard. 
A HACCP plan for such fish and fishery products shall address any 
other food safety hazards that are reasonably likely to occur.
9. Sanitation in the Plan
    The question of the role of processing plant hygiene (i.e., 
traditional sanitation controls) in HACCP is addressed at length in the 
``Sanitation'' section of this preamble. As explained in that section, 
FDA is requiring that processors address plant sanitation by monitoring 
for certain key sanitation conditions and practices apart from critical 
control point monitoring activities, or by including sanitation 
controls as part of the HACCP plan, or by adopting some combination of 
these two approaches, at the option of the processor. To reflect this 
approach, in paragraph (f) in Sec. 123.6 on the inclusion of sanitation 
controls in the HACCP plan FDA has stated: ``(f) Sanitation controls 
may be included in the HACCP plan. However, to the extent that they are 
monitoring in accordance with Sec. 123.11(b), they need not be included 
in the HACCP plan and vice versa.''
    FDA recognizes that, in many processing operations (e.g., cooked, 
ready-to-eat fishery products, smoked fishery products, and molluscan 
shellfish) sanitation controls, such as hand and equipment washing and 
sanitizing, are critical to the safety of the food because they serve 
to minimize the risk of pathogen introduction into finished products 
that may not be further cooked before consumption (Ref. 3, p. 267). For 
this reason, some processors may elect to include the control of 
sanitation conditions and practices in their HACCP plan in addition to, 
or in place of, monitoring for such conditions and practices apart from 
the HACCP plan. Based in part on experience gained from the seafood 
HACCP pilot project operated jointly by FDA and DOC, however, FDA also 
recognizes that sanitation controls may be difficult to fit in HACCP 
plans, with appropriate CL's and corrective actions sometimes being 
elusive. For this reason, some processors may elect to rely exclusively 
on sanitation controls that are not part of the HACCP plan. FDA 
considers either approach to be acceptable, so long as whatever 
approach is chosen is fully implemented and followed.
10. Nonsafety Issues
    68. FDA proposed in Sec. 123.6(c) to recommend, but not to require, 
that HACCP plans include controls for such nonsafety hazards as 
economic adulteration and decomposition that are not related to safety. 
Additionally, FDA proposed to append to the regulations at Appendix D 
guidance on how a processor can use a HACCP-based approach to ensure 
that fish and fishery products are in compliance with the economic 
adulteration and misbranding provisions of the act. Approximately 75 
comments addressed these proposed provisions. The vast majority of 
these comments urged that proposed Sec. 123.6(c) and proposed Appendix 
D of part 123 be eliminated from the regulations. Some of these 
comments suggested that it might be appropriate for the contents of 
proposed Appendix D to be included in the Guide.
    Those that argued for removal of the recommendation that HACCP be 
used to control nonsafety hazards from the regulations stated that: (1) 
HACCP for safety purposes will be a big enough challenge for both the 
industry and regulators, and that inclusion of nonsafety hazards might 
be overwhelming; (2) nonsafety hazards, such as economic fraud and 
decomposition, are covered adequately by existing FDA regulations and 
standards and by industry quality control programs; (3) inclusion of 
nonsafety hazards deviates from the internationally recognized NACMCF 
recommendations; and (4) inclusion of nonsafety hazards, even as a 
recommendation, would dilute and jeopardize a desirable industry focus 
on safety. One comment stated that processing plant personnel and 
supervisors should be trained to expect serious consequences when CL 
deviations occur because this heightens their attention to monitoring 
and control. However, the comment further argued, the consequence of 
violating a nonsafety CL is likely to be relatively minor. The comment 
argued that, as a result, plant personnel and supervisors will become 
confused about the significance of CL deviations.
    A significant minority of the comments favored the treatment of 
nonsafety hazards such as economic fraud and decomposition in the same 
manner in which safety hazards are treated in these regulations, with 
mandatory HACCP controls. These comments argued that: the same 
conditions of processing that affect the occurrence of safety hazards 
affect the occurrence of such nonsafety hazards as decomposition and 
economic fraud, making the two control systems compatible; an 
improvement in consumer confidence in seafood cannot be achieved 
without improvements relative to economic deception and decomposition; 
decomposition is the number one cause of FDA legal action with respect 
to seafood; decomposition is a good indication of time and temperature 
abuse, which has a significant impact on the growth of pathogens; the 
seafood industry considers economic fraud to be the most significant 
hazard affecting the marketing of its products; species substitution 
can be safety related, as in the case of the substitution of a 
scombroid species for a nonscombroid species; HACCP controls would 
likely enhance compliance with existing nonsafety standards; and 
inclusion of controls for economic fraud and decomposition would not 
significantly increase the costs to industry.
    FDA concludes that the HACCP system will have to mature, and much 
will have to be learned, before it can be determined whether a 
mandatory HACCP program should include nonsafety matters. Because these 
regulations reflect a first step in terms of mandating HACCP, the 
agency is comfortable as a matter of policy that they should initiate a 
system that focuses on food safety. Additionally, the statutory 
provisions that form the basis for these regulations are safety 
provisions. FDA's application of HACCP is intended for the effective 
enforcement of sections 402(a) (1) and (a)(4) of the act, which apply 
to products that contain substances that may render the product 
injurious to health and to processing conditions that are insanitary 
and that could render a product injurious to health. Thus, the only 
real issue is whether the final regulations should retain the 
recommendations with regard to the application of HACCP to nonsafety 
matters.
    FDA is persuaded by the comments that the proposed recommendations 
for HACCP controls of nonsafety matters, coupled with the presence of 
proposed Appendix D of part 123, have the potential for causing 
confusion about the agency's expectations and 

[[Page 65126]]
enforcement policies. FDA recognizes the point raised by a number of 
comments that advisory provisions are often confused with or misapplied 
as requirements. Given this fact and the emerging nature of HACCP, FDA 
has decided to eliminate proposed Sec. 123.6(c) and Appendix D of part 
123. FDA will consider including the concepts that underlay these 
provisions in the first edition of the Guide, however, because the 
Guide is understood as being the repository for recommendations 
relating to seafood HACCP.
    The agency's decision to eliminate reference to nonsafety hazards 
from these regulations notwithstanding, such hazards as economic 
adulteration, decomposition not normally associated with human illness, 
general unfitness for food, and misbranding constitute violations of 
the act and are subject to regulatory action by FDA (see sections 
402(a)(3) and 403 of the act (21 U.S.C. 343)). When inspections by FDA 
investigators reveal violations of these provisions of the act, FDA 
will take enforcement action as it deems appropriate. Processors who 
are able to accommodate a HACCP system that covers both safety and 
nonsafety hazards may find advantage in doing so, in order to better 
ensure compliance with existing nonsafety regulations and standards.
11. ``Shall Render Adulterated''
    FDA proposed to provide that: Failure of a processor or importer 
to have and implement an HACCP plan that complies with this section 
or to operate in accordance with the requirements of this part, 
shall render the products of that processor or importer adulterated 
under section 402(a)(4) of the act.

    The preamble to the proposed regulations explained that the 
proposed regulations set out those requirements that the agency had 
tentatively concluded are the minimum necessary to ensure that the 
processing of fish and fishery products will not result in product that 
is injurious to health. FDA tentatively determined that such minimum 
requirements include the establishment of HACCP preventive controls. 
The preamble further explained that section 402(a)(4) of the act, among 
other things, deems a food to be adulterated if it is prepared, packed, 
or held under insanitary conditions whereby it may have been rendered 
injurious to health.
    69. A significant number of comments, primarily from processors and 
trade associations, opposed the proposed language of this provision. 
The comments urged that the word ``may'' replace the word ``shall'' in 
order to establish that instances of noncompliance with the regulations 
do not automatically constitute adulteration. They contended that, 
because FDA will not be preapproving HACCP plans, a negative finding on 
the first FDA inspection could, under the language that was proposed, 
cause the agency to consider all product produced to that point to be 
adulterated. The comments stated that each case of noncompliance should 
be evaluated on its own merits.
    FDA fully agrees that each case should be judged on its merits but 
does not agree that it is necessary to change the regulations in order 
to establish this principle. The purpose of Sec. 123.6(g), which sets 
out this language, is not to create a legal presumption that food is 
adulterated if there is not perfect adherence to these regulations but 
to make clear that certain types of preventive controls are so 
fundamental to ensuring the safety of seafood that if there is not 
adherence to them, the food cannot be considered to have been produced 
in accordance with section 402(a)(4) of the act.
    As a practical matter, FDA expects to exercise broad regulatory 
discretion in deciding when violations of these regulations warrant 
regulatory action, just as it does now for other situations. The agency 
will analyze each case on its merits, based at least in part on the 
potential for harm that exists.
    The agency's primary concern is that processors develop HACCP plans 
that address the hazards that are reasonably likely to occur. When 
deficiencies in HACCP plans are detected during FDA inspections, the 
agency usually will first attempt to seek voluntary correction of the 
situation. Only when such voluntary correction is not forthcoming is it 
likely that FDA will elect to pursue regulatory action. It must be 
noted, however, that, where HACCP plan deficiencies result in 
significant potential for consumer harm, the agency will evaluate the 
need for corrective action with respect to the product that has been 
produced as well as to the HACCP plan itself.
    In this regard, FDA notes that a change from ``shall'' to ``may'' 
in the provision would be more compatible with guidelines than with 
regulations. Consequently, the agency has retained the term ``shall'' 
in Sec. 123.6(g). However, to clarify that a decision on whether to 
take regulatory action will involve discretion based on the public 
health significance of the violation, a sentence has been added to 
indicate that when a violation occurs, FDA will evaluate the processors 
overall implementation of its HACCP plan in deciding how best to remedy 
the violation.
    Consistent with the revisions to the requirements for imported 
products contained in Sec. 123.12, the word ``importers'' has been 
eliminated from Sec. 123.6. As described in the ``Imported Products'' 
section of this preamble, the proposed requirement that an importer 
develop a HACCP plan (Sec. 123.11) has been eliminated in favor of a 
requirement for importer verification procedures. This change 
eliminated the relevance of Sec. 123.6 to importers.
    Consistent with the revision to Sec. 123.6(a) and (b) that 
processors have HACCP plans only when a hazard analysis reveals one or 
more food safety hazards that are reasonably likely to occur, 
Sec. 123.6(g) has been amended to state that a processor's failure to 
have a HACCP plan shall render the fish or fishery products adulterated 
only when a HACCP plan is necessary.

F. Corrective Actions

    The fifth HACCP principle, as articulated by the NACMCF, is that 
processors establish the corrective actions that they will take should 
monitoring show that a CL has been exceeded. The NACMCF's expectation 
is that these corrective actions should be predetermined and written 
into the processor's HACCP plan.
    In the proposed regulations, FDA tentatively chose to incorporate 
the principle of corrective action without requiring predetermined 
corrective action plans in the processor's HACCP plan. Instead, FDA 
proposed minimum, generic corrective action procedures for processors 
to follow. In so doing, FDA was trying to minimize the burden of the 
mandatory requirements of HACCP, especially for small processors. FDA 
tentatively concluded that the procedures set out in proposed 
Sec. 123.7 represented the minimum requirements necessary to ensure 
that processors respond effectively to deviations that could affect 
safety, and that if those procedures were followed, specific corrective 
action plans, although desirable, would not be necessary.
    FDA proposed in Sec. 123.7 to require that deviations from CL's 
trigger a series of actions, including: Segregating and holding the 
product, making a determination of the acceptability of the product for 
distribution, taking appropriate remedial action with respect to the 
product and the cause of the deviation, and documenting the actions 
taken. In the preamble to the proposed regulations, FDA invited comment 
on the wisdom of this approach as opposed to requiring that 
predetermined corrective action plans be made part of the HACCP plan. A 
large number of comments responded to 

[[Page 65127]]
that request. Additional comments addressed the specifics of the 
proposed generic-type requirements in Sec. 123.7.
1. Should Corrective Actions Be Predetermined?
    70. Approximately half of the comments supported the corrective 
action system proposed by the agency or a variation of it, and the 
other half called for mandatory predetermined corrective action plans. 
Many of those that supported mandatory corrective action plans urged 
consistency with the HACCP recommendations of the NACMCF. These 
comments noted that the NACMCF recommendations are consistent with 
Codex Alimentarius Commission standards. They predicted that 
compatibility of the final regulations with such international 
standards would minimize confusion for processors and importers, smooth 
international adoption of HACCP principles, and facilitate trade. The 
comments stressed that predetermining corrective action is an essential 
component of a processor's HACCP program, with the seven principles 
being so closely intertwined that overall success is probable only if 
all are intact.
    A number of comments argued that a processor's implementation of a 
corrective action plan would eliminate indecision and confusion about 
what corrective action should be taken in the event of a deviation from 
a CL. For example, one comment pointed out that corrective actions 
written into the HACCP plan would eliminate the need for employees to 
substantiate to management the correctness of their response to a 
deviation, because the corrective action plan would provide the right 
actions to be taken for each particular deviation. A few comments 
stated that, if the appropriate corrective actions are detailed in the 
HACCP plan, responses by employees to CL failures are more likely to be 
immediate (reducing product losses) and effective (reducing wasted 
effort). These comments further noted that corrective action plans are 
particularly necessary when individuals qualified to make product 
safety evaluations are not readily available.
    One comment asserted that the strength of the HACCP system is that 
it is preventive, and that corrective action plans are fundamental in 
preventing a product, for which there is a safety concern, from 
reaching the consumer. The comment further stated that written 
corrective action plans should provide for the documentation of the 
following: (1) The cause of the deviation, (2) the action taken to 
ensure that the deviation does not reoccur, (3) the results of the risk 
evaluation, and (4) product disposition.
    Many comments did not agree that corrective action plans should be 
required. A few comments argued that developing a corrective action 
plan is impractical and can be unduly restrictive because of the 
diversity and complexity of seafood products and of seafood processing 
operations. One comment noted that many situations exist in which the 
appropriate response to a CL failure is not apparent until the details 
of the particular situation are known. Several stated that a corrective 
action plan is less preferable than having responsible and 
knowledgeable personnel, adequately trained in HACCP, available to 
evaluate a deviation from a CL. If such personnel are available, one 
comment noted, deviations can be handled on a case-by-case basis, with 
appropriate documentation of the disposition of the affected product.
    Several comments argued that the lack of a corrective action plan 
is not sufficient evidence to demonstrate that a product is 
adulterated. The comments argued that the proposed requirement that a 
processor establish CL's and perform and record appropriate corrective 
actions when these limits are exceeded, provides sufficient 
demonstration of hazard control.
    A number of comments that advocated the concept of predetermined 
corrective action plans urged that processors be given the option of 
writing such plans or of following a series of minimum mandatory 
actions, like those proposed by FDA, when CL failures occur. In the 
preamble to the proposed regulations the agency did, in fact, encourage 
processors to predetermine corrective actions as part of the 
preparation of a HACCP plan.
    On this issue, the merits of the various approaches tend to 
balance. Consequently, FDA agrees with those comments that urged that 
the regulations provide processors with the option of developing their 
own corrective action plans as part of their HACCP plans or of 
following a generic model corrective action plan, provided in the 
regulations, should a deviation occur.
    The agency accepts the view that predetermined plans have the 
potential to provide processors with benefits, as pointed out by the 
comments, such as faster action when a deviation occurs, less need to 
justify to management the appropriateness of the corrective action 
after it has been taken, and a more timely response to the deviation 
when trained or otherwise qualified individuals are not readily 
available to make determinations. On the other hand, FDA has not been 
provided with information on which it can conclude that these 
benefits--as desirable as they may be--need to be mandated in order to 
protect the public health. Processors can build them into their HACCP 
systems if they so choose, but the public health will be protected so 
long as shipment of the affected product into commerce does not occur 
until the significance of the deviation has been assessed and 
appropriately resolved.
    This outcome is assured both with specific predetermined corrective 
action plans and with the minimum generic model that FDA is requiring 
as an alternative. Without additional evidence from actual experience, 
which was not provided by the comments, FDA cannot conclude that the 
overall success of HACCP depends on whether processors have specific 
predetermined plans for events that might not necessarily occur.
    Consequently, FDA has revised Sec. 123.7 to permit, but not to 
require, processors to include in their HACCP plans any written 
corrective action plans that they develop. When a deviation from a CL 
occurs, Sec. 123.7(a) requires that processors either: (1) Follow a 
corrective action plan that is appropriate for the particular 
deviation, or (2) follow the series of actions provided in 
Sec. 123.7(c). The steps in Sec. 123.7(c) constitute a minimum generic 
model for corrective actions and, as will be explained below, closely 
match those that were contained in the proposed regulations.
    The final regulations at Sec. 123.7(b) define an appropriate 
corrective action plan as one that addresses both the safety of the 
product that was being processed when the CL failure occurred and the 
cause of the deviation. In this respect, the contents of the corrective 
action plan are consistent with the views of the NACMCF (Ref. 34, pp. 
199-200). The corrective action must ensure that any unsafe product is 
not distributed.
    FDA advises that action necessary to correct the product may 
involve any one or more of the following steps: Immediately 
reprocessing the product; diverting the product to another use where it 
can be used safely; segregating the product, holding it, and having it 
evaluated by a competent expert; or destroying the product. In order to 
ensure that subsequent product is not subjected to the same deviation, 
the corrective action must be sufficient to bring the process back 
under control (Ref. 34, pp. 199-200). FDA advises that such action may 
involve, where appropriate: adjustments to those process parameters 
that have an effect 

[[Page 65128]]
on the relevant CL (e.g., flow rate, temperature, source of raw 
materials); temporarily diverting product around a point in the process 
at which problems are being encountered; or temporarily stopping 
production until the problem can be corrected.
    Section 123.7(c) describes the steps that a processor must take 
whenever there is a deviation from a CL but no corrective action plan 
to follow. As stated above, these steps constitute a minimum generic-
type corrective action plan. The objectives of these steps are the same 
as those of a preconceived plan: To ensure that adulterated product 
does not enter commerce and to correct the cause of the deviation. 
Because it is a generic-type plan that is intended to be applicable to 
any situation, some of the steps, such as segregating and holding the 
affected product (Sec. 123.7(c)(1)), might not be necessary if the 
corrective action had been predetermined. This aspect of the generic-
type plan may provide processors with an incentive to predetermine 
corrective actions whenever practical.
    Another such incentive is the requirement, at Sec. 123.7(c)(5), 
that the processor reassess the adequacy of its HACCP plan when a 
deviation occurs. This requirement does not exist where a corrective 
action plan exists. The reason for the distinction is that, on one 
hand, if a processor has assessed its process and decided that CL 
failures are likely to occur from time to time at particular points, 
those failures, when they occur, do not represent a failure of the plan 
but a foreseeable occurrence. On the other hand, if the processor has 
not made such an assessment, and a failure occurs, it is not possible 
to say what the failure means. The processor must assess whether the 
deviation is the result of a system-wide problem that is not being 
properly addressed by the plan or simply a failure that could be 
expected to occur in the normal course of things. The failure must be 
fully assessed, and if it represents a failure of the plan, the plan 
must be modified to reduce the risk of reoccurrence.
    The agency is convinced that the corrective action approach 
contained in the final regulations (i.e., predetermined corrective 
action plans at the option of the processor) adheres to the principles 
of HACCP as recommended by NACMCF (Ref. 34, pp. 199-200) and will not 
result in undue burden, confusion, or trade difficulties. At the same 
time, these regulations will provide the flexibility needed to 
accommodate the varying levels of HACCP sophistication within the 
industry. FDA is satisfied that employee indecision in responding to CL 
deviations will not result in a public health problem in the absence of 
corrective action plans because the final regulations contain a set of 
well defined actions that are to be followed if a deviation occurs and 
no predetermined plan exists. The actions outlined in Sec. 123.7(d) 
ensure that no unsafe product will enter commerce, and that a 
normalization of processing conditions will be effected as quickly as 
possible. While the agency sees merit in the argument that 
predetermined corrective action plans will, in many cases, be 
economically beneficial to a processor (e.g., minimize product loss and 
wasted effort), such economic factors will, in and of themselves, 
motivate processors to predetermine appropriate corrective actions, but 
they do not mean that the agency needs to require the adoption of 
predetermined plans.
    71. A few comments recommended that FDA review corrective action 
plans for adequacy during, or in advance of, the first regulatory 
visit. This review, the comments asserted, would help to avoid a 
situation in which the processor takes a corrective action in 
conformance with its HACCP plan, but the agency later determines that 
the action was inadequate.
    FDA agrees that these comments reflect a desirable ideal but must 
acknowledge that such a review ordinarily will not be feasible. If 
processors complete their HACCP plans, including any corrective action 
plans that they choose to develop, before the effective date of these 
regulations, they may be able to obtain a review of those plans as part 
of a routine FDA inspection.
    In any event, the agency intends to review corrective action plans 
that a processor includes as part of its HACCP plan during routine 
regulatory inspections. Where the investigator finds a shortcoming in 
the corrective action plan, the investigator will discuss it with the 
processor. As with a failure to meet any other provision of these 
regulations, in determining its response to such a shortcoming, the 
agency will consider the totality of the situation and the likelihood 
that the shortcoming will have an adverse impact on the safety of the 
product. If a corrective action plan has not actually been used as of 
the time of the investigator's review, and as a consequence of its 
review the agency advises the processor that the corrective action plan 
needs to be improved, it is likely that FDA will advise the processor 
to follow the alternative procedure in these regulations until the 
upgrade occurs.
2. Assessing the Product for Safety
    72. FDA received comments on specific aspects of the generic-type 
corrective action plan provided in proposed Sec. 123.7(a). A 
significant number of comments opposed the provision that would have 
required an ``immediate'' safety assessment when a CL deviation occurs. 
One comment stated that, because an appropriately trained individual 
may not be immediately available to make a determination of the 
acceptability of the lot, the provision should be modified to require 
segregation and holding of the affected product until either a timely 
safety review by a properly trained individual has been completed, or a 
determination has been made that the appropriate predetermined 
corrective action plan has been followed. A number of other comments 
also suggested that the phrase ``immediate review'' be revised to 
``timely review.'' One comment recommended that FDA specify a maximum 
amount of time in which to evaluate the product, for example within 24 
hours. Another comment advised that FDA permit processors to cook or 
freeze fresh product involved in a CL deviation, until an evaluation 
can be completed.
    FDA agrees that immediate review is not necessary. As long as the 
review occurs before the product is distributed, the public health will 
be sufficiently protected. Consequently, while Sec. 123.7(c)(2) 
requires a review to determine the acceptability of the affected 
product for distribution, it does not require that the review be 
immediate, nor does it otherwise specify a timeframe for review. If 
there is a chance that the product is still fit for commerce, FDA 
expects that economic considerations will dictate the timing of the 
review. FDA agrees that, in many cases, it would be advantageous for a 
processor to cook or freeze a product pending results of a safety 
evaluation. The agency has no objection to such an action as long as 
the processor maintains the identity of, and its control over, the lot.
    FDA has also modified Sec. 123.7(c)(2) from the proposal to require 
that the review of the product be conducted by someone with adequate 
training or experience, although FDA is not tying adequate training to 
training in HACCP (see Sec. 123.10) as it did in the proposal. FDA made 
this change because, as comments pointed out, a 3-day course in HACCP 
would not necessarily qualify someone to make many public health 
determinations of this nature. The basis for this modification is more 
fully 

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described in the ``Training'' section of this preamble.
3. Documenting Corrective Actions
    In Sec. 123.7(d), FDA is retaining the proposed requirement that 
records of corrective actions be kept. As with the proposal, such 
records are subject to the general recordkeeping requirements of 
Sec. 123.9. The records must document the actions taken in following 
either a predetermined corrective action plan or the corrective action 
procedures specified in Sec. 123.7(c).
    73. One comment suggested that the absence of written corrective 
action plans would make it more difficult to document a response to a 
deviation. It went on to explain that, with a plan, the processor could 
simply note, for example, that ``the product was recooked in accordance 
with `Section B of the Plan.''' It pointed out that more extensive 
documentation would be necessary if a processor did not have a 
predetermined plan.
    FDA does not agree with this comment. Section Sec. 123.7(d) 
requires that the corrective action taken by a processor be fully 
documented. It is the agency's intent that such documentation provide 
the specifics about the actions that were taken and not simply refer to 
a written procedure. In the example given, records of the recooking 
operation, equivalent to monitoring records for such an operation, 
i.e., cooking, would be necessary to document that the operation was 
performed in a manner that would render the product safe. Thus, similar 
documentation would be necessary whether a plan exists or not.
    It is worth noting that Sec. 123.7(d) now states that corrective 
action records are subject to verification in accordance with 
Sec. 123.8(a)(3)(ii). This requirement is not new but reflects the fact 
that record review is deemed to be a verification activity in the final 
regulations but was not classified as such in the proposal. A further 
discussion of this matter can be found in the section of this preamble 
that follows.

G. Verification

1. Overview
    Verification is one of the seven commonly recognized principles of 
HACCP. In the preamble to the proposed regulations, FDA acknowledged 
and discussed the recommendations of the NACMCF as they relate to 
verification. According to the NACMCF, verification essentially 
involves: (1) Verifying that the CL's are adequate to control the 
hazards; (2) ensuring that the HACCP plan is working properly, e.g., 
that it is being followed, and that appropriate decisions are being 
made about corrective actions; and (3) ensuring that there is 
documented, periodic revalidation of the plan to make sure that it is 
still relevant to raw materials as well as to conditions and processes 
in the plant.
2. Need for Verification Requirement in Regulations
    In the preamble to the proposed regulations, FDA encouraged 
processors to adopt verification practices but did not propose to 
require that a processor's HACCP plan specify the verification 
procedures. Rather, the agency tentatively concluded that verification 
of a HACCP plan would effectively occur through: (1) Comparison of the 
plan to guidance documents such as FDA's draft Guide; (2) technical 
assistance provided through trade associations, universities, and 
government agencies; (3) mandatory review of monitoring and corrective 
action records by trained individuals before product distribution; (4) 
mandatory reassessment of the adequacy of the HACCP plan as a 
consequence of CL deviations; (5) reliance on the recommendations in 
FDA guidelines that processors of cooked, ready-to-eat seafood products 
use the expertise of ``processing authorities,'' i.e., third-party 
experts; (6) mandatory training; and (7) investigator review of the 
entire HACCP system during routine agency inspections. FDA requested 
comment on whether this approach is adequate to ensure that the 
verification principle was being properly addressed.
    74. A large number of comments responded to this request. 
Approximately one-third of these comments stated that FDA's proposed 
approach to HACCP verification was adequate. The other comments argued 
that verification should be specifically mandated as a part of a firm's 
HACCP program.
    A few of the comments favoring the proposed approach contended that 
a HACCP plan lacking verification procedures should not be grounds for 
FDA to consider a product to be adulterated. Several comments stated 
that processors will engage in verification activities without a 
requirement, as a natural outgrowth of a HACCP program, because without 
such activities, HACCP will not work. For this reason, they argued, it 
is not necessary to mandate that verification procedures be included in 
processor's HACCP plans.
    Of the comments that supported the need for specifically-mandated 
verification activities, a significant number urged the agency to adopt 
such a requirement to be consistent with the HACCP recommendations of 
the NACMCF. These comments noted that the NACMCF recommendations are 
consistent with Codex Alimentarius Commission standards. They predicted 
that compatibility of the final regulations with such international 
standards would minimize confusion for processors and importers, smooth 
international adoption of HACCP principles, and facilitate trade. The 
comments stressed that verification is an essential component of a 
processor's HACCP program, and that the seven principles are so closely 
intertwined that overall success is probable only if all are intact.
    One of the comments stated that verification should involve a 
continual review and improvement of the HACCP system. The comment added 
that verification is a primary responsibility of processors, one that 
is equivalent in importance to plan development. Several comments 
stated that the benefits of HACCP verification include: Assurance that 
all CCP's are identified, assurance that the plan is being followed, a 
mechanism for third party oversight of the plan development process, a 
means of measuring the success of a HACCP system, and information on 
trends in the frequency and reasons for CL deviations. One comment 
suggested that firms should be required to perform verification 
activities at least annually.
    A few comments stated that although the proposed regulations 
included some required practices that could be deemed to be 
verification, such as the calibration of process-monitoring instruments 
and plan reassessment and modification in response to a CL failure, the 
entire concept of verification should be addressed more fully in a 
separate section of the final regulations. One of these comments 
suggested that the following verification activities be specifically 
mandated: Calibration of process control instruments, validation of 
software for computer control systems, and daily review of monitoring 
records.
    One comment stated that, without a requirement for specific 
verification activities, processors would rely strictly on end-product 
testing to evaluate the success of the HACCP plan, and that such an 
approach would diminish the effectiveness of the entire HACCP system. 
Several comments stated that HACCP plan verification procedures 

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should include detailed government and industry audits and product 
analyses.
    One comment, from a consumer advocacy organization, challenged 
whether effective verification would really occur through the measures 
cited in the preamble. The comment stated that ``third-party technical 
assistance'' is not a mandatory part of the HACCP program and, 
therefore, can not be counted on as a verification procedure. It added 
that such technical assistance would tend to be performed during plan 
development, and that verification must be an ongoing procedure. The 
comment stated that a ``review of all HACCP-monitoring records by 
trained individuals before distribution of product'' is not verifiable 
by the agency because a firm can cut corners by having their employees 
sign the records without reviewing them. The comment argued that FDA 
auditing of consumer complaints and mandatory in-process and end-
product testing are important verification procedures.
    A few comments suggested that FDA should include a requirement that 
written verification procedures be in place, but that the agency need 
not prescribe specific verification activities, or should do so only 
sparingly.
    FDA notes that the proposed regulations contained specific 
provisions identified by many of the comments as appropriate 
verification steps. For example, the proposed requirement that the 
HACCP plan adequately address the food safety hazards that are 
reasonably likely to occur (Sec. 123.6(c) in this final rule) is a 
continuing, rather than a one-time requirement. Thus, to continually be 
in compliance with it, a responsible processor would have to engage in 
some form of reassessment. Other provisions in the proposal that 
comments identified as verification steps included: The required 
calibration of process monitoring instruments; the required validation 
of computer software; the requirement that consumer complaints be 
reviewed to assess whether they indicate a problem at a CCP; and the 
requirement that HACCP-monitoring and corrective action records be 
reviewed before distribution of the product. FDA now realizes, however, 
that by not specifically requiring verification as such, the proposal 
generated considerable confusion about whether FDA intended to include 
or exclude the principle of verification from processors' HACCP 
programs. FDA has concluded, therefore, that verification is important 
enough to be an explicit part of the regulations. FDA has made it such 
in the final rule at Sec. 123.6(c)(6) and in a new section for 
verification, Sec. 123.8.
     Section 123.6(c)(6) requires that processors include in their 
HACCP plans a list of the verification procedures that they will use 
and the frequency of those procedures. This provision is consistent 
with the view of the NACMCF that a processor's verification procedures 
should be addressed in the HACCP plan (Ref. 34, pp. 200-202). FDA does 
not expect that this requirement will be particularly burdensome for 
the processor for two reasons. First, the requirement that verification 
procedures be listed in the HACCP plans is really only a variation of 
the proposal in that FDA proposed to require a number of the activities 
that it is now designating as verification activities in 
Sec. 123.6(b)(4) (e.g., calibration of monitoring instruments and 
review of consumer complaints). Second, a list of the steps that a 
processor determines are appropriately a part of the annual 
reassessment of the HACCP plan need not be extensive or detailed. FDA 
recognizes that, at least initially, much of the annual verification 
procedure could take the form of meetings and discussion, and may not 
lend itself well to a detailed listing of steps. FDA believes that the 
annual verification procedure should be allowed to evolve, and that a 
requirement that the listing of steps in the plan be detailed before an 
annual verification ever occurs could adversely affect that evolution.
    The new section on verification, Sec. 123.8, describes the minimum 
components of a processor verification program. Among other things, the 
agency has consolidated there those aspects of the proposal that, 
according to comments, should be designated as verification activities. 
Section Sec. 123.8 contains little in the way of detail that was not 
included in the proposed regulations. In addition, it is designed to be 
generally consistent with the verification concepts expressed by the 
NACMCF, as requested by comments, and at the same time, not unduly 
burdensome.
3. Verifying the HACCP Plan
     Section 123.8(a) requires that processors with HACCP plans verify 
two aspects of their HACCP systems: (1) That their HACCP plans are 
adequate to control food safety hazards that are reasonably likely to 
occur, and (2) that their plans are being effectively implemented. 
Verifying these two aspects is, essentially, what the NACMCF refers to 
as the first and second of the four processes of verification (Ref. 34, 
p. 201).
     Second, Sec. 123.8(a)(1) requires that a reassessment of the HACCP 
plan occur whenever there are any changes of the type listed in these 
regulations that could alter the plan, or at least annually. The NACMCF 
takes the view that verification must occur on a periodic, regular 
basis (Ref. 34, p. 202), although no specific timeframes are suggested. 
FDA agrees with the NACMCF and the comments that verification of the 
adequacy of the HACCP plan should be conducted on a regular basis, even 
in the absence of a recognized change, to ensure that the plan 
continues to address all of the reasonably likely food safety hazards 
with appropriate CL's and monitoring procedures. It is essential that 
processors verify the adequacy of their plans and that this 
verification occur on a periodic basis. Processors should conduct the 
review at intervals that are appropriate for their processes. FDA 
agrees with one of the comments, however, that this interval be no more 
than a year in order to ensure that the plan remains adequate to 
address the hazards associated with the species and processes (Ref. 
206, p. 1084).
     The regulations at Sec. 123.8(a)(1) provide examples of changes 
that could trigger a reassessment. These include changes in raw 
materials, product formulation, processing methods or systems, finished 
product distribution systems, or the intended use or consumers of the 
finished product. These examples are derived from the NACMCF materials 
on the ``five preliminary steps'' that form the basis for the HACCP 
plan (Ref. 34, pp. 188 and 201). A change in any of these areas could 
necessitate a change in the plan in order to respond to any new hazards 
that may have been introduced or to maintain preventive control over 
existing ones. It is important to recognize that this list is not all 
inclusive.
    Section 123.8(a)(1) requires that the plan reassessment be 
performed by an individual that has been trained in HACCP in accordance 
with Sec. 123.10. This requirement is a logical outgrowth of the 
proposed requirement in Sec. 123.9 that a HACCP-trained individual be 
responsible for the initial development of, and subsequent 
modifications to, the HACCP plan. These kinds of activities require an 
understanding of the principles of HACCP and plan development as 
obtained through training that is at least equivalent to the course 
required in Sec. 123.10.
    Section 123.8(a)(1) also requires that, where a reassessment 
reveals that the HACCP plan is inadequate, the processor shall 
immediately modify the 

[[Page 65131]]
plan. Failure of a processor to immediately modify its HACCP plan after 
it has determined that the plan is inadequate would result in the 
processor operating under a plan that is not in conformance with these 
regulations.
    FDA recognizes that the methods that processors will use to verify 
that the plan is still adequate will vary, based on individual 
preferences and past experience. FDA agrees with comments that urged 
the agency to permit maximum flexibility in the development of 
verification procedures that are tailored to individual operations. 
Nonetheless, the agency encourages processors to consider the guidance 
in the March 20, 1992, NACMCF publication, ``Hazard Analysis and 
Critical Control Point System.''
    Moreover, FDA believes that the best way for the agency to judge 
the merits of a processor's annual verification will be through its own 
continuing determinations of whether the processor's overall HACCP 
system remains appropriate for the circumstances. These determinations 
will occur as a product of the agency's ongoing inspection program.
    On this subject, FDA is sensitive to the comment that the absence 
of verification procedures from a HACCP plan should not, in and of 
itself, cause a food to be deemed adulterated under 402(a)(4) of the 
act. Nonetheless, the absence of verification could jeopardize the 
likelihood of success of the overall program. For example, monitoring a 
critical cooking step with a thermometer that has not been calibrated 
provides little assurance that the CL is actually being met, and 
failure to review records may allow the absence of monitoring or 
improper corrective action to go unnoticed for extended periods of 
time. Should the agency find itself in the position of having to react 
to the absence of adequate verification procedures in a processor's 
HACCP plan, in deciding whether to bring regulatory action, the agency 
will consider the totality of the situation, and the likelihood that it 
would have an adverse impact on the final food, as it would in 
considering a processor's failure to meet any specific provision.
4. Verifying the Implementation of the Plan
     The regulations at Sec. 123.8(a)(2) and (a)(3) require ongoing 
verification activities in addition to the annual reassessment. These 
ongoing activities are in keeping with the NACMCF's view that 
verification must also take the form of ``frequent reviews'' (Ref. 34, 
p. 201). Frequent reviews relate primarily to whether the HACCP plan is 
functioning effectively on a day-to-day basis. It is important to note 
that, for the most part, the requirements in these sections were 
proposed in other parts of the regulations and are now being compiled 
in Sec. 123.8(a)(2) and (a)(3). Several comments on these provisions 
pointed out that they were verification steps and should be referred to 
as such. FDA agrees and has brought them together in this new 
verification section of the final regulations. Section 123.8(a)(2) 
requires that processors review consumer complaints (proposed at 
Sec. 123.6(b)(4)), calibrate process monitoring instruments (proposed 
at Sec. 123.6(b)(4)), and perform periodic end-product or in-process 
testing, as appropriate, in accordance with written procedures for 
these activities in the HACCP plan.
     Section II H. of this preamble addresses the review of consumer 
complaints at some length.
     The provision on the calibration of monitoring instruments 
(Sec. 123.8(a)(2)(ii)) is brought forward with no substantive change 
from the proposal. Calibration is an important activity and involves 
readily defined procedures that can easily be provided in the plan.
     Calibration can include the validation of computer hardware and 
software. FDA proposed to require that the HACCP plan detail the 
methods of computer software validation to be used by the processor. 
FDA received a small number of comments both for and against computer 
software validation as a worthwhile part of verification. Two comments 
supported the need for consumer software verification. But two comments 
suggested that computer software verification would be an unnecessary 
expense because it would result in only marginally improved 
reliability.
     The agency has worked extensively with the low-acid canned food 
industry to verify computer hardware and software that the industry is 
now using to operate or control various processing functions. That 
experience has demonstrated to FDA both the desirability and the 
feasibility of verifying computer hardware and software. For low-acid 
canned foods, the industry is using computers to perform several 
functions, including monitoring compliance with CL's, controlling the 
processing operations, taking corrective actions, and recordkeeping 
(Ref. 221).
     In a HACCP system such as that being established for seafood by 
these regulations, FDA is interested in ensuring that hardware and 
software for computers that monitor compliance with a CL be verified. 
However, when computers are used as process-monitoring instruments, 
they must be calibrated in accordance with Sec. 123.8(a)(2)(ii). The 
other functions that a computer can perform, as listed above, can be 
verified through procedures required elsewhere in these regulations 
(e.g., recordkeeping can be verified through the review of records by a 
trained individual in accordance with Sec. 123.8(a)(3)). Consequently, 
the agency has concluded that it is not necessary for these final 
regulations to include a specific requirement for computer validation.
     Instead, the agency acknowledges that the proper frequency of 
equipment calibration is entirely dependent upon the type of instrument 
and the conditions of its use. Therefore, FDA is not being prescriptive 
in this regard. FDA has, however, provided guidance on the subject in 
the draft Guide. Additional guidance should be obtainable from the 
manufacturer of the instrument. The nature and frequency of the 
calibration effort should be determined at the time of HACCP plan 
development and should be included in the plan to ensure that it is 
regularly and appropriately done. The agency is convinced that without 
such formalization, calibration, which, for some instruments, may be 
done as infrequently as once per year, may be overlooked.
5. Product Testing
    75. Section 123(8)(a)(2)(iii), which lists the performing of end-
product or in-process testing, is a new provision. FDA requested 
comment on what tests, including or in place of end-product testing, 
should be used to measure the success of the HACCP program, both in 
terms of individual firms and the national program as a whole, and how 
frequently such tests should be administered (Ref. 208 at 4183). A 
large number of respondents addressed FDA's request for comment. 
Approximately half of these comments supported the need for an end-
product testing requirement. The other half objected to such a 
requirement or suggested that the need should be determined on a case-
by-case basis.
    A number of consumer advocacy organizations suggested that end 
product testing is essential because no other verification mechanism 
provides public confidence that HACCP programs are actually resulting 
in a safer product. Several comments stated that regular 
microbiological testing would help a processor determine whether there 
are sources of contamination that are not being controlled.

[[Page 65132]]

    A few comments suggested that such testing should be performed more 
frequently during plan development and validation, and then reduced to 
some lower level as part of a firm's verification efforts. Another 
comment suggested that testing should be performed quarterly by those 
processors with a poor record of compliance and annually by those with 
a good record.
    Several comments suggested that the need for and frequency of 
product analysis should be established as part of the HACCP plan 
development process. One of these comments noted that the frequency of 
testing may fluctuate depending, in part, upon changes in personnel, 
raw materials, equipment, and product formulation.
    A number of comments stated that end-product testing is a 
questionable method for measuring the success of a HACCP system. One of 
these comments stated that end-product testing measures the 
effectiveness of the plan for a small, finite portion of production and 
has limited value in measuring the success of the HACCP plan overall.
    One comment stressed that finished product testing is contrary to 
the concept of HACCP, i.e., a reliance upon preventive controls at 
critical points throughout the system. Another comment contended that 
mandatory microbiological analysis of foods would be inappropriate 
because: (1) Statistically valid sampling programs for pathogens are 
not economically feasible because of the low incidence of pathogens in 
most foods; (2) the use of indicator organisms to predict the presence 
of pathogens is not always reliable and, where it is not, can become 
merely a test for aesthetics; and (3) microbiological analysis of foods 
is often costly, imprecise, and slow, and, therefore, not suitable for 
real time data generation.
    The agency acknowledges the shortcomings of product testing, 
especially microbiological testing, used for process control as pointed 
out by the comments. The NACMCF, in its comments in response to FDA's 
questions about product testing, reiterated its view that, while 
verification is essential to the success of HACCP, end-product testing 
has limited value for measuring the success of a HACCP system. Comments 
also noted that in-process or finished product testing should not 
normally be a prerequisite for lot release under a HACCP program.
    However, FDA recognizes that many processors will find that product 
testing has a role to play in the verification of HACCP systems, and 
the agency wishes to encourage incorporation of testing into HACCP 
plans, where appropriate. Consequently, the regulations at 
Sec. 123.8(a)(2)(iii) list end-product and in-process testing as a 
verification activity at the option of the processor.
    The agency provided guidance concerning appropriate attributes for 
product testing in the draft Guide and intends to elaborate on it in 
the first edition of the Guide.
6. Records Review
    Section Sec. 123.8(a)(3) requires that a trained individual review 
all records that document monitoring of CCP's, the taking of corrective 
actions, the calibrating of any process control instruments, and the 
performing of any end-product or in-process testing. The review of 
HACCP records by a trained individual was included in the proposed 
regulations at Sec. 123.8(b). In response to comments that urged 
consistency with the recommendations of the NACMCF, FDA has designated 
this review a verification function for purposes of the final 
regulations and has included it in the section on verification. 
Specifically, the proposed regulations provided that a HACCP-trained 
individual review the monitoring records, sanitation control records, 
and corrective action records before distribution of the product to 
which the records relate. Under the proposal, the individual's review 
would include records of process monitoring instrument calibration, 
because the agency characterized these records as monitoring records.
    The comments that FDA received on these provisions focused on the 
proposed requirement that the review by the trained individual occur 
before the product could be shipped. Several comments objected, stating 
that such a review before shipment was unnecessary, because under the 
corrective action provisions of the proposed regulation, any CL 
deviation caught by the observer/operator would necessitate the 
segregation and holding of the affected product before shipment until 
the safety of the product could be assured. One comment further stated 
that linking lot release to record review before shipment 
underestimates the level of control attainable through the monitoring 
and corrective action principles of HACCP.
    Comments from several processors and trade associations stated 
that, for some processors, it would be impractical to withhold the 
shipment of every lot until HACCP records could be verified and signed. 
These comments noted that, with the use of today's high speed 
processing lines, it is normal practice for some processors to begin 
shipping products before the end of the shift (lot). Several comments 
also stated that holding a product until the HACCP records could be 
reviewed could result in a product being subjected to unfavorable 
conditions during storage, which could compromise both quality and 
safety.
    Several comments urged that processors be permitted to review the 
HACCP records at the end of the day or at the end of the shift, even if 
this review occurred after distribution. Others suggested that record 
review should be performed within a ``reasonable time'' of production 
of the record.
    The agency remains convinced that the coupling of lot release with 
verification-type record review provides a valuable added level of 
safety assurance. This kind of record review before shipment is a 
regulatory requirement for low-acid canned foods and acidified foods. 
FDA's experience with these industries is that record review before 
distribution has been instrumental in preventing the introduction of 
potentially hazardous foods into commerce (Ref. 221). The agency 
encourages processors to institute such a program whenever possible.
    However, FDA accepts from the comments that the proposed 
requirement would cause certain processors to delay shipping perishable 
products and thus present an unacceptable burden to them. The agency 
therefore is not requiring that record review occur before shipment.
    Uncoupling record review from lot release leaves as the primary 
purpose for record review the periodic verification that the HACCP plan 
is appropriate and is being properly implemented. Record review needs 
to occur with sufficient frequency so as to ensure that any problems in 
the design and implementation of the HACCP plan are uncovered promptly 
and to facilitate prompt modifications. The concept is roughly that of 
a ``feedback loop,'' with information coming out of the record review 
process in such a timely manner that it can have impact on the 
production of subsequent lots of the product.
    FDA is convinced that a weekly review of HACCP monitoring and 
corrective action records would provide the industry with the necessary 
flexibility to handle highly perishable commodities without 
interruption, while still facilitating speedy feedback of information. 
FDA is reluctant to allow the level of flexibility provided by such 
language as ``reasonable time,'' out of concern for the confusion that 
it 

[[Page 65133]]
would generate. FDA's experience with low-acid canned foods and 
acidified foods has demonstrated that review of these kinds of records 
is a critical verification tool. FDA is, therefore, adopting the 
proposed provision as Sec. 123.8(a)(3) with one revision. As set out in 
the final rule, it requires that the HACCP-trained individual review 
the monitoring records of CCP's and the records that document the 
taking of corrective actions within 1 week of the making of the 
records, rather than before shipment, as a part of a processor's 
verification activities (Sec. 123.8(a)(3) (i) and (ii)).
    FDA agrees, on the other hand, that this principle need not apply 
to the review of records of such verification activities as process 
control instrument calibration and product testing. The frequency of 
these activities will be variable and dependent upon the HACCP plan 
development process. Consequently, setting a specific review frequency 
for these records is not warranted. Section 123.8(a)(3)(iii) reflects 
this conclusion. It requires that the HACCP-trained individual review 
the calibration records within a reasonable time after the records are 
made, rather than before any additional products are shipped. It also 
applies the same ``reasonable time'' standard to any end-product 
testing records that are made.
    The proposed regulations did not address the review of end-product 
testing records by a trained individual. The requirement in these final 
regulations for a review of such records reflects the principle 
contained in the proposal that there be a verification-type review by a 
trained individual of the HACCP records that are being created by the 
processor. In this respect, the responsibilities of the trained 
individual are unchanged from those that were contemplated in the 
proposal, although details relating to those responsibilities have been 
modified based on the comments.
    Section Sec. 123.8(b) requires that processors take appropriate 
corrective action whenever a review of a consumer complaint, or any 
other verification procedure, reveals the need to do so. This provision 
is essentially a restatement of the proposal regarding consumer 
complaints, expanded to include the results of verification procedures 
for purposes of emphasis. Verification was not specifically included in 
the proposal. FDA is including a reference to it here to remind 
processors not to preclude the possibility that information obtained 
through verification could lead to the taking of a corrective action. 
This possibility exists even though, more often than not, verification 
will not provide the kind of immediate feedback that the processor will 
receive from monitoring. Corrective actions based on information 
received through verification will be exceptions to the rule. However, 
processors should be mindful of the possibility.
7. Verifying the Hazard Analysis
    Section 123.8(c) requires that, whenever a processor does not have 
a HACCP plan because a hazard analysis has not revealed any food safety 
hazards that are reasonably likely to occur and that can be controlled 
through HACCP, the processor must reassess the hazard analysis whenever 
a change occurs that could reasonably affect whether such a hazard 
exists. FDA has included examples of such changes in Sec. 123.8(c). The 
list is identical to that provided in Sec. 123.8(a)(1), for when a plan 
must be reassessed. Consequently, any change in these factors should 
warrant a reassessment to be certain that a plan is still not needed.
    FDA has concluded that, under a mandatory HACCP system, the 
principle of verification applies equally to a decision that a HACCP 
plan is not necessary as it does to a decision that the plan continues 
to be adequate. Circumstances change, and processors must be alert to 
whether the exemption from the requirement to have a plan continues to 
apply to them.
    Section 123.8(d) requires that processors document calibration and 
product testing in records that are subject to the recordkeeping 
requirements of the regulations at Sec. 123.9. The requirement that 
records be kept of process monitoring instrument calibration was 
included in the proposed regulations at Sec. 123.6(b)(5). The 
requirement that records of end-product testing be kept is consistent 
with the general recordkeeping principles of HACCP. The one exception 
is that FDA is not requiring records that document the review of 
consumer complaints. The agency is satisfied that the requirement for a 
processor to review consumer complaints relating to potential safety 
concerns will be sufficient for this kind of verification activity. 
Moreover, as explained in the discussion of consumer complaints 
elsewhere in this preamble, FDA is persuaded that most consumer 
complaints will involve matters unrelated to the mandatory HACCP 
system.

H. Consumer Complaints

1. Background
    In the proposed regulations, FDA tentatively concluded that each 
processor's HACCP system had to utilize any consumer complaints that 
the processor receives that allege a problem with product safety. 
Several provisions described how consumer complaints were to be used. 
In one, FDA proposed to require that a processor's monitoring efforts 
include the use of consumer complaints, and that its HACCP plan reflect 
how they will be used. In a second provision, FDA proposed to require 
that, when a processor receives a consumer complaint that may be 
related to the performance of a CCP or that may reflect a CL deviation, 
the processor determine whether a corrective action is warranted, and, 
if so, take one in accordance with the specified corrective action 
procedures. FDA also proposed to require that the taking of such 
corrective actions be fully documented in records. Finally, FDA 
proposed to require that consumer complaints that relate to the 
operation of a CCP or to a possible CL deviation be included as part of 
the processor's HACCP records and be available for agency review and 
copying.
    FDA's rationale for proposing these requirements was that consumer 
complaints may be the first alert that a processor has that problems 
are occurring that are not being detected or prevented by the 
processor's HACCP controls. While the goal of a HACCP system is to 
prevent all likely hazards from occurring, no system is foolproof. The 
agency tentatively concluded,therefore, that each HACCP system should 
take advantage of consumer complaints as they relate to the operation 
of CCP's. FDA also tentatively concluded that it might be necessary for 
the agency to review those complaints in order to be able to verify 
whether a processor is taking necessary steps to review its HACCP 
controls and take corrective actions as necessary in response to 
consumer complaints. The agency emphasized that it was referring solely 
to complaints relating to the operation of the HACCP CCP's (i.e., those 
that allege a problem with human food safety) and not to consumer 
complaints generally.
2. Consumer Complaints as Verification Tools
    76. FDA received a large number of comments on the advisability of 
handling consumer complaints in the manner that the agency proposed. 
Generally speaking, the comments 

[[Page 65134]]
addressed two broad issues: Whether consumer complaints are relevant to 
a HACCP system, and if they are relevant, how they should be used. The 
question of whether FDA should have access to consumer complaints was a 
significant concern that comments found germane to both issues. 
Approximately one-fifth of the comments supported the proposed system 
or a variant of the system (i.e., they believed that consumer 
complaints are relevant to a HACCP system). Some of those who voiced 
general support urged more comprehensive agency access to consumer 
complaints, and others urged that some restriction on agency access be 
put in place. The remaining approximately four-fifths of the comments, 
principally from seafood and other food processors and trade 
associations, argued that consumer complaints have no place in a HACCP 
system.
    Those comments that opposed the mandatory use of consumer 
complaints in a HACCP system provided a variety of reasons. The 
comments argued that consumer complaints are generally: (1) Unrelated 
to the safety of the product; (2) not received in a timely manner that 
would facilitate control of the process and are, in this way, akin to 
finished product testing; (3) erroneous and sometimes exaggerated or 
fraudulent; (4) vague; (5) subjective and nonscientific; (6) associated 
with hazards that develop during transportation, storage, and retail 
marketing, rather than processing, if they identify food safety hazards 
of any kind; (7) not traceable to a specific processing plant or lot of 
product; and (8) not readily associated with a specific CCP or CL 
failure, even where it is likely that they are the result of a problem 
during processing. These comments asserted that, therefore, consumer 
complaints are not an appropriate monitoring tool.
    A number of these comments suggested that, given the problems 
listed above, sorting through the large volume of consumer complaints 
that are received by most large firms to identify those few that might 
be able to be linked to the performance of a specific CCP would be a 
waste of both the processor's and the agency's time. These comments 
stated that such a review of consumer complaints would divert their 
efforts from more productive tasks.
    Several comments raised additional questions about consumer 
complaints as a HACCP verification tool. They suggested that there are 
better, more effective means of verifying that the HACCP plan is 
working properly. These suggestions are covered in the ``Verification'' 
section of this preamble. These comments further argued that consumer 
complaints are not identified in the NACMCF recommendations as a useful 
verification tool.
    A relatively small, diverse group of comments, including those from 
a seafood processor, a seafood trade association, a State regulatory 
agency, an individual, and a professional organization, supported the 
handling of consumer complaints as proposed. One of these comments 
suggested that consumer complaints could be useful in FDA's efforts to 
verify that processors' HACCP programs are effective.
    Another group of comments, from consumer advocacy organizations and 
a State regulatory agency, agreed that consumer complaints are an 
appropriate part of HACCP. One of the comments noted that the consumer 
performs the final quality control check, and that if a consumer finds 
a problem egregious enough to take the time to write a letter, the 
information contained in that letter should be considered in any 
evaluation of the adequacy of the relevant HACCP plan. The comment 
further argued that consumer complaints could bring to light 
unidentified CCP's. This benefit, the comment contended, would not be 
possible under the proposed regulations because the agency limited 
consumer complaints in a HACCP system to those that may be related to a 
CL deviation at an existing CCP. Finally, one of the comments noted 
that the inclusion of consumer complaint access in the proposed 
regulations is the one area in which the agency delivers on its ``water 
to table'' commitment.
    FDA is persuaded that consumer complaints generally will not make 
an effective monitoring tool in a HACCP system, primarily because they 
tend not to provide the kind of immediate, reliable feedback expected 
of a HACCP-monitoring system. FDA agrees with the comments that 
suggested that monitoring procedures under HACCP must provide the 
processor with immediate feedback on whether the process is under 
control and be scientifically sound.
    FDA is not persuaded, however, that consumer complaints are 
irrelevant to HACCP systems. The agency received no comments that were 
able to demonstrate that outside sources of information should not, 
where appropriate, supplement a processor's own monitoring as a way of 
determining whether the process is in control. Moreover, a number of 
comments stated that they go to some lengths to examine the consumer 
complaints that they receive. The question, then, is whether consumer 
complaints can serve some legitimate verification purpose in a HACCP 
system.
    While consumer complaints are not specifically addressed in the 
NACMCF HACCP recommendations, the verification portion of that document 
states, in part, that verification inspections should be conducted, 
``When foods produced have been implicated as a vehicle of foodborne 
disease.'' This statement is a recognition that information from 
sources outside the processing plant can and should be considered in 
the verification of a HACCP plan. In fact, it is FDA's experience that 
consumer injury or illness complaints to the agency occasionally point 
out problems traceable to defective controls at the food processing 
facility (Ref. 207). Where information that has potential relevance to 
food safety is available to a processor as a result of its own consumer 
complaint system, it is entirely appropriate for the processor to 
consider that information in assessing the adequacy of its HACCP 
program. FDA accepts the possibility that many, if not most, consumer 
complaints that a processor receives will not be germane to safety, 
that many will turn out not to be valid, and that others will relate to 
events at retail or that are otherwise beyond the ability of the 
processor to control. Nonetheless, FDA strongly believes--and the 
comments support this view--that a responsible processor will at least 
review consumer complaints to determine their potential value and take 
steps to correct the product or the process, when such stops are 
warranted.
    FDA has concluded, therefore, that processors should evaluate the 
consumer complaints that they receive to determine whether the 
complaints relate to the performance of CCP's, or reveal the existence 
of unidentified CCP's, as part of their HACCP verification procedures. 
The agency acknowledges that the absence of consumer complaints does 
not, by itself, verify the adequacy of a HACCP system. However, after 
taking into account all the concerns raised by the comments, the agency 
is of the view that those consumer complaints that a processor does 
receive, and that allege a safety problem, can be of value as a 
verification tool and should serve that purpose. This conclusion is 
reflected in the requirements of Sec. 123.8 of these final regulations 
(see discussion in the ``Verification'' section of this preamble), 
which lists the review of consumer complaints as an appropriate 
verification activity (Sec. 123.8(a)(2)(i)).
    As explained earlier in this preamble, because the agency regards 
consumer 

[[Page 65135]]
complaints as a verification tool rather than a monitoring tool, FDA 
has modified Sec. 123.6(c)(4) to eliminate the proposal requirement 
that the HACCP plan describe how consumer complaints will be used in 
the monitoring of CCP's. The agency has also modified Sec. 123.6(c)(7) 
to eliminate the proposed requirement that consumer complaints be part 
of a processor's HACCP-monitoring records.
    FDA has concluded that when a review of a consumer complaint 
reveals a need for the processor to take corrective action (e.g., 
recall, destruction, or reprocessing of the product or modification of 
the process to reduce the risk of reoccurrence of the problem), such 
action must be taken in conformance with the applicable corrective 
action procedures of these regulations. This conclusion is reflected in 
of Sec. 123.8(b) which states that processors shall immediately follow 
the procedures in Sec. 123.7 whenever a review of a consumer complaint, 
or any other verification procedure, reveals the need to take a 
corrective action. The corrective action provisions are discussed in 
the ``Corrective Actions'' section of this preamble.
    As suggested by several of the comments, records of corrective 
action relative to consumer complaints need not include the original 
consumer complaint. However, it is unlikely that a comprehensive record 
of the corrective action taken could be generated without at least the 
critical information contained in the complaint, such as the nature of 
the complaint and identification of the product in question. 
Identification of the complainant is not likely to be critical.
3. Agency Access to Consumer Complaints
    77. Many comments questioned whether FDA should have access to 
consumer complaints. Several comments argued that no other food 
industry is required to provide access to consumer complaints. A few 
specifically cited the absence of such a requirement in the low-acid 
canned foods regulations (part 113).
    One comment noted that FDA has methods other than access to a 
company's consumer complaint file to obtain information about product 
defects that affect safety, including direct calls from consumers and 
health professionals, MedWatch, and reporting to the Center for Disease 
Control and Prevention (CDC). Another comment suggested that it would 
be more efficient to devise a system whereby consumers are encouraged 
to submit complaints about product safety directly to FDA rather than 
to mandate access to corporate files.
    Several comments suggested that consumer complaint files should 
remain a private company matter, and that open access to these files is 
likely to result in regulatory abuse. A few comments further argued 
that, by mandating complaint file access, the agency would penalize 
those firms with good consumer complaint gathering systems and possibly 
deter others from developing such systems.
    A relatively small, diverse group of comments, including seafood 
processors, a seafood trade association, and a Federal government 
agency, submitted that, while it is appropriate for FDA to mandate that 
processors utilize consumer complaints in assessing the effectiveness 
of their HACCP program, it is not necessary for the agency to have 
direct access to the firms' complaint files. The comments suggested two 
alternatives to providing direct access to complaint files: (1) 
Allowing processors to prepare Notices of Unusual Occurrence and 
Corrective Action (NUOCA) that described the action taken in response 
to consumer complaints that relate to product safety; or (2) allowing 
processors to prepare a matrix of complaints, as is currently used in 
the voluntary, fee-for-service HACCP program being operated by NMFS.
    Others in this group suggested that FDA have access only to written 
complaints, or only to consumer complaints, as opposed to trade 
complaints, which the comment argued are often submitted for commercial 
advantage only. One comment noted that it would be impossible for 
processing vessels to retain consumer complaints on board the vessel, 
and that provision should be made for these to be stored at the 
corporate office. Other comments urged that FDA access to consumer 
complaints not include the right to copy them, or that, in some other 
way, they be protected from public disclosure.
    Another group of comments, composed of consumer advocacy 
organizations and a State regulatory agency, urged that all consumer 
complaints, regardless of their potential relationship to product 
safety, be included in a processor's HACCP records and be available for 
FDA review. These comments suggested that the FDA investigator should 
make the determination of which complaints are relevant for follow up 
rather than the firm. They further suggested that the investigator can 
ignore any complaints that are not relevant to safety controls at the 
processing facility.
    Unquestionably, FDA has an essential role to play as a regulatory 
verifier of HACCP. As described earlier, the agency received a number 
of comments that raised concerns about the veracity of a mandatory 
HACCP system in the absence of adequate regulatory review. Moreover, 
FDA has concluded that this role cannot be carried out without the 
ability to review HACCP plans and a narrow category of processor's 
records (i.e., those that relate to how a processor is controlling the 
critical safety aspects of its operations). The agency is not 
interested in expanding this access beyond those records that are the 
minimum necessary to carry out this responsibility.
    With regard to consumer complaints, FDA is persuaded by the 
comments that, especially when used as HACCP verification records 
rather than HACCP-monitoring records as originally proposed, the public 
health benefits that may accrue from agency access to these kinds of 
records would probably be minimal and are outweighed by the concerns 
that have been expressed.
    FDA is satisfied that agency review of a processor's overall 
verification scheme, plus access to records that document any 
corrective actions that were taken as a result of information obtained 
through consumer complaints, review of those complaints that consumers 
regularly send to the agency, the ability to conduct unannounced 
inspections, and access to monitoring records and plans, should be 
enough for FDA to adequately verify processor's HACCP systems.
    FDA also accepts that the burden on processors if they had to 
segregate complaints that have a potential relationship to product 
safety from those that relate to product quality, economic issues, 
customer satisfaction, and other nonsafety issues, would be great and 
is not warranted by any potential gain in product safety. Many firms 
would have to take this step to make safety-related complaints 
available to FDA. Similarly, the agency recognizes that a significant 
burden would be placed upon its inspectional force if it had to verify 
that a processor had properly categorized its complaints.
    The alternative of FDA having access to all consumer complaints and 
making its own determinations about which relate to safety, as some 
comments suggested, is simply not practicable. In addition, it is not 
the desire of FDA to penalize those firms that have large, expensive 
complaint gathering systems, by mandating that they provide all 
information so gathered for agency review, or to discourage others from 
developing such systems. 

[[Page 65136]]

    In the preamble to the proposed regulations, FDA stated that more 
than half of the seafood-related consumer complaints that it receives 
relate to product quality, filth, and economic deception concerns. 
Access to all consumer complaints is, therefore, unnecessary to ensure 
product safety.
    FDA has, therefore, removed from what is now Sec. 123.9(c) the 
requirement that consumer complaints relating to safety be available to 
the agency. The agency reiterates, however, that processors should 
utilize all available information as they evaluate the adequacy of 
their HACCP plans and their implementation. Consumer complaints are one 
potential source of information, and a significant group of comments 
recognized the value of consumer complaints in the verification 
process.

I. Records

    FDA proposed that records required by the regulations: (1) Contain 
certain information, (2) be completed at the time of the activity, (3) 
be signed by the operator or observer, (4) be reviewed for completeness 
and compliance with the HACCP plan and signed and dated by the 
reviewer, (5) be retained for specified periods of time, and (6) be 
available for review and copying by FDA.
    FDA received a large number of comments that addressed these 
proposed recordkeeping requirements. These comments were from a diverse 
group of commenters, including large and small processors, trade 
associations, individuals, Federal, State, and foreign government 
agencies, consumer advocacy groups, professional societies, and 
academics. Several comments provided arguments that support the need in 
a mandatory HACCP program for records in general, and none specifically 
argued in opposition to that concept. Most of the comments addressed 
specific issues that relate to recordkeeping.
    Those comments that supported the need for records stated that 
recordkeeping is a key component of HACCP. One processor's comment 
noted that HACCP records must be kept in good order so that problems 
can be easily tracked to their root cause. One comment stated that 
HACCP records facilitate an evaluation of safety conditions over time, 
rather than through a ``snap shot'' inspection. Another processor noted 
that HACCP recordkeeping is not overly burdensome, and that the 
proposed regulations would not require it to maintain any records in 
addition to those that it already maintains.
1. Details and Signatures
    78. FDA proposed that all HACCP-monitoring records (including 
records of process-monitoring instrument calibration), sanitation 
control records, and corrective action records identify the date of the 
activity that the record reflects. One comment recommended that the 
final regulations should also require that the time of each observation 
be recorded, to make it easier to link records to specific lots of 
product. A comment from a trade association requested that the records 
be required to identify the establishment where the activity occurred 
to reduce the potential for confusion in firms with multiple processing 
facilities.
    FDA agrees with both comments that the date and time on records 
will help to connect information on the records to specific lots of 
product, and that the name and location of the processor will help link 
information to a specific processing facility.
    The agency has, therefore, modified Sec. 123.9(a)(1) and (a)(2) to 
state, in part, that the required records must include: ``(1) The name 
and location of the processor or importer; (2) The date and time of the 
activity that the record reflects.''
    79. FDA proposed to require that HACCP-monitoring records 
(including records of process-monitoring instrument calibration) and 
sanitation control records be signed by the observer/operator. A few 
comments supported the proposed requirement on the grounds that it 
fosters accuracy and accountability in the recordkeeping process. One 
comment opposed the proposed requirement, raising concern about the 
legal liability that it imposed upon the workers that sign the records. 
A few comments suggested that the observer/operator be allowed to 
initial, instead of sign, the records.
    FDA agrees with the comments that suggested that a signature on 
monitoring and sanitation control records is necessary to ensure 
accountability in the recordkeeping process. FDA also hopes that it 
will enhance workers' sense of responsibility and pride in their 
participation in the HACCP system of preventive controls. Regarding 
worker liability, those that deliberately falsify records are liable 
whether they sign the records or not. In any event, the falsification 
of records cannot be condoned and should not be tolerated by 
processors.
    FDA further agrees that the purpose for the observer/ operator's 
signature is achieved if the observer/operator either signs or initials 
the monitoring records.
    FDA proposed to require the signature of the observer/operator on 
all records involving observations or measurements made during 
processing or related activities. This specification of the kinds of 
records in which signatures were required would have had the effect of 
exempting consumer complaints, which were considered to be monitoring 
records in the proposal from this requirement. However, the use of 
consumer complaints as monitoring records has not been carried forward 
to these final regulations. Consequently, limiting the records that 
must be signed to involving observations or measurements is no longer 
necessary, and FDA has deleted it for purposes of clarification (see 
Sec. 123.9(a)).
    FDA has also deleted the proposed provision that the observer/
operator need not sign corrective action records. The agency proposed 
to require that only a trained individual sign these records. FDA is 
requiring the signature or initials of the observer/operator on 
corrective action records in order to be consistent with the corrective 
action provisions of these regulations. In Sec. 123.7, for example, 
processors may now predetermine their corrective actions in ways that 
empower observer/operators to take corrective measures, especially in 
the absence of a trained individual. The likelihood that a trained 
individual might not be present at the moment when a corrective action 
must be initiated is enhanced by the fact that such an individual need 
not be an employee of the processor (see Sec. 123.10). Conversely, the 
presence of a trained individual during the initiation of a corrective 
action need not preclude the observer/operator from taking corrective 
steps, as appropriate. Finally, the agency has concluded that the 
burden imposed by requiring the signature or initials of the observer/
operator whenever that individual participates in the making of a 
corrective action record is inconsequential.
    80. Several comments questioned whether the proposed requirement 
that monitoring records include the ``identity of the product, product 
code * * *,'' meant that all fish and fishery products were required to 
bear a product code.
    It was not the intent of the agency to require product codes on 
such products, only to require that they be listed on appropriate 
records when they are used. The purpose of the proposed requirement was 
to facilitate linkage between records and product. To clarify this 
point, FDA has modified what is now Sec. 123.9(a)(4) to read, ``(4) 
Where 

[[Page 65137]]
appropriate, the identity of the product and the production code, if 
any.''
    81. Several comments suggested that FDA not specify the components 
of required records. These comments argued that many processors have 
existing forms that can appropriately be used as HACCP records.
    It is not FDA's intent in Sec. 123.9(a) to specify record format or 
content, beyond certain minimum, essential components. Processor's are 
encouraged to use existing records, making modifications only as 
necessary to meet the previously described requirements.
2. Retention and Storage
     FDA proposed to require that processors retain monitoring 
(including process monitoring instrument calibration), sanitation 
control, and corrective action records for 1 year after the date that 
they were prepared for refrigerated products and for 2 years for frozen 
or preserved products. FDA also proposed that records used to 
substantiate the adequacy of equipment or processes be retained for 2 
years after the date that they apply to products being processed.
    82. Several comments stated that these proposed retention times 
were too long. Most of these comments suggested record retention times 
of from 90 days to 1 year for refrigerated products and from 6 months 
to 1 year for frozen products. One comment argued that 1 year is a 
sufficient period for record retention unless the records relate to a 
CL deviation, in which case they should be held for 3 years. Another 
comment urged that the agency not mandate record retention times but 
require processors to identify appropriate retention time requirements 
in their HACCP plans.
    FDA rejects those comments that requested a reduction in the 
proposed mandatory record retention period. While it may be true that 
most refrigerated products will be unusable within 90 days, as 
suggested by one of the comments, retention times of less than 1 year 
do not provide for sufficient access for the processor's or FDA's 
verification activities. (See revised Sec. 123.8(a)(1) and the 
accompanying preamble discussion of the minimum 1-year frequency of 
plan reassessment.) No new, substantive comment was provided relative 
to record retention times for frozen or preserved products that would 
warrant a reduction for those products.
    Thus, FDA has made no changes to Sec. 123.9(b).
    83. FDA proposed that, in the case of processing facilities that 
close between seasonal packs, records could be transferred to another 
accessible location between seasonal packs, as long as they were 
returned during the next active season. Comments from several 
processors and trade associations urged the agency to modify the 
requirement to: (a) Allow for permanent transfer from the facility and 
(b) include both remote processing sites and processing vessels 
regardless of whether they close seasonally. Comments from operators of 
processing vessels and remote processing sites and from a trade 
association requested that FDA allow HACCP records to be kept on the 
processing vessel or remote site for a period of time and then be 
transferred permanently to the processor's corporate, or closest 
business office. The comments argued that the records in those 
locations would be more easily stored, safer, and more readily 
accessible to regulators than they would be at remote sites and on 
processing vessels. Additionally, they argued that corporate 
verification activities often would be performed at the land-based 
facilities. Transfer of the records to these facilities would promote 
verification in these circumstances. Comments opposing the requirement 
that the records be returned to a seasonally closed facility once the 
facilities reopened expressed concern that return of the records to the 
reopened locations could result in lost records.
    FDA has been persuaded to accommodate the difficulties associated 
with record storage on processing vessels and remote processing sites 
by allowing HACCP records to be moved from such facilities to another 
reasonably accessible location at the end of the seasonal pack without 
requiring that the records all be returned for the following season 
(Sec. 123.9(b)(3)). Additionally, the agency will, as proposed, allow 
HACCP records from any facility that is closed between seasonal packs 
to be permanently transferred to another reasonably accessible 
location. However, FDA points out that, in most instances, the agency 
will need to examine processing records onsite in order to conduct an 
effective verification inspection. For this reason, records must be so 
stored that they can be promptly returned to the processing facility 
upon demand by FDA. In order to maintain inspectional efficiency, the 
time period between an FDA request for the records and their arrival 
should not ordinarily exceed 24 hours.
    84. Several comments urged FDA to provide for the use of computers 
to maintain HACCP records.
    It was not the intent of the agency to preclude such records. To 
make this fact clear, FDA has added a new paragraph, Sec. 123.9(f), to 
the final regulation, which reads, ``(f) Records maintained on 
computers. The use of records maintained on computers is acceptable, 
provided that appropriate controls are implemented to ensure the 
integrity of the electronic data and signatures.''
    In the Federal Register of August 31, 1994 (59 FR 45160), FDA 
proposed separate regulations at 21 CFR 11 that, if adopted, will 
become the standard for determining what constitutes appropriate 
controls for electronic records, electronic signatures, and handwritten 
signatures executed to electronic records. In the interim, processors 
are encouraged to look to industry standards for guidance.
3. Confidentiality of Records
    85. In the preamble to the proposed regulation, FDA stated that, as 
a preliminary matter, HACCP plans and monitoring records appear to fall 
within the bounds of trade secret or commercial confidential 
information and would, therefore, be protected from public disclosure 
by section 301(j) of the act (21 U.S.C. 331) and by the Freedom of 
Information Act (FOIA) and the Department of Health and Human Services 
(DHHS) and FDA regulations promulgated pursuant to these laws. FDA 
specifically invited comment on the issue of public disclosure of HACCP 
records and on whether FDA has any discretion about the releasability 
of any HACCP records that it may eventually have in its possession. A 
large number of comments responded to FDA's request for comment, 
especially in the context of the provision in the regulations 
(Sec. 123.9(c) in this final rule), that provides that all required 
records and plans must be available for review and copying.
    A large number of comments, from processors, trade associations, 
professional associations, State and Federal agencies, and individuals, 
contended that HACCP records and plans are trade secrets and should 
under no circumstances be released to the public. Comments from several 
consumer advocacy groups countered that in many cases HACCP records and 
plans will not contain trade secret information or will contain only 
limited trade secret information, and that the nonsecret parts (i.e., 
most of their contents) should, therefore, be available to the public.
    Many of the comments that supported protection from public 
disclosure urged that the final regulations contain controls over the 
agency's access to, and 

[[Page 65138]]
copying of, HACCP plans and records as the only guaranteed way to 
ensure confidentiality. The comments argued that the potential harm 
from exposure of HACCP plans and records to competitors or to the 
public is considerable and carries the threat of increased costs, 
misuse, and damage to the integrity of a firm and its products.
    Several comments contended that HACCP records will be trade secret 
because they will be process-specific and, therefore, will contain such 
information as processing times and temperatures. They stated that 
these processing parameters may differ from company to company based on 
product formulas.
    A few comments argued that there is no precedent for public access 
to industry-generated records. Some of these comments stated that 
processing records are regarded as trade secret under the LACF 
regulations, and they noted that Sec. 108.35(d)(3)(ii) deems processing 
information submitted to FDA to be trade secret within the meaning of 
301(j) of the act and within the meaning of the FOIA. Other comments 
asked that FDA protect HACCP plans and records in the same way that the 
agency protects processing and quality control data that are submitted 
to FDA under cooperative quality assurance agreements (i.e., 
manufacturing methods or processes, including quality control 
procedures, are deemed not to be releasable unless the information that 
they contain has already been released or is otherwise no longer trade 
secret or confidential commercial per Secs. 20.111(d)(2) and 20.114 (21 
CFR 20.111(d)(2) and 20.114)).
    Several comments suggested that FDA specifically declare that: (1) 
HACCP plans and records are trade secrets; (2) section 301(j) of the 
act and the FOIA prohibit disclosure of trade secret or confidential 
commercial information and give the agency no discretion whether to 
release these types of records; and (3) Sec. 20.81 provides for 
disclosure of trade secret or confidential commercial information only 
if the information has been previously disclosed to the public.
    One comment proposed that, if FDA felt obliged to release some 
HACCP-related information pursuant to FOIA requests, reports of regular 
inspections be released instead of HACCP plans and records, because 
such reports are likely to contain less sensitive information. Another 
comment suggested that, to avoid releasing proprietary information, the 
agency should describe or explain information that is contained in 
HACCP plans and records in general terms rather than release the 
records themselves. The comment asserted that this step would serve to 
inform consumers about the relative safety of the product and the 
effectiveness of the HACCP system, while not divulging specific process 
parameters that are trade secret or confidential commercial.
    Conversely, comments from consumer advocacy groups argued that, for 
the most part, HACCP plans and records are not trade secret or 
confidential commercial. The comments asserted that much of the 
information contained in these plans and records involves the 
application of basic sanitary engineering and is already in the public 
domain, as evidenced by the draft FDA Guide.
    The consumer advocacy groups argued that, given the limited 
resources that FDA can devote to monitoring HACCP compliance, public 
access to HACCP records should be as broad as allowed under the law, so 
that consumer confidence in, and understanding of, the seafood supply 
can be fostered. One comment asserted that the public's right and need 
to know about matters involving public health should be the basis from 
which the agency formulates public access policy. Another comment 
stated that consumers are the intended beneficiaries of the HACCP 
seafood proposal and therefore should have the right to determine 
through record inspection whether processors are properly implementing 
the HACCP requirements. These comments urged FDA to routinely collect 
HACCP plans and records from processors to facilitate agency 
verification activities and public review of the effectiveness of the 
HACCP system. One comment from a consumer advocacy group asserted that 
Public Citizen Health Research Group v. FDA, 704 F.2d 1280 (D.C. Cir. 
1983) narrowly defined trade secrets in such a way that HACCP plans and 
the records at issue in this rulemaking could not be considered trade 
secret.
    Unquestionably, adoption of a mandatory HACCP system will place 
significant documentation requirements on seafood processors. As a 
result, they will produce records that reflect processing designs and 
equipment and certain types of day-to-day operations. They will be 
available to FDA. FDA strongly believes that it is in the public 
interest to require that these records be maintained, and that the 
agency have access to them. Such records and access are necessary to 
effectuate a mandatory system of preventive controls for safety. As 
stated in the preamble to the proposed regulations, FDA expects to take 
possession of records on a case-by-case basis, and only when there is a 
specific need to do so. The agency categorically rejects the view that 
FDA should be a collection point for HACCP records and plans so that 
they may be made publicly available. Nevertheless, the apprehension 
expressed by many comments about the consequences of public disclosure 
of these new types of records is certainly understandable.
    FDA agrees with the views expressed by consumer advocacy 
organizations that the public needs ways to be able to judge how and 
whether it is benefiting from a HACCP system. Neither the agency nor 
the industry can reasonably expect that the public will simply take the 
government's word for it. It remains to be seen, however, whether 
public access to information about processors that processors have 
traditionally held as protected is the only way, or the best way, to 
provide the public with information about this system.
    FDA is considering how meaningful data can be extracted from the 
inspectional process and prepared in such a manner that it could be 
released without jeopardizing trade secret and confidential commercial 
information and yet be useful to both FDA and the public in evaluating 
this program. FDA is considering developing standardized reports that 
would be completed by investigators at the conclusion of routine HACCP-
based inspections and become part of agency files. As presently 
conceived, these reports would contain a summary of the status of the 
HACCP program in effect at the firm, similar to the suggestion of two 
of the comments.
    Nonetheless, the question is whether, as FDA preliminarily 
concluded, most plans and records to be generated under this program 
will be subject to protection under existing law and FOIA regulations. 
FDA's experience in seafood processing plants, its experience with 
HACCP, and its understanding from the cost-benefit modeling that has 
been done in the preparation of these regulations is that HACCP plans 
will take each processor some time and money to develop. Thus, the 
agency concludes that HACCP plans generally will meet the definition of 
trade secret, including the court's definition in Public Citizen Health 
Research Group v. FDA, supra. Plans that incorporate unique time-
temperature regimens to achieve product safety, or other parameters 
that are processor-specific and that are the result of considerable 
research and effort, will surely meet this definition.
    Moreover, there is value in a plan to a company that produces it 
for no other reason than that it took work to write. The equity in such 
a product is not 

[[Page 65139]]
readily given away to competitors. FDA knows from its own experience 
that plant configurations tend to be unique to individual processors, 
or at least have unique features (Ref. 222). While generic plans will 
have great utility in many circumstances, they serve primarily as 
starting points for processors to develop their own plans. FDA expects 
that its Guide will help serve that purpose, but firms will still need 
to expend time and money to tailor HACCP to their individual 
circumstances.
    Additionally, the agency has come to the conclusion, as a matter of 
policy, that records and plans should be protected to the extent 
possible in order to promote the implementation of HACCP across the 
seafood industry. FDA has concluded that the public will benefit from 
the protection of records because it will actually strengthen the HACCP 
system. So long as the legitimate public need to be able to evaluate 
the system can be met through other means, the confidentiality of HACCP 
records and plans generally will foster the industry's acceptance of 
HACCP. Even though HACCP may be mandatory under these regulations, in 
order for it to succeed, processors must be committed to it because 
they see value in it for themselves. Fear of public disclosure of 
matters that have long been regarded as confidential business matters 
could significantly undermine that commitment. FDA concludes, 
therefore, that it is in the public interest to foster tailored HACCP 
plans that demonstrate understanding and thought, rather than promote 
the use of rote plans and minimally acceptable standards due to fear of 
public disclosure.
    FDA understands that it cannot make promises of confidentiality 
that exceed the permissible boundaries established under FOIA, nor does 
the agency wish to do so in this case. The agency still does not expect 
that it will be in possession of a large volume of plans and records at 
any given moment. However, given the significant interest in this 
subject as conveyed by the comments, FDA has concluded that the final 
regulations should reflect the fact that the HACCP plans and records 
that do come into FDA's possession will generally meet the definition 
of either trade secret or commercial confidential materials. A 
statement to this effect in the final regulations will help to make 
this fact as widely understood as possible and will clarify the 
agency's position on this matter. This fact is codified at 
Sec. 123.9(d)(1), which reads as follows:

    (d) Public disclosure. (1) Subject to the limitations in 
paragraph (d)(2) of this section, all plans and records required by 
this part are not available for public disclosure unless they have 
been previously disclosed to the public as defined in Sec. 20.81 of 
this chapter, or they relate to a product or ingredient that has 
been abandoned and they no longer represent a trade secret or 
confidential commercial or financial information as defined in 
Sec. 20.61 of this chapter.

    The agency acknowledges that there could be exceptions to this 
general rule. The nature of information in HACCP plans and records 
varies. Some of it could be generally available processing methodology 
or procedures, based on generic or model HACCP plans or guidelines 
developed by the agency or some other public source, that is 
sufficiently reflective of an industry standard that it has little if 
any proprietary value. In such a case, in response to an FOIA request, 
there may not be a valid reason for protecting this information. The 
agency has concluded that there should be a provision that makes clear 
that it will make information available in appropriate circumstances. 
Consequently, the final regulations in Sec. 123.9(d)(2), state:

    (2) However, these records and plans may be subject to 
disclosure to the extent that they involve materials that are 
otherwise publicly available, or that disclosure could not 
reasonably be expected to cause a competitive hardship, such as 
generic-type HACCP plans that reflect standard industry practices.

    There is precedent for describing in regulations the records that 
have protected status. The low-acid canned food regulations at 
Sec. 108.35(l) provide that, except under certain limited situations, 
filed scheduled processes submitted to FDA are not available for public 
disclosure. Additionally, Sec. 108.35(d) provides that data submitted 
to the agency to support these processes are to be treated as trade 
secret. These materials are analogous to HACCP plans, and their 
treatment is consistent with the agency's views relative to the 
protected status of HACCP plans. The comments that suggested that the 
low-acid canned foods regulations grant trade secret status to the 
monitoring records that are required to be kept by part 113 are 
incorrect. These records are not provided any special status in those 
regulations.
4. Agency Access to Records
    86. Several comments suggested that the final regulations should 
require processors to provide access by FDA to HACCP records only after 
the submission by the agency of a written request for specific records 
it deems necessary to review. The comments noted that this approach 
would be similar to Sec. 108.35(h) in the LACF regulations, because 
processors are familiar and satisfied with such procedures.
    FDA remains convinced that access to HACCP documents is essential 
to the agency's verification of a firm's HACCP system. A key feature of 
the HACCP verification process is access by government investigators to 
the HACCP plan, to monitoring records kept according to the plan, and 
to records of corrective actions that were taken in response to CL 
deviations. Examination of HACCP records enables an investigator to see 
how the processing facility or the importer operates over time rather 
than how it is functioning at one particular moment in time. 
Additionally, it will enable the regulator to review the adequacy of 
the processor's or the importer's preventive control system itself.
    FDA rejects the idea of being required to request in writing access 
to HACCP plans and records. The agency is convinced that it has 
sufficiently limited its access to those records and plans that are 
minimally necessary to adequately evaluate the adequacy of a firm's 
HACCP system. Section 123.9(c) has been modified slightly to clarify to 
which records FDA is required to be granted access.
    The comments are correct that the emergency permit regulations for 
low-acid canned foods at Sec. 108.35 require that FDA issue a written 
request for access to monitoring records. However, the written request 
has proven to be merely a mechanical exercise. It has not in any way 
served to affect the outcome of FDA access to records, nor is it 
associated with any managerial control over the activities of FDA 
investigators, with respect to the kind or numbers of records to which 
they seek access. Moreover, the bottled water regulations at 
Sec. 129.80(h), promulgated subsequent to the low-acid canned food 
regulations, do not contain a requirement for the issuance of a written 
request for records. FDA is not aware of any undue concerns expressed 
by the bottled water industry relative to agency abuse of its records 
access authority as a result of the lack of a written request 
requirement in those regulations. FDA further notes that its 
investigators are required to present a written notice of inspection to 
management of the firm at the start of each inspection. The notice 
explains the authority of the investigator to conduct an inspection of 
the facility. The agency has concluded that there is no need to further 
encumber the efficient enforcement of these regulations with a 

[[Page 65140]]
written request for those records to which it is entitled to have 
access. It has chosen to use the more recent regulations, bottled 
water, as the model for these regulations with respect to records 
access.
5. Agency Copying of Records
    87. A large number of comments opposed the provision in the 
proposal that provided for FDA copying of HACCP plans and records, 
mostly because of concern about public disclosure. Several comments 
stated that the agency should be permitted to obtain copies only to 
support a regulatory action and only after FDA has obtained a subpoena. 
Several other comments suggested that FDA be permitted to copy only 
those records that relate to a CL failure.
    Several comments requested that FDA provide safeguards to control 
potentially abusive regulatory practices by establishing rules to be 
followed when copying records. The comments stated that the rules 
should accomplish the following: Identify investigators authorized to 
copy records, limit copying to records pertaining directly to CCP's, 
require prior written authorization for copying from the investigator's 
supervisor, require that the authorization identify the specific 
records to be copied and the reason that they are needed, require that 
a responsible company executive receive each request before any copying 
is permitted, and permit the company to question the purpose for the 
request before records are copied.
    Comments from several consumer advocacy groups, on the other hand, 
supported the agency's need to copy records.
    There are two primary reasons for the agency to copy HACCP plans 
and records: (1) To facilitate expert review of such issues as the 
identification of appropriate hazards and CL's in HACCP plans and the 
evaluation of the adequacy of corrective actions taken in response to 
CL failures; and (2) to document suspected inadequacies of the HACCP 
plan or the firm's implementation of the plan for possible regulatory 
followup.
    Limiting the copying of records to those situations in which 
regulatory action is contemplated or in which a subpoena could be 
obtained would serve neither the needs of the industry nor the agency. 
Resolution of differences in food safety control strategies through 
scientific review and dialog, where possible, is superior to reliance 
solely upon the legal system for such resolution. Similarly, limiting 
the copying of records to instances involving CL deviations would 
inappropriately restrict the agency's ability to evaluate potential 
problems in the identification of CCP's, the establishment of CL's, and 
other scientific issues, which, in some cases, may be beyond the 
expertise of agency investigators.
    Industry comments have expressed considerable concern, as discussed 
in the ``Compliance'' section of this preamble, that there will be no 
mechanism for dialog with the agency if a firm disagrees with an 
investigator's findings with regard to the sufficiency of HACCP plans 
and records. The agency is strongly committed to dialog whenever 
possible. Provision of a means by which senior reviewers at agency 
headquarters will have access to HACCP plans and records will 
facilitate that process.
    FDA has concluded that the restrictions on copying of records 
suggested by the comments would significantly interfere with that 
access. It would be highly inefficient for FDA to identify a special 
class of investigators that are permitted to copy HACCP records and 
plans. FDA investigators are responsible for conducting inspections and 
investigations to enforce a wide array of regulations, and FDA field 
managers need the flexibility to assign work in an efficient and 
effective manner. Copying, like record access, is limited to the 
records specified in Sec. 123.9(c). It would be highly impractical for 
supervisory preapproval to be accorded to an investigator for the 
copying of specific records. Until an investigator has evaluated a 
HACCP plan and validated the operations of the plant, it is not likely 
that the investigator will know with any certainty what HACCP records 
are appropriate for review. Additionally, inspections are often done in 
remote locations and under highly flexible itineraries that preclude 
close contact between the investigator and particular supervisor. 
Certainly, FDA investigators will make every effort to obtain HACCP 
plans and records from responsible individuals of the firm and will, if 
necessary, explain the relevance of the requested records to the 
recordkeeping requirements of these regulations.
    The agency is unconvinced of the need to modify Sec. 123.9(c) in 
response to the aforementioned comments, except that reference to 
consumer complaints in this section has been eliminated as discussed in 
the ``Consumer Complaints'' section of this preamble.
    88. Several comments questioned the phrase ``duly authorized 
officers and employees'' used in this section. Some felt that it 
referred, at least in part, to employees of the firm, and others felt 
that it excluded officials of State regulatory agencies that may adopt 
these regulations by reference.
    The intent of the proposed regulations was to grant records access 
to regulatory agency officers and employees, not officers or employees 
of a firm. The language was intended to be flexible enough to cover 
State officials if their agency adopted the regulations by reference. 
FDA has changed the wording of the regulations to address these 
concerns.
    The modified paragraph in Sec. 123.9(c) reads:

    (c) Official review. All records required by this part and all 
plans and procedures required by this part shall be available for 
official review and copying at reasonable times.

J. Training

    A large number of comments addressed the proposed training 
requirements. FDA proposed to require that each processor and importer 
employ at least one individual who has successfully completed a 
training course that has been approved by FDA on the application of 
HACCP to fish and fishery products processing. FDA also proposed that 
the trained person or persons be responsible for, at a minimum, 
developing and modifying the HACCP plan, evaluating the adequacy of 
corrective actions taken in response to CL deviations, and reviewing 
monitoring records before shipment.
    In the preamble to the proposed regulations, FDA specifically 
requested comment on: (1) Whether the need for training could be 
satisfied by different gradations of training (e.g., based on 
complexity or size of operation or on the degree of risk posed by the 
products being produced); (2) whether other training formats, such as 
video tapes, might be effective, at least under some circumstances 
(e.g., a small business whose processing involved few hazards); (3) 
whether, assuming the regulations are adopted by FDA, training in HACCP 
received before they are effective should be ``grandfathered'' as 
fulfilling the training requirement; and (4) whether some or all of the 
training requirements should be deleted or modified as a means of 
reducing the burden on the industry.
1. The Need for Mandatory Training
    89. Most of the comments that addressed the question of whether 
there should be a mandatory training requirement expressed support for 
it. A significant portion of these comments acknowledged the need for 
at least one 

[[Page 65141]]
trained individual at each processing facility. Those that provided 
reasons for their support contended that properly trained personnel are 
essential to the development and effectiveness of HACCP controls, and 
that training is necessary to ensure consistency of approach.
    Those few comments that expressed reservations about the overall 
HACCP training requirement generally acknowledged the need for a 
trained individual in the plant but opposed a compulsory training 
program. Two comments, from State governments, expressed concerns about 
the financial burden of training on small businesses and questioned the 
need for making such a provision mandatory.
    The overwhelming support in the comments for HACCP training is 
indicative of the nearly universal view that training is essential to 
the effective implementation of a HACCP system. As stated in the 
preamble to the proposed regulations, this view is shared by the NAS 
based on the success of the training requirement in FDA's HACCP-based 
regulations for low-acid canned foods at part 113 (Ref. 54). The 
primary concern expressed about mandatory training is the cost.
    The agency is convinced that its efforts with the Alliance will 
facilitate the development and implementation of a low cost training 
program. As mentioned above, the Alliance is a cooperative effort 
between Federal and State food regulatory agencies, academia, and the 
fish and fishery products industry to provide support to the industry 
in meeting its needs relative to HACCP training, technical assistance, 
and research. Presently, the Alliance Steering Committee is comprised 
of representatives of FDA, the U.S. Department of Agriculture (USDA), 
NMFS, AFDO and its six regional affiliates, the Sea Grant Colleges, the 
ISSC, the National Fisheries Institute, and the National Food 
Processors Association (NFPA).
    The goals of the Alliance are to develop: a HACCP training course 
that will meet the requirements of these regulations, a mechanism for 
delivering the training to the fish and fishery products industry, a 
compendium of established methods for controlling hazards in the fish 
and fishery products industry, and a mechanism for coordinating the 
research efforts of the participating agencies to facilitate the 
development of improved methods of hazard identification and control.
    The training course materials are in an advanced stage of 
development and are expected to be publicly available shortly after the 
publication of these regulations. The AFDO regional affiliates have 
agreed to work within their regions to identify regulatory and industry 
training needs and qualified trainers who are interested in 
participating in the Alliance-sponsored training. They have also agreed 
to serve as the course coordinators for the Alliance-sponsored 
training, which will be conducted on a cost-recovery basis.
    The Alliance is developing a 3-day course, divided about equally 
among: (1) The fundamentals of HACCP, based on the recommendations of 
the NACMCF; (2) the requirements of these regulations and the 
recommendations of the Guide; and (3) a practical exercise in HACCP 
plan development.
    FDA is sensitive to the concerns expressed about the cost of 
training but is optimistic that training will not be unnecessarily 
burdensome on small business, either in actual out- of-pocket expenses 
or in lost productivity. As was previously mentioned, FDA is working 
with the Alliance to produce a low cost, 3-day HACCP-training course 
for the seafood industry, that is intended to meet the requirements of 
these regulations. Current plans are for the course to be offered 
through a variety of public institutions, including Sea Grant colleges. 
As indicated earlier, in this setting the course is expected to be 
offered on a cost recovery basis. It is likely that the course will 
also be offered by private institutions, using their own fee structure.
    The other cost associated with the training requirement is the lost 
productivity for the duration of the course. FDA is convinced that, 
with the flexibility in course structure, described elsewhere in this 
section, training can be taken at times when it would least affect the 
operations of the firm (e.g., during an off-season, at night). 
Moreover, FDA is convinced by the comments that, as a general rule, the 
benefits of training will significantly outweigh the burden. The agency 
has concluded that with certain modifications from the proposal as 
described below, training should remain a feature of these regulations.
    The agency has made one modification in response to requests that 
it modify the training requirement to reduce financial burden, 
especially on smaller processors. FDA acknowledges that a short course 
in HACCP has its limitations. For example, a 3-day course might not 
have anything important to offer to an individual who has significant 
job experience working with or for an individual who is well-versed in 
HACCP. In such a situation, if the processor loses the trained 
individual, it should be able to replace him or her with the individual 
who has, in effect, apprenticed with the trained individual without 
having to send the apprentice to a course in HACCP training, assuming, 
of course, that the apprenticeship has imparted a level of knowledge at 
least equivalent to that that could be provided by the training. The 
agency has modified the regulations to provide for this kind of 
situation by permitting adequate job experience to qualify and 
individual to perform the functions of the trained individual.
    Note that all references in this preamble to a trained individual 
mean an individual who meets the requirements of Sec. 123.10 through 
either completion of a course or job experience that provides an 
equivalent level of knowledge.
2. Who Should Provide Training?
    90. A significant number of comments identified organizations or 
individuals that they considered to be qualified to conduct or develop 
HACCP-training courses. The majority of the comments, which included 
remarks from processors, trade associations, and State governments, 
suggested that FDA should either conduct such training or at least 
approve the relevant course material. A few of the comments that 
recommended that FDA conduct the courses also recommended that FDA 
provide the courses at no cost or financially support the training. The 
comments that endorsed FDA approved courses asserted that this approach 
would result in a standardized, comprehensive training program that 
emphasizes the minimum acceptable HACCP requirements.
    Other comments recommended that training programs could be 
conducted by NFPA or other trade associations, ISSC, Sea Grant colleges 
and other academic institutions, consultants, and State and local 
regulatory agencies. The comments acknowledged the cost savings that 
could be realized with trade association- provided training and through 
the HACCP training experience already possessed by the NFPA. One 
comment suggested that allowing many training programs would offer 
hundreds of professionals the opportunity to contribute to the 
development of HACCP. A few comments suggested that FDA publish a 
listing of approved training courses.
    A comment from the ISSC cautioned that organization does not 
support the shifting of public health training in the area of molluscan 
shellfish away from itself. The comment further stated that the 
organization would work cooperatively with the Alliance in the 
development of a HACCP-training 

[[Page 65142]]
course, which it suggested should be Federally subsidized and ISSC 
endorsed.
    A few comments suggested that the Alliance be permitted to develop 
the standard for HACCP training, and that the results be shared with 
all prospective trainers. A few additional comments urged that HACCP 
training be based on the recommendations of NACMCF, because such 
efforts would result in a training program that was well defined.
    FDA generally agrees with these comments. The agency does not 
intend to run HACCP-training courses for the industry. Rather, FDA 
must, of necessity, focus its HACCP training on government 
investigators. The agency anticipates that industry training will be 
conducted privately and through academia. This division of labor is 
based on the model that has worked well for the training requirement 
for low-acid canned foods.
    FDA agrees, moreover, that there should be widespread opportunity 
for conducting HACCP training. It is not the agency's intent to specify 
or limit the field of qualified trainers.
    The training course that is under development by the Alliance is 
based on the recommendations of the NACMCF. After reviewing the final 
draft of the Alliance training materials, FDA intends to publish a 
notice of availability of the documents in the Federal Register. It is 
the agency's intent to utilize the Alliance materials as the standard 
against which other course materials may be judged.
    The agency strongly encourages trainers to evaluate their courses, 
past, present, and future, against the Alliance materials when they 
become available and to modify or adapt curricula, where necessary, to 
ensure that they are consistent with, and provide at least an 
equivalent level of instruction to, the Alliance course. Where 
previously conducted training fails to meet this standard, it may 
suffice to provide supplemental materials or instruction so that the 
cumulative training is at least equivalent to the Alliance course. FDA 
also encourages the fish and fishery products industry to confirm with 
past or prospective trainers that a particular course is equivalent to 
and consistent with the Alliance materials. The agency has no plans to 
publish a list of ``approved'' courses other than the Alliance course 
materials.
    Finally, it should be noted that FDA resources will not be 
sufficient to fund the training of all appropriate regulators (i.e., 
State or local regulators). The agency is confident, however, that 
Alliance training will provide a low cost opportunity for high quality 
HACCP training for State or local regulators as well as for processors.
    Because FDA will not be approving in advance specific courses other 
than the Alliance curriculum, and in response to comments, the final 
regulations have been modified at Sec. 123.10 to require that training 
courses be ``at least equivalent to the standardized curriculum 
recognized as adequate by the U.S. Food and Drug Administration.'' FDA 
had proposed to require that training courses be ``approved by the Food 
and Drug Administration.''
3. Should Training Be ``Grandfathered?''
    91. A large number of comments addressed the question of whether 
training in HACCP received before the effective date of these 
regulations should be ``grandfathered'' as fulfilling the training 
requirement. All of these comments supported the grandfathering of such 
training. Many of the these comments recommended specific training 
courses that FDA should grandfather. Approximately half of these 
comments requested that those trained under NMFS' HACCP training 
program be grandfathered. Those that provided reasons referenced the 
large number that had been trained at the time of the writing of the 
comment (1,310 domestically and 394 overseas) and stressed that NMFS' 
training was more comprehensive than that which would be necessary 
under FDA's HACCP approach, especially because the NMFS program covers 
nonsafety hazards in addition to safety hazards.
    Other comments supported grandfathering HACCP courses conducted by 
NFPA, Sea Grant colleges, State regulatory agencies and those 
organizations sanctioned by such agencies to provide HACCP training, 
and Pacific Fisheries Services. One comment suggested that graduation 
from a Better Process Control School, as required by parts 113 and 114 
for processors of acidified and low-acid canned foods, should be 
considered to meet the requirements of these regulations. Another 
comment urged that any training program based on the HACCP principles 
recommended by the NACMCF should be grandfathered.
    One comment suggested that, in order to grandfather courses, FDA 
would need to develop a system to determine the effectiveness of the 
training that has been conducted. The comment recommended the use of 
testing or curriculum review as evaluation tools. The comment further 
encouraged the development of a formal approval process for previously 
conducted training.
    FDA has concluded that it is not in a position to grandfather HACCP 
training received before the issuance of these regulations. Blanket 
grandfathering would pose the risk of sanctioning training that does 
not fully prepare processors for operating under these regulations, and 
case-by-case grandfathering would be unduly demanding on agency 
resources.
    On the other hand, the agency will not presume that HACCP training 
received prior to the issuance of these regulations will have to be 
repeated. FDA will challenge the adequacy of prior training only when a 
processor's performance demonstrates a lack of understanding of HACCP 
principles.
    Nonetheless, FDA encourages processors to update any prior training 
to ensure that they have a thorough understanding of the requirements 
of these regulations. It may well be that many traditional HACCP 
courses will need only minimal supplementation to accommodate them to 
the provisions of these regulations, and that there will be no need for 
a processor to repeat an entire course. As mentioned above, partial, 
supplemental courses may be offered, or reading materials developed by 
the course offerer and sent to the processor may suffice. There are 
numerous possibilities.
    FDA is also not in a position to make determinations in advance 
about the acceptability of courses that will be offered after the 
issuance of these regulations. FDA agrees with the comment that, in 
order to do so, the agency would have to develop a system for course 
evaluation. Review of course materials, auditing of course 
presentations, testing, and other evaluation tools that FDA might have 
to employ are labor intensive and are not the most efficient use of 
agency resources. Rather, the adequacy of courses will have to be 
evaluated by FDA on a case-by-case basis, when inspectional or other 
evidence causes the agency to question whether the course meets the 
requirements of Sec. 123.10.
    The ultimate determination of the success of training is whether 
processors are operating effective HACCP systems. In the initial stages 
of the program, at least, FDA's primary focus will have to be on 
whether HACCP plans are adequate, and the systems are being effectively 
implemented. FDA's interest in the adequacy of training will increase 
when plans and systems fail to demonstrate an adequate understanding of 
HACCP and its application to seafood.
    Nonetheless, FDA can state that the Better Processing School 
curriculum for 

[[Page 65143]]
acidified and low-acid canned foods will not be adequate to meet the 
training requirement of these regulations. The Better Processing School 
was developed to instruct acidified and low-acid canned food processors 
in how to safely process such products to control the hazard of the 
development of botulinal toxin in accordance with the requirements of 
parts 113 and 114. The course does not provide instruction in the 
principles of HACCP or address other hazards (e.g., histamine 
development) to which these products might also be exposed.
4. Course Curriculum
    92. A few comments suggested that the training be divided into a 
basic HACCP core and interchangeable segments based on the portions of 
the industry of interest to the students (e.g., vessels, cooked, ready-
to-eat fishery products, molluscan shellfish, and smoked fish).
    As mentioned previously, the Alliance course includes three 
segments: A basic HACCP core, the requirements of these regulations, 
and the development of a HACCP plan. The first two segments are 
applicable to the entire fish and fishery products industry. The 
Alliance has acknowledged the need to develop industry-specific 
features for the third segment. The agency is in agreement with the 
Alliance and with the comment in this regard and would encourage the 
development of such directed courses.
    93. In response to FDA's invitation to comment on the advisability 
of alternate training formats, several comments expressed support for 
the use of video tapes by small processors of low-risk products. A few 
additional comments did not specifically address video taped training 
but stated that, while it is desirable to have uniform training, 
ultimately training should involve ``whatever it takes.'' One comment 
suggested that home study courses and education via television might be 
acceptable alternatives to more formal, for-fee training mechanisms. A 
few comments opposed courses that consist exclusively of video tapes, 
based on concern for a potential limitation in the level of 
understanding that could result from this type of noninteractive 
training method.
    FDA agrees with the comments that expressed concern with teaching 
methods, such as video tapes, that lack instructor/student interaction. 
However, in the interest of providing flexibility in meeting the 
training requirement of these regulations, the agency has concluded 
that any teaching format is acceptable so long as it provides a level 
of understanding at least equivalent to that provided by the Alliance 
training program. FDA is aware that video tape training is widely used 
for a variety of purposes. The agency cannot conclude that video-based 
HACCP training will not accomplish the purposes of the training 
requirement. For remote site processors, video-based training may be 
the only practical method available.
    It is unlikely, however, that two or three 2-hour video tapes, as 
one comment suggested, will provide an equivalent level of training to 
the 3-day Alliance course under development. On the other hand, a 
series of video presentations, perhaps in conjunction with a 1-day 
workshop, may be adequate.
    94. A few comments addressed the length of the training course. One 
suggested that 3 days would be overly burdensome on small businesses 
because of the loss of manpower during the course. Another suggested 
that 3 days was not long enough to furnish the needed information. One 
comment suggested that the length of training should be based on the 
level of experience of the student and the level of complexity of the 
processing operation.
    FDA has concluded, based, in part, on its participation in the 
Alliance, that the 3-day Alliance curriculum is the minimum necessary 
to develop an adequate understanding of HACCP principles and essentials 
of HACCP plan development. If the curriculum were reduced any further, 
processors would risk having to take more time later to implement their 
HACCP systems as a result of trial and error, and as a result, the 
quality of their HACCP programs would be jeopardized.
    Nonetheless, FDA is not specifying in the regulations how long the 
course must take, only that it be equivalent in terms of curriculum to 
the standardized curriculum recognized as adequate by the agency. If 
true equivalency can be achieved in less time, FDA would have no 
objection. Moreover, depending upon the circumstances, FDA would have 
no objection to training that can be imparted in segments at convenient 
times so as to cause only a minimal disruption to the work schedule.
    Section 123.10, therefore, states that the training must be ``at 
least equivalent to the standardized curriculum recognized as adequate 
by the U.S. Food and Drug Administration.'' This provision will also 
accommodate the use of food processing experts, who have received 
training in HACCP that is far more extensive than that planned by the 
Alliance. FDA recognizes that it would be inappropriate to limit the 
universe of experts to those who have taken a course based on the 
Alliance 3-day curriculum. The issue of the use of consultants and 
other experts will be further discussed later in this section.
5. Do Importers Need Training?
    95. A few comments suggested that FDA should provide separate or 
specialized training aids for importers. Two of these comments noted 
that importers have not, historically, been involved with the 
processing of seafood commodities. The comments requested that FDA work 
with trade associations that represent importers in setting up 
workshops, developing specialized training materials for importers, and 
recognizing training provided by foreign institutions.
    FDA has reassessed the need for training to accomplish the HACCP 
functions assigned to importers, especially in light of changes in the 
imports provisions of these final regulations. These changes are fully 
discussed in the ``Imports'' section of this preamble. In summary, 
importers are now required to conduct verification activities but are 
no longer required to have full HACCP plans of their own unless they 
also meet the definition of a ``processor.'' FDA has concluded that 
HACCP training, while desirable, is not essential to the preparation of 
importers' verification procedures, as specified at Sec. 123.12(a)(2). 
For this reason, training is not required for importers, and all 
reference to required training for importer functions has been dropped 
from Sec. 123.10.
    Nonetheless, the agency is aware that importers may be unfamiliar 
with the technical aspects of fish and fishery product processing and 
HACCP control procedures. Knowledge about these matters would be 
helpful for purposes of verification. To meet this need, FDA plans to 
include in the Guide specific materials relating to importers' 
verification procedures. In addition, as has traditionally been the 
case, the agency intends to continue to interact with, and provide 
information to, the import industry through trade associations and 
other forums, within the limits of budget constraints. Moreover, 
importers may want to participate in the training courses that are 
offered by the Alliance.
    Finally, the agency agrees with the comment that suggested that 
training overseas should be conducted by foreign institutions 
recognized for their expertise in seafood processing and HACCP control. 
This issue will be further discussed in the ``Imports'' section of this 
preamble. 

[[Page 65144]]

6. Testing and Retraining
    96. Several comments supported the mandatory use of testing to 
assess whether an individual has successfully completed HACCP training. 
Two comments further recommended that the agency could consider the 
training requirement to be met if a person successfully passes an 
examination.
    The agency is not opposed to testing at the end of a course but 
prefers not to mandate that courses include tests. Trainers will be 
free to include or not include testing as part of their training 
efforts. The issue of student evaluation is one that is still being 
debated in the Alliance relative to Alliance-sponsored training 
courses.
    However, testing alone does not provide the kind of exposure to the 
concepts of HACCP that is necessary to result in company understanding 
and commitment. The function of training is to prepare industry to meet 
the requirements of the regulations, not to test competency. The true 
test will be whether processors are able to implement their HACCP 
systems. Processors will be judged as plans are reviewed, and plant 
operations are evaluated, during inspections.
    97. A few comments recommended mandatory retraining or continuing 
education. The comments stated that as new information about the 
science of fish and fishery products hazards and the technology of 
their control becomes available, there will need to be some method for 
introducing this information to previously trained individuals. One 
comment, on the other hand, urged that training be limited to a single 
event and not be subject to periodic renewal.
    The primary purpose of the training is to teach the fundamentals of 
HACCP. These are unlikely to change over time. A comprehensive 
discussion of seafood hazards and controls is far too extensive for 
inclusion in a 3-day training session. The agency has concluded that 
information about the technology that is available to control hazards 
should be made available to the industry through the Guide, the 
Alliance Compendium of Established Processes, and other modes of 
technical assistance. FDA supports the idea of continuing education and 
will encourage it, but the agency is not prepared to mandate it in 
these final regulations.
    98. A comment suggested that the regulations mandate remedial or 
enhanced training for a first time violator whose infractions have 
resulted from a misunderstanding of HACCP principles.
    Whenever an infraction occurs, the nature of the remedy that is 
warranted depends on factors such as the public health significance of 
the infraction. The agency has administrative warnings and, when 
necessary, a range of regulatory actions available to it. (See the 
``Compliance'' section of this preamble for a more thorough discussion 
of compliance philosophy under HACCP and available remedies.) 
Ultimately, however, it will be the processor who will be responsible 
for correcting the deficiencies in its HACCP system. Part of that 
responsibility will be determining the most appropriate method of 
resolving any failure to fully understand HACCP principles, whether 
through remedial training, hiring a consultant, or taking some other 
step. So long as an appropriate outcome can be obtained, FDA would 
prefer not to mandate any particular method of remediation in these 
regulations. Processors certainly may wish to consider additional 
education as an option, however.
7. Gradations of Training
    99. Several comments addressed whether the HACCP training 
requirement could be satisfied by different gradations of training, 
depending on the complexity or size of the operation or on the degree 
of risks posed by the product being produced. The majority of these 
comments supported the concept of variable levels of HACCP training. 
Most did not provide the basis of their support. Those that did 
suggested that small or large scale processing of low-risk products 
would not likely require any special training, and that small scale 
processing of even high-risk products would allow for individual 
examination of every fish, an option that is not possible in large 
scale processing. One comment further suggested the use of variances to 
exclude certain industry members from the training requirement, rather 
than providing a blanket exemption for a segment of the industry.
    A minority of the comments on this subject opposed any variations 
in the level of training. Several of these comments stated that the 
necessity for HACCP education and training does not vary based on the 
size of a company, and that a standard training curriculum should be 
developed for all companies, regardless of their size. Some of these 
comments stated that smaller processing operations may be inherently 
less safe, and that, cumulatively, they represent a large amount of the 
seafood making its way to the consumer. One comment stated that smaller 
processing operations may actually have a greater need for employee 
training, compared to some larger processing operations that may 
already have trained staff.
    The agency agrees with the comments that suggested that the need 
for HACCP training does not vary solely by the size of the processor. 
An understanding of the principles of HACCP is essential for the 
successful implementation of a HACCP program, regardless of 
establishment size. The agency agrees with the assertion that, in many 
cases, the training needs of small businesses may, in fact, be greater 
than those of large firms, because they frequently lack the trained 
quality control and research and development staffs that are common in 
large firms. Moreover, small businesses comprise a significant portion 
of certain high-risk segments of the fish and fishery products 
industry, such as processors of molluscan shellfish and cooked, ready-
to-eat products. Training will be critical to ensure the success of 
HACCP in these segments.
    Although the agency expects that the complexity of HACCP plans will 
vary with the number and type of hazards associated with a processing 
operation, an understanding of the basic principles of HACCP, and how 
to apply those principles to the processor's operations, will remain 
essential. The curriculum under development by the Alliance is designed 
to provide a very basic grounding in these matters. As stated earlier, 
the Alliance has acknowledged a need to tailor part of the course so 
that it can be directed toward specific industry segments. This 
approach may be the best way to provide flexibility in the program, so 
that training can match the degree of complexity and risk that is 
encountered by the processor. FDA will continue to encourage the 
development of industry-specific training features.
    The agency is not persuaded that the ability of a processor to 
individually examine all fish because of the small scale of operations 
will reduce the processor's need to understand the hazards associated 
with seafood and the specifics of a systematic approach for controlling 
them. FDA has long taken the position that observing each fish on an 
assembly line is an inappropriate way to ensure seafood safety (Ref. 
208, p. 4146). While matters relating to the quality of the fish can be 
observed in this manner, safety matters often cannot.
8. Duties of the Trained Individual
    100. Several comments suggested that a firm be permitted to hire a 
consultant, or an outside expert, who is not an employee of the firm, 
to perform the functions required of a trained individual. Two trade 
associations 

[[Page 65145]]
argued that contracting for the development of a HACCP plan by a 
professional consultant could be more efficient and cost effective, 
especially for many small companies. Related comments pointed out that 
some of the proposed functions of the trained individual either did not 
require a person to be onsite continually (e.g., plan development) or 
required expertise that could not realistically be obtained in a 3-day 
course (e.g., making decisions about whether product that has been 
subject to a deviation is safe to release into commerce).
    While the agency considers training employees to be preferable to 
hiring outside consultants in terms of fostering the appropriate 
corporate culture and commitment to HACCP, FDA recognizes the 
importance of ensuring the flexibility that firms, especially small 
businesses, may need to comply with the regulations in a cost-effective 
manner. The agency also accepts that for some processors, the expertise 
that may be needed from time to time could best be provided by an 
expert consultant. Consequently, the agency is modifying Sec. 123.10 to 
read as follows: ``* * * the following functions shall be performed by 
an individual who has successfully completed a course of instruction * 
* *.'' The requirement that processors employ a trained individual has 
been eliminated. Moreover, FDA has modified Sec. 123.10(c) to state, 
``The trained individual need not be an employee of the processor.''
    101. A number of comments asked whether the regulations would 
require a separate trained individual for each processing location of 
each company or just one per company.
     FDA intends that the functions enumerated in Sec. 123.10 be 
performed by a trained individual. The number of employees a processor 
must train, or the consultants that must be hired, in order to ensure 
that trained individuals perform these functions is left to the 
judgment of the processor. For some firms, one individual will be 
sufficient. Others will need to secure the services of more than one 
such individual, either as employees or as consultants. Whether these 
individuals are located at each facility, at a corporate headquarters, 
at a consulting firm, or at some combination of these arrangements is 
to be determined by each individual processor.
    102. A few comments were concerned about the logistics of the 
routine functions that the agency proposed must be performed by someone 
with HACCP training (i.e., record review and deviation handling). 
Specifically, they argued that the proposed requirements would actually 
require each firm to have more than one trained individual because of 
work weeks that routinely exceed 40 hours, vacations, illnesses, and 
employee turnover. The consequence, the comments suggested, would drive 
up the cost of training.
    FDA acknowledges that, for certain situations, these comments may 
be correct. However, the agency has made three changes in the final 
regulations to minimize this possibility. First, as stated above, a 
processor may hire trained consultants on an as-needed basis. Second, 
as discussed in the ``Verification'' section of the preamble, the 
regulations do not include the proposed requirement that a trained 
individual review monitoring records before the product to which the 
records relate is shipped. These final regulations require only a 
weekly review. As a result, the need to have a trained individual 
onsite every day has become substantially reduced. Third, as described 
below, FDA has decided not to require that the trained individual 
evaluate CL deviations and corrective actions. This modification 
reduces still further the need to have a trained individual onsite at 
all times. In addition, as described previously, the agency is allowing 
processors to employ individuals whose training has been obtained 
through on-the-job experience. Thus, for example, a processor that 
needs the services of two trained individuals could satisfy the 
requirements of these regulations by employing an individual who has 
been trained in an adequate course and a second individual who has 
apprenticed sufficiently with the first individual to have mastered the 
subject.
    As a related matter, the provision in the final regulations that 
provides for the development of corrective action plans (see the 
``Corrective Actions'' section of this preamble) could eliminate the 
need to bring an expert onto the scene in many instances in which 
corrective action is necessary. The processor may be able to follow the 
corrective action plan without having to rely on an expert or trained 
individual. This procedure could permit further savings.
    103. Some comments suggested that there should be different 
categories of trained individuals, with different responsibilities. 
These comments, from individuals, processors, and trade associations, 
asserted that a firm should have one HACCP trained person capable of 
conducting or overseeing the routine operation of the HACCP program, 
but that this individual should not necessarily be responsible for 
designing a firm's HACCP plan or making complex scientific evaluations.
    Another comment suggested that it was unrealistic to expect that a 
training program would provide the level of expertise necessary for a 
person to make a determination on whether a deviation may have rendered 
a product injurious to health or otherwise adulterated.
    FDA generally agrees with these comments. It was never the agency's 
intent to limit the processor's use of experts to employees whose 
training included the course prescribed by these regulations, 
especially in the areas of HACCP plan development and the evaluation of 
CL deviations and corrective actions (i.e., making evaluations about 
whether product that has been subject to a deviation is safe to ship). 
While FDA is convinced that a short course in HACCP principles is 
important to the success of the overall program, the agency also 
recognizes that such a course has its limitations.
    FDA has deleted the proposed requirement that the HACCP-trained 
individual be required to evaluate CL deviations and corrective actions 
to allow for the use of experts in other appropriate scientific 
disciplines that have not been trained in accordance with these 
regulations. For example, the agency does not expect that a processor 
will be able to determine the public health consequences of every 
possible deviation without the assistance of experts. The kind of 
expertise necessary would likely involve disciplines other than HACCP. 
Moreover, the agency agrees that it is unreasonable to expect that 
successful completion of a 3-day HACCP course alone would qualify an 
individual to make determinations about the safety of products involved 
in a CL failure. HACCP training in such a situation could only 
reasonably be expected to help ensure that appropriate corrective 
action measures are taken and recorded from a HACCP perspective. 
Consistent with this change, FDA has modified Sec. 123.7(c)(2) to state 
that a determination of acceptability for distribution into commerce of 
products that may have been affected by a deviation must be made by 
individuals with the expertise to make such a determination, and that 
such individuals need not be those who meet the requirements of 
Sec. 123.10.
    Nonetheless, FDA expects that, at a minimum, an individual trained 
in accordance with these regulations will perform the verification 
function of reviewing records of corrective actions to ensure that they 
are complete, and that an appropriate corrective action was taken 
(i.e., one that was predetermined in the HACCP plan, or 

[[Page 65146]]
one that was determined by a qualified expert to be sufficient to 
render the product safe). Section 123.10(c) requires that the trained 
individual perform certain record reviews associated with the 
verification principle of HACCP, including reviews of corrective action 
records (see Sec. 123.8(a)(3)(ii)).
    FDA has modified Sec. 123.10 from the proposal to clarify and to 
conform this section to other features of the regulations. A summary of 
these modifications follows.
    FDA has revised Sec. 123.10(a) to clarify that when a trained 
individual develops an HACCP plan for a processor, this effort may 
involve adapting a model or generic-type plan for use by that 
processor. FDA received a significant number of comments on the pros 
and cons of model or generic-type HACCP plans. This subject is 
addressed in various places in the preamble, most notably in the 
section entitled ``Other Issues.'' In summary, the development of model 
plans can be of great benefit to the industry, especially small 
businesses, so long as the model plans are tailored by processors to 
meet their individual situations and are not simply copied verbatim. 
The agency is convinced that, in most cases, generic or model plans 
will need to be modified to some extent to fully accommodate the 
specifics of the processor's operations.
    Section 123.10(b) provides, in part, that the trained individual is 
responsible for reassessing and modifying the HACCP plan in accordance 
with corrective action procedures specified in Sec. 123.7(c)(5). This 
requirement is not new. It should be noted, however, that, unlike the 
proposal, the final rule requires the trained individual to perform 
these functions only when the processor does not have a predetermined 
corrective action plan that addresses the specific deviation. As 
explained in the ``Corrective Action'' section of this preamble, a 
review and reassessment of the plan should not ordinarily be necessary 
when a corrective action was anticipated, as reflected by the existence 
of a predetermined corrective action plan.
    Section 123.10(b) also requires that a trained individual perform 
the annual reassessment of the processor's HACCP plan as required by 
Sec. 123.8(a)(1). A new feature of the regulations, this requirement 
parallels the mandate that each processor engage in verification 
activities (see Sec. 123.8(a)). It is a logical outgrowth of the 
principle, central to both the proposal and this final rule, that plan 
development be performed by individuals who possess the knowledge and 
skills that are obtained through training in HACCP.
    Section 123.10(c) requires that a trained individual perform 
certain record reviews as enumerated in Sec. 123.8(a)(3). This 
requirement is not new except for the review of records of end-product 
testing, if any. End-product testing was not addressed in the proposal 
but, as explained in the ``Verification'' section of the preamble, has 
been added as an optional verification activity. The review of end-
product testing records by a trained individual is a logical outgrowth 
of the principle that was reflected in the proposal in Sec. 123.8(b) 
that a trained individual review all HACCP records for completeness and 
consistency with written HACCP procedures.
    Finally, it should be noted that the requirement in the proposed 
regulations that trained individuals perform certain functions for 
importers has been dropped entirely. This deletion is consistent with 
the changes that FDA is making in the provisions that applied to 
importers in this final rule. These revisions are described elsewhere 
in this preamble. In summary, importers are given alternatives to 
having HACCP plans and are not required to take the kinds of actions 
for which a trained individual has been determined to be essential.

 K. Sanitation

1. Background
    FDA proposed to require that processors conduct sanitation 
inspections at specified frequencies to ensure that each of up to 18 
specified sanitation conditions are maintained in the processing 
facility where they are relevant to the type of processing being 
performed. The agency also proposed to require that processors maintain 
sanitation control records, and that they take and document corrective 
actions when the specified conditions were not met. In addition, FDA 
encouraged, but did not propose to require, processors to make use of 
written SSOP's to ensure that the necessary sanitation measures were 
implemented.
    FDA tentatively concluded that sanitation controls are necessary in 
these regulations because: (1) Sanitation practices directly affect the 
microbiological safety of seafood products that are not further cooked 
by the consumer, such as cooked, ready-to-eat products, smoked 
products, raw molluscan shellfish, and other fish that are consumed 
raw; (2) sanitation practices are relevant to the microbiological 
safety of seafood products even where these products are to be cooked 
by the consumer; (3) sanitation practices directly affect the chemical 
and physical safety of seafood products; (4) nearly half the consumer 
complaints relating to seafood that FDA receives in a typical year are 
related to plant or food hygiene; and (5) inspections conducted by FDA 
and NMFS demonstrate that a significant portion of seafood processors 
operate under poor sanitation conditions.
    The MSSP, conducted by NMFS, concluded that sanitation controls 
could be included in HACCP plans without overloading HACCP. Moreover, 
the FDA/NMFS HACCP-based seafood pilot program included sanitation 
CCP's. Nonetheless, FDA tentatively concluded that monitoring and 
recordkeeping for the 18 specific sanitation conditions specified in 
the proposal should be permitted to occur outside of a processor's 
HACCP plan so as not to overload it. Because these sanitation controls 
relate to an entire facility, not just to a limited number of CCP's, 
FDA felt that they would not all fit well within an HACCP plan.
    FDA took this prescriptive approach to sanitation to assist 
processors so that they would not have to figure out how, or whether, 
to include sanitation in their HACCP plans and to help them resolve the 
sanitation problems that the seafood industry has chronically 
experienced. By requiring a specific, daily sanitation regime that 
incorporates HACCP-type features (i.e., monitoring and recordkeeping) 
to help the processor track sanitation in its plant, FDA hoped to 
foster a culture of, and commitment to, good sanitation practices that 
has been lacking in a significant portion of the industry.
2. Should the Regulations Deal With Sanitation?
    FDA requested comment on whether sanitation control measures should 
be addressed by processors in accordance with the proposed approach, or 
whether the regulations should require that processors address 
sanitation in their HACCP plans.
    More than 250 comments addressed various aspects of the proposed 
sanitation requirements, more comments than addressed any other aspect 
of the proposed regulations. Approximately 100 of these comments 
addressed FDA's questions about the approach to sanitation control in 
these regulations. The remaining comments focused on specific 
sanitation provisions.
    104. Approximately 10 percent of those that responded to the 
requests supported the proposed approach. These comments were from 
processors, 

[[Page 65147]]
consumer advocacy groups, State, Federal, and foreign government 
agencies, and a trade association. Approximately five percent of the 
comments, from processors, trade associations, and State government 
agencies, objected to the inclusion of any explicit sanitation controls 
in these regulations. It is not clear, however, whether the latter 
comments were objecting to sanitation controls as part of HACCP where 
appropriate for safety or to any sanitation approach beyond HACCP. The 
remaining approximately 85 percent of the comments, principally from 
processors, trade associations, and State and Federal government 
agencies, generally acknowledged the need for these regulations to 
address sanitation in seafood processing plants but objected to one or 
more of the specifics of the proposal.
    Those that supported the proposed approach argued that sanitation 
controls are a critical component of the regulations because: (1) 
Addressing the insanitary practices in the seafood processing industry 
is essential to improved consumer confidence; (2) effective sanitation 
controls are a prerequisite to the proper functioning of a HACCP 
system; and (3) sanitation controls are critical to the management of 
microbiological hazards in both products that will not be cooked by the 
consumer and those that will be cooked, the latter because of the 
potential for cross-contamination in the kitchen. The comments 
suggested that a prescriptive approach to sanitation is warranted 
because the FDA and NMFS inspection results cited in the preamble to 
the proposal documented the failure of a significant percentage of the 
industry to control key sanitation conditions and practices. Moreover, 
these comments continued, the enumeration of specific controls relieves 
the industry of the burden of identifying the most significant areas of 
concern.
    Several comments stated that sanitation requirements for seafood 
processors are necessary because guidelines do not have the force of 
regulation and therefore are more difficult to enforce. One comment 
stated that including sanitation requirements in these regulations 
would simplify compliance for seafood processors because the HACCP and 
sanitation requirements would be in one place. One comment stated that 
some processors would be more inclined to implement sanitation control 
measures if all processors were subject to the same mandatory 
requirements.
    Many of the comments that objected to the manner in which FDA 
proposed to treat sanitation acknowledged that effective sanitation 
controls are essential to the proper functioning of a HACCP system. As 
with comments that supported the proposed approach, a few of these 
comments identified sanitation as a prerequisite to HACCP.
    The comments that objected to the inclusion of any sanitation 
requirements in these regulations provided reasons that the agency 
believes are more relevant to the question of how these regulations 
should address sanitation than to whether they should address the 
issue. For this reason, the arguments presented in these comments are 
addressed later in this section.
    FDA accepts the view expressed by the overwhelming majority of 
comments (i.e., those that advocated the proposed approach and those 
that advocated other sanitation control mechanisms) that sanitation is 
relevant to the goals of these regulations and should be addressed in 
them. The primary source of pathogenic microorganisms for most fish 
(i.e., wild-caught fish) is the processing plant environment (Ref. 3, 
p. 267). The control of sanitation in the plant is the most effective 
way to minimize pathogens, and, for products that are not given a final 
heat treatment after packaging, it is the only way to minimize them at 
that stage in the chain of distribution (Refs. 3, p. 10; 7, p. 27; 204; 
and 205). This situation is nearly the reverse of that for red meat and 
poultry, where pathogens are likely to have originated from the raw 
materials before they enter the plant (Refs. 36, p. 197; 209; and 210, 
p. 1).
    A significant body of opinion holds, moreover, that good sanitation 
is a necessary foundation for HACCP. This view was articulated in 
comments to this rulemaking and in the proposed rule to establish HACCP 
and other requirements for the beef and poultry industries issued by 
USDA (Ref. 211). USDA proposed both SOPs for sanitation as a 
prerequisite to a HACCP plan and sanitation as part of HACCP where 
critical for safety (Ref. 211, p. 6789).
    FDA concludes, therefore, that these regulations cannot fully 
address all matters relevant to safety, or significantly contribute to 
the restoration of consumer confidence in seafood without providing for 
major improvements in sanitation. Therefore, these regulations address 
sanitation.
3. Why Isn't Part 110 (21 CFR Part 110) Adequate To Deal With 
Sanitation Concerns?
    105. Some comments asserted that it would be adequate to rely on 
the existing CGMP's in part 110, which provide guidance of general 
applicability to all foods. A variation on that concern was the view 
that the sanitation standards in part 110 need not be codified in these 
regulations because they are adequately expressed in that part. The 
NACMCF pointed out that the CGMP's have proven adequate for a wide 
variety of processed foods under FDA's jurisdiction. Some comments 
stated that part 110 should be made mandatory for seafood and fully 
enforced.
    Good sanitation is already mandatory for all foods. Section 
402(a)(4) of the act deems food to be adulterated if processed under 
insanitary conditions. The CGMP's in part 110 articulate the kinds of 
conditions and practices that need to be followed in order to avoid 
producing an adulterated product under section 402(a)(4) of the act.
    Nevertheless, while FDA has been enforcing the sanitation standards 
contained in part 110 for many years, as indicated earlier, it has not 
succeeded in developing a culture throughout the seafood industry in 
which processors assume an operative role in controlling sanitation in 
their plants. The statistics relating to the incidence of insanitation 
cited in the preamble to the proposed regulations (Ref. 208 at 4161-
4162) clearly demonstrate that such a culture is not adequately in 
place. The following observation about culture in the preamble to 
USDA's proposed HACCP rules for beef and poultry is applicable here as 
well:

    * * * Identification of sanitation requirements has been viewed 
by some establishment owners and personnel as the inspector's 
responsibility. Such establishments often fail to take the 
initiative to find and remedy insanitary conditions, relying instead 
on the inspector to find deficiencies. (Ref. 211, p. 6788)

    Moreover, FDA points out that while the CGMP's state that 
sanitation controls should occur as frequently as necessary, they are 
silent with regard to monitoring by the processor to ensure for itself 
that sanitation controls are being followed.
    For these reasons, FDA concludes that part 110 alone has not proven 
to be adequate for the seafood industry. In order to ensure that firms 
take full responsibility for sanitation in their plants, which is 
strongly related to the production of safe and wholesome seafood, FDA 
has concluded that it is necessary to include sanitation requirements 
in these regulations.
4. Why Isn't the Proposed Approach Appropriate?
    106. Many comments that agreed that sanitation should be addressed 
in the regulations, as well as some that opposed addressing it, 
objected that the 

[[Page 65148]]
proposal was too prescriptive. These comments asserted that: (1) The 
proposed 18 sanitation controls are overly prescriptive and inflexible 
and are not appropriate for all processors; (2) the codification of 
prescriptive sanitation requirements as regulations limits the ability 
of processors to keep pace with advances in science and technology; (3) 
the proposed sanitation controls have the effect of establishing 
eighteen CCP's, which are not always appropriate; and (4) the proposed 
sanitation provisions duplicate or contradict existing State or NSSP 
requirements. FDA will respond to these criticisms.
    Many comments that argued that the 18 specific sanitation controls 
that FDA proposed were too prescriptive provided examples of how this 
approach could deny processors the flexibility necessary to develop and 
implement sanitation programs that are effective for the specific 
conditions in which they are to be used. Some of these examples are as 
follows:
    (1) A few comments challenged the proposed ``easily cleanable'' 
standard for equipment, suggesting that in some applications (e.g., at 
sea processing and old equipment) this standard may not be attainable 
and may not be necessary as long as the equipment is, in fact, cleaned;
    (2) A large number of comments challenged the proposed 4-hour 
equipment cleaning frequency, suggesting that it is unwarranted in some 
situations (e.g., refrigerated processing facilities) because it is 
inconsistent with actual microbiological growth rates. It is unduly 
burdensome in other situations (e.g., surimi processing facilities), 
according to the comments, because it would limit shifts to 4 hours, 
would interrupt production, and would require hours of equipment 
breakdown time;
    (3) A few comments challenged the proposed ``impermeable'' standard 
for gloves and outer garments that contact food or food contact 
surfaces, suggesting that in some instances it was impractical (e.g., 
filleting fish);
    (4) A significant number of comments challenged the proposed 4-hour 
hand sanitizer strength test frequency, suggesting that replacement of 
dips rather than checking concentration may be appropriate, as may be 
the use of automated hand washing and sanitizing systems; and,
    (5) A number of comments challenged the proposed requirement that 
hand washing and sanitizing stations be located in processing areas, 
suggesting that they need only be easily accessible.
    These comments have general merit and have persuaded the agency 
that a less prescriptive approach is appropriate to ensure that the 
regulations do not impose impractical, unduly burdensome, or 
excessively rigid requirements.
    107. Another concern with FDA's approach was that codifying 
specific sanitation control procedures would not enable processors to 
keep their sanitation programs updated with advances in science and 
technology. As an example, the NACMCF comment cited recent industry 
experience with other foods that has shown that the proposed 
requirement of midshift cleaning and sanitizing in packaging rooms for 
ready-to-eat foods, may with many current sanitation practices actually 
be counterproductive to the control of Listeria monocytogenes. The 
NACMCF advised that codification of a midshift cleaning requirement 
would have prevented these industries from modifying their cleaning 
procedures to adjust to the new information.
    FDA agrees that sanitation requirements should be sufficiently 
flexible to permit the incorporation of new information and better 
procedures.
    108. A number of the comments, including more than half of those 
that opposed any new form of sanitation controls, argued that the 
sanitation control approach proposed by FDA would effectively establish 
eighteen mandatory sanitation CCP's that may not always be appropriate.
    These comments may have been the result of a misunderstanding of 
the relationship between processor HACCP plans and the proposed 
sanitation controls. While the proposed controls involved monitoring 
and recordkeeping, they were not proposed as part of a processor's 
HACCP system. FDA did not intend to designate them as CCP's. FDA 
believes that the provisions of these final rules make clear that the 
necessary sanitary controls need not be considered to be CCP's.
    109. A large number of the comments that objected to the manner in 
which FDA proposed to handle sanitation argued that the proposed 
sanitation provisions are redundant with State and local regulations 
and, with respect to molluscan shellfish, with the NSSP.
    FDA acknowledges that the NSSP and most State seafood control 
programs include provisions, much like FDA's CGMP's, that are designed 
to control processing plant sanitation. These other provisions, like 
the CGMP's, serve as baseline standards for sanitation. However, the 
rates of noncompliance with existing CGMP standards, as detailed in the 
preamble to the proposed regulations (Ref. 208 at 4161-4162), 
demonstrate a need for a system in which processors are responsible for 
not only meeting these baseline standards but also routinely auditing 
their facilities and operations to ensure that they are meeting them. 
In this way, the sanitation requirements of these regulations build 
upon existing sanitation requirements, at the Federal, State, and local 
levels.
    The more generalized nature of these final regulations with respect 
to sanitation should mitigate the concerns of the comments that 
complained about the conflict between, and duplication with, existing 
sanitation standards.
    As discussed elsewhere in this preamble, FDA encourages adoption of 
these regulations by State and local regulatory agencies. FDA is 
convinced that, in many cases, the regulations can be quite easily 
overlaid on existing State, local, and NSSP requirements.
5. What Is the Appropriate Approach to Sanitation?
    Based on its review of the comments, FDA has been convinced that a 
modification of its approach to sanitation is appropriate. FDA 
concludes that its approach in the proposal was too inflexible and 
could have made it more difficult in certain circumstances to 
incorporate new technologies and information.
    The comments argued for one or more of several approaches that they 
identified as being more appropriate than FDA's proposed approach: (1) 
Requiring that each processor develop and follow a SSOP that is 
specifically tailored to a processing operation; (2) including 
sanitation controls in the HACCP plan where they are critical to 
product safety; and (3) retaining the general approach of the proposed 
regulations but somehow reducing the number of specific requirements. 
Approximately 85 percent of those that opposed the way that sanitation 
was treated in the proposal advocated one or a combination of the first 
two of the approaches, with the recommendations evenly split between 
the two. The small number of comments that objected to including any 
specific sanitation requirements in the regulations may also have been 
arguing that sanitation should not be part of HACCP but should be 
controlled solely through CGMP's.
    a. Inclusion of sanitation controls in HACCP plans.
    110. There was strong support in the comments for the inclusion of 
sanitation controls in HACCP plans, particularly where the controls are 
necessary to protect the safety of the product. The comments stated 
that a processor's 

[[Page 65149]]
hazard analysis may reveal the need to control certain aspects of 
sanitation in the HACCP plan, especially to control hazards involving 
microbiological contamination. One comment noted that sanitation 
controls are likely to be components of the HACCP plans of molluscan 
shellfish processors.
    Given the strong support that sanitation controls should be 
included in HACCP plans where they are critical to safety, FDA has no 
objection to processors including sanitation controls in their HACCP 
plans. Consequently, these final regulations state in Sec. 123.6(f) and 
Sec. 123.11(d) that sanitation controls for safety may be included in 
HACCP plans.
    The agency has concerns, however, as to whether including 
sanitation controls in a HACCP plan will be adequate to ensure that 
appropriate conditions exist in a plant. The conditions that would be 
addressed in the HACCP plan will likely be those that are most 
critically and directly related to product safety. Other situations 
that are relevant to safety, but in a less direct way, would probably 
not be controlled through HACCP. For example, following the NACMCF 
recommendations for hazard analysis and HACCP plan development would 
likely result in the identification of a number of equipment and hand 
washing controls at CCP's in the HACCP plan for the processing of a 
cooked, ready-to-eat product to minimize the risk of microbiological 
contamination but not in the identification of these same controls in 
the HACCP plan for a raw finished product that would normally be cooked 
before consumption. In the latter case, however, attention to 
sanitation would still be important in the processing plant to prevent 
contamination of the product, given that the ultimate consumer cook may 
be inadequate, or that the product, once contaminated, could be a 
source of cross-contamination to other foods.
    Likewise, the potential for contamination of either a cooked, 
ready-to-eat product or a raw product as a result of rodent activity in 
a processing plant, or as a result of improper use of pesticides on or 
near the product, would not likely be identified in a HACCP plan. All 
of these conditions are relevant to the safety of the product and 
should be addressed by processors. It is not clear whether HACCP can 
fully succeed in plants that are not in control of general sanitation 
practices.
The inclusion of sanitation in HACCP--as desirable as it may be--will 
not fully resolve this problem.
    b. SSOP.
    111. As indicated above, a significant number of comments that 
addressed alternatives to the prescriptive approach to sanitation in 
the proposal preferred a SSOP, either alone or in combination with 
critical sanitation controls in HACCP. Significantly, the NACMCF was 
among those that made this suggestion. NMFS' comment stated that, in 
its experience, the development of SSOP's by processors in its 
voluntary program has been associated with marked improvement in 
sanitation. Many comments stated that much of the seafood processing 
industry already has SSOP's, and that those that do not should develop 
them.
    FDA agrees that the development by processors of an SSOP would be a 
beneficial step. FDA therefore is recommending in Sec. 123.11(a) that:

    Each processor should have and implement a written sanitation 
standard operating procedure (herein referred to as SSOP) or similar 
document that is specific to each location where fish and fishery 
products are produced.

    An SSOP places the primary burden for identifying relevant controls 
on the food processor. To meet this burden, it will be necessary for 
the processor to think through each operation and identify where, and 
how frequently, appropriate sanitation measures are necessary. The 
process of doing so will foster the type of culture that FDA is trying 
to promote, in which processors assume an operative role in controlling 
sanitation in their plants.
    FDA is adopting Sec. 123.11 pursuant to sections 402(a)(4) and 
701(a) of the act to ensure that seafood is not produced under 
insanitary conditions whereby it may be rendered injurious to health. 
It grows directly out of proposed Sec. 123.10, but, as stated above, it 
reflects the agency's efforts to make the sanitation requirements more 
flexible.
    FDA has not elected to make the development of an SSOP mandatory 
because it recognizes that some processors may be able to achieve 
satisfactory sanitation conditions and practices without having to 
commit their sanitation control procedures to writing. The agency 
remains convinced however, that such satisfactory conditions are 
unlikely to be achieved without periodic monitoring of the operations. 
For this reason the agency has retained at Sec. 123.11(b) the mandatory 
sanitation monitoring requirements proposed at Sec. 123.10(c). 
Sanitation monitoring will be further discussed in the next section of 
this preamble.
    Where a processor elects to develop an SSOP it should specify how 
it will meet those sanitation conditions and practices that are to be 
monitored in accordance with Sec. 123.11(b). These conditions and 
practices will also be discussed in the next section.
    Both Sec. 123.11(d) and Sec. 123.6(f) provide that sanitation 
controls that are monitored in accordance with Sec. 123.11(b) need not 
be included in the HACCP plan and vice versa. The purpose of these 
provisions is to allow processors to incorporate those sanitation 
controls into their HACCP plans that they believe are appropriately 
addressed through HACCP, without having to duplicate those controls in 
a separate sanitation program.
6. Monitoring and Corrective Actions
    The regulations no longer contain specific monitoring frequencies 
to ensure that proper sanitation conditions are being met, as was 
proposed at Sec. 123.10(c). In keeping with the agency's decision to 
reduce the prescriptive nature of the sanitation requirements, 
Sec. 123.11(b) now requires that each processor monitor the conditions 
and practices during processing with sufficient frequency to ensure, at 
a minimum, conformance with certain key sanitation conditions and 
practices as specified in part 110.
    112. The agency arrived at this approach in response to the 
comments. As part of the agency's efforts to achieve flexibility, it 
examined the 18 sanitation controls that it proposed at Sec. 123.10(a) 
in light of the comments that argued that they were overly 
prescriptive. FDA proposed the 18 sanitation controls to ensure that, 
where relevant to the processing operation, important areas of concern 
were addressed in each plant. The preamble addressed at some length why 
each of them was significant and relevant to safety. Moreover, although 
considerable comment was received that challenged the manner in which a 
particular processor should address these sanitation conditions and the 
situations in which they should be considered applicable, only two 
comments challenged the significance of these conditions or the need 
for them to be controlled when they are determined to be germane, and 
neither comment provided a basis for doubting the significance of these 
controls.
    FDA concludes that, where relevant to a processor's operation, the 
processor should monitor sanitation conditions and practices relating 
to the general subject areas reflected by the 18 specific sanitation 
controls because they are important for ensuring the safety of the 
product. As in the proposal, each processor will be responsible for 
determining which of the subject areas are relevant to its plant and 
process. However, unlike the proposal, the 

[[Page 65150]]
processor will be free to tailor the sanitation controls to the 
circumstances of its operation, as long as it does so in a manner that 
ensures the effectiveness of those controls. The regulations do not 
specify the manner in which control must be achieved. FDA will provide 
guidance on how to ensure appropriate sanitation control in the Guide. 
FDA is deferring consideration of the comments that it received on the 
specific sanitation control measures that it described in the proposal 
until it prepares the Guide.
    In order to ensure that processors monitor the general subject 
areas reflected by the 18 specific sanitation controls listed in the 
proposal, FDA has concluded that it is appropriate to list in the 
regulations the sanitation controls that should be considered. This 
list will ensure that the most significant sanitation controls are 
considered by the processor in formulating the measures that it will 
institute in its plant.
    The controls that FDA is listing in Sec. 123.11(b) no longer 
contain sanitation standards that are beyond part 110 or repeat 
specific standards that are contained in that part. Instead, 
Sec. 123.11(b) now states that the processor shall ensure that actions 
are taken to ensure that those sanitary conditions that are contained 
in part 110 and that are relevant to the plant are maintained in eight 
general areas:
    (1) The safety of the water that comes into contact with food or 
food contact surfaces or is used in the manufacture of ice 
(Sec. 123.11(b)(1)). This control derives from proposed Sec. 123.10 
(a)(1) and (a)(2) relating to water quality and treatment and to cross 
connections between potable and nonpotable water systems.
    Water is used in virtually all seafood processing facilities for 
washing product, equipment, and employees' hands, for transporting fish 
in flumes, and as an ingredient. Contaminated water can serve as a 
vehicle for contamination of the product, both directly and indirectly 
(Refs. 63; 64; 65, p. 49; 66; 67; and 68, pp. 1 and 2). Cross 
connections, which include situations that allow for back siphonage 
into a potable system from a nonpotable system under negative pressure 
conditions, can result in the chemical or microbiological contamination 
of the potable water system (Refs. 64; 65, pp. 50 and 51; 68; 71; and 
72).
    This matter was one of the two, as indicated above, about which FDA 
received a comment that challenged the need for a sanitation control. A 
comment suggested that the safety of the water supply is within the 
jurisdiction of local health authorities, and that a processor should 
not have to deal with that issue.
    FDA acknowledges that many State and local jurisdictions exercise 
control over both public and private water supplies. In the case of 
private wells, they often permit and inspect the construction of the 
well and collect periodic water samples for microbiological and 
chemical attributes. Where such is the case, it may be reasonable for 
the processor to rely upon these measures. However, in the absence of 
appropriate controls by a public authority, FDA has concluded that the 
processor must exercise whatever control is necessary to ensure that 
the water supply is safe. To do otherwise would be to subject the 
product to an unacceptable safety risk from the contaminants that may 
be introduced by the water.
    (2) The condition and cleanliness of food contact surfaces, 
including utensils, gloves, and outer garments (Sec. 123.11(b)(2)). 
This control derives from proposed Sec. 123.10 (a)(3) through (a)(5) 
relating to the design, workmanship, materials, and maintenance of food 
contact surfaces; the cleaning and sanitizing of these surfaces, 
including the frequency of cleaning and sanitizing; the impermeability 
of gloves and outer garments that contact food; and the maintenance of 
gloves and outer garments.
    Utensils, equipment, aprons, gloves, outer garments, and other food 
contact surfaces can be vehicles for microbial contamination of both 
the raw and finished products. Food contact surfaces that contain 
breaks, pits, cuts, or grooves, or that are porous or corroded, may 
harbor pathogenic microorganisms that can migrate to the product and 
contaminate it. These kinds of surfaces are difficult to clean (Refs. 
65, pp. 20, and 36-48; 72, pp. 166-167; 73; and 83). Where food contact 
surfaces are constructed of toxic materials, the product may be 
directly contaminated (Ref. 74). Inadequately cleaned food contact 
surfaces can serve as a reservoir for pathogenic microorganisms, 
especially if biofilms are allowed to form, in which microorganisms can 
be entrapped and shielded from the action of cleaning and sanitizing 
compounds.
    (3) The prevention of cross-contamination from insanitary objects 
to food, food packaging material, and other food contact surfaces, 
including utensils, gloves, and outer garments, and from raw product to 
cooked product (Sec. 123.11(b)(3)). This control derives from proposed 
Sec. 123.10 (a)(6), (a)(7), (a)(13), and (a)(18), relating to employee 
practices to prevent contamination, to physical separation of raw and 
cooked product, and to plant design to prevent contamination.
    Employees and food contact surfaces can serve as vectors in the 
transmission of pathogenic microorganisms to the food. These 
microorganisms can be introduced to the product from outside areas, 
rest rooms, contaminated raw materials, waste or waste receptacles, 
floors, and other insanitary objects. In the processing of cooked 
products, the raw material may also serve as a reservoir of pathogenic 
microorganisms. Employees or equipment that touch the raw material can 
transmit these microorganisms to the cooked product (Refs. 7, 63, 64, 
73, 74, 84, and 85). Finally, proper construction of the processing 
plant is essential if other sanitary measures are to be successful. For 
example, incompatible operations, such as handling of raw materials and 
handling of cooked product, should be isolated (Refs. 71, 74, 87, and 
88).
    (4) The maintenance of hand washing, hand sanitizing, and toilet 
facilities (Sec. 123.11(b)(4)). This control derives from proposed 
Sec. 123.10 (a)(8) and (a)(16), relating to the location and 
maintenance of hand washing and sanitizing facilities, and toilet 
facilities.
    Employee's hands can serve as a vector for the transmission of 
pathogenic microorganisms to the food. Hand washing and sanitizing, 
when performed using suitable preparations are effective means of 
preventing such transmission. Toilet facilities eliminate from the 
processing environment pathogenic microorganisms shed in fecal material 
(Refs. 63, 64, 73, 74, 84, and 85).
    (5) The protection of food, food packaging material, and food 
contact surfaces from adulteration with lubricants, fuel, pesticides, 
cleaning compounds, sanitizing agents, condensate, and other chemical, 
physical, and biological contaminants (Sec. 123.11(b)(5)). This control 
derives from proposed Sec. 123.10(a)(9), (a)(11), and (a)(12), relating 
to the protection of food from various microbiological, chemical, and 
physical contaminants.
    The use of toxic compounds (e.g., pesticides, cleaning and 
sanitizing agents, and lubricants) is frequently necessary in the 
processing environment. Food and food packaging materials should be 
protected or removed from areas where pesticides are used, and caustic 
cleaning compounds should be thoroughly removed from food contact 
surfaces before processing begins (Ref. 74). Condensate which forms on 
an insanitary surface and then falls on the 

[[Page 65151]]
product may carry with it pathogenic microorganisms (Ref. 65, pp. 24-
25).
    This measure is the second about which FDA received a comment that 
challenged the value of having a sanitation control. A comment 
suggested that preventing the formation of condensate on ceilings above 
processing is, in some situations, physically impossible. The comment 
did not suggest that condensate is irrelevant to safety.
    FDA reasserts that condensate is relevant but acknowledges that 
there are instances in which it may be impractical for it to be fully 
eliminated. In these instances, after taking all reasonable measures to 
minimize the development of condensate, the processor will need to take 
steps to protect the product from the dripping condensate or to ensure 
that the surface from which it is dripping is sanitary. The development 
of a written SSOP processor should tailor its sanitation controls to 
its particular situation in order to accomplish this objective.
    (6) The proper labeling, storage, and use of toxic compounds 
(Sec. 123.11(b)(6)). This control derives from proposed 
Sec. 123.10(a)(10), relating to the overall handling of toxic compounds 
to protect against contamination of food. Improper use of toxic 
compounds is a frequent cause of product adulteration throughout the 
food industry. Proper labeling, storage, and use of the compounds is 
necessary to minimize the risk of occurrence of such incidents (Ref. 
74).
    (7) The control of employee health conditions that could result in 
the microbiological contamination of food, food packaging materials, 
and food contact surfaces (Sec. 123.11(a)(7)). This control derives 
from proposed Sec. 123.10(a)(15), relating to the exclusion of persons 
who appear to have an illness, wound, or other affliction that could be 
a source of microbial contamination.
    Employees can serve as a reservoir of diseases, such as 
salmonellosis, shigellosis, and hepatitis, that can be transmitted to 
consumers by foods. Additionally, open sores, boils, or infected wounds 
present the potential for contamination of the food with such 
pathogenic microorganisms as Staphylococcus aureus (Refs. 22, 74, and 
84).
    (8) Exclusion of pests from the food plant (Sec. 123.11(b)(8)). 
This control derives from the proposed requirements at 
Sec. 123.10(a)(17). Pests, such as rodents, birds, and insects carry a 
variety of human disease agents, which they can introduce to the 
processing environment (Refs. 63, 64, 73, and 84).
    113. FDA proposed at Sec. 123.10(a)(14) that, ``Refrigeration units 
that store raw materials, in-process, or finished fish or fishery 
products that are cooked, ready-to-eat, smoked, or made in whole or in 
part from scombroid toxin forming species shall be operated at a 
temperature of 40  deg.F (4.4  deg.C) or below.'' The purpose of the 
proposed requirement was to ensure that processors control the 
microbiological hazards associated with refrigerated storage for these 
particularly susceptible products. A significant number of comments 
argued the control of temperature in refrigerated storage is a 
processing hazard rather than a sanitation issue, and should be covered 
by a firm's HACCP plan.
    FDA agrees with these comments and has not included a provision on 
refrigeration in the sanitation section of these regulations. A large 
number of comments were received relative to the appropriateness of a 
40  deg.F (4.4  deg.C) limit. These comments are no longer relevant to 
these regulations but will be addressed in the redrafting of the Guide.
    FDA has also incorporated the corrective action requirement 
relative to sanitation conditions proposed at Sec. 123.10(d) in 
Sec. 123.11(b). Section 123.11(b) the processor shall, correct in a 
timely manner those sanitation conditions and practices that are not 
met. The phrase ``in a timely manner'' did not appear in the language 
of proposed Sec. 123.10(d). However, it was implicit that corrections 
should be made as quickly as possible so as not to subject subsequently 
processed product to conditions that could both jeopardize their safety 
and render them adulterated. FDA has added the phrase for clarity.
    Note that the other corrective action requirements in these 
regulations, i.e., those in Sec. 123.7, do not apply to sanitation 
controls that are exclusively addressed in Sec. 123.11. The controls in 
Sec. 123.7 apply to a processor's HACCP system only.
7. Records
    114. FDA received approximately 20 comments that addressed the 
issue of sanitation records. Many others discussed recordkeeping in 
general but did not specifically mention records of sanitation 
controls. These latter comments have already been addressed in the 
``Records'' section of this preamble.
    Of those that commented specifically on sanitation records, 
approximately three-fifths, from processors and trade associations, 
objected to the proposed requirement that processors maintain records 
that demonstrate compliance with the appropriate sanitation standards. 
In fact, a number of comments listed this issue as a significant reason 
for their objection to the overall proposed approach to sanitation 
control. The comments suggested that sanitation recordkeeping is costly 
and has not been demonstrated to be effective. None of these comments 
provided any data in support of their statements. Some argued that, 
while they accepted the notion of records for CCP monitoring, they 
opposed records of sanitation monitoring.
    The remaining comments that addressed the issue of sanitation 
records, from consumer advocacy groups, an individual, a Federal 
government agency, a trade association, and a seafood broker, supported 
the need for such records. These comments argued that sanitation 
records are essential to ensure that processors adhere to established 
sanitary standards, and that they need not be extensive.
    FDA does not find the arguments against the requirement for 
sanitation control records to be compelling. The agency concludes that 
the burden will be minimal. Checklist type or simple notation records 
will suffice in most instances. Creating them should be incidental to 
monitoring. Monitoring to ensure that sanitation is under control is 
the responsibility of all processors.
    Monitoring and recording of sanitation conditions is as much a key 
to the success in improving those conditions, and, hence, to increasing 
consumer confidence in the seafood processing industry, as is the 
development by a processor of an SSOP. As in the case of HACCP records, 
sanitation records require that processors engage in systematic 
monitoring of their own sanitation practices and conditions. It enables 
them to see trends. Moreover, participation in recordkeeping helps 
empower the work force and foster responsibility. It also allows the 
regulator to assess a processor's compliance over a period of time, not 
just at the time of an inspection.
    FDA believes that the records bearing on the monitoring of relevant 
sanitation conditions and practices and FDA's access to such records 
are all essential if Sec. 123.11 is to be an effective regulatory 
strategy. Therefore, FDA has concluded that the recordkeeping 
requirement proposed at Sec. 123.10(b) will be retained. To reflect 
other modifications in this section, Sec. 123.11(c) has been modified 
to read, ``Each processor shall maintain sanitation control records 
that, at a minimum, document the monitoring and corrections prescribed 
by paragraph (b) 

[[Page 65152]]
of this section. These records are subject to the requirements of 
Sec. 123.9.''
    Additionally, FDA has moved the requirement that sanitation 
corrections be documented from proposed Sec. 123.10 (d) to Sec. 123.11 
(b).
    Finally, FDA notes that Sec. 123.11 does not contain any mention of 
importers. The lack of a mention of importers in this section reflects 
the position that the agency is taking in these regulations that, to 
the extent that importers are also processors, they would be subject to 
the sanitation requirements in this section. To the extent that they 
serve as importers only, the sanitation provisions are not relevant to 
their operations.

L. Imports

1. Background
    The majority of seafood consumed in the United States is imported. 
FDA's surveillance system for imports largely consists of reviewing the 
customs entries for fish and fishery products being offered for entry 
into the United States, engaging in wharf examinations and sample 
collections for laboratory analysis, and placing products with a 
history of problems on automatic detention. As with domestic 
inspections, this method is basically a ``snapshot'' approach that 
places a significant burden on the government to uncover problems. It 
has failed to result in full compliance or consumer confidence in the 
safety of imported seafood. Consequently, the agency tentatively 
concluded that HACCP controls should apply to imported fish and fishery 
products as well as to domestic products. Among other things, FDA 
proposed that the definition of ``processor'' explicitly include those 
who process seafood in foreign countries.
    In addition, FDA tentatively concluded that the importer should 
share some responsibility with the foreign processor for safety. More 
often than not, it is an U.S. importer, rather than the foreign 
processor, who actually offers imported fish and fishery products for 
entry into the United States. The preamble noted that, while many 
importers are conscientious about the safety of the products that they 
import, others have little understanding of the potential hazards 
associated with their products. Thus, the agency tentatively concluded 
that the existing system of import controls had not promoted a sense of 
responsibility in the import industry.
    Therefore, in addition to proposing to require that foreign 
processors that export to the United States comply with part 123, FDA 
proposed that importers of fish and fishery products take steps to 
ensure that their shipments are obtained from such processors. 
Specifically, FDA proposed that importers: (1) Have and implement a 
HACCP plan that describes how the product will be processed while under 
their control; (2) maintain a copy of the foreign processor's HACCP 
plan; and (3) take affirmative steps to ensure that the imported fish 
or fishery product was produced in conformance with the foreign 
processor's HACCP plan and with the proposed sanitation requirements. 
The agency also proposed that importers need not take affirmative steps 
if the fish or fishery product was imported from a country with which 
FDA has a MOU documenting the equivalency of the foreign inspection 
system with the U.S. system.
2. Should Imports Be Subject to These Regulations?
    115. Approximately 70 comments addressed various aspects of the 
proposed requirements for imports. Approximately half of the comments 
that addressed the import provisions argued that it is necessary to 
subject imported products to the same regulatory requirements as 
domestically processed products. These comments were submitted by 
processors, trade associations, State and foreign government agencies, 
professional associations, and individuals. Many of these comments 
argued that exempting foreign processors from the requirements of these 
regulations would put the domestic industry at an unfair economic 
disadvantage. Other comments stated that the import requirements would 
increase consumer confidence in seafood because they would ensure that 
imported fishery products have been produced under the same HACCP 
requirements and held to the same sanitation standards as domestically 
produced product. A few comments suggested that imported products are 
more likely to present safety hazards than domestically-produced 
products because of a lack of understanding of CGMP's on the part of 
foreign processors. One comment asserted that a number of countries, 
including Canada, the EU, Iceland, and Thailand are in varying stages 
of establishing HACCP programs for their own domestic seafood 
processors.
    Most of the remaining comments (approximately one-half) did not 
comment on whether HACCP controls should be required for imported fish 
and fishery products but discussed aspects of the agency's proposed 
approach. These comments will be addressed later in this section.
    FDA did not receive any comments that persuaded it that imports 
should be exempt from the requirements of these regulations. On the 
contrary, the comments reflect a nearly universal recognition that the 
safety of seafood cannot be adequately ensured if the majority of 
products (that is, imports) are not subject to the same controls as 
domestic products.
    Therefore, the agency has not modified the regulations' basic 
approach for imports.
    116. Only two comments objected to the concept that imported fish 
or fishery products should meet the same requirements as those for 
domestic products. One of these comments argued that FDA should be 
tolerant of a foreign processor that may not have the knowledge or time 
to develop a HACCP plan before its product is ready for export and 
urged the agency to develop a temporary waiver system to accommodate 
such firms.
    FDA is convinced that a 2-year implementation period, as discussed 
in the ``Effective Date and Compliance'' section of this preamble, will 
provide sufficient time for processors, both within and outside the 
United States, to develop and implement HACCP plans and otherwise come 
into compliance with the provisions of these regulations. The comment 
provided no basis for treating foreign processors any differently than 
domestic processors in this regard.
    117. Another comment suggested that raw material fish and fishery 
products imported for further processing in the United States should be 
exempt from the requirements of the regulations but provided no reason 
to support that position.
    The exemption requested by the comment would make it difficult, if 
not impossible, to control environmental hazards that may be associated 
with these products. This preamble and the preamble to the proposed 
regulations fully discuss the conclusions of the NAS, which identified 
raw material hazards, such as microbiological contamination in 
molluscan shellfish and natural toxins in both shellfish and finfish, 
as among the most pressing problems that must be addressed to ensure 
seafood safety. For the most part, these hazards are best addressed at 
the time of harvest and by primary processors, through HACCP, at the 
time of receipt. In many cases, there is little opportunity for control 
beyond the latter point. Raw material fish and fishery products for 
further processing comprise a substantial portion of fish 

[[Page 65153]]
and fishery products imported into the United States (Ref. 212, p. 49). 
Thus, to exempt foreign processing of such products from the 
requirements of these regulations would be to greatly diminish the 
scope and, therefore, the overall effectiveness of these regulations.
    118. One comment that supported the need for equitable treatment of 
imported and domestically produced products urged the agency to provide 
the same opportunities for processors abroad to familiarize themselves 
with the requirements of these regulations as it does the domestic 
industry. The comment argued that just printing the regulations in the 
Federal Register would not fulfill that responsibility. The comment 
further suggested that FDA send copies of guidance materials to all 
known foreign seafood processors, preferably in their native language.
    FDA acknowledges the difficulty in reaching foreign processors with 
information about the requirements of these regulations. However, mass 
mailings to, and multiple translations of, these regulations and the 
Guide for all foreign seafood processors that export to the United 
States would not be practicable for FDA.
    The agency intends to reach foreign processors primarily by 
briefing foreign embassy staffs and by communicating with U.S. 
importers during public and trade association meetings. Based on 
experience in disseminating information about U.S. requirements to the 
import community, the agency expects that these two groups will provide 
the necessary information and guidance materials (in the appropriate 
languages) to the foreign processors that they represent. This same 
approach was used in disseminating information about the proposed 
regulations. In fact, FDA became aware of a Japanese translation of the 
proposal shortly after it issued.
    In addition, FDA traditionally has provided training and technical 
assistance for foreign processors and government officials on a variety 
of food control topics, within the constraints of budget and manpower. 
These projects have principally been conducted in developing countries, 
often those in which the agency has become aware of a particular 
problem that threatens the safety of products offered for entry into 
the United States. FDA anticipates that these kinds of projects will 
continue, and that they will focus more closely on HACCP. FDA also 
expects that HACCP training, performed in accordance with the 
standardized training materials under development by the Alliance (see 
the ``Training'' section of this preamble), will provide further 
opportunity for foreign processors to be exposed to the requirements of 
these regulations.
3. Should Importers Be Subject to These Regulations?
    119. Approximately half of those who commented on the import 
provisions addressed whether the importer should be required to take 
steps to ensure that its shipment originates from a foreign processor 
that operates under HACCP. Approximately half of these comments favored 
the concept and half opposed it, with both groups being diverse in 
their representation.
    Of those who opposed it, many argued that these requirements should 
be the responsibility of the government, and that FDA should not 
require that importers enforce them. A number of these comments further 
argued that equivalent foreign government inspection systems cannot be 
presumed to be in place, and that the only way to achieve a ``level 
playing field'' is for FDA to perform inspections of foreign processors 
at the same frequency, and using the same standards, that the agency 
applies to domestic processors. One comment suggested that it may be 
necessary to obtain legislative authority to perform foreign 
inspections, as a condition of importation. Another comment suggested 
that FDA auditing of foreign processor compliance would give importers 
assurance that the products that they obtain from such sources had been 
produced in accordance with appropriate U.S. standards.
    One comment, while not opposed to mandatory importer 
responsibilities, nonetheless argued that FDA should spend as much time 
and effort inspecting foreign processors as it does on domestic 
processors because over 50 percent of the seafood consumed in the 
United States is imported. The comment continued that, ``to do any less 
would be an unfair burden to domestic processors and would not 
accomplish the stated goal to significantly improve the safety of 
seafood consumed in the U.S.''
    One comment argued that there is no real cost savings in assigning 
importers the responsibility of verifying foreign processor compliance 
rather than assigning that responsibility to FDA, because importers 
will merely pass along the additional costs to the consumer. Another 
comment noted that many small importers obtain products from over 25 
countries, and that they cannot afford to provide the surveillance 
necessary to ensure compliance.
    Another comment argued that many importers function simply as 
brokers, connecting a buyer with a seller, and that they lack the 
expertise, manpower, and facilities to evaluate the adequacy of a 
processor's HACCP controls. One comment stated, ``Many of the people 
involved in importing never see the product and know nothing about 
fish--these are people in a small room with a battery of phones!'' 
Another comment argued against placing reliance for assuring the safety 
of imported seafood on persons who have a financial interest in the 
product but lack the required knowledge about seafood safety.
    One comment argued that requiring importers to exercise control 
over their suppliers has no parallel in the proposed domestic HACCP 
scheme. The comment stated that domestic processors must control the 
hazards that are introduced during their processing operations but need 
not be involved in verifying the control of those hazards associated 
with their supplier's operations. Some comments argued that the 
responsibility for controlling hazards that are reasonably likely to 
occur should be assigned to the foreign processor, while others argued 
that it should be assigned to the U.S. processor to whom the importer 
sells the product. One comment asserted that importers are not in a 
position to exercise control over the processing of products in foreign 
plants any more than they are in a position to exercise control over 
how the products are handled by their customers.
    Most of those comments that supported the concept of importer 
responsibility provided no reason. However, one comment stated that 
requirements on importers would ensure that someone in the United 
States would be legally responsible for the safety and wholesomeness of 
each imported product.
    FDA recognizes that requiring importers to take steps to ensure 
that foreign processors from whom they purchase seafood products are in 
compliance with these regulations could necessitate significant changes 
in the operations of importers who have limited their activities to 
matching buyers with sellers based on product specifications that may 
have had little to do with safety. However, for two reasons, FDA cannot 
agree that responsibility with regard to safety is inappropriate for 
importers.
    First, it has always been the importer's responsibility to offer 
for entry into this country products that are not adulterated under 
U.S. law. It is a prohibited act, under section 301(a) of the act, to 
introduce into interstate commerce an adulterated food. Thus, an 
importer would be committing a prohibited act if it failed to ensure 
that 

[[Page 65154]]
the food that it is offering for import into the United States is not 
adulterated under section 402 of the act, including section 402(a)(4), 
one of the principal provisions on which these regulations are based.
    Currently, however, the importer is not required to operate in a 
proactive manner to ensure that it is meeting this responsibility. 
Rather, the importer need only offer products for entry into commerce 
and thereby place the burden on the government to find a problem. Many 
importers traditionally have purchased ``FDA rejection insurance'' to 
hedge against that possibility. The government can shift the burden to 
the importer by placing the importer's products on automatic detention 
if it finds problems that warrant such a step, but in most instances 
the burden remains on the government.
    Second, responsible importers understand the issues related to the 
safety of the seafood products that they import and customarily require 
that foreign suppliers conform to their product specifications and 
applicable U.S. regulations relating to safety. These importers take 
various measures to ensure that a foreign processor can comply with 
their specifications and safety requirements before they agree to 
purchase products from the foreign processor.
    Thus, it is feasible for importers to take steps to ensure that 
they are not offering adulterated products for entry into U.S. 
commerce. Requiring such measures will not be a significant added 
burden for many importers, particularly as HACCP principles become more 
widely used and understood in international commerce. Foreign 
processors that want to participate in the export market, not only to 
the United States but to the EU, Canada, and an increasing number of 
other countries, will implement HACCP and sanitation control programs 
and will be prepared to address an importer's needs for verification.
    FDA does not agree that there is no parallel in the domestic scheme 
to the importer's responsibility to ensure that the goods it is 
offering were produced under HACCP. Domestic processors, like importers 
must work with their suppliers (e.g., fishermen) to ensure that all 
reasonably likely hazards (e.g. natural toxins and agricultural and 
industrial chemical contaminants) are controlled. FDA is confident that 
importers, like processors, will realize that ensuring that foreign 
processors institute preventive control systems is a cost effective 
means of ensuring that the products that they offer for entry into the 
United States will consistently meet FDA's entry requirements and will 
be safe for consumption. FDA also disagrees with those comments that 
suggested that a requirement that importers take steps to ensure that 
the products they offer for entry have been produced under a HACCP plan 
is an abrogation of FDA's responsibilities. As stated previously, the 
industry has a responsibility to ensure that the food that it 
introduces into interstate commerce is not adulterated. FDA has a 
responsibility to verify that industry is meeting its obligation and to 
take remedial action if industry fails to do so. Importers, who are 
usually the owners of the products that they are offering into 
commerce, are a part of that industry. FDA cannot accept that importers 
have no responsibility to ensure that their products are not 
adulterated.
    The agency recognizes that probably the most effective way for a 
regulatory agency to evaluate a processor's compliance with the HACCP 
and sanitation requirements is through onsite inspection of facilities, 
practices, and records. FDA has performed a limited number of 
inspections of foreign processors and, within its budgetary 
limitations, will continue to do so to enforce these regulations. 
However, such inspections are costly, and any attempt to significantly 
increase their number would require additional resources.
    FDA will continue its traditional import surveillance role, 
utilizing entry document review, wharf examinations, sample 
collections, and automatic detentions as screening tools. These tools 
indirectly evaluate the adequacy of HACCP and sanitation controls and 
will continue to be useful in detecting significant problems. While 
end-product testing and evaluation are not adequate substitutes for 
preventive controls in ensuring the safety of a product, they can 
provide verification where appropriate (Ref. 34, pp. 201-202).
    FDA has concluded that requiring HACCP controls, together with 
import surveillance and periodic inspections of importers to ensure 
their compliance with the requirements of Sec. 123.12, will better 
ensure the safety of imports than the current system.
    In a related matter, Sec. 123.3(g) makes clear that, under ordinary 
circumstances, freight forwarders, custom house brokers, carriers, or 
steamship representatives will not be required to fulfill the 
obligations of an importer. It is possible, although FDA has no way to 
know with any certainty, that some of those that objected to being 
required to fulfill those obligations would, as a result of these 
clarifications, find that they would not be expected to do so.
4. Memoranda of Understanding (MOU's)
    120. Many of the comments that objected to the importer 
responsibility provisions of the proposal on the grounds that the 
government is the appropriate entity to ensure foreign processor 
compliance, stated that the most effective means of ensuring such 
compliance would be for FDA to enter into MOU's with the governments of 
exporting nations. Approximately one-third of those that commented in 
any way on the importer provisions urged FDA make the negotiation of 
MOU's a high priority. Only one comment objected to the development of 
MOU's.
    Several comments argued that FDA should develop MOU's with all 
countries from which seafood is imported. One of these comments pointed 
out that to do otherwise would unfairly cause the obligations of 
importers to vary considerably. A few comments argued that the 
existence of an MOU should be a prerequisite for the importation of 
seafood products from a country. One of these comments stated that 
mandatory MOU's would reduce the complexity of the present import 
surveillance situation, reduce the number of countries exporting 
seafood to the United States, and encourage the development of improved 
food safety programs in exporting countries. Another comment asserted 
that MOU development is appropriate because government-to-government 
relationships and audits can be free of influence from packers and 
importers, whereas foreign suppliers may be prone to provide false 
assurances about their programs to prospective importers.
    One comment urged FDA to fully describe the process and criteria 
for developing and evaluating MOU's and expressed concern about the 
process because of the varying level of sophistication of foreign 
seafood control programs. One comment stated that the foreign 
government should be responsible for evaluating the foreign processor's 
HACCP plan, inspecting the foreign processor, periodically analyzing 
products produced by the foreign processor, and issuing health 
certificates. A few comments stated that FDA should monitor the 
effectiveness of the foreign government's control program in a manner 
that is authorized in the MOU. These comments stated that, under the 
MOU's, the foreign government should provide FDA with periodic lists of 
processors that meet the requirements of these regulations, or, 
alternately, that all seafood processors 

[[Page 65155]]
in the country would be required to meet the requirements.
    One comment urged FDA to publish periodic reports on the status of 
MOU's on seafood products and to make them available to all importers. 
This comment and others argued that it should be FDA's responsibility 
to notify importers about changes in the status of MOU's, rather than 
be the responsibility of the importer to find out about any changes. 
One of these comments noted that, because a change in the status of an 
MOU could be very detrimental to importers, there must be sufficient 
lead time to allow importers to develop alternate verification 
procedures when changes do occur.
    Another comment urged FDA to coordinate with U.S. importers and 
exporters in developing a schedule for MOU development. The same 
comment urged FDA to assign more resources to the development of MOU's.
    On the other hand, one comment stated that the MOU development 
process is overly open-ended and could result in inconsistencies 
between domestic and foreign requirements. The comment argued that this 
inconsistency could result in an economic disadvantage for domestic 
processors.
    FDA agrees with those comments that urged that the agency give high 
priority to the establishment of MOU's with U.S. seafood trading 
partners. In the absence of significant numbers of agency inspections 
of foreign processing facilities, FDA acknowledges that an MOU can be 
the most efficient and effective mechanism for ensuring that foreign 
processing plants are operating in compliance with the requirements of 
these regulations. FDA also agrees that the potential for signing an 
MOU with FDA is likely to serve as an incentive for the improvement of 
regulatory food control programs and processing conditions in seafood 
exporting countries, especially where the existence of an MOU serves to 
excuse the importer of products from that country from certain 
verification activities.
    FDA has concluded that the development of MOU's or similar 
agreements with foreign regulatory agencies is an appropriate method 
for ensuring that foreign processors that export to the United States 
are in compliance with the requirements of these regulations. Moreover, 
as suggested by several comments, the agency has determined that, where 
an MOU exists, there is no need for the importer to perform any 
independent verification procedures for purposes of these regulations. 
In this situation, the importer should be able to rely upon the foreign 
regulatory authority to ensure compliance by foreign processors.
    FDA is therefore retaining the provision on MOU's from the proposal 
but modifying it to provide that, where an importer elects to obtain a 
fish or fishery product from a country with which FDA has an active MOU 
or other similar agreement, the importer need not engage in any 
independent verification activities.
    The agency has developed an internal protocol for developing MOU's 
and is negotiating agreements with several countries. FDA is committed 
to negotiating as many MOU's as possible. Also in the Federal Register 
of June 15, 1995 (60 FR 31485), FDA published the notice of 
availability of a new Compliance Policy Guide on MOU's.
    However, it is not reasonable to expect that an agreement could be 
reached with all countries from which seafood is imported into the 
United States. The barriers to achieving such a result include the 
inadequacy of foreign regulatory programs and the lack of interest on 
the part of some foreign governments in entering into an agreement. The 
availability of FDA resources also can affect at least how long it 
takes FDA to enter into a particular MOU.
    For these reasons, the existence of an MOU or similar agreement as 
a requirement of entry of fish or fishery products into the United 
States would result in an enormous negative economic impact to a major 
segment of the U.S. seafood industry. Moreover, such a restriction is 
not warranted from a public health perspective given the alternative 
means of verifying the existence of HACCP controls that are provided in 
these regulations.
    Experience obtained in part in the international portion of the 
FDA/NMFS seafood HACCP pilot project has demonstrated that foreign 
seafood regulatory programs vary considerably, both in their 
capabilities and in their structures. Likewise, foreign seafood 
processing conditions are highly variable. Thus, FDA cannot simply 
follow a boiler plate format in negotiating MOU's. Rather, they must be 
tailored to the specifics of the situation presented by a particular 
country. It is possible that some agreements can provide simply for the 
submission of lists of approved processors to FDA at regular intervals; 
others may require much more extensive FDA involvement before and after 
goods flow under the agreement. Some agreements may cover all of a 
country's seafood processors, while others may be targeted to specific 
species or product forms, depending on factors such as the capability 
of the foreign regulatory authority.
    In any case, all agreements can be expected to provide for FDA 
verification of the effectiveness of the foreign programs, including 
onsite visits. FDA is principally interested in two- way agreements, 
that is, agreements that acknowledge the acceptability of the U.S. 
regulatory system to the foreign government as well as the 
acceptability of the foreign regulatory system to the U.S. government.
    The agency will make every reasonable effort to communicate with 
the industry about changes in the status of MOU's through Federal 
Register notifications and other means. FDA is open to suggestions 
about the best ways to communicate in this regard.
    Nevertheless, it will ultimately be the importer's responsibility 
to keep appraised of any changes in the status of MOU's.
    The agency is also receptive to the views of the seafood industry 
and others about how countries should be prioritized for the purpose of 
negotiating MOU's. Any information that the agency receives on this 
topic will be coupled with existing information concerning the 
likelihood of negotiation success and the types and quantity of 
products typically offered for entry from the country in question.
5. Importer Verification Procedures
    121. The remaining comments discussed specific aspects of the 
proposed importer requirements. Some of these comments argued that the 
responsibilities that were proposed for importers are onerous, 
unworkable, and inefficient but offered nothing in support of these 
assertions.
    A number of comments objected to the proposed requirement that all 
importers have and implement a HACCP plan. Several of these comments 
contended that an importer's plan can only address the hazards that 
occur during the time that products are under the importer's control 
(i.e., from the time the importer takes possession of the product until 
it is shipped to its customer), and that requiring that the plan cover 
this point is inconsistent with the principles of HACCP. One comment 
agreed that an importer should be required to develop a plan if it also 
processes the product, as in the case of an importer who stores the 
product. The comment asserted that, in such a case, however, the 
importer's HACCP plan would be minimal. The comment further asserted 
that the foreign processor should be the party responsible for 
developing a HACCP plan that addresses the hazards 

[[Page 65156]]
introduced during processing in the foreign plant. The comment 
recommended that, as an alternative to having a HACCP plan, an importer 
should be able to develop SOP's that outline the steps that it will 
take to determine whether to purchase the product from a foreign 
supplier.
    A number of comments supported the proposed requirement for 
importer HACCP plans but provided no reasons for their support.
    The agency agrees that it would be inappropriate to require that 
importers have and implement a HACCP plan regardless of whether they 
process the products they import. As stated elsewhere in this preamble, 
HACCP is a system that provides immediate feedback, through the 
monitoring of CCP's, as to whether a process is under control. Unless 
an importer is also a processor, there are no CCP's in the classic 
sense for the importer to monitor, and from which to obtain real-time 
feedback. Consequently, only where importers also process in accordance 
with the definition of that term at Sec. 123.3(k) will they be required 
to have and implement a HACCP plan that meets the requirements of 
Sec. 123.6. Those food safety hazards that can be controlled by the 
foreign processor must be addressed in the foreign processor's HACCP 
plan in accordance with Sec. 123.6.
    Consequently, FDA has revised the regulations to limit the 
responsibilities of importers. Instead of having to maintain their own 
HACCP plan, under Sec. 123.12(a), in the absence of an MOU or similar 
agreement, importers only need to maintain and implement written 
verification procedures for ensuring that the fish and fishery products 
that they offer for import into the United States have been processed 
in accordance with the requirements of these regulations. The only 
exception to this rule would be if the importer itself engages in 
processing, such as holding food, in which case the importer would, as 
stated above, also be a processor and subject to Sec. 123.6.
    122. In determining the nature of the verification procedures that 
an importer must have and implement, FDA considered the comments that 
addressed the appropriate functions and existing procedures of 
importers. Several comments noted that importers routinely purchase 
products according to specifications and observed that these 
specifications could be the basis for reasonable control measures for 
importers. The NACMCF recommended that importers be required to 
maintain product specifications that are relevant to product safety for 
fish and fishery products that they import. The NACMCF listed water 
activity, pH, histamine content, and, perhaps, pathogen limits as 
examples of specifications that importers might set in an effort to 
ensure product safety.
    The agency agrees with the comments that product specifications can 
be useful tools with which importers can exercise some control over the 
products that they purchase and offer for entry into the United States. 
In fact, FDA stated in the preamble to the proposed regulations that 
the purpose of an importer's plan was, in part, to include criteria for 
how the importer will decide to purchase seafood. FDA is also 
encouraged by the fact that the comments generally agreed that having 
product specifications would not constitute a new burden for many 
importers.
    For these reasons, the agency in Sec. 123.12(a)(2)(i), is requiring 
that the importer's written verification procedures include product 
specifications that are designed to ensure that the product is not 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic 
Act because it may be injurious to health or have been processed under 
insanitary conditions. These are the adulteration sections that relate 
to the safety of fish.
    In many cases, importers will find existing Federal food safety 
standards, including tolerances and guidelines, to be useful 
specifications. In other cases, specifications may need to be tailored 
to the circumstances. For example, the importer might need to ensure 
that the temperature of a modified atmosphere packaged product, when it 
comes off a ship, is 38  deg.F (in such foods there is a risk of C. 
botulinum type E growth and toxin development which can occur at 
temperatures as low as 38  deg.F), although the CGMP's at 
Sec. 110.80(b)(3)(i) state only that refrigerated foods should be 
stored at 45  deg.F or below. The importer is encouraged to seek the 
advice of qualified experts, as needed, in setting specifications. The 
same resources available to help domestic processors in setting CL's 
are available to importers, including the Guide; Sea Grant Institution 
and other academics; Federal, State, and local food safety regulatory 
agencies; consultants; the Alliance and other training courses; and 
published literature.
6. Affirmative Steps: General
    As a second part of the importer's verification procedure, FDA is 
essentially retaining from the proposal, in Sec. 123.12(a)(2)(ii), the 
requirement that the importer take affirmative steps to ensure that the 
products being offered for entry are actually being produced under 
controls that meet the requirements of these regulations. In order for 
product specifications to be meaningful, importers must take steps to 
establish that their suppliers are in fact operating in a manner that 
can reasonably be expected to produce a product that meets those 
specifications. Effective verification involves scrutinizing the 
standard, much like evaluating whether the HACCP plan continues to be 
appropriate, and scrutinizing performance to determine whether the 
standard is consistently reached, much like reviewing monitoring 
records (Ref. 34, p. 201). FDA is adopting this approach in 
Sec. 123.12(a)(2)(ii).
    Among the affirmative steps that FDA proposed that a processor take 
were: (1) Obtaining the foreign processor's HACCP-monitoring records; 
(2) obtaining a certificate from a foreign government inspection 
authority certifying that the firm is operating under a valid HACCP 
plan or certification on a lot-by-lot basis; (3) regularly inspecting a 
supplier's facilities; (4) periodic end-product testing by the importer 
or a private laboratory hired by the importer; or (5) other such 
verification measures as appropriate. FDA listed these affirmative 
steps as examples of the types of measures that would be acceptable to 
the agency. FDA does not wish to predetermine all the possible ways 
that an importer could perform affirmative steps.
    123. A number of comments objected to each of the affirmative steps 
that FDA listed in the proposed regulations, and a few expressed 
support for each. However, few of the comments provided any reasons for 
their positions.
    One comment suggested that the best means by which an importer can 
ensure that the conditions at a foreign processing facility are at 
least equivalent to those required of domestic processors is for the 
importer to verify the adequacy and implementation of the foreign 
processor's HACCP plan during a visit to the facility. Another comment 
stated that, ``without both audits and HACCP records, foreign plants 
(possibly domestic facilities too) will not adhere to the letter of the 
FDA regulation and assure safe product in the market.''
    Conversely, a number of comments argued that it would be unworkable 
for importers to conduct inspections of foreign processors. One of 
these comments stated that to justify the expense of such an 
undertaking would necessitate that a highly trained, competent 
individual perform the function.
    As stated earlier, FDA remains convinced that importers must 
exercise 

[[Page 65157]]
sufficient control over the fish and fishery products that they offer 
for entry into their country to ensure that the products are produced 
pursuant to the requirements of these regulations. The agency 
recognizes that any one of the affirmative steps may not be appropriate 
or feasible for a particular importer or foreign processor. The 
regulations allow importers to select an affirmative step that is 
workable for their circumstances and to develop appropriate affirmative 
steps other than those listed in the regulations (see 
Sec. 123.12(a)(2)(ii)(F)). However, such measures must provide at least 
an equivalent level of assurance of foreign processor compliance as 
that provided by the listed affirmative steps.
    Additionally, FDA has modified the importer requirements to allow 
for the performance of any of the affirmative steps by a competent 
third party (Sec. 123.12(b)). This provision provides even greater 
flexibility to importers in meeting the requirements of these 
regulations.
    Thus, FDA is not persuaded that the affirmative steps are not 
feasible or appropriate and has included them in these final 
regulations.
    124. A comment argued that government certificates should not be 
acceptable unless they are issued by countries with which FDA has 
signed an MOU or similar agreement. The comment asserted that, 
especially in developing countries, there may be different 
interpretations of the regulations, and differences in competency, 
credibility, infrastructure, intent, and uniformity that might bring 
the utility of such certificates into question.
    FDA acknowledges that it is likely to have a higher level of 
confidence in certificates received from a government entity with which 
it has signed an agreement than with one with which no agreement 
exists. However, as discussed above, it is unlikely that the agency 
will be able to negotiate an MOU with every country that exports 
seafood to the United States. Thus, there may be countries that have 
excellent certification programs with which FDA, for a variety of 
reasons, simply does not have an opportunity to enter into an 
agreement. Moreover, if the agency learns, either through its own 
routine surveillance activities, consumer complaints, or other means, 
that there is evidence that a country is routinely issuing certificates 
inappropriately, the agency will try to inform firms that import fish 
or fishery products from that country that it will expect them to use 
other means of verification if they want to avoid the appearance that 
those products are adulterated under section 402(a)(4) of the act (see 
Sec. 123.12(d)).
    125. One comment urged that certification be permitted on a 
continuing basis rather than requiring lot-by-lot certification.
    FDA agrees that continuing certification is appropriate and notes 
that the language and intent of the proposed regulations would have 
allowed for it. Nonetheless, in an effort to further clarify this 
situation, the agency provided in Sec. 123.12(a)(2)(ii)(B) that: 
``Obtaining either a continuing or lot-by-lot certificate * * *'' will 
be one way to satisfy the requirement that an importer take affirmative 
steps to ensure that the product is produced in accordance with the 
requirements of this part.
7. Foreign Processor HACCP Plans
    126. Approximately 15 comments addressed whether importers should 
be required to have on file copies of the HACCP plans of each of their 
foreign processors. Approximately half of these comments supported such 
a requirement, although for the most part they provided no reasons for 
their support. The other half objected to the requirement. One of these 
comments argued that possession of a foreign processor's HACCP plan 
would be cumbersome for the importer and would provide no assurance 
that product shipped by that processor was processed in accordance with 
the plan. One comment cautioned that it would be unrealistic to expect 
that importers could make any but a rudimentary judgment as to the 
adequacy of foreign processors' HACCP plans. Such judgments, these 
comments asserted, should be reserved for the regulator when the plans 
are assessed during inspections of importers' records.
    One comment cited the possibility of breaches in confidentiality 
because commercially sensitive material would be supplied to importers. 
A related comment suggested that, to solve the confidentiality problem, 
the foreign processors' HACCP plans should be filed directly with FDA 
rather than with importers.
    Although the agency continues to believe that a foreign processor's 
HACCP plan provides a useful basis for verification, FDA is persuaded 
by the comments that there are logistical and other issues that could 
render the retention of HACCP plans by importers unmanageable in some 
cases. FDA has also concluded that, in most cases, affirmative steps 
such as those listed in Sec. 123.12(a)(2)(ii) (e.g., onsite inspection 
by the importer and certification by a foreign government agency) will 
be adequate to enable an importer to verify that the products being 
imported are safe in accordance with the requirements of these 
regulations.
    As described previously, the NACMCF recommendations describe two 
primary goals of verification: (1) Ensure that the plan is adequate to 
address the hazards that are likely to affect the product; and (2) 
ensure that the plan is being consistently implemented. The affirmative 
steps listed in Sec. 123.12(a)(2)(ii) are designed to address both of 
these functions. For example, obtaining HACCP and sanitation monitoring 
records from the foreign processor (Sec. 123.12(a)(2)(ii)(A)) enables 
the importer to confirm that the foreign processor has addressed the 
relevant hazards and sanitation concerns (i.e., those for which there 
are monitoring records), and that it is monitoring to ensure that these 
concerns are under control during the production of lots that are 
shipped to the importer. Similarly, obtaining governmental or third 
party certification of foreign processor compliance with the 
requirements of these regulations (Sec. 123.12(a)(2)(ii)(B)) or 
inspecting the foreign processor directly (Sec. 123.12(a)(2)(ii)(C)) 
enables the importer to confirm that the foreign processor has an 
adequate HACCP plan and SSOP, and that the relevant sanitation and 
safety concerns are being controlled for those lots that are shipped to 
the importer. The affirmative step options provided for by 
Sec. 123.12(a)(2)(ii)(D) and (a)(2)(ii)(E) are discussed later in this 
section.
    Consequently, FDA has not included a requirement that importers of 
fish and fishery products have on file the HACCP plans of each of their 
foreign suppliers in these final regulations.
    Nonetheless, FDA points out that maintaining copies of these plans 
could be one of several measures that an importer could incorporate 
into its affirmative steps. Therefore, these final regulations in 
Sec. 123.12(a)(2)(ii)(D) incorporate the concept as one of the 
affirmative steps that an importer may choose to use for verification 
purposes.
    127. One comment noted that the plans of foreign processors would 
normally be prepared in the native language of the country of origin 
and asked whether FDA would require that these documents be translated 
into English. On the other hand, another comment recommended that HACCP 
plans be maintained in both the language of the native country and in 
English.
    FDA agrees with the comment that argued that a copy of a 
processor's HACCP plan would not, by itself, 

[[Page 65158]]
provide adequate assurance that a given shipment of imported product 
was processed in compliance with that HACCP plan or that the sanitation 
requirements of Sec. 123.11 were met. One additional thing is needed to 
provide such assurance: a written guarantee from the foreign processor 
that the products shipped to the importer are processed in accordance 
with these regulations. The guarantee is necessary to demonstrate that 
the HACCP and sanitation control systems are being implemented for 
products shipped to the importer. An importer should be able to make a 
reasonable judgement about the validity of the guarantee through a 
rudimentary review of the plan, as described below. Therefore, FDA is 
including these requirements in Sec. 123.12(a)(2)(ii)(D).
    FDA is also providing in Sec. 123.12(a)(2)(ii)(D) that the foreign 
processors' HACCP plans that are maintained by importers be written in 
English, so that they will be meaningful to the importer and will allow 
for regulatory review.
    128. As stated above, one comment cautioned the agency about the 
ability of many importers to evaluate the adequacy of HACCP plans that 
they might retain.
    FDA acknowledges that many importers may not have the technical 
expertise to evaluate the adequacy of seafood HACCP plans. However, the 
agency is convinced that, as a result of the importers' assessment of 
the food safety hazards that are reasonably likely to be presented by 
the product, the importer should have developed some general 
expectations about the content of the HACCP plan (e.g., which hazards 
should be addressed). The importer should be able to spot any obvious 
shortcomings and to discuss them with the foreign processor. It is not 
enough that importers simply file away the documents upon receipt. 
Importers may find it advantageous to make a judgment about the 
likelihood that their product specifications will be met and to insist 
that they be given a guarantee that contains assurances that the 
specifications will be met.
    129. Regarding the comment that complained about the potential loss 
of confidentiality of foreign processor HACCP plans that are provided 
to importers, since the agency has eliminated the requirement that all 
importers retain copies of foreign processor plans, the significance of 
this issue has been minimized. In the case where a foreign processor 
does not wish to share its plan with the importer, the processor and 
the importer would need to agree upon another means of providing for 
importer verification.
    130. Regarding the comment that suggested that all foreign 
processors file their plans with FDA, the resource demands on the 
agency that would come with such an undertaking would be prohibitive. 
FDA cannot accept this suggestion.
8. Other Affirmative Steps
    As a related matter, FDA has determined that, in the absence of a 
requirement that importers maintain a copy of the foreign processor's 
HACCP plan, finished product tests alone are insufficient as an 
importer affirmative step to ensure that the foreign processor is 
operating in accordance with these regulations. Finished product 
testing alone has a small statistical likelihood of detecting defects 
in a product, especially when the occurrence of such a defect is an 
uncommon event, as is the case with most seafood hazards (Ref. 213). 
The proposed requirement for the importer to obtain a copy of the 
foreign processor's HACCP plan, in addition to performing finished 
product testing, would have provided indirect evidence that HACCP 
controls are in place and would have lent support to a conclusion, 
based upon the analytical findings, that the relevant hazards are under 
control. In the absence of such evidence, the importer cannot 
reasonably conclude that the hazards are being controlled based solely 
on a negative analytical finding. For this reason FDA has required in 
Sec. 123.12(a)(2)(ii)(E) that such sampling be accompanied by a written 
guarantee from the foreign processor that products being shipped to the 
importer are processed in a manner consistent with the requirements of 
these regulations. The guarantee provides the importer with reasonable 
assurance that HACCP and sanitation controls are in place and are being 
implemented, in a manner similar to the way that the foreign 
processor's HACCP plan would have under the requirements of the 
proposed regulations. Under this alternative, the importer would not 
have to maintain a copy of the HACCP plan.
    For clarification and consistency within the document, FDA has 
revised the language of two of the affirmative steps to include 
reference to the sanitation provisions of the regulations. In both the 
proposed regulations and these final regulations the stated purpose of 
the affirmative steps is to enable the importer to verify that the fish 
or fishery product was processed under conditions that meet both the 
HACCP and sanitation requirements of these regulations. However, the 
formulations of two of the affirmative steps in the proposal did not 
make specific reference to sanitation. To avoid confusion over what the 
affirmative steps should cover, Sec. 123.12(a)(2)(ii)(A) now reads 
``Obtaining from the foreign processor the HACCP and sanitation 
monitoring records * * *'' and Sec. 123.12(a)(2)(ii)(B) reads ``* * * 
certifying that the imported fish or fishery product is or was 
processed in accordance with the requirements of this part.''
    131. Several comments asked the agency to specify the frequency 
with which the importer affirmative steps must be taken. A few comments 
suggested that the frequency should be no greater than the frequency of 
equivalent FDA verification activities.
    It would not be practical for the agency to specify frequencies for 
affirmative steps that would be appropriate in all circumstances. 
Consistent with the frequency of monitoring by processors, importers 
should take affirmative steps to monitor their suppliers with 
sufficient frequency to accomplish its purpose--that is, to provide the 
importer with reasonable assurance that the foreign processor is 
operating in compliance with these regulations.
    It would be inappropriate to tie importer affirmative step 
frequencies to average FDA sampling and inspection frequencies. FDA 
sample collection and inspection frequencies are determined, in part, 
by the compliance history of individual firms, agency priorities, and 
overall agency resources, not simply on a desired average minimum rate 
of verification. Thus, FDA's rate of inspection has no bearing on how 
frequently an importer should monitor a supplier.
    132. A number of comments urged that the agency permit importers to 
contract with third parties to perform verification activities on their 
behalf. Two comments opposed such a provision but did not provide 
reasons for their position.
    Several comments urged that certificates by nongovernmental third 
parties be accepted as an affirmative step. One of these comments, from 
a trade association, suggested that an equivalent arrangement has been 
accepted by FDA in controlling the importation of canned mushrooms from 
the Peoples Republic of China. This same comment argued that a system 
where individual importers inspect each of their suppliers is highly 
inefficient. The comment suggested that a single, technically competent 
party should perform the inspections. The trade association offered to 
serve as a 

[[Page 65159]]
clearinghouse for the reports of such inspections. Likewise, the 
association offered to serve as a clearinghouse for finished product 
sample results for imported products, reducing the number of samples 
needed when the same product is imported by a number of importers. The 
comment further suggested that the association be permitted to hold 
foreign processor HACCP plans for its members, and perhaps for 
nonmembers. The comment argued that acceptance of this suggestion would 
reduce the number of duplicate records for the same product stored by 
various importers.
    The agency accepts that third party verification can be an 
appropriate and efficient control mechanism. Such a system is 
consistent with the use of third parties by processors for plan 
development, record review, and CL deviation evaluation. Therefore, FDA 
has added a new provision at Sec. 123.12(b), that reads, ``An importer 
may hire a competent third party to assist with or perform any or all 
of the verification activities specified in paragraph (a)(2) of this 
section, including writing the importer's verification procedures on 
the importer's behalf.'' It is worth pointing out that where an 
importer uses the services of a third party, the importer remains 
responsible for the verification procedures that are performed. The 
importers must be able to demonstrate that appropriate verification 
measures have been performed. This step may involve providing an FDA 
investigator with a copy of the foreign processor's HACCP plan, results 
of end-product sampling, results of an onsite inspection, the foreign 
processor's monitoring records, or the foreign processor's written 
guarantee. Third parties must, of course, be competent to perform the 
duties in question, and FDA reserves the right to challenge such 
competency. The agency has no objection to the use of clearinghouses 
for importer verification activities, as long as the forgoing 
requirements are met.
9. Importer Records
    As previously mentioned, the proposed regulations would have 
required that importers develop and implement a HACCP plan. One effect 
of such a requirement would have been that importers would have had to 
maintain appropriate records. As has been explained, FDA is adopting 
only those essential components of the proposed approach that the 
agency considers to be practicable for importers. One such component is 
recordkeeping. Recordkeeping is essential in documenting for the 
benefit of importers and the agency the affirmative steps of importers, 
in the same way that it is essential in documenting the monitoring, 
corrective action, and verification activities of processors. For this 
reason, the agency has retained the recordkeeping aspect of the 
proposal for importers, in a manner that is consistent with the overall 
approach for importers in these final regulations. Section 123.12(c), 
which treats importer records identically to processor records, reads, 
``The importer shall maintain records, in English, that document the 
performance and results of the affirmative steps specified in paragraph 
(a)(2)(ii) of this section. These records shall be subject to the 
applicable provisions of Sec. 123.9.''
    133. FDA proposed that importers encourage foreign processors to 
obtain HACCP training. A few comments urged the agency to make it clear 
that foreign processors must comply with the same training requirements 
as are applicable to domestic processors. One comment urged the agency 
to permit HACCP- training courses for foreign processors to be 
conducted in the country of origin by ``an official agency.''
    FDA agrees that the need for training is the same for foreign 
processors as it is for domestic processors. The intended benefits of 
the training requirements are fully discussed in the ``Training'' 
section of this preamble. Nonetheless, the agency finds that the 
proposed requirement that importers encourage foreign processors to 
obtain training is unnecessary. Foreign processors that ship seafood 
products to the United States are advised of the training requirement 
of these regulations in the same way that they are advised of the other 
requirements of these regulations, through publication of the 
regulations. In addition, as mentioned elsewhere in this preamble, FDA 
intends to provide the embassies of seafood exporting countries with 
information concerning these regulations in order that they may in turn 
provide it to the processors in their countries. Consequently, FDA is 
not adopting this provision.
    FDA has no objection to HACCP training being performed in the 
country of origin by ``an official agency'' or other entity, as long as 
the course of instruction is at least equivalent to that provided by 
the standardized course under development by the Alliance.
10. Determination of Compliance
    FDA proposed to require that there be evidence that imported fish 
and fishery products were processed under conditions that comply with 
the requirements of these regulations, and that if assurances that this 
was the case did not exist, the product would appear to be adulterated 
and would be denied entry. This section of the proposed regulations 
provided five types of evidence that the agency would consider as 
adequate to provide such assurance.
    134. A few comments supported these provisions. However, a few 
comments suggested that, if the importer is unable to provide assurance 
that a HACCP system is in place, the importer should be permitted to 
conduct finished product testing rather than having the product denied 
entry. One comment urged that importers be held only to a ``best 
efforts'' standard in determining whether their suppliers are in 
compliance with these regulations. This comment suggested that if an 
importer cannot determine that such compliance exists after using its 
best efforts, the importer's product should not be banned from the 
United States.
    The purpose of these regulations is to cause processors of fish and 
fishery products, both domestic and foreign, to develop and implement 
HACCP systems of preventive controls to ensure the safety of their 
products. The importer requirements are designed to impose an 
obligation on importers to ensure that, like domestic products, the 
products that they are importing are not adulterated within the meaning 
of section 402(a)(4) of the act. This requirement means that importers 
must be able to satisfy themselves, and ultimately FDA, that the fish 
and fishery products that they are offering for import were produced 
subject to a HACCP system and sanitation controls designed to prevent 
insanitary processing conditions that may render the food injurious to 
health. If an importer does not have evidence that shows that the 
products were produced subject to such controls, it should not offer 
the product for import into this country. The lack of such evidence 
creates the appearance of adulteration that cannot be overcome by the 
collection and analysis of a finished product sample by an importer. 
Given the problems that can arise in seafood processing if HACCP and 
sanitation controls are not in place, under sections 402(a)(4), 701(a), 
and 801(a) of the act, FDA is adopting Sec. 123.12(d), which provides 
that if evidence does not exist that an imported fish or fishery 
product has been processed under conditions that are equivalent to 
those required of domestic processors, the product will appear to be 
adulterated.
    Section 123.12(d) derives from proposed Sec. 123.12 (a) and (b). 
FDA has combined these provisions and, as 

[[Page 65160]]
suggested by a comment, has used terminology consistent with the rest 
of the regulation in Sec. 123.12(d). While proposed Sec. 123.12 (a)(1) 
through (a)(5), which described the types of evidence that could be 
used to demonstrate compliance with the proposed regulations, reflected 
important principles for the importation of fish, based on the 
comments, FDA finds that these provisions were causing confusion, and 
that the statute can appropriately be implemented without including 
them in the final rule. For this reason, FDA has not adopted these 
provisions.
    135. One comment asked what documents, if any, would have to be 
presented to FDA at the time of entry concerning the status of the 
foreign processor. Another comment suggested that importers should note 
on the entry documents that a HACCP plan is available for the foreign 
processor. This comment stated that FDA would have an opportunity to 
review the plan as part of its determination of whether to allow entry 
of the product.
    FDA is not requiring that evidence of the importers' affirmative 
steps be presented along with the existing U.S. Customs Service entry 
documents as a matter of routine practice. It is possible that, in some 
circumstances, such a step will be necessary (e.g., where the agency 
has reason to believe that inappropriate conditions exist in the 
foreign processing facility). However, typically, the importer will be 
able to retain such evidence in its files and to make it available to 
the agency when FDA performs an inspection at the importer's place of 
business. Such a system is necessary because of the time that is 
necessary for the agency to properly review the importer's 
documentation of its affirmative steps and of the foreign processors' 
HACCP plans. Nonetheless, the agency is willing to explore alternate 
methods of implementing the import requirements of these regulations, 
such as that suggested by the comment. FDA welcomes a continuing public 
dialog about this matter.
    136. One comment asked whether FDA would maintain an approved list 
of foreign processors.
    The agency has no plans to maintain such a list, nor is it apparent 
upon what basis such a list would be prepared. A possible exception 
would be as part of an MOU arrangement, where the foreign country would 
agree to provide a list of ``approved'' firms to FDA. In such a 
situation, FDA would use reasonable means to inform the import industry 
of the purpose and contents of the list and update them as rapidly as 
possible when changes are made.
    137. One comment expressed concern that the same foreign processor 
HACCP plan might be reviewed by different FDA investigators in 
different ports of entry, and that these investigators might reach 
different conclusions as to its adequacy. The comment urged that the 
agency coordinate such reviews, as well as reviews of importers' 
affirmative steps, in a way that would minimize inconsistencies.
    FDA acknowledges that the situation might well arise where 
different investigators review the same foreign processor HACCP plan as 
a part of different importer inspections. To minimize inconsistencies 
in such reviews, the agency intends to train its inspectional staff in 
the requirements of these regulations and the application of HACCP 
principles to seafood processing, including training on the Guide. The 
agency also intends to develop guidance relative to importer 
verification activities.

M. Guidelines or Regulations?

1. Background
    FDA recognizes that many processors will need guidance in the 
preparation of HACCP plans, and that HACCP plans will vary in 
complexity. The agency is committed to providing the industry with 
technical assistance that includes general guidelines for HACCP plans 
and the contents of plans for specific types of products and processes.
    As part of FDA's seafood HACCP proposal, the agency included 
guidelines, in the form of appendices, on how processors of cooked, 
ready-to-eat products and products involving scombrotoxin-forming 
species could meet various provisions of the proposed regulations 
relating to the development and implementation of HACCP plans. FDA 
regards these products as being high-risk relative to other seafoods. 
They involve special considerations or special hazards for which 
additional guidance would likely be useful.
    Cooked, ready-to-eat fishery products present an elevated risk of a 
microbiological hazard compared to most other seafood products. They 
are cooked as part of processing and might not receive additional 
cooking by consumers before consumption. Consequently, to be safe, 
these products must not contain pathogens at a level that will cause 
disease and must not be subjected to time-temperature abuse that would 
allow any existing pathogens to grow to unacceptable levels.
    Scombrotoxin-forming species are fish that can form a toxin if 
exposed after death for significant periods to temperatures that permit 
the growth of certain bacteria. Scombrotoxin can result in a mild to 
severe allergic response in humans.
    The guidelines for these products contained advice about hazards 
that are reasonably likely to occur and on details for HACCP plans for 
the control of these hazards. In addition to asking for comments on the 
substance of the guidelines, the agency asked for comment on whether 
these guidelines should remain as guidelines, or whether some or all of 
them should be adopted as regulations. As regulations, they would, 
essentially, tell processors that certain hazards must be controlled in 
their HACCP plans, identify in advance critical points in the 
processing of these products that processors must control to minimize 
these hazards, and tell processors what they would have to do, at a 
minimum, to maintain proper control of those critical points.
    In another appendix to the proposed regulations, FDA published 
excerpts from the draft Guide, mentioned earlier in this preamble, for 
the stated purposes of publicizing the existence of that draft Guide 
and of providing processors with information about the types of 
guidance that the agency expected would be available in it.
    One of the excerpts that FDA published was guidance on the 
processing of smoked and smoke-flavored fish. These products represent 
a significant hazard relative to contamination with C. botulinum, 
especially when packaged in reduced oxygen atmosphere packaging. FDA 
requested comment on whether this guidance should remain solely within 
the Guide, whether it should be provided an appendix to the 
regulations, or whether it should be adopted as regulations. The effect 
of adopting these materials as regulations would be the same as for the 
appendices described above.
    If these materials remained in the form of guidelines, processors 
would be free to adopt them or not, so long as measures that provide an 
equivalent or superior degree of safety are implemented.
    138. Approximately 55 comments responded to FDA's request for 
comment on whether these materials should remain as guidelines or be 
adopted as regulations. The majority of comments preferred guidelines. 
A few comments suggested that FDA initially issue guidelines, then 
possibly convert them to regulations after gaining experience with them 
as adjuncts to a functioning HACCP system or after pilot testing them. 
A few comments preferred to retain some of the materials as 

[[Page 65161]]
guidelines and convert others to regulations.
    Over one-third of those who commented on this subject supported 
guidelines in general, without distinguishing among the three 
guidelines. They argued that guidelines are in keeping with the general 
philosophy of HACCP that processors assume responsibility for the 
safety of their products. Some stated that detailed regulations for 
processors to follow would not provide an adequate incentive to 
processors to develop a full understanding of the hazards associated 
with their products or processes. The result could be the development 
of rote HACCP plans that might be inadequate for safety in specific 
situations.
    Some comments pointed out that, while guidelines can assist 
processors to identify controls, guidelines probably could never 
properly identify the CCP's and limits for all processors given the 
uniqueness of individual processing methods. In the case of 
regulations, processors would be obliged to adhere to the presented 
limits regardless of their appropriateness to the operation. Many of 
these comments preferred the flexibility that guidelines provide in 
permitting HACCP controls to evolve with a changing knowledge base and 
new technologies. Some expressed concern that if the guidelines were 
adopted as regulations, the industry would bear an unnecessary burden 
of having to petition FDA for amendments in order to accommodate new 
products or processes. Modifications to the regulations could take 
considerable time.
    Several comments specifically objected to adopting either the 
guidelines for cooked, ready-to-eat products or the guidelines for 
scombroid toxin-forming species, or both, as regulations. The reasons 
were generally the same as those given by those comments that supported 
the use of guidelines generally.
    One comment did express the concern that adopting the scombroid 
guideline as regulations would have the effect of adopting a policy 
action level for histamine as a defacto regulation without a formal 
notice and comment rulemaking.
    Several comments requested that guidelines only appear in the 
Guide, and not in appendices to the regulations, to alleviate 
confusion.
    However, FDA did receive a number of comments that urged the agency 
to adopt these guidelines as regulations. These comments cited a need 
for minimum enforceable standards for these products to ensure the 
protection of the public health. The comments argued that minimum 
standards would avoid confusion about what is enforceable, and what is 
not. They pointed out that as regulations, these provisions could be 
more readily enforced.
    FDA believes that all of these comments have merit. Guidelines can 
provide flexibility that regulations sometimes lack. Moreover, because 
they are advisory in nature, guidelines are less likely to be followed 
by rote.
    FDA thus agrees that, ideally, HACCP should serve as a catalyst for 
processors to develop a full understanding of the relationships between 
their products and processes and human food safety and to devise 
controls for ensuring safety. There may well be more than one way to 
reach an appropriate safety endpoint. Regulations might not always take 
such alternatives into account.
    On the other hand, in those cases involving high-risk products 
where adherence to scientifically established minimum standards or 
procedures is necessary to ensure a safe product by design, and those 
minimums are not likely to change, there is good reason to make those 
minimums something more than advisories. In those types of situations, 
it makes no sense to act as if the work that scientifically established 
the minimum processing conditions had not been done.
2. Cooked, Ready-To-Eat Products and Scombroid Species
    These, then, are the considerations that FDA has weighed. In the 
case of cooked, ready-to-eat products and products made in whole or in 
part from scombroid toxin-forming species, FDA is persuaded that the 
guidelines should remain as guidelines, at least until there is enough 
experience with them to determine whether a change to regulations is 
warranted. The agency has concluded that processors should be given 
maximum flexibility, at least initially, to identify the reasonably 
likely hazards and the CCP's and CL's for those hazards that are most 
appropriate for their manufacturing processes. FDA will examine over 
time whether processors are achieving an adequate degree of preventive 
control for these products under the guidelines, and whether they are 
doing so by following the guidelines exactly or partially or by relying 
on alternative approaches.
    FDA acknowledges that many comments objected to the details of the 
appendices. These comments will be addressed when the first edition of 
the Guide is published. FDA recognizes that these materials will be 
more easily modified and improved if they remain as guidelines, at 
least for the time being.
    FDA agrees that all of these guidelines should appear solely in the 
Guide. There are no appendices to these final regulations.
3. Smoked and Smoke-Flavored Fishery Products
    The guidance for smoked and smoke-flavored fish contained specific 
processing parameters (i.e., time and temperature of smoking and 
finished product salt and nitrite concentrations) to be met in the 
processing of such products, and control mechanisms for ensuring that 
they are met. C. botulinum toxin production is prevented in smoked and 
smoke-flavored fish by controlling these interrelated variables, as 
well as by controlling the temperature of the product throughout the 
chain of distribution.
    139. Approximately 25 comments addressed whether these materials 
should be regulations or guidelines. About half of the comments, 
representing State and Federal regulatory agencies, professional 
associations, and others, urged that the materials be codified as 
regulations. The remainder, representing processors and trade 
associations, requested that the guidelines remain as guidelines.
    A number of the comments that urged that the smoked and smoke-
flavored fish guidelines be issued as regulations asserted that 
regulations are more easily enforceable, would provide clear direction 
to the industry, and would provide much needed nationwide uniformity in 
the processing of smoked fish. One comment from a State regulatory 
agency observed that processors are not adhering to existing 
guidelines, such as the 1991 recommendations for these products by 
AFDO, and are unlikely to change their operations in response to 
another guideline. Several comments argued that the States need Federal 
regulations to support their own efforts to regulate the industry and 
to foster uniformity among the various existing State requirements. One 
of these comments also stated that such regulations are needed to 
ensure the safety of smoked fish, because the product has a history of 
involvement in botulism outbreaks, is handled more than most other 
products, increasing the risk of microbiological contamination, and is 
frequently not cooked prior to consumption. One comment suggested that 
the guidelines be tested in pilot programs before making them 
mandatory, and that research information on smoked fish be disseminated 
to industry through 

[[Page 65162]]
technical bulletins, workshops, and meetings.
    Several of the comments that suggested that the proposed guidelines 
remain as guidelines argued that FDA has not demonstrated that present 
practices in the smoked fish industry are causing risks that would 
justify regulations, and that there have been no recent incidents of 
botulism attributable to smoked fish. Several comments stated that most 
of the problems with smoked fish in the past have resulted from abuse 
of the product at retail or by the consumer.
    A few comments objected to FDA's contention that large portions of 
the industry do not conduct final product testing and to the inference 
that all smoked fish processors do not monitor the composition of their 
products. The comments stated that responsible companies do conduct 
product testing on a regular and routine schedule, have scheduled 
processes, and are aware of what they are doing.
    Other comments recommended that FDA enforcement of the current 
CGMP's, coupled with State and local enforcement of the Food Code for 
smoked products that are produced in restaurants, retail, and food 
service establishments, would make it unnecessary to treat smoked fish 
products any differently than other products under these HACCP 
regulations. One comment suggested that guidelines would have the same 
impact as regulations because HACCP plans would be rejected by FDA if 
they do not contain the recommended controls, and because States would 
adopt the guidelines as regulations.
    One comment argued that the issuance of prescriptive regulations 
would eliminate the diversity in the types of smoked fish products 
available and result in a ``homogeneous'' market. Another comment 
counseled that the issuance of a regulation would cause Alaskan native 
salmon processors to abandon their traditional trade.
    The agency remains convinced that smoked and smoke-flavored fish is 
a potentially hazardous food. While cases of botulism have not been 
attributed to commercially prepared smoked or smoke-flavored fish in 
over 30 years, the outbreaks of the 1960's clearly demonstrate the 
potential for such occurrence. Virtually all the research that has been 
conducted establish that processors need to control time, temperature, 
and salinity (T-T-S) parameters and other matters for these products in 
order to provide adequate barriers to toxin production (Ref. 214).
    As the preamble to the proposed regulations pointed out, FDA and a 
number of States have longstanding concerns that the actions of a 
significant portion of the smoked fish industry do not demonstrate a 
full appreciation for the nature of the risks. FDA and New York State 
surveys of the smoked fish industry in the late 1980's, for example, 
showed that many processors did not routinely control their T-T-S 
parameters.
    The comments have not persuaded FDA that, even without regulations, 
processors will employ preventive controls to ensure the safety of 
these products as a matter of design and not of chance. Botulism 
derives from one of the most dangerous toxins known to exist. Controls 
to prevent the formation of this toxin cannot be left to chance. HACCP 
controls for this hazard are highly appropriate because HACCP requires 
that the processor analyze its operation to determine how hazards 
affecting its product can arise, and that it institute specific 
controls to prevent those hazards. The majority of comments that 
addressed smoked and smoke flavored fish products either supported the 
concept of HACCP controls or did not argue against them.
    140. The question, therefore, is whether, in addition to requiring 
HACCP plans for these products, FDA should mandate specific CCP's, 
minimum CL's, monitoring frequencies, and other matters that processors 
would have to include in their HACCP plans. If the agency were to 
codify draft guidelines as regulations, the agency would be answering 
that question in the affirmative. The preamble to the proposed 
regulations identified the T-T-S parameters in the draft guidelines as 
being scientifically established minimums for ensuring that toxin 
produced by C. botulinum will not be produced over the shelf life of 
the product under refrigerated conditions and under conditions of 
moderate temperature abuse. FDA has been urged for years to mandate 
such T-T-S parameters for these products. In 1988 and 1989, for 
example, AFDO passed resolutions asking FDA to expedite the development 
of regulations for the safe processing of smoked fish. The comments to 
this rulemaking that supported regulations over guidelines support the 
mandating of specific T-T-S parameters.
    However, a significant number of other comments challenged whether 
some of the parameters in the guidelines were actually minimums, as FDA 
had contended. They specifically objected to the minimum water-phase 
salt levels in the draft guidelines for air packaged smoked 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 little as 2.5 percent water phase salt (less 
than the minimum stated in the guidelines), and requested that FDA 
reexamine the existing scientific data. A few comments stated that air-
packaged smoked fish has a limited shelf life in the refrigerated state 
and that NMFS research has shown that spoilage occurs before toxin 
production. One comment stated that NMFS, New York State Department of 
Agriculture and Markets, and AFDO all consider a minimum water-phase 
salt content of 2.5 percent to be acceptable for air-packaged products.
    A few comments suggested that an alternative to specifying T-T-S 
parameters would be to require that all processors have a scheduled 
process for air-packaged products. The comment stated that this 
requirement has been successful in the State of New York and has 
enabled industry to produce products with water-phase salt 
concentrations that are lower than those proposed by FDA. A few 
comments suggested that the high salt levels proposed by FDA for smoked 
and smoke-flavored products would be counterproductive to those 
government programs aimed at reducing salt in the human diet and would 
be unacceptable, or only marginally acceptable, to consumers. Other 
comments suggested that the necessary minimum salt levels for smoked 
and smoke-flavored fish might be reduced by shortening the shelf life 
of the product or by storing and distributing the product frozen.
    The comments have persuaded FDA that it may be possible for 
processors to use parameters other than those in FDA's draft guidelines 
and still produce a safe product. Moreover, the NACMCF has recently 
endorsed AFDO's recommended parameters for smoked and smoke-flavored 
fish. Most notably, these recommendations differ from those in FDA's 
draft guidelines in that they provide for a minimum finished product 
water phase salt content in air-packed product of 2.5 percent, whereas 
the FDA proposal provided for a range of minimum values of from 2.5 
percent to 3.5 percent, depending upon other processing parameters.
    The agency acknowledges, therefore, that some recommended T-T-S 
parameters differ from those in FDA's draft guidelines. FDA 
acknowledges the possibility that other safe T-T-S parameters exist as 
well. It is reasonable to suppose that there is more to be learned 
about how the development of C. botulinum toxin is controlled in these 
products, given the lack of reported illnesses in recent years. Thus, 
while 

[[Page 65163]]
FDA strongly believes that the T-T-S parameters in its draft guidelines 
provide effective controls for botulism, the agency accepts that they 
are not necessarily the only effective controls, or that all effective 
controls have been identified.
    Consequently, the agency has concluded that, at least for now, the 
most appropriate place for such guidance on T-T-S parameters and 
related matters is the Guide, and that it would not be appropriate to 
adopt specific parameters for the processing of smoked fish by 
regulation. However, because of the extreme nature of the hazard, and 
in response to comments, FDA has chosen to codify a rudimentary 
performance standard for the control of botulism in these products from 
the draft guidelines (item number 11). As incorporated at subpart B, 
Sec. 123.16, the performance standard reads:

    In order to meet the requirements of subpart A of this part, 
processors of smoked and smoke-flavored fishery products, except 
those subject to the requirements of part 113 or 114 of this 
chapter, shall include in their HACCP plans how they are controlling 
the food safety hazard associated with the formation of toxin by C. 
botulinum for at least as long as the shelf life of the product 
under normal and moderate abuse conditions.

    This requirement responds in part to the comments that proposed 
that FDA require that all processors scientifically establish scheduled 
processes for smoked and smoke-flavored fish, rather that mandate 
specific T-T-S parameters and other matters. It requires processors to 
establish CL's that are both appropriate to their operation and 
scientifically sound. Because botulism is undoubtedly a hazard that 
must be controlled in the production of these products, subpart B of 
part 123 does not impose a requirement that would not exist in its 
absence. It has been included for emphasis and as a reminder to 
processors. The Guide will provide processors with assistance with 
regard to specific T-T-S parameters and related matters.
    141. FDA proposed that, with certain exceptions, fish to be smoked 
or salted be eviscerated and free of residual viscera. The preamble to 
the proposed regulations explained that salted or smoked uneviscerated 
fish present a potential hazard for the development of C. botulinum 
toxin production. The viscera of fish contain the majority of C. 
botulinum normally present.
    One comment argued that the entire evisceration provision should be 
moved to the Guide. Another comment suggested that specific 
evisceration requirements be codified but not as part of sanitation.
    These regulations require in subpart B of part 123 that the 
processors of smoked and smoke-flavored fish describe in their HACCP 
plans how they are controlling the food safety hazard associated with 
the formation of toxin by C. botulinum. Specific types of controls will 
be provided in the Guide. Because evisceration is one form of control 
for this toxin, it will be covered in the Guide as well and need not be 
included in the regulations. Consequently, FDA has not included this 
proposed provision in these final regulations.

N. Molluscan Shellfish

1. Background
    In addition to the general HACCP provisions in subpart A of part 
123, FDA proposed subpart C of part 123--``Raw Molluscan Shellfish,'' 
which set forth specific requirements for the processing of fresh or 
frozen molluscan shellfish. Proposed subpart C of part 123 described 
certain types of controls that processors of these products must 
include in their HACCP plans in order to meet the requirements of 
subpart A of part 123.
    Specifically, FDA proposed to require that processors of raw 
molluscan shellfish identify in their HACCP plans how they are 
controlling the origin of the molluscan shellfish that they process. 
FDA proposed to require that these controls include accepting only 
molluscan shellfish that originated from growing waters that are 
approved by a shellfish control authority, that are from harvesters 
that are licensed or from processors that are certified by a shellfish 
control authority, and that are properly tagged or labeled. In 
addition, FDA proposed to require that processors maintain records to 
document that each lot of raw molluscan shellfish meets these 
requirements. FDA also proposed to amend Sec. 1240.60 (21 CFR 1240.60) 
to provide for a system of tagging for shellstock and labeling for 
shucked molluscan shellfish as a means of source identification.
    It is important to note that shellfish control authorities in the 
United States are generally agencies of State governments, and that the 
tagging of molluscan shellfish is an important aspect of State 
shellfish control programs. As discussed below, reference to aspects of 
existing State programs in these Federal regulations is not intended to 
supplant or override the State programs in any way. Rather, these 
provisions are intended to strengthen the Federal system in ways that 
will complement, and thereby better support, State programs.
    Molluscan shellfish consumed raw or partially cooked pose unique 
public health risks. As the preamble to the proposed regulations noted, 
they probably cause the majority of all seafood-related illnesses in 
the United States. This situation is not unexpected, given the nature 
of the product and the way that it is consumed. The preamble documented 
a relationship between the microbiological quality of molluscan 
shellfish growing waters and the incidence of molluscan shellfish-borne 
disease. It also noted that naturally occurring toxins may accumulate 
in molluscan shellfish because they are filter-feeding animals.
    The NSSP was established as a cooperative program among FDA, State 
regulatory agencies, and the molluscan shellfish industry, relying on 
section 361 of the PHS Act (42 U.S.C. 264), to provide for the 
classification and patrol of shellfish growing waters and the 
inspection and certification of shellfish processors. The preamble to 
the proposal reaffirmed FDA's support for the NSSP but noted the 
difficulties that are associated with ensuring the safety of these 
uncooked products. As the preamble stated, FDA tentatively determined 
that it could strengthen and provide additional support for the 
cooperative program through these regulations.
2. Should There Be Specific Requirements for Raw Molluscan Shellfish?
    FDA received approximately 45 comments about the proposed 
requirements for raw molluscan shellfish. The responses were from 
processors, trade associations, State and Federal government agencies, 
individuals, consumer advocacy groups, and a foreign country. 
Approximately half of these comments urged FDA to eliminate proposed 
subpart C of part 123 and the proposed amendment to Sec. 1240.60, while 
the other half acknowledged the advisability of including these kinds 
of provisions but commented on, or questioned, various specifics of 
them.
    The comments that generally supported the need for specific 
requirements for raw molluscan shellfish were from trade associations, 
molluscan shellfish industry members, consumer advocacy groups, Federal 
and State government agencies, individuals, and a professional 
organization. A number of comments noted that special requirements for 
molluscan shellfish are warranted because of the association of these 
products with illness. One 

[[Page 65164]]
comment in particular stated that, with respect to seafood, molluscan 
shellfish ``serve as the primary source of illness due to ingestion.'' 
One comment noted that Federal regulations relating to source of origin 
controls for raw molluscan shellfish would enable FDA to lend support 
to the States in the administration of the NSSP. Another comment 
suggested that the proposed regulations would improve FDA's regulatory 
effectiveness with regard to molluscan shellfish control. The comment 
from the ISSC stated that ``The Conference has long recognized and 
supported expansion of FDA authority to assist States in assuring the 
safety of molluscan shellfish.''
    The comments that suggested that subpart C of part 123 and the 
amendment to Sec. 1240.60 be deleted were from State government 
agencies and seafood processors. A number of the comments that 
suggested deletion of the proposed provisions stated that the tagging 
and labeling requirements of the NSSP are designed not to serve as a 
control to prevent harvesting from closed areas but to assist States in 
tracing shellfish that are implicated in illness outbreaks back to the 
harvest area. The comments went on to state that harvesters who 
illegally harvest from closed waters do not identify the shellfish as 
originating from the closed area. The comments maintained that 
preventing illegal harvesting is the key to reducing the incidence of 
illness, and that the only known method to achieve this goal is through 
effective law enforcement, including the patrol of closed waters.
    A number of these comments argued that increased FDA funding and 
support for State molluscan shellfish control and patrol efforts would 
do more than the proposed rule to deter illegal harvesting, to increase 
States' compliance with the NSSP, and reduce the number of illnesses 
caused by molluscan shellfish. The comments went on to state that the 
proposed regulations unnecessarily duplicate the requirements now in 
place in the Manual of Operations for the NSSP. They contended that 
formal adoption of NSSP requirements into Federal regulations would 
release State agencies from their cooperative relationship with FDA 
under the NSSP.
    One comment noted that the weaknesses in State molluscan shellfish 
control programs are in areas not addressed by the proposed 
regulations, such as improperly classified growing waters; the ability 
of State growing water classification programs to respond to breakdowns 
at waste water treatment facilities or unexpected climatic events that 
affect the quality of molluscan shellfish growing waters; and improper 
handling by caterers and consumers. The comment concluded that the 
proposed HACCP provisions for molluscan shellfish will, therefore, not 
reduce the incidence of illness attributable to such products.
    As previously mentioned, FDA is a partner with State and foreign 
regulatory authorities and with industry in the NSSP. The NSSP Manual 
of Operations provides the standards for State and foreign molluscan 
shellfish regulatory programs that belong to the cooperative program, 
as well as for processors. The participating States routinely adopt 
those standards as law or regulations, but the NSSP itself has neither 
Federal nor State regulatory stature.
    Each participating State and foreign nation classifies and monitors 
its molluscan shellfish growing waters, controls harvesting, inspects 
molluscan shellfish processors, and issues certificates for those that 
meet the shellfish control authority's criteria. FDA evaluates State 
and foreign molluscan shellfish control programs and publishes monthly 
the ``Interstate Certified Shellfish Shippers List,'' which lists the 
molluscan shellfish processors that are certified under the cooperative 
program. States that are in the program are not willing to receive 
shellfish from noncertified shippers.
    FDA disagrees with the comments that suggest that establishment of 
the proposed source controls in Federal regulations would supplant the 
similar and, in some cases more stringent, requirements of 
participating States and foreign nations or the standards set forth in 
the NSSP. Rather, the agency is convinced that they will reinforce and 
support these requirements and standards.
    The molluscan shellfish industry is subject to significant 
regulatory oversight in those States that participate in the NSSP. 
However, the quality and effectiveness of State laws and enforcement 
activities can vary considerably as a function of the financial and 
administrative support available to the responsible State units (Ref. 
7, p. 15). For example, FDA documented discrepancies in State 
enforcement practices during its 1994 evaluation of State programs to 
determine compliance with the NSSP standards (Ref. 215). Moreover, 
although all harvesting States participate in the NSSP, many other 
States do not.
    Based on these factors, FDA proposed, and is now adopting, subpart 
C of part 123 and amendments to Sec. 1240.60 to support and strengthen 
the shellfish program in two ways. First, these provisions will 
complement the efforts of the States. FDA recognizes that while States 
are making significant and important efforts to ensure that all 
shellfish harvested in their jurisdiction are taken only from open 
waters and then properly tagged, some shellfish that do not meet these 
requirements inevitably escape State control. The new provisions will 
allow FDA to take action against shellfish that are not harvested from 
open waters or that are not properly tagged if it encounters such 
shellfish in interstate commerce and make the gravamen of such action 
the origination from unopen waters or the lack of proper tagging 
itself, rather than evidence that the shellfish are injurious to 
health.
    Second, the regulations require that processors only use shellfish 
that originate from growing waters that have been approved for 
harvesting and that have been properly tagged. Failure to do so can 
result in Federal regulatory action against the product or against the 
processor itself. This fact should provide a significant incentive to 
processors to ensure that they are not receiving shellfish that do not 
meet these requirements.
    Taken as a whole, rather than diminishing in any way the importance 
of State programs, FDA's regulations elevate the importance of those 
programs. These regulations make proper origin and tagging--concepts 
that derive directly from the NSSP--keys to the unimpeded movement of 
shellfish in interstate, as well as intrastate, commerce.
    Moreover, these requirements extend these control measures to 
imported products, enabling FDA to more efficiently and effectively 
ensure the safety of imported raw molluscan shellfish. At present, the 
agency must resort to advising State regulatory authorities of the 
prospective entry of raw molluscan shellfish from an uncertified source 
(Ref. 216, part V, p. 5). While States normally take action against 
uncertified imported raw molluscan shellfish, FDA is aware that 
uncertified imports enter interstate commerce (Ref. 107).
    FDA acknowledges that uniform Federal tagging and record-keeping 
requirements will not completely eliminate illegal harvesting. The 
agency agrees with the comments that rigorous enforcement of closed 
area restrictions by State regulatory agencies will always be needed. 
Unquestionably, increased funding would help State efforts to classify 
and patrol growing areas. However, FDA does not have resources for this 
purpose. Nonetheless, the agency remains convinced that there are 

[[Page 65165]]
significant, positive steps that can be taken to strengthen source 
controls as part of HACCP, and thereby to support the cooperative 
program.
    A processor's most significant safety control for raw molluscan 
shellfish is at the point of receipt. If processors refuse to accept 
molluscan shellfish for which there is no assurance that they have been 
legally harvested, the incentive for illegal harvesting would be 
eliminated. FDA participation in a number of covert investigations into 
illegal molluscan shellfish harvesting in recent years has convinced 
the agency that, in many cases, processors are aware of the illegal 
harvesting activity of their suppliers (Ref. 217). If the provisions of 
these regulations can help foster a culture change in that respect, 
shellfish safety will be significantly enhanced.
    Based on these considerations, the agency proposed that, as a 
universal aspect of the HACCP plans for these products, molluscan 
shellfish processors engage in certain activities to ensure that the 
products that they receive originate only from waters that have been 
approved by a shellfish control authority (e.g., checking tags on 
containers of shellstock, licenses of fishermen, and certification of 
suppliers). Molluscan shellfish that are clearly improperly tagged or 
from questionable sources must be rejected by processors as a 
requirement of their HACCP plans. It is reasonable to conclude that, as 
more processors adopt HACCP and exercise greater control over their 
suppliers, the amount of illegally harvested shellfish offered for sale 
will decrease, because the market for such product will decline.
    While it is true that the tagging requirements of the NSSP were 
primarily designed as a means of tracing back molluscan shellfish 
involved in incidences of illness to their harvest area, they have also 
served as a key component in efforts by FDA and State regulators and 
industry to ensure that molluscan shellfish that are placed in commerce 
originate from areas that are approved by a shellfish control 
authority. It is certainly true that the tags on containers of 
molluscan shellfish that are harvested from closed waters are often 
falsified to disguise their true origin. However, such falsification 
carries potential Federal and State penalties and is a focus of current 
molluscan shellfish control programs.
    Regarding the comments that pointed to weaknesses in State 
programs, at retail, in the classification of molluscan shellfish 
growing waters, and elsewhere, which are not directly addressed by 
these regulations, the agency acknowledges that HACCP plans and 
specific source control requirements cannot serve as a substitute for 
improvements in the food safety system that directly address these 
weaknesses. Regulatory systems will always have their strengths and 
weaknesses, and research to better understand and control hazards will 
always be needed. Nonetheless, these comments provide no reason for FDA 
to abandon its efforts to remedy existing agency weaknesses and, in 
particular, to lend support to the States in those areas to which these 
regulations do relate.
    141. One comment stated that references cited in the preamble to 
the proposed regulations in support of the tagging requirements (Refs. 
102 through 109) do not provide convincing evidence of a need for such 
a measure. The comment stated that, for the most part, the references 
that FDA cited document corrective actions taken by State regulatory 
agencies that would likely be the same measures that FDA officials 
would take under the proposed regulations. In addition, the comment 
stated that a failure to have properly tagged shellfish does not always 
mean that the shellfish were harvested illegally. The comment pointed 
out that the absence of a tag could mean simply that the tag was lost.
    The references in the question contain examples of problems 
associated with molluscan shellfish tagging, recordkeeping, and 
harvesting. FDA cited these references to demonstrate that, in some 
cases, the deterrent effect of existing State tagging requirements and 
sanctions is inadequate to prevent problems from arising (Refs. 102, 
103, and 109). The problems documented in the references helped 
persuade FDA to propose Federal source control requirements to help 
deter the interstate shipment of shellfish from unapproved harvest 
areas. FDA did not intend to imply that the State actions that were 
documented in these references were incorrect, or that FDA would have 
responded in a different manner. FDA continues to believe that the 
references are relevant and supportive to its intended assertion.
    A few comments maintained that a better strategy for decreasing 
illness from the consumption of molluscan shellfish would be to 
increase the education efforts of FDA and of the ISSC that are directed 
toward consumers and the medical community to alert susceptible 
individuals to the risks associated with the consumption of raw 
molluscan shellfish.
    The agency agrees that consumer education can play a vital role in 
reducing illnesses associated with the consumption of raw molluscan 
shellfish, particularly in medically compromised individuals. During 
the period of 1984 through 1994, the agency expended nearly $1 million 
to alert the public to the risks of raw molluscan shellfish consumption 
by distributing brochures to consumer groups, groups that represent 
those with special medical conditions, and consumers; developing a 
video news release; issuing press releases; and establishing the toll-
free, FDA Seafood Hotline. Included in this expenditure is the agency's 
efforts to inform the medical community about the illnesses associated 
with the consumption of raw molluscan shellfish by providing 
informative articles to medical bulletins and journals and by mailing 
brochures and news articles to target professional groups. The agency 
will continue its consumer education efforts, but such efforts alone 
will be insufficient to address the hazards posed by the consumption of 
raw molluscan shellfish harvested from unapproved growing waters. The 
existing and planned consumer education efforts are geared toward 
individuals in high-risk consumer groups, advising them to avoid 
molluscan shellfish that have not been fully cooked. The risks posed by 
viruses, toxins, and many bacteria are to the population as a whole. 
There is little advice that the agency could provide that would enable 
consumers to protect themselves from these kinds of hazards in 
molluscan shellfish.
    143. Several comments questioned the validity of FDA's statement 
that molluscan shellfish consumed raw or partially cooked pose unique 
public health risks and probably cause the majority of all seafood-
related illnesses in the United States.
    The comments provided no data upon which to conclude that either 
the NAS or FDA is wrong in this regard. FDA remains convinced that the 
statements made in the preamble to the proposed regulations are valid, 
and that the references support these statements.
3. Cooked Versus Raw Molluscan Shellfish
    144. Comments from a number of State agencies, trade associations, 
seafood processors, and the ISSC objected to the use of the terms 
``raw'' and ``fresh or frozen'' in the title of part 123 subpart C and 
the text of the proposed regulations on shellfish. These comments were 
concerned because these terms would have the effect of exempting canned 
and any other heat- processed molluscan shellfish from the source 
control, recordkeeping, and 

[[Page 65166]]
tagging provisions of subpart C of part 123 and Sec. 1240.60(b).
    The comments stated that limiting these provisions to raw products 
would allow foreign firms to continue to heat-treat or can molluscan 
shellfish that are harvested from foreign waters that do not meet NSSP 
standards and to export them to the United States. The comments stated 
that this situation was not in the best interest of the public health 
because of the potential for the presence of heat-stable natural 
toxins, such as paralytic shellfish poison or amnesiac shellfish 
poison, as well as chemical contaminants. The comments also complained 
that, because State laws and regulations require that all molluscan 
shellfish harvested in the United States come from waters approved by a 
shellfish control authority regardless of whether they are to be 
consumed raw or cooked, continuing to allow foreign processors who 
export cooked shellfish to the United States to use molluscan shellfish 
from unapproved growing waters places the domestic shellfish industry 
at a competitive disadvantage. Other comments requested that FDA 
clarify whether canned shellfish were included in subpart C of part 123 
but did not suggest that canned and other heat-processed shellfish be 
included.
    FDA has responded to these comments generally in response to 
comment 34, supra. The agency adds the following points:
    It is important to recognize that foreign processors who export 
cooked molluscan shellfish to the United States now will have to have 
HACCP systems through which they identify and control hazards that are 
reasonably likely to occur. These hazards include heat stable toxins 
and chemical contaminants that would cause these products to be 
adulterated under U.S. law.
    To further clarify that the requirements of subpart C of part 123 
apply only to the processing of molluscan shellfish that are not heat 
treated or treated in some other manner by the processor to eliminate 
microorganisms of public health concern, FDA has modified the language 
at Sec. 123.20 to read, ``This subpart augments subpart A of this part 
by setting forth specific requirements for processing fresh or frozen 
molluscan shellfish, where such processing does not include a treatment 
that ensures the destruction of vegetative cells of microorganisms of 
public health concern.''
4. Shellfish Control Authorities
    FDA proposed to require that processors only process molluscan 
shellfish that originate from waters approved for harvesting by a 
shellfish control authority. The term ``shellfish control authority'' 
is defined at Sec. 123.3(o) to include foreign government health 
authorities that are legally responsible for the administration of a 
program that includes classification of molluscan shellfish growing 
areas.
    145. Two trade associations questioned how a processor could 
evaluate the competency of a foreign shellfish control authority. They 
stated that FDA should require that a foreign country that exports 
shellfish to the United States have an agreement with the agency that 
establishes that a competent shellfish control authority exists in that 
country, and that the foreign shellfish program meets NSSP standards. 
One comment from a seafood processor argued that it would be 
unreasonable to require processors to verify that molluscan shellfish 
from all over the world are caught or cultivated in waters that meet 
NSSP standards. The comment stated, moreover, that a processor could 
not keep abreast of which countries have current shellfish agreements 
with FDA and which countries do not.
    FDA acknowledges the merits of requiring that a foreign country 
that exports shellfish to the United States have an agreement with the 
agency but has concluded that, given the significance of such a 
requirement and the agency's failure to raise the possibility of 
imposing it in the proposal, it is beyond the scope of this rulemaking. 
Even though FDA is not imposing such a requirement, it is the case that 
the only means by which a processor can ensure that the molluscan 
shellfish of foreign origin that it receives are in compliance with the 
requirements of subpart C of part 123 of these regulations is by 
determining whether the foreign shellfish control authority is formally 
recognized by FDA. It is not likely that the processor could employ any 
other process that would give it assurance that molluscan shellfish 
harvesting waters that are approved by the shellfish control authority 
are properly classified. Such a determination is appropriately 
performed through government to government audit.
5. Shellfish From Federal Waters
    146. Comments from a significant number of trade associations and 
seafood processors stated that a requirement that shellfish originate 
only in waters ``approved for harvesting by a shellfish control 
authority'' would preclude harvesting in Federal waters unless the 
Federal government introduced a formal approval process for waters 
under its purview through a Federal shellfish control authority.
    Under the current system, State agencies are responsible for 
approving molluscan shellfish growing waters. However, State 
jurisdiction extends only to waters that are within three miles of the 
shore. Waters beyond that point but up to 200 miles offshore are under 
the jurisdiction of the Federal government. The comments pointed out 
that the harvesting of molluscan shellfish is permitted in all of the 
oceanic waters under Federal control unless there is a specific Federal 
action to declare an area unsafe under the provisions of the Magnuson 
Fishery Conservation and Management Act. The comments further noted 
that large volumes of molluscan shellfish are harvested in Federal 
waters.
    How Federal waters will be classified, and by whom, has not been 
fully resolved. The comments are correct that the proposed requirement, 
if incorporated into the final rule, would pose significant problems 
for molluscan shellfish processors who receive product harvested from 
Federal waters. Therefore, FDA has modified Sec. 123.28(b) to allow for 
the receipt of molluscan shellfish that are harvested in U.S. Federal 
waters except where such waters are specifically closed to harvesting 
by an agency of the Federal government. This provision is consistent 
with the provisions of the Magnuson Act.
    It is worth noting that, by allowing Federal waters to be open 
unless they are specifically closed, this system is the opposite of the 
State system, under which waters are closed unless they are 
affirmatively classified so as to be open. This difference is 
reasonable from a public health standpoint because there is less 
likelihood that Federal waters will be affected by pollution than will 
near shore State waters.
    Furthermore, because there is no Federal authority to license 
shellfish harvesters who fish in Federal waters, FDA has modified 
Sec. 123.28(c) to require only that a harvester be in compliance with 
such licensure requirements as may apply to the harvesting of molluscan 
shellfish, rather than specifically requiring licensure.
6. Tagging and Recordkeeping Requirements
    147. FDA proposed recordkeeping requirements for processors to 
follow with respect to shellstock and shucked molluscan shellfish in 
Sec. 123.28 and requirements for the information to be included on the 
shellstock tag in Sec. 1240.60. A few comments stated that 

[[Page 65167]]
the proposed molluscan shellfish tag and record requirements were too 
specific, and that placing such requirements in the form of regulations 
would make it difficult to make timely changes to these requirements as 
future needs may dictate. The comments asserted that FDA or the ISSC 
may wish to modify the content or form of molluscan shellfish tags or 
records to improve product traceability. They suggested that FDA write 
the tagging and recordkeeping requirements at Sec. 123.28 and 
Sec. 1240.60 in general terms and allow the specific form and 
information required on the tags to be addressed by the NSSP. The 
comments went on to urge that, if the agency were determined to include 
specific tagging and recordkeeping requirements as part of the final 
regulations, they should be fully consistent with current NSSP 
guidelines.
    It is not the agency's intent that the provisions of Sec. 123.28 
and Sec. 1240.60 would preclude the ISSC or State agencies from 
adopting additional recordkeeping or tagging requirements. The 
recordkeeping and tagging requirements in these regulations are the 
minimum necessary to ensure that shellfish can be traced through 
distribution channels, back to the harvest source. FDA explained why 
each of the specific requirements is necessary in the preamble to the 
proposed regulations, and the comments did not take issue with the 
agency's explanation with respect to any of the particulars. Therefore, 
FDA disagrees with the comments that the recordkeeping or tagging 
requirements are more restrictive than they need to be, or that they 
would interfere with the NSSP tagging program.
    Moreover, as stated previously, the agency has drafted the 
regulations broadly enough so as not to conflict with any improvements 
that the ISSC may wish to make in the form that a tag may take or in 
how information on tags is to be stored. The definition of the word 
``tag'' at Sec. 123.3(t) (added at Sec. 1240.3(u) for consistency) 
reads, in part, ``a record of harvesting information attached to a 
container of shellstock * * *.'' This definition is sufficiently broad 
to include such systems as bar codes, embossed plastic, or other 
nontraditional methods of identification that may be used by the 
industry in the future. The agency is supportive of efforts to improve 
the existing methods of recording harvesting information.
    Nonetheless, it is important for the regulations to identify the 
minimum specific information that must appear on a tag. During past 
illness outbreaks, FDA, State regulatory agencies, and industry have 
had difficulty tracing the implicated shellfish to their sources, 
especially after they have been in the possession of several different 
processors (Refs. 99; 100; 102-106; 109; 218; and 219, pp. 37-39). 
These difficulties in tracing the shellfish have occurred because the 
shellfish were not in compliance with the tagging and recordkeeping 
provisions of the NSSP. The requirements at Sec. 123.28 will enable FDA 
to help the States to enforce minimum tagging and recordkeeping 
requirements for imported and domestic products. Moreover, the agency 
believes that placing the tagging and recordkeeping requirements in 
Federal regulations will emphasize the nationwide importance of this 
information in protecting the public health, as described earlier.
    148. One comment noted that the NSSP does not specify that the name 
of the harvester must be on a molluscan shellfish tag, but that the 
proposed regulations would require this information.
    The NSSP specifies that the number assigned to the harvester by the 
shellfish control authority must be listed on the tag. The agency 
recognizes that there may be a variety of effective ways to identify 
the harvester of the molluscan shellfish, depending on the method of 
harvest, State requirements, and local tradition. For this reason, the 
agency has modified Sec. 1240.60(b) to read that the tag shall 
disclose:

* * * by whom they were harvested (i.e., the identification number 
assigned to the harvester by the shellfish control authority or, if 
such identification numbers are not assigned, the name of the harvester 
or the name or registration number of the harvester's vessel).

For consistency, FDA has made a similar change in Sec. 123.28(c)(5).
     149. A significant number of comments recommended that FDA modify 
Sec. 1240.60(b) to allow bills of lading or other shipping documents to 
accompany bulk shipments of shellstock in lieu of tags, as long as they 
provide the same information. A few comments suggested that bills of 
lading or other shipping documents be used in lieu of tags on 
individual containers of shellstock when a shipment consists of a large 
volume of shellstock in sacks or boxes. Several comments asked for 
clarification of the impact of the proposed requirements on current 
repacking operations that commingle shellstock from various harvesters 
into one container.
    FDA recognizes that an inconsistency existed between proposed 
Sec. 123.28 and proposed Sec. 1240.60 because the former would have 
allowed shipping documents to provide the required information for bulk 
shipment, and the latter would not. FDA agrees with the comments that 
recommended providing for the use of shipping documents and has 
modified Sec. 1240.60(b) to provide the needed consistency. Under 
existing industry practice the truck, cage, or vessel hold serve the 
same purpose as a container for the shellstock, making tagging 
impractical. In that case, the shipping document serves the same 
function as the tag.
    However, the agency does not agree with the suggestion that 
containers of shellstock in large shipments be allowed to be covered by 
shipping documents in lieu of tags. FDA cannot justify treating 
shellstock in large shipments differently than shellstock in smaller 
shipments, nor could the terms ``large'' or ``small'' be readily 
defined. Large shipments can be subdivided, perhaps many times, or 
commingled with other lots of molluscan shellfish. The source 
information would, therefore, be necessary on each container to ensure 
proper identification. Without tags, the identity of individual 
containers could be lost. FDA is requiring that all shellstock, even 
after repacking, bear a tag that identifies the prescribed information, 
including the identification of the harvesters to ensure that all 
shellstock is readily traceable (Sec. 1240.60).
7. Other Considerations
    150. Comments from a few trade associations and from seafood 
processors stated that FDA should require a production code on each 
container of shucked molluscan shellfish. The comments suggested that 
the code consist of an identifying mark that allows the processor to 
determine where the remainder of the lot was shipped, and where and 
when the relevant shellstock was harvested.
    FDA agrees that production codes can be useful on containers of 
shucked molluscan shellfish to facilitate trace back of questionable 
product. The agency encourages the use of codes by molluscan shellfish 
processors. However, such a requirement is not within the scope of the 
proposed regulations. The agency will consider whether such a 
requirement should be pursued in a separate rulemaking.
    151. Comments from several consumer groups stated that if a warning 
label is not mandated by FDA on raw molluscan shellfish to alert at-
risk consumers of the danger to health posed by the product, FDA should 
require that Gulf Coast oyster processors adequately cook the product 
to 

[[Page 65168]]
eliminate risks from Vibrio vulnificus during periods when shellfish 
cannot be harvested free from this bacterium. They further stated that 
cooking should not be required when the shellfish are free from this 
bacterium.
    FDA agrees that effective controls are needed to protect consumers 
from the hazard posed by V. vulnificus in Gulf Coast oysters during 
certain times of the year. The agency is evaluating the potential 
effectiveness of a variety of control mechanisms. Mandating specific 
mechanisms, however, would be outside the scope of this rulemaking. FDA 
is therefore taking these comments under advisement.
    152. A few comments urged that the word ``processor'' be changed to 
``certified dealer and licensed harvester'' throughout Sec. 123.28 to 
make the terminology consistent with the NSSP and to clarify that these 
requirements apply to everyone who buys and sells shellfish before the 
shellfish reach the retail marketplace. The comments also recommended 
changing the word ``shipper'' to ``processor or packer'' in the 
provision that is codified at Sec. 123.28(d)(3) in these final 
regulations to include the shucker, repacker, shipper, reshipper, or 
depurator.
    As mentioned in the ``Definitions'' section of this preamble, the 
agency has concluded that the definition for ``processor'' covers all 
NSSP classifications of shellfish dealers, without specifically naming 
each one. For consistency throughout the regulations, use of the term 
will remain unchanged.
    FDA agrees, however, that the word ``shipper,'' as the agency used 
it in the proposed regulations, could cause confusion because that term 
has a different meaning in the NSSP Manual of Operations. Therefore, 
FDA has changed the language of the final regulations to read ``packer 
or repacker.'' The certification number of the packer or repacker is 
readily available to the processor since it is required, under the NSSP 
standards, on each label of shucked product. For consistency, FDA has 
modified Sec. 1240.60(c) to also read ``packer or repacker'' where it 
had previously read ``processor.''
    153. A few comments stated that proposed Sec. 123.28(b), which 
referred to molluscan shellfish that ``originate from growing areas 
that are approved for harvesting,'' appears to prohibit processors from 
using products from harvest waters classified under the NSSP as 
``conditionally restricted.'' Under the NSSP, shellstock taken from 
such waters cannot be directly marketed for human consumption but can 
be ``relayed'' to an open growing area for harvest at a later date. In 
addition, the comments pointed out that the word ``approved'' is a 
formal classification designation used in the NSSP. These comments said 
that harvesting is permitted from areas with other than ``approved'' 
classifications but would appear to be prohibited under the provisions 
of proposed Sec. 123.28(b). The comments suggested use of the term 
``open'' growing waters, which would apply to several different NSSP 
harvest area classifications.
    FDA agrees that the word ``originate'', as used in proposed 
Sec. 123.28(b), is too restrictive and has revised this section to say 
``harvested from.'' With regard to the word ``approved,'' FDA concludes 
that no change is warranted. The proposal neither adopted nor 
referenced the NSSP growing water classification system. The phrase 
``approved for harvesting'' should not be construed to be limited to 
those waters classified by a State under the NSSP as ``approved'' 
areas. The phrase ``approved for harvesting'' is used in the final 
regulations for its common sense meaning (i.e., those areas from which 
harvesting is allowed), which FDA believes is appropriate.
    154. For clarification purposes, definitions for the terms 
``certification number'', ``shellfish control authority'', and ``tag'' 
have been added at Sec. 1240.3(s), (t), and (u), respectively. These 
definitions are taken directly from Sec. 123.3.
    155. One comment urged that the regulations be modified to 
specifically state that a HACCP plan for raw molluscan shellfish that 
contains the controls specified in subpart C of part 123 is deemed to 
meet the requirements of Sec. 123.6.
    The agency disagrees with this comment. The requirements of subpart 
C of part 123 are designed to control the environmental hazards 
associated with the harvest waters from which molluscan shellfish are 
taken, particularly those relating to sewage- related pathogens, 
chemical contaminants, and natural toxins. For this reason, they must 
be included in the HACCP plans of all raw molluscan shellfish 
processors. However, they are not intended to control process-related 
hazards resulting from, for example, time-temperature abuse of the 
product, improper use of food additives, or metal fragments. To control 
these hazards, the processor needs to follow the general approach set 
out in subpart A of part 123. The agency has developed the two subparts 
to be complementary and has strived to eliminate any redundancy in 
their provisions. Thus, it is theoretically possible that a HACCP plan 
that contains the controls specified in subpart C alone of part 123 
still might not meet all the requirements of Sec. 123.6.
    FDA has made two modifications in Sec. 1240.60(b) for clarity only. 
Where the proposed regulations required that the tag identify the ``* * 
* place where harvested * * *,'' FDA has added, ``(by State and 
site).'' This change makes Sec. 1240.60(b) consistent with 
Sec. 123.28(c)(2). Additionally, where the proposed regulations stated 
that improperly tagged or labeled product would be ``subject to seizure 
and destruction,'' FDA has amended the language to read, ``subject to 
seizure or refusal of entry, and destruction.'' This change is to make 
clear that, for imported products, the appropriate regulatory procedure 
is refusal of entry, rather than seizure.

O. Compliance and Effective Date

1. Effective Date
    FDA proposed that these final regulations be effective and enforced 
1 year after the date that they are published in the Federal Register. 
The purpose of this proposed effective date was to provide processors 
with enough time to develop and implement HACCP plans. The agency 
invited comment on whether 1 year would be adequate.
    156. FDA received more than 60 comments about the proposed 
effective date. Virtually all comments agreed that the agency should 
provide some period before the regulations become effective. The 
comments either agreed with a 1-year implementation period or requested 
a longer period of 2 years or more. There were also a number of 
comments that responded to the agency's question about whether 
implementation dates should be staggered based on such factors as size 
of firm and level of risk.
    A minority of comments stated that 1 year for implementation is 
adequate. These comments argued that after 1 year, the industry would 
have had 3-years notice of the requirements. The comments argued that 3 
years was sufficient total time to be informed about impending 
regulations. Another comment stated that one year might be sufficient 
for the seafood industry, but other food industries could need 
considerably more time.
    Several comments recommended that FDA provide an implementation 
period of longer than 1 year but did not recommend a specific 
alternative. These comments were concerned that HACCP training would 
not be completed in time for a 1-year implementation date; that foreign 
processors would need more 

[[Page 65169]]
time to implement HACCP; and that 1 year after Canada required HACCP 
for its seafood industry, only half of its firms had complied.
    The largest number of comments on this topic recommended that FDA 
make the regulations effective 2 years after publication. The reason 
most often cited was that it will be more than 1 year before most of 
the affected firms can complete HACCP training. The next most 
frequently cited reason was that firms and trade associations needed 
more time for HACCP plan development. Several comments also discussed 
the time required to modify equipment and raise capital; to respond to 
initial, voluntary reviews of HACCP plans by regulatory agencies; and 
for Federal, State, and local officials to understand HACCP and how to 
enforce it and to arrange for cooperative enforcement. A few comments 
stated that FDA needs sufficient time to develop agreements with 
foreign countries.
    Several comments contended that more than 2 years should be allowed 
to implement the regulation. These comments mentioned the cultural 
change that HACCP will require and concern about the impact that the 
regulations will have on small firms as well as on large firms with 
multiple products and lines. They also mentioned the time needed for 
training.
    Over 20 comments recommended that FDA stagger effective dates. A 
majority of these comments stated that such a phased-in start-up should 
be based on product risk. The remainder of the comments split in favor 
of either considering both the size of a firm and the risk from the 
products it makes or just the size of a firm.
    A smaller number of comments argued against a staggered start. 
These comments expressed the view that small firms and foreign products 
should not be treated differently and pointed out that all firms will 
already have had 3 years of notice. Some of these comments stated that 
it would be hard to justify staggering implementation based on risk 
when the illness data are so incomplete. Others expressed the view that 
administering a staggered start would use up valuable resources and 
only result in confusion; that staggering would put some firms at a 
competitive disadvantage; and that it might encourage procrastination.
    After fully considering all of these comments, FDA agrees with the 
comments that suggested that a 2-year effective date is appropriate. 
Based on FDA's participation with the Alliance that is developing 
training materials for this program, FDA has come to realize that 2 
years must be provided to establish training programs and to give 
participants enough time to take them. Two years is also the minimum 
time necessary to train regulatory personnel. The additional time is 
also necessary so that the States will have a full opportunity to 
understand and respond to the effects of these regulations. It will 
also increase the likelihood that more agreements with other countries 
will exist.
    The additional year will also increase the opportunity for 
processors to engage in ``voluntary'' HACCP inspections in advance of 
the effective date in order to obtain preliminary, nonregulatory 
feedback from the agency on their progress.
    The agency acknowledges that it has urged the industry to begin 
preparing for HACCP well before the issuance of these final 
regulations. However, as this preamble amply demonstrates, a 
significant number of questions were raised as a result of the proposal 
that could not be answered until now. Moreover, the entire support 
structure for HACCP, including the issuance of the first edition of the 
Guide and the development of training courses, model plans, and other 
forms of technical assistance that will be useful to the industry, and 
especially to small businesses, will not be in place in time to permit 
a 1-year effective date.
    On the other hand, more than 2 years does not appear at this time 
to be warranted. The agency is concerned that additional time would 
adversely affect the momentum for this program without adding 
significantly to the likelihood that it will succeed.
    On the other hand, FDA is sensitive to the need to ensure that 
small businesses will not incur an unreasonable threat to their 
survival by an effective date that is too short. The agency intends to 
monitor the progress of the industry after the regulations are 
published and invites feedback on this subject. If FDA determines that 
the effective date is placing a significant and unreasonable burden on 
the industry, particularly on small businesses, the agency would be 
willing to consider an extension for as much as one additional year or 
some form of additional technical assistance. The agency would consider 
whether the delay is needed for training, drafting plans, or taking 
other measures that directly relate to the installation of a HACCP 
system, or whether the time is needed to comply with existing CGMP's, 
which are a prerequisite for HACCP. FDA will likely be reluctant to 
give firms an extended period of time to achieve compliance with 
existing requirements.
    FDA also finds that there is not an adequate basis at this time for 
staggering the starts based on size or risk. The arguments for and 
against staggering generally parallel those for and against exempting 
firms from these regulations altogether on the basis of either size or 
risk. These arguments are discussed in the section of this preamble 
entitled ``Should Some Types of Processors Be Exempt?'' In summary, a 
good case can be made that implementation by small firms should not be 
delayed because such firms account for much of the products with 
significant potential for risk, such as cooked, ready-to-eat products. 
Moreover, most seafood processors are small firms. Risk-based, as 
opposed to size-based, criteria for staggering firms would inevitably 
be arbitrary to some degree because data from foodborne illness 
reporting systems tend to skew the reports toward more easily 
diagnosable illnesses.
    The comments received on the subject of staggering do not provide a 
ready way to overcome these problems. Moreover, the 2-year effective 
date (rather than 1 year as proposed), guidance, technical assistance, 
and training that will be available to all processors should make 
staggering much less necessary than it otherwise might have been.
    As stated above, however, the agency welcomes feedback on the 
progress that processors are making to implement HACCP that could have 
a bearing on whether staggering or an extension of the effective date 
would be appropriate, especially for small businesses.
    157. Several comments asked for a form of staggering based on when 
an inspection occurs before the effective date. These comments stated 
that processors who voluntarily submit to inspection under the 
regulations before the effective date and are advised that their HACCP 
systems are not yet in compliance with the regulations should have at 
least a 6-month grace period to correct the problems. The example given 
in these comments was that of a processor who is so advised 1 day 
before the effective date and thus is inevitably out of compliance on 
the effective date.
    As reflected in the comments, inspections of HACCP systems before 
the effective date will occur because a firm desires feedback and 
volunteers for it when an FDA investigator arrives for an inspection. 
That feedback will constitute informal advice only and will provide 
training for the investigator as well as for the processor. There may 
be some advantage to a processor to obtain feedback and training sooner 
rather than 

[[Page 65170]]
later, but the results will have no formal status with the agency and 
would not warrant an extension of the effective date.
    The agency has heard considerable concern that it will 
automatically seek to seize or otherwise remove from commerce all 
products being produced under a HACCP system that is determined to be 
deficient in any respect. That concern is unfounded. The consequence of 
being out of compliance with HACCP requirements, on the first 
inspection after implementation or otherwise, is addressed throughout 
this section. In summary, FDA's reaction will depend, as it does today, 
on the overall public health significance of the deficiency.
2. Public Meetings
    158. One comment suggested that FDA conduct public meetings to 
explain the requirements of these regulations to the seafood processing 
industry between the publication date and effective date of these 
regulations. The comment also encouraged a coordination of research, 
training, and educational efforts between industry and FDA in order to 
facilitate the implementation of this HACCP program.
    FDA fully agrees with the comment. It is the intent of the agency 
to engage in a dialog with industry, through a combination of public 
meetings and discussions at trade association meetings, to facilitate a 
thorough understanding of the regulations. FDA's affiliation with the 
Alliance reflects the agency's commitment to a cooperative relationship 
among industry, government (Federal and State), and academia in the 
areas of research, training, and technical assistance.
3. Penalties for Noncompliance
    159. A significant number of comments, from processors and trade 
associations, requested that FDA address how noncompliance with the 
mandatory sanitation control procedures will be handled. Several of 
these comments also requested that FDA describe the penalties that can 
be imposed upon a processor and its officers for: Failure of a 
processor to have and implement a HACCP plan; noncompliance with 
sanitation control procedures; and failure to meet minor requirements 
of the regulations, such as the lack of a signature on a document. One 
comment stated that FDA's legal authorities and enforcement procedures 
do not provide a means for the agency to respond in a manner that is 
related to the severity of deficiencies--that is, a less severe 
response to a less significant deficiency.
    FDA has a longstanding practice of tailoring its regulatory 
response to the facts. A deviation from any of the provisions of these 
regulations, including those involving the control of sanitation, 
carries the potential for regulatory action pursuant to section 
402(a)(4) of the act. However, FDA intends to enforce these regulations 
in a manner that focuses on those deviations that have the greatest 
potential for causing harm. It is not FDA's intent to pursue regulatory 
action against a product or a processor exclusively for clerical errors 
or minor errors of omission. To do so would certainly not be an 
efficient use of agency resources, nor would it be in the best 
interests of the consuming public.
    The penalty provisions for food found to be adulterated are 
described at ``Prohibited Acts and Penalties,'' in chapter III of the 
act. The statutory sanctions that FDA may seek include seizure and 
condemnation of a food and injunction and criminal penalties against a 
person (i.e., a firm and its responsible management).
    FDA may also use existing administrative procedures, such as 
warning letters and conferences with a processor, to bring instances of 
noncompliance to the processor's attention as it frequently does under 
its current inspection programs.
    The agency cannot state precisely what type of action it will take 
when it detects a deficiency because FDA evaluates each deficiency on a 
case-by-case basis to determine the public health significance of the 
violation and the appropriate response.
4. Preapproval of HACCP Plans
    In the preamble to the proposed regulations, FDA tentatively 
concluded that HACCP plans would not have to be submitted to the agency 
or otherwise preapproved before their implementation by processors. The 
reasons for the agency's tentative conclusion included: (1) HACCP plans 
should be judged in the context of the processing plant, a process best 
accomplished during routine FDA inspections of processing facilities; 
and (2) the agency does not have sufficient resources to review HACCP 
plans from all domestic and foreign seafood processors in advance of 
either HACCP implementation by the processor or the conduct of HACCP-
based inspections by FDA.
    160. Approximately 20 comments addressed this issue. About two-
thirds of these comments, from consumer advocacy groups, processors, 
trade associations, and State government agencies, contended that a 
processor should be required to file a HACCP plan and obtain approval 
from FDA before implementing the plan. The remaining comments, from 
processors, trade associations, and a foreign government, agreed with 
FDA's tentative conclusion that HACCP plans need not be submitted to 
the agency or preapproved before they are implemented.
    Some of the comments favoring preapproval argued that FDA should 
have control over the design of each plan before it is implemented to 
ensure that all of the CCP's are identified, and that appropriate 
records will be kept. Other comments contended that, in the absence of 
a preapproved plan, a processor may implement a plan that FDA would 
later judge to be inadequate, possibly raising concerns about the 
product already produced under the plan.
    Several comments in opposition to preapproval argued that it would 
be too expensive and difficult for both FDA and the processors (the 
latter because implementation would be delayed while processors waited 
for FDA to preapprove the plan and every subsequent change to the 
plan). One comment expressed concern that, in formally approving a 
HACCP plan, regulatory authorities would assume some responsibility for 
the HACCP system of an individual processor.
    A few comments stated that HACCP plans will evolve as operations 
are adjusted, based on the processor's verification activities. These 
comments argued that a requirement for the preapproval of HACCP plans 
would encumber a processor's ability to update its HACCP plan.
    The resource situation since the proposal was issued in January, 
1994, has not changed in any way that would make the preapproval of 
HACCP plans by FDA practicable. Thus, FDA's analysis of the comments 
has focused on whether a lack of preapproval raises significant 
implementation problems that the agency must address. The comments have 
not convinced the agency that it does. FDA finds that a preapproval 
system would unduly burden the agency's resources, without providing 
significant advantages to the public health. The effectiveness of a 
HACCP plan, including monitoring, recordkeeping, and verification, can 
best be evaluated under actual operating conditions.
    The preapproval of HACCP plans is distinguishable from the 
situation for low acid canned foods, where FDA reviews submissions of 
scheduled processes and revisions to these processes without hinging 
that review on a visual inspection of the facility. For 

[[Page 65171]]
low-acid canned foods, the submission relates solely to the adequacy of 
the cooking process to control one hazard (C. botulinum). This process 
lends itself to a paper evaluation.
    FDA agrees with the comments that suggested that a requirement for 
agency approval of a processor's changes to an existing HACCP plan 
would unnecessarily slow the process of plan improvement. The ability 
to modify the plan quickly based on feedback from verification 
activities is an important aspect of HACCP that could be degraded by a 
preapproval requirement.
    With regard to the concern that the lack of plan preapproval will 
expose a processor to risk of product loss if a HACCP plan, under which 
it had been operating, is deemed by FDA to be inadequate, the agency 
advises that there are several issues that should mitigate this 
concern. First, the agency is committed to providing guidance, in the 
form of the Guide, to assist processors in the development of HACCP 
plans that are likely to be acceptable to the agency. The Guide will be 
further discussed later in this section.
    Second, FDA is convinced that the training requirements of these 
regulations will serve to inform the regulated industry about the 
expectations of the agency with respect to HACCP plan content. FDA is 
working closely with the Alliance to ensure that training reflects FDA 
policy.
    Third, FDA recognizes and accepts that, for HACCP plans to be 
effective and efficient, they must be tailored to the operating 
conditions of the individual processor. Of necessity, this fact means 
that there may be multiple ways to control an individual hazard. 
Consequently, FDA investigators will be trained to objectively evaluate 
the processor's HACCP plan from the standpoint of whether it 
accomplishes its intended function (i.e., hazard control), rather than 
whether it follows any preconceived model.
    Finally, as described earlier, for the HACCP program, FDA intends 
to respond proportionally to deficiencies that it finds during 
inspections. The nature of the agency's response will depend on the 
totality of the situation and on the public health implications of the 
deficiency. When circumstances permit, the processor will be given the 
opportunity to make appropriate corrections.
5. Filing Plans With FDA
    161. A few comments stated that FDA should require processors to 
file HACCP plans with the agency, not necessarily to obtain 
preapproval, but to allow FDA to compile HACCP plans from all seafood 
processors. The comments suggested that FDA selectively audit a sample 
of processor HACCP plans from the file copies, perhaps based on product 
risk, the presence or absence of certain CCP's, or other relevant 
factors. Some of these comments recommended that FDA request voluntary 
submission of plans prior to the implementation deadline.
    A file, or library, of HACCP plans of all seafood processors would 
likely present various benefits from the standpoint of trend analysis 
and program evaluation. The agency finds, however, that the burdens 
would outweigh the benefits, largely for the same reasons that rule out 
the preapproval of plans by FDA. For example, the library would have to 
be updated every time that any processor updated its plan. Therefore, 
FDA is not requiring that processors file their plans with the agency.
6. Third Party-Approval
    162. Several comments urged FDA to include a provision requiring 
third-party approval of processors' HACCP plans, especially if 
preapproval by FDA is not required. The comments suggested that the 
lack of a requirement for a processor to use a disciplinary team 
approach to develop a HACCP plan, as suggested by the NACMCF, coupled 
with infrequent FDA inspections, could mean that a processor might 
operate for years without an appropriate plan. The comments noted that 
competent processing authorities are available to provide third-party 
plan approvals and audits.
    On the other hand, one comment argued that a requirement for third 
party HACCP plan approval is not necessary. This comment stated that a 
nonregulatory first inspection would obviate any form of preapproval.
    FDA recognizes that some processors may benefit from obtaining 
third-party assistance in developing their HACCP plans and in 
evaluating their implementation. An independent audit is often helpful 
in locating problems in a system and offers the benefit of bringing in 
expertise not always possessed by many seafood processors. FDA is aware 
that some processors have engaged in these kinds of arrangements in the 
past and encourages their use.
    However, the agency cannot agree that third party assistance should 
serve as an ``approval'' for regulatory purposes. First, to maximize 
consistency and fair treatment, the responsibility for the initial 
HACCP plan evaluation (outside of the processor's own verification 
activities) belongs to FDA, through routine inspections of processing 
plants. Second, establishing, certifying, and auditing a network of 
third parties whose approvals FDA would automatically accept would 
impose significant burdens on the agency that FDA could not 
accommodate.
    As discussed above, FDA is engaging in significant efforts to 
facilitate the development of appropriate HACCP plans. The overall high 
level of policy guidance and technical assistance that will be 
available to processors from FDA and a variety of other sources should 
minimize the incidence of processors developing and implementing plans 
that do not address those hazards that are reasonably likely to occur. 
Therefore, FDA is not providing for third-party approval of HACCP 
plans.
7. The First Inspection
    In the preamble to the proposed regulations, FDA tentatively 
concluded that, after the effective date of these regulations, FDA's 
review of processors' HACCP plans and procedures would occur at the 
time of the routine establishment inspection. FDA requested comment on 
whether the first HACCP review should be nonregulatory, even though the 
inspection of the processor would otherwise be regulatory.
    163. Approximately 30 comments, mostly representing processors and 
trade associations, addressed this issue. All but one of the comments 
asked that the first review of a processor's HACCP plan and procedures 
be nonregulatory. Approximately one-fourth of these comments further 
asked that the second such evaluation also be nonregulatory.
    The comments stated that a nonregulatory visit by FDA would assist 
the processor in determining deficiencies in its plan without fear of 
enforcement action and would provide FDA investigators with hands-on 
experience in a HACCP-based inspection. The comments suggested that 
this arrangement would foster a cooperative spirit between the agency 
and the industry and would provide the time necessary for the 
investigator to discuss with the processor how the plan should be 
tailored to address the details of the processor's operation.
    One comment stated that the initiation of a sweeping, new program 
will generate many questions and will necessitate innumerable judgments 
on the part of both processors and investigators. The comment suggested 
that it would be preferable for these questions and judgments to occur 
during nonregulatory visits.
    On the other hand, one comment suggested that the first review of a 
processor's HACCP plan should be 

[[Page 65172]]
regulatory, because once the effective date has been reached, 
compliance with the regulations should be enforced.
    FDA agrees with the comments that suggested that a smooth 
transition to a mandatory HACCP system of preventive controls is more 
likely the result of dialogue than regulatory action. For HACCP to 
succeed, processors must be committed to it because they perceive 
benefits to themselves from its use other than simply the avoidance of 
regulatory sanctions.
    FDA has concluded that a 2-year effective date, rather than the 1-
year date that was proposed, will provide substantial opportunity for 
dialogue. Moreover, the proportional response to problems that FDA 
intends to employ, taking into account the newness of the system, 
should obviate many of the comments' concerns about excessive 
regulatory sanctions early in the process. Consequently, FDA concludes 
that an officially designated, nonregulatory first inspection is not 
necessary.
    FDA has concluded that 2 years is sufficient time for a processor 
to train employees or secure properly trained consultants, perform a 
hazard analysis, develop a HACCP plan, and implement and evaluate HACCP 
control procedures that will comply with these regulations. The 
additional year will enable the agency's field investigative force and 
the industry to begin sorting out many of the issues that are likely to 
develop during implementation.
    As stated earlier, the agency intends to perform informal HACCP 
evaluations of willing processors during routine inspections conducted 
during the 2-year implementation period. These evaluations should serve 
to aid the development of both the industry's HACCP programs and the 
agency's HACCP inspectional skills. They will also largely take the 
place of the proposed type of nonregulatory inspections.
    FDA agrees with the comment that pointed out that the initiation of 
this program will generate many questions and issues that will have to 
be worked out between processors and the agency. Moreover, FDA accepts 
that, despite the years of groundwork and the pilot programs that have 
been the basis for agency policy decisions to date, there will be 
details that will have to evolve over time as the program is 
implemented. It is highly likely that this evolution will continue well 
after the effective date of these regulations. FDA will take this 
factor into account in its initial interactions with processors after 
the effective date. The agency may find it appropriate to use its 
regulatory discretion when it finds a basis for concern about a 
processor's HACCP plan or procedures that relate to a matter about 
which policy is still being formulated.
    However, the agency is concerned that there could be significant 
problems if it officially designated its HACCP review during the first 
inspection as being nonregulatory. First, such a step could create 
unfair situations. For example, FDA could find itself in the position 
of pursuing regulatory action against one processor for failure to 
adequately control a particular hazard while, at the same time, 
treating a similar deficiency by another processor as 
``nonregulatory.'' Second, it could foster actions by firms to avoid 
application of the regulations, such as name changes or reorganizations 
to create the argument that the ``new firm'' is entitled to a 
nonregulatory inspection. Third, it is not clear how long such a policy 
should last. Arguably, the reasons in support of a nonregulatory first 
inspection become much weaker in the case of a firm that goes into 
business for the first time a number of years after the effective date 
of the program.
    For all of the foregoing reasons, FDA has concluded that it can 
accomplish the things that led it to inquire about the possibility of, 
and the comments to support, designating the first HACCP inspection as 
a nonregulatory inspection without making such a designation and 
creating the problems that such a designation could cause.
8. Role of the FDA Investigator
    164. In the preamble to the proposal, FDA stated its tentative 
conclusion that its investigators would, among other things, evaluate 
the adequacy of processors' HACCP plans during routine inspections. A 
few comments objected to this role for the investigators. These 
comments stated that investigators should be responsible for verifying 
that the processor has performed a hazard analysis; developed a HACCP 
plan where warranted; implemented the HACCP plan; and recognized, 
corrected, and recorded deviations from the HACCP plan. The comments 
further stated that investigators should not be in a position to 
challenge the adequacy or design of a HACCP plan.
    The comments pointed out that HACCP plans are tailored for each 
operation, designed by either a company team or a knowledgeable 
individual thoroughly familiar with the operation. They questioned 
whether an FDA investigator would have the expertise to determine the 
acceptability of the plan.
    Many FDA investigators already have considerable training in HACCP 
and food science, and most have an academic background in the sciences. 
They will also receive training during the implementation period that 
focuses on compliance with these regulations. The investigators will be 
exposed to the Guide, among other sources, for information about 
potential hazards to be considered for particular products and 
processes. This exposure, coupled with investigators' experience with 
the industries with which they work, will give them a sound basis for 
making screening determinations about the adequacy of processors' HACCP 
plans. There is little doubt that the caliber of investigator screening 
decisions will improve with experience with these regulations and with 
exposure to more and varied processor HACCP programs. FDA is confident 
that its field investigative staff will quickly adjust to the task of 
fostering compliance with these regulations, as they have to past 
initiatives.
    Where investigators are unsure about the adequacy of a processor's 
HACCP plan, they will have ready access to, and will be encouraged to 
consult with, district, regional, and headquarters experts. 
Investigators will also be instructed to discuss with plant management 
the reasons and scientific support for hazard analysis and HACCP plan 
decisions that are in question. Where, because of the complexity of a 
particular situation, the investigator cannot reach a decision about 
the adequacy of a particular aspect of a processor's HACCP plan, the 
investigator will be instructed to collect as much information, 
including supporting data, as is necessary in order to facilitate 
further agency review.
    Therefore, FDA concludes that the existing system adequately 
addresses the concerns of the comments.
9. Disagreements and Appeals
    165. A significant number of comments, primarily from processors 
and trade associations, stated that FDA should have a mechanism to 
resolve differences between an FDA investigator and a processor 
regarding the adequacy of the processor's HACCP plan, especially given 
the subjective nature of the determination as to what the hazards are 
that are reasonably likely to occur and that therefore must be 
controlled through HACCP. The comments contended that a cooperative 
discussion between FDA and the processor's HACCP experts would be 
preferable to an enforcement confrontation, and that this discussion 
would allow a processor to explain its decisions and procedures. Other 
comments urged FDA to formalize an 

[[Page 65173]]
appeal process in the regulations that would establish a processor's 
rights to contest any HACCP compliance action by FDA. Moreover, these 
comments stated that FDA should not take enforcement action based on a 
disagreement in the field between an investigator and the developers of 
the plan.
    As previously mentioned, agency investigators will be instructed to 
discuss their concerns about potential inadequacies in processor HACCP 
plans with the management of the firm in an effort to learn the basis 
of the firm's decisions. If the investigator retains concern that a 
plan is inadequate in some regard even after discussing it with the 
firm, the investigator will list findings on the report that is 
provided to the management of the firm at the conclusion of the 
inspection (Inspectional Observations, FDA483). The FDA483 only 
represents the opinion of the investigator and is not necessarily the 
final opinion of the agency. The investigator will document the 
processor's response to, or explanation of, the findings listed on the 
FDA483 report.
    It has been longstanding FDA policy to conduct an internal review 
of investigators' inspectional findings before initiating regulatory 
action. There is an opportunity at each stage for discussion between 
the firm and the agency. These FDA review practices will not change 
under a HACCP-based system.
    Based on the foregoing, the agency concludes that the concern 
expressed in the comments about possible precipitous compliance action 
as a result of the findings of FDA investigators is unwarranted. It is 
worth repeating that the agency intends to engage in conflict 
resolution through dialogue wherever possible and appropriate. Given 
these facts, FDA has concluded that a provision for a special appeals 
process for matters concerning these regulations is not necessary.
10. Status of the ``Guide''
    In the preamble to the proposed regulations, FDA discussed the 
``five preliminary steps'' to HACCP recommended by the NACMCF. These 
steps lead a processor through a logical process for identifying 
hazards that are likely to occur in a product and for developing a 
HACCP plan. In an effort to facilitate this process, especially for the 
many small businesses involved in seafood processing, FDA is developing 
the Guide, a draft of which was made available shortly after 
publication of the proposed regulations. The draft Guide provides 
information on hazards and appropriate controls by species and by 
product type. The preamble said that the information contained in the 
draft Guide is the kind of information that would likely result in a 
HACCP plan that is acceptable to the agency. FDA received considerable 
comment on the contents of the draft Guide and intends to publish a 
redrafted first edition shortly after the publication of these 
regulations.
    166. A number of comments expressed concern about how the Guide 
would be used by FDA investigators when evaluating a processor's HACCP 
plan. The commenters were troubled by the prospect that FDA 
investigators would not be trained to evaluate HACCP plans that differ 
from the Guide, and that, therefore, they would take exception to a 
HACCP plan that deviates from the Guide. The comments stated that 
industry experience with HACCP demonstrates the need to provide 
flexibility so that HACCP plans can be tailored to the specific 
operating conditions of a processor.
    Other comments stated that the Guide did not provide express 
guidance on the meaning of the key phrase ``reasonably likely to 
occur.'' The comments stated that the Guide should clarify whether it 
is FDA's intention that the hazards identified in the Guide are the 
``reasonably likely'' hazards under all conditions for the specific 
species and processing operations that are listed.
    Several comments cautioned that the Guide should not be 
characterized as a ``safe harbor,'' i.e., that FDA should not promote 
strict adherence to the Guide regardless of the circumstances. Such a 
characterization, they argued, could cause processors to omit the 
critical hazard analysis step in HACCP plan development and risk 
developing plans that do not fit the conditions of their processes.
    The Guide is, in the agency's opinion, a compilation of the best 
available information on the subject of hazards and controls in seafood 
processing. It contains FDA's recommendations as to the hazards that it 
believes are ``reasonably likely'' to occur in specific species and 
finished product forms under ordinary circumstances, but it also 
provides information on rarer hazards as well. FDA recognizes that the 
first edition of the Guide must clearly distinguish between the two.
    The term ``reasonably likely'' is now effectively defined in 
Sec. 123.6(a). It is worth noting that, under Sec. 123.6(a), whether a 
hazard is ``reasonably likely'' will depend, at least in part, on the 
circumstances that exist at the time that the hazard analysis is 
conducted. For example, a certain toxin might be rare, but if it starts 
presenting itself in fish and becomes known, it may warrant a new 
hazard analysis that may identify it as ``reasonably likely'' for a 
period of time.
    FDA also recognizes that circumstances may occur in which hazards 
will exist that are not identified in the Guide. These hazards may be 
the result of a previously unidentified phenomenon (e.g., the 
identification of a natural toxin in a species previously not 
associated with that toxin) or of unique conditions in the way that the 
product is handled by a particular processor (e.g., unusual equipment 
or processing methods). Thus, a definitive determination of 
``reasonably likely to occur'' can come only as a result of a carefully 
conducted hazard analysis performed for a specific product under 
specific processing conditions.
    FDA recognizes that a HACCP approach requires flexibility and will 
endeavor to make the Guide consistent with such flexibility. FDA will 
provide training to its investigators so that they will be prepared to 
evaluate a HACCP plan that is not consistent with the Guide and to 
evaluate the effectiveness of controls that differ from those suggested 
in the Guide. The agency agrees that the Guide is not a ``safe harbor'' 
for all situations. Processors who utilize the Guide should compare it 
to their own circumstances and make whatever adjustments in the 
approach suggested in the Guide that are necessary.
11. Trade With the EU
    167. One comment suggested that, because of directives issued by 
the EU, many processors may need early recognition of their HACCP 
programs by FDA. The comment further suggested that early recognition 
could be used by the agency as a means of training FDA inspectional 
personnel.
    FDA is aware of the directives of the EU. The agency intends to 
consider how it can best help processors respond to those directives, 
among other factors, as it formulates its plans for implementation of 
these regulations.
12. Measuring Program Success
    In the preamble to the proposed regulations, FDA asked for comment 
on what tests should be used to measure the success of the HACCP 
program as a whole, and how often those tests should be conducted.
    168. A significant number of comments stated that indicators of the 
success of the seafood HACCP program could include: A reduction in the 
number of seafood-borne illnesses; improved consumer confidence in 

[[Page 65174]]
seafood consumption; and a reduction in the number of violative 
products that enter the marketplace. Several comments stated that 
periodic inspections of, and sampling at, processors and importers by 
FDA, State, and foreign officials, coupled with illness reporting from 
a strengthened CDC program, would provide adequate verification of the 
effectiveness of the program. However, two other comments stated that 
the success of the seafood HACCP program cannot be measured solely by a 
decrease in illnesses, because many food-borne illnesses are the result 
of problems in the retail sector, which is neither covered by these 
regulations nor adequately regulated by the States.
    The agency agrees with those comments that suggested that the 
ultimate goal of these regulations should be the improved safety of 
fish and fishery products--a reduction in the actual number of seafood-
related illnesses. FDA will continue to closely monitor the CDC system, 
as well as reports of illness and death attributable to the consumption 
of seafood that it receives from other sources, for trends that may 
indicate an emerging problem or the intensification or modification of 
an existing problem. However, the agency also agrees with those 
comments that suggested that, because many of the seafood-related 
illnesses are attributable to recreational or subsistence fishing or to 
problems in the retail and food-service sectors (Ref. 7, pp. 2; 15; 27; 
and 28), improvements in process controls that result from the 
implementation of HACCP may not be fully reflected by a reduction in 
the number of illnesses. Additionally, as has been previously 
discussed, the CDC system encompasses only reported illnesses and is an 
imperfect means of judging reductions in actual numbers of illnesses. 
FDA is supportive of a strengthening of the CDC reporting system.
    Based in part on the comments received, the agency will be looking 
at ways to assess a relationship between success of the HACCP program 
and levels of consumer confidence, levels of violative product in the 
marketplace, improvements in the quality and quantity of preventive 
controls throughout the industry; and the results of FDA and 
cooperating State and foreign inspections. As indicated in the summary 
of the Regulatory Impact Analysis elsewhere in this preamble, FDA is 
planning to evaluate key features of this program within the first 
several years of implementation. This evaluation will include an 
assessment of its effectiveness.
    169. One comment suggested that end-product testing should be used 
by FDA for program surveillance purposes, particularly for imports. 
This comment encouraged FDA to conduct statistically reliable baseline 
and monitoring surveys, modeled after those used in the MSSP, conducted 
by NMFS, to: (1) Determine how often consumer hazards occur; (2) set 
specific goals, objectives, and operational strategies for the HACCP 
program; and (3) provide a means by which the program's success can be 
measured.
    FDA has historically collected and analyzed surveillance samples 
during and outside the course of its routine inspections. The purposes 
for these sample collections, in many ways, align with those suggested 
by the comment. The agency is committed to continued surveillance 
sampling and intends to use such sampling in an assessment of the HACCP 
program.
    170. Another comment suggested that HACCP will only be successful 
in improving confidence in seafood if the program is accompanied by a 
consumer education effort that explains the benefits of HACCP. The 
comment encouraged FDA to perform a baseline study that assesses the 
level of consumer anxiety with respect to seafood consumption and 
compare it to the results of a study that it performs sometime in the 
future.
    FDA agrees that another major goal of these regulations is to 
increase consumer confidence in the safety of seafood. The agency 
recognizes that publication and enforcement of regulations aimed at 
improving seafood safety alone will not achieve that goal. Consumers 
must be informed of the benefits of producing products under HACCP 
preventive controls. Within its budgetary constraints, the agency 
intends to engage in a program of consumer education for that purpose. 
The prospect of baseline and followup studies of consumer confidence 
(or anxiety) will also be considered.

P. Other Issues

    FDA received a number of additional comments that did not address 
any specific provision of the proposal, although some of them were in 
response to invitations in the preamble to comment on various subjects.
1. Relationship to Other Programs
    In the preamble to the proposed regulations, FDA invited comment on 
how FDA's HACCP program for seafood processors should mesh with 
existing State HACCP programs for seafood, in order to avoid imposing 
inconsistent Federal and State HACCP requirements. In the preamble, FDA 
acknowledged that many States are under considerable pressure to cut 
back on programs where there is an overlapping Federal program. 
Nonetheless, the agency urged States to maintain, if not strengthen, 
their seafood programs and to work with FDA to develop an integrated 
Federal/State, HACCP-based seafood control program.
    171. Approximately 12 comments, representing processors, trade 
associations, and State government agencies, recommended that FDA 
coordinate its HACCP program with existing State and Federal seafood 
control programs. Several comments emphasized that a coordinated effort 
would ensure uniform application and interpretation of HACCP 
principles, while preventing duplication of effort that wastes limited 
enforcement resources. One comment stated that such a coordinated 
effort would be facilitated if only a single HACCP plan were required 
for each processing facility, rather than one that was designed to meet 
FDA requirements and another that would meet State requirements. 
Another comment noted that a multitude of differing HACCP regulations 
would only serve to confuse processors and dilute the effectiveness of 
the Federal program. The comment further recommended that FDA work with 
AFDO to promote State laws and regulations that are compatible with 
FDA's HACCP program.
    One comment suggested the formation of a task force representing 
the food industry, FDA, USDA, and DOC to work towards the goal of 
reducing regulatory duplication.
    The agency agrees that there is a need for Federal/State 
partnership to facilitate the efficient implementation of HACCP 
programs. FDA believes that coordination with the States would permit 
both the agency and the States to leverage their inspectional 
resources. FDA, as well as the States, would benefit by dividing the 
workload and sharing data and other information. Such coordination 
would also benefit industry through consistent inspections and 
regulatory requirements.
    The agency has already begun to coordinate its efforts with the 
States on seafood. The formation of the Alliance, to which AFDO is a 
member, is one such endeavor. The Alliance is described in detail in 
the ``Training'' section of this preamble.
    With FDA's support, AFDO passed a resolution supporting the 
development of FDA/State partnership agreements at its 1994 meeting in 
Portland, ME (Ref. 220). The resolution specifically recommended that 
HACCP be the basis of such partnerships and noted the 

[[Page 65175]]
shared roles of FDA and State regulators in seafood safety, the limited 
resources of both levels of government, and the existence and the 
potential impact of the Alliance.
    Meanwhile, FDA is increasing its use of partnership agreements with 
State enforcement agencies. For instance, the Northeast Region of FDA 
has entered into a threeway partnership agreement with the Northeast 
Food and Drug Officials Association and individual States to provide 
industry with HACCP training at the retail level. FDA also expects to 
enter into partnership agreements with States to implement HACCP pilot 
programs for foods other than seafood. FDA's Northeast Region has 
already signed such an agreement with the Commonwealth of 
Massachusetts, and more are anticipated.
    These initiatives demonstrate the agency's desire to coordinate its 
efforts with the States. The agency's cooperative efforts in the area 
of HACCP reflect a trend. The agency has used cooperative efforts in 
other areas, such as pesticide sampling and workplan sharing. FDA will 
continue to explore ways to coordinate the Federal and State role in 
the regulation of seafood.
    172. A number of comments recommended that States act as the 
primary enforcement agencies for these HACCP regulations, while FDA's 
responsibility would be to evaluate the States' compliance with HACCP 
inspection protocols. Some of these comments suggested that such a 
program could be patterned after the NSSP.
    FDA is adopting these HACCP regulations to implement and enforce 
the act. While FDA plans to work cooperatively with the States in all 
ways possible, the agency cannot delegate its authority under the act. 
It is possible that in some aspects of seafood processing, the States 
will serve as the primary enforcement agencies, with FDA serving 
primarily an auditing function. However, responsibility for enforcing 
the act and these regulations must remain with FDA.
    173. A number of comments, from processors, trade associations, and 
one consumer advocacy group, maintained that FDA's HACCP regulations 
should preempt any existing State HACCP programs. The comments 
contended that Federal preemption would ultimately reduce confusion 
caused by conflicting State programs, reduce costs, and promote 
uniformity. Examples of the specific areas of conflict were not 
provided by the comments.
    As was previously stated, FDA intends to work through AFDO and 
through Federal/State partnerships to seek consistency in State 
regulatory approaches to HACCP for seafood inspection and through the 
NSSP process and the ISSC to attain this goal specifically for 
molluscan shellfish. Moreover, processors in each State must comply 
with Federal HACCP requirements if their product moves in interstate 
commerce. For these reasons, the agency has concluded that there is no 
need for Federal preemption of State regulatory requirements.
    174. Several comments encouraged FDA to work closely with NMFS to 
coordinate FDA's program with the existing NMFS' HACCP program. The 
comments noted that cooperation with NMFS would help the two agencies 
avoid wasteful duplication of effort and would reduce the burden on 
those firms already operating under the NMFS program.
    FDA agrees with these comments and notes that FDA and NMFS are 
coordinating their HACCP programs to ensure compatibility. Nonetheless, 
FDA advises that the NMFS program is a voluntary, fee-for-service 
program and is likely to continue to include features that go beyond 
the requirements of these regulations, especially in the area of 
preventive controls for economic fraud and plant and food hygiene.
    A 1974 MOU between FDA and NMFS recognizes the respective roles of 
the two agencies and commits the two agencies to consistency and 
cooperation. FDA will continue to work with NMFS to maintain a 
coordinated Federal effort.
2. ``Whistleblower'' Protection
    175. A few comments urged that these regulations include 
``whistleblower'' protection for employees of seafood processors. 
Whistleblower protection is designed to protect workers from being 
fired or otherwise discriminated against for revealing wrongdoing by 
their employers. The wrongdoing in this case, presumably, would likely 
involve the falsification of HACCP records. The comments argued that: 
``Whistleblowers are iispensable as the eyes and ears for overextended 
FDA personnel making limited spot checks. The public's line of defense 
will be no stronger than the shield protecting industry worker's rights 
to obey and help enforce this law.''
    One concern that FDA has heard about the credibility of a HACCP 
system is that important records can be falsified. It is alleged that, 
without whistleblower protection, it is much less likely that the 
agency will know about falsifications.
    While the agency is confident, based in part on its experience 
reviewing records in the low-acid canned food program, that it can 
detect falsification, FDA also expects from experience that it will be 
alerted to possible wrongdoing from time to time by employees of 
processors even in the absence of whistleblower protection. FDA has 
received, and acted upon, confidential information from employees of 
regulated firms for decades. This assistance has proven invaluable on 
many occasions. The only protection to these employees available from 
FDA has been confidentiality.
    The question raised by the comments is whether, in addition to the 
actions against the product or the processor that would be available to 
FDA as a result of violations of the requirements of the act and these 
regulations, there must be specific protection for employees in order 
for the program to succeed. The agency has concluded that, like other 
FDA programs, this program can be successful in the absence of specific 
whistleblower protection, and that congressional action would be 
necessary to provide protection other than confidentiality.
    FDA cannot provide whistleblower protection in these regulations. 
FDA believes--and case law bears out--that there must be a nexus 
between the conduct being required by regulations and the focus of the 
underlying statute, in this case primarily section 402(a)(4) of the 
act. An analysis of the application of section 402(a)(4) of the act to 
these regulations can be found in the ``Legal Basis'' section of this 
preamble.
    While FDA has determined that an assessment of processing risks and 
a plan that ensures that these risks are minimized has the requisite 
nexus to section 402(a)(4) of the act, and that this nexus justifies 
adopting these regulations, the agency does not see a sufficient nexus 
between whistleblower protection and the prevention of adulteration of 
food. If a firm retaliates against an employee who brings complaints or 
other information about the firm to FDA, the implication of such an 
action is that there is a condition at the firm that may need 
investigation, not that the products produced by the firm are 
necessarily adulterated. It may be the case that the products are 
adulterated, but such a conclusion does not flow as directly from 
section 402(a)(4) of the act as does the conclusion that seafood 
products not produced under a HACCP plan have been produced under 
insanitary conditions whereby they may have been rendered injurious to 
health. For this reason, FDA concludes that it lacks 

[[Page 65176]]
clearcut authority to provide whistleblower protection in these 
regulations.
3. Separation of Quality Control (QC) and Production
    176. A few comments requested that the regulations mandate 
structural independence within a processing firm between ``HACCP QC 
[quality control] personnel'' and ``production'' personnel. Otherwise, 
according to the comments, ``HACCP QC personnel could still be hired 
and fired by a production supervisor.''
    FDA does not believe that a change in the regulations would be 
beneficial in this regard. It is important to recognize that, under 
HACCP, production personnel are the observer/operators who perform the 
initial monitoring of CCP's as well as the recordkeeping that documents 
the results of this monitoring. The operation of the HACCP system must 
involve the whole organization, not just QC personnel.
    However, it is reasonable to expect that, where practical, 
verification activities should be performed by individuals other than 
those who made the records in the first place. For verification, the 
agency encourages the kind of organizational separation that is being 
urged in the comments.
    The agency recognizes, however, that many seafood companies will 
not be large enough to have distinct, independent organizational units 
that can verify each other's work. The seafood industry is 
characterized by small businesses. FDA has concluded that such a 
requirement is not practical for this industry.
    It is worth noting that the regulations at parts 113 and 114 for 
low-acid canned foods and acidified foods contain recordkeeping 
requirements and some verification requirements that are similar to the 
provisions of these regulations. In certain respects, parts 113 and 114 
served as models for the seafood HACCP program. Those regulations have 
succeeded even though they do not require a separation between QC 
personnel and production personnel. Given this history, the agency is 
reluctant to mandate the internal structure of seafood processors.
4. Education
    177. FDA received a number of comments on the subject of seafood 
safety education. These comments were in response to an invitation in 
the preamble to the proposed regulations for comments on risk reduction 
activities that could be regarded as complementary to HACCP, primarily 
directed toward postprocessing handling. In addition, FDA asked for 
comment on appropriate education and information that should be 
directed toward consumers and recreational fishermen, even though 
education aimed at these groups is actually outside the scope of this 
rulemaking. FDA made this request based on a recognition that HACCP 
cannot reasonably be expected to solve every problem. The agency 
recognizes that HACCP must be integrated into a comprehensive program 
for seafood safety. Education is another important component of that 
program. As one comment noted:

    * * * the responsibility for seafood safety should be met at 
every level of seafood distribution, from harvesters to processors 
to retailers, restaurants and, finally, the consumers themselves. 
Regulations are not a substitute for informed and responsible 
behavior and it is impractical to extend the scope of the proposed 
regulations to everyone involved in handling and consuming seafood.

    The comments overwhelmingly endorsed the value of education. They 
strongly supported education for: (1) Consumers on the handling and 
purchasing of seafood, especially through brochures at the point of 
purchase and information available at pharmacies, and on the 
significance of HACCP, especially with regard to the government's 
verification role; (2) recreational fishermen, provided by the State 
during licensure (with guidance from the Federal government) and 
through articles in popular fishing and outdoors magazines; (3) 
subsistence fishermen; (4) retailers, including food service and 
restaurants.
    FDA greatly appreciates these comments. The agency agrees that 
education is an essential complementary activity to HACCP as well as to 
other aspects of FDA's overall seafood program. The comments will be 
taken into account as the agency develops its educational program.
    178. FDA also invited comment on whether the agency should consider 
proposing to require handling instructions for consumers on the 
labeling of seafood. Any action that FDA were to take along these lines 
would be as part of a separate rulemaking.
    The agency received about 20 comments on this issue. Approximately 
half of those comments supported the notion of mandatory safe handling 
instructions. One business noted that safe handling instructions would 
help to ensure the safety of a product through the distribution chain, 
while another business said that such instructions had a real potential 
to decrease seafood-related illness. One individual commented that safe 
handling instructions would increase consumer confidence in these 
products. One industry comment noted that a task force composed of 
industry, Federal and State agencies, and consumers should agree on the 
appropriate statement. Some comments indicated that safe handling 
instructions might be appropriate for high-risk products.
    The remainder of the comments on this issue disagreed that safe 
handling instructions for seafood should be required by FDA. Many of 
these comments noted that most seafood products include such 
instructions voluntarily. One trade association commented that such a 
requirement would limit retailers' flexibility and creativity and 
impose significant new costs on retailers and consumers. Most of those 
comments noted that requiring new information would detract from other 
labeling requirements.
    FDA appreciates these comments and the different points of view 
that they represent. The agency will use the comments in its 
deliberations on this issue.
    179. Finally, FDA described some of its educational efforts aimed 
at medically compromised individuals about avoiding raw molluscan 
shellfish and invited comment on types of education and information 
activities that might be useful in this regard. The agency received 
about a dozen comments on this subject.
    Most of these comments addressed whether there should be mandatory 
warning labeling for raw molluscan shellfish. A majority of the 
comments stated that the agency should require warning labeling. Three 
comments from consumer groups stressed the need to protect high-risk 
individuals. One State government commented that warnings for raw 
molluscan shellfish should be tied to specific locations and times of 
year. One professional association requested that the warning state 
that the shellfish should only be eaten if it is certified and tagged.
    Three comments stated that warning labels would be inappropriate. 
One comment noted that shellfish are not consumed in enough quantity to 
be a problem. Another comment stated that warning labels would unduly 
alarm those not at risk and that better channels exist for educating 
those at risk.
    A few comments did not specifically address warning labels but 
recommended that FDA target advice directly to compromised individuals. 
Those comments suggested that FDA direct information to the medical 
community involved in the treatment of those individuals. 

[[Page 65177]]

    Again, FDA thanks the comments for providing views on a matter that 
is outside the scope of this rulemaking. FDA is working to provide 
information to at-risk populations and its strategy on how best to do 
so is evolving. The agency will take the comments into account as it 
develops policy in this area.
    In summary, the agency agrees that education is an essential 
complementary activity to HACCP as well as to other aspects of FDA's 
overall seafood program. The comments relating to education will be 
useful to the agency as it develops its education programs.
5. Traceback Mechanisms
    180. One comment recommended that FDA develop and incorporate 
methods to trace back fish and mandate such traceback in these 
regulations. The comment described the use of bar codes and computer-
based tracking numbers by a meat products company that enable it to 
trace a specific cut of meat from a store or restaurant to its source.
    The agency acknowledges that traceback to the water would be useful 
for certain species of fish associated with certain hazards, e.g., 
ciguatoxin. On the other hand, traceback to the water for scombrotoxin 
would not be particularly useful, although traceback through the 
distribution chain to find out the source of mishandling would be 
useful. The agency urges the industry to consider this comment. FDA 
advises that it is willing to explore this idea further, although not 
as part of this rulemaking.
6. Tribal Governments
    181. FDA received a few comments on the effect of these regulations 
on tribal governments. The preamble to the proposed regulations noted 
that Executive Order 12875 of October 26, 1993, requires, among other 
things, consultation with tribal governments before the formal 
promulgation of regulations containing unfunded Federal mandates. While 
FDA does not believe that these regulations impose an unfunded Federal 
mandate, the agency wishes to foster consultation on matters that might 
significantly affect tribal communities. Consequently, FDA requested 
comment on the economic effect of the regulations on tribal 
governments.
    FDA received no comments from tribal governments. One comment, from 
a tribal business, stated that the impact of the regulations on tribal 
governments will be beneficial because they will result in safe 
products, positive consumer perceptions, and positive market impacts. 
The other comment that mentioned this subject was from an academic, who 
expressed the view that the regulations will have a major impact on 
tribal groups involved in fisheries and contains unfunded Federal 
mandates. The comment did not elaborate. Neither of these comments 
justifies any change in these regulations.
    The agency remains interested in fostering consultation with tribal 
communities as they see fit and encourages correspondence from tribal 
governments.
7. HACCP System Improvements
    182. A comment urged that there be a process to continually amend 
or update these regulations.
    FDA points out that such a mechanism exists in its regulations. 
Under Sec. 10.30 (21 CFR 10.30), interested persons are provided with a 
process by which they can petition the agency to amend and update these 
regulations.
    From a less mechanistic viewpoint, the agency recognizes that these 
regulations represent a pioneering program that has not been attempted 
before. While the agency believes that sufficient groundwork has been 
laid to adopt these regulations and to begin to implement them, FDA 
also acknowledges that full scale implementation will reveal 
modifications that may be necessary, both in the short and long terms. 
Consequently, the agency will be highly receptive to feedback from all 
parties who are affected by these regulations and will remain open to 
changes that are necessary in the regulations. The ``Verification'' 
section of this preamble reflects the agency's interest in evaluating 
this program.
    183. A number of comments asked for improvements in the foodborne-
illness reporting system operated by CDC. Some comments urged 
collaboration between FDA and CDC. One comment advocated the creation 
of an active reporting system.
    These comments are essentially outside the scope of this 
rulemaking. Nonetheless, the agency recognizes that the strength of the 
foodborne-illness reporting system bears directly on the ability of the 
agency to measure the public health impact of HACCP. Both FDA and CDC 
agree that underreporting is an undesirable feature of the current 
system. FDA and CDC have been collaborating on an active-type reporting 
system. The limiting factor, however, will always be resources. 
Significant improvements in the current system will involve 
considerable expense.
    184. One comment provided views on factors that would limit the 
effectiveness of HACCP. The comment cited:

    [P]oor commitment by company management and lack of allocation 
of necessary resources; improper training; lack of understanding and 
planning in all stages of implementation of a plan[,] and failure to 
recognize the need to understand the corporate culture change which 
must accompany an effective HACCP program.

    FDA agrees with this comment but hopes that company management will 
embrace HACCP and recognize the benefits that it offers to the firm.

III. Paperwork Reduction Act of 1995

    This final rule contains collections of information that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title, 
description, and respondent description of the information collections 
are shown below along with an estimate of the annual recordkeeping and 
periodic reporting burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    Title: Reporting and recordkeeping requirements for processors and 
importers of fish and fishery products under the provisions of 21 CFR 
parts 123 and 1240. Procedures for the Safe and Sanitary Processing and 
Importing of Fish and Fishery Products.
    Description: This regulation implements the use of Hazard Analysis 
and Critical Control Point (HACCP) methodology to ensure that processed 
and imported fish and fishery products are safe within the meaning of 
sections 402(a)(1) and 402(a)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342(a)(1) and 342(a)(4)).
    Description of Respondents: Businesses or other for profit 
organizations.
    Although the January 28, 1994, proposed rule provided a 60 day 
comment period (extended to 90 days in the April 7, 1994, Federal 
Register, 59 FR 16578) under the Paperwork Reduction Act of 1980, and 
this final rule incorporates the comments received, as required by 44 
U.S.C. section 3507(d), FDA is providing additional opportunities for 
public comment under the Paperwork Reduction Act of 1995, which applies 
to this final rule and was enacted after the expiration of the comment 
period.
    Therefore, the agency solicits public comment on the information 
collection requirements in order to: (1) Evaluate whether the proposed 
collection of information is necessary for the proper 

[[Page 65178]]
performance of the functions of the agency, including whether the 
information will have practical utility; (2) evaluate the accuracy of 
the agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) enhance the quality, utility, and clarity of the information 
to be collected; and (4) minimize the burden of the collection of 
information on those who are to respond, including through the use of 
appropriate automated, electronic, mechanical, or other technological 
collection techniques or other forms of information technology, e.g., 
permitting electronic submission of responses.
    Individuals and organizations may submit comments on the 
information collection requirements by February 16, 1996, and should 
direct comments to FDA's Dockets Management Branch (address above).
    Prior to the effective date of this final rule, FDA will publish a 
notice in the Federal Register when the information collection 
requirements in this rule are submitted for OMB approval, and again 
when OMB makes a decision to approve, modify or disapprove the 
information collection requirements.
    Sections of this final rule require that certain businesses collect 
information and keep records. Under Public Law 104-13 Federal agencies 
are required to estimate the hours and costs attributable to 
collections of information, as defined in 44 U.S.C. 3502(3), that are 
required by Federal regulation. Table 1 sets forth an estimate of the 
hours that are required annually for compliance with each section in 
part 123 that requires regulated entities to collect or record 
information.

               Table 1.--Estimated Average Annual Information Collection and Recordkeeping Burden               
----------------------------------------------------------------------------------------------------------------
                                                                               No. of                           
                           21 CFR                                No. of    responses per   Hours per     Total  
                                                              respondents  respondent\1\  response\2\    hours  
----------------------------------------------------------------------------------------------------------------
123.6(a),(b),(d)............................................       4,850             1            16   77,600\3\
123.6(c)(5).................................................       4,850             4           0.3       5,280
123.8(a)(1),(c).............................................       4,850             1             4      19,400
123.12(a)(2)(ii)............................................       1,000            80           0.2      16,000
123.6(c)(7).................................................       4,850           280           0.3     470,400
123.7(d)....................................................       1,940             4           0.1       1,940
123.8(d)....................................................       4,850            47           0.1      22,795
123.11(c)...................................................       4,850           280           0.1     135,800
123.12(c)...................................................       1,000            80           0.1       8,000
123.12(a)(2)................................................          20             1            20    4,000\3\
123.10......................................................          24             1            24   116,400\3
                                                                                                               \
    First year total burden hours...........................  ...........  .............  ...........    877,615
    Annual 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 activities will vary considerably among 
processors and importers of fish and fishery products, depending on the 
type and number of products involved, and the nature of the equipment 
or instruments required to monitor critical control points. The burdens 
have been estimated using the typical small seafood processing firm as 
a model because these firms represent a significant proportion of the 
industry.
    The burden estimate in Table 1 includes only those collections of 
information under this rule that are not already required under current 
statutes and regulations and are being added by this rule. For example, 
the current good manufacturing practices provisions in 21 CFR part 110 
already require that all food processors ensure good sanitary practices 
and conditions, monitor the quality of incoming materials, monitor and 
control food temperatures to prevent bacterial growth, and perform 
certain corrective actions and verification procedures.
    In addition, the estimate does not include collections of 
information that are a usual and customary part of businesses' normal 
activities. For example, the tagging and labelling of molluscan 
shellfish (Sec. 1240.60) is a customary and usual practice among 
seafood processors. Consequently, the estimates in Table 1 accounts 
only for new information collection and recording requirements 
attributable to part 123.
    There are no additional capital costs associated with this 
regulation that are not also attributable to the preexisting 
requirements of part 110.
    FDA estimated in the proposal that the total burden to all 
respondents would be 2,826,850 hours. That estimate, however, 
significantly overestimated the burden because it included activities 
performed by domestic processors that are not related to information 
collection and recordkeeping, and, more significantly, did not account 
for existing regulatory requirements and usual and customary business 
practices, as described above.
    The agency has recalculated the recordkeeping burden in a manner 
that is more consistent with the intent of Public Law 104-13. 
Therefore, the burdens presented in Table 1 are those actually 
associated with collecting and recording the pertinent HACCP 
information. The burdens for HACCP plan development, plan reassessment, 
and record review are also included in the recalculated burden. In 
estimating the time for the preparation of a HACCP plan, the agency 
believes that a significant portion of the training hours can also be 
characterized as time spent on preparation of the plan.
    Additionally, the agency recognizes that the regulations will place 
a burden on seafood importers. For this reason, FDA has included in the 
burden 

[[Page 65179]]
estimate the time necessary for importers to develop a written 
verification plan, verify compliance of imports, and keep records of 
their verification activities.
    Few comments provided information on the number of hours that a 
processor would expend on information collection and recordkeeping, as 
described in the preamble to the proposed regulation. One comment 
estimated that the annual burden would vary from 200 to over 700 hours, 
depending on the type of product, and another comment suggested that 
one hour per day, or 365 hours per year, would be required. One comment 
stated that the agency's estimate of 650 hours per year was reasonable. 
Another comment estimated four to five hours per day, or 1,820 hours 
per year as the likely burden. None of these comments provided 
information to support how the commenters arrived at their estimates.
    It seems likely that the estimates suggested by the comments were 
calculated based on the same errors that the agency made in the 
proposal, that is, by combining the burdens associated with HACCP data 
collection and recordkeeping with other HACCP activities unrelated to 
information collection and recordkeeping, with usual and customary 
information collection and recordkeeping practices, and with 
collections of information required by the provisions of the Federal 
Food, Drug, and Cosmetic Act and implementing regulations. This 
conclusion is supported by the fact that some of the comments expressed 
agreement with the agency's calculations. For these reasons, FDA 
concludes that no changes in its corrected calculations are necessary 
to respond to the comments.

IV. Economic Impact

A. Introduction

    In accordance with Executive Order 12866 and the Regulatory 
Flexibility Act, FDA has examined the impacts of the final rule. 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety effects; 
distributive impacts; and equity). The Regulatory Flexibility Act (Pub. 
L. 96-354) requires analyzing options for regulatory relief for small 
businesses.
    The Unfunded Mandates Reform Act (Pub. L. 104-4) requires (in 
section 202) that agencies prepare an assessment of anticipated costs 
and benefits before proposing any rule that may result in an annual 
expenditure by State, local and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 (adjusted annually for 
inflation). The Unfunded Mandates Reform Act also requires (in section 
205) that the agency identify and consider a reasonable number of 
regulatory alternatives and, from these alternatives, select the least 
costly, most cost-effective, or least burdensome alternative that 
achieves the objective of the rule. Even though FDA finds that the 
costs of this final rule may be below $100 million a year, estimating 
these costs is a difficult task involving uncertainties. This analysis, 
together with the preamble published in the Federal Register and 
supporting analysis and materials, constitutes a final RIA. Therefore, 
FDA has treated the final rule as an economically significant 
regulatory action under Executive Order 12866. Consequently, the agency 
has completed this full RIA which demonstrates that this rule is 
consistent with the principles set forth in the Executive Order and in 
these two statutes. In addition, this document has been reviewed by the 
Office of Management and Budget as an economically significant 
regulatory action under Executive Order 12866. FDA has concluded that 
the net benefits of this rule (benefits minus costs) are largest for 
the regulatory option selected as specified by Executive Order 12866. 
FDA has also concluded that, pursuant to the Unfunded Mandates Act, the 
regulatory option selected is the least burdensome option to accomplish 
the goal of controlling all physical, chemical, and microbiological 
hazards reasonably likely to be present in seafood.
    As a part of the preamble to the proposed regulation, FDA published 
a summary of the Preliminary Regulatory Impact Analysis (PRIA) and 
placed on file with FDA's Docket Managements Branch the complete PRIA. 
In addition, FDA has placed the full final Regulatory Impact analysis 
on file at Dockets Management Branch (address above).
    FDA has fully reviewed the information on which the PRIA was based, 
the comments on the PRIA, and other available information on the costs 
and benefits of HACCP for the seafood industry. Based on this review, 
FDA has arrived at two estimates of the costs in this final rule as 
well as upper and lower estimates of benefits. As can be seen in the 
agency's summary of costs and benefits are summarized in Table 2, FDA 
believes that the costs of the final rule will range from $677 million 
to $1.488 while the benefits will range from $1.435 to $2.561 billion. 
In its final analysis, the agency maintains that the total benefits of 
this mandatory seafood HACCP rule will exceed the total costs.
Regulatory Options
    The agency raised and received comment on a number of regulatory 
options in the PRIA. The most significant two options raised were 
regulating only high risk products or the most serious hazards and 
providing regulatory relief for small businesses. The first option is 
inconsistent with the objective of this regulation, to control all 
physical, chemical or microbiological hazards reasonably likely to be 
found in seafood products. Although FDA has not granted relief only for 
small business, the agency has extended the compliance date for all 
firms from 1 year to 2 years.

                                  Table 2.--Summary of Total Costs and Benefits                                 
----------------------------------------------------------------------------------------------------------------
                                                                  Costs adjusted                                
                                                  Costs from FDA     from NMFS    Benefits lower  Benefits upper
                      Year                            models           model        (millions)      (millions)  
                                                    (millions)      (millions)                                  
----------------------------------------------------------------------------------------------------------------
1...............................................             $69            $162             $73            $108
2...............................................              42            9173             108                
3...............................................              41              83              85             156
4...............................................              38              80              87             158
                                                 ---------------------------------------------------------------
      Total\1\..................................             677           1,482           1,435          2,561 
----------------------------------------------------------------------------------------------------------------
\1\The total defines the total discounted costs and benefits beyond the 4th year and discounted at 6 percent.   

 
[[Page 65180]]


B. Costs

    In the PRIA, FDA was reluctant to rely only on results of the 
limited experience with HACCP in the seafood industry. FDA balanced the 
reports of some seafood firms, which showed that the costs of HACCP 
were low, with a study of the costs of HACCP that had been done under 
contract with NMFS by A. T. Kearney, Inc. (Contract No. NA88AA-H-
SK006). This study showed significantly higher costs (as reflected in 
the range of cost estimates summarized above) but had several flaws 
that engender skepticism about its results as well. For example, none 
of the plants that were the subjects of the study had actually 
implemented HACCP, and the system whose costs were studied was 
significantly more demanding than the system embodied in the 21 CFR 
part 123. Despite these facts, the cost estimates in the PRIA were 
based on the results of the NMFS study because FDA considered it to 
represent the best evidence available at that time.
    As explained more fully below, FDA used modeling technique and the 
experience reported about seafood firms to produce estimates that are 
in general agreement and that are approximately one-fourth of those 
estimated in the NMFS study reported in the PRIA.
    In estimating the costs in this PRIA, there are three checks that 
have helped ensure the accuracy of the costs that would be imposed by 
adoption of this regulation. The first is the cost comments, but these, 
the agency's analysis revealed, were in most cases rather general, not 
well supported, and of only marginal assistance. The second is modeling 
by FDA experts based on their experience with the use of HACCP in the 
seafood industry; working with aquatic species and the public health 
problems that they present; inspecting and studying both seafood plants 
and low acid canned food plants (which have operated under HACCP 
principles for almost two decades); and participating in the FDA-NMFS 
seafood pilot. The results of this modeling are detailed below. The 
third source is information that FDA received from firms that have 
actually implemented HACCP. Even though FDA finds that the costs of 
this final rule may be below $100 million, estimating these costs is a 
difficult task involving some uncertainties. The agency recognizes that 
the rule may affect in a material way a sector of the economy. 
Therefore, FDA has treated the final rule as a significant regulatory 
action under Executive Order 12866. Consequently, the agency has 
completed a full Regulatory Impact Analysis.
    The agency received approximately 230 comments on issues involving 
the PRIA. These comments are fully summarized and addressed in the full 
RIA which is included in the record as Reference 229. However, because 
of the problems with these comments noted above, FDA did not generally 
use them in the revised estimates reported here and in the full RIA. 
The reasons for this are more fully explained in the full RIA.
    These adjusted NMFS model cost estimates result in per plant costs 
for domestic manufacturers of $23,000 in the first year and $13,000 in 
subsequent years. Total costs for compliance with these regulations 
using the adjusted NMFS data are shown in Table 3. FDA has also 
concluded that the PRIA represents a reasonable upper estimate of the 
costs of HACCP. Table 3 also summarizes the specific cost estimates 
that FDA arrived at using data from the NMFS model with cost 
refinements received from commenters and FDA seafood industry experts.

         Table 3.--Disaggregated Costs From Adjusted NMFS Model         
------------------------------------------------------------------------
                                                                 Million
------------------------------------------------------------------------
1st Year:                                                               
  Domestic manufacturers and Importers........................      $112
  Major plant repair and renovation...........................        13
  Sea Grant expertise.........................................         1
  Repackers and warehouses....................................        14
  Harvesters for rejected raw product.........................         1
  Shellfish vessels...........................................         3
  Foreign processors..........................................        18
                                                               ---------
      Total...................................................       162
                                                               =========
2d Year:                                                                
  Domestic manufacturers......................................        65
  Sea Grant expertise.........................................         1
  Repackers and warehouses....................................        14
  Shellfish vessels...........................................         1
  Foreign processors..........................................        10
                                                               ---------
      Total...................................................        91
                                                               =========
3d Year:                                                                
  Domestic manufacturers......................................        65
  Sea Grant expertise.........................................         1
  Repackers and warehouses....................................        14
  IQF Shellfish plants........................................         3
                                                               ---------
      Total...................................................        83
                                                               =========
4th Year:                                                               
  Domestic manufacturers......................................        65
  Sea Grant expertise.........................................         1
  Repackers and warehouses....................................        14
                                                               ---------
      Total...................................................       80 
Total discounted costs beyond the 4th year and discounted at 6 percent, 
 the costs are $1,482 million.                                          
------------------------------------------------------------------------

1. Alternative Model for Estimating the Costs
    In addition to the cost estimate based on the NMFS modeling, FDA is 
presenting a second cost estimate for these regulations. The 
uncertainties associated with the choices made by seafood processors to 
control hazards justify providing a range of potential costs based on 
more than one model.
    In examples created by seafood experts within FDA, the cost of 
compliance with these regulations was estimated for two small 
hypothetical seafood processors that the agency believes to be 
representative of a significant portion of the seafood industry. One of 
the plants is assumed to be in substantial compliance with existing 
CGMP requirements. Therefore, the costs experienced by that plant are 
attributable exclusively to the establishment and maintenance of a 
HACCP system. The other plant has some CGMP deficiencies that the 
agency believes are typical of those displayed by seafood processors. 
This plant is identical to the first plant except for the CGMP 
deviations. The costs calculated for this second plant represent the 
cost associated with the establishment and maintenance of HACCP as well 
as costs associated with the correction and monitoring of sanitation 
conditions.
    The models concern two plants that cut and package tuna which is 
received frozen and that also distribute orange roughy fillets. The 
complexity of the processing operations, and the nature and number of 
hazards, are assumed to be roughly equivalent to that of the other 
types of operations. FDA recognizes the difficulty in validating these 
assumptions. Nonetheless, the results demonstrate that processors may 
have costs that are significantly below the averages estimated by means 
of the NMFS report. As discussed later, data received from firms that 
have implemented HACCP are generally supportive of the results of this 
modeling.
    a. Small plant cost example 1. This is the example of a firm that 
is a processor of frozen tuna steaks and distributor of imported orange 
roughy fillets who receives all fish frozen. This plant is 

[[Page 65181]]
located in a major seafood processing region, so there is no need for 
plant personnel to travel to other cities to receive training as it 
would be available locally. This processor operates 280 days per year. 
The plant manager is paid $15 per hour and production workers are paid 
$8.50 per hour. No food safety hazards are reasonably likely to occur 
in orange roughy, so a written hazard analysis shows hazards for tuna 
only. This processor has no need to make CGMP improvements so the plant 
costs are limited to the following:
    (1) Training--($760). This is calculated as follows: $400 tuition 
plus the opportunity cost of training time ($24 hours x $15 per hour). 
The processor is expected to do most of the hazard analysis during the 
class.
    (2) HACCP Plan Refinement--($240). This is calculated by taking 16 
hours billed at $15 per hour using the FDA Fish and Fishery Products 
Hazards and Controls Guide.
    (3) Plant Sanitation Audit--($0). This is done 3 times daily for 20 
minutes each time. However, because the firm is modeled as being in 
compliance with existing CGMP's, it is assumed that these audits are 
already being done. It is assumed that there is a negligible cost for 
recordkeeping.
    i. Critical Control Points (CCP). (4) Receiving CCP (histamine)--
($3,200). This processor gets a freezing log from the tuna harvester 
and makes a visual check of the fish to see that they are frozen. The 
processor keeps a copy of the freezing log and makes a note of the 
visual check. The fish are then transferred to a plant freezer. The 
monitoring takes 15 minutes per lot for 4 lots per day. Similar 
monitoring is already occurring and the marginal cost for the 
recordkeeping is negligible.
    The processor drills a representative sample of each lot and 
performs an organoleptic examination for decomposition of the tuna. It 
is assumed that this monitoring is not being done previous to this 
regulation and takes 20 minutes 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 recordkeeping costs are negligible.
    (5) Cutting CCP (metal fragments)--($0). A worker checks the saw 
blade at every break to look for broken saw teeth and keeps a log of 
checking on the teeth. Monitoring takes a few minutes per break. It is 
assumed that there is a negligible marginal cost for the monitoring and 
recordkeeping. Fish is weighed, packed, labeled and returned to the 
freezer.
    ii. Corrective actions. (6) Problems with incoming product--($0). 
It is expected that product rejects in the first year would be higher 
but they would return to current levels in the second year as 
harvesters became aware of the processor's new requirements. The total 
cost for the industry is $1 million for the first year and zero in the 
following years. Because harvesters and not processors bear the cost of 
rejected raw product, this cost is included in Table 4 as a separate 
line item and not in Table 3 which includes only costs borne by 
processors.
    (7) A saw tooth breaks every two years--($20). A worker needs to 
examine potentially affected product every 2 years. This is expected to 
take 4 hours billed at $8.50 to check two hours worth of cutting.
    iii. Verification. (8) Record review--($400). This involves a 
review of five sanitation records, five receiving records, and a log 
book for the cutting operation. These are expected to be very simple 
(e.g., check mark records). Consequently, this review is expected to 
take 30 minutes per week billed at $15 per hour.
    (9) Review hazard analysis & HACCP plan--($60). This is expected to 
take 4 hours per year at $15 per hour.
    (10) Administrative changes--20 percent of all of the other costs 
in the first year and 10 percent in the second year.
    b. Small plant cost example 2. The categories of costs that are 
different from Example 1 are explained below.
    (1) Plant Sanitation Audit--($2,800). This will need to be done 3 
times daily taking approximately 20 minutes for each audit. It is 
assumed that some minimal sanitation assessment is already being done 
once per day, but an additional 40 minutes would be required to perform 
three adequate audits. Again, it is assumed that there is a negligible 
cost for recordkeeping.
    (2) Extra Equipment Cleaning and Sanitizing--($2,480). This is 
assumed to take 1 hour per day billed at $8.50 per hour. Also, 
additional water, and cleaning and sanitizing materials are assumed to 
cost $100.
    (3) Eliminate Fly Infestation--($330). Torn screens need to be 
repaired taking 2 hours billed at $8.50 per hour. Also, screening 
materials assumed to cost $15 are needed. An exterminator to apply 
pesticides costs $300.
    Table 4 represents the models described above in tabular form.

                                      Table 4.--FDA Models of Small Plants                                      
----------------------------------------------------------------------------------------------------------------
                                                                Small plant 1 (no GMP      Small plant 2 (GMP   
                                                                       costs)                    costs)         
                          Category                           ---------------------------------------------------
                                                                 Year 1      Year 2--      Year 1      Year 2-- 
----------------------------------------------------------------------------------------------------------------
Training....................................................          760            0          760            0
HACCP plan refinement.......................................          240            0          240            0
Sanitation audit............................................            0            0        2,800        2,800
Receiving CCP...............................................        3,200        3,200        3,200        3,200
Cutting CCP.................................................            0            0            0            0
Sawtooth monitoring.........................................           20           20           20           20
Record review...............................................          400          400          400          400
HACCP plan review...........................................           60           60           60           60
Equipment cleaning..........................................            0            0        2,500        2,500
Eliminate pests.............................................            0            0          330            0
Administration..............................................          940          370        2,100          900
    Per plant costs.........................................       $5,600       $4,000      $12,400       $9,900
----------------------------------------------------------------------------------------------------------------

    In order to estimate an average plant cost from these FDA model 
plants, FDA assumed that, based on the results of the agency's 1990/
1991 survey of the seafood industry, 20 percent of small firms are 
similar to the model plant that requires some GMP improvements (Small 
Plant 2) and that 80 percent of the small firms are similar to the 
model plant that is in compliance with current CGMP's (Small Plant 1). 
The agency has also assumed that the cost of 

[[Page 65182]]
compliance for large firms is the same as that of small firms. There 
are offsetting considerations that have led the agency to make this 
assumption in this model. For example, agency experience suggests that 
it is likely that small firms will, on average, have larger sanitation 
costs and thus incur greater expenses to rectify existing CGMP 
deviations. Large firms, on the other hand, are more likely to have a 
greater number of products and processing lines, resulting in greater 
costs of plan development and monitoring. However, the agency believes 
that large firms are more likely to already have preventive controls, 
formalized sanitation programs, and record keeping systems in place 
than small firms. Additionally, large firms are more likely to take on 
new monitoring regimes with their existing quality control and 
production staffs than are small firms. The agency believes that these 
considerations would counteract each other and should result in fairly 
equal costs for large and small firms.
    To complete the FDA model, FDA assumed that exporters (one- half of 
the 1,000 large firms) would only need to spend $1,000 in order to 
comply with this rule. Combining the two plant total costs as reported 
in Table 4 and weighting the proportion of the industry they are 
assumed to represent, average plant costs are estimated to be $6,400 in 
the first year and $4,800 in subsequent years.
    The foreign processor costs associated with this rule and passed on 
to U.S. consumers are estimated to be 13 percent of the average 
domestic plant costs. The total cost of this regulation using this 
method of cost modeling is $71 million in the first year and $38 
million in the fourth year and beyond.
    Total costs for compliance with these regulations using the FDA 
model are shown 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 Costs                                                           
Domestic 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) Costs                                   
Domestic 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 explanations that would account for the 
uncertainty between the FDA and NMFS models. Virtually all of the 
difference can be explained by the two different estimates of what it 
would take to come into compliance with 21 CFR part 110 (FDA's CGMP 
regulations). In the case of the NMFS study, the contractors estimated 
the cost of coming into full compliance with all CGMPs. Using this 
methodology, they found that approximately 80 percent of the plants 
were out of compliance. On the other hand, the FDA model uses the 
results of FDA's own survey of the industry, which only listed plants 
as being out of compliance if the CGMP violations were related to 
potential contamination of the seafood product. In this case, FDA found 
that only about 20 percent of the firms were out of compliance. In 
addition, the FDA cost model assumes the simplest, least expensive 
corrective action to solve the CGMP violation. The NMFS model did not 
use the same approach in all cases.
2. Other Cost Reports
    Reports received by FDA on the cost of implementing HACCP discussed 
below appear generally to support the results of FDA modeling across 
the seafood industry. While the modeling was limited to certain types 
of small operations, the firms for which FDA has information on 
reported costs represent a cross section of processing operation types, 
including canned, fresh, frozen, smoked/salted, molluscan shellfish, 
and cooked, ready-to-eat products as well as warehouses and repacking 
operations. It should be noted that these costs are reported only as an 
additional source of information. They were not used to generate FDA's 
model plants.
    The cost information obtained from industry includes responses to a 
1991 evaluation questionnaire from four firms that participated in the 
FDA/NOAA seafood HACCP pilot in 1990-1991. It also includes information 
provided to FDA from seven firms through the assistance of the National 
Food Processors Association. (These 7 firms operate a total of 44 
processing plants.) It further includes information from two seafood 
trade associations, the National Fisheries Institute and the New 
England Fisheries Development Association 

[[Page 65183]]
(NEFDA), which provided FDA with summary information about member firms 
that had implemented HACCP systems. The 2 seafood trade associations 
provided information on 16 firms. NEFDA operated a HACCP pilot with 
member firms through a Federal grant. All of this information was 
received by FDA before the publication of the proposed regulations and 
was reported in the PRIA. After the publication of the proposal, FDA 
received information from a large processor-exporter on its HACCP 
start-up costs. This processor reported start up costs of $1,000 per 
plant. In total, FDA has information on 86 plants (Refs. 129 and 223).
    Many of these firms have implemented HACCP as participants in 
either pilot programs, the NOAA fee-for-service program, or the State 
of Alaska program, and therefore their HACCP systems have been subject 
to some form of third party verification. Virtually all of these plants 
have developed HACCP plans, many of which included critical control 
points for quality or economic fraud or both in addition to safety. In 
this respect, many firms implemented a more extensive form of HACCP 
than is being mandated by FDA.
    More complete information on start-up costs received from 22 firms 
who have implemented HACCP is summarized in Table 6. Some of these 
costs are for multi-plant firms and some for firms operating only one 
plant.

                        Table 6.--Start-Up Costs                        
------------------------------------------------------------------------
          No. of firms                      Start-up costs ($)          
------------------------------------------------------------------------
4...............................                        <1,000          
15..............................                   1,000-5,000          
1...............................                  5,000-10,000          
1...............................                 10,000-15,000          
1...............................                       >20,000          
------------------------------------------------------------------------

    FDA notes that there are several uncertainties with these data. The 
agency does not have sufficient information to extrapolate the costs 
observed by these firms to the entire industry. FDA also does not know 
the extent of previous HACCP-type activities in these firms so that 
they may have different incremental costs than the industry average. 
Additionally, for subsequent year costs, some of the firms reported 
costs that exceeded the start-up costs shown in the table although some 
were below, and it is not clear if costs that might be incurred in 
order to comply with CGMP's are represented.
    Nevertheless, the range of reported costs, are consistent with the 
FDA model for a processing operation that does not incur such costs. 
Notably, the estimates developed for NMFS of the costs of operating 
HACCP systems for small businesses are consistent with the FDA model 
and with the reports to FDA by trade associations discussed above.\1\ 
Thus, three independent sources of information suggest that annual 
HACCP costs, at least for small businesses, are within a range of 
$3,000 to $6,000 per plant if sanitation costs are not included. 
Although the HACCP cost estimates made for NMFS did not include certain 
aspects of a HACCP system such as HACCP plan development, plan 
verification, and taking corrective actions, the estimates did include 
the costs of operating HACCP systems for quality and economic 
adulteration in addition to safety. These costs were not included in 
the NMFS cost estimates reported here. The FDA HACCP system involves 
safety only and is therefore less expensive.

    \11\The costs referred to here are those estimated for NMFS for 
the type of HACCP system it was studying. For the purposes of the 
PRIA and RIA, FDA made adjustments to the costs estimated for NMFS 
so as to be consistent with FDA's own regulation. These adjusted 
costs from the NMFS models are the estimates presented earlier in 
this document.
---------------------------------------------------------------------------

    It is also worth noting that three independent sources (FDA's own 
inspection experience, NMFS inspection experience with plants 
purchasing its voluntary inspection services, and the contractor's 
report for NMFS) confirm the existence of sanitation deficiencies in 
some seafood plants. Because FDA holds that these conditions must be 
corrected under existing requirements, the costs associated with these 
corrections will be borne by processors regardless of whether 
sanitation provisions are included in the seafood HACCP regulations or 
somewhere else. Sanitation controls for processors may address a number 
of enteric pathogens discussed elsewhere in this analysis including 
Salmonella, Shigella, hepatitis A, L. monocytogenes, campylobacter, and 
C. botulinum. Contamination may come from either the raw product or 
from poor hygiene practices such as insufficient control of vermin 
(flies and rodents) or insanitary water. In addition, poor sanitation 
may cause contamination of the product with pesticides, lubricants, 
cleaning compounds, or other toxic substances because of improper 
labeling, storage or use. The system in the seafood HACCP regulations 
is based on the monitoring of sanitation conditions by processors. FDA 
is not aware of any method for processors to take control of the 
sanitation conditions within their plants other than by a method that 
involves routine monitoring. Recording the results of these 
observations, as required by the regulations, need involve only minimal 
additional cost.
3. Seafood Prices
    A number of comments referred to the effect that the regulation 
will have on the price of seafood that consumers experience at the 
retail level. In the PRIA, it was presumed that most of the cost of 
compliance of the proposed regulations would be passed on to consumers. 
In the PRIA, it was calculated that if the domestic industry passed on 
to consumers all of the costs estimated in the PRIA, prices for 
domestically produced seafood would increase by less than 1 percent in 
the first year and less than one-half of 1 percent in succeeding years. 
It was noted in the PRIA that price changes of such magnitude are 
unlikely to have a significant impact on general seafood purchases.
    Some commenters claimed that all of the cost of the regulation 
would be born by processors, and that none of the increase in cost 
would be passed on to consumers. These commenters explained that 
seafood is currently at a disadvantage compared to other flesh foods 
for consumers' food dollars because seafood has a higher price per 
pound. If the relative price of seafood were to increase further, 
consumers would eat less seafood. The commenter also explained that 
domestic seafood processors are at a competitive disadvantage compared 
with seafood that can be imported at low cost (i.e., lower wages). If 
domestic processors were to raise their prices, seafood imports would 
take an even larger part of the seafood market away from domestically 
produced seafood.
    Other comments said that processors will pass on all of the cost of 
the regulation, and that the regulation will cause the consumer price 
of seafood to rise. Some said that the price increase would be large 
enough to cause a decrease in seafood consumption.
    Both theories have some merit, although neither is completely 
correct. The agency agrees that, all other things remaining the same, 
an increase in the price of seafood will decrease seafood consumption 
and increase the consumption of other fresh foods. However, the 
decision of a consumer to purchase a product depends on a number of 
factors.
    Seafood includes many invertebrate and vertebrate species which 
vary in price per pound, often by over 100 percent, for a particular 
species (depending, in part, on seasonal supply). Such diversity, 
compared with 

[[Page 65184]]
meat and poultry, makes it clear that there is not perfect substitution 
among the flesh foods. Nevertheless, data bases on food consumption are 
equally clear at showing that as people have increased their 
consumption of various seafood products, they have reduced their 
consumption of meat and poultry.
    There are other nonprice factors in the consumption decision. A 
consumer survey found that taste, quality, and freshness were rated 
above price (``moderately important'') in decisions to order seafood in 
a restaurant or to purchase for preparation at home. In a survey of 
retailers' experiences, consumers ranked quality ahead of price in 
making seafood selections and rated the need for information on cooking 
as a concern equal to price (Refs. 244 and 225).
    Another relevant consideration is the fact that a disproportionate 
percentage of seafood is consumed in restaurants as a luxury item where 
the cost of the raw material is not as important a factor in the 
purchasing decisions made by these consumers.
    All of this information is consistent with other data in this 
analysis that suggests that a 1 percent change in price results in less 
than one-half of one percent change in seafood consumption.
    Another major factor that lessens any competitive cost advantage 
meat and poultry products might experience from an increase in seafood 
cost is that USDA is proposing similar HACCP regulations for meat and 
poultry. USDA's proposal, if finalized for meat and poultry products, 
suggests that all segments of the flesh food market may face cost 
increases in the near future. It is entirely possible that the price of 
seafood relative to meat and poultry will not change. The agency agrees 
that some seafood imports have a cost advantage over domestically 
produced seafood, primarily due to lower labor and capital costs of 
production. However, because the regulation applies to imports as well 
as domestic products and because importers from EU member nations will 
soon be under HACCP requirements and experiencing increased costs, it 
is reasonable to assume that the price of imported seafood relative to 
domestic seafood will not change.
    In the short run, the ability of producers to pass on cost 
increases is largely determined by the elasticity of demand (the degree 
to which consumers reduce their consumption of a good in response to a 
given increase in price) and the elasticity of supply (the degree to 
which producers increase their production of a good in response to a 
given increase in price). The elasticity of demand is determined in 
turn by, among other things, the presence or absence of close 
substitutes. Thus, for example, if there are close substitutes and the 
price of a good goes up, consumers will not continue to consume the 
higher priced good but switch to one of the substitutes.
    If manufacturers know that consumers will not switch to a 
substitute when there is a price increase, then they are free to pass 
along all of the increased costs (from complying with the regulation) 
in the form of price increases. However, where there are close 
substitutes for seafood, such as other flesh foods, consumers respond 
to price increases by reducing their consumption of the high priced 
good. Rather than attempting to pass on all of the costs of the 
regulation in the form of higher prices, producers must accept reduced 
profits and bear some, if not all, of the burden of the cost increase.
    In very competitive markets, such as the market for flesh food, 
where meat, fish, and poultry are considered substitutes, producers 
bear the entire burden of any increases in fixed costs. Fixed costs are 
costs that do not change, despite the size of the firm and changes in 
the level of output. Examples of fixed costs are costs of plant, 
equipment, and management; much of these costs are expected to be borne 
by processors. Because large firms spread fixed costs over larger 
output, they may be able to pass on these costs when smaller firms 
cannot.
    In addition, also in the short run, producers may bear some portion 
of the variable costs that cannot be profitably passed on to consumers. 
Variable costs are costs that vary with changes in the amount of 
output. Examples of variable costs are costs of raw materials and 
hourly labor. However, it is likely that much of the variable costs 
will be passed on to consumers.
    When firms in a competitive market cannot pass on all of a cost 
increase in the short run, profits decline. Beyond some point profits 
become either so low or negative that the firm is forced to close 
(discussed more fully in the Regulatory Flexibility Analysis below). In 
the long run, the exit of these marginal firms reduces the industry 
supply (of seafood) and permits the remaining firms to raise prices to 
cover the full costs of production, both variable and fixed costs. 
Thus, in the long run, seafood prices will rise by the full cost of the 
regulation.
    A few comments requested a better analysis of price changes. These 
commenters criticized the approach used to estimate price increases in 
the Executive Summary of the PRIA. Rather than dividing the estimated 
domestic cost of the regulation by the total domestic production, the 
commenters suggested estimating price changes for each market segment. 
The advantages of this approach are that different types of seafood are 
treated separately (the change in the price of raw tuna might be very 
different from the change in the price of ready-to-eat shrimp cocktail) 
and that different sized firms are treated separately (small firms may 
be forced to raise prices more than large firms).
    FDA agrees that this method of determining price changes is more 
legitimate than the method employed in the PRIA. However, FDA did not 
receive any information from commenters that would enable the agency to 
calculate prices in this manner. It is worth noting, however, that the 
contractor that performed the study upon which many of the estimated 
costs in this RIA are based did take product type into account when 
estimating cost increases. That contractor estimated a range of cost 
increases from negligible to 1.3 percent, depending on the product. 
Again, it is important to note that that study included costs for the 
control of types of hazards not covered by this final regulation.
    Finally, while the methodology used in the PRIA might not produce 
accurate price changes, it suggests that overall price increases due to 
this regulation could well have a negligible effect on demand.

C. Benefits

    In the PRIA, FDA estimated that the proposed option, which is being 
adopted in this final rule, would: (1) Reduce the amount of foodborne 
illness that results from consumption of seafood and; (2) generate 
significant nutrition benefits as a result of the increased consumption 
of seafood (brought about by a decrease in consumer anxiety) with a 
concomitant decrease in the consumption of meat and poultry; (3) reduce 
the amount of rent seeking (rent seeking is a term economists have 
applied to activities which do not contribute to societal welfare but 
only seek to transfer resources from one party to another); and (4) 
generate export benefits by allowing U.S. exporters to continue to 
export to countries requiring HACCP.
    The last benefit, the export benefit, is characterized as the 
benefit to firms exporting to countries that require federal oversight 
and certification of HACCP programs. In addition to the benefits cited 
in the PRIA, the agency is addressing benefits derived from reduced 
enforcement costs, and is discussing other unquantified benefits of 
adopting the seafood HACCP 

[[Page 65185]]
regulations. The agency has fully considered all of the comments on 
benefits. These estimates are more fully explained in the full RIA. 
What follows is FDA's conclusion as to how these benefits should be 
valued.
1. Safety Benefits
    In the tables below, FDA presents revised estimates of the benefits 
of mandatory HACCP for seafood processors. Several changes from the 
preamble to the proposal are noteworthy. First, based on the comment 
that said that FDA had underestimated the number of cases, FDA has 
reestimated the baseline numbers of cases for certain illnesses (Ref. 
226). Next, some changes were made to the valuations of particular 
cases, as better information was obtained concerning the probabilities 
of death per type of illness. Finally, as mentioned above, some changes 
have been made to the estimates of the percentages of the illnesses 
reduced.
    Although Canada, for example, has mandatory HACCP for its seafood 
processors, no data exist on the efficacy of HACCP. Therefore, for the 
percentages of the illnesses reduced, FDA used three different types of 
its experts (seafood experts, epidemiologists familiar with microbial 
hazards, and microbiologists) to address the efficacy of seafood HACCP. 
Each of these experts reviewed the literature on each type of hazard as 
well as the requirements of HACCP. The ranges reflect likely upper and 
lower bounds on how effective HACCP will be at controlling production 
deficiencies by processors, including indirect controls exerted by 
processors on the owners of harvesting vessels. In addition, the tables 
reflect the fact that some of the cases of illness are not addressable 
by this rule as they are caused by either consumer or restaurant 
mishandling or poor fishing practices by recreational fishermen.
    In order to calculate the number of cases (annual cases resulting 
from exposure to hazards associated with seafood consumption) that 
would be reduced by HACCP, each of the four experts followed a series 
of methodical steps. The first was to determine the types of seafood 
associated with each hazard. The second step consisted of reviewing the 
various aspects of the rule to determine the areas of seafood 
harvesting and processing that the rule could affect. The third step 
was to eliminate those cases that could not be affected by the rule.
    These would be cases that seafood processors could neither 
eliminate through processing nor prevent from being introduced, either 
by their own staff or by control over raw materials. Cases caused or 
controlled by factors outside of the HACCP system include recreational 
harvest (approximately 20 percent of all seafood harvested) that does 
not pass through processing plants and problems caused by restaurant, 
supermarket or consumer improper cooking or mishandling. In addition, 
there will be some types of hazards that will not, for the foreseeable 
future, be controllable by means other than avoiding contaminated 
waters, which will not be 100 percent effective (ciguatera, for 
example). Until rapid, inexpensive tests are developed, HACCP cannot be 
100% effective at controlling these hazards.
    Once each expert had accounted for those cases that could not 
potentially be reached by this rule, the experts then assessed the 
likely effectiveness of control steps associated with broad sanitation 
improvements and mandatory controls on specific hazards and specific 
species.
    Ciguatera: Both the lower and upper bound reductions in illness are 
relatively small in the near term because there does not yet exist a 
rapid, inexpensive test for this toxin. Processors and commercial 
fishermen must rely on information about whether geographic areas are 
ciguatoxic. Moreover, many illnesses are attributable to recreational 
harvest.
    Hepatitis A virus: This illness derives mostly from molluscan 
shellfish. For molluscan shellfish, the controls are harvesting from 
approved waters and good sanitation in the plant. These regulations 
specifically involve both types of controls. The upper bound number is 
50 percent of the total estimated number of illnesses largely because 
of the problems that states have in patrolling and controlling 
illegally harvested molluscan shellfish.
    Norwalk virus: This illness derives from raw molluscan shellfish 
that are contaminated from human pollution in harvesting areas. Control 
involves harvesting from approve waters. These regulations include this 
kind of control. The upper bound number is 50 percent of the total 
estimated number of illnesses largely because of the problems that 
states have in patrolling and controlling illegally harvested molluscan 
shellfish and because of the uncertainty of the control of sewage from 
harvesting and recreational vessels.
    Vibrio vulnificus: This illness essentially derives from eating raw 
molluscan shellfish from the Gulf of Mexico. Vibrio vulnificus is a 
naturally occurring, ubiquitous, marine organism. The lower and upper 
bound numbers reflect the fact that controls are newly emerging for 
this organism and still have uncertainties associated with them.
    Table 6a sets out the new estimates of baseline cases of foodborne 
disease related to HACCP and the range of cases averted by HACCP.

               Table 6a.--Estimate of Annual Cases Averted              
------------------------------------------------------------------------
                                                 Number of    Number of 
                                    Estimated      cases        cases   
              Hazard                number of     averted      averted  
                                     cases\1\    (lower)\2\   (upper)\1\
------------------------------------------------------------------------
Anasakis.........................          100           25           60
Campylobacter jejuni.............          200          100          150
Ciguatera........................        1,600           96          200
Clostridium botulinum............           10            3            5
Clostridium perfringens..........          200          100          150
Diphyllobothrum latum............        1,000          250          600
Giardia..........................           30           15           23
Hepatitis A Virus................        1,000          150          500
Other Marine Toxins..............           20  ...........            1
Norwalk Virus....................      100,000       15,000       50,000
Other Vibrio's...................        1,000          200          500
Paralytic Shellfish Poisoning....           10  ...........            1
Salmonella non typhi.............          200          100          150
Scombrotoxin.....................        8,000        4,000       6,000 

[[Page 65186]]
                                                                        
Shigella.........................          200          100          150
Vibrio 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                
------------------------------------------------------------------------
                                                           Total cost of
                 Hazard                   Value per case      seafood   
                                                              illness   
------------------------------------------------------------------------
Anasakis................................          $1,703        $170,332
Campylobacter jejuni....................           9,390       1,877,924
Ciguatera...............................          15,247      24,395,438
Clostridium botuli num..................         223,252       2,232,524
Clostridium perfrin gens................           6,551       1,310,164
Diphyllobothrum latum...................           2,753       2,752,617
Giardia.................................           6,104         183,112
Hepatitis A Virus.......................          22,669      22,668,870
Other Marine Toxins.....................             269           5,380
Norwalk Virus...........................             575      57,500,000
Other Vibrio's..........................           2,955       2,954,842
Paralytic shellfish poisoning...........          92,356       1,200,628
Salmonella non-typhi....................           8,199       1,639,756
Scombrotoxin............................             339       2,708,755
Shigella................................          16,750       3,349,961
Vibrio 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 the third year following the 
date of implementation (undiscounted).

    Table 8.--Estimate of the Efficacy of Mandatory HACCP at Reducing   
                   Foodborne Disease in the Third Year                  
------------------------------------------------------------------------
                                            Lower bound     Upper bound 
                 Hazards                   estimate (3d    estimate (3d 
                                               year)           year)    
------------------------------------------------------------------------
Anasakis................................         $42,583        $102,199
Campylobacter jejuni....................         938,962       1,408,443
Ciguatera...............................       1,463,726       3,049,430
Clostridium botulinum...................         558,131       1,116,262
Clostridium perfringens.................         655,082         982,623
Diphyllobothrum latum...................         688,154       1,651,570
Giardia.................................          91,556         137,334
Hepatitis A Virus.......................       3,400,331      11,334,435
Other Marine Toxins.....................  ..............             269
Norwalk Virus...........................       8,625,000      28,750,000
Other Vibrio's..........................         590,968       1,477,421
Paralytic Shellfish Poisoning...........  ..............          46,178
Salmonella non-typhi....................         819,878       1,229,817
Scombrotoxin............................       1,354,377       2,031,566
Shigella................................       1,674,981       2,512,471
Vibrio 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 categories of seafood (to the 
extent the data allow).

                                                                        

[[Page 65187]]
 Table 9.--Association of Particular Hazards With Categories of Seafood 
------------------------------------------------------------------------
                                    Estimated                           
             Hazards                number of       Affected species    
                                      cases                             
------------------------------------------------------------------------
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 year in Table 10 (undiscounted).

                       Table 10.--Safety Benefits                       
------------------------------------------------------------------------
                                               Lower bound   Upper bound
                    Year                        benefits      benefits  
------------------------------------------------------------------------
1...........................................    32,957,233    67,897,751
2...........................................    32,957,233    67,897,751
3...........................................    45,010,733   116,097,537
4 and beyond................................    45,010,733   116,097,537
------------------------------------------------------------------------

3. Nutrition Benefits From Mandatory Seafood HACCP and Increased 
Consumer Confidence
    In the PRIA, FDA estimated what the potential nutrition benefits 
might be if reduced consumer anxiety over seafood safety led to 
increased sales. FDA hypothesized that this might lead to consumers 
eating lower fat meals (on average) as they replaced higher fat meat 
and poultry with lower fat seafood.
    The agency has considered this issue in greater detail in the full 
RIA. FDA acknowledged in the PRIA that the entire estimate of nutrition 
benefits resulting from increased sales of seafood at the expense of 
meat and poultry sales is speculative. Although the agency believes 
that increased consumer confidence would result from having a state-of-
the-art HACCP system in place for the seafood industry, no data were 
received to confidently predict the ultimate increase in the quantity 
of seafood sold as a result of this regulation. Sales data of this type 
were also not available before or after the agency initiated its low 
acid canned food regulations. Finally, the agency was unable to 
determine if any increase in consumer confidence would offset a price 
increase resulting from HACCP costs.
    The agency was equally concerned about possible nutrition benefits 
as to whether there would be an exact exchange in the nutrient profile 
between fish as prepared and meat and poultry. The agency finds that 
some fish dishes as consumed are eaten fried or served with heavy 
sauces, and that different species of fish have different fat profiles. 
Thus, for some consumers who make substitutions of fish meals for meat 
and poultry, it is not totally clear if there will be a favorable 
decrease in fat intake. Because there are too many unknown variables 
surrounding these substitutes and the lack of sales data, the agency is 
unable to quantify this benefit.
4. Rent Seeking
    Rent seeking activities were characterized in the proposal as 
``public and private resources (which) have been expended in attempts 
to alter the level of regulatory effort toward seafood safety, as well 
as alter which Federal agency should oversee the industry.'' ``Rent 
seeking'' is a term economists have applied to activities that do not 
contribute to societal welfare but only seek to transfer resources from 
one party to another. An example often given is lobbying to change the 
ownership of a government granted special privilege so that profits 
change hands. In many cases, however, it is difficult to distinguish 
between activities that ultimately indirectly benefit society from 
those that only transfer profits. The proposal hypothesized that one 
benefit of the regulation was to reduce the social costs of rent 
seeking.
    One commenter noted that the reason large firms support HACCP is 
because they must have HACCP to export to Europe. The commenter noted 
that mandated HACCP would ``ensure that all domestic processing firms 
face the same costs, thereby reducing any competitive disadvantage.''
    FDA does not agree that this is a justification for HACCP. The 
reason for implementing HACCP is to reduce the incidence of foodborne 
disease. However, FDA agrees that this ``rent-seeking'' argument may 
explain some support for HACCP by larger exporting firms. It is 
important to note, however, that there are small firms who export to 
Europe as well.
5. Export Benefits
    In the PRIA, FDA asserted that one benefit (unquantified) of the 
rule was to allow firms now exporting to the EU to continue to do so 
because of the EU requirement for a federally overseen voluntary HACCP 
program. Several commenters noted that some countries that import 
seafood from the United States are beginning to require HACCP. One 
commenter noted that more than 30 percent of seafood produced in the 
United States is exported. The same commenter noted the disruption in 
trade when French authorities did not coordinate their seafood safety 
requirements with ``other officials.'' Several commenters noted the 
need for more Memoranda of Understandings (MOU's) between the United 
States and other countries for seafood. One suggested that such MOU's 
be based upon HACCP as defined by various international bodies. 
Finally, one commenter noted that FDA ``should take into account how 
the international 

[[Page 65188]]
community is implementing HACCP before the agency imposes regulations 
that may create unnecessary trade barriers.''
    As discussed in the PRIA, this program will benefit those seafood 
processors who are exporting to nations requiring HACCP. However, as 
also noted in the PRIA, there is in place a federally overseen HACCP 
program, specifically, the program being offered to processors by the 
National Marine Fisheries Service (NMFS).
    FDA has made an estimate of the cost savings to exporting firms of 
being in FDA's mandatory program in lieu of the NMFS program. The 
alternative to NMFS review (if FDA were not to adopt this regulation) 
would be inspection of product that is offered for entry into the EU on 
an entry-by-entry basis and the payment of a significant fee for these 
inspection services. With approximately 2 billion pounds being exported 
each year, this savings of resources amounts to, at a minimum, $20 
million per year.
    In addition, although the EU has announced the requirement that 
HACCP be in place by January 1, 1996, adoption of a U.S. plan reduces 
some of the uncertainty for U.S. firms and firms exporting to the 
United States concerning the ultimate form of an internationally agreed 
upon HACCP requirement.
6. Reduced Enforcement Costs
    Comments qualitatively mentioned other benefits including fewer 
product recalls and other enforcement actions. FDA agrees that there 
will be fewer product recalls, seizures, injunctions and detentions of 
seafood and seafood products. As examples of what benefits could have 
accrued in 1994, the agency has calculated the value of each of these 
actions and addressed them below.
    a. Seizures. A seizure is a civil action designed to remove 
violative goods from consumer channels. Table 11 shows the actions and 
their associated costs that follow a determination that a violation 
exists and that goods should be seized.

                        Table 11.--Seizure Steps                        
------------------------------------------------------------------------
               Action                       Hours/Other           Cost  
------------------------------------------------------------------------
Federal personnel collect and         120....................    $12,840
 analyze samples, write up                                              
 recommendations (program and                                           
 general counsel), review the case                                      
 and make recommendations to the                                        
 U.S. attorney.                                                         
U.S. attorney files complaint and     16.....................      1,712
 Court orders goods arrested.                                           
U.S. Marshal and other federal        8......................        856
 official seizes goods at location.   Travel.................        200
Firm hires attorney to contest/       16.....................      1,712
 accept action.                                                         
Food is reconditioned by firm.......  16 firm................      1,712
                                      16 Federal lower valued      1,712
                                       food2.                           
Food is denatured (converted to a     16 firm................      1,712
 non-food use) or;.                   8 Federal lower valued         856
                                       food2.                           
Food is destroyed...................  8 firm.................        856
                                      8 Federal lost food1...       856 
------------------------------------------------------------------------
\1\The rate of $107 per hour represents the cost of a loaded (including 
  equipment and benefits) employee plus headquarters support of         
  approximately 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 benefits are expected to be 
approximately $290,000 each year.

                                           Table 12.--Seizures in 1994                                          
----------------------------------------------------------------------------------------------------------------
                                                                        Administrative                          
                            Problem                               No.      costs\1\      Action\2\      Total   
----------------------------------------------------------------------------------------------------------------
Decomposition (Destroy)........................................      5        $17,320       $46,565     $320,925
Filth (Denature)...............................................      3         17,320         8,709       78,087
Chemicals (Destroy)............................................      2         17,320        10,108       54,856
Other (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 food was reconditioned.                           
\3\This number may well underestimate the benefit. FDA recently completed a seizure proceeding (not filed in    
  1994) in which $5 million of product 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. Table 13 shows the actions 
and their associated costs that follow a determination that a sample is 
violative, the following actions take place.

                       Table 13.--Detention Steps                       
------------------------------------------------------------------------
                Action                        Hours/other        Cost\2\
------------------------------------------------------------------------
Federal personnel send a detention     2.......................     $214
 notice to the importer with an                                         
 opportunity to introduce testimony.                                    
Importer hires attorney and            16......................    1,712
 introduces evidence. Submits                                           
 response application.                                                  
Determination of action to take......  24......................    2,568
Reshipment allowed, or...............  10......................    1,070
                                       Travel, Cost to Reship..     200 

[[Page 65189]]
                                                                        
Product is denatured, or.............  8, Loss of value,\2\          856
                                        Cost of denaturing,\2\,         
                                        Reselling costs\2\.             
Goods are destroyed under Federal      16, Loss of product\1\..         
 supervision.                                                           
------------------------------------------------------------------------
\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                                         
----------------------------------------------------------------------------------------------------------------
                                            Number of                                  Detention      Detention 
                 Reason                    detentions    Quantity\1\   Dollars\1\   disposition\2\    admin\3\  
----------------------------------------------------------------------------------------------------------------
Borates.................................            25        21,484     1,827,173        183,017        112,350
C. botulinum............................             1       113,790       363,434        363,434          4,494
E.coli/coliforms........................            14       254,774       742,786        149,413         62,916
Histamines..............................             2    98,023,014     1,361,714        273,199          8,988
Lead....................................             2       102,188        87,440          9,044          8,988
Listeria/Other Pathogens................            51     2,792,808    21,369,692      4,274,794        229,194
Mercury.................................            11     7,338,900    12,720,272      1,272,327         49,434
Poisonous/Deleterious sub-nec...........             7       180,000       446,025        446,025         31,458
Salmonella/arizona......................           129   221,543,300    76,137,973     15,228,451        579,726
Staphylocci.............................             6        55,810       199,550         40,766         26,964
Sulfites................................            23       713,653     8,100,620        810,362        103,362
Unsafe 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 were calculated.                                                                    
\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 estimated to 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 industry would be approximately 
$12 million per year.
    c. Automatic detentions. Automatic detentions place each lot of 
imported products on detention upon arrival at the border until the 
importer has demonstrated that the products do not violate the Federal 
Food, Drug, and Cosmetic Act. This is normally done by the importer 
hiring independent labs to sample each lot. Table 15 shows the number 
and types of relevant automatic detentions that took place in 1994.

                 Table 15.--Automatic Detentions in 1994                
------------------------------------------------------------------------
                                  Number of                             
            Reason                automatic      Sample        Storage  
                                 detentions      cost\1\       cost\2\  
------------------------------------------------------------------------
Borates.......................            53      $132,500      $182,717
C. botulinum..................           104       260,000        36,343
E.coli/coliforms..............             8        20,000        74,279
Histamines....................            63       157,500       136,171
Lead..........................             1         2,500         8,744
Listeria/Other Pathogens......           236       590,000     2,136,969
Mercury.......................           397       992,500     1,272,027
Pesticide chlorothalanil......             1         2,500            50
Poisonous and Deleterious sub-                                          
 nec..........................             4        10,000        44,603
Salmonella/arizona............           759     1,897,500     7,613,797
Staphylocci...................             0             0        19,955
Sulfites......................            12        30,000       810,062
Underprocessed................             3         7,500        15,454
Unsafe 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 at a 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 above automatic detentions are 
eliminated each year, then the benefits will be approximately $6 
million per year.
    d. Recalls. The costs of recalls to a firm vary from inexpensive 
notification 

[[Page 65190]]
of consignees to several million dollars, depending on the nature of 
the hazard, the type of seafood, the cost and amount of product 
involved, and the distribution chain of the product. The costs of a 
recall include searching for the recalled products, removing them from 
retail and wholesale outlets, replacing the adulterated product, 
effectiveness checks, and disposal or reconditioning. In some cases 
recalls cause marketing disruptions, loss of shelf space, and 
subsequent losses in sales via publicity.
    FDA costs include investigative and analytical time and expenses, 
administrative costs, cost of samples, and auditing time.
    FDA assumes that the costs of recalls borne by firms are directly 
related to the distribution costs associated with the products and to 
the size of the contaminated lots. Distribution costs account for about 
one-third of the final value of seafood. FDA assumes that the firm must 
bear the full amount of the distribution costs of the recall. In 
addition, the other costs listed above raise the total cost of recalls 
borne by firms to one-half the value of the product. FDA uses one-half 
the value of the product as the base for the estimate of total recall 
costs. The total recall cost of seafood processing firms in 1994 is 
estimated to be $2,461,906, as shown in table 16. FDA audit checks for 
seafood took 474 hours in 1994. FDA assumes that total FDA costs per 
recall were proportional to audit hours. The cost per hour of an audit 
check is $107, giving an FDA audit cost of $50,718 (474 x 107). FDA 
collected 72 samples at $250 per sample, giving sample costs of $18,000 
(72 x 250). FDA thus estimates additional costs due to recalls to be 
$68,718 ($50,718 + $18,000). The total recall cost is estimated to be 
$2,530,624 ($2,461,906 + $68,718). Again, the estimate for the purpose 
of this benefits analysis assumes that half of all recalls will be 
prevented or about $1,250,000.

                                           Table 16.--Recalls in 1994                                           
----------------------------------------------------------------------------------------------------------------
                 Fish                              Hazards                      Amount                Total     
----------------------------------------------------------------------------------------------------------------
Canned tuna...........................  Filth, decomposed, punctured   6,599 cases.............         $150,687
                                         cans, short weight.                                                    
Crab..................................  L. monocytogenes.............  16,156 lbs..............           64,624
Escolar fish..........................  Decomposed, sc ombroid,        1,719 lbs...............            1,614
                                         illness.                                                               
Herring, salted Schmaltz..............  L. monocytogenes.............  1,200 lbs...............            1,740
Hilsha fish...........................  Salmonella...................  2,000 lbs...............            2,100
Lobster...............................  L. monocytogenes, salmonella.  25,920 lbs..............          243,648
Mahi mahi, fresh......................  Decomposed...................  575 lbs.................              834
Nova chips............................  L. monocytogenes.............  54 lbs..................              157
Oysters, shellstock...................  V. vulnificus................  9,219,430 lbs...........        1,843,886
Oysters, shucked......................  V. vulnificus................  21,944 lbs..............           87,776
Sardines, flat fillets................  Rusty, leaky, decomposed.....  33,600, 13 oz cans......           50,400
Smoked catfish, salmon, sturgeon, tuna  L. monocytogenes.............  1,060 lbs...............            2,963
Tuna steaks...........................  Decomposed...................  7,110 lbs...............           11,477
                                                                                                ----------------
      Total...........................  .............................  ........................     2,461,906.00
----------------------------------------------------------------------------------------------------------------

    e. Injunctions. Injunctions are the most severe form of domestic 
penalties whereby a firm is enjoined from producing/distributing a 
product until a violation is remedied. There are approximately 5 
injunctions by FDA against seafood products each year costing the firm 
an average of about $70,000 and FDA an average of about $30,000 each or 
about $500,000 per year. These costs include court costs, analytical 
testing costs, inspections costs, and lost production costs. Again, if 
this rule reduced injunctions by half, societal savings would be 
$250,000.
    Total enforcement benefits are the sum of all of the reduced 
enforcement costs estimated to be approximately $20 million per year.
7. Other Benefits
    Commenters also mentioned benefits including better process control 
(resulting in lower production costs) and improved employee morale.
    FDA believes that there may be ``re-engineering'' types of benefits 
associated with these regulations. For both seafood and other foods for 
which HACCP has been implemented, FDA has received information that 
firms have found cost-saving innovations in other areas as they 
implement HACCP. These innovations are considered trade secrets by 
firms and thus, their description (actual process innovations) and 
quantification is impossible as firms have not released this data into 
the public domain. This phenomenon involves unexpected savings and 
efficiencies as a result of establishing a new system in a processing 
operation. The majority of firms that have previously instituted HACCP 
reported that they believed that the advantages they derived from HACCP 
were worth the costs to them in terms of better control over their 
operations, better sanitation, and greater efficiencies, such as 
reduced waste. Virtually all foresaw long-term benefits from operating 
under HACCP.
    Improved employee morale depends on how HACCP is implemented. If, 
for example, employees are (1) participating in day-to-day monitoring 
of critical control points, (2) allowed through corrective action plans 
to participate in corrective actions including shutting down a line 
when a critical limit has been exceeded, and (3) are rewarded for this 
decision rather than penalized or forced to rigorously defend their 
actions, then employee morale may increase. Such an increase in morale, 
if valid, may lead to greater productivity. However, it is in the 
direct financial interest of every company to maintain employee morale 
such that any additional benefit from this regulation is likely to be 
small.
    A final benefit will be realized for finfish where processing 
plants and vessels, in an effort to control for histamine formation, 
keep fish cooled from harvest to retail. This will simultaneously 
decrease the decomposition rate that causes seafood to be thrown out 
because of organoleptic problems. The same situation exists relative to 
cooked, ready-to-eat products and smoked fish. One retailer cited 
losses of 4 percent to 8 percent of all seafood because of 
decomposition. If some of this decomposition begins prior to arrival at 
the retail level and is reduced in any degree by this 

[[Page 65191]]
regulation, benefits could potentially be large.
    However, FDA recognizes that there is also a short term cost (e.g., 
as molluscan shellfish harvesters attempt to supply processors with 
untagged shellfish or from vessels without sanitary facilities aboard 
and find the harvest rejected). The same will also be true for finfish 
which have not been properly temperature controlled from harvest to 
processor. These harvests will be discarded although this behavior is 
not expected to occur often, or more than once in any instance.

D. Costs and Benefits of Sanitation

    A portion of the costs and benefits of this rule derive from the 
improvements in the facilities and CGMP's in seafood plants. Although 
all food manufacturing plants are required to produce food under 
sanitary conditions now, FDA's experience, and that of others, indicate 
that many seafood processors are not producing seafood under those 
conditions. The sanitation, monitoring, and recordkeeping provisions of 
this rule are expected to drive processors to improve their sanitation 
conditions and thus reduce the need for FDA to enforce CGMP's through 
regulatory actions. These provisions will produce net increases in 
societal welfare with accompanying costs and benefits.
    Current goods manufacturing practices include such things as 
cleanliness and habits of personnel, the conditions of buildings and 
facilities, equipment, production and process controls, and conditions 
of warehousing and distribution of the product. It is difficult to 
differentiate between costs and benefits that are HACCP-related and 
those that are sanitation-related. For example, processors are required 
under HACCP to keep records that show that CGMP's such as ``Measures 
such as sterilizing, irradiating, pasteurizing, freezing, 
refrigerating, controlling pH or controlling aw that are taken to 
destroy or prevent the growth of undesirable microorganisms, 
particularly those of public health significance, shall be adequate 
under the conditions of manufacture, handling, and distribution to 
prevent food from being adulterated within the meaning of the act'' are 
being followed (see 21 CFR 110.80(a) (2) and (4)). However, the 
benefits derive from making plant and processing changes, uncovering 
problems in processing due to recordkeeping and taking corrective 
action which prevents hazardous seafood from being sold. Thus, HACCP 
and CGMP's are inextricably intertwined and it is difficult to 
calculate the marginal benefits and marginal costs of each.

E. Costs and Benefits Attributable to Foreign Governments

    FDA has reported the portion of the increased costs that are 
expected to be passed on to U.S. consumers by foreign processors. The 
justification for this action is that FDA has not included safety 
benefits that foreign consumers may enjoy when foreign firms that 
export to the United States introduce HACCP into their plants. FDA has 
also included, as a benefit of this regulation, reduced enforcement 
actions toward products produced by foreign firms and reduced illnesses 
that U.S. consumers suffer from imported seafood.
    In a benefit-cost analysis, costs and benefits are attributable to 
choices made among competing options. However, in this rule, there are 
difficulties in assigning the costs and benefits to choices made by FDA 
to require HACCP of domestic and foreign seafood processors. This 
difficulty arises because other countries either already require HACCP 
or have indicated that they will do so in the near future--for both 
their domestic and imported seafood products. No costs or benefits 
should be ascribed to choices made by the U.S. Government in this rule 
that affect firms already complying with foreign regulations, if the 
regulations are the same and no changes need to be made to be in 
compliance with the U.S. regulation.
    Thus, foreign firms in those countries who export to the United 
States may be required to comply first with the U.S. plan or first with 
their own country's plan; the timing is impossible to predict. However, 
FDA does have evidence from the European Union that the seafood 
produced by the following countries (at least seafood for export) have 
met the EU 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, New Zealand, Norway, Peru, 
Philippines, Sweden, Taiwan, Thailand, and Turkey.

F. Conclusion

    As the above analysis demonstrates, FDA finds that the estimated 
benefits exceed the estimated costs. The estimated costs are 
approximately one third of those in the PRIA, ranging from $677 million 
to $1.488 billion. These estimated costs were based primarily on the 
reports of some seafood firms and modeling done by FDA experts based on 
their experience with HACCP but also considered the study done under 
contract with NMFS. The benefits range from $1.435 billion to $2.561 
billion and include benefits from safety, nutrition, increased consumer 
confidence, rent seeking activities, exports, and reduced enforcement 
costs.

G. Final Regulatory Flexibility Analysis

    The Regulatory Flexibility Act (Pub. L. 96-354) requires analyzing 
options for regulatory relief for small businesses. In the PRIA, FDA 
listed for comment a series of regulatory options on how to grant 
regulatory relief for small firms. In that document, FDA defined small 
firms as having less than $1 million in annual gross revenue (for non-
shrimp processors) and less than $2 million for shrimp processors. In 
the PRIA, regulatory options for small business relief included:
    (1) Requiring HACCP-type controls for those critical control points 
in individual plants that have a history of failure.
    (2) Exempting very small processors from the requirements in the 
proposed regulatory option.
    (3) Allowing a longer implementation period such that HACCP 
requirements may be phased in over a longer period of time.
    (4) Providing generic HACCP plans (without mandatory control 
points) for certain types of operations, providing federal 
verification, or less frequent monitoring of critical control points.
    FDA received a large number of comments on these options and on the 
costs that small businesses would incur as a result of the proposed 
option.
    The agency has fully considered all of the comments received on its 
regulatory flexibility analysis and has responded to these comments in 
the full RIA. What follows is a summary of FDA's major conclusions from 
the analysis.
    FDA received comments on whether there should be exemptions for 
processors based on either the size of the processor or the degree of 
risk associated with the product or process. For example, one commenter 
supported the exemption of small firms on the basis that small firms 
that represent 75 percent of the industry in terms of the number of 
plants, produce less than 10 percent of the seafood consumed.
    FDA has concluded that there should be no exemptions for small 
firms. Small processors often engage in relatively high risk seafood 
processing, and an exemption based on size could inappropriately exempt 
high risk operations. An exemption based on risk might entail knowing 
which seafood might be responsible for a reported and confirmed 
illness. The agency finds however that because underreporting and 
skewed reporting of foodborne 

[[Page 65192]]
illnesses occurs it is not always directly possible to relate the 
reported illnesses to risk. This subject is also discussed at length in 
the preambles to both the proposed and final rule.
    One comment recommended that no firms be completely exempt, but 
that some firms be subject to different HACCP requirements depending on 
size. The smaller the firm, the less strict the record-keeping, 
testing, and monitoring requirements. The use of a short form for 
recordkeeping and informal monitoring was supported in some comments.
    Again, this is a topic that is extensively covered in the preamble 
to the final rule. FDA notes that HACCP depends on the degree of risk 
and complexity of processing and that HACCP requirements for each plant 
are calibrated based on these factors. Whether the plant is large or 
small, if there are few hazards and simple processes, HACCP 
requirements are inherently minimal. If there are no hazards, no HACCP 
plan is required. Overall, however the agency believes that many 
smaller firms are associated with simpler processes and that the HACCP 
system already accommodates the commenter's concern.
    In the long run, as processors adopt HACCP and attempt to pass 
costs on to consumers, the retail price of seafood will rise by less 
than 1 percent. In the absence of an increase in consumer demand that 
may result from this regulation, as the price of seafood rises, 
consumers will purchase less seafood. As producers fail to sell all of 
the seafood offered at the higher price, output must fall. Moreover, 
output must decrease in the highest cost sector of the industry, 
generally small processors. Although it is possible that small 
processors will cut back production but stay in business, the small 
profit margins of some small seafood producers strongly imply that the 
reduction in output will come about because small processors go out of 
business. For every one percent increase in the price of seafood, 
approximately 140 small processors could go out of business. The 
estimated number comes from the following calculation. FDA has 
estimated that as costs are passed on, HACCP will raise the price of 
seafood to consumers. The price elasticity of demand, which is the 
percentage change in quantity purchased divided by the percentage 
change in price, is estimated to be -0.37 for seafood (Ref. 227). A one 
percent increase in the price consumers pay for seafood should 
therefore reduce the quantity purchased by 0.37 percent (1 percent 
times -0.37). FDA believes that the entire reduction in output 
attributable to HACCP will be borne by small processors who go out of 
business. Although close to 80 percent of seafood processors are 
classified as small, small processors account for only 10 percent of 
total industry output (Ref. 228). In the case of a 0.37 percent decline 
in total processing output represents a decline in the output of small 
processors of 3.7 percent (0.37 percent divided by 0.10). If the 
decline in the number of processors were proportional to the decline in 
the output of small processors, the reduction in the number of 
processors would be 3.7 percent in the case of a 1 percent price 
increase. FDA is uncertain as to what price increase will actually 
occur.
    The agency finds that the number of small seafood processors that 
go out of business will be determined by the cost per unit (or per 
plant) of implementing HACCP, the effect of HACCP on seafood prices, 
the ability of small plants to pass costs on to consumers, the current 
practices of the plants and the implementation time. The analysis has 
assumed that the regulation will have no positive effect on the demand 
for seafood. If the regulation in fact increases consumer confidence in 
seafood sufficiently to increase the demand for seafood, then the 
effect on small business would be less.
    Although the economic impact on small firms is difficult to 
predict, many small firms should be able to implement HACCP at low 
cost, as they have already fulfilled many of its basic requirements. 
The closer a firm's current practices are to HACCP, the lower the cost 
of HACCP and the more likely is firm survival. Some small firms occupy 
market niches that allow them to pass on more of their costs than the 
industry average, increasing their likelihood of survival.
    The effect of HACCP on small seafood processors depends on their 
costs of compliance and on the changes in the relative price of 
seafood. FDA expects the relative price increase attributable to HACCP 
to be small. For many small firms, the flexibility built into the 
regulation strongly implies that HACCP costs will be low. In 
consideration of small firms, the agency has extended the effective 
date to 2 years from publication. FDA will also be publishing a Guide 
that will provide small processors with valuable information for 
developing and implementing HACCP. Additionally, the agency, in 
cooperation with Sea Grant Universities and others through the Seafood 
HACCP Alliance, will be providing to small firms assistance on training 
and other needs.
    FDA recognizes that HACCP is an innovative regulatory system that 
has not been applied on a large scale to ongoing commercial enterprises 
in the United States. For this reason all of the agency's estimates of 
firm behavior, costs and benefits necessarily involve substantial 
uncertainty. As explained in this Regulatory Impact Analysis, FDA has 
used modeling techniques and informed judgements rather than firm 
empirical data to estimate many effects. In order to determine the 
accuracy of these estimates, and also to assist in possible mid-course 
corrections, FDA and HHS plan to conduct an evaluation study during the 
first few years after the effective date of these regulations. This 
study could focus on each major type of one-time or continuing 
compliance cost, on different types of firms, on different sizes of 
firms (with particular attention to the smallest firms), and on both 
costs required by the regulation and on costs that firms may incur 
unnecessarily. It could also address the ability of firms to understand 
and implement HACCP properly, and any other problems that may impede 
rapid and inexpensive implementation. This study could also include an 
exploratory analysis of benefits, addressing both improvements in 
processing as measured by elimination of hazards and, to the extent 
permitted by existing data systems, early trends in reported incidence 
of illness caused by seafood.

V. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (59 FR 4142, January 28, 
1994). No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment, and that an environmental impact 
statement is not required.

VI. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. Committee on Diet and Health, Food and Nutrition Board, 
Commission on Life Sciences, National Research Council, ``Diet and 
Health: Implications for Reducing Chronic Disease Risk,'' National 
Academy Press, Washington, DC, 1989.
    2. National Heart, Lung, and Blood Institute, DHHS, ``National 
Cholesterol Education Program: Report of the Expert Panel on 
Population Strategies for Blood Cholesterol Reduction, Executive 
Summary,'' NIH Publication No. 90-3047, National Institutes of 
Health, Bethesda, MD, 1990. 

[[Page 65193]]

    3. Hackney, C., and D. Ward, ed., ``Microbiology of Marine Food 
Products,'' Van Nostrand Reinhold, 1991.
    4. Roper, W. L., Director, Centers for Disease Control, letter 
to the Honorable John D. Dingell, May 2, 1990.
    5. Otwell, W. S., ``Seafood Safety in Question,'' MTS Journal, 
25(1):23-29.
    6. FDA, DHHS, ``Seafood Safety,'' May 10, 1993.
    7. Ahmed, F. E., ed., Committee on Evaluation of the Safety of 
Fishery Products, Food and Nutrition Board, Institute of Medicine, 
NAS, Seafood Safety, National Academy Press, 1991.
    8. Rhodehamel, E. J., ``Overview of Biological, Chemical, and 
Physical Hazards,'' HACCP: Principles and Applications, Van Nostrand 
Reinhold, 1992.
    9. Colwell, R. R. ed., ``Natural Toxins and Human Pathogens in 
the Marine Environment,'' Report of a Sea Grant-Sponsored Workshop, 
A Maryland Sea Grant Publication, undated.
    10. Stone, R., ed., ``Single-Celled Killer in Monterey Bay,'' 
Science, November 22, 1991.
    11. Letter to John A. Sandor from Thomas J. Billy, March 22, 
1993.
    12. Bier, J. W., T. L. Deardorff, G. J. Jackson, and R. B. 
Raybourne, ``Human Anisakiasis,'' Bailliere's Clinical Tropical 
Medicine and Communicable Diseases, 2(3):723-733, 1987.
    13. Liston, J., Statement before the Senate Committee on 
Commerce, Science, and Transportation, U.S. Senate, June 30, 1992.
    14. Mayer, B. K., and D. R. Ward, ``Microbiology of Finfish and 
Finfish Processing,'' Microbiology of Marine Food Processing, Van 
Nostrand Reinhold, 1991.
    15. Spitzig, P., memorandum, ``Decomposition Data From the 
Seafood Regulatory Action Database,'' May 14, 1992.
    16. FDA, DHHS, ``The Fish List: FDA Guide to Acceptable Market 
Names for Food Fish Sold in Interstate Commerce,'' 1988.
    17. Letter From Skip Widtfeldt, Seafood Permit Coordinator, 
State of Alaska Department of Environmental Conservation, to Alaska 
Seafood Processors, January 17, 1992.
    18. Nardi, G., ``HACCP: A View From the Inside,'' American 
Seafood Institute Report, April 1992.
    19. Coons, K., ``HACCP is Here,'' Seafood Supplier, May/June 
1992.
    20. Kraemer, D. W., memorandum, ``Unique Nature of Seafood 
Processing Industry,'' May 6, 1993.
    21. Kraemer, D. W., memorandum, ``High Risk Survey--Cooked Ready 
to Eat Results,'' March 1, 1993.
    22. Bryan, F. L., ``What the Sanitarian Should Know About 
Staphylococci and Salmonellae in Non-Dairy Products: I. 
Staphylococci,'' Journal of Milk and Food Technology, 31(4):110-116, 
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in Hot-process (Smoked) Salmon,'' Journal of Food Protection, 
45(9):833, 1982.
    180. Eklund, M. W., testimony presented at New York State 
Department of Agriculture and Markets' hearing, May 13, 1989.
    181. Newberry, R. E., Letter to City Smoked Fish Co., Use of 
Colors in Smoked Salmon, March 11, 1985.
    182. National Fisheries Institute, Inc., ``Techniques For 
Smoking Fish,'' Washington, DC.
    183. Borgstrom, G., ``Smoking,'' in ``Fish as Food, Processing: 
Part I, Vol. 3,'' p. 88, Academic Press, New York, 1965.
    184. Kautter, D. A., memorandum, ``Aqueous Phase Salt 
Concentration for Vacuum Packaged Cold-smoked Fish,'' April 6, 1990.
    185. Eklund, M. W. et al., ``Feasibility of a Heat-
pasteurization Process for the Inactivation of Nonproteolytic 
Clostridium Botulinum Types B and E in Vacuum-packaged, Hot-process 
Smoked Fish,'' Journal of Food Protection, 51(9):720, 1988.
    186. Eklund, M. W., D. I. Wieler, and F. T. Poysky, ``Outgrowth 
and Toxin Production of Nonproteolytic Type B Clostridium Botulinum 
at 3.3 to 5.6  deg.C,'' Journal of Bacteriology, 93(4):1461, 1967.
    187. Solomon, H. M. et al., ``Effect of Low Temperatures on 
Growth of Clostridium Botulinum Spores in Meat of the Blue Crab,'' 
Journal of Food Protection, 40(1):5, 1977.
    188. Ohye, D. F., and W. J. Scott, ``Studies in the Physiology 
of Clostridium Botulinum Type E,'' Australian Journal of Biological 
Science, 10:85, 1956.
    189. National Research Council, ``An Evaluation of the Role of 
Microbiological Criteria for Foods and Food Ingredients,'' p. 249, 
National Academy Press, Washington, DC.
    190. Federal Standard, ``Sanitation Standards For Fish Plants,'' 
FED-STD-369, Academy of Health Sciences, U.S. Army, Fort Sam 
Houston, Houston, TX, August 2, 1977.
    191. Masso T. W., letters to T. Schwarz With AFDO Resolution No. 
8, June 8, 1990.
    192. Bryan, F. L., ``Application of HACCP to Ready-to-eat 
Chilled Foods,'' Food Technology, 44(7):70, 1990.
    193. Tartakow, I. J., and J. H. Vorperian, (eds.), ``Foodborne 
and Waterborne Diseases: Their Epidemiologic Characteristics,'' p. 
50-52, AVI Publishing Co., Westport, CN, 1981.
    194. Rhodehamel, J. E., N. R. Reddy, and M. D. Pierson, 
``Botulism: The Causative Agent and its Control in Foods: A 
Review,'' Food Control, 3(3):125-143, 1992.
    195. FDA, ``Human Foods; Current Good Manufacturing Practice 
(Sanitation) in Manufacturing, Processing, Packing, or Holding 
Smoked Fish,'' 34 FR 17176, October 23, 1969.
    196. FDA, Part 110--Current Good Manufacturing Practice in 
Manufacturing, Packing, or Holding Human Food (21 CFR part 110).
    197. FDA, FDA Inspections Manual, Chapter 5, Establishment 
Inspection, Subchapter 530, Food.
    198. Center for Disease Control, ``Fish Botulism--Hawaii, 
1990,'' Morbidity and Mortality Weekly, 40(24):412-414, June 21, 
1991.
    199. FDA, ``Studies in Food Sanitation Control--Year Five, 
Contract No. 223-80-2295, Task XVI, Effect of Controlled Humidity of 
Processing Ovens at High Operating Temperatures on Production of 
Smoked Fish,'' June 14, 1984.
    200. Printout of FDA FY 90/91 Domestic Fish and Fishery Products 
Assignment Inspection Data as of August 6, 1991.
    201. Daniels, Richard W., ``Applying HACCP to New Generation 
Refrigerated Foods at Retail and Beyond,'' Food Technology, June 
1991.
    202. Consent Decree Regarding Shellfish Sanitation Issues, No. 
9213, Subproceeding 89-3, United States of America, et al., 
Plaintiffs, v. State of Washington, et al., Defendants, May 5, 1994.
    203. Taylor, S. L., and S. S. Sumner, ``Determination of 
Histamine, Putrescine, and Cadaverine,'' Seafood Quality 
Determination, edited by D. E. Kramer and J. Liston, Elsevier 
Science Publishers B. V., Amsterdam, November, 1986.
    204. Wentz, B. A., A. P. Duran, A. Swartzentruber, A. H. Schwab, 
F. D. McClure, D. Archer, R. B. Read, ``Microbiological Quality of 
Crabmeat During Processing,'' Journal of Food Protection, 48(1):44-
49, January, 1985.
    205. Phillips, F. A., and J. T. Peeler, ``Bacteriological Survey 
of the Blue Crab Industry,'' Applied Microbiology, 24:958-966, 1972.
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Processors Association, ``HACCP Implementation: A Generic Model for 
Chilled Foods,'' Journal of Food Protection, 56(12):1077-1084, 
December 1993.
    207. FDA Memorandum to Patricia Spitzig from Oliver D. Cook, 
July 11, 1995, concerning relationships between consumer complaints 
and process controls.
    208. Department of Health and Human Services and Food and Drug 
Administration, ``21 CFR Parts 123 and 1240: Proposal To Establish 
Procedures for the Safe Processing and Importing of Fish and Fishery 
Products; Proposed Rule,'' 59 FR 4142, No. 19, January 28, 1994.
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Slaughter Practices on the Bacteriology of the Red Meat Carcass,'' 
Journal of the Royal Society of Health, (1), 1980.
    210. Huss, H. H., ``Assurance of seafood quality'', FAO 
Fisheries Technical Paper 334, Food and Agriculture Organization of 
the United Nations, Rome, 1994.
    211. Department of Agriculture, Food Safety and Inspection 
Service, ``9 CFR Parts 308, 310, 318, 320, 325, 326, 327, and 381: 
Pathogen Reduction; Hazard Analysis and Critical Control Point 
(HACCP) Systems; Proposed Rule,'' 60 FR 6774, No. 23, February 3, 
1995.
    212. National Marine Fisheries Service, National Oceanic and 
Atmospheric Administration, U.S. Department of Commerce, Fisheries 
of the United States, 1993, Current Fisheries Statistics No. 9300, 
Silver Spring, MD, May, 1994.
    213. Bauman, H. E., ``Introduction to HACCP'', HACCP: Principles 
and Applications, edited by Pierson, M. D., and D. A. Corlett, Van 
Nostrand Reinhold, New York, 1992.
    214. Eklund, M. W., ``Significance of Clostridium Botulinum in 
Fishery Products Preserved Short Of Sterilization,'' Food 
Technology, December 1982.
    215. Diane E. Thompson, Associate Commissioner for Legislative 
Affairs, letter to Representative Edolphus Towns, December 14, 1994, 
concerning molluscan shellfish safety.
    216. FDA, ``Import Seafood Products Compliance Program FY*95/96/
97*,'' Compliance Program Guidance Manual, (Program 7303.844), 
October 1994.
    217. July 11, 1995, Memorandum to the Administrative Record for 
Docket No. 93N-0195 from Don Kraemer, CFSAN, FDA, concerning illegal 
harvesting of molluscan shellfish.
    218. Dowell, S. F., C. Groves, K. B. Kirkland, et. al., ``A 
Multistate Outbreak of Oyster-Associated Gastroenteritis: 
Implications for Interstate Tracing of Contaminated Shellfish,'' 
Journal of Infectious Diseases, University of Chicago, vol. 171, 
1995. 

[[Page 65197]]

    219. Aristequieta, C., I. Koenders, D. Windham, et. al., 
``Multistate Outbreak of Viral Gastroenteritis Associated with 
Consumption of Oysters--Apalachicola Bay, Florida, December 1994-
January 1995,'' Morbidity and Mortality Weekly Report 1995, 44:37-
39.
    220. Association of Food and Drug Officials, ``1994 Proceedings 
Issue of The Association of Food And Drug Officials,'' September 
1994.
    221. Kraemer, D., memorandum, ``FDA Experiences with Low-Acid 
Canned Foods,'' August 17, 1995.
    222. Kraemer, D., memorandum, ``Unique Configuration of HACCP 
Plans,'' August 17, 1995.
    223. Letter from Jim Yonker of Ocean Beauty Seafood to Mary 
Snyder, FDA Office of Seafood, dated June 29, 1995.
    224. Perkins, Caroline, ``1993 SB Consumer Survey Findings,'' 
Seafood Business, Nov./Dec. 1993, 12:7, p.47.
    225. Freeman, Kris, Eighth Annual Retail Survey, Seafood 
Business, Sept/Oct 1993 12:6, p.46.
    226. Amler, Robert W. and Bruce H. Dull, Closing the Gap: The 
Burden of Unnecessary Illness, ``Infectious and Parasitic Diseases'' 
by Bennett, John V., M.D. et al., Oxford University Press, New York, 
1987.
    227. Marasco, Richard, ``Food from the Sea: An Economic 
Perspective on the Seafood Market,'' Marine Economics: Production 
and Marketing of Seafood Products, December 1974, p. 1031.
    228. Dressel, David M. and Teh-Wei Hu, ``The U.S. Seafood 
Processing Industry: An Economic Profile for Policy and Regulatory 
Analysts,'' National Fisheries Institute in Cooperation with the 
National Marine Fisheries Service, 1983.
    229. Final Regulatory Impact Analysis.

List of Subjects

21 CFR Part 123

    Fish, Fishery products, Imports, Reporting and recordkeeping 
requirements, Seafood.

21 CFR Part 1240

    Communicable diseases, Public health, Travel restrictions, Water 
supply.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, title 21 CFR 
chapter I is amended as follows:
    1. New part 123 is added to read as follows:

PART 123--FISH AND FISHERY PRODUCTS

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-Flavored Fishery 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 Service Act (42 U.S.C. 241, 242l, 264).

Subpart A--General Provisions


Sec. 123.3  Definitions.

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (the act) and in part 110 of this 
chapter are applicable to such terms when used in this part, except 
where they are herein redefined. The following definitions shall also 
apply:
    (a) Certification number means a unique combination of letters and 
numbers assigned by a shellfish control authority to a molluscan 
shellfish processor.
    (b) Critical control point means a point, step, or procedure in a 
food process at which control can be applied, and a food safety hazard 
can as a result be prevented, eliminated, or reduced to acceptable 
levels.
    (c) Critical limit means the maximum or minimum value to which a 
physical, biological, or chemical parameter must be controlled at a 
critical control point to prevent, eliminate, or reduce to an 
acceptable level the occurrence of the identified food safety hazard.
    (d) Fish means fresh or saltwater finfish, crustaceans, other forms 
of aquatic animal life (including, but not limited to, alligator, frog, 
aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of 
such animals) other than birds or mammals, and all mollusks, where such 
animal life is intended for human consumption.
    (e) Fishery product means any human food product in which fish is a 
characterizing ingredient.
    (f) Food safety hazard means any biological, chemical, or physical 
property that may cause a food to be unsafe for human consumption.
    (g) Importer means either the U.S. owner or consignee at the time 
of entry into the United States, or the U.S. agent or representative of 
the foreign owner or consignee at the time of entry into the United 
States, who is responsible for ensuring that goods being offered for 
entry into the United States are in compliance with all laws affecting 
the importation. For the purposes of this definition, ordinarily the 
importer is not the custom house broker, the freight forwarder, the 
carrier, or the steamship representative.
    (h) Molluscan shellfish means any edible species of fresh or frozen 
oysters, clams, mussels, or scallops, or edible portions of such 
species, except when the product consists entirely of the shucked 
adductor muscle.
    (i) Preventive measure means physical, chemical, or other factors 
that can be used to control an identified food safety hazard.
    (j) Process-monitoring instrument means an instrument or device 
used to indicate conditions during processing at a critical control 
point.
    (k)(1) Processing means, with respect to fish or fishery products: 
Handling, storing, preparing, heading, eviscerating, shucking, 
freezing, changing into different market forms, manufacturing, 
preserving, packing, labeling, dockside unloading, or holding.
    (2) The regulations in this part do not apply to:
    (i) Harvesting or transporting fish or fishery products, without 
otherwise engaging in processing.
    (ii) Practices such as heading, eviscerating, or freezing intended 
solely to prepare a fish for holding on board a harvest vessel.
    (iii) The operation of a retail establishment.
    (l) Processor means any person engaged in commercial, custom, or 
institutional processing of fish or fishery products, either in the 
United States or in a foreign country. A processing includes any person 
engaged in the production of foods that are to be used in market or 
consumer tests.
    (m) Scombroid toxin-forming species means tuna, bluefish, mahi 
mahi, and other species, whether or not in the family Scombridae, in 
which significant levels of histamine may be produced in the fish flesh 
by decarboxylation of free histidine as a result of exposure of the 
fish after capture to temperatures that permit the growth of mesophilic 
bacteria.
    (n) Shall is used to state mandatory requirements.
    (o) Shellfish control authority means a Federal, State, or foreign 
agency, or sovereign tribal government, legally responsible for the 
administration of a program that includes activities such as 
classification of molluscan shellfish growing areas, enforcement of 

[[Page 65198]]
molluscan shellfish harvesting controls, and certification of molluscan 
shellfish processors.
    (p) Shellstock means raw, in-shell molluscan shellfish.
    (q) Should is used to state recommended or advisory procedures or 
to identify recommended equipment.
    (r) Shucked shellfish means molluscan shellfish that have one or 
both shells removed.
    (s) Smoked or smoke-flavored fishery products means the finished 
food prepared by:
    (1) Treating fish with salt (sodium chloride), and
    (2) Subjecting it to the direct action of smoke from burning wood, 
sawdust, or similar material and/or imparting to it the flavor of smoke 
by a means such as immersing it in a solution of wood smoke.
    (t) Tag means a record of harvesting information attached to a 
container of shellstock by the harvester or processor.


Sec. 123.5  Current good manufacturing practice.

    (a) Part 110 of this chapter applies in determining whether the 
facilities, methods, practices, and controls used to process fish and 
fishery products are safe, and whether these products have been 
processed under sanitary conditions.
    (b) The purpose of this part is to set forth requirements specific 
to the processing of fish and fishery products.


Sec. 123.6  Hazard Analysis and Hazard Analysis Critical Control Point 
(HACCP) Plan.

    (a) Hazard analysis. Every processor shall conduct, or have 
conducted for it, a hazard analysis to determine whether there are food 
safety hazards that are reasonably likely to occur for each kind of 
fish and fishery product processed by that processor and to identify 
the preventive measures that the processor can apply to control those 
hazards. Such food safety hazards can be introduced both within and 
outside the processing plant environment, including food safety hazards 
that can occur before, during, and after harvest. A food safety hazard 
that is reasonably likely to occur is one for which a prudent processor 
would establish controls because experience, illness data, scientific 
reports, or other information provide a basis to conclude that there is 
a reasonable possibility that it will occur in the particular type of 
fish or fishery product being processed in the absence of those 
controls.
    (b) The HACCP plan. Every processor shall have and implement a 
written HACCP plan whenever a hazard analysis reveals one or more food 
safety hazards that are reasonably likely to occur, as described in 
paragraph (a) of this section. A HACCP plan shall be specific to:
    (1) Each location where fish and fishery products are processed by 
that processor; and
    (2) Each kind of fish and fishery product processed by the 
processor. The plan may group kinds of fish and fishery products 
together, or group kinds of production methods together, if the food 
safety hazards, critical control points, critical limits, and 
procedures required to be identified and performed in paragraph (c) of 
this section are identical for all fish and fishery products so grouped 
or for all production methods so grouped.
    (c) The contents of the HACCP plan. The HACCP plan shall, at a 
minimum:
    (1) List the food safety hazards that are reasonably likely to 
occur, as identified in accordance with paragraph (a) of this section, 
and that thus must be controlled for each fish and fishery product. 
Consideration should be given to whether any food safety hazards are 
reasonably likely to occur as a result of the 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 
other species where a food safety hazard has been associated with 
decomposition;
    (vii) Parasites, where the processor has knowledge or has reason to 
know that the parasite-containing fish or fishery product will be 
consumed without a process sufficient to kill the parasites, or where 
the processor represents, labels, or intends for the product to be so 
consumed;
    (viii) Unapproved use of direct or indirect food or color 
additives; and
    (ix) Physical hazards;
    (2) List the critical control points for each of the identified 
food safety hazards, including as appropriate:
    (i) Critical control points designed to control food safety hazards 
that could be introduced in the processing plant environment; and
    (ii) Critical control points designed to control food safety 
hazards introduced outside the processing plant environment, including 
food safety hazards that occur before, during, and after harvest;
    (3) List the critical limits that must be met at each of the 
critical control points;
    (4) List the procedures, and frequency thereof, that will be used 
to monitor each of the critical control points to ensure compliance 
with the critical limits;
    (5) Include any corrective action plans that have been developed in 
accordance with Sec. 123.7(b), to be followed in response to deviations 
from critical limits at critical control points;
    (6) List the verification procedures, and frequency thereof, that 
the processor will use in accordance with Sec. 123.8(a);
    (7) Provide for a recordkeeping system that documents the 
monitoring of the critical control points. The records shall contain 
the actual values and observations obtained during monitoring.
    (d) Signing and dating the HACCP plan. (1) The HACCP plan shall be 
signed and dated, either by the most responsible individual onsite at 
the processing facility or by a higher level official of the processor. 
This signature shall signify that the HACCP plan has been accepted for 
implementation by the firm.
    (2) The HACCP plan shall be dated and signed:
    (i) Upon initial acceptance;
    (ii) Upon any modification; and
    (iii) Upon verification of the plan in accordance with 
Sec. 123.8(a)(1).
    (e) Products subject to other regulations. For fish and fishery 
products that are subject to the requirements of part 113 or 114 of 
this chapter, the HACCP plan need not list the food safety hazard 
associated with the formation of Clostridium botulinum toxin in the 
finished, hermetically sealed container, nor list the controls to 
prevent that food safety hazard. A HACCP plan for such fish and fishery 
products shall address any other food safety hazards that are 
reasonably likely to occur.
    (f) Sanitation. Sanitation controls may be included in the HACCP 
plan. However, to the extent that they are monitored in accordance with 
Sec. 123.11(b) they need not be included in the HACCP plan, and vice 
versa.
    (g) Legal basis. Failure of a processor to have and implement a 
HACCP plan that complies with this section whenever a HACCP plan is 
necessary, otherwise operate in accordance with the requirements of 
this part, shall render the fish or fishery products of that processor 
adulterated under section 402(a)(4) of the act. Whether a processor's 
actions are consistent with ensuring the safety of food will be 
determined through an evaluation of the processors overall 
implementation of its HACCP plan, if one is required. 

[[Page 65199]]



Sec. 123.7  Corrective actions.

    (a) Whenever a deviation from a critical limit occurs, a processor 
shall take corrective action either by:
    (1) Following a corrective action plan that is appropriate for the 
particular deviation, or
    (2) Following the procedures in paragraph (c) of this section.
    (b) Processors may develop written corrective action plans, which 
become part of their HACCP plans in accordance with Sec. 123.6(c)(5), 
by which they predetermine the corrective actions that they will take 
whenever there is a deviation from a critical limit. A corrective 
action plan that is appropriate for a particular deviation is one that 
describes the steps to be taken and assigns responsibility for taking 
those steps, to ensure that:
    (1) No product enters commerce that is either injurious to health 
or is otherwise adulterated as a result of the deviation; and
    (2) The cause of the deviation is corrected.
    (c) When a deviation from a critical limit occurs and the processor 
does not have a corrective action plan that is appropriate for that 
deviation, the processor shall:
    (1) Segregate and hold the affected product, at least until the 
requirements of paragraphs (c)(2) and (c)(3) of this section are met;
    (2) Perform or obtain a review to determine the acceptability of 
the affected product for distribution. The review shall be performed by 
an individual or individuals who have adequate training or experience 
to perform such a review. Adequate training may or may not include 
training in accordance with Sec. 123.10;
    (3) Take corrective action, when necessary, with respect to the 
affected product to ensure that no product enters commerce that is 
either injurious to health or is otherwise adulterated as a result of 
the deviation;
    (4) Take corrective action, when necessary, to correct the cause of 
the deviation;
    (5) Perform or obtain timely reassessment by an individual or 
individuals who have been trained in accordance with Sec. 123.10, to 
determine whether the HACCP plan needs to be modified to reduce the 
risk of recurrence of the deviation, and modify the HACCP plan as 
necessary.
    (d) All corrective actions taken in accordance with this section 
shall be fully documented in records that are subject to verification 
in accordance with Sec. 123.8(a)(3)(ii) and the recordkeeping 
requirements of Sec. 123.9.


Sec. 123.8  Verification.

    (a) Overall verification. Every processor shall verify that the 
HACCP plan is adequate to control food safety hazards that are 
reasonably likely to occur, and that the plan is being effectively 
implemented. Verification shall include, at a minimum:
    (1) Reassessment of the HACCP plan. A reassessment of the adequacy 
of the HACCP plan whenever any changes occur that could affect the 
hazard analysis or alter the HACCP plan in any way or at least 
annually. Such changes may include changes in the following: Raw 
materials or source of raw materials, product formulation, processing 
methods or systems, finished product distribution systems, or the 
intended use or consumers of the finished product. The reassessment 
shall be performed by an individual or individuals who have been 
trained in accordance with Sec. 123.10. The HACCP plan shall be 
modified immediately whenever a reassessment reveals that the plan is 
no longer adequate to fully meet the requirements of Sec. 123.6(c).
    (2) Ongoing verification activities. Ongoing verification 
activities including:
    (i) A review of any consumer complaints that have been received by 
the processor to determine whether they relate to the performance of 
critical control points or reveal the existence of unidentified 
critical control points;
    (ii) The calibration of process-monitoring instruments; and,
    (iii) At the option of the processor, the performing of periodic 
end-product or in-process testing.
    (3) Records review. A review, including signing and dating, by an 
individual who has been trained in accordance with Sec. 123.10, of the 
records that document:
    (i) The monitoring of critical control points. The purpose of this 
review shall be, at a minimum, to ensure that the records are complete 
and to verify that they document values that are within the critical 
limits. This review shall occur within 1 week of the day that the 
records are made;
    (ii) The taking of corrective actions. The purpose of this review 
shall be, at a minimum, to ensure that the records are complete and to 
verify that appropriate corrective actions were taken in accordance 
with Sec. 123.7. This review shall occur within 1 week of the day that 
the records are made; and
    (iii) The calibrating of any process control instruments used at 
critical control points and the performing of any periodic end-product 
or in-process testing that is part of the processor's verification 
activities. The purpose of these reviews shall be, at a minimum, to 
ensure that the records are complete, and that these activities 
occurred in accordance with the processor's written procedures. These 
reviews shall occur within a reasonable time after the records are 
made.
    (b) Corrective actions. Processors shall immediately follow the 
procedures in Sec. 123.7 whenever any verification procedure, including 
the review of a consumer complaint, reveals the need to take a 
corrective action.
    (c) Reassessment of the hazard analysis. Whenever a processor does 
not have a HACCP plan because a hazard analysis has revealed no food 
safety hazards that are reasonably likely to occur, the processor shall 
reassess the adequacy of that hazard analysis whenever there are any 
changes that could reasonably affect whether a food safety hazard now 
exists. Such changes may include, but are not limited to changes in: 
Raw materials or source of raw materials, product formulation, 
processing methods or systems, finished product distribution systems, 
or the intended use or consumers of the finished product. The 
reassessment shall be performed by an individual or individuals who 
have been trained in accordance with Sec. 123.10.
    (d) Recordkeeping. The calibration of process-monitoring 
instruments, and the performing of any periodic end-product and in-
process testing, in accordance with paragraphs (a)(2)(ii) through (iii) 
of this section shall be documented in records that are subject to the 
recordkeeping requirements of Sec. 123.9.


Sec. 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, if any. Processing and other information shall be 
entered on records at the time that it is observed.
    (b) Record retention. (1) All records required by this part shall 
be retained at the processing facility or importer's place of business 
in the United States for at least 1 year after the date they were 
prepared in the case of refrigerated products and for at least 2 years 
after the date they were prepared in the case of frozen, preserved, or 
shelf-stable products.
    (2) Records that relate to the general adequacy of equipment or 
processes being used by a processor, including the 

[[Page 65200]]
results of scientific studies and evaluations, shall be retained at the 
processing facility or the importer's place of business in the United 
States for at least 2 years after their applicability to the product 
being produced at the facility.
    (3) If the processing facility is closed for a prolonged period 
between seasonal packs, or if record storage capacity is limited on a 
processing vessel or at a remote processing site, the records may be 
transferred to some other reasonably accessible location at the end of 
the seasonal pack but shall be immediately returned for official review 
upon demand.
    (c) Official review. All records required by this part and all 
plans and procedures required by this part shall be available for 
official review and copying at reasonable times.
    (d) Public disclosure. (1) Subject to the limitations in paragraph 
(d)(2) of this section, all plans and records required by this part are 
not available for public disclosure unless they have been previously 
disclosed to the public as defined in Sec. 20.81 of this chapter or 
they relate to a product or ingredient that has been abandoned and they 
no longer represent a trade secret or confidential commercial or 
financial information as defined in Sec. 20.61 of this chapter.
    (2) However, these records and plans may be subject to disclosure 
to the extent that they are otherwise publicly available, or that 
disclosure could not reasonably be expected to cause a competitive 
hardship, such as generic-type HACCP plans that reflect standard 
industry practices.
     (e) Tags. Tags as defined in Sec. 123.3(t) are not subject to the 
requirements of this section unless they are used to fulfill the 
requirements of Sec. 123.28(c).
    (f) Records maintained on computers. The maintenance of records on 
computers is acceptable, provided that appropriate controls are 
implemented to ensure the integrity of the electronic data and 
signatures.


Sec. 123.10  Training.

     At a minimum, the following functions shall be performed by an 
individual who has successfully completed training in the application 
of HACCP principles to fish and fishery product processing at least 
equivalent to that received under standardized curriculum recognized as 
adequate by the U.S. Food and Drug Administration or who is otherwise 
qualified through job experience to perform these functions. Job 
experience will qualify an individual to perform these functions if it 
has provided knowledge at least equivalent to that provided through the 
standardized curriculum.
    (a) Developing a HACCP plan, which could include adapting a model 
or generic-type HACCP plan, that is appropriate for a specific 
processor, in order to meet the requirements of Sec. 123.6(b);
    (b) Reassessing and modifying the HACCP plan in accordance with the 
corrective action procedures specified in Sec. 123.7(c)(5), the HACCP 
plan in accordance with the verification activities specified in 
Sec. 123.8(a)(1), and the hazard analysis in accordance with the 
verification activities specified in Sec. 123.8(c); and
    (c) Performing the record review required by Sec. 123.8(a)(3); The 
trained individual need not be an employee of the processor.


Sec. 123.11  Sanitation control procedures.

    (a) Sanitation SOP. Each processor should have and implement a 
written sanitation standard operating procedure (herein referred to as 
SSOP) or similar document that is specific to each location where fish 
and fishery products are produced. The SSOP should specify how the 
processor will meet those sanitation conditions and practices that are 
to be monitored in accordance with paragraph (b) of this section.
    (b) Sanitation monitoring. Each processor shall monitor the 
conditions and practices during processing with sufficient frequency to 
ensure, at a minimum, conformance with those conditions and practices 
specified in part 110 of this chapter that are both appropriate to the 
plant and the food being processed and relate to the following:
    (1) Safety of the water that comes into contact with food or food 
contact surfaces, or is used in the manufacture of ice;
    (2) Condition and cleanliness of food contact surfaces, including 
utensils, gloves, and outer garments;
    (3) Prevention of cross-contamination from insanitary objects to 
food, food packaging material, and other food contact surfaces, 
including utensils, gloves, and outer garments, and from raw product to 
cooked product;
    (4) Maintenance of hand washing, hand sanitizing, and toilet 
facilities;
    (5) Protection of food, food packaging material, and food contact 
surfaces from adulteration with lubricants, fuel, pesticides, cleaning 
compounds, sanitizing agents, condensate, and other chemical, physical, 
and biological contaminants;
    (6) Proper labeling, storage, and use of toxic compounds;
    (7) Control of employee health conditions that could result in the 
microbiological contamination of food, food packaging materials, and 
food contact surfaces; and
    (8) Exclusion of pests from the food plant.
     The processor shall correct in a timely manner, those conditions 
and practices that are not met.
    (c) Sanitation control records. Each processor shall maintain 
sanitation control records that, at a minimum, document the monitoring 
and corrections prescribed by paragraph (b) of this section. These 
records are subject to the requirements of Sec. 123.9.
    (d) Relationship to HACCP plan. Sanitation controls may be included 
in the HACCP plan, required by Sec. 123.6(b). However, to the extent 
that they are monitored in accordance with paragraph (b) of this 
section they need not be included in the HACCP plan, and vice versa.


Sec. 123.12  Special requirements for imported products.

    This section sets forth specific requirements for imported fish and 
fishery products.
    (a) Importer verification. Every importer of fish or fishery 
products shall either:
    (1) Obtain the fish or fishery product from a country that has an 
active memorandum of understanding (MOU) or similar agreement with the 
Food and Drug Administration, that covers the fish or fishery product 
and documents the equivalency or compliance of the inspection system of 
the foreign country with the U.S. system, accurately reflects the 
current situation between the signing parties, and is functioning and 
enforceable in its entirety; or
    (2) Have and implement written verification procedures for ensuring 
that the fish and fishery products that they offer for import into the 
United States were processed in accordance with the requirements of 
this part. The procedures shall list at a minimum:
    (i) Product specifications that are designed to ensure that the 
product is not adulterated under section 402 of the Federal Food, Drug, 
and Cosmetic Act because it may be injurious to health or have been 
processed under insanitary conditions, and,
    (ii) Affirmative steps that may include any of the following:
    (A) Obtaining from the foreign processor the HACCP and sanitation 
monitoring records required by this part that relate to the specific 
lot of fish or fishery products being offered for import;
    (B) Obtaining either a continuing or lot-by-lot certificate from an 
appropriate 

[[Page 65201]]
foreign government inspection authority or competent third party 
certifying that the imported fish or fishery product is or was 
processed in accordance with the requirements of this part;
    (C) Regularly inspecting the foreign processor's facilities to 
ensure that the imported fish or fishery product is being processed in 
accordance with the requirements of this part;
    (D) Maintaining on file a copy, in English, of the foreign 
processor's HACCP plan, and a written guarantee from the foreign 
processor that the imported fish or fishery product is processed in 
accordance with the requirements of the part;
    (E) Periodically testing the imported fish or fishery product, and 
maintaining on file a copy, in English, of a written guarantee from the 
foreign processor that the imported fish or fishery product is 
processed in accordance with the requirements of this part or,
    (F) Other such verification measures as appropriate that provide an 
equivalent level of assurance of compliance with the requirements of 
this part.
    (b) Competent third party. An importer may hire a competent third 
party to assist with or perform any or all of the verification 
activities specified in paragraph (a)(2) of this section, including 
writing the importer's verification procedures on the importer's 
behalf.
    (c) Records. The importer shall maintain records, in English, that 
document the performance and results of the affirmative steps specified 
in paragraph (a)(2)(ii) of this section. These records shall be subject 
to the applicable provisions of Sec. 123.9.
    (d) Determination of compliance. There must be evidence that all 
fish and fishery products offered for entry into the United States have 
been processed under conditions that comply with this part. If 
assurances do not exist that the imported fish or fishery product has 
been processed under conditions that are equivalent to those required 
of domestic processors under this part, the product will appear to be 
adulterated and will be denied entry.

Subpart B--Smoked and Smoke-flavored Fishery Products


Sec. 123.15  General.

    This subpart augments subpart A of this part by setting forth 
specific requirements for processing smoked and smoke-flavored fishery 
products.


Sec. 123.16  Process controls.

    In order to meet the requirements of subpart A of this part, 
processors of smoked and smoke-flavored fishery products, except those 
subject to the requirements of part 113 or 114 of this chapter, shall 
include in their HACCP plans how they are controlling the food safety 
hazard associated with the formation of toxin by Clostridium botulinum 
for at least as long as the shelf life of the product under normal and 
moderate abuse conditions.

Subpart C--Raw Molluscan Shellfish


Sec. 123.20  General.

    This subpart augments subpart A of this part by setting forth 
specific requirements for processing fresh or frozen molluscan 
shellfish, where such processing does not include a treatment that 
ensures the destruction of vegetative cells of microorganisms of public 
health concern.


Sec. 123.28  Source controls.

    (a) In order to meet the requirements of subpart A of this part as 
they apply to microbiological contamination, chemical contamination, 
natural toxins, and related food safety hazards, processors shall 
include in their HACCP plans how they are controlling the origin of the 
molluscan shellfish they process to ensure that the conditions of 
paragraphs (b), (c), and (d) of this section are met.
    (b) Processors shall only process molluscan shellfish harvested 
from growing waters approved for harvesting by a shellfish control 
authority. In the case of molluscan shellfish harvested from U.S. 
Federal waters, the requirements of this paragraph will be met so long 
as the shellfish have not been harvested from waters that have been 
closed to harvesting by an agency of the Federal government.
    (c) To meet the requirements of paragraph (b) of this section, 
processors who receive shellstock shall accept only shellstock from a 
harvester that is in compliance with such licensure requirements as may 
apply to the harvesting of molluscan shellfish or from a processor that 
is certified by a shellfish control authority, and that has a tag 
affixed to each container of shellstock. The tag shall bear, at a 
minimum, the information required in Sec. 1240.60(b) of this chapter. 
In place of the tag, bulk shellstock shipments may be accompanied by a 
bill of lading or similar shipping document that contains the 
information required in Sec. 1240.60(b) of this chapter. Processors 
shall maintain records that document that all shellstock have met the 
requirements of this section. These records shall document:
    (1) The date of harvest;
    (2) The location of harvest by State and 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 
the harvester's vessel, or an identification number issued to the 
harvester by the shellfish control authority.
    (d) To meet the requirements of paragraph (b) of this section, 
processors who receive shucked molluscan shellfish shall accept only 
containers of shucked molluscan shellfish that bear a label that 
complies with Sec. 1240.60(c) of this chapter. Processors shall 
maintain records that document that all shucked molluscan shellfish 
have met the requirements of this section. These records 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 
the product.

PART 1240--CONTROL OF COMMUNICABLE DISEASES

    2. The authority citation for 21 CFR part 1240 continues to read as 
follows:

    Authority: Secs. 215, 311, 361, 368 of the Public Health Service 
Act (42 U.S.C. 216, 243, 264, 271).

    3. Section 1240.3 is amended by revising paragraph (r), and by 
adding new paragraphs (s), (t), and (u) to read as follows:


Sec. 1240.3  General definitions.

 * * * * *
    (r) Molluscan shellfish. Any edible species of fresh or frozen 
oysters, clams, mussels, and scallops or edible portions thereof, 
except when the product consists entirely of the shucked adductor 
muscle.
    (s) Certification number means a unique combination of letters and 
numbers assigned by a shellfish control authority to a molluscan 
shellfish processor.
    (t) Shellfish control authority means a Federal, State, or foreign 
agency, or sovereign tribal government, legally responsible for the 
administration of a program that includes activities such as 
classification of molluscan shellfish growing areas, enforcement of 
molluscan shellfish harvesting controls, and certification of molluscan 
shellfish processors.
    (u) Tag means a record of harvesting information attached to a 
container of shellstock by the harvester or processor.
    4. Section 1240.60 is amended by revising the section heading, by 

[[Page 65202]]
    redesignating the existing text as paragraph (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:


Sec. 1240.60  Molluscan shellfish.

 * * * * *
    (b) All shellstock shall bear a tag that discloses the date and 
place they were harvested (by State and site), type and quantity of 
shellfish, and by whom they were harvested (i.e., the identification 
number assigned to the harvester by the shellfish control authority, 
where applicable or, if such identification numbers are not assigned, 
the name of the harvester or the name or registration number of the 
harvester's vessel). In place of the tag, bulk shellstock shipments may 
be accompanied by a bill of lading or similar shipping document that 
contains the same information.
    (c) All containers of shucked molluscan shellfish shall bear a 
label that identifies the name, address, and certification number of 
the packer or repacker of the molluscan shellfish.
    (d) Any molluscan shellfish without such a tag, shipping document, 
or label, or with a tag, shipping document, or label that does not bear 
all the information required by paragraphs (b) and (c) of this section, 
shall be subject to seizure or refusal of entry, and destruction.


    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