Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
Federal RegisterDec 18, 1995
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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
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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
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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
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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
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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
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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
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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 t
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