[Federal Register Volume 60, Number 242 (Monday, December 18, 1995)]
[Rules and Regulations]
[Pages 65096-65202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30332]
[[Page 65095]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 123 and 1240
Procedures for the Safe and Sanitary Processing and Importing of Fish
and Fishery Products; Final Rule
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 /
Rules and Regulations
[[Page 65096]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 123 and 1240
[Docket No. 93N-0195]
RIN 0910-AA10
Procedures for the Safe and Sanitary Processing and Importing of
Fish and Fishery Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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
[[Page 65097]]
B. Costs
1. Alternative Model for Estimating the Costs
a. Small plant cost example 1
i. Critical Control Points (CCP)
ii. Corrective Actions
b. Small Plant Cost Example 2
2. Other Cost Reports
3. Seafood Prices
C. Benefits
1. Safety Benefits
2. Summary of Safety Benefits
3. Nutrition Benefits from Mandatory Seafood HACCP and Increased
Consumer Confidence
4. Rent Seeking
5. Export Benefits
6. Reduce Enforcement Costs
a. Seizures
b. Detentions
c. Automatic Detentions
d. Recalls
e. Injunctions
7. Other Benefits
C. Benefits
D. Costs and Benefits of Sanitation
E. Costs and Benefits Attributable to Foreign Governments
F. Conclusion
G. Final Regulatory Flexibility Analysis
V. Environmental Impact
VI. References
List of Subjects
I. Background
A. The Proposal
In the Federal Register of January 28, 1994 (59 FR 4142), FDA
published a proposed rule to establish requirements relating to the
processing and importing of seafood for commercial distribution in the
United States. The requirements involved the application of HACCP
principles by processors and importers to ensure food safety to the
maximum extent practicable. HACCP is a system by which food processors
evaluate the kinds of hazards that could affect their products,
institute controls to keep these hazards from occurring or to
significantly minimize their occurrence, monitor the performance of
those controls, and maintain records of this monitoring as a matter of
routine practice.
In addition to publishing the proposed rule, FDA published in the
Federal Register of April 7, 1994 (59 FR 16655), a notice of
availability of draft guidelines, primarily directed toward processors,
on how to develop HACCP controls for specific types of processing
operations. The notice of availability requested comments on the draft.
Among other things, these draft guidelines, which were titled the
``Fish and Fishery Products Hazards and Controls Guide'' (the Guide),
inventoried known likely food safety hazards associated with many
species of seafood and many processing methods and made recommendations
on ways to control those hazards. Comments received by FDA on the draft
Guide are under review. The agency intends to publish the first edition
of the Guide before the effective date of these regulations.
FDA established on the proposed rule a comment period of 90 days,
to end on April 28, 1994. The agency also asked for comment on the
draft guidelines by the same date. During that comment period, FDA held
public meetings in nine cities to help ensure that the public was aware
of the proposal, to answer questions about its contents, and to
encourage participation in the rulemaking process through the
submission of comments. In addition, at these meetings, FDA staff
explained to the public how to use the draft guidelines to develop
HACCP controls in specific processing operations.
The agency received several written requests for an extension of
the comment period. After considering these requests, FDA published a
notice in the Federal Register on April 7, 1994 (59 FR 16578),
announcing a 30-day extension of the comment period to May 31, 1994,
for both the proposed rule and the draft guidelines.
B. Factual Basis for the Proposal--Summary
In the preamble to the proposed rule, FDA stated five principal
reasons for this initiative: (1) To create a more effective and
efficient system for ensuring the safety of seafood than currently
exists; (2) to enhance consumer confidence; (3) to take advantage of
the developmental work on the application of HACCP-type preventive
controls for seafood that had already been undertaken by industry,
academia, some States, and the Federal government; (4) to respond to
requests by seafood industry representatives that the Federal
government institute a mandatory, HACCP-type inspection system for
their products; and (5) to provide U.S. seafood with continued access
to world markets, where HACCP-type controls are increasingly becoming
the norm.
The preamble to the proposal cited the conclusion of a 1991 study
on seafood safety by the National Academy of Sciences' (NAS) Institute
of Medicine that, while most seafoods on the market are unlikely to
cause illness to the consumer, there are significant areas of risk and
illnesses that do occur. The study concluded that improvements in the
current system of regulatory control are needed and repeatedly
recommended the application of HACCP controls where warranted.
Ensuring the safety of seafood presents special challenges to both
the industry and the regulator. Seafood consists of hundreds of edible
species from around the world. Depending upon species and habitat,
seafood can be subject to a wide range of hazards before harvest,
including bacteria and viruses, toxic chemicals, natural toxins, and
parasites. The harvesting of previously underutilized species--a
practice that is increasing because of the depletion of traditionally
harvested species--can be expected to create new source and process
hazards that must be identified and controlled.
Unlike beef and poultry, seafood is still predominately a wild-
caught flesh food that frequently must be harvested under difficult
conditions and at varying distances from processing, transport, and
retail facilities. It is also subject to significant recreational
harvest, some of which finds its way into commercial channels. As fish
farming (aquaculture) increases, new problems emerge as a result of
habitat, husbandry, and drug use.
An additional complicating factor in ensuring the safety of seafood
is the fact that no other flesh food is imported in the quantity, or
from as many countries, as seafood. Over 55 percent of seafood consumed
in this country is imported from approximately 135 countries. Several
of these countries have advanced regulatory structures for seafood
safety, but many others are developing nations that lack
infrastructures capable of supporting national programs for seafood
regulations comparable to those in more developed nations.
To ensure safety, it is of utmost importance that those who handle
and process seafood commercially understand the hazards associated with
this type of food, know which hazards are associated with the types of
products with which they are involved, and keep these hazards from
occurring through a routine system of preventive controls. For the most
part, however, seafood processors and importers are not required,
through licensure or examination, to demonstrate an understanding of
seafood hazards as a prerequisite to being able to do business. In
fact, there is evidence that such an understanding does not exist in a
significant portion of the industry. A survey conducted by FDA from
1992 to 1993 of manufacturers of ready-to-eat seafood products revealed
that, in significant measure, firms have not been employing the types
of preventive processing controls necessary to ensure a safe product by
design. FDA and State surveys have also revealed that many
[[Page 65098]]
processors of smoked and smoke-flavored fish are operating outside of
the parameters that have been demonstrated through scientific research
to be necessary to ensure that the hazard from botulism is adequately
controlled.
Because of seafood's unique characteristics (e.g., the fact that it
is predominantly wild caught and presents a wide range of possible
hazards), FDA began to question whether the current Federal regulatory
system, which was developed for the general food supply, is best suited
for the seafood industry. Seafood processors are subject to periodic,
unannounced, mandatory inspection by FDA. These inspections provide the
agency with a ``snapshot'' of conditions at a facility at the moment of
inspection, but assumptions must be made about conditions before and
after that inspection. Concern about the reliability of these
assumptions over the intervals between inspections creates questions
about the adequacy of the system.
Inspections today verify the industry's knowledge of hazards and
controls largely by inference. Whether a company produces products that
are adulterated, or whether conditions in its plant are consistent with
current good manufacturing practice (CGMP), are measures of how well
the company understands what is necessary to produce a safe and
wholesome product. This system places a burden on the Government to
find a problem and to prove that it exists, rather than on the firm to
establish for itself, for the regulator, and for consumers, that it has
adequate controls in place to ensure safety.
Given the nature and frequency of the current inspection system for
seafood, it has failed to produce a situation in which the public has
full confidence in the safety and wholesomeness of these products.
There has been a similar failure with respect to imports.
Media and other public attention on seafood safety, and on the
adequacy of the current regulatory program for seafood, has been
substantial in recent years. Many hearings on the sufficiency and
direction of the Federal seafood safety program have been held in both
Houses of Congress since the late 1980's, and numerous bills have been
considered for the stated purpose of improving seafood safety. This
public concern has motivated representatives of the U.S. seafood
industry to request that FDA develop a HACCP-based program for these
products.
Although not a public health issue, international trade is also a
major consideration in determining the advisability and benefits of a
new system of seafood regulation. Participation in the international
trade in seafood is critical to U.S. consumers and to the U.S. seafood
industry. The United States is the world's second largest seafood
importing nation and the second largest exporter of fishery products.
The international movement toward harmonization, coupled with the
Codex Alimentarious Commission's adoption of HACCP for international
use, clearly argue for the adoption of this approach in the United
States for seafood. Failure by the United States to adopt a mandatory,
HACCP-based system could ultimately undermine its export success, with
considerable economic consequences. Such failure also would undermine
the United States ability to meet growing international expectations
that it enter into mutual recognition-type agreements with trading
partners based on HACCP.
II. The Comments
FDA received over 250 submissions from over 200 commentors on both
the proposed regulations and the draft Guide. Individual companies, the
majority of which are in the seafood business, submitted slightly over
half of the comments. Nearly 40 trade associations submitted comments.
As with the companies, the majority of these associations represent
seafood interests, but a significant minority have memberships
reflecting a range of food products.
Comments were also received from consumer advocacy and similar
groups, and coalitions of such groups. All totaled, the views of over
50 organizations were represented in these comments.
Other commenters included State agencies, the Association of Food
and Drug Officials (AFDO), the Interstate Shellfish Sanitation
Conference (ISSC), several scientific associations and bodies,
departments of three universities, foreign governments, and about 25
individuals.
Overall, the comments covered virtually every aspect of the
proposal and guidelines. FDA appreciates the effort, interest, and
thoughtfulness reflected by these comments.
The following materials address the significant comments that were
received on the proposed regulations, both on the specific provisions
of the proposal and on related matters. The materials on the provisions
of the proposed regulations explain, among other things, why the agency
did or did not modify the provisions based on the comments. Any
provisions not addressed below were not changed substantively or were
not the subject of significant comment.
FDA will respond to those comments that relate solely to the draft
Guide when the first edition of that document is completed and made
available to the public. The agency intends to address those comments
in a notice of availability to be published in the Federal Register.
A. Legal Basis
1. Introduction
About 25 comments addressed the legal basis for these regulations.
Nearly half of these comments were either companies that process foods
other than seafood or trade associations that represent such companies,
some of who indicated that they were motivated to comment, at least in
part, by the possible precedent that these regulations could set for
HACCP programs beyond seafood. Some of these comments deferred comment
on the legal basis for the HACCP regulations for seafood but commented
on whether the legal basis that FDA was proposing for seafood would be
appropriate for mandatory HACCP programs for other kinds of foods.
FDA is issuing these HACCP regulations for seafood under various
sections of the Federal Food, Drug, and Cosmetic Act (the act),
including, most significantly, sections 402 (a)(1) and (a)(4) and
701(a) (21 U.S.C. 342 (a)(1) and (a)(4) and 371(a)). Section 402(a)(1)
of the act states that a food is adulterated if it bears or contains
any poisonous or deleterious substance that may render the food
injurious to health. Section 402(a)(4) of the act states that a food is
adulterated if it has been prepared, packed, or held under insanitary
conditions whereby it may have been contaminated with filth, or whereby
it may have been rendered injurious to health. It is important to
recognize that section 402(a)(4) of the act addresses conditions that
may render a food injurious to health, rather than conditions that have
actually caused the food to be injurious. See United States v. 1,200
Cans, Pasteurized Whole Eggs, Etc., 339 F. Supp. 131, 141 (N.D. Ga.
1972). The question is thus whether the conditions in a plant are such
that it is reasonably possible that the food may be rendered injurious
to health. The agency believes that, if a seafood processor does not
incorporate certain basic controls into its procedures for preparing,
packing, and holding food, it is reasonably possible that the food may
be rendered injurious to health and, therefore, adulterated under the
act. Section 701(a) of the act
[[Page 65099]]
authorizes the agency to adopt regulations for the efficient
enforcement of the act.
2. General Authority
1. One comment stated that FDA had not met its responsibility to
present the shortcomings in the existing law when demonstrating the
need for these regulations.
FDA believes that this comment is misguided. The agency's statutory
authority is not deficient in this area. FDA does have a
responsibility, however, to demonstrate that there is a need for the
regulations, and that the regulations are reasonably related to the
purposes of the act that they are designed to advance. FDA has
fulfilled this responsibility.
As outlined above, the act provides a broad statutory framework for
Federal regulation to ensure human food will not be injurious to health
and to prevent commerce in adulterated foods. As the record in this
proceeding amply demonstrates, there is a range of circumstances and
conditions that have raised concerns about how the safety of seafood
sold in this country is ensured. Given these concerns and its
responsibility under the act, FDA has concluded that it is necessary to
require that firms incorporate certain basic measures into how they
process seafood. The agency also concludes that failure to incorporate
these measures into a firm's processing procedures would mean that the
firm would be producing the product under insanitary conditions whereby
it may be rendered injurious to health. (See United States v. Nova
Scotia Food Products Corp., 568 F.2d 240, 247 (2d Cir. 1977).)
2. A few comments took the view that FDA lacked the authority to
issue these regulations because Congress had considered legislation
relating to seafood safety in recent years but had not enacted it. Much
of this legislation contained provisions authorizing the establishment
of a mandatory Federal inspection program based on HACCP-type
principles. According to the comments, Congress' failure to authorize
this program after considering doing so indicated that the contents of
FDA's seafood HACCP regulations remain within the domain of Congress
and have not been delegated to FDA to implement.
FDA does not agree with this contention. Unquestionably, seafood
safety has received considerable attention from Congress in recent
years, most notably in the late 1980's through the early 1990's. Many
hearings were held on the subject in both the House of Representatives
and the Senate during this period, and several bills were introduced in
both chambers. The high water mark for this activity occurred at the
end of the 101st Congress when differing seafood safety bills passed
both chambers. These bills could not be reconciled before the end of
the term, however, so nothing was enacted. Legislation introduced in
the 102d Congress did not pass either chamber.
The fact that Congress has considered the issue of seafood safety,
however, does not preclude FDA from implementing a mandatory seafood
HACCP program. The effect of legislation that was never enacted on a
Federal agency's initiatives was considered in National Confectioners
Association v. Califano, 569 F.2d 690, 693 n.9 (D.C. Cir. 1978), a case
involving a challenge to FDA's statutory authority to issue good
manufacturing practice regulations for candy making. The court rejected
an argument that the existence of legislation that was not enacted that
would have given FDA express authority to require some of the things
that the agency included in its regulations indicated that Congress
intended to exclude such authority from the act as it was then written.
Instead, as will be discussed below, in upholding the validity of the
regulations, the court looked at whether the statutory scheme as a
whole justified the promulgation of the regulations.
It is true that a deliberate refusal by Congress to authorize a
specific program would at least be one factor to be weighed in
determining the validity of a regulation. See Toilet Goods Association
v. Gardner, 387 U.S. 158 (1967). The expiration of the 101st Congress
before competing seafood bills could be reconciled did not, however,
amount to a refusal on the part of Congress to authorize a mandatory
HACCP program, including HACCP-based inspections for seafood. Thus, FDA
concludes that there is no merit to the comments' assertion.
3. Insanitary Conditions
3. Several comments, most of whom were trade associations or
companies involved in the processing of products other than seafood,
questioned whether section 402(a)(4) of the act was an appropriate
authority upon which to base a mandatory HACCP program. Most of the
concern hinged on whether a failure to have a HACCP plan, or to keep
HACCP records, could really be considered an ``insanitary'' condition
under section 402(a)(4) of the act. Some questioned whether safety
issues relating to chemical or physical hazards, or to pesticides,
unapproved additives, and drug residues, as included in the proposed
regulations, could be deemed to have been the result of insanitary
conditions. Two comments expressed the view that section 402(a)(4) of
the act does not concern food safety generally but only safety problems
caused by insanitary conditions.
The relevant case law supports a broad reading of ``insanitary.''
In Nova Scotia, supra, 568 F.2d at 247, the court read ``insanitary''
to cover a wide set of circumstances necessary to ensure that food was
not produced under conditions that may render it injurious to health.
Specifically, the court concluded that FDA's regulations mandating
time-temperature-salinity requirements for smoked fish products were
within the agency's statutory authority under section 402(a)(4) of the
act. The court rejected the argument that ``insanitary'' limited
coverage under section 402(a)(4) of the act only to bacterial hazards
that could enter the raw fish from equipment in the processing
environment and not to proper processing to kill bacteria that entered
the processing facility in the raw fish itself.
Acceptance of a restrictive reading of section 402(a)(4) of the
act, the court in Nova Scotia noted, would probably invalidate several
existing FDA regulations, including those relating to the thermal
processing of low-acid canned foods in part 113 (21 CFR part 113). When
dealing with the public health, the court concluded, the statute should
not be read too restrictively but consistent with the act's overall
purpose to protect the public health. (See also United States v. Bacto-
Unidisk, 394 U.S. 784, 798 (1969); United States v. Dotterweich, 320
U.S. 277, 280 (1943).)
4. Notwithstanding these cases, one comment cited the case of
United States v. General Foods Corp, 446 F. Supp 740 (1978), aff'd 591
F.2d 1332 (2d Cir. 1978), for the proposition that a failure to have a
HACCP plan could not alone be a violation of section 402(a)(4) of the
act because it would not constitute insanitation.
FDA does not agree that the General Foods case stands for this
proposition. Rather, the court in General Foods explicitly recognized
that ``[b]ecause the purpose of 402(a)(4) is to prevent contamination,
or nip it in the bud, actual contamination of the finished product need
not be shown.'' Id. at 752. Significantly, the court appeared to be
impressed with the preventive controls that were in place in the
defendant's plant and took these into consideration in deciding that
the agency had failed to prove that section 402(a)(4) of the act had
been violated. However, the court did not deal at all with the limits
on
[[Page 65100]]
FDA's authority to do rulemaking under sections 402(a)(4) and 701(a) of
the act to establish standards for such preventive controls.
Thus, it is not inconsistent with General Foods for FDA to adopt
HACCP regulations that are designed to define the minimum steps that a
seafood processor must take to ensure that the food that it produces is
not prepared under conditions that may render it injurious to health.
Clearly, given the risks inherent in many seafood operations, if a
processor does not identify the critical control points in its process,
and does not monitor what goes on at those points, there is a
reasonable possibility that the food that it produces will be injurious
to health.
A primary objective of the seafood HACCP regulations is to
establish a system of preventive controls for human food safety. The
HACCP plan is a fundamental step in the development of these controls.
It is the step in which the manufacturer analyzes its process,
identifies the points at which problems may occur, and establishes the
parameters that must be met if those problems are to be avoided. Thus,
failure to have a HACCP plan would, in fact, constitute an ``insanitary
condition'' as this term must be understood in light of the relevant
case law.
Section 402(a)(4) was added to the act to ensure ``the observance
of those precautions which consciousness of the obligation imposed upon
producers of perishable food products should require in the preparation
of food for consumption by human beings.'' Hearings before the Senate
Committee on Commerce, S. 2800, 73d Cong., 2d Sess., Mar. 1934, as
cited in United States v. 1,200 Cans, Pasteurized Whole Eggs, Etc.,
supra, 339 F. Supp. 140-141. Clearly, HACCP reflects the emerging,
internationally recognized understanding of the precautions necessary
to produce safe food. These regulations embrace HACCP and provide
processors with directions for establishing HACCP systems and operating
them as a matter of routine custom and habit that will ensure the
safety of the food that they produce. Thus, FDA finds that operation
under an effective HACCP system is necessary to meet a processor's
obligation under section 402(a)(4) of the act.
4. Records
In Confectioners, the court upheld FDA's authority to issue
regulations under section 402(a)(4) of the act that included
recordkeeping requirements. The recordkeeping provisions of the
regulations were challenged on the grounds that they would permit
prosecution where processing conditions were completely sanitary, but
the records were deficient. Such an outcome, it was argued, would be
beyond the scope of section 402(a)(4) of the act.
Citing Toilet Goods, the court rejected this argument and held that
the primary consideration was whether the statutory scheme as a whole,
not just section 402(a)(4) of the act, justified the agency's
regulations. The court pointed out that this consideration involved an
inquiry into practicalities as well as statutory purpose, i.e.,
enforcement problems encountered by FDA and the need for various forms
of supervision in order to accomplish the goals of the act.
5. Two comments expressed the view that the holding in
Confectioners should be limited to the specific facts in that case. One
comment stated that the case only upheld FDA's authority to impose
recordkeeping requirements on firms to facilitate recalls of
potentially dangerous products. The other comment noted that the case
only granted FDA access to shipping records. The comment pointed out
that FDA already has access to such records from carriers under section
703 of the act.
While it is true that the records that FDA was requiring, and to
which the agency claimed access under the regulations involved in
Confectioners, were source coding and distribution records in order to
facilitate recalls, the court's ruling involved broad principles
relating to the validity of the regulations generally and was not
limited to recalls or shipping records. The court stated that in light
of the statutory scheme as a whole, ``we find no basis for the
Association's distinction between the FDA's role in preventing and
remedying commerce in adulterated foods. The agency believes that the
Act imposes on the FDA an equal duty to perform each role.'' Id. at
694. This statement simply is not consistent with the narrow reading
suggested by the comment. Rather, it fully supports FDA's authority to
adopt regulations to prevent the introduction of adulterated foods into
interstate commerce. Clearly, compliance with FDA's seafood HACCP
regulations will help to achieve that end.
It is also true, as one comment pointed out, that section 703 of
the act expressly grants FDA access to shipping records and not to the
kinds of processing records required in these regulations. FDA cannot
agree, however, that Confectioners stands for the proposition that FDA
should have access only to food manufacturers' shipping records because
those are the only kinds of records to which FDA has access under
section 703 of the act. The court concluded that the narrow scope of
section 703 of the act is not a limitation on the right of the agency
to require recordkeeping and have access to records that are outside
the scope of section 703 of the act, so long as the recordkeeping
requirement is limited, clearly assists the efficient enforcement of
the act, and the burden of recordkeeping is not unreasonably onerous
(569 F.2d at 693 n.9).
The recordkeeping required under these regulations passes the
Confectioners test. First, the recordkeeping requirements are limited.
The HACCP recordkeeping and record access requirements in the final
rule are tied specifically to the critical control points (CCP's) in
the manufacturing process. In other words, the recordkeeping
requirements are limited to those points in the process at which
control is essential if assurance that the resultant product will not
be injurious to health is to be achieved.
Second, the recordkeeping assists in the efficient enforcement of
the act. The recordkeeping requirements, by focusing on the CCP's,
ensure that the processor and the agency focus on those aspects of
processing that most jeopardize food safety. Unlike the current
inspection system, recordkeeping in a HACCP-type system documents that
preventive controls are being followed and enables the regulator to
verify this fact. Such a system, therefore, assists in effective and
efficient enforcement of the act.
Finally, the HACCP-recordkeeping burden is not unduly onerous. It
is limited to those aspects of processing that are critical to food
safety. Documentation that control is being maintained over these
aspects of processing need only be a minor additional step in most
instances. The documentation required in the final rule is narrowly
tailored to ensure that only essential information needs to be
recorded.
6. Several comments questioned whether FDA may have access to HACCP
records and plans on the grounds that the act does not explicitly
authorize such access. Some of these comments pointed to the lack of
authorization in section 704 of the act (21 U.S.C. 74), the provision
that authorizes the inspection of food processors and other types of
establishments. The comments pointed out that section 704 of the act
authorizes agency access to certain records relating to prescription
drugs and medical devices during the course of those inspections but
not to records relating to
[[Page 65101]]
foods. One comment felt that the specific grant of records access for
drugs and devices in section 704 of the act precluded expansion of
access to records not specifically mentioned in the act. Other comments
felt that FDA was barred from access simply because the act does not
expressly grant it.
FDA does not agree, as the agency's authority under sections 402
and 701(a) of the act to issue these regulations provides ample
authority for records access. The line of cases cited above stands for
the proposition that a lack of explicit delegated authority does not
invalidate agency regulations so long as the regulations are consistent
with the act's overriding purpose. In Confectioners, the court upheld
FDA's authority to adopt recordkeeping requirements in the absence of
an explicit delegation of authority. In that case, moreover, the court
found no evidence that Congress intended to immunize food processors
from limited recordkeeping (569 F.2d at 695). Similarly, the court in
Nova Scotia concluded, in the absence of such evidence, that there was
no impediment to a broad reading of the statute based on the general
purpose of the Congress in protecting public health (568 F.2d at 248).
FDA has concluded, therefore, that these regulations are consistent
with section 704 of the act and with the act as a whole. Because the
preventive controls required by HACCP are essential to the production
of safe food as a matter of design, the statutory scheme is benefited
by agency access to records that demonstrate that these controls are
being systematically applied. The case law supports FDA's authority to
require such recordkeeping and to have access to such records.
Other countries, including Canada, the European Union (EU) Norway,
Australia, and New Zealand, which have already implemented HACCP-type
systems, have deemed it necessary to the success of their systems to
provide for recordkeeping and record access along the lines of this
regulation (for either their entire seafood industries or seafood
export industries). Thus, it is widely accepted that recordkeeping and
inspectional access are essential components of a HACCP-type seafood
system. In addition, in order to maintain other countries' faith in the
safety standards of U.S. seafood exports, FDA needs similar access to
records showing HACCP implementation.
7. One comment expressed the view that the copying of records by
FDA, as authorized by these regulations, is beyond the scope of section
704 of the act.
FDA points out that it is not acting under section 704 of the act.
To effectuate the broad purposes of the act, there may be some
circumstances in which access to the records would be meaningless
without the opportunity to copy them. While the agency does not
anticipate that copying will be necessary in most instances, perhaps
the most readily predictable circumstance in which copying would be
necessary is when an investigator needs assistance from relevant
experts in headquarters to evaluate the record. Without copying, it
would be necessary for the agency to rely solely on the notations and
report of the investigator.
This reliance may not be adequate in many circumstances. For
example, there may be a deviation from a critical limit (CL) that poses
no health risks. Without the ability to show a copy of the records to
someone within the agency with the necessary expertise in the area, an
investigator would have to cite the company for a violation. If,
however, an agency expert determined that the deviation posed no safety
risks, the agency could use its enforcement discretion not to pursue a
violation.
8. One comment expressed the view that the act does not support a
mandatory HACCP program that includes access to records for the entire
seafood industry. According to the comment, the act permits FDA access
to records only under extreme conditions where there is a potential for
injury, but, the comment noted, hazards are only associated with a
small percentage of fish.
FDA cannot agree. While it is true that those seafood-related
illnesses that are reported to public health authorities tend to be
associated with a limited number of species, potential hazards are much
broader. As indicated above, the 1991 NAS report on seafood safety
provides an extensive inventory of hazards.
For the benefit of the commentor it is worth noting that if a
processor is involved with species and processes for which there are no
food safety hazards that are reasonably likely to occur, a HACCP plan
will not be necessary under these regulations. As will be discussed
later in this preamble, the agency anticipates a post-implementation
dialog with firms on whether they have hazards that must be controlled
in accordance with these regulations and, if so, how many.
9. One comment expressed the view that the authority to inspect
ordinary food records has not been asserted before. This statement was
made in support of the contention that there is no statutory basis for
FDA access to ordinary food records.
The legal basis for FDA's access to records has already been fully
addressed in this preamble. It is important to note that the agency is
not claiming a right of access to food records coextensive with that
for drugs and devices under section 704 of the act. Rather, FDA is
asserting a right to access to records that is narrowly tailored to
advance the purposes of the sections of the act that it is implementing
here, i.e., records relating to the CCP's in a firm's process.
While the agency is not sure what the comment meant by ``ordinary''
food records, it is worth pointing out that the position in this
regulation on agency access to records is a longstanding interpretation
for regulations of this type. Agency access to processing and
production records has been required since the early 1970's in FDA's
regulations for thermally processed low-acid foods packaged in
hermetically sealed containers (part 113) and for acidified foods part
114 (21 CFR 114). As discussed in the new section, these regulations
were issued primarily under the authority of both sections 402(a)(4)
and 404 of the act (21 U.S.C. 344), neither of which specifically
mention access to records.
5. Relevance of Section 404 of the Act
10. Several comments expressed the view that FDA should base HACCP
regulations on section 404 of the act rather than on section 402(a)(4)
of the act. Some of these comments were referring to these seafood
HACCP regulations, while others were primarily concerned with any HACCP
regulations that FDA might issue for other foods. Other comments
expressed the view that FDA's existing low-acid canned food regulations
should serve as a model for new HACCP programs. Because some of the
low-acid canned food regulations have been issued under section 404 of
the act, all of these comments may have been making the same general
point.
Most of those that advocated use of section 404 of the act as the
legal basis expressed concerns about the appropriateness of relying on
section 402(a)(4) of the act and the narrow grants of access to records
in the act, especially in section 704 of the act, and concluded that
the act only grants the agency access to records under extreme
situations. One comment urged that FDA issue the seafood HACCP
regulations under the authority of section 404 of the act in order to
enhance the agency's ability to achieve compliance through the permit
system.
[[Page 65102]]
Section 404 of the act is entitled ``Emergency Permit Control.'' It
authorizes FDA to establish a permit system for processors of food that
may be injurious to health when two conditions are met: (1)
Contamination is with microorganisms, and (2) the injurious nature of
the product cannot be adequately determined after the product enters
interstate commerce. Section 404 of the act authorizes FDA to inspect
firms that operate under this permit system but does not mention
records or FDA access to records.
As indicated previously, FDA has issued regulations under this
authority. Regulations at part 108 (21 CFR part 108) subpart A
establish the permit system generally. Regulations at part 108 subpart
B establish that acidified foods and thermally processed low-acid foods
in hermetically sealed containers (i.e., low-acid canned foods, or
``LACF'') meet the criteria in section 404 of the act and are therefore
subject to the permit system. Subpart B requires processors of these
foods to register with FDA and to submit detailed information to FDA on
their manufacturing processes.
As an adjunct to these regulations, FDA has also issued the
regulations, referred to previously, at part 113 and part 114 for these
products. These latter regulations require the maintenance of day-to-
day processing records that are retained by the processor and are in
addition to the processing information that must be sent to FDA. FDA
investigators have access to, and may copy, these records
(Secs. 108.25(g) and 108.35(h)).
While the permit system may have some compliance advantages, as
pointed out by one comment, there are other considerations in this case
that are more important. The permit system is, as the title of section
404 of the act declares, an ``emergency'' system. Because it is an
extreme remedy for extreme situations, FDA has used section 404 of the
act relatively sparingly.
In the case of seafood, although FDA strongly believes that a HACCP
system will correct deficiencies in the current system and provide
significant further assurance of safety, the agency cannot conclude
that seafood is in an overall state of emergency from a public health
standpoint. This conclusion is consistent with the position taken by
the NAS. The NAS' Institute of Medicine, in its 1991 report entitled
``Seafood Safety,'' devoted hundreds of pages to areas of risk and made
numerous recommendations about control measures, including the
application of HACCP where appropriate. However, the NAS also concluded
that most seafood in the U.S. marketplace is unlikely to cause illness.
FDA believes that, for seafood at least, HACCP should be the norm
rather than an exceptional remedy for an extreme situation. A
functioning HACCP system reflects an understanding of the wide range of
hazards to which seafood may always be subject and provides for a
systematic application of the preventive controls necessary to minimize
the occurrence of those hazards. It is the most effective and efficient
way known of ensuring food safety as a matter of design. In this
regard, FDA has concluded that, for seafood, the efficient enforcement
of the act should not have to depend on a finding of an emergency under
section 404 of the act.
It is also worth noting that section 404 of the act would limit the
application of HACCP to hazards by reason of contamination from
microorganisms. FDA is not aware of any HACCP expert or authoritative
body, including the National Advisory Committee for Microbiological
Criteria for Foods (NACMCF), which advocates limiting HACCP to these
hazards only. A full discussion of hazards to which seafood HACCP
should apply appears later in this preamble.
FDA does not agree that section 404 of the act is the only basis
for these seafood HACCP regulations, or that it would be a more
appropriate basis. It is not clear, moreover, how section 404 of the
act can be cited as supporting the proposition that the agency only has
access to records in extreme situations. As indicated earlier, section
404 of the act contains no express grant of access to records. Again,
FDA has concluded from the case law that, under appropriate
circumstances, the agency has access to specific types of records on
foods and food processing for specific purposes, where such access is
not expressly provided for in the act, but the agency cannot conclude
that this right is limited to extreme situations. Some of the comments
provided examples of extreme situations to which HACCP regulations
should be limited from their standpoint. These examples raise important
issues that will be addressed elsewhere in this preamble.
11. Two comments expressed the view that the LACF regulations
should serve as a model for the types of records that would be
accessible under HACCP regulations.
FDA did in fact use the LACF regulations as a model in that regard.
The HACCP plan required here is similar to the scheduled processes that
processors must submit in the LACF regulations. Likewise, there is
little difference between the HACCP-monitoring records required here
and the day-to-day processing records that are required in LACF
regulations.
B. HACCP Pro and Con
1. Overview
Nearly half of the comments included specific statements of support
or opposition for the concept of a mandatory HACCP program to ensure
the safety of seafood. The supporters outnumbered the opponents by over
10 to 1.
Nearly all of those who supported the approach also had technical
comments on various provisions in the proposal. Some conditioned their
support on the availability of additional enforcement authorities or
resources for FDA. These aspects of their comments will be responded to
elsewhere in this preamble. A small number of these comments supported
the concept of a mandatory HACCP program for seafood but opposed the
proposal as drafted.
The supporters of the concept included most of the seafood trade
associations that commented, businesses, consumer advocacy
organizations, Federal and State agencies, professional societies,
academics, and a member of Congress. The reasons for this support
included: Enhancement of consumer confidence, the superiority of HACCP-
type preventive controls over traditional CGMP-type controls and end-
product sampling, the view that HACCP is the most efficient and
effective way to ensure safety, and the view that a mandatory HACCP
system reflects an appropriate assigning of primary responsibility to
industry for producing safe food. Other reasons included a leveling of
the competitive playing field, both domestically and internationally;
the need for prompt adoption of a mandatory HACCP program by FDA to
enable the seafood industry to maintain its market position in Europe
and elsewhere throughout the world; greater productivity; and increased
industry control over processing.
One large seafood trade association stated:
[The association] strongly supports the adoption of a
comprehensive regulatory program by the FDA which is designed for
fish and seafood using HACCP principles. HACCP systems have been
applied successfully by individual firms in our industry, and they
have been shown to be a very cost-effective way of controlling
safety hazards. Of equal importance, the adoption of a HACCP-based
regulatory program should lead to more effective and efficient use
of FDA resources, and less disruption of the processing and
importing of seafood for consumers.
[[Page 65103]]
A small number of comments expressed opposition to the mandatory
HACCP approach for seafood, however. One State comment expressed the
view that HACCP would not have any significant effect on reducing
illnesses from molluscan shellfish. Another comment stated that,
overall, seafood-related illness data do not justify mandatory HACCP
for seafood. (Several other comments questioned the need for these
regulations in light of the NAS' conclusion that commercial seafood is
generally safe. These comments either generally opposed the proposed
regulations as drafted, or opposed its application to the comments'
segments of the seafood industry, but did not express opposition to
mandatory HACCP as a concept.) None of these comments supplied any new
seafood-related illness data.
2. The Significance of the Illness Data
The preamble to the proposed regulations described broadly what is
known and not known about the extent of seafood-related illness in the
United States. Foodborne illnesses tend to be significantly
underreported to public health authorities. Consequently, precise data
on the numbers and causes of foodborne illness in this country do not
exist. FDA does know, however, that illness from seafood does occur,
and that a wide variety of hazards have been identified that could
cause illness from seafood (see Ref. 7, pp. 1-13). The overwhelming
majority of these hazards are amenable to preventive controls. FDA's
draft Guide addresses controls for over 20 specific types of safety
hazards.
The primary purpose of these regulations is to ensure that
preventive controls are systematically applied in seafood processing as
a matter of routine custom and usage, and in a way that can be verified
by company management as well as by regulatory authorities. Thus, while
the reported illness data are highly relevant to whether these
regulations should be issued, they are not the sole basis for the
regulations.
For molluscan shellfish in particular, FDA agrees with the
commenters who believe that the principles of the National Shellfish
Sanitation Program (NSSP) should continue to form the basis for the
molluscan shellfish safety program in this country. There is no clear
alternative to proper water classification and patrol by State
authorities as the basis for molluscan shellfish safety. HACCP provides
processors with an excellent system for ensuring that these preventive-
type controls are adhered to in a systematic way.
It may be argued--and some comments made the point--that the best
way to reduce the overall number of illnesses from raw molluscan
shellfish is to provide additional resources to the States to enhance
their water classification and monitoring abilities. Classifying and
patrolling shellfish harvesting waters are important means of
preventing molluscan shellfish that have been contaminated from sewage
from entering the marketplace. However, additional Federal resources
will probably not be available for this purpose in the foreseeable
future. It is imperative, therefore, that the system that is in place
be made as efficient as possible.
It would be incongruous to exempt from a national system of
preventive controls the processors of products identified by the NAS as
the source of the greatest numbers of seafood-associated illnesses. FDA
strongly believes that HACCP controls will help shellfish processors
and regulators alike to better focus on potential safety problems and
less on tangential matters than historically has been the case. A full
discussion of the application of HACCP to raw molluscan shellfish
appears later in this preamble.
3. Exempt Specific Industry Segments?
12. Comments stating that HACCP systems should not be mandated for
specific industry segments usually referred to either the crab
processing or the catfish industries. These comments generally
expressed the view that HACCP requirements for these industries were
not necessary.
FDA advises that these regulations are flexible enough so that
HACCP-type controls are not required where they are not necessary,
i.e., where it is reasonably likely that hazards do not exist. It is
the agency's experience, however, that there are reasonably likely
hazards associated with crabmeat as a cooked, ready-to-eat product,
including the growth of pathogens as a result of time-temperature abuse
of the product and the potential for pathogen survival from inadequate
pasteurization. There are reasonably likely hazards associated with the
processing of catfish (e.g., contamination from agricultural chemicals,
improperly used aquaculture drugs, and a variety of hazards resulting
from the in-plant processing operations). It is incumbent on processors
of these products to know and control such hazards.
The agency recognizes that whether reasonably likely hazards exist
involves case-by-case determinations. As will be discussed in the
``HACCP plan'' section of this preamble, processors will be given every
opportunity to demonstrate why no hazards exist in their operations.
4. Would Voluntary HACCP Be Superior?
13. Some comments believed that a voluntary approach to HACCP for
seafood would be preferable to a mandatory approach. One reason given
for this view was that, under a mandatory system, the risk of
regulatory action by FDA would compel processors to design HACCP
controls that were the minimum necessary to comply with the rule. There
would be a significant disincentive for processors to design HACCP
plans that have the greatest practical impact on food safety out of
fear that occasional failure to meet those higher standards would
trigger a regulatory response.
If voluntary HACCP systems were already universal, or nearly so in
the seafood industry, and they generally applied safety controls that
were beyond the minimum needed for safety, FDA would see little reason
to establish a mandatory system. However, HACCP is not the norm, and
given the current situation in the seafood industry, FDA finds that
making HACCP mandatory is necessary to ensure that safe, wholesome, and
unadulterated product is produced. Thus, FDA is adopting part 123 (21
CFR part 123).
The agency acknowledges the possibility that, under a mandatory
system, firms will perceive that they are on safer ground with FDA if
they establish minimum acceptable controls that are more easily met,
rather than more stringent controls that are beyond the minimum
necessary to ensure safety and, therefore, are harder to meet. For
example, in deciding what CCP's to identify in a HACCP plan, a
processor might err on the side of inclusion under a voluntary plan but
keep the number of CCP's down to the minimum acceptable to FDA if
having a plan is mandatory.
It remains to be seen whether processors will really choose to
behave this way under a mandatory system. The choices that processors
will make may depend, in part, on FDA policy toward HACCP plans that
are beyond the minimum. The logic in favor of the agency initiating
regulatory action when a processor fails to meet its own CL but
succeeds in meeting a minimum level that would have been an acceptable
CL to FDA, would be that the firm is out of control vis a vis its own
preventive process. The logic against initiating regulatory action
would be that the processor is still in control in terms of meeting
minimum necessary safety parameters, and that the product is, in
[[Page 65104]]
FDA's opinion, safe to eat. As an additional factor, FDA does not want
to discourage firms from establishing preventive controls for
themselves that are beyond the minimum necessary to ensure safety.
In evaluating monitoring records, FDA will first determine whether
the recorded values are within the processor's critical limits as set
out in its HACCP plan. Where values are found that are outside the
CL's, the agency will determine the cause and extent of such
occurrences, and what corrective action, if any, the processor has
taken. Where product that was involved in a CL deviation was
distributed without first being subjected to appropriate corrective
action, FDA will determine the cause and extent of the control failure.
In determining the appropriate agency regulatory response to CL
deviations, FDA will assess the public health risk that the product
poses. This assessment will, in part, involve a determination of
whether the minimum limit necessary to ensure safety was breached. FDA
acknowledges that this level and the processor's CL may not always be
the same. The agency is not likely to take action against a product
that it finds poses no significant public health risk, regardless of
whether it has or has not met the processor's CL.
Nonetheless, processors must establish controls to ensure that
appropriate corrective actions are taken when their CL's are breached.
Where such controls fail, FDA expects processors to redesign their
control mechanisms as necessary. Chronic failure to appropriately
respond to CL deviations demonstrates that a processor's HACCP system
is inadequate, and that fact could cause FDA to have some regulatory
concern.
14. Another comment urged that HACCP for seafood should be
voluntary on the grounds that FDA lacks the resources and statutory
enforcement authorities to operate a mandatory system. Other comments
expressed the same types of concerns about FDA resources and
enforcement authorities without concluding that a voluntary system
would be preferable. One comment, from a consumer advocacy organization
representing several other organizations, supported the concept of a
mandatory HACCP system but expressed reservations about FDA's ability
to adequately perform HACCP-based inspections of processors without
additional resources. Other commenters expressed the same kinds of
concerns. The comment pointed out that because HACCP inspections will
take longer than current inspections, the intervals between inspections
will increase significantly, creating ``an unenforced industry honor
system.'' The commenter, and some others, also advocated additional
enforcement authorities.
The success of this program will depend on a number of factors. One
of these factors, unquestionably, will be the ability of a regulatory
authority, or authorities, to adequately monitor processors' HACCP
systems through inspections. If the frequency of inspections is too
low, safety may not be ensured, consumer confidence may be eroded, and
the accusation that the program is self-regulatory may have merit, even
though a HACCP-based inspection allows the investigator to view a
firm's critical operations over time, not just at the moment of the
inspection.
The use of a HACCP-based system bears on the adequacy of FDA's
inspection resources in two important respects. The first is the effect
of the use of HACCP-based inspections on inspection frequencies. The
time needed to conduct a HACCP-based inspection will undoubtedly vary
depending on the number of hazards, complexity of the operation, and
other factors. The first round of HACCP inspections will likely take
longer--possibly as much as twice as long in high-risk and complex
operations--as the CGMP-based inspections FDA presently conducts, but
the time-per-inspection is likely to drop significantly thereafter. It
remains to be seen whether inspection times will eventually shorten to
current times, or whether HACCP-based inspections will always take
longer on average. In any event, FDA finds some merit in the comments'
basic concerns about inspection frequencies.
Second, as a countervailing matter, a HACCP-based inspection can be
a more efficient and effective inspection than a CGMP-based inspection,
largely because it can be highly focused on matters that are critical
to safety, and because access to key safety monitoring records allows
the investigator to evaluate the process over time. Thus, some
compensation for increased intervals between inspections will be
provided by the fact that the investigator gets not merely a snapshot
of the operation of the plant in time but a broad view of how the plant
has been operated over the preceding months or even years, as reflected
in the plant's records. Thus, FDA concludes that, on balance, the
somewhat longer inspection intervals that might occur under a HACCP-
based system would be fully compensated for by the broader view
provided by a HACCP-based inspection.
In addition, FDA intends to increase the frequency and improve the
consistency of processor inspections through HACCP-based work sharing
partnerships with the States. One of the agency's goals is for these
regulations to serve as a basis for partnerships that involves a
pooling of resources.
While FDA acknowledges the comments' concerns about resources, the
agency would not agree that the HACCP program should be abandoned
because of resource constraints. Quite the contrary, resource
constraints make it imperative that FDA seafood inspections be based on
the most effective and efficient system devised to date. HACCP is that
system. Moreover, the agency believes that there is enough flexibility
in a HACCP-based inspection system to permit gradations in
implementation (e.g., focusing on the most extreme hazards; selectively
reviewing records) to accommodate whatever resource situation exists at
any given moment.
With regard to enforcement authorities, as made clear above, the
act provides ample authority for the establishment and implementation
of a HACCP-based system by FDA. Regardless of whether additional
authorities might be desirable, there simply is no reason for FDA not
to proceed to establish and implement a HACCP-based system forthwith.
15. Another comment expressed opposition to mandatory HACCP for the
seafood industry on the grounds that HACCP diverts the responsibility
for ensuring a safe product from the government to the fish processors.
FDA's intent is not to transfer its legitimate responsibilities
with regard to food safety to the regulated industry. In point of fact,
the industry already has responsibility under the law to produce a safe
product. HACCP helps to clarify, however, how responsibility for human
food safety is divided between industry and the regulator.
Industry, as stated above, must take primary responsibility for the
production of safe food, while the regulator must be responsible for
setting standards (including program regulations such as these),
verifying that the industry is doing its job, and taking remedial
action when it is not. HACCP requires that the industry be aware of the
human food safety hazards that are reasonably likely to occur, and that
industry operate under a system that is designed to ensure that those
hazards are not realized. Thus, HACCP enables the industry to
demonstrate that it is meeting its legitimate responsibilities.
[[Page 65105]]
5. Other Issues
16. One comment supported the concept of HACCP but expressed the
view that the regulation drafting process should be started over by
forming a committee consisting of representatives from various segments
of the seafood industry, and appropriate government and university
personnel. A few other comments expressed the view that FDA had acted
too quickly in issuing the proposed regulations and also requested that
FDA start over by engaging in discussions with industry, foreign
regulatory agencies, academia, and consumers. These latter comments,
which were mostly from companies not primarily involved in the
processing of seafood, preferred a voluntary approach to HACCP, with
mandatory applications only in exceptional situations. FDA did not act
too quickly, or without appropriate consultation, in issuing the
proposal in this proceeding. As the preamble to the proposed rule
documented at some length, the proposal was the culmination of an
extensive process by FDA and others, including the seafood industry
itself, that led major representatives of that industry to request the
issuance of the proposal. Before that, industry trade associations
testified repeatedly before Congress in the late 1980's through the
early 1990's in support of legislation that would have required a
mandatory inspection system for seafood based on HACCP principles.
FDA participated in pilot programs in the past such as the seafood
HACCP pilot conducted jointly by FDA and the National Marine Fisheries
Service (NMFS) of the Department of Commerce (DOC) in 1990 to 1991. In
addition, FDA ran programs with seven other countries. In developing
these regulations, the agency also took advantage of information from
the Model Seafood Surveillance Project (MSSP). The MSSP was conducted
by the DOC at the request of Congress in 1986 to design an inspection
system for seafood consistent with HACCP principles. As part of the
MSSP project, 49 workshops were conducted involving 1,200 industry,
State, and university participants. Canada currently has a HACCP
system, and the EU has issued directives that move in that direction.
The agency has concluded that sufficient field trials have already
taken place to conclude that HACCP is a viable method of hazard control
for the seafood industry.
Public input into the development of the HACCP approach contained
in these regulations has been substantial. As described earlier in this
preamble, FDA engaged in a series of ``town meetings'' in nine cities
across the country shortly after the proposal was published in order to
answer questions about the proposed regulations and encourage comments.
The public response to FDA's proposal contributed substantially to the
contents of the final regulations.
C. Should Some Types of Processors Be Exempt?
In the preamble to the proposed regulations FDA asked for comment
on whether either processors of ``low-risk'' products or small
processors, or both, should be exempted from the requirements of the
final regulations. The agency asked for information on whether the
regulatory burden could be reduced without compromising the public
health protection goals of the regulations, and whether there exists a
rational way to distinguish ``high risk'' from ``low risk,'' and big
processors from little processors, for purposes of HACCP.
1. Exempt Low Risk?
The most obvious way of distinguishing high-risk products from low-
risk products would be on the basis of reported, confirmed, seafood-
related illnesses. The preamble to the proposed regulations pointed out
some problems with this approach. First, the agency pointed out that
the underreporting and skewed reporting that occurs with respect to
foodborne illness creates significant concern as to whether reported
illnesses represent a reliable enough factor to serve as the basis for
an exemption to these regulations. Second, FDA stated that it was
concerned that there could be a significant potential for harm that
could be controlled by HACCP but that would not have shown up in the
data that is relied on to establish risk. For example, while there may
be no reported cases of botulism associated with some products that
have the potential for Clostridium botulinum toxin, the severity of the
consequences of the hazard warrant preventive controls. Likewise, while
there may be no reported cases of domoic acid intoxication associated
with shellfish from a particular area, preventive controls are
warranted as soon as a such a case is made public. Thus, the preamble
asked whether potential for harm might be a reasonable way to
distinguish high-risk from low-risk products for purposes of an
exemption. FDA was interested in whether comments could provide usable
criteria for such an exemption.
About 45 comments addressed the question of whether the regulations
should apply to high-risk products only. Roughly two-thirds of these
comments preferred a high-risk approach. For the most part, they either
did not define ``high risk,'' or defined it as including essentially
the top three reported seafood- related illnesses (virus-related from
raw molluscan shellfish, scombrotoxin, and ciguatoxin). For the most
part, other hazards were assumed to represent a low risk.
17. One comment recommended that the regulations initially cover
the hazards reported at the highest levels of to the Centers for
Disease Control and Prevention (CDC) because these hazards are at least
known to be causing illness, and that the agency should phase in other
hazards as appropriate if the foodborne-illness reporting system were
to reveal a need to do so.
Few comments were received on whether there could be a basis for
distinguishing high risk from low risk other than reported illnesses.
Some comments suggested that the agency should consider severity of
illness as a criterion. Some of these comments specifically cited
smoked and smoke-flavored fish as products that should be covered on
this basis because of the devastating effects of botulism. A few
comments expressed the view that mandatory HACCP should be limited to
hazards that can cause loss of life or irreversible injury.
Several comments objected to a ``low risk'' exemption in any form.
Some pointed out that, given the underreporting and skewed reporting
that exists, the CDC foodborne-illness reporting system does not
provide a suitable basis for making determinations of comparative risk
(i.e., high risk versus low risk). These comments expressed concern
that linking the requirements of these regulations to illness reporting
that has already occurred would have the effect of exempting emerging
hazards, at least until they caused reported illness.
Other comments stated that there is no significant advantage to
exempting low-risk products because processors of these products will
have simpler HACCP plans than those who process products with more
potential safety hazards. One comment stated that a high risk-only
approach made some sense but, as a practical matter, would negate the
added assurance to consumers from HACCP that seafood is safe and
processed under some form of regulation. According to this comment,
from a large seafood trade association, it is more important that the
entire food category be recognized as having been subjected to modern
safety assurance
[[Page 65106]]
procedures than that the regulations exempt the low risk end of the
industry.
FDA has considered these points of view and has concluded that, at
least for now, there is no reasonable way to divide seafood products
into high risk and low risk for purposes of these regulations. The
comments that suggested defining ``high risk'' in terms of the most
frequently reported illnesses are correct that the volume of reporting
tends to concentrate substantially in the three hazard areas mentioned
above. Because illnesses that are confirmed and reported tend to be
those that are the most easily traced or diagnosed, however, the
relative significance of the high level of reporting in these three
areas--as well as the drop-off in reporting in other areas--is not
fully known. Moreover, illnesses associated with chronic hazards are
virtually unreported because of the difficulties in associating such
illnesses to specific food sources.
The comments did not include any new data that would reveal whether
the risks associated with the most reported illnesses are actually the
highest risks or only the most apparent. No new information was
provided to allow FDA to determine whether distinguishing high risk
from low risk on the basis of reported illnesses would constitute a
rational division for purposes of these regulations. Nor has FDA been
supplied with information that would allow it to conclude whether other
valid criteria exist.
FDA agrees with the comments that pointed out that the requirements
of HACCP are less when risks are low. Moreover, as will be discussed
later in this preamble, FDA has revised the final regulations to
provide that HACCP plans are not required when there are no reasonably
likely safety hazards to control. Thus, HACCP inherently tends to
distinguish between high- and low-risk products without the need for
explicit exemptions.
FDA also agrees that broad exemptions would put at risk some of the
principal objectives of these regulations. Explicit exemptions make the
system less flexible and might not cover emerging situations for which
preventive controls are necessary to keep illnesses from occurring in
the first place. A system that includes such exemptions would likely
not provide as much consumer confidence as would a complete HACCP
system. In addition, FDA notes that the benefits to the industry in
international trade from adopting a HACCP system might be minimized if
such exemptions were adopted because the United States' international
trading partners are opting for complete systems.
2. Exempt Small Processors?
18. Over 60 comments addressed the question of whether the
regulations should exempt small businesses. About five out of six of
these comments opposed an exemption.
Those that supported an exemption for small businesses expressed
concern about the effect of the general costs of implementation,
particularly the costs of training and recordkeeping. One comment
observed that many small businesses are economically-strapped, old,
family enterprises that support an often fragile local economy. Another
comment expressed the view that small businesses should be exempt
because they are not involved in international trade. One comment noted
that the highest volume producers (i.e., large businesses) are where a
mistake affects the most consumers.
One comment recommended that FDA develop exemption procedures to
relieve small companies of paperwork and training requirements,
especially if they produce low-risk products. A few comments suggested
that small businesses, or at least small businesses with good records,
be exempt from ``positive'' recordkeeping, i.e., recording the results
of each monitoring. Under this kind of exemption, small businesses
would only record unusual occurrences and corrective actions.
The majority of comments that argued against exempting small
businesses provided a number of reasons. One comment pointed out that
as much as half of seafood consumed in the United States is from small
firms. Several comments stated that size is not related to risk. Small
firms are the major producers of many high-risk products (e.g. cooked,
ready-to-eat and raw molluscan shellfish). Thus, according to the
comment, the final regulations would represent a futile exercise if
small firms were not included. One comment observed that small
companies sometimes represent more of a risk potential than large
companies due to lack of enough trained quality control personnel.
Other comments pointed out that small businesses with simple operations
would have simple plans and a minimum of recordkeeping.
One comment pointed to difficulties that FDA would have in
administering exemptions to the regulations, particularly in
distinguishing between firms that were and were not entitled to an
exemption. Another concern expressed by comments was the potential
unfairness of exempting some companies while requiring HACCP of others.
One State that has implemented mandatory HACCP for seafood
processors observed that HACCP requirements had not proven to be an
excessive burden to small businesses in that State.
Some comments that supported including small businesses in the
coverage of the HACCP requirement recommended, nonetheless, that FDA
should provide assistance to small businesses through guidelines, model
plans, and technical and financial assistance. Some comments
acknowledged that small firms can work through trade groups on common
plans and training.
Other comments felt that dropping small firms from the final
regulations would adversely affect consumer confidence. One comment
expressed fear that the international standing of FDA's seafood safety
program would be in jeopardy if the regulations were to exempt some
firms.
FDA does not know how to exempt small business without jeopardizing
the public health objectives of the regulations. An exemption for small
processors of ``low-risk'' products would run into the difficulties
explained above in the discussion of whether these regulations should
only apply to ``high-risk'' products. FDA agrees with the comments
that, in the seafood industry, the size of the operation often does not
coincide with the number or type of hazards that must be controlled in
order to ensure a safe product (i.e., small size does not automatically
mean minimal hazards). For example, cooked, ready-to-eat seafood
processing, a relatively complex manufacturing operation, typically
requiring a larger than average number of CCP's, is concentrated in the
small business portion of the seafood industry. Additionally, the
processing of raw molluscan shellfish, a product identified by NAS as
being associated with a disproportionately large percentage of the
seafood-borne illnesses, is most commonly performed by small firms. FDA
also agrees that, because seafood businesses tend to be small, an
exemption for small businesses could make HACCP the exception, rather
than the rule, in this industry.
The concerns expressed in the comments about the possible adverse
consequences of these regulations on small business, however, should
not be taken lightly, and the agency has not done so. FDA has no desire
to establish a mandatory regime that cannot be met by otherwise
responsible companies,
[[Page 65107]]
small or otherwise, that are producing safe food. Indeed, these
regulations are based on the premises that: (1) Preventive controls for
safety should be within the reach of anyone who is producing seafood
for commerce (i.e., preventive controls should not be prohibitively
burdensome, either financially or conceptually); and (2) it is in the
public interest that everyone who is producing seafood for commerce
should practice preventive control for human food safety. The
fundamental question that the issue of whether to exempt small business
raises is whether these premises are valid.
Having fully considered the comments on this issue, FDA is not
persuaded that awareness of likely food safety hazards would cause
financial hardship to small businesses, or that having reasonable,
practical controls for those hazards will cause undue harm. As will be
discussed in the ``Records'' section of this preamble, the costs
associated with the recordkeeping requirements of HACCP are really
incidental to the cost of monitoring and need not place a significant
burden on small businesses. For example, after checking the temperature
of a refrigerator, the observer need only take an additional moment to
document the result of the observation. The agency cannot emphasize too
strongly that, in most instances, only very simple recordkeeping is
needed to adequately serve the purposes of the system. The question
from the agency's standpoint, therefore, is whether the actual
monitoring of critical operations, at reasonable frequencies, would be
prohibitively expensive to the small operator. FDA has not been
provided with a basis for such a conclusion.
This leaves plan development and training as costs. The guidelines
that FDA is making available on plan development should help
substantially to keep development costs down. FDA is also aware that
trade associations and others are interested in developing model plans
that, when used in concert with the guidelines, should further reduce
the resources that a firm will need for plan development. The creation
of a HACCP plan does require some thought and effort by the processor
to ensure that hazards and controls are understood and identified.
Nonetheless, the guidelines and model plans will enable small
processors to be able to apply the thought and effort necessary to
create a HACCP plan with maximum efficiency and minimum cost.
FDA is requiring that all processors either employ at least one
trained individual or contract for services from at least one trained
individual, as needed. There are unavoidable costs associated with this
requirement. It is imperative that these costs be affordable to small
business and be no greater than necessary. As discussed at length in
the ``Training'' section of this preamble, FDA has been extensively
involved with a consortium called the ``Seafood HACCP Alliance'' (the
Alliance) consisting of representatives from Federal and State
agencies, industry, and academia, to create a uniform, core training
program that will meet the requirements of these regulations and will
cost very little. The agency is also aware of HACCP training that has
been provided for years for members of industry by NMFS and others. As
an additional matter, FDA is allowing job experience to serve as a form
of training in order to avoid the unnecessary expense to a processor of
having to pay for a HACCP course when at least one employee already has
knowledge that is equivalent to that provided by the course.
These efforts should alleviate the concerns of those who believe
that the training requirement will be too burdensome on small business.
The agency will monitor the situation closely once this training gets
underway. If costs turn out to be significantly higher than FDA
anticipates, the agency will consider some modification to the
requirement.
While the agency regrets that grant monies are not available to
small businesses from FDA, the effort that the agency is investing in
guidelines and training development is a form of subsidy that should
keep costs down generally.
D. Definitions
1. General
In addition to relying on the definitions contained in the act and
those in the umbrella good manufacturing practice regulations at part
110 (21 CFR 110), FDA proposed at Sec. 123.3 (a) through (t) to define
20 terms that are essential to the interpretation of part 123.
Approximately 100 comments addressed various aspects of the proposed
definitions at Sec. 123.3.
The majority of the comments on definitions were concerned with the
meanings that FDA proposed for ``processor'' (Sec. 123.3(n)) and
``processing'' (Sec. 123.3(m)). These comments generally asked for
clarification about the applicability of the definitions to a given
commercial activity, or contended that the definitions should be
amended to either include or exclude certain activities. Most of the
other comments that addressed the definitions were primarily concerned
with the meanings proposed for ``fish,'' fishery product,'' ``critical
control point,'' ``cooked ready-to-eat,'' and ``importer.'' As a result
of the comments as well as agency decisions to modify other provisions
in part 123, FDA has deleted, revised, and added definitions to those
proposed at Sec. 123.3.
2. Cooked, Ready-To-Eat Fishery Product
19. The proposed regulations contained a definition for ``cooked,
ready-to-eat fishery product'' at Sec. 123.3(b). The term was used at
proposed Sec. 123.10(a) and in the appendices to the proposed
regulations. The final regulations no longer contain this term, and the
appendices are not being codified. For these reasons, FDA has
eliminated the definition of ``cooked, ready-to-eat fishery product''
from the final regulations.
Nonetheless, a large number of comments expressed concerns about
the definition as it was proposed. In general, the comments urged that
certain products be excluded from the definition of ``cooked, ready-to-
eat fishery products;'' those that are not fully cooked by the
processor or that will be recooked by the consumer, and low-acid canned
foods subject to the provisions of part 113.
FDA recognizes the significance of the use of the term. Because the
agency has excluded use of the term in these final regulations, it will
defer consideration of the comments until drafting of the Guide.
3. Critical Control Point (CCP)
FDA proposed at Sec. 123.3(c) to define a critical control point as
``a point in a food process where there is a high probability that
improper control may cause, allow, or contribute to a hazard in the
final food.'' The word ``hazard'' in this definition was intended to
refer primarily to food safety hazards. It could also have applied to
quality and economic hazards, however, because the agency was proposing
at Sec. 123.6(c) to encourage processors to apply HACCP to these
hazards as well.
20. A significant number of comments urged the agency to modify the
definition so that it clearly addresses only food safety. These
comments recommended that the word ``hazard'' should be prefaced with
either ``food safety'' or ``health,'' or that FDA should codify the
definition for ``hazard'' that has been recommended by the NACMCF.
Several of the comments urged FDA to adopt the NACMCF definition
for
[[Page 65108]]
``critical control point'' so that the agency's regulations would be
consistent with nationally and internationally agreed upon HACCP
definitions. One objected to the phrases: ``high probability,'' because
of its connotation in statistical applications; ``improper control,''
because of a lack of a standard for proper control; and ``cause, allow,
or contribute,'' because it could allow the elevation of trivial
concerns to critical control point status.
FDA is persuaded by those comments that urged consistency with the
NACMCF definition for ``critical control point.'' The agency has,
therefore, modified proposed Sec. 123.3(c) (redesignated as
Sec. 123.3(b)) to read, ``Critical control point means a point, step,
or procedure in a food process at which control can be applied, and a
food safety hazard can as a result be prevented, eliminated, or reduced
to acceptable levels.'' The modified language is consistent with the
agency's decision to limit the HACCP provisions of part 123 to the
avoidance of food safety hazards (see the ``HACCP Plan'' section of
this preamble for discussion). It is also compatible with modifications
described elsewhere in this preamble aimed at greater consistency with
the NACMCF recommendations. The wording change will not have any
practical impact on the requirements of the regulations because the
definition still reflects the agency's intent to require that seafood
be processed in a way that eliminates, to the extent possible, the
chance that it will be rendered injurious to health by procedures that
are under the control of the processor.
The NACMCF definition does not contain the phrases that were
objected to by one of the comments as described above. Thus, the
concerns raised by this comment have been resolved.
21. A few comments, however, stated that the definition should also
apply to the control of all decomposition because it is a major problem
associated with seafood.
FDA acknowledges that, because of the highly perishable nature of
fish, decomposition is probably the most common problem associated with
seafood. The agency further acknowledges the comments that expressed
concern that failure to control this problem will continue to adversely
affect consumer confidence. The industry especially should heed this
concern and consider the application of HACCP principles to
decomposition, if necessary, to help maintain the quality of its
products.
Nonetheless, decomposition that is not associated with safety is
not appropriately a part of these mandatory HACCP regulations but
should remain subject to traditional good manufacturing practices
controls (see, e.g., Sec. 110.80(b) (21 CFR 110.80(b))). As discussed
earlier, these regulations are being issued, in part, under section
402(a)(4) of the act. That section provides that a food is adulterated
if it is prepared, packed, or held under insanitary conditions whereby
it may have been rendered injurious to health. While decomposition in
some species can be injurious to health and is therefore within the
scope of section 402(a)(4) of the act, most decomposition affects the
quality of seafood but not its safety. Decomposition that affects
quality but not safety is subject to section 402(a)(3) of the act.
Therefore, FDA is not subjecting decomposition that is not safety
related to the requirements of these final regulations but will
continue to regulate decomposition under traditional CGMP control.
FDA points out that it has defined ``food safety hazard,'' a term
that the agency uses in the definition of ``critical control point,''
in Sec. 123.3(f). The agency discusses this definition, which is
consistent with the NACMCF recommended definition, later in this
section.
4. Critical Limit (CL)
FDA proposed in Sec. 123.3(d) to define a ``critical limit'' as
``the maximum or minimum value to which a physical, biological, or
chemical parameter must be controlled at a critical control point to
minimize the risk of occurrence of the identified hazard.'' In the
preamble to the proposed regulations, the agency explained that the
proposed definition was intended to be consistent with the concept of
the NACMCF recommended definition, which reads, ``a criterion that must
be met for each preventive measure associated with a critical control
point.'' However, the proposed definition was also intended to be more
explanatory than is the NACMCF definition, especially as it relates to
the assignment of a minimum or maximum value and in the relationship of
these values to a minimization of the risk, rather than to an absolute
elimination of risk.
22. Several comments stated that the proposed definition of a
``critical limit'' should be modified to be the definition recommended
by the NACMCF. The comments asserted that the NACMCF definition is the
internationally accepted standard, and that its use in the regulations
would avoid confusion. A few comments argued that FDA's use of the
phrase ``minimize the risk'' implies that the CL must be set to attain
the lowest possible risk, unlike the ``reduce to an acceptable level''
standard in the NACMCF definition for CCP.
Although FDA agrees that the definitions in these regulations
should closely adhere to the NACMCF's recommended definitions, the
agency concludes that, in this instance, FDA's wording is more
descriptive for regulatory purposes and more useful to processors.
However, FDA has been persuaded that the phrase ``minimize the risk''
may be misinterpreted as requiring outcomes that are not realistically
achievable by a processor. To provide clarification and consistency
with the revised definition of ``critical control point,'' FDA has
replaced the phrase ``minimize the risk'' with the phrase ``prevent,
eliminate, or reduce to an acceptable level'' in the final regulation
(now codified as Sec. 123.3(c)). As noted previously, this language
also appears in the NACMCF definition of ``critical control point.''
The new language correctly provides for the making of scientific
judgments about appropriate degrees of hazard reduction, based on the
nature of the hazard and the availability of controls, and is more
consistent than the proposed language with accepted HACCP convention.
23. One comment stated that the word ``identified'' should be
deleted from the proposed definition.
FDA is not persuaded to make any modification to the definition in
response to this comment. The ``identified hazard'' refers to the
hazard identified in the HACCP plan.
24. One comment stated that the phrase ``in the end product''
should be added following the word ``hazard'' in the proposed
definition.
FDA is not persuaded to make any modification to the definition in
response to this comment. Food safety hazards are, by definition, those
that cause ``a food to be unsafe for human consumption.'' This
definition implies a consideration of the end product that will be
offered for human consumption.
25. One comment objected to the phrase ``the maximum or minimum
value'' in the definition, stating that, as in the case of certain food
additives, there are situations where both a maximum and a minimum
value exist, and a processor is required to maintain the process
between these values.
FDA is not persuaded to make any changes to the proposed language
in response to this comment. The word ``or,'' which the agency uses in
the definition, is inclusive. Thus, properly read, Sec. 123.3(c) states
that a CL is the maximum value, the minimum value, or both the maximum
and minimum
[[Page 65109]]
values within which the parameter must be controlled to protect against
the occurrence of a food safety hazard.
For consistency with the definition of ``critical control point,''
FDA has added the phrase ``food safety'' before the word ``hazard'' in
the text of Sec. 123.3(c). The language in the final regulation now
reads, ``Critical limit means the maximum or minimum value to which a
physical, biological, or chemical parameter must be controlled at a
critical control point to prevent, eliminate, or reduce to an
acceptable level the occurrence of the identified food safety hazard.''
5. Fish
26. FDA proposed to define ``fish'' as ``fresh or saltwater
finfish, molluscan shellfish, crustaceans, and other forms of aquatic
animal life other than birds or mammals.'' A significant number of
comments suggested that FDA should modify this definition to clarify
whether it includes species such as sea snails, abalone, frogs,
alligators, turtles, other reptiles, amphibians, sea cucumbers, plants,
or algae.
FDA agrees that this type of clarification would be helpful and has
modified the definition at Sec. 123.3(d) to read:
Fish means fresh or saltwater finfish, crustaceans, other forms
of aquatic animal life (including, but not limited to, alligator,
frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin) other
than birds or mammals, and all mollusks, where such animal life is
intended for human consumption.
The term ``mollusks'' includes abalone, sea snails, and land snails
(e.g., escargot and any other terrestrial gastropods, such as the giant
African land snail (Achatina fulica)). The addition of examples of
aquatic animal life and the mention of mollusks are intended to make
clear which species are covered by the term ``fish.'' Water-dwelling
reptiles and amphibians other than alligators, turtles, and frogs have
not been specifically listed because they are not significant
commercial food sources in the United States. Finally, FDA notes that,
consistent with the proposed definition, aquatic plants (including
algae) are excluded. This definition is consistent with the traditional
treatment of these products by FDA.
The new language also serves to emphasize that these regulations
apply only to those products that are intended for human consumption.
This point was explicit in the proposed definition for ``fishery
product'' but was inadvertently not mentioned in the proposed
definition of ``fish.''
27. Two comments contended that there should be separate
definitions for finfish and shellfish, to differentiate between
relative levels of safety concerns (e.g., high and low risk).
FDA disagrees with this comment. Such a differentiation would serve
no purpose in these regulations. The purpose of these regulations is to
set up a unitary system that responds to a particular product based on
the risks it presents, not to establish a system that is divided up
based on risk presented. The merits of differentiating between products
on the basis of risk is addressed in the section of the preamble
entitled ``Should Some Types of Processors be Exempt?''
6. Fishery Product
FDA proposed to define ``fishery product'' as ``any edible human
food derived in whole or in part from fish, including fish that has
been processed in any manner.'' The preamble to the proposed
regulations stated that the intent of the definition was to include
products that contain seafood as an ingredient as well as those
products that are comprised of seafood alone, because hazards derived
from seafood are reasonably likely to occur in both types of products.
28. A few comments urged that FDA exclude from the meaning of
``fishery product'' any product that is made in whole or in part from
commercially sterilized fishery products subject to the requirements of
parts 113 and 114, (i.e., thermally processed low-acid canned foods and
acidified foods).
FDA disagrees with this comment. Although such foods are required
to be produced in accordance with certain HACCP-type control procedures
to reduce the risk of the hazard of C. botulinum toxin production,
these control measures do not address other potential hazards. For
example, part 113 provides no assurance that the raw material used in
the canning of tuna will be free from contamination with dangerous
levels of histamine. Likewise, products made in part from low-acid
canned foods and acidified foods can also present hazards that must be
addressed. For example, a salad made in part from canned tuna can be
subjected to recontamination with pathogenic microorganisms and time-
temperature abuse during preparation.
Although FDA cannot exclude those products made in whole or in part
from low acid canned foods or from acidified foods from the definition
of a ``fishery product,'' it is worth noting that the agency has
exempted processors who are following the requirements of part 113 or
part 114 from having to include controls for C. botulinum in their
HACCP plans. This hazard is already addressed by the requirements in
those parts (see Sec. 123.6(e) of these regulations and the ``HACCP
Plan'' section of this preamble).
29. One comment suggested that the language of the proposed
definition inappropriately excludes fish roe.
FDA points out that the phrase ``any edible human food product
derived in whole or in part from fish,'' in the proposal was intended
to cover these products. FDA, however, has modified the definition of
``fishery product,'' and it no longer includes this language.
Therefore, to make clear that roe are covered, FDA has made explicit in
the definition of ``fish'' that the roe of the covered animals are
included.
30. A significant number of comments urged that the definition
exclude products that contain only a minimal amount of fish. These
comments suggested various standards that FDA should apply to exclude
such foods from the definition. These included: Products that contain
less than 50 percent fish; products that contain less than 10 percent
fish; products that contain 2 percent or less of cooked, or 3 percent
or less of raw, fish; products in which fish is not a characterizing
ingredient; and products that contain any nonfish ingredient unless a
hazard analysis identifies a significant hazard associated with the
fish ingredient. The comments provided no justification for the
percentages suggested.
FDA agrees that foods that contain inconsequential amounts of fish,
such as Worcestershire sauce, are not the types of foods that should
come under the purview of these regulations. It is doubtful that they
pose reasonably likely hazards associated with their fish components.
Moreover, these products are neither represented nor perceived as being
fish-based foods.
The comments provided FDA with no basis, however, upon which to
select a specific minimum content of fish ingredient for the definition
of ``fishery product.'' There is no obvious minimum percentage of fish
on which to exempt a food that contains only a small amount of fish
from the provisions of these regulations.
Instead, the agency accepts the comment that, to meet the
definition of a ``fishery product,'' a food should be characterized by
the qualities of the fish that it contains. Thus, these regulations
will apply to those foods whose basic nature is defined by the fish
that they contain. Accordingly FDA has modified the proposed definition
(Sec. 123.3(e)) to read in part, ``Fishery product means any edible
human food product in
[[Page 65110]]
which fish is a characterizing ingredient.'' This revision will serve
to ensure that mandatory HACCP requirements do not apply to products
that contain inconsequential amounts of fish from a public health
standpoint.
31. One comment stated that fish oil that is intended for use in
human food should not be subject to the requirements of these
regulations until it has been separated, through initial processing,
from the oil that will be used for animal feeds and other industrial
purposes. FDA does not find that the comment provided sufficient
justification to treat this product differently from other human food
products processed from fish. The agency acknowledges that the hazards
associated with these products may be minimal. If that is the case, the
fish oil processor's burden will also be minimal, perhaps limited to
training expenses and the performance of a hazard analysis. Moreover,
these regulations do not apply to products that are not for human
consumption and fish oil processors that are confident that their
production will not be used for human consumption need not apply the
requirements of these regulations.
7. Food Safety Hazard
32. A number of the comments recommended that FDA define ``safety
hazard'' or ``food safety hazard.'' Several of these comments
recommended that FDA adopt a definition that is consistent with the
NACMCF recommended definition for ``hazard.'' The comments were
primarily concerned with the coverage of these regulations. They urged
that the regulations be clear that only food safety hazards need be
addressed by the HACCP plan and argued that a definition would help to
accomplish that.
The NACMCF definition of ``food safety hazard'' reads, ``A
biological, chemical, or physical property that may cause a food to be
unsafe for consumption.'' While FDA provided no definition of ``food
safety hazard'' in the proposed regulations, it did raise the issue of
the coverage of the regulations in proposed Sec. 123.6(b) (redesignated
as Sec. 123.6(c)), which mandated coverage of food safety hazards only
and listed nine types of food safety hazards posed by the various types
of fish and fishery products. This list included examples of
biological, chemical, and physical hazards. Additionally, the preamble
to the proposed regulations discussed at length the significance of a
number of these types of hazards.
FDA agrees that the meaning ascribed by the agency to a food safety
hazard should be as clear as possible in these regulations. The
examples of hazards in the proposed regulations--and codified in these
final regulations--are consistent with the NACMCF definition for a food
safety hazard. Therefore, for the sake of clarity, FDA has decided to
characterize these examples in a definition Sec. 123.3(f), which reads,
``Food safety hazard means any biological, chemical, or physical
property that may cause a food to be unsafe for human consumption.''
The only difference between this definition and the NACMCF
recommendation is the addition of the word ``human.'' FDA has included
this word to prevent confusion about the application of these
regulations to pet or animal feed.
In keeping with the new definition, and to provide further
clarification about the nature of the hazards that are required to be
addressed by these regulations, the term ``hazard'' has been changed to
``food safety hazard'' where it appears throughout the codified portion
of this document.
8. Harvester
FDA proposed to define ``harvester'' as ``a person who has an
identification number issued by a shellfish control authority for
commercially taking molluscan shellfish by any means from a growing
area.'' After review, the agency has concluded that it was not
necessary to limit ``harvesters'' to those persons who have an
identification number, primarily because in some jurisdictions,
identification numbers may not be issued by a shellfish control
authority. Without this limitation, FDA has concluded that there is no
need to establish a particular meaning for this term for the purposes
of these regulations. Therefore, the agency has removed this definition
from the final regulations.
9. Importer
FDA proposed to define ``importer'' as ``a person, or his
representative in the United States, who is responsible for ensuring
that goods being offered for entry into the United States are in
compliance with all laws affecting the importation.'' The preamble to
the proposed regulations explained that the importer is the owner of
the imported goods or the owner's representative in the United States.
The preamble further noted that freight forwarders, food brokers, food
jobbers, carriers, and steamship representatives would not usually be
considered to be the importer of the product for the purposes of these
regulations because they are not usually in a position to make
decisions that can ensure the safety of the product. However, the
preamble did not categorically rule out that these individuals could be
the importer because sometimes they may be in a position to make
decisions relevant to safety.
33. Several comments stated that FDA should modify the definition
of ``importer'' to specifically exclude intermediary agents involved in
the importing process, such as freight forwarders, licensed U.S.
customs brokers, food brokers, food jobbers, carriers, and steamship
representatives. These comments noted that, although imported products
may enter the United States under the name of an intermediary, this
practice is done for convenience in handling the paperwork at the port
of entry. The comments stated that the intermediary has little
responsibility for conducting the negotiations with an overseas
producer and rarely takes possession of the products. Therefore, the
comments stated, the intermediary has limited influence on the safety
of the imported goods. Two comments pointed out, for example, that
customs brokers that provide their clients with the service of using
the broker's customs bond are listed as the ``importer of record'' and
may thereby, unintentionally, be regarded as importers under the
proposed definition, even though they do not own or control the product
being imported.
Conversely, two comments argued that agents, such as food brokers,
should be included in the definition of an ``importer'' because they
bring product into the United States and sell it. The comments argued
that the brokers should, therefore, be held responsible for ensuring
that the foreign processor complies with the provisions of these
regulations, to avoid an unfair advantage over domestic processors.
FDA concludes, based on the information provided in the comments,
that these intermediaries can neither be categorically included or
excluded. However, the agency recognizes that the number and type of
comments on this issue demonstrate that the language of proposed
Sec. 123.3(h) was inadequate to convey the agency's intent, as
articulated in the preamble. For this reason, FDA has clarified the
definition of ``importer'' in Sec. 123.3(g) to read, in part:
Importer means either the U.S. owner or consignee at the time of
entry into the United States, or the U.S. agent or representative of
the foreign owner or consignee at the time of entry into the United
States, who is responsible for ensuring that goods being offered for
entry into the United States are in compliance with all laws
affecting the importation.
[[Page 65111]]
Reference to the owner or consignee of the imported goods parallels the
language in section 801 of the act (21 U.S.C. 381).
Because the ownership of imported products can change many times in
a relatively short period of time after entry, the party who is the
owner or consignee at the time that these products are offered for
entry must be identified as the importer. As the person that has the
ability to decide whether to offer the product for entry, this person
is in a position to ensure that the product is processed under
appropriate controls and to demonstrate this fact to FDA.
FDA must be able to verify the existence of the evidence of
compliance by the foreign processor. This evidence, according to the
provisions of Sec. 123.12, is to be in the possession of the
``importer.'' It must be available in the United States, however, if
FDA is to consider the information in deciding whether to admit the
products. Thus, where products are offered for entry by a U.S. owner or
consignee, that owner or consignee will, for purposes of these
regulations, be considered the importer because it will have control of
this evidence. Where products are often offered for entry without a
U.S. owner or consignee, the U.S. agent of the foreign owner or
consignee will be considered the ``importer'' for purposes of these
regulations to make clear who will be expected to have this evidence
for such products.
FDA recognizes that the U.S. owner or consignee of the product, or
the U.S. representative of the foreign owner or consignee, at the time
of entry into the United States may also serve other functions. For
example, it may also be a food broker for, or warehouser or processor
of, the product. It may, in some instances, also be the freight
forwarder, customhouse broker, or carrier for the product. These other
functions will not matter, however, if the person is the U.S. owner or
consignee of the product, or the U.S. representative of the foreign
owner or consignee, at the time of entry into the United States. From
FDA's experience, while certainly not impossible, it is at least
unlikely that this qualification will be met by the customhouse broker,
the freight forwarder, the carrier, or the steamship representative.
The agency has attempted to clarify this definition by including a
sentence that reads, ``For the purposes of this definition, ordinarily
the importer is not the custom house broker, the freight forwarder, the
carrier, or the steamship representative.'' Further, FDA does not
intend to rely exclusively upon the assignment of the ``Importer of
Record'' or the holder of the U.S. Customs Surety Bond in determining
the ``importer'' for the purposes of these regulations, as was
suggested in the preamble to the proposed regulations. In some
instances the ``Importer of Record'' or the holder of the U.S. Customs
Surety Bond will not meet the qualifications of an importer that are
set out in Sec. 123.3(g).
10. Lot of Molluscan Shellfish
FDA proposed to define a ``lot of molluscan shellfish'' as ``a
collection of shellstock or containers of shellstock of no more than 1
day's harvest from a single, defined growing area harvested by one or
more harvesters.'' Because of language changes that FDA has made in
subpart C of part 123, this term isno longer used in the regulations.
Consequently, FDA has decided that there is no need to define this term
and has eliminated the definition.
11. Molluscan Shellfish
34. Comments from a number of State agencies, trade associations,
seafood processors, and the ISSC objected to the use of the term
``fresh or frozen'' in the proposed definition of ``Molluscan
shellfish.'' The comments were concerned because this definition would
have the effect of exempting canned and any other heat-processed
molluscan shellfish from the source control, recordkeeping, and tagging
provisions of proposed subpart C of part 123 and proposed
Sec. 1240.60(b).
The comments stated that limiting these provisions to raw products
would allow foreign firms to continue to heat-treat or can molluscan
shellfish that are harvested from foreign waters that do not meet
National Shellfish Sanitation Program (NSSP) standards and to export
them to the United States. The comments stated that this situation was
not in the best interest of the public health because of the potential
for the presence of heat-stable natural toxins, such as paralytic
shellfish poison or amnesiac shellfish poison, as well as chemical
contaminants. The comments also complained that, because State laws and
regulations require that all molluscan shellfish harvested in the
United States come from waters approved by a shellfish control
authority regardless of whether they are to be consumed raw or
cooked,continuing to allow foreign processors who export cooked
shellfish to the United States to use molluscan shellfish from
unapproved growing waters places the domestic shellfish industry at a
competitive disadvantage.
FDA believes that these comments are generally valid but are beyond
the scope of this rulemaking. The point of this rulemaking it to
determine whether FDA should require that HACCP be followed in the
processing of seafood. The question of whether cooked molluscan
shellfish that is being offered for import into this country is being
harvested in a manner that creates public health concerns and unfair
competitive advantages is a separate matter that the agency will
address, if necessary, in the future.
Similar issues with respect to the use of the term ``fresh or
frozen'' and the term ``raw'' in proposed subpart C of part 123 of
these regulations and in proposed part 1240 are discussed in the
``Molluscan Shellfish'' section of this preamble (see comment 144).
12. Potable Water
FDA proposed to define ``potable water'' as ``water which meets the
U.S. Environmental Protection Agency's Primary Drinking Water
Regulations as set forth in 40 CFR part 141.'' Because of changes that
the agency has made in proposed Sec. 123.10 (redesignated as
Sec. 123.11), the term is no longer used in these regulations.
Consequently, FDA has eliminated the definition.
Nonetheless, a significant number of comments questioned when it
would be necessary for processing water to meet the definition of
``potable water.'' Because it is likely that both terms (i.e.,
processing water and potable water) will be used in the first edition
of the Guide, FDA will consider these comments during the redrafting of
the Guide.
13. Preventive Measure
FDA has added a definition for the term ``preventive measure'' at
Sec. 123.3(i). Although the term was not used in the proposal, the
concept of preventive measures was a fundamental part of the hazard
analysis that was implicit in proposed Sec. 123.6(b). ``Preventive
measure'' is used in the final regulations in Sec. 123.6(a) in the
description of a hazard analysis.
FDA proposed to require that all processors create a HAACP plan.
Based on comments received, however, as explained below, FDA has
decided to require that processors conduct hazard analyses to determine
whether they need to develop a HACCP plan. This decision necessitates
that FDA define ``preventive measure.'' In accordance with the
recommendations of the NACMCF (see Ref. 34, p. 189), a hazard analysis
must identify both the food safety hazards that are reasonably likely
to occur and the preventive measures that are available to the
processor to control such hazards.
[[Page 65112]]
Identifying the preventive measures is necessary in order to
determine whether a processing step is a CCP for that hazard. A
processing step cannot be a CCP for a hazard if no preventive measure
is available at that step to control the hazard. The definition of
``preventive measure'' in these regulations is essentially the same as
that recommended by the NACMCF.
14. Process Monitoring Instrument
The term ``process control instrument'' was used in the proposal
for consistency with the phrase ``the procedures * * * that will be
used to control and monitor each of the critical control points.'' For
consistency with the NACMCF principles of HACCP, FDA has modified the
language of Sec. 123.6(c)(4) to eliminate the word ``control.'' In
order to achieve consistency within these regulations, the agency has
concluded that the appropriate term for such instruments is, therefore,
a ``process monitoring instrument.''
15. Processing and Processor
Along with the term ``importers,'' the terms ``processor'' and
``processing'' collectively define who is subject to these regulations.
FDA proposed to define ``processing'' as:
[W]ith respect to fish or fishery products, handling, storing,
preparing, heading, gutting, shucking, freezing, changing into
different market forms, manufacturing, preserving, packing,
labeling, or holding. Practices such as heading or gutting intended
solely to prepare a fish for holding on board a harvest vessel are
excluded. This regulation does not cover the operation of a retail
establishment.
FDA proposed to define ``processor'' as:
[A]ny person engaged in commercial, custom, or institutional
processing of fish or fishery products, either in the United States
or in a foreign country. Persons engaged in the production of foods
that are to be used in market or consumer tests are also included.
Persons who only harvest or transport seafood, without otherwise
engaging in processing, are not covered by these regulations.
a. Vessels, carriers, and retail. As explained in the preamble to
the proposed regulations, the definitions of ``processor'' and
``processing'' excluded fishing vessels that essentially only harvest,
transportation companies that carry but do not otherwise process fish
and fishery products, and retail establishments. FDA invited comment on
these exclusions.
In the preamble, FDA acknowledged that food safety hazards can be
introduced at these three points in the commercial distribution chain.
However, FDA tentatively decided to exclude fishing vessels, carriers,
and retailers from the definition of ``processor''--and thus from
direct coverage under these regulations--because of practical
considerations, such as the fact that the large size of the U.S.
fishing fleet and the large numbers of carriers and retailers would
overwhelm any rational Federal inspection system, and because the
agency believed that the public health goals of the regulations could
still be met.
FDA expressed its tentative view that the HACCP regulations would
affect fishing vessels and carriers indirectly though the controls that
processors impose to meet their obligations under HACCP. As for retail
establishments, the preamble explained that, historically, they have
been the regulatory responsibility of State and local governments. FDA
traditionally has provided support through training, technical
assistance, and the development of model codes. Since the issuance of
the proposal, FDA has published its retail and institutional ``Food
Code,'' with the recommendation that it be adopted by State and local
jurisdictions. The Food Code covers handling and receiving practices at
retail, and its most recent version includes HACCP elements.
FDA's approach to these issues is based on agency discretion and
does not derive from a lack of statutory authority. FDA has broad
authority to regulate Food that is shipped in interstate commerce.
While carriers are exempt from most direct FDA regulation in accordance
with section 703 of the act (21 U.S.C. 373), the food being transported
is not exempt. Moreover, FDA has authority under the Public Health
Service Act (the PHS Act) (42 U.S.C. 264) to take such measures as it
deems necessary to prevent the introduction, transmission, or spread of
communicable disease from foreign countries into the States or from one
State or possession into any other State or possession.
FDA received a significant volume of comment on the question of
coverage by these regulations of fishing vessels, carriers, and retail
establishments. The majority of comments strongly favored inclusion of
these entities within the scope of the these regulations.
35. The arguments relating to vessels and carriers tended to
overlap. Those who favored inclusion noted that hazards--particularly
those associated with time-temperature abuse and insanitation--can
originate with fishing vessels and carriers. The comments argued that
not controlling the conditions under which seafood is harvested and
transported would amount to leaving CCP's unregulated. One comment
observed that carriers have an incentive to turn off refrigeration
units to save gas.
Several comments expressed the view that exclusion of vessels and
carriers from the coverage of these regulations unfairly makes
processors responsible for these aspects of seafood production. One
comment pointed out that vessels, especially those that harvest
scombroid toxin-forming species, should be legally responsible for any
safety hazards that they cause through improper handling. Some comments
asserted that HACCP can be practiced on fishing vessels and by
carriers, at least with regard to temperature controls.
One State agency expressed the view that holding processors
responsible for the behavior of fishing vessels has, in its experience,
not worked, nor has education of fishing vessel owners or voluntary
compliance by owners. The comment did not document the basis for these
conclusions, however. Some comments argued that, while it would be
difficult to include all vessels and carriers, those involved with
high-risk products should be included.
Comments in favor of excluding vessels and carriers from these
HACCP regulations noted that FDA's rationale for exclusion was prudent
given the number, location, and diversity of the U.S. fishing fleet and
the complexity of transport arrangements. For carriers, one comment
noted that partial loads that are dropped off in different locations
would be especially difficult to control. Some comments asserted that
direct regulation of these entities was not necessary because
processors could establish minimum requirements as a condition of
purchase, as part of their HACCP systems. Some comments urged, however,
that fishing vessels be subject to HACCP requirements when they deliver
directly to an entity that is not subject to these regulations (e.g., a
restaurant). One comment argued that receiving firms should require
that product be in the same condition that it was in when it left the
previous processor.
Some comments questioned the ability of fishing vessels and
carriers to comply with HACCP requirements. A number of comments
favored alternatives to HACCP, such as guidelines and standard
operating procedures (SOP's).
FDA is impressed by the strong support for inclusion, of fishing
vessels and carriers in the coverage of these regulations. Some of this
support was based on concern over the loss of quality because of poor
handling
[[Page 65113]]
practices (e.g., the effect of time-temperature abuse on shelf life and
spoilage unrelated to safety) rather than on food safety
considerations. Nonetheless, members of these two industries should be
aware that significant concerns have been expressed with regard to
their practices.
For some species and products, the practices of fishing vessels and
transporters can have significant public health consequences. These
practices can put pressure on a processor who is receiving these
products to carefully scrutinize the condition of incoming materials.
The practices can also put pressure on a processor to determine whether
carriers are suitable to transport their finished products (e.g., that
carriers have proper refrigeration).
The agency appreciates the argument that all entities that can
affect safety in the distribution chain should accept and share this
responsibility. These points notwithstanding, FDA received no comment
that provided information about how the agency could operate an
inspection program for carriers and harvest vessels with its current
resources. For this reason, the agency concludes that such a program is
impractical at this time.
When processors accept raw materials for processing, especially
from vessels, they assume some responsibility for the condition of the
incoming materials, regardless of how others are regulated. This is
true under both general commercial law and the laws administered by
FDA. Carriers likewise have responsibilities. If a carrier fails to
exercise such controls as are necessary, food that it carries may be
rendered adulterated and the owner of the product, i.e., the processor,
could suffer product loss. Food handlers generally should exercise
sufficient control over the products in their custody to ensure that
any food safety hazards that are reasonably likely to occur during that
period are being addressed.
As an additional matter, FDA agrees with those comments that
advocated a step-wise regulatory approach to these entities.
Mandatory HACCP for seafood is a pioneering venture. While the
groundwork has been prepared for it through pilot projects and other
efforts over the years, there is no substitute for actual experience
once it is operating. The agency would prefer, therefore, to construct
the system through a series of manageable steps if it needs to do so,
rather than to risk overextending itself and the system initially.
While these regulations exempt carriers and harvest vessels from direct
coverage, experience with the application of a mandatory HACCP program
may, at some later date, cause the agency to reconsider its approach.
For fishing vessels, FDA intends, for the time being, to issue good
handling practice guidelines. To that end, the agency is studying those
issued by the State of Alaska and by the Codex Alimentarius Commission
of the Food and Agriculture Organization/World Health Organization,
among other such available guidance. FDA will evaluate the effect of
these guidelines, in addition to any requirements that States have or
may adopt regarding fishing vessel practices, and reassess at a later
date whether there is a need for mandatory Federal controls. The agency
invites continued correspondence and the sharing of views on this
matter.
The comments that recommended that vessels that sell directly to
``non-HACCP'' establishments (e.g., restaurants) should be required to
have HACCP plans are advised that the Food Code addresses the subject
of source control for retail establishments and recommends the
requirement of HACCP plans for retail establishments in some
circumstances. This matter relates principally to State and local laws
and is addressed below in the discussion of retail establishments.
For carriers, the situation is complicated by the restriction in
section 703 of the act that was described previously. As one comment
recommended, FDA has had conversations with other Federal agencies on
the subject of transportation of food and will continue to do so. In
the meantime, FDA strongly recommends that processors review the
material in the Guide on how they can exercise control over incoming
raw materials as well as over shipments of their own products. One
emerging area that the agency is monitoring--and processors should
consider also--is the development of inexpensive time-temperature
sensors that indicate whether proper temperatures have been maintained
over a period of time.
36. The question of the inclusion of retail establishments within
the mandatory seafood HACCP system involves some different
considerations. Processors have less influence, if any, over how their
products are handled at retail than they do over how their products are
handled by vessel operators or carriers. Some comments pointed out, for
example, that a processor's best efforts could be for naught if the
product is subsequently mishandled at retail.
Several comments pointed out that many retail establishments carry
out activities that meet the definition of ``processing.'' According to
these comments, such establishments should not be exempt from HACCP
requirements.
Other comments took the view that these regulations should not
apply to retail establishments, primarily for the reasons provided in
the preamble to the proposal. Some recommended that retail
establishments should not be subject to the regulations so long as the
Food Code applies to them. Others suggested that HACCP should apply if
the retail establishment buys directly from a fishing vessel or from
sport fishermen. Some suggested better consumer education and voluntary
HACCP-type programs.
FDA agrees that there are hazards that occur at the retail level
that can render meaningless the controls that may have been in place
elsewhere in the chain of production and distribution. The NAS has
cited retail and food service establishments as sources of seafood-
related illnesses (see Ref. 7, p. 27). FDA is convinced--and the
comments support--that proper controls at the retail level are
imperative to ensuring a safe product.
Nonetheless, FDA's observation in the preamble to the proposed
regulations remains valid that retail establishments pose an inspection
burden well beyond the capacity of FDA. No comments have provided any
basis for the agency to conclude otherwise or would justify the
significant shift of resources that would be necessary for FDA to even
begin to address the retail sector in a meaningful way. FDA notes that
State and local governments provide significant regulation of the
retail food sector. FDA has committed the resources that it has
available for addressing retail problems, by providing training and
technical assistance to State and local governments. Most
significantly, FDA has provided guidance in the form of the Food Code,
which provides the latest and best scientifically based advice about
preventing foodborne illness for adoption by those jurisdictions that
have regulatory responsibility for food service, retail, and vending
operations.
It is worth noting that the Food Code suggests the use of HACCP
controls at retail in some circumstances where comments argued for such
controls as part of these regulations. Under the regulatory controls
suggested in the Food Code, a retail establishment that purchases a
scombroid toxin forming species of fish from a recreational harvester,
for example, would need a HACCP plan relating to how it will ensure
that fish had been handled so as to avoid time-temperature abuse. Under
[[Page 65114]]
the Food Code, fish caught recreationally generally require the
approval of a regulatory authority in order to be sold to a retail
establishment. The States should be aware that the Food Code is
responsive to concerns raised by comments in these respects. FDA urges
the States to consider adopting the Food Code for retail and
institutional operations.
It is worth noting that the Food Code applies HACCP requirements to
retail establishments as an exception for extreme situations, rather
than as the rule. There is still much to be learned about the
application of HACCP to retail establishments. Also, it may not be wise
to single out seafood for the application of HACCP at retail. Retail
operations can be complex and involve the handling of many types of
foods. Trying to operate a HACCP system solely for seafood could divert
attention away from important safety practices for high-risk products
other than seafood.
For all these reasons, therefore, the agency concludes that FDA
should not mandate HACCP systems for the seafood component of retail
establishments at this time. Also, the agency has not been provided
with any information on how an FDA inspection program for such
establishments would be feasible. Nonetheless, the agency will take all
comments on retail establishments under advisement for future
consideration as the system evolves.
It is important to note, however, that where a processor engages in
mixed operations (i.e., some retail and some wholesale), as in the case
of cash-and-carry warehouses noted by one of the comments, the
wholesale portion of the operations will be subject to the provisions
of these regulations. As a further point of clarification in response
to one comment, FDA has traditionally, and will continue to, classify
central kitchens that distribute product to retail outlets that are
owned by the same firm as a retail operation.
b. Warehouses. In the preamble to the proposed regulations FDA
stated that the definition of ``processor'' included warehouses.
Warehouses store fish and fishery products, one of the operations
included in the proposed definition of ``processing.'' A ``processor''
is simply an entity that engages in processing.
There are food safety hazards that can be introduced while storing
a product (e.g., in a warehouse). These hazards include, among other
things, pathogen growth in cooked, ready-to-eat products and histamine
development in scombroid toxin-forming species, as a result of improper
storage temperatures. Nonetheless, the warehouse environment usually
has few hazards compared to complex processing operations.
Consequently, the preamble to the proposed regulations invited comment
on whether warehouses should be exempted from the definition of
``processor'' and, by implication, whether ``storing'' should not be
included in the definition of ``processing,'' as one way of scaling the
regulations back in terms of cost and burden.
37. The comments split about evenly on this subject. Those that
gave a reason for including warehouses cited the need to monitor
storage temperatures for species that are prone to safety hazards if
they are temperature abused. Those that opposed and provided a reason
tended to argue that storage alone should not subject an establishment
to the requirements of the regulations. A related concern was the view
that warehouse operators do not have a thorough knowledge of the
products that they handle and only store products that are provided to
them by others. This concern was expressed both by those who objected
to the inclusion of warehouses and those who simply asked for
clarification about the role of warehouses. Others who asked for
clarification expressed the view that warehouses could be responsible
for conditions during storage.
After consideration of these comments, FDA has decided to retain
warehouses (e.g., public storage warehouses, foodservice distribution
warehouses, and wholesale grocers) within the definition of
``processor'' and to retain ``storing'' within the definition of
``processing.'' It is important to recognize that section 402(a)(4) of
the act covers storage along with other forms of processing. It states
that a product is adulterated if it is ``prepared, packed, or held
under unsanitary conditions * * * whereby it may have been rendered
injurious to health.'' These regulations are being issued for the
efficient enforcement of section 402(a)(4) of the act. Moreover, as
described above, hazards can be introduced as well as controlled during
storage. HACCP is an appropriate system for the control of these
hazards.
FDA believes that the burden on warehouses will be minimal given
the simplicity of the operation and the fact that, in most cases, a
warehouseman's responsibility under HACCP will only extend to
conditions within the warehouse that could cause a safety hazard to
occur.
For the most part, hazards deriving from the environment
(pesticides, etc.) will be controlled during the initial processing of
the product (i.e., by the first processor to take possession). As a
result, subsequent processors will receive products that are generally
free of environmental hazards and thus will not need to establish HACCP
controls for them. More often than not, storing will not be the first
processing operation. Thus, a warehouse will not usually be responsible
for environmental hazards. The same principle holds true for hazards
arising during processing operations that occur before storage in a
warehouse. Those hazards must be controlled during the prior processing
and generally not during storage.
There may be occasions, however, when storage is the first
processing operation (e.g., when a warehouse will be the first
processor to receive raw material fish from a fisherman or aquacultural
producer). Under these circumstances, the warehouse, rather than a
distant owner of the product, may be in the best position to obtain
information that may be needed about harvest site, fishing practices,
and transportation to the dock that would be germane to safety. There
should be some arrangement between the warehouse and the owner on this
matter to ensure that environmental hazards are properly addressed.
38. One comment objected to the inclusion of storage within the
definition of processing on the grounds that FDA should not dictate
where CCP's should be.
The agency is not attempting to do so. FDA acknowledges that
whether storage is a CCP will depend on the circumstances. For example,
refrigerated storage of a scombroid species will likely be designated
as a CCP, whereas dry storage of canned fish will not likely be
considered as such.
39. Another comment objected to including ``airline warehousing''
within these regulations.
If airlines hold product as part of their usual course of business
as carriers, they are exempt from having HACCP plans in accordance with
section 703 of the act.
c. Other processing operations. 40. A few comments requested
clarification on whether waterfront facilities that unload vessels and
pack the catch for shipment to buyers are engaging in processing and
thus meet the definition of ``processor.''
These firms perform activities such as handling and storing that
are included in the definition of processing and fall within the
purview of the ``prepared, packed, or held'' clause of section
402(a)(4) of the act. Additionally, these activities warrant coverage
under these regulations because of their relationship to reasonably
likely hazards. For example, these firms are, by design, usually the
first processors to receive
[[Page 65115]]
the product from the fisherman or aquacultural producer. As such, they
are often in the best position to control environmental hazards, as was
previously discussed. They also often store the product, at least for
short periods of time. In this capacity, they may be responsible for
ensuring that the product is not exposed to time- temperature abuse, a
phenomenon that critically affects the safety of some products.
For these reasons, FDA has clarified the definition of
``processing'' at proposed Sec. 123.3(m) (redesignated as
Sec. 123.3(k)) to specifically include dockside unloading.
41. One comment took the view that only processors who own the
products that they are processing should be subject to these
regulations and suggested that the term ``processor-owner'' be
substituted for ``processor.'' Several other comments questioned
whether custom processors that do not own the product, should be
subject to the provisions of these regulations.
The definition of ``processor'' does not hinge on ownership. As
indicated earlier, whether a product is adulterated under section
402(a)(4) of the act depends on the condition under which it was
``prepared, packed, or held.'' Ownership is not a relevant factor.
Consistent with this principle, these regulations define a processor as
simply an entity that engages in processing. ``Processing'' is defined
as including a number of activities, such as manufacturing and packing,
that are normally performed by a custom packer.
Like warehouses that store products for distant owners, custom
packers are often in the best position to exercise HACCP controls for
the products that they process. Because of the real-time nature of
HACCP (i.e., because monitoring provides immediate feedback as to
whether a hazard is being controlled), the processor can most
effectively apply HACCP monitoring controls to a food being processed,
regardless of whether the processor is the actual owner of the food.
FDA recognizes that it will often be beneficial for the custom
processor and the owner of the product to fully discuss and agree upon
the HACCP controls that will be effected by the custom processor while
the product is in its possession.
42. One comment argued that custom packers should be included
within the scope of these regulations because these processors often
can or smoke recreationally caught products and are often the only
commercial entity that can assure the safety of such products. While
the definition of ``processing'' clearly covers the kinds of activities
performed by custom packers, it is not the intent of these regulations
to address arrangements between a recreational fisherman and a custom
packer for the processing of fish for the personal use of the
fisherman. The regulations only cover custom packing that is performed
on behalf of an owner who intends to introduce the fish into interstate
commerce. Nonetheless, the agency does not believe that clarification
to the regulations is needed on this point.
43. One comment urged that aquacultural producers that also
eviscerate the fish before delivery to a processing plant be required
to comply with the requirements of these regulations.
FDA agrees with the comment and further states that the process of
eviscerating is specifically included in the definition of
``processing.'' Eviscerating is excluded from the definition only when
it occurs on a harvest vessel for the purpose of preparing the fish for
holding en route to the processor.
44. A few comments objected to FDA including labeling in the
definition of ``processing.'' The comments argued that labeling
operations are unlikely to introduce hazards to the product. FDA has
considered these comments but finds that there is potential during some
labeling operations for the development of hazards. For example,
improperly controlled labeling operations for scombroid species could
result in time-temperature abuse of the product, increasing the risk of
histamine contamination. Cooked, ready-to-eat products could similarly
be subjected to time-temperature abuse, resulting in the potential for
pathogen growth. The inclusion of labeling in the list of processing
operations is not intended to imply that this step should always, or
even frequently, be considered a CCP. That can only be determined
through the conduct of a hazard analysis.
FDA proposed to exempt ``heading or gutting intended solely to
prepare a fish for holding on board a harvest vessel'' from the
definition of ``processing.'' In drafting the proposed regulations, FDA
was concerned that, in the absence of such an exemption, harvest
vessels that are presently heading or gutting fish would stop the
practice to avoid being subject to the requirements of these
regulations. FDA did not want an inadvertent consequence of these
regulations to be a reduction in product quality. In addition, FDA
tentatively concluded that safety hazards introduced by these
operations are generally minimal.
45. One comment noted that FDA should include the practice of
freezing fish on harvest vessels in the list of exempted operations.
FDA agrees that freezing is an operation that is routinely used
onboard a harvest vessel in order to preserve the quality of the fish
until it is landed for further processing (e.g., freezing performed
onboard tuna harvesting vessels). For this reason, the agency has
revised the definition of ``processing'' to include an exemption for
onboard freezing.
46. One comment suggested that FDA also exempt onboard scallop
shucking operations.
Unlike shucking other molluscan shellfish, shucking scallops
involves eviscerating, a procedure that falls within the exemption in
Sec. 123.3(k). Consequently, onboard shucking of scallops does not
constitute processing for purposes of these regulations. The agency
does not believe that a change in the definition is necessary in this
regard.
47. One comment suggested that, with respect to molluscan
shellfish, ``processors'' should include shellfish shippers,
reshippers, shucker-packers, repackers, and depurators.
The persons that perform all of these types of operations are
``processors'' under Sec. 123.3(k)(1) and subject to the provisions of
these regulations. Thus, the agency has concluded that no change in the
definition is necessary.
16. Scombroid Toxin-Forming Species
The term ``scombroid toxin-forming species'' appears in
Sec. 123.6(c)(1)(vi) of this final rule. While FDA did not propose to
define this term in the codified portion of the proposed regulations,
it did propose to define it in part 123 appendix B as:
[T]una, bluefish, mahi mahi, mackerel, sardines, herring,
kahawai, anchovies, marlin, and other species, whether or not of the
family Scombridae, in which significant levels of histamine may be
produced in the fish flesh by decarboxylation of free histidine as a
result of exposure of the fish after capture to temperatures that
permit the growth of mesophilic bacteria.
Appendix B of part 123 is no longer included in these regulations, as
is discussed elsewhere in this preamble. Consequently, FDA is
transferring the definition from part 123 appendix B to Sec. 123.3(m)
to clarify the meaning of Sec. 123.6(c)(1)(vi).
48. A number of comments objected to the inclusion of herring in
the list of scombroid toxin-forming species, arguing that there has
been no association between herring and cases of histamine poisoning.
In response to the comments, FDA has modified the definition of
scombroid
[[Page 65116]]
toxin forming species to make specific reference to only tuna,
bluefish, and mahi mahi, since the overwhelming majority of scombroid
poisonings are associated with these types of fish. Processors should
assess the potential of other species to product histamine. The key to
the definition is whether significant levels of histamine may be
produced in the flesh of the fish.
17. Shellfish Control Authority
FDA proposed to define ``shellfish control authority'' as ``a
Federal or State health authority, or foreign government health
authority, legally responsible for the administration of a program that
includes classification of molluscan shellfish growing areas,
enforcement of harvesting controls, and certification of molluscan
shellfish processors.''
49. A few comments pointed out that the definition should not
require that a shellfish control authority be a State ``health''
authority because in some States the responsibility is vested in other
than a health agency, such as a resource management agency.
FDA recognizes that these comments are correct. For this reason,
the agency has modified the language in Sec. 123.3(o) to read, in part,
``State agency.'' FDA believes that this term is sufficiently broad to
encompass any of the present State arrangements. FDA has made a
parallel change with respect to foreign government authorities, in
order to accommodate the same kind of variations in regulatory
arrangements. These final regulations similarly refer to a ``foreign
agency.''
50. One comment, from a State regulatory agency, stated that within
the United States, FDA should be the responsible shellfish control
authority and should mandate that processors register with FDA, much as
it has done with low-acid canned foods and medical devices. The comment
further stated that a requirement in Federal regulations that State
agencies perform this function may be unconstitutional.
The comment misconstrued the provision. The provision is intended
to define the term ``shellfish control authority'' rather than to
provide substantive requirements. Furthermore, these regulations at no
point mandate that States perform certain functions.
51. Some comments expressed concern that the proposed definition of
``shellfish control authority'' was too narrow in that it did not
include any entities that could serve the function of a shellfish
control authority for Federal waters. The effect of the proposal, the
comments pointed out, would be to close unnecessarily all molluscan
shellfish harvesting in Federal waters.
It was never FDA's intent to close Federal waters to molluscan
shellfish harvesting. These waters are beyond the jurisdiction of State
shellfish control authorities, and no Federal agency classifies them in
the same way that States classify their own waters. FDA is seeking a
means to classify Federal waters. An agreement with NMFS relating to
the classification of Federal waters is one possible solution. For this
reason, FDA has modified proposed Sec. 123.3(o) to state that a
shellfish control authority may be ``a Federal agency.'' This subject
is also discussed in the ``Molluscan Shellfish'' section of this
preamble.
52. One comment urged that FDA provide for the possibility of
sovereign tribal governments serving as shellfish control authorities.
FDA recognizes that the proposed definition was deficient because
it failed to include tribal governments in the list of possible
shellfish control authorities. The agency, the State of Washington, and
19 Indian tribes have recently entered into a settlement that will
likely result in such an arrangement in the State of Washington (Ref.
202). When such governments meet the necessary criteria, it is the
intent of the agency to formally recognize them for purposes of
classifying shellfish growing waters and certifying shellfish
processing plants for inclusion on the Interstate Certified Shellfish
Shippers List. To provide for this situation, FDA has modified the
definition of ``shellfish control authority'' to include ``sovereign
tribal governments.''
FDA has also recognized that in many cases the functions of
``classification of molluscan shellfish growing areas, enforcement of
harvesting controls, and certification of molluscan shellfish,'' as
listed in the proposed regulations, are not carried out by a single
agency. To provide for such a situation, FDA has modified the proposed
language at Sec. 123.3(o) to read, ``program that includes activities
such as,'' rather than simply ``program that includes.''
18. Smoked and Smoke-Flavored Fishery Products
The terms such as ``smoked fishery products,'' ``smoked fish,''
``smoked and smoke-flavored fishery products'' were used in the
proposed regulations and throughout appendix 1 to the proposal. As a
result of decisions discussed elsewhere in this preamble, reference to
``smoked and smoke-flavored fishery products'' has been eliminated in
these regulations except in part 123, subpart B.
While no definition of ``smoked and smoke-flavored fishery
products'' was included in the definitions section of the proposed
regulations, the terms ``smoke-flavored fish'' and ``smoked fish'' were
separately defined in appendix 1 to the proposal as: ``Smoked-flavored
fish means fish that is prepared by treating it with salt (sodium
chloride) and then imparting to it the flavor of smoke by other than
the direct action of smoke, such as immersing it in a solution of
liquid smoke,'' and ``Smoked fish means fish that is prepared by
treating it with salt (sodium chloride) and then subjecting it to the
direct action of smoke from burning wood, sawdust, or similar
material.'' FDA solicited comment on the materials in appendix 1.
Because the term is used in these final regulations and FDA is
concerned that there may be confusion about its application, the agency
has determined that a definition of ``smoked and smoke-flavored fishery
products'' is needed in the codified portion of these regulations. FDA
has included one at Sec. 123.3(s) that is consistent with those
proposed in the appendix 1 to the proposal. Section Sec. 123.3(s)
reads:
Smoked or smoke-flavored fishery products means the finished
food prepared by: (1) Treating fish with salt (sodium chloride), and
(2) subjecting it to the direct action of smoke from burning wood,
sawdust, or similar material and/or imparting to it the flavor of
smoke by a means such as immersing it in a solution of wood smoke.
FDA received numerous comments on the regulatory treatment of smoked
and smoke-flavored fishery products, but none that would affect this
definition.
E. The HACCP Plan
Approximately 100 comments addressed one or more of the provisions
of proposed Sec. 123.6. This section of the proposed regulations set
out who must write and implement a HACCP plan, and what the HACCP plan
must include.
1. Preliminary Steps
FDA proposed in Sec. 123.6 to require that all processors of fish
and fishery products prepare and implement a HACCP plan that identifies
the hazards that are reasonably likely to occur and thus that must be
controlled for that product. In the proposal, FDA acknowledged the
process recommended by the NACMCF for developing a HACCP plan but did
not propose to require that processors follow it. The process
recommended by the NACMCF includes: Assembling a HACCP team, describing
the food and its distribution, identifying the intended use and
consumers of the food, developing a flow diagram, verifying the
[[Page 65117]]
flow diagram, and performing a hazard analysis (Ref. 34, pp. 187-188).
All but the last of these have been identified by NACMCF as the ``five
preliminary steps'' of HACCP.
It was, and still is, the agency's belief that processors would
benefit from a process that included these five steps as well as a
hazard analysis in order to successfully arrive at an appropriate HACCP
plan. Nonetheless, the agency did not propose to require adherence to
the ``five preliminary steps,'' or explicitly propose to require that a
hazard analysis be performed. So long as the processor had, in the end,
a HACCP system that was appropriate for species and process, and was
being implemented effectively, the agency tentatively concluded that
these regulations did not need to manage the process any further.
53. A number of the comments contended that FDA should require that
firms adhere to these procedures in preparing a HACCP plan.
Specifically, a few comments argued that the proposed rule
significantly diminished the potential effectiveness of HACCP by not
requiring that processors engage in the ``five preliminary steps.'' The
comments argued that inclusion of the preliminary steps would
facilitate international trade and reduce confusion on the part of
seafood importers and exporters through consistency with an
internationally recognized standard for HACCP.
Several other comments urged that the NACMCF recommendation for the
development of a process flow diagram, in particular, by a processor be
made mandatory. These comments identified several benefits from such a
requirement: To facilitate employee implementation of the plan, to
facilitate processor verification activities, to reduce the time needed
for regulators to review the manufacturing process, and to enable the
regulator to determine whether the processor properly considered the
entire manufacturing process. One comment stated that FDA's assumption
that flow diagrams are burdensome or unnecessary is contrary to the
1992 NACMCF Report which notes that flow diagrams could be simple
representations that accurately depict the steps in a process, rather
than detailed, technical drawings.
FDA acknowledges that, for the reasons stated in the comments, many
processors will find that the development of a flow diagram is a useful
preliminary step to the preparation of a HACCP plan. Other processors
may find, however, that, because of the simplicity of their operations,
the preparation of a written flow diagram is an unnecessary step. In
either case, FDA is convinced that a processor's decision to develop or
not to develop a flow diagram will be, and should be, driven by its
perception of the benefits of doing so. The comments received on this
subject were not sufficiently persuasive for the agency to conclude
that a flow diagram should be made mandatory. The comments provided no
basis to find that in the absence of a flow diagram, a processor could
not properly develop a HACCP plan, or that a plan, so developed, would
likely cause the HACCP program to fail.
As some of the comments pointed out, there may be some benefit to
the regulator to have access to a flow diagram during an inspection,
but this convenience is not a sufficient reason to mandate it. FDA
investigators will likely develop their own flow diagrams during their
in-plant inspections and compare them with the decisions reached by the
processor in the development of the HACCP plan (e.g., the
identification of hazards and CCP's). While it may be beneficial for
the investigator to be able to compare his or her flow diagram with
that of the processor, it is not essential to the conduct of the
inspection.
FDA agrees with the comments that stated that the other four
elements of the ``five preliminary steps'' are desirable attributes of
the HACCP development process. However, the agency has not been
persuaded that, in the absence of a regulatory requirement that they be
followed, the HACCP program is unlikely to succeed. In order to write
an appropriate plan some or all of these steps will likely have to be
performed, even without a regulatory requirement to do so. However, if
a processor can write a plan without these steps, the goals of the
regulations will still have been met. For FDA to require them to be
performed and documented in every case would add burden and reduce
flexibility unnecessarily. Moreover, FDA is unconvinced that any
inhibition to foreign trade is likely to occur if adherence to these
steps is not required. FDA believes that foreign trading partners will
be satisfied by the presence of a successful HACCP system and will not
reject U.S. exports because steps preliminary to HACCP were not
documented.
Even without a requirement mandating specific preliminary steps,
FDA believes that most processors will follow the spirit, if not the
exact letter, of the recommended procedures. These procedures provide
the processor with a recognized method of plan development that will
help lead to a successful outcome. FDA is primarily interested in that
outcome. The NACMCF recommendation for the assembly of a HACCP team, in
particular, could be a significant burden for the many small businesses
operating in the seafood industry. For these reasons, the final
regulations do not mandate any preliminary steps that processors must
perform as a prerequisite to conducting a hazard analysis or drafting a
HACCP plan.
2. Conducting a Hazard Analysis
54. A number of comments from trade associations and processors
objected to the requirement in the proposal that every processor have
and implement a written HACCP plan. These comments contended that FDA
should revise this provision to require that a processor first conduct
a hazard analysis to determine whether any food safety hazards exist
that can be controlled through HACCP and then prepare and implement a
HACCP plan only when the hazard analysis identifies at least one such
food safety hazard. One comment stated that conducting a hazard
analysis is the first step in a two-step process, with developing a
HACCP plan being the second step. The comments urged consistency with
the NACMCF recommendations in this regard.
FDA agrees with the approach suggested by the comments and believes
that it is essentially consistent with what the agency proposed.
Although FDA did not explicitly propose to require that every processor
conduct a hazard analysis, completion of such an analysis by every
processor was implicit in the requirement in proposed Sec. 123.6(b)(1)
and (b)(2) that processors identify both the hazards that are
reasonably likely to occur and the CCP's for each of these hazards.
In response to the comments, FDA has decided to clarify its
regulations to make the requirement that a hazard analysis be conducted
explicit rather than implicit in order to clarify the steps that are
required as part of a HACCP system. Moreover, this change allows the
agency to make clear that conducting the analysis may or may not lead
to the preparation of a HACCP plan.
Thus, FDA is providing in Sec. 123.6(a) that processors shall
conduct a hazard analysis or have one conducted on their behalf. It is
the agency's expectation that most seafood processors will, after
performing a hazard analysis, find it necessary to control for at least
one hazard and, therefore, be obligated to prepare a HACCP plan.
However, when no hazard is reasonably likely to occur, there is no
reason to prepare a HACCP plan. Therefore, Sec. 123.6(b) states, in
[[Page 65118]]
part, ``(b) The HACCP plan. Every processor shall have and implement a
written HACCP plan whenever a hazard analysis reveals one or more food
safety hazards that are reasonably likely to occur, as described in
paragraph (a) of this section.''
The agency does not believe that the methodology of conducting
hazard analyses is sufficiently standardized at this time to justify
mandating what the analysis must include. FDA encourages processors to
utilize the NACMCF document as guidance in performing this activity. In
addition, the agency recognizes that the best way for it to verify a
processor's hazard analysis is indirectly, through its own evaluations
of whether a processor ought to have a HACCP plan, and whether a HACCP
plan appropriately identifies the food safety hazards and CCP's that
are reasonably likely to occur. In other words, it is the end product
of the hazard analysis, the HACCP plan and its implementation, that
should be judged by the regulator. For this reason, the agency is not
requiring that hazard analyses be performed according to a standardized
regimen, or that they be documented in writing for FDA review.
Even though FDA is not requiring that the hazard analysis be
available to the agency, there may be cases in which it would be to the
processor's advantage to have a carefully documented written hazard
analysis to show to FDA. Such documentation may prove useful in
resolving differences between the processor and the agency about
whether a HACCP plan is needed and about the selection of hazards,
CCP's, and CL's. Written hazard analyses may also be useful to
processors in that they may help provide the rationale for the
establishment of critical limits and other plan components. Having the
basis for these decisions available may be helpful when processors
experience changes in personnel, especially those associated with the
HACCP process, and in responding to unanticipated CL deviations.
3. Types of Hazards
FDA received a number of comments on the types of hazards that a
mandatory HACCP system should control, and that the hazard analysis
should examine. The proposed regulations did not distinguish among
hazards but proposed to require that HACCP plans identify all food
safety hazards that are reasonably likely to occur. The comments that
addressed the question of what types of hazards mandatory HACCP should
address generally preferred that its focus be on some subset of
hazards, rather than on the entire spectrum that could cause seafood to
be adulterated. The comments argued that the hazards that were not the
focus of the HACCP regime established by the regulations could be
covered by more traditional food safety mechanisms. A review of these
comments follows.
55. Several comments, from processors and trade associations,
stated that the hazard analysis should only be used to identify those
food safety hazards that have the potential to cause ``serious adverse
health consequences.'' These comments stated that such consequences
included those that would trigger a ``Class I'' recall as defined by
FDA, particularly those that involve contamination of the food with
pathogenic microorganisms. A Class I recall involves a situation in
which there is a reasonable probability that the use of, or exposure
to, a violative product will cause serious adverse health consequences
or death and would not be used to respond to situations in which the
health consequences are temporary, medically reversible, or remote (21
CFR 7.3(m)(1) and (m)(2)). Other processor comments suggested the use
of the phrase ``significant food safety hazard'' to limit the scope of
the HACCP regime without proposing a definition for the phrase.
One comment stated that focusing on truly serious hazards is the
only way to keep the number of CCP's to a minimum, so that a HACCP plan
can realistically be implemented. The comment also stated that having
too many CCP's, or CCP's that are not related to serious health risks,
would so burden food processing personnel that effective compliance
with the HACCP plan would be undermined, and it would be significantly
more difficult to control truly critical processes.
Several of these comments argued that hazards should have
immediate, as well as serious, health consequences before being
required to be identified in a HACCP plan. These and several other
processor comments generally expressed the view that hazards that can
cause a food to be adulterated under the act, but that do not have the
potential to cause acute illness, should not be required to be included
in a HACCP plan. For example, two of the comments stated that FDA
should not use the HACCP regulations to ensure conformity with food
additive regulations, pesticide residue tolerances, or action levels
for environmental contaminants. One comment stated that although
process controls that are similar to HACCP controls are often used by
food manufacturers to monitor these kinds of contaminants, the controls
should not be regarded as part of HACCP because they do not address
acute health hazards. A few comments suggested that existing regulatory
programs are adequate to address these types of hazards.
On the other hand, comments from one trade association and a number
of individuals acknowledged that drug residues and pesticide residues
should be addressed by HACCP plans; where they are likely to occur at
levels over tolerance. Comments from a number of processors of
aquaculture-raised finfish acknowledged that drug and pesticide
residues are food safety hazards that affect their industry, but these
comments questioned the appropriateness of the control mechanisms
provided in FDA's draft Guide. Finally, comments from several consumer
advocacy groups expressed continued concern for the hazards posed by
environmental contaminants.
Having considered these comments, FDA confirms its tentative view,
reflected in the proposal, that HACCP should be the norm, rather than
the exception, for controlling safety related hazards in the seafood
industry. Existing standards for such contaminants as drug residues,
pesticides, and industrial contaminants, are established to ensure that
their presence in foods does not render the food unsafe. Processors of
fish and fishery products are obliged to produce foods that meet these
standards.
Processors are obliged to exercise control over all food safety
hazards that are reasonably likely to occur. A failure to do so would
mean that the food was prepared under insanitary conditions whereby it
may have been rendered injurious to health or is otherwise adulterated.
The criteria for including a food safety hazard in a processor's HACCP
plan should be the degree to which the hazard is likely to develop in
that product (e.g., based on the processing technique, the harvest
location, the species) and not the nature or immediacy of the illness
or injury that it is likely to cause.
FDA views as highly speculative the concerns, expressed by a few
comments from the food industry, that inclusion in HACCP of those
hazards that generally require chronic exposure to produce disease will
dilute HACCP systems to the point of shifting industry resources away
from acute toxicity hazards. No evidence was submitted to support such
claims. The pilot HACCP program conducted jointly by FDA and NMFS, the
current NMFS voluntary HACCP program, and the NMFS Model Seafood Safety
Program all included controls for food additives, primarily a nonacute
[[Page 65119]]
food safety hazard, and there has been no diminution of control of
acute hazards as a result. Moreover, the agency is convinced that when
determining, in accordance with Sec. 123.6(a), what contaminant hazards
are ``reasonably likely'' to occur in a particular type of product,
most processors will have very few, if any, of these chronic exposure-
type hazards to manage through HACCP as opposed to through some other
method of control.
FDA intends to monitor the progress of the seafood HACCP program to
judge, among other things, whether the application of HACCP to food
safety hazards generally, rather than to the most extreme acute
hazards, overloads the HACCP system and dilutes its effectiveness for
all hazards. Until such an effect is actually found to occur, FDA is
persuaded that the systematic application of preventive controls to
food safety hazards generally will provide the American consumers with
the most effective and efficient food safety system that has been
devised to date. If FDA were to determine that HACCP needs to be scaled
back in order to make it work, the agency will take appropriate steps
to make such a change.
One other factor bears mention in this regard. FDA has long been
aware of consumer concern about environmental contaminants in fish and
fishery products. As previously mentioned, this concern was expressed
in the comments to the proposed regulations. The chance that these
regulations will increase consumer confidence in the safety of seafood
products would be greatly diminished if these regulations did not
require processors to consider the risks from these contaminants as
part of their hazard analysis.
56. A comment from a trade association stated that, while there is
potential for an unapproved direct or indirect food or color additive
to be a health hazard, the use of an additive that has not been listed
for use in fish but is routinely used throughout the food industry
would not necessarily be likely to cause harm to human health. The
comment said that a control for use of the additive should not be
required to be included in a HACCP plan.
Under the act, certain products, such as food additives, new animal
drugs, including new animal drugs intended for use in aquaculture, and
pesticides, require premarket approval before they may be legally used.
Moreover, this approval can be limited so that the product may only be
used legally on or with specific foods, or for specific purposes, for
which approval has been obtained. This limitation reflects a
longstanding realization that the safety of these types of products is
variable and must be established on a use-by-use basis. Whether an
additive, drug, or pesticide is safe for a particular use, in a
particular food, at a particular level, depends on factors such as the
amount of the food that is consumed and, if the additive, drug, or
pesticide is ingested in a living animal before capture, how the
product is metabolized in that animal.
Therefore, a food additive that has been approved for use in some
foods, but not fish and fishery products, is deemed by the act to be
unsafe for use with fish and fishery products. FDA is not in a position
to change this aspect of the law through regulations. Consequently, the
agency has not created an exemption from the requirement for HACCP
controls for safety hazards caused by the presence of unapproved
additives or other products that lack premarket approval for fish or
fishery products.
The agency is aware that it is possible that some of these products
may pose no meaningful risk in fish and fishery products at levels
approved or allowed in other foods. It is the obligation of the
proponent of the use of the substance to follow applicable statutory
procedure to establish this fact to FDA's satisfaction.
57. In the preamble to the proposed regulation, FDA specifically
invited comment on whether, in order to reduce the burden of HACCP on
the industry, as in the Canadian fishery products HACCP regulation, the
agency should limit its HACCP approach to cover only those hazards that
are introduced within the confines of the processing plant. This type
of limitation would eliminate mandatory control of environmental
hazards such as pesticides, natural toxins, industrial contaminants,
and aquaculture drugs through the HACCP system.
One comment contended that a processor of fishery products would be
in a difficult position attempting to exercise control over problems
that occur during harvesting. The comment stated that the purpose of
HACCP is to require that each processor be responsible for minimizing
those serious hazards that it is in the best position to control, but
that the proposed regulations would force the processor to take
responsibility for hazards that it may be poorly suited to control. The
comment argued that FDA's intent was to deploy HACCP solely as a way of
reducing the agency's inspectional burden. The comment further stated
that the focus should be on finding those few CCP's within a specific
process where a serious hazard can best be controlled. Several other
comments expressed confusion about the application of HACCP to
environmental hazards.
The preamble to the proposed regulations described the link between
environmental hazards, such as natural toxins (e.g., ciguatera toxin,
domoic acid, and saxitoxin), histamine, and various viral and bacterial
pathogens, and human disease. The NAS' ``Seafood Safety'' report (Ref.
7, p. 1) suggested that the most significant reduction in illness from
seafood would come from the control of environmental hazards. To
eliminate coverage of such hazards from these regulations would be to
eliminate the greatest share of anticipated benefits.
The preamble to the proposed regulations provided a number of ways
in which the processor can exercise control over environmental hazards.
This control derives from the fact that responsible processors already
exercise discretion in obtaining their raw materials. Control is
achieved by checking tags on containers of molluscan shellfish to
ensure that they are harvested only from approved waters, checking with
fishermen to ensure that finfish do not originate from harvest areas
that are closed due to the presence of excessive agricultural or
industrial contaminants, and physically examining incoming histamine-
forming species for evidence of decomposition and insisting that
harvest vessels exercise control over the time and temperature of
storage for these species. Similarly, processors of aquaculture-raised
species can audit or otherwise insist on a producer controls over the
use of animal drugs or other hazards resulting from inappropriate
husbandry practices. In a HACCP system, these are examples of controls
that can be applied at the first CCP, i.e., at the receipt of raw
materials.
FDA concludes that the measures that a processor takes to ensure
that its raw materials are free of environmental hazards are a critical
part of a seafood HACCP program. Responsible processors already
exercise the kind of control necessary to ensure that their raw
materials do not present such a hazard. If a likely hazard exists, it
would not be sufficient to use the price offered for raw materials to
be the only measure to protect against the hazard.
For these reasons, FDA has retained environmental hazards in the
list of food safety hazards that processors should consider in
Sec. 123.6(c)(1). To clarify that there are hazards that occur before
receipt of raw materials that can be controlled nonetheless by
examination or discretion at the
[[Page 65120]]
receiving CCP, FDA has modified Sec. 123.6 by including the following
sentence in Sec. 123.6(a), ``Such food safety hazards can be introduced
both within and outside the processing plant environment, including
food safety hazards that can occur before, during, and after harvest.''
For consistency, Sec. 123.6(c)(2) needs a space here provides for
both types of CCP's, and now reads:
(2) List the critical control points for each of the identified
food safety hazards, including, as appropriate: (i) Critical control
points designed to control food safety hazards that could be
introduced in the processing plant environment, and (ii) Critical
control points designed to control food safety hazards introduced
outside the processing plant environment, including food safety
hazards that occur before, during, and after harvest.
Because most of the environmental hazards to which fish are exposed
will be controlled by the first processor to take possession of the
fish from the fisherman or aquacultural producer, whether that
processor is located in the United States or in another country,
subsequent processors need not focus on these hazards in their HACCP
plans. For example, pesticide contamination of inland and near shore
finfish can be effectively controlled by the first processor by
purchasing from fishermen who do not harvest in areas that have been
closed by regulatory authorities, and drug residue contamination can be
effectively controlled by the first processor by purchasing from
aquaculture producers who use animal drugs properly.
4. When Is a Hazard Reasonably Likely To Occur?
In the proposal, FDA identified nine categories of safety hazards
that might occur in fishery products. The agency tentatively concluded
that a processor must establish HACCP controls when one or more of the
listed hazards is reasonably likely to occur.
58. A number of comments, from processors and a trade association,
questioned whether certain of these nine hazard categories by
themselves justify a HACCP plan. The comments challenged the likelihood
that some of these hazards would cause harm and asked for clarification
on how a processor is to determine whether a hazard is ``reasonably
likely to occur.'' One comment held that, if the term ``reasonably
likely to occur'' is linked to actual incidents of illness caused by a
given hazard, it would be inappropriate to define some of the listed
hazard categories as reasonably likely to occur. This comment also
requested that FDA clarify whether the hazards identified in its draft
Guide are those that the agency believes are reasonably likely to occur
under all conditions for the listed species and processing methods. The
comment further noted that residues of industrial or agricultural
chemicals present in seafood are usually not present at levels that are
reasonably likely to be a safety hazard, even in many of those species
that are listed in the Guide as presenting that hazard.
As discussed in the preamble to the proposed regulations, FDA
recognizes that HACCP need not be used to control every theoretical
hazard, no matter how remote the likelihood of its occurrence.
Moreover, as discussed earlier in this preamble, case law interpreting
section 402(a)(4) of the act has held that conditions must be such as
to create a reasonable possibility that a hazard will occur in order
for product to be adulterated under that section of the law. (See
United States v. 1,200 Cans, Pasteurized Whole Eggs, Etc., 339 F. Supp.
140-141.)
Unquestionably, historical occurrence of reported illness is an
appropriate starting place for the identification of food safety
hazards that are reasonably likely to occur in the absence of controls.
For example, illness from scombrotoxin in those species that form the
toxin if subjected to time and temperature abuse after harvest is one
of the most frequently reported illnesses from seafood. Moreover, the
relationship between abuse after harvest and the formation of the toxin
is well established. FDA can say with comfort, therefore, that
scombrotoxin poisoning is a hazard that is reasonably likely to occur
in the absence of appropriate controls for scombrotoxin-forming species
of fish.
For some hazards, however, the incidence of reported illness is
very low. A good example is illness from the consumption of raw fish
species that are prone to parasites. The low number of reported
illnesses is probably attributable to underreporting and to the fact
that controls for this hazard (e.g., commercial blast freezing that
kills parasites) generally exist. However, it is well established that
in the absence of controls, infection from parasites is a hazard that
is reasonably likely to occur when a species that is prone to parasites
is consumed raw.
The incidence of reported illness that is linked to a specific food
is virtually nonexistent when the illness is the result of chronic
exposure to a chemical contaminant. It is extremely difficult, for
example, to link a specific case of cancer to a specific contaminant in
food. However, where public health officials have determined that a
contaminant represents a chronic health hazard, the standard control
strategy to be employed by processors for such contaminants is to
ensure that their presence in food remains below specific levels.
Processors are advised of such chronic health hazard determinations
through FDA action levels, publications (e.g., Federal Registers at 55
FR 14359, April 17, 1990; 58 FR 11609, February 26, 1993; and 58 FR
48368, September 15, 1993), or other similar guidance documents. If the
contaminant is present in food in an amount that is above that level,
the food represents a hazard to health that the evidence from the
chronic studies shows is reasonably likely to occur. The question,
then, is whether the likelihood of finding a fish in which the
contaminant is at a higher than acceptable level is an event that is
reasonably likely to occur. For open ocean species of fish, for
example, a finding of pesticide residues above nationally established
tolerances can be a very rare event. For near shore species in certain
locations, however, a finding above tolerance can occur often enough so
as to warrant controlling for it as a matter of reasonable prudence.
The incidence of reported illness for a particular hazard may also
be nonexistent or very low because the hazard may be too new to have
generated reported illnesses. The emergence of natural toxins harmful
to humans in species or in locales where the toxin has not been found
before is a well known phenomenon in seafood. While FDA does not expect
that HACCP controls should be in place to control for the possibility
of such hazards--the hazard may or may not ever occur--the agency
strongly believes that once a hazard does emerge and is identified,
HACCP controls are highly appropriate to keep illnesses from occurring.
For the duration of the a hazard, it must be treated as one that is
reasonably likely to occur.
To provide clarification on the above points, FDA has modified
Sec. 123.6 by including the following sentence in new Sec. 123.6(a):
A food safety hazard that is reasonably likely to occur is one
for which a prudent processor would establish controls because
experience, illness data, scientific reports, or other information,
provide a basis to conclude that there is a reasonable possibility
that it will occur in the particular type of fish or fishery product
being processed in the absence of those controls.
To reinforce that it was not FDA's intent to suggest that all of
the nine hazard categories that it listed in Sec. 123.6(c)(1) are
reasonably likely to
[[Page 65121]]
occur in all circumstances, the agency has modified the language in
this provision to read in part, ``Consideration should be given to
whether any food safety hazards are reasonably likely to occur as a
result of the following:'' (the list of nine categories follows in the
text).
The Guide is not intended as a definitive list of the hazards that
are reasonably likely to occur, under all conditions, for those species
and processing methods listed.
HACCP is a operation-specific process. For this reason, the
processor must decide on a case-by-case basis what hazards it needs to
address; that is, what hazards are reasonably likely to occur. The
purpose of the hazards portion of the Guide is to provide a listing of
hazards, by fish species and by finished product type, that FDA knows
to have a reasonable potential for occurrence in the product.
FDA encourages processors to use the Guide, as well as any other
available information, to decide what hazards need to be addressed in
any particular plan. Processors need to recognize that they need to use
judgment in applying the Guide to their own particular circumstances.
For example, a processor of one species of fish may find that pesticide
contamination is listed as a hazard for the species, but may be aware
of credible data that demonstrate that the water from which it obtains
its fish is free of such contamination. In that case, the processor is
free to deviate from the guidance. FDA intends to clarify the Guide on
this point by distinguishing between hazards that are reasonably likely
to occur all of the time (e.g., histamine in species that are prone to
it) and hazards that are reasonably likely to occur under certain
circumstances (e.g., certain toxins when a ``bloom'' is occurring).
5. The Plan: Specific Considerations
59. FDA proposed that HACCP plans be specific to each processing
location and to each kind of fish and fishery product processed by a
processor, except that the plan may group kinds of fish and fishery
products together if the hazards, CCP's, CL's, and procedures required
to be included in the plan are identical. A few comments from
processors and trade associations suggested that production methods
should also be allowed to be grouped together so long as the hazards
and the control procedures for the production methods are identical.
The comments suggested that grouping would reduce the paperwork burden
on some processors without altering the benefits attainable through
HACCP.
FDA agrees with the suggestion for the reason presented by the
comments and has modified Sec. 123.6(b) accordingly, to read, in part:
A HACCP plan shall be specific to: (1) Each location where fish
and fishery products are processed by that processor; and (2) Each
kind of fish and fishery product processed by the processor. The
plan may group kinds of fish and fishery products together, or group
kinds of production methods together, if the food safety hazards,
critical control points, critical limits, and procedures required to
be identified and performed in paragraph (c) of this section are
identical for all fish and fishery products so grouped or for all
production methods so grouped.
60. In the proposal, FDA specified that a HACCP plan must identify:
The applicable food safety hazards; the CCP's; the CL's; the control
and monitoring procedures; and the recordkeeping procedures. A few
comments suggested that FDA use the word ``list'' or ``include'' rather
than ``identify'' to describe a requirement for an item to appear in
the HACCP plan. The comments suggested that it is not clear from the
word ``identify'' whether the regulations are intended to require that
the plan contain or include the actual values (e.g., the temperature of
a refrigerator) or a description of the procedures, or whether it is
permissible simply to make reference to their existence in a guideline
or other source.
FDA's intent is that a HACCP plan explicitly include the value or a
description of the procedures for each of the required HACCP elements.
FDA agrees that a word such as ``list'' would be less ambiguous.
Therefore, FDA has revised Sec. 123.6 (c)(1), (c)(2), (c)(3), and
(c)(4) by substituting the word ``list'' where the word ``identify''
appeared in the proposed regulations.
FDA has also revised Sec. 123.6(c) by making another clarifying
change. The agency has added the phrase ``at a minimum'' to the
introductory statement to make clear that the required plan contents do
not restrict a processor from including additional information in the
plan, where it may be appropriate.
61. Two comments requested that FDA specify that decomposition,
listed as one of the hazard categories in the proposal, is a hazard
only in scombroid toxin-forming species.
These comments stated that decomposition in other species is not a
safety hazard but is an economic and aesthetic problem.
FDA agrees with the comments in part. FDA's intent was to require
control of decomposition in a HACCP plan only when it represents a food
safety hazard. As described in the preamble to the proposed
regulations, histamine (scombroid toxin) development as a result of
microbiological decomposition in certain species of fish is a well
recognized food safety hazard (Ref. 5, p. 24). There are some early
indications, however, that the development of putrescine and
cadaverine, also byproducts of decomposition of fish, under certain
circumstances, may also represent food safety hazards (Ref. 203, p.
240). For this reason, FDA is hesitant to limit the safety concern
associated with decomposition to the production of histamine.
Accordingly, FDA has modified Sec. 123.6(c)(1)(vi) to read,
``Decomposition in scombroid toxin- forming species or in any other
species where a food safety hazard has been associated with
decomposition.''
62. Comments from two State government agencies and a trade
association stated that FDA should eliminate parasites as a safety
hazard that must be considered for inclusion in a processor's HACCP
plan. The comments noted that, with respect to pathogens, FDA makes the
assumption that raw fish will be further processed by cooking, and
that, therefore, that the pathogens will be destroyed and not pose a
health hazard. The comments urged that the same rationale be applied to
raw fish that may contain parasites. The comments further suggested
that the retail level is appropriate point of control for parasites,
and that the provisions of the Food Code are adequate to address this
issue.
The comments further argued that parasites pose a hazard only in
certain species that are consumed raw, and that mandatory control
procedures for all fish that are consumed raw would create an enormous
economic hardship for some segments of the industry. In particular, one
of the comments contended that parasites have never been a problem in
the large tunas that are eaten raw, and that it should not be necessary
to freeze such fish before they are sold for raw consumption.
FDA's intent is to require control of parasites in a HACCP plan
only in those instances when parasites are reasonably likely to occur
in the portion of the flesh that is consumed, and the presence of the
parasites will present a food safety hazard (e.g., where the fish is
offered for raw consumption). To clarify this intent, FDA has modified
Sec. 123.6(c)(1)(vii) to read:
Parasites, where the processor has knowledge or has reason to
know that the parasite-containing fish or fishery product will be
consumed without a process sufficient to remove the hazard, or where
the processor represents, labels, or intends for the product to be
so consumed.
[[Page 65122]]
With regard to the comparison made by comments that FDA is
requiring control of parasites in raw fish but not pathogens in raw
fish, the characterization of FDA's policy towards pathogens is
inaccurate. The sanitation provisions of these regulations are
designed, in large part, to minimize the presence of pathogens in fish
and fishery products, whether they are raw or further processed. The
major opportunity for the introduction of enteric pathogens to
processed fish and fishery products is from the processing environment
as a result of insanitary practices rather than by the carcass of the
animal (Refs. 3, p. 267; and 7, p. 33). For this reason, sanitation
controls designed to prevent contamination of fish flesh are important
to minimize the levels of enteric pathogens found on processed fish
(Refs. 3, p. 10; 7, p. 27; 204; and 205). The agency is convinced that,
if followed, these controls will be effective in minimizing the
presence of such pathogens. Moreover, FDA has long enforced a zero
tolerance for the presence of Salmonella on raw fish, based, in part,
on the avoidability of such contamination through the application of
CGMP's.
63. One comment stated that the term ``physical hazards'' in the
proposal could be interpreted to include nonsafety related hazards.
In Sec. 123.6(c), physical hazards are one of nine listed causes of
``food safety hazards'' that processors should consider for listing in
their HACCP plans (Sec. 123.6(c)(1)(ix)). Thus, the agency believes
that the language of this section clearly applies to food safety
hazards only, and no modification of the provision is necessary in
response to this comment.
FDA proposed that HACCP plans include the CL's that must be met at
each CCP. FDA received no significant comment on this section
(Sec. 123.6(c)(3)) and has made no substantive changes to it.
FDA proposed to require that HACCP plans include the procedures for
both ``monitoring'' and ``controlling'' the CCP's. FDA recognizes that
monitoring and controlling serve different purposes, and that the
appropriate HACCP principle is the monitoring of CCP's to ensure
conformance with the CL (Ref. 34, p. 197). How a processor exercises
control is not critical to product safety so long as the CL is not
exceeded. There are many ways to maintain control. No one way or list
of ways needs to be stated in the plan so long as monitoring is taking
place at an appropriate frequency to ensure that control is occurring
and to detect CL deviations when they occur. For this reason, FDA has
modified Sec. 123.6(c)(4) to read, ``(4) List the procedures, and
frequency thereof, that will be used to monitor each of the critical
control points to ensure compliance with the critical limits.''
FDA has also eliminated the reference in Sec. 123.6(c)(4) to
consumer complaints as a monitoring tool. As explained in more detail
in the ``Consumer Complaints'' section of this preamble, FDA has
concluded in response to comments that consumer complaints generally do
not provide the processor with the kind of immediate feedback about
whether the process is under control that monitoring should provide in
a HACCP system. Consumer complaints may provide the processor with
information that would be useful for verification purposes, however.
These regulations therefore require processors to take consumer
complaints into account as verification tools (Sec. 123.8(a)(2)(ii).
Likewise, FDA has moved the reference in the proposed regulations
to the calibration of process monitoring instruments to the new
``Verification'' section of these regulations (Sec. 123.8), and it has
eliminated the specific reference to computer software validation. As
explained in more detail in the ``Verification'' section of this
preamble, FDA has concluded in response to comments that calibration is
a verification function that provides the processor with information
about whether its monitoring equipment is functioning properly.
Computer software validation is a form of calibration and need not be
addressed separately in these regulations.
64. In the preamble to the proposed regulations, FDA asked for
comment on whether guarantees from suppliers should be considered as an
acceptable way of meeting the proposed monitoring requirement. Comments
from a number of processors responded that a certificate from a
producer that a lot of raw material fish is free from unacceptable
levels of pesticide and drug residues should be an acceptable means of
monitoring the hazards of animal drug and pesticide residues in
aquaculture-raised fish. The comment held that reliance on suppliers'
certificates may be necessary because of the logistical problems that
could be associated with analyzing raw materials for pesticides and
drug residues. Of particular concern, the comments said, is the time
necessary to analyze the samples. The comments further stated that the
certificates should be based on participation in an industry-wide
quality assurance program designed to ensure that the raw materials are
free from these hazards.
FDA believes that caution is warranted on the subject of supplier
guarantees. Where more direct controls are available, they should be
used. In the case of aquaculture-raised fish, more definitive controls
than the acceptance of a certificate attesting to the absence of
unapproved drug residues alone are available to a processor, and these
controls are not unduly burdensome. They include the review of the
supplier's animal drug control records when the lot is offered for sale
and a system of onsite audits of the supplier, either by the processor
or by a third party. Such alternatives are also available for most raw
material hazards (e.g., checking container tags and harvester licenses
as a means of controlling microbiological contamination in molluscan
shellfish, and checking vessel storage records as a means of
controlling histamine development in scombroid species). However, the
agency recognizes that there may be some instances in which such
controls are not possible, and suppliers' certificates or guarantees
are the only available monitoring tool. In those cases, verification of
the effectiveness of the certificates may be critical. Thus, the extent
to which suppliers' guarantees can be relied upon will have to be
considered on a case-by-case basis. However, FDA has made no change in
Sec. 123.6(c)(4) in response to the comments.
FDA has added Sec. 123.6(c)(5) that describes requirements of the
HACCP plan with regard to corrective actions. As explained in more
detail in the ``Corrective Actions'' section of this preamble, FDA has
concluded in response to comments that these regulations should provide
the processor with the option of predetermining corrective actions.
Predetermined corrective action procedures have the potential to enable
a processor to take faster action when a deviation occurs than would be
possible in the absence of such procedures, and to make a more timely
response to the deviation when trained or otherwise qualified
individuals are not readily available.
FDA has also added Sec. 123.6(c)(6), which describes the
requirements of the HACCP plan with regard to verification. As
explained in more detail in the ``Verification'' section of this
preamble, FDA has concluded in response to comments that a processor
needs to specifically include in its HACCP plan the verification
procedures that it will use and the frequency with which it will use
those procedures. FDA finds
[[Page 65123]]
that inclusion of this information in the plan is necessary to
underscore that a processor has an ongoing obligation to be sure that
the verification steps that it has determined are necessary are readily
ascertainable by the processor and its employees as well as by
regulatory officials.
FDA proposed to require that HACCP plans provide for a
recordkeeping system that documents the monitoring of CCP's. The
proposed regulations also provided that the records must include the
actual values obtained during monitoring and any consumer complaints
that relate to the operation of CCP's or possible CL deviations. FDA
has removed the latter provision, relating to consumer complaints, from
Sec. 123.6(c)(7). As explained above, these final regulations treat
consumer complaints as verification tools rather than monitoring tools.
Consequently, consumer complaints need not be included in a
recordkeeping system that documents the monitoring of CCP's. A full
discussion of issues relating to consumer complaints is presented in
the ``Consumer Complaint'' section of this preamble.
6. Positive Versus Negative Recordkeeping
The preamble to the proposed regulations invited comment on whether
it was necessary for the results of monitoring (i.e., the actual
values) to be recorded regardless of whether a CL was met (positive
recordkeeping), or whether it was only necessary to record information
when a CL was not met (negative recordkeeping). The agency noted that
negative recordkeeping is presumably less expensive than positive
recordkeeping.
65. A substantial number of comments addressed this issue.
Approximately two-thirds of these comments, including those from trade
associations, processors, Federal, State, and foreign government
agencies, consumer advocacy groups, and a professional society,
supported requiring positive records. The remaining one-third of the
comments that addressed this issue, from trade associations,
processors, and Federal and State government agencies, argued that
records should only be required when a CL deviation occurs, or that
positive records should be required or encouraged, but that FDA should
be granted access to only the negative records.
In general, the comments supporting the need for positive records
recognized that monitoring records serve two major purposes: To
facilitate the identification of trends that would lead to a loss of
control if not caught in time and to document compliance with, or
deviations from, CL's. Comments from a large processor and a trade
association stated that, based on their extensive experience with
HACCP, positive monitoring records provide a pattern of results and
values that is much more meaningful than sporadic negative records
alone. Several comments stated that positive recordkeeping facilitates
the taking of corrective action before the CL's are exceeded.
Several comments stated that a provision that required only
negative records would penalize the firms that already maintain records
of all CCP observations. A few comments suggested that neither firm
management nor FDA could verify that the monitoring procedures
specified in a processor's HACCP plan are being carried out if only
records of deviations from CL's are kept, because there would be no
records to indicate that the other checks were actually being made. A
comment from a consumer group further argued that allowing the use of
negative records alone could create the opportunity for processors to
limit their monitoring, because no records would be needed to
demonstrate that such monitoring was performed.
Most comments that supported the use of negative records alone
stated that positive recordkeeping and the review of positive records
was overly burdensome for both the industry and the regulator. A few
comments stated that positive records generate massive databases that
disguise CL deviations, rather than illuminate them. No examples of
this phenomenon were provided, however. One comment suggested that
since FDA inspects most processors once a year or less, it is
questionable whether the agency would be in a position to pick up
trends in the data from a review of all the positive records that would
be retained. Another comment stated that it is just as unrealistic to
expect FDA investigators to review all positive records as it is for
FDA to inspect all fish. A few comments argued that the sheer volume of
the paperwork produced with positive recordkeeping would result in
technical or clerical errors by processors that could result in
products being deemed by FDA to be adulterated.
Several comments suggested that a system where CL deviations
trigger remedial actions, which are properly documented, should be
sufficient for FDA's verification purposes. One comment suggested that
because processors can falsify positive records as well as negative
records, FDA was mistaken if its motive for proposing to require
positive records over negative records was to help prevent unscrupulous
processors from circumventing the system. An additional comment
supported limiting mandatory HACCP recordkeeping to negative records
because FDA could not rule out the possibility that future court
decisions or changes in FDA policy might permit the disclosure of HACCP
records in FDA's possession, and negative recordkeeping would reduce a
company's potential exposure.
FDA's reasons for proposing positive records match those in the
comments that support these kinds of records. As the preamble to the
proposed regulations noted, recordkeeping is the key to HACCP, enabling
the processor and the regulator to see the operation through time.
Negative records alone do not allow this assessment over time and do
not provide assurance that the appropriate monitoring was even
performed.
FDA cannot conclude from the comments that supported negative
records that the burden of positive recordkeeping is excessive or
otherwise outweighs the benefits. The agency acknowledges that a
requirement for positive records may be more burdensome than one that
only requires negative records. However, FDA received no new data on
this issue. Positive recordkeeping can be extremely simple and need not
take much longer to perform than the monitoring necessary to determine
whether the process is in control (e.g., noting the temperature of a
refrigerator in a logbook located next to the refrigerator). The agency
is convinced that this minimal additional effort greatly increases the
chances that a processor's HACCP program will be successful.
Based largely on FDA's experience with the positive recordkeeping
requirements in the low-acid canned food and the acidified food
industries, FDA does not agree that the volume of positive records that
a system will generate will defeat the system by hiding CL deviations
or trends toward such deviations. FDA's regulations at parts 113 and
114 require that these industries perform positive recordkeeping at
identified CCP's. The industry itself requested this requirement.
FDA has found that these processors have no trouble making positive
records, and that both the processors themselves and the regulators
become adept at reviewing them and deriving benefits from them that
would not have been available from negative records. These benefits
have included being able to pinpoint with confidence when a
[[Page 65124]]
deviation began and ended, being able to react to trends toward a loss
of control, and being able to prove that CCP's were actually being
monitored as often as necessary to ensure control. The relative volume
of records has not served as a roadblock in this regard.
It is unlikely that FDA investigators will review all monitoring
records during routine inspections, except in highly unusual
circumstances. As has been the case with FDA inspections of low-acid
canned foods and acidified foods, the agency will, in most cases,
select records to represent the production since the last inspection.
This technique has proven to be both effective and efficient.
As for the concern that the agency will declare product adulterated
on the basis of technical or clerical errors in positive-type records,
the agency advises that it is not its intent to pursue regulatory
action against product solely because of clerical or related errors in
mandatory records. FDA does not take such actions against processors of
low-acid canned foods or acidified foods, and it will not do so against
seafood processors. FDA will consider the entire situation, and its
potential for impact on human health, in formulating a response to
deviations from these regulations.
As for the comment that FDA might as well mandate negative records
because positive records can be successfully falsified, FDA advises
that the possibility that records will be falsified--and that
falsifiers will get away with it--is an issue that involves the
fundamental credibility of the system. From FDA's standpoint, the
agency's decades-long experience reviewing positive records on low-acid
canned foods and acidified foods gives it confidence that its
investigators can detect falsifications. However, FDA did not propose
positive records for the purpose of catching falsifiers. FDA proposed
positive records because this approach confers benefits on both the
industry and the regulator that outweigh the additional work of
maintaining them. Aside from the view, to which FDA strongly adheres,
that most processors are honest and will not falsify records, the
agency strongly believes that most processors will quickly see the
benefits to themselves of a properly operating HACCP system based on
positive records and will insist that their records be accurately
completed.
One such benefit should be a more motivated workforce. HACCP
monitoring and recordkeeping can and should be done by the workers who
operate the system at the CCP's, not by quality control personnel. To
the extent that these workers experience a sense of responsibility and
pride associated with making accurate daily notations, the processor
can expect to benefit.
Regarding public disclosure of records as mentioned by one of the
comments, FDA continues to believe that possession of monitoring
records by the agency will be more the exception than the rule, and
that these kinds of records are protected from public disclosure in any
event. The protection of records is addressed in detail in the
``Records'' section of this preamble.
FDA has therefore not modified the requirement that processors'
monitoring records include the actual values obtained during the
monitoring.
7. Signing the Plan
66. In the preamble to the proposed regulations, FDA specifically
invited comment on whether HACCP plans should be required to be signed
by a representative of the firm and, if so, by whom. Approximately 30
comments responded to the inquiry. About two-thirds of these comments,
from processors, trade associations, professional associations, and
Federal, State, and foreign national governmental agencies, supported
the need for a signature. The remaining comments, mostly from
processors and trade associations, argued that a signature was
unnecessary.
Those that favored a requirement for a signature on HACCP plans
stated that the signature does the following: Demonstrates formal
adoption of the HACCP plan, solidifies responsibility for adherence to
the plan, and fosters a sense of management ownership. The comments
made the following suggestions with regard to who should be the
signatory (in order of preference): Onsite manager, most responsible
individual of the firm, any senior manager, HACCP coordinator, and all
HACCP team members. Those comments that argued against a mandatory
signature on the plan stated that the existence of a HACCP plan itself
constitutes management support for the plan.
FDA agrees with the comments that recommended a requirement for
HACCP plans to be signed by a representative of the firm. As suggested
by the comments, such a signature will provide direct evidence of
management's acceptance of the plan for implementation. FDA cannot
stress enough that for HACCP to succeed, there must be a clear
commitment to it from the top of the firm on down. Management must set
a strong example in this regard. A signature requirement will remind
management of this important responsibility and will signal to all
employees that the firm regards the HACCP plan as a document to be
taken seriously. Additionally, the representative's signature, along
with the date of signing, would serve to minimize potential confusion
over the authenticity of any differing versions or editions of the
document that might exist. FDA has concluded that the burden of such a
requirement would be minimal, and has added a new paragraph at
Sec. 123.6(d), that reads:
(d) Signing and dating the HACCP plan. (1) The HACCP plan shall
be signed and dated, either by the most responsible individual
onsite at the processing facility or by a higher level official of
the processor. This signature shall signify that the plan has been
accepted for implementation by the firm. (2) The HACCP plan shall be
dated and signed: (i) Upon initial acceptance; (ii) Upon any
modification; and (iii) upon verification of the plan * * *.''
As will be discussed fully in the ``Verification'' section of this
preamble, the adequacy of the HACCP plan must be reassessed, and
modified as needed, whenever significant changes in the firm's
operations occur, but no less than once per year. These reassessments
and modifications are necessary to ensure that the plan remains current
and is responsive to emerging problems. The signature of the firm
representative will be valuable in documenting that these reassessments
and modifications are performed as required. Particularly if no
modification of the plan is needed, reassessment can be verified by FDA
only if documentation, such as a signature, is maintained by the firm.
8. Relationship to Parts 113 and 114
67. A few comments urged that the final regulations provide that if
a processor of low-acid canned fishery products is in compliance with
FDA's regulations for these products under part 113, it would also be
in compliance with these HACCP regulations with respect to the control
of the hazard of C. botulinum toxin production. The regulations at part
113 establish HACCP-type controls for this hazard.
FDA agrees that there is no need for a processor to restate in its
HACCP plan the requirements of part 113 or 114. It is also not
necessary for such a processor to institute controls in addition to
those specified in parts 113 and 114 in order to control the hazard of
C. botulinum toxin production. Consequently, processors who must comply
with the requirements of part 113 or 114 need not address this hazard
at all in their HACCP plans. However, it is important to note that
other hazards may be reasonably likely to occur in an
[[Page 65125]]
acidified or low-acid canned fishery product. These hazards must be
addressed in the HACCP plan, as appropriate. For example, processors of
canned tuna will likely need to identify in their HACCP plans how they
will control the development of histamine before the canning process.
Accordingly, to clarify what is required of processors of acidified and
low-acid canned fishery products, FDA has added Sec. 123.6(e), which
reads:
For fish and fishery products that are subject to the
requirements of part 113 or 114 of this chapter, the HACCP plan need
not list the food safety hazard associated with the formation of
Clostridium botulinum toxin in the finished, hermetically sealed
container, nor list the controls to prevent that food safety hazard.
A HACCP plan for such fish and fishery products shall address any
other food safety hazards that are reasonably likely to occur.
9. Sanitation in the Plan
The question of the role of processing plant hygiene (i.e.,
traditional sanitation controls) in HACCP is addressed at length in the
``Sanitation'' section of this preamble. As explained in that section,
FDA is requiring that processors address plant sanitation by monitoring
for certain key sanitation conditions and practices apart from critical
control point monitoring activities, or by including sanitation
controls as part of the HACCP plan, or by adopting some combination of
these two approaches, at the option of the processor. To reflect this
approach, in paragraph (f) in Sec. 123.6 on the inclusion of sanitation
controls in the HACCP plan FDA has stated: ``(f) Sanitation controls
may be included in the HACCP plan. However, to the extent that they are
monitoring in accordance with Sec. 123.11(b), they need not be included
in the HACCP plan and vice versa.''
FDA recognizes that, in many processing operations (e.g., cooked,
ready-to-eat fishery products, smoked fishery products, and molluscan
shellfish) sanitation controls, such as hand and equipment washing and
sanitizing, are critical to the safety of the food because they serve
to minimize the risk of pathogen introduction into finished products
that may not be further cooked before consumption (Ref. 3, p. 267). For
this reason, some processors may elect to include the control of
sanitation conditions and practices in their HACCP plan in addition to,
or in place of, monitoring for such conditions and practices apart from
the HACCP plan. Based in part on experience gained from the seafood
HACCP pilot project operated jointly by FDA and DOC, however, FDA also
recognizes that sanitation controls may be difficult to fit in HACCP
plans, with appropriate CL's and corrective actions sometimes being
elusive. For this reason, some processors may elect to rely exclusively
on sanitation controls that are not part of the HACCP plan. FDA
considers either approach to be acceptable, so long as whatever
approach is chosen is fully implemented and followed.
10. Nonsafety Issues
68. FDA proposed in Sec. 123.6(c) to recommend, but not to require,
that HACCP plans include controls for such nonsafety hazards as
economic adulteration and decomposition that are not related to safety.
Additionally, FDA proposed to append to the regulations at Appendix D
guidance on how a processor can use a HACCP-based approach to ensure
that fish and fishery products are in compliance with the economic
adulteration and misbranding provisions of the act. Approximately 75
comments addressed these proposed provisions. The vast majority of
these comments urged that proposed Sec. 123.6(c) and proposed Appendix
D of part 123 be eliminated from the regulations. Some of these
comments suggested that it might be appropriate for the contents of
proposed Appendix D to be included in the Guide.
Those that argued for removal of the recommendation that HACCP be
used to control nonsafety hazards from the regulations stated that: (1)
HACCP for safety purposes will be a big enough challenge for both the
industry and regulators, and that inclusion of nonsafety hazards might
be overwhelming; (2) nonsafety hazards, such as economic fraud and
decomposition, are covered adequately by existing FDA regulations and
standards and by industry quality control programs; (3) inclusion of
nonsafety hazards deviates from the internationally recognized NACMCF
recommendations; and (4) inclusion of nonsafety hazards, even as a
recommendation, would dilute and jeopardize a desirable industry focus
on safety. One comment stated that processing plant personnel and
supervisors should be trained to expect serious consequences when CL
deviations occur because this heightens their attention to monitoring
and control. However, the comment further argued, the consequence of
violating a nonsafety CL is likely to be relatively minor. The comment
argued that, as a result, plant personnel and supervisors will become
confused about the significance of CL deviations.
A significant minority of the comments favored the treatment of
nonsafety hazards such as economic fraud and decomposition in the same
manner in which safety hazards are treated in these regulations, with
mandatory HACCP controls. These comments argued that: the same
conditions of processing that affect the occurrence of safety hazards
affect the occurrence of such nonsafety hazards as decomposition and
economic fraud, making the two control systems compatible; an
improvement in consumer confidence in seafood cannot be achieved
without improvements relative to economic deception and decomposition;
decomposition is the number one cause of FDA legal action with respect
to seafood; decomposition is a good indication of time and temperature
abuse, which has a significant impact on the growth of pathogens; the
seafood industry considers economic fraud to be the most significant
hazard affecting the marketing of its products; species substitution
can be safety related, as in the case of the substitution of a
scombroid species for a nonscombroid species; HACCP controls would
likely enhance compliance with existing nonsafety standards; and
inclusion of controls for economic fraud and decomposition would not
significantly increase the costs to industry.
FDA concludes that the HACCP system will have to mature, and much
will have to be learned, before it can be determined whether a
mandatory HACCP program should include nonsafety matters. Because these
regulations reflect a first step in terms of mandating HACCP, the
agency is comfortable as a matter of policy that they should initiate a
system that focuses on food safety. Additionally, the statutory
provisions that form the basis for these regulations are safety
provisions. FDA's application of HACCP is intended for the effective
enforcement of sections 402(a) (1) and (a)(4) of the act, which apply
to products that contain substances that may render the product
injurious to health and to processing conditions that are insanitary
and that could render a product injurious to health. Thus, the only
real issue is whether the final regulations should retain the
recommendations with regard to the application of HACCP to nonsafety
matters.
FDA is persuaded by the comments that the proposed recommendations
for HACCP controls of nonsafety matters, coupled with the presence of
proposed Appendix D of part 123, have the potential for causing
confusion about the agency's expectations and
[[Page 65126]]
enforcement policies. FDA recognizes the point raised by a number of
comments that advisory provisions are often confused with or misapplied
as requirements. Given this fact and the emerging nature of HACCP, FDA
has decided to eliminate proposed Sec. 123.6(c) and Appendix D of part
123. FDA will consider including the concepts that underlay these
provisions in the first edition of the Guide, however, because the
Guide is understood as being the repository for recommendations
relating to seafood HACCP.
The agency's decision to eliminate reference to nonsafety hazards
from these regulations notwithstanding, such hazards as economic
adulteration, decomposition not normally associated with human illness,
general unfitness for food, and misbranding constitute violations of
the act and are subject to regulatory action by FDA (see sections
402(a)(3) and 403 of the act (21 U.S.C. 343)). When inspections by FDA
investigators reveal violations of these provisions of the act, FDA
will take enforcement action as it deems appropriate. Processors who
are able to accommodate a HACCP system that covers both safety and
nonsafety hazards may find advantage in doing so, in order to better
ensure compliance with existing nonsafety regulations and standards.
11. ``Shall Render Adulterated''
FDA proposed to provide that: Failure of a processor or importer
to have and implement an HACCP plan that complies with this section
or to operate in accordance with the requirements of this part,
shall render the products of that processor or importer adulterated
under section 402(a)(4) of the act.
The preamble to the proposed regulations explained that the
proposed regulations set out those requirements that the agency had
tentatively concluded are the minimum necessary to ensure that the
processing of fish and fishery products will not result in product that
is injurious to health. FDA tentatively determined that such minimum
requirements include the establishment of HACCP preventive controls.
The preamble further explained that section 402(a)(4) of the act, among
other things, deems a food to be adulterated if it is prepared, packed,
or held under insanitary conditions whereby it may have been rendered
injurious to health.
69. A significant number of comments, primarily from processors and
trade associations, opposed the proposed language of this provision.
The comments urged that the word ``may'' replace the word ``shall'' in
order to establish that instances of noncompliance with the regulations
do not automatically constitute adulteration. They contended that,
because FDA will not be preapproving HACCP plans, a negative finding on
the first FDA inspection could, under the language that was proposed,
cause the agency to consider all product produced to that point to be
adulterated. The comments stated that each case of noncompliance should
be evaluated on its own merits.
FDA fully agrees that each case should be judged on its merits but
does not agree that it is necessary to change the regulations in order
to establish this principle. The purpose of Sec. 123.6(g), which sets
out this language, is not to create a legal presumption that food is
adulterated if there is not perfect adherence to these regulations but
to make clear that certain types of preventive controls are so
fundamental to ensuring the safety of seafood that if there is not
adherence to them, the food cannot be considered to have been produced
in accordance with section 402(a)(4) of the act.
As a practical matter, FDA expects to exercise broad regulatory
discretion in deciding when violations of these regulations warrant
regulatory action, just as it does now for other situations. The agency
will analyze each case on its merits, based at least in part on the
potential for harm that exists.
The agency's primary concern is that processors develop HACCP plans
that address the hazards that are reasonably likely to occur. When
deficiencies in HACCP plans are detected during FDA inspections, the
agency usually will first attempt to seek voluntary correction of the
situation. Only when such voluntary correction is not forthcoming is it
likely that FDA will elect to pursue regulatory action. It must be
noted, however, that, where HACCP plan deficiencies result in
significant potential for consumer harm, the agency will evaluate the
need for corrective action with respect to the product that has been
produced as well as to the HACCP plan itself.
In this regard, FDA notes that a change from ``shall'' to ``may''
in the provision would be more compatible with guidelines than with
regulations. Consequently, the agency has retained the term ``shall''
in Sec. 123.6(g). However, to clarify that a decision on whether to
take regulatory action will involve discretion based on the public
health significance of the violation, a sentence has been added to
indicate that when a violation occurs, FDA will evaluate the processors
overall implementation of its HACCP plan in deciding how best to remedy
the violation.
Consistent with the revisions to the requirements for imported
products contained in Sec. 123.12, the word ``importers'' has been
eliminated from Sec. 123.6. As described in the ``Imported Products''
section of this preamble, the proposed requirement that an importer
develop a HACCP plan (Sec. 123.11) has been eliminated in favor of a
requirement for importer verification procedures. This change
eliminated the relevance of Sec. 123.6 to importers.
Consistent with the revision to Sec. 123.6(a) and (b) that
processors have HACCP plans only when a hazard analysis reveals one or
more food safety hazards that are reasonably likely to occur,
Sec. 123.6(g) has been amended to state that a processor's failure to
have a HACCP plan shall render the fish or fishery products adulterated
only when a HACCP plan is necessary.
F. Corrective Actions
The fifth HACCP principle, as articulated by the NACMCF, is that
processors establish the corrective actions that they will take should
monitoring show that a CL has been exceeded. The NACMCF's expectation
is that these corrective actions should be predetermined and written
into the processor's HACCP plan.
In the proposed regulations, FDA tentatively chose to incorporate
the principle of corrective action without requiring predetermined
corrective action plans in the processor's HACCP plan. Instead, FDA
proposed minimum, generic corrective action procedures for processors
to follow. In so doing, FDA was trying to minimize the burden of the
mandatory requirements of HACCP, especially for small processors. FDA
tentatively concluded that the procedures set out in proposed
Sec. 123.7 represented the minimum requirements necessary to ensure
that processors respond effectively to deviations that could affect
safety, and that if those procedures were followed, specific corrective
action plans, although desirable, would not be necessary.
FDA proposed in Sec. 123.7 to require that deviations from CL's
trigger a series of actions, including: Segregating and holding the
product, making a determination of the acceptability of the product for
distribution, taking appropriate remedial action with respect to the
product and the cause of the deviation, and documenting the actions
taken. In the preamble to the proposed regulations, FDA invited comment
on the wisdom of this approach as opposed to requiring that
predetermined corrective action plans be made part of the HACCP plan. A
large number of comments responded to
[[Page 65127]]
that request. Additional comments addressed the specifics of the
proposed generic-type requirements in Sec. 123.7.
1. Should Corrective Actions Be Predetermined?
70. Approximately half of the comments supported the corrective
action system proposed by the agency or a variation of it, and the
other half called for mandatory predetermined corrective action plans.
Many of those that supported mandatory corrective action plans urged
consistency with the HACCP recommendations of the NACMCF. These
comments noted that the NACMCF recommendations are consistent with
Codex Alimentarius Commission standards. They predicted that
compatibility of the final regulations with such international
standards would minimize confusion for processors and importers, smooth
international adoption of HACCP principles, and facilitate trade. The
comments stressed that predetermining corrective action is an essential
component of a processor's HACCP program, with the seven principles
being so closely intertwined that overall success is probable only if
all are intact.
A number of comments argued that a processor's implementation of a
corrective action plan would eliminate indecision and confusion about
what corrective action should be taken in the event of a deviation from
a CL. For example, one comment pointed out that corrective actions
written into the HACCP plan would eliminate the need for employees to
substantiate to management the correctness of their response to a
deviation, because the corrective action plan would provide the right
actions to be taken for each particular deviation. A few comments
stated that, if the appropriate corrective actions are detailed in the
HACCP plan, responses by employees to CL failures are more likely to be
immediate (reducing product losses) and effective (reducing wasted
effort). These comments further noted that corrective action plans are
particularly necessary when individuals qualified to make product
safety evaluations are not readily available.
One comment asserted that the strength of the HACCP system is that
it is preventive, and that corrective action plans are fundamental in
preventing a product, for which there is a safety concern, from
reaching the consumer. The comment further stated that written
corrective action plans should provide for the documentation of the
following: (1) The cause of the deviation, (2) the action taken to
ensure that the deviation does not reoccur, (3) the results of the risk
evaluation, and (4) product disposition.
Many comments did not agree that corrective action plans should be
required. A few comments argued that developing a corrective action
plan is impractical and can be unduly restrictive because of the
diversity and complexity of seafood products and of seafood processing
operations. One comment noted that many situations exist in which the
appropriate response to a CL failure is not apparent until the details
of the particular situation are known. Several stated that a corrective
action plan is less preferable than having responsible and
knowledgeable personnel, adequately trained in HACCP, available to
evaluate a deviation from a CL. If such personnel are available, one
comment noted, deviations can be handled on a case-by-case basis, with
appropriate documentation of the disposition of the affected product.
Several comments argued that the lack of a corrective action plan
is not sufficient evidence to demonstrate that a product is
adulterated. The comments argued that the proposed requirement that a
processor establish CL's and perform and record appropriate corrective
actions when these limits are exceeded, provides sufficient
demonstration of hazard control.
A number of comments that advocated the concept of predetermined
corrective action plans urged that processors be given the option of
writing such plans or of following a series of minimum mandatory
actions, like those proposed by FDA, when CL failures occur. In the
preamble to the proposed regulations the agency did, in fact, encourage
processors to predetermine corrective actions as part of the
preparation of a HACCP plan.
On this issue, the merits of the various approaches tend to
balance. Consequently, FDA agrees with those comments that urged that
the regulations provide processors with the option of developing their
own corrective action plans as part of their HACCP plans or of
following a generic model corrective action plan, provided in the
regulations, should a deviation occur.
The agency accepts the view that predetermined plans have the
potential to provide processors with benefits, as pointed out by the
comments, such as faster action when a deviation occurs, less need to
justify to management the appropriateness of the corrective action
after it has been taken, and a more timely response to the deviation
when trained or otherwise qualified individuals are not readily
available to make determinations. On the other hand, FDA has not been
provided with information on which it can conclude that these
benefits--as desirable as they may be--need to be mandated in order to
protect the public health. Processors can build them into their HACCP
systems if they so choose, but the public health will be protected so
long as shipment of the affected product into commerce does not occur
until the significance of the deviation has been assessed and
appropriately resolved.
This outcome is assured both with specific predetermined corrective
action plans and with the minimum generic model that FDA is requiring
as an alternative. Without additional evidence from actual experience,
which was not provided by the comments, FDA cannot conclude that the
overall success of HACCP depends on whether processors have specific
predetermined plans for events that might not necessarily occur.
Consequently, FDA has revised Sec. 123.7 to permit, but not to
require, processors to include in their HACCP plans any written
corrective action plans that they develop. When a deviation from a CL
occurs, Sec. 123.7(a) requires that processors either: (1) Follow a
corrective action plan that is appropriate for the particular
deviation, or (2) follow the series of actions provided in
Sec. 123.7(c). The steps in Sec. 123.7(c) constitute a minimum generic
model for corrective actions and, as will be explained below, closely
match those that were contained in the proposed regulations.
The final regulations at Sec. 123.7(b) define an appropriate
corrective action plan as one that addresses both the safety of the
product that was being processed when the CL failure occurred and the
cause of the deviation. In this respect, the contents of the corrective
action plan are consistent with the views of the NACMCF (Ref. 34, pp.
199-200). The corrective action must ensure that any unsafe product is
not distributed.
FDA advises that action necessary to correct the product may
involve any one or more of the following steps: Immediately
reprocessing the product; diverting the product to another use where it
can be used safely; segregating the product, holding it, and having it
evaluated by a competent expert; or destroying the product. In order to
ensure that subsequent product is not subjected to the same deviation,
the corrective action must be sufficient to bring the process back
under control (Ref. 34, pp. 199-200). FDA advises that such action may
involve, where appropriate: adjustments to those process parameters
that have an effect
[[Page 65128]]
on the relevant CL (e.g., flow rate, temperature, source of raw
materials); temporarily diverting product around a point in the process
at which problems are being encountered; or temporarily stopping
production until the problem can be corrected.
Section 123.7(c) describes the steps that a processor must take
whenever there is a deviation from a CL but no corrective action plan
to follow. As stated above, these steps constitute a minimum generic-
type corrective action plan. The objectives of these steps are the same
as those of a preconceived plan: To ensure that adulterated product
does not enter commerce and to correct the cause of the deviation.
Because it is a generic-type plan that is intended to be applicable to
any situation, some of the steps, such as segregating and holding the
affected product (Sec. 123.7(c)(1)), might not be necessary if the
corrective action had been predetermined. This aspect of the generic-
type plan may provide processors with an incentive to predetermine
corrective actions whenever practical.
Another such incentive is the requirement, at Sec. 123.7(c)(5),
that the processor reassess the adequacy of its HACCP plan when a
deviation occurs. This requirement does not exist where a corrective
action plan exists. The reason for the distinction is that, on one
hand, if a processor has assessed its process and decided that CL
failures are likely to occur from time to time at particular points,
those failures, when they occur, do not represent a failure of the plan
but a foreseeable occurrence. On the other hand, if the processor has
not made such an assessment, and a failure occurs, it is not possible
to say what the failure means. The processor must assess whether the
deviation is the result of a system-wide problem that is not being
properly addressed by the plan or simply a failure that could be
expected to occur in the normal course of things. The failure must be
fully assessed, and if it represents a failure of the plan, the plan
must be modified to reduce the risk of reoccurrence.
The agency is convinced that the corrective action approach
contained in the final regulations (i.e., predetermined corrective
action plans at the option of the processor) adheres to the principles
of HACCP as recommended by NACMCF (Ref. 34, pp. 199-200) and will not
result in undue burden, confusion, or trade difficulties. At the same
time, these regulations will provide the flexibility needed to
accommodate the varying levels of HACCP sophistication within the
industry. FDA is satisfied that employee indecision in responding to CL
deviations will not result in a public health problem in the absence of
corrective action plans because the final regulations contain a set of
well defined actions that are to be followed if a deviation occurs and
no predetermined plan exists. The actions outlined in Sec. 123.7(d)
ensure that no unsafe product will enter commerce, and that a
normalization of processing conditions will be effected as quickly as
possible. While the agency sees merit in the argument that
predetermined corrective action plans will, in many cases, be
economically beneficial to a processor (e.g., minimize product loss and
wasted effort), such economic factors will, in and of themselves,
motivate processors to predetermine appropriate corrective actions, but
they do not mean that the agency needs to require the adoption of
predetermined plans.
71. A few comments recommended that FDA review corrective action
plans for adequacy during, or in advance of, the first regulatory
visit. This review, the comments asserted, would help to avoid a
situation in which the processor takes a corrective action in
conformance with its HACCP plan, but the agency later determines that
the action was inadequate.
FDA agrees that these comments reflect a desirable ideal but must
acknowledge that such a review ordinarily will not be feasible. If
processors complete their HACCP plans, including any corrective action
plans that they choose to develop, before the effective date of these
regulations, they may be able to obtain a review of those plans as part
of a routine FDA inspection.
In any event, the agency intends to review corrective action plans
that a processor includes as part of its HACCP plan during routine
regulatory inspections. Where the investigator finds a shortcoming in
the corrective action plan, the investigator will discuss it with the
processor. As with a failure to meet any other provision of these
regulations, in determining its response to such a shortcoming, the
agency will consider the totality of the situation and the likelihood
that the shortcoming will have an adverse impact on the safety of the
product. If a corrective action plan has not actually been used as of
the time of the investigator's review, and as a consequence of its
review the agency advises the processor that the corrective action plan
needs to be improved, it is likely that FDA will advise the processor
to follow the alternative procedure in these regulations until the
upgrade occurs.
2. Assessing the Product for Safety
72. FDA received comments on specific aspects of the generic-type
corrective action plan provided in proposed Sec. 123.7(a). A
significant number of comments opposed the provision that would have
required an ``immediate'' safety assessment when a CL deviation occurs.
One comment stated that, because an appropriately trained individual
may not be immediately available to make a determination of the
acceptability of the lot, the provision should be modified to require
segregation and holding of the affected product until either a timely
safety review by a properly trained individual has been completed, or a
determination has been made that the appropriate predetermined
corrective action plan has been followed. A number of other comments
also suggested that the phrase ``immediate review'' be revised to
``timely review.'' One comment recommended that FDA specify a maximum
amount of time in which to evaluate the product, for example within 24
hours. Another comment advised that FDA permit processors to cook or
freeze fresh product involved in a CL deviation, until an evaluation
can be completed.
FDA agrees that immediate review is not necessary. As long as the
review occurs before the product is distributed, the public health will
be sufficiently protected. Consequently, while Sec. 123.7(c)(2)
requires a review to determine the acceptability of the affected
product for distribution, it does not require that the review be
immediate, nor does it otherwise specify a timeframe for review. If
there is a chance that the product is still fit for commerce, FDA
expects that economic considerations will dictate the timing of the
review. FDA agrees that, in many cases, it would be advantageous for a
processor to cook or freeze a product pending results of a safety
evaluation. The agency has no objection to such an action as long as
the processor maintains the identity of, and its control over, the lot.
FDA has also modified Sec. 123.7(c)(2) from the proposal to require
that the review of the product be conducted by someone with adequate
training or experience, although FDA is not tying adequate training to
training in HACCP (see Sec. 123.10) as it did in the proposal. FDA made
this change because, as comments pointed out, a 3-day course in HACCP
would not necessarily qualify someone to make many public health
determinations of this nature. The basis for this modification is more
fully
[[Page 65129]]
described in the ``Training'' section of this preamble.
3. Documenting Corrective Actions
In Sec. 123.7(d), FDA is retaining the proposed requirement that
records of corrective actions be kept. As with the proposal, such
records are subject to the general recordkeeping requirements of
Sec. 123.9. The records must document the actions taken in following
either a predetermined corrective action plan or the corrective action
procedures specified in Sec. 123.7(c).
73. One comment suggested that the absence of written corrective
action plans would make it more difficult to document a response to a
deviation. It went on to explain that, with a plan, the processor could
simply note, for example, that ``the product was recooked in accordance
with `Section B of the Plan.''' It pointed out that more extensive
documentation would be necessary if a processor did not have a
predetermined plan.
FDA does not agree with this comment. Section Sec. 123.7(d)
requires that the corrective action taken by a processor be fully
documented. It is the agency's intent that such documentation provide
the specifics about the actions that were taken and not simply refer to
a written procedure. In the example given, records of the recooking
operation, equivalent to monitoring records for such an operation,
i.e., cooking, would be necessary to document that the operation was
performed in a manner that would render the product safe. Thus, similar
documentation would be necessary whether a plan exists or not.
It is worth noting that Sec. 123.7(d) now states that corrective
action records are subject to verification in accordance with
Sec. 123.8(a)(3)(ii). This requirement is not new but reflects the fact
that record review is deemed to be a verification activity in the final
regulations but was not classified as such in the proposal. A further
discussion of this matter can be found in the section of this preamble
that follows.
G. Verification
1. Overview
Verification is one of the seven commonly recognized principles of
HACCP. In the preamble to the proposed regulations, FDA acknowledged
and discussed the recommendations of the NACMCF as they relate to
verification. According to the NACMCF, verification essentially
involves: (1) Verifying that the CL's are adequate to control the
hazards; (2) ensuring that the HACCP plan is working properly, e.g.,
that it is being followed, and that appropriate decisions are being
made about corrective actions; and (3) ensuring that there is
documented, periodic revalidation of the plan to make sure that it is
still relevant to raw materials as well as to conditions and processes
in the plant.
2. Need for Verification Requirement in Regulations
In the preamble to the proposed regulations, FDA encouraged
processors to adopt verification practices but did not propose to
require that a processor's HACCP plan specify the verification
procedures. Rather, the agency tentatively concluded that verification
of a HACCP plan would effectively occur through: (1) Comparison of the
plan to guidance documents such as FDA's draft Guide; (2) technical
assistance provided through trade associations, universities, and
government agencies; (3) mandatory review of monitoring and corrective
action records by trained individuals before product distribution; (4)
mandatory reassessment of the adequacy of the HACCP plan as a
consequence of CL deviations; (5) reliance on the recommendations in
FDA guidelines that processors of cooked, ready-to-eat seafood products
use the expertise of ``processing authorities,'' i.e., third-party
experts; (6) mandatory training; and (7) investigator review of the
entire HACCP system during routine agency inspections. FDA requested
comment on whether this approach is adequate to ensure that the
verification principle was being properly addressed.
74. A large number of comments responded to this request.
Approximately one-third of these comments stated that FDA's proposed
approach to HACCP verification was adequate. The other comments argued
that verification should be specifically mandated as a part of a firm's
HACCP program.
A few of the comments favoring the proposed approach contended that
a HACCP plan lacking verification procedures should not be grounds for
FDA to consider a product to be adulterated. Several comments stated
that processors will engage in verification activities without a
requirement, as a natural outgrowth of a HACCP program, because without
such activities, HACCP will not work. For this reason, they argued, it
is not necessary to mandate that verification procedures be included in
processor's HACCP plans.
Of the comments that supported the need for specifically-mandated
verification activities, a significant number urged the agency to adopt
such a requirement to be consistent with the HACCP recommendations of
the NACMCF. These comments noted that the NACMCF recommendations are
consistent with Codex Alimentarius Commission standards. They predicted
that compatibility of the final regulations with such international
standards would minimize confusion for processors and importers, smooth
international adoption of HACCP principles, and facilitate trade. The
comments stressed that verification is an essential component of a
processor's HACCP program, and that the seven principles are so closely
intertwined that overall success is probable only if all are intact.
One of the comments stated that verification should involve a
continual review and improvement of the HACCP system. The comment added
that verification is a primary responsibility of processors, one that
is equivalent in importance to plan development. Several comments
stated that the benefits of HACCP verification include: Assurance that
all CCP's are identified, assurance that the plan is being followed, a
mechanism for third party oversight of the plan development process, a
means of measuring the success of a HACCP system, and information on
trends in the frequency and reasons for CL deviations. One comment
suggested that firms should be required to perform verification
activities at least annually.
A few comments stated that although the proposed regulations
included some required practices that could be deemed to be
verification, such as the calibration of process-monitoring instruments
and plan reassessment and modification in response to a CL failure, the
entire concept of verification should be addressed more fully in a
separate section of the final regulations. One of these comments
suggested that the following verification activities be specifically
mandated: Calibration of process control instruments, validation of
software for computer control systems, and daily review of monitoring
records.
One comment stated that, without a requirement for specific
verification activities, processors would rely strictly on end-product
testing to evaluate the success of the HACCP plan, and that such an
approach would diminish the effectiveness of the entire HACCP system.
Several comments stated that HACCP plan verification procedures
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should include detailed government and industry audits and product
analyses.
One comment, from a consumer advocacy organization, challenged
whether effective verification would really occur through the measures
cited in the preamble. The comment stated that ``third-party technical
assistance'' is not a mandatory part of the HACCP program and,
therefore, can not be counted on as a verification procedure. It added
that such technical assistance would tend to be performed during plan
development, and that verification must be an ongoing procedure. The
comment stated that a ``review of all HACCP-monitoring records by
trained individuals before distribution of product'' is not verifiable
by the agency because a firm can cut corners by having their employees
sign the records without reviewing them. The comment argued that FDA
auditing of consumer complaints and mandatory in-process and end-
product testing are important verification procedures.
A few comments suggested that FDA should include a requirement that
written verification procedures be in place, but that the agency need
not prescribe specific verification activities, or should do so only
sparingly.
FDA notes that the proposed regulations contained specific
provisions identified by many of the comments as appropriate
verification steps. For example, the proposed requirement that the
HACCP plan adequately address the food safety hazards that are
reasonably likely to occur (Sec. 123.6(c) in this final rule) is a
continuing, rather than a one-time requirement. Thus, to continually be
in compliance with it, a responsible processor would have to engage in
some form of reassessment. Other provisions in the proposal that
comments identified as verification steps included: The required
calibration of process monitoring instruments; the required validation
of computer software; the requirement that consumer complaints be
reviewed to assess whether they indicate a problem at a CCP; and the
requirement that HACCP-monitoring and corrective action records be
reviewed before distribution of the product. FDA now realizes, however,
that by not specifically requiring verification as such, the proposal
generated considerable confusion about whether FDA intended to include
or exclude the principle of verification from processors' HACCP
programs. FDA has concluded, therefore, that verification is important
enough to be an explicit part of the regulations. FDA has made it such
in the final rule at Sec. 123.6(c)(6) and in a new section for
verification, Sec. 123.8.
Section 123.6(c)(6) requires that processors include in their
HACCP plans a list of the verification procedures that they will use
and the frequency of those procedures. This provision is consistent
with the view of the NACMCF that a processor's verification procedures
should be addressed in the HACCP plan (Ref. 34, pp. 200-202). FDA does
not expect that this requirement will be particularly burdensome for
the processor for two reasons. First, the requirement that verification
procedures be listed in the HACCP plans is really only a variation of
the proposal in that FDA proposed to require a number of the activities
that it is now designating as verification activities in
Sec. 123.6(b)(4) (e.g., calibration of monitoring instruments and
review of consumer complaints). Second, a list of the steps that a
processor determines are appropriately a part of the annual
reassessment of the HACCP plan need not be extensive or detailed. FDA
recognizes that, at least initially, much of the annual verification
procedure could take the form of meetings and discussion, and may not
lend itself well to a detailed listing of steps. FDA believes that the
annual verification procedure should be allowed to evolve, and that a
requirement that the listing of steps in the plan be detailed before an
annual verification ever occurs could adversely affect that evolution.
The new section on verification, Sec. 123.8, describes the minimum
components of a processor verification program. Among other things, the
agency has consolidated there those aspects of the proposal that,
according to comments, should be designated as verification activities.
Section Sec. 123.8 contains little in the way of detail that was not
included in the proposed regulations. In addition, it is designed to be
generally consistent with the verification concepts expressed by the
NACMCF, as requested by comments, and at the same time, not unduly
burdensome.
3. Verifying the HACCP Plan
Section 123.8(a) requires that processors with HACCP plans verify
two aspects of their HACCP systems: (1) That their HACCP plans are
adequate to control food safety hazards that are reasonably likely to
occur, and (2) that their plans are being effectively implemented.
Verifying these two aspects is, essentially, what the NACMCF refers to
as the first and second of the four processes of verification (Ref. 34,
p. 201).
Second, Sec. 123.8(a)(1) requires that a reassessment of the HACCP
plan occur whenever there are any changes of the type listed in these
regulations that could alter the plan, or at least annually. The NACMCF
takes the view that verification must occur on a periodic, regular
basis (Ref. 34, p. 202), although no specific timeframes are suggested.
FDA agrees with the NACMCF and the comments that verification of the
adequacy of the HACCP plan should be conducted on a regular basis, even
in the absence of a recognized change, to ensure that the plan
continues to address all of the reasonably likely food safety hazards
with appropriate CL's and monitoring procedures. It is essential that
processors verify the adequacy of their plans and that this
verification occur on a periodic basis. Processors should conduct the
review at intervals that are appropriate for their processes. FDA
agrees with one of the comments, however, that this interval be no more
than a year in order to ensure that the plan remains adequate to
address the hazards associated with the species and processes (Ref.
206, p. 1084).
The regulations at Sec. 123.8(a)(1) provide examples of changes
that could trigger a reassessment. These include changes in raw
materials, product formulation, processing methods or systems, finished
product distribution systems, or the intended use or consumers of the
finished product. These examples are derived from the NACMCF materials
on the ``five preliminary steps'' that form the basis for the HACCP
plan (Ref. 34, pp. 188 and 201). A change in any of these areas could
necessitate a change in the plan in order to respond to any new hazards
that may have been introduced or to maintain preventive control over
existing ones. It is important to recognize that this list is not all
inclusive.
Section 123.8(a)(1) requires that the plan reassessment be
performed by an individual that has been trained in HACCP in accordance
with Sec. 123.10. This requirement is a logical outgrowth of the
proposed requirement in Sec. 123.9 that a HACCP-trained individual be
responsible for the initial development of, and subsequent
modifications to, the HACCP plan. These kinds of activities require an
understanding of the principles of HACCP and plan development as
obtained through training that is at least equivalent to the course
required in Sec. 123.10.
Section 123.8(a)(1) also requires that, where a reassessment
reveals that the HACCP plan is inadequate, the processor shall
immediately modify the
[[Page 65131]]
plan. Failure of a processor to immediately modify its HACCP plan after
it has determined that the plan is inadequate would result in the
processor operating under a plan that is not in conformance with these
regulations.
FDA recognizes that the methods that processors will use to verify
that the plan is still adequate will vary, based on individual
preferences and past experience. FDA agrees with comments that urged
the agency to permit maximum flexibility in the development of
verification procedures that are tailored to individual operations.
Nonetheless, the agency encourages processors to consider the guidance
in the March 20, 1992, NACMCF publication, ``Hazard Analysis and
Critical Control Point System.''
Moreover, FDA believes that the best way for the agency to judge
the merits of a processor's annual verification will be through its own
continuing determinations of whether the processor's overall HACCP
system remains appropriate for the circumstances. These determinations
will occur as a product of the agency's ongoing inspection program.
On this subject, FDA is sensitive to the comment that the absence
of verification procedures from a HACCP plan should not, in and of
itself, cause a food to be deemed adulterated under 402(a)(4) of the
act. Nonetheless, the absence of verification could jeopardize the
likelihood of success of the overall program. For example, monitoring a
critical cooking step with a thermometer that has not been calibrated
provides little assurance that the CL is actually being met, and
failure to review records may allow the absence of monitoring or
improper corrective action to go unnoticed for extended periods of
time. Should the agency find itself in the position of having to react
to the absence of adequate verification procedures in a processor's
HACCP plan, in deciding whether to bring regulatory action, the agency
will consider the totality of the situation, and the likelihood that it
would have an adverse impact on the final food, as it would in
considering a processor's failure to meet any specific provision.
4. Verifying the Implementation of the Plan
The regulations at Sec. 123.8(a)(2) and (a)(3) require ongoing
verification activities in addition to the annual reassessment. These
ongoing activities are in keeping with the NACMCF's view that
verification must also take the form of ``frequent reviews'' (Ref. 34,
p. 201). Frequent reviews relate primarily to whether the HACCP plan is
functioning effectively on a day-to-day basis. It is important to note
that, for the most part, the requirements in these sections were
proposed in other parts of the regulations and are now being compiled
in Sec. 123.8(a)(2) and (a)(3). Several comments on these provisions
pointed out that they were verification steps and should be referred to
as such. FDA agrees and has brought them together in this new
verification section of the final regulations. Section 123.8(a)(2)
requires that processors review consumer complaints (proposed at
Sec. 123.6(b)(4)), calibrate process monitoring instruments (proposed
at Sec. 123.6(b)(4)), and perform periodic end-product or in-process
testing, as appropriate, in accordance with written procedures for
these activities in the HACCP plan.
Section II H. of this preamble addresses the review of consumer
complaints at some length.
The provision on the calibration of monitoring instruments
(Sec. 123.8(a)(2)(ii)) is brought forward with no substantive change
from the proposal. Calibration is an important activity and involves
readily defined procedures that can easily be provided in the plan.
Calibration can include the validation of computer hardware and
software. FDA proposed to require that the HACCP plan detail the
methods of computer software validation to be used by the processor.
FDA received a small number of comments both for and against computer
software validation as a worthwhile part of verification. Two comments
supported the need for consumer software verification. But two comments
suggested that computer software verification would be an unnecessary
expense because it would result in only marginally improved
reliability.
The agency has worked extensively with the low-acid canned food
industry to verify computer hardware and software that the industry is
now using to operate or control various processing functions. That
experience has demonstrated to FDA both the desirability and the
feasibility of verifying computer hardware and software. For low-acid
canned foods, the industry is using computers to perform several
functions, including monitoring compliance with CL's, controlling the
processing operations, taking corrective actions, and recordkeeping
(Ref. 221).
In a HACCP system such as that being established for seafood by
these regulations, FDA is interested in ensuring that hardware and
software for computers that monitor compliance with a CL be verified.
However, when computers are used as process-monitoring instruments,
they must be calibrated in accordance with Sec. 123.8(a)(2)(ii). The
other functions that a computer can perform, as listed above, can be
verified through procedures required elsewhere in these regulations
(e.g., recordkeeping can be verified through the review of records by a
trained individual in accordance with Sec. 123.8(a)(3)). Consequently,
the agency has concluded that it is not necessary for these final
regulations to include a specific requirement for computer validation.
Instead, the agency acknowledges that the proper frequency of
equipment calibration is entirely dependent upon the type of instrument
and the conditions of its use. Therefore, FDA is not being prescriptive
in this regard. FDA has, however, provided guidance on the subject in
the draft Guide. Additional guidance should be obtainable from the
manufacturer of the instrument. The nature and frequency of the
calibration effort should be determined at the time of HACCP plan
development and should be included in the plan to ensure that it is
regularly and appropriately done. The agency is convinced that without
such formalization, calibration, which, for some instruments, may be
done as infrequently as once per year, may be overlooked.
5. Product Testing
75. Section 123(8)(a)(2)(iii), which lists the performing of end-
product or in-process testing, is a new provision. FDA requested
comment on what tests, including or in place of end-product testing,
should be used to measure the success of the HACCP program, both in
terms of individual firms and the national program as a whole, and how
frequently such tests should be administered (Ref. 208 at 4183). A
large number of respondents addressed FDA's request for comment.
Approximately half of these comments supported the need for an end-
product testing requirement. The other half objected to such a
requirement or suggested that the need should be determined on a case-
by-case basis.
A number of consumer advocacy organizations suggested that end
product testing is essential because no other verification mechanism
provides public confidence that HACCP programs are actually resulting
in a safer product. Several comments stated that regular
microbiological testing would help a processor determine whether there
are sources of contamination that are not being controlled.
[[Page 65132]]
A few comments suggested that such testing should be performed more
frequently during plan development and validation, and then reduced to
some lower level as part of a firm's verification efforts. Another
comment suggested that testing should be performed quarterly by those
processors with a poor record of compliance and annually by those with
a good record.
Several comments suggested that the need for and frequency of
product analysis should be established as part of the HACCP plan
development process. One of these comments noted that the frequency of
testing may fluctuate depending, in part, upon changes in personnel,
raw materials, equipment, and product formulation.
A number of comments stated that end-product testing is a
questionable method for measuring the success of a HACCP system. One of
these comments stated that end-product testing measures the
effectiveness of the plan for a small, finite portion of production and
has limited value in measuring the success of the HACCP plan overall.
One comment stressed that finished product testing is contrary to
the concept of HACCP, i.e., a reliance upon preventive controls at
critical points throughout the system. Another comment contended that
mandatory microbiological analysis of foods would be inappropriate
because: (1) Statistically valid sampling programs for pathogens are
not economically feasible because of the low incidence of pathogens in
most foods; (2) the use of indicator organisms to predict the presence
of pathogens is not always reliable and, where it is not, can become
merely a test for aesthetics; and (3) microbiological analysis of foods
is often costly, imprecise, and slow, and, therefore, not suitable for
real time data generation.
The agency acknowledges the shortcomings of product testing,
especially microbiological testing, used for process control as pointed
out by the comments. The NACMCF, in its comments in response to FDA's
questions about product testing, reiterated its view that, while
verification is essential to the success of HACCP, end-product testing
has limited value for measuring the success of a HACCP system. Comments
also noted that in-process or finished product testing should not
normally be a prerequisite for lot release under a HACCP program.
However, FDA recognizes that many processors will find that product
testing has a role to play in the verification of HACCP systems, and
the agency wishes to encourage incorporation of testing into HACCP
plans, where appropriate. Consequently, the regulations at
Sec. 123.8(a)(2)(iii) list end-product and in-process testing as a
verification activity at the option of the processor.
The agency provided guidance concerning appropriate attributes for
product testing in the draft Guide and intends to elaborate on it in
the first edition of the Guide.
6. Records Review
Section Sec. 123.8(a)(3) requires that a trained individual review
all records that document monitoring of CCP's, the taking of corrective
actions, the calibrating of any process control instruments, and the
performing of any end-product or in-process testing. The review of
HACCP records by a trained individual was included in the proposed
regulations at Sec. 123.8(b). In response to comments that urged
consistency with the recommendations of the NACMCF, FDA has designated
this review a verification function for purposes of the final
regulations and has included it in the section on verification.
Specifically, the proposed regulations provided that a HACCP-trained
individual review the monitoring records, sanitation control records,
and corrective action records before distribution of the product to
which the records relate. Under the proposal, the individual's review
would include records of process monitoring instrument calibration,
because the agency characterized these records as monitoring records.
The comments that FDA received on these provisions focused on the
proposed requirement that the review by the trained individual occur
before the product could be shipped. Several comments objected, stating
that such a review before shipment was unnecessary, because under the
corrective action provisions of the proposed regulation, any CL
deviation caught by the observer/operator would necessitate the
segregation and holding of the affected product before shipment until
the safety of the product could be assured. One comment further stated
that linking lot release to record review before shipment
underestimates the level of control attainable through the monitoring
and corrective action principles of HACCP.
Comments from several processors and trade associations stated
that, for some processors, it would be impractical to withhold the
shipment of every lot until HACCP records could be verified and signed.
These comments noted that, with the use of today's high speed
processing lines, it is normal practice for some processors to begin
shipping products before the end of the shift (lot). Several comments
also stated that holding a product until the HACCP records could be
reviewed could result in a product being subjected to unfavorable
conditions during storage, which could compromise both quality and
safety.
Several comments urged that processors be permitted to review the
HACCP records at the end of the day or at the end of the shift, even if
this review occurred after distribution. Others suggested that record
review should be performed within a ``reasonable time'' of production
of the record.
The agency remains convinced that the coupling of lot release with
verification-type record review provides a valuable added level of
safety assurance. This kind of record review before shipment is a
regulatory requirement for low-acid canned foods and acidified foods.
FDA's experience with these industries is that record review before
distribution has been instrumental in preventing the introduction of
potentially hazardous foods into commerce (Ref. 221). The agency
encourages processors to institute such a program whenever possible.
However, FDA accepts from the comments that the proposed
requirement would cause certain processors to delay shipping perishable
products and thus present an unacceptable burden to them. The agency
therefore is not requiring that record review occur before shipment.
Uncoupling record review from lot release leaves as the primary
purpose for record review the periodic verification that the HACCP plan
is appropriate and is being properly implemented. Record review needs
to occur with sufficient frequency so as to ensure that any problems in
the design and implementation of the HACCP plan are uncovered promptly
and to facilitate prompt modifications. The concept is roughly that of
a ``feedback loop,'' with information coming out of the record review
process in such a timely manner that it can have impact on the
production of subsequent lots of the product.
FDA is convinced that a weekly review of HACCP monitoring and
corrective action records would provide the industry with the necessary
flexibility to handle highly perishable commodities without
interruption, while still facilitating speedy feedback of information.
FDA is reluctant to allow the level of flexibility provided by such
language as ``reasonable time,'' out of concern for the confusion that
it
[[Page 65133]]
would generate. FDA's experience with low-acid canned foods and
acidified foods has demonstrated that review of these kinds of records
is a critical verification tool. FDA is, therefore, adopting the
proposed provision as Sec. 123.8(a)(3) with one revision. As set out in
the final rule, it requires that the HACCP-trained individual review
the monitoring records of CCP's and the records that document the
taking of corrective actions within 1 week of the making of the
records, rather than before shipment, as a part of a processor's
verification activities (Sec. 123.8(a)(3) (i) and (ii)).
FDA agrees, on the other hand, that this principle need not apply
to the review of records of such verification activities as process
control instrument calibration and product testing. The frequency of
these activities will be variable and dependent upon the HACCP plan
development process. Consequently, setting a specific review frequency
for these records is not warranted. Section 123.8(a)(3)(iii) reflects
this conclusion. It requires that the HACCP-trained individual review
the calibration records within a reasonable time after the records are
made, rather than before any additional products are shipped. It also
applies the same ``reasonable time'' standard to any end-product
testing records that are made.
The proposed regulations did not address the review of end-product
testing records by a trained individual. The requirement in these final
regulations for a review of such records reflects the principle
contained in the proposal that there be a verification-type review by a
trained individual of the HACCP records that are being created by the
processor. In this respect, the responsibilities of the trained
individual are unchanged from those that were contemplated in the
proposal, although details relating to those responsibilities have been
modified based on the comments.
Section Sec. 123.8(b) requires that processors take appropriate
corrective action whenever a review of a consumer complaint, or any
other verification procedure, reveals the need to do so. This provision
is essentially a restatement of the proposal regarding consumer
complaints, expanded to include the results of verification procedures
for purposes of emphasis. Verification was not specifically included in
the proposal. FDA is including a reference to it here to remind
processors not to preclude the possibility that information obtained
through verification could lead to the taking of a corrective action.
This possibility exists even though, more often than not, verification
will not provide the kind of immediate feedback that the processor will
receive from monitoring. Corrective actions based on information
received through verification will be exceptions to the rule. However,
processors should be mindful of the possibility.
7. Verifying the Hazard Analysis
Section 123.8(c) requires that, whenever a processor does not have
a HACCP plan because a hazard analysis has not revealed any food safety
hazards that are reasonably likely to occur and that can be controlled
through HACCP, the processor must reassess the hazard analysis whenever
a change occurs that could reasonably affect whether such a hazard
exists. FDA has included examples of such changes in Sec. 123.8(c). The
list is identical to that provided in Sec. 123.8(a)(1), for when a plan
must be reassessed. Consequently, any change in these factors should
warrant a reassessment to be certain that a plan is still not needed.
FDA has concluded that, under a mandatory HACCP system, the
principle of verification applies equally to a decision that a HACCP
plan is not necessary as it does to a decision that the plan continues
to be adequate. Circumstances change, and processors must be alert to
whether the exemption from the requirement to have a plan continues to
apply to them.
Section 123.8(d) requires that processors document calibration and
product testing in records that are subject to the recordkeeping
requirements of the regulations at Sec. 123.9. The requirement that
records be kept of process monitoring instrument calibration was
included in the proposed regulations at Sec. 123.6(b)(5). The
requirement that records of end-product testing be kept is consistent
with the general recordkeeping principles of HACCP. The one exception
is that FDA is not requiring records that document the review of
consumer complaints. The agency is satisfied that the requirement for a
processor to review consumer complaints relating to potential safety
concerns will be sufficient for this kind of verification activity.
Moreover, as explained in the discussion of consumer complaints
elsewhere in this preamble, FDA is persuaded that most consumer
complaints will involve matters unrelated to the mandatory HACCP
system.
H. Consumer Complaints
1. Background
In the proposed regulations, FDA tentatively concluded that each
processor's HACCP system had to utilize any consumer complaints that
the processor receives that allege a problem with product safety.
Several provisions described how consumer complaints were to be used.
In one, FDA proposed to require that a processor's monitoring efforts
include the use of consumer complaints, and that its HACCP plan reflect
how they will be used. In a second provision, FDA proposed to require
that, when a processor receives a consumer complaint that may be
related to the performance of a CCP or that may reflect a CL deviation,
the processor determine whether a corrective action is warranted, and,
if so, take one in accordance with the specified corrective action
procedures. FDA also proposed to require that the taking of such
corrective actions be fully documented in records. Finally, FDA
proposed to require that consumer complaints that relate to the
operation of a CCP or to a possible CL deviation be included as part of
the processor's HACCP records and be available for agency review and
copying.
FDA's rationale for proposing these requirements was that consumer
complaints may be the first alert that a processor has that problems
are occurring that are not being detected or prevented by the
processor's HACCP controls. While the goal of a HACCP system is to
prevent all likely hazards from occurring, no system is foolproof. The
agency tentatively concluded,therefore, that each HACCP system should
take advantage of consumer complaints as they relate to the operation
of CCP's. FDA also tentatively concluded that it might be necessary for
the agency to review those complaints in order to be able to verify
whether a processor is taking necessary steps to review its HACCP
controls and take corrective actions as necessary in response to
consumer complaints. The agency emphasized that it was referring solely
to complaints relating to the operation of the HACCP CCP's (i.e., those
that allege a problem with human food safety) and not to consumer
complaints generally.
2. Consumer Complaints as Verification Tools
76. FDA received a large number of comments on the advisability of
handling consumer complaints in the manner that the agency proposed.
Generally speaking, the comments
[[Page 65134]]
addressed two broad issues: Whether consumer complaints are relevant to
a HACCP system, and if they are relevant, how they should be used. The
question of whether FDA should have access to consumer complaints was a
significant concern that comments found germane to both issues.
Approximately one-fifth of the comments supported the proposed system
or a variant of the system (i.e., they believed that consumer
complaints are relevant to a HACCP system). Some of those who voiced
general support urged more comprehensive agency access to consumer
complaints, and others urged that some restriction on agency access be
put in place. The remaining approximately four-fifths of the comments,
principally from seafood and other food processors and trade
associations, argued that consumer complaints have no place in a HACCP
system.
Those comments that opposed the mandatory use of consumer
complaints in a HACCP system provided a variety of reasons. The
comments argued that consumer complaints are generally: (1) Unrelated
to the safety of the product; (2) not received in a timely manner that
would facilitate control of the process and are, in this way, akin to
finished product testing; (3) erroneous and sometimes exaggerated or
fraudulent; (4) vague; (5) subjective and nonscientific; (6) associated
with hazards that develop during transportation, storage, and retail
marketing, rather than processing, if they identify food safety hazards
of any kind; (7) not traceable to a specific processing plant or lot of
product; and (8) not readily associated with a specific CCP or CL
failure, even where it is likely that they are the result of a problem
during processing. These comments asserted that, therefore, consumer
complaints are not an appropriate monitoring tool.
A number of these comments suggested that, given the problems
listed above, sorting through the large volume of consumer complaints
that are received by most large firms to identify those few that might
be able to be linked to the performance of a specific CCP would be a
waste of both the processor's and the agency's time. These comments
stated that such a review of consumer complaints would divert their
efforts from more productive tasks.
Several comments raised additional questions about consumer
complaints as a HACCP verification tool. They suggested that there are
better, more effective means of verifying that the HACCP plan is
working properly. These suggestions are covered in the ``Verification''
section of this preamble. These comments further argued that consumer
complaints are not identified in the NACMCF recommendations as a useful
verification tool.
A relatively small, diverse group of comments, including those from
a seafood processor, a seafood trade association, a State regulatory
agency, an individual, and a professional organization, supported the
handling of consumer complaints as proposed. One of these comments
suggested that consumer complaints could be useful in FDA's efforts to
verify that processors' HACCP programs are effective.
Another group of comments, from consumer advocacy organizations and
a State regulatory agency, agreed that consumer complaints are an
appropriate part of HACCP. One of the comments noted that the consumer
performs the final quality control check, and that if a consumer finds
a problem egregious enough to take the time to write a letter, the
information contained in that letter should be considered in any
evaluation of the adequacy of the relevant HACCP plan. The comment
further argued that consumer complaints could bring to light
unidentified CCP's. This benefit, the comment contended, would not be
possible under the proposed regulations because the agency limited
consumer complaints in a HACCP system to those that may be related to a
CL deviation at an existing CCP. Finally, one of the comments noted
that the inclusion of consumer complaint access in the proposed
regulations is the one area in which the agency delivers on its ``water
to table'' commitment.
FDA is persuaded that consumer complaints generally will not make
an effective monitoring tool in a HACCP system, primarily because they
tend not to provide the kind of immediate, reliable feedback expected
of a HACCP-monitoring system. FDA agrees with the comments that
suggested that monitoring procedures under HACCP must provide the
processor with immediate feedback on whether the process is under
control and be scientifically sound.
FDA is not persuaded, however, that consumer complaints are
irrelevant to HACCP systems. The agency received no comments that were
able to demonstrate that outside sources of information should not,
where appropriate, supplement a processor's own monitoring as a way of
determining whether the process is in control. Moreover, a number of
comments stated that they go to some lengths to examine the consumer
complaints that they receive. The question, then, is whether consumer
complaints can serve some legitimate verification purpose in a HACCP
system.
While consumer complaints are not specifically addressed in the
NACMCF HACCP recommendations, the verification portion of that document
states, in part, that verification inspections should be conducted,
``When foods produced have been implicated as a vehicle of foodborne
disease.'' This statement is a recognition that information from
sources outside the processing plant can and should be considered in
the verification of a HACCP plan. In fact, it is FDA's experience that
consumer injury or illness complaints to the agency occasionally point
out problems traceable to defective controls at the food processing
facility (Ref. 207). Where information that has potential relevance to
food safety is available to a processor as a result of its own consumer
complaint system, it is entirely appropriate for the processor to
consider that information in assessing the adequacy of its HACCP
program. FDA accepts the possibility that many, if not most, consumer
complaints that a processor receives will not be germane to safety,
that many will turn out not to be valid, and that others will relate to
events at retail or that are otherwise beyond the ability of the
processor to control. Nonetheless, FDA strongly believes--and the
comments support this view--that a responsible processor will at least
review consumer complaints to determine their potential value and take
steps to correct the product or the process, when such stops are
warranted.
FDA has concluded, therefore, that processors should evaluate the
consumer complaints that they receive to determine whether the
complaints relate to the performance of CCP's, or reveal the existence
of unidentified CCP's, as part of their HACCP verification procedures.
The agency acknowledges that the absence of consumer complaints does
not, by itself, verify the adequacy of a HACCP system. However, after
taking into account all the concerns raised by the comments, the agency
is of the view that those consumer complaints that a processor does
receive, and that allege a safety problem, can be of value as a
verification tool and should serve that purpose. This conclusion is
reflected in the requirements of Sec. 123.8 of these final regulations
(see discussion in the ``Verification'' section of this preamble),
which lists the review of consumer complaints as an appropriate
verification activity (Sec. 123.8(a)(2)(i)).
As explained earlier in this preamble, because the agency regards
consumer
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complaints as a verification tool rather than a monitoring tool, FDA
has modified Sec. 123.6(c)(4) to eliminate the proposal requirement
that the HACCP plan describe how consumer complaints will be used in
the monitoring of CCP's. The agency has also modified Sec. 123.6(c)(7)
to eliminate the proposed requirement that consumer complaints be part
of a processor's HACCP-monitoring records.
FDA has concluded that when a review of a consumer complaint
reveals a need for the processor to take corrective action (e.g.,
recall, destruction, or reprocessing of the product or modification of
the process to reduce the risk of reoccurrence of the problem), such
action must be taken in conformance with the applicable corrective
action procedures of these regulations. This conclusion is reflected in
of Sec. 123.8(b) which states that processors shall immediately follow
the procedures in Sec. 123.7 whenever a review of a consumer complaint,
or any other verification procedure, reveals the need to take a
corrective action. The corrective action provisions are discussed in
the ``Corrective Actions'' section of this preamble.
As suggested by several of the comments, records of corrective
action relative to consumer complaints need not include the original
consumer complaint. However, it is unlikely that a comprehensive record
of the corrective action taken could be generated without at least the
critical information contained in the complaint, such as the nature of
the complaint and identification of the product in question.
Identification of the complainant is not likely to be critical.
3. Agency Access to Consumer Complaints
77. Many comments questioned whether FDA should have access to
consumer complaints. Several comments argued that no other food
industry is required to provide access to consumer complaints. A few
specifically cited the absence of such a requirement in the low-acid
canned foods regulations (part 113).
One comment noted that FDA has methods other than access to a
company's consumer complaint file to obtain information about product
defects that affect safety, including direct calls from consumers and
health professionals, MedWatch, and reporting to the Center for Disease
Control and Prevention (CDC). Another comment suggested that it would
be more efficient to devise a system whereby consumers are encouraged
to submit complaints about product safety directly to FDA rather than
to mandate access to corporate files.
Several comments suggested that consumer complaint files should
remain a private company matter, and that open access to these files is
likely to result in regulatory abuse. A few comments further argued
that, by mandating complaint file access, the agency would penalize
those firms with good consumer complaint gathering systems and possibly
deter others from developing such systems.
A relatively small, diverse group of comments, including seafood
processors, a seafood trade association, and a Federal government
agency, submitted that, while it is appropriate for FDA to mandate that
processors utilize consumer complaints in assessing the effectiveness
of their HACCP program, it is not necessary for the agency to have
direct access to the firms' complaint files. The comments suggested two
alternatives to providing direct access to complaint files: (1)
Allowing processors to prepare Notices of Unusual Occurrence and
Corrective Action (NUOCA) that described the action taken in response
to consumer complaints that relate to product safety; or (2) allowing
processors to prepare a matrix of complaints, as is currently used in
the voluntary, fee-for-service HACCP program being operated by NMFS.
Others in this group suggested that FDA have access only to written
complaints, or only to consumer complaints, as opposed to trade
complaints, which the comment argued are often submitted for commercial
advantage only. One comment noted that it would be impossible for
processing vessels to retain consumer complaints on board the vessel,
and that provision should be made for these to be stored at the
corporate office. Other comments urged that FDA access to consumer
complaints not include the right to copy them, or that, in some other
way, they be protected from public disclosure.
Another group of comments, composed of consumer advocacy
organizations and a State regulatory agency, urged that all consumer
complaints, regardless of their potential relationship to product
safety, be included in a processor's HACCP records and be available for
FDA review. These comments suggested that the FDA investigator should
make the determination of which complaints are relevant for follow up
rather than the firm. They further suggested that the investigator can
ignore any complaints that are not relevant to safety controls at the
processing facility.
Unquestionably, FDA has an essential role to play as a regulatory
verifier of HACCP. As described earlier, the agency received a number
of comments that raised concerns about the veracity of a mandatory
HACCP system in the absence of adequate regulatory review. Moreover,
FDA has concluded that this role cannot be carried out without the
ability to review HACCP plans and a narrow category of processor's
records (i.e., those that relate to how a processor is controlling the
critical safety aspects of its operations). The agency is not
interested in expanding this access beyond those records that are the
minimum necessary to carry out this responsibility.
With regard to consumer complaints, FDA is persuaded by the
comments that, especially when used as HACCP verification records
rather than HACCP-monitoring records as originally proposed, the public
health benefits that may accrue from agency access to these kinds of
records would probably be minimal and are outweighed by the concerns
that have been expressed.
FDA is satisfied that agency review of a processor's overall
verification scheme, plus access to records that document any
corrective actions that were taken as a result of information obtained
through consumer complaints, review of those complaints that consumers
regularly send to the agency, the ability to conduct unannounced
inspections, and access to monitoring records and plans, should be
enough for FDA to adequately verify processor's HACCP systems.
FDA also accepts that the burden on processors if they had to
segregate complaints that have a potential relationship to product
safety from those that relate to product quality, economic issues,
customer satisfaction, and other nonsafety issues, would be great and
is not warranted by any potential gain in product safety. Many firms
would have to take this step to make safety-related complaints
available to FDA. Similarly, the agency recognizes that a significant
burden would be placed upon its inspectional force if it had to verify
that a processor had properly categorized its complaints.
The alternative of FDA having access to all consumer complaints and
making its own determinations about which relate to safety, as some
comments suggested, is simply not practicable. In addition, it is not
the desire of FDA to penalize those firms that have large, expensive
complaint gathering systems, by mandating that they provide all
information so gathered for agency review, or to discourage others from
developing such systems.
[[Page 65136]]
In the preamble to the proposed regulations, FDA stated that more
than half of the seafood-related consumer complaints that it receives
relate to product quality, filth, and economic deception concerns.
Access to all consumer complaints is, therefore, unnecessary to ensure
product safety.
FDA has, therefore, removed from what is now Sec. 123.9(c) the
requirement that consumer complaints relating to safety be available to
the agency. The agency reiterates, however, that processors should
utilize all available information as they evaluate the adequacy of
their HACCP plans and their implementation. Consumer complaints are one
potential source of information, and a significant group of comments
recognized the value of consumer complaints in the verification
process.
I. Records
FDA proposed that records required by the regulations: (1) Contain
certain information, (2) be completed at the time of the activity, (3)
be signed by the operator or observer, (4) be reviewed for completeness
and compliance with the HACCP plan and signed and dated by the
reviewer, (5) be retained for specified periods of time, and (6) be
available for review and copying by FDA.
FDA received a large number of comments that addressed these
proposed recordkeeping requirements. These comments were from a diverse
group of commenters, including large and small processors, trade
associations, individuals, Federal, State, and foreign government
agencies, consumer advocacy groups, professional societies, and
academics. Several comments provided arguments that support the need in
a mandatory HACCP program for records in general, and none specifically
argued in opposition to that concept. Most of the comments addressed
specific issues that relate to recordkeeping.
Those comments that supported the need for records stated that
recordkeeping is a key component of HACCP. One processor's comment
noted that HACCP records must be kept in good order so that problems
can be easily tracked to their root cause. One comment stated that
HACCP records facilitate an evaluation of safety conditions over time,
rather than through a ``snap shot'' inspection. Another processor noted
that HACCP recordkeeping is not overly burdensome, and that the
proposed regulations would not require it to maintain any records in
addition to those that it already maintains.
1. Details and Signatures
78. FDA proposed that all HACCP-monitoring records (including
records of process-monitoring instrument calibration), sanitation
control records, and corrective action records identify the date of the
activity that the record reflects. One comment recommended that the
final regulations should also require that the time of each observation
be recorded, to make it easier to link records to specific lots of
product. A comment from a trade association requested that the records
be required to identify the establishment where the activity occurred
to reduce the potential for confusion in firms with multiple processing
facilities.
FDA agrees with both comments that the date and time on records
will help to connect information on the records to specific lots of
product, and that the name and location of the processor will help link
information to a specific processing facility.
The agency has, therefore, modified Sec. 123.9(a)(1) and (a)(2) to
state, in part, that the required records must include: ``(1) The name
and location of the processor or importer; (2) The date and time of the
activity that the record reflects.''
79. FDA proposed to require that HACCP-monitoring records
(including records of process-monitoring instrument calibration) and
sanitation control records be signed by the observer/operator. A few
comments supported the proposed requirement on the grounds that it
fosters accuracy and accountability in the recordkeeping process. One
comment opposed the proposed requirement, raising concern about the
legal liability that it imposed upon the workers that sign the records.
A few comments suggested that the observer/operator be allowed to
initial, instead of sign, the records.
FDA agrees with the comments that suggested that a signature on
monitoring and sanitation control records is necessary to ensure
accountability in the recordkeeping process. FDA also hopes that it
will enhance workers' sense of responsibility and pride in their
participation in the HACCP system of preventive controls. Regarding
worker liability, those that deliberately falsify records are liable
whether they sign the records or not. In any event, the falsification
of records cannot be condoned and should not be tolerated by
processors.
FDA further agrees that the purpose for the observer/ operator's
signature is achieved if the observer/operator either signs or initials
the monitoring records.
FDA proposed to require the signature of the observer/operator on
all records involving observations or measurements made during
processing or related activities. This specification of the kinds of
records in which signatures were required would have had the effect of
exempting consumer complaints, which were considered to be monitoring
records in the proposal from this requirement. However, the use of
consumer complaints as monitoring records has not been carried forward
to these final regulations. Consequently, limiting the records that
must be signed to involving observations or measurements is no longer
necessary, and FDA has deleted it for purposes of clarification (see
Sec. 123.9(a)).
FDA has also deleted the proposed provision that the observer/
operator need not sign corrective action records. The agency proposed
to require that only a trained individual sign these records. FDA is
requiring the signature or initials of the observer/operator on
corrective action records in order to be consistent with the corrective
action provisions of these regulations. In Sec. 123.7, for example,
processors may now predetermine their corrective actions in ways that
empower observer/operators to take corrective measures, especially in
the absence of a trained individual. The likelihood that a trained
individual might not be present at the moment when a corrective action
must be initiated is enhanced by the fact that such an individual need
not be an employee of the processor (see Sec. 123.10). Conversely, the
presence of a trained individual during the initiation of a corrective
action need not preclude the observer/operator from taking corrective
steps, as appropriate. Finally, the agency has concluded that the
burden imposed by requiring the signature or initials of the observer/
operator whenever that individual participates in the making of a
corrective action record is inconsequential.
80. Several comments questioned whether the proposed requirement
that monitoring records include the ``identity of the product, product
code * * *,'' meant that all fish and fishery products were required to
bear a product code.
It was not the intent of the agency to require product codes on
such products, only to require that they be listed on appropriate
records when they are used. The purpose of the proposed requirement was
to facilitate linkage between records and product. To clarify this
point, FDA has modified what is now Sec. 123.9(a)(4) to read, ``(4)
Where
[[Page 65137]]
appropriate, the identity of the product and the production code, if
any.''
81. Several comments suggested that FDA not specify the components
of required records. These comments argued that many processors have
existing forms that can appropriately be used as HACCP records.
It is not FDA's intent in Sec. 123.9(a) to specify record format or
content, beyond certain minimum, essential components. Processor's are
encouraged to use existing records, making modifications only as
necessary to meet the previously described requirements.
2. Retention and Storage
FDA proposed to require that processors retain monitoring
(including process monitoring instrument calibration), sanitation
control, and corrective action records for 1 year after the date that
they were prepared for refrigerated products and for 2 years for frozen
or preserved products. FDA also proposed that records used to
substantiate the adequacy of equipment or processes be retained for 2
years after the date that they apply to products being processed.
82. Several comments stated that these proposed retention times
were too long. Most of these comments suggested record retention times
of from 90 days to 1 year for refrigerated products and from 6 months
to 1 year for frozen products. One comment argued that 1 year is a
sufficient period for record retention unless the records relate to a
CL deviation, in which case they should be held for 3 years. Another
comment urged that the agency not mandate record retention times but
require processors to identify appropriate retention time requirements
in their HACCP plans.
FDA rejects those comments that requested a reduction in the
proposed mandatory record retention period. While it may be true that
most refrigerated products will be unusable within 90 days, as
suggested by one of the comments, retention times of less than 1 year
do not provide for sufficient access for the processor's or FDA's
verification activities. (See revised Sec. 123.8(a)(1) and the
accompanying preamble discussion of the minimum 1-year frequency of
plan reassessment.) No new, substantive comment was provided relative
to record retention times for frozen or preserved products that would
warrant a reduction for those products.
Thus, FDA has made no changes to Sec. 123.9(b).
83. FDA proposed that, in the case of processing facilities that
close between seasonal packs, records could be transferred to another
accessible location between seasonal packs, as long as they were
returned during the next active season. Comments from several
processors and trade associations urged the agency to modify the
requirement to: (a) Allow for permanent transfer from the facility and
(b) include both remote processing sites and processing vessels
regardless of whether they close seasonally. Comments from operators of
processing vessels and remote processing sites and from a trade
association requested that FDA allow HACCP records to be kept on the
processing vessel or remote site for a period of time and then be
transferred permanently to the processor's corporate, or closest
business office. The comments argued that the records in those
locations would be more easily stored, safer, and more readily
accessible to regulators than they would be at remote sites and on
processing vessels. Additionally, they argued that corporate
verification activities often would be performed at the land-based
facilities. Transfer of the records to these facilities would promote
verification in these circumstances. Comments opposing the requirement
that the records be returned to a seasonally closed facility once the
facilities reopened expressed concern that return of the records to the
reopened locations could result in lost records.
FDA has been persuaded to accommodate the difficulties associated
with record storage on processing vessels and remote processing sites
by allowing HACCP records to be moved from such facilities to another
reasonably accessible location at the end of the seasonal pack without
requiring that the records all be returned for the following season
(Sec. 123.9(b)(3)). Additionally, the agency will, as proposed, allow
HACCP records from any facility that is closed between seasonal packs
to be permanently transferred to another reasonably accessible
location. However, FDA points out that, in most instances, the agency
will need to examine processing records onsite in order to conduct an
effective verification inspection. For this reason, records must be so
stored that they can be promptly returned to the processing facility
upon demand by FDA. In order to maintain inspectional efficiency, the
time period between an FDA request for the records and their arrival
should not ordinarily exceed 24 hours.
84. Several comments urged FDA to provide for the use of computers
to maintain HACCP records.
It was not the intent of the agency to preclude such records. To
make this fact clear, FDA has added a new paragraph, Sec. 123.9(f), to
the final regulation, which reads, ``(f) Records maintained on
computers. The use of records maintained on computers is acceptable,
provided that appropriate controls are implemented to ensure the
integrity of the electronic data and signatures.''
In the Federal Register of August 31, 1994 (59 FR 45160), FDA
proposed separate regulations at 21 CFR 11 that, if adopted, will
become the standard for determining what constitutes appropriate
controls for electronic records, electronic signatures, and handwritten
signatures executed to electronic records. In the interim, processors
are encouraged to look to industry standards for guidance.
3. Confidentiality of Records
85. In the preamble to the proposed regulation, FDA stated that, as
a preliminary matter, HACCP plans and monitoring records appear to fall
within the bounds of trade secret or commercial confidential
information and would, therefore, be protected from public disclosure
by section 301(j) of the act (21 U.S.C. 331) and by the Freedom of
Information Act (FOIA) and the Department of Health and Human Services
(DHHS) and FDA regulations promulgated pursuant to these laws. FDA
specifically invited comment on the issue of public disclosure of HACCP
records and on whether FDA has any discretion about the releasability
of any HACCP records that it may eventually have in its possession. A
large number of comments responded to FDA's request for comment,
especially in the context of the provision in the regulations
(Sec. 123.9(c) in this final rule), that provides that all required
records and plans must be available for review and copying.
A large number of comments, from processors, trade associations,
professional associations, State and Federal agencies, and individuals,
contended that HACCP records and plans are trade secrets and should
under no circumstances be released to the public. Comments from several
consumer advocacy groups countered that in many cases HACCP records and
plans will not contain trade secret information or will contain only
limited trade secret information, and that the nonsecret parts (i.e.,
most of their contents) should, therefore, be available to the public.
Many of the comments that supported protection from public
disclosure urged that the final regulations contain controls over the
agency's access to, and
[[Page 65138]]
copying of, HACCP plans and records as the only guaranteed way to
ensure confidentiality. The comments argued that the potential harm
from exposure of HACCP plans and records to competitors or to the
public is considerable and carries the threat of increased costs,
misuse, and damage to the integrity of a firm and its products.
Several comments contended that HACCP records will be trade secret
because they will be process-specific and, therefore, will contain such
information as processing times and temperatures. They stated that
these processing parameters may differ from company to company based on
product formulas.
A few comments argued that there is no precedent for public access
to industry-generated records. Some of these comments stated that
processing records are regarded as trade secret under the LACF
regulations, and they noted that Sec. 108.35(d)(3)(ii) deems processing
information submitted to FDA to be trade secret within the meaning of
301(j) of the act and within the meaning of the FOIA. Other comments
asked that FDA protect HACCP plans and records in the same way that the
agency protects processing and quality control data that are submitted
to FDA under cooperative quality assurance agreements (i.e.,
manufacturing methods or processes, including quality control
procedures, are deemed not to be releasable unless the information that
they contain has already been released or is otherwise no longer trade
secret or confidential commercial per Secs. 20.111(d)(2) and 20.114 (21
CFR 20.111(d)(2) and 20.114)).
Several comments suggested that FDA specifically declare that: (1)
HACCP plans and records are trade secrets; (2) section 301(j) of the
act and the FOIA prohibit disclosure of trade secret or confidential
commercial information and give the agency no discretion whether to
release these types of records; and (3) Sec. 20.81 provides for
disclosure of trade secret or confidential commercial information only
if the information has been previously disclosed to the public.
One comment proposed that, if FDA felt obliged to release some
HACCP-related information pursuant to FOIA requests, reports of regular
inspections be released instead of HACCP plans and records, because
such reports are likely to contain less sensitive information. Another
comment suggested that, to avoid releasing proprietary information, the
agency should describe or explain information that is contained in
HACCP plans and records in general terms rather than release the
records themselves. The comment asserted that this step would serve to
inform consumers about the relative safety of the product and the
effectiveness of the HACCP system, while not divulging specific process
parameters that are trade secret or confidential commercial.
Conversely, comments from consumer advocacy groups argued that, for
the most part, HACCP plans and records are not trade secret or
confidential commercial. The comments asserted that much of the
information contained in these plans and records involves the
application of basic sanitary engineering and is already in the public
domain, as evidenced by the draft FDA Guide.
The consumer advocacy groups argued that, given the limited
resources that FDA can devote to monitoring HACCP compliance, public
access to HACCP records should be as broad as allowed under the law, so
that consumer confidence in, and understanding of, the seafood supply
can be fostered. One comment asserted that the public's right and need
to know about matters involving public health should be the basis from
which the agency formulates public access policy. Another comment
stated that consumers are the intended beneficiaries of the HACCP
seafood proposal and therefore should have the right to determine
through record inspection whether processors are properly implementing
the HACCP requirements. These comments urged FDA to routinely collect
HACCP plans and records from processors to facilitate agency
verification activities and public review of the effectiveness of the
HACCP system. One comment from a consumer advocacy group asserted that
Public Citizen Health Research Group v. FDA, 704 F.2d 1280 (D.C. Cir.
1983) narrowly defined trade secrets in such a way that HACCP plans and
the records at issue in this rulemaking could not be considered trade
secret.
Unquestionably, adoption of a mandatory HACCP system will place
significant documentation requirements on seafood processors. As a
result, they will produce records that reflect processing designs and
equipment and certain types of day-to-day operations. They will be
available to FDA. FDA strongly believes that it is in the public
interest to require that these records be maintained, and that the
agency have access to them. Such records and access are necessary to
effectuate a mandatory system of preventive controls for safety. As
stated in the preamble to the proposed regulations, FDA expects to take
possession of records on a case-by-case basis, and only when there is a
specific need to do so. The agency categorically rejects the view that
FDA should be a collection point for HACCP records and plans so that
they may be made publicly available. Nevertheless, the apprehension
expressed by many comments about the consequences of public disclosure
of these new types of records is certainly understandable.
FDA agrees with the views expressed by consumer advocacy
organizations that the public needs ways to be able to judge how and
whether it is benefiting from a HACCP system. Neither the agency nor
the industry can reasonably expect that the public will simply take the
government's word for it. It remains to be seen, however, whether
public access to information about processors that processors have
traditionally held as protected is the only way, or the best way, to
provide the public with information about this system.
FDA is considering how meaningful data can be extracted from the
inspectional process and prepared in such a manner that it could be
released without jeopardizing trade secret and confidential commercial
information and yet be useful to both FDA and the public in evaluating
this program. FDA is considering developing standardized reports that
would be completed by investigators at the conclusion of routine HACCP-
based inspections and become part of agency files. As presently
conceived, these reports would contain a summary of the status of the
HACCP program in effect at the firm, similar to the suggestion of two
of the comments.
Nonetheless, the question is whether, as FDA preliminarily
concluded, most plans and records to be generated under this program
will be subject to protection under existing law and FOIA regulations.
FDA's experience in seafood processing plants, its experience with
HACCP, and its understanding from the cost-benefit modeling that has
been done in the preparation of these regulations is that HACCP plans
will take each processor some time and money to develop. Thus, the
agency concludes that HACCP plans generally will meet the definition of
trade secret, including the court's definition in Public Citizen Health
Research Group v. FDA, supra. Plans that incorporate unique time-
temperature regimens to achieve product safety, or other parameters
that are processor-specific and that are the result of considerable
research and effort, will surely meet this definition.
Moreover, there is value in a plan to a company that produces it
for no other reason than that it took work to write. The equity in such
a product is not
[[Page 65139]]
readily given away to competitors. FDA knows from its own experience
that plant configurations tend to be unique to individual processors,
or at least have unique features (Ref. 222). While generic plans will
have great utility in many circumstances, they serve primarily as
starting points for processors to develop their own plans. FDA expects
that its Guide will help serve that purpose, but firms will still need
to expend time and money to tailor HACCP to their individual
circumstances.
Additionally, the agency has come to the conclusion, as a matter of
policy, that records and plans should be protected to the extent
possible in order to promote the implementation of HACCP across the
seafood industry. FDA has concluded that the public will benefit from
the protection of records because it will actually strengthen the HACCP
system. So long as the legitimate public need to be able to evaluate
the system can be met through other means, the confidentiality of HACCP
records and plans generally will foster the industry's acceptance of
HACCP. Even though HACCP may be mandatory under these regulations, in
order for it to succeed, processors must be committed to it because
they see value in it for themselves. Fear of public disclosure of
matters that have long been regarded as confidential business matters
could significantly undermine that commitment. FDA concludes,
therefore, that it is in the public interest to foster tailored HACCP
plans that demonstrate understanding and thought, rather than promote
the use of rote plans and minimally acceptable standards due to fear of
public disclosure.
FDA understands that it cannot make promises of confidentiality
that exceed the permissible boundaries established under FOIA, nor does
the agency wish to do so in this case. The agency still does not expect
that it will be in possession of a large volume of plans and records at
any given moment. However, given the significant interest in this
subject as conveyed by the comments, FDA has concluded that the final
regulations should reflect the fact that the HACCP plans and records
that do come into FDA's possession will generally meet the definition
of either trade secret or commercial confidential materials. A
statement to this effect in the final regulations will help to make
this fact as widely understood as possible and will clarify the
agency's position on this matter. This fact is codified at
Sec. 123.9(d)(1), which reads as follows:
(d) Public disclosure. (1) Subject to the limitations in
paragraph (d)(2) of this section, all plans and records required by
this part are not available for public disclosure unless they have
been previously disclosed to the public as defined in Sec. 20.81 of
this chapter, or they relate to a product or ingredient that has
been abandoned and they no longer represent a trade secret or
confidential commercial or financial information as defined in
Sec. 20.61 of this chapter.
The agency acknowledges that there could be exceptions to this
general rule. The nature of information in HACCP plans and records
varies. Some of it could be generally available processing methodology
or procedures, based on generic or model HACCP plans or guidelines
developed by the agency or some other public source, that is
sufficiently reflective of an industry standard that it has little if
any proprietary value. In such a case, in response to an FOIA request,
there may not be a valid reason for protecting this information. The
agency has concluded that there should be a provision that makes clear
that it will make information available in appropriate circumstances.
Consequently, the final regulations in Sec. 123.9(d)(2), state:
(2) However, these records and plans may be subject to
disclosure to the extent that they involve materials that are
otherwise publicly available, or that disclosure could not
reasonably be expected to cause a competitive hardship, such as
generic-type HACCP plans that reflect standard industry practices.
There is precedent for describing in regulations the records that
have protected status. The low-acid canned food regulations at
Sec. 108.35(l) provide that, except under certain limited situations,
filed scheduled processes submitted to FDA are not available for public
disclosure. Additionally, Sec. 108.35(d) provides that data submitted
to the agency to support these processes are to be treated as trade
secret. These materials are analogous to HACCP plans, and their
treatment is consistent with the agency's views relative to the
protected status of HACCP plans. The comments that suggested that the
low-acid canned foods regulations grant trade secret status to the
monitoring records that are required to be kept by part 113 are
incorrect. These records are not provided any special status in those
regulations.
4. Agency Access to Records
86. Several comments suggested that the final regulations should
require processors to provide access by FDA to HACCP records only after
the submission by the agency of a written request for specific records
it deems necessary to review. The comments noted that this approach
would be similar to Sec. 108.35(h) in the LACF regulations, because
processors are familiar and satisfied with such procedures.
FDA remains convinced that access to HACCP documents is essential
to the agency's verification of a firm's HACCP system. A key feature of
the HACCP verification process is access by government investigators to
the HACCP plan, to monitoring records kept according to the plan, and
to records of corrective actions that were taken in response to CL
deviations. Examination of HACCP records enables an investigator to see
how the processing facility or the importer operates over time rather
than how it is functioning at one particular moment in time.
Additionally, it will enable the regulator to review the adequacy of
the processor's or the importer's preventive control system itself.
FDA rejects the idea of being required to request in writing access
to HACCP plans and records. The agency is convinced that it has
sufficiently limited its access to those records and plans that are
minimally necessary to adequately evaluate the adequacy of a firm's
HACCP system. Section 123.9(c) has been modified slightly to clarify to
which records FDA is required to be granted access.
The comments are correct that the emergency permit regulations for
low-acid canned foods at Sec. 108.35 require that FDA issue a written
request for access to monitoring records. However, the written request
has proven to be merely a mechanical exercise. It has not in any way
served to affect the outcome of FDA access to records, nor is it
associated with any managerial control over the activities of FDA
investigators, with respect to the kind or numbers of records to which
they seek access. Moreover, the bottled water regulations at
Sec. 129.80(h), promulgated subsequent to the low-acid canned food
regulations, do not contain a requirement for the issuance of a written
request for records. FDA is not aware of any undue concerns expressed
by the bottled water industry relative to agency abuse of its records
access authority as a result of the lack of a written request
requirement in those regulations. FDA further notes that its
investigators are required to present a written notice of inspection to
management of the firm at the start of each inspection. The notice
explains the authority of the investigator to conduct an inspection of
the facility. The agency has concluded that there is no need to further
encumber the efficient enforcement of these regulations with a
[[Page 65140]]
written request for those records to which it is entitled to have
access. It has chosen to use the more recent regulations, bottled
water, as the model for these regulations with respect to records
access.
5. Agency Copying of Records
87. A large number of comments opposed the provision in the
proposal that provided for FDA copying of HACCP plans and records,
mostly because of concern about public disclosure. Several comments
stated that the agency should be permitted to obtain copies only to
support a regulatory action and only after FDA has obtained a subpoena.
Several other comments suggested that FDA be permitted to copy only
those records that relate to a CL failure.
Several comments requested that FDA provide safeguards to control
potentially abusive regulatory practices by establishing rules to be
followed when copying records. The comments stated that the rules
should accomplish the following: Identify investigators authorized to
copy records, limit copying to records pertaining directly to CCP's,
require prior written authorization for copying from the investigator's
supervisor, require that the authorization identify the specific
records to be copied and the reason that they are needed, require that
a responsible company executive receive each request before any copying
is permitted, and permit the company to question the purpose for the
request before records are copied.
Comments from several consumer advocacy groups, on the other hand,
supported the agency's need to copy records.
There are two primary reasons for the agency to copy HACCP plans
and records: (1) To facilitate expert review of such issues as the
identification of appropriate hazards and CL's in HACCP plans and the
evaluation of the adequacy of corrective actions taken in response to
CL failures; and (2) to document suspected inadequacies of the HACCP
plan or the firm's implementation of the plan for possible regulatory
followup.
Limiting the copying of records to those situations in which
regulatory action is contemplated or in which a subpoena could be
obtained would serve neither the needs of the industry nor the agency.
Resolution of differences in food safety control strategies through
scientific review and dialog, where possible, is superior to reliance
solely upon the legal system for such resolution. Similarly, limiting
the copying of records to instances involving CL deviations would
inappropriately restrict the agency's ability to evaluate potential
problems in the identification of CCP's, the establishment of CL's, and
other scientific issues, which, in some cases, may be beyond the
expertise of agency investigators.
Industry comments have expressed considerable concern, as discussed
in the ``Compliance'' section of this preamble, that there will be no
mechanism for dialog with the agency if a firm disagrees with an
investigator's findings with regard to the sufficiency of HACCP plans
and records. The agency is strongly committed to dialog whenever
possible. Provision of a means by which senior reviewers at agency
headquarters will have access to HACCP plans and records will
facilitate that process.
FDA has concluded that the restrictions on copying of records
suggested by the comments would significantly interfere with that
access. It would be highly inefficient for FDA to identify a special
class of investigators that are permitted to copy HACCP records and
plans. FDA investigators are responsible for conducting inspections and
investigations to enforce a wide array of regulations, and FDA field
managers need the flexibility to assign work in an efficient and
effective manner. Copying, like record access, is limited to the
records specified in Sec. 123.9(c). It would be highly impractical for
supervisory preapproval to be accorded to an investigator for the
copying of specific records. Until an investigator has evaluated a
HACCP plan and validated the operations of the plant, it is not likely
that the investigator will know with any certainty what HACCP records
are appropriate for review. Additionally, inspections are often done in
remote locations and under highly flexible itineraries that preclude
close contact between the investigator and particular supervisor.
Certainly, FDA investigators will make every effort to obtain HACCP
plans and records from responsible individuals of the firm and will, if
necessary, explain the relevance of the requested records to the
recordkeeping requirements of these regulations.
The agency is unconvinced of the need to modify Sec. 123.9(c) in
response to the aforementioned comments, except that reference to
consumer complaints in this section has been eliminated as discussed in
the ``Consumer Complaints'' section of this preamble.
88. Several comments questioned the phrase ``duly authorized
officers and employees'' used in this section. Some felt that it
referred, at least in part, to employees of the firm, and others felt
that it excluded officials of State regulatory agencies that may adopt
these regulations by reference.
The intent of the proposed regulations was to grant records access
to regulatory agency officers and employees, not officers or employees
of a firm. The language was intended to be flexible enough to cover
State officials if their agency adopted the regulations by reference.
FDA has changed the wording of the regulations to address these
concerns.
The modified paragraph in Sec. 123.9(c) reads:
(c) Official review. All records required by this part and all
plans and procedures required by this part shall be available for
official review and copying at reasonable times.
J. Training
A large number of comments addressed the proposed training
requirements. FDA proposed to require that each processor and importer
employ at least one individual who has successfully completed a
training course that has been approved by FDA on the application of
HACCP to fish and fishery products processing. FDA also proposed that
the trained person or persons be responsible for, at a minimum,
developing and modifying the HACCP plan, evaluating the adequacy of
corrective actions taken in response to CL deviations, and reviewing
monitoring records before shipment.
In the preamble to the proposed regulations, FDA specifically
requested comment on: (1) Whether the need for training could be
satisfied by different gradations of training (e.g., based on
complexity or size of operation or on the degree of risk posed by the
products being produced); (2) whether other training formats, such as
video tapes, might be effective, at least under some circumstances
(e.g., a small business whose processing involved few hazards); (3)
whether, assuming the regulations are adopted by FDA, training in HACCP
received before they are effective should be ``grandfathered'' as
fulfilling the training requirement; and (4) whether some or all of the
training requirements should be deleted or modified as a means of
reducing the burden on the industry.
1. The Need for Mandatory Training
89. Most of the comments that addressed the question of whether
there should be a mandatory training requirement expressed support for
it. A significant portion of these comments acknowledged the need for
at least one
[[Page 65141]]
trained individual at each processing facility. Those that provided
reasons for their support contended that properly trained personnel are
essential to the development and effectiveness of HACCP controls, and
that training is necessary to ensure consistency of approach.
Those few comments that expressed reservations about the overall
HACCP training requirement generally acknowledged the need for a
trained individual in the plant but opposed a compulsory training
program. Two comments, from State governments, expressed concerns about
the financial burden of training on small businesses and questioned the
need for making such a provision mandatory.
The overwhelming support in the comments for HACCP training is
indicative of the nearly universal view that training is essential to
the effective implementation of a HACCP system. As stated in the
preamble to the proposed regulations, this view is shared by the NAS
based on the success of the training requirement in FDA's HACCP-based
regulations for low-acid canned foods at part 113 (Ref. 54). The
primary concern expressed about mandatory training is the cost.
The agency is convinced that its efforts with the Alliance will
facilitate the development and implementation of a low cost training
program. As mentioned above, the Alliance is a cooperative effort
between Federal and State food regulatory agencies, academia, and the
fish and fishery products industry to provide support to the industry
in meeting its needs relative to HACCP training, technical assistance,
and research. Presently, the Alliance Steering Committee is comprised
of representatives of FDA, the U.S. Department of Agriculture (USDA),
NMFS, AFDO and its six regional affiliates, the Sea Grant Colleges, the
ISSC, the National Fisheries Institute, and the National Food
Processors Association (NFPA).
The goals of the Alliance are to develop: a HACCP training course
that will meet the requirements of these regulations, a mechanism for
delivering the training to the fish and fishery products industry, a
compendium of established methods for controlling hazards in the fish
and fishery products industry, and a mechanism for coordinating the
research efforts of the participating agencies to facilitate the
development of improved methods of hazard identification and control.
The training course materials are in an advanced stage of
development and are expected to be publicly available shortly after the
publication of these regulations. The AFDO regional affiliates have
agreed to work within their regions to identify regulatory and industry
training needs and qualified trainers who are interested in
participating in the Alliance-sponsored training. They have also agreed
to serve as the course coordinators for the Alliance-sponsored
training, which will be conducted on a cost-recovery basis.
The Alliance is developing a 3-day course, divided about equally
among: (1) The fundamentals of HACCP, based on the recommendations of
the NACMCF; (2) the requirements of these regulations and the
recommendations of the Guide; and (3) a practical exercise in HACCP
plan development.
FDA is sensitive to the concerns expressed about the cost of
training but is optimistic that training will not be unnecessarily
burdensome on small business, either in actual out- of-pocket expenses
or in lost productivity. As was previously mentioned, FDA is working
with the Alliance to produce a low cost, 3-day HACCP-training course
for the seafood industry, that is intended to meet the requirements of
these regulations. Current plans are for the course to be offered
through a variety of public institutions, including Sea Grant colleges.
As indicated earlier, in this setting the course is expected to be
offered on a cost recovery basis. It is likely that the course will
also be offered by private institutions, using their own fee structure.
The other cost associated with the training requirement is the lost
productivity for the duration of the course. FDA is convinced that,
with the flexibility in course structure, described elsewhere in this
section, training can be taken at times when it would least affect the
operations of the firm (e.g., during an off-season, at night).
Moreover, FDA is convinced by the comments that, as a general rule, the
benefits of training will significantly outweigh the burden. The agency
has concluded that with certain modifications from the proposal as
described below, training should remain a feature of these regulations.
The agency has made one modification in response to requests that
it modify the training requirement to reduce financial burden,
especially on smaller processors. FDA acknowledges that a short course
in HACCP has its limitations. For example, a 3-day course might not
have anything important to offer to an individual who has significant
job experience working with or for an individual who is well-versed in
HACCP. In such a situation, if the processor loses the trained
individual, it should be able to replace him or her with the individual
who has, in effect, apprenticed with the trained individual without
having to send the apprentice to a course in HACCP training, assuming,
of course, that the apprenticeship has imparted a level of knowledge at
least equivalent to that that could be provided by the training. The
agency has modified the regulations to provide for this kind of
situation by permitting adequate job experience to qualify and
individual to perform the functions of the trained individual.
Note that all references in this preamble to a trained individual
mean an individual who meets the requirements of Sec. 123.10 through
either completion of a course or job experience that provides an
equivalent level of knowledge.
2. Who Should Provide Training?
90. A significant number of comments identified organizations or
individuals that they considered to be qualified to conduct or develop
HACCP-training courses. The majority of the comments, which included
remarks from processors, trade associations, and State governments,
suggested that FDA should either conduct such training or at least
approve the relevant course material. A few of the comments that
recommended that FDA conduct the courses also recommended that FDA
provide the courses at no cost or financially support the training. The
comments that endorsed FDA approved courses asserted that this approach
would result in a standardized, comprehensive training program that
emphasizes the minimum acceptable HACCP requirements.
Other comments recommended that training programs could be
conducted by NFPA or other trade associations, ISSC, Sea Grant colleges
and other academic institutions, consultants, and State and local
regulatory agencies. The comments acknowledged the cost savings that
could be realized with trade association- provided training and through
the HACCP training experience already possessed by the NFPA. One
comment suggested that allowing many training programs would offer
hundreds of professionals the opportunity to contribute to the
development of HACCP. A few comments suggested that FDA publish a
listing of approved training courses.
A comment from the ISSC cautioned that organization does not
support the shifting of public health training in the area of molluscan
shellfish away from itself. The comment further stated that the
organization would work cooperatively with the Alliance in the
development of a HACCP-training
[[Page 65142]]
course, which it suggested should be Federally subsidized and ISSC
endorsed.
A few comments suggested that the Alliance be permitted to develop
the standard for HACCP training, and that the results be shared with
all prospective trainers. A few additional comments urged that HACCP
training be based on the recommendations of NACMCF, because such
efforts would result in a training program that was well defined.
FDA generally agrees with these comments. The agency does not
intend to run HACCP-training courses for the industry. Rather, FDA
must, of necessity, focus its HACCP training on government
investigators. The agency anticipates that industry training will be
conducted privately and through academia. This division of labor is
based on the model that has worked well for the training requirement
for low-acid canned foods.
FDA agrees, moreover, that there should be widespread opportunity
for conducting HACCP training. It is not the agency's intent to specify
or limit the field of qualified trainers.
The training course that is under development by the Alliance is
based on the recommendations of the NACMCF. After reviewing the final
draft of the Alliance training materials, FDA intends to publish a
notice of availability of the documents in the Federal Register. It is
the agency's intent to utilize the Alliance materials as the standard
against which other course materials may be judged.
The agency strongly encourages trainers to evaluate their courses,
past, present, and future, against the Alliance materials when they
become available and to modify or adapt curricula, where necessary, to
ensure that they are consistent with, and provide at least an
equivalent level of instruction to, the Alliance course. Where
previously conducted training fails to meet this standard, it may
suffice to provide supplemental materials or instruction so that the
cumulative training is at least equivalent to the Alliance course. FDA
also encourages the fish and fishery products industry to confirm with
past or prospective trainers that a particular course is equivalent to
and consistent with the Alliance materials. The agency has no plans to
publish a list of ``approved'' courses other than the Alliance course
materials.
Finally, it should be noted that FDA resources will not be
sufficient to fund the training of all appropriate regulators (i.e.,
State or local regulators). The agency is confident, however, that
Alliance training will provide a low cost opportunity for high quality
HACCP training for State or local regulators as well as for processors.
Because FDA will not be approving in advance specific courses other
than the Alliance curriculum, and in response to comments, the final
regulations have been modified at Sec. 123.10 to require that training
courses be ``at least equivalent to the standardized curriculum
recognized as adequate by the U.S. Food and Drug Administration.'' FDA
had proposed to require that training courses be ``approved by the Food
and Drug Administration.''
3. Should Training Be ``Grandfathered?''
91. A large number of comments addressed the question of whether
training in HACCP received before the effective date of these
regulations should be ``grandfathered'' as fulfilling the training
requirement. All of these comments supported the grandfathering of such
training. Many of the these comments recommended specific training
courses that FDA should grandfather. Approximately half of these
comments requested that those trained under NMFS' HACCP training
program be grandfathered. Those that provided reasons referenced the
large number that had been trained at the time of the writing of the
comment (1,310 domestically and 394 overseas) and stressed that NMFS'
training was more comprehensive than that which would be necessary
under FDA's HACCP approach, especially because the NMFS program covers
nonsafety hazards in addition to safety hazards.
Other comments supported grandfathering HACCP courses conducted by
NFPA, Sea Grant colleges, State regulatory agencies and those
organizations sanctioned by such agencies to provide HACCP training,
and Pacific Fisheries Services. One comment suggested that graduation
from a Better Process Control School, as required by parts 113 and 114
for processors of acidified and low-acid canned foods, should be
considered to meet the requirements of these regulations. Another
comment urged that any training program based on the HACCP principles
recommended by the NACMCF should be grandfathered.
One comment suggested that, in order to grandfather courses, FDA
would need to develop a system to determine the effectiveness of the
training that has been conducted. The comment recommended the use of
testing or curriculum review as evaluation tools. The comment further
encouraged the development of a formal approval process for previously
conducted training.
FDA has concluded that it is not in a position to grandfather HACCP
training received before the issuance of these regulations. Blanket
grandfathering would pose the risk of sanctioning training that does
not fully prepare processors for operating under these regulations, and
case-by-case grandfathering would be unduly demanding on agency
resources.
On the other hand, the agency will not presume that HACCP training
received prior to the issuance of these regulations will have to be
repeated. FDA will challenge the adequacy of prior training only when a
processor's performance demonstrates a lack of understanding of HACCP
principles.
Nonetheless, FDA encourages processors to update any prior training
to ensure that they have a thorough understanding of the requirements
of these regulations. It may well be that many traditional HACCP
courses will need only minimal supplementation to accommodate them to
the provisions of these regulations, and that there will be no need for
a processor to repeat an entire course. As mentioned above, partial,
supplemental courses may be offered, or reading materials developed by
the course offerer and sent to the processor may suffice. There are
numerous possibilities.
FDA is also not in a position to make determinations in advance
about the acceptability of courses that will be offered after the
issuance of these regulations. FDA agrees with the comment that, in
order to do so, the agency would have to develop a system for course
evaluation. Review of course materials, auditing of course
presentations, testing, and other evaluation tools that FDA might have
to employ are labor intensive and are not the most efficient use of
agency resources. Rather, the adequacy of courses will have to be
evaluated by FDA on a case-by-case basis, when inspectional or other
evidence causes the agency to question whether the course meets the
requirements of Sec. 123.10.
The ultimate determination of the success of training is whether
processors are operating effective HACCP systems. In the initial stages
of the program, at least, FDA's primary focus will have to be on
whether HACCP plans are adequate, and the systems are being effectively
implemented. FDA's interest in the adequacy of training will increase
when plans and systems fail to demonstrate an adequate understanding of
HACCP and its application to seafood.
Nonetheless, FDA can state that the Better Processing School
curriculum for
[[Page 65143]]
acidified and low-acid canned foods will not be adequate to meet the
training requirement of these regulations. The Better Processing School
was developed to instruct acidified and low-acid canned food processors
in how to safely process such products to control the hazard of the
development of botulinal toxin in accordance with the requirements of
parts 113 and 114. The course does not provide instruction in the
principles of HACCP or address other hazards (e.g., histamine
development) to which these products might also be exposed.
4. Course Curriculum
92. A few comments suggested that the training be divided into a
basic HACCP core and interchangeable segments based on the portions of
the industry of interest to the students (e.g., vessels, cooked, ready-
to-eat fishery products, molluscan shellfish, and smoked fish).
As mentioned previously, the Alliance course includes three
segments: A basic HACCP core, the requirements of these regulations,
and the development of a HACCP plan. The first two segments are
applicable to the entire fish and fishery products industry. The
Alliance has acknowledged the need to develop industry-specific
features for the third segment. The agency is in agreement with the
Alliance and with the comment in this regard and would encourage the
development of such directed courses.
93. In response to FDA's invitation to comment on the advisability
of alternate training formats, several comments expressed support for
the use of video tapes by small processors of low-risk products. A few
additional comments did not specifically address video taped training
but stated that, while it is desirable to have uniform training,
ultimately training should involve ``whatever it takes.'' One comment
suggested that home study courses and education via television might be
acceptable alternatives to more formal, for-fee training mechanisms. A
few comments opposed courses that consist exclusively of video tapes,
based on concern for a potential limitation in the level of
understanding that could result from this type of noninteractive
training method.
FDA agrees with the comments that expressed concern with teaching
methods, such as video tapes, that lack instructor/student interaction.
However, in the interest of providing flexibility in meeting the
training requirement of these regulations, the agency has concluded
that any teaching format is acceptable so long as it provides a level
of understanding at least equivalent to that provided by the Alliance
training program. FDA is aware that video tape training is widely used
for a variety of purposes. The agency cannot conclude that video-based
HACCP training will not accomplish the purposes of the training
requirement. For remote site processors, video-based training may be
the only practical method available.
It is unlikely, however, that two or three 2-hour video tapes, as
one comment suggested, will provide an equivalent level of training to
the 3-day Alliance course under development. On the other hand, a
series of video presentations, perhaps in conjunction with a 1-day
workshop, may be adequate.
94. A few comments addressed the length of the training course. One
suggested that 3 days would be overly burdensome on small businesses
because of the loss of manpower during the course. Another suggested
that 3 days was not long enough to furnish the needed information. One
comment suggested that the length of training should be based on the
level of experience of the student and the level of complexity of the
processing operation.
FDA has concluded, based, in part, on its participation in the
Alliance, that the 3-day Alliance curriculum is the minimum necessary
to develop an adequate understanding of HACCP principles and essentials
of HACCP plan development. If the curriculum were reduced any further,
processors would risk having to take more time later to implement their
HACCP systems as a result of trial and error, and as a result, the
quality of their HACCP programs would be jeopardized.
Nonetheless, FDA is not specifying in the regulations how long the
course must take, only that it be equivalent in terms of curriculum to
the standardized curriculum recognized as adequate by the agency. If
true equivalency can be achieved in less time, FDA would have no
objection. Moreover, depending upon the circumstances, FDA would have
no objection to training that can be imparted in segments at convenient
times so as to cause only a minimal disruption to the work schedule.
Section 123.10, therefore, states that the training must be ``at
least equivalent to the standardized curriculum recognized as adequate
by the U.S. Food and Drug Administration.'' This provision will also
accommodate the use of food processing experts, who have received
training in HACCP that is far more extensive than that planned by the
Alliance. FDA recognizes that it would be inappropriate to limit the
universe of experts to those who have taken a course based on the
Alliance 3-day curriculum. The issue of the use of consultants and
other experts will be further discussed later in this section.
5. Do Importers Need Training?
95. A few comments suggested that FDA should provide separate or
specialized training aids for importers. Two of these comments noted
that importers have not, historically, been involved with the
processing of seafood commodities. The comments requested that FDA work
with trade associations that represent importers in setting up
workshops, developing specialized training materials for importers, and
recognizing training provided by foreign institutions.
FDA has reassessed the need for training to accomplish the HACCP
functions assigned to importers, especially in light of changes in the
imports provisions of these final regulations. These changes are fully
discussed in the ``Imports'' section of this preamble. In summary,
importers are now required to conduct verification activities but are
no longer required to have full HACCP plans of their own unless they
also meet the definition of a ``processor.'' FDA has concluded that
HACCP training, while desirable, is not essential to the preparation of
importers' verification procedures, as specified at Sec. 123.12(a)(2).
For this reason, training is not required for importers, and all
reference to required training for importer functions has been dropped
from Sec. 123.10.
Nonetheless, the agency is aware that importers may be unfamiliar
with the technical aspects of fish and fishery product processing and
HACCP control procedures. Knowledge about these matters would be
helpful for purposes of verification. To meet this need, FDA plans to
include in the Guide specific materials relating to importers'
verification procedures. In addition, as has traditionally been the
case, the agency intends to continue to interact with, and provide
information to, the import industry through trade associations and
other forums, within the limits of budget constraints. Moreover,
importers may want to participate in the training courses that are
offered by the Alliance.
Finally, the agency agrees with the comment that suggested that
training overseas should be conducted by foreign institutions
recognized for their expertise in seafood processing and HACCP control.
This issue will be further discussed in the ``Imports'' section of this
preamble.
[[Page 65144]]
6. Testing and Retraining
96. Several comments supported the mandatory use of testing to
assess whether an individual has successfully completed HACCP training.
Two comments further recommended that the agency could consider the
training requirement to be met if a person successfully passes an
examination.
The agency is not opposed to testing at the end of a course but
prefers not to mandate that courses include tests. Trainers will be
free to include or not include testing as part of their training
efforts. The issue of student evaluation is one that is still being
debated in the Alliance relative to Alliance-sponsored training
courses.
However, testing alone does not provide the kind of exposure to the
concepts of HACCP that is necessary to result in company understanding
and commitment. The function of training is to prepare industry to meet
the requirements of the regulations, not to test competency. The true
test will be whether processors are able to implement their HACCP
systems. Processors will be judged as plans are reviewed, and plant
operations are evaluated, during inspections.
97. A few comments recommended mandatory retraining or continuing
education. The comments stated that as new information about the
science of fish and fishery products hazards and the technology of
their control becomes available, there will need to be some method for
introducing this information to previously trained individuals. One
comment, on the other hand, urged that training be limited to a single
event and not be subject to periodic renewal.
The primary purpose of the training is to teach the fundamentals of
HACCP. These are unlikely to change over time. A comprehensive
discussion of seafood hazards and controls is far too extensive for
inclusion in a 3-day training session. The agency has concluded that
information about the technology that is available to control hazards
should be made available to the industry through the Guide, the
Alliance Compendium of Established Processes, and other modes of
technical assistance. FDA supports the idea of continuing education and
will encourage it, but the agency is not prepared to mandate it in
these final regulations.
98. A comment suggested that the regulations mandate remedial or
enhanced training for a first time violator whose infractions have
resulted from a misunderstanding of HACCP principles.
Whenever an infraction occurs, the nature of the remedy that is
warranted depends on factors such as the public health significance of
the infraction. The agency has administrative warnings and, when
necessary, a range of regulatory actions available to it. (See the
``Compliance'' section of this preamble for a more thorough discussion
of compliance philosophy under HACCP and available remedies.)
Ultimately, however, it will be the processor who will be responsible
for correcting the deficiencies in its HACCP system. Part of that
responsibility will be determining the most appropriate method of
resolving any failure to fully understand HACCP principles, whether
through remedial training, hiring a consultant, or taking some other
step. So long as an appropriate outcome can be obtained, FDA would
prefer not to mandate any particular method of remediation in these
regulations. Processors certainly may wish to consider additional
education as an option, however.
7. Gradations of Training
99. Several comments addressed whether the HACCP training
requirement could be satisfied by different gradations of training,
depending on the complexity or size of the operation or on the degree
of risks posed by the product being produced. The majority of these
comments supported the concept of variable levels of HACCP training.
Most did not provide the basis of their support. Those that did
suggested that small or large scale processing of low-risk products
would not likely require any special training, and that small scale
processing of even high-risk products would allow for individual
examination of every fish, an option that is not possible in large
scale processing. One comment further suggested the use of variances to
exclude certain industry members from the training requirement, rather
than providing a blanket exemption for a segment of the industry.
A minority of the comments on this subject opposed any variations
in the level of training. Several of these comments stated that the
necessity for HACCP education and training does not vary based on the
size of a company, and that a standard training curriculum should be
developed for all companies, regardless of their size. Some of these
comments stated that smaller processing operations may be inherently
less safe, and that, cumulatively, they represent a large amount of the
seafood making its way to the consumer. One comment stated that smaller
processing operations may actually have a greater need for employee
training, compared to some larger processing operations that may
already have trained staff.
The agency agrees with the comments that suggested that the need
for HACCP training does not vary solely by the size of the processor.
An understanding of the principles of HACCP is essential for the
successful implementation of a HACCP program, regardless of
establishment size. The agency agrees with the assertion that, in many
cases, the training needs of small businesses may, in fact, be greater
than those of large firms, because they frequently lack the trained
quality control and research and development staffs that are common in
large firms. Moreover, small businesses comprise a significant portion
of certain high-risk segments of the fish and fishery products
industry, such as processors of molluscan shellfish and cooked, ready-
to-eat products. Training will be critical to ensure the success of
HACCP in these segments.
Although the agency expects that the complexity of HACCP plans will
vary with the number and type of hazards associated with a processing
operation, an understanding of the basic principles of HACCP, and how
to apply those principles to the processor's operations, will remain
essential. The curriculum under development by the Alliance is designed
to provide a very basic grounding in these matters. As stated earlier,
the Alliance has acknowledged a need to tailor part of the course so
that it can be directed toward specific industry segments. This
approach may be the best way to provide flexibility in the program, so
that training can match the degree of complexity and risk that is
encountered by the processor. FDA will continue to encourage the
development of industry-specific training features.
The agency is not persuaded that the ability of a processor to
individually examine all fish because of the small scale of operations
will reduce the processor's need to understand the hazards associated
with seafood and the specifics of a systematic approach for controlling
them. FDA has long taken the position that observing each fish on an
assembly line is an inappropriate way to ensure seafood safety (Ref.
208, p. 4146). While matters relating to the quality of the fish can be
observed in this manner, safety matters often cannot.
8. Duties of the Trained Individual
100. Several comments suggested that a firm be permitted to hire a
consultant, or an outside expert, who is not an employee of the firm,
to perform the functions required of a trained individual. Two trade
associations
[[Page 65145]]
argued that contracting for the development of a HACCP plan by a
professional consultant could be more efficient and cost effective,
especially for many small companies. Related comments pointed out that
some of the proposed functions of the trained individual either did not
require a person to be onsite continually (e.g., plan development) or
required expertise that could not realistically be obtained in a 3-day
course (e.g., making decisions about whether product that has been
subject to a deviation is safe to release into commerce).
While the agency considers training employees to be preferable to
hiring outside consultants in terms of fostering the appropriate
corporate culture and commitment to HACCP, FDA recognizes the
importance of ensuring the flexibility that firms, especially small
businesses, may need to comply with the regulations in a cost-effective
manner. The agency also accepts that for some processors, the expertise
that may be needed from time to time could best be provided by an
expert consultant. Consequently, the agency is modifying Sec. 123.10 to
read as follows: ``* * * the following functions shall be performed by
an individual who has successfully completed a course of instruction *
* *.'' The requirement that processors employ a trained individual has
been eliminated. Moreover, FDA has modified Sec. 123.10(c) to state,
``The trained individual need not be an employee of the processor.''
101. A number of comments asked whether the regulations would
require a separate trained individual for each processing location of
each company or just one per company.
FDA intends that the functions enumerated in Sec. 123.10 be
performed by a trained individual. The number of employees a processor
must train, or the consultants that must be hired, in order to ensure
that trained individuals perform these functions is left to the
judgment of the processor. For some firms, one individual will be
sufficient. Others will need to secure the services of more than one
such individual, either as employees or as consultants. Whether these
individuals are located at each facility, at a corporate headquarters,
at a consulting firm, or at some combination of these arrangements is
to be determined by each individual processor.
102. A few comments were concerned about the logistics of the
routine functions that the agency proposed must be performed by someone
with HACCP training (i.e., record review and deviation handling).
Specifically, they argued that the proposed requirements would actually
require each firm to have more than one trained individual because of
work weeks that routinely exceed 40 hours, vacations, illnesses, and
employee turnover. The consequence, the comments suggested, would drive
up the cost of training.
FDA acknowledges that, for certain situations, these comments may
be correct. However, the agency has made three changes in the final
regulations to minimize this possibility. First, as stated above, a
processor may hire trained consultants on an as-needed basis. Second,
as discussed in the ``Verification'' section of the preamble, the
regulations do not include the proposed requirement that a trained
individual review monitoring records before the product to which the
records relate is shipped. These final regulations require only a
weekly review. As a result, the need to have a trained individual
onsite every day has become substantially reduced. Third, as described
below, FDA has decided not to require that the trained individual
evaluate CL deviations and corrective actions. This modification
reduces still further the need to have a trained individual onsite at
all times. In addition, as described previously, the agency is allowing
processors to employ individuals whose training has been obtained
through on-the-job experience. Thus, for example, a processor that
needs the services of two trained individuals could satisfy the
requirements of these regulations by employing an individual who has
been trained in an adequate course and a second individual who has
apprenticed sufficiently with the first individual to have mastered the
subject.
As a related matter, the provision in the final regulations that
provides for the development of corrective action plans (see the
``Corrective Actions'' section of this preamble) could eliminate the
need to bring an expert onto the scene in many instances in which
corrective action is necessary. The processor may be able to follow the
corrective action plan without having to rely on an expert or trained
individual. This procedure could permit further savings.
103. Some comments suggested that there should be different
categories of trained individuals, with different responsibilities.
These comments, from individuals, processors, and trade associations,
asserted that a firm should have one HACCP trained person capable of
conducting or overseeing the routine operation of the HACCP program,
but that this individual should not necessarily be responsible for
designing a firm's HACCP plan or making complex scientific evaluations.
Another comment suggested that it was unrealistic to expect that a
training program would provide the level of expertise necessary for a
person to make a determination on whether a deviation may have rendered
a product injurious to health or otherwise adulterated.
FDA generally agrees with these comments. It was never the agency's
intent to limit the processor's use of experts to employees whose
training included the course prescribed by these regulations,
especially in the areas of HACCP plan development and the evaluation of
CL deviations and corrective actions (i.e., making evaluations about
whether product that has been subject to a deviation is safe to ship).
While FDA is convinced that a short course in HACCP principles is
important to the success of the overall program, the agency also
recognizes that such a course has its limitations.
FDA has deleted the proposed requirement that the HACCP-trained
individual be required to evaluate CL deviations and corrective actions
to allow for the use of experts in other appropriate scientific
disciplines that have not been trained in accordance with these
regulations. For example, the agency does not expect that a processor
will be able to determine the public health consequences of every
possible deviation without the assistance of experts. The kind of
expertise necessary would likely involve disciplines other than HACCP.
Moreover, the agency agrees that it is unreasonable to expect that
successful completion of a 3-day HACCP course alone would qualify an
individual to make determinations about the safety of products involved
in a CL failure. HACCP training in such a situation could only
reasonably be expected to help ensure that appropriate corrective
action measures are taken and recorded from a HACCP perspective.
Consistent with this change, FDA has modified Sec. 123.7(c)(2) to state
that a determination of acceptability for distribution into commerce of
products that may have been affected by a deviation must be made by
individuals with the expertise to make such a determination, and that
such individuals need not be those who meet the requirements of
Sec. 123.10.
Nonetheless, FDA expects that, at a minimum, an individual trained
in accordance with these regulations will perform the verification
function of reviewing records of corrective actions to ensure that they
are complete, and that an appropriate corrective action was taken
(i.e., one that was predetermined in the HACCP plan, or
[[Page 65146]]
one that was determined by a qualified expert to be sufficient to
render the product safe). Section 123.10(c) requires that the trained
individual perform certain record reviews associated with the
verification principle of HACCP, including reviews of corrective action
records (see Sec. 123.8(a)(3)(ii)).
FDA has modified Sec. 123.10 from the proposal to clarify and to
conform this section to other features of the regulations. A summary of
these modifications follows.
FDA has revised Sec. 123.10(a) to clarify that when a trained
individual develops an HACCP plan for a processor, this effort may
involve adapting a model or generic-type plan for use by that
processor. FDA received a significant number of comments on the pros
and cons of model or generic-type HACCP plans. This subject is
addressed in various places in the preamble, most notably in the
section entitled ``Other Issues.'' In summary, the development of model
plans can be of great benefit to the industry, especially small
businesses, so long as the model plans are tailored by processors to
meet their individual situations and are not simply copied verbatim.
The agency is convinced that, in most cases, generic or model plans
will need to be modified to some extent to fully accommodate the
specifics of the processor's operations.
Section 123.10(b) provides, in part, that the trained individual is
responsible for reassessing and modifying the HACCP plan in accordance
with corrective action procedures specified in Sec. 123.7(c)(5). This
requirement is not new. It should be noted, however, that, unlike the
proposal, the final rule requires the trained individual to perform
these functions only when the processor does not have a predetermined
corrective action plan that addresses the specific deviation. As
explained in the ``Corrective Action'' section of this preamble, a
review and reassessment of the plan should not ordinarily be necessary
when a corrective action was anticipated, as reflected by the existence
of a predetermined corrective action plan.
Section 123.10(b) also requires that a trained individual perform
the annual reassessment of the processor's HACCP plan as required by
Sec. 123.8(a)(1). A new feature of the regulations, this requirement
parallels the mandate that each processor engage in verification
activities (see Sec. 123.8(a)). It is a logical outgrowth of the
principle, central to both the proposal and this final rule, that plan
development be performed by individuals who possess the knowledge and
skills that are obtained through training in HACCP.
Section 123.10(c) requires that a trained individual perform
certain record reviews as enumerated in Sec. 123.8(a)(3). This
requirement is not new except for the review of records of end-product
testing, if any. End-product testing was not addressed in the proposal
but, as explained in the ``Verification'' section of the preamble, has
been added as an optional verification activity. The review of end-
product testing records by a trained individual is a logical outgrowth
of the principle that was reflected in the proposal in Sec. 123.8(b)
that a trained individual review all HACCP records for completeness and
consistency with written HACCP procedures.
Finally, it should be noted that the requirement in the proposed
regulations that trained individuals perform certain functions for
importers has been dropped entirely. This deletion is consistent with
the changes that FDA is making in the provisions that applied to
importers in this final rule. These revisions are described elsewhere
in this preamble. In summary, importers are given alternatives to
having HACCP plans and are not required to take the kinds of actions
for which a trained individual has been determined to be essential.
K. Sanitation
1. Background
FDA proposed to require that processors conduct sanitation
inspections at specified frequencies to ensure that each of up to 18
specified sanitation conditions are maintained in the processing
facility where they are relevant to the type of processing being
performed. The agency also proposed to require that processors maintain
sanitation control records, and that they take and document corrective
actions when the specified conditions were not met. In addition, FDA
encouraged, but did not propose to require, processors to make use of
written SSOP's to ensure that the necessary sanitation measures were
implemented.
FDA tentatively concluded that sanitation controls are necessary in
these regulations because: (1) Sanitation practices directly affect the
microbiological safety of seafood products that are not further cooked
by the consumer, such as cooked, ready-to-eat products, smoked
products, raw molluscan shellfish, and other fish that are consumed
raw; (2) sanitation practices are relevant to the microbiological
safety of seafood products even where these products are to be cooked
by the consumer; (3) sanitation practices directly affect the chemical
and physical safety of seafood products; (4) nearly half the consumer
complaints relating to seafood that FDA receives in a typical year are
related to plant or food hygiene; and (5) inspections conducted by FDA
and NMFS demonstrate that a significant portion of seafood processors
operate under poor sanitation conditions.
The MSSP, conducted by NMFS, concluded that sanitation controls
could be included in HACCP plans without overloading HACCP. Moreover,
the FDA/NMFS HACCP-based seafood pilot program included sanitation
CCP's. Nonetheless, FDA tentatively concluded that monitoring and
recordkeeping for the 18 specific sanitation conditions specified in
the proposal should be permitted to occur outside of a processor's
HACCP plan so as not to overload it. Because these sanitation controls
relate to an entire facility, not just to a limited number of CCP's,
FDA felt that they would not all fit well within an HACCP plan.
FDA took this prescriptive approach to sanitation to assist
processors so that they would not have to figure out how, or whether,
to include sanitation in their HACCP plans and to help them resolve the
sanitation problems that the seafood industry has chronically
experienced. By requiring a specific, daily sanitation regime that
incorporates HACCP-type features (i.e., monitoring and recordkeeping)
to help the processor track sanitation in its plant, FDA hoped to
foster a culture of, and commitment to, good sanitation practices that
has been lacking in a significant portion of the industry.
2. Should the Regulations Deal With Sanitation?
FDA requested comment on whether sanitation control measures should
be addressed by processors in accordance with the proposed approach, or
whether the regulations should require that processors address
sanitation in their HACCP plans.
More than 250 comments addressed various aspects of the proposed
sanitation requirements, more comments than addressed any other aspect
of the proposed regulations. Approximately 100 of these comments
addressed FDA's questions about the approach to sanitation control in
these regulations. The remaining comments focused on specific
sanitation provisions.
104. Approximately 10 percent of those that responded to the
requests supported the proposed approach. These comments were from
processors,
[[Page 65147]]
consumer advocacy groups, State, Federal, and foreign government
agencies, and a trade association. Approximately five percent of the
comments, from processors, trade associations, and State government
agencies, objected to the inclusion of any explicit sanitation controls
in these regulations. It is not clear, however, whether the latter
comments were objecting to sanitation controls as part of HACCP where
appropriate for safety or to any sanitation approach beyond HACCP. The
remaining approximately 85 percent of the comments, principally from
processors, trade associations, and State and Federal government
agencies, generally acknowledged the need for these regulations to
address sanitation in seafood processing plants but objected to one or
more of the specifics of the proposal.
Those that supported the proposed approach argued that sanitation
controls are a critical component of the regulations because: (1)
Addressing the insanitary practices in the seafood processing industry
is essential to improved consumer confidence; (2) effective sanitation
controls are a prerequisite to the proper functioning of a HACCP
system; and (3) sanitation controls are critical to the management of
microbiological hazards in both products that will not be cooked by the
consumer and those that will be cooked, the latter because of the
potential for cross-contamination in the kitchen. The comments
suggested that a prescriptive approach to sanitation is warranted
because the FDA and NMFS inspection results cited in the preamble to
the proposal documented the failure of a significant percentage of the
industry to control key sanitation conditions and practices. Moreover,
these comments continued, the enumeration of specific controls relieves
the industry of the burden of identifying the most significant areas of
concern.
Several comments stated that sanitation requirements for seafood
processors are necessary because guidelines do not have the force of
regulation and therefore are more difficult to enforce. One comment
stated that including sanitation requirements in these regulations
would simplify compliance for seafood processors because the HACCP and
sanitation requirements would be in one place. One comment stated that
some processors would be more inclined to implement sanitation control
measures if all processors were subject to the same mandatory
requirements.
Many of the comments that objected to the manner in which FDA
proposed to treat sanitation acknowledged that effective sanitation
controls are essential to the proper functioning of a HACCP system. As
with comments that supported the proposed approach, a few of these
comments identified sanitation as a prerequisite to HACCP.
The comments that objected to the inclusion of any sanitation
requirements in these regulations provided reasons that the agency
believes are more relevant to the question of how these regulations
should address sanitation than to whether they should address the
issue. For this reason, the arguments presented in these comments are
addressed later in this section.
FDA accepts the view expressed by the overwhelming majority of
comments (i.e., those that advocated the proposed approach and those
that advocated other sanitation control mechanisms) that sanitation is
relevant to the goals of these regulations and should be addressed in
them. The primary source of pathogenic microorganisms for most fish
(i.e., wild-caught fish) is the processing plant environment (Ref. 3,
p. 267). The control of sanitation in the plant is the most effective
way to minimize pathogens, and, for products that are not given a final
heat treatment after packaging, it is the only way to minimize them at
that stage in the chain of distribution (Refs. 3, p. 10; 7, p. 27; 204;
and 205). This situation is nearly the reverse of that for red meat and
poultry, where pathogens are likely to have originated from the raw
materials before they enter the plant (Refs. 36, p. 197; 209; and 210,
p. 1).
A significant body of opinion holds, moreover, that good sanitation
is a necessary foundation for HACCP. This view was articulated in
comments to this rulemaking and in the proposed rule to establish HACCP
and other requirements for the beef and poultry industries issued by
USDA (Ref. 211). USDA proposed both SOPs for sanitation as a
prerequisite to a HACCP plan and sanitation as part of HACCP where
critical for safety (Ref. 211, p. 6789).
FDA concludes, therefore, that these regulations cannot fully
address all matters relevant to safety, or significantly contribute to
the restoration of consumer confidence in seafood without providing for
major improvements in sanitation. Therefore, these regulations address
sanitation.
3. Why Isn't Part 110 (21 CFR Part 110) Adequate To Deal With
Sanitation Concerns?
105. Some comments asserted that it would be adequate to rely on
the existing CGMP's in part 110, which provide guidance of general
applicability to all foods. A variation on that concern was the view
that the sanitation standards in part 110 need not be codified in these
regulations because they are adequately expressed in that part. The
NACMCF pointed out that the CGMP's have proven adequate for a wide
variety of processed foods under FDA's jurisdiction. Some comments
stated that part 110 should be made mandatory for seafood and fully
enforced.
Good sanitation is already mandatory for all foods. Section
402(a)(4) of the act deems food to be adulterated if processed under
insanitary conditions. The CGMP's in part 110 articulate the kinds of
conditions and practices that need to be followed in order to avoid
producing an adulterated product under section 402(a)(4) of the act.
Nevertheless, while FDA has been enforcing the sanitation standards
contained in part 110 for many years, as indicated earlier, it has not
succeeded in developing a culture throughout the seafood industry in
which processors assume an operative role in controlling sanitation in
their plants. The statistics relating to the incidence of insanitation
cited in the preamble to the proposed regulations (Ref. 208 at 4161-
4162) clearly demonstrate that such a culture is not adequately in
place. The following observation about culture in the preamble to
USDA's proposed HACCP rules for beef and poultry is applicable here as
well:
* * * Identification of sanitation requirements has been viewed
by some establishment owners and personnel as the inspector's
responsibility. Such establishments often fail to take the
initiative to find and remedy insanitary conditions, relying instead
on the inspector to find deficiencies. (Ref. 211, p. 6788)
Moreover, FDA points out that while the CGMP's state that
sanitation controls should occur as frequently as necessary, they are
silent with regard to monitoring by the processor to ensure for itself
that sanitation controls are being followed.
For these reasons, FDA concludes that part 110 alone has not proven
to be adequate for the seafood industry. In order to ensure that firms
take full responsibility for sanitation in their plants, which is
strongly related to the production of safe and wholesome seafood, FDA
has concluded that it is necessary to include sanitation requirements
in these regulations.
4. Why Isn't the Proposed Approach Appropriate?
106. Many comments that agreed that sanitation should be addressed
in the regulations, as well as some that opposed addressing it,
objected that the
[[Page 65148]]
proposal was too prescriptive. These comments asserted that: (1) The
proposed 18 sanitation controls are overly prescriptive and inflexible
and are not appropriate for all processors; (2) the codification of
prescriptive sanitation requirements as regulations limits the ability
of processors to keep pace with advances in science and technology; (3)
the proposed sanitation controls have the effect of establishing
eighteen CCP's, which are not always appropriate; and (4) the proposed
sanitation provisions duplicate or contradict existing State or NSSP
requirements. FDA will respond to these criticisms.
Many comments that argued that the 18 specific sanitation controls
that FDA proposed were too prescriptive provided examples of how this
approach could deny processors the flexibility necessary to develop and
implement sanitation programs that are effective for the specific
conditions in which they are to be used. Some of these examples are as
follows:
(1) A few comments challenged the proposed ``easily cleanable''
standard for equipment, suggesting that in some applications (e.g., at
sea processing and old equipment) this standard may not be attainable
and may not be necessary as long as the equipment is, in fact, cleaned;
(2) A large number of comments challenged the proposed 4-hour
equipment cleaning frequency, suggesting that it is unwarranted in some
situations (e.g., refrigerated processing facilities) because it is
inconsistent with actual microbiological growth rates. It is unduly
burdensome in other situations (e.g., surimi processing facilities),
according to the comments, because it would limit shifts to 4 hours,
would interrupt production, and would require hours of equipment
breakdown time;
(3) A few comments challenged the proposed ``impermeable'' standard
for gloves and outer garments that contact food or food contact
surfaces, suggesting that in some instances it was impractical (e.g.,
filleting fish);
(4) A significant number of comments challenged the proposed 4-hour
hand sanitizer strength test frequency, suggesting that replacement of
dips rather than checking concentration may be appropriate, as may be
the use of automated hand washing and sanitizing systems; and,
(5) A number of comments challenged the proposed requirement that
hand washing and sanitizing stations be located in processing areas,
suggesting that they need only be easily accessible.
These comments have general merit and have persuaded the agency
that a less prescriptive approach is appropriate to ensure that the
regulations do not impose impractical, unduly burdensome, or
excessively rigid requirements.
107. Another concern with FDA's approach was that codifying
specific sanitation control procedures would not enable processors to
keep their sanitation programs updated with advances in science and
technology. As an example, the NACMCF comment cited recent industry
experience with other foods that has shown that the proposed
requirement of midshift cleaning and sanitizing in packaging rooms for
ready-to-eat foods, may with many current sanitation practices actually
be counterproductive to the control of Listeria monocytogenes. The
NACMCF advised that codification of a midshift cleaning requirement
would have prevented these industries from modifying their cleaning
procedures to adjust to the new information.
FDA agrees that sanitation requirements should be sufficiently
flexible to permit the incorporation of new information and better
procedures.
108. A number of the comments, including more than half of those
that opposed any new form of sanitation controls, argued that the
sanitation control approach proposed by FDA would effectively establish
eighteen mandatory sanitation CCP's that may not always be appropriate.
These comments may have been the result of a misunderstanding of
the relationship between processor HACCP plans and the proposed
sanitation controls. While the proposed controls involved monitoring
and recordkeeping, they were not proposed as part of a processor's
HACCP system. FDA did not intend to designate them as CCP's. FDA
believes that the provisions of these final rules make clear that the
necessary sanitary controls need not be considered to be CCP's.
109. A large number of the comments that objected to the manner in
which FDA proposed to handle sanitation argued that the proposed
sanitation provisions are redundant with State and local regulations
and, with respect to molluscan shellfish, with the NSSP.
FDA acknowledges that the NSSP and most State seafood control
programs include provisions, much like FDA's CGMP's, that are designed
to control processing plant sanitation. These other provisions, like
the CGMP's, serve as baseline standards for sanitation. However, the
rates of noncompliance with existing CGMP standards, as detailed in the
preamble to the proposed regulations (Ref. 208 at 4161-4162),
demonstrate a need for a system in which processors are responsible for
not only meeting these baseline standards but also routinely auditing
their facilities and operations to ensure that they are meeting them.
In this way, the sanitation requirements of these regulations build
upon existing sanitation requirements, at the Federal, State, and local
levels.
The more generalized nature of these final regulations with respect
to sanitation should mitigate the concerns of the comments that
complained about the conflict between, and duplication with, existing
sanitation standards.
As discussed elsewhere in this preamble, FDA encourages adoption of
these regulations by State and local regulatory agencies. FDA is
convinced that, in many cases, the regulations can be quite easily
overlaid on existing State, local, and NSSP requirements.
5. What Is the Appropriate Approach to Sanitation?
Based on its review of the comments, FDA has been convinced that a
modification of its approach to sanitation is appropriate. FDA
concludes that its approach in the proposal was too inflexible and
could have made it more difficult in certain circumstances to
incorporate new technologies and information.
The comments argued for one or more of several approaches that they
identified as being more appropriate than FDA's proposed approach: (1)
Requiring that each processor develop and follow a SSOP that is
specifically tailored to a processing operation; (2) including
sanitation controls in the HACCP plan where they are critical to
product safety; and (3) retaining the general approach of the proposed
regulations but somehow reducing the number of specific requirements.
Approximately 85 percent of those that opposed the way that sanitation
was treated in the proposal advocated one or a combination of the first
two of the approaches, with the recommendations evenly split between
the two. The small number of comments that objected to including any
specific sanitation requirements in the regulations may also have been
arguing that sanitation should not be part of HACCP but should be
controlled solely through CGMP's.
a. Inclusion of sanitation controls in HACCP plans.
110. There was strong support in the comments for the inclusion of
sanitation controls in HACCP plans, particularly where the controls are
necessary to protect the safety of the product. The comments stated
that a processor's
[[Page 65149]]
hazard analysis may reveal the need to control certain aspects of
sanitation in the HACCP plan, especially to control hazards involving
microbiological contamination. One comment noted that sanitation
controls are likely to be components of the HACCP plans of molluscan
shellfish processors.
Given the strong support that sanitation controls should be
included in HACCP plans where they are critical to safety, FDA has no
objection to processors including sanitation controls in their HACCP
plans. Consequently, these final regulations state in Sec. 123.6(f) and
Sec. 123.11(d) that sanitation controls for safety may be included in
HACCP plans.
The agency has concerns, however, as to whether including
sanitation controls in a HACCP plan will be adequate to ensure that
appropriate conditions exist in a plant. The conditions that would be
addressed in the HACCP plan will likely be those that are most
critically and directly related to product safety. Other situations
that are relevant to safety, but in a less direct way, would probably
not be controlled through HACCP. For example, following the NACMCF
recommendations for hazard analysis and HACCP plan development would
likely result in the identification of a number of equipment and hand
washing controls at CCP's in the HACCP plan for the processing of a
cooked, ready-to-eat product to minimize the risk of microbiological
contamination but not in the identification of these same controls in
the HACCP plan for a raw finished product that would normally be cooked
before consumption. In the latter case, however, attention to
sanitation would still be important in the processing plant to prevent
contamination of the product, given that the ultimate consumer cook may
be inadequate, or that the product, once contaminated, could be a
source of cross-contamination to other foods.
Likewise, the potential for contamination of either a cooked,
ready-to-eat product or a raw product as a result of rodent activity in
a processing plant, or as a result of improper use of pesticides on or
near the product, would not likely be identified in a HACCP plan. All
of these conditions are relevant to the safety of the product and
should be addressed by processors. It is not clear whether HACCP can
fully succeed in plants that are not in control of general sanitation
practices.
The inclusion of sanitation in HACCP--as desirable as it may be--will
not fully resolve this problem.
b. SSOP.
111. As indicated above, a significant number of comments that
addressed alternatives to the prescriptive approach to sanitation in
the proposal preferred a SSOP, either alone or in combination with
critical sanitation controls in HACCP. Significantly, the NACMCF was
among those that made this suggestion. NMFS' comment stated that, in
its experience, the development of SSOP's by processors in its
voluntary program has been associated with marked improvement in
sanitation. Many comments stated that much of the seafood processing
industry already has SSOP's, and that those that do not should develop
them.
FDA agrees that the development by processors of an SSOP would be a
beneficial step. FDA therefore is recommending in Sec. 123.11(a) that:
Each processor should have and implement a written sanitation
standard operating procedure (herein referred to as SSOP) or similar
document that is specific to each location where fish and fishery
products are produced.
An SSOP places the primary burden for identifying relevant controls
on the food processor. To meet this burden, it will be necessary for
the processor to think through each operation and identify where, and
how frequently, appropriate sanitation measures are necessary. The
process of doing so will foster the type of culture that FDA is trying
to promote, in which processors assume an operative role in controlling
sanitation in their plants.
FDA is adopting Sec. 123.11 pursuant to sections 402(a)(4) and
701(a) of the act to ensure that seafood is not produced under
insanitary conditions whereby it may be rendered injurious to health.
It grows directly out of proposed Sec. 123.10, but, as stated above, it
reflects the agency's efforts to make the sanitation requirements more
flexible.
FDA has not elected to make the development of an SSOP mandatory
because it recognizes that some processors may be able to achieve
satisfactory sanitation conditions and practices without having to
commit their sanitation control procedures to writing. The agency
remains convinced however, that such satisfactory conditions are
unlikely to be achieved without periodic monitoring of the operations.
For this reason the agency has retained at Sec. 123.11(b) the mandatory
sanitation monitoring requirements proposed at Sec. 123.10(c).
Sanitation monitoring will be further discussed in the next section of
this preamble.
Where a processor elects to develop an SSOP it should specify how
it will meet those sanitation conditions and practices that are to be
monitored in accordance with Sec. 123.11(b). These conditions and
practices will also be discussed in the next section.
Both Sec. 123.11(d) and Sec. 123.6(f) provide that sanitation
controls that are monitored in accordance with Sec. 123.11(b) need not
be included in the HACCP plan and vice versa. The purpose of these
provisions is to allow processors to incorporate those sanitation
controls into their HACCP plans that they believe are appropriately
addressed through HACCP, without having to duplicate those controls in
a separate sanitation program.
6. Monitoring and Corrective Actions
The regulations no longer contain specific monitoring frequencies
to ensure that proper sanitation conditions are being met, as was
proposed at Sec. 123.10(c). In keeping with the agency's decision to
reduce the prescriptive nature of the sanitation requirements,
Sec. 123.11(b) now requires that each processor monitor the conditions
and practices during processing with sufficient frequency to ensure, at
a minimum, conformance with certain key sanitation conditions and
practices as specified in part 110.
112. The agency arrived at this approach in response to the
comments. As part of the agency's efforts to achieve flexibility, it
examined the 18 sanitation controls that it proposed at Sec. 123.10(a)
in light of the comments that argued that they were overly
prescriptive. FDA proposed the 18 sanitation controls to ensure that,
where relevant to the processing operation, important areas of concern
were addressed in each plant. The preamble addressed at some length why
each of them was significant and relevant to safety. Moreover, although
considerable comment was received that challenged the manner in which a
particular processor should address these sanitation conditions and the
situations in which they should be considered applicable, only two
comments challenged the significance of these conditions or the need
for them to be controlled when they are determined to be germane, and
neither comment provided a basis for doubting the significance of these
controls.
FDA concludes that, where relevant to a processor's operation, the
processor should monitor sanitation conditions and practices relating
to the general subject areas reflected by the 18 specific sanitation
controls because they are important for ensuring the safety of the
product. As in the proposal, each processor will be responsible for
determining which of the subject areas are relevant to its plant and
process. However, unlike the proposal, the
[[Page 65150]]
processor will be free to tailor the sanitation controls to the
circumstances of its operation, as long as it does so in a manner that
ensures the effectiveness of those controls. The regulations do not
specify the manner in which control must be achieved. FDA will provide
guidance on how to ensure appropriate sanitation control in the Guide.
FDA is deferring consideration of the comments that it received on the
specific sanitation control measures that it described in the proposal
until it prepares the Guide.
In order to ensure that processors monitor the general subject
areas reflected by the 18 specific sanitation controls listed in the
proposal, FDA has concluded that it is appropriate to list in the
regulations the sanitation controls that should be considered. This
list will ensure that the most significant sanitation controls are
considered by the processor in formulating the measures that it will
institute in its plant.
The controls that FDA is listing in Sec. 123.11(b) no longer
contain sanitation standards that are beyond part 110 or repeat
specific standards that are contained in that part. Instead,
Sec. 123.11(b) now states that the processor shall ensure that actions
are taken to ensure that those sanitary conditions that are contained
in part 110 and that are relevant to the plant are maintained in eight
general areas:
(1) The safety of the water that comes into contact with food or
food contact surfaces or is used in the manufacture of ice
(Sec. 123.11(b)(1)). This control derives from proposed Sec. 123.10
(a)(1) and (a)(2) relating to water quality and treatment and to cross
connections between potable and nonpotable water systems.
Water is used in virtually all seafood processing facilities for
washing product, equipment, and employees' hands, for transporting fish
in flumes, and as an ingredient. Contaminated water can serve as a
vehicle for contamination of the product, both directly and indirectly
(Refs. 63; 64; 65, p. 49; 66; 67; and 68, pp. 1 and 2). Cross
connections, which include situations that allow for back siphonage
into a potable system from a nonpotable system under negative pressure
conditions, can result in the chemical or microbiological contamination
of the potable water system (Refs. 64; 65, pp. 50 and 51; 68; 71; and
72).
This matter was one of the two, as indicated above, about which FDA
received a comment that challenged the need for a sanitation control. A
comment suggested that the safety of the water supply is within the
jurisdiction of local health authorities, and that a processor should
not have to deal with that issue.
FDA acknowledges that many State and local jurisdictions exercise
control over both public and private water supplies. In the case of
private wells, they often permit and inspect the construction of the
well and collect periodic water samples for microbiological and
chemical attributes. Where such is the case, it may be reasonable for
the processor to rely upon these measures. However, in the absence of
appropriate controls by a public authority, FDA has concluded that the
processor must exercise whatever control is necessary to ensure that
the water supply is safe. To do otherwise would be to subject the
product to an unacceptable safety risk from the contaminants that may
be introduced by the water.
(2) The condition and cleanliness of food contact surfaces,
including utensils, gloves, and outer garments (Sec. 123.11(b)(2)).
This control derives from proposed Sec. 123.10 (a)(3) through (a)(5)
relating to the design, workmanship, materials, and maintenance of food
contact surfaces; the cleaning and sanitizing of these surfaces,
including the frequency of cleaning and sanitizing; the impermeability
of gloves and outer garments that contact food; and the maintenance of
gloves and outer garments.
Utensils, equipment, aprons, gloves, outer garments, and other food
contact surfaces can be vehicles for microbial contamination of both
the raw and finished products. Food contact surfaces that contain
breaks, pits, cuts, or grooves, or that are porous or corroded, may
harbor pathogenic microorganisms that can migrate to the product and
contaminate it. These kinds of surfaces are difficult to clean (Refs.
65, pp. 20, and 36-48; 72, pp. 166-167; 73; and 83). Where food contact
surfaces are constructed of toxic materials, the product may be
directly contaminated (Ref. 74). Inadequately cleaned food contact
surfaces can serve as a reservoir for pathogenic microorganisms,
especially if biofilms are allowed to form, in which microorganisms can
be entrapped and shielded from the action of cleaning and sanitizing
compounds.
(3) The prevention of cross-contamination from insanitary objects
to food, food packaging material, and other food contact surfaces,
including utensils, gloves, and outer garments, and from raw product to
cooked product (Sec. 123.11(b)(3)). This control derives from proposed
Sec. 123.10 (a)(6), (a)(7), (a)(13), and (a)(18), relating to employee
practices to prevent contamination, to physical separation of raw and
cooked product, and to plant design to prevent contamination.
Employees and food contact surfaces can serve as vectors in the
transmission of pathogenic microorganisms to the food. These
microorganisms can be introduced to the product from outside areas,
rest rooms, contaminated raw materials, waste or waste receptacles,
floors, and other insanitary objects. In the processing of cooked
products, the raw material may also serve as a reservoir of pathogenic
microorganisms. Employees or equipment that touch the raw material can
transmit these microorganisms to the cooked product (Refs. 7, 63, 64,
73, 74, 84, and 85). Finally, proper construction of the processing
plant is essential if other sanitary measures are to be successful. For
example, incompatible operations, such as handling of raw materials and
handling of cooked product, should be isolated (Refs. 71, 74, 87, and
88).
(4) The maintenance of hand washing, hand sanitizing, and toilet
facilities (Sec. 123.11(b)(4)). This control derives from proposed
Sec. 123.10 (a)(8) and (a)(16), relating to the location and
maintenance of hand washing and sanitizing facilities, and toilet
facilities.
Employee's hands can serve as a vector for the transmission of
pathogenic microorganisms to the food. Hand washing and sanitizing,
when performed using suitable preparations are effective means of
preventing such transmission. Toilet facilities eliminate from the
processing environment pathogenic microorganisms shed in fecal material
(Refs. 63, 64, 73, 74, 84, and 85).
(5) The protection of food, food packaging material, and food
contact surfaces from adulteration with lubricants, fuel, pesticides,
cleaning compounds, sanitizing agents, condensate, and other chemical,
physical, and biological contaminants (Sec. 123.11(b)(5)). This control
derives from proposed Sec. 123.10(a)(9), (a)(11), and (a)(12), relating
to the protection of food from various microbiological, chemical, and
physical contaminants.
The use of toxic compounds (e.g., pesticides, cleaning and
sanitizing agents, and lubricants) is frequently necessary in the
processing environment. Food and food packaging materials should be
protected or removed from areas where pesticides are used, and caustic
cleaning compounds should be thoroughly removed from food contact
surfaces before processing begins (Ref. 74). Condensate which forms on
an insanitary surface and then falls on the
[[Page 65151]]
product may carry with it pathogenic microorganisms (Ref. 65, pp. 24-
25).
This measure is the second about which FDA received a comment that
challenged the value of having a sanitation control. A comment
suggested that preventing the formation of condensate on ceilings above
processing is, in some situations, physically impossible. The comment
did not suggest that condensate is irrelevant to safety.
FDA reasserts that condensate is relevant but acknowledges that
there are instances in which it may be impractical for it to be fully
eliminated. In these instances, after taking all reasonable measures to
minimize the development of condensate, the processor will need to take
steps to protect the product from the dripping condensate or to ensure
that the surface from which it is dripping is sanitary. The development
of a written SSOP processor should tailor its sanitation controls to
its particular situation in order to accomplish this objective.
(6) The proper labeling, storage, and use of toxic compounds
(Sec. 123.11(b)(6)). This control derives from proposed
Sec. 123.10(a)(10), relating to the overall handling of toxic compounds
to protect against contamination of food. Improper use of toxic
compounds is a frequent cause of product adulteration throughout the
food industry. Proper labeling, storage, and use of the compounds is
necessary to minimize the risk of occurrence of such incidents (Ref.
74).
(7) The control of employee health conditions that could result in
the microbiological contamination of food, food packaging materials,
and food contact surfaces (Sec. 123.11(a)(7)). This control derives
from proposed Sec. 123.10(a)(15), relating to the exclusion of persons
who appear to have an illness, wound, or other affliction that could be
a source of microbial contamination.
Employees can serve as a reservoir of diseases, such as
salmonellosis, shigellosis, and hepatitis, that can be transmitted to
consumers by foods. Additionally, open sores, boils, or infected wounds
present the potential for contamination of the food with such
pathogenic microorganisms as Staphylococcus aureus (Refs. 22, 74, and
84).
(8) Exclusion of pests from the food plant (Sec. 123.11(b)(8)).
This control derives from the proposed requirements at
Sec. 123.10(a)(17). Pests, such as rodents, birds, and insects carry a
variety of human disease agents, which they can introduce to the
processing environment (Refs. 63, 64, 73, and 84).
113. FDA proposed at Sec. 123.10(a)(14) that, ``Refrigeration units
that store raw materials, in-process, or finished fish or fishery
products that are cooked, ready-to-eat, smoked, or made in whole or in
part from scombroid toxin forming species shall be operated at a
temperature of 40 deg.F (4.4 deg.C) or below.'' The purpose of the
proposed requirement was to ensure that processors control the
microbiological hazards associated with refrigerated storage for these
particularly susceptible products. A significant number of comments
argued the control of temperature in refrigerated storage is a
processing hazard rather than a sanitation issue, and should be covered
by a firm's HACCP plan.
FDA agrees with these comments and has not included a provision on
refrigeration in the sanitation section of these regulations. A large
number of comments were received relative to the appropriateness of a
40 deg.F (4.4 deg.C) limit. These comments are no longer relevant to
these regulations but will be addressed in the redrafting of the Guide.
FDA has also incorporated the corrective action requirement
relative to sanitation conditions proposed at Sec. 123.10(d) in
Sec. 123.11(b). Section 123.11(b) the processor shall, correct in a
timely manner those sanitation conditions and practices that are not
met. The phrase ``in a timely manner'' did not appear in the language
of proposed Sec. 123.10(d). However, it was implicit that corrections
should be made as quickly as possible so as not to subject subsequently
processed product to conditions that could both jeopardize their safety
and render them adulterated. FDA has added the phrase for clarity.
Note that the other corrective action requirements in these
regulations, i.e., those in Sec. 123.7, do not apply to sanitation
controls that are exclusively addressed in Sec. 123.11. The controls in
Sec. 123.7 apply to a processor's HACCP system only.
7. Records
114. FDA received approximately 20 comments that addressed the
issue of sanitation records. Many others discussed recordkeeping in
general but did not specifically mention records of sanitation
controls. These latter comments have already been addressed in the
``Records'' section of this preamble.
Of those that commented specifically on sanitation records,
approximately three-fifths, from processors and trade associations,
objected to the proposed requirement that processors maintain records
that demonstrate compliance with the appropriate sanitation standards.
In fact, a number of comments listed this issue as a significant reason
for their objection to the overall proposed approach to sanitation
control. The comments suggested that sanitation recordkeeping is costly
and has not been demonstrated to be effective. None of these comments
provided any data in support of their statements. Some argued that,
while they accepted the notion of records for CCP monitoring, they
opposed records of sanitation monitoring.
The remaining comments that addressed the issue of sanitation
records, from consumer advocacy groups, an individual, a Federal
government agency, a trade association, and a seafood broker, supported
the need for such records. These comments argued that sanitation
records are essential to ensure that processors adhere to established
sanitary standards, and that they need not be extensive.
FDA does not find the arguments against the requirement for
sanitation control records to be compelling. The agency concludes that
the burden will be minimal. Checklist type or simple notation records
will suffice in most instances. Creating them should be incidental to
monitoring. Monitoring to ensure that sanitation is under control is
the responsibility of all processors.
Monitoring and recording of sanitation conditions is as much a key
to the success in improving those conditions, and, hence, to increasing
consumer confidence in the seafood processing industry, as is the
development by a processor of an SSOP. As in the case of HACCP records,
sanitation records require that processors engage in systematic
monitoring of their own sanitation practices and conditions. It enables
them to see trends. Moreover, participation in recordkeeping helps
empower the work force and foster responsibility. It also allows the
regulator to assess a processor's compliance over a period of time, not
just at the time of an inspection.
FDA believes that the records bearing on the monitoring of relevant
sanitation conditions and practices and FDA's access to such records
are all essential if Sec. 123.11 is to be an effective regulatory
strategy. Therefore, FDA has concluded that the recordkeeping
requirement proposed at Sec. 123.10(b) will be retained. To reflect
other modifications in this section, Sec. 123.11(c) has been modified
to read, ``Each processor shall maintain sanitation control records
that, at a minimum, document the monitoring and corrections prescribed
by paragraph (b)
[[Page 65152]]
of this section. These records are subject to the requirements of
Sec. 123.9.''
Additionally, FDA has moved the requirement that sanitation
corrections be documented from proposed Sec. 123.10 (d) to Sec. 123.11
(b).
Finally, FDA notes that Sec. 123.11 does not contain any mention of
importers. The lack of a mention of importers in this section reflects
the position that the agency is taking in these regulations that, to
the extent that importers are also processors, they would be subject to
the sanitation requirements in this section. To the extent that they
serve as importers only, the sanitation provisions are not relevant to
their operations.
L. Imports
1. Background
The majority of seafood consumed in the United States is imported.
FDA's surveillance system for imports largely consists of reviewing the
customs entries for fish and fishery products being offered for entry
into the United States, engaging in wharf examinations and sample
collections for laboratory analysis, and placing products with a
history of problems on automatic detention. As with domestic
inspections, this method is basically a ``snapshot'' approach that
places a significant burden on the government to uncover problems. It
has failed to result in full compliance or consumer confidence in the
safety of imported seafood. Consequently, the agency tentatively
concluded that HACCP controls should apply to imported fish and fishery
products as well as to domestic products. Among other things, FDA
proposed that the definition of ``processor'' explicitly include those
who process seafood in foreign countries.
In addition, FDA tentatively concluded that the importer should
share some responsibility with the foreign processor for safety. More
often than not, it is an U.S. importer, rather than the foreign
processor, who actually offers imported fish and fishery products for
entry into the United States. The preamble noted that, while many
importers are conscientious about the safety of the products that they
import, others have little understanding of the potential hazards
associated with their products. Thus, the agency tentatively concluded
that the existing system of import controls had not promoted a sense of
responsibility in the import industry.
Therefore, in addition to proposing to require that foreign
processors that export to the United States comply with part 123, FDA
proposed that importers of fish and fishery products take steps to
ensure that their shipments are obtained from such processors.
Specifically, FDA proposed that importers: (1) Have and implement a
HACCP plan that describes how the product will be processed while under
their control; (2) maintain a copy of the foreign processor's HACCP
plan; and (3) take affirmative steps to ensure that the imported fish
or fishery product was produced in conformance with the foreign
processor's HACCP plan and with the proposed sanitation requirements.
The agency also proposed that importers need not take affirmative steps
if the fish or fishery product was imported from a country with which
FDA has a MOU documenting the equivalency of the foreign inspection
system with the U.S. system.
2. Should Imports Be Subject to These Regulations?
115. Approximately 70 comments addressed various aspects of the
proposed requirements for imports. Approximately half of the comments
that addressed the import provisions argued that it is necessary to
subject imported products to the same regulatory requirements as
domestically processed products. These comments were submitted by
processors, trade associations, State and foreign government agencies,
professional associations, and individuals. Many of these comments
argued that exempting foreign processors from the requirements of these
regulations would put the domestic industry at an unfair economic
disadvantage. Other comments stated that the import requirements would
increase consumer confidence in seafood because they would ensure that
imported fishery products have been produced under the same HACCP
requirements and held to the same sanitation standards as domestically
produced product. A few comments suggested that imported products are
more likely to present safety hazards than domestically-produced
products because of a lack of understanding of CGMP's on the part of
foreign processors. One comment asserted that a number of countries,
including Canada, the EU, Iceland, and Thailand are in varying stages
of establishing HACCP programs for their own domestic seafood
processors.
Most of the remaining comments (approximately one-half) did not
comment on whether HACCP controls should be required for imported fish
and fishery products but discussed aspects of the agency's proposed
approach. These comments will be addressed later in this section.
FDA did not receive any comments that persuaded it that imports
should be exempt from the requirements of these regulations. On the
contrary, the comments reflect a nearly universal recognition that the
safety of seafood cannot be adequately ensured if the majority of
products (that is, imports) are not subject to the same controls as
domestic products.
Therefore, the agency has not modified the regulations' basic
approach for imports.
116. Only two comments objected to the concept that imported fish
or fishery products should meet the same requirements as those for
domestic products. One of these comments argued that FDA should be
tolerant of a foreign processor that may not have the knowledge or time
to develop a HACCP plan before its product is ready for export and
urged the agency to develop a temporary waiver system to accommodate
such firms.
FDA is convinced that a 2-year implementation period, as discussed
in the ``Effective Date and Compliance'' section of this preamble, will
provide sufficient time for processors, both within and outside the
United States, to develop and implement HACCP plans and otherwise come
into compliance with the provisions of these regulations. The comment
provided no basis for treating foreign processors any differently than
domestic processors in this regard.
117. Another comment suggested that raw material fish and fishery
products imported for further processing in the United States should be
exempt from the requirements of the regulations but provided no reason
to support that position.
The exemption requested by the comment would make it difficult, if
not impossible, to control environmental hazards that may be associated
with these products. This preamble and the preamble to the proposed
regulations fully discuss the conclusions of the NAS, which identified
raw material hazards, such as microbiological contamination in
molluscan shellfish and natural toxins in both shellfish and finfish,
as among the most pressing problems that must be addressed to ensure
seafood safety. For the most part, these hazards are best addressed at
the time of harvest and by primary processors, through HACCP, at the
time of receipt. In many cases, there is little opportunity for control
beyond the latter point. Raw material fish and fishery products for
further processing comprise a substantial portion of fish
[[Page 65153]]
and fishery products imported into the United States (Ref. 212, p. 49).
Thus, to exempt foreign processing of such products from the
requirements of these regulations would be to greatly diminish the
scope and, therefore, the overall effectiveness of these regulations.
118. One comment that supported the need for equitable treatment of
imported and domestically produced products urged the agency to provide
the same opportunities for processors abroad to familiarize themselves
with the requirements of these regulations as it does the domestic
industry. The comment argued that just printing the regulations in the
Federal Register would not fulfill that responsibility. The comment
further suggested that FDA send copies of guidance materials to all
known foreign seafood processors, preferably in their native language.
FDA acknowledges the difficulty in reaching foreign processors with
information about the requirements of these regulations. However, mass
mailings to, and multiple translations of, these regulations and the
Guide for all foreign seafood processors that export to the United
States would not be practicable for FDA.
The agency intends to reach foreign processors primarily by
briefing foreign embassy staffs and by communicating with U.S.
importers during public and trade association meetings. Based on
experience in disseminating information about U.S. requirements to the
import community, the agency expects that these two groups will provide
the necessary information and guidance materials (in the appropriate
languages) to the foreign processors that they represent. This same
approach was used in disseminating information about the proposed
regulations. In fact, FDA became aware of a Japanese translation of the
proposal shortly after it issued.
In addition, FDA traditionally has provided training and technical
assistance for foreign processors and government officials on a variety
of food control topics, within the constraints of budget and manpower.
These projects have principally been conducted in developing countries,
often those in which the agency has become aware of a particular
problem that threatens the safety of products offered for entry into
the United States. FDA anticipates that these kinds of projects will
continue, and that they will focus more closely on HACCP. FDA also
expects that HACCP training, performed in accordance with the
standardized training materials under development by the Alliance (see
the ``Training'' section of this preamble), will provide further
opportunity for foreign processors to be exposed to the requirements of
these regulations.
3. Should Importers Be Subject to These Regulations?
119. Approximately half of those who commented on the import
provisions addressed whether the importer should be required to take
steps to ensure that its shipment originates from a foreign processor
that operates under HACCP. Approximately half of these comments favored
the concept and half opposed it, with both groups being diverse in
their representation.
Of those who opposed it, many argued that these requirements should
be the responsibility of the government, and that FDA should not
require that importers enforce them. A number of these comments further
argued that equivalent foreign government inspection systems cannot be
presumed to be in place, and that the only way to achieve a ``level
playing field'' is for FDA to perform inspections of foreign processors
at the same frequency, and using the same standards, that the agency
applies to domestic processors. One comment suggested that it may be
necessary to obtain legislative authority to perform foreign
inspections, as a condition of importation. Another comment suggested
that FDA auditing of foreign processor compliance would give importers
assurance that the products that they obtain from such sources had been
produced in accordance with appropriate U.S. standards.
One comment, while not opposed to mandatory importer
responsibilities, nonetheless argued that FDA should spend as much time
and effort inspecting foreign processors as it does on domestic
processors because over 50 percent of the seafood consumed in the
United States is imported. The comment continued that, ``to do any less
would be an unfair burden to domestic processors and would not
accomplish the stated goal to significantly improve the safety of
seafood consumed in the U.S.''
One comment argued that there is no real cost savings in assigning
importers the responsibility of verifying foreign processor compliance
rather than assigning that responsibility to FDA, because importers
will merely pass along the additional costs to the consumer. Another
comment noted that many small importers obtain products from over 25
countries, and that they cannot afford to provide the surveillance
necessary to ensure compliance.
Another comment argued that many importers function simply as
brokers, connecting a buyer with a seller, and that they lack the
expertise, manpower, and facilities to evaluate the adequacy of a
processor's HACCP controls. One comment stated, ``Many of the people
involved in importing never see the product and know nothing about
fish--these are people in a small room with a battery of phones!''
Another comment argued against placing reliance for assuring the safety
of imported seafood on persons who have a financial interest in the
product but lack the required knowledge about seafood safety.
One comment argued that requiring importers to exercise control
over their suppliers has no parallel in the proposed domestic HACCP
scheme. The comment stated that domestic processors must control the
hazards that are introduced during their processing operations but need
not be involved in verifying the control of those hazards associated
with their supplier's operations. Some comments argued that the
responsibility for controlling hazards that are reasonably likely to
occur should be assigned to the foreign processor, while others argued
that it should be assigned to the U.S. processor to whom the importer
sells the product. One comment asserted that importers are not in a
position to exercise control over the processing of products in foreign
plants any more than they are in a position to exercise control over
how the products are handled by their customers.
Most of those comments that supported the concept of importer
responsibility provided no reason. However, one comment stated that
requirements on importers would ensure that someone in the United
States would be legally responsible for the safety and wholesomeness of
each imported product.
FDA recognizes that requiring importers to take steps to ensure
that foreign processors from whom they purchase seafood products are in
compliance with these regulations could necessitate significant changes
in the operations of importers who have limited their activities to
matching buyers with sellers based on product specifications that may
have had little to do with safety. However, for two reasons, FDA cannot
agree that responsibility with regard to safety is inappropriate for
importers.
First, it has always been the importer's responsibility to offer
for entry into this country products that are not adulterated under
U.S. law. It is a prohibited act, under section 301(a) of the act, to
introduce into interstate commerce an adulterated food. Thus, an
importer would be committing a prohibited act if it failed to ensure
that
[[Page 65154]]
the food that it is offering for import into the United States is not
adulterated under section 402 of the act, including section 402(a)(4),
one of the principal provisions on which these regulations are based.
Currently, however, the importer is not required to operate in a
proactive manner to ensure that it is meeting this responsibility.
Rather, the importer need only offer products for entry into commerce
and thereby place the burden on the government to find a problem. Many
importers traditionally have purchased ``FDA rejection insurance'' to
hedge against that possibility. The government can shift the burden to
the importer by placing the importer's products on automatic detention
if it finds problems that warrant such a step, but in most instances
the burden remains on the government.
Second, responsible importers understand the issues related to the
safety of the seafood products that they import and customarily require
that foreign suppliers conform to their product specifications and
applicable U.S. regulations relating to safety. These importers take
various measures to ensure that a foreign processor can comply with
their specifications and safety requirements before they agree to
purchase products from the foreign processor.
Thus, it is feasible for importers to take steps to ensure that
they are not offering adulterated products for entry into U.S.
commerce. Requiring such measures will not be a significant added
burden for many importers, particularly as HACCP principles become more
widely used and understood in international commerce. Foreign
processors that want to participate in the export market, not only to
the United States but to the EU, Canada, and an increasing number of
other countries, will implement HACCP and sanitation control programs
and will be prepared to address an importer's needs for verification.
FDA does not agree that there is no parallel in the domestic scheme
to the importer's responsibility to ensure that the goods it is
offering were produced under HACCP. Domestic processors, like importers
must work with their suppliers (e.g., fishermen) to ensure that all
reasonably likely hazards (e.g. natural toxins and agricultural and
industrial chemical contaminants) are controlled. FDA is confident that
importers, like processors, will realize that ensuring that foreign
processors institute preventive control systems is a cost effective
means of ensuring that the products that they offer for entry into the
United States will consistently meet FDA's entry requirements and will
be safe for consumption. FDA also disagrees with those comments that
suggested that a requirement that importers take steps to ensure that
the products they offer for entry have been produced under a HACCP plan
is an abrogation of FDA's responsibilities. As stated previously, the
industry has a responsibility to ensure that the food that it
introduces into interstate commerce is not adulterated. FDA has a
responsibility to verify that industry is meeting its obligation and to
take remedial action if industry fails to do so. Importers, who are
usually the owners of the products that they are offering into
commerce, are a part of that industry. FDA cannot accept that importers
have no responsibility to ensure that their products are not
adulterated.
The agency recognizes that probably the most effective way for a
regulatory agency to evaluate a processor's compliance with the HACCP
and sanitation requirements is through onsite inspection of facilities,
practices, and records. FDA has performed a limited number of
inspections of foreign processors and, within its budgetary
limitations, will continue to do so to enforce these regulations.
However, such inspections are costly, and any attempt to significantly
increase their number would require additional resources.
FDA will continue its traditional import surveillance role,
utilizing entry document review, wharf examinations, sample
collections, and automatic detentions as screening tools. These tools
indirectly evaluate the adequacy of HACCP and sanitation controls and
will continue to be useful in detecting significant problems. While
end-product testing and evaluation are not adequate substitutes for
preventive controls in ensuring the safety of a product, they can
provide verification where appropriate (Ref. 34, pp. 201-202).
FDA has concluded that requiring HACCP controls, together with
import surveillance and periodic inspections of importers to ensure
their compliance with the requirements of Sec. 123.12, will better
ensure the safety of imports than the current system.
In a related matter, Sec. 123.3(g) makes clear that, under ordinary
circumstances, freight forwarders, custom house brokers, carriers, or
steamship representatives will not be required to fulfill the
obligations of an importer. It is possible, although FDA has no way to
know with any certainty, that some of those that objected to being
required to fulfill those obligations would, as a result of these
clarifications, find that they would not be expected to do so.
4. Memoranda of Understanding (MOU's)
120. Many of the comments that objected to the importer
responsibility provisions of the proposal on the grounds that the
government is the appropriate entity to ensure foreign processor
compliance, stated that the most effective means of ensuring such
compliance would be for FDA to enter into MOU's with the governments of
exporting nations. Approximately one-third of those that commented in
any way on the importer provisions urged FDA make the negotiation of
MOU's a high priority. Only one comment objected to the development of
MOU's.
Several comments argued that FDA should develop MOU's with all
countries from which seafood is imported. One of these comments pointed
out that to do otherwise would unfairly cause the obligations of
importers to vary considerably. A few comments argued that the
existence of an MOU should be a prerequisite for the importation of
seafood products from a country. One of these comments stated that
mandatory MOU's would reduce the complexity of the present import
surveillance situation, reduce the number of countries exporting
seafood to the United States, and encourage the development of improved
food safety programs in exporting countries. Another comment asserted
that MOU development is appropriate because government-to-government
relationships and audits can be free of influence from packers and
importers, whereas foreign suppliers may be prone to provide false
assurances about their programs to prospective importers.
One comment urged FDA to fully describe the process and criteria
for developing and evaluating MOU's and expressed concern about the
process because of the varying level of sophistication of foreign
seafood control programs. One comment stated that the foreign
government should be responsible for evaluating the foreign processor's
HACCP plan, inspecting the foreign processor, periodically analyzing
products produced by the foreign processor, and issuing health
certificates. A few comments stated that FDA should monitor the
effectiveness of the foreign government's control program in a manner
that is authorized in the MOU. These comments stated that, under the
MOU's, the foreign government should provide FDA with periodic lists of
processors that meet the requirements of these regulations, or,
alternately, that all seafood processors
[[Page 65155]]
in the country would be required to meet the requirements.
One comment urged FDA to publish periodic reports on the status of
MOU's on seafood products and to make them available to all importers.
This comment and others argued that it should be FDA's responsibility
to notify importers about changes in the status of MOU's, rather than
be the responsibility of the importer to find out about any changes.
One of these comments noted that, because a change in the status of an
MOU could be very detrimental to importers, there must be sufficient
lead time to allow importers to develop alternate verification
procedures when changes do occur.
Another comment urged FDA to coordinate with U.S. importers and
exporters in developing a schedule for MOU development. The same
comment urged FDA to assign more resources to the development of MOU's.
On the other hand, one comment stated that the MOU development
process is overly open-ended and could result in inconsistencies
between domestic and foreign requirements. The comment argued that this
inconsistency could result in an economic disadvantage for domestic
processors.
FDA agrees with those comments that urged that the agency give high
priority to the establishment of MOU's with U.S. seafood trading
partners. In the absence of significant numbers of agency inspections
of foreign processing facilities, FDA acknowledges that an MOU can be
the most efficient and effective mechanism for ensuring that foreign
processing plants are operating in compliance with the requirements of
these regulations. FDA also agrees that the potential for signing an
MOU with FDA is likely to serve as an incentive for the improvement of
regulatory food control programs and processing conditions in seafood
exporting countries, especially where the existence of an MOU serves to
excuse the importer of products from that country from certain
verification activities.
FDA has concluded that the development of MOU's or similar
agreements with foreign regulatory agencies is an appropriate method
for ensuring that foreign processors that export to the United States
are in compliance with the requirements of these regulations. Moreover,
as suggested by several comments, the agency has determined that, where
an MOU exists, there is no need for the importer to perform any
independent verification procedures for purposes of these regulations.
In this situation, the importer should be able to rely upon the foreign
regulatory authority to ensure compliance by foreign processors.
FDA is therefore retaining the provision on MOU's from the proposal
but modifying it to provide that, where an importer elects to obtain a
fish or fishery product from a country with which FDA has an active MOU
or other similar agreement, the importer need not engage in any
independent verification activities.
The agency has developed an internal protocol for developing MOU's
and is negotiating agreements with several countries. FDA is committed
to negotiating as many MOU's as possible. Also in the Federal Register
of June 15, 1995 (60 FR 31485), FDA published the notice of
availability of a new Compliance Policy Guide on MOU's.
However, it is not reasonable to expect that an agreement could be
reached with all countries from which seafood is imported into the
United States. The barriers to achieving such a result include the
inadequacy of foreign regulatory programs and the lack of interest on
the part of some foreign governments in entering into an agreement. The
availability of FDA resources also can affect at least how long it
takes FDA to enter into a particular MOU.
For these reasons, the existence of an MOU or similar agreement as
a requirement of entry of fish or fishery products into the United
States would result in an enormous negative economic impact to a major
segment of the U.S. seafood industry. Moreover, such a restriction is
not warranted from a public health perspective given the alternative
means of verifying the existence of HACCP controls that are provided in
these regulations.
Experience obtained in part in the international portion of the
FDA/NMFS seafood HACCP pilot project has demonstrated that foreign
seafood regulatory programs vary considerably, both in their
capabilities and in their structures. Likewise, foreign seafood
processing conditions are highly variable. Thus, FDA cannot simply
follow a boiler plate format in negotiating MOU's. Rather, they must be
tailored to the specifics of the situation presented by a particular
country. It is possible that some agreements can provide simply for the
submission of lists of approved processors to FDA at regular intervals;
others may require much more extensive FDA involvement before and after
goods flow under the agreement. Some agreements may cover all of a
country's seafood processors, while others may be targeted to specific
species or product forms, depending on factors such as the capability
of the foreign regulatory authority.
In any case, all agreements can be expected to provide for FDA
verification of the effectiveness of the foreign programs, including
onsite visits. FDA is principally interested in two- way agreements,
that is, agreements that acknowledge the acceptability of the U.S.
regulatory system to the foreign government as well as the
acceptability of the foreign regulatory system to the U.S. government.
The agency will make every reasonable effort to communicate with
the industry about changes in the status of MOU's through Federal
Register notifications and other means. FDA is open to suggestions
about the best ways to communicate in this regard.
Nevertheless, it will ultimately be the importer's responsibility
to keep appraised of any changes in the status of MOU's.
The agency is also receptive to the views of the seafood industry
and others about how countries should be prioritized for the purpose of
negotiating MOU's. Any information that the agency receives on this
topic will be coupled with existing information concerning the
likelihood of negotiation success and the types and quantity of
products typically offered for entry from the country in question.
5. Importer Verification Procedures
121. The remaining comments discussed specific aspects of the
proposed importer requirements. Some of these comments argued that the
responsibilities that were proposed for importers are onerous,
unworkable, and inefficient but offered nothing in support of these
assertions.
A number of comments objected to the proposed requirement that all
importers have and implement a HACCP plan. Several of these comments
contended that an importer's plan can only address the hazards that
occur during the time that products are under the importer's control
(i.e., from the time the importer takes possession of the product until
it is shipped to its customer), and that requiring that the plan cover
this point is inconsistent with the principles of HACCP. One comment
agreed that an importer should be required to develop a plan if it also
processes the product, as in the case of an importer who stores the
product. The comment asserted that, in such a case, however, the
importer's HACCP plan would be minimal. The comment further asserted
that the foreign processor should be the party responsible for
developing a HACCP plan that addresses the hazards
[[Page 65156]]
introduced during processing in the foreign plant. The comment
recommended that, as an alternative to having a HACCP plan, an importer
should be able to develop SOP's that outline the steps that it will
take to determine whether to purchase the product from a foreign
supplier.
A number of comments supported the proposed requirement for
importer HACCP plans but provided no reasons for their support.
The agency agrees that it would be inappropriate to require that
importers have and implement a HACCP plan regardless of whether they
process the products they import. As stated elsewhere in this preamble,
HACCP is a system that provides immediate feedback, through the
monitoring of CCP's, as to whether a process is under control. Unless
an importer is also a processor, there are no CCP's in the classic
sense for the importer to monitor, and from which to obtain real-time
feedback. Consequently, only where importers also process in accordance
with the definition of that term at Sec. 123.3(k) will they be required
to have and implement a HACCP plan that meets the requirements of
Sec. 123.6. Those food safety hazards that can be controlled by the
foreign processor must be addressed in the foreign processor's HACCP
plan in accordance with Sec. 123.6.
Consequently, FDA has revised the regulations to limit the
responsibilities of importers. Instead of having to maintain their own
HACCP plan, under Sec. 123.12(a), in the absence of an MOU or similar
agreement, importers only need to maintain and implement written
verification procedures for ensuring that the fish and fishery products
that they offer for import into the United States have been processed
in accordance with the requirements of these regulations. The only
exception to this rule would be if the importer itself engages in
processing, such as holding food, in which case the importer would, as
stated above, also be a processor and subject to Sec. 123.6.
122. In determining the nature of the verification procedures that
an importer must have and implement, FDA considered the comments that
addressed the appropriate functions and existing procedures of
importers. Several comments noted that importers routinely purchase
products according to specifications and observed that these
specifications could be the basis for reasonable control measures for
importers. The NACMCF recommended that importers be required to
maintain product specifications that are relevant to product safety for
fish and fishery products that they import. The NACMCF listed water
activity, pH, histamine content, and, perhaps, pathogen limits as
examples of specifications that importers might set in an effort to
ensure product safety.
The agency agrees with the comments that product specifications can
be useful tools with which importers can exercise some control over the
products that they purchase and offer for entry into the United States.
In fact, FDA stated in the preamble to the proposed regulations that
the purpose of an importer's plan was, in part, to include criteria for
how the importer will decide to purchase seafood. FDA is also
encouraged by the fact that the comments generally agreed that having
product specifications would not constitute a new burden for many
importers.
For these reasons, the agency in Sec. 123.12(a)(2)(i), is requiring
that the importer's written verification procedures include product
specifications that are designed to ensure that the product is not
adulterated under section 402 of the Federal Food, Drug, and Cosmetic
Act because it may be injurious to health or have been processed under
insanitary conditions. These are the adulteration sections that relate
to the safety of fish.
In many cases, importers will find existing Federal food safety
standards, including tolerances and guidelines, to be useful
specifications. In other cases, specifications may need to be tailored
to the circumstances. For example, the importer might need to ensure
that the temperature of a modified atmosphere packaged product, when it
comes off a ship, is 38 deg.F (in such foods there is a risk of C.
botulinum type E growth and toxin development which can occur at
temperatures as low as 38 deg.F), although the CGMP's at
Sec. 110.80(b)(3)(i) state only that refrigerated foods should be
stored at 45 deg.F or below. The importer is encouraged to seek the
advice of qualified experts, as needed, in setting specifications. The
same resources available to help domestic processors in setting CL's
are available to importers, including the Guide; Sea Grant Institution
and other academics; Federal, State, and local food safety regulatory
agencies; consultants; the Alliance and other training courses; and
published literature.
6. Affirmative Steps: General
As a second part of the importer's verification procedure, FDA is
essentially retaining from the proposal, in Sec. 123.12(a)(2)(ii), the
requirement that the importer take affirmative steps to ensure that the
products being offered for entry are actually being produced under
controls that meet the requirements of these regulations. In order for
product specifications to be meaningful, importers must take steps to
establish that their suppliers are in fact operating in a manner that
can reasonably be expected to produce a product that meets those
specifications. Effective verification involves scrutinizing the
standard, much like evaluating whether the HACCP plan continues to be
appropriate, and scrutinizing performance to determine whether the
standard is consistently reached, much like reviewing monitoring
records (Ref. 34, p. 201). FDA is adopting this approach in
Sec. 123.12(a)(2)(ii).
Among the affirmative steps that FDA proposed that a processor take
were: (1) Obtaining the foreign processor's HACCP-monitoring records;
(2) obtaining a certificate from a foreign government inspection
authority certifying that the firm is operating under a valid HACCP
plan or certification on a lot-by-lot basis; (3) regularly inspecting a
supplier's facilities; (4) periodic end-product testing by the importer
or a private laboratory hired by the importer; or (5) other such
verification measures as appropriate. FDA listed these affirmative
steps as examples of the types of measures that would be acceptable to
the agency. FDA does not wish to predetermine all the possible ways
that an importer could perform affirmative steps.
123. A number of comments objected to each of the affirmative steps
that FDA listed in the proposed regulations, and a few expressed
support for each. However, few of the comments provided any reasons for
their positions.
One comment suggested that the best means by which an importer can
ensure that the conditions at a foreign processing facility are at
least equivalent to those required of domestic processors is for the
importer to verify the adequacy and implementation of the foreign
processor's HACCP plan during a visit to the facility. Another comment
stated that, ``without both audits and HACCP records, foreign plants
(possibly domestic facilities too) will not adhere to the letter of the
FDA regulation and assure safe product in the market.''
Conversely, a number of comments argued that it would be unworkable
for importers to conduct inspections of foreign processors. One of
these comments stated that to justify the expense of such an
undertaking would necessitate that a highly trained, competent
individual perform the function.
As stated earlier, FDA remains convinced that importers must
exercise
[[Page 65157]]
sufficient control over the fish and fishery products that they offer
for entry into their country to ensure that the products are produced
pursuant to the requirements of these regulations. The agency
recognizes that any one of the affirmative steps may not be appropriate
or feasible for a particular importer or foreign processor. The
regulations allow importers to select an affirmative step that is
workable for their circumstances and to develop appropriate affirmative
steps other than those listed in the regulations (see
Sec. 123.12(a)(2)(ii)(F)). However, such measures must provide at least
an equivalent level of assurance of foreign processor compliance as
that provided by the listed affirmative steps.
Additionally, FDA has modified the importer requirements to allow
for the performance of any of the affirmative steps by a competent
third party (Sec. 123.12(b)). This provision provides even greater
flexibility to importers in meeting the requirements of these
regulations.
Thus, FDA is not persuaded that the affirmative steps are not
feasible or appropriate and has included them in these final
regulations.
124. A comment argued that government certificates should not be
acceptable unless they are issued by countries with which FDA has
signed an MOU or similar agreement. The comment asserted that,
especially in developing countries, there may be different
interpretations of the regulations, and differences in competency,
credibility, infrastructure, intent, and uniformity that might bring
the utility of such certificates into question.
FDA acknowledges that it is likely to have a higher level of
confidence in certificates received from a government entity with which
it has signed an agreement than with one with which no agreement
exists. However, as discussed above, it is unlikely that the agency
will be able to negotiate an MOU with every country that exports
seafood to the United States. Thus, there may be countries that have
excellent certification programs with which FDA, for a variety of
reasons, simply does not have an opportunity to enter into an
agreement. Moreover, if the agency learns, either through its own
routine surveillance activities, consumer complaints, or other means,
that there is evidence that a country is routinely issuing certificates
inappropriately, the agency will try to inform firms that import fish
or fishery products from that country that it will expect them to use
other means of verification if they want to avoid the appearance that
those products are adulterated under section 402(a)(4) of the act (see
Sec. 123.12(d)).
125. One comment urged that certification be permitted on a
continuing basis rather than requiring lot-by-lot certification.
FDA agrees that continuing certification is appropriate and notes
that the language and intent of the proposed regulations would have
allowed for it. Nonetheless, in an effort to further clarify this
situation, the agency provided in Sec. 123.12(a)(2)(ii)(B) that:
``Obtaining either a continuing or lot-by-lot certificate * * *'' will
be one way to satisfy the requirement that an importer take affirmative
steps to ensure that the product is produced in accordance with the
requirements of this part.
7. Foreign Processor HACCP Plans
126. Approximately 15 comments addressed whether importers should
be required to have on file copies of the HACCP plans of each of their
foreign processors. Approximately half of these comments supported such
a requirement, although for the most part they provided no reasons for
their support. The other half objected to the requirement. One of these
comments argued that possession of a foreign processor's HACCP plan
would be cumbersome for the importer and would provide no assurance
that product shipped by that processor was processed in accordance with
the plan. One comment cautioned that it would be unrealistic to expect
that importers could make any but a rudimentary judgment as to the
adequacy of foreign processors' HACCP plans. Such judgments, these
comments asserted, should be reserved for the regulator when the plans
are assessed during inspections of importers' records.
One comment cited the possibility of breaches in confidentiality
because commercially sensitive material would be supplied to importers.
A related comment suggested that, to solve the confidentiality problem,
the foreign processors' HACCP plans should be filed directly with FDA
rather than with importers.
Although the agency continues to believe that a foreign processor's
HACCP plan provides a useful basis for verification, FDA is persuaded
by the comments that there are logistical and other issues that could
render the retention of HACCP plans by importers unmanageable in some
cases. FDA has also concluded that, in most cases, affirmative steps
such as those listed in Sec. 123.12(a)(2)(ii) (e.g., onsite inspection
by the importer and certification by a foreign government agency) will
be adequate to enable an importer to verify that the products being
imported are safe in accordance with the requirements of these
regulations.
As described previously, the NACMCF recommendations describe two
primary goals of verification: (1) Ensure that the plan is adequate to
address the hazards that are likely to affect the product; and (2)
ensure that the plan is being consistently implemented. The affirmative
steps listed in Sec. 123.12(a)(2)(ii) are designed to address both of
these functions. For example, obtaining HACCP and sanitation monitoring
records from the foreign processor (Sec. 123.12(a)(2)(ii)(A)) enables
the importer to confirm that the foreign processor has addressed the
relevant hazards and sanitation concerns (i.e., those for which there
are monitoring records), and that it is monitoring to ensure that these
concerns are under control during the production of lots that are
shipped to the importer. Similarly, obtaining governmental or third
party certification of foreign processor compliance with the
requirements of these regulations (Sec. 123.12(a)(2)(ii)(B)) or
inspecting the foreign processor directly (Sec. 123.12(a)(2)(ii)(C))
enables the importer to confirm that the foreign processor has an
adequate HACCP plan and SSOP, and that the relevant sanitation and
safety concerns are being controlled for those lots that are shipped to
the importer. The affirmative step options provided for by
Sec. 123.12(a)(2)(ii)(D) and (a)(2)(ii)(E) are discussed later in this
section.
Consequently, FDA has not included a requirement that importers of
fish and fishery products have on file the HACCP plans of each of their
foreign suppliers in these final regulations.
Nonetheless, FDA points out that maintaining copies of these plans
could be one of several measures that an importer could incorporate
into its affirmative steps. Therefore, these final regulations in
Sec. 123.12(a)(2)(ii)(D) incorporate the concept as one of the
affirmative steps that an importer may choose to use for verification
purposes.
127. One comment noted that the plans of foreign processors would
normally be prepared in the native language of the country of origin
and asked whether FDA would require that these documents be translated
into English. On the other hand, another comment recommended that HACCP
plans be maintained in both the language of the native country and in
English.
FDA agrees with the comment that argued that a copy of a
processor's HACCP plan would not, by itself,
[[Page 65158]]
provide adequate assurance that a given shipment of imported product
was processed in compliance with that HACCP plan or that the sanitation
requirements of Sec. 123.11 were met. One additional thing is needed to
provide such assurance: a written guarantee from the foreign processor
that the products shipped to the importer are processed in accordance
with these regulations. The guarantee is necessary to demonstrate that
the HACCP and sanitation control systems are being implemented for
products shipped to the importer. An importer should be able to make a
reasonable judgement about the validity of the guarantee through a
rudimentary review of the plan, as described below. Therefore, FDA is
including these requirements in Sec. 123.12(a)(2)(ii)(D).
FDA is also providing in Sec. 123.12(a)(2)(ii)(D) that the foreign
processors' HACCP plans that are maintained by importers be written in
English, so that they will be meaningful to the importer and will allow
for regulatory review.
128. As stated above, one comment cautioned the agency about the
ability of many importers to evaluate the adequacy of HACCP plans that
they might retain.
FDA acknowledges that many importers may not have the technical
expertise to evaluate the adequacy of seafood HACCP plans. However, the
agency is convinced that, as a result of the importers' assessment of
the food safety hazards that are reasonably likely to be presented by
the product, the importer should have developed some general
expectations about the content of the HACCP plan (e.g., which hazards
should be addressed). The importer should be able to spot any obvious
shortcomings and to discuss them with the foreign processor. It is not
enough that importers simply file away the documents upon receipt.
Importers may find it advantageous to make a judgment about the
likelihood that their product specifications will be met and to insist
that they be given a guarantee that contains assurances that the
specifications will be met.
129. Regarding the comment that complained about the potential loss
of confidentiality of foreign processor HACCP plans that are provided
to importers, since the agency has eliminated the requirement that all
importers retain copies of foreign processor plans, the significance of
this issue has been minimized. In the case where a foreign processor
does not wish to share its plan with the importer, the processor and
the importer would need to agree upon another means of providing for
importer verification.
130. Regarding the comment that suggested that all foreign
processors file their plans with FDA, the resource demands on the
agency that would come with such an undertaking would be prohibitive.
FDA cannot accept this suggestion.
8. Other Affirmative Steps
As a related matter, FDA has determined that, in the absence of a
requirement that importers maintain a copy of the foreign processor's
HACCP plan, finished product tests alone are insufficient as an
importer affirmative step to ensure that the foreign processor is
operating in accordance with these regulations. Finished product
testing alone has a small statistical likelihood of detecting defects
in a product, especially when the occurrence of such a defect is an
uncommon event, as is the case with most seafood hazards (Ref. 213).
The proposed requirement for the importer to obtain a copy of the
foreign processor's HACCP plan, in addition to performing finished
product testing, would have provided indirect evidence that HACCP
controls are in place and would have lent support to a conclusion,
based upon the analytical findings, that the relevant hazards are under
control. In the absence of such evidence, the importer cannot
reasonably conclude that the hazards are being controlled based solely
on a negative analytical finding. For this reason FDA has required in
Sec. 123.12(a)(2)(ii)(E) that such sampling be accompanied by a written
guarantee from the foreign processor that products being shipped to the
importer are processed in a manner consistent with the requirements of
these regulations. The guarantee provides the importer with reasonable
assurance that HACCP and sanitation controls are in place and are being
implemented, in a manner similar to the way that the foreign
processor's HACCP plan would have under the requirements of the
proposed regulations. Under this alternative, the importer would not
have to maintain a copy of the HACCP plan.
For clarification and consistency within the document, FDA has
revised the language of two of the affirmative steps to include
reference to the sanitation provisions of the regulations. In both the
proposed regulations and these final regulations the stated purpose of
the affirmative steps is to enable the importer to verify that the fish
or fishery product was processed under conditions that meet both the
HACCP and sanitation requirements of these regulations. However, the
formulations of two of the affirmative steps in the proposal did not
make specific reference to sanitation. To avoid confusion over what the
affirmative steps should cover, Sec. 123.12(a)(2)(ii)(A) now reads
``Obtaining from the foreign processor the HACCP and sanitation
monitoring records * * *'' and Sec. 123.12(a)(2)(ii)(B) reads ``* * *
certifying that the imported fish or fishery product is or was
processed in accordance with the requirements of this part.''
131. Several comments asked the agency to specify the frequency
with which the importer affirmative steps must be taken. A few comments
suggested that the frequency should be no greater than the frequency of
equivalent FDA verification activities.
It would not be practical for the agency to specify frequencies for
affirmative steps that would be appropriate in all circumstances.
Consistent with the frequency of monitoring by processors, importers
should take affirmative steps to monitor their suppliers with
sufficient frequency to accomplish its purpose--that is, to provide the
importer with reasonable assurance that the foreign processor is
operating in compliance with these regulations.
It would be inappropriate to tie importer affirmative step
frequencies to average FDA sampling and inspection frequencies. FDA
sample collection and inspection frequencies are determined, in part,
by the compliance history of individual firms, agency priorities, and
overall agency resources, not simply on a desired average minimum rate
of verification. Thus, FDA's rate of inspection has no bearing on how
frequently an importer should monitor a supplier.
132. A number of comments urged that the agency permit importers to
contract with third parties to perform verification activities on their
behalf. Two comments opposed such a provision but did not provide
reasons for their position.
Several comments urged that certificates by nongovernmental third
parties be accepted as an affirmative step. One of these comments, from
a trade association, suggested that an equivalent arrangement has been
accepted by FDA in controlling the importation of canned mushrooms from
the Peoples Republic of China. This same comment argued that a system
where individual importers inspect each of their suppliers is highly
inefficient. The comment suggested that a single, technically competent
party should perform the inspections. The trade association offered to
serve as a
[[Page 65159]]
clearinghouse for the reports of such inspections. Likewise, the
association offered to serve as a clearinghouse for finished product
sample results for imported products, reducing the number of samples
needed when the same product is imported by a number of importers. The
comment further suggested that the association be permitted to hold
foreign processor HACCP plans for its members, and perhaps for
nonmembers. The comment argued that acceptance of this suggestion would
reduce the number of duplicate records for the same product stored by
various importers.
The agency accepts that third party verification can be an
appropriate and efficient control mechanism. Such a system is
consistent with the use of third parties by processors for plan
development, record review, and CL deviation evaluation. Therefore, FDA
has added a new provision at Sec. 123.12(b), that reads, ``An importer
may hire a competent third party to assist with or perform any or all
of the verification activities specified in paragraph (a)(2) of this
section, including writing the importer's verification procedures on
the importer's behalf.'' It is worth pointing out that where an
importer uses the services of a third party, the importer remains
responsible for the verification procedures that are performed. The
importers must be able to demonstrate that appropriate verification
measures have been performed. This step may involve providing an FDA
investigator with a copy of the foreign processor's HACCP plan, results
of end-product sampling, results of an onsite inspection, the foreign
processor's monitoring records, or the foreign processor's written
guarantee. Third parties must, of course, be competent to perform the
duties in question, and FDA reserves the right to challenge such
competency. The agency has no objection to the use of clearinghouses
for importer verification activities, as long as the forgoing
requirements are met.
9. Importer Records
As previously mentioned, the proposed regulations would have
required that importers develop and implement a HACCP plan. One effect
of such a requirement would have been that importers would have had to
maintain appropriate records. As has been explained, FDA is adopting
only those essential components of the proposed approach that the
agency considers to be practicable for importers. One such component is
recordkeeping. Recordkeeping is essential in documenting for the
benefit of importers and the agency the affirmative steps of importers,
in the same way that it is essential in documenting the monitoring,
corrective action, and verification activities of processors. For this
reason, the agency has retained the recordkeeping aspect of the
proposal for importers, in a manner that is consistent with the overall
approach for importers in these final regulations. Section 123.12(c),
which treats importer records identically to processor records, reads,
``The importer shall maintain records, in English, that document the
performance and results of the affirmative steps specified in paragraph
(a)(2)(ii) of this section. These records shall be subject to the
applicable provisions of Sec. 123.9.''
133. FDA proposed that importers encourage foreign processors to
obtain HACCP training. A few comments urged the agency to make it clear
that foreign processors must comply with the same training requirements
as are applicable to domestic processors. One comment urged the agency
to permit HACCP- training courses for foreign processors to be
conducted in the country of origin by ``an official agency.''
FDA agrees that the need for training is the same for foreign
processors as it is for domestic processors. The intended benefits of
the training requirements are fully discussed in the ``Training''
section of this preamble. Nonetheless, the agency finds that the
proposed requirement that importers encourage foreign processors to
obtain training is unnecessary. Foreign processors that ship seafood
products to the United States are advised of the training requirement
of these regulations in the same way that they are advised of the other
requirements of these regulations, through publication of the
regulations. In addition, as mentioned elsewhere in this preamble, FDA
intends to provide the embassies of seafood exporting countries with
information concerning these regulations in order that they may in turn
provide it to the processors in their countries. Consequently, FDA is
not adopting this provision.
FDA has no objection to HACCP training being performed in the
country of origin by ``an official agency'' or other entity, as long as
the course of instruction is at least equivalent to that provided by
the standardized course under development by the Alliance.
10. Determination of Compliance
FDA proposed to require that there be evidence that imported fish
and fishery products were processed under conditions that comply with
the requirements of these regulations, and that if assurances that this
was the case did not exist, the product would appear to be adulterated
and would be denied entry. This section of the proposed regulations
provided five types of evidence that the agency would consider as
adequate to provide such assurance.
134. A few comments supported these provisions. However, a few
comments suggested that, if the importer is unable to provide assurance
that a HACCP system is in place, the importer should be permitted to
conduct finished product testing rather than having the product denied
entry. One comment urged that importers be held only to a ``best
efforts'' standard in determining whether their suppliers are in
compliance with these regulations. This comment suggested that if an
importer cannot determine that such compliance exists after using its
best efforts, the importer's product should not be banned from the
United States.
The purpose of these regulations is to cause processors of fish and
fishery products, both domestic and foreign, to develop and implement
HACCP systems of preventive controls to ensure the safety of their
products. The importer requirements are designed to impose an
obligation on importers to ensure that, like domestic products, the
products that they are importing are not adulterated within the meaning
of section 402(a)(4) of the act. This requirement means that importers
must be able to satisfy themselves, and ultimately FDA, that the fish
and fishery products that they are offering for import were produced
subject to a HACCP system and sanitation controls designed to prevent
insanitary processing conditions that may render the food injurious to
health. If an importer does not have evidence that shows that the
products were produced subject to such controls, it should not offer
the product for import into this country. The lack of such evidence
creates the appearance of adulteration that cannot be overcome by the
collection and analysis of a finished product sample by an importer.
Given the problems that can arise in seafood processing if HACCP and
sanitation controls are not in place, under sections 402(a)(4), 701(a),
and 801(a) of the act, FDA is adopting Sec. 123.12(d), which provides
that if evidence does not exist that an imported fish or fishery
product has been processed under conditions that are equivalent to
those required of domestic processors, the product will appear to be
adulterated.
Section 123.12(d) derives from proposed Sec. 123.12 (a) and (b).
FDA has combined these provisions and, as
[[Page 65160]]
suggested by a comment, has used terminology consistent with the rest
of the regulation in Sec. 123.12(d). While proposed Sec. 123.12 (a)(1)
through (a)(5), which described the types of evidence that could be
used to demonstrate compliance with the proposed regulations, reflected
important principles for the importation of fish, based on the
comments, FDA finds that these provisions were causing confusion, and
that the statute can appropriately be implemented without including
them in the final rule. For this reason, FDA has not adopted these
provisions.
135. One comment asked what documents, if any, would have to be
presented to FDA at the time of entry concerning the status of the
foreign processor. Another comment suggested that importers should note
on the entry documents that a HACCP plan is available for the foreign
processor. This comment stated that FDA would have an opportunity to
review the plan as part of its determination of whether to allow entry
of the product.
FDA is not requiring that evidence of the importers' affirmative
steps be presented along with the existing U.S. Customs Service entry
documents as a matter of routine practice. It is possible that, in some
circumstances, such a step will be necessary (e.g., where the agency
has reason to believe that inappropriate conditions exist in the
foreign processing facility). However, typically, the importer will be
able to retain such evidence in its files and to make it available to
the agency when FDA performs an inspection at the importer's place of
business. Such a system is necessary because of the time that is
necessary for the agency to properly review the importer's
documentation of its affirmative steps and of the foreign processors'
HACCP plans. Nonetheless, the agency is willing to explore alternate
methods of implementing the import requirements of these regulations,
such as that suggested by the comment. FDA welcomes a continuing public
dialog about this matter.
136. One comment asked whether FDA would maintain an approved list
of foreign processors.
The agency has no plans to maintain such a list, nor is it apparent
upon what basis such a list would be prepared. A possible exception
would be as part of an MOU arrangement, where the foreign country would
agree to provide a list of ``approved'' firms to FDA. In such a
situation, FDA would use reasonable means to inform the import industry
of the purpose and contents of the list and update them as rapidly as
possible when changes are made.
137. One comment expressed concern that the same foreign processor
HACCP plan might be reviewed by different FDA investigators in
different ports of entry, and that these investigators might reach
different conclusions as to its adequacy. The comment urged that the
agency coordinate such reviews, as well as reviews of importers'
affirmative steps, in a way that would minimize inconsistencies.
FDA acknowledges that the situation might well arise where
different investigators review the same foreign processor HACCP plan as
a part of different importer inspections. To minimize inconsistencies
in such reviews, the agency intends to train its inspectional staff in
the requirements of these regulations and the application of HACCP
principles to seafood processing, including training on the Guide. The
agency also intends to develop guidance relative to importer
verification activities.
M. Guidelines or Regulations?
1. Background
FDA recognizes that many processors will need guidance in the
preparation of HACCP plans, and that HACCP plans will vary in
complexity. The agency is committed to providing the industry with
technical assistance that includes general guidelines for HACCP plans
and the contents of plans for specific types of products and processes.
As part of FDA's seafood HACCP proposal, the agency included
guidelines, in the form of appendices, on how processors of cooked,
ready-to-eat products and products involving scombrotoxin-forming
species could meet various provisions of the proposed regulations
relating to the development and implementation of HACCP plans. FDA
regards these products as being high-risk relative to other seafoods.
They involve special considerations or special hazards for which
additional guidance would likely be useful.
Cooked, ready-to-eat fishery products present an elevated risk of a
microbiological hazard compared to most other seafood products. They
are cooked as part of processing and might not receive additional
cooking by consumers before consumption. Consequently, to be safe,
these products must not contain pathogens at a level that will cause
disease and must not be subjected to time-temperature abuse that would
allow any existing pathogens to grow to unacceptable levels.
Scombrotoxin-forming species are fish that can form a toxin if
exposed after death for significant periods to temperatures that permit
the growth of certain bacteria. Scombrotoxin can result in a mild to
severe allergic response in humans.
The guidelines for these products contained advice about hazards
that are reasonably likely to occur and on details for HACCP plans for
the control of these hazards. In addition to asking for comments on the
substance of the guidelines, the agency asked for comment on whether
these guidelines should remain as guidelines, or whether some or all of
them should be adopted as regulations. As regulations, they would,
essentially, tell processors that certain hazards must be controlled in
their HACCP plans, identify in advance critical points in the
processing of these products that processors must control to minimize
these hazards, and tell processors what they would have to do, at a
minimum, to maintain proper control of those critical points.
In another appendix to the proposed regulations, FDA published
excerpts from the draft Guide, mentioned earlier in this preamble, for
the stated purposes of publicizing the existence of that draft Guide
and of providing processors with information about the types of
guidance that the agency expected would be available in it.
One of the excerpts that FDA published was guidance on the
processing of smoked and smoke-flavored fish. These products represent
a significant hazard relative to contamination with C. botulinum,
especially when packaged in reduced oxygen atmosphere packaging. FDA
requested comment on whether this guidance should remain solely within
the Guide, whether it should be provided an appendix to the
regulations, or whether it should be adopted as regulations. The effect
of adopting these materials as regulations would be the same as for the
appendices described above.
If these materials remained in the form of guidelines, processors
would be free to adopt them or not, so long as measures that provide an
equivalent or superior degree of safety are implemented.
138. Approximately 55 comments responded to FDA's request for
comment on whether these materials should remain as guidelines or be
adopted as regulations. The majority of comments preferred guidelines.
A few comments suggested that FDA initially issue guidelines, then
possibly convert them to regulations after gaining experience with them
as adjuncts to a functioning HACCP system or after pilot testing them.
A few comments preferred to retain some of the materials as
[[Page 65161]]
guidelines and convert others to regulations.
Over one-third of those who commented on this subject supported
guidelines in general, without distinguishing among the three
guidelines. They argued that guidelines are in keeping with the general
philosophy of HACCP that processors assume responsibility for the
safety of their products. Some stated that detailed regulations for
processors to follow would not provide an adequate incentive to
processors to develop a full understanding of the hazards associated
with their products or processes. The result could be the development
of rote HACCP plans that might be inadequate for safety in specific
situations.
Some comments pointed out that, while guidelines can assist
processors to identify controls, guidelines probably could never
properly identify the CCP's and limits for all processors given the
uniqueness of individual processing methods. In the case of
regulations, processors would be obliged to adhere to the presented
limits regardless of their appropriateness to the operation. Many of
these comments preferred the flexibility that guidelines provide in
permitting HACCP controls to evolve with a changing knowledge base and
new technologies. Some expressed concern that if the guidelines were
adopted as regulations, the industry would bear an unnecessary burden
of having to petition FDA for amendments in order to accommodate new
products or processes. Modifications to the regulations could take
considerable time.
Several comments specifically objected to adopting either the
guidelines for cooked, ready-to-eat products or the guidelines for
scombroid toxin-forming species, or both, as regulations. The reasons
were generally the same as those given by those comments that supported
the use of guidelines generally.
One comment did express the concern that adopting the scombroid
guideline as regulations would have the effect of adopting a policy
action level for histamine as a defacto regulation without a formal
notice and comment rulemaking.
Several comments requested that guidelines only appear in the
Guide, and not in appendices to the regulations, to alleviate
confusion.
However, FDA did receive a number of comments that urged the agency
to adopt these guidelines as regulations. These comments cited a need
for minimum enforceable standards for these products to ensure the
protection of the public health. The comments argued that minimum
standards would avoid confusion about what is enforceable, and what is
not. They pointed out that as regulations, these provisions could be
more readily enforced.
FDA believes that all of these comments have merit. Guidelines can
provide flexibility that regulations sometimes lack. Moreover, because
they are advisory in nature, guidelines are less likely to be followed
by rote.
FDA thus agrees that, ideally, HACCP should serve as a catalyst for
processors to develop a full understanding of the relationships between
their products and processes and human food safety and to devise
controls for ensuring safety. There may well be more than one way to
reach an appropriate safety endpoint. Regulations might not always take
such alternatives into account.
On the other hand, in those cases involving high-risk products
where adherence to scientifically established minimum standards or
procedures is necessary to ensure a safe product by design, and those
minimums are not likely to change, there is good reason to make those
minimums something more than advisories. In those types of situations,
it makes no sense to act as if the work that scientifically established
the minimum processing conditions had not been done.
2. Cooked, Ready-To-Eat Products and Scombroid Species
These, then, are the considerations that FDA has weighed. In the
case of cooked, ready-to-eat products and products made in whole or in
part from scombroid toxin-forming species, FDA is persuaded that the
guidelines should remain as guidelines, at least until there is enough
experience with them to determine whether a change to regulations is
warranted. The agency has concluded that processors should be given
maximum flexibility, at least initially, to identify the reasonably
likely hazards and the CCP's and CL's for those hazards that are most
appropriate for their manufacturing processes. FDA will examine over
time whether processors are achieving an adequate degree of preventive
control for these products under the guidelines, and whether they are
doing so by following the guidelines exactly or partially or by relying
on alternative approaches.
FDA acknowledges that many comments objected to the details of the
appendices. These comments will be addressed when the first edition of
the Guide is published. FDA recognizes that these materials will be
more easily modified and improved if they remain as guidelines, at
least for the time being.
FDA agrees that all of these guidelines should appear solely in the
Guide. There are no appendices to these final regulations.
3. Smoked and Smoke-Flavored Fishery Products
The guidance for smoked and smoke-flavored fish contained specific
processing parameters (i.e., time and temperature of smoking and
finished product salt and nitrite concentrations) to be met in the
processing of such products, and control mechanisms for ensuring that
they are met. C. botulinum toxin production is prevented in smoked and
smoke-flavored fish by controlling these interrelated variables, as
well as by controlling the temperature of the product throughout the
chain of distribution.
139. Approximately 25 comments addressed whether these materials
should be regulations or guidelines. About half of the comments,
representing State and Federal regulatory agencies, professional
associations, and others, urged that the materials be codified as
regulations. The remainder, representing processors and trade
associations, requested that the guidelines remain as guidelines.
A number of the comments that urged that the smoked and smoke-
flavored fish guidelines be issued as regulations asserted that
regulations are more easily enforceable, would provide clear direction
to the industry, and would provide much needed nationwide uniformity in
the processing of smoked fish. One comment from a State regulatory
agency observed that processors are not adhering to existing
guidelines, such as the 1991 recommendations for these products by
AFDO, and are unlikely to change their operations in response to
another guideline. Several comments argued that the States need Federal
regulations to support their own efforts to regulate the industry and
to foster uniformity among the various existing State requirements. One
of these comments also stated that such regulations are needed to
ensure the safety of smoked fish, because the product has a history of
involvement in botulism outbreaks, is handled more than most other
products, increasing the risk of microbiological contamination, and is
frequently not cooked prior to consumption. One comment suggested that
the guidelines be tested in pilot programs before making them
mandatory, and that research information on smoked fish be disseminated
to industry through
[[Page 65162]]
technical bulletins, workshops, and meetings.
Several of the comments that suggested that the proposed guidelines
remain as guidelines argued that FDA has not demonstrated that present
practices in the smoked fish industry are causing risks that would
justify regulations, and that there have been no recent incidents of
botulism attributable to smoked fish. Several comments stated that most
of the problems with smoked fish in the past have resulted from abuse
of the product at retail or by the consumer.
A few comments objected to FDA's contention that large portions of
the industry do not conduct final product testing and to the inference
that all smoked fish processors do not monitor the composition of their
products. The comments stated that responsible companies do conduct
product testing on a regular and routine schedule, have scheduled
processes, and are aware of what they are doing.
Other comments recommended that FDA enforcement of the current
CGMP's, coupled with State and local enforcement of the Food Code for
smoked products that are produced in restaurants, retail, and food
service establishments, would make it unnecessary to treat smoked fish
products any differently than other products under these HACCP
regulations. One comment suggested that guidelines would have the same
impact as regulations because HACCP plans would be rejected by FDA if
they do not contain the recommended controls, and because States would
adopt the guidelines as regulations.
One comment argued that the issuance of prescriptive regulations
would eliminate the diversity in the types of smoked fish products
available and result in a ``homogeneous'' market. Another comment
counseled that the issuance of a regulation would cause Alaskan native
salmon processors to abandon their traditional trade.
The agency remains convinced that smoked and smoke-flavored fish is
a potentially hazardous food. While cases of botulism have not been
attributed to commercially prepared smoked or smoke-flavored fish in
over 30 years, the outbreaks of the 1960's clearly demonstrate the
potential for such occurrence. Virtually all the research that has been
conducted establish that processors need to control time, temperature,
and salinity (T-T-S) parameters and other matters for these products in
order to provide adequate barriers to toxin production (Ref. 214).
As the preamble to the proposed regulations pointed out, FDA and a
number of States have longstanding concerns that the actions of a
significant portion of the smoked fish industry do not demonstrate a
full appreciation for the nature of the risks. FDA and New York State
surveys of the smoked fish industry in the late 1980's, for example,
showed that many processors did not routinely control their T-T-S
parameters.
The comments have not persuaded FDA that, even without regulations,
processors will employ preventive controls to ensure the safety of
these products as a matter of design and not of chance. Botulism
derives from one of the most dangerous toxins known to exist. Controls
to prevent the formation of this toxin cannot be left to chance. HACCP
controls for this hazard are highly appropriate because HACCP requires
that the processor analyze its operation to determine how hazards
affecting its product can arise, and that it institute specific
controls to prevent those hazards. The majority of comments that
addressed smoked and smoke flavored fish products either supported the
concept of HACCP controls or did not argue against them.
140. The question, therefore, is whether, in addition to requiring
HACCP plans for these products, FDA should mandate specific CCP's,
minimum CL's, monitoring frequencies, and other matters that processors
would have to include in their HACCP plans. If the agency were to
codify draft guidelines as regulations, the agency would be answering
that question in the affirmative. The preamble to the proposed
regulations identified the T-T-S parameters in the draft guidelines as
being scientifically established minimums for ensuring that toxin
produced by C. botulinum will not be produced over the shelf life of
the product under refrigerated conditions and under conditions of
moderate temperature abuse. FDA has been urged for years to mandate
such T-T-S parameters for these products. In 1988 and 1989, for
example, AFDO passed resolutions asking FDA to expedite the development
of regulations for the safe processing of smoked fish. The comments to
this rulemaking that supported regulations over guidelines support the
mandating of specific T-T-S parameters.
However, a significant number of other comments challenged whether
some of the parameters in the guidelines were actually minimums, as FDA
had contended. They specifically objected to the minimum water-phase
salt levels in the draft guidelines for air packaged smoked and smoke-
flavored fish. Generally, these comments stated that there is little
safety concern with air-packaged smoked or smoke-flavored fish (hot or
cold smoked) containing as little as 2.5 percent water phase salt (less
than the minimum stated in the guidelines), and requested that FDA
reexamine the existing scientific data. A few comments stated that air-
packaged smoked fish has a limited shelf life in the refrigerated state
and that NMFS research has shown that spoilage occurs before toxin
production. One comment stated that NMFS, New York State Department of
Agriculture and Markets, and AFDO all consider a minimum water-phase
salt content of 2.5 percent to be acceptable for air-packaged products.
A few comments suggested that an alternative to specifying T-T-S
parameters would be to require that all processors have a scheduled
process for air-packaged products. The comment stated that this
requirement has been successful in the State of New York and has
enabled industry to produce products with water-phase salt
concentrations that are lower than those proposed by FDA. A few
comments suggested that the high salt levels proposed by FDA for smoked
and smoke-flavored products would be counterproductive to those
government programs aimed at reducing salt in the human diet and would
be unacceptable, or only marginally acceptable, to consumers. Other
comments suggested that the necessary minimum salt levels for smoked
and smoke-flavored fish might be reduced by shortening the shelf life
of the product or by storing and distributing the product frozen.
The comments have persuaded FDA that it may be possible for
processors to use parameters other than those in FDA's draft guidelines
and still produce a safe product. Moreover, the NACMCF has recently
endorsed AFDO's recommended parameters for smoked and smoke-flavored
fish. Most notably, these recommendations differ from those in FDA's
draft guidelines in that they provide for a minimum finished product
water phase salt content in air-packed product of 2.5 percent, whereas
the FDA proposal provided for a range of minimum values of from 2.5
percent to 3.5 percent, depending upon other processing parameters.
The agency acknowledges, therefore, that some recommended T-T-S
parameters differ from those in FDA's draft guidelines. FDA
acknowledges the possibility that other safe T-T-S parameters exist as
well. It is reasonable to suppose that there is more to be learned
about how the development of C. botulinum toxin is controlled in these
products, given the lack of reported illnesses in recent years. Thus,
while
[[Page 65163]]
FDA strongly believes that the T-T-S parameters in its draft guidelines
provide effective controls for botulism, the agency accepts that they
are not necessarily the only effective controls, or that all effective
controls have been identified.
Consequently, the agency has concluded that, at least for now, the
most appropriate place for such guidance on T-T-S parameters and
related matters is the Guide, and that it would not be appropriate to
adopt specific parameters for the processing of smoked fish by
regulation. However, because of the extreme nature of the hazard, and
in response to comments, FDA has chosen to codify a rudimentary
performance standard for the control of botulism in these products from
the draft guidelines (item number 11). As incorporated at subpart B,
Sec. 123.16, the performance standard reads:
In order to meet the requirements of subpart A of this part,
processors of smoked and smoke-flavored fishery products, except
those subject to the requirements of part 113 or 114 of this
chapter, shall include in their HACCP plans how they are controlling
the food safety hazard associated with the formation of toxin by C.
botulinum for at least as long as the shelf life of the product
under normal and moderate abuse conditions.
This requirement responds in part to the comments that proposed
that FDA require that all processors scientifically establish scheduled
processes for smoked and smoke-flavored fish, rather that mandate
specific T-T-S parameters and other matters. It requires processors to
establish CL's that are both appropriate to their operation and
scientifically sound. Because botulism is undoubtedly a hazard that
must be controlled in the production of these products, subpart B of
part 123 does not impose a requirement that would not exist in its
absence. It has been included for emphasis and as a reminder to
processors. The Guide will provide processors with assistance with
regard to specific T-T-S parameters and related matters.
141. FDA proposed that, with certain exceptions, fish to be smoked
or salted be eviscerated and free of residual viscera. The preamble to
the proposed regulations explained that salted or smoked uneviscerated
fish present a potential hazard for the development of C. botulinum
toxin production. The viscera of fish contain the majority of C.
botulinum normally present.
One comment argued that the entire evisceration provision should be
moved to the Guide. Another comment suggested that specific
evisceration requirements be codified but not as part of sanitation.
These regulations require in subpart B of part 123 that the
processors of smoked and smoke-flavored fish describe in their HACCP
plans how they are controlling the food safety hazard associated with
the formation of toxin by C. botulinum. Specific types of controls will
be provided in the Guide. Because evisceration is one form of control
for this toxin, it will be covered in the Guide as well and need not be
included in the regulations. Consequently, FDA has not included this
proposed provision in these final regulations.
N. Molluscan Shellfish
1. Background
In addition to the general HACCP provisions in subpart A of part
123, FDA proposed subpart C of part 123--``Raw Molluscan Shellfish,''
which set forth specific requirements for the processing of fresh or
frozen molluscan shellfish. Proposed subpart C of part 123 described
certain types of controls that processors of these products must
include in their HACCP plans in order to meet the requirements of
subpart A of part 123.
Specifically, FDA proposed to require that processors of raw
molluscan shellfish identify in their HACCP plans how they are
controlling the origin of the molluscan shellfish that they process.
FDA proposed to require that these controls include accepting only
molluscan shellfish that originated from growing waters that are
approved by a shellfish control authority, that are from harvesters
that are licensed or from processors that are certified by a shellfish
control authority, and that are properly tagged or labeled. In
addition, FDA proposed to require that processors maintain records to
document that each lot of raw molluscan shellfish meets these
requirements. FDA also proposed to amend Sec. 1240.60 (21 CFR 1240.60)
to provide for a system of tagging for shellstock and labeling for
shucked molluscan shellfish as a means of source identification.
It is important to note that shellfish control authorities in the
United States are generally agencies of State governments, and that the
tagging of molluscan shellfish is an important aspect of State
shellfish control programs. As discussed below, reference to aspects of
existing State programs in these Federal regulations is not intended to
supplant or override the State programs in any way. Rather, these
provisions are intended to strengthen the Federal system in ways that
will complement, and thereby better support, State programs.
Molluscan shellfish consumed raw or partially cooked pose unique
public health risks. As the preamble to the proposed regulations noted,
they probably cause the majority of all seafood-related illnesses in
the United States. This situation is not unexpected, given the nature
of the product and the way that it is consumed. The preamble documented
a relationship between the microbiological quality of molluscan
shellfish growing waters and the incidence of molluscan shellfish-borne
disease. It also noted that naturally occurring toxins may accumulate
in molluscan shellfish because they are filter-feeding animals.
The NSSP was established as a cooperative program among FDA, State
regulatory agencies, and the molluscan shellfish industry, relying on
section 361 of the PHS Act (42 U.S.C. 264), to provide for the
classification and patrol of shellfish growing waters and the
inspection and certification of shellfish processors. The preamble to
the proposal reaffirmed FDA's support for the NSSP but noted the
difficulties that are associated with ensuring the safety of these
uncooked products. As the preamble stated, FDA tentatively determined
that it could strengthen and provide additional support for the
cooperative program through these regulations.
2. Should There Be Specific Requirements for Raw Molluscan Shellfish?
FDA received approximately 45 comments about the proposed
requirements for raw molluscan shellfish. The responses were from
processors, trade associations, State and Federal government agencies,
individuals, consumer advocacy groups, and a foreign country.
Approximately half of these comments urged FDA to eliminate proposed
subpart C of part 123 and the proposed amendment to Sec. 1240.60, while
the other half acknowledged the advisability of including these kinds
of provisions but commented on, or questioned, various specifics of
them.
The comments that generally supported the need for specific
requirements for raw molluscan shellfish were from trade associations,
molluscan shellfish industry members, consumer advocacy groups, Federal
and State government agencies, individuals, and a professional
organization. A number of comments noted that special requirements for
molluscan shellfish are warranted because of the association of these
products with illness. One
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comment in particular stated that, with respect to seafood, molluscan
shellfish ``serve as the primary source of illness due to ingestion.''
One comment noted that Federal regulations relating to source of origin
controls for raw molluscan shellfish would enable FDA to lend support
to the States in the administration of the NSSP. Another comment
suggested that the proposed regulations would improve FDA's regulatory
effectiveness with regard to molluscan shellfish control. The comment
from the ISSC stated that ``The Conference has long recognized and
supported expansion of FDA authority to assist States in assuring the
safety of molluscan shellfish.''
The comments that suggested that subpart C of part 123 and the
amendment to Sec. 1240.60 be deleted were from State government
agencies and seafood processors. A number of the comments that
suggested deletion of the proposed provisions stated that the tagging
and labeling requirements of the NSSP are designed not to serve as a
control to prevent harvesting from closed areas but to assist States in
tracing shellfish that are implicated in illness outbreaks back to the
harvest area. The comments went on to state that harvesters who
illegally harvest from closed waters do not identify the shellfish as
originating from the closed area. The comments maintained that
preventing illegal harvesting is the key to reducing the incidence of
illness, and that the only known method to achieve this goal is through
effective law enforcement, including the patrol of closed waters.
A number of these comments argued that increased FDA funding and
support for State molluscan shellfish control and patrol efforts would
do more than the proposed rule to deter illegal harvesting, to increase
States' compliance with the NSSP, and reduce the number of illnesses
caused by molluscan shellfish. The comments went on to state that the
proposed regulations unnecessarily duplicate the requirements now in
place in the Manual of Operations for the NSSP. They contended that
formal adoption of NSSP requirements into Federal regulations would
release State agencies from their cooperative relationship with FDA
under the NSSP.
One comment noted that the weaknesses in State molluscan shellfish
control programs are in areas not addressed by the proposed
regulations, such as improperly classified growing waters; the ability
of State growing water classification programs to respond to breakdowns
at waste water treatment facilities or unexpected climatic events that
affect the quality of molluscan shellfish growing waters; and improper
handling by caterers and consumers. The comment concluded that the
proposed HACCP provisions for molluscan shellfish will, therefore, not
reduce the incidence of illness attributable to such products.
As previously mentioned, FDA is a partner with State and foreign
regulatory authorities and with industry in the NSSP. The NSSP Manual
of Operations provides the standards for State and foreign molluscan
shellfish regulatory programs that belong to the cooperative program,
as well as for processors. The participating States routinely adopt
those standards as law or regulations, but the NSSP itself has neither
Federal nor State regulatory stature.
Each participating State and foreign nation classifies and monitors
its molluscan shellfish growing waters, controls harvesting, inspects
molluscan shellfish processors, and issues certificates for those that
meet the shellfish control authority's criteria. FDA evaluates State
and foreign molluscan shellfish control programs and publishes monthly
the ``Interstate Certified Shellfish Shippers List,'' which lists the
molluscan shellfish processors that are certified under the cooperative
program. States that are in the program are not willing to receive
shellfish from noncertified shippers.
FDA disagrees with the comments that suggest that establishment of
the proposed source controls in Federal regulations would supplant the
similar and, in some cases more stringent, requirements of
participating States and foreign nations or the standards set forth in
the NSSP. Rather, the agency is convinced that they will reinforce and
support these requirements and standards.
The molluscan shellfish industry is subject to significant
regulatory oversight in those States that participate in the NSSP.
However, the quality and effectiveness of State laws and enforcement
activities can vary considerably as a function of the financial and
administrative support available to the responsible State units (Ref.
7, p. 15). For example, FDA documented discrepancies in State
enforcement practices during its 1994 evaluation of State programs to
determine compliance with the NSSP standards (Ref. 215). Moreover,
although all harvesting States participate in the NSSP, many other
States do not.
Based on these factors, FDA proposed, and is now adopting, subpart
C of part 123 and amendments to Sec. 1240.60 to support and strengthen
the shellfish program in two ways. First, these provisions will
complement the efforts of the States. FDA recognizes that while States
are making significant and important efforts to ensure that all
shellfish harvested in their jurisdiction are taken only from open
waters and then properly tagged, some shellfish that do not meet these
requirements inevitably escape State control. The new provisions will
allow FDA to take action against shellfish that are not harvested from
open waters or that are not properly tagged if it encounters such
shellfish in interstate commerce and make the gravamen of such action
the origination from unopen waters or the lack of proper tagging
itself, rather than evidence that the shellfish are injurious to
health.
Second, the regulations require that processors only use shellfish
that originate from growing waters that have been approved for
harvesting and that have been properly tagged. Failure to do so can
result in Federal regulatory action against the product or against the
processor itself. This fact should provide a significant incentive to
processors to ensure that they are not receiving shellfish that do not
meet these requirements.
Taken as a whole, rather than diminishing in any way the importance
of State programs, FDA's regulations elevate the importance of those
programs. These regulations make proper origin and tagging--concepts
that derive directly from the NSSP--keys to the unimpeded movement of
shellfish in interstate, as well as intrastate, commerce.
Moreover, these requirements extend these control measures to
imported products, enabling FDA to more efficiently and effectively
ensure the safety of imported raw molluscan shellfish. At present, the
agency must resort to advising State regulatory authorities of the
prospective entry of raw molluscan shellfish from an uncertified source
(Ref. 216, part V, p. 5). While States normally take action against
uncertified imported raw molluscan shellfish, FDA is aware that
uncertified imports enter interstate commerce (Ref. 107).
FDA acknowledges that uniform Federal tagging and record-keeping
requirements will not completely eliminate illegal harvesting. The
agency agrees with the comments that rigorous enforcement of closed
area restrictions by State regulatory agencies will always be needed.
Unquestionably, increased funding would help State efforts to classify
and patrol growing areas. However, FDA does not have resources for this
purpose. Nonetheless, the agency remains convinced that there are
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significant, positive steps that can be taken to strengthen source
controls as part of HACCP, and thereby to support the cooperative
program.
A processor's most significant safety control for raw molluscan
shellfish is at the point of receipt. If processors refuse to accept
molluscan shellfish for which there is no assurance that they have been
legally harvested, the incentive for illegal harvesting would be
eliminated. FDA participation in a number of covert investigations into
illegal molluscan shellfish harvesting in recent years has convinced
the agency that, in many cases, processors are aware of the illegal
harvesting activity of their suppliers (Ref. 217). If the provisions of
these regulations can help foster a culture change in that respect,
shellfish safety will be significantly enhanced.
Based on these considerations, the agency proposed that, as a
universal aspect of the HACCP plans for these products, molluscan
shellfish processors engage in certain activities to ensure that the
products that they receive originate only from waters that have been
approved by a shellfish control authority (e.g., checking tags on
containers of shellstock, licenses of fishermen, and certification of
suppliers). Molluscan shellfish that are clearly improperly tagged or
from questionable sources must be rejected by processors as a
requirement of their HACCP plans. It is reasonable to conclude that, as
more processors adopt HACCP and exercise greater control over their
suppliers, the amount of illegally harvested shellfish offered for sale
will decrease, because the market for such product will decline.
While it is true that the tagging requirements of the NSSP were
primarily designed as a means of tracing back molluscan shellfish
involved in incidences of illness to their harvest area, they have also
served as a key component in efforts by FDA and State regulators and
industry to ensure that molluscan shellfish that are placed in commerce
originate from areas that are approved by a shellfish control
authority. It is certainly true that the tags on containers of
molluscan shellfish that are harvested from closed waters are often
falsified to disguise their true origin. However, such falsification
carries potential Federal and State penalties and is a focus of current
molluscan shellfish control programs.
Regarding the comments that pointed to weaknesses in State
programs, at retail, in the classification of molluscan shellfish
growing waters, and elsewhere, which are not directly addressed by
these regulations, the agency acknowledges that HACCP plans and
specific source control requirements cannot serve as a substitute for
improvements in the food safety system that directly address these
weaknesses. Regulatory systems will always have their strengths and
weaknesses, and research to better understand and control hazards will
always be needed. Nonetheless, these comments provide no reason for FDA
to abandon its efforts to remedy existing agency weaknesses and, in
particular, to lend support to the States in those areas to which these
regulations do relate.
141. One comment stated that references cited in the preamble to
the proposed regulations in support of the tagging requirements (Refs.
102 through 109) do not provide convincing evidence of a need for such
a measure. The comment stated that, for the most part, the references
that FDA cited document corrective actions taken by State regulatory
agencies that would likely be the same measures that FDA officials
would take under the proposed regulations. In addition, the comment
stated that a failure to have properly tagged shellfish does not always
mean that the shellfish were harvested illegally. The comment pointed
out that the absence of a tag could mean simply that the tag was lost.
The references in the question contain examples of problems
associated with molluscan shellfish tagging, recordkeeping, and
harvesting. FDA cited these references to demonstrate that, in some
cases, the deterrent effect of existing State tagging requirements and
sanctions is inadequate to prevent problems from arising (Refs. 102,
103, and 109). The problems documented in the references helped
persuade FDA to propose Federal source control requirements to help
deter the interstate shipment of shellfish from unapproved harvest
areas. FDA did not intend to imply that the State actions that were
documented in these references were incorrect, or that FDA would have
responded in a different manner. FDA continues to believe that the
references are relevant and supportive to its intended assertion.
A few comments maintained that a better strategy for decreasing
illness from the consumption of molluscan shellfish would be to
increase the education efforts of FDA and of the ISSC that are directed
toward consumers and the medical community to alert susceptible
individuals to the risks associated with the consumption of raw
molluscan shellfish.
The agency agrees that consumer education can play a vital role in
reducing illnesses associated with the consumption of raw molluscan
shellfish, particularly in medically compromised individuals. During
the period of 1984 through 1994, the agency expended nearly $1 million
to alert the public to the risks of raw molluscan shellfish consumption
by distributing brochures to consumer groups, groups that represent
those with special medical conditions, and consumers; developing a
video news release; issuing press releases; and establishing the toll-
free, FDA Seafood Hotline. Included in this expenditure is the agency's
efforts to inform the medical community about the illnesses associated
with the consumption of raw molluscan shellfish by providing
informative articles to medical bulletins and journals and by mailing
brochures and news articles to target professional groups. The agency
will continue its consumer education efforts, but such efforts alone
will be insufficient to address the hazards posed by the consumption of
raw molluscan shellfish harvested from unapproved growing waters. The
existing and planned consumer education efforts are geared toward
individuals in high-risk consumer groups, advising them to avoid
molluscan shellfish that have not been fully cooked. The risks posed by
viruses, toxins, and many bacteria are to the population as a whole.
There is little advice that the agency could provide that would enable
consumers to protect themselves from these kinds of hazards in
molluscan shellfish.
143. Several comments questioned the validity of FDA's statement
that molluscan shellfish consumed raw or partially cooked pose unique
public health risks and probably cause the majority of all seafood-
related illnesses in the United States.
The comments provided no data upon which to conclude that either
the NAS or FDA is wrong in this regard. FDA remains convinced that the
statements made in the preamble to the proposed regulations are valid,
and that the references support these statements.
3. Cooked Versus Raw Molluscan Shellfish
144. Comments from a number of State agencies, trade associations,
seafood processors, and the ISSC objected to the use of the terms
``raw'' and ``fresh or frozen'' in the title of part 123 subpart C and
the text of the proposed regulations on shellfish. These comments were
concerned because these terms would have the effect of exempting canned
and any other heat- processed molluscan shellfish from the source
control, recordkeeping, and
[[Page 65166]]
tagging provisions of subpart C of part 123 and Sec. 1240.60(b).
The comments stated that limiting these provisions to raw products
would allow foreign firms to continue to heat-treat or can molluscan
shellfish that are harvested from foreign waters that do not meet NSSP
standards and to export them to the United States. The comments stated
that this situation was not in the best interest of the public health
because of the potential for the presence of heat-stable natural
toxins, such as paralytic shellfish poison or amnesiac shellfish
poison, as well as chemical contaminants. The comments also complained
that, because State laws and regulations require that all molluscan
shellfish harvested in the United States come from waters approved by a
shellfish control authority regardless of whether they are to be
consumed raw or cooked, continuing to allow foreign processors who
export cooked shellfish to the United States to use molluscan shellfish
from unapproved growing waters places the domestic shellfish industry
at a competitive disadvantage. Other comments requested that FDA
clarify whether canned shellfish were included in subpart C of part 123
but did not suggest that canned and other heat-processed shellfish be
included.
FDA has responded to these comments generally in response to
comment 34, supra. The agency adds the following points:
It is important to recognize that foreign processors who export
cooked molluscan shellfish to the United States now will have to have
HACCP systems through which they identify and control hazards that are
reasonably likely to occur. These hazards include heat stable toxins
and chemical contaminants that would cause these products to be
adulterated under U.S. law.
To further clarify that the requirements of subpart C of part 123
apply only to the processing of molluscan shellfish that are not heat
treated or treated in some other manner by the processor to eliminate
microorganisms of public health concern, FDA has modified the language
at Sec. 123.20 to read, ``This subpart augments subpart A of this part
by setting forth specific requirements for processing fresh or frozen
molluscan shellfish, where such processing does not include a treatment
that ensures the destruction of vegetative cells of microorganisms of
public health concern.''
4. Shellfish Control Authorities
FDA proposed to require that processors only process molluscan
shellfish that originate from waters approved for harvesting by a
shellfish control authority. The term ``shellfish control authority''
is defined at Sec. 123.3(o) to include foreign government health
authorities that are legally responsible for the administration of a
program that includes classification of molluscan shellfish growing
areas.
145. Two trade associations questioned how a processor could
evaluate the competency of a foreign shellfish control authority. They
stated that FDA should require that a foreign country that exports
shellfish to the United States have an agreement with the agency that
establishes that a competent shellfish control authority exists in that
country, and that the foreign shellfish program meets NSSP standards.
One comment from a seafood processor argued that it would be
unreasonable to require processors to verify that molluscan shellfish
from all over the world are caught or cultivated in waters that meet
NSSP standards. The comment stated, moreover, that a processor could
not keep abreast of which countries have current shellfish agreements
with FDA and which countries do not.
FDA acknowledges the merits of requiring that a foreign country
that exports shellfish to the United States have an agreement with the
agency but has concluded that, given the significance of such a
requirement and the agency's failure to raise the possibility of
imposing it in the proposal, it is beyond the scope of this rulemaking.
Even though FDA is not imposing such a requirement, it is the case that
the only means by which a processor can ensure that the molluscan
shellfish of foreign origin that it receives are in compliance with the
requirements of subpart C of part 123 of these regulations is by
determining whether the foreign shellfish control authority is formally
recognized by FDA. It is not likely that the processor could employ any
other process that would give it assurance that molluscan shellfish
harvesting waters that are approved by the shellfish control authority
are properly classified. Such a determination is appropriately
performed through government to government audit.
5. Shellfish From Federal Waters
146. Comments from a significant number of trade associations and
seafood processors stated that a requirement that shellfish originate
only in waters ``approved for harvesting by a shellfish control
authority'' would preclude harvesting in Federal waters unless the
Federal government introduced a formal approval process for waters
under its purview through a Federal shellfish control authority.
Under the current system, State agencies are responsible for
approving molluscan shellfish growing waters. However, State
jurisdiction extends only to waters that are within three miles of the
shore. Waters beyond that point but up to 200 miles offshore are under
the jurisdiction of the Federal government. The comments pointed out
that the harvesting of molluscan shellfish is permitted in all of the
oceanic waters under Federal control unless there is a specific Federal
action to declare an area unsafe under the provisions of the Magnuson
Fishery Conservation and Management Act. The comments further noted
that large volumes of molluscan shellfish are harvested in Federal
waters.
How Federal waters will be classified, and by whom, has not been
fully resolved. The comments are correct that the proposed requirement,
if incorporated into the final rule, would pose significant problems
for molluscan shellfish processors who receive product harvested from
Federal waters. Therefore, FDA has modified Sec. 123.28(b) to allow for
the receipt of molluscan shellfish that are harvested in U.S. Federal
waters except where such waters are specifically closed to harvesting
by an agency of the Federal government. This provision is consistent
with the provisions of the Magnuson Act.
It is worth noting that, by allowing Federal waters to be open
unless they are specifically closed, this system is the opposite of the
State system, under which waters are closed unless they are
affirmatively classified so as to be open. This difference is
reasonable from a public health standpoint because there is less
likelihood that Federal waters will be affected by pollution than will
near shore State waters.
Furthermore, because there is no Federal authority to license
shellfish harvesters who fish in Federal waters, FDA has modified
Sec. 123.28(c) to require only that a harvester be in compliance with
such licensure requirements as may apply to the harvesting of molluscan
shellfish, rather than specifically requiring licensure.
6. Tagging and Recordkeeping Requirements
147. FDA proposed recordkeeping requirements for processors to
follow with respect to shellstock and shucked molluscan shellfish in
Sec. 123.28 and requirements for the information to be included on the
shellstock tag in Sec. 1240.60. A few comments stated that
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the proposed molluscan shellfish tag and record requirements were too
specific, and that placing such requirements in the form of regulations
would make it difficult to make timely changes to these requirements as
future needs may dictate. The comments asserted that FDA or the ISSC
may wish to modify the content or form of molluscan shellfish tags or
records to improve product traceability. They suggested that FDA write
the tagging and recordkeeping requirements at Sec. 123.28 and
Sec. 1240.60 in general terms and allow the specific form and
information required on the tags to be addressed by the NSSP. The
comments went on to urge that, if the agency were determined to include
specific tagging and recordkeeping requirements as part of the final
regulations, they should be fully consistent with current NSSP
guidelines.
It is not the agency's intent that the provisions of Sec. 123.28
and Sec. 1240.60 would preclude the ISSC or State agencies from
adopting additional recordkeeping or tagging requirements. The
recordkeeping and tagging requirements in these regulations are the
minimum necessary to ensure that shellfish can be traced through
distribution channels, back to the harvest source. FDA explained why
each of the specific requirements is necessary in the preamble to the
proposed regulations, and the comments did not take issue with the
agency's explanation with respect to any of the particulars. Therefore,
FDA disagrees with the comments that the recordkeeping or tagging
requirements are more restrictive than they need to be, or that they
would interfere with the NSSP tagging program.
Moreover, as stated previously, the agency has drafted the
regulations broadly enough so as not to conflict with any improvements
that the ISSC may wish to make in the form that a tag may take or in
how information on tags is to be stored. The definition of the word
``tag'' at Sec. 123.3(t) (added at Sec. 1240.3(u) for consistency)
reads, in part, ``a record of harvesting information attached to a
container of shellstock * * *.'' This definition is sufficiently broad
to include such systems as bar codes, embossed plastic, or other
nontraditional methods of identification that may be used by the
industry in the future. The agency is supportive of efforts to improve
the existing methods of recording harvesting information.
Nonetheless, it is important for the regulations to identify the
minimum specific information that must appear on a tag. During past
illness outbreaks, FDA, State regulatory agencies, and industry have
had difficulty tracing the implicated shellfish to their sources,
especially after they have been in the possession of several different
processors (Refs. 99; 100; 102-106; 109; 218; and 219, pp. 37-39).
These difficulties in tracing the shellfish have occurred because the
shellfish were not in compliance with the tagging and recordkeeping
provisions of the NSSP. The requirements at Sec. 123.28 will enable FDA
to help the States to enforce minimum tagging and recordkeeping
requirements for imported and domestic products. Moreover, the agency
believes that placing the tagging and recordkeeping requirements in
Federal regulations will emphasize the nationwide importance of this
information in protecting the public health, as described earlier.
148. One comment noted that the NSSP does not specify that the name
of the harvester must be on a molluscan shellfish tag, but that the
proposed regulations would require this information.
The NSSP specifies that the number assigned to the harvester by the
shellfish control authority must be listed on the tag. The agency
recognizes that there may be a variety of effective ways to identify
the harvester of the molluscan shellfish, depending on the method of
harvest, State requirements, and local tradition. For this reason, the
agency has modified Sec. 1240.60(b) to read that the tag shall
disclose:
* * * by whom they were harvested (i.e., the identification number
assigned to the harvester by the shellfish control authority or, if
such identification numbers are not assigned, the name of the harvester
or the name or registration number of the harvester's vessel).
For consistency, FDA has made a similar change in Sec. 123.28(c)(5).
149. A significant number of comments recommended that FDA modify
Sec. 1240.60(b) to allow bills of lading or other shipping documents to
accompany bulk shipments of shellstock in lieu of tags, as long as they
provide the same information. A few comments suggested that bills of
lading or other shipping documents be used in lieu of tags on
individual containers of shellstock when a shipment consists of a large
volume of shellstock in sacks or boxes. Several comments asked for
clarification of the impact of the proposed requirements on current
repacking operations that commingle shellstock from various harvesters
into one container.
FDA recognizes that an inconsistency existed between proposed
Sec. 123.28 and proposed Sec. 1240.60 because the former would have
allowed shipping documents to provide the required information for bulk
shipment, and the latter would not. FDA agrees with the comments that
recommended providing for the use of shipping documents and has
modified Sec. 1240.60(b) to provide the needed consistency. Under
existing industry practice the truck, cage, or vessel hold serve the
same purpose as a container for the shellstock, making tagging
impractical. In that case, the shipping document serves the same
function as the tag.
However, the agency does not agree with the suggestion that
containers of shellstock in large shipments be allowed to be covered by
shipping documents in lieu of tags. FDA cannot justify treating
shellstock in large shipments differently than shellstock in smaller
shipments, nor could the terms ``large'' or ``small'' be readily
defined. Large shipments can be subdivided, perhaps many times, or
commingled with other lots of molluscan shellfish. The source
information would, therefore, be necessary on each container to ensure
proper identification. Without tags, the identity of individual
containers could be lost. FDA is requiring that all shellstock, even
after repacking, bear a tag that identifies the prescribed information,
including the identification of the harvesters to ensure that all
shellstock is readily traceable (Sec. 1240.60).
7. Other Considerations
150. Comments from a few trade associations and from seafood
processors stated that FDA should require a production code on each
container of shucked molluscan shellfish. The comments suggested that
the code consist of an identifying mark that allows the processor to
determine where the remainder of the lot was shipped, and where and
when the relevant shellstock was harvested.
FDA agrees that production codes can be useful on containers of
shucked molluscan shellfish to facilitate trace back of questionable
product. The agency encourages the use of codes by molluscan shellfish
processors. However, such a requirement is not within the scope of the
proposed regulations. The agency will consider whether such a
requirement should be pursued in a separate rulemaking.
151. Comments from several consumer groups stated that if a warning
label is not mandated by FDA on raw molluscan shellfish to alert at-
risk consumers of the danger to health posed by the product, FDA should
require that Gulf Coast oyster processors adequately cook the product
to
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eliminate risks from Vibrio vulnificus during periods when shellfish
cannot be harvested free from this bacterium. They further stated that
cooking should not be required when the shellfish are free from this
bacterium.
FDA agrees that effective controls are needed to protect consumers
from the hazard posed by V. vulnificus in Gulf Coast oysters during
certain times of the year. The agency is evaluating the potential
effectiveness of a variety of control mechanisms. Mandating specific
mechanisms, however, would be outside the scope of this rulemaking. FDA
is therefore taking these comments under advisement.
152. A few comments urged that the word ``processor'' be changed to
``certified dealer and licensed harvester'' throughout Sec. 123.28 to
make the terminology consistent with the NSSP and to clarify that these
requirements apply to everyone who buys and sells shellfish before the
shellfish reach the retail marketplace. The comments also recommended
changing the word ``shipper'' to ``processor or packer'' in the
provision that is codified at Sec. 123.28(d)(3) in these final
regulations to include the shucker, repacker, shipper, reshipper, or
depurator.
As mentioned in the ``Definitions'' section of this preamble, the
agency has concluded that the definition for ``processor'' covers all
NSSP classifications of shellfish dealers, without specifically naming
each one. For consistency throughout the regulations, use of the term
will remain unchanged.
FDA agrees, however, that the word ``shipper,'' as the agency used
it in the proposed regulations, could cause confusion because that term
has a different meaning in the NSSP Manual of Operations. Therefore,
FDA has changed the language of the final regulations to read ``packer
or repacker.'' The certification number of the packer or repacker is
readily available to the processor since it is required, under the NSSP
standards, on each label of shucked product. For consistency, FDA has
modified Sec. 1240.60(c) to also read ``packer or repacker'' where it
had previously read ``processor.''
153. A few comments stated that proposed Sec. 123.28(b), which
referred to molluscan shellfish that ``originate from growing areas
that are approved for harvesting,'' appears to prohibit processors from
using products from harvest waters classified under the NSSP as
``conditionally restricted.'' Under the NSSP, shellstock taken from
such waters cannot be directly marketed for human consumption but can
be ``relayed'' to an open growing area for harvest at a later date. In
addition, the comments pointed out that the word ``approved'' is a
formal classification designation used in the NSSP. These comments said
that harvesting is permitted from areas with other than ``approved''
classifications but would appear to be prohibited under the provisions
of proposed Sec. 123.28(b). The comments suggested use of the term
``open'' growing waters, which would apply to several different NSSP
harvest area classifications.
FDA agrees that the word ``originate'', as used in proposed
Sec. 123.28(b), is too restrictive and has revised this section to say
``harvested from.'' With regard to the word ``approved,'' FDA concludes
that no change is warranted. The proposal neither adopted nor
referenced the NSSP growing water classification system. The phrase
``approved for harvesting'' should not be construed to be limited to
those waters classified by a State under the NSSP as ``approved''
areas. The phrase ``approved for harvesting'' is used in the final
regulations for its common sense meaning (i.e., those areas from which
harvesting is allowed), which FDA believes is appropriate.
154. For clarification purposes, definitions for the terms
``certification number'', ``shellfish control authority'', and ``tag''
have been added at Sec. 1240.3(s), (t), and (u), respectively. These
definitions are taken directly from Sec. 123.3.
155. One comment urged that the regulations be modified to
specifically state that a HACCP plan for raw molluscan shellfish that
contains the controls specified in subpart C of part 123 is deemed to
meet the requirements of Sec. 123.6.
The agency disagrees with this comment. The requirements of subpart
C of part 123 are designed to control the environmental hazards
associated with the harvest waters from which molluscan shellfish are
taken, particularly those relating to sewage- related pathogens,
chemical contaminants, and natural toxins. For this reason, they must
be included in the HACCP plans of all raw molluscan shellfish
processors. However, they are not intended to control process-related
hazards resulting from, for example, time-temperature abuse of the
product, improper use of food additives, or metal fragments. To control
these hazards, the processor needs to follow the general approach set
out in subpart A of part 123. The agency has developed the two subparts
to be complementary and has strived to eliminate any redundancy in
their provisions. Thus, it is theoretically possible that a HACCP plan
that contains the controls specified in subpart C alone of part 123
still might not meet all the requirements of Sec. 123.6.
FDA has made two modifications in Sec. 1240.60(b) for clarity only.
Where the proposed regulations required that the tag identify the ``* *
* place where harvested * * *,'' FDA has added, ``(by State and
site).'' This change makes Sec. 1240.60(b) consistent with
Sec. 123.28(c)(2). Additionally, where the proposed regulations stated
that improperly tagged or labeled product would be ``subject to seizure
and destruction,'' FDA has amended the language to read, ``subject to
seizure or refusal of entry, and destruction.'' This change is to make
clear that, for imported products, the appropriate regulatory procedure
is refusal of entry, rather than seizure.
O. Compliance and Effective Date
1. Effective Date
FDA proposed that these final regulations be effective and enforced
1 year after the date that they are published in the Federal Register.
The purpose of this proposed effective date was to provide processors
with enough time to develop and implement HACCP plans. The agency
invited comment on whether 1 year would be adequate.
156. FDA received more than 60 comments about the proposed
effective date. Virtually all comments agreed that the agency should
provide some period before the regulations become effective. The
comments either agreed with a 1-year implementation period or requested
a longer period of 2 years or more. There were also a number of
comments that responded to the agency's question about whether
implementation dates should be staggered based on such factors as size
of firm and level of risk.
A minority of comments stated that 1 year for implementation is
adequate. These comments argued that after 1 year, the industry would
have had 3-years notice of the requirements. The comments argued that 3
years was sufficient total time to be informed about impending
regulations. Another comment stated that one year might be sufficient
for the seafood industry, but other food industries could need
considerably more time.
Several comments recommended that FDA provide an implementation
period of longer than 1 year but did not recommend a specific
alternative. These comments were concerned that HACCP training would
not be completed in time for a 1-year implementation date; that foreign
processors would need more
[[Page 65169]]
time to implement HACCP; and that 1 year after Canada required HACCP
for its seafood industry, only half of its firms had complied.
The largest number of comments on this topic recommended that FDA
make the regulations effective 2 years after publication. The reason
most often cited was that it will be more than 1 year before most of
the affected firms can complete HACCP training. The next most
frequently cited reason was that firms and trade associations needed
more time for HACCP plan development. Several comments also discussed
the time required to modify equipment and raise capital; to respond to
initial, voluntary reviews of HACCP plans by regulatory agencies; and
for Federal, State, and local officials to understand HACCP and how to
enforce it and to arrange for cooperative enforcement. A few comments
stated that FDA needs sufficient time to develop agreements with
foreign countries.
Several comments contended that more than 2 years should be allowed
to implement the regulation. These comments mentioned the cultural
change that HACCP will require and concern about the impact that the
regulations will have on small firms as well as on large firms with
multiple products and lines. They also mentioned the time needed for
training.
Over 20 comments recommended that FDA stagger effective dates. A
majority of these comments stated that such a phased-in start-up should
be based on product risk. The remainder of the comments split in favor
of either considering both the size of a firm and the risk from the
products it makes or just the size of a firm.
A smaller number of comments argued against a staggered start.
These comments expressed the view that small firms and foreign products
should not be treated differently and pointed out that all firms will
already have had 3 years of notice. Some of these comments stated that
it would be hard to justify staggering implementation based on risk
when the illness data are so incomplete. Others expressed the view that
administering a staggered start would use up valuable resources and
only result in confusion; that staggering would put some firms at a
competitive disadvantage; and that it might encourage procrastination.
After fully considering all of these comments, FDA agrees with the
comments that suggested that a 2-year effective date is appropriate.
Based on FDA's participation with the Alliance that is developing
training materials for this program, FDA has come to realize that 2
years must be provided to establish training programs and to give
participants enough time to take them. Two years is also the minimum
time necessary to train regulatory personnel. The additional time is
also necessary so that the States will have a full opportunity to
understand and respond to the effects of these regulations. It will
also increase the likelihood that more agreements with other countries
will exist.
The additional year will also increase the opportunity for
processors to engage in ``voluntary'' HACCP inspections in advance of
the effective date in order to obtain preliminary, nonregulatory
feedback from the agency on their progress.
The agency acknowledges that it has urged the industry to begin
preparing for HACCP well before the issuance of these final
regulations. However, as this preamble amply demonstrates, a
significant number of questions were raised as a result of the proposal
that could not be answered until now. Moreover, the entire support
structure for HACCP, including the issuance of the first edition of the
Guide and the development of training courses, model plans, and other
forms of technical assistance that will be useful to the industry, and
especially to small businesses, will not be in place in time to permit
a 1-year effective date.
On the other hand, more than 2 years does not appear at this time
to be warranted. The agency is concerned that additional time would
adversely affect the momentum for this program without adding
significantly to the likelihood that it will succeed.
On the other hand, FDA is sensitive to the need to ensure that
small businesses will not incur an unreasonable threat to their
survival by an effective date that is too short. The agency intends to
monitor the progress of the industry after the regulations are
published and invites feedback on this subject. If FDA determines that
the effective date is placing a significant and unreasonable burden on
the industry, particularly on small businesses, the agency would be
willing to consider an extension for as much as one additional year or
some form of additional technical assistance. The agency would consider
whether the delay is needed for training, drafting plans, or taking
other measures that directly relate to the installation of a HACCP
system, or whether the time is needed to comply with existing CGMP's,
which are a prerequisite for HACCP. FDA will likely be reluctant to
give firms an extended period of time to achieve compliance with
existing requirements.
FDA also finds that there is not an adequate basis at this time for
staggering the starts based on size or risk. The arguments for and
against staggering generally parallel those for and against exempting
firms from these regulations altogether on the basis of either size or
risk. These arguments are discussed in the section of this preamble
entitled ``Should Some Types of Processors Be Exempt?'' In summary, a
good case can be made that implementation by small firms should not be
delayed because such firms account for much of the products with
significant potential for risk, such as cooked, ready-to-eat products.
Moreover, most seafood processors are small firms. Risk-based, as
opposed to size-based, criteria for staggering firms would inevitably
be arbitrary to some degree because data from foodborne illness
reporting systems tend to skew the reports toward more easily
diagnosable illnesses.
The comments received on the subject of staggering do not provide a
ready way to overcome these problems. Moreover, the 2-year effective
date (rather than 1 year as proposed), guidance, technical assistance,
and training that will be available to all processors should make
staggering much less necessary than it otherwise might have been.
As stated above, however, the agency welcomes feedback on the
progress that processors are making to implement HACCP that could have
a bearing on whether staggering or an extension of the effective date
would be appropriate, especially for small businesses.
157. Several comments asked for a form of staggering based on when
an inspection occurs before the effective date. These comments stated
that processors who voluntarily submit to inspection under the
regulations before the effective date and are advised that their HACCP
systems are not yet in compliance with the regulations should have at
least a 6-month grace period to correct the problems. The example given
in these comments was that of a processor who is so advised 1 day
before the effective date and thus is inevitably out of compliance on
the effective date.
As reflected in the comments, inspections of HACCP systems before
the effective date will occur because a firm desires feedback and
volunteers for it when an FDA investigator arrives for an inspection.
That feedback will constitute informal advice only and will provide
training for the investigator as well as for the processor. There may
be some advantage to a processor to obtain feedback and training sooner
rather than
[[Page 65170]]
later, but the results will have no formal status with the agency and
would not warrant an extension of the effective date.
The agency has heard considerable concern that it will
automatically seek to seize or otherwise remove from commerce all
products being produced under a HACCP system that is determined to be
deficient in any respect. That concern is unfounded. The consequence of
being out of compliance with HACCP requirements, on the first
inspection after implementation or otherwise, is addressed throughout
this section. In summary, FDA's reaction will depend, as it does today,
on the overall public health significance of the deficiency.
2. Public Meetings
158. One comment suggested that FDA conduct public meetings to
explain the requirements of these regulations to the seafood processing
industry between the publication date and effective date of these
regulations. The comment also encouraged a coordination of research,
training, and educational efforts between industry and FDA in order to
facilitate the implementation of this HACCP program.
FDA fully agrees with the comment. It is the intent of the agency
to engage in a dialog with industry, through a combination of public
meetings and discussions at trade association meetings, to facilitate a
thorough understanding of the regulations. FDA's affiliation with the
Alliance reflects the agency's commitment to a cooperative relationship
among industry, government (Federal and State), and academia in the
areas of research, training, and technical assistance.
3. Penalties for Noncompliance
159. A significant number of comments, from processors and trade
associations, requested that FDA address how noncompliance with the
mandatory sanitation control procedures will be handled. Several of
these comments also requested that FDA describe the penalties that can
be imposed upon a processor and its officers for: Failure of a
processor to have and implement a HACCP plan; noncompliance with
sanitation control procedures; and failure to meet minor requirements
of the regulations, such as the lack of a signature on a document. One
comment stated that FDA's legal authorities and enforcement procedures
do not provide a means for the agency to respond in a manner that is
related to the severity of deficiencies--that is, a less severe
response to a less significant deficiency.
FDA has a longstanding practice of tailoring its regulatory
response to the facts. A deviation from any of the provisions of these
regulations, including those involving the control of sanitation,
carries the potential for regulatory action pursuant to section
402(a)(4) of the act. However, FDA intends to enforce these regulations
in a manner that focuses on those deviations that have the greatest
potential for causing harm. It is not FDA's intent to pursue regulatory
action against a product or a processor exclusively for clerical errors
or minor errors of omission. To do so would certainly not be an
efficient use of agency resources, nor would it be in the best
interests of the consuming public.
The penalty provisions for food found to be adulterated are
described at ``Prohibited Acts and Penalties,'' in chapter III of the
act. The statutory sanctions that FDA may seek include seizure and
condemnation of a food and injunction and criminal penalties against a
person (i.e., a firm and its responsible management).
FDA may also use existing administrative procedures, such as
warning letters and conferences with a processor, to bring instances of
noncompliance to the processor's attention as it frequently does under
its current inspection programs.
The agency cannot state precisely what type of action it will take
when it detects a deficiency because FDA evaluates each deficiency on a
case-by-case basis to determine the public health significance of the
violation and the appropriate response.
4. Preapproval of HACCP Plans
In the preamble to the proposed regulations, FDA tentatively
concluded that HACCP plans would not have to be submitted to the agency
or otherwise preapproved before their implementation by processors. The
reasons for the agency's tentative conclusion included: (1) HACCP plans
should be judged in the context of the processing plant, a process best
accomplished during routine FDA inspections of processing facilities;
and (2) the agency does not have sufficient resources to review HACCP
plans from all domestic and foreign seafood processors in advance of
either HACCP implementation by the processor or the conduct of HACCP-
based inspections by FDA.
160. Approximately 20 comments addressed this issue. About two-
thirds of these comments, from consumer advocacy groups, processors,
trade associations, and State government agencies, contended that a
processor should be required to file a HACCP plan and obtain approval
from FDA before implementing the plan. The remaining comments, from
processors, trade associations, and a foreign government, agreed with
FDA's tentative conclusion that HACCP plans need not be submitted to
the agency or preapproved before they are implemented.
Some of the comments favoring preapproval argued that FDA should
have control over the design of each plan before it is implemented to
ensure that all of the CCP's are identified, and that appropriate
records will be kept. Other comments contended that, in the absence of
a preapproved plan, a processor may implement a plan that FDA would
later judge to be inadequate, possibly raising concerns about the
product already produced under the plan.
Several comments in opposition to preapproval argued that it would
be too expensive and difficult for both FDA and the processors (the
latter because implementation would be delayed while processors waited
for FDA to preapprove the plan and every subsequent change to the
plan). One comment expressed concern that, in formally approving a
HACCP plan, regulatory authorities would assume some responsibility for
the HACCP system of an individual processor.
A few comments stated that HACCP plans will evolve as operations
are adjusted, based on the processor's verification activities. These
comments argued that a requirement for the preapproval of HACCP plans
would encumber a processor's ability to update its HACCP plan.
The resource situation since the proposal was issued in January,
1994, has not changed in any way that would make the preapproval of
HACCP plans by FDA practicable. Thus, FDA's analysis of the comments
has focused on whether a lack of preapproval raises significant
implementation problems that the agency must address. The comments have
not convinced the agency that it does. FDA finds that a preapproval
system would unduly burden the agency's resources, without providing
significant advantages to the public health. The effectiveness of a
HACCP plan, including monitoring, recordkeeping, and verification, can
best be evaluated under actual operating conditions.
The preapproval of HACCP plans is distinguishable from the
situation for low acid canned foods, where FDA reviews submissions of
scheduled processes and revisions to these processes without hinging
that review on a visual inspection of the facility. For
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low-acid canned foods, the submission relates solely to the adequacy of
the cooking process to control one hazard (C. botulinum). This process
lends itself to a paper evaluation.
FDA agrees with the comments that suggested that a requirement for
agency approval of a processor's changes to an existing HACCP plan
would unnecessarily slow the process of plan improvement. The ability
to modify the plan quickly based on feedback from verification
activities is an important aspect of HACCP that could be degraded by a
preapproval requirement.
With regard to the concern that the lack of plan preapproval will
expose a processor to risk of product loss if a HACCP plan, under which
it had been operating, is deemed by FDA to be inadequate, the agency
advises that there are several issues that should mitigate this
concern. First, the agency is committed to providing guidance, in the
form of the Guide, to assist processors in the development of HACCP
plans that are likely to be acceptable to the agency. The Guide will be
further discussed later in this section.
Second, FDA is convinced that the training requirements of these
regulations will serve to inform the regulated industry about the
expectations of the agency with respect to HACCP plan content. FDA is
working closely with the Alliance to ensure that training reflects FDA
policy.
Third, FDA recognizes and accepts that, for HACCP plans to be
effective and efficient, they must be tailored to the operating
conditions of the individual processor. Of necessity, this fact means
that there may be multiple ways to control an individual hazard.
Consequently, FDA investigators will be trained to objectively evaluate
the processor's HACCP plan from the standpoint of whether it
accomplishes its intended function (i.e., hazard control), rather than
whether it follows any preconceived model.
Finally, as described earlier, for the HACCP program, FDA intends
to respond proportionally to deficiencies that it finds during
inspections. The nature of the agency's response will depend on the
totality of the situation and on the public health implications of the
deficiency. When circumstances permit, the processor will be given the
opportunity to make appropriate corrections.
5. Filing Plans With FDA
161. A few comments stated that FDA should require processors to
file HACCP plans with the agency, not necessarily to obtain
preapproval, but to allow FDA to compile HACCP plans from all seafood
processors. The comments suggested that FDA selectively audit a sample
of processor HACCP plans from the file copies, perhaps based on product
risk, the presence or absence of certain CCP's, or other relevant
factors. Some of these comments recommended that FDA request voluntary
submission of plans prior to the implementation deadline.
A file, or library, of HACCP plans of all seafood processors would
likely present various benefits from the standpoint of trend analysis
and program evaluation. The agency finds, however, that the burdens
would outweigh the benefits, largely for the same reasons that rule out
the preapproval of plans by FDA. For example, the library would have to
be updated every time that any processor updated its plan. Therefore,
FDA is not requiring that processors file their plans with the agency.
6. Third Party-Approval
162. Several comments urged FDA to include a provision requiring
third-party approval of processors' HACCP plans, especially if
preapproval by FDA is not required. The comments suggested that the
lack of a requirement for a processor to use a disciplinary team
approach to develop a HACCP plan, as suggested by the NACMCF, coupled
with infrequent FDA inspections, could mean that a processor might
operate for years without an appropriate plan. The comments noted that
competent processing authorities are available to provide third-party
plan approvals and audits.
On the other hand, one comment argued that a requirement for third
party HACCP plan approval is not necessary. This comment stated that a
nonregulatory first inspection would obviate any form of preapproval.
FDA recognizes that some processors may benefit from obtaining
third-party assistance in developing their HACCP plans and in
evaluating their implementation. An independent audit is often helpful
in locating problems in a system and offers the benefit of bringing in
expertise not always possessed by many seafood processors. FDA is aware
that some processors have engaged in these kinds of arrangements in the
past and encourages their use.
However, the agency cannot agree that third party assistance should
serve as an ``approval'' for regulatory purposes. First, to maximize
consistency and fair treatment, the responsibility for the initial
HACCP plan evaluation (outside of the processor's own verification
activities) belongs to FDA, through routine inspections of processing
plants. Second, establishing, certifying, and auditing a network of
third parties whose approvals FDA would automatically accept would
impose significant burdens on the agency that FDA could not
accommodate.
As discussed above, FDA is engaging in significant efforts to
facilitate the development of appropriate HACCP plans. The overall high
level of policy guidance and technical assistance that will be
available to processors from FDA and a variety of other sources should
minimize the incidence of processors developing and implementing plans
that do not address those hazards that are reasonably likely to occur.
Therefore, FDA is not providing for third-party approval of HACCP
plans.
7. The First Inspection
In the preamble to the proposed regulations, FDA tentatively
concluded that, after the effective date of these regulations, FDA's
review of processors' HACCP plans and procedures would occur at the
time of the routine establishment inspection. FDA requested comment on
whether the first HACCP review should be nonregulatory, even though the
inspection of the processor would otherwise be regulatory.
163. Approximately 30 comments, mostly representing processors and
trade associations, addressed this issue. All but one of the comments
asked that the first review of a processor's HACCP plan and procedures
be nonregulatory. Approximately one-fourth of these comments further
asked that the second such evaluation also be nonregulatory.
The comments stated that a nonregulatory visit by FDA would assist
the processor in determining deficiencies in its plan without fear of
enforcement action and would provide FDA investigators with hands-on
experience in a HACCP-based inspection. The comments suggested that
this arrangement would foster a cooperative spirit between the agency
and the industry and would provide the time necessary for the
investigator to discuss with the processor how the plan should be
tailored to address the details of the processor's operation.
One comment stated that the initiation of a sweeping, new program
will generate many questions and will necessitate innumerable judgments
on the part of both processors and investigators. The comment suggested
that it would be preferable for these questions and judgments to occur
during nonregulatory visits.
On the other hand, one comment suggested that the first review of a
processor's HACCP plan should be
[[Page 65172]]
regulatory, because once the effective date has been reached,
compliance with the regulations should be enforced.
FDA agrees with the comments that suggested that a smooth
transition to a mandatory HACCP system of preventive controls is more
likely the result of dialogue than regulatory action. For HACCP to
succeed, processors must be committed to it because they perceive
benefits to themselves from its use other than simply the avoidance of
regulatory sanctions.
FDA has concluded that a 2-year effective date, rather than the 1-
year date that was proposed, will provide substantial opportunity for
dialogue. Moreover, the proportional response to problems that FDA
intends to employ, taking into account the newness of the system,
should obviate many of the comments' concerns about excessive
regulatory sanctions early in the process. Consequently, FDA concludes
that an officially designated, nonregulatory first inspection is not
necessary.
FDA has concluded that 2 years is sufficient time for a processor
to train employees or secure properly trained consultants, perform a
hazard analysis, develop a HACCP plan, and implement and evaluate HACCP
control procedures that will comply with these regulations. The
additional year will enable the agency's field investigative force and
the industry to begin sorting out many of the issues that are likely to
develop during implementation.
As stated earlier, the agency intends to perform informal HACCP
evaluations of willing processors during routine inspections conducted
during the 2-year implementation period. These evaluations should serve
to aid the development of both the industry's HACCP programs and the
agency's HACCP inspectional skills. They will also largely take the
place of the proposed type of nonregulatory inspections.
FDA agrees with the comment that pointed out that the initiation of
this program will generate many questions and issues that will have to
be worked out between processors and the agency. Moreover, FDA accepts
that, despite the years of groundwork and the pilot programs that have
been the basis for agency policy decisions to date, there will be
details that will have to evolve over time as the program is
implemented. It is highly likely that this evolution will continue well
after the effective date of these regulations. FDA will take this
factor into account in its initial interactions with processors after
the effective date. The agency may find it appropriate to use its
regulatory discretion when it finds a basis for concern about a
processor's HACCP plan or procedures that relate to a matter about
which policy is still being formulated.
However, the agency is concerned that there could be significant
problems if it officially designated its HACCP review during the first
inspection as being nonregulatory. First, such a step could create
unfair situations. For example, FDA could find itself in the position
of pursuing regulatory action against one processor for failure to
adequately control a particular hazard while, at the same time,
treating a similar deficiency by another processor as
``nonregulatory.'' Second, it could foster actions by firms to avoid
application of the regulations, such as name changes or reorganizations
to create the argument that the ``new firm'' is entitled to a
nonregulatory inspection. Third, it is not clear how long such a policy
should last. Arguably, the reasons in support of a nonregulatory first
inspection become much weaker in the case of a firm that goes into
business for the first time a number of years after the effective date
of the program.
For all of the foregoing reasons, FDA has concluded that it can
accomplish the things that led it to inquire about the possibility of,
and the comments to support, designating the first HACCP inspection as
a nonregulatory inspection without making such a designation and
creating the problems that such a designation could cause.
8. Role of the FDA Investigator
164. In the preamble to the proposal, FDA stated its tentative
conclusion that its investigators would, among other things, evaluate
the adequacy of processors' HACCP plans during routine inspections. A
few comments objected to this role for the investigators. These
comments stated that investigators should be responsible for verifying
that the processor has performed a hazard analysis; developed a HACCP
plan where warranted; implemented the HACCP plan; and recognized,
corrected, and recorded deviations from the HACCP plan. The comments
further stated that investigators should not be in a position to
challenge the adequacy or design of a HACCP plan.
The comments pointed out that HACCP plans are tailored for each
operation, designed by either a company team or a knowledgeable
individual thoroughly familiar with the operation. They questioned
whether an FDA investigator would have the expertise to determine the
acceptability of the plan.
Many FDA investigators already have considerable training in HACCP
and food science, and most have an academic background in the sciences.
They will also receive training during the implementation period that
focuses on compliance with these regulations. The investigators will be
exposed to the Guide, among other sources, for information about
potential hazards to be considered for particular products and
processes. This exposure, coupled with investigators' experience with
the industries with which they work, will give them a sound basis for
making screening determinations about the adequacy of processors' HACCP
plans. There is little doubt that the caliber of investigator screening
decisions will improve with experience with these regulations and with
exposure to more and varied processor HACCP programs. FDA is confident
that its field investigative staff will quickly adjust to the task of
fostering compliance with these regulations, as they have to past
initiatives.
Where investigators are unsure about the adequacy of a processor's
HACCP plan, they will have ready access to, and will be encouraged to
consult with, district, regional, and headquarters experts.
Investigators will also be instructed to discuss with plant management
the reasons and scientific support for hazard analysis and HACCP plan
decisions that are in question. Where, because of the complexity of a
particular situation, the investigator cannot reach a decision about
the adequacy of a particular aspect of a processor's HACCP plan, the
investigator will be instructed to collect as much information,
including supporting data, as is necessary in order to facilitate
further agency review.
Therefore, FDA concludes that the existing system adequately
addresses the concerns of the comments.
9. Disagreements and Appeals
165. A significant number of comments, primarily from processors
and trade associations, stated that FDA should have a mechanism to
resolve differences between an FDA investigator and a processor
regarding the adequacy of the processor's HACCP plan, especially given
the subjective nature of the determination as to what the hazards are
that are reasonably likely to occur and that therefore must be
controlled through HACCP. The comments contended that a cooperative
discussion between FDA and the processor's HACCP experts would be
preferable to an enforcement confrontation, and that this discussion
would allow a processor to explain its decisions and procedures. Other
comments urged FDA to formalize an
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appeal process in the regulations that would establish a processor's
rights to contest any HACCP compliance action by FDA. Moreover, these
comments stated that FDA should not take enforcement action based on a
disagreement in the field between an investigator and the developers of
the plan.
As previously mentioned, agency investigators will be instructed to
discuss their concerns about potential inadequacies in processor HACCP
plans with the management of the firm in an effort to learn the basis
of the firm's decisions. If the investigator retains concern that a
plan is inadequate in some regard even after discussing it with the
firm, the investigator will list findings on the report that is
provided to the management of the firm at the conclusion of the
inspection (Inspectional Observations, FDA483). The FDA483 only
represents the opinion of the investigator and is not necessarily the
final opinion of the agency. The investigator will document the
processor's response to, or explanation of, the findings listed on the
FDA483 report.
It has been longstanding FDA policy to conduct an internal review
of investigators' inspectional findings before initiating regulatory
action. There is an opportunity at each stage for discussion between
the firm and the agency. These FDA review practices will not change
under a HACCP-based system.
Based on the foregoing, the agency concludes that the concern
expressed in the comments about possible precipitous compliance action
as a result of the findings of FDA investigators is unwarranted. It is
worth repeating that the agency intends to engage in conflict
resolution through dialogue wherever possible and appropriate. Given
these facts, FDA has concluded that a provision for a special appeals
process for matters concerning these regulations is not necessary.
10. Status of the ``Guide''
In the preamble to the proposed regulations, FDA discussed the
``five preliminary steps'' to HACCP recommended by the NACMCF. These
steps lead a processor through a logical process for identifying
hazards that are likely to occur in a product and for developing a
HACCP plan. In an effort to facilitate this process, especially for the
many small businesses involved in seafood processing, FDA is developing
the Guide, a draft of which was made available shortly after
publication of the proposed regulations. The draft Guide provides
information on hazards and appropriate controls by species and by
product type. The preamble said that the information contained in the
draft Guide is the kind of information that would likely result in a
HACCP plan that is acceptable to the agency. FDA received considerable
comment on the contents of the draft Guide and intends to publish a
redrafted first edition shortly after the publication of these
regulations.
166. A number of comments expressed concern about how the Guide
would be used by FDA investigators when evaluating a processor's HACCP
plan. The commenters were troubled by the prospect that FDA
investigators would not be trained to evaluate HACCP plans that differ
from the Guide, and that, therefore, they would take exception to a
HACCP plan that deviates from the Guide. The comments stated that
industry experience with HACCP demonstrates the need to provide
flexibility so that HACCP plans can be tailored to the specific
operating conditions of a processor.
Other comments stated that the Guide did not provide express
guidance on the meaning of the key phrase ``reasonably likely to
occur.'' The comments stated that the Guide should clarify whether it
is FDA's intention that the hazards identified in the Guide are the
``reasonably likely'' hazards under all conditions for the specific
species and processing operations that are listed.
Several comments cautioned that the Guide should not be
characterized as a ``safe harbor,'' i.e., that FDA should not promote
strict adherence to the Guide regardless of the circumstances. Such a
characterization, they argued, could cause processors to omit the
critical hazard analysis step in HACCP plan development and risk
developing plans that do not fit the conditions of their processes.
The Guide is, in the agency's opinion, a compilation of the best
available information on the subject of hazards and controls in seafood
processing. It contains FDA's recommendations as to the hazards that it
believes are ``reasonably likely'' to occur in specific species and
finished product forms under ordinary circumstances, but it also
provides information on rarer hazards as well. FDA recognizes that the
first edition of the Guide must clearly distinguish between the two.
The term ``reasonably likely'' is now effectively defined in
Sec. 123.6(a). It is worth noting that, under Sec. 123.6(a), whether a
hazard is ``reasonably likely'' will depend, at least in part, on the
circumstances that exist at the time that the hazard analysis is
conducted. For example, a certain toxin might be rare, but if it starts
presenting itself in fish and becomes known, it may warrant a new
hazard analysis that may identify it as ``reasonably likely'' for a
period of time.
FDA also recognizes that circumstances may occur in which hazards
will exist that are not identified in the Guide. These hazards may be
the result of a previously unidentified phenomenon (e.g., the
identification of a natural toxin in a species previously not
associated with that toxin) or of unique conditions in the way that the
product is handled by a particular processor (e.g., unusual equipment
or processing methods). Thus, a definitive determination of
``reasonably likely to occur'' can come only as a result of a carefully
conducted hazard analysis performed for a specific product under
specific processing conditions.
FDA recognizes that a HACCP approach requires flexibility and will
endeavor to make the Guide consistent with such flexibility. FDA will
provide training to its investigators so that they will be prepared to
evaluate a HACCP plan that is not consistent with the Guide and to
evaluate the effectiveness of controls that differ from those suggested
in the Guide. The agency agrees that the Guide is not a ``safe harbor''
for all situations. Processors who utilize the Guide should compare it
to their own circumstances and make whatever adjustments in the
approach suggested in the Guide that are necessary.
11. Trade With the EU
167. One comment suggested that, because of directives issued by
the EU, many processors may need early recognition of their HACCP
programs by FDA. The comment further suggested that early recognition
could be used by the agency as a means of training FDA inspectional
personnel.
FDA is aware of the directives of the EU. The agency intends to
consider how it can best help processors respond to those directives,
among other factors, as it formulates its plans for implementation of
these regulations.
12. Measuring Program Success
In the preamble to the proposed regulations, FDA asked for comment
on what tests should be used to measure the success of the HACCP
program as a whole, and how often those tests should be conducted.
168. A significant number of comments stated that indicators of the
success of the seafood HACCP program could include: A reduction in the
number of seafood-borne illnesses; improved consumer confidence in
[[Page 65174]]
seafood consumption; and a reduction in the number of violative
products that enter the marketplace. Several comments stated that
periodic inspections of, and sampling at, processors and importers by
FDA, State, and foreign officials, coupled with illness reporting from
a strengthened CDC program, would provide adequate verification of the
effectiveness of the program. However, two other comments stated that
the success of the seafood HACCP program cannot be measured solely by a
decrease in illnesses, because many food-borne illnesses are the result
of problems in the retail sector, which is neither covered by these
regulations nor adequately regulated by the States.
The agency agrees with those comments that suggested that the
ultimate goal of these regulations should be the improved safety of
fish and fishery products--a reduction in the actual number of seafood-
related illnesses. FDA will continue to closely monitor the CDC system,
as well as reports of illness and death attributable to the consumption
of seafood that it receives from other sources, for trends that may
indicate an emerging problem or the intensification or modification of
an existing problem. However, the agency also agrees with those
comments that suggested that, because many of the seafood-related
illnesses are attributable to recreational or subsistence fishing or to
problems in the retail and food-service sectors (Ref. 7, pp. 2; 15; 27;
and 28), improvements in process controls that result from the
implementation of HACCP may not be fully reflected by a reduction in
the number of illnesses. Additionally, as has been previously
discussed, the CDC system encompasses only reported illnesses and is an
imperfect means of judging reductions in actual numbers of illnesses.
FDA is supportive of a strengthening of the CDC reporting system.
Based in part on the comments received, the agency will be looking
at ways to assess a relationship between success of the HACCP program
and levels of consumer confidence, levels of violative product in the
marketplace, improvements in the quality and quantity of preventive
controls throughout the industry; and the results of FDA and
cooperating State and foreign inspections. As indicated in the summary
of the Regulatory Impact Analysis elsewhere in this preamble, FDA is
planning to evaluate key features of this program within the first
several years of implementation. This evaluation will include an
assessment of its effectiveness.
169. One comment suggested that end-product testing should be used
by FDA for program surveillance purposes, particularly for imports.
This comment encouraged FDA to conduct statistically reliable baseline
and monitoring surveys, modeled after those used in the MSSP, conducted
by NMFS, to: (1) Determine how often consumer hazards occur; (2) set
specific goals, objectives, and operational strategies for the HACCP
program; and (3) provide a means by which the program's success can be
measured.
FDA has historically collected and analyzed surveillance samples
during and outside the course of its routine inspections. The purposes
for these sample collections, in many ways, align with those suggested
by the comment. The agency is committed to continued surveillance
sampling and intends to use such sampling in an assessment of the HACCP
program.
170. Another comment suggested that HACCP will only be successful
in improving confidence in seafood if the program is accompanied by a
consumer education effort that explains the benefits of HACCP. The
comment encouraged FDA to perform a baseline study that assesses the
level of consumer anxiety with respect to seafood consumption and
compare it to the results of a study that it performs sometime in the
future.
FDA agrees that another major goal of these regulations is to
increase consumer confidence in the safety of seafood. The agency
recognizes that publication and enforcement of regulations aimed at
improving seafood safety alone will not achieve that goal. Consumers
must be informed of the benefits of producing products under HACCP
preventive controls. Within its budgetary constraints, the agency
intends to engage in a program of consumer education for that purpose.
The prospect of baseline and followup studies of consumer confidence
(or anxiety) will also be considered.
P. Other Issues
FDA received a number of additional comments that did not address
any specific provision of the proposal, although some of them were in
response to invitations in the preamble to comment on various subjects.
1. Relationship to Other Programs
In the preamble to the proposed regulations, FDA invited comment on
how FDA's HACCP program for seafood processors should mesh with
existing State HACCP programs for seafood, in order to avoid imposing
inconsistent Federal and State HACCP requirements. In the preamble, FDA
acknowledged that many States are under considerable pressure to cut
back on programs where there is an overlapping Federal program.
Nonetheless, the agency urged States to maintain, if not strengthen,
their seafood programs and to work with FDA to develop an integrated
Federal/State, HACCP-based seafood control program.
171. Approximately 12 comments, representing processors, trade
associations, and State government agencies, recommended that FDA
coordinate its HACCP program with existing State and Federal seafood
control programs. Several comments emphasized that a coordinated effort
would ensure uniform application and interpretation of HACCP
principles, while preventing duplication of effort that wastes limited
enforcement resources. One comment stated that such a coordinated
effort would be facilitated if only a single HACCP plan were required
for each processing facility, rather than one that was designed to meet
FDA requirements and another that would meet State requirements.
Another comment noted that a multitude of differing HACCP regulations
would only serve to confuse processors and dilute the effectiveness of
the Federal program. The comment further recommended that FDA work with
AFDO to promote State laws and regulations that are compatible with
FDA's HACCP program.
One comment suggested the formation of a task force representing
the food industry, FDA, USDA, and DOC to work towards the goal of
reducing regulatory duplication.
The agency agrees that there is a need for Federal/State
partnership to facilitate the efficient implementation of HACCP
programs. FDA believes that coordination with the States would permit
both the agency and the States to leverage their inspectional
resources. FDA, as well as the States, would benefit by dividing the
workload and sharing data and other information. Such coordination
would also benefit industry through consistent inspections and
regulatory requirements.
The agency has already begun to coordinate its efforts with the
States on seafood. The formation of the Alliance, to which AFDO is a
member, is one such endeavor. The Alliance is described in detail in
the ``Training'' section of this preamble.
With FDA's support, AFDO passed a resolution supporting the
development of FDA/State partnership agreements at its 1994 meeting in
Portland, ME (Ref. 220). The resolution specifically recommended that
HACCP be the basis of such partnerships and noted the
[[Page 65175]]
shared roles of FDA and State regulators in seafood safety, the limited
resources of both levels of government, and the existence and the
potential impact of the Alliance.
Meanwhile, FDA is increasing its use of partnership agreements with
State enforcement agencies. For instance, the Northeast Region of FDA
has entered into a threeway partnership agreement with the Northeast
Food and Drug Officials Association and individual States to provide
industry with HACCP training at the retail level. FDA also expects to
enter into partnership agreements with States to implement HACCP pilot
programs for foods other than seafood. FDA's Northeast Region has
already signed such an agreement with the Commonwealth of
Massachusetts, and more are anticipated.
These initiatives demonstrate the agency's desire to coordinate its
efforts with the States. The agency's cooperative efforts in the area
of HACCP reflect a trend. The agency has used cooperative efforts in
other areas, such as pesticide sampling and workplan sharing. FDA will
continue to explore ways to coordinate the Federal and State role in
the regulation of seafood.
172. A number of comments recommended that States act as the
primary enforcement agencies for these HACCP regulations, while FDA's
responsibility would be to evaluate the States' compliance with HACCP
inspection protocols. Some of these comments suggested that such a
program could be patterned after the NSSP.
FDA is adopting these HACCP regulations to implement and enforce
the act. While FDA plans to work cooperatively with the States in all
ways possible, the agency cannot delegate its authority under the act.
It is possible that in some aspects of seafood processing, the States
will serve as the primary enforcement agencies, with FDA serving
primarily an auditing function. However, responsibility for enforcing
the act and these regulations must remain with FDA.
173. A number of comments, from processors, trade associations, and
one consumer advocacy group, maintained that FDA's HACCP regulations
should preempt any existing State HACCP programs. The comments
contended that Federal preemption would ultimately reduce confusion
caused by conflicting State programs, reduce costs, and promote
uniformity. Examples of the specific areas of conflict were not
provided by the comments.
As was previously stated, FDA intends to work through AFDO and
through Federal/State partnerships to seek consistency in State
regulatory approaches to HACCP for seafood inspection and through the
NSSP process and the ISSC to attain this goal specifically for
molluscan shellfish. Moreover, processors in each State must comply
with Federal HACCP requirements if their product moves in interstate
commerce. For these reasons, the agency has concluded that there is no
need for Federal preemption of State regulatory requirements.
174. Several comments encouraged FDA to work closely with NMFS to
coordinate FDA's program with the existing NMFS' HACCP program. The
comments noted that cooperation with NMFS would help the two agencies
avoid wasteful duplication of effort and would reduce the burden on
those firms already operating under the NMFS program.
FDA agrees with these comments and notes that FDA and NMFS are
coordinating their HACCP programs to ensure compatibility. Nonetheless,
FDA advises that the NMFS program is a voluntary, fee-for-service
program and is likely to continue to include features that go beyond
the requirements of these regulations, especially in the area of
preventive controls for economic fraud and plant and food hygiene.
A 1974 MOU between FDA and NMFS recognizes the respective roles of
the two agencies and commits the two agencies to consistency and
cooperation. FDA will continue to work with NMFS to maintain a
coordinated Federal effort.
2. ``Whistleblower'' Protection
175. A few comments urged that these regulations include
``whistleblower'' protection for employees of seafood processors.
Whistleblower protection is designed to protect workers from being
fired or otherwise discriminated against for revealing wrongdoing by
their employers. The wrongdoing in this case, presumably, would likely
involve the falsification of HACCP records. The comments argued that:
``Whistleblowers are iispensable as the eyes and ears for overextended
FDA personnel making limited spot checks. The public's line of defense
will be no stronger than the shield protecting industry worker's rights
to obey and help enforce this law.''
One concern that FDA has heard about the credibility of a HACCP
system is that important records can be falsified. It is alleged that,
without whistleblower protection, it is much less likely that the
agency will know about falsifications.
While the agency is confident, based in part on its experience
reviewing records in the low-acid canned food program, that it can
detect falsification, FDA also expects from experience that it will be
alerted to possible wrongdoing from time to time by employees of
processors even in the absence of whistleblower protection. FDA has
received, and acted upon, confidential information from employees of
regulated firms for decades. This assistance has proven invaluable on
many occasions. The only protection to these employees available from
FDA has been confidentiality.
The question raised by the comments is whether, in addition to the
actions against the product or the processor that would be available to
FDA as a result of violations of the requirements of the act and these
regulations, there must be specific protection for employees in order
for the program to succeed. The agency has concluded that, like other
FDA programs, this program can be successful in the absence of specific
whistleblower protection, and that congressional action would be
necessary to provide protection other than confidentiality.
FDA cannot provide whistleblower protection in these regulations.
FDA believes--and case law bears out--that there must be a nexus
between the conduct being required by regulations and the focus of the
underlying statute, in this case primarily section 402(a)(4) of the
act. An analysis of the application of section 402(a)(4) of the act to
these regulations can be found in the ``Legal Basis'' section of this
preamble.
While FDA has determined that an assessment of processing risks and
a plan that ensures that these risks are minimized has the requisite
nexus to section 402(a)(4) of the act, and that this nexus justifies
adopting these regulations, the agency does not see a sufficient nexus
between whistleblower protection and the prevention of adulteration of
food. If a firm retaliates against an employee who brings complaints or
other information about the firm to FDA, the implication of such an
action is that there is a condition at the firm that may need
investigation, not that the products produced by the firm are
necessarily adulterated. It may be the case that the products are
adulterated, but such a conclusion does not flow as directly from
section 402(a)(4) of the act as does the conclusion that seafood
products not produced under a HACCP plan have been produced under
insanitary conditions whereby they may have been rendered injurious to
health. For this reason, FDA concludes that it lacks
[[Page 65176]]
clearcut authority to provide whistleblower protection in these
regulations.
3. Separation of Quality Control (QC) and Production
176. A few comments requested that the regulations mandate
structural independence within a processing firm between ``HACCP QC
[quality control] personnel'' and ``production'' personnel. Otherwise,
according to the comments, ``HACCP QC personnel could still be hired
and fired by a production supervisor.''
FDA does not believe that a change in the regulations would be
beneficial in this regard. It is important to recognize that, under
HACCP, production personnel are the observer/operators who perform the
initial monitoring of CCP's as well as the recordkeeping that documents
the results of this monitoring. The operation of the HACCP system must
involve the whole organization, not just QC personnel.
However, it is reasonable to expect that, where practical,
verification activities should be performed by individuals other than
those who made the records in the first place. For verification, the
agency encourages the kind of organizational separation that is being
urged in the comments.
The agency recognizes, however, that many seafood companies will
not be large enough to have distinct, independent organizational units
that can verify each other's work. The seafood industry is
characterized by small businesses. FDA has concluded that such a
requirement is not practical for this industry.
It is worth noting that the regulations at parts 113 and 114 for
low-acid canned foods and acidified foods contain recordkeeping
requirements and some verification requirements that are similar to the
provisions of these regulations. In certain respects, parts 113 and 114
served as models for the seafood HACCP program. Those regulations have
succeeded even though they do not require a separation between QC
personnel and production personnel. Given this history, the agency is
reluctant to mandate the internal structure of seafood processors.
4. Education
177. FDA received a number of comments on the subject of seafood
safety education. These comments were in response to an invitation in
the preamble to the proposed regulations for comments on risk reduction
activities that could be regarded as complementary to HACCP, primarily
directed toward postprocessing handling. In addition, FDA asked for
comment on appropriate education and information that should be
directed toward consumers and recreational fishermen, even though
education aimed at these groups is actually outside the scope of this
rulemaking. FDA made this request based on a recognition that HACCP
cannot reasonably be expected to solve every problem. The agency
recognizes that HACCP must be integrated into a comprehensive program
for seafood safety. Education is another important component of that
program. As one comment noted:
* * * the responsibility for seafood safety should be met at
every level of seafood distribution, from harvesters to processors
to retailers, restaurants and, finally, the consumers themselves.
Regulations are not a substitute for informed and responsible
behavior and it is impractical to extend the scope of the proposed
regulations to everyone involved in handling and consuming seafood.
The comments overwhelmingly endorsed the value of education. They
strongly supported education for: (1) Consumers on the handling and
purchasing of seafood, especially through brochures at the point of
purchase and information available at pharmacies, and on the
significance of HACCP, especially with regard to the government's
verification role; (2) recreational fishermen, provided by the State
during licensure (with guidance from the Federal government) and
through articles in popular fishing and outdoors magazines; (3)
subsistence fishermen; (4) retailers, including food service and
restaurants.
FDA greatly appreciates these comments. The agency agrees that
education is an essential complementary activity to HACCP as well as to
other aspects of FDA's overall seafood program. The comments will be
taken into account as the agency develops its educational program.
178. FDA also invited comment on whether the agency should consider
proposing to require handling instructions for consumers on the
labeling of seafood. Any action that FDA were to take along these lines
would be as part of a separate rulemaking.
The agency received about 20 comments on this issue. Approximately
half of those comments supported the notion of mandatory safe handling
instructions. One business noted that safe handling instructions would
help to ensure the safety of a product through the distribution chain,
while another business said that such instructions had a real potential
to decrease seafood-related illness. One individual commented that safe
handling instructions would increase consumer confidence in these
products. One industry comment noted that a task force composed of
industry, Federal and State agencies, and consumers should agree on the
appropriate statement. Some comments indicated that safe handling
instructions might be appropriate for high-risk products.
The remainder of the comments on this issue disagreed that safe
handling instructions for seafood should be required by FDA. Many of
these comments noted that most seafood products include such
instructions voluntarily. One trade association commented that such a
requirement would limit retailers' flexibility and creativity and
impose significant new costs on retailers and consumers. Most of those
comments noted that requiring new information would detract from other
labeling requirements.
FDA appreciates these comments and the different points of view
that they represent. The agency will use the comments in its
deliberations on this issue.
179. Finally, FDA described some of its educational efforts aimed
at medically compromised individuals about avoiding raw molluscan
shellfish and invited comment on types of education and information
activities that might be useful in this regard. The agency received
about a dozen comments on this subject.
Most of these comments addressed whether there should be mandatory
warning labeling for raw molluscan shellfish. A majority of the
comments stated that the agency should require warning labeling. Three
comments from consumer groups stressed the need to protect high-risk
individuals. One State government commented that warnings for raw
molluscan shellfish should be tied to specific locations and times of
year. One professional association requested that the warning state
that the shellfish should only be eaten if it is certified and tagged.
Three comments stated that warning labels would be inappropriate.
One comment noted that shellfish are not consumed in enough quantity to
be a problem. Another comment stated that warning labels would unduly
alarm those not at risk and that better channels exist for educating
those at risk.
A few comments did not specifically address warning labels but
recommended that FDA target advice directly to compromised individuals.
Those comments suggested that FDA direct information to the medical
community involved in the treatment of those individuals.
[[Page 65177]]
Again, FDA thanks the comments for providing views on a matter that
is outside the scope of this rulemaking. FDA is working to provide
information to at-risk populations and its strategy on how best to do
so is evolving. The agency will take the comments into account as it
develops policy in this area.
In summary, the agency agrees that education is an essential
complementary activity to HACCP as well as to other aspects of FDA's
overall seafood program. The comments relating to education will be
useful to the agency as it develops its education programs.
5. Traceback Mechanisms
180. One comment recommended that FDA develop and incorporate
methods to trace back fish and mandate such traceback in these
regulations. The comment described the use of bar codes and computer-
based tracking numbers by a meat products company that enable it to
trace a specific cut of meat from a store or restaurant to its source.
The agency acknowledges that traceback to the water would be useful
for certain species of fish associated with certain hazards, e.g.,
ciguatoxin. On the other hand, traceback to the water for scombrotoxin
would not be particularly useful, although traceback through the
distribution chain to find out the source of mishandling would be
useful. The agency urges the industry to consider this comment. FDA
advises that it is willing to explore this idea further, although not
as part of this rulemaking.
6. Tribal Governments
181. FDA received a few comments on the effect of these regulations
on tribal governments. The preamble to the proposed regulations noted
that Executive Order 12875 of October 26, 1993, requires, among other
things, consultation with tribal governments before the formal
promulgation of regulations containing unfunded Federal mandates. While
FDA does not believe that these regulations impose an unfunded Federal
mandate, the agency wishes to foster consultation on matters that might
significantly affect tribal communities. Consequently, FDA requested
comment on the economic effect of the regulations on tribal
governments.
FDA received no comments from tribal governments. One comment, from
a tribal business, stated that the impact of the regulations on tribal
governments will be beneficial because they will result in safe
products, positive consumer perceptions, and positive market impacts.
The other comment that mentioned this subject was from an academic, who
expressed the view that the regulations will have a major impact on
tribal groups involved in fisheries and contains unfunded Federal
mandates. The comment did not elaborate. Neither of these comments
justifies any change in these regulations.
The agency remains interested in fostering consultation with tribal
communities as they see fit and encourages correspondence from tribal
governments.
7. HACCP System Improvements
182. A comment urged that there be a process to continually amend
or update these regulations.
FDA points out that such a mechanism exists in its regulations.
Under Sec. 10.30 (21 CFR 10.30), interested persons are provided with a
process by which they can petition the agency to amend and update these
regulations.
From a less mechanistic viewpoint, the agency recognizes that these
regulations represent a pioneering program that has not been attempted
before. While the agency believes that sufficient groundwork has been
laid to adopt these regulations and to begin to implement them, FDA
also acknowledges that full scale implementation will reveal
modifications that may be necessary, both in the short and long terms.
Consequently, the agency will be highly receptive to feedback from all
parties who are affected by these regulations and will remain open to
changes that are necessary in the regulations. The ``Verification''
section of this preamble reflects the agency's interest in evaluating
this program.
183. A number of comments asked for improvements in the foodborne-
illness reporting system operated by CDC. Some comments urged
collaboration between FDA and CDC. One comment advocated the creation
of an active reporting system.
These comments are essentially outside the scope of this
rulemaking. Nonetheless, the agency recognizes that the strength of the
foodborne-illness reporting system bears directly on the ability of the
agency to measure the public health impact of HACCP. Both FDA and CDC
agree that underreporting is an undesirable feature of the current
system. FDA and CDC have been collaborating on an active-type reporting
system. The limiting factor, however, will always be resources.
Significant improvements in the current system will involve
considerable expense.
184. One comment provided views on factors that would limit the
effectiveness of HACCP. The comment cited:
[P]oor commitment by company management and lack of allocation
of necessary resources; improper training; lack of understanding and
planning in all stages of implementation of a plan[,] and failure to
recognize the need to understand the corporate culture change which
must accompany an effective HACCP program.
FDA agrees with this comment but hopes that company management will
embrace HACCP and recognize the benefits that it offers to the firm.
III. Paperwork Reduction Act of 1995
This final rule contains collections of information that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title,
description, and respondent description of the information collections
are shown below along with an estimate of the annual recordkeeping and
periodic reporting burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
Title: Reporting and recordkeeping requirements for processors and
importers of fish and fishery products under the provisions of 21 CFR
parts 123 and 1240. Procedures for the Safe and Sanitary Processing and
Importing of Fish and Fishery Products.
Description: This regulation implements the use of Hazard Analysis
and Critical Control Point (HACCP) methodology to ensure that processed
and imported fish and fishery products are safe within the meaning of
sections 402(a)(1) and 402(a)(4) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342(a)(1) and 342(a)(4)).
Description of Respondents: Businesses or other for profit
organizations.
Although the January 28, 1994, proposed rule provided a 60 day
comment period (extended to 90 days in the April 7, 1994, Federal
Register, 59 FR 16578) under the Paperwork Reduction Act of 1980, and
this final rule incorporates the comments received, as required by 44
U.S.C. section 3507(d), FDA is providing additional opportunities for
public comment under the Paperwork Reduction Act of 1995, which applies
to this final rule and was enacted after the expiration of the comment
period.
Therefore, the agency solicits public comment on the information
collection requirements in order to: (1) Evaluate whether the proposed
collection of information is necessary for the proper
[[Page 65178]]
performance of the functions of the agency, including whether the
information will have practical utility; (2) evaluate the accuracy of
the agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) enhance the quality, utility, and clarity of the information
to be collected; and (4) minimize the burden of the collection of
information on those who are to respond, including through the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses.
Individuals and organizations may submit comments on the
information collection requirements by February 16, 1996, and should
direct comments to FDA's Dockets Management Branch (address above).
Prior to the effective date of this final rule, FDA will publish a
notice in the Federal Register when the information collection
requirements in this rule are submitted for OMB approval, and again
when OMB makes a decision to approve, modify or disapprove the
information collection requirements.
Sections of this final rule require that certain businesses collect
information and keep records. Under Public Law 104-13 Federal agencies
are required to estimate the hours and costs attributable to
collections of information, as defined in 44 U.S.C. 3502(3), that are
required by Federal regulation. Table 1 sets forth an estimate of the
hours that are required annually for compliance with each section in
part 123 that requires regulated entities to collect or record
information.
Table 1.--Estimated Average Annual Information Collection and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
No. of
21 CFR No. of responses per Hours per Total
respondents respondent\1\ response\2\ hours
----------------------------------------------------------------------------------------------------------------
123.6(a),(b),(d)............................................ 4,850 1 16 77,600\3\
123.6(c)(5)................................................. 4,850 4 0.3 5,280
123.8(a)(1),(c)............................................. 4,850 1 4 19,400
123.12(a)(2)(ii)............................................ 1,000 80 0.2 16,000
123.6(c)(7)................................................. 4,850 280 0.3 470,400
123.7(d).................................................... 1,940 4 0.1 1,940
123.8(d).................................................... 4,850 47 0.1 22,795
123.11(c)................................................... 4,850 280 0.1 135,800
123.12(c)................................................... 1,000 80 0.1 8,000
123.12(a)(2)................................................ 20 1 20 4,000\3\
123.10...................................................... 24 1 24 116,400\3
\
First year total burden hours........................... ........... ............. ........... 877,615
Annual recurring total hours............................ ........... ............. ........... 679,615
----------------------------------------------------------------------------------------------------------------
\1\Based on an estimated average of 280 working days per year.
\2\Estimated average time per 8 hour work day unless one time response.
\3\Nonrecurring burdens.
The above estimates include the information collection requirements in the following sections:
123.16 Smoked Fish--process controls (see 123.6(b))
123.28(a) Source Controls--Molluscan Shellfish (see 123.6(b))
123.28(c),(d) Records--molluscan shellfish (see 123.6(c)(7))
123.9 Records control general (see recording and records)
The time and costs of these activities will vary considerably among
processors and importers of fish and fishery products, depending on the
type and number of products involved, and the nature of the equipment
or instruments required to monitor critical control points. The burdens
have been estimated using the typical small seafood processing firm as
a model because these firms represent a significant proportion of the
industry.
The burden estimate in Table 1 includes only those collections of
information under this rule that are not already required under current
statutes and regulations and are being added by this rule. For example,
the current good manufacturing practices provisions in 21 CFR part 110
already require that all food processors ensure good sanitary practices
and conditions, monitor the quality of incoming materials, monitor and
control food temperatures to prevent bacterial growth, and perform
certain corrective actions and verification procedures.
In addition, the estimate does not include collections of
information that are a usual and customary part of businesses' normal
activities. For example, the tagging and labelling of molluscan
shellfish (Sec. 1240.60) is a customary and usual practice among
seafood processors. Consequently, the estimates in Table 1 accounts
only for new information collection and recording requirements
attributable to part 123.
There are no additional capital costs associated with this
regulation that are not also attributable to the preexisting
requirements of part 110.
FDA estimated in the proposal that the total burden to all
respondents would be 2,826,850 hours. That estimate, however,
significantly overestimated the burden because it included activities
performed by domestic processors that are not related to information
collection and recordkeeping, and, more significantly, did not account
for existing regulatory requirements and usual and customary business
practices, as described above.
The agency has recalculated the recordkeeping burden in a manner
that is more consistent with the intent of Public Law 104-13.
Therefore, the burdens presented in Table 1 are those actually
associated with collecting and recording the pertinent HACCP
information. The burdens for HACCP plan development, plan reassessment,
and record review are also included in the recalculated burden. In
estimating the time for the preparation of a HACCP plan, the agency
believes that a significant portion of the training hours can also be
characterized as time spent on preparation of the plan.
Additionally, the agency recognizes that the regulations will place
a burden on seafood importers. For this reason, FDA has included in the
burden
[[Page 65179]]
estimate the time necessary for importers to develop a written
verification plan, verify compliance of imports, and keep records of
their verification activities.
Few comments provided information on the number of hours that a
processor would expend on information collection and recordkeeping, as
described in the preamble to the proposed regulation. One comment
estimated that the annual burden would vary from 200 to over 700 hours,
depending on the type of product, and another comment suggested that
one hour per day, or 365 hours per year, would be required. One comment
stated that the agency's estimate of 650 hours per year was reasonable.
Another comment estimated four to five hours per day, or 1,820 hours
per year as the likely burden. None of these comments provided
information to support how the commenters arrived at their estimates.
It seems likely that the estimates suggested by the comments were
calculated based on the same errors that the agency made in the
proposal, that is, by combining the burdens associated with HACCP data
collection and recordkeeping with other HACCP activities unrelated to
information collection and recordkeeping, with usual and customary
information collection and recordkeeping practices, and with
collections of information required by the provisions of the Federal
Food, Drug, and Cosmetic Act and implementing regulations. This
conclusion is supported by the fact that some of the comments expressed
agreement with the agency's calculations. For these reasons, FDA
concludes that no changes in its corrected calculations are necessary
to respond to the comments.
IV. Economic Impact
A. Introduction
In accordance with Executive Order 12866 and the Regulatory
Flexibility Act, FDA has examined the impacts of the final rule.
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety effects;
distributive impacts; and equity). The Regulatory Flexibility Act (Pub.
L. 96-354) requires analyzing options for regulatory relief for small
businesses.
The Unfunded Mandates Reform Act (Pub. L. 104-4) requires (in
section 202) that agencies prepare an assessment of anticipated costs
and benefits before proposing any rule that may result in an annual
expenditure by State, local and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 (adjusted annually for
inflation). The Unfunded Mandates Reform Act also requires (in section
205) that the agency identify and consider a reasonable number of
regulatory alternatives and, from these alternatives, select the least
costly, most cost-effective, or least burdensome alternative that
achieves the objective of the rule. Even though FDA finds that the
costs of this final rule may be below $100 million a year, estimating
these costs is a difficult task involving uncertainties. This analysis,
together with the preamble published in the Federal Register and
supporting analysis and materials, constitutes a final RIA. Therefore,
FDA has treated the final rule as an economically significant
regulatory action under Executive Order 12866. Consequently, the agency
has completed this full RIA which demonstrates that this rule is
consistent with the principles set forth in the Executive Order and in
these two statutes. In addition, this document has been reviewed by the
Office of Management and Budget as an economically significant
regulatory action under Executive Order 12866. FDA has concluded that
the net benefits of this rule (benefits minus costs) are largest for
the regulatory option selected as specified by Executive Order 12866.
FDA has also concluded that, pursuant to the Unfunded Mandates Act, the
regulatory option selected is the least burdensome option to accomplish
the goal of controlling all physical, chemical, and microbiological
hazards reasonably likely to be present in seafood.
As a part of the preamble to the proposed regulation, FDA published
a summary of the Preliminary Regulatory Impact Analysis (PRIA) and
placed on file with FDA's Docket Managements Branch the complete PRIA.
In addition, FDA has placed the full final Regulatory Impact analysis
on file at Dockets Management Branch (address above).
FDA has fully reviewed the information on which the PRIA was based,
the comments on the PRIA, and other available information on the costs
and benefits of HACCP for the seafood industry. Based on this review,
FDA has arrived at two estimates of the costs in this final rule as
well as upper and lower estimates of benefits. As can be seen in the
agency's summary of costs and benefits are summarized in Table 2, FDA
believes that the costs of the final rule will range from $677 million
to $1.488 while the benefits will range from $1.435 to $2.561 billion.
In its final analysis, the agency maintains that the total benefits of
this mandatory seafood HACCP rule will exceed the total costs.
Regulatory Options
The agency raised and received comment on a number of regulatory
options in the PRIA. The most significant two options raised were
regulating only high risk products or the most serious hazards and
providing regulatory relief for small businesses. The first option is
inconsistent with the objective of this regulation, to control all
physical, chemical or microbiological hazards reasonably likely to be
found in seafood products. Although FDA has not granted relief only for
small business, the agency has extended the compliance date for all
firms from 1 year to 2 years.
Table 2.--Summary of Total Costs and Benefits
----------------------------------------------------------------------------------------------------------------
Costs adjusted
Costs from FDA from NMFS Benefits lower Benefits upper
Year models model (millions) (millions)
(millions) (millions)
----------------------------------------------------------------------------------------------------------------
1............................................... $69 $162 $73 $108
2............................................... 42 9173 108
3............................................... 41 83 85 156
4............................................... 38 80 87 158
---------------------------------------------------------------
Total\1\.................................. 677 1,482 1,435 2,561
----------------------------------------------------------------------------------------------------------------
\1\The total defines the total discounted costs and benefits beyond the 4th year and discounted at 6 percent.
[[Page 65180]]
B. Costs
In the PRIA, FDA was reluctant to rely only on results of the
limited experience with HACCP in the seafood industry. FDA balanced the
reports of some seafood firms, which showed that the costs of HACCP
were low, with a study of the costs of HACCP that had been done under
contract with NMFS by A. T. Kearney, Inc. (Contract No. NA88AA-H-
SK006). This study showed significantly higher costs (as reflected in
the range of cost estimates summarized above) but had several flaws
that engender skepticism about its results as well. For example, none
of the plants that were the subjects of the study had actually
implemented HACCP, and the system whose costs were studied was
significantly more demanding than the system embodied in the 21 CFR
part 123. Despite these facts, the cost estimates in the PRIA were
based on the results of the NMFS study because FDA considered it to
represent the best evidence available at that time.
As explained more fully below, FDA used modeling technique and the
experience reported about seafood firms to produce estimates that are
in general agreement and that are approximately one-fourth of those
estimated in the NMFS study reported in the PRIA.
In estimating the costs in this PRIA, there are three checks that
have helped ensure the accuracy of the costs that would be imposed by
adoption of this regulation. The first is the cost comments, but these,
the agency's analysis revealed, were in most cases rather general, not
well supported, and of only marginal assistance. The second is modeling
by FDA experts based on their experience with the use of HACCP in the
seafood industry; working with aquatic species and the public health
problems that they present; inspecting and studying both seafood plants
and low acid canned food plants (which have operated under HACCP
principles for almost two decades); and participating in the FDA-NMFS
seafood pilot. The results of this modeling are detailed below. The
third source is information that FDA received from firms that have
actually implemented HACCP. Even though FDA finds that the costs of
this final rule may be below $100 million, estimating these costs is a
difficult task involving some uncertainties. The agency recognizes that
the rule may affect in a material way a sector of the economy.
Therefore, FDA has treated the final rule as a significant regulatory
action under Executive Order 12866. Consequently, the agency has
completed a full Regulatory Impact Analysis.
The agency received approximately 230 comments on issues involving
the PRIA. These comments are fully summarized and addressed in the full
RIA which is included in the record as Reference 229. However, because
of the problems with these comments noted above, FDA did not generally
use them in the revised estimates reported here and in the full RIA.
The reasons for this are more fully explained in the full RIA.
These adjusted NMFS model cost estimates result in per plant costs
for domestic manufacturers of $23,000 in the first year and $13,000 in
subsequent years. Total costs for compliance with these regulations
using the adjusted NMFS data are shown in Table 3. FDA has also
concluded that the PRIA represents a reasonable upper estimate of the
costs of HACCP. Table 3 also summarizes the specific cost estimates
that FDA arrived at using data from the NMFS model with cost
refinements received from commenters and FDA seafood industry experts.
Table 3.--Disaggregated Costs From Adjusted NMFS Model
------------------------------------------------------------------------
Million
------------------------------------------------------------------------
1st Year:
Domestic manufacturers and Importers........................ $112
Major plant repair and renovation........................... 13
Sea Grant expertise......................................... 1
Repackers and warehouses.................................... 14
Harvesters for rejected raw product......................... 1
Shellfish vessels........................................... 3
Foreign processors.......................................... 18
---------
Total................................................... 162
=========
2d Year:
Domestic manufacturers...................................... 65
Sea Grant expertise......................................... 1
Repackers and warehouses.................................... 14
Shellfish vessels........................................... 1
Foreign processors.......................................... 10
---------
Total................................................... 91
=========
3d Year:
Domestic manufacturers...................................... 65
Sea Grant expertise......................................... 1
Repackers and warehouses.................................... 14
IQF Shellfish plants........................................ 3
---------
Total................................................... 83
=========
4th Year:
Domestic manufacturers...................................... 65
Sea Grant expertise......................................... 1
Repackers and warehouses.................................... 14
---------
Total................................................... 80
Total discounted costs beyond the 4th year and discounted at 6 percent,
the costs are $1,482 million.
------------------------------------------------------------------------
1. Alternative Model for Estimating the Costs
In addition to the cost estimate based on the NMFS modeling, FDA is
presenting a second cost estimate for these regulations. The
uncertainties associated with the choices made by seafood processors to
control hazards justify providing a range of potential costs based on
more than one model.
In examples created by seafood experts within FDA, the cost of
compliance with these regulations was estimated for two small
hypothetical seafood processors that the agency believes to be
representative of a significant portion of the seafood industry. One of
the plants is assumed to be in substantial compliance with existing
CGMP requirements. Therefore, the costs experienced by that plant are
attributable exclusively to the establishment and maintenance of a
HACCP system. The other plant has some CGMP deficiencies that the
agency believes are typical of those displayed by seafood processors.
This plant is identical to the first plant except for the CGMP
deviations. The costs calculated for this second plant represent the
cost associated with the establishment and maintenance of HACCP as well
as costs associated with the correction and monitoring of sanitation
conditions.
The models concern two plants that cut and package tuna which is
received frozen and that also distribute orange roughy fillets. The
complexity of the processing operations, and the nature and number of
hazards, are assumed to be roughly equivalent to that of the other
types of operations. FDA recognizes the difficulty in validating these
assumptions. Nonetheless, the results demonstrate that processors may
have costs that are significantly below the averages estimated by means
of the NMFS report. As discussed later, data received from firms that
have implemented HACCP are generally supportive of the results of this
modeling.
a. Small plant cost example 1. This is the example of a firm that
is a processor of frozen tuna steaks and distributor of imported orange
roughy fillets who receives all fish frozen. This plant is
[[Page 65181]]
located in a major seafood processing region, so there is no need for
plant personnel to travel to other cities to receive training as it
would be available locally. This processor operates 280 days per year.
The plant manager is paid $15 per hour and production workers are paid
$8.50 per hour. No food safety hazards are reasonably likely to occur
in orange roughy, so a written hazard analysis shows hazards for tuna
only. This processor has no need to make CGMP improvements so the plant
costs are limited to the following:
(1) Training--($760). This is calculated as follows: $400 tuition
plus the opportunity cost of training time ($24 hours x $15 per hour).
The processor is expected to do most of the hazard analysis during the
class.
(2) HACCP Plan Refinement--($240). This is calculated by taking 16
hours billed at $15 per hour using the FDA Fish and Fishery Products
Hazards and Controls Guide.
(3) Plant Sanitation Audit--($0). This is done 3 times daily for 20
minutes each time. However, because the firm is modeled as being in
compliance with existing CGMP's, it is assumed that these audits are
already being done. It is assumed that there is a negligible cost for
recordkeeping.
i. Critical Control Points (CCP). (4) Receiving CCP (histamine)--
($3,200). This processor gets a freezing log from the tuna harvester
and makes a visual check of the fish to see that they are frozen. The
processor keeps a copy of the freezing log and makes a note of the
visual check. The fish are then transferred to a plant freezer. The
monitoring takes 15 minutes per lot for 4 lots per day. Similar
monitoring is already occurring and the marginal cost for the
recordkeeping is negligible.
The processor drills a representative sample of each lot and
performs an organoleptic examination for decomposition of the tuna. It
is assumed that this monitoring is not being done previous to this
regulation and takes 20 minutes per lot for 4 lots per day. Monitoring
is billed at $8.50 per hour. Also, there is a cost for a new drill
($50) and it is assumed that recordkeeping costs are negligible.
(5) Cutting CCP (metal fragments)--($0). A worker checks the saw
blade at every break to look for broken saw teeth and keeps a log of
checking on the teeth. Monitoring takes a few minutes per break. It is
assumed that there is a negligible marginal cost for the monitoring and
recordkeeping. Fish is weighed, packed, labeled and returned to the
freezer.
ii. Corrective actions. (6) Problems with incoming product--($0).
It is expected that product rejects in the first year would be higher
but they would return to current levels in the second year as
harvesters became aware of the processor's new requirements. The total
cost for the industry is $1 million for the first year and zero in the
following years. Because harvesters and not processors bear the cost of
rejected raw product, this cost is included in Table 4 as a separate
line item and not in Table 3 which includes only costs borne by
processors.
(7) A saw tooth breaks every two years--($20). A worker needs to
examine potentially affected product every 2 years. This is expected to
take 4 hours billed at $8.50 to check two hours worth of cutting.
iii. Verification. (8) Record review--($400). This involves a
review of five sanitation records, five receiving records, and a log
book for the cutting operation. These are expected to be very simple
(e.g., check mark records). Consequently, this review is expected to
take 30 minutes per week billed at $15 per hour.
(9) Review hazard analysis & HACCP plan--($60). This is expected to
take 4 hours per year at $15 per hour.
(10) Administrative changes--20 percent of all of the other costs
in the first year and 10 percent in the second year.
b. Small plant cost example 2. The categories of costs that are
different from Example 1 are explained below.
(1) Plant Sanitation Audit--($2,800). This will need to be done 3
times daily taking approximately 20 minutes for each audit. It is
assumed that some minimal sanitation assessment is already being done
once per day, but an additional 40 minutes would be required to perform
three adequate audits. Again, it is assumed that there is a negligible
cost for recordkeeping.
(2) Extra Equipment Cleaning and Sanitizing--($2,480). This is
assumed to take 1 hour per day billed at $8.50 per hour. Also,
additional water, and cleaning and sanitizing materials are assumed to
cost $100.
(3) Eliminate Fly Infestation--($330). Torn screens need to be
repaired taking 2 hours billed at $8.50 per hour. Also, screening
materials assumed to cost $15 are needed. An exterminator to apply
pesticides costs $300.
Table 4 represents the models described above in tabular form.
Table 4.--FDA Models of Small Plants
----------------------------------------------------------------------------------------------------------------
Small plant 1 (no GMP Small plant 2 (GMP
costs) costs)
Category ---------------------------------------------------
Year 1 Year 2-- Year 1 Year 2--
----------------------------------------------------------------------------------------------------------------
Training.................................................... 760 0 760 0
HACCP plan refinement....................................... 240 0 240 0
Sanitation audit............................................ 0 0 2,800 2,800
Receiving CCP............................................... 3,200 3,200 3,200 3,200
Cutting CCP................................................. 0 0 0 0
Sawtooth monitoring......................................... 20 20 20 20
Record review............................................... 400 400 400 400
HACCP plan review........................................... 60 60 60 60
Equipment cleaning.......................................... 0 0 2,500 2,500
Eliminate pests............................................. 0 0 330 0
Administration.............................................. 940 370 2,100 900
Per plant costs......................................... $5,600 $4,000 $12,400 $9,900
----------------------------------------------------------------------------------------------------------------
In order to estimate an average plant cost from these FDA model
plants, FDA assumed that, based on the results of the agency's 1990/
1991 survey of the seafood industry, 20 percent of small firms are
similar to the model plant that requires some GMP improvements (Small
Plant 2) and that 80 percent of the small firms are similar to the
model plant that is in compliance with current CGMP's (Small Plant 1).
The agency has also assumed that the cost of
[[Page 65182]]
compliance for large firms is the same as that of small firms. There
are offsetting considerations that have led the agency to make this
assumption in this model. For example, agency experience suggests that
it is likely that small firms will, on average, have larger sanitation
costs and thus incur greater expenses to rectify existing CGMP
deviations. Large firms, on the other hand, are more likely to have a
greater number of products and processing lines, resulting in greater
costs of plan development and monitoring. However, the agency believes
that large firms are more likely to already have preventive controls,
formalized sanitation programs, and record keeping systems in place
than small firms. Additionally, large firms are more likely to take on
new monitoring regimes with their existing quality control and
production staffs than are small firms. The agency believes that these
considerations would counteract each other and should result in fairly
equal costs for large and small firms.
To complete the FDA model, FDA assumed that exporters (one- half of
the 1,000 large firms) would only need to spend $1,000 in order to
comply with this rule. Combining the two plant total costs as reported
in Table 4 and weighting the proportion of the industry they are
assumed to represent, average plant costs are estimated to be $6,400 in
the first year and $4,800 in subsequent years.
The foreign processor costs associated with this rule and passed on
to U.S. consumers are estimated to be 13 percent of the average
domestic plant costs. The total cost of this regulation using this
method of cost modeling is $71 million in the first year and $38
million in the fourth year and beyond.
Total costs for compliance with these regulations using the FDA
model are shown in Table 5.
Table 5.--Disaggreagated Costs From FDA Model
------------------------------------------------------------------------
------------------------------------------------------------------------
1st Year Costs:
Domestic manufacturers and importers.......... $32 million.
Major plant repair and renovation............. 13 million.
Sea Grant expertise........................... 1 million.
Repackers and warehouses...................... 14 million.
Harvesters for rejected raw product........... 1 million.
Shellfish vessels............................. 3 million.
Foreign processors............................ 5 million.
Total......................................... 69 million.
2d Year Costs
Domestic manufacturers........................ $ 23 million.
Sea Grant expertise........................... 1 million.
Repackers and warehouses...................... 14 million.
Shellfish vessels............................. 1 million.
Foreign processors............................ 3 million.
Total..................................... 42 million.
3d Year Costs:
Domestic manufacturers........................ 23 million.
Sea a grant expertise......................... 1 million.
Repackers and warehouses...................... 14 million.
IQF Shellfish plants.......................... 3 million.
Total..................................... 41 million.
4th Year (and subsequent years) Costs
Domestic manufactures......................... 23 million.
Sea Grant expertise........................... 1 million.
Repackers and warehouses...................... 14 million.
Total..................................... 38 million.
Total Discounted Costs:
Beyond the 4th year and discounted at 6
percent, the costs are $677 million.
------------------------------------------------------------------------
There are a number of explanations that would account for the
uncertainty between the FDA and NMFS models. Virtually all of the
difference can be explained by the two different estimates of what it
would take to come into compliance with 21 CFR part 110 (FDA's CGMP
regulations). In the case of the NMFS study, the contractors estimated
the cost of coming into full compliance with all CGMPs. Using this
methodology, they found that approximately 80 percent of the plants
were out of compliance. On the other hand, the FDA model uses the
results of FDA's own survey of the industry, which only listed plants
as being out of compliance if the CGMP violations were related to
potential contamination of the seafood product. In this case, FDA found
that only about 20 percent of the firms were out of compliance. In
addition, the FDA cost model assumes the simplest, least expensive
corrective action to solve the CGMP violation. The NMFS model did not
use the same approach in all cases.
2. Other Cost Reports
Reports received by FDA on the cost of implementing HACCP discussed
below appear generally to support the results of FDA modeling across
the seafood industry. While the modeling was limited to certain types
of small operations, the firms for which FDA has information on
reported costs represent a cross section of processing operation types,
including canned, fresh, frozen, smoked/salted, molluscan shellfish,
and cooked, ready-to-eat products as well as warehouses and repacking
operations. It should be noted that these costs are reported only as an
additional source of information. They were not used to generate FDA's
model plants.
The cost information obtained from industry includes responses to a
1991 evaluation questionnaire from four firms that participated in the
FDA/NOAA seafood HACCP pilot in 1990-1991. It also includes information
provided to FDA from seven firms through the assistance of the National
Food Processors Association. (These 7 firms operate a total of 44
processing plants.) It further includes information from two seafood
trade associations, the National Fisheries Institute and the New
England Fisheries Development Association
[[Page 65183]]
(NEFDA), which provided FDA with summary information about member firms
that had implemented HACCP systems. The 2 seafood trade associations
provided information on 16 firms. NEFDA operated a HACCP pilot with
member firms through a Federal grant. All of this information was
received by FDA before the publication of the proposed regulations and
was reported in the PRIA. After the publication of the proposal, FDA
received information from a large processor-exporter on its HACCP
start-up costs. This processor reported start up costs of $1,000 per
plant. In total, FDA has information on 86 plants (Refs. 129 and 223).
Many of these firms have implemented HACCP as participants in
either pilot programs, the NOAA fee-for-service program, or the State
of Alaska program, and therefore their HACCP systems have been subject
to some form of third party verification. Virtually all of these plants
have developed HACCP plans, many of which included critical control
points for quality or economic fraud or both in addition to safety. In
this respect, many firms implemented a more extensive form of HACCP
than is being mandated by FDA.
More complete information on start-up costs received from 22 firms
who have implemented HACCP is summarized in Table 6. Some of these
costs are for multi-plant firms and some for firms operating only one
plant.
Table 6.--Start-Up Costs
------------------------------------------------------------------------
No. of firms Start-up costs ($)
------------------------------------------------------------------------
4............................... <1,000 15..............................="" 1,000-5,000="" 1...............................="" 5,000-10,000="" 1...............................="" 10,000-15,000="" 1...............................="">20,000
------------------------------------------------------------------------
FDA notes that there are several uncertainties with these data. The
agency does not have sufficient information to extrapolate the costs
observed by these firms to the entire industry. FDA also does not know
the extent of previous HACCP-type activities in these firms so that
they may have different incremental costs than the industry average.
Additionally, for subsequent year costs, some of the firms reported
costs that exceeded the start-up costs shown in the table although some
were below, and it is not clear if costs that might be incurred in
order to comply with CGMP's are represented.
Nevertheless, the range of reported costs, are consistent with the
FDA model for a processing operation that does not incur such costs.
Notably, the estimates developed for NMFS of the costs of operating
HACCP systems for small businesses are consistent with the FDA model
and with the reports to FDA by trade associations discussed above.\1\
Thus, three independent sources of information suggest that annual
HACCP costs, at least for small businesses, are within a range of
$3,000 to $6,000 per plant if sanitation costs are not included.
Although the HACCP cost estimates made for NMFS did not include certain
aspects of a HACCP system such as HACCP plan development, plan
verification, and taking corrective actions, the estimates did include
the costs of operating HACCP systems for quality and economic
adulteration in addition to safety. These costs were not included in
the NMFS cost estimates reported here. The FDA HACCP system involves
safety only and is therefore less expensive.
\11\The costs referred to here are those estimated for NMFS for
the type of HACCP system it was studying. For the purposes of the
PRIA and RIA, FDA made adjustments to the costs estimated for NMFS
so as to be consistent with FDA's own regulation. These adjusted
costs from the NMFS models are the estimates presented earlier in
this document.
---------------------------------------------------------------------------
It is also worth noting that three independent sources (FDA's own
inspection experience, NMFS inspection experience with plants
purchasing its voluntary inspection services, and the contractor's
report for NMFS) confirm the existence of sanitation deficiencies in
some seafood plants. Because FDA holds that these conditions must be
corrected under existing requirements, the costs associated with these
corrections will be borne by processors regardless of whether
sanitation provisions are included in the seafood HACCP regulations or
somewhere else. Sanitation controls for processors may address a number
of enteric pathogens discussed elsewhere in this analysis including
Salmonella, Shigella, hepatitis A, L. monocytogenes, campylobacter, and
C. botulinum. Contamination may come from either the raw product or
from poor hygiene practices such as insufficient control of vermin
(flies and rodents) or insanitary water. In addition, poor sanitation
may cause contamination of the product with pesticides, lubricants,
cleaning compounds, or other toxic substances because of improper
labeling, storage or use. The system in the seafood HACCP regulations
is based on the monitoring of sanitation conditions by processors. FDA
is not aware of any method for processors to take control of the
sanitation conditions within their plants other than by a method that
involves routine monitoring. Recording the results of these
observations, as required by the regulations, need involve only minimal
additional cost.
3. Seafood Prices
A number of comments referred to the effect that the regulation
will have on the price of seafood that consumers experience at the
retail level. In the PRIA, it was presumed that most of the cost of
compliance of the proposed regulations would be passed on to consumers.
In the PRIA, it was calculated that if the domestic industry passed on
to consumers all of the costs estimated in the PRIA, prices for
domestically produced seafood would increase by less than 1 percent in
the first year and less than one-half of 1 percent in succeeding years.
It was noted in the PRIA that price changes of such magnitude are
unlikely to have a significant impact on general seafood purchases.
Some commenters claimed that all of the cost of the regulation
would be born by processors, and that none of the increase in cost
would be passed on to consumers. These commenters explained that
seafood is currently at a disadvantage compared to other flesh foods
for consumers' food dollars because seafood has a higher price per
pound. If the relative price of seafood were to increase further,
consumers would eat less seafood. The commenter also explained that
domestic seafood processors are at a competitive disadvantage compared
with seafood that can be imported at low cost (i.e., lower wages). If
domestic processors were to raise their prices, seafood imports would
take an even larger part of the seafood market away from domestically
produced seafood.
Other comments said that processors will pass on all of the cost of
the regulation, and that the regulation will cause the consumer price
of seafood to rise. Some said that the price increase would be large
enough to cause a decrease in seafood consumption.
Both theories have some merit, although neither is completely
correct. The agency agrees that, all other things remaining the same,
an increase in the price of seafood will decrease seafood consumption
and increase the consumption of other fresh foods. However, the
decision of a consumer to purchase a product depends on a number of
factors.
Seafood includes many invertebrate and vertebrate species which
vary in price per pound, often by over 100 percent, for a particular
species (depending, in part, on seasonal supply). Such diversity,
compared with
[[Page 65184]]
meat and poultry, makes it clear that there is not perfect substitution
among the flesh foods. Nevertheless, data bases on food consumption are
equally clear at showing that as people have increased their
consumption of various seafood products, they have reduced their
consumption of meat and poultry.
There are other nonprice factors in the consumption decision. A
consumer survey found that taste, quality, and freshness were rated
above price (``moderately important'') in decisions to order seafood in
a restaurant or to purchase for preparation at home. In a survey of
retailers' experiences, consumers ranked quality ahead of price in
making seafood selections and rated the need for information on cooking
as a concern equal to price (Refs. 244 and 225).
Another relevant consideration is the fact that a disproportionate
percentage of seafood is consumed in restaurants as a luxury item where
the cost of the raw material is not as important a factor in the
purchasing decisions made by these consumers.
All of this information is consistent with other data in this
analysis that suggests that a 1 percent change in price results in less
than one-half of one percent change in seafood consumption.
Another major factor that lessens any competitive cost advantage
meat and poultry products might experience from an increase in seafood
cost is that USDA is proposing similar HACCP regulations for meat and
poultry. USDA's proposal, if finalized for meat and poultry products,
suggests that all segments of the flesh food market may face cost
increases in the near future. It is entirely possible that the price of
seafood relative to meat and poultry will not change. The agency agrees
that some seafood imports have a cost advantage over domestically
produced seafood, primarily due to lower labor and capital costs of
production. However, because the regulation applies to imports as well
as domestic products and because importers from EU member nations will
soon be under HACCP requirements and experiencing increased costs, it
is reasonable to assume that the price of imported seafood relative to
domestic seafood will not change.
In the short run, the ability of producers to pass on cost
increases is largely determined by the elasticity of demand (the degree
to which consumers reduce their consumption of a good in response to a
given increase in price) and the elasticity of supply (the degree to
which producers increase their production of a good in response to a
given increase in price). The elasticity of demand is determined in
turn by, among other things, the presence or absence of close
substitutes. Thus, for example, if there are close substitutes and the
price of a good goes up, consumers will not continue to consume the
higher priced good but switch to one of the substitutes.
If manufacturers know that consumers will not switch to a
substitute when there is a price increase, then they are free to pass
along all of the increased costs (from complying with the regulation)
in the form of price increases. However, where there are close
substitutes for seafood, such as other flesh foods, consumers respond
to price increases by reducing their consumption of the high priced
good. Rather than attempting to pass on all of the costs of the
regulation in the form of higher prices, producers must accept reduced
profits and bear some, if not all, of the burden of the cost increase.
In very competitive markets, such as the market for flesh food,
where meat, fish, and poultry are considered substitutes, producers
bear the entire burden of any increases in fixed costs. Fixed costs are
costs that do not change, despite the size of the firm and changes in
the level of output. Examples of fixed costs are costs of plant,
equipment, and management; much of these costs are expected to be borne
by processors. Because large firms spread fixed costs over larger
output, they may be able to pass on these costs when smaller firms
cannot.
In addition, also in the short run, producers may bear some portion
of the variable costs that cannot be profitably passed on to consumers.
Variable costs are costs that vary with changes in the amount of
output. Examples of variable costs are costs of raw materials and
hourly labor. However, it is likely that much of the variable costs
will be passed on to consumers.
When firms in a competitive market cannot pass on all of a cost
increase in the short run, profits decline. Beyond some point profits
become either so low or negative that the firm is forced to close
(discussed more fully in the Regulatory Flexibility Analysis below). In
the long run, the exit of these marginal firms reduces the industry
supply (of seafood) and permits the remaining firms to raise prices to
cover the full costs of production, both variable and fixed costs.
Thus, in the long run, seafood prices will rise by the full cost of the
regulation.
A few comments requested a better analysis of price changes. These
commenters criticized the approach used to estimate price increases in
the Executive Summary of the PRIA. Rather than dividing the estimated
domestic cost of the regulation by the total domestic production, the
commenters suggested estimating price changes for each market segment.
The advantages of this approach are that different types of seafood are
treated separately (the change in the price of raw tuna might be very
different from the change in the price of ready-to-eat shrimp cocktail)
and that different sized firms are treated separately (small firms may
be forced to raise prices more than large firms).
FDA agrees that this method of determining price changes is more
legitimate than the method employed in the PRIA. However, FDA did not
receive any information from commenters that would enable the agency to
calculate prices in this manner. It is worth noting, however, that the
contractor that performed the study upon which many of the estimated
costs in this RIA are based did take product type into account when
estimating cost increases. That contractor estimated a range of cost
increases from negligible to 1.3 percent, depending on the product.
Again, it is important to note that that study included costs for the
control of types of hazards not covered by this final regulation.
Finally, while the methodology used in the PRIA might not produce
accurate price changes, it suggests that overall price increases due to
this regulation could well have a negligible effect on demand.
C. Benefits
In the PRIA, FDA estimated that the proposed option, which is being
adopted in this final rule, would: (1) Reduce the amount of foodborne
illness that results from consumption of seafood and; (2) generate
significant nutrition benefits as a result of the increased consumption
of seafood (brought about by a decrease in consumer anxiety) with a
concomitant decrease in the consumption of meat and poultry; (3) reduce
the amount of rent seeking (rent seeking is a term economists have
applied to activities which do not contribute to societal welfare but
only seek to transfer resources from one party to another); and (4)
generate export benefits by allowing U.S. exporters to continue to
export to countries requiring HACCP.
The last benefit, the export benefit, is characterized as the
benefit to firms exporting to countries that require federal oversight
and certification of HACCP programs. In addition to the benefits cited
in the PRIA, the agency is addressing benefits derived from reduced
enforcement costs, and is discussing other unquantified benefits of
adopting the seafood HACCP
[[Page 65185]]
regulations. The agency has fully considered all of the comments on
benefits. These estimates are more fully explained in the full RIA.
What follows is FDA's conclusion as to how these benefits should be
valued.
1. Safety Benefits
In the tables below, FDA presents revised estimates of the benefits
of mandatory HACCP for seafood processors. Several changes from the
preamble to the proposal are noteworthy. First, based on the comment
that said that FDA had underestimated the number of cases, FDA has
reestimated the baseline numbers of cases for certain illnesses (Ref.
226). Next, some changes were made to the valuations of particular
cases, as better information was obtained concerning the probabilities
of death per type of illness. Finally, as mentioned above, some changes
have been made to the estimates of the percentages of the illnesses
reduced.
Although Canada, for example, has mandatory HACCP for its seafood
processors, no data exist on the efficacy of HACCP. Therefore, for the
percentages of the illnesses reduced, FDA used three different types of
its experts (seafood experts, epidemiologists familiar with microbial
hazards, and microbiologists) to address the efficacy of seafood HACCP.
Each of these experts reviewed the literature on each type of hazard as
well as the requirements of HACCP. The ranges reflect likely upper and
lower bounds on how effective HACCP will be at controlling production
deficiencies by processors, including indirect controls exerted by
processors on the owners of harvesting vessels. In addition, the tables
reflect the fact that some of the cases of illness are not addressable
by this rule as they are caused by either consumer or restaurant
mishandling or poor fishing practices by recreational fishermen.
In order to calculate the number of cases (annual cases resulting
from exposure to hazards associated with seafood consumption) that
would be reduced by HACCP, each of the four experts followed a series
of methodical steps. The first was to determine the types of seafood
associated with each hazard. The second step consisted of reviewing the
various aspects of the rule to determine the areas of seafood
harvesting and processing that the rule could affect. The third step
was to eliminate those cases that could not be affected by the rule.
These would be cases that seafood processors could neither
eliminate through processing nor prevent from being introduced, either
by their own staff or by control over raw materials. Cases caused or
controlled by factors outside of the HACCP system include recreational
harvest (approximately 20 percent of all seafood harvested) that does
not pass through processing plants and problems caused by restaurant,
supermarket or consumer improper cooking or mishandling. In addition,
there will be some types of hazards that will not, for the foreseeable
future, be controllable by means other than avoiding contaminated
waters, which will not be 100 percent effective (ciguatera, for
example). Until rapid, inexpensive tests are developed, HACCP cannot be
100% effective at controlling these hazards.
Once each expert had accounted for those cases that could not
potentially be reached by this rule, the experts then assessed the
likely effectiveness of control steps associated with broad sanitation
improvements and mandatory controls on specific hazards and specific
species.
Ciguatera: Both the lower and upper bound reductions in illness are
relatively small in the near term because there does not yet exist a
rapid, inexpensive test for this toxin. Processors and commercial
fishermen must rely on information about whether geographic areas are
ciguatoxic. Moreover, many illnesses are attributable to recreational
harvest.
Hepatitis A virus: This illness derives mostly from molluscan
shellfish. For molluscan shellfish, the controls are harvesting from
approved waters and good sanitation in the plant. These regulations
specifically involve both types of controls. The upper bound number is
50 percent of the total estimated number of illnesses largely because
of the problems that states have in patrolling and controlling
illegally harvested molluscan shellfish.
Norwalk virus: This illness derives from raw molluscan shellfish
that are contaminated from human pollution in harvesting areas. Control
involves harvesting from approve waters. These regulations include this
kind of control. The upper bound number is 50 percent of the total
estimated number of illnesses largely because of the problems that
states have in patrolling and controlling illegally harvested molluscan
shellfish and because of the uncertainty of the control of sewage from
harvesting and recreational vessels.
Vibrio vulnificus: This illness essentially derives from eating raw
molluscan shellfish from the Gulf of Mexico. Vibrio vulnificus is a
naturally occurring, ubiquitous, marine organism. The lower and upper
bound numbers reflect the fact that controls are newly emerging for
this organism and still have uncertainties associated with them.
Table 6a sets out the new estimates of baseline cases of foodborne
disease related to HACCP and the range of cases averted by HACCP.
Table 6a.--Estimate of Annual Cases Averted
------------------------------------------------------------------------
Number of Number of
Estimated cases cases
Hazard number of averted averted
cases\1\ (lower)\2\ (upper)\1\
------------------------------------------------------------------------
Anasakis......................... 100 25 60
Campylobacter jejuni............. 200 100 150
Ciguatera........................ 1,600 96 200
Clostridium botulinum............ 10 3 5
Clostridium perfringens.......... 200 100 150
Diphyllobothrum latum............ 1,000 250 600
Giardia.......................... 30 15 23
Hepatitis A Virus................ 1,000 150 500
Other Marine Toxins.............. 20 ........... 1
Norwalk Virus.................... 100,000 15,000 50,000
Other Vibrio's................... 1,000 200 500
Paralytic Shellfish Poisoning.... 10 ........... 1
Salmonella non typhi............. 200 100 150
Scombrotoxin..................... 8,000 4,000 6,000
[[Page 65186]]
Shigella......................... 200 100 150
Vibrio vulnificus (3d year)...... 60 12 30
--------------------------------------
Total...................... 113,630 20,151 58,520
------------------------------------------------------------------------
\1\These numbers were determined in consultation with representatives
from the Centers for Disease Control and Prevention.
\2\The upper and lower bounds were determined by a panel of scientists
at CFSAN (Dr. George P. Hoskin, Dr. Karl C. Klontz, Dr. Kaye I
Wachsmuth and Dr. Thomas C. Wilcox.
Table 7 reflects revised estimates of the total cost of seafood
illness.
Table 7.--Annual Cost of Seafood Illness
------------------------------------------------------------------------
Total cost of
Hazard Value per case seafood
illness
------------------------------------------------------------------------
Anasakis................................ $1,703 $170,332
Campylobacter jejuni.................... 9,390 1,877,924
Ciguatera............................... 15,247 24,395,438
Clostridium botuli num.................. 223,252 2,232,524
Clostridium perfrin gens................ 6,551 1,310,164
Diphyllobothrum latum................... 2,753 2,752,617
Giardia................................. 6,104 183,112
Hepatitis A Virus....................... 22,669 22,668,870
Other Marine Toxins..................... 269 5,380
Norwalk Virus........................... 575 57,500,000
Other Vibrio's.......................... 2,955 2,954,842
Paralytic shellfish poisoning........... 92,356 1,200,628
Salmonella non-typhi.................... 8,199 1,639,756
Scombrotoxin............................ 339 2,708,755
Shigella................................ 16,750 3,349,961
Vibrio vulnificus....................... 2,008,917 120,535,039
-------------------------------
Total............................. .............. 245,485,342
------------------------------------------------------------------------
Table 8 shows the estimates of the efficacy of mandatory seafood
HACCP at reducing foodborne disease in the third year following the
date of implementation (undiscounted).
Table 8.--Estimate of the Efficacy of Mandatory HACCP at Reducing
Foodborne Disease in the Third Year
------------------------------------------------------------------------
Lower bound Upper bound
Hazards estimate (3d estimate (3d
year) year)
------------------------------------------------------------------------
Anasakis................................ $42,583 $102,199
Campylobacter jejuni.................... 938,962 1,408,443
Ciguatera............................... 1,463,726 3,049,430
Clostridium botulinum................... 558,131 1,116,262
Clostridium perfringens................. 655,082 982,623
Diphyllobothrum latum................... 688,154 1,651,570
Giardia................................. 91,556 137,334
Hepatitis A Virus....................... 3,400,331 11,334,435
Other Marine Toxins..................... .............. 269
Norwalk Virus........................... 8,625,000 28,750,000
Other Vibrio's.......................... 590,968 1,477,421
Paralytic Shellfish Poisoning........... .............. 46,178
Salmonella non-typhi.................... 819,878 1,229,817
Scombrotoxin............................ 1,354,377 2,031,566
Shigella................................ 1,674,981 2,512,471
Vibrio vulnificus (3d year)............. 24,107,004 60,267,519
-------------------------------
Total............................. 45,010,733 116,097,537
------------------------------------------------------------------------
Finally, in response to the comments, FDA has attempted in Table 9
to associate particular hazards with categories of seafood (to the
extent the data allow).
[[Page 65187]]
Table 9.--Association of Particular Hazards With Categories of Seafood
------------------------------------------------------------------------
Estimated
Hazards number of Affected species
cases
------------------------------------------------------------------------
Anasakis......................... 100 Raw Finfish.
Campylobacter jejuni............. 200 Cooked Ready-to-Eat
Fish, Smoked Fish,
Molluscan Shellfish.
Ciguatera........................ 1600 Tropical, reef
associated species of
finfish.
Clostridium botulinum............ 10 Vacuum Packaged Fish,
Smoked and Salted Fish.
Clostridium perfringens.......... 200 Cooked Ready-to-Eat
Fish, Smoked Fish,
Molluscan Shellfish.
Diphyllobothrum latum............ 1000 Raw Finfish.
Giardia.......................... 30 Cooked Ready-to-Eat
Fish, Smoked Fish,
Molluscan Shellfish.
Hepatitis A Virus................ 1000 Cooked Ready-to-Eat
Fish, Smoked Fish,
Molluscan Shellfish.
Other Marine Toxins.............. 20 Molluscan Shellfish.
Norwalk Virus.................... 100,000 Molluscan Shellfish.
Other Vibrio's................... 1,000 Cooked Ready-to-Eat
Fish, Smoked Fish,
Molluscan Shellfish.
Salmonella non-typhi............. 200 Cooked Ready-to-Eat
Fish, Smoked Fish,
Molluscan Shellfish.
Scombrotoxin..................... 8,000 Scombroid Species of
Finfish.
Paralytic Shellfish Poisoning.... 10 Molluscan Shellfish.
Shigella......................... 200 Cooked Ready-to-Eat
Fish, Smoked Fish,
Molluscan Shellfish.
Vibrio vulnificus................ 60 Molluscan Shellfish.
-------------
Total...................... 113,630
------------------------------------------------------------------------
2. Summary of Safety Benefits
The safety benefits are shown by year in Table 10 (undiscounted).
Table 10.--Safety Benefits
------------------------------------------------------------------------
Lower bound Upper bound
Year benefits benefits
------------------------------------------------------------------------
1........................................... 32,957,233 67,897,751
2........................................... 32,957,233 67,897,751
3........................................... 45,010,733 116,097,537
4 and beyond................................ 45,010,733 116,097,537
------------------------------------------------------------------------
3. Nutrition Benefits From Mandatory Seafood HACCP and Increased
Consumer Confidence
In the PRIA, FDA estimated what the potential nutrition benefits
might be if reduced consumer anxiety over seafood safety led to
increased sales. FDA hypothesized that this might lead to consumers
eating lower fat meals (on average) as they replaced higher fat meat
and poultry with lower fat seafood.
The agency has considered this issue in greater detail in the full
RIA. FDA acknowledged in the PRIA that the entire estimate of nutrition
benefits resulting from increased sales of seafood at the expense of
meat and poultry sales is speculative. Although the agency believes
that increased consumer confidence would result from having a state-of-
the-art HACCP system in place for the seafood industry, no data were
received to confidently predict the ultimate increase in the quantity
of seafood sold as a result of this regulation. Sales data of this type
were also not available before or after the agency initiated its low
acid canned food regulations. Finally, the agency was unable to
determine if any increase in consumer confidence would offset a price
increase resulting from HACCP costs.
The agency was equally concerned about possible nutrition benefits
as to whether there would be an exact exchange in the nutrient profile
between fish as prepared and meat and poultry. The agency finds that
some fish dishes as consumed are eaten fried or served with heavy
sauces, and that different species of fish have different fat profiles.
Thus, for some consumers who make substitutions of fish meals for meat
and poultry, it is not totally clear if there will be a favorable
decrease in fat intake. Because there are too many unknown variables
surrounding these substitutes and the lack of sales data, the agency is
unable to quantify this benefit.
4. Rent Seeking
Rent seeking activities were characterized in the proposal as
``public and private resources (which) have been expended in attempts
to alter the level of regulatory effort toward seafood safety, as well
as alter which Federal agency should oversee the industry.'' ``Rent
seeking'' is a term economists have applied to activities that do not
contribute to societal welfare but only seek to transfer resources from
one party to another. An example often given is lobbying to change the
ownership of a government granted special privilege so that profits
change hands. In many cases, however, it is difficult to distinguish
between activities that ultimately indirectly benefit society from
those that only transfer profits. The proposal hypothesized that one
benefit of the regulation was to reduce the social costs of rent
seeking.
One commenter noted that the reason large firms support HACCP is
because they must have HACCP to export to Europe. The commenter noted
that mandated HACCP would ``ensure that all domestic processing firms
face the same costs, thereby reducing any competitive disadvantage.''
FDA does not agree that this is a justification for HACCP. The
reason for implementing HACCP is to reduce the incidence of foodborne
disease. However, FDA agrees that this ``rent-seeking'' argument may
explain some support for HACCP by larger exporting firms. It is
important to note, however, that there are small firms who export to
Europe as well.
5. Export Benefits
In the PRIA, FDA asserted that one benefit (unquantified) of the
rule was to allow firms now exporting to the EU to continue to do so
because of the EU requirement for a federally overseen voluntary HACCP
program. Several commenters noted that some countries that import
seafood from the United States are beginning to require HACCP. One
commenter noted that more than 30 percent of seafood produced in the
United States is exported. The same commenter noted the disruption in
trade when French authorities did not coordinate their seafood safety
requirements with ``other officials.'' Several commenters noted the
need for more Memoranda of Understandings (MOU's) between the United
States and other countries for seafood. One suggested that such MOU's
be based upon HACCP as defined by various international bodies.
Finally, one commenter noted that FDA ``should take into account how
the international
[[Page 65188]]
community is implementing HACCP before the agency imposes regulations
that may create unnecessary trade barriers.''
As discussed in the PRIA, this program will benefit those seafood
processors who are exporting to nations requiring HACCP. However, as
also noted in the PRIA, there is in place a federally overseen HACCP
program, specifically, the program being offered to processors by the
National Marine Fisheries Service (NMFS).
FDA has made an estimate of the cost savings to exporting firms of
being in FDA's mandatory program in lieu of the NMFS program. The
alternative to NMFS review (if FDA were not to adopt this regulation)
would be inspection of product that is offered for entry into the EU on
an entry-by-entry basis and the payment of a significant fee for these
inspection services. With approximately 2 billion pounds being exported
each year, this savings of resources amounts to, at a minimum, $20
million per year.
In addition, although the EU has announced the requirement that
HACCP be in place by January 1, 1996, adoption of a U.S. plan reduces
some of the uncertainty for U.S. firms and firms exporting to the
United States concerning the ultimate form of an internationally agreed
upon HACCP requirement.
6. Reduced Enforcement Costs
Comments qualitatively mentioned other benefits including fewer
product recalls and other enforcement actions. FDA agrees that there
will be fewer product recalls, seizures, injunctions and detentions of
seafood and seafood products. As examples of what benefits could have
accrued in 1994, the agency has calculated the value of each of these
actions and addressed them below.
a. Seizures. A seizure is a civil action designed to remove
violative goods from consumer channels. Table 11 shows the actions and
their associated costs that follow a determination that a violation
exists and that goods should be seized.
Table 11.--Seizure Steps
------------------------------------------------------------------------
Action Hours/Other Cost
------------------------------------------------------------------------
Federal personnel collect and 120.................... $12,840
analyze samples, write up
recommendations (program and
general counsel), review the case
and make recommendations to the
U.S. attorney.
U.S. attorney files complaint and 16..................... 1,712
Court orders goods arrested.
U.S. Marshal and other federal 8...................... 856
official seizes goods at location. Travel................. 200
Firm hires attorney to contest/ 16..................... 1,712
accept action.
Food is reconditioned by firm....... 16 firm................ 1,712
16 Federal lower valued 1,712
food2.
Food is denatured (converted to a 16 firm................ 1,712
non-food use) or;. 8 Federal lower valued 856
food2.
Food is destroyed................... 8 firm................. 856
8 Federal lost food1... 856
------------------------------------------------------------------------
\1\The rate of $107 per hour represents the cost of a loaded (including
equipment and benefits) employee plus headquarters support of
approximately 70 percent.
\2\Total seizure costs are calculated in Table 12.
Table 12 shows the seizures in 1994. Assuming that half of all
seizures are prevented each year, the benefits are expected to be
approximately $290,000 each year.
Table 12.--Seizures in 1994
----------------------------------------------------------------------------------------------------------------
Administrative
Problem No. costs\1\ Action\2\ Total
----------------------------------------------------------------------------------------------------------------
Decomposition (Destroy)........................................ 5 $17,320 $46,565 $320,925
Filth (Denature)............................................... 3 17,320 8,709 78,087
Chemicals (Destroy)............................................ 2 17,320 10,108 54,856
Other (Destroyed).............................................. 4 17,320 14,212 126,128
------------------------------------------------
Total.................................................... 14 .............. ........... \3\579,996
----------------------------------------------------------------------------------------------------------------
\1\Costs of items (1) through (4) in the preceding Table totaled are $17,320.
\2\The actions that are typically taken for each type of hazard are listed in the PROBLEM column. Costs include
the value of destroyed food multiplied by the number of actions or, in the case of denaturing, it is assumed
that 10 percent of the value of the product is retained. No food was reconditioned.
\3\This number may well underestimate the benefit. FDA recently completed a seizure proceeding (not filed in
1994) in which $5 million of product was condemned. Thus, preventing seizure can have a significantly higher
value than that reflected in this table.
b. Detentions. A detention is a procedure for preventing violative
products from entering the United States. Table 13 shows the actions
and their associated costs that follow a determination that a sample is
violative, the following actions take place.
Table 13.--Detention Steps
------------------------------------------------------------------------
Action Hours/other Cost\2\
------------------------------------------------------------------------
Federal personnel send a detention 2....................... $214
notice to the importer with an
opportunity to introduce testimony.
Importer hires attorney and 16...................... 1,712
introduces evidence. Submits
response application.
Determination of action to take...... 24...................... 2,568
Reshipment allowed, or............... 10...................... 1,070
Travel, Cost to Reship.. 200
[[Page 65189]]
Product is denatured, or............. 8, Loss of value,\2\ 856
Cost of denaturing,\2\,
Reselling costs\2\.
Goods are destroyed under Federal 16, Loss of product\1\..
supervision.
------------------------------------------------------------------------
\1\These costs are calculated in table 14 which gives estimates of the
numbers and estimated costs for detentions in 1994.
\2\Seizure can have a significantly higher value than that reflected in
this table.
Table 14.--Detentions in 1994
----------------------------------------------------------------------------------------------------------------
Number of Detention Detention
Reason detentions Quantity\1\ Dollars\1\ disposition\2\ admin\3\
----------------------------------------------------------------------------------------------------------------
Borates................................. 25 21,484 1,827,173 183,017 112,350
C. botulinum............................ 1 113,790 363,434 363,434 4,494
E.coli/coliforms........................ 14 254,774 742,786 149,413 62,916
Histamines.............................. 2 98,023,014 1,361,714 273,199 8,988
Lead.................................... 2 102,188 87,440 9,044 8,988
Listeria/Other Pathogens................ 51 2,792,808 21,369,692 4,274,794 229,194
Mercury................................. 11 7,338,900 12,720,272 1,272,327 49,434
Poisonous/Deleterious sub-nec........... 7 180,000 446,025 446,025 31,458
Salmonella/arizona...................... 129 221,543,300 76,137,973 15,228,451 579,726
Staphylocci............................. 6 55,810 199,550 40,766 26,964
Sulfites................................ 23 713,653 8,100,620 810,362 103,362
Unsafe food additives--NEC.............. 5 67,160 540,201 540,201 22,470
-----------------------------------------------------------------------
Total............................. 276 ............ ............ 23,591,033 1,240,344
----------------------------------------------------------------------------------------------------------------
\1\Quantity and dollars include the total amount of both detentions and automatic detentions and are shown to
illustrate how detentions were calculated.
\2\Disposition included reshipping which was estimated to be 10 percent times the number of shipments (quantity)
times the value per shipment (dollars/quantity); reconditioning which was estimated to be 20 percent of the
value of the shipment (dollars) or destruction which was estimated to be 100 percent of the value of the
shipment.
\3\Administrative costs are estimated to be $4,494 per detention, the sum of the first three rows of the
previous table.
Assuming just half of these detentions are prevented by HACCP,
benefits to the federal government and industry would be approximately
$12 million per year.
c. Automatic detentions. Automatic detentions place each lot of
imported products on detention upon arrival at the border until the
importer has demonstrated that the products do not violate the Federal
Food, Drug, and Cosmetic Act. This is normally done by the importer
hiring independent labs to sample each lot. Table 15 shows the number
and types of relevant automatic detentions that took place in 1994.
Table 15.--Automatic Detentions in 1994
------------------------------------------------------------------------
Number of
Reason automatic Sample Storage
detentions cost\1\ cost\2\
------------------------------------------------------------------------
Borates....................... 53 $132,500 $182,717
C. botulinum.................. 104 260,000 36,343
E.coli/coliforms.............. 8 20,000 74,279
Histamines.................... 63 157,500 136,171
Lead.......................... 1 2,500 8,744
Listeria/Other Pathogens...... 236 590,000 2,136,969
Mercury....................... 397 992,500 1,272,027
Pesticide chlorothalanil...... 1 2,500 50
Poisonous and Deleterious sub-
nec.......................... 4 10,000 44,603
Salmonella/arizona............ 759 1,897,500 7,613,797
Staphylocci................... 0 0 19,955
Sulfites...................... 12 30,000 810,062
Underprocessed................ 3 7,500 15,454
Unsafe food additives--NEC.... 3 7,500 54,020
-----------------------------------------
Total................... 1,644 4,110,000 12,405,191
------------------------------------------------------------------------
\1\1 Calculation of costs assumes that, for each product placed on
automatic detention, 10 lots per year will be analyzed with 1 sample
each at a cost of $250 per sample.
\2\Assumes storage costs equals 10 percent of the stated value of the
goods.
Again assuming that half of the above automatic detentions are
eliminated each year, then the benefits will be approximately $6
million per year.
d. Recalls. The costs of recalls to a firm vary from inexpensive
notification
[[Page 65190]]
of consignees to several million dollars, depending on the nature of
the hazard, the type of seafood, the cost and amount of product
involved, and the distribution chain of the product. The costs of a
recall include searching for the recalled products, removing them from
retail and wholesale outlets, replacing the adulterated product,
effectiveness checks, and disposal or reconditioning. In some cases
recalls cause marketing disruptions, loss of shelf space, and
subsequent losses in sales via publicity.
FDA costs include investigative and analytical time and expenses,
administrative costs, cost of samples, and auditing time.
FDA assumes that the costs of recalls borne by firms are directly
related to the distribution costs associated with the products and to
the size of the contaminated lots. Distribution costs account for about
one-third of the final value of seafood. FDA assumes that the firm must
bear the full amount of the distribution costs of the recall. In
addition, the other costs listed above raise the total cost of recalls
borne by firms to one-half the value of the product. FDA uses one-half
the value of the product as the base for the estimate of total recall
costs. The total recall cost of seafood processing firms in 1994 is
estimated to be $2,461,906, as shown in table 16. FDA audit checks for
seafood took 474 hours in 1994. FDA assumes that total FDA costs per
recall were proportional to audit hours. The cost per hour of an audit
check is $107, giving an FDA audit cost of $50,718 (474 x 107). FDA
collected 72 samples at $250 per sample, giving sample costs of $18,000
(72 x 250). FDA thus estimates additional costs due to recalls to be
$68,718 ($50,718 + $18,000). The total recall cost is estimated to be
$2,530,624 ($2,461,906 + $68,718). Again, the estimate for the purpose
of this benefits analysis assumes that half of all recalls will be
prevented or about $1,250,000.
Table 16.--Recalls in 1994
----------------------------------------------------------------------------------------------------------------
Fish Hazards Amount Total
----------------------------------------------------------------------------------------------------------------
Canned tuna........................... Filth, decomposed, punctured 6,599 cases............. $150,687
cans, short weight.
Crab.................................. L. monocytogenes............. 16,156 lbs.............. 64,624
Escolar fish.......................... Decomposed, sc ombroid, 1,719 lbs............... 1,614
illness.
Herring, salted Schmaltz.............. L. monocytogenes............. 1,200 lbs............... 1,740
Hilsha fish........................... Salmonella................... 2,000 lbs............... 2,100
Lobster............................... L. monocytogenes, salmonella. 25,920 lbs.............. 243,648
Mahi mahi, fresh...................... Decomposed................... 575 lbs................. 834
Nova chips............................ L. monocytogenes............. 54 lbs.................. 157
Oysters, shellstock................... V. vulnificus................ 9,219,430 lbs........... 1,843,886
Oysters, shucked...................... V. vulnificus................ 21,944 lbs.............. 87,776
Sardines, flat fillets................ Rusty, leaky, decomposed..... 33,600, 13 oz cans...... 50,400
Smoked catfish, salmon, sturgeon, tuna L. monocytogenes............. 1,060 lbs............... 2,963
Tuna steaks........................... Decomposed................... 7,110 lbs............... 11,477
----------------
Total........................... ............................. ........................ 2,461,906.00
----------------------------------------------------------------------------------------------------------------
e. Injunctions. Injunctions are the most severe form of domestic
penalties whereby a firm is enjoined from producing/distributing a
product until a violation is remedied. There are approximately 5
injunctions by FDA against seafood products each year costing the firm
an average of about $70,000 and FDA an average of about $30,000 each or
about $500,000 per year. These costs include court costs, analytical
testing costs, inspections costs, and lost production costs. Again, if
this rule reduced injunctions by half, societal savings would be
$250,000.
Total enforcement benefits are the sum of all of the reduced
enforcement costs estimated to be approximately $20 million per year.
7. Other Benefits
Commenters also mentioned benefits including better process control
(resulting in lower production costs) and improved employee morale.
FDA believes that there may be ``re-engineering'' types of benefits
associated with these regulations. For both seafood and other foods for
which HACCP has been implemented, FDA has received information that
firms have found cost-saving innovations in other areas as they
implement HACCP. These innovations are considered trade secrets by
firms and thus, their description (actual process innovations) and
quantification is impossible as firms have not released this data into
the public domain. This phenomenon involves unexpected savings and
efficiencies as a result of establishing a new system in a processing
operation. The majority of firms that have previously instituted HACCP
reported that they believed that the advantages they derived from HACCP
were worth the costs to them in terms of better control over their
operations, better sanitation, and greater efficiencies, such as
reduced waste. Virtually all foresaw long-term benefits from operating
under HACCP.
Improved employee morale depends on how HACCP is implemented. If,
for example, employees are (1) participating in day-to-day monitoring
of critical control points, (2) allowed through corrective action plans
to participate in corrective actions including shutting down a line
when a critical limit has been exceeded, and (3) are rewarded for this
decision rather than penalized or forced to rigorously defend their
actions, then employee morale may increase. Such an increase in morale,
if valid, may lead to greater productivity. However, it is in the
direct financial interest of every company to maintain employee morale
such that any additional benefit from this regulation is likely to be
small.
A final benefit will be realized for finfish where processing
plants and vessels, in an effort to control for histamine formation,
keep fish cooled from harvest to retail. This will simultaneously
decrease the decomposition rate that causes seafood to be thrown out
because of organoleptic problems. The same situation exists relative to
cooked, ready-to-eat products and smoked fish. One retailer cited
losses of 4 percent to 8 percent of all seafood because of
decomposition. If some of this decomposition begins prior to arrival at
the retail level and is reduced in any degree by this
[[Page 65191]]
regulation, benefits could potentially be large.
However, FDA recognizes that there is also a short term cost (e.g.,
as molluscan shellfish harvesters attempt to supply processors with
untagged shellfish or from vessels without sanitary facilities aboard
and find the harvest rejected). The same will also be true for finfish
which have not been properly temperature controlled from harvest to
processor. These harvests will be discarded although this behavior is
not expected to occur often, or more than once in any instance.
D. Costs and Benefits of Sanitation
A portion of the costs and benefits of this rule derive from the
improvements in the facilities and CGMP's in seafood plants. Although
all food manufacturing plants are required to produce food under
sanitary conditions now, FDA's experience, and that of others, indicate
that many seafood processors are not producing seafood under those
conditions. The sanitation, monitoring, and recordkeeping provisions of
this rule are expected to drive processors to improve their sanitation
conditions and thus reduce the need for FDA to enforce CGMP's through
regulatory actions. These provisions will produce net increases in
societal welfare with accompanying costs and benefits.
Current goods manufacturing practices include such things as
cleanliness and habits of personnel, the conditions of buildings and
facilities, equipment, production and process controls, and conditions
of warehousing and distribution of the product. It is difficult to
differentiate between costs and benefits that are HACCP-related and
those that are sanitation-related. For example, processors are required
under HACCP to keep records that show that CGMP's such as ``Measures
such as sterilizing, irradiating, pasteurizing, freezing,
refrigerating, controlling pH or controlling aw that are taken to
destroy or prevent the growth of undesirable microorganisms,
particularly those of public health significance, shall be adequate
under the conditions of manufacture, handling, and distribution to
prevent food from being adulterated within the meaning of the act'' are
being followed (see 21 CFR 110.80(a) (2) and (4)). However, the
benefits derive from making plant and processing changes, uncovering
problems in processing due to recordkeeping and taking corrective
action which prevents hazardous seafood from being sold. Thus, HACCP
and CGMP's are inextricably intertwined and it is difficult to
calculate the marginal benefits and marginal costs of each.
E. Costs and Benefits Attributable to Foreign Governments
FDA has reported the portion of the increased costs that are
expected to be passed on to U.S. consumers by foreign processors. The
justification for this action is that FDA has not included safety
benefits that foreign consumers may enjoy when foreign firms that
export to the United States introduce HACCP into their plants. FDA has
also included, as a benefit of this regulation, reduced enforcement
actions toward products produced by foreign firms and reduced illnesses
that U.S. consumers suffer from imported seafood.
In a benefit-cost analysis, costs and benefits are attributable to
choices made among competing options. However, in this rule, there are
difficulties in assigning the costs and benefits to choices made by FDA
to require HACCP of domestic and foreign seafood processors. This
difficulty arises because other countries either already require HACCP
or have indicated that they will do so in the near future--for both
their domestic and imported seafood products. No costs or benefits
should be ascribed to choices made by the U.S. Government in this rule
that affect firms already complying with foreign regulations, if the
regulations are the same and no changes need to be made to be in
compliance with the U.S. regulation.
Thus, foreign firms in those countries who export to the United
States may be required to comply first with the U.S. plan or first with
their own country's plan; the timing is impossible to predict. However,
FDA does have evidence from the European Union that the seafood
produced by the following countries (at least seafood for export) have
met the EU standard for HACCP-- Albania, Australia, Austria, Belgium,
Brazil, Canada, Chile, Columbia, Denmark, Ecuador, England, Faro Is.,
Finland, France, Germany, Greece, Holland, Iceland, Indonesia, Ireland,
Italy, Japan, Luxembourg, Mexico, Morocco, New Zealand, Norway, Peru,
Philippines, Sweden, Taiwan, Thailand, and Turkey.
F. Conclusion
As the above analysis demonstrates, FDA finds that the estimated
benefits exceed the estimated costs. The estimated costs are
approximately one third of those in the PRIA, ranging from $677 million
to $1.488 billion. These estimated costs were based primarily on the
reports of some seafood firms and modeling done by FDA experts based on
their experience with HACCP but also considered the study done under
contract with NMFS. The benefits range from $1.435 billion to $2.561
billion and include benefits from safety, nutrition, increased consumer
confidence, rent seeking activities, exports, and reduced enforcement
costs.
G. Final Regulatory Flexibility Analysis
The Regulatory Flexibility Act (Pub. L. 96-354) requires analyzing
options for regulatory relief for small businesses. In the PRIA, FDA
listed for comment a series of regulatory options on how to grant
regulatory relief for small firms. In that document, FDA defined small
firms as having less than $1 million in annual gross revenue (for non-
shrimp processors) and less than $2 million for shrimp processors. In
the PRIA, regulatory options for small business relief included:
(1) Requiring HACCP-type controls for those critical control points
in individual plants that have a history of failure.
(2) Exempting very small processors from the requirements in the
proposed regulatory option.
(3) Allowing a longer implementation period such that HACCP
requirements may be phased in over a longer period of time.
(4) Providing generic HACCP plans (without mandatory control
points) for certain types of operations, providing federal
verification, or less frequent monitoring of critical control points.
FDA received a large number of comments on these options and on the
costs that small businesses would incur as a result of the proposed
option.
The agency has fully considered all of the comments received on its
regulatory flexibility analysis and has responded to these comments in
the full RIA. What follows is a summary of FDA's major conclusions from
the analysis.
FDA received comments on whether there should be exemptions for
processors based on either the size of the processor or the degree of
risk associated with the product or process. For example, one commenter
supported the exemption of small firms on the basis that small firms
that represent 75 percent of the industry in terms of the number of
plants, produce less than 10 percent of the seafood consumed.
FDA has concluded that there should be no exemptions for small
firms. Small processors often engage in relatively high risk seafood
processing, and an exemption based on size could inappropriately exempt
high risk operations. An exemption based on risk might entail knowing
which seafood might be responsible for a reported and confirmed
illness. The agency finds however that because underreporting and
skewed reporting of foodborne
[[Page 65192]]
illnesses occurs it is not always directly possible to relate the
reported illnesses to risk. This subject is also discussed at length in
the preambles to both the proposed and final rule.
One comment recommended that no firms be completely exempt, but
that some firms be subject to different HACCP requirements depending on
size. The smaller the firm, the less strict the record-keeping,
testing, and monitoring requirements. The use of a short form for
recordkeeping and informal monitoring was supported in some comments.
Again, this is a topic that is extensively covered in the preamble
to the final rule. FDA notes that HACCP depends on the degree of risk
and complexity of processing and that HACCP requirements for each plant
are calibrated based on these factors. Whether the plant is large or
small, if there are few hazards and simple processes, HACCP
requirements are inherently minimal. If there are no hazards, no HACCP
plan is required. Overall, however the agency believes that many
smaller firms are associated with simpler processes and that the HACCP
system already accommodates the commenter's concern.
In the long run, as processors adopt HACCP and attempt to pass
costs on to consumers, the retail price of seafood will rise by less
than 1 percent. In the absence of an increase in consumer demand that
may result from this regulation, as the price of seafood rises,
consumers will purchase less seafood. As producers fail to sell all of
the seafood offered at the higher price, output must fall. Moreover,
output must decrease in the highest cost sector of the industry,
generally small processors. Although it is possible that small
processors will cut back production but stay in business, the small
profit margins of some small seafood producers strongly imply that the
reduction in output will come about because small processors go out of
business. For every one percent increase in the price of seafood,
approximately 140 small processors could go out of business. The
estimated number comes from the following calculation. FDA has
estimated that as costs are passed on, HACCP will raise the price of
seafood to consumers. The price elasticity of demand, which is the
percentage change in quantity purchased divided by the percentage
change in price, is estimated to be -0.37 for seafood (Ref. 227). A one
percent increase in the price consumers pay for seafood should
therefore reduce the quantity purchased by 0.37 percent (1 percent
times -0.37). FDA believes that the entire reduction in output
attributable to HACCP will be borne by small processors who go out of
business. Although close to 80 percent of seafood processors are
classified as small, small processors account for only 10 percent of
total industry output (Ref. 228). In the case of a 0.37 percent decline
in total processing output represents a decline in the output of small
processors of 3.7 percent (0.37 percent divided by 0.10). If the
decline in the number of processors were proportional to the decline in
the output of small processors, the reduction in the number of
processors would be 3.7 percent in the case of a 1 percent price
increase. FDA is uncertain as to what price increase will actually
occur.
The agency finds that the number of small seafood processors that
go out of business will be determined by the cost per unit (or per
plant) of implementing HACCP, the effect of HACCP on seafood prices,
the ability of small plants to pass costs on to consumers, the current
practices of the plants and the implementation time. The analysis has
assumed that the regulation will have no positive effect on the demand
for seafood. If the regulation in fact increases consumer confidence in
seafood sufficiently to increase the demand for seafood, then the
effect on small business would be less.
Although the economic impact on small firms is difficult to
predict, many small firms should be able to implement HACCP at low
cost, as they have already fulfilled many of its basic requirements.
The closer a firm's current practices are to HACCP, the lower the cost
of HACCP and the more likely is firm survival. Some small firms occupy
market niches that allow them to pass on more of their costs than the
industry average, increasing their likelihood of survival.
The effect of HACCP on small seafood processors depends on their
costs of compliance and on the changes in the relative price of
seafood. FDA expects the relative price increase attributable to HACCP
to be small. For many small firms, the flexibility built into the
regulation strongly implies that HACCP costs will be low. In
consideration of small firms, the agency has extended the effective
date to 2 years from publication. FDA will also be publishing a Guide
that will provide small processors with valuable information for
developing and implementing HACCP. Additionally, the agency, in
cooperation with Sea Grant Universities and others through the Seafood
HACCP Alliance, will be providing to small firms assistance on training
and other needs.
FDA recognizes that HACCP is an innovative regulatory system that
has not been applied on a large scale to ongoing commercial enterprises
in the United States. For this reason all of the agency's estimates of
firm behavior, costs and benefits necessarily involve substantial
uncertainty. As explained in this Regulatory Impact Analysis, FDA has
used modeling techniques and informed judgements rather than firm
empirical data to estimate many effects. In order to determine the
accuracy of these estimates, and also to assist in possible mid-course
corrections, FDA and HHS plan to conduct an evaluation study during the
first few years after the effective date of these regulations. This
study could focus on each major type of one-time or continuing
compliance cost, on different types of firms, on different sizes of
firms (with particular attention to the smallest firms), and on both
costs required by the regulation and on costs that firms may incur
unnecessarily. It could also address the ability of firms to understand
and implement HACCP properly, and any other problems that may impede
rapid and inexpensive implementation. This study could also include an
exploratory analysis of benefits, addressing both improvements in
processing as measured by elimination of hazards and, to the extent
permitted by existing data systems, early trends in reported incidence
of illness caused by seafood.
V. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the proposed rule (59 FR 4142, January 28,
1994). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment, and that an environmental impact
statement is not required.
VI. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Committee on Diet and Health, Food and Nutrition Board,
Commission on Life Sciences, National Research Council, ``Diet and
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2. National Heart, Lung, and Blood Institute, DHHS, ``National
Cholesterol Education Program: Report of the Expert Panel on
Population Strategies for Blood Cholesterol Reduction, Executive
Summary,'' NIH Publication No. 90-3047, National Institutes of
Health, Bethesda, MD, 1990.
[[Page 65193]]
3. Hackney, C., and D. Ward, ed., ``Microbiology of Marine Food
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5. Otwell, W. S., ``Seafood Safety in Question,'' MTS Journal,
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6. FDA, DHHS, ``Seafood Safety,'' May 10, 1993.
7. Ahmed, F. E., ed., Committee on Evaluation of the Safety of
Fishery Products, Food and Nutrition Board, Institute of Medicine,
NAS, Seafood Safety, National Academy Press, 1991.
8. Rhodehamel, E. J., ``Overview of Biological, Chemical, and
Physical Hazards,'' HACCP: Principles and Applications, Van Nostrand
Reinhold, 1992.
9. Colwell, R. R. ed., ``Natural Toxins and Human Pathogens in
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15. Spitzig, P., memorandum, ``Decomposition Data From the
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17. Letter From Skip Widtfeldt, Seafood Permit Coordinator,
State of Alaska Department of Environmental Conservation, to Alaska
Seafood Processors, January 17, 1992.
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1992.
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to Eat Results,'' March 1, 1993.
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of Salmonella spp. in Cantaloupe, Watermelon, and Honeydew Melons,''
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26. Eklund, M. W. et al., ``Inhibition of Clostridium Botulinum
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on Food Hygiene Washington D.C., 28 October-1 November 1991.''
47. ``Communication From The President of the United States
Transmitting the Final Legal Text of the U.S.-Canada Free-Trade
Agreement, The Proposed U.S.-Canada Free-Trade Agreement
Implementation Act of 1988, and a Statement of Administrative
Action, Pursuant to 19 U.S.C. 2112(e)(2), 2212(a),'' House Document
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Processing,'' Food Technology, 46(12) 73-76, 1992.
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Indicator Bacteria in Shellstock and Commercially Processed Oysters
From the Gulf Coast,'' Journal of Food Protection, 55(9):667-671,
1992.
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Analytical Chemists International, Vol. 75, September/October 1992.
51. Corlett, D. A., Jr., and Pierson, M. D., ed., HACCP:
Principles and Applications, Van Nostrand Reinhold, 1991.
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of Thermal Process Control, Acidification and Container Closure
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and Assignment of Risk Categories,'' HACCP: Principles and
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61. Data summary sheets.
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1974.
[[Page 65194]]
64. FDA, DHHS, ``FDA Fact Sheet: Shigella in Food,'' December
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Review,'' January 1978.
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71. National Sanitation Foundation, Ann Arbor, Michigan,
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List of Subjects
21 CFR Part 123
Fish, Fishery products, Imports, Reporting and recordkeeping
requirements, Seafood.
21 CFR Part 1240
Communicable diseases, Public health, Travel restrictions, Water
supply.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, title 21 CFR
chapter I is amended as follows:
1. New part 123 is added to read as follows:
PART 123--FISH AND FISHERY PRODUCTS
Subpart A--General Provisions
Sec.
123.3 Definitions.
123.5 Current good manufacturing practice.
123.6 Hazard Analysis and Hazard Analysis Critical Control Point
(HACCP) plan.
123.7 Corrective actions.
123.8 Verification.
123.9 Records.
123.10 Training.
123.11 Sanitation control procedures.
123.12 Special requirements for imported products.
Subpart B--Smoked and Smoke-Flavored Fishery Products
123.15 General.
123.16 Process controls.
Subpart C--Raw Molluscan Shellfish
123.20 General.
123.28 Source controls.
Authority: Secs. 201, 402, 403, 406, 409, 701, 704, 721, 801,
903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342,
343, 346, 348, 371, 374, 379e, 381, 393); secs. 301, 307, 361 of the
Public Health Service Act (42 U.S.C. 241, 242l, 264).
Subpart A--General Provisions
Sec. 123.3 Definitions.
The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (the act) and in part 110 of this
chapter are applicable to such terms when used in this part, except
where they are herein redefined. The following definitions shall also
apply:
(a) Certification number means a unique combination of letters and
numbers assigned by a shellfish control authority to a molluscan
shellfish processor.
(b) Critical control point means a point, step, or procedure in a
food process at which control can be applied, and a food safety hazard
can as a result be prevented, eliminated, or reduced to acceptable
levels.
(c) Critical limit means the maximum or minimum value to which a
physical, biological, or chemical parameter must be controlled at a
critical control point to prevent, eliminate, or reduce to an
acceptable level the occurrence of the identified food safety hazard.
(d) Fish means fresh or saltwater finfish, crustaceans, other forms
of aquatic animal life (including, but not limited to, alligator, frog,
aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of
such animals) other than birds or mammals, and all mollusks, where such
animal life is intended for human consumption.
(e) Fishery product means any human food product in which fish is a
characterizing ingredient.
(f) Food safety hazard means any biological, chemical, or physical
property that may cause a food to be unsafe for human consumption.
(g) Importer means either the U.S. owner or consignee at the time
of entry into the United States, or the U.S. agent or representative of
the foreign owner or consignee at the time of entry into the United
States, who is responsible for ensuring that goods being offered for
entry into the United States are in compliance with all laws affecting
the importation. For the purposes of this definition, ordinarily the
importer is not the custom house broker, the freight forwarder, the
carrier, or the steamship representative.
(h) Molluscan shellfish means any edible species of fresh or frozen
oysters, clams, mussels, or scallops, or edible portions of such
species, except when the product consists entirely of the shucked
adductor muscle.
(i) Preventive measure means physical, chemical, or other factors
that can be used to control an identified food safety hazard.
(j) Process-monitoring instrument means an instrument or device
used to indicate conditions during processing at a critical control
point.
(k)(1) Processing means, with respect to fish or fishery products:
Handling, storing, preparing, heading, eviscerating, shucking,
freezing, changing into different market forms, manufacturing,
preserving, packing, labeling, dockside unloading, or holding.
(2) The regulations in this part do not apply to:
(i) Harvesting or transporting fish or fishery products, without
otherwise engaging in processing.
(ii) Practices such as heading, eviscerating, or freezing intended
solely to prepare a fish for holding on board a harvest vessel.
(iii) The operation of a retail establishment.
(l) Processor means any person engaged in commercial, custom, or
institutional processing of fish or fishery products, either in the
United States or in a foreign country. A processing includes any person
engaged in the production of foods that are to be used in market or
consumer tests.
(m) Scombroid toxin-forming species means tuna, bluefish, mahi
mahi, and other species, whether or not in the family Scombridae, in
which significant levels of histamine may be produced in the fish flesh
by decarboxylation of free histidine as a result of exposure of the
fish after capture to temperatures that permit the growth of mesophilic
bacteria.
(n) Shall is used to state mandatory requirements.
(o) Shellfish control authority means a Federal, State, or foreign
agency, or sovereign tribal government, legally responsible for the
administration of a program that includes activities such as
classification of molluscan shellfish growing areas, enforcement of
[[Page 65198]]
molluscan shellfish harvesting controls, and certification of molluscan
shellfish processors.
(p) Shellstock means raw, in-shell molluscan shellfish.
(q) Should is used to state recommended or advisory procedures or
to identify recommended equipment.
(r) Shucked shellfish means molluscan shellfish that have one or
both shells removed.
(s) Smoked or smoke-flavored fishery products means the finished
food prepared by:
(1) Treating fish with salt (sodium chloride), and
(2) Subjecting it to the direct action of smoke from burning wood,
sawdust, or similar material and/or imparting to it the flavor of smoke
by a means such as immersing it in a solution of wood smoke.
(t) Tag means a record of harvesting information attached to a
container of shellstock by the harvester or processor.
Sec. 123.5 Current good manufacturing practice.
(a) Part 110 of this chapter applies in determining whether the
facilities, methods, practices, and controls used to process fish and
fishery products are safe, and whether these products have been
processed under sanitary conditions.
(b) The purpose of this part is to set forth requirements specific
to the processing of fish and fishery products.
Sec. 123.6 Hazard Analysis and Hazard Analysis Critical Control Point
(HACCP) Plan.
(a) Hazard analysis. Every processor shall conduct, or have
conducted for it, a hazard analysis to determine whether there are food
safety hazards that are reasonably likely to occur for each kind of
fish and fishery product processed by that processor and to identify
the preventive measures that the processor can apply to control those
hazards. Such food safety hazards can be introduced both within and
outside the processing plant environment, including food safety hazards
that can occur before, during, and after harvest. A food safety hazard
that is reasonably likely to occur is one for which a prudent processor
would establish controls because experience, illness data, scientific
reports, or other information provide a basis to conclude that there is
a reasonable possibility that it will occur in the particular type of
fish or fishery product being processed in the absence of those
controls.
(b) The HACCP plan. Every processor shall have and implement a
written HACCP plan whenever a hazard analysis reveals one or more food
safety hazards that are reasonably likely to occur, as described in
paragraph (a) of this section. A HACCP plan shall be specific to:
(1) Each location where fish and fishery products are processed by
that processor; and
(2) Each kind of fish and fishery product processed by the
processor. The plan may group kinds of fish and fishery products
together, or group kinds of production methods together, if the food
safety hazards, critical control points, critical limits, and
procedures required to be identified and performed in paragraph (c) of
this section are identical for all fish and fishery products so grouped
or for all production methods so grouped.
(c) The contents of the HACCP plan. The HACCP plan shall, at a
minimum:
(1) List the food safety hazards that are reasonably likely to
occur, as identified in accordance with paragraph (a) of this section,
and that thus must be controlled for each fish and fishery product.
Consideration should be given to whether any food safety hazards are
reasonably likely to occur as a result of the following:
(i) Natural toxins;
(ii) Microbiological contamination;
(iii) Chemical contamination;
(iv) Pesticides;
(v) Drug residues;
(vi) Decomposition in scombroid toxin-forming species or in any
other species where a food safety hazard has been associated with
decomposition;
(vii) Parasites, where the processor has knowledge or has reason to
know that the parasite-containing fish or fishery product will be
consumed without a process sufficient to kill the parasites, or where
the processor represents, labels, or intends for the product to be so
consumed;
(viii) Unapproved use of direct or indirect food or color
additives; and
(ix) Physical hazards;
(2) List the critical control points for each of the identified
food safety hazards, including as appropriate:
(i) Critical control points designed to control food safety hazards
that could be introduced in the processing plant environment; and
(ii) Critical control points designed to control food safety
hazards introduced outside the processing plant environment, including
food safety hazards that occur before, during, and after harvest;
(3) List the critical limits that must be met at each of the
critical control points;
(4) List the procedures, and frequency thereof, that will be used
to monitor each of the critical control points to ensure compliance
with the critical limits;
(5) Include any corrective action plans that have been developed in
accordance with Sec. 123.7(b), to be followed in response to deviations
from critical limits at critical control points;
(6) List the verification procedures, and frequency thereof, that
the processor will use in accordance with Sec. 123.8(a);
(7) Provide for a recordkeeping system that documents the
monitoring of the critical control points. The records shall contain
the actual values and observations obtained during monitoring.
(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be
signed and dated, either by the most responsible individual onsite at
the processing facility or by a higher level official of the processor.
This signature shall signify that the HACCP plan has been accepted for
implementation by the firm.
(2) The HACCP plan shall be dated and signed:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) Upon verification of the plan in accordance with
Sec. 123.8(a)(1).
(e) Products subject to other regulations. For fish and fishery
products that are subject to the requirements of part 113 or 114 of
this chapter, the HACCP plan need not list the food safety hazard
associated with the formation of Clostridium botulinum toxin in the
finished, hermetically sealed container, nor list the controls to
prevent that food safety hazard. A HACCP plan for such fish and fishery
products shall address any other food safety hazards that are
reasonably likely to occur.
(f) Sanitation. Sanitation controls may be included in the HACCP
plan. However, to the extent that they are monitored in accordance with
Sec. 123.11(b) they need not be included in the HACCP plan, and vice
versa.
(g) Legal basis. Failure of a processor to have and implement a
HACCP plan that complies with this section whenever a HACCP plan is
necessary, otherwise operate in accordance with the requirements of
this part, shall render the fish or fishery products of that processor
adulterated under section 402(a)(4) of the act. Whether a processor's
actions are consistent with ensuring the safety of food will be
determined through an evaluation of the processors overall
implementation of its HACCP plan, if one is required.
[[Page 65199]]
Sec. 123.7 Corrective actions.
(a) Whenever a deviation from a critical limit occurs, a processor
shall take corrective action either by:
(1) Following a corrective action plan that is appropriate for the
particular deviation, or
(2) Following the procedures in paragraph (c) of this section.
(b) Processors may develop written corrective action plans, which
become part of their HACCP plans in accordance with Sec. 123.6(c)(5),
by which they predetermine the corrective actions that they will take
whenever there is a deviation from a critical limit. A corrective
action plan that is appropriate for a particular deviation is one that
describes the steps to be taken and assigns responsibility for taking
those steps, to ensure that:
(1) No product enters commerce that is either injurious to health
or is otherwise adulterated as a result of the deviation; and
(2) The cause of the deviation is corrected.
(c) When a deviation from a critical limit occurs and the processor
does not have a corrective action plan that is appropriate for that
deviation, the processor shall:
(1) Segregate and hold the affected product, at least until the
requirements of paragraphs (c)(2) and (c)(3) of this section are met;
(2) Perform or obtain a review to determine the acceptability of
the affected product for distribution. The review shall be performed by
an individual or individuals who have adequate training or experience
to perform such a review. Adequate training may or may not include
training in accordance with Sec. 123.10;
(3) Take corrective action, when necessary, with respect to the
affected product to ensure that no product enters commerce that is
either injurious to health or is otherwise adulterated as a result of
the deviation;
(4) Take corrective action, when necessary, to correct the cause of
the deviation;
(5) Perform or obtain timely reassessment by an individual or
individuals who have been trained in accordance with Sec. 123.10, to
determine whether the HACCP plan needs to be modified to reduce the
risk of recurrence of the deviation, and modify the HACCP plan as
necessary.
(d) All corrective actions taken in accordance with this section
shall be fully documented in records that are subject to verification
in accordance with Sec. 123.8(a)(3)(ii) and the recordkeeping
requirements of Sec. 123.9.
Sec. 123.8 Verification.
(a) Overall verification. Every processor shall verify that the
HACCP plan is adequate to control food safety hazards that are
reasonably likely to occur, and that the plan is being effectively
implemented. Verification shall include, at a minimum:
(1) Reassessment of the HACCP plan. A reassessment of the adequacy
of the HACCP plan whenever any changes occur that could affect the
hazard analysis or alter the HACCP plan in any way or at least
annually. Such changes may include changes in the following: Raw
materials or source of raw materials, product formulation, processing
methods or systems, finished product distribution systems, or the
intended use or consumers of the finished product. The reassessment
shall be performed by an individual or individuals who have been
trained in accordance with Sec. 123.10. The HACCP plan shall be
modified immediately whenever a reassessment reveals that the plan is
no longer adequate to fully meet the requirements of Sec. 123.6(c).
(2) Ongoing verification activities. Ongoing verification
activities including:
(i) A review of any consumer complaints that have been received by
the processor to determine whether they relate to the performance of
critical control points or reveal the existence of unidentified
critical control points;
(ii) The calibration of process-monitoring instruments; and,
(iii) At the option of the processor, the performing of periodic
end-product or in-process testing.
(3) Records review. A review, including signing and dating, by an
individual who has been trained in accordance with Sec. 123.10, of the
records that document:
(i) The monitoring of critical control points. The purpose of this
review shall be, at a minimum, to ensure that the records are complete
and to verify that they document values that are within the critical
limits. This review shall occur within 1 week of the day that the
records are made;
(ii) The taking of corrective actions. The purpose of this review
shall be, at a minimum, to ensure that the records are complete and to
verify that appropriate corrective actions were taken in accordance
with Sec. 123.7. This review shall occur within 1 week of the day that
the records are made; and
(iii) The calibrating of any process control instruments used at
critical control points and the performing of any periodic end-product
or in-process testing that is part of the processor's verification
activities. The purpose of these reviews shall be, at a minimum, to
ensure that the records are complete, and that these activities
occurred in accordance with the processor's written procedures. These
reviews shall occur within a reasonable time after the records are
made.
(b) Corrective actions. Processors shall immediately follow the
procedures in Sec. 123.7 whenever any verification procedure, including
the review of a consumer complaint, reveals the need to take a
corrective action.
(c) Reassessment of the hazard analysis. Whenever a processor does
not have a HACCP plan because a hazard analysis has revealed no food
safety hazards that are reasonably likely to occur, the processor shall
reassess the adequacy of that hazard analysis whenever there are any
changes that could reasonably affect whether a food safety hazard now
exists. Such changes may include, but are not limited to changes in:
Raw materials or source of raw materials, product formulation,
processing methods or systems, finished product distribution systems,
or the intended use or consumers of the finished product. The
reassessment shall be performed by an individual or individuals who
have been trained in accordance with Sec. 123.10.
(d) Recordkeeping. The calibration of process-monitoring
instruments, and the performing of any periodic end-product and in-
process testing, in accordance with paragraphs (a)(2)(ii) through (iii)
of this section shall be documented in records that are subject to the
recordkeeping requirements of Sec. 123.9.
Sec. 123.9 Records.
(a) General requirements. All records required by this part shall
include:
(1) The name and location of the processor or importer;
(2) The date and time of the activity that the record reflects;
(3) The signature or initials of the person performing the
operation; and
(4) Where appropriate, the identity of the product and the
production code, if any. Processing and other information shall be
entered on records at the time that it is observed.
(b) Record retention. (1) All records required by this part shall
be retained at the processing facility or importer's place of business
in the United States for at least 1 year after the date they were
prepared in the case of refrigerated products and for at least 2 years
after the date they were prepared in the case of frozen, preserved, or
shelf-stable products.
(2) Records that relate to the general adequacy of equipment or
processes being used by a processor, including the
[[Page 65200]]
results of scientific studies and evaluations, shall be retained at the
processing facility or the importer's place of business in the United
States for at least 2 years after their applicability to the product
being produced at the facility.
(3) If the processing facility is closed for a prolonged period
between seasonal packs, or if record storage capacity is limited on a
processing vessel or at a remote processing site, the records may be
transferred to some other reasonably accessible location at the end of
the seasonal pack but shall be immediately returned for official review
upon demand.
(c) Official review. All records required by this part and all
plans and procedures required by this part shall be available for
official review and copying at reasonable times.
(d) Public disclosure. (1) Subject to the limitations in paragraph
(d)(2) of this section, all plans and records required by this part are
not available for public disclosure unless they have been previously
disclosed to the public as defined in Sec. 20.81 of this chapter or
they relate to a product or ingredient that has been abandoned and they
no longer represent a trade secret or confidential commercial or
financial information as defined in Sec. 20.61 of this chapter.
(2) However, these records and plans may be subject to disclosure
to the extent that they are otherwise publicly available, or that
disclosure could not reasonably be expected to cause a competitive
hardship, such as generic-type HACCP plans that reflect standard
industry practices.
(e) Tags. Tags as defined in Sec. 123.3(t) are not subject to the
requirements of this section unless they are used to fulfill the
requirements of Sec. 123.28(c).
(f) Records maintained on computers. The maintenance of records on
computers is acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic data and
signatures.
Sec. 123.10 Training.
At a minimum, the following functions shall be performed by an
individual who has successfully completed training in the application
of HACCP principles to fish and fishery product processing at least
equivalent to that received under standardized curriculum recognized as
adequate by the U.S. Food and Drug Administration or who is otherwise
qualified through job experience to perform these functions. Job
experience will qualify an individual to perform these functions if it
has provided knowledge at least equivalent to that provided through the
standardized curriculum.
(a) Developing a HACCP plan, which could include adapting a model
or generic-type HACCP plan, that is appropriate for a specific
processor, in order to meet the requirements of Sec. 123.6(b);
(b) Reassessing and modifying the HACCP plan in accordance with the
corrective action procedures specified in Sec. 123.7(c)(5), the HACCP
plan in accordance with the verification activities specified in
Sec. 123.8(a)(1), and the hazard analysis in accordance with the
verification activities specified in Sec. 123.8(c); and
(c) Performing the record review required by Sec. 123.8(a)(3); The
trained individual need not be an employee of the processor.
Sec. 123.11 Sanitation control procedures.
(a) Sanitation SOP. Each processor should have and implement a
written sanitation standard operating procedure (herein referred to as
SSOP) or similar document that is specific to each location where fish
and fishery products are produced. The SSOP should specify how the
processor will meet those sanitation conditions and practices that are
to be monitored in accordance with paragraph (b) of this section.
(b) Sanitation monitoring. Each processor shall monitor the
conditions and practices during processing with sufficient frequency to
ensure, at a minimum, conformance with those conditions and practices
specified in part 110 of this chapter that are both appropriate to the
plant and the food being processed and relate to the following:
(1) Safety of the water that comes into contact with food or food
contact surfaces, or is used in the manufacture of ice;
(2) Condition and cleanliness of food contact surfaces, including
utensils, gloves, and outer garments;
(3) Prevention of cross-contamination from insanitary objects to
food, food packaging material, and other food contact surfaces,
including utensils, gloves, and outer garments, and from raw product to
cooked product;
(4) Maintenance of hand washing, hand sanitizing, and toilet
facilities;
(5) Protection of food, food packaging material, and food contact
surfaces from adulteration with lubricants, fuel, pesticides, cleaning
compounds, sanitizing agents, condensate, and other chemical, physical,
and biological contaminants;
(6) Proper labeling, storage, and use of toxic compounds;
(7) Control of employee health conditions that could result in the
microbiological contamination of food, food packaging materials, and
food contact surfaces; and
(8) Exclusion of pests from the food plant.
The processor shall correct in a timely manner, those conditions
and practices that are not met.
(c) Sanitation control records. Each processor shall maintain
sanitation control records that, at a minimum, document the monitoring
and corrections prescribed by paragraph (b) of this section. These
records are subject to the requirements of Sec. 123.9.
(d) Relationship to HACCP plan. Sanitation controls may be included
in the HACCP plan, required by Sec. 123.6(b). However, to the extent
that they are monitored in accordance with paragraph (b) of this
section they need not be included in the HACCP plan, and vice versa.
Sec. 123.12 Special requirements for imported products.
This section sets forth specific requirements for imported fish and
fishery products.
(a) Importer verification. Every importer of fish or fishery
products shall either:
(1) Obtain the fish or fishery product from a country that has an
active memorandum of understanding (MOU) or similar agreement with the
Food and Drug Administration, that covers the fish or fishery product
and documents the equivalency or compliance of the inspection system of
the foreign country with the U.S. system, accurately reflects the
current situation between the signing parties, and is functioning and
enforceable in its entirety; or
(2) Have and implement written verification procedures for ensuring
that the fish and fishery products that they offer for import into the
United States were processed in accordance with the requirements of
this part. The procedures shall list at a minimum:
(i) Product specifications that are designed to ensure that the
product is not adulterated under section 402 of the Federal Food, Drug,
and Cosmetic Act because it may be injurious to health or have been
processed under insanitary conditions, and,
(ii) Affirmative steps that may include any of the following:
(A) Obtaining from the foreign processor the HACCP and sanitation
monitoring records required by this part that relate to the specific
lot of fish or fishery products being offered for import;
(B) Obtaining either a continuing or lot-by-lot certificate from an
appropriate
[[Page 65201]]
foreign government inspection authority or competent third party
certifying that the imported fish or fishery product is or was
processed in accordance with the requirements of this part;
(C) Regularly inspecting the foreign processor's facilities to
ensure that the imported fish or fishery product is being processed in
accordance with the requirements of this part;
(D) Maintaining on file a copy, in English, of the foreign
processor's HACCP plan, and a written guarantee from the foreign
processor that the imported fish or fishery product is processed in
accordance with the requirements of the part;
(E) Periodically testing the imported fish or fishery product, and
maintaining on file a copy, in English, of a written guarantee from the
foreign processor that the imported fish or fishery product is
processed in accordance with the requirements of this part or,
(F) Other such verification measures as appropriate that provide an
equivalent level of assurance of compliance with the requirements of
this part.
(b) Competent third party. An importer may hire a competent third
party to assist with or perform any or all of the verification
activities specified in paragraph (a)(2) of this section, including
writing the importer's verification procedures on the importer's
behalf.
(c) Records. The importer shall maintain records, in English, that
document the performance and results of the affirmative steps specified
in paragraph (a)(2)(ii) of this section. These records shall be subject
to the applicable provisions of Sec. 123.9.
(d) Determination of compliance. There must be evidence that all
fish and fishery products offered for entry into the United States have
been processed under conditions that comply with this part. If
assurances do not exist that the imported fish or fishery product has
been processed under conditions that are equivalent to those required
of domestic processors under this part, the product will appear to be
adulterated and will be denied entry.
Subpart B--Smoked and Smoke-flavored Fishery Products
Sec. 123.15 General.
This subpart augments subpart A of this part by setting forth
specific requirements for processing smoked and smoke-flavored fishery
products.
Sec. 123.16 Process controls.
In order to meet the requirements of subpart A of this part,
processors of smoked and smoke-flavored fishery products, except those
subject to the requirements of part 113 or 114 of this chapter, shall
include in their HACCP plans how they are controlling the food safety
hazard associated with the formation of toxin by Clostridium botulinum
for at least as long as the shelf life of the product under normal and
moderate abuse conditions.
Subpart C--Raw Molluscan Shellfish
Sec. 123.20 General.
This subpart augments subpart A of this part by setting forth
specific requirements for processing fresh or frozen molluscan
shellfish, where such processing does not include a treatment that
ensures the destruction of vegetative cells of microorganisms of public
health concern.
Sec. 123.28 Source controls.
(a) In order to meet the requirements of subpart A of this part as
they apply to microbiological contamination, chemical contamination,
natural toxins, and related food safety hazards, processors shall
include in their HACCP plans how they are controlling the origin of the
molluscan shellfish they process to ensure that the conditions of
paragraphs (b), (c), and (d) of this section are met.
(b) Processors shall only process molluscan shellfish harvested
from growing waters approved for harvesting by a shellfish control
authority. In the case of molluscan shellfish harvested from U.S.
Federal waters, the requirements of this paragraph will be met so long
as the shellfish have not been harvested from waters that have been
closed to harvesting by an agency of the Federal government.
(c) To meet the requirements of paragraph (b) of this section,
processors who receive shellstock shall accept only shellstock from a
harvester that is in compliance with such licensure requirements as may
apply to the harvesting of molluscan shellfish or from a processor that
is certified by a shellfish control authority, and that has a tag
affixed to each container of shellstock. The tag shall bear, at a
minimum, the information required in Sec. 1240.60(b) of this chapter.
In place of the tag, bulk shellstock shipments may be accompanied by a
bill of lading or similar shipping document that contains the
information required in Sec. 1240.60(b) of this chapter. Processors
shall maintain records that document that all shellstock have met the
requirements of this section. These records shall document:
(1) The date of harvest;
(2) The location of harvest by State and site;
(3) The quantity and type of shellfish;
(4) The date of receipt by the processor; and
(5) The name of the harvester, the name or registration number of
the harvester's vessel, or an identification number issued to the
harvester by the shellfish control authority.
(d) To meet the requirements of paragraph (b) of this section,
processors who receive shucked molluscan shellfish shall accept only
containers of shucked molluscan shellfish that bear a label that
complies with Sec. 1240.60(c) of this chapter. Processors shall
maintain records that document that all shucked molluscan shellfish
have met the requirements of this section. These records shall
document:
(1) The date of receipt;
(2) The quantity and type of shellfish; and
(3) The name and certification number of the packer or repacker of
the product.
PART 1240--CONTROL OF COMMUNICABLE DISEASES
2. The authority citation for 21 CFR part 1240 continues to read as
follows:
Authority: Secs. 215, 311, 361, 368 of the Public Health Service
Act (42 U.S.C. 216, 243, 264, 271).
3. Section 1240.3 is amended by revising paragraph (r), and by
adding new paragraphs (s), (t), and (u) to read as follows:
Sec. 1240.3 General definitions.
* * * * *
(r) Molluscan shellfish. Any edible species of fresh or frozen
oysters, clams, mussels, and scallops or edible portions thereof,
except when the product consists entirely of the shucked adductor
muscle.
(s) Certification number means a unique combination of letters and
numbers assigned by a shellfish control authority to a molluscan
shellfish processor.
(t) Shellfish control authority means a Federal, State, or foreign
agency, or sovereign tribal government, legally responsible for the
administration of a program that includes activities such as
classification of molluscan shellfish growing areas, enforcement of
molluscan shellfish harvesting controls, and certification of molluscan
shellfish processors.
(u) Tag means a record of harvesting information attached to a
container of shellstock by the harvester or processor.
4. Section 1240.60 is amended by revising the section heading, by
[[Page 65202]]
redesignating the existing text as paragraph (a) and adding the word
``molluscan'' before the word ``shellfish'' the two times that it
appears, and by adding new paragraphs (b), (c), and (d) to read as
follows:
Sec. 1240.60 Molluscan shellfish.
* * * * *
(b) All shellstock shall bear a tag that discloses the date and
place they were harvested (by State and site), type and quantity of
shellfish, and by whom they were harvested (i.e., the identification
number assigned to the harvester by the shellfish control authority,
where applicable or, if such identification numbers are not assigned,
the name of the harvester or the name or registration number of the
harvester's vessel). In place of the tag, bulk shellstock shipments may
be accompanied by a bill of lading or similar shipping document that
contains the same information.
(c) All containers of shucked molluscan shellfish shall bear a
label that identifies the name, address, and certification number of
the packer or repacker of the molluscan shellfish.
(d) Any molluscan shellfish without such a tag, shipping document,
or label, or with a tag, shipping document, or label that does not bear
all the information required by paragraphs (b) and (c) of this section,
shall be subject to seizure or refusal of entry, and destruction.
Dated: October 3, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc 95-30332 Filed 12-11-95; 10:40 am]
BILLING CODE 4160-01-P
