21 CFR 123 and 1240
Part I, Preamble, pp. 65095-65152 | Part II, Preamble, pp. 65152-65197 | Part III, Regulation, pp. 65197-65202
Federal Register: December 18, 1995 (Volume 60, Number 242)
Rules and Regulations
Page 65095-65202
From the Federal Register Online via GPO Access wais.access.gpo.gov
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
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
Page 65112
Identifying the preventive measures is necessary in order to
determine whether a processing step is a CCP for that hazard. A
processing step cannot be a CCP for a hazard if no preventive measure
is available at that step to control the hazard. The definition of
``preventive measure'' in these regulations is essentially the same as
that recommended by the NACMCF.
14. Process Monitoring Instrument
The term ``process control instrument'' was used in the proposal
for consistency with the phrase ``the procedures * * * that will be
used to control and monitor each of the critical control points.'' For
consistency with the NACMCF principles of HACCP, FDA has modified the
language of Sec. 123.6(c)(4) to eliminate the word ``control.'' In
order to achieve consistency within these regulations, the agency has
concluded that the appropriate term for such instruments is, therefore,
a ``process monitoring instrument.''
15. Processing and Processor
Along with the term ``importers,'' the terms ``processor'' and
``processing'' collectively define who is subject to these regulations.
FDA proposed to define ``processing'' as:
W ith respect to fish or fishery products, handling, storing,
preparing, heading, gutting, shucking, freezing, changing into
different market forms, manufacturing, preserving, packing,
labeling, or holding. Practices such as heading or gutting intended
solely to prepare a fish for holding on board a harvest vessel are
excluded. This regulation does not cover the operation of a retail
establishment.
FDA proposed to define ``processor'' as:
A ny person engaged in commercial, custom, or institutional
processing of fish or fishery products, either in the United States
or in a foreign country. Persons engaged in the production of foods
that are to be used in market or consumer tests are also included.
Persons who only harvest or transport seafood, without otherwise
engaging in processing, are not covered by these regulations.
a. Vessels, carriers, and retail. As explained in the preamble to
the proposed regulations, the definitions of ``processor'' and
``processing'' excluded fishing vessels that essentially only harvest,
transportation companies that carry but do not otherwise process fish
and fishery products, and retail establishments. FDA invited comment on
these exclusions.
In the preamble, FDA acknowledged that food safety hazards can be
introduced at these three points in the commercial distribution chain.
However, FDA tentatively decided to exclude fishing vessels, carriers,
and retailers from the definition of ``processor''--and thus from
direct coverage under these regulations--because of practical
considerations, such as the fact that the large size of the U.S.
fishing fleet and the large numbers of carriers and retailers would
overwhelm any rational Federal inspection system, and because the
agency believed that the public health goals of the regulations could
still be met.
FDA expressed its tentative view that the HACCP regulations would
affect fishing vessels and carriers indirectly though the controls that
processors impose to meet their obligations under HACCP. As for retail
establishments, the preamble explained that, historically, they have
been the regulatory responsibility of State and local governments. FDA
traditionally has provided support through training, technical
assistance, and the development of model codes. Since the issuance of
the proposal, FDA has published its retail and institutional ``Food
Code,'' with the recommendation that it be adopted by State and local
jurisdictions. The Food Code covers handling and receiving practices at
retail, and its most recent version includes HACCP elements.
FDA's approach to these issues is based on agency discretion and
does not derive from a lack of statutory authority. FDA has broad
authority to regulate Food that is shipped in interstate commerce.
While carriers are exempt from most direct FDA regulation in accordance
with section 703 of the act (21 U.S.C. 373), the food being transported
is not exempt. Moreover, FDA has authority under the Public Health
Service Act (the PHS Act) (42 U.S.C. 264) to take such measures as it
deems necessary to prevent the introduction, transmission, or spread of
communicable disease from foreign countries into the States or from one
State or possession into any other State or possession.
FDA received a significant volume of comment on the question of
coverage by these regulations of fishing vessels, carriers, and retail
establishments. The majority of comments strongly favored inclusion of
these entities within the scope of the these regulations.
35. The arguments relating to vessels and carriers tended to
overlap. Those who favored inclusion noted that hazards--particularly
those associated with time-temperature abuse and insanitation--can
originate with fishing vessels and carriers. The comments argued that
not controlling the conditions under which seafood is harvested and
transported would amount to leaving CCP's unregulated. One comment
observed that carriers have an incentive to turn off refrigeration
units to save gas.
Several comments expressed the view that exclusion of vessels and
carriers from the coverage of these regulations unfairly makes
processors responsible for these aspects of seafood production. One
comment pointed out that vessels, especially those that harvest
scombroid toxin-forming species, should be legally responsible for any
safety hazards that they cause through improper handling. Some comments
asserted that HACCP can be practiced on fishing vessels and by
carriers, at least with regard to temperature controls.
One State agency expressed the view that holding processors
responsible for the behavior of fishing vessels has, in its experience,
not worked, nor has education of fishing vessel owners or voluntary
compliance by owners. The comment did not document the basis for these
conclusions, however. Some comments argued that, while it would be
difficult to include all vessels and carriers, those involved with
high-risk products should be included.
Comments in favor of excluding vessels and carriers from these
HACCP regulations noted that FDA's rationale for exclusion was prudent
given the number, location, and diversity of the U.S. fishing fleet and
the complexity of transport arrangements. For carriers, one comment
noted that partial loads that are dropped off in different locations
would be especially difficult to control. Some comments asserted that
direct regulation of these entities was not necessary because
processors could establish minimum requirements as a condition of
purchase, as part of their HACCP systems. Some comments urged, however,
that fishing vessels be subject to HACCP requirements when they deliver
directly to an entity that is not subject to these regulations (e.g., a
restaurant). One comment argued that receiving firms should require
that product be in the same condition that it was in when it left the
previous processor.
Some comments questioned the ability of fishing vessels and
carriers to comply with HACCP requirements. A number of comments
favored alternatives to HACCP, such as guidelines and standard
operating procedures (SOP's).
FDA is impressed by the strong support for inclusion, of fishing
vessels and carriers in the coverage of these regulations. Some of this
support was based on concern over the loss of quality because of poor
handling
Page 65113
practices (e.g., the effect of time-temperature abuse on shelf life and
spoilage unrelated to safety) rather than on food safety
considerations. Nonetheless, members of these two industries should be
aware that significant concerns have been expressed with regard to
their practices.
For some species and products, the practices of fishing vessels and
transporters can have significant public health consequences. These
practices can put pressure on a processor who is receiving these
products to carefully scrutinize the condition of incoming materials.
The practices can also put pressure on a processor to determine whether
carriers are suitable to transport their finished products (e.g., that
carriers have proper refrigeration).
The agency appreciates the argument that all entities that can
affect safety in the distribution chain should accept and share this
responsibility. These points notwithstanding, FDA received no comment
that provided information about how the agency could operate an
inspection program for carriers and harvest vessels with its current
resources. For this reason, the agency concludes that such a program is
impractical at this time.
When processors accept raw materials for processing, especially
from vessels, they assume some responsibility for the condition of the
incoming materials, regardless of how others are regulated. This is
true under both general commercial law and the laws administered by
FDA. Carriers likewise have responsibilities. If a carrier fails to
exercise such controls as are necessary, food that it carries may be
rendered adulterated and the owner of the product, i.e., the processor,
could suffer product loss. Food handlers generally should exercise
sufficient control over the products in their custody to ensure that
any food safety hazards that are reasonably likely to occur during that
period are being addressed.
As an additional matter, FDA agrees with those comments that
advocated a step-wise regulatory approach to these entities.
Mandatory HACCP for seafood is a pioneering venture. While the
groundwork has been prepared for it through pilot projects and other
efforts over the years, there is no substitute for actual experience
once it is operating. The agency would prefer, therefore, to construct
the system through a series of manageable steps if it needs to do so,
rather than to risk overextending itself and the system initially.
While these regulations exempt carriers and harvest vessels from direct
coverage, experience with the application of a mandatory HACCP program
may, at some later date, cause the agency to reconsider its approach.
For fishing vessels, FDA intends, for the time being, to issue good
handling practice guidelines. To that end, the agency is studying those
issued by the State of Alaska and by the Codex Alimentarius Commission
of the Food and Agriculture Organization/World Health Organization,
among other such available guidance. FDA will evaluate the effect of
these guidelines, in addition to any requirements that States have or
may adopt regarding fishing vessel practices, and reassess at a later
date whether there is a need for mandatory Federal controls. The agency
invites continued correspondence and the sharing of views on this
matter.
The comments that recommended that vessels that sell directly to
``non-HACCP'' establishments (e.g., restaurants) should be required to
have HACCP plans are advised that the Food Code addresses the subject
of source control for retail establishments and recommends the
requirement of HACCP plans for retail establishments in some
circumstances. This matter relates principally to State and local laws
and is addressed below in the discussion of retail establishments.
For carriers, the situation is complicated by the restriction in
section 703 of the act that was described previously. As one comment
recommended, FDA has had conversations with other Federal agencies on
the subject of transportation of food and will continue to do so. In
the meantime, FDA strongly recommends that processors review the
material in the Guide on how they can exercise control over incoming
raw materials as well as over shipments of their own products. One
emerging area that the agency is monitoring--and processors should
consider also--is the development of inexpensive time-temperature
sensors that indicate whether proper temperatures have been maintained
over a period of time.
36. The question of the inclusion of retail establishments within
the mandatory seafood HACCP system involves some different
considerations. Processors have less influence, if any, over how their
products are handled at retail than they do over how their products are
handled by vessel operators or carriers. Some comments pointed out, for
example, that a processor's best efforts could be for naught if the
product is subsequently mishandled at retail.
Several comments pointed out that many retail establishments carry
out activities that meet the definition of ``processing.'' According to
these comments, such establishments should not be exempt from HACCP
requirements.
Other comments took the view that these regulations should not
apply to retail establishments, primarily for the reasons provided in
the preamble to the proposal. Some recommended that retail
establishments should not be subject to the regulations so long as the
Food Code applies to them. Others suggested that HACCP should apply if
the retail establishment buys directly from a fishing vessel or from
sport fishermen. Some suggested better consumer education and voluntary
HACCP-type programs.
FDA agrees that there are hazards that occur at the retail level
that can render meaningless the controls that may have been in place
elsewhere in the chain of production and distribution. The NAS has
cited retail and food service establishments as sources of seafood-
related illnesses (see Ref. 7, p. 27). FDA is convinced--and the
comments support--that proper controls at the retail level are
imperative to ensuring a safe product.
Nonetheless, FDA's observation in the preamble to the proposed
regulations remains valid that retail establishments pose an inspection
burden well beyond the capacity of FDA. No comments have provided any
basis for the agency to conclude otherwise or would justify the
significant shift of resources that would be necessary for FDA to even
begin to address the retail sector in a meaningful way. FDA notes that
State and local governments provide significant regulation of the
retail food sector. FDA has committed the resources that it has
available for addressing retail problems, by providing training and
technical assistance to State and local governments. Most
significantly, FDA has provided guidance in the form of the Food Code,
which provides the latest and best scientifically based advice about
preventing foodborne illness for adoption by those jurisdictions that
have regulatory responsibility for food service, retail, and vending
operations.
It is worth noting that the Food Code suggests the use of HACCP
controls at retail in some circumstances where comments argued for such
controls as part of these regulations. Under the regulatory controls
suggested in the Food Code, a retail establishment that purchases a
scombroid toxin forming species of fish from a recreational harvester,
for example, would need a HACCP plan relating to how it will ensure
that fish had been handled so as to avoid time-temperature abuse. Under
Page 65114
the Food Code, fish caught recreationally generally require the
approval of a regulatory authority in order to be sold to a retail
establishment. The States should be aware that the Food Code is
responsive to concerns raised by comments in these respects. FDA urges
the States to consider adopting the Food Code for retail and
institutional operations.
It is worth noting that the Food Code applies HACCP requirements to
retail establishments as an exception for extreme situations, rather
than as the rule. There is still much to be learned about the
application of HACCP to retail establishments. Also, it may not be wise
to single out seafood for the application of HACCP at retail. Retail
operations can be complex and involve the handling of many types of
foods. Trying to operate a HACCP system solely for seafood could divert
attention away from important safety practices for high-risk products
other than seafood.
For all these reasons, therefore, the agency concludes that FDA
should not mandate HACCP systems for the seafood component of retail
establishments at this time. Also, the agency has not been provided
with any information on how an FDA inspection program for such
establishments would be feasible. Nonetheless, the agency will take all
comments on retail establishments under advisement for future
consideration as the system evolves.
It is important to note, however, that where a processor engages in
mixed operations (i.e., some retail and some wholesale), as in the case
of cash-and-carry warehouses noted by one of the comments, the
wholesale portion of the operations will be subject to the provisions
of these regulations. As a further point of clarification in response
to one comment, FDA has traditionally, and will continue to, classify
central kitchens that distribute product to retail outlets that are
owned by the same firm as a retail operation.
b. Warehouses. In the preamble to the proposed regulations FDA
stated that the definition of ``processor'' included warehouses.
Warehouses store fish and fishery products, one of the operations
included in the proposed definition of ``processing.'' A ``processor''
is simply an entity that engages in processing.
There are food safety hazards that can be introduced while storing
a product (e.g., in a warehouse). These hazards include, among other
things, pathogen growth in cooked, ready-to-eat products and histamine
development in scombroid toxin-forming species, as a result of improper
storage temperatures. Nonetheless, the warehouse environment usually
has few hazards compared to complex processing operations.
Consequently, the preamble to the proposed regulations invited comment
on whether warehouses should be exempted from the definition of
``processor'' and, by implication, whether ``storing'' should not be
included in the definition of ``processing,'' as one way of scaling the
regulations back in terms of cost and burden.
37. The comments split about evenly on this subject. Those that
gave a reason for including warehouses cited the need to monitor
storage temperatures for species that are prone to safety hazards if
they are temperature abused. Those that opposed and provided a reason
tended to argue that storage alone should not subject an establishment
to the requirements of the regulations. A related concern was the view
that warehouse operators do not have a thorough knowledge of the
products that they handle and only store products that are provided to
them by others. This concern was expressed both by those who objected
to the inclusion of warehouses and those who simply asked for
clarification about the role of warehouses. Others who asked for
clarification expressed the view that warehouses could be responsible
for conditions during storage.
After consideration of these comments, FDA has decided to retain
warehouses (e.g., public storage warehouses, foodservice distribution
warehouses, and wholesale grocers) within the definition of
``processor'' and to retain ``storing'' within the definition of
``processing.'' It is important to recognize that section 402(a)(4) of
the act covers storage along with other forms of processing. It states
that a product is adulterated if it is ``prepared, packed, or held
under unsanitary conditions * * * whereby it may have been rendered
injurious to health.'' These regulations are being issued for the
efficient enforcement of section 402(a)(4) of the act. Moreover, as
described above, hazards can be introduced as well as controlled during
storage. HACCP is an appropriate system for the control of these
hazards.
FDA believes that the burden on warehouses will be minimal given
the simplicity of the operation and the fact that, in most cases, a
warehouseman's responsibility under HACCP will only extend to
conditions within the warehouse that could cause a safety hazard to
occur.
For the most part, hazards deriving from the environment
(pesticides, etc.) will be controlled during the initial processing of
the product (i.e., by the first processor to take possession). As a
result, subsequent processors will receive products that are generally
free of environmental hazards and thus will not need to establish HACCP
controls for them. More often than not, storing will not be the first
processing operation. Thus, a warehouse will not usually be responsible
for environmental hazards. The same principle holds true for hazards
arising during processing operations that occur before storage in a
warehouse. Those hazards must be controlled during the prior processing
and generally not during storage.
There may be occasions, however, when storage is the first
processing operation (e.g., when a warehouse will be the first
processor to receive raw material fish from a fisherman or aquacultural
producer). Under these circumstances, the warehouse, rather than a
distant owner of the product, may be in the best position to obtain
information that may be needed about harvest site, fishing practices,
and transportation to the dock that would be germane to safety. There
should be some arrangement between the warehouse and the owner on this
matter to ensure that environmental hazards are properly addressed.
38. One comment objected to the inclusion of storage within the
definition of processing on the grounds that FDA should not dictate
where CCP's should be.
The agency is not attempting to do so. FDA acknowledges that
whether storage is a CCP will depend on the circumstances. For example,
refrigerated storage of a scombroid species will likely be designated
as a CCP, whereas dry storage of canned fish will not likely be
considered as such.
39. Another comment objected to including ``airline warehousing''
within these regulations.
If airlines hold product as part of their usual course of business
as carriers, they are exempt from having HACCP plans in accordance with
section 703 of the act.
c. Other processing operations. 40. A few comments requested
clarification on whether waterfront facilities that unload vessels and
pack the catch for shipment to buyers are engaging in processing and
thus meet the definition of ``processor.''
These firms perform activities such as handling and storing that
are included in the definition of processing and fall within the
purview of the ``prepared, packed, or held'' clause of section
402(a)(4) of the act. Additionally, these activities warrant coverage
under these regulations because of their relationship to reasonably
likely hazards. For example, these firms are, by design, usually the
first processors to receive
Page 65115
the product from the fisherman or aquacultural producer. As such, they
are often in the best position to control environmental hazards, as was
previously discussed. They also often store the product, at least for
short periods of time. In this capacity, they may be responsible for
ensuring that the product is not exposed to time- temperature abuse, a
phenomenon that critically affects the safety of some products.
For these reasons, FDA has clarified the definition of
``processing'' at proposed Sec. 123.3(m) (redesignated as
Sec. 123.3(k)) to specifically include dockside unloading.
41. One comment took the view that only processors who own the
products that they are processing should be subject to these
regulations and suggested that the term ``processor-owner'' be
substituted for ``processor.'' Several other comments questioned
whether custom processors that do not own the product, should be
subject to the provisions of these regulations.
The definition of ``processor'' does not hinge on ownership. As
indicated earlier, whether a product is adulterated under section
402(a)(4) of the act depends on the condition under which it was
``prepared, packed, or held.'' Ownership is not a relevant factor.
Consistent with this principle, these regulations define a processor as
simply an entity that engages in processing. ``Processing'' is defined
as including a number of activities, such as manufacturing and packing,
that are normally performed by a custom packer.
Like warehouses that store products for distant owners, custom
packers are often in the best position to exercise HACCP controls for
the products that they process. Because of the real-time nature of
HACCP (i.e., because monitoring provides immediate feedback as to
whether a hazard is being controlled), the processor can most
effectively apply HACCP monitoring controls to a food being processed,
regardless of whether the processor is the actual owner of the food.
FDA recognizes that it will often be beneficial for the custom
processor and the owner of the product to fully discuss and agree upon
the HACCP controls that will be effected by the custom processor while
the product is in its possession.
42. One comment argued that custom packers should be included
within the scope of these regulations because these processors often
can or smoke recreationally caught products and are often the only
commercial entity that can assure the safety of such products. While
the definition of ``processing'' clearly covers the kinds of activities
performed by custom packers, it is not the intent of these regulations
to address arrangements between a recreational fisherman and a custom
packer for the processing of fish for the personal use of the
fisherman. The regulations only cover custom packing that is performed
on behalf of an owner who intends to introduce the fish into interstate
commerce. Nonetheless, the agency does not believe that clarification
to the regulations is needed on this point.
43. One comment urged that aquacultural producers that also
eviscerate the fish before delivery to a processing plant be required
to comply with the requirements of these regulations.
FDA agrees with the comment and further states that the process of
eviscerating is specifically included in the definition of
``processing.'' Eviscerating is excluded from the definition only when
it occurs on a harvest vessel for the purpose of preparing the fish for
holding en route to the processor.
44. A few comments objected to FDA including labeling in the
definition of ``processing.'' The comments argued that labeling
operations are unlikely to introduce hazards to the product. FDA has
considered these comments but finds that there is potential during some
labeling operations for the development of hazards. For example,
improperly controlled labeling operations for scombroid species could
result in time-temperature abuse of the product, increasing the risk of
histamine contamination. Cooked, ready-to-eat products could similarly
be subjected to time-temperature abuse, resulting in the potential for
pathogen growth. The inclusion of labeling in the list of processing
operations is not intended to imply that this step should always, or
even frequently, be considered a CCP. That can only be determined
through the conduct of a hazard analysis.
FDA proposed to exempt ``heading or gutting intended solely to
prepare a fish for holding on board a harvest vessel'' from the
definition of ``processing.'' In drafting the proposed regulations, FDA
was concerned that, in the absence of such an exemption, harvest
vessels that are presently heading or gutting fish would stop the
practice to avoid being subject to the requirements of these
regulations. FDA did not want an inadvertent consequence of these
regulations to be a reduction in product quality. In addition, FDA
tentatively concluded that safety hazards introduced by these
operations are generally minimal.
45. One comment noted that FDA should include the practice of
freezing fish on harvest vessels in the list of exempted operations.
FDA agrees that freezing is an operation that is routinely used
onboard a harvest vessel in order to preserve the quality of the fish
until it is landed for further processing (e.g., freezing performed
onboard tuna harvesting vessels). For this reason, the agency has
revised the definition of ``processing'' to include an exemption for
onboard freezing.
46. One comment suggested that FDA also exempt onboard scallop
shucking operations.
Unlike shucking other molluscan shellfish, shucking scallops
involves eviscerating, a procedure that falls within the exemption in
Sec. 123.3(k). Consequently, onboard shucking of scallops does not
constitute processing for purposes of these regulations. The agency
does not believe that a change in the definition is necessary in this
regard.
47. One comment suggested that, with respect to molluscan
shellfish, ``processors'' should include shellfish shippers,
reshippers, shucker-packers, repackers, and depurators.
The persons that perform all of these types of operations are
``processors'' under Sec. 123.3(k)(1) and subject to the provisions of
these regulations. Thus, the agency has concluded that no change in the
definition is necessary.
16. Scombroid Toxin-Forming Species
The term ``scombroid toxin-forming species'' appears in
Sec. 123.6(c)(1)(vi) of this final rule. While FDA did not propose to
define this term in the codified portion of the proposed regulations,
it did propose to define it in part 123 appendix B as:
T una, bluefish, mahi mahi, mackerel, sardines, herring,
kahawai, anchovies, marlin, and other species, whether or not of the
family Scombridae, in which significant levels of histamine may be
produced in the fish flesh by decarboxylation of free histidine as a
result of exposure of the fish after capture to temperatures that
permit the growth of mesophilic bacteria.
Appendix B of part 123 is no longer included in these regulations, as
is discussed elsewhere in this preamble. Consequently, FDA is
transferring the definition from part 123 appendix B to Sec. 123.3(m)
to clarify the meaning of Sec. 123.6(c)(1)(vi).
48. A number of comments objected to the inclusion of herring in
the list of scombroid toxin-forming species, arguing that there has
been no association between herring and cases of histamine poisoning.
In response to the comments, FDA has modified the definition of
scombroid
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toxin forming species to make specific reference to only tuna,
bluefish, and mahi mahi, since the overwhelming majority of scombroid
poisonings are associated with these types of fish. Processors should
assess the potential of other species to product histamine. The key to
the definition is whether significant levels of histamine may be
produced in the flesh of the fish.
17. Shellfish Control Authority
FDA proposed to define ``shellfish control authority'' as ``a
Federal or State health authority, or foreign government health
authority, legally responsible for the administration of a program that
includes classification of molluscan shellfish growing areas,
enforcement of harvesting controls, and certification of molluscan
shellfish processors.''
49. A few comments pointed out that the definition should not
require that a shellfish control authority be a State ``health''
authority because in some States the responsibility is vested in other
than a health agency, such as a resource management agency.
FDA recognizes that these comments are correct. For this reason,
the agency has modified the language in Sec. 123.3(o) to read, in part,
``State agency.'' FDA believes that this term is sufficiently broad to
encompass any of the present State arrangements. FDA has made a
parallel change with respect to foreign government authorities, in
order to accommodate the same kind of variations in regulatory
arrangements. These final regulations similarly refer to a ``foreign
agency.''
50. One comment, from a State regulatory agency, stated that within
the United States, FDA should be the responsible shellfish control
authority and should mandate that processors register with FDA, much as
it has done with low-acid canned foods and medical devices. The comment
further stated that a requirement in Federal regulations that State
agencies perform this function may be unconstitutional.
The comment misconstrued the provision. The provision is intended
to define the term ``shellfish control authority'' rather than to
provide substantive requirements. Furthermore, these regulations at no
point mandate that States perform certain functions.
51. Some comments expressed concern that the proposed definition of
``shellfish control authority'' was too narrow in that it did not
include any entities that could serve the function of a shellfish
control authority for Federal waters. The effect of the proposal, the
comments pointed out, would be to close unnecessarily all molluscan
shellfish harvesting in Federal waters.
It was never FDA's intent to close Federal waters to molluscan
shellfish harvesting. These waters are beyond the jurisdiction of State
shellfish control authorities, and no Federal agency classifies them in
the same way that States classify their own waters. FDA is seeking a
means to classify Federal waters. An agreement with NMFS relating to
the classification of Federal waters is one possible solution. For this
reason, FDA has modified proposed Sec. 123.3(o) to state that a
shellfish control authority may be ``a Federal agency.'' This subject
is also discussed in the ``Molluscan Shellfish'' section of this
preamble.
52. One comment urged that FDA provide for the possibility of
sovereign tribal governments serving as shellfish control authorities.
FDA recognizes that the proposed definition was deficient because
it failed to include tribal governments in the list of possible
shellfish control authorities. The agency, the State of Washington, and
19 Indian tribes have recently entered into a settlement that will
likely result in such an arrangement in the State of Washington (Ref.
202). When such governments meet the necessary criteria, it is the
intent of the agency to formally recognize them for purposes of
classifying shellfish growing waters and certifying shellfish
processing plants for inclusion on the Interstate Certified Shellfish
Shippers List. To provide for this situation, FDA has modified the
definition of ``shellfish control authority'' to include ``sovereign
tribal governments.''
FDA has also recognized that in many cases the functions of
``classification of molluscan shellfish growing areas, enforcement of
harvesting controls, and certification of molluscan shellfish,'' as
listed in the proposed regulations, are not carried out by a single
agency. To provide for such a situation, FDA has modified the proposed
language at Sec. 123.3(o) to read, ``program that includes activities
such as,'' rather than simply ``program that includes.''
18. Smoked and Smoke-Flavored Fishery Products
The terms such as ``smoked fishery products,'' ``smoked fish,''
``smoked and smoke-flavored fishery products'' were used in the
proposed regulations and throughout appendix 1 to the proposal. As a
result of decisions discussed elsewhere in this preamble, reference to
``smoked and smoke-flavored fishery products'' has been eliminated in
these regulations except in part 123, subpart B.
While no definition of ``smoked and smoke-flavored fishery
products'' was included in the definitions section of the proposed
regulations, the terms ``smoke-flavored fish'' and ``smoked fish'' were
separately defined in appendix 1 to the proposal as: ``Smoked-flavored
fish means fish that is prepared by treating it with salt (sodium
chloride) and then imparting to it the flavor of smoke by other than
the direct action of smoke, such as immersing it in a solution of
liquid smoke,'' and ``Smoked fish means fish that is prepared by
treating it with salt (sodium chloride) and then subjecting it to the
direct action of smoke from burning wood, sawdust, or similar
material.'' FDA solicited comment on the materials in appendix 1.
Because the term is used in these final regulations and FDA is
concerned that there may be confusion about its application, the agency
has determined that a definition of ``smoked and smoke-flavored fishery
products'' is needed in the codified portion of these regulations. FDA
has included one at Sec. 123.3(s) that is consistent with those
proposed in the appendix 1 to the proposal. Section Sec. 123.3(s)
reads:
Smoked or smoke-flavored fishery products means the finished
food prepared by: (1) Treating fish with salt (sodium chloride), and
(2) subjecting it to the direct action of smoke from burning wood,
sawdust, or similar material and/or imparting to it the flavor of
smoke by a means such as immersing it in a solution of wood smoke.
FDA received numerous comments on the regulatory treatment of smoked
and smoke-flavored fishery products, but none that would affect this
definition.
E. The HACCP Plan
Approximately 100 comments addressed one or more of the provisions
of proposed Sec. 123.6. This section of the proposed regulations set
out who must write and implement a HACCP plan, and what the HACCP plan
must include.
1. Preliminary Steps
FDA proposed in Sec. 123.6 to require that all processors of fish
and fishery products prepare and implement a HACCP plan that identifies
the hazards that are reasonably likely to occur and thus that must be
controlled for that product. In the proposal, FDA acknowledged the
process recommended by the NACMCF for developing a HACCP plan but did
not propose to require that processors follow it. The process
recommended by the NACMCF includes: Assembling a HACCP team, describing
the food and its distribution, identifying the intended use and
consumers of the food, developing a flow diagram, verifying the
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flow diagram, and performing a hazard analysis (Ref. 34, pp. 187-188).
All but the last of these have been identified by NACMCF as the ``five
preliminary steps'' of HACCP.
It was, and still is, the agency's belief that processors would
benefit from a process that included these five steps as well as a
hazard analysis in order to successfully arrive at an appropriate HACCP
plan. Nonetheless, the agency did not propose to require adherence to
the ``five preliminary steps,'' or explicitly propose to require that a
hazard analysis be performed. So long as the processor had, in the end,
a HACCP system that was appropriate for species and process, and was
being implemented effectively, the agency tentatively concluded that
these regulations did not need to manage the process any further.
53. A number of the comments contended that FDA should require that
firms adhere to these procedures in preparing a HACCP plan.
Specifically, a few comments argued that the proposed rule
significantly diminished the potential effectiveness of HACCP by not
requiring that processors engage in the ``five preliminary steps.'' The
comments argued that inclusion of the preliminary steps would
facilitate international trade and reduce confusion on the part of
seafood importers and exporters through consistency with an
internationally recognized standard for HACCP.
Several other comments urged that the NACMCF recommendation for the
development of a process flow diagram, in particular, by a processor be
made mandatory. These comments identified several benefits from such a
requirement: To facilitate employee implementation of the plan, to
facilitate processor verification activities, to reduce the time needed
for regulators to review the manufacturing process, and to enable the
regulator to determine whether the processor properly considered the
entire manufacturing process. One comment stated that FDA's assumption
that flow diagrams are burdensome or unnecessary is contrary to the
1992 NACMCF Report which notes that flow diagrams could be simple
representations that accurately depict the steps in a process, rather
than detailed, technical drawings.
FDA acknowledges that, for the reasons stated in the comments, many
processors will find that the development of a flow diagram is a useful
preliminary step to the preparation of a HACCP plan. Other processors
may find, however, that, because of the simplicity of their operations,
the preparation of a written flow diagram is an unnecessary step. In
either case, FDA is convinced that a processor's decision to develop or
not to develop a flow diagram will be, and should be, driven by its
perception of the benefits of doing so. The comments received on this
subject were not sufficiently persuasive for the agency to conclude
that a flow diagram should be made mandatory. The comments provided no
basis to find that in the absence of a flow diagram, a processor could
not properly develop a HACCP plan, or that a plan, so developed, would
likely cause the HACCP program to fail.
As some of the comments pointed out, there may be some benefit to
the regulator to have access to a flow diagram during an inspection,
but this convenience is not a sufficient reason to mandate it. FDA
investigators will likely develop their own flow diagrams during their
in-plant inspections and compare them with the decisions reached by the
processor in the development of the HACCP plan (e.g., the
identification of hazards and CCP's). While it may be beneficial for
the investigator to be able to compare his or her flow diagram with
that of the processor, it is not essential to the conduct of the
inspection.
FDA agrees with the comments that stated that the other four
elements of the ``five preliminary steps'' are desirable attributes of
the HACCP development process. However, the agency has not been
persuaded that, in the absence of a regulatory requirement that they be
followed, the HACCP program is unlikely to succeed. In order to write
an appropriate plan some or all of these steps will likely have to be
performed, even without a regulatory requirement to do so. However, if
a processor can write a plan without these steps, the goals of the
regulations will still have been met. For FDA to require them to be
performed and documented in every case would add burden and reduce
flexibility unnecessarily. Moreover, FDA is unconvinced that any
inhibition to foreign trade is likely to occur if adherence to these
steps is not required. FDA believes that foreign trading partners will
be satisfied by the presence of a successful HACCP system and will not
reject U.S. exports because steps preliminary to HACCP were not
documented.
Even without a requirement mandating specific preliminary steps,
FDA believes that most processors will follow the spirit, if not 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
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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
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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
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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
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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.
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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
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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
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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.
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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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
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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
processor to control such hazards.
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,
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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
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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
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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)
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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.
Part II, Preamble, pp. 65152-65197