[Federal Register Volume 62, Number 33 (Wednesday, February 19, 1997)]
[Notices]
[Pages 7465-7467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4022]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93F-0195]
Fish and Fishery Products Hazards and Controls Guide;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
[[Page 7466]]
availability of the first edition of the ``Fish and Fishery Products
Hazards and Controls Guide'' (the guide). FDA has prepared the guide
as, among other things, an adjunct to the regulations it issued on the
safe and sanitary processing and importing of fish and fishery products
using Hazard Analysis and Critical Control Point (HACCP) methodology.
DATES: Submit written comments on the guide by May 20, 1997. Comments
received after that date will be considered for subsequent editions.
ADDRESSES: Submit written requests for single copies of the guide to
the Office of Seafood (HFS-400), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3133. The guide may also be
obtained from FDA district offices (contact Donald Kraemer (address
below) for FDA district office addresses). Send two self-addressed
adhesive labels to assist those offices in processing your requests.
Copies of the guide on diskette (in WordPerfect 6.0) may be ordered for
$30.00 each, plus handling, from the National Technical Information
Service (NTIS), U.S. Department of Commerce, by calling 703-487-4650
and requesting PB96-503180. Paper copies may be ordered for $30.00
each, plus handling, by requesting PB 96-207337. The diskette and paper
copies may be ordered as a set for $50.00, plus handling, by requesting
PB96-207329. Payment may be made by charge card (American Express,
VISA, or Mastercard), check, money order, or other billing arrangements
made with NTIS. Rush orders may be placed by calling 800-553-NTIS.
Persons with access to the Internet may obtain the guide via the World
Wide Web at FDA's web site (http://www.fda.gov) by selecting ``Foods''
and then selecting ``HACCP.'' Alternately, it may be accessed directly
at http://www.cfsan.fda.gov/lrd/haccpsub.html.
The guide is also being issued as a companion document to the
``HACCP: Hazard Analysis Critical Control Point Training Curriculum''
(the training document), which was developed by the Seafood HACCP
Alliance for Training and Education (the Alliance). The Alliance is an
organization of Federal and State regulators, including FDA, academia,
and food industry trade associations. FDA encourages processors of fish
and fishery products to use the two documents together in the
development of their HACCP systems. Copies of the training document and
the guide may be obtained from North Carolina Sea Grant, North Carolina
State University, P.O. Box 8605, Raleigh, NC 27695, 919-515-2454. The
cost for both of these documents is $35.00, payable by check or money
order to ``N.C. Sea Grant.'' Submit written comments on the guide to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Requests and
comments should be identified with the docket number found in brackets
in the heading of this document. The guide and received comments are
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Donald W. Kraemer, Center for Food
Safety and Applied Nutrition (HFS-400), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3160.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 18, 1995
(60 FR 65096), FDA published a final rule entitled ``Procedures for the
Safe and Sanitary Processing and Importing of Fish and Fishery
Products,'' which requires that HACCP principles be applied in the
commercial processing of fish and fishery products for distribution in
interstate commerce. HACCP involves: (1) The identification of food
safety hazards that are reasonably likely to occur in a particular
product; (2) the selection of the appropriate control measures to
reduce the risk of occurrence of these hazards; and (3) the preparation
of a HACCP plan that sets out how these measures will be applied.
To aid processors in responding to the new requirements and in
developing their HACCP plans, FDA has developed the guide. The controls
and practices provided in the guide are, for the most part,
recommendations and guidance to the fish and fishery products industry.
The guide provides information that will likely result in a HACCP plan
that is acceptable to FDA under ordinary circumstances. However, the
guide is in no way a binding set of requirements. Processors may choose
to use other control measures, provided that they provide an equivalent
degree of assurance that the product will be safe. Nor is the guide a
substitute for the performance of a hazard analysis by a processor of
fish or fishery products, as required by FDA's regulations. A hazard
analysis is an assessment of what, if any, food safety hazards are
reasonably likely to occur in a product being produced by a specific
processor, and whether those hazards can be controlled by that
processor. While the guide contains FDA's best advice for most ordinary
circumstances, it does not cover every situation. For example, hazards
not covered by the guide may be relevant to certain products in certain
circumstances. In particular, processors should be alert to new or
emerging problems (e.g., the occurrence of natural toxins in fish not
previously associated with that toxin).
In the Federal Register of March 18, 1994 (59 FR 12949), FDA
published a notice of availability of a draft version of the guide (the
draft guide) and requested comments on it. The agency has carefully
reviewed the comments it received. Based on these comments, FDA has
made significant changes in the format and content of the guide. Given
the magnitude of the changes, FDA believes that additional comment by
the public would be useful.
A number of comments stated that, while the draft guide provided
useful information on fish and fishery products hazards and controls,
it did not adequately explain how to develop a HACCP plan on the basis
of this information.
In response to these comments, the agency has revised the guide to
provide a step-by-step procedure for the preparation of a HACCP plan.
The agency has tried to provide information that will help the
processor answer questions that are likely to arise during this
process.
To further facilitate HACCP plan development, the guide provides
samples of key portions of HACCP plans for each of the categories of
hazards that are discussed. The guide also contains a fill-in-the-blank
HACCP plan and a blank hazard analysis worksheet that may be used by
processors.
Many comments stressed that the draft guide unnecessarily
restricted their flexibility in developing hazard control strategies
that were uniquely tailored to their operations. It did so, they
contended, by limiting its advice to only one or a few control
strategies per hazard even though other strategies may also exist,
depending upon the circumstances.
It was never the intent of the guide to limit a processor's
flexibility to only the control strategies provided in the guide. The
agency could not realistically provide advice on every valid control
strategy that might be available under every circumstance. Nonetheless,
the guide is intended to be as inclusive as is reasonably possible
about known control strategies. Therefore, FDA has revised the guide to
provide more control strategy examples than were provided in the draft
guide. For example, the guide includes
[[Page 7467]]
recommended maximum exposure times for temperature-sensitive fishery
products for a variety of exposure temperatures and target pathogens,
rather than one ``rule-of-thumb'' maximum exposure time, as was the
case in the draft guide.
The agency recognizes, however, that the inclusion of more control
strategies greatly lengthens the guide and could make it more difficult
for the smaller, less sophisticated processor to use. FDA specifically
invites comment on whether this will in fact be the case and on whether
the agency should attempt to develop an abbreviated version of the
guide for those who might benefit from it.
The guide includes tables of potential food safety hazards that may
be associated with the hundreds of species of fish (vertebrate and
invertebrate), as well as the numerous product forms (e.g., breaded,
cooked, raw), that are commercially marketed in the United States.
These tables are designed to aid the processor in the performance of
the hazard analysis.
A separate chapter is devoted to each category of hazard (e.g.,
parasites, natural toxins, pathogen growth, metal fragments). Each
chapter includes the steps necessary to complete the hazard analysis
and, ultimately, the HACCP plan for that hazard. These steps include:
(1) Understanding the potential hazard; (2) determining whether the
potential hazard is significant and must therefore be controlled; (3)
identifying the critical control points, where the hazard can best be
controlled; (4) setting the critical limits, to which the operation
must be held at the critical control points; (5) establishing the
monitoring procedures, to ensure that the critical limits are
consistently being met; (6) establishing corrective action procedures
for when the critical limit is not met; (7) establishing a
recordkeeping system to document the performance of the monitoring,
corrective action, and verification procedures; and (8) establishing
verification procedures.
There are two areas that were addressed in the draft guide but are
not included in the first edition because they are the subject of
policy reevaluation by FDA. The agency will update the guide in these
areas when the policy reevaluation is complete.
The first of these areas involves the chemical methyl mercury. A
number of comments objected to the testing regimen that the draft guide
recommended for the control of the methyl mercury hazard in certain
species of fish. The agency's recommendation was based on the 1.0 part
per million action level for methyl mercury. While FDA has not changed
this action level, the agency is reevaluating its policy in light of
significant new data on the health effects of methyl mercury from
consumption of fish that have become available since the action level
was developed.
One other area in which the guidance contained in the guide is
incomplete is the hazard of pathogens in raw fish and fishery products
that are intended to be cooked by the consumer or end user. FDA policy
identifies pathogens in such products as adulterants under the Federal
Food, Drug, and Cosmetic Act. FDA is still evaluating what would
constitute an appropriate hazard analysis, and what would constitute
the appropriate HACCP controls for these products. The agency welcomes
comment on this subject.
FDA expects that its reevaluation of the methyl mercury action
level and its pathogen policy will be completed before the effective
date of the regulations. When the reevaluation is completed, FDA will,
among other things, update the guide by including advice on how to
assess the significance of these potential hazards, and what controls,
if any, are necessary to ensure the safety of fish.
The guide, which provides advice on how to prepare a HACCP plan
when a plan is required by 21 CFR part 123, should be used until
superseded by a subsequent edition. Although this guidance does not
create or confer any rights, for or on any person, and does not operate
to bind FDA, it does represent the agency's best thinking on how to
prepare a HACCP plan for the processing of fish and fishery products.
Interested persons may, on or before May 20, 1997, submit to the
Dockets Management Branch (address above) written comments on the guide
for consideration in the preparation of the second edition of the
guide. Comments received after that date will be considered for
subsequent editions. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. The guide and received comments may be seen in the
office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 11, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-4022 Filed 2-18-97; 8:45 am]
BILLING CODE 4160-01-F
