[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]


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

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.

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

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/<difference>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