[Federal Register Volume 66, Number 167 (Tuesday, August 28, 2001)]
[Notices]
[Pages 45318-45319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21624]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 93N-0195]


Guidance for Industry: Fish and Fishery Products Hazards and 
Controls Guidance, Third Edition; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the revised guidance for industry (third edition) 
entitled ``Fish and Fishery Products Hazards and Controls Guidance'' 
(the guidance). The guidance supports and complements FDA regulations 
for the safe and sanitary processing and importing of fish and fishery 
products using hazard analysis and critical control point (HACCP) 
methods. The guidance represents the agency's current views on 
potential hazards in seafood products and how to control them, and it 
is designed to assist seafood processors in the development of HACCP 
plans. The guidance is revised about every 2 years to address comments 
and to reflect our current understanding of seafood hazards and control 
methods.

DATES: General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written comments on the guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers

[[Page 45319]]

Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments. Submit written requests for 
single copies of the guidance to the Office of Seafood (HFS-415), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW., Washington DC 20204. Send one-self 
adhesive address label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Anthony P. Brunetti, Center for Food 
Safety and Applied Nutrition (HFS-415), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3150.

SUPPLEMENTARY INFORMATION:

I. Background

    We (FDA) are announcing the availability of the third edition of 
the ``Fish and Fishery Products Hazards and Controls Guidance'' (the 
guidance). A summary of the changes incorporated in the third edition 
are listed in the introduction of the guidance.
    Under our HACCP regulations at parts 123 and 1240 (21 CFR parts 123 
and 1240) processors and importers of fish and fishery products are 
required to operate preventive control systems that incorporate the 
principles of HACCP. Under Sec. 123.6(g), fish and fishery products are 
adulterated under section 402(a)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342) if a processor or importer fails to have 
and implement a HACCP plan when one is necessary, or otherwise fails to 
meet any of the requirements of the regulations. The primary purpose of 
the guidance is to help processors and importers of seafood products 
identify the likelihood that a food safety hazard may occur in their 
product, and to guide them in the preparation of appropriate HACCP 
plans for those hazards that are reasonably likely to occur.
    We published the first edition of the guidance in September 1996, 
about 1 year before the seafood HACCP regulations became effective, and 
issued the second edition in January 1998. The guidance describes 
current information relating to: (1) Potential hazards associated with 
the known commercial species of vertebrate and invertebrate seafood; 
(2) potential hazards associated with certain processing operations; 
(3) HACCP strategies that may be used to control the potential hazards; 
and (4) other information related to food safety.
    FDA is not seeking public comment before implementing this edition 
of the guidance because we have determined that it is not feasible or 
appropriate in accordance with 21 CFR 10.115(g)(2). We revise this 
guidance relatively frequently to keep it up-to-date. When revising 
each edition, we consider both any formal comments received on the 
previous edition and informal feedback obtained from our HACCP 
inspections. Thus, each edition is effectively a ``draft'' for the next 
edition and each new addition has the benefit of significant up-to-date 
public comment.
    The guidance represents the agency's current thinking on the 
potential hazards that are associated with various seafood species and 
certain processing operations, and how their occurrence can be avoided 
with HACCP controls when they are reasonably likely to occur, as 
required under parts 123 and 1240 (pertaining to the safe and sanitary 
processing of fish and fishery products). It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute and regulations.

II. Electronic Access

    Copies of this guidance for industry are available on the Internet 
at http://vm.cfsan.fda.gov/~dms/guidance.html.

    Dated: August 20, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-21624 Filed 8-27-01; 8:45 am]
BILLING CODE 4160-01-S