[Federal Register Volume 76, Number 82 (Thursday, April 28, 2011)]
[Pages 23823-23824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10234]



Food and Drug Administration

[Docket No. FDA-2011-D-0287]

Guidance for Industry on Fish and Fishery Products Hazards and 
Controls, Fourth Edition; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Fish and Fishery 
Products Hazards and Controls Guidance, Fourth Edition.'' The updated 
guidance supports and complements FDA's regulations for the safe and 
sanitary processing and importing of fish and fishery products using 
hazard analysis and critical control point (HACCP) methods.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Contact the Florida Sea Grant, IFAS-Extension Bookstore, 
University of Florida, P.O. Box 110011, Gainesville, FL 32611-0011, 1-
800-226-1764, for single copies of this guidance. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Bruce F. Wilson, Center for Food 
Safety and Applied Nutrition (HFS-325), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2300.


I. Background

    FDA is announcing the availability of the guidance for industry 
entitled ``Fish and Fishery Products Hazards and Controls Guidance, 
Fourth Edition.'' This guidance is being issued consistent with FDA's 
good guidance practices (GGP) regulation (Sec.  10.115 (21 CFR 
10.115)). This guidance is being implemented without prior public 
comment because the Agency has determined that prior public 
participation is not feasible or appropriate (Sec.  10.115(g)(2)). The 
Agency made this determination because the updated information in this 
guidance will significantly enhance the seafood industry's ability to 
protect the public health and will provide important recommendations 
for conducting a hazard analysis and implementing a HACCP plan. 
Although this guidance document is immediately in effect, it remains 
subject to comment in accordance with the Agency's GGP regulation.
    This guidance provides industry with information that will assist 
processors of seafood products in identifying the likelihood that a 
food safety hazard may occur in their product and will guide them in 
the preparation of appropriate HACCP plans for those hazards that are 
reasonably likely to occur. A summary of the changes from the third 
edition is included in the discussion section of the guidance.
    Under FDA's fish and fishery products regulations (part 123 (21 CFR 
part 123)), processors of fish and fishery products are required to 
operate preventive control systems under the principles of HACCP. Fish 
and fishery products are adulterated under section 402(a)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(4)) if a 
processor fails to have and implement a HACCP plan when one is 

[[Page 23824]]

(Sec.  123.6(g)) or otherwise fails to meet any of the requirements of 
the fish and fishery products regulations (part 123).
    FDA published the first edition of the guidance in September 1996 
(about 1 year before the fish and fishery products regulations became 
effective), issued the second edition in January 1998, and issued the 
third edition in June 2001. In February 2008, FDA updated the third 
edition to include ciguatera fish poisoning guidance for northern Gulf 
of Mexico processors and seafood processors that purchase grouper, 
amberjack, and related predatory reef species captured from the 
northern Gulf of Mexico. On January 4, 2011, the President signed into 
law the FDA Food Safety Modernization Act (FSMA) (Pub. L 111-353). 
Section 103(h) of FSMA requires FDA to update the Fish and Fisheries 
Products Hazard and Control Guidance within 180 days to take into 
account advances in technology. This updated guidance satisfies the 
requirements of section 103(h). The guidance provides 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.
    There are a number of important changes to this edition of the 
HACCP guidance. For example, a new chapter has been added containing 
guidance for the control of pathogen survival through processes 
designed to retain raw product characteristics; food safety hazards are 
identified for additional species; new control recommendations are 
listed for the natural toxin action level for diarrhetic shellfish 
poisoning; and tolerances for additional chemical hazards are listed.
    The guidance represents the Agency's current thinking on fish and 
fishery products hazards and controls. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternate approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    The guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 123.6(a), (b), (c), (c)(5), and (c)(7), 
123.7(d), 123.8(a)(1), (c), and (d), 123.11(c), 123.12(a)(2), 
(a)(2)(ii), and (c) have been approved under OMB control number 0910-

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/UCM251970.pdf or http://www.regulations.gov. Always access an FDA 
document by using the FDA Web site listed previously to find the most 
current version of the guidance.

    Dated: April 22, 2011,
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10234 Filed 4-27-11; 8:45 am]