[Federal Register Volume 73, Number 139 (Friday, July 18, 2008)]
[Notices]
[Pages 41361-41362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0264]


Draft Compliance Policy Guide Sec. 540.370 Fish and Fishery 
Products -- Decomposition; 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 draft Compliance Policy Guide Sec. 540.370 Fish and 
Fishery Products -- Decomposition (the draft CPG). The draft CPG, when 
final, will provide FDA staff with current regulatory action guidance 
relating to decomposition in fish and fishery products.

DATES: Although you can comment on any CPG at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on the 
draft CPG before it begins work on the final version of the CPG, submit 
written or electronic comments on the draft CPG by September 16, 2008.

ADDRESSES:  Submit written requests for single copies of the draft CPG 
to the Division of Compliance Policy (HFC-230), Office of Enforcement, 
Office of Regulatory Affairs, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 240-632-6861. Submit written comments on the draft CPG to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http//www.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
CPG.

FOR FURTHER INFORMATION CONTACT: Robert D. Samuels, Center for Food 
Safety and Applied Nutrition (HFS-325), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-2300.

SUPPLEMENTARY INFORMATION:

I. Background

    The draft CPG is intended to provide guidance to FDA staff for 
taking enforcement actions when fish and fishery products are 
adulterated under section 402(a)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 USC. 342(a)(3)), in that they consist in whole or in 
part of a decomposed substance. The draft CPG provides regulatory 
action guidance relating to FDA's direct reference enforcement policy 
on decomposition in fish and fishery products. The draft describes a 
two-class, pass/fail evaluating approach for detecting the presence of 
decomposition by sensory or chemical analysis.
    The draft CPG, when final, will replace the following withdrawn and 
revoked CPGs relating to decomposition in fish and shrimp:
    1. CPG Sec. 540.575 -- Fish - Fresh and Frozen -- Adulteration 
Involving Decomposition (CPG 7108.05). See the notice of withdrawal 
published elsewhere in this issue of the Federal Register.
    2. CPG Sec. 560.650 Canned and Cooked/Frozen Shrimp -- Adulterated 
by Decomposition (CPG 7119.13), revoked on July 5, 1995 (60 FR 35038).
    3. CPG Sec. 540.400 Shrimp - Fresh or Frozen, Raw, Headless, Peeled 
or Breaded - Adulteration Involving Decomposition (CPG 7108.11), 
revoked December 24, 1996 (61 FR 67837).
    The draft CPG applies a more consistent sampling and sample 
evaluation process to a broader spectrum of fishery products. Some of 
the revoked CPGs provided regulatory action guidance criteria that were 
based on a three-class organoleptic evaluation methodology for which 
gradations of decomposition had to be distinguished and more advanced 
decomposed portions were weighted more heavily than other decomposed 
portions in formulating a regulatory position. FDA expects that the 
two-class, pass/fail organoleptic methodology is easier to implement 
and provides more consistency in results.
    The draft CPG is being issued as Level 1 draft guidance consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). The 
draft CPG, when finalized, will represent FDA's current thinking 
regarding enforcement criteria relating to the adulteration of fish and 
fishery products due to the presence of

[[Page 41362]]

decomposition. 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 statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft CPG from 
FDA's Office of Regulatory Affairs home page. It may be accessed at 
http://www.fda.gov/ora under ``Compliance Reference.''

    Dated: June 30, 2008.
Margaret O'K. Glavin,
Associate Commissioner for Regulatory Affairs.
[FR Doc. E8-16453 Filed 7-17-08; 8:45 am]
BILLING CODE 4160-01-S