[Federal Register: July 18, 2008 (Volume 73, Number 139)]
[Notices]
[Page 41361-41362]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy08-94]
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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