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

NOTICE: NOTICES

ACTION: Draft Compliance Policy Guide Sec. 540.370:

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Draft Compliance Policy Guide Sec. 540.370 Fish and Fishery Products -- Decomposition; Availability

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.

DOCUMENT 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.

SUMMARY: Fish and Fishery Products Decomposition; Availability,

SUPPLEMENTAL INFORMATION

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 twoclass, 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The draft CPG, when final, will replace the following withdrawn and revoked CPGs relating to decomposition in fish and shrimp: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 threeclass 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 twoclass, 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
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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 Governmentwide, 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. E816453 Filed 71708; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Robert D. Samuels, Center for Food Safety and Applied Nutrition (HFS325), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 207403835, 3014362300.