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

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

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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.

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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 Start Printed Page 41362decomposition. 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.”

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Dated: June 30, 2008.

Margaret O'K. Glavin,

Associate Commissioner for Regulatory Affairs.

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[FR Doc. E8-16453 Filed 7-17-08; 8:45 am]

BILLING CODE 4160-01-S