[Federal Register Volume 66, Number 243 (Tuesday, December 18, 2001)]
[Notices]
[Page 65214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31024]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0503]


Draft Compliance Policy Guide: ``Filth from Insects, Rodents, and 
Other Pests in Food;'' 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 a draft compliance policy guide (CPG) currently 
entitled ``Filth from Insects, Rodents, and Other Pests in Food.'' The 
purpose of this draft CPG is to revise, clarify, and redefine existing 
guidance on the interpretation of filth in foods within the context of 
current science. The draft CPG will provide written guidance to FDA 
components as well as to the industry.

DATES: Submit written or electronic comments on this draft CPG by 
February 19, 2002.

ADDRESSES: Submit written requests for single copies of the draft CPG 
``Filth from Insects, Rodents, and Other Pests in Food'' to the 
Director, Division of Compliance Policy (HFC-230), Office of 
Enforcement, 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 301-827-
0482. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the document.
    Submit written comments on the draft CPG to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:
    Technical Questions Concerning Filth in Foods: Alan R. Olsen, 
Microanalytical Branch (HFS-315), Office of Plant, Dairy Foods, and 
Beverages, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4438, FAX 
202-205-4091.
    Questions Concerning Regulatory Actions: MaryLynn Datoc, Division 
of Compliance Policy (HFC-230), Office of Enforcement, Office of 
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0413, FAX 301-827-0482.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed a draft CPG to revise, clarify, and redefine 
existing guidance on foods that contain filth from insects, rodents, 
and other pests to reflect recent advances in science. The purpose of 
this draft CPG is to provide clear policy to FDA's field and 
headquarters staff with regard to filth from insects, rodents, and 
other pests in foods. It also contains information that may be useful 
to the regulated industry and to the public.
    The draft CPG, when finalized, will supersede the current CPG and 
represents the agency's current thinking on the subject. 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 
an approach satisfies the requirements of applicable statutes or 
regulations.
    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115).

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments on the draft CPG 
entitled ``Filth from Insects, Rodents, and Other Pests in Food.'' Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments should be identified with the docket number 
found in brackets in the heading of this document. A copy of the draft 
CPG and received comments may be seen in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Copies of the draft CPG may also be downloaded to a personal 
computer with access to the Internet. The Office of Regulatory Affairs 
home page includes the draft CPG and may be accessed at http://www.fda.gov/ora under ``Compliance References.''

    Dated: December 11, 2001.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 01-31024 Filed 12-17-01; 8:45 am]
BILLING CODE 4160-01-S