[Federal Register Volume 67, Number 243 (Wednesday, December 18, 2002)]
[Notices]
[Pages 77500-77501]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-31721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0468]


Draft Guidance for Industry on Manufacture and Labeling of Raw 
Meat Foods for Companion and Captive Noncompanion Carnivores and 
Omnivores; 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availability of the draft guidance for industry ([numsign]122) entitled 
``Manufacture and Labeling of Raw Meat Foods for Companion and Captive 
Noncompanion Carnivores and Omnivores.'' This draft guidance document 
is intended to provide specific guidance on the manufacture and 
labeling of foods that contain raw meat, or other raw animal tissues, 
for consumption by dogs, cats, other companion or pet animals, and 
captive noncompanion animal carnivores and omnivores.

DATES: Submit written or electronic comments on the draft guidance by 
March 3, 2003, to ensure their adequate consideration in preparation of 
the final document. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Communications Staff (HFV-12), Center for 
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855. Send one self-addressed adhesive label to assist 
that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit written comments on the draft guidance document to the 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. Comments should be identified 
with the full title of the draft guidance document and the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: William Burkholder, Center for 
Veterinary Medicine (HFV-228), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0179, e-mail: 
bburkhol@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Commercial foods for carnivorous and omnivorous animals containing 
raw meat, or other raw animal tissues, have been on the market for many 
years for use by zoos, mink farms, dog-racing facilities, and other 
professional establishments. Some of these products have included meat 
and other tissues from mammals and poultry that have died other than 
from slaughter or have otherwise been unfit for human consumption. 
Products containing such tissues are adulterated under section 402(a) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)). 
However, FDA's Compliance Policy Guide 7126.23 provides that 
investigation should only be conducted as a followup to complaints or 
reports of injuries. When raw meat or raw animal tissues were purchased 
and used by zoos, mink farms, dog-racing facilities, or other 
professional establishments, there was a presumption that the purchaser 
was aware of the potential food safety and nutritional deficiency risks 
of using such products. However, the new trend is toward use of raw 
meat foods by pet owners and others who may not be as aware of the 
potential harm.
    FDA does not believe that raw meat foods are consistent with the 
goal of protecting the public from significant health risks, 
particularly when such products are brought into the home and/or used 
to feed domestic pets. Objective data derived specifically from 
commercial raw meat pet foods are sparse for quantifying the magnitude 
of risk to public health from such products. However, the potential for 
risk to public health from such products is undeniable, and the 
magnitude of such risk is likely significant given the microbiological 
results from studies of ingredients that could compose such products 
and the limited sampling of commercial raw pet foods themselves. 
Therefore, for firms choosing to manufacture and market raw meat and 
raw animal tissue products, more specific guidance for industry is 
warranted for how such products could be manufactured and labeled to 
protect pet owners and pets from risks

[[Page 77501]]

involving food safety and nutritional deficiency.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the agency's current thinking about the 
manufacture and labeling of raw meat foods for companion and captive 
noncompanion carnivores and omnivores. 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.

III. Comments

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this draft guidance 
document. Two copies of mailed comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. The draft guidance and received comments are available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.

IV. Electronic Access

    Electronic comments may be submitted on the Internet at http://
www.fda.gov/dockets/ecomments. Once on this site, select ``02D-0468--
Manufacture and Labeling of Raw Meat Foods for Companion and Captive 
Noncompanion Carnivores and Omnivores'' and follow the directions. 
Copies of this draft guidance may be obtained on the Internet from the 
CVM home page at http://www.fda.gov/cvm.

    Dated: December 8, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-31721 Filed 12-17-02; 8:45 am]
BILLING CODE 4160-01-S