[Federal Register: December 18, 2002 (Volume 67, Number 243)]
[Notices]
[Page 77500-77501]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de02-86]
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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Draft Guidance for Industry on Manufacture and Labeling of Raw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availability of the draft guidance for industry ([numsign]122) entitled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 This draft guidance document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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Communications Staff (HFV-12), Center for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INFORMATION section for electronic access to the draft guidance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Submit written comments on the draft guidance document to the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with the full title of the draft guidance document and the docket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