[Federal Register Volume 68, Number 217 (Monday, November 10, 2003)]
[Notices]
[Pages 63805-63806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28192]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0498]
Compliance Program Guidance Manual 7371.009; Bovine Spongiform
Encephalopathy/Ruminant Feed Ban Inspections; 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 compliance program guidance manual (CP) entitled
``Bovine Spongiform Encepholopathy/Ruminant Feed Ban Inspections.''
This CP is intended to assist investigators in determining compliance
with the FDA regulation prohibiting the use of specified animal
proteins in ruminant feeds (21 CFR 589.2000). The purpose of this
regulation is to prevent the establishment and/or amplification within
the United States of bovine spongiform encephalopathy (BSE), a fatal
degenerative nerve disease of cattle.
DATES: Submit written or electronic comments on the CP at any time.
ADDRESSES: Submit written requests for single copies of the CP to the
Communications Staff (HFV-12), Center for Veterinary Medicine (CVM),
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests.
Copies of the CP also may be downloaded to a personal computer with
access to the Internet. The CVM home page includes a link to the CP and
may be accessed at http://www.fda.gov/cvm. Submit written comments on
the CP 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.fda.gov/dockets/ecomments.
Comments should be identified with the full title of the guidance
document and the docket number found in the heading of this document.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this compliance program: Neal Bataller, Center for Veterinary Medicine,
HFV-230, Food and Drug Administration, 7500 Standish Pl., Rm. E441,
Rockville, MD 20855, 301-827-0163, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On August 4, 1997, the ruminant feed ban regulation in Sec.
589.2000 (21 CFR 589.2000) became effective. This regulation prohibits
the use of certain proteins derived from mammalian tissues in the
feeding of ruminant animals. The regulation is intended to prevent the
establishment and/or amplification within the United States of BSE, a
fatal degenerative nerve disease of cattle.
BSE is the bovine form of a group of uniformly fatal neurological
diseases known as transmissible spongiform encephalopathies (TSEs). BSE
appears to be spread through the feeding to cattle of protein derived
from TSE-infected animal tissues. Specifically, epidemiologic evidence
gathered in the United Kingdom suggests an association between BSE and
the feeding to cattle of protein derived from sheep infected with
scrapie, another TSE. BSE represents a public health concern based on
the possible connection between BSE and a form of human TSE, new
variant Creutzfeldt-Jacob disease (nv-CJD), that is believed to have
resulted from people eating ruminant tissues infected with the BSE
agent. BSE has had a devastating economic effect on the livestock
industry in countries where it has been identified or suspected. BSE
has not been diagnosed in the United States.
The regulation in Sec. 589.2000 affects renderers, protein
blenders, commercial animal feed manufacturers, distributors (including
retailers), transporters of animal feed and feed ingredients, on-farm
animal feed mixers, and ruminant feeders. Based on the acute need to
prevent the entry and spread of BSE, FDA has set a goal of full
compliance with the regulation. This CP is intended to assist in the
conduct of inspections to enforce Sec. 589.2000 and thereby minimize
risk to human or animal health.
II. Significance of Guidance
This CP is being issued as a level 1 guidance consistent with our
good guidance practices (GGPs) regulation in Sec. 10.115 (21 CFR
10.115). It is being implemented immediately without prior public
comment, under Sec. 10.115(g)(2), because of the agency's urgent need
to provide guidance and instructions to both agency and state
investigators in conducting inspections under Sec. 589.2000 for
preventing the introduction and amplication of BSE in the United
States. Such guidance is presently not available. However, under GGPs,
FDA requests comments on the guidance and will revise the document, if
appropriate. Comments will be considered by the agency in the
development of future policy.
The CP represents the FDA's current thinking on the subject. It
does not create or confer any rights for or on any person and will not
operate to bind FDA or the public. Alternative methods may be used as
long as they satisfy the requirements of the applicable statutes and
regulations.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this guidance
document. Two copies of any 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. A copy
of the guidance and received comments are available for public
examination in the Division of Dockets Management
[[Page 63806]]
between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Copies of the CP may also be downloaded to a personal computer with
access to the Internet. The CVM home page includes a link to the CP and
may be accessed at http://www.fda.gov/cvm.
Dated: November 3, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28192 Filed 11-7-03; 8:45 am]
BILLING CODE 4160-01-S