[Federal Register: September 30, 2004 (Volume 69, Number 189)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0438]
Guidance for Industry: Use of Material from Bovine Spongiform
Encephalopathy-Positive Cattle in Animal Feed; Availability
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry (174) entitled ``Use
of Material from BSE-Positive Cattle in Animal Feed.'' This guidance
document describes FDA's current thinking regarding the use in all
animal feed of all material from cattle that test positive for BSE
(bovine spongiform encephalopathy).
DATES: Submit written or electronic comments on agency guidances at any
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments on the
guidance via the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Comments should be identified with the full title of the guidance and
the docket number found in brackets in the heading of this document.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
Submit written requests for single copies of the guidance 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
FOR FURTHER INFORMATION CONTACT: Burt Pritchett, Center for Veterinary
Medicine (HFV-222), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6860, e-mail: firstname.lastname@example.org.
BSE belongs to a family of animal and human diseases called
transmissible spongiform encephalopathies (TSEs). These include BSE or
``mad cow'' disease in cattle; scrapie in sheep and goats; and
classical and variant Creutzfeldt-Jakob diseases (CJD and vCJD) in
humans. There is no known treatment for these diseases, and there is no
vaccine to prevent them. In addition, although validated postmortem
diagnostic tests are available, there are no validated diagnostic tests
for BSE or other TSEs that can be used to test for the disease in live
animals or humans.
Under FDA's BSE feed regulation (21 CFR 589.2000) any protein-
containing portion of mammalian animals is prohibited for use in feed
for ruminant animals with the exception of certain products. FDA took
this action to minimize the potential for any undetected BSE
infectivity in animal feed to spread to ruminants via their feed. This
guidance document describes FDA's recommendations regarding the use in
all animal feed of all material from cattle that test positive for BSE.
II. Paperwork Reduction Act of 1995
FDA concludes that this guidance contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
III. Significance of Guidance
This level 1 guidance is being issued consistent with FDA's 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 FDA believes that, in light of the
increased BSE testing activities by the U.S. Department of Agriculture,
it is of public health importance to clarify that cattle that test
positive for BSE are adulterated and are not to be used in any animal
This guidance represents the agency's current thinking on the
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternate method may be
used as long as it satisfies the requirements of applicable statutes
As with all of FDA's guidance, the public is encouraged to submit
written or electronic comments with new data or other new information
pertinent to this guidance. FDA periodically will review the comments
in the docket and, where appropriate, will amend the guidance. The
public will be notified of any such amendments through a document in
the Federal Register.
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
V. Electronic Access
Copies of this guidance document may be obtained from the Center
for Veterinary Medicine home page (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm) and from the Division of Dockets Management Web site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
Dated: September 24, 2004.
Assistant Commissioner for Policy.
[FR Doc. 04-22014 Filed 9-29-04; 8:45 am]
BILLING CODE 4160-01-S