[Federal Register: September 30, 2004 (Volume 69, Number 189)]
[Page 58448]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.

ACTION: Notice.


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: burt.pritchett@fda.gov.


I. Background

    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 
and regulations.

IV. Comments

    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 
through Friday.

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.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22014 Filed 9-29-04; 8:45 am]