[Federal Register Volume 62, Number 17 (Monday, January 27, 1997)]
[Proposed Rules]
[Pages 3847-3848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1987]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. 96N-0135]
RIN 0901-AA91


Proposed Rule to Prohibit Animal Proteins From Ruminants and 
Minks From Use in Ruminant Feed; Notice of Open Public Forums

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public forum.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing two open 
public forums to discuss the

[[Page 3848]]

notice of proposed rulemaking that provides that animal protein derived 
from ruminant and mink tissues is not generally recognized as safe for 
use in ruminant feeds and is a food additive under the Federal Food, 
Drug, and Cosmetic Act. As such, without a food additive regulation or 
an exemption, its use in ruminant feeds would be prohibited. While the 
proposed rule is a preventive measure, the public forums are not 
preventive measures. Issuance of the proposed rule is part of a series 
of preventive measures that the agency has taken to protect animals 
from transmissible degenerative neurological diseases and to minimize 
any potential risk that such diseases could be transmitted from animal 
to humans. The agency's proposal and related policy issues will be 
discussed at the forums. The forums are intended to provide an 
opportunity for comments from industry and consumers.

DATES: The public forums are scheduled as follows:
1. Tuesday, February 4, 1997, from 1 p.m. to 4 p.m., St. Louis, MO.
 2. Thursday, February 13, 1997, from 9 a.m. to 12 m., Washington, DC.

ADDRESSES: The open public forums will be held at the following 
locations:
    St. Louis--Henry VIII Hotel and Conference Center, 4690 North 
Lindbergh Blvd., St. Louis, MO, 314-731-3040.
    Washington--Holiday Inn--Capitol, 550 C St. SW., Washington, DC, 
202-479-4000.

FOR FURTHER INFORMATION CONTACT:
    Regarding the St. Louis, MO, open public forum: Charles M. Breen, 
Office of Regulatory Affairs (HFR-SW400), Food and Drug Administration, 
12 Sunnen Dr., suite 122, St. Louis, MO 63143, 314-645-1167, FAX 314-
645-2969.
    Regarding the Washington, DC, open public forum: Susan Mackie, 
Office of Consumer Affairs (HFE-3), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4407, FAX 301-443-9767.
    Those persons interested in attending the St. Louis, MO, open 
public forum, should register by faxing their name(s), firm name/
affiliation, address, telephone and facsimile numbers to Charles M. 
Breen at 314-645-2969, or send a request for registration by mail to 
Charles Breen (address above).
    Those persons interested in attending the Washington, DC, open 
public forum, should register by calling Susan Mackie at 301-827-4407 
or by faxing or mailing their name(s), firm name/affiliation, address, 
telephone and facsimile numbers to Susan Mackie (address above).

    Persons unable to attend this open public forum, or those who wish 
to submit their questions or comments in advance of this open public 
forum, should submit them to the appropriate contact person listed 
above.
    There is no registration fee for these open public forums. However, 
due to space limitations, preregistration is required and early 
registration is recommended.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 3, 1997 
(62 FR 552), FDA published a notice of proposed rulemaking that would 
prohibit using rendered animal protein from mink and from ruminants, 
animals such as cows, sheep, and goats, in the manufacture of ruminant 
feeds. FDA will hold two open public forums to discuss its proposal, 
which is the latest in a series of preventive measures, including a 
voluntary industry moratorium, that FDA, other Federal agencies, and 
industry have taken to protect animals from transmissible degenerative 
neurological diseases and to minimize any potential risk that such 
diseases could be transmitted from animals to humans. These animal 
diseases are known as transmissible spongiform encephalopathies 
(TSE's). Bovine spongiform encephalopathy (BSE) is among the more 
commonly known of these diseases.
    FDA's proposed regulation would prohibit the use of rendered 
ruminant and mink proteins in feed intended for ruminants. In addition 
to prohibiting products with the potential to spread TSE's, the 
proposed rule also requires process and control systems to ensure that 
ruminant feed does not contain the prohibited tissues.
    The agency's proposal and related policy issues will be discussed 
at the forums. The forums are intended to provide an opportunity for 
feedback and comments from industry and consumers.
    The St. Louis, MO, open public forum is intended primarily to 
discuss the interests of renderers, animal feed manufacturers, and 
feedlot operators. The agency will be prepared to consider questions 
related to the economic assessment. The Washington, DC, open public 
forum is intended primarily to discuss the interests of consumers and 
the general public.
    Full transcripts of each open public forum will be made. The 
transcripts will be incorporated into the administrative record of the 
proposed rule and placed on file in the public docket (Docket No. 96N-
0135) for the proposal.
    Persons submitting comments or (questions) at the open public 
forums are encouraged to submit their comments in advance in writing. 
Such comments will be placed in the public docket for the proposed rule 
and presented at the open public forums. Persons unable to attend the 
forums are also encouraged to submit comments on the proposal to the 
public docket, and any such questions or comments submitted in advance 
will be presented at the forums.
    Persons making comments at the forums should limit their remarks to 
a few minutes and if possible to fewer than 5 minutes to encourage 
dialogue during the forum and to permit as many people as possible to 
participate. Persons may submit expanded versions of their oral 
comments in writing to the public docket.

    Dated: January 22, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-1987 Filed 1-23-97; 11:31 am]
BILLING CODE 4160-01-F