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From: TSS ()
Subject: Substances Prohibited From Use in Animal Food or Feed; Proposed Rule [Docket No. 2002N-0273] (formerly Docket No. 02N-0273)
Date: November 6, 2005 at 7:26 pm PST

[Federal Register: October 6, 2005 (Volume 70, Number 193)]
[Proposed Rules]
[Page 58569-58601]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc05-29]


[[Page 58569]]

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Part III

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 589

Substances Prohibited From Use in Animal Food or Feed; Proposed Rule


[[Page 58570]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. 2002N-0273] (formerly Docket No. 02N-0273)
RIN 0910-AF46


Substances Prohibited From Use in Animal Food or Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the agency's regulations to prohibit the use of certain cattle origin
materials in the food or feed of all animals. These materials include
the following: The brains and spinal cords from cattle 30 months of age
and older, the brains and spinal cords from cattle of any age not
inspected and passed for human consumption, the entire carcass of
cattle not inspected and passed for human consumption if the brains and
spinal cords have not been removed, tallow that is derived from the
materials prohibited by this proposed rule that contains more than 0.15
percent insoluble impurities, and mechanically separated beef that is
derived from the materials prohibited by this proposed rule. These
measures will further strengthen existing safeguards designed to help
prevent the spread of bovine spongiform encephalopathy (BSE) in U.S.
cattle.

DATES: Submit written or electronic comments by December 20, 2005.
Submit written comments on the information collection provisions by
November 7, 2005.

ADDRESSES: You may submit comments, identified by [Docket No. 2002N-
0273 or RIN 0910-AF46], by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.

Follow the instructions for submitting comments.
Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.

Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and Docket No(s). or Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, including any personal

information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm

and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

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.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
A. Bovine Spongiform Encephalopathy
B. Current Animal Feed Safeguards in the United States
C. Risk of BSE in North America
D. Additional Measures Considered to Strengthen Animal Feed
Safeguards
1. Comments on November 6, 2002 Advance Notice of Proposed
Rulemaking (ANPRM)
2. Actions in Response to Washington State Case
3. Comments on July 14, 2004 ANPRM
II. Proposed Measures to Strengthen Animal Feed Safeguards
A. FDA Response to Comments to the 2004 ANPRM
B. Additional Measures to Further Strengthen Feed Protection
C. Basis for Proposing to Apply Additional Measures to All Animal
Food and Feed
D. Cattle Materials Proposed to be Prohibited From Use in All
Animal Food and Feed
E. Disposal of Cattle Materials Prohibited in Animal Feed
III. Description of Proposed Rule and Legal Authority
A. Definitions
B. Proposed Requirements
C. Proposed Recordkeeping and Access Requirements
D. Conforming Changes to 21 CFR 589.2000--Animal Proteins
Prohibited in Ruminant Feed
E. Legal Authority
IV. Analysis of Economic Impacts
A. Summary of Proposed Regulatory Impact Analysis
B. Need for Regulation
C. Benefits
D. Costs
E. Government Costs
F. Sensitivity Analysis
G. Regulatory Flexibility Analysis
V. Paperwork Reduction Act
VI. Environmental Impact
VII. Federalism
VIII. Comments
IX. References

I. Background

A. Bovine Spongiform Encephalopathy


snip...full text;


http://www.fda.gov/OHRMS/DOCKETS/98fr/05-20196.htm

Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument


Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA


https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed


Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

Asante/Collinge et al, that BSE transmission to the 129-methionine

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


TSS




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