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HARKIN, DURBIN SHED LIGHT ON SHORTCOMINGS IN U.S. ANTI-BSE EFFORTS
Cite GAO report highlighting surveillance, compliance questions under
FDA feed rules
MONDAY, MARCH 14, 2005
PHOTO, VIDEO, OR MORE INFO AVAILABLE
(See below )
WASHINGTON, D.C. A Government Accountability Office (GAO)
investigation into the Food and Drug Administrations (FDA) enforcement
of its ruminant-to-ruminant feed ban found that FDA could not say how
many plants were actually in compliance with feed ban rules and lacked
testing procedures to detect prohibited material in animal feed. The
report, requested by Senators Tom Harkin (D-IA) and Richard Durbin
(D-IL), comes on the heels of increased attention on the effectiveness
of such feed bans, both in Canada and the United States. Feeding protein
material from one ruminant (animals whose stomachs are divided into four
parts, such as cattle and deer) to another is believed to be the major
route by which BSE is transmitted among animals. The FDA
ruminant-to-ruminant feed ban is the linchpin of the U.S. strategy for
preventing the spread of BSE to U.S. cattle herds, Harkin said. Yet
the GAO found substantial shortcomings in enforcing the ban, including
failure to monitor feed plants adequately and to test animal feed for
prohibited ruminant byproducts. Common sense tells us the best way to
measure compliance is to sample feed to make sure it does not contain
ruminant byproducts. Despite what FDA asserts, technology is available
for testing feed to detect ruminant byproducts. FDA should use this
technology. The loopholes that allow BSE risk materials into animal
feed must be closed, Durbin said. The United States food supply is
still the safest in the world, but we must take the steps necessary to
keep it that way. This GAO report is one more link in a long chain of
evidence that the threat of BSE is not being taken seriously enough. In
1997, FDA prohibited ruminant byproducts in ruminant feed and began
requiring firms handling both prohibited ruminant byproducts and
ruminant feed to keep these materials separate. Since enactment,
questions have persisted concerning FDAs enforcement of and industry
compliance with the ban. The GAO report creates even more questions by
shooting holes in FDAs claim of 99% compliance with its regulations.
The report found this claim by FDA misleading because it is based on
inspecting only a fraction of feed plants and does not count actual
violations of the feed rules if the plants involved are later found in
compliance. The GAO also noted that because feed plants are not required
to register with FDA, not all plants that make animal feed and are
subject to FDA inspection have even been identified, or inspected. In
addition to raising questions about the validity of FDAs compliance
reports, the GAO cited a number of other shortcomings in FDAs
enforcement of the ruminant-to-ruminant feed ban. Specifically, the
report noted that FDA fails to set consistent standards for cleaning
machinery and transport vehicles that handle both prohibited and allowed
feed materials and fails to conduct timely inspections in all known
plants. This report makes it crystal clear that much work remains to
get compliance with the ruminant-to-ruminant feed ban to where it needs
to be, the senators said. It is critically important that U.S.
anti-BSE efforts are above and beyond questioning to assure consumers
beef is safe, to protect animal health and to help reassure foreign
markets and encourage them to reopen to U.S. cattle and beef exports. We
hope FDA and the Department of Agriculture take this report seriously
and immediately act to rectify the problems outlined. Harkin is the
ranking Democrat on the Senate Agriculture, Nutrition and Forestry
Committee and Durbin is the Senate Democratic Whip. A copy of the report
is available at www.gao.gov
,
harkin.senate.gov or by request.
# # #
http://harkin.senate.gov/news.cfm?id=233457
GAO-02-183 Mad Cow Disease: Improvements in the Animal Feed Ban and
Other Regulatory Areas ...
... on Importing Animals and Met BSE Testing Goals Earlier Than Many
Countries, but Its Feed Ban Is More Permissive: ...
http://www.gao.gov/htext/d02183.html - 136.6KB - GAO Reports, Text Version
11 Mar 05
http://www.gao.gov/htext/d02183.html
GAO-04-259T Bioterrorism: A Threat to Agriculture and the Food Supply
... 2002). ... Mad Cow Disease: Improvements in the Animal Feed Ban and
Other Regulatory Areas Would Strengthen U.S. Prevention Efforts ... at
food processors; (2) FDA to strengthen enforcement of the feed ban; and
(3) the Department of Homeland Security to correct security ...
http://www.gao.gov/htext/d04259t.html - 41.9KB - GAO Reports, Text Version
http://www.gao.gov/htext/d04259t.html
GAO-05-51 Food Safety: USDA and FDA Need to Better Ensure Prompt and
Complete Recalls of ...
... Methodology: ... Appendix II: Federal Actions Associated with the
Discovery of an Animal in the United States Infected with BSE: ...
States Infected with BSE: ... Beef Recall Was Triggered by a
BSE-Positive Sample from One Cow: ...
http://www.gao.gov/htext/d0551.html - 179.1KB - GAO Reports, Text Version
11 Mar 05
http://www.gao.gov/htext/d0551.html
GAO-02-754 Public Health: Blood Supply Generally Adequate Despite New
Donor Restrictions
... BSE: bovine spongiform encephalopathy: ... transmitting variant
Creutzfeldt-Jakob Disease (vCJD), the human form of bovine spongiform
encephalopathy (BSE), or "mad cow" disease, through transfusion. These
"donor deferrals," or exclusions, prevent individuals ...
http://www.gao.gov/htext/d02754.html - 74.6KB - GAO Reports, Text Version
http://www.gao.gov/htext/d02754.html
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
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7
http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm
[PDF] Appendices to PL107-9 Inter-agency Working Group Final Report 1-1
File Format: PDF/Adobe Acrobat - View as HTML
Agent, Weapons of Mass Destruction Operations Unit Federal Bureau of
those who provided comments in response to Docket No. ...
Meager 8/18/01 Terry S. Singeltary Sr ...
www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
# Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of
2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] -
TSS 1/27/03 (0)
Docket Management
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]
http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm
Dockets Entered On October 2, 2003 Table of Contents, Docket #,
Title, 1978N-0301,
OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr.
Vol #: 1, ...
www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm
Daily Dockets Entered on 02/05/03
DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2.
... Vol#: 1.
03N-0009 Federal Preemption of State & Local Medical Device Requireme. ...
www.fda.gov/ohrms/dockets/dailys/03/Feb03/020503/020503.htm
Docket Management
Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater
Comment Number: EC -1
Accepted - Volume 1
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be11.html
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfe.html
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfc.html
Daily Dockets - 04/10/03
... 00D-1662 Use of Xenotransplantation Products in Humans.
EMC 98 Terry S. Singeltary Sr. Vol#: 3. 01F ...
www.fda.gov/ohrms/dockets/dailys/03/Apr03/041003/041003.htm - 05-20-2003
- Cached
2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed
EMC 1
Terry S. Singeltary Sr.
Vol #:
1
http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm
2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed
EMC 7
Terry S. Singeltary Sr.
Vol #:
1
2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed
EMC 7
Terry S. Singeltary Sr.
Vol #:
1
http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant
APE 5 National Renderers Association, Inc. Vol#: 2
APE 6 Animal Protein Producers Industry Vol#: 2
APE 7 Darling International Inc. Vol#: 2
EMC 1 Terry S. Singeltary Sr. Vol#: 3
http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm
Send Post-Publication Peer Review to journal:
Re: RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob
disease in the United States
Email Terry S. Singeltary:
flounder@wt.net
I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to
comment on the CDC's attempts to monitor the occurrence of emerging
forms of CJD. Asante, Collinge et al [1] have reported 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. However, CJD and all human TSEs are not reportable
nationally. CJD and all human TSEs must be made reportable in every
state and internationally. I hope that the CDC does not continue to
expect us to still believe that the 85%+ of all CJD cases which are
sporadic are all spontaneous, without route/source. We have many TSEs in
the USA in both animal and man. CWD in deer/elk is spreading rapidly and
CWD does transmit to mink, ferret, cattle, and squirrel monkey by
intracerebral inoculation. With the known incubation periods in other
TSEs, oral transmission studies of CWD may take much longer. Every
victim/family of CJD/TSEs should be asked about route and source of this
agent. To prolong this will only spread the agent and needlessly expose
others. In light of the findings of Asante and Collinge et al, there
should be drastic measures to safeguard the medical and surgical arena
from sporadic CJDs and all human TSEs. I only ponder how many sporadic
CJDs in the USA are type 2 PrPSc?
http://www.neurology.org/cgi/eletters/60/2/176#535
TSS
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