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From: TSS ()
Subject: CVM Reports BSE Inspection Figures as of March 5, 2005 (USA feeding cows to cows in 2005)
Date: April 15, 2005 at 7:05 am PST

-------- Original Message --------
Subject: CVM Reports BSE Inspection Figures as of March 5, 2005 (USA feeding cows to cows in 2005)
Date: Fri, 15 Apr 2005 09:13:05 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy


JANUARY/FEBRUARY 2005
BSE INSPECTION UPDATE
CVM Reports BSE Inspection Figures
as of March 5
As of March 5, 2005, the Food and
Drug Administration (FDA) had
received more than 35,000 reports of
inspections done under the ruminant
feed rule designed to prevent the
establishment and spread of bovine
spongiform encephalopathy (BSE) in
the United States.
Approximately 70 percent of the inspections
were conducted by State of-
fi cials under contract to FDA, with the
remainder conducted by FDA offi cials.
Inspections conducted by State
and FDA investigators are classifi ed
to refl ect the compliance status at the
time of the inspection, based upon
whether objectionable conditions were
(Continued, next page)

FDA VETERINARIAN JANUARY/FEBRUARY 2005 11
&BSE Inspection Figures as of March 5 (Continued)
documented. Based on the conditions
found, inspection results are recorded
in one of three classifi cations:
" OAI (Offi cial Action Indicated)
when inspectors fi nd signifi cant objectionable
conditions or practices
and believe that regulatory sanctions
are warranted to address the
establishments lack of compliance
with the regulation. An example of
an OAI classifi cation would be fi ndings
of manufacturing procedures
insuffi cient to ensure that ruminant
feed is not contaminated with prohibited
material. Inspectors will
promptly re-inspect facilities classi-
fi ed OAI after regulatory sanctions
have been applied to determine
whether the corrective actions are
adequate to address the objectionable
conditions.
" VAI (Voluntary Action Indicated)
when inspectors fi nd objectionable
conditions or practices that do not
meet the threshold of regulatory signifi
cance, but warrant an advisory to
inform the establishment that inspectors
found conditions or practices
that should be voluntarily corrected.
VAI violations are typically technical
violations of the 1997 BSE Feed
Rule. These violations include minor
recordkeeping lapses or conditions
involving non-ruminant feeds.
" NAI (No Action Indicated) when
inspectors fi nd no objectionable
conditions or practices or, if they
fi nd objectionable conditions, those
conditions are of a minor nature and
do not justify further actions.
(Note: The following fi gures are as of
March 5.)
Renderers
These fi rms are the fi rst to handle
and process (i.e., render) animal proteins.
After they process the material,
they send it to feed mills and/or protein
blenders for use as a feed ingredient.
" Number of active fi rms whose initial
inspection has been reported to
FDA  255
" Number of active fi rms handling
materials prohibited from use in
ruminant feed  169 (66 percent of
those active fi rms inspected)
Of those 169 fi rms:
? 1 (0.6 percent) was classifi ed as
OAI
? 6 (3.5 percent) were classifi ed as
VAI
Licensed feed mills
" In the inspection report database,
FDA lists medicated feed licensed
feed mills separately from non-licensed
feed mills. But the licensing
has nothing to do with handling
prohibited materials under the
feed ban regulation. FDA requires
feed mills to have medicated feed
licenses to manufacture and distribute
feed using certain potent drug
products, usually those requiring
some pre-slaughter withdrawal time,
to produce certain medicated feed
products.
" Number of active fi rms whose initial
inspection has been reported to
FDA  1,066
" Number of active fi rms handling
materials prohibited from use in
ruminant feed  402 (38 percent of
those active fi rms inspected)
Of those 402 fi rms:
? 1 (0.2 percent) was classifi ed as
OAI
? 9 (2.2 percent) were classifi ed as
VAI
Feed Mills Not Licensed by FDA
These feed mills are not licensed by
the FDA to produce medicated feeds.
" Number of active fi rms whose initial
inspection has been reported to
FDA  5,133
" Number of active fi rms handling
materials prohibited from use in
ruminant feed  1,785 (35 percent
of those active fi rms inspected)
Of those 1,785 fi rms:
? 4 (0.2 percent) were classifi ed as
OAI
? 30 (1.7 percent) were classifi ed
as VAI
Protein blenders
These fi rms blend rendered animal
protein for the purpose of producing
feed ingredients used by feed mills.
" Number of active fi rms whose initial
inspection has been reported to
FDA  302
" Number of active fi rms handling
materials prohibited from use in
ruminant feed  86 (28 percent of
those active fi rms inspected)
Of those 86 fi rms:
? 0 were classifi ed as OAI
? 3 (3.5 percent) were classifi ed as
VAI
Renderers, feed mills, protein
blenders
This category includes any fi rm that
is represented by any of the above four
categories, but includes only those
fi rms that manufacture, process or
blend animal feed or feed ingredients
using prohibited materials.
" Number of active renderers, feed
mills, and protein blenders whose
initial inspection has been reported
to FDA  6,526
" Number of active renderers, feed
mills, and protein blenders processing
with prohibited materials  568
(8.7 percent of those active fi rms
inspected)
Of those 568 fi rms:
? 6 (1.1 percent) were classifi ed as
OAI
? 22 (3.9 percent) were classifi ed
as VAI
(Continued, next page)
FDA VETERINARIAN JANUARY/FEBRUARY 2005 12
Other fi rms inspected
Examples of such fi rms include ruminant
feeders, on-farm mixers, pet food
manufacturers, animal feed salvagers,
distributors, retailers and animal feed
transporters.
" Number of active fi rms whose initial
inspection has been reported to
FDA  12,009
" Number of active fi rms handling
materials prohibited from use in
ruminant feed  3,001 (30 percent of
those active fi rms inspected)
&BSE Inspection Figures as of March 5 (Continued)
Of those 3,001 fi rms:
? 11 (0.4 percent) were classifi ed
as OAI
? 89 (3.0 percent) were classifi ed
as VAI
Total Firms
" Number of active fi rms whose initial
inspection has been reported to
FDA  15,249
" Number of active fi rms handling
materials prohibited from use in
ruminant feed  3,804 (25 percent of
those active fi rms inspected)
Of those 3,804 fi rms:
? 13 (0.3 percent) were classifi ed
as OAI
? 95 (2.5 percent) were classifi ed
as VAI
(Note: A single fi rm that has more than
one function can be listed in different
industry segments, which also means
that the total may be less than a combination
of all the segments.)

http://www.fda.gov/cvm/Documents/JanFeb05.pdf


What GAO Found
United States Government Accountability Office
Why GAO Did This Study
Highlights
Accountability Integrity Reliability
www.gao.gov/cgi-bin/getrpt?GAO-05-101.
To view the full product, including the scope
and methodology, click on the link above.
For more information, contact Robert A.
Robinson at (202) 512-3841 or
robinsonr@gao.gov.
Highlights of GAO-05-101, a report to
congressional requesters
February 2005
MAD COW DISEASE
FDAs Management of the Feed Ban Has
Improved, but Oversight Weaknesses
Continue to Limit Program Effectiveness
FDA has made needed improvements to its management and oversight of the
feed-ban rule in response to GAOs 2002 report, but program weaknesses
continue to limit the effectiveness of the ban and place U.S. cattle at
risk of
spreading BSE. Improvements made include FDA establishing a uniform
method of conducting compliance inspections and training FDA inspectors,
as well as state inspectors who carry out inspections under agreements with
FDA, on the new method. FDA also implemented new data-entry procedures
that are designed to more reliably track feed-ban inspection results.
Consequently, FDA has a better management tool for overseeing compliance
with the feed-ban rule and a data system that better conforms to standard
database management practices. However, various program weaknesses
continue to undermine the nations firewall against BSE. For example:
" FDA acknowledges that there are more feed manufacturers and
transporters, on-farm mixers, and other feed industry businesses that are
subject to the feed ban than the approximately 14,800 firms inspected to
date; however, it has no uniform approach for identifying additional
firms.
" FDA has not reinspected approximately 2,800, or about 19 percent, of
those businesses, in 5 or more years; several hundred are potentially
high risk. FDA does not know whether those businesses now use
prohibited material in their feed.
" FDAs feed-ban inspection guidance does not include instructions to
routinely sample cattle feed to test for potentially prohibited material as
part of the compliance inspection. Instead, it includes guidance for
inspectors to visually examine facilities and equipment and review
invoices and other documents.
" Feed intended for export is not required to carry a caution label Do not
feed to cattle or other ruminants, when the label would be required if
the feed were sold domestically. Without that statement, feed containing
prohibited material could be inadvertently or intentionally diverted back
to U.S. cattle or given to foreign cattle.
" FDA has not always alerted USDA and states when it learned that cattle
may have been given feed that contained prohibited material. This lapse
has been occurring even though FDAs guidance calls for such
communication.
" Although research suggests that cattle can get BSE from ingesting even a
small amount of infected material, inspectors do not routinely inspect or
review cleanout procedures for vehicles used to haul cattle feed.
More than 5 million cattle across
Europe have been killed to stop the
spread of bovine spongiform
encephalopathy (BSE), commonly
called mad cow disease. Found in
26 countries, including Canada and
the United States, BSE is believed
to spread through animal feed that
contains protein from BSE-infected
animals. Consuming meat from
infected cattle has also been linked
to the deaths of about 150 people
worldwide. In 1997, the Food and
Drug Administration (FDA) issued
a feed-ban rule prohibiting certain
animal protein (prohibited
material) in feed for cattle and
other ruminant animals. FDA and
38 states inspect firms in the feed
industry to enforce this critical
firewall against BSE. In 2002, GAO
reported a number of weaknesses
in FDAs enforcement of the feed
ban and recommended corrective
actions. This report looks at FDAs
efforts since 2002 to ensure
industry compliance with the feed
ban and protect U.S. cattle.
What GAO Recommends
GAO recommends FDA, among
other things, develop procedures
for finding additional firms subject
to the feed-ban and using tests to
augment inspections. FDA said the
study was thorough but disagreed
on four of nine recommendations.
GAO continues to believe that,
given the discovery of BSE in North
America and the oversight gaps
described in the report, the
recommended actions are needed
to protect U.S. cattle from BSE.


3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,
but Oversight Weaknesses Continue to Limit Program Effectiveness.
GAO-05-101, Feb. 25.
http://www.gao.gov/cgi-bin/getrpt?GAO-05-101
Highlights - http://www.gao.gov/highlights/d05101high.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Publication date: 20 August 2004

Adopted July 2004 (Question N° EFSA-Q-2003-083)

* 167 kB Report
* 105 kB Summary

Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html

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

TSS





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