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From: TSS ()
Subject: MARCH 2005 UPDATE ON FEED ENFORCEMENT ACTIVITIES TO LIMIT THE SPREAD OF BSE
Date: March 18, 2005 at 7:42 am PST

-------- Original Message --------
Subject: MARCH 2005 UPDATE ON FEED ENFORCEMENT ACTIVITIES TO LIMIT THE SPREAD OF BSE
Date: Fri, 18 Mar 2005 09:35:18 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@KALIV.UNI-KARLSRUHE.DE


##################### Bovine Spongiform Encephalopathy #####################

CVM Update

<

March 17, 2005

MARCH 2005 UPDATE ON FEED ENFORCEMENT ACTIVITIES TO LIMIT THE SPREAD OF BSE

To help prevent the establishment and amplification of BSE through feed
in the United States, FDA implemented a final rule that prohibits the
use of most mammalian protein in feeds for ruminant animals. This rule,
Title 21 Part 589.2000 of the Code of Federal Regulations, here called
the Ruminant Feed Ban ,
became effective on August 4, 1997.

This is an update on FDA enforcement activities regarding the ruminant
feed regulation. FDA's CVM has assembled data from the inspections that
have been conducted AND whose final inspection report has been recorded
in the FDA's inspection database as of March 5, 2005 . As of March 5,
2005 , FDA had received over 35,000 inspection reports. The majority of
these inspections (around 70%) were conducted by State officials under
contract to FDA, with the remainder conducted by FDA officials.

Inspections conducted by FDA or State investigators are classified to
reflect the compliance status at the time of the inspection based upon
the objectionable conditions documented. These inspection conclusions
are reported as Official Action Indicated (OAI), Voluntary Action
Indicated (VAI), or No Action Indicated (NAI).

An OAI inspection classification occurs when significant objectionable
conditions or practices were found and regulatory sanctions are
warranted in order to address the establishment's lack of compliance
with the regulation. An example of an OAI inspection classification
would be findings of manufacturing procedures insufficient to ensure
that ruminant feed is not contaminated with prohibited material.
Inspections classified with OAI violations will be promptly re-inspected
following the regulatory sanctions to determine whether adequate
corrective actions have been implemented.

A VAI inspection classification occurs when objectionable conditions or
practices were found that do not meet the threshold of regulatory
significance, but do warrant advisory actions to inform the
establishment of findings that should be voluntarily corrected.
Inspections classified with VAI violations are more technical violations
of the Ruminant Feed Ban. These include provisions such as minor
recordkeeping lapses and conditions involving non-ruminant feeds.

An NAI inspection classification occurs when no objectionable conditions
or practices were found during the inspection or the significance of the
documented objectionable conditions found does not justify further actions.

The results to date are reported here both by “segment of industry” and
“in total”. NOTE – A single firm can opera te as more than one firm
type. As a result, the categories of the different industry segments are
not mutually exclusive.

RENDERERS

These firms are the first to handle and process (i.e., render) animal
proteins and to send these processed materials to feed mills and/or
protein blenders for use as a feed ingredient.

*

Number of active firms whose initial inspection has been reported
to FDA – 255

*

Number of active firms handling materials prohibited from use in
ruminant feed – 169 (66% of those active firms inspected)

*

Of the 169 active firms handling prohibited materials, their most
recent inspection revealed that:

o

1 firm (0.6%) was classified as OAI

o

6 firms (3.5%) were classified as VAI

LICENSED FEED MILLS

FDA licenses these feed mills to produce medicated feed products. The
license is required to manufacture and distribute feed using certain
potent drug products, usually those requiring some pre-slaughter
withdrawal time. This licensing has nothing to do with handling
prohibited materials under the feed ban regulation. A medicated feed
license from FDA is not required to handle materials prohibited under
the Ruminant Feed Ban.

*

Number of active firms whose initial inspection has been reported
to FDA – 1,066

*

Number of active firms handling materials prohibited from use in
ruminant feed – 402 (38% of those active firms inspected)

*

Of the 402 active firms handling prohibited materials, their most
recent inspection revealed that:

o

1 firm (0.2%) was classified as OAI

o

9 firms (2.2%) were classified as VAI

FEED MILLS NOT LICENSED BY FDA

These feed mills are not licensed by the FDA to produce medicated feeds.

*

Number of active firms whose initial inspection has been reported
to FDA – 5,133

*

Number of active firms handling materials prohibited from use in
ruminant feed – 1,785 (35% of those active firms inspected)

*

Of the 1,785 active firms handling prohibited materials, their
most recent inspection revealed that:

o

4 firms (0.2%) were classified as OAI

o

30 firms (1.7%) were classified as VAI

PROTEIN BLENDERS

These firms blend rendered animal protein for the purpose of producing
quality feed ingredients that will be used by feed mills.

*

Number of active firms whose initial inspection has been reported
to FDA -- 302

*

Number of active firms handling materials prohibited from use in
ruminant feed – 86 (28% of those active firms inspected)

*

Of the 86 active firms handling prohibited materials, their most
recent inspection revealed that:

o

0 firms (0%) were classified as OAI

o

3 firms (3.5%) were classified as VAI

RENDERERS, FEED MILLS, AND PROTEIN BLENDERS

This category includes only those firms in the above four categories any
firm that actually use prohibited material to is represented by any of
the above four categories, but includes only those firms that
manufacture, process, or blend animal feed or feed ingredients utilizing
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% of those active
firms inspected)

*

Of the 568 of active renderers, feed mills, and protein blenders
processing with prohibited materials, their most recent inspection
revealed that:

o

6 firms (1.1%) were classified as OAI

o

22 firms (3.9%) were classified as VAI

OTHER FIRMS INSPECTED

Examples of such firms include ruminant feeders, on-farm mixers, pet
food manufacturers, animal feed salvagers, distributors, retailers, and
animal feed transporters.

*

Number of active firms whose initial inspection has been reported
to FDA – 12,009

*

Number of active firms handling materials prohibited from use in
ruminant feed – 3,001 (30% of those active firms inspected)

*

Of the 3,001 active firms handling prohibited materials, their
most recent inspection revealed that:

o

11 firms (0.4%) were classified as OAI

o

89 firms (3.0%) were classified as VA

TOTAL FIRMS

Note that a single firm can be reported under more than one firm
category; therefore, the summation of the individual OAI/VAI firm
categories will be more than the actual total number of OAI/VAI firms,
as presented below.

*

Number of active firms whose initial inspection has been reported
to FDA – 15,249

*

Number of active firms handling materials prohibited from use in
ruminant feed – 3,804 (25% of those active firms inspected)

*

Of the 3,804 active firms handling prohibited materials, their
most recent inspection revealed that:

o

13 firms (0.3%) were classified as OAI

o

95 firms (2.5%) were classified as VAI

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

Issued by:
FDA, Center for Veterinary Medicine,
Office of Management and Communications, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (301) 827-3800 FAX: (301) 827-4065
Internet Web Site: http://www.fda.gov/cvm

http://www.fda.gov/cvm/index/updates/BSE0305.htm

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

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
FDA’s 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 GAO’s 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 nation’s 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.
• FDA’s 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 FDA’s 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 FDA’s enforcement of the feed
ban and recommended corrective
actions. This report looks at FDA’s
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.

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


TSS

######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########






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