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From: TSS (216-119-144-60.ipset24.wt.net)
Subject: NOVEMBER 2004 UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES
Date: November 23, 2004 at 11:14 am PST

-------- Original Message --------
Subject: NOVEMBER 2004 UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES
Date: Tue, 23 Nov 2004 13:11:11 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE


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

CVM Update

November 23, 2004

NOVEMBER 2004 UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

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 (BSE) 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 November 6, 2004 . As of
November 6, 2004 , FDA had received over 33,000 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 complia nc e status at the time of the inspection based upon
the objectionable conditions documented. These inspection co nc lusions
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 sa nc tions are
warranted in order to address the establishment's lack of complia nc e
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 sa nc tions 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
significa nc e, 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 i nc lude 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 significa nc e 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  251

*

Number of active firms handling materials prohibited from use in
ruminant feed  163 (65% of those active firms inspected)

*

Of the 163 active firms handling prohibited materials, their most
recent inspection revealed that:

o

0 firms (0%) were classified as OAI

o

5 firms (3.1%) 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  1,085

*

Number of active firms handling materials prohibited from use in
ruminant feed  405 (37% of those active firms inspected)

*

Of the 405 active firms handling prohibited materials, their most
recent inspection revealed that:

o

2 firms (0.5%) were 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  5,107

*

Number of active firms handling materials prohibited from use in
ruminant feed  1,611 (32% of those active firms inspected)

*

Of the 1,611 active firms handling prohibited materials, their
most recent inspection revealed that:

o

8 firms (0.5%) were classified as OAI

o

25 firms (1.6%) 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 -- 301

*

Number of active firms handling materials prohibited from use in
ruminant feed  83 (28% of those active firms inspected)

*

Of the 83 active firms handling prohibited materials, their most
recent inspection revealed that:

o

1 firm (1.2%) was classified as OAI

o

3 firms (3.6%) were classified as VAI

RENDERERS, FEED MILLS, AND PROTEIN BLENDERS

This category i nc ludes 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  6,511

*

Number of active renderers, feed mills, and protein blenders
processing with prohibited materials  578 (8.9% of those active
firms inspected)

*

Of the 578 of active renderers, feed mills, and protein blenders
processing with prohibited materials, their most recent inspection
revealed that:

o

10 firms (1.7%) were classified as OAI

o

16 firms (2.8%) were classified as VAI

OTHER FIRMS INSPECTED

Examples of such firms i nc lude 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  11,523

*

Number of active firms handling materials prohibited from use in
ruminant feed  2,693 (23% of those active firms inspected)

*

Of the 2,693 active firms handling prohibited materials, their
most recent inspection revealed that:

o

15 firms (0.6%) were classified as OAI

o

79 firms (2.9%) were classified as VAI

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  14,853

*

Number of active firms handling materials prohibited from use in
ruminant feed  3,444 (23% of those active firms inspected)

*

Of the 3,444 active firms handling prohibited materials, their
most recent inspection revealed that:

o

16 firms (0.5%) were classified as OAI

o

89 firms (2.6%) 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

=========================

TSS wrote 11/17/04 BSE-L ;

> snip...
>
> http://www.accessdata3.fda.gov/BSEInspect/bse_excel.jsp
>
> Greetings,
>
> this is more evidence of the fact that the FDA et al do not want you
> to know what violations there are of the 8/4/97 tse feed ban. this spread
> sheet is so problematic and confusing that there is no way in hell
> someone
> can quickly go over it to find recent violations and what they may be.
> JUST
> another system set up to deceive and confuse. something that use to be so
> simple and user friendly for consumer protection, has once again
> disappeared
> into the abyss of politics of the bush administration...TSS


THANK YOU!..............TSS

############## BSE-L-subscribe-request@kaliv.uni-karlsruhe.de ##############






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