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From: TSS ()
Subject: Meat and Poultry Inspection: Report of the Secretary of Agriculture to the U.S. Congress 2001 - 2004 (BSE) ???
Date: May 30, 2005 at 10:14 am PST

Date: Mon, 30 May 2005 12:08:50 -0500
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: Meat and Poultry Inspection: Report of the Secretary of
Agriculture to the U.S. Congress 2001 - 2004 (BSE) ???

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

Greetings list members,

I have been looking for urls to the Meat & Poultry Inspection: Report of the
Secretary of Agriculture to the U.S. Congress for each year from 2001
through 2004. I have been unable to find any such report on USDA or APHIS or
FSIS site? If anyone would have those urls handy, it would be most
appreciated to pass them through the list. i can only find 1996 through
2000.

thank you,
terry


Annual and Periodic Reports
a.. Meat and Poultry Inspection: Report of the Secretary of Agriculture to
the U.S. Congress

a.. 2000 (Issued February 2003) [PDF, 93 pp. 768 KB]
b.. 1999 (Issued March 2001)
c.. 1998 (Issued June 2000; HTML text with PDF attachments)
d.. 1997 (Issued November 1999; PDF, 950 KB)
e.. 1996 (Issued September 1997; PDF, 257 KB)

I HAVE BEEN ABLE TO FIND THESE REPORTS;


Congressional Research Service ~ The Library of Congress

Order Code IB10127

Mad Cow Disease:

Agricultural Issues for Congress

Updated January 13, 2005

Geoffrey S. Becker

Resources, Science, and Industry Division

Congressional Research Service ~ The Library of Congres

snip...

In May 2004 in response to a lawsuit,

USDA acknowledged it had erred administratively

by permitting millions of pounds of

previously suspended Canadian beef cuts to

enter. A court agreement limited such imports

to lower-risk beef until appropriate rulemaking

(see above) is completed. However, another

lawsuit against the rule has been filed.

snip...

Meat Recall. USDA's Food Safety and Inspection Service (FSIS), which
inspects

most meat and poultry for human food, determined that the brain, spinal
cord, and part of the

lower intestine of the BSE cow - tissues most likely to be infective - had
been removed

at slaughter. It also announced "out of an abundance of caution" a voluntary
recall of 10,410

pounds of raw beef from 20 animals slaughtered on the same day as the BSE
cow at a Moses

Lake, Washington, facility. Officials, who in early February 2004 expanded
the recall to

38,000 pounds, said some meat likely was consumed, but they attempted to
reassure

consumers that the meat posed "zero risk" to human health. ...

snip...

PLEASE NOTE;

107
Vet Pathol 42:107-108 (2005)
Letters to the Editor
Editor:
Absence of evidence is not always evidence of absence.
In the article ''Failure to detect prion protein (PrPres) by
immunohistochemistry in striated muscle tissues of animals
experimentally inoculated with agents of transmissible spongiform
encephalopathy,'' recently published in Veterinary
Pathology (41:78-81, 2004), PrPres was not detected in striated
muscle of experimentally infected elk, cattle, sheep, and
raccoons by immunohistochemistry (IHC). Negative IHC,
however, does not exclude the presence of PrPSc. For example,
PrPres was detected in skeletal muscle in 8 of 32
humans with the prion disease, sporadic Creutzfeldt-Jakob
disease (CJD), using sodium phosphotungstic acid (NaPTA)
precipitation and western blot.1 The NaPTA precipitation,
described by Wadsworth et al.,3 concentrates the abnormal
isoform of the prion, PrPres, from a large tissue homogenate
volume before western blotting. This technique has increased
the sensitivity of the western blot up to three orders
of magnitude and could be included in assays to detect
PrPres. Extremely conspicuous deposits of PrPres in muscle
were detected by IHC in a recent case report of an individual
with inclusion body myositis and CJD.2 Here, PrPres was
detected in the muscle by immunoblotting, IHC, and paraf-
fin-embedded tissue blot. We would therefore caution that,
in addition to IHC, highly sensitive biochemical assays and
bioassays of muscle are needed to assess the presence or
absence of prions from muscle in experimental and natural
TSE cases.
Christina Sigurdson, Markus Glatzel, and Adriano Aguzzi
Institute of Neuropathology
University Hospital of Zurich
Zurich, Switzerland
References
1 Glatzel M, Abela E, et al: Extraneural pathologic prion
protein in sporadic Creutzfeldt-Jakob disease. N Engl J
Med 349(19):1812-1820, 2003
2 Kovacs GG, Lindeck-Pozza E, et al: Creutzfeldt-Jakob
disease and inclusion body myositis: abundant diseaseassociated
prion protein in muscle. Ann Neurol 55(1):
121-125, 2004
3 Wadsworth JDF, Joiner S, et al: Tissue distribution of protease
resistant prion protein in variant CJD using a highly
sensitive immuno-blotting assay. Lancet 358:171-180,
2001. ... TSS

snip...

3 The United States, Canada, and Mexico have worked through the OIE World
Organization for

Animal Health (or OIE, the French acronym) on new guidance for resuming
trade with countries that

have reported BSE. See The OIE standards on BSE: a guide for understanding
and proper

implementation, January 2004, at
[http://www.oie.int/eng/press/en_040109.htm].

4 USDA backgrounder on BSE, July 10, 2003. For more details, see CRS Issue
Brief IB10082, Meat

and Poultry Inspection Issues. The APHIS website on surveillance is at
[http://www.aphis.usda.gov/

lpa/issues/bse/bse-surveillance.html].

5 See CVM and Ruminant Feed (BSE) Inspections, at
[http://www.fda.gov/cvm/index/bse/

RuminantFeedInspections.htm]. For background on the rendering industry, also
see CRS Report

RS21771, Animal Rendering: Economics and Policy.

CRS-3

Domestic Cattle "Feed Ban". FDA, which regulates animal feed ingredients,

banned most mammalian proteins from cattle feed on August 4, 1997.5
Exceptions have

existed for blood and blood products; gelatin; inspected, processed, and
cooked meat

products for human consumption (such as restaurant plate waste); milk
products; and

products containing pork and equine proteins only. Most mammalian proteins
can still be

fed to other animals such as pigs, poultry, and pets. To ensure compliance,
FDA

enforcement includes education, and inspections of the estimated 264
renderers (firms that

IB10127 01-13-05

prepare animal parts not destined for human food), and of all known feed
mills (as many as

9,240 or more, according to the agency). ...

snip...

PLEASE NOTE ;

CVM Update

July 29, 2004

JULY 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 July 17, 2004 . As of
July 17, 2004 , FDA had received over 31,000 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 operate 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  244

*

Number of active firms handling materials prohibited from use in
ruminant feed  161 (66% of those active firms inspected)

*

Of the 161 active firms handling prohibited materials, their most
recent inspection revealed that:

o

0 firms (0%) were classified as OAI

o

4 firms (2.5%) 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  1,081

*

Number of active firms handling materials prohibited from use in
ruminant feed  367 (34% of those active firms inspected)

*

Of the 367 active firms handling prohibited materials, their most
recent inspection revealed that:

o

3 firms (0.8%) were classified as OAI

o

5 firms (1.4%) 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  5,059

*

Number of active firms handling materials prohibited from use in
ruminant feed  1,358 (27% of those active firms inspected)

*

Of the 1,358 active firms handling prohibited materials, their
most recent inspection revealed that:

o

6 firms (0.4%) were classified as OAI

o

36 firms (2.7%) 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 -- 267

*

Number of active firms handling materials prohibited from use in
ruminant feed -- 67 (25% of those active firms inspected)

*

Of the 67 active firms handling prohibited materials, their most
recent inspection revealed that:

o

1 firm (1.5%) was classified as OAI

o

2 firms (3.0%) were classified as VAI

RENDERERS, FEED MILLS, AND PROTEIN BLENDERS

This category includes any firm that 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  6,452

*

Number of active renderers, feed mills, and protein blenders
processing with prohibited materials  556 (8.6% of those active
firms inspected)

*

Of the 556 of active renderers, feed mills, and protein blenders
processing with prohibited materials, their most recent inspection
revealed that:

o

8 firms (1.4%) were classified as OAI

o

19 firms (3.4%) 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  10,915

*

Number of active firms handling materials prohibited from use in
ruminant feed  2,205 (20% of those active firms inspected)

*

Of the 2,205 active firms handling prohibited materials, their
most recent inspection revealed that:

o

16 firms (0.7%) were classified as OAI

o

76 firms (3.4%) 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  14,355

*

Number of active firms handling materials prohibited from use in
ruminant feed  2,901 (20% of those active firms inspected)

*

Of the 2,901 active firms handling prohibited materials, their
most recent inspection revealed that:

o

17 firms (0.6%) were classified as OAI

o

86 firms (3.0%) 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/bse72004up.htm

LET'S TAKE A BETTER LOOK ;

June 15, 2004

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. David W. Bernauer
CEO and Chairman of the Board
Walgreen co.
200 Wilmot Rd.
Deerfield, IL 60015

Dear Mr. Bernauer:

Inspection of your firms warehouse at 5100 Lake Terrace N.E., Mt.
Vernon, Illinois, by the Illinois Department of Public Health and the
U.S. Food and Drug Administration (FDA) on February 25, 26, and 27, and
March 2, 2004, documented numerous insanitary conditions which caused
the food and drug products stored there to become adulterated.

Our inspection showed that the food and drug products stored and held at
your facility violated the Federal Food, Drug, and Cosmetic Act (the
Act), rendering them adulterated. These adulterated fwd and drug
products: a) consisted in whole or in part of filthy substances,
including rodent fecal pellets, rodent hair, and insects, in violation
of Section 402(a)(3) of the Act [21 U.S.C. 342(a)(3)]; and/or b) had
been held under insanitary conditions whereby they have become
contaminated with rodent filth, in violation of Sections 402(a)(4) and
501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4), 351(a)(2)(a)].

Evidence of rodent activity documented throughout the old and new
warehouse included dead mice in traps, excreta pellets, and gnawed paper
material observed in, on, and near food and drugs stored in the
warehouse. Rodents gnaw holes were observed into several packaged food
products with rodent hairs at gnaw holes into products. Many more fecal
pellets were on food and drug packages and still more were found near
the stored foods, drugs, and cosmetics in the warehouse.

Other conditions observed during the inspection that could be
contributing factors to rodent infestation include damaged and/or poorly
fitting rail and truck dock doors, gaps around a conduit entry into the
building, and the structural condition of the concrete and expansion
gaps at floor/wall/support beam junctions in various areas of the
warehouse allowing the entry or harborage of pests. Additionally, the
investigators observed cobwebs, dead insects, dust, debris, product
spillage, and papers in the warehouse, indicating a general lack of good
sanitation practices.

Also, products that contain or may contain animal protein prohibited
ruminant feed (BSE material) failed to bear the caution statement, Do
not feed to cattle or other ruminants. Specifically, pet food products
were salvaged, repackaged, and donated to [redacted] and other similar
organizations in the area, without the proper labeling and agreement
that they would not be used for ruminants. Please refer to Title 21,
Code of Federal Regulations, Section 589.2000, concerning these
requirements.

Our laboratory confirmed the findings of rodent excreta, rodent hairs on
product gnaw holes, and rodent gnawed fibers (packaging material)
sampled from the warehouse during the inspection.

The above listed violations are not intended to be all-inclusive. It is
your responsibility to assure adherence with each requirement of the Act
and its implementing regulations. The investigators reported that you
destroyed food products that showed evidence of contamination and began
to take some steps to correct the insanitary conditions in your
facility. We request that you take prompt action to correct all violations.

Please provide this office, within 15 working days of receipt of this
letter, a detailed response stating the actions you plan to take and
have taken to correct and prevent the recurrence of these objectionable
conditions. Provide the time within which corrections will be completed,
reasons why any corrective action cannot be completed, and documentation
to show that corrections have been made. Failure to take prompt action
to correct all violations may result in regulatory action without
further notice. Such action includes seizure and/or injunction.

Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the Chicago District Office.

Sincerely,

/s/

Scott J. MacIntire
District Director

cc:
Stephen J. Lawrence,
Distribution Center Manager
Walgreen Co.
5100 Lake Terrace NE
Mount Vernon, IL 62864-9665

http://www.fda.gov/foi/warning_letters/g4853d.htm


RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

_______________________________

PRODUCT

a) Bulk whole corn. Recall # V-150-4;
b) Bulk rolled corn. Recall # V-151-4;
c) Bulk rolled corn with added fat. Recall # V-152-4.

CODE

No coding information is used.

RECALLING FIRM/MANUFACTURER

Fresno Farming LlC, Traver, CA, by letters on June 30, 2004. Firm
initiated recall is ongoing.

REASON
Corn for feed may be contaminated with RUMINANT MEAT AND BONE MEAL.

VOLUME OF PRODUCT IN COMMERCE
Unknown.

DISTRIBUTION
Unknown.
____________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html


Greetings list members,

VOLUME OF PRODUCT IN COMMERCE
UNKNOWN.

DISTRIBUTION
UNKNOWN.

gotta love those USDA BSE/TSE triple fire walls ;-).....TSS

PRODUCT
Product is custom made steer/cattle feed packaged in 100 lb. poly bags.
The product has no labeling. Recall # V-001-5.
CODE
The product has no lot code. All custom made feed purchased between June
24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated
September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is
prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 80 1ű2 tons of steer/cattle feed.
DISTRIBUTION
OH.

_______________________________

PRODUCT
Product is custom made sheep/goat feed packaged in 100 lb. poly bags.
The product has no labeling. Recall # V-002-5.
CODE
The product has no lot code. All custom made feed purchased between June
24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated
September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is
prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 8 tons.
DISTRIBUTION
OH.

_______________________________

END OF ENFORCEMENT REPORT FOR October 20, 2004

http://www.fda.gov/TSS

Public Health Service
Food and Drug Administration

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 9S9214421
Telephone: 425-486-8788
FAX: 425- 483-4996


November 18, 2004

VIA FEDEX

In reply refer to Warning Letter SEA 05-07

William B. Parrish, Chairman of the Board
Parrish & Heimbecker Limited
360 Main Street
Winnipeg, Manitoba, R3C 323 Canada

WARNING LETTER

Dear Mr. Parrish:

An inspection of your feed mill operation, Conway Feed, Inc., located at
18700 Main Street, Conway, Washington, conducted by a Washington State
Department of Agriculture Investigator, on June 17, 18 and 22, 2004, under
contract with the Food and Drug Administration (FDA), found significant
deviations from the requirements set forth in Title 21, Code of Fedederal
Regulations, Part 589.2000 (21 CFR 589.2000) Animal Proteins Prohibited in
Ruminant Feed. The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations
cause products being manufactured and/or distributed by this facility to be
adulterated within the meaning of Section 402(a)(4) and misbranded within
the meaning of Section 403(a) and 403(f) of the Federal Food, Drug and
Cosmetic Act (the Act).

Our investigation found that because you failed to adequately inspect the
label of a raw material, au ingredient with the cautionary statement Do Not
Feed to Cattle or Other Ruminants was used in the manufacture of your
finished product, Game Bird Crum/Pellet. Your final product, however, did
not have the cautionary statement. Because this fish meal may have contained
prohibited animal proteins, any product produced with it must have the
cautionary label. See 21 CFR 589.2000(d)(1).

The investigation also revealed that the label of your Game Bird Crum/Pellet
feed did not list fish meal as an ingredient. According to the information
we collected during the inspection fish meal is routinely added to this
ration. All ingredients are required to be listed on the label in descending
order of predominance by weight. See 21 CFR 501.4(a).

The above is not intended to be an all-inclusive list of deviations from the
regulations. As a manufacturer of materials intended for animal feed use,
you are responsible for assuring that your overall operation and the
products you manufacture and distribute are in compliance with the law. We
have enclosed a copy of the FDAs Small Entity Compliance Guide to assist
you with complying with the regulation.

You should take prompt action to correct these violations, and you should
establish a system whereby such violations do not recur. Failure to promptly
correct these violations may result in regulatory action without further
notice, such as seizure and/or injunction.

You should notify this office in writing within 15 working days of receipt
of this letter, of the steps you have taken to bring your firm into
compliance with the Iaw. Your response should include an explanation of each
step being taken to correct the violations, and prevent their recurrence. If
corrective action cannot be completed in 15 working days, state the reason
for the delay and the date by which the corrections will be completed.
Include copies of any available documentation demonstrating that corrections
have been made.

Please send your reply to the Food and Drug Administration, Attention: Bruce
Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington
98021. If you have questions regarding any issue in this letter, please
contact Mr. Bruce Williamson at (425) 483-4976.

If you have questions regarding any issue in this letter, please contact Mr.
Bruce Williamson at (425) 483-4976.

Sincerely,

/S/

Charles M. Breen
District Director

cc: Scott C. McKnight, General Manager
Conway Feed Inc.
18700 Main Street
Conway, WA 98238-0576

Enclosure: Form FDA 483
Small Entity Compliance Guide

http://www.fda.gov/foi/warning_letters/g5086d.htm


Public Health Service
Food and Drug Administration

New Orleans District
Southeast Region
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
Telephone: 504-253-4519
Facsimile: 504-253-4520


December 9, 2004

WARNING LETTER NO. 2005-NOL-07

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. Alan O. Bostick, President
Sunshine Mills, Inc.
500 6th Street SW
Red Bay, Alabama 35582

Dear Mr. Bostick:

On September 7 and 14, 2004, a United States Food and Drug Administration
(FDA) investigator inspected your animal feed manufacturing facility,
located at 2103 South Gloster Street, Tupelo, Mississippi. The inspection
revealed significant deviations from the requirements set forth in Title 21,
Code of Federal Regulations, Part 589.2000 (21 CFR 589.2000) - Animal
Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent
the establishment and amplification of Bovine Spongiform Encephalopathy
(BSE). Because you failed to follow the requirements of this regulation,
products you manufactured and/or distributed are misbranded within the
meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act
(the Act).

The inspection indicated you manufacture products containing beef meat and
bone meal. Products that contain or may contain protein derived from
mammalian tissues, as defined by 21 CFR 589.2000(a), and are intended for
use in animal feed, must be labeled with the cautionary statement Do not
feed to cattle or other ruminants. This is required by 21 CFR
589.2000(c)(1)(i). Your firm failed to label your non-ruminant products with
this required cautionary statement. Specifically, the products that
contained protein derived from mammalian tissues but lacked the required
statement included your Happy Fisherman and Premier catfish feeds. Under
21 CFR 589.2000(g)(2), failure of these feeds to bear the required
cautionary statement causes them to be misbranded under Section 403(a)(1) of
the Act.

The above is not intended to be an all-inclusive list of deviations from
regulations. As a manufacturer of materials intended for animal feed use,
you are responsible for assuring your overall operation and products you
manufacture and distribute are in compliance with the law. A copy of FDAs
Small Entity Compliance Guide is enclosed to assist you in complying with
the regulations.

You should take prompt action to correct these violations and establish a
system whereby such violations do not recur. Failure to promptly correct
these violations may result in regulatory action, such as seizure and/or
injunction, without further notice.

We are aware you sent label corrections for the last shipment of each of the
mislabeled products. You also stated you plan [redacted] However, you should
notify this office in writing, within 15 working days of the receipt of this
letter, of the steps you have taken to bring your firm into compliance with
the law. Your response should include an explanation of each step taken to
correct violations and prevent their recurrence. If corrective action cannot
be completed within 15 working days, state the reason for delay and date by
which corrections will be completed. Include copies of any available
documentation demonstrating corrections have been made.

Please send your reply to the U.S. Food and Drug Administration, Attention:
Nicole F. Hardin, Compliance Officer, at the above address. If you have
questions regarding any issue in this letter, please contact Ms. Hardin at
(504) 253-4519.

Sincerely,

/s

H. Tyler Thornburg
District Director
New Orleans District

Enclosures:
FDA Form 483
FDAs Small Entity Compliance Guide
21 CFR 589.2000

cc:
[redacted]
General Manager
Sunshine Mills, Inc.
2103 South Gloster Street
Tupelo, Mississippi 38801

http://www.fda.gov/foi/warning_letters/g5105d.htm


Public Health Service
Food and Drug Administration

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145


January 12, 2005

Ref: 2005-DAL-WL-11

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. William L. Brown, Owner
Brown Cattle Company
1 Feed Lot Road
P.O. Box 281
Petrolia, TX 76377

Dear Mr. Brown:

An inspection of your ruminant feeding operation located at 1 Feed Lot Road,
Petrolia, Texas, was conducted on August 24 and September 8, 2004 by an
Investigator from the Food and Drug Administration (FDA). The inspection
found significant deviations from
the requirements set forth in Title 21, Code of Federal Regulations, Part
589.2000 - Animal Proteins Prohibited in Ruminant Feed (21 CFR 589.2000).
This regulation is intended to prevent the establishment and amplification
of Bovine Spongiform Encephalopathy (BSE).

Our inspection revealed that you feed prohibited material, as defined by 21
CFR 598.2000(a), to ruminants. This prohibited material consists of human
food processing waste, which is derived from corn dog manufacturing and
contains hot dogs and corn dogs. Inspected meat products that have been
cooked and offered for human food and further heat processed for animal feed
are not prohibited material. This is more fully described in Guidance for
Industry 76, which was previously provided to your firm. The human food
processing waste you are using has not been further heat processed. The
failure to further heat process this material causes the feed to be
adulterated within the meaning of Section 402(a)(2)(C)(i) of the Federal,
Food, Drug, and Cosmetic Act.

During our previous inspection on January 17, 2002, copies of the BSE
Guidance documents 69, 70 and 76 and 21 CFR 589.2000, the BSE regulation,
were provided to and discussed with you.

Failure to correct these violations may result in FDA taking regulatory
action without further notice including, but not limited to, seizure and/or
injunction.

It is necessary for you to take action on this matter now. Please notify
this office in writing within fifteen (15) working days from the date you
received this letter. Your response should specifically identify the actions
you are taking to correct the violations and provide specific timeframes for
achieving compliance. Also, as part of your written response, you should
provide information regarding the current feeding practices followed at your
facility and information pertaining to the planned marketing of your
animals. Your reply should be sent to Edwin Ramos, Compliance Officer, at
the above stated address. If you have any questions concerning the stated
matters, you may contact Mr. Ramos at 214-253-5218.

Sincerely,

/s/

Michael A. Chappell

Dallas District Director

http://www.fda.gov/foi/warning_letters/g5175d.htm


Public Health Service
Food and Drug Administration

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145

February 7, 2005

Ref: 2005-DAL-WL-12

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Dwayne Woody, Owner
W.W. Cattle Company
6391 Old Agnes Road
Poolville, TX 76487

Dear Mr. Woody:

An inspection of your feed manufacturing operation located at 6391 Old Agnes
Road, Poolville, Texas, was conducted on August 27 and September 2, 2004 by
an Investigator from the Food and Drug Administration (FDA). The inspection
found significant deviations from the requirements set forth in Title 21,
Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in
Ruminant Feed (21 CFR 589.2000). This regulation is intended to prevent the
establishment and amplification of Bovine Spongiform Encephalopathy (BSE).
Because you failed to follow the requirements of this regulation, the corn
dogs containing cooked meat and other ingredients used for manufacturing
ruminant feed are adulterated within the meaning of Section 402(a)(2)(C)(i)
and misbranded within the meaning of Section 403(a)(1) of the Federal, Food,
Drug and Cosmetic Act (the Act).

The use of protein derived from mammalian tissues, as defined in 21 CFR
589.2000(a)(1), as an animal feed ingredient or in animal feeds must comply
with the requirements of 21 CFR 589.2000. That regulation provides that the
use of protein derived from mammalian tissues in ruminant feed is
prohibited. The definition of "protein derived from mammalian tissues"
excludes inspected meat products which have been cooked and offered for
human food, such as the corn dogs you receive, that have been further heat
processed for use in animal feed. This requirement was previously
communicated to you in an April 3, 2001 letter from the Texas State Feed and
Fertilizer Control Service. In the absence of the required further heat
processing, such products for use in ruminant feeds are adulterated under
Section 402(a)(2)(C)(i) of the Act.

Our inspection revealed that whole corn dogs which contain protein derived
from mammalian tissues and are sold by your firm to the [redacted] for use
in ruminant feed are not subjected to further adulterated feed under Section
402(a)(2)(C)(i) of the Act.

In addition, because the whole corn dogs are not subjected to further heat
processing and are thus not exempt from the regulation, they must bear the
caution statement, "Do not feed to cattle or other ruminants." Our
inspection revealed that they do not bear this caution statement, which
causes them to be misbranded animal feed under Section 403(a)(1) of the Act.

Copies of the BSE Guidance documents 69, 70 and 76 were provided to Mr.
Billy J. Brooks, General Manager, and further discussed by personnel from
the Texas Feed and Fertilizer Control Service. Also, you received a copy of
the 21 CFR 589.2000, the BSE regulation which was again explained in more
specific detail. These serious violations of the law may result in FDA
taking regulatory action without further notice to you. These actions
include, but are not limited to, seizure and/or a court injunction against
further sale of protein derived from mammalian tissues for use in ruminant
feed or ruminant feed containing such materials.

It is necessary for you to take action on this matter now. Please notify
this office in writing within fifteen (15) working days from the date you
received this letter. Your response should specifically identify the actions
you are taking to correct the violations that would involve the continued
use of corn dogs to manufacture ruminant feed and provide specific
timeframes for achieving compliance. Your reply should be sent to Edwin
Ramos, Compliance Officer, at the above stated address. If you have any
questions concerning the stated matters, you may contact Mr. Ramos at
214-253-5218.

Sincerely,
/s/

Michael A. Chappell
Dallas District Director

http://www.fda.gov/foi/warning_letters/g5184d.htm


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.


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

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


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

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08
d?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?O
penDocument&AutoFramed

snip...CONTINUE...TSS

CRS-8

Testing Issues

Publicizing Test Results. In late June 2004, USDA had announced that
preliminary

screening tests had shown "inconclusive" (i.e., possible positive) results
for BSE in two

animals. They emphasized that neither animal, whose whereabouts they
declined to identify,

had entered the food supply and that they posed no safety threat. Subsequent
tests at the

Ames laboratory found that neither animal had BSE.

On November 18, 2004, another "inconclusive" was reported by USDA. After
further,

confirmatory testing, USDA announced on November 23 that this test sample
also was

negative for BSE. At their start, officials had warned the public that the
rapid screening tests

might produce so-called false positives that later may prove to be BSE
negatives. Still, the

department had come under intense criticism for both its test sampling
procedures and its

reporting of results. For example, cattle markets were volatile during the
several days it took

to conduct more rigorous tests on the first two inconclusives: the industry
first reacted

negatively, and then prices then seemed to rise and fall in response to
rumors about the

animals' type, location, and status.

Officials had defended their decision to make preliminary results known as
quickly as

possible. They argued further that even if subsequent testing were to find a
U.S. cow to have

BSE, the various BSE safeguards now in place would protect public health by
assuring that

no infective materials reach consumers (or could spread to other animals).
By early August

USDA had altered its announcement policy. Now, if the initial screening test
is

"inconclusive," the department will screen two more samples from the same
carcass, and

only make an announcement if one of the two samples also tests
inconclusively, and

necessitates further testing at the Ames laboratory. (This occurred in the
November case.)

Testing Protocol. BSE testing matters were the focus of a joint hearing held
July 14,

2004, by the House Government Reform and Agriculture Committees. USDA's
Inspector

General (IG) testified on a draft OIG report which cites a number of
limitations in the

department's expanded surveillance plan. For example, testing results may be
unreliable

because the plan: is not truly random because participation is voluntary;
assumes that BSE

is confined only to the high-risk cattle population while other studies show
that healthylooking

animals could have BSE; does not include a process for obtaining animals
that die

on farms; cannot obtain a statistically appropriate geographical
representation of the cattle

population; does not allow APHIS to find and test enough cattle in the
high-risk population.

The final OIG report, issued in late August 2004, generally parallels the
preliminary findings.

Secretary Veneman and other USDA officials defended their testing, noting
among

other things that the OIG observations were based on the plan before it was
implemented and

that many of the report's recommendations have been addressed. APHIS is
receiving a

representative mix of samples from all locations, reaching deeply into the
higher-risk cattle

population, and the statistical basis for the sampling is sound, officials
asserted. They added

that adjustments have been made as the result of ongoing assessments of the
program.

After it was widely reported that USDA had failed to test a suspicious cow
in Texas

in late April 2004, the department announced revisions in its BSE sampling
procedures.

(The cow was condemned so its meat never entered the food supply, USDA
said.) USDA

stated that it was retraining inspectors, mandating that FSIS rather than
APHIS personnel

IB10127 01-13-05

collect brain samples, and requiring that all cattle condemned antemortem
(before slaughter

for human food) be tested for BSE, not just those with suspicious symptoms.
In a review of

the Texas case, OIG found that officials had erred - but did not engage in
intentional

misconduct or knowingly provide misleading information - in failing to to
test the

suspicious Texas cow. OIG reached similar conclusions about how the
department had

characterized the Washington BSE cow as nonambulatory in December 2003.

Private Testing. Several smaller firms (notably Creekstone Farms Premium
Beef)

have expressed interest in testing all of their cattle for BSE - as the
Japanese were

demanding. USDA has asserted that 100% testing is not scientifically based.
USDA, which

claims authority to approve test methods and their uses under the
Virus-Serum-Toxin Act,

denied the Creekstone request. USDA and meat industry officials are
concerned, among

other things, that consenting to 100% testing would undermine trade
negotiations, be costly,

and misleadingly imply that BSE-tested meat is safer than untested meat.9

snip...

A CLOSER LOOK AT THIS ;

USDA vets question agency's mad cow lab

By Steve Mitchell
United Press International
Published 2/9/2004 7:06 PM

WASHINGTON, Feb. 9 (UPI) -- The federal laboratory in Ames, Iowa, that
conducts all of the nation's tests for mad cow disease has a history of
producing ambiguous and conflicting results -- to the point where many
federal meat inspectors have lost confidence in it, Department of
Agriculture veterinarians and a deer rancher told United Press
International.

The veterinarians also claim the facility -- part of the USDA and known as
the National Veterinary Services Laboratories -- has refused to release
testing results to them and has been so secretive some suspect it is
covering up additional mad cow cases. ...

http://www.upi.com/view.cfm?StoryID=20040209-061848-3665r


UPI Exclusive: No mad cow tests in Wash.

By Steve Mitchell
United Press International
Published 1/15/2004 2:46 PM

WASHINGTON, Jan. 15 (UPI) -- Federal agriculture officials did not test any
commercial cattle for mad cow disease through the first seven months of 2003
in Washington state -- where the first U.S. case of the disease was detected
last month -- according to records obtained by United Press International.

The U.S. Department of Agriculture's records of mad cow screenings,
conducted on 35,000 animals between 2001 to 2003, also reveal no animals
were tested for the past two years at Vern's Moses Lake Meats, the
Washington slaughterhouse where the mad cow case was first detected.

In addition, no mad cow tests were conducted during the two-year period at
any of the six federally registered slaughterhouses in Washington state.
This includes Washington's biggest slaughterhouse, Washington Beef in
Toppen ish -- the 17th largest in the country, which slaughters 290,000 head
per year -- and two facilities in Pasco that belong to Tyson, the largest
beef slaughtering company in the United States.

In 2002, nearly every test conducted in Washington was on animals from
Midway Meats in Centralia, the packing plant where Vern's Moses sent the
infected cow carcass. The meat was distributed to several states where some
people apparently consumed it, raising concerns about the possibility of
contracting the human equivalent of mad cow, an always fatal, brain-wasting
condition known as variant Creutzfeldt-Jakob disease. ...

http://www.upi.com/view.cfm?StoryID=20040114-041124-1470r


FDA Statement

FOR IMMEDIATE RELEASE
Statement
May 4, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA


Statement on Texas Cow With Central Nervous System Symptoms

On Friday, April 30 th , the Food and Drug Administration learned that a cow
with central nervous system symptoms had been killed and shipped to a
processor for rendering into animal protein for use in animal feed.

FDA, which is responsible for the safety of animal feed, immediately began
an investigation. On Friday and throughout the weekend, FDA investigators
inspected the slaughterhouse, the rendering facility, the farm where the
animal came from, and the processor that initially received the cow from the
slaughterhouse.

FDA's investigation showed that the animal in question had already been
rendered into "meat and bone meal" (a type of protein animal feed). Over the
weekend FDA was able to track down all the implicated material. That
material is being held by the firm, which is cooperating fully with FDA.

Cattle with central nervous system symptoms are of particular interest
because cattle with bovine spongiform encephalopathy or BSE, also known as
"mad cow disease," can exhibit such symptoms. In this case, there is no way
now to test for BSE. But even if the cow had BSE, FDA's animal feed rule
would prohibit the feeding of its rendered protein to other ruminant animals
(e.g., cows, goats, sheep, bison).

FDA is sending a letter to the firm summarizing its findings and informing
the firm that FDA will not object to use of this material in swine feed
only. If it is not used in swine feed, this material will be destroyed. Pigs
have been shown not to be susceptible to BSE. If the firm agrees to use the
material for swine feed only, FDA will track the material all the way
through the supply chain from the processor to the farm to ensure that the
feed is properly monitored and used only as feed for pigs.

To protect the U.S. against BSE, FDA works to keep certain mammalian protein
out of animal feed for cattle and other ruminant animals. FDA established
its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that
the disease spreads by feeding infected ruminant protein to cattle.

Under the current regulation, the material from this Texas cow is not
allowed in feed for cattle or other ruminant animals. FDA's action
specifying that the material go only into swine feed means also that it will
not be fed to poultry.

FDA is committed to protecting the U.S. from BSE and collaborates closely
with the U.S. Department of Agriculture on all BSE issues. The animal feed
rule provides crucial protection against the spread of BSE, but it is only
one of several such firewalls. FDA will soon be improving the animal feed
rule, to make this strong system even stronger.

####

http://www.fda.gov/bbs/topics/news/2004/NEW01061.html

TSS

------------------------------------------------------------------------
Date
------------------------------------------------------------------------

APHIS Statement: June 29 Inconclusive BSE Test is Negative
07/02/2004

APHIS Statement: First Inconclusive BSE Test is Negative
06/30/2004

APHIS Statement Regarding Second Inconclusive BSE Test
06/29/2004

APHIS Statement Regarding First Inconclusive BSE Test
06/25/2004

Week 25
(11/1511/21)
7,900
1
Negative
0
7,901

Week 5
(6/287/4)
3,500
1
Negative
0
3,501
Week 4
(6/216/27)
3,254
1
Negative
0
3,255


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


USDA orders silence on mad cow in Texas

By Steve Mitchell
United Press International
Published 5/11/2004 10:16 PM

WASHINGTON, May 11 (UPI) -- The U.S. Department of Agriculture has issued an
order instructing its inspectors in Texas, where federal mad cow disease
testing policies recently were violated, not to talk about the cattle
disorder with outside parties, United Press International has learned.

The order, sent May 6 by e-mail from the USDA's Dallas district office, was
issued in the wake of the April 27 case at Lone Star Beef in San Angelo, in
which a cow displaying signs of a brain disorder was not tested for mad cow
disease despite a federal policy to screen all such animals.

The deadly illness also is known as bovine spongiform encephalopathy.

Both the USDA and its Inspector General -- amid allegations that an offsite
supervisor overruled the opinion of the inspectors onsite and made the final
decision not to test the animal -- have opened up investigations to
determine why agency policy was violated.

The order, which was obtained by UPI, was issued by Ijaz Qazi, circuit
supervisor for the USDA's Food Safety and Inspection Service's Dallas
district, which covers the entire state. It reads: "All BSE inquiries MUST
be directed to Congressional Public Affairs Phone 202-720-9113 attention Rob
Larew OR Steve Khon. This is an urgent message. Any question contact me.
Ijaz Qazi."

Although the language might sound innocuous, experienced inspectors familiar
with USDA parlance have taken to referring to the notice as a "gag order."

The National Joint Council of Food Inspection Locals -- the national
inspectors union -- considers the order a violation of inspectors' free
speech rights and is considering legal action against the USDA for breaching
the labor agreement they have with the agency.

Inspectors alleged the order also suggests the agency is concerned about its
personnel leaking damaging information about either the Texas case or the
USDA's overall mad cow disease surveillance program, which has come under
fire since the discovery of an infected cow in Washington state last
December.

"Anytime the government suppresses an individual's freedom of speech, that's
unconstitutional," Gary Dahl, president of Local 925, the Colorado
inspectors union, told UPI.

Stanley Painter, chairman of the National Joint Council, said the USDA has
sent out notices in the past stating inspectors cannot talk to reporters.

"It's an intimidation thing," Painter told UPI. Inspectors have the right to
talk to anybody about any subject, as long as they clarify they are not
speaking on behalf of the USDA and they are not doing it on government time,
he said.

USDA spokesman Steven Cohen said he was not familiar with the notice from
the Dallas office. He said he would look into it, but did not respond by
UPI's publication time. In general, Cohen said, "There's an expectation any
statement on behalf of the agency would come from the office of
communications (in Washington.)"

Asked if employees could speak freely as long as they clarified that their
views did not reflect those of the agency, Cohen said, "We'd rather that
agency policy be communicated by those in a position to speak for the
agency."

Qazi told UPI the notice was not issued in conjunction with the Texas case
and it was routine agency practice that outside inquiries be referred to the
Washington office. He said inspectors are free to talk to outside parties,
including reporters, and he did not consider the e-mail a violation of the
labor agreement with the inspectors.

Painter said the USDA's efforts to keep its employees from talking about mad
cow would be better spent "with issues like protecting the consuming public
instead of trying to hide things." He added he would "just about bet his
last nickel" agency management was attempting to suppress information about
the Texas case.

"To keep federal employees from reporting government waste, misuse of
appropriations -- those types of things -- that's not a good thing either,"
Dahl said. "If there is something wrong, let's get it out in the open --
let's get it fixed. We're working for the public, the American consumers. I
think they have the right to know this," he said.

"And believe me there's so many indicators saying that the USDA's mad cow
testing program is broken," Dahl added.

At least one member of Congress, Sen. Tom Harkin, D-Iowa, agrees.

Harkin, a long-time critic of the USDA, sent a letter to Agriculture
Secretary Ann Veneman on Monday, saying the Texas incident "calls into
question the effectiveness and reliability of USDA's current and proposed
surveillance system."

The USDA has proposed testing more than 200,000 cows -- or 10 times its
current rate -- in an expanded program scheduled to begin June 1. Harkin
wrote in the five-page letter, however, that given the realities of the
cattle industry, it is "quite doubtful" the USDA will be able to test that
many cows, particularly because it had difficulty finding 20,000 last year.

"We simply cannot tolerate a BSE testing system that fails to give valid
answers to critical questions for U.S. consumers and foreign customers,"
Harkin said in the letter, which sharply criticizes the agency's failure to
address explicitly how its new surveillance program will be implemented.

"We look forward to receiving (Harkin's) letter and having the opportunity
to review it and respond to him," USDA spokesman Ed Loyd told UPI. "USDA has
acknowledged there was a failure in not testing that cow in Texas for BSE,
so we are all working to ensure that does not occur again."

Jim Rogers, a spokesman for USDA's Animal and Plant Health Inspection
Service, which oversees the agency's mad cow surveillance program, told UPI
the agency has tested about 15,500 animals since fiscal year 2004 began, on
Oct. 1, 2003. However, the agency has refused to identify the states and
facilities from which the cows originated. Rogers said UPI would have to
seek that information through the Freedom of Information Act.

The question is central to the USDA's implementation of its expanded
surveillance program. Downer cows -- those unable to stand or walk -- made
up the bulk of the animals the agency tested for mad cow in previous years,
but these were banned from being slaughtered for human consumption in
December. This means the agency inspectors no longer can obtain brain
samples from these cows at slaughterhouses as they could in the past.

Furthermore, the USDA has not provided any evidence it has worked out
agreements with rendering facilities or ranchers, where downers and dead
cows are now most likely to be found, to obtain the extra animals for
testing.

Loyd said the agency is "working very hard to get animals on the farm that
would never show up in a processing facility," and he was "not aware of any
issues" that would delay the launch of the new program.

However, he was unable to provide the names or locations of the rendering
facilities where the agency will be obtaining cow brains for BSE testing. He
said he would look into it but did not return two follow-up phone calls from
UPI before publication.

--

Steve Mitchell is UPI's Medical Correspondent. E-mail sciencemail@upi.com

Copyright © 2001-2004 United Press International

http://www.upi.com/view.cfm?StoryID=20040511-015527-4917r


USDA did not test possible mad cows

By Steve Mitchell
United Press International
Published 6/8/2004 9:30 PM

WASHINGTON, June 8 (UPI) -- The U.S. Department of Agriculture claims it
tested 500 cows with signs of a brain disorder for mad cow disease last
year, but agency documents obtained by United Press International show the
agency tested only half that number.

USDA officials said the difference is made up in animals tested at state
veterinary diagnostic laboratories, but these animals were not tested using
the "gold standard" test employed by the agency for confirming a case of the
deadly disease. Instead, the state labs used a less sensitive test that
experts say could miss mad cow cases.

In addition, the state lab figures were not included in a March 2004 USDA
document estimating the number of animals most likely to be infected among
U.S. herds, and apparently were not given to a congressional committee that
had requested agency data on the number of cows with brain disorder signs
that had been tested for the disease.

"This is just adding to the demise of USDA's credibility," said Felicia
Nestor, senior policy adviser to the Government Accountability Project, a
group in Washington, D.C., that works with federal whistleblowers.

"If the USDA is going to exclude from testing the animals most likely to
have the disease, that would seem to have a very negative impact on the
reliability of their conclusion," Nestor told UPI.

Nestor, who has monitored the USDA's mad cow surveillance program closely
for several years, asked, "Are they deliberately avoiding testing animals
that look like they have the disease?"

Concerns about the number of cows in U.S. herds with brain disorder symptoms
have been heightened due to the recent case in Texas, in which USDA
officials failed to test an animal with such symptoms, also known as central
nervous system or CNS signs. This was a violation of USDA policy, which
stipulates all CNS cows should be tested because they are considered the
most likely to be mad cow infected. To date, the Washington cow that tested
positive last December is the only confirmed case of mad cow disease -- also
known as bovine spongiform encephalopathy -- among U.S. herds.

The Texas incident has alarmed the public and members of Congress because
humans can contract a fatal brain disorder called variant Creutzfeldt-Jakob
disease from consuming meat infected with the mad cow pathogen. If the
USDA's surveillance program is allowing the riskiest cows to go untested, it
raises concerns about the ability of the monitoring system to detect the
disease reliably in U.S. herds, Rep. Henry Waxman, D-Calif., charged in a
May 13 letter to Agriculture Secretary Ann Veneman.

Dr. Peter Lurie, of the consumer group Public Citizen, said CNS cows should
be the one category that absolutely has to be tested to have a sound
surveillance system.

"CNS animals are far and away the most important animals to test," said
Lurie, who has done several analyses of the USDA's mad cow surveillance
program.

"If there's any category that needs 100 percent testing, that's it, because
they would be the most likely place to find mad cow in America," he told
UPI. "Any CNS cow that slips into the food supply represents a major case of
malpractice by USDA, and similarly, the failure to test the brain of that
animal to see if it was indeed infected is really a failure to protect the
public."

USDA officials said the agency has no estimate on how many CNS cows occur in
U.S. herds. But spokesman Ed Loyd has told UPI, and at least one other media
outlet, that 500 CNS cows were tested in fiscal year 2003. Yet agency
testing records for the first 10 months of FY 2003, obtained by UPI under
the Freedom of Information Act, show only 254 animals that fall under the
CNS category -- or about half the number Loyd cited.

After failing to respond to repeated requests from UPI for clarification of
the apparent discrepancy, Loyd finally offered the explanation that an
additional 45 CNS cows were tested by the USDA during the final two months
of FY 2003. The remainder, he said, was made up by CNS cases tested at
various state veterinary diagnostic laboratories.

"We also include data reported to us from state veterinary diagnostic
laboratories, and all of these are CNS cases that have been tested for BSE
using a histological examination," Loyd said.

"We were not using any other labs during this period, other than (the USDA
lab), to run the IHC tests for BSE, which is the gold standard," he said.
"This (state laboratory) information contributes important data to our
surveillance effort."

However, the state labs did not use the immunohistochemistry test, which the
USDA has called the "gold standard" for diagnosing mad cow disease. Instead,
the labs used a different test called histopathology, which the USDA itself
does not use to confirm a case, opting instead for the more sensitive IHC
test.

The histopathology test, unlike the IHC test, does not detect prions --
misfolded proteins that serve as a marker for infection and can be spotted
early on in the course of the illness. Rather, it screens for the
microscopic holes in the brain that are characteristic of advanced mad cow
disease.

According to the USDA's Web site, histopathology proves reliable only if the
brain sample is removed soon after the death of the animal. If there is too
much of a delay, the Web site states, it can be "very difficult to confirm a
diagnosis by histopathology" because the brain structures may have begun to
disintegrate.

That is one reason the agency began using the IHC test -- it can confirm a
diagnosis if the brain has begun disintegrating or been frozen for shipping.

The state labs used histopathology to screen 266 CNS cases in FY 2003, as
well as 257 cases in FY 2002, according to Loyd. He did not explain why this
information was not included in the testing records the agency provided to
UPI and has not responded to requests for the identity of the state labs.

Linda Detwiler, a former USDA veterinarian who oversaw the agency's mad cow
testing program, told UPI the histopathology test probably is adequate for
screening CNS cows. If they have mad cow disease, she said, it would likely
be an advanced stage that should be obvious.

Other mad cow disease experts, however, said having a back-up test such as
IHC would be advisable, because histopathology tests sometimes can miss
evidence of infection.

The Food and Agriculture Organization of the United Nations offers similar
recommendations in its protocol for conducing a histopathology test. The
protocol states that even if histopathology is negative, "further sampling
should be undertaken" in cases "where clinical signs have strongly suggested
BSE" -- a criteria that includes all of the cows tested at the state labs.

The USDA seems to agree on the need for a back-up test. Its expanded
surveillance program, which began June 1, calls for using IHC -- or another
test called Western blot -- to confirm any positives found on rapid tests.
The March 15 document that describes the new program does not mention using
histopathology to confirm cases of mad cow disease.

"Subtle changes can be missed on histopathology that would probably not be
as easy to miss using IHC," said Elizabeth Mumford, a veterinarian and BSE
expert at Safe Food Solutions in Bern, Switzerland, a company that provides
advice on reducing mad cow risk to industry and governments.

"Therefore I believe it is valuable to run (histopathology)," Mumford told
UPI.

She noted that in Europe, two tests -- neither one the histopathology
test -- are used to ensure no cases are missed. A rapid test is used
initially for screening, followed by IHC as a confirmatory test.

Markus Moser, a molecular biologist and chief executive officer of the Swiss
firm Prionics, which manufactures tests for detecting mad cow disease,
agrees about the possibility of a case being missed by histopathology.

"There were cases which were (histopathology) negative but still clearly
positive with the other (testing) methods," Moser said. "BSE testing based
on histology on sub-optimal tissue was probably one of the reasons why
Germany was allegedly BSE-free until our test discovered that they were not"
in 2000, Moser told UPI.

He agreed with Detwiler that histopathology should be suitable for most
cases of CNS cows, but added it still can fail to detect the disease in some
CNS cases -- particularly if the sample is not optimum.

"It is difficult, if not impossible, to distinguish the subtle changes in a
diseased brain from artifacts like ruptures in the tissue due to tissue
damage during the sampling, transport or preparation," he said.

Loyd asserted the additional CNS cases from the state labs actually yielded
a total of 565 such cows the USDA had tested -- 65 more than his original
figure of 500. Whether the USDA considers its total to be 500 or 565,
however, either figure would exceed the agency's own estimates for the total
number of such cows that it identifies annually.

According to data the USDA provided to the House Committee on Government
Reform, and numbers the agency included in the March document about its
expanded surveillance plan, only 201 to 249 CNS cows are identified at
slaughterhouses. Approximately 129 additional cases occur on farms annually.
At most, that yields a combined total of 378 CNS cows, or nearly 200 less
than the 565 Loyd claims the agency tested.

The USDA surveillance plan document makes no mention of the number of CNS
animals tested at state veterinary diagnostic labs. The figure also does not
appear to be included in the agency's estimates of the number of high-risk
animals that occur in the United States each year. The latter number was
used to help the USDA calculate the number of animals it will screen for mad
cow disease in its expanded surveillance plan.

USDA officials also did not include the state lab figures in response to a
question from the House Committee on Government Reform, a source close to
the issue told UPI. The committee, on which Waxman is the ranking Democrat,
had requested in a March 8 letter to Veneman that she provide "the number of
BSE tests that were conducted on cattle exhibiting central nervous system
symptoms" for each of the last five years.

Loyd did not respond to a request from UPI asking why agency officials did
not provide that information to the committee or include it in USDA's
explanation of its expanded surveillance plan.

The committee has taken note of the CNS issue and plans to delve into it
further in a hearing slated for sometime in the next few months.

"The committee will explore this and other issues surrounding USDA and BSE
testing at a hearing later this summer," Drew Crockett, spokesman for the
committee, told UPI.

--

Steve Mitchell is UPI's Medical Correspondent. E-mail sciencemail@upi.com

Copyright © 2001-2004 United Press International

http://www.upi.com/view.cfm?StoryID=20040608-014607-3865r

Q&A Dr. Jean-Philippe Deslys

1. What is the standard regime for testing of suspect animals in the EU?

The regime is an initial screening by a high-output test, the Bio-Rad test.
If a result raises suspicion, a confirmatory test is conducted with the
Western blot test.

2. How long has this been the case?

Its a fairly recent development. Only recently has the Western blot test
become sensitive enough, with the addition of phospohtungstic acid
precipitation step. The Bio-Rad test (which Deslys helped develop) is
extremely sensitive, and the standard Western blot is extremely reliable
with high-signal test results. However, it had to be made more sensitive for
low-signal (samples with low density of malformed prions) samples. It has
been made more sensitive.

Reproducibility is the problem with the IHC test. It is not standardized;
depending on the lab and its protocols, or even on the technician involved
in the test, one can get conflicting results.

3. Is there a way to measure the three tests in sensitivity, accuracy and
objectivity?

Historically, yes. The IHC was the gold standard at one point, but we have
shifted to the Western blot. It requires less work, it is more sensitive and
its results are reproducible. IHC relies on localization. If you have a weak
signal case, you may get lucky and test a spot with a high concentration of
prions. But the opposite it true too; you can miss an infection by testing a
sample with low concentrations. Western blot is much better for low signal
situations.

4. The USDA in 2003 used the Western blot to confirm the BSE case in
Washington state, and it sent samples to the U.K. for independent testing.
In the case this November, which it announced was negative, it instead used
the IHC test and did not send samples to the U.K. Is this good science?

Its not logical. If you have two consecutive questionable screenings, you
do another test. I can only advise, its managements duty at USDA to make
the decisions. But when you have a discrepancy between the rapid test and
the IHC, it is only logical to confirm it with another test.

5. We are hearing now about a new strain of BSE, atypical BSE or aBSE. Or
BaSE. We have heard that IHC, the so-called gold standard, cannot detect the
variant. Is this true?

Yes. There have been a few cases, one in Italy, one in Belgium, one here in
France. It seems to only affect very old animals. The distribution in the
brain is very different than we see with BSE, it looks very different. The
IHC test will come back negative.

This his a very recent phenomenon. I have no opinion on its virulence. We do
not know where it comes from. It could be a version of sporadic infection.
Western blot caught them, but we would not even know it existed if we
werent running systematic testing in the EU.

BSE was around for a long time before we caught it and by then, it was
everywhere. It had become highly infectious. It probably amplified due to
low-temperature rendering. The disease was recycled through the food chain,
and was given time to amplify. By the time it was identified, even good
cooking couldnt eliminate it.

I cant stress enough that systematic testing is necessary. Withdrawing all
positives from the food chain is the best way to break the cycle.

What can happen with testing of only cattle that are clearly at risk is that
several can remain undetected. Canada has tested about 30,000 head of cattle
and has three positives. That would indicate that there are probably
undiscovered cases. And what happens then is that the disease is allowed to
amplify. You have to maintain testing.

When people choose to protect their economic interests over public health,
it can have a boomerang effect. It happened all through Europe. They always
deny; its not OUR problem, it is our neighbors problem. And then a single
case is discovered and the public reacts. The economic results are
devastating. It would be better to just assume BSE is present and use
systematic testing as protection. That way, the public is reassured that it
is not entering the food supply.

By systematic testing, I mean doing as we do in the EU, which is to test
every animal over 30 months of age when it is slaughtered. In Europe, three
times as many cases of BSE have been caught by systematic testing as by
clinical testing (of clearly sick animals). In 2004, eight clinical cases
were discovered, 29 were discovered at rendering plants, and 17 at
slaughter. We should be using these tests as a weapon to protect the public
and to give them assurance that the food supply is being protected.

6. USDAs list of specified risk materials excludes some products, like
blood and bone meal, that are banned in the EU and UK. Is our feed supply
safe?

With SRMs, where do you stop? Tests have found prions in meat, nerves travel
through meat, and so on. The main infectivity is in the brain and the spinal
cord. A blood and bone meal ban in animal feed is not really necessary,
because except in cases of highly infective animals, it is unlikely that
they are dangerous in themselves. If you combine systematic testing and
targeted SRM removal, the brain and the spinal column in cattle over 30
months, you can have a compromise that is both safer and less costly than
expanded feed bans.

Certainly, you can stop the spread of BSE with a total ban on offal. But it
has to be a total ban. It cant be given to sheep or swine or poultry. It
would be very expensive and virtually impossible to accomplish. You can have
farmers using the wrong feed or transportation errors.

Systematic testing makes far more sense. I think of it as a thermometer. It
not only allows us to catch the disease, it also allows us to monitor its
progress. We can watch the levels of infectivity and if they start going up
instead of down, we can take measures.

To an extent, our environment is contaminated. About 10 percent of wild
animals test positive for TSEs. If you recycle these agents, they can evolve
and get more dangerous. This is probably what happened with BSE. It wasnt
very dangerous until it evolved to the disease we know today.

People complain that testing is very expensive. It is much more expensive to
kill and test whole herds.

7. In your opinion, is infected feed the sole method of transmission of BSE,
apart from the very rare maternal transmission?

Feed is the main problem. However, we are seeing some other possibilities,
including through fat and greases. Calves are fed milk extracts, with the
cream removed. To make it nutritious, they are using fat and grease from
cattle.

(FOLLOW QUESTION: Would that allow BSE to develop into an infective level in
cattle younger than 30 months, assuming they might be getting infected at a
younger age?)

8. You were involved in a study that tested two primates who were fed
infected brain tissue. One eventually died of TSE; the other survived. The
press reported that the main finding was that it would take something on the
order of 1.5 kilograms of infected matter to create an infection, but that
seems to be an oversimplification. Could you explain it further?

The findings suggest that as little as five grams is enough to infect. The
1.5 kilo figure is the amount of infected tissue that would have to be
ingested from an animal that would be below the threshold of infection, and
would test negative. In other words, even though a younger animal may be
developing the disease, it would take a considerable amount of tissue to
transmit the disease.

An animal could be just below the testing level, and not be particularly
dangerous. But that is why you have to keep testing. Once it reaches the
threshold, it can become highly infective.

9. BSE is a pretty horrifying disease, but overall, it has killed less than
200 humans, and only a handful in recent years. Listeria, by comparison,
kills thousands every year. Overall, how do you rate the threat from BSE?


The overall risk is not particularly high. Over two million infected animals
went into the food chain in Europe, 400,000 of them before the SRMs, the
brains and spinal column, were removed from the carcass. Less than 200 died,
and less than 4,000 are at risk of developing the disease. What we know now
is that one particle is not going to kill you. There has to be condensation
of the prions to be truly dangerous.

This is not a sterile world. But the danger is that now that the crisis
appears to be over, attention will turn elsewhere and that will allow the
disease to amplify again. Just as we stopped paying attention to AIDS when
medication seemed to control it, then were surprised when a new and more
infectious and aggressive strain appeared, we could be surprised by a more
serious strain of BSE. That is why I support systematic testing for the long
term. The object is to keep levels of BSE low, and to recognize the danger
if it suddenly pops back up. ...

SNIP...CONTINUE...TSS

6 See [http://www.fda.gov/cvm/index/updates/bse72001.htm] and
[http://www.gao.gov/].

7 Joshua Cohen and George M. Gray, Evaluation of the Potential Spread of BSE
in Cattle and

Possible Human Exposure Following Introduction of Infectivity into the
United States from Canada,

pp. 1-2 (undated 2003 report), Harvard Center for Risk Analysis, School of
Public Health,

[http://www.aphis.usda.gov/lpa/issues/bse/harvard_10-3/text_wrefs.pdf]. The
Harvard risk analysis

considered import as well as domestic practices in its assessment. Both the
GAO and the Harvard

study did note that noncompliance with the feed ban could occur at many
points in the feed chain.

Moreover, FDA does not actually test the feed for prohibited material.

CRS-4

Assessments of the BSE Safeguards

Some had criticized the effectiveness of the 1997 feed ban. For example, a
February

2002 GAO study (Mad Cow Disease: An Improvement in the Animal Feed Ban;
GAO-02-

183) reported that 364 out of 10,576 firms inspected by FDA were still out
of compliance.

FDA in July 2003 began to assert that industry compliance has been exceeding
99%.6

The GAO report also asserted that the FDA was using flawed data to track
compliance,

and had no clear enforcement strategy for firms that were not obeying the
ban. The 2002

GAO report states, "Federal actions do not sufficiently ensure that all
BSE-infected animals

or products are kept out or that if BSE were found, it would be detected
promptly and not

spread to other cattle through animal feed or enter the human food supply."
The report also

had criticized USDA's failure to test the brains of cattle that die on farms
(which

subsequently resulted in a change in the testing program) and questioned the
adequacy of the

inspection procedures for imported meats. Another GAO report on the FDA feed
ban is

anticipated early this year.

On the other hand, a USDA-funded study issued in November 2001 by the
Harvard

Center for Risk Analysis, based on a three-year risk analysis, stated in
part that "BSE is

extremely unlikely to become established in the United States.... Similarly
there appears to

be no potential for an epidemic of BSE resulting from scrapie, chronic
wasting disease, or

other cross-species transmission of similar diseases found in the U.S.... If
the disease does

indeed occur spontaneously in cattle, as some have suggested, it would
result in one to two

cases per year with little spread. Only a small amount of potentially
dangerous tissues would

reach the human food supply and be available for possible human
consumption."

After a BSE case was found in Canada in May 2003, USDA asked Harvard to
reassess

the risk. Harvard responded that although "the possible introduction of BSE
into the U.S.

from Canada cannot be dismissed," the likelihood is very low, and U.S.
protective measures

by now would have contained any possible spread. The Harvard study is based
on a

computer simulation, which several critics indicate could be based upon
arguable

assumptions. The study authors acknowledge that their model is "not amenable
to formal

validation because there are no controlled experiments in which the
introduction and

consequences of BSE introduction to a country has been monitored and
measured." But the

authors assert that they tested the model's predictions against an actual
small BSE outbreak

in Switzerland and found them "reasonably close to empirical observations."7

IB10127 01-13-05

However, the Harvard reassessment also noted that a group of cattle imported
into

Canada from the United Kingdom in 1993 included one that was found to have
BSE. The

report observed that if additional animals in this group harbored BSE, were
slaughtered and

rendered, infectivity may have been introduced into the Canadian and U.S.
cattle feed

supplies before the 1997 feed ban was implemented in both countries. "If
additional animals

were infected, they may have been exported to the U.S. as well.... [It]
appears that any

related introduction of BSE into the U.S. from Canada would have been due to
the import

of either infected animals or contaminated feed. Imports are a plausible
source of

introduction of BSE into the U.S. from Canada because the American and
Canadian beef

industries are closely linked. During the previous five years, the U.S. on
average imported

over 1.2 million cattle and 185,000 tons of feed annually from Canada"
(Harvard, 2003).

snip...

WHAT ABOUT that surppressed PEER REVIEW OF THAT HARVARD BSE STUDY OCTOBER
31, 2002, A CLOSER LOOK;

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf

SNIP...CONTINUE...TSS

Policy Changes After the U.S. BSE Case

USDA. The U.S. BSE incident caused USDA officials to re-examine their
existing

safeguards. On December 30, 2003, the Secretary of Agriculture announced the
following

steps to strengthen the safeguards, most focusing on FSIS-regulated
practices where cattle

are slaughtered and processed. The Secretary also asked an international
panel to assess U.S.

actions, and she also announced that BSE surveillance would be expanded.

snip...

> re-examine their existing safeguards

how about re-examine there over all june 2004 BSE ENHANCED COVER-UP OF BSE
IN THE USA...TSS

snip...

15 See the APHIS website at
[http://www.aphis.usda.gov/lpa/issues/bse/bse.html], and CRS Report

RL32627, Bovine Spongiform Encephalopathy ("Mad Cow Disease") and Canadian
Beef Imports.

CRS-13

USDA Actions to Readmit Canadian Beef and Cattle.15 As of mid-January, a

new U.S. rule to allow younger live cattle and other additional Canadian
ruminants and

products was still in play, set to take effect March 7, 2005. That final
rule was announced

December 29, 2004, and published in the January 4, 2005, Federal Register.
However, a

growing number of critics have called on USDA to rescind it or at least
delay and reconsider

it in light of the new BSE cases.

Back in late May 2003, the United States had issued an interim final rule
placing

Canada under its standing BSE import restrictions - that is, all Canadian
ruminants (cattle,

sheep, goats, deer, elk, etc.) and ruminant products were prohibited from
entering the United

States. It began to ease that ban on August 8, 2003, when USDA announced
that it would

accept applications for permits to import selected ruminant products from
Canada, including

boneless beef from cattle under 30 months old and boneless veal from calves
no older than

36 weeks at slaughter; and boneless sheep and goat meat from animals under
12 months old.

USDA's decision was based on what it said was a "thorough scientific
analysis" that found

minimal risk from these imports. The August 2003 announcement was not
accompanied by

formal rulemaking.

On November 4, 2003, USDA did publish in the Federal Register a proposed
rule to

change its standing BSE policy so as to allow imports of certain live
ruminants and products

from "minimal risk" regions, including Canada. Permitted would be imports of
cattle for

slaughter under 30 months old; sheep and goats for slaughter under 12
months; cervids (e.g.,

deer and elk) for immediate slaughter; and various other products from these
animals.

However, APHIS already was further expanding the list of allowed (so-called
low risk)

products. A list published on August 15, 2003, included, in addition to the
products

announced on August 8 (see above), bone-in as well as boneless veal (but not
bone-in beef),

and trimmings (if such trim was from otherwise low-risk boneless cuts). A
reported October

22 version of the list included beef lips, tongues, hearts and kidneys. The
August 15 and

October 22 lists were posted on the APHIS website, but neither was
accompanied by a

Federal Register issuance, press release or other public communication.

On April 19, 2004, USDA published on its website, again without further
rulemaking

or public notice, yet another list and memorandum effectively expanding
permitted Canadian

products to include bone-in as well as boneless beef from under-30-month
cattle. A group

of cattlemen led by Ranchers-Cattlemen Action Legal Fund, United
Stockgrowers of

America (R-CALF USA), filed a lawsuit to stop the expanded imports, and, on
April 26, a

IB10127 01-13-05

16 Ranchers Cattlemen Action Legal Fund USA vs. USDA (CV-04-51-BLG-RFC).

CRS-14

federal judge in Montana issued a temporary restraining order to halt the
imports. Among

other issues, the judge cited concerns about whether USDA followed
appropriate rulemaking

procedures.16 USDA subsequently reached an agreement with plaintiffs that it
would not

allow beef and veal products beyond the types listed on August 15, 2003 (see
above), until

issuance of the final rule that was first proposed on November 4, 2003.

In an accounting of what had come in so far, the department reported that a
total of

518.6 million pounds of Canadian beef and veal products had entered the
United States

between September 1, 2003, and April 30, 2004. Of this, 18.9 million pounds
were boneless

or bone-in veal; 241 million pounds were boneless beef cuts; 238 million
pounds were

boneless beef trim; nearly 7 million pounds were liver, tripe or cheek meat;
1.5 million

pounds were tongue, heart or kidney; 5.6 million pounds were "further
processed" including

partly or fully cooked hamburger, hot dogs, deli meats, sausages, jerky,
etc., and about

142,000 pounds were bone-in beef cuts. USDA officials stated that only 7.3
million pounds

of the 518.6 million pound total incorrectly came in under categories not
covered by the

August 8 announcement (as modified by the August 15 list), and that none of
these additional

products posed any food safety risk. Officials stated further that Secretary
Veneman had

been unaware that APHIS had expanded the list of eligible products after
August 8, 2003.

The final version of the November 4, 2003, proposal was announced on
December 29,

2004, several hours before Canada revealed its second possible BSE finding.
Specifically,

the rule creates a new category of "minimal risk" BSE regions - those in
which

BSE-infected animals have been diagnosed, but where sufficient regulatory
measures have

been in place to ensure that the introduction of BSE into the United States
is unlikely. The

rule further classifies Canada in this category, the first such region to
qualify, based on what

USDA declared was "a thorough risk analysis." (In addition, a region with
effective BSE

regulatory measures that has never detected the disease, but cannot be
considered BSE-free,

can qualify as a "minimal risk.") The following additional products are
being made eligible

for importation from Canada:

! Cattle and other bovines for feeding and for immediate slaughter. All
cattle

must be under 30 months of age and be slaughtered at less than 30 months.

All cattle must be moved in closed containers, be tagged on the ear to
enable

traceback to their birth herds, and be accompanied by health and other

information, among other requirements. Feeder cattle must be branded and

can only be moved to a single feedlot, and from that lot directly to
slaughter.

! Sheep and goats (ovines and caprines) for feeding and immediate slaughter,

which must be under 12 months of age and slaughtered by 12 months.

Similar movement and identification rules apply to these animals.

! Most meat from bovines, ovines, caprines, and cervids (deer, elk, etc.).
This

includes, for example, bone-in cuts and cuts from cattle over 30 months.

! Certain other products and byproducts including bovine livers and tongues,

gelatin, and tallow.

Congress has 60 legislative days from publication to review the rule, as
provided for in

the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C.
801-808). The

60-day period is required to allow for congressional review whenever a rule
is deemed

IB10127 01-13-05

CRS-15

significant. Constituents and industry interests are already weighing in
with their reactions,

which have been mixed. An apparently growing number of producers and others
have

expressed strong doubts about the rule. Many of the producers worry about
the impact on

cattle prices if large numbers of Canadian cattle begin to cross the border;
others believe that

opening the border to potentially risky Canadian animals could undermine
efforts to regain

the Japanese and other skittish foreign markets. R-CALF filed another
lawsuit in a Montana

federal court on January 10, 2005, to overturn the rule, arguing that it
"creates an unjustified

and unnecessary increased risk of infection of the U.S. cattle herd ... and
of importing meat

contaminated with BSE into the United States." NCBA demanded that USDA and
FDA

investigate Canada's feed ban compliance before the rule is implemented.

Others have defended USDA's assertion that - because Canada has in place
safeguards

that are at least equivalent to those of the United States, and because the
North American

market has become an integrated one - the rulemaking is reasonable.
Supporters of the rule

contend that the Department's assessment of risk has been thorough and
sound. They believe

it is necessary if the United States wants to convince other countries that
U.S. beef also is

safe. Several believe USDA should have gone further. For example, the
American Meat

Institute, representing meat packers, filed a federal lawsuit charging that
USDA lacks any

scientific basis for continuing to ban imports of over-30-month-old cattle,
even though meat

from over-30-month-old cattle will be permitted. (U.S. meat packers also are
concerned that

the rule puts them at a competitive disadvantage because they won't have
equal access to the

over-30 animals that Canada will kill. Several plants already have reported
cutbacks in

operations due to what they say are cattle shortages.)

Congressional Response

BSE is expected to remain a high priority for many Members of the 109th
Congress. A

number of them already have joined others in calling for a delay or
rescission of the Canada

rule (see above). BSE, and specifically the Canada situation, was a major
topic during the

Senate Agriculture Committee's January 6 confirmation hearing for nominated
Agriculture

Secretary Michael Johanns, who repeatedly pledged his full attention and
cooperation on the

matter. The committee has scheduled a hearing on BSE and trade for February
3. Hearings

before other committees are possible as well.

Representative Pomeroy introduced a bill (H.R. 187) to prohibit the Canada
rule "unless

United States access to major markets for United States exports of cattle
and beef products

is equivalent or better than the access status accorded such exports as of
January 1, 2003."

Separately, in a January 5, 2005, letter to the incoming Secretary of
Agriculture, Senator

Conrad and Representative Waxman charged that USDA had failed to review
significant

evidence questioning the effectiveness of the Canadian feed ban, and called
on him to

investigate.

So far, USDA and FDA have been using their existing statutory authorities to
address

BSE developments, including adoption of new safeguards. However, several
bills proposing

additional changes, introduced (but generally not passed) in the 108th
Congress, could reemerge

in the 109th Congress.

For example, companion bills offered in 2003 (S. 1202 and H.R. 3546) would
have

required a traceability system for all stages of production, processing, and
distribution of both

IB10127 01-13-05

CRS-16

meat and poultry and their products, essentially from the birthplace of
source animals to the

consumer. In 2004, other bills (H.R. 3787, H.R. 3822, H.R. 3961, H.R. 4005,
S. 2008, S.

2070) setting various requirements for a national livestock ID system were
introduced.

Ruminant ID systems would have been required in two wider-ranging BSE and
other prion

prevention-related bills (S. 2007 and H.R. 3714, respectively).

The BSE issue was raised in the debate over whether to delay and/or modify
mandatory

country-of-origin labeling (COOL) of meats and other foods, initially set by
the 2002 farm

bill to take effect in September 2004. The consolidated FY2004 appropriation
(P.L. 108-

199) postponed mandatory COOL for meat for two years. Several bills (H.R.
3732, H.R.

3993, S. 2451) then proposed reinstatement of the original 2004
implementation date.

However, the House Agriculture Committee on July 21, 2004, approved H.R.
4576, which

would have replaced mandatory COOL with a voluntary program. Other bills
amending

COOL included H.R. 2270 and H.R. 3083 (see also CRS Report 97-508,
Country-of-Origin

Labeling for Foods). None advanced further.

In November 2003, the Senate had approved an amendment to the FY2003

appropriations bill to prohibit FSIS inspections of downed animals
(effectively keeping them

out of the food supply). A similar House floor amendment to the bill last
summer was

narrowly defeated, and the Senate amendment was removed in the House-Senate
conference

on the measure. Earlier, both houses of the 107th Congress had included in
their respective

farm bills a ban on marketing downers unless they were humanely euthanized.
Farm bill

conferees dropped the provision from the final version (P.L. 107-171),
instead directing the

Secretary to study industry downer practices and issue rules if necessary.
Bills in the 108th

Congress to ban downers include H.R. 2519 and S. 1298.

Another bill, H.R. 3705, would have required BSE tests on all cattle
destined for human

food. S. 2051 focused on strengthening animal feed rules. Several (H.R.
2057, H.R. 2430,

H.R. 2431, H.R. 2636, H.R. 4001, S. 1036) were introduced to increase
support for research

and surveillance on chronic wasting disease (CWD) in deer and elk or on
other TSEs.

CRS-16...END

FULL TEXT OF THIS REPORT HERE;

http://www.ncseonline.org/NLE/CRSreports/05jan/IB10127.pdf

Meat and Poultry Inspection Issues

Updated January 7, 2005

Geoffrey S. Becker

Resources, Science, and Industry Division

CONTENTS

SUMMARY

MOST RECENT DEVELOPMENTS

BACKGROUND AND ANALYSIS

Current Standard Inspection and HACCP Systems

Authorities

State Inspection

Import Inspection

Basic Features of Inspection Systems

Meat Safety and BSE

U.S. Case

Canada Rule

BSE Surveillance

Inspection Funding Issues

FSIS Bioterrorism Preparedness

Other Legislative and Administrative Issues

Humane Slaughter

Equine Slaughter

Meat Traceability

HACCP-Related Legal Action

Pathogen Performance Standards

E. coli O157:H7

Listeria monocytogenes

Recall and Civil Penalty Proposals

LEGISLATION

109th Congress

108th Congress

IB10082 01-07-05

Congressional Research Service ~ The Library of Congress

Meat and Poultry Inspection Issues

SUMMARY

The U.S. Department of Agriculture's

(USDA's) Food Safety and Inspection Service

(FSIS) is responsible for inspecting most

meat, poultry, and processed egg products for

safety, wholesomeness, and proper labeling.

The Food and Drug Administration (FDA) is

responsible for ensuring the safety of all other

foods, including seafood.

In the early 1990s, food safety officials

recognized that most foodborne illness cases

traced to meat and poultry products were

being caused by naturally occurring microbiological

contamination that was not being

adequately addressed by the traditional, sight-,

smell-, and touch-based system of inspection.

Through the federal rule-making process,

FSIS developed and initiated the Hazard

Analysis and Critical Control Point (HACCP)

system at all federally inspected slaughtering

and processing plants. HACCP regulations

require all firms to implement preventive

actions at each point along the manufacturing

chain where microbial contamination is likely

to occur. FSIS inspectors monitor the performance

of firms' HACCP systems in addition

to performing traditional inspection under the

existing statutes.

Despite data suggesting HACCP-related

reductions in pathogen levels, periodic recalls

of very large amounts of product continue to

illustrate the difficulty of preventing contamination

in processed products. Several bills

addressing aspects of this issue were introduced

in the 108th Congress, and could resurface

in the 109th Congress. These include

proposals to give FSIS the authority to (1)

mandate recalls of suspected contaminated

products; (2) set and enforce performance

standards for foodborne pathogens under

HACCP; and (3) impose civil penalties for

violations of inspection laws and regulations.

In December 2003, USDA announced the

first confirmed U.S. case of bovine spongiform

encephalopathy (BSE). On January 12,

2004, FSIS published interim rules banning

potentially higher BSE-risk cattle parts and

non-ambulatory ("downer") cattle from food,

prohibiting the labeling as "meat" of mechanically

removed muscle tissue; and banning a

form of pre-slaughter stunning that can potentially

spread infective brain and nervous

system tissue into the meat.

Since January 12, any carcass tested for

BSE must be held until negative results are

received. In June 2004, USDA began a 12-18

month program to test 200,000-268,000 cattle

for BSE (compared with 20,000 in 2003).

The Administration has been criticized

for its handling of some aspects of the BSE

situation. For example, USDA officials acknowledged

last year that they had failed to

follow proper rulemaking procedures in readmitting

certain types of beef from Canada,

which reported its own BSE cases in early

2003 and late 2004. Final rules to permit

younger Canadian live cattle and additional

types of Canadian beef to enter the United

States were published by USDA in the January

4, 2005, Federal Register.

The FY2005 agriculture appropriation

(Division A of H.R. 4818; P.L. 108-447)

provides $823.8 million for FSIS. Congressional

deliberations on the FY2006 FSIS

budget are expected to begin in February with

submission of the Administration's budget

proposal.

IB10082 01-07-05

CRS-1

MOST RECENT DEVELOPMENTS

The U.S. Department of Agriculture (USDA) on January 4, 2005, published
final rules

to permit younger Canadian live cattle and additional types of Canadian beef
to enter the

United States. These rules, scheduled to take effect in early March, are
subject to a 60-day

Congressional review period, during which committee hearings on them are
likely.

The rules were unveiled as Canada was investigating the discovery of its
second case

of BSE, in another Alberta dairy cow. U.S. and Canadian officials said that
the discovery

did not present any food safety danger, and that it would not slow
implementation of the

import rule - despite criticism by some lawmakers that opening the border
was premature.

BACKGROUND AND ANALYSIS

Current Standard Inspection and HACCP Systems

FSIS carries out its duties with total staff of nearly 10,000, and an annual
appropriation

of more than $800 million. In addition, FSIS uses revenue from fees paid by
the packing

industry for overtime (above three shifts) and holiday inspection services,
and by private

laboratories that apply for FSIS certification to perform official meat
testing and sampling

(they originally were authorized in 1919). Revenue from the fees amounts to
more than $100

million annually in additional program support. More than 7,500 of FSIS's
employees,

roughly 1,000 of them veterinarians, are at some 6,200 plants and import
stations nationwide.

Traditional inspection under the original statutes comprises constant
organoleptic

inspection (for appearance, odor, and feel) at slaughter operations and
daily inspection of

sample products and operations at processing plants. In the early 1990s,
following years of

debate over how to respond to mounting evidence that invisible,
microbiological

contamination on meat and poultry posed greater public health risks than
visible defects (the

focus of traditional inspection methods), FSIS began to add testing for
pathogenic bacteria

on various species and products to its inspection system.

In 1995, under existing statutes, FSIS published a proposed rule to
systematize these

program changes in a mandatory program called the Hazard Analysis and
Critical Control

Point (HACCP) system. In this system, hazards are identified and risks are
analyzed in each

phase of production, "critical control points" for preventing such hazards
are identified and

monitored, and corrective actions are taken when necessary. Record keeping
and verification

are used to ensure that the system is working. FSIS published the final rule
in 1996, and

since January 2000 all slaughter and processing operations are required to
have HACCP

plans in place. HACCP is intended to operate as an adjunct to the
traditional methods of

inspection, which still are mandatory under the original statutes.

Authorities. The Federal Meat Inspection Act of 1906, as amended (21 U.S.C.
601

et seq.), requires USDA to inspect all cattle, sheep, swine, goats, and
horses brought into any

plant to be slaughtered and processed into products for human consumption.
The 1957

Poultry Products Inspection Act, as amended (21 U.S.C. 451 et seq.), made
poultry

inspection mandatory for any domesticated birds intended for use as human
food. The

IB10082 01-07-05

current list of included species is chickens, turkeys, ducks, geese,
guineas, ratites (ostrich,

emu, and rhea), and squabs (pigeons up to one month old).

FSIS also offers voluntary, fee-for-service inspection for buffalo,
antelope, reindeer, elk,

migratory water fowl, game birds, and rabbits, which is authorized under the
Agricultural

Marketing Act (7 U.S.C. 1621). These so-called "exotic" meat species are
regulated by the

FDA (under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq.)
if they are not

inspected under the voluntary FSIS program. FDA has jurisdiction over meat
products from

exotic species in interstate commerce, even if they bear the USDA inspection
mark.

In May 1995, the authority for processed egg inspection was transferred from
USDA's

Agricultural Marketing Service to FSIS. The Egg Products Inspection Act, as
amended (21

U.S.C. 1031 et seq.), is the authority under which FSIS assures the safety
of liquid, frozen,

and dried egg products, domestic and imported, and the safe disposition of
damaged and dirty

eggs. FDA holds regulatory authority over shell eggs used in restaurants and
sold in stores.

State Inspection. Twenty-eight states currently have their own meat and/or
poultry

inspection programs covering about 2,100 small or very small establishments.
The states run

the programs cooperatively with FSIS, which provides up to 50% of the funds
for operating

them, or about $50 million annually. A state program operating under a
cooperative

agreement with FSIS must demonstrate that its system is equivalent to
federal inspection.

However, meat and poultry products produced under state inspection are
limited to intrastate

commerce only. About half of the states have discontinued their inspection
systems for meat

or poultry (or both). In these states FSIS has assumed responsibility for
inspection at the

formerly state-inspected plants, although actual inspection is performed by
state personnel.

snip...

CRS-4

Meat Safety and BSE

Bovine spongiform encephalopathy (BSE, or "mad cow disease") entered the
U.S.

public policy spotlight in 2003, with the discovery of the first native
North American cases

in 2003. (Canadian officials found a third case in December 2004, announcing
confirmation

of the disease on January 2, 2005.)

First diagnosed in Britain in 1986, BSE is a slowly progressive, incurable
disease

affecting the central nervous system of cattle. Scientists consider BSE to
be related to similar

diseases, called transmissible spongiform encephalopathies (TSEs), that
occur in other

species. Investigators in the British BSE outbreak connected the use in
cattle feeds of animal

protein from TSE-infected sheep with the appearance of BSE in cattle. In
1997, European

scientists determined that there was a possible link between consumption of
infected tissue

from BSE cattle and an outbreak in humans of a newer variant of a fatal
brain disease called

Creutzfeldt-Jakob disease (nvCJD) that had begun in Europe in the late
1980s.

FSIS is one of the three federal agencies primarily responsible for keeping
BSE out of

the food supply. The other two agencies involved in BSE are APHIS and the
FDA (part of

the Department of Health and Human Services). The Centers for Disease
Control and

Prevention (CDC) also play a role regarding public health protection. (For
more in-depth

coverage of BSE and related livestock industry and public health issues, see
CRS Issue Brief

IB10127, Mad Cow Disease: Agricultural Issues for Congress; and CRS Report
RL32199,

Bovine Spongiform Encephalopathy (BSE): Current and Proposed Safeguards.)

APHIS, which (among other things) is responsible for protecting U.S.
agriculture from

foreign diseases, in 1989 imposed a ban on the import of all live ruminants
from countries

where BSE is known to exist. In 1991, APHIS banned the import of rendered
by-products

from ruminants, and then it banned, as of December 2000, the import of all
rendered animal

protein products (whether from ruminants or not).

After the Canadian BSE announcement of the first North American case in May
2003,

APHIS banned all ruminants and products from Canada. In August 2003 APHIS
announced

it was permitting the entry of some products (notably boneless beef from
cattle under 30

months) after determining that they were low-risk. In November 2003, APHIS
proposed a

rule to allow imports of primarily younger live ruminants, along with
additional types of beef

and other ruminants and ruminant products, from a new category of BSE
"minimal risk"

regions, the first one to be Canada.

U.S. Case. While this proposed rule was pending, the U.S. case was
discovered in

December 2003. Officials reassured the public that any human health risks
were minimal,

and that no high-risk tissues had entered the food supply. However, they
announced, out of

"an abundance of caution," a voluntary recall of 38,000 pounds of meat from
20 animals

slaughtered at the same plant that day, and acknowledged that some of it
likely had been

consumed. FSIS also published, as interim final rules in the January 12,
2004, Federal

Register, several actions to bolster U.S. BSE protection systems, effective
immediately:

IB10082 01-07-05

CRS-5

! Downer (nonambulatory) cattle are no longer allowed into federally

inspected or state-inspected slaughter and processing facilities.

! Cattle selected for testing cannot be marked as "inspected and passed"

until confirmation is received that they have tested negative for BSE.

! Specified risk materials (SRM), which include the skull, brain,

trigeminal ganglia, eyes, vertebral column, spinal column, and dorsal

root ganglia of cattle over 30 months of age, and the small intestine of

cattle of all ages, are now prohibited from the human food supply.

! Slaughter facilities are required to develop and implement procedures

to remove, segregate, and dispose of SRM and make information

readily available for review by FSIS inspection personnel.

! SRM from cattle 30 months or older cannot be in a product labeled as

"meat" if derived from advanced meat recovery (AMR) technology,

which USDA said would help ensure it does not contain spinal tissue.

! Mechanically separated meat may not be used for human food.

! Air injection stunning is banned, to ensure that portions of the animal

brain are not dislocated into the carcass.

FDA, which regulates animal feed ingredients domestically, banned the
feeding of most

mammalian proteins to ruminants in August 1997. Until recently, periodic
surveys indicated

less than full compliance with the regulations. A February 2002 Government
Accountability

Office (GAO) study reported that 364 out of 10,576 firms inspected by FDA
(out of at least

11,741 total firms potentially handling ruminant material) were still out of
compliance with

FDA's labeling, record keeping, and commingling requirements. In July 2003,
however,

FDA reported that compliance had reached 99%.

Nevertheless, the animal feed ban remains a focus of efforts to improve U.S.
BSE

safeguards. The FDA had announced on January 26, 2004, that it would tighten
feed

ingredient and processing rules. On July 14, 2004, FDA took tentative steps
to do so with

an advance notice of proposed rulemaking (ANPR), in which it said it was
considering a ban

on specified risk materials (SRMs, which are designated higher-risk cattle
parts such as

brains and spinal cords) from all animal feeds. Industry groups said they
were pleased that

the agency was proceeding carefully but concerned about compliance costs.
Consumer

advocates argued that rulemaking was moving too slowly. The July 14 ANPR was
issued

jointly with USDA and sought comments on a number of additional BSE
preventive steps

being considered.

Canada Rule. Earlier, on April 19, 2004, while the November 2003 proposal to

expand Canadian imports was still under consideration, APHIS posted on its
website a

decision to add bone-in beef from under-30-month cattle to the list of
permitted imports. On

April 26, a federal judge in Montana issued a temporary restraining order
banning these

additional imports, citing concerns about food safety and USDA's failure to
follow proper

rulemaking procedures. By May 2004, USDA acknowledged that it had not
followed such

procedures in allowing some 7.3 million pounds of certain types of Canadian
beef products

into the United States that were not on the list of so-called "low-risk"
beef products USDA

first publicized widely in August 2003. The 7.3 million pounds were among a
total of 518.6

million pounds of Canadian beef that the United States has admitted from
September 2003

through April 2004. It also promised not to permit any of these additional
types of beef from

Canada until after it issued a final rule on what it proposed in November
2003.

IB10082 01-07-05

CRS-6

USDA published the final rule on BSE "minimal risk" regions, and on
permitted

Canadian imports, in the January 4, 2005, Federal Register, to take effect
March 7, 2005.

The rule makes Canada eligible to export to the United States live cattle
under the age of 30

months, along with other ruminants, most types of beef (including from
cattle over 30

months) and other cattle and ruminant products. Importers must adhere to
strict branding and

tracking requirements, and slaughter the cattle by 30 months of age, among
other

requirements. USDA said Canada qualified as minimal risk because it had
specified BSE

safeguards in place, such as adequate ongoing surveillance for BSE, a ban on
high-risk

materials in the food and feed supply, appropriate risk assessment measures,
and strong

restrictions on imports from other BSE countries.

Some congressional critics, notably several from northern cattle-producing
states,

argued that USDA should not have opened the border to live cattle at a time
when yet

another Canadian BSE case was being investigated, and when U.S. negotiators
are trying to

convince the Japanese and other important foreign markets to begin accepting
U.S. beef.

USDA officials countered that the new rule is based on a thorough scientific
analysis of the

potential risks, that denying Canada entry of safe products was inconsistent
with the U.S.

negotiating stance that U.S. beef is safe, and that a few new BSE cases were
always possible,

particularly in older cattle born prior to the 1997 feed ban (see below).
All three North

American cases were in such cattle, according to authorities.

BSE Surveillance. Prior to the appearance of the first U.S. case of BSE in
December

2003, FSIS's role in keeping the disease out of the food supply was to put
the agency's

inspection force on alert to detect and divert from processing any cattle
showing suspicious

clinical symptoms, and to contact an APHIS inspector to evaluate the animal
and dispatch

a brain tissue sample to the National Veterinary Services Laboratory in
Ames, Iowa, for

testing. USDA (APHIS) by 2003 was testing approximately 20,000 cattle
annually for BSE,

focusing particularly on high-risk animals, including downers (animals that
cannot walk at

slaughter establishments), those that die on farms, older animals, and those
with signs of

neurological distress.

USDA began, in June 2004, a new 12- to 18-month surveillance program to test
as

many as 268,000 or more mostly higher-risk animals. USDA's aim is to measure
the extent,

if any, of BSE in U.S. herds; officials assert it is not a safety assurance
program per se.

USDA has approved various "rapid tests" for the initial BSE screening in
designated

laboratories around the country. If these tests indicate samples may be
BSE-positive, the

samples are forwarded to Ames for confirmation through a more sophisticated
test. More

than 167,000 had been tested through December 31, all negative for BSE.
(Test results are

posted on the agency website.)

USDA in April 2004 denied a request by a private meat company, Creekstone
Farms,

to use a rapid test to screen all of its cattle for BSE as a way to
re-establish the firm's foreign

markets lost after the U.S. BSE finding. USDA has argued that such "100%
testing" is

unscientific, would imply falsely that meat from BSE-tested animals is safer
than that from

untested cattle, and would undermine government-to-government negotiations
to reopen

markets. Creekstone has argued that it would test merely to satisfy
marketing demands.

On July 14, 2004, the House Government Reform and Agriculture Committees
held a

joint hearing on BSE surveillance. USDA's Inspector General (IG) testified
that USDA

IB10082 01-07-05

CRS-7

officials erred - but did not engage in intentional misconduct or knowingly
provide

misleading information - when they failed to test a suspicious cow for BSE
in Texas in

April 2004, and when they characterized the Washington BSE cow as
nonambulatory in

December 2003. The IG also testified on weaknesses in USDA's BSE
surveillance and ways

to strengthen it.

The new nominee for Secretary of Agriculture, Governor Johanns of Nebraska,
was

peppered with a variety of questions and comments about BSE at his January 6
confirmation

hearing before the Senate Committee on Agriculture. The committee chairman
announced

that he will convene another hearing specifically on the Canadian import
rule, which

Congress has 60 legislative days to review and can overturn (unless vetoed
by the President).

However, Members might raise additional topics, such as the difficulties of
reopening

additional foreign markets to U.S. beef, progress on implementing a national
animal

identification program (see "Meat Traceability," below), complaints from
some USDA meat

inspectors and others that packers are not fully complying with the new
in-plant BSE

safeguards, and the status of possible changes in the FDA feed ban, for
example.

Inspection Funding Issues

From time to time in the past, FSIS has had difficulty in sufficiently
staffing its service

obligations to the meat and poultry industries. Usually a combination of
factors causes these

shortages, including new technologies that increase plant production speeds
and volume,

insufficient appropriated funds to hire additional inspectors at times of
unexpected increases

in demand for inspections, problems in finding qualified people to work in
dangerous or

unpleasant environments or at remote locations, etc. These staffing problems
have been

exacerbated by the addition of HACCP requirements on top of the traditional
carcass-bycarcass

inspection duties. In order to monitor the staffing situation more closely,
Congress

included language in the conference report to accompany the FY2000 USDA
appropriations

law (P.L. 106-78), requiring FSIS to prepare a quarterly report on budget
execution, staffing

levels, and staffing needs (these are available on the FSIS website under
"Communications

to Congress"; see
[http://www.fsis.usda.gov/oa/congress/congress.htm#Annual]).

In order to address staffing problems, most administrations over the past 20
years have

proposed in their annual budget requests to charge the meat-packing industry
new user fees

sufficient to cover the entire cost or a portion of federal inspection
services. The primary

rationale for more comprehensive user fees has been that resources would
then be adequate

to hire new inspectors as necessary. USDA economists estimate that the cost
passed on to

consumers from such a fee would be no more than one cent per pound.
Congressional

appropriators have rejected new user fee proposals every year, stating that
the safety of the

food supply is a legitimate responsibility of the government. In addition,
some Members

have argued that the large meat recalls that have occurred since HACCP was
implemented

illustrate why the government should retain taxpayer-funded regulatory
oversight.

The Bush Administration's initial FY2005 budget proposal (February 2004)
reiterated

user fee proposals made in FY2003 and FY2004 to increase the industry's
reimbursement

for FSIS inspection beyond one shift per day. The Administration's rationale
is that the

regular working day should be considered standard inspection, and any
services provided

beyond that time should be considered additional, hence subject to a higher
fee schedule.

Congressional appropriators traditionally have rejected these proposals, and
in recent years

IB10082 01-07-05

they have included report language stating that they will not consider
offsetting FSIS

appropriations with greater revenue from user fees unless authorizing
legislation has first

been passed. No new fees are assumed in the FY2005 appropriation (see
below).

The FY2005 Consolidated Appropriations Act (P.L. 108-447, H.R. 4818) sets a
level

of $823.8 million for FSIS in FY2005, close to the Senate-reported (S. 2803)
level and a

$43.9 million increase from the FY2004 enacted level. The House-passed bill
(H.R. 4766)

recommended $824.7 million. In P.L. 108-447, and also part of the FSIS
overall total, are

$17.3 million for frontline inspectors and humane slaughter enforcement;
$20.7 million for

regulatory and scientific training; $3 million for overseeing BSE-related
FSIS rules; $7.2

million for inspector training; and increases for food defense activities,
including $2.1

million for biosurveillance, $2 million for the Food Emergency Response
Network, and $1.5

million for the network's data systems support. Conferees also included $2.7
million for

Codex Alimentarius activities.

Congressional review of the FY2006 FSIS budget will begin with submission of
the

President's FY2006 proposal in early February 2005.

snip...


LEGISLATION

109th Congress

H.R. 187 (Pomeroy)

To prohibit operation during a calendar year of USDA's final rule to
establish standards

for the designation of minimal-risk regions for the introduction of BSE into
the United

States, including designation of Canada as a minimal-risk region, unless
U.S. access to major

markets for United States exports of cattle and beef products is equivalent
to or better than

the access status accorded such exports as of January 1, 2003. Introduced
January 4, 2005;

referred to the Committee on Agriculture.

snip...

H.R. 3705 (Miller)

The Mad Cow Testing Act of 2004 would have amended the Federal Meat
Inspection

Act to require BSE testing on all cattle for human food, with testing done
by APHIS and

costs borne by packers/processors. Introduced January 20, 2004; referred to
Committee on

Agriculture.

H.R. 4121 (Rehberg)

The Consumer and Producer Protection Act of 2004 would amend the Federal
Meat

Inspection Act to permit inspection of nonambulatory cattle unable to walk
due to "fatigue,

stress, obdurator nerve paralysis, obesity, or one or more broken or
fractured appendages,

severed tendons or ligaments, or dislocated joints." Introduced April 1,
2004; referred to

Committee on Agriculture.

snip...

CRS-16

S. 1298 (Akaka)/H.R. 2519 (Ackerman)

The Downed Animal Protection Act would direct the Secretary of Agriculture
to

promulgate regulations to provide for the humane treatment, handling, and
disposition of

nonambulatory livestock by a covered entity, including a requirement that
they be humanely

euthanized. It would prohibit such animals from being inspected and passed
for human food

in Federal Meat Inspection Act establishments. S. 1298 introduced June 19,
2003; referred

to the Committee on Agriculture. H.R. 2519 introduced June 19, 2003;
referred to the

Committee on Agriculture. (See H.R. 2673 for related amendments.)

S. 2007 (Durbin)/H.R. 3714 (DeLauro)

The BSE and Other Prion Disease Prevention and Public Health Protection Act
would

set new restrictions intended to ensure that many imported foods, feeds,
nutritional

supplements, medicines, cosmetics, and other specified articles do not
harbor BSE

infectivity; prohibit such articles from entering interstate or foreign
commerce if they contain

specified risk materials from ruminants; spell out new procedures for FDA
oversight of

animal feed; mandate a national ruminant identification program; and
establish new

programs for prion disease monitoring and testing, among other things. S.
2007 introduced

January 20, 2004; referred to Committee on Agriculture; H.R. 3714 introduced
January 21,

2004; referred to Committees on Agriculture; Energy and Commerce; and Ways
and Means.

S. 2051 (Cantwell)

The Animal Feed Protection Act of 2004 would prohibit in interstate or
foreign

commerce animal feeds, nutritional supplements, and animal medicines that
contain specified

risk materials from ruminants, any ruminant materials from USDA-designated
BSE

countries, or any materials from ruminants with neurological disease signs.
Introduced

February 5, 2004; referred to Committee on Agriculture.

S. 2910 (Durbin)/H.R. 5259 (DeLauro)

The Safe Food Act of 2004 would consolidate federal food safety
responsibilities,

including those of FSIS and FDA, under a new Food Safety Administration.
Introduced

October 7, 2004. S. 2910 referred to the Senate Committee on Agriculture;
H.R. 5929

referred to the Committees on Energy and Commerce, and on Agriculture.

http://www.ncseonline.org/NLE/CRSreports/05jan/IB10082.pdf

Meat & Poultry Inspection: Report of the Secretary of Agriculture to the
U.S. Congress

a.. 2000 (Feb 2003) | PDF (768 k)
b.. 1999 (Mar 2001)
c.. 1998 (Jun 2000)
d.. 1997 (PDF Only, Nov 1999, 950 k)
e.. 1996 (PDF Only, Sep 1997, 257 k)

FoodNet Reports
a.. 1998 Report to Congress: FoodNet: An Active Surveillance System for
Bacterial Foodborne Diseases in the United States (Mar 1999)
b.. 1997 Report to Congress: FoodNet: An Active Surveillance System for
Bacterial Foodborne Diseases in the United States (Apr 1998)
c.. 1996 Report to Congress: FSIS/CDC/FDA Sentinel Site Study: The
Establishment and Implementation of an Active Surveillance System for
Bacterial Foodborne Diseases in the United States (Feb 1997)

Updates: Budget Execution, Staffing Levels & Staffing Needs
a.. FY 2001 - First Quarter
b.. FY 2001 - Second Quarter
c.. FY 2001 - Third Quarter
d.. FY 2001 - Fourth Quarter
e.. FY 2000 - First Quarter
f.. FY 2000 - Second Quarter
g.. FY 2000 - Third Quarter
h.. FY 2000 - Fourth Quarter


http://www.fsis.usda.gov/News_&_Events/Periodic_Reports/index.asp

Testimony
Special Reports
a.. Consumer Safety Officers

a.. Report on Consumer Safety Officers to the United States House and
Senate Appropriations Committees (February 15, 2000)
a.. Transmittal Letter
a.. Country of Origin Labeling

a.. Mandatory Country of Origin Labeling of Imported Fresh Muscle Cuts
of Beef and Lamb (January 2000)
a.. Handling or Inspection of Nonambulatory Animals

a.. Current Food Safety and Inspection Service Laws and Policies
Regarding The Handling or Inspection of Nonambulatory Animals (May 2001)
a.. Transmittal Letter
a.. Humane Handling and Slaughter Enforcement Activities

a.. Humane Handling and Slaughter Enforcement Activities - Report to
Congress, March 2003
b.. 2002 Report
a.. Transmittal Letter, March 15, 2002
b.. PDF (best for printing)
a.. Report and Attachments 1 - 4 (March 2002) [399 KB, 28 pages]
b.. Attachment 5: United States Department of Agriculture, Animal
and Plant Health Inspection Service:
Animal Welfare Report, Fiscal Year 2000, Report of the Secretary of
Agriculture to the President of the Senate and the Speaker of the House of
Representatives, APHIS 41-35-071 [17 MB, 41 pages - leaving this site]
c.. Attachment 6: Federal Register: December 7, 2001 (Volume 66,
Number 236)
Commercial Transportation of Equines to Slaughter; Final Rule (221
KB, 80 pages)
c.. HTML (Text) [includes links to all attachments. Note: Attachment 5
is only available as PDF.]
a.. Import Equivalence and Reinspection Processes

a.. Report (March 2004, PDF Only) and Attachments:
a.. List of Equivalent Countries (PDF)
b.. Example of Equivalence Audit Cover Letter and Questionnaires (PDF)
c.. Example of Audit Checklists for Initial Equivalence (PDF)
d.. Example of Proposed Rule (PDF)
e.. Example of Decision Memorandum (PDF)
f.. Reinspection Data from FY 1999-2003 (PDF)
a.. Interstate Shipment of State-Inspected Meat and Poultry Products

a.. Feasibility & Design of an Interstate Shipment Pilot for Ohio (March
2002)
b.. Draft Bill: Transmittal Letter (November 2, 1999)
a.. Federal Meat and Poultry State Inspection Act of 1999
b.. Statement of Secretary of Agriculture Dan Glickman on Senate
Introduction of The New Markets for State-Inspected Meat Act (November 19,
1999 )
c.. Senate Bill 1988, introduced as the New Markets for State-Inspected
Meat Act of 1999
a.. PDF version of S.1988*
a.. Ratites

a.. Public Health Benefits Assessment of Mandatory Ratite Inspection
(June 4, 1999)
b.. Cost-Effectiveness Analysis of Voluntary versus Mandatory Federal
Inspection of Ratite Meats (July 1998)
a.. Recalls

a.. Report on Meat and Poultry Recalls to the United States House and
Senate Appropriations Committees (January 30, 2000)
a.. Transmittal Letter
b.. Executive Summary
c.. For copies of the full report, contact the Congressional and
Public Affairs Staff (numbers listed at the at the bottom of this page).
b.. Improving Recalls at the Food Safety and Inspection Service: Report
of the Recall Policy Working Group [also available in PDF, 66 pp. KB]
(Posted August 10, 1998)
a.. Risk-Based Inspection

a.. Report on Risk-Based Inspection to the United States House and
Senate Appropriations Committees (March 2, 2001)
a.. Transmittal Letter
Annual and Periodic Reports
a.. Meat and Poultry Inspection: Report of the Secretary of Agriculture to
the U.S. Congress

a.. 2000 (Issued February 2003) [PDF, 93 pp. 768 KB]
b.. 1999 (Issued March 2001)
c.. 1998 (Issued June 2000; HTML text with PDF attachments)
d.. 1997 (Issued November 1999; PDF, 950 KB)
e.. 1996 (Issued September 1997; PDF, 257 KB)
a.. FoodNet Reports

a.. 1998 Report to Congress: FoodNet: An Active Surveillance System for
Bacterial Foodborne Diseases in the United States (Issued March 1999)
b.. 1997 Report to Congress: FoodNet: An Active Surveillance System for
Bacterial Foodborne Diseases in the United States (Issued April 1998)
c.. 1996 Report to Congress: FSIS/CDC/FDA Sentinel Site Study: The
Establishment and Implementation of an Active Surveillance System for
Bacterial Foodborne Diseases in the United States (Issued February 1997)
a.. Updates: Budget Execution, Staffing Levels and Staffing Needs

a.. FY 2001 -- First Quarter, Second Quarter, Third Quarter, Fourth
Quarter
b.. FY 2000 -- First Quarter, Second Quarter, Third Quarter, Fourth
Quarter
http://www.fsis.usda.gov/oa/Congress/congress.htm
Report of the Secretary of Agriculture to the US Congress, 1999
Meat, Poultry, and Egg Products Inspection 1999 Report of the Secretary of
Agriculture to the US Congress. Preface. The Food Safety and Inspection
Service ...
www.fsis.usda.gov/oa/pubs/rtc99/rtc99.htm - 18k - Cached - Similar pages

Report of the Secretary of Agriculture to the US Congress, 2000
Meat, Poultry, and Egg Products Inspection 2000 Report of the Secretary of
Agriculture to the US Congress. A PDF version of the full report (93 pp.
...
www.fsis.usda.gov/oa/pubs/rtc2000/rtc2000.htm - 19k - Cached - Similar
pages
[ More results from www.fsis.usda.gov ]

-------- Original Message --------
Subject: FSIS FOOD INSPECTOR CONVICTED FELONY BRIBERY FOR PASSING
DOWNERS/TSE FOR CONSUMPTION
Date: Tue, 9 Nov 2004 11:42:15 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE


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

Issued June 2000


Meat, Poultry, and Egg Products Inspection


1998 Report of the Secretary of Agriculture to the United States Congress


snip...

*

In March 1998, an FSIS food inspector and a Federal plant in New
York were each sentenced on one felony count of bribery. The
inspector was assessed a criminal fine of $17,000, assessed a $100
special assessment fee, and placed on probation for 5 years. The
inspector was also required to serve 6 months in home detention
and complete 200 hours of community service. The Federal plant was
assessed a criminal fine of $10,000, paid a $100 special
assessment fee, and was placed on probation for 5 years. The
investigation revealed that the inspector accepted money in
exchange for inspecting and passing downer (dying, diseased or
disabled) livestock that were supposed to be inspected by an FSIS
veterinarian and for allowing company employees to slaughter
animals and to use inspection brands when the inspector was not
present.

snip...


Civil Enforcement Actions

The following Civil Enforcement Actions are a representative sample of
actions taken during FY 1998:

* In June 1998, an Illinois Federal plant entered into a settlement
agreement with the USDA and the United States Attorney for
violating the FMIA, PPIA, and False Claims Act (FCA). The firm
agreed to pay the Court-ordered civil penalty of $20,000. The
investigation revealed that the firm prepared various meat and/or
poultry egg rolls without the benefit of Federal inspection, sold
and transported the non-federally inspected products in interstate
commerce, and used the official mark of meat and poultry
inspection without authorization...

snip...

http://www.fsis.usda.gov/OA/pubs/rtc98.htm

FSIS REPORT TO CONGRESS 1996

HELL, why not sell those 'DOWNERS' for our GIs to eat,
maybe that is why some got CJD;

In June 1996, a U.S. District Court for the Northern District of
California in
Oakland, California, sentenced the former vice president of a closed meat
processing establishment and the establishment for violations of the
Federal
Meat Inspection Act. The official paid $250,000 as part of a
restitution/fine
payment, received 5 years' probation, and was required to perform 1,000
hours
of community service. The firm was ordered to pay $500,000 in restitution
to
the Defense Logistics Agency of the U.S. Department of Defense. In
addition,
three co-defendants were sentenced for selling adulterated meat to the now
defunct establishment. The co-defendants were convicted of illegally
slaughtering cattle and transporting and selling the adulterated meat to
the now
defunct firm, knowing the meat would be processed for resale and human
consumption. The former vice president admitted buying dead, dying,
diseased, or disabled cattle from the co-defendants and using the
adulterated
meat to prepare meat products for commercial sales and for Government
military contracts. The investigation was conducted in 1993 by the USDA
Office of Inspector General, officials from the Defense Criminal
Investigation
Service, and FSIS compliance officers. Restitution to the military was
initiated under the Affirmative Civil Enforcement program...

snip...

http://www.fsis.usda.gov/OA/pubs/rtc96.pdf

February 2003


Meat, Poultry, and Egg Products Inspection
2000 Report of the Secretary of Agriculture to the U.S. Congress

snip...

MORE BRIBERY FOR PASSING DOWNERS FOR HUMAN/ANIMAL
CONSUMPTION...TSS

* June 2000. A USDA Judicial Officer (JO) issued a Decision
upholding indefinite withdrawal of inspection services from a meat
and poultry company located in Greenville, New York. The JO's
Decision upheld an Administrative Law Judge's (ALJ) Decision. The
decisions were the result of an administrative hearing before the
ALJ wherein USDA presented evidence to show that the company was
"unfit" for inspection service. The proceeding to withdraw
inspection was based on the company's felony conviction of bribing
a public official. An investigation revealed that the company
provided money to an inspector in exchange for inspecting and
passing dying, diseased, or disabled livestock requiring
additional inspection by a Veterinary Medical Officer. The
inspector and company were convicted in separate trials. The
company has appealed to a U.S. District Court...

snip...


http://www.fsis.usda.gov/OA/pubs/rtc2000/rtc2000chap3.htm#4

March 2001


Meat, Poultry, and Egg Products Inspection
1999 Report of the Secretary of Agriculture to the U.S. Congress


Preface

snip...

January 1999. The owner of an export inspection station was sentenced on
two felony counts for using simulated export certificates with intent to
defraud. The defendant was sentenced to 3 years' probation and fined
$10,000. The investigation revealed that the defendant fraudulently
exported approximately 3 million pounds of meat and poultry products to
Mexico.

snip...

http://www.fsis.usda.gov/OA/pubs/rtc99/rtc99chap3.htm


* 2000
(Issued February 2003) [PDF
, 93 pp. 768 KB]
* 1999 (Issued
March 2001)
* 1998 (Issued June
2000; HTML text with PDF attachments)
* 1997 (Issued November
1999; PDF, 950 KB)
* 1996 (Issued
September 1997; PDF, 257 KB)

TSS

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#################

BrainTalk Communities - Fsis Food Inspector Convicted Felony ...
Meat, Poultry, and Egg Products Inspection 1998 Report of the Secretary of
Agriculture to ... 2000 Report of the Secretary of Agriculture to the US
Congress ...
brain.hastypastry.net/forums/ archive/index.php/t-49556.html - 9k - Cached -
Similar pages

TSS

#################### https://lists.aegee.org/bse-l.html
####################

---------------------------------
----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Monday, May 30, 2005 12:08 PM
Subject: Meat and Poultry Inspection: Report of the Secretary of Agriculture
to the U.S. Congress 2001 - 2004 (BSE) ???





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