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From: TSS (216-119-144-34.ipset24.wt.net)
Subject: Re: 1 in 2 CHANCE OF GETTING BSE AKA MAD COW BY THE ORAL ROUTE (PRIMATE STUDY)
Date: January 27, 2005 at 8:35 am PST

In Reply to: 1 in 2 CHANCE OF GETTING BSE AKA MAD COW BY THE ORAL ROUTE (PRIMATE STUDY) posted by TSS on January 27, 2005 at 7:03 am:

-------- Original Message --------
Subject: Re: 1 in 2 CHANCE OF GETTING BSE AKA MAD COW BY THE ORAL ROUTE (PRIMATE STUDY)
Date: Thu, 27 Jan 2005 10:37:58 -0600
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
CC: cjdvoice , webmaster@meatami.com
References: <41F90505.4060604@wt.net>


> LOOKS like a 1 in 2 chance to develop BSE by the oral route to me,
> but somehow the media and the industry/GOV. will spin this into
> no risk...
>
> TSS

AMERICAN MEAT INSTITUTE FOUNDATION SAYS LANCET STUDY SUPPORTS EFFICACY
OF EXISTING BSE FIREWALLS TO PROTECT HUMAN HEALTH

(Attribute Statement to AMI Foundation President James H. Hodges)

Washington, DC, January 27, 2005  A study that appeared today in the
on-line Lancet supports what scientists have known -- that a significant
species barrier exists to prevent the transfer of bovine spongiform
encephalopathy (BSE) or Mad Cow Disease to humans.

The authors estimate that a person would have to eat at least 3.3 pounds
of infected neural tissue to be at risk of developing variant
Creutzfeldt-Jakob Disease (vCJD)  something that is unlikely to happen
in the U.S. because tissues that could contain the BSE agent if an
animal is infected are required to be removed from the human food
supply. The authors also said that infectivity transfer from cattle to
humans could be 7 to 20 times lower than cattle to cattle transmission
through ingestion of the BSE agent. The study was done by French
scientist Jean-Phillipe Deslys and his colleagues.

Early in the BSE epidemic in the United Kingdom, before scientists fully
understood BSE or its transmission, Britons routinely and unknowingly
consumed infected parts from cattle like brains. Yet less than 150 human
cases of vCJD have occurred in the UK and the trend toward fewer vCJD
cases each year has continued for the past four years. Thats in
comparison to more than 180,000 cases of BSE being diagnosed since the
late 1980s and an estimated 3-4 million cases that could have occurred
without clinical diagnosis, but were destroyed without testing.

Although the study has limitations that prevent accurately estimating
the minimum infective dose for humans, its findings indicate that the
BSE firewalls in place in the United States will continue to protect the
public health. In simplest terms, Americans can continue to enjoy beef
with confidence.

-30-

Janet M. Riley

Senior Vice President, Public Affairs and Professional Development

American Meat Institute/NHDSC

1150 Connecticut Ave. NW, 12th Floor

Washington, DC. 20036

AMI: 202-587-4200

My direct line: 202-587-4245

My cell: 703/801-2238

Fax: 202-587-4300

SOME FACTS NOW;


Letter addressing apparent retaliation against Charles S. Painter,
Chairman of the National Joint Council of Food Inspection Locals

January 26, 2005

Secretary Mike Johanns
United States Department of Agriculture
Room 200-A, Whitten Building
12th Street and Jefferson Drive, S.W.
Washington, DC 20250

Dear Secretary Johanns,

We are writing to express our concern about apparent retaliation against
Charles S. Painter, Chairman of the National Joint Council of Food
Inspection Locals, who recently made disclosures covered by the
Whistleblower Protection Act about the agencys rules on bovine
spongiform encephalopathy. Further, we are concerned about the agencys
decision to involve seven more union officials in the investigation of
Mr. Painter, rather than use easily accessible agency records to answer
their questions about particular plants where such problems may be
occurring.

On December 8, 2004, Mr. Painter sent a letter, on behalf of the NJC, to
Mr. William Smith, Assistant Administrator for Field Operations of the
USDAs Food Safety Inspection Service. The letter presented concerns
about the removal of specified risk materials (SRMs) from cattle and
FSIS inspectors ability to enforce the export requirements for products
destined for Mexico. Specifically, the letter states that members of the
union had reported that:

1. Plant employees are not correctly identifying and marking all
heads and carcasses of animals over 30 months old. Therefore,
plant employees and government personnel further down the line are
unaware that numerous parts should be removed as SRMs and these
high risk materials are entering the food supply.

2. [O]n-line inspectors are not authorized to take actions when they
see plant employees sending products that do not meet export
requirements past the point on the line where they can be
identified and removed.

In his letter, Mr. Painter did not identify specific plants where
reports had come from, because he did not know them. In fact, he chose
not to learn the identity of the plants so that he would not be forced
to disclose this information, which could allow the agency to take
retaliatory action against the inspectors assigned to these plants.

Rather than dealing with the serious problems identified in Mr.
Painters letter, the agency instead directed extraordinary resources to
attacking the NCJ Chairman and other regional union presidents.
Specifically, on December 23, an FSIS compliance officer appeared
unannounced at the home of Mr. Painter, while he was on annual leave, to
question him about the allegations in the letter. Mr. Painter explained
that the intent of his letter was to point out problems with overall
FSIS policy. In fact, his letter suggests why the reports from several
plants are likely just the tip of the iceberg:

We are concerned, however, that since on-line Inspectors are not
instructed to perform this examination, most will not do so,
therefore most age determinations will not be reviewed by the
government. Additionally, since so many on-line Inspectors are
recent hires, these new employees will be even less likely to
perform this check. Inevitably, the majority of 30+ animals missed
by plant employees will continue down the line and SRMs will enter
the food supply.

Nevertheless, just a few days later, on December 28, 2004, Mr. Painter
received a notice from FSIS that he was under formal investigation for
failing to disclose the plants and inspectors involved in the incidents
described in his letter. On January 6, 2005, Mr. Painter endured a three
hour interrogation in which he repeatedly stated that he did not know
the identities of particular plants the agency should investigate in
addressing the policy failure addressed in his letter. On January 7,
2005, seven regional council presidents for the NJC were also ordered to
appear in Washington, D.C. on January 11, 2005, for an interview.

This case presents a classic example of the value and necessity of
whistleblowers. The decision by FSIS officials to attack the messenger
and ignore the message not only fails agency employees who are merely
trying to do their job, but also fails consumers who depend on the
agency to adequately safeguard the meat they feed their families.

Additionally, it is important to note that the NJC raised their concerns
in hopes that the agency would address an inadequate policy which
applies to all cattle slaughter plants. But if in response to this
concern about policy, the agency felt compelled to investigate the
performance of individual plants, it has methods for doing so that do
not require harassing union officials or other employees. The agencys
options include searching their database of non-compliance reports or
contacting district offices to inquire about plant performance on these
regulations, methods similar to those used to fulfill FOIA requests and
other routine evaluations. Rather than pursue these methods, the agency
chose to spend time and money pursuing retaliatory investigations of
union officials. We are also concerned that, to date, the agency has not
initiated any efforts to address the overall policy that leaves plant
employees in charge of determining the age of cattle, and instead has
chosen to make this an issue of the performance at specific plants.

Your agency showed disrespect for its own inspectors and violated the
public trust when you repeatedly used the media to imply that the
problems described in Mr. Painters letter were unfounded.[1]

Further, by opening a formal investigation of Mr. Painter, the agency is
attempting to restrict the rights of concerned federal employees and
citizens to freely express concerns to the public.

When Congress reauthorized the Whistleblower Protection Act in 1994, it
recognized whistleblowers as the "eyewitnesses in the front lines as
public policy is implemented" and thus mandated that agencies create a
climate where whistleblowers disclosures are encouraged and acted upon.
Contrary to this mandate, Mr. Painter is being illegally investigated
and discredited in the press.

The concerns outlined by Mr. Painters letter are of vital interest to
consumers, especially in light of recent announcements of the discovery
of two more cases of BSE in Canada and the agencys intent to
re-establish imports of live animals from Canada. The public has the
right to know that the reality inside meat plants is not the same as the
picture being painted for the media by USDA officials in Washington, D.C.

When FSIS inspectors feel they have no option left other than going
public with their concerns, that should serve as a wakeup call for the
agency to recommit itself to protecting public health, not as an excuse
to retaliate against its own employees. We urge you to reconsider the
decision to initiate a formal misconduct investigation of Mr. Painter,
and instead, to direct agency resources to taking steps necessary to
establish an environment inside FSIS that encourages employees to
disclose issues of waste, fraud, or threats to public health. Consumers
deserve no less.

We would appreciate a response to our concerns about this matter. Please
respond to Wenonah Hauter at Public Citizen, (202) 454-5132, 215
Pennsylvania Ave. SE, Washington DC 20003.

Sincerely,


American Corn Growers Association

Cancer Prevention Coalition

Center for Food Safety

Community Nutrition Institute

Consumer Federation of America

Consumer Policy Institute/Consumers Union

Creutzfeldt-Jakob Disease Foundation, Inc.

Family Farm Defenders

Government Accountability Project

Global Resource Action Center for the Environment

Institute for Agriculture and Trade Policy

Iowa Farmers Union

Lane County Food Coalition

Organic Consumers Association

Organization for Competitive Markets

Public Citizen

Safe Tables Our Priority

The Humane Society of the United States

Weston A. Price Foundation


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

[1]

For example, agency representatives have been quoted repeatedly as
saying Public Health Veterinarians, who are assigned to every slaughter
plant in America, perform ante mortem and postmortem inspection on every
animal. This is false. Most often, especially in the largest plants,
veterinarians do ante mortem and postmortem inspection only on those
animals which are segregated for veterinarian disposition by FSIS
inspectors.

http://www.citizen.org/cmep/foodsafety/madcow/articles.cfm?ID=12883

To read Charles Painter's letter, please go to following link (TAKES FOREVER TO LOAD, BUT WILL
LOAD EVENTUALLY, worth the effort though and need
to file away for later day...TSS)

http://www.citizen.org/documents/NJCletter-12-8-04.pdf


MORE FACTS;

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 JOs
Decision upheld an Administrative Law Judges (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 companys 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 http://www.fsis.usda.gov/OA/pubs/rtc2000/rtc2000.htm
(Issued February 2003) [PDF
http://www.fsis.usda.gov/OA/pubs/rtc2000/report.pdf 93 pp. 768 KB]
* 1999 http://www.fsis.usda.gov/OA/pubs/rtc99/rtc99.htm (Issued
March 2001)
* 1998 http://www.fsis.usda.gov/OA/pubs/rtc98.htm (Issued June
2000; HTML text with PDF attachments)
* 1997 http://www.fsis.usda.gov/OA/pubs/rtc97.pdf (Issued November
1999; PDF, 950 KB)
* 1996 http://www.fsis.usda.gov/OA/pubs/rtc96.pdf (Issued
September 1997; PDF, 257 KB)

MORE FACTS;

PRODUCT
Custom dairy cattle feed made for two customers. Recall # V-123-4.
CODE
None.
RECALLING FIRM/MANUFACTURER
Maribel Grain Co., Maribel, WI, by visit on February 25, 2004. Firm
initiated recall is complete.
REASON
Possible cross contamination of cattle feed by steamed bone meal which
is prohibited material.
VOLUME OF PRODUCT IN COMMERCE
2,040 pounds.
DISTRIBUTION
WI.

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

PRODUCT
B & G Seed Co., PIG GROWER, 50 lbs. Recall # V-126-4.
CODE
All.
RECALLING FIRM/MANUFACTURER
B & G Seed Company, Inc., Hull, GA, by telephone on March 30, 2004. Firm
initiated recall is ongoing.
REASON
Feed contains meat & bone meal (prohibited material), without the
mandatory ruminant warning on the label.
VOLUME OF PRODUCT IN COMMERCE
25/50 lb. bags.
DISTRIBUTION
GA.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00843.html

PRODUCT
Custom deer feed made for a Wisconsin farm. The product was in bags
holding about 40 pounds each. Recall # V-122-4.
CODE
1-30-04 on the product invoice and mixing record.
RECALLING FIRM/MANUFACTURER
Crivitz Feed Mill, Crivitz, WI, by telephone on February 20, 2004.
Wisconsin State initiated recall is complete.
REASON
The recalled deer feed contained steamed bone meal which is prohibited
material in feed for ruminants.
VOLUME OF PRODUCT IN COMMERCE
515 pounds.
DISTRIBUTION
WI.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00842.html

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

PRODUCT
ZuPreem Feline Diet, 14.0 oz cans for Non-Domesticated
Carnivores in the families Fedlidae, Canidea, and Hyenadea.
Recall # V-115-4.
CODE
6910 S1 SF01 military time of production: 06:05.
RECALLING FIRM/MANUFACTURER
Menu Foods, Inc., Pennsauken, NJ, by telephone on February 2, 2004. FDA
initiated recall is complete.
REASON
LACF Feiline Diet for non-domestic carnivores does not carry the BSE
warning statement.
VOLUME OF PRODUCT IN COMMERCE
1,620 cases.
DISTRIBUTION
KS.

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

PRODUCT
Product is a horse supplement packed into a 5 lb. Plastic
container with a yellow/green/red/brown label printed in
part "FORMULA: Each 5 pounds contains: Chondroitin Sulfate
27,000 mg D-Glucosamine HCL 100,000 mg Collagen hydrolyzed
27,000 MSM (methysulfonylmethane) 2,500 mg. Carti-Flex
COMPLEX net wt. 5 lbs, a concentrated natural joint
supplement containing Glucosamine HCL, Chondroitin sulfate,
Hydrolixed collagen and MSM". Recall # V-116-4.
CODE
All codes without the required cautionary statement are under recall.
RECALLING FIRM/MANUFACTURER
Interfarma Corporation, Miami, FL, by letters on February 4, 2004. FDA
initiated recall is ongoing.
REASON
This animal feed product does not contain the required BSE cautionary
statement: "Do Not Feed to Cattle or Other Ruminants".
VOLUME OF PRODUCT IN COMMERCE
80 cases 4-5 lb. Containers per case.
DISTRIBUTION
Venezuela, Nicaragua and Guatemala.

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

PRODUCT
Calf Primer II-R (Monensin) sold in bulk. Recall # V-113-4.
CODE
93125 (1-7-04).
RECALLING FIRM/MANUFACTURER
Tennessee Farmers Cooperative, La Vergne, TN, by telephone on January 9,
2004. Firm initiated recall is complete.
REASON
Calf feed, which had a medicated swine feed inadvertently mixed into it,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
28,040 pounds.
DISTRIBUTION
TN.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00840.html

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 1û2 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/

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

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

USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS


Public Health Service
Food and Drug Administration

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700


VIA HAND DELIVERY

Our Reference No. 1000123954

June 23, 2004

Ronald M. Foster, Manager
Randall C. Boyce, Manager
Trevor O. Foster, Manager
George P. Foster, Manager
Fresno Farming LLC
P.O. Box 457
1000 Davis Street
Livingston, California

WARNING LETTER

Dear Mssrs. Foster, Boyce, Foster, and Foster:

The U.S. Food and Drug Administration (FDA) conducted an inspection of
your medicated animal feed mill operation, Fresco Farming LLC, located
in Traver, California from April 14, 2004 through May 6, 2004, and found
significant deviations from the requirements set forth in Title 21, Code
of Federal Regulations, Section 589.2000 (21 C.F.R. 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 this rule, products
you manufactured and distributed are adulterated within the meaning of
Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act)
because they were prepared, packed, or held under insanitary conditions
whereby they may have been rendered injurious to health.

Our inspection found the following violations of 21 C.F.R. 589.2000:

1. Failure to provide for measures to avoid commingling or
cross-contamination of products that contain or may contain protein
derived from mammalian tissues into animal protein or feeds that may be
used for ruminants to comply with 21 C.F.R. 589.2000(e)(1)(iii).

* Your firm uses a vacuum system to clean up spilled product in the
tunnel area. This tunnel area houses the two receiving conveyor
systems and the elevators for the two conveyor systems. When
product, including ruminant meat and bone meal, is spilled onto
the floor of this area, the spilled product is vacuumed up by the
vacuum system and, via a discharge hose, was placed into a
conveyor system that your firm had designated as free of ruminant
meat and bone meal. Your firm admitted that it was unaware of the
vacuum system discharging into the conveyor systems designated as
free of ruminant meat and bone meal and that this had been in
place since April 2003. Your firm remedied this problem during
FDAs April/May 2004 inspection by removing the discharge hose
connection to the conveyer system that your firm had designated as
free of ruminant meat and bone meal .
* Your firm uses a dust collection system that pulls dust from
systems that receive both ruminant meat and bone meal and feed
ingredients intended for ruminants. This dust system then
discharged collected product back into the two conveyor systems
via a cross connection, thereby making it likely that ruminant
meat and bone meal became commingled with ruminant feed
ingredients. Your firm admitted that it was unaware of the cross
connection and that it had been in place since April 2003. Your
firm removed the cross connection during FDAs April/May 2004
inspection.

2. Failure to maintain written procedures specifying the clean-out
procedure or other means, and specifying the procedures for separating
products that contain or may contain protein derived from mammalian
tissue from all other protein products from the time of receipt until
the time of shipment, to comply with 21 C.F.R. 589.2000(e)(1)(iv). This
observation was also noted during FDAs July/August 2003 inspection of
your firm.

* There are no written procedures for separating products that
contain prohibited material from ingredients used in ruminant
feeds from the time of receipt until the time of shipment.
* The written procedure for cleaning out or flushing equipment after
mixing feeds containing prohibited material was not adequate to
prevent contamination of ruminant feed with prohibited material.

3. Failure to maintain records sufficient to track materials that
contain protein derived from mammalian tissues throughout their receipt,
processing, and distribution to comply with 21 C.F.R. 589.2000(e)(1)(i).
This observation was also noted during FDAs July/August 2003 inspection
of your firm.

* Specifically, your firm has failed to develop and implement
complete written procedures to separate ruminant meat and bone
meal from feed ingredients intended for ruminants from the time of
receipt until the time of distribution. The written procedures
that do exist fail to address the use of equipment common to
ruminant meat and bone meal and ruminant feed ingredients.

The above is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of materials intended for use as animal
feed, you are responsible for assuring that your overall operation and
the products you manufacture and distribute are in compliance with the law.
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 fifteen (15) working
days of receiving 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 being taken to correct the violations and
prevent their recurrence. If corrective actions cannot be completed in
fifteen (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 U.S. Food and Drug Administration,
Attention: Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay
Parkway, Alameda, California 94502-7070. If you have questions regarding
this letter, please contact Ms. Kishida at (510) 337-6824.

Sincerely,

/s/

CD Moss, Acting DD for
Barbara J. Cassens
District Director
San Francisco District

cc:
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
C. Michael Blasco, Feed Mill Manager
Fresno Farming LLC
P.O. Box 430
Traver, California 93673

http://www.fda.gov/foi/warning_letters/g4849d.htm


Public Health Service
Food and Drug Administration

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


July 12, 2004

WARNING LETTER
CHI-16-04

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Donald E. Hamilton, President/Owner
Illini Feeds, Inc.
P.O. Box 86, 1145 State Hwy. 94
Aledo, Illinois 61231

Dear Mr. Hamilton:

On February 19 and 20, 2004, the Food and Drug Administration (FDA)
conducted an inspection of your animal feed handling facility located at
1145 State Highway 94, Aledo, Illinois. The inspection found 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. This regulation is intended to prevent the
establishment and amplification of Bovine Spongiform Encephalopathy
(BSE). The deviations cause the swine feed manufactured by your facility
to be misbranded within the meaning of Section 403(a)(1) of the Federal
Food, Drug, and Cosmetic Act (the Act).

Our investigation found that salvaged pet food containing prohibited
material was added as an ingredient to the swine products manufactured
at your facility. During the inspection, our investigator found that you
failed to label your non-ruminant products with the required caution
statement - Do not feed to cattle or other ruminants. [21 CFR
589.2000(d)(1)]

The above is not intended to be an all-inclusive list of violations. As
a manufacturer of materials intended for use in animal feed, you are
responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law.

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

During the inspection, you told the investigator that you would put the
required cautionary statement on your products that contain prohibited
material, and maintain tracking documents for all incoming ingredients,
including animal proteins prohibited in ruminant feed. Please notify
this office in writing within 15 working days of receiving this letter
of any further steps you have taken to assure that your firm is in
compliance with the law. Your response should also include an
explanation of each step taken to correct the violations, and prevent
their recurrence. Please include copies of any available documentation
such as written procedures, corrected labeling, etc., demonstrating that
corrections have been made. If corrections cannot be completed within 15
working days, state the reason for the delay and the date by which the
corrections will be completed.

Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the above address.

Sincerely,

/s/

Scott J. MacIntire
District Director

http://www.fda.gov/foi/warning_letters/g4840d.htm


Public Health Service
Food and Drug Administration

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


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 ;-)

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

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

* 167 kB Report
* 105 kB Summary

Summary of the Scientific Report

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

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

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

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

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html

USA BSE GBR RAISED TO BSE GBR III

Working Group Report on the Assessment of the Geographical BSE-Risk (GBR
III) of USA 2004 ''extremely/very unstable BSE/cattle system''

USA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf>


CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf


MEXICO

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf

Canada and the United States have been raised to level III (presence of
BSE likely but not confirmed, or confirmed at a lower level) following a
new assessment taking into account the most recent evidence. EFSAs
Scientific Expert Working Group on geographic BSE risk assessment also
evaluated the status of Mexico and South Africa which were classified as
level III.

http://www.efsa.eu.int/press_room/press_release/575_en.html

European Food Safety Authority
20 August 2004
PRESS RELEASE
EFSA publishes Geographical BSE-Risk (GBR) assessments for
Australia, Canada, Mexico, Norway, South Africa, Sweden
and the United States of America
The European Food Safety Authority (EFSA) has issued today seven up-to-date
scientific reports on the Geographical Bovine Spongiform Encephalopathy
(BSE)
Risk (GBR) assessments for Australia, Canada, Mexico, Norway, South Africa
Sweden and the United States of America. While Australias GBR level I
(i.e.
presence of BSE in domestic cattle is highly unlikely) is maintained,
that of Norway
has been raised to level II (presence of BSE unlikely but not excluded),
Sweden
remains at GBR level II and those of Canada and the United States have
been raised
to level III (presence of BSE likely but not confirmed, or confirmed at
a lower level)
following a new assessment taking into account the most recent
evidence. EFSAs
Scientific Expert Working Group on geographic BSE risk assessment also
evaluated
the status of Mexico and South Africa which were classified as level III.
In 2003 EFSA was requested by the European Commission (EC) to re-assess the
Geographical Bovine Spongiform Encephalopathy (BSE) risk (GBR) for 13
countries:
Australia, Botswana, Canada, Costa Rica, El Salvador, Nicaragua,
Namibia, Norway,
Mexico, Panama, Swaziland, Sweden and the United States. Although the
European
Commission did not specifically seek advice from EFSA relating to the
appearance of
BSE in South Africa, the working group decided to carry out a risk
assessment for this
country under a self-tasking mandate in order to allow for a meaningful
evaluation of the
three other countries in the Southern African Region for which a GBR
assessment was
requested (i.e. Botswana, Namibia, Swaziland). EFSAs Scientific Expert
Working
Group on the Assessment of the GBR has completed to date those
assessments relating to
Australia, Canada, Mexico, Norway, South Africa, Sweden and the United
States of
America. The GBR assessments for the remaining countries will be
finalized by the end
of 2004.
In conducting the GBR assessments, EFSAs GBR working group followed the
methodology developed by the former Scientific Steering Committee of DG
Health and
Consumer Safety (DG SANCO) of the European Commission which is described
in its
final opinion on GBR assessment1. The risk assessments published today
are based on
up-to-date data provided by the countries concerned as well as other
sources of data (i.e.
Eurostat and country export data) covering the period of 1980 to 2003.
A detailed analysis for each country is presented in the Scientific
Reports which can be
found at:
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/catindex_en.html

For media enquiries, please contact:
Carola Sondermann, Senior Press Officer
Tel: +32 2 337 2294
Carola.Sondermann@efsa.eu.int
Or EFSA Communications Director, Anne-Laure Gassin
Tel: +32 2 337 2248
Anne-Laure.Gassin@efsa.eu.int
For more background information about the European Food Safety
Authority, go to:
http://www.efsa.eu.int/
Notes to editors
1. The Geographical BSE-Risk (GBR) is a qualitative indicator of the
likelihood of the
presence of one or more cattle being infected with BSE, pre-clinically
as well as
1 Final opinion on the Geographical Risk of Bovine Spongiform
Encephalopathy (GBR) (Adopted on 6
July 2000). http://europa.eu.int/comm/food/fs/sc/ssc/out113_en.pdf
Updated opinion on the Geographical Risk of Bovine Spongiform
Encephalopathy (GBR) (adopted on 11
January 2002). http://europa.eu.int/comm/food/fs/sc/ssc/out243_en.pdf
clinically, at a given point in time, in a country. Where its presence
is confirmed, the
GBR gives an indication of the level of infection.
2. The GBR assessments are based on information submitted by countries
concerned in
response to a European Commission recommendation in 1998 setting out the
information
requirements for such an assessment.2 The information concerns in
particular imports of
bovines and meat and bone meal (MBM) from the United Kingdom and other
BSE-risk
countries, rendering standards for animal by-products, use of so called
Specified Risk
Materials (SRMs), feeding of MBM to ruminants etcetera.
3. The table below shows the current GBR levels of the seven countries
assessed by
EFSA so far, as well as their former classification where available.
GBR
level
Presence of one or more cattle clinically or
pre-clinically infected with the BSE agent in
a geographical region/country
GBR of the country/Region
Current status
(status before)
I Highly unlikely
Australia (I)
II Unlikely but not excluded
Norway (I), Sweden (II)
III Likely but not confirmed or confirmed at a
lower level
Canada (II), Mexico (N/A),
South Africa (N/A), USA (II)
IV Confirmed at a higher level
N/A= not applicable, i.e. not assessed before
2 Preliminary-opinion on a method to assess the geographical BSE-Risk of
Countries or Regions (adopted
on 10 December 1998).
http://europa.eu.int/comm/food/fs/sc/ssc/out35_en.html

http://www.efsa.eu.int/press_room/press_release/575/pr_biohaz02_gbr_en1.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of the United States of America (USA)

Adopted July 2004 (Question N° EFSA-Q-2003-083)
[20 August 2004]

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html


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

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

* 167 kB Report


* 105 kB Summary

Summary of the Scientific Report

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

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

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

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

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html


SUMMARY

javascript:popwindow('http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573/sr03_biohaz02_usa_report_summary_en1.pdf',750,480,1,0,1,0,0,1,1,0)


REPORT USA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573/sr03_biohaz02_usa_report_v2_en1.pdf


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Australia

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

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Canada

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

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Mexico

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

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Norway

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

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of South Africa

Adopted July 2004 (Question N° EFSA-Q-2003-074)

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Sweden

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

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of the United States of America (USA)

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

[20 August 2004]


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/catindex_en.html


ONE YEAR PREVIOUSLY ;

From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Tuesday, July 29, 2003 1:03 PM
To: fdadockets@oc.fda.gov
Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

snip...

PLUS, if the USA continues to flagrantly ignore the _documented_ science
to date about the known TSEs in the USA (let alone the undocumented TSEs
in cattle), it is my opinion, every other Country that is dealing with
BSE/TSE should boycott the USA and demand that the SSC reclassify the
USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the
SSC to _flounder_ any longer on this issue, should also be regarded with
great suspicion as well. NOT to leave out the OIE and it's terribly
flawed system of disease surveillance. the OIE should make a move on CWD
in the USA, and make a risk assessment on this as a threat to human
health. the OIE should also change the mathematical formula for testing
of disease. this (in my opinion and others) is terribly flawed as well.
to think that a sample survey of 400 or so cattle in a population of 100
million, to think this will find anything, especially after seeing how
many TSE tests it took Italy and other Countries to find 1 case of BSE
(1 million rapid TSE test in less than 2 years, to find 102 BSE cases),
should be proof enough to make drastic changes of this system. the OIE
criteria for BSE Country classification and it's interpretation is very
problematic. a text that is suppose to give guidelines, but is not
understandable, cannot be considered satisfactory. the OIE told me 2
years ago that they were concerned with CWD, but said any changes might
take years. well, two years have come and gone, and no change in
relations with CWD as a human health risk. if we wait for politics and
science to finally make this connection, we very well may die before any
decisions
or changes are made. this is not acceptable. we must take the politics
and the industry out of any final decisions of the Scientific community.
this has been the problem from day one with this environmental man made
death sentence. some of you may think i am exaggerating, but you only
have to see it once, you only have to watch a loved one die from this
one time, and you will never forget, OR forgive...yes, i am still very
angry... but the transmission studies DO NOT lie, only the politicians
and the industry do... and they are still lying to this day...TSS


http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

Mad Cow 'Firewalls' Just a Smokescreen

by Thomas O. McGarity
July 22, 2004

It's been seven months since the discovery of a mad cow-infected
Holstein in Washington state, time enough for the administration to have
developed a comprehensive regulatory response to protect the U.S. beef
supply. Indeed, to listen to the rhetoric of Agriculture Secretary Ann
Veneman, you'd think the administration had done just that. In
particular, the administration is fond of referring to a series of
"firewalls" in place to prevent protein from infected cattle from
reaching the food supply. On closer inspection, however, it turns out
that the administration's mad cow "firewalls" are more about public
relations than food safety, and that instead of protecting the
beef-eating public, the administration seems more focused on protecting
the beef industry's profits.

Veneman announced the discovery of the first U.S. case of mad cow on
Dec. 23, 2003. Almost in the same breath, she declared that any risk to
public health in the United States was "extremely low." Officials
predicted that mad cow would not spread to other animals because of
regulatory "firewalls" USDA and the Food and Drug Administration had
previously erected. In fact, Veneman boasted, she planned to eat beef
for Christmas. A few days later, USDA and FDA both announced their
intention to strengthen and supplement existing protections.

An investigation by the Center for Progressive Regulation (CPR) has
concluded, however, that the administration's actions don't match its
rhetoric. The much ballyhooed "firewalls" are so poorly conceived and
implemented that they provide far less protection than the American
consumer expects and deserves. In particular, a critical loophole in the
regulations permits slaughterhouses to get away with doing no testing
whatsoever for mad cow contamination in edible meat.

The government initially erected three "firewalls": controls barring
U.S. companies from importing cattle and feed from countries
experiencing mad cow outbreaks; a surveillance program to identify
suspect cattle and conduct tests on a small number of them; and
restrictions on the kinds of protein that can be included in cattle feed.

After the discovery of the infected Holstein, officials announced two
additional "firewalls" aimed specifically at protecting human health: a
ban on the use of "downer" (unable to walk) cattle in human food; and a
regulatory program to ensure that highly infective "specified risk
materials," including brains, spinal cords and small intestines, do not
contaminate edible meat. Unfortunately, none of these "firewalls"
provide the precautionary protections implied in the "firewall" metaphor
and demanded by the meat safety laws.

USDA shredded its own restrictions on imports when it covertly permitted
U.S. meatpackers to import 33 million pounds of beef from Canada between
September 2003 and May 2004 despite Veneman's August 2003 announcement
that she was extending a ban on such meat. And while USDA has expanded
its surveillance firewall, the number of cattle tested for mad cow
disease in the United States is still pitifully small. Indeed, the
program remains entirely voluntary. USDA has adamantly rejected any sort
of universal approach for testing all cattle, and even refused to let
one company conduct universal testing on its own nickel!

FDA promised in January to enhance its feed restriction firewall by
eliminating some questionable exemptions, but in the face of resistance
from the rendering and poultry industries, it has reneged on that promise.

Most troublesome of all is an obscure, but gaping loophole in the
firewall governing the handling of "specified risk materials" (SRMs)
from slaughtered cattle. The regulation permits industry to elect not to
implement rigorous standards for specific controls, simply by asserting
 as almost all establishments apparently have  that mad cow disease is
unlikely to be a problem in their facility. After reaching that
conclusion on their own, companies are allowed to follow far less
rigorous, industry-drafted Standard Operation Procedures to keep SRM out
of edible meat. They are required to have a written plan, but not to
follow it. Neither are they required to check for mad cow, or to perform
simple tests for brain and other risky nervous system tissues in edible
meat. Not surprisingly, it appears that most of the beef industry has
taken this less burdensome path. As a result, the administration's
assurances about safeguards and firewalls, at least with respect to U.S.
beef processing plants, amount to little more than rhetoric.

The sad truth is that the firewalls are designed more to protect the
meat industry from economic loss than to protect Americans from mad cow.
The consequence: American consumers are at an unnecessarily greater risk
of contracting a debilitating and always fatal disease.

Thomas O. McGarity, an expert in food safety law, is a professor of law
at the University of Texas and president of the Center for Progressive
Regulation.

http://www.americanprogress.org/site/pp.asp?c=biJRJ8OVF&b=127964


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

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument

Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA


https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed


Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf


Terry S. Singeltary Sr. wrote:

> ##################### Bovine Spongiform Encephalopathy
> #####################
>
> Risk of oral infection with bovine spongiform encephalopathy agent in
> primates
>
> Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian
> Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia,
> Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown,
> Jean-Philippe Deslys
>
> Summary The uncertain extent of human exposure to bovine spongiform
> encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob
> disease (vCJD)--is compounded by incomplete knowledge about the
> efficiency of oral infection and the magnitude of any bovine-to-human
> biological barrier to transmission. We therefore investigated oral
> transmission of BSE to non-human primates. We gave two macaques a 5 g
> oral dose of brain homogenate from a BSE-infected cow. One macaque
> developed vCJD-like neurological disease 60 months after exposure,
> whereas the other remained free of disease at 76 months. On the basis
> of these findings and data from other studies, we made a preliminary
> estimate of the food exposure risk for man, which provides additional
> assurance that existing public health measures can prevent
> transmission of BSE to man.
>
> Published online January 27, 2005
>
> http://www.thelancet.com/journal/journal.isa
>
> LOOKS like a 1 in 2 chance to develop BSE by the oral route to me,
> but somehow the media and the industry/GOV. will spin this into
> no risk...
>
> TSS
>
> ######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html
> ##########
>
>






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