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From: TSS ()
Subject: Re: Agriculture Secretary Mike Johanns At the U.S. Department of Agriculture BSE Roundtable June 9, 2005
Date: June 9, 2005 at 2:58 pm PST

In Reply to: Agriculture Secretary Mike Johanns At the U.S. Department of Agriculture BSE Roundtable June 9, 2005 posted by TSS on June 9, 2005 at 1:55 pm:

Greetings,

this is in reply to Johann, DeHaven, Collins and Masters,
on the BSE Round Table event.

a few comments below please on this BSeee;


----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Thursday, June 09, 2005 3:47 PM
Subject: Dr. Barbara Masters Food Safety and Inspection Service USDA BSE Roundtable The University of Minnesota St. Paul, Minnesota June 9, 2005


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


Release No. 0203.05
Contact:
Office of Communications (202) 720-4623


REMARKS AS PREPARED FOR DELIVERY By Acting Administrator, Dr. Barbara Masters The Food Safety and Inspection Service U.S. Department of Agriculture BSE Roundtable The University of Minnesota St. Paul, Minnesota June 9, 2005
Introduction

Good morning everyone. Today, I will focus my remarks on the public health aspects of BSE.

The Food Safety and Inspection Service (FSIS) uses science-based policies to effectively protect the health and well being of consumers worldwide against the threat of BSE and other food safety threats. Science-based policies are built on the public health model, which includes: assessment, policy development and assurance, or verification of effectiveness.

Historical Perspective

For more than a decade, the U.S. Department of Agriculture has had an aggressive program in place for surveillance, detection, and response to BSE. This program is led by APHIS, which has the responsibility for the health of live animals.

FSIS plays a strong role in the identification of samples from high-risk animals for this program. FSIS has over 7,500 inspection personnel in approximately 6,300 slaughter or processing establishments each and every day verifying the safety of meat, poultry and egg products. This includes identification and condemnation of cattle showing central nervous system symptoms on ante-mortem inspection. ........

snip.....

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

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

IN FACT, i must bring this up again.
IN TEXAS, when they are really worried about a mad cow,
when the cow is clinical and stumbling and staggering, TEXAS
does not bother TESTING the cow at all. nope, they just send
it directly to be rendered head and all to get rid of all evidence.
the june 2004 enhanced bse cover-up was just that. the USA
could test every cow that goes to slaughter, and it would be meaningless
unless properly done with the most sensitive testing to date.
but not in TEXAS or any other state in the USA.............


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

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

continued;

The authority to monitor and enforce the animal feed ban rests with the Food and Drug Administration.

snip..........

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

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


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/TSS


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


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

USA BSE GBR SHOULD BE GBR III, but someone dropped the ball...TSS


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


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

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

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

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


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


PART 2


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


TSS

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

continued;

Our actions involved extensive collaboration among our agencies. Together we implemented regulatory actions and policy changes to create multiple firewalls to strengthen and protect against the introduction and spread of BSE in U.S. cattle and against human exposure to the BSE agent.

The detection of a single case of BSE in a cow imported from Canada on December 23, 2003 led us to further strengthen our BSE safeguards to protect human health.

I will now focus on FSIS' BSE measures that were taken following that finding.

On December 30, 2003, one week after the announcement of the positive BSE animal, then Secretary of Agriculture Ann Veneman, made a major policy announcement--the prohibition of the slaughter of non-ambulatory disabled cattle from the food supply, the removal of Specified Risk Materials from the food supply, as well as other actions to protect human and animal health.

Ban on Non-Ambulatory Disabled Cattle

USDA immediately put the ban on non-ambulatory disabled cattle into effect. These animals were considered unfit for human food.

FSIS' public health veterinarians are responsible for enforcing this ban, and we have provided them with training on when cattle are to be condemned at slaughter.

Following USDA's ban on non-ambulatory disabled cattle, FSIS issued four Federal Register documents, three rules and one notice.

These regulations were published within 20 days after the positive finding in Washington State. The process for publishing such rules normally would have taken several months to years.

FSIS had already done considerable work that laid the groundwork for these interim final rules. Several proactive measures had already been implemented to safeguard our beef supply not only for U.S. consumers but for our trading partners around the world.

Using science as a foundation, based in part on the Harvard-BSE risk assessment, we were able to take immediate action. This risk assessment reviewed available scientific information related to BSE and other TSEs; assessed pathways by which BSE could potentially occur in the United States and identified measures that could be taken to protect human and animal health in the United States.

The key findings of the Harvard BSE risk assessment were used in conjunction with the most current scientific literature and information from the BSE epidemic in the United Kingdom and elsewhere in Europe. This information was used to develop the interim final rules to address the food safety concerns arising from the finding of BSE in the United States. ....

snip...

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

THE HARVARD BSE STUDY USDA/APHIS ET AL WERE SO PROUD OF WAS TERRIBLY FLAWED;

suppressed peer review of Harvard study October 31, 2002

MIND you the Harvard BSE risk ass. was partially funded by the very
industry it
was assessing.

ABOUT 132 pages;

October 31, 2002
Review of the Evaluation of the
Potential for Bovine Spongiform
Encephalopathy in the United States
Conducted by the Harvard Center for Risk Analysis,
Harvard School of Public Health and Center for
Computational Epidemiology, College of Veterinary
Medicine, Tuskegee University
Final Report
Prepared for
U.S. Department of Agriculture
Food Safety and Inspection Service
Office of Public Health and Science
Prepared by
RTI
Health, Social, and Economics Research
Research Triangle Park, NC 27709
RTI Project Number 07182.024

snip...

3.2 HAVE THE DATA BEEN CORRECTLY
INTERPRETED AND EMPHASIZED?
1) The H-T BSE study authors have done their best to
incorporate the existing data in their estimates of the parameters
selected for inclusion in the model. Not much hard data exist that
could be used directly for setting parameter values. Therefore, the
authors used indirect data to justify logical arguments for setting a
parameter to a particular range of values. The authors may have
included some factors in their model simply because some indirect
data could be found.
The reviewers had concerns that the importance of some parameters
has been overestimated and others underestimated.
2) A rather optimistic choice was made in case of doubt or
insufficient hard evidence or data. These concerns relate to overall
model weaknesses in the general comments section. In the
summary section, on Pages 98 and 99, several of the main issues
that involve assumptions that cannot be verified with confidence are
discussed, and several of them could serve as perfect examples of
what has been argued here, that optimistic choices for favorable
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Section 3  Identification of Data and Critical Evaluation of Evidence
outcome or reassuring nuances are presented (e.g., the
implementation rates, the remote chance that an infected animal
had been imported from the UK).
Reviewers commented on the import of MBM.
3) The UK export statistics mention a shipment of 20 tons to
the U.S. in 1989. Such a quantity was enough to spark the Swiss
epidemic. This part of import risk was considered negligible
probably because the U.S. authorities could not corroborate this
figure. The statement (Page 22, second paragraph, last sentence)
that overseas shipping of MBM was economically noncompetitive
seems questionable because at least for the period when MBM was
almost available for free in the UK, it did get all the way to South-
East Asia in large quantities. Figures from Southern State
Cooperative of recent years are moot in this respect.
A reviewer also commented on the import of live cattle from the
UK.
4) Because the USDA reported that about half of the animals
imported in the risk period did not really enter the food chain, these
were considered to carry no risk (Section 3.4.3). The report does
not provide details or evidence to support this statement. Other
arguments regarding the potential risk of import of live cattle from
the UK, such as animals not being from a BSE-infected farm, and
BSE not being a recognized disease (Page iii, last paragraph), are
questionable. Admittedly, not many were imported at the peak of
the risk period.
5) With respect to rendering (Table 3-3, Page 61), two log
reduction for atmospheric continuous rendering with added fat is
optimistic. Also there is a doubt about the statement on Page 25
(Appendix 1, second paragraph, last sentence) that addition of fat
increases the inactivation.
6) In Section 3.1.2.3 on stunning, it is assumed for the base
case that air-injected stunning is not used in the U.S., based on
conversations with involved persons (Page 55, first paragraph,
seventh line). However, it seems that the model is based on
unlikely events such as air-injected stunning. Therefore, the model
may be limited and may become obsolete. In Section 3.1.2.4 (Page
56, second paragraph, last sentence), the assumption that stunners
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not using air injection never cause contamination of the blood
(during exsanguination) with brain material needs to be modified.
7) The remark in Section 4.5 in the last line on Page 99 does
not sound very scientific: exposure could not have been
substantial because we did not see many cases, having in mind the
German experience. About the level of achieved surveillance, more
will follow.
8) In Section 2.3.9.1 on plate waste, it is said to mainly contain
vegetable material (third paragraph, second sentence), and
vegetable protein must be added to give it the correct nutritional
value. The major question is why one would not add mammalian
protein here instead of vegetable?
9) A reviewer commented on ProbPassAM (Section 2.1.1,
Appendix 1, Page 9). If it is their intent, the authors should specify
that ProbPassAM is the probability that a BSE-infected animal, not
just an animal, passes AM inspection. The authors state that the
probability of an animal passing AM inspection is age dependent.
They provide the references that were used to derive these
estimates. Because BSE evolves slowly, their argument that BSE in
older animals is more likely to be detected makes sense, but the
age-dependent variation is for animals without clinical signs. Thus,
the probabilities really represent the age-dependant chance
occurrence that an infected animal passes. Variations in
probabilities for the three age categories are minute (to third
decimal, Appendix 1, Section 3.1.1, Page 38). The authors do not
specify variation in ProbPassAM in animals with clinical signs by
the actual clinical signs, where variation in the probability among
animals is likely to be higher than variation among age categories.
Therefore, it appears that in one instance the parameter is
overestimated and in the other underestimated.
What is important from an inspection point of view is to pay greater
attention to early signs of disease. The probabilities also do not
reflect improvements in detection over the 20-year time span. If the
0.10 probability chosen by the authors is an average probability of
passing infected animals with early signs and animals with late
signs, perhaps it is appropriate. If it represents the probability of
passing an infected animal in the later stages of disease, then the
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Section 3  Identification of Data and Critical Evaluation of Evidence
Figure 3-1. Forrester
(rate/state) Diagram to
Depict Relationships
between Population
Parameters
estimate is probably high, because the neurological signs would be
obvious to an inspector.
10) Reviewers commented on the cattle population parameters
(Appendix 3A). The output tables list epidemic statistics such as the
numbers of cattle infected and the numbers infected exhibiting
clinical signs. It appears that cattle population parameters were
included in the model to simulate epidemic statistics, which is also
suggested in Figure 3-1 of the H-T BSE study report. Cattle
population parameters specified in the H-T BSE study report are
ProbBirth, ProbDeath, and InitSize. From an epidemiological point
of view, these variables can be used to estimate the size of the
national herd, which can define cattle at risk, and transmission of
prions, for instance between cow and calf, which can define spread.
However, the authors do not define clearly how the population
parameters affect the output. That is, the mathematical
relationships, if there are any, among the population parameters.
Figure 3-1 in the H-T BSE report is not sufficient in describing the
relationships. The authors do not report the density-dependent
process used. They might consider using Forrester (rate/state)
diagrams to depict the relationships in an easy to understand figure.
For instance, a simple way to convey to the reader the factors that
affect the size of the cattle population might be as shown in
Figure 3-1.
Population Birth
Rate
0.0833
at Time t
Death
Rate
A rate that increases the population and a rate that decreases the
population determine the size of the herd at a point in time. Then
the authors can elaborate. For instance, the rate of increase is
affected by the current age-specific size of the population at time t-1
and the birth rate. The rate at which the population decreases is
affected by the death/slaughter rate. The number culled for slaughter
(and other factors) affects the death rate.
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In Table 3.4.1, the natural death rate is age-specific (Appendix 1,
Page 45). It should be reported that the unit for age is months, and
that the values tabulated are for beef cattle. Overall, the units of
measurement should be included in all tables. Throughout the
report, the stage of production is not considered. For instance, the
death rate is different for stocker cattle on pasture than for feedlot
cattle and varies seasonally and geographically and certainly by
producer. When should details such as these be included in the
model and when should they be excluded? More rationale should
be given for the variables selected and for those omitted.
Population parameters were important in the Great Britain outbreak
because destroying infected animals served to reduce the incidence
rate and disease spread. It is unclear how the population
parameters are used in this model.
11) About maternal transmission, one reviewer noted the
following. The parameters beginCalving and endCalving, the
beginning and ending age when cows give birth, are defined in
Appendix 1, Pages 10 and 11. They are included presumably to
estimate maternal transmission of prions to offspring or perhaps to
determine the period at which transmission could occur. However,
the actual relationship among the variables is not described.
Therefore, one would have to examine the computer code to
understand the relationships. Again, the authors might consider
depicting the relationship as shown in Figure 3-2.
ProbTrans is a probability that a new born calf becomes infected
if the mother is infected and the mother has lived through at least a
fixed fraction of her incubation period and its value is 0.1
(Appendix 1, Section 2.2.2, Page 10). The fixed fraction is specified
by parameter and its value is 0.833
(Appendix 1, Section 3.1.7.3, Page 76). Therefore, it appears that
probTrans is a conditional probability that can take on one of the
two values, which might be depicted by a Warnier-Orr diagram that
the authors could use as a means of making the relationship easier
for the reader to understand:
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Section 3  Identification of Data and Critical Evaluation of Evidence
Figure 3-2. Forrester
Diagram to Depict
Relationships for
Begincalving and
Endcalving
Rate
BSE
Calves
BSE
Mom
Transmit
(ProbTrans)
Moms
Time
since
infected
[Fraction of incubation period > 0.833] {ProbTrans = 10%
[Fraction of incubation period < 0.833] {ProbTrans = 0%
If the condition within the square brackets [ ] is true, then the
assignment to the right of the curly brace { is made. Also, the
authors need to specify if the fraction is >0.833 or ?0.833.
12) Apparently, the incubation period for BSE is assigned a value
between 0 and >130 months according to the probability
distribution ClinicalDate (Appendix 1, Pages 73-76). It is
assumed that although the table indicates >130 months, the highest
value actually used was 130.
13) A few assumptions are based on data extrapolated from
dairy cattle and beef cattle or other animals. Do the results sum
over all types of cattle?
14) The number of cattle among which blood meal from a single
slaughtered animal is divided is estimated as described in Section
2.3.1 (Appendix 1, Page 11). Apparently, the blood collected from
individual animals at slaughter establishments is pooled. The
authors calculate the expected amount of blood meal consumed by
a dairy cow to determine the number of animals (88) fed by a single
4,000 lb batch of blood meal. It is not clear how this number is
used along with estimates of blood meal consumption (Table 3.3.3,
Appendix 1, Page 39) by each bovine type, gender, and age
combination to estimate the number of cattle infected by blood.
Also, the value for the number of animals fed by a single batch of
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blood meal is reported as 88 in Appendix 1, on Pages 11 and 23,
but 89 in Appendix I, Page 66. Which of these two numbers is
correct? Because the units in the output tables (Appendix 3A) are
not given, it can only be a guess that the value for blood (in mode of
infection) represents cattle numbers infected by blood.
15) One reviewer commented on the lack of emphasis on
exposure routes. It is generally accepted that the highest risk for BSE
is from
Z import of live cattle or MBM from a country with BSE;
Z an internal processing system that is incapable of reducing
infectivity below a certain threshold level (mainly the
rendering system); and
Z exposure of ruminants to the end products of the second
way (be it purposely or accidental, by cross-contamination).
Although it is commendable that all possible routes and potential
risks are addressed, the emphasis could have been placed more on
the above limited number of priority routes, instead of dwelling on
sometimes highly theoretical routes. In other words, some of the
reported unlikely infection routes are easily dismissed by the model
with a simple statement, whereas others are investigated to a
surprisingly deep level. This comment is also related to the general
comment on complexity and level of detail.
The study apparently treats the scrapie transmission (Section 2.3.3,
Page 23) and the spontaneous BSE case (Section 2.3.1, Page 21) at
the same level as the above listed priority routes. Below we provide
an example of this inconsistency with what is considered major
risks.
It is stated that from 750,000 up to 2.5 million animals are imported
annually from Mexico and Canada (Section 2.3.2.3, Page 22).
However, the H-T BSE study report does not address what happens
in Mexico in terms of MBM exposure. In general, the report says it
was extremely unlikely that those animals posed a risk of
introducing BSE in the U.S. Perhaps the imported animals do not
pose any risk, but what if they had been fed contaminated starter
ratios as calves in Mexico? Even if such animals would not live
until patent clinical stages, they can introduce infectivity into the
system. The Scientific Study Committee (SCC) concluded that this
was an area for consideration (or concern) in the case of the U.S.
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Section 3  Identification of Data and Critical Evaluation of Evidence
16) The third paragraph on Page iii discusses the risk presented
by the 334 animals brought into the U.S. from the UK between
1980 and 1989. The text states: These animals were imported as
breeding stock, not as beef or dairy breeding animals. This fact is
likely to have reduced their potential for exposure to BSE before
their export from the UK (fifth line). There is a misunderstanding
here as discussed below.
The cattle exported from the UK have carried a greater risk of being
infected by BSE than the other members of their natal cohorts that
were not exported. An assessment based solely on the incidence in
the home-based remnant of the cohort can therefore be misleading.
The reason for this elevated risk is because the exported animals are
more likely to have received commercial concentrate feed,
especially beef breeds that had a much lower exposure to feedstuffs
containing MBM. One reason for this was to ensure that they were
in the best physical condition. Examples of this apparent differential
risk for exported animals are the animals of the Saler breed, which
was exported to Canada, and animals exported to Denmark and
Germany. More generally, at the beginning of the clinical
epidemic, pedigree dairy herds were disproportionally represented.
Their exposure to MBM was relatively greater than for other
commercial herds, because of showing animals and general
traditions of managing such herds. Unfortunately a proportion of
the early affected pedigree herds was the source of Friesian heifers
for export to Portugal to restock after the Contagious Bovine
Pleuropneumonia (CBPP) outbreak there.
17) The second paragraph in Section 2.1.1 on Page 6 describes
transmission of TSE disease in the case of sheep-borne scrapie. It is
stated that TSE transmission has been inked to the use of vaccines.
There is not much evidence that a relatively crudely prepared
louping ill vaccine has been associated with transmission. The
evidence from the Italian outbreak is far from conclusive.
18) It would have been more correct if at least experimentally
was inserted after transmitted in the second sentence of the
second paragraph of Section 2.1.2.
19) With reference to Anderson et al. (1996), it is stated in
Section 2.1.3, third paragraph, that the susceptibility of animals
peaks at 1.31 years of age and then decreases based on back
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calculation of the BSE model. There not only is a slight
misunderstanding of the Anderson paper, but also an error in this
paper that unfortunately has never been amended.
The peak susceptibility quoted is not derived by a back calculation.
However, it is derived from a research institutes cattle herd that had
a very unusual feeding profile and this is the error. In Great
Britain, exposure to feedstuffs containing MBM is relatively rare
between 6 months of age and approximately 2 years when heifers
start to calve. This error is perpetuated in the Woolhouse and
Anderson (1997) paper, which is not a separate investigation (i.e.,
both papers are part of the same investigation). Moreover, it has not
been possible to determine the profile of age-dependent
susceptibility and whether it does occur. This would require a
laboratory-based study because the natural feeding pattern
throughout the first 2 years of the life of cattle in Great Britain
precludes the necessary epidemiological analysis of this putative
age-dependent susceptibility.
The synthesis of the current evidence on this aspect is important to
the risk assessment. If there is an age-dependent susceptibility it is
not absolute. That is, all ages are susceptible. The age at which
cattle are exposed orally and parentally to the BSE agent in
experimental challenges in Great Britain has been 4 months. This is
the age at which calves would have achieved their maximum intake
of commercial concentrate feedstuffs under Great Britain conditions.
The results from the British attack rate study, involving oral exposure
to varying amounts of brain tissue from terminal cases of BSE, has
resulted in an incubation period/age at clinical onset distribution
similar to that observed in naturally occurring cases. The
epidemiological evidence from the epidemic in Great Britain is that
age at exposure does not influence the incubation period.
In the ninth line of the third paragraph, it is hypothesized that agerelated
susceptibility is associated with permeability of the intestine
to large protein. A reference to the hypothesis is required because
the change in permeability of the bovine intestine with age does not
explain the apparent age-dependent susceptibility. The quoted
changes occur too early after birth.
In the second paragraph on Page 12, findings from the attack rate
experiments are discussed for the dose of BSE agent. The
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Section 3  Identification of Data and Critical Evaluation of Evidence
researchers should have made themselves aware of the attack rate
study conducted in Great Britain. The lowest dose in the original
study (a follow-up study using lower doses is in progress) was 1g.
The results of this study should have been included here. There
appears to be some confusion here and therefore a concern that the
researchers may not have made the best use of the research results
available, which is a trap generally advised against in terms of
interpretation and use of the results of the bovine pathogenesis
study. Essentially, the researchers have assumed that all of the
animals in the pathogenesis study, exposed to 100g brain orally,
had an incubation period of 36 months. This is not true and
probably arises from a lack of synthesis of the results from these two
studies; the attack rate study, although initiated at the same time as
the pathogenesis study, was the scoping study for the latter. The
problem is that in the attack rate study the 10 animals were exposed
to 100g brain orally. However, the same exposure dose used in the
pathogenesis study had incubation periods that ranged from 33 to
61 months. It is not correct to assume that all of the pathogenesis
study animals had the same relatively short incubation period.
Therefore, the proportional calculation described in Section 2.10.1,
Appendix 1 will produce conservative estimates of infectivity and
underestimate this value.
20) Section 2.2.1 describes scrapie in sheep as one of the
possible causes of the BSE epidemic in the UK. The section is a
little muddled in that it starts discussing transmission of sheep
scrapie between sheep and then goes on to the sheep scrapie origin.
The latter is a little simplistic and half-hearted. Again, this section is
a little short on primary references and reviews of considerations of
the origin, for example Kimberlin (1997). The comment on the
feeding of concentrates to calves not taking place other than in
Great Britain except Australia (Page 14, last sentence) is not true.
The EU-sponsored Great Britain exercise clearly indicated that the
feeding of concentrates containing MBM to calves was not restricted
to Great Britain/UK. Thus, there is a misquotation regarding the
feeding of concentrates to calves, which needs to be corrected to
make accurate international comparisons. Finally, the last sentence
of Section 2.2.1 could be misinterpreted by the uninformed to mean
that cattle are not susceptible to oral exposure to sheep scrapie.
This is not true.
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21) Section 2.2.2 discusses sporadic BSE as one of the possible
causes for the UK epidemic. The first sentence of this section is
rather vague and conflicting. Is this referring to relativity to all other
countries or just to the U.S.? The evidence suggests that this is only
true for the U.S. Occurrence of sporadic BSE according to age of
cattle is discussed in the second paragraph. The age distributions of
the UK animals are specifically mentioned. However, other
European countries certainly have dairy cow populations with
similar age distributions, which needs to be considered here.
22) As discussed in Section 2.2.3, toxic agents and other
hypotheses as a possible cause of the BSE epidemic in the UK are
discussed here. The other hypotheses may not deserve any great
attention in such a risk assessment. They could have been
dismissed either by reference to reviews by others such as the
Spongiform Encephalopathy Advisory Committee (SEAC) in Great
Britain or by the EUs SSC. As it stands, it is misleading. For
example, the Organophosphate Pesticides hypothesis has not
been a singular hypothesis. It has changed significantly throughout
the epidemic by its protagonist. Also, in the last sentence in the first
paragraph of Section 2.2.3.2, it is stated that resulting conditions
from copper deficiency had signs and pathological changes similar
to those of BSE, which is not true. Section 2.2.3.5 discusses
pituitary hormones, but the fact that transmission via hormones
derived from bovine pituitaries was considered in the original
epidemiological study has been ignored.
23) As discussed in Section 2.3.7.1, there is a theoretical risk
that cattle could be exposed to a TSE from porcine-derived protein.
One of the two potential sources of this exposure can be a natural
TSE that infects pigs. Section 2.3.7.1 discusses infectivity in pigs
due to TSE infection. BSE in pigs, as a clinical disease or subclinical
infection, has been a concern worldwide. They were clearly of
potential importance in Great Britain because of the inclusion rate
of MBM. In simple terms pigs could represent an effective sump
for the BSE agent, in which the BSE agent is effectively removed
from the feed system, or at the other extreme they could represent a
means of amplification.
The evidence from Great Britain could have perhaps been used to
strengthen this section. This is so specifically for the last part of the
second paragraph and the third paragraph on Page 29. Some
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Section 3  Identification of Data and Critical Evaluation of Evidence
evidence indicates that subclinical infection is not a problem in
pigs, and this is not presented. Also, some evidence shows that
clinical disease in pigs has not occurred in the pig population in
Great Britain. This has probably got lost in various reports.
However, if one assumes that the incubation period in pigs is the
same as that for BSE in cattle and the surveillance for neurological
disease in pigs in Great Britain is equally effective for such disease
in cattle, then the number of expected cases in the pig population in
Great Britain can be tens of thousands. On the first assumption
there is no evidence to dismiss it. On the second assumption,
evidence indicates that the surveillance of disease, including
neurological disease, in pigs is more effective than in cattle in Great
Britain.
BSE in pigs was detected by a neuropathologist whose specialism
was neurological disease in pigs. Also, during the BSE epidemic
outbreaks of neurological disease in pigs in Great Britain were
detected, brought to the attention of MAFF scientists, and
investigated. The main point is that the third paragraph on Page 29
has a touch of innumeracy. The percentage of pigs slaughtered at
less than 6 months of age is not an important statistic compared to
the number of pigs that reach a potentially susceptible age (~5
years), and this is what the analysis of the pig population referred to
above was concerned with. There is really no evidence that pigs
are important in the epidemiology of BSE, but quoting percentages
rather than absolute numbers is not helpful in such an important risk
assessment.
24) Actions taken in the UK to check BSE are described in
Section 2.4.2, Page 37. The fifth sentence (line 7) indicates that the
ban on specific bovine offal (SBO) as ingredients in feed stuff helps
to identify tissues with the highest infectivity. It should be indicated
that these high risk tissues were identified as a result of research on
sheep scrapie. This sentence also could be more fully referenced.
The last sentence of the paragraph is more accurate if it is moved to
be the penultimate sentence. Because by 1997 the additional ban
on the use of mammalian-derived protein in 1996 could not
possibly have had any effect on the clinical incidence.
To make the second paragraph more realistic, it may be noted that
the SBO ban, with respect to the human food supply, was
introduced in 1989 because of the knowledge that when the
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scrapie agent successfully crosses to another species, it can have
altered transmission characteristics with respect to other species.
Also, the tissues listed as the SBOs, such as brain and spinal cord
from cattle older than 6 months, are incomplete.
The chronology of events that is suggested in the third paragraph is
not correct. The national surveillance for Creutzfeldt-Jakob Disease
(CJD) was formally instigated in May 1990, which is clear from the
CJD Surveillance Units website. In Table 2-2, the chronology of
BSE-regulated actions in the UK contains errors. For example, there
was no selective culling in 1990, and spinal cord in animals older
than 6 months was included in the original SBO ban. There are
perhaps some other important exclusions even though this is a
summary table. For a detailed chronology, refer to the six monthly
progress report on the BSE epidemic published by the Ministry of
Agriculture, Fisheries, and Food (MAFF) (now the Department for
Environment, Food, and Rural Affairs or DEFRA), which is available
on their web site.
The two measures to prevent the BSE epidemic described in the last
two paragraphs of this section are confused as different bans. The
reality was that in March 1996, the SEACs recommendation was for
the deboning of carcasses of animals older than 30 months of age
together with the removal of all obvious lymphatic and nervous
tissues. This was not possible because of an insufficient number of
deboning plants. The political decision was therefore made, at the
Prime Ministerial level, to remove all animals over 30 months old
from the human chain. The ban on bone-in-beef was introduced as
a precautionary measure as a result of the later results from the BSE
pathogenesis study (in cattle) conducted in Great Britain that
suggested that infectivity may be present in dorsal root ganglia.
25) In Section 2.4.5, BSE surveillance in the U.S. was evaluated.
The section reads as if there is a little complacency about the
surveillance for BSE, and CJD/vCJD in the U.S. A more critical
evaluation appears to be appropriate. There have clearly been a
number of problems with surveillance for clinical BSE. The first is
the general level of surveillance in the U.S. and other countries.
The second is the fact that at low incidence BSE is clearly a difficult
disease to identify because of its more behavioral, rather than
neurological, clinical presentation in at least the early clinical phase
and the rather variable clinical signs. Thirdly, a concentration on
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Section 3  Identification of Data and Critical Evaluation of Evidence
suspect rabies cases has not proved to be very effective within
continental Europe; this is mainly because rabies is endemic in the
less cattle-dense areas and such surveillance (on its own) can
therefore exclude a significant proportion of the cattle population.
Fourthly, downer cows are probably not the best targets for BSE
surveillance.
The time frame of the BSE risk assessment work is not clear. The
executive summary indicates a starting year of 1998 and the
scientific references section contains some papers published in May
2001. An improved awareness of the extent and magnitude of the
incidence of BSE in EU member states in continental Europe
emerged towards the end of 2000. Any comment on the omission
of what has been learned or stressed from this additional
surveillance in Europe, arising from the use of the more rapid and
economical tests described in Section 2.4.1, may be misplaced.
However, two related aspects emerge. The first is that testing
animals at slaughter improves quite dramatically our knowledge on
the incidence of BSE in countries with a low incidence of clinical
BSE and therefore a relatively poor awareness of the intricacies of
the clinical picture. Secondly, targeting surveillance to the more
general category of fallen stock/casualty slaughter animals, rather
than just downer cows is a much more effective method.
A comparison of surveillance for CJD/vCJD in the U.S. with that in
the UK and the more widely based EU funded surveillance project
would have been helpful because there do seem to be some
differences. A lack of change in the observed incidence of CJD in
the U.S. could be interpreted as providing evidence of no increased
intensity in surveillance. This comment is made in light of the
findings from those countries that have participated in the
international project on CJD surveillance.

snip...

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


TSE USA UPDATE 2005

SCRAPIE USA MONTHLY REPORT 2005

AS of March 31, 2005, there were 70 scrapie infected source flocks (Figure 3). There were 11 new infected and source flocks reported in March (Figure 4) with a total of 51 flocks reported for FY 2005 (Figure 5). The total infected and source flocks that have been released in FY 2005 are 39 (Figure 6), with 1 flock released in March. The ratio of infected and source flocks released to newly infected and source flocks for FY 2005 = 0.76 : 1. IN addition, as of March 31, 2005, 225 scrapie cases have been confirmed and reported by the National Veterinary Services Laboratories (NVSL), of which 53 were RSSS cases (Figure 7). This includes 57 newly confirmed cases in March 2005 (Figure 8). Fourteen cases of scrapie in goats have been reported since 1990 (Figure 9). The last goat cases was reported in January 2005. New infected flocks, source flocks, and flocks released or put on clean-up plans for FY 2005 are depicted in Figure 10. ...

FULL TEXT ;

http://www.aphis.usda.gov/vs/nahps/scrapie/monthly_report/monthly-report.html


June 15, 2005 USDA takes steps to battle CWD

Chronic wasting disease survey and certification program in the works
The Department of Agriculture's Animal and Plant Health Inspection Service is seeking approval from the Office of Management and Budget to launch a national chronic wasting disease study and CWD herd certification program. The certification program and study are aimed at supporting the captive deer and elk industry in the United States and reducing CWD in captive herds. If the study and program are approved, participation will be voluntary.

Dr. Randy Pritchard, a veterinary medical officer with USDA-APHIS Veterinary Services who focuses on CWD, says he hopes the certification program and survey will be approved by fall 2005. "There is not a lot of information available for this industry," he said.

First detected in 1967, CWD has been found in members of the deer family, which include white-tailed deer, mule deer, and elk. To date, the disease has been identified in 13 states (see map) and two Canadian provinces.

In April, APHIS announced it was seeking OMB approval for a study that would collect information, through the National Animal Health Monitoring System, on the health and management practices of up to 5,600 cervid producers. "All indications are that it will be approved," Dr. Pritchard said.

If given the green light, the study will describe the farmed/captive cervid industry and identify the most efficient ways to contact producers for outreach purposes. In addition to other information, APHIS will track how long particular herds have been monitored for CWD.

"It is really important that people know that this is a voluntary study and that it is completely confidential," Dr. Pritchard said. "They won't be giving us any identification information. There will be no way to tie this back to an individual."

The agency will also use the collected information to prepare descriptive reports and information sheets that will be disseminated to cervid producers, stakeholders, academia, and other interested parties.

Dr. Pritchard says APHIS hopes to tie the survey to the national herd certification program, which is also awaiting approval from the OMB. The proposed rule on this certification program was published in the Federal Register on Dec. 24, 2003. "There were numerous comments from that, and it has taken awhile to sort through all of those," Dr. Pritchard said.

Dr. Dean Goeldner, APHIS CWD program coordinator, says that the agency has reviewed the comments and made some changes to the proposed rule. He says the final rule is still a few months away from being published.

Jurisdiction over captive deer and elk varies from state to state, and several states already enroll deer and elk herd owners in voluntary state certification programs. The proposed national herd certification program will recognize state programs that meet equivalent requirements, and allow cervid owners who reside in states without equivalent certification programs to directly enroll in the national certification program. The goal is to ensure that interstate movement of captive deer and elk does not spread CWD.

The national program will focus primarily on animal identification, regular CWD herd surveillance, testing of animals that die in monitored herds or are sent for slaughter, and limiting of new acquisitions to animals from herds that are also enrolled in the program. State and federal agencies will work together to trace the movements of animals with CWD and identify animals and herds that were exposed to them.

"I think this national program is very important, and the reason it is important is it would help standardize the approach taken by individuals states. It offers states a blueprint on which to build their programs," said Dr. William Hueston, director of the Center for Animal Health and Food Safety at the University of Minnesota. "It would really facilitate the whole interstate movement of these animals."

The proposed national program would not apply to animals being held for CWD research purposes, but to all other types of captive deer and elk. Most captive deer and elk are farmed, raised either for sale as meat, for sale as breeding animals, for harvest of antler velvet, or for hunting on private game facilities. A smaller number of captive deer and elk are maintained in zoos, other exhibitions, or research facilities.

Linking the CWD survey and herd certification program is commonsense, according to Dr. Pritchard. "The national certification program would be an ideal time to do this survey," he said. "Most of the time, the questionnaire is going to be administered by a field veterinarian, so our hope was that they would already be on the farm for the certification program."

Producers will be able to go through the certification process but skip the survey, if they so desire, and vice versa.

Although APHIS expects both the certification program and study to be given the go-ahead, it may move forward with the study if that is approved first. Staff at APHIS' CWD program have received a barrage of questions from the public, many of which they have not been able to answer because of a lack of data.

"We searched for answers to some of those questions and found out pretty quickly that those answers are not available, at least on an national level," Dr. Pritchard said. "We don't have a lot of knowledge about this industry."

Information collected through the survey should help.

–Kate O'Rourke

http://www.avma.org/onlnews/javma/jun05/050615d.asp


June 15, 2005

CWD found in New York wildlife
Chronic wasting disease, a transmissible encephalopathy, has been identified in two wild deer in Oneida County, New York. This news came shortly after the identification of five cases of CWD in farmed deer herds in the same county, which is located in the central part of the state (see JAVMA, May 15, 2005, page 1633). New York is the first state east of Illinois to have animals identified with the disease.

The wildlife cases were discovered through the New York State Department of Environmental Conservation's intensive monitoring efforts that were put into place after the disease was identified in captive herds.

In response to the wildlife cases, the DEC filed emergency regulations regarding the handling, transport, and management of deer in the state to prevent further spread of the disease in the wild. For example, the regulations prohibit the movement of certain animal parts out of a containment area established in and around Oneida County, and establish mandatory checkpoints for deer hunters in this area. They also include a number of provisions to be followed by individuals and facilities across the state. Implemented on April 29, the emergency regulations will be effective for 90 days. The DEC is in the process of developing permanent regulations.

At press time, the DEC, along with the Department of Agriculture's Wildlife Services program, had tested 317 wild deer in central New York as part of its investigation and had not identified any further cases of CWD in the wild. Investigators were still trying to determine the source or sources of the disease in the state. Since 2002, the DEC has collected more than 3,700 samples from wild white-tailed deer.

http://www.avma.org/onlnews/javma/jun05/050615p.asp


May 15, 2005
CWD found in New York
Disease makes first appearance in eastern United States; New York responds
Chronic wasting disease, a transmissible encephalopathy, has made its debut in farmed deer herds in the eastern United States. At press time, CWD had just been confirmed in five deer from two herds in Oneida County, New York. This is the first time the disease has been identified in any state east of Illinois.

Until now, CWD had been identified only in Colorado, Illinois, Kansas, Minnesota, Montana, Nebraska, New Mexico, Oklahoma, South Dakota, Utah, Wisconsin, and Wyoming. Saskatchewan and Alberta in Canada have also reported CWD infections. The disease has been found in captive animals in some states and provinces and in the wild in others. In some areas, the disease is found in both captive and wild animals.

Chronic wasting disease, first detected in 1967, has been found in members of the deer family, which include white-tailed deer, mule deer, and elk. Researchers hypothesize that prions, infectious proteins, cause the disease, but more research is needed into the fatal neurologic illness.

Responding to the positive cases in New York, Dr. William Hueston, director of the Center for Animal Health and Food Safety at the University of Minnesota, says he won't be surprised if the disease is found in additional states.

States that have experienced CWD have taken steps to regulate the movement of farmed deer and elk, but not all states have followed suit. The Department of Agriculture's Animal and Plant Health Inspection Service provides support for CWD prevention and surveillance for farmed and wild elk and deer as well as indemnification dollars for captive herds that must be destroyed. Many states, however, still struggle to fund state surveillance programs.

"The challenge is that most of the states are stretched very thin in their animal health resources," Dr. Hueston said. "Largely, legislators and legislatures have the attitude, which I perfectly understand, that if we don't have a problem, why should we pay for additional veterinary services or animal health programs? That is all well and good, as long as you don't get a new problem emerging."

The political climate is also a factor. "We are in an era where, in general, the majority of the people would like to see a smaller government and less laws, and that creates a window of opportunity for emerging diseases," Dr. Hueston said.

In New York, the responsibility for controlling CWD is shared by the USDA and two state departments. The Department of Environmental Conservation issues licenses to individuals who possess, import, or sell white-tailed deer, and also routinely tests New York's wild deer. The Department of Agriculture and Markets monitors the health and movement of all captive deer and elk for the presence of CWD. In July 2004, this department initiated the CWD Enhanced Surveillance and Monitoring Program. This program requires captive deer and elk herd owners to take various actions, including routine sampling and testing, animal identification, and an annual herd inventory.

On March 31, 2005, the NYSDAM announced they had confirmed the first case of CWD in the state. The animal, a six-year-old, white-tailed doe, was slaughtered from a captive herd as part of the state's mandatory surveillance. Preliminary tests performed at the New York State Veterinary Diagnostic Laboratory at Cornell University determined the presumptive positive, which was confirmed by the National Veterinary Services Laboratories in Ames, Iowa.

Nathan Rudgers, New York State commissioner of agriculture, said the identification demonstrated that the state control program is working. "Our control program achieves what it's intended to do, and that's to rapidly detect disease, if it's out there, and provide the proper protocols to quickly respond," he said.

The subsequent investigation revealed that one of the herds associated with the index animal had recently sent another sample to New York's veterinary diagnostic laboratory to be tested for CWD. The white-tailed deer had died from aspiration pneumonia, which is often associated with the disease. Because of the direct connection with the index herd, the department expedited the testing procedure by rerouting the sample to the NVSL, which announced the sample was positive.

The NYSDAM quarantined and depopulated the two herds in which the positive deer were found, and testing revealed three more deer with CWD from the index herd. Herds associated with the infected herds were also quarantined and, at press time, an investigation had been initiated to find and test any susceptible deer that came into contact with the index herd. Investigators were attempting to determine the source of the infection, and the NYSDEC was also conducting surveillance in surrounding wild deer populations.

The DEC is implementing precautionary regulations limiting transportation and possession of whole carcasses and some parts of wild deer taken near the location of the infected captive herds. The regulations will be similar to those currently in place for importation of carcasses and parts of deer into New York.

For the latest on the investigation, visit www.agmkt.state.ny.us/AI/cwd.html.

– Kate O'Rourke


http://www.avma.org/onlnews/javma/may05/050515h.asp


TSS

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

continued;


I will now briefly summarize the interim final rules.

Test and Hold

First, FSIS issued a notice providing that any animals that are tested for BSE will not be marked as "inspected and passed" until our public health veterinarian receives confirmation that the cattle have, in fact, tested negative for BSE. We are referring to this as the "test-and-hold" policy.

Specified Risk Materials

FSIS published a second document, an interim final rule, to require that "specified risk materials" or SRMs from cattle do not enter the food supply.

We identified the brain, skull, eyes, trigeminal ganglia, spinal cord, central portions of the vertebral column and dorsal root ganglia of cattle 30 months of age and older as SRMs. Additionally we declared the tonsils and distal ileum of all cattle as SRMs. All SRMs are prohibited for use as human food.

This list of SRMs is consistent with international guidelines and actions taken by Canada. FDA took a similar action with the foods they regulate.

Banning SRMs from the food supply represents the most effective firewall for protecting public health.

Advanced Meat Recovery

The second rule involved product produced using advanced meat recovery (AMR). FSIS had previously established and enforced regulations that prohibit spinal cord from being included in AMR products labeled as "meat."

This rule expanded that prohibition to include dorsal root ganglia, or DRG. DRG are clusters of nerve cells along the vertebral column, in addition to the spinal cord tissue. Also, because the vertebral column and skull in cattle 30 months and older are considered inedible, we do not allow them to be used in processing Advance Meat Recovery products.

Banning Air-Injection Stunning

Finally, the third rule banned air-injection stunning equipment. This was done to ensure that portions of the brain are not dislocated into the tissues of the carcass as a consequence of stunning cattle during the slaughter process.

While the use of this type of stunning device is not common, officially banning its use not only ensures that it will be prohibited domestically, but will also make it a requirement for equivalency in establishments outside the United States when slaughtering for export to the U.S.

Summary of Actions

The actions I just reviewed are all science-based measures, designed to further minimize potential human exposure to the BSE agent through the consumption of beef and beef food products.

In addition to these actions, FSIS began collecting and submitting samples from ante-mortem condemned cattle to the APHIS enhanced surveillance program.

Stakeholder Feedback

To allow interested parties and stakeholders the opportunity to comment on the additional regulatory and policy measures under consideration FSIS, APHIS, and FDA published a joint advance notice of proposed rulemaking, or ANPR, to inform the public about what these agencies plan for keeping BSE out of the U.S.

Each agency laid out questions to solicit feedback. FSIS specifically sought comments on whether a country's BSE status should be taken into account when determining whether a country's meat inspection system is equivalent to the U.S. regulations including the provisions in the FSIS interim final rules.

In addition to the more than 22,000 comments we received, to help finalize our BSE rules, we will be reviewing data from APHIS' enhanced BSE surveillance program once it is completed. Additionally, we will review data from the updated Harvard BSE Risk Assessment that is being revised to evaluate the impacts of the FSIS interim final rules.

In the interim, through these rules-Banning Non-Ambulatory Disabled Cattle; Removing Specified Risk Materials; and Banning Air-Injection Stunning- in concert with FDA's feed ban and APHIS' surveillance program, FSIS is confident that we have an effective system, which protects public health.

Closing

The single BSE case in the United States led to changes and reevaluations of food safety system across our country.

It also led to an opportunity to build upon the strong partnerships we have with our sister agencies, APHIS, FDA, and other organizations.

Together, we must continue to rely on science-based solutions to prevent BSE from affecting animal and public health. ........snip

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

SOME REAL SCIENCE HERE, NOT THE BSeee
or junk science above;

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

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


Gerald Wells: Report of the Visit to USA, April-May 1989

snip...

The general opinion of those present was that BSE, as an
overt disease phenomenon, _could exist in the USA, but if it did,
it was very rare. The need for improved and specific surveillance
methods to detect it as recognised...

snip...

It is clear that USDA have little information and _no_ regulatory
responsibility for rendering plants in the US...

snip...

3. Prof. A. Robertson gave a brief account of BSE. The US approach
was to accord it a _very low profile indeed_. Dr. A Thiermann showed
the picture in the ''Independent'' with cattle being incinerated and thought
this was a fanatical incident to be _avoided_ in the US _at all costs_...

snip...

http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf

To be published in the Proceedings of the
Fourth International Scientific Congress in
Fur Animal Production. Toronto, Canada,
August 21-28, 1988

Evidence That Transmissible Mink Encephalopathy
Results from Feeding Infected Cattle

R.F. Marsh* and G.R. Hartsough

•Department of Veterinary Science, University of Wisconsin-Madison, Madison,
Wisconsin 53706; and ^Emba/Creat Lakes Ranch Service, Thiensville, Wisconsin 53092

ABSTRACT
Epidemiologic investigation of a new incidence of
transmissible mink encephalopathy (TME) in Stetsonville, Wisconsin
suggests that the disease may have resulted from feeding infected
cattle to mink. This observation is supported by the transmission of
a TME-like disease to experimentally inoculated cattle, and by the
recent report of a new bovine spongiform encephalopathy in
England.

INTRODUCTION

Transmissible mink encephalopathy (TME) was first reported in 1965 by Hartsough
and Burger who demonstrated that the disease was transmissible with a long incubation
period, and that affected mink had a spongiform encephalopathy similar to that found in
scrapie-affecied sheep (Hartsough and Burger, 1965; Burger and Hartsough, 1965).
Because of the similarity between TME and scrapie, and the subsequent finding that the
two transmissible agents were indistinguishable (Marsh and Hanson, 1969), it was
concluded that TME most likely resulted from feeding mink scrapie-infecied sheep.
The experimental transmission of sheep scrapie to mink (Hanson et al., 1971)
confirmed the close association of TME and scrapie, but at the same time provided
evidence that they may be different. Epidemiologic studies on previous incidences of
TME indicated that the incubation periods in field cases were between six months and
one year in length (Harxsough and Burger, 1965). Experimentally, scrapie could not be
transmitted to mink in less than one year.
To investigate the possibility that TME may be caused by a (particular strain of
scrapie which might be highly pathogenic for mink, 21 different strains of the scrapie
agent, including their sheep or goat sources, were inoculated into a total of 61 mink.
Only one mink developed a progressive neurologic disease after an incubation period of
22 mon..s (Marsh and Hanson, 1979). These results indicated that TME was either caused
by a strain of sheep scrapie not yet tested, or was due to exposure to a scrapie-like agent
from an unidentified source.

OBSERVATIONS AND RESULTS

A New Incidence of TME. In April of 1985, a mink rancher in Stetsonville, Wisconsin
reported that many of his mink were "acting funny", and some had died. At this time, we
visited the farm and found that approximately 10% of all adult mink were showing
typical signs of TME: insidious onset characterized by subtle behavioral changes, loss of
normal habits of cleanliness, deposition of droppings throughout the pen rather than in a
single area, hyperexcitability, difficulty in chewing and swallowing, and tails arched over
their _backs like squirrels. These signs were followed by progressive deterioration of
neurologic function beginning with locomoior incoordination, long periods of somnolence
in which the affected mink would stand motionless with its head in the corner of the
cage, complete debilitation, and death. Over the next 8-10 weeks, approximately 40% of
all the adult mink on the farm died from TME.
Since previous incidences of TME were associated with common or shared feeding
practices, we obtained a careful history of feed ingredients used over the past 12-18
months. The rancher was a "dead stock" feeder using mostly (>95%) downer or dead dairy
cattle and a few horses. Sheep had never been fed.

Experimental Transmission. The clinical diagnosis of TME was confirmed by
histopaihologic examination and by experimental transmission to mink after incubation
periods of four months. To investigate the possible involvement of cattle in this disease
cycle, two six-week old castrated Holstein bull calves were inoculated intracerebrally
with a brain suspension from affected mink. Each developed a fatal spongiform
encephalopathy after incubation periods of 18 and 19 months.

DISCUSSION
These findings suggest that TME may result from feeding mink infected cattle and
we have alerted bovine practitioners that there may exist an as yet unrecognized
scrapie-like disease of cattle in the United States (Marsh and Hartsough, 1986). A new
bovine spongiform encephalopathy has recently been reported in England (Wells et al.,
1987), and investigators are presently studying its transmissibility and possible
relationship to scrapie. Because this new bovine disease in England is characterized by
behavioral changes, hyperexcitability, and agressiveness, it is very likely it would be
confused with rabies in the United Stales and not be diagnosed. Presently, brains from
cattle in the United States which are suspected of rabies infection are only tested with
anti-rabies virus antibody and are not examined histopathologically for lesions of
spongiform encephalopathy.
We are presently pursuing additional studies to further examine the possible
involvement of cattle in the epidemiology of TME. One of these is the backpassage of
our experimental bovine encephalopathy to mink. Because (here are as yet no agent-
specific proteins or nucleic acids identified for these transmissible neuropathogens, one
means of distinguishing them is by animal passage and selection of the biotype which
grows best in a particular host. This procedure has been used to separate hamster-
adapted and mink-udapted TME agents (Marsh and Hanson, 1979). The intracerebral
backpassage of the experimental bovine agent resulted in incubations of only four months
indicating no de-adaptation of the Stetsonville agent for mink after bovine passage.
Mink fed infected bovine brain remain normal after six months. It will be essential to
demonstrate oral transmission fiom bovine to mink it this proposed epidemiologic
association is to be confirmed.

ACKNOWLEDGEMENTS
These studies were supported by the College of Agricultural and Life Sciences,
University of Wisconsin-Madison and by a grant (85-CRCR-1-1812) from the United
States Department of Agriculture. The authors also wish to acknowledge the help and
encouragement of Robert Hanson who died during the course of these investigations.

REFERENCES
Burger, D. and Hartsough, G.R. 1965. Encephalopathy of mink. II. Experimental and
natural transmission. J. Infec. Dis. 115:393-399.
Hanson, R.P., Eckroade, R.3., Marsh, R.F., ZuRhein, C.M., Kanitz, C.L. and Gustatson,
D.P. 1971. Susceptibility of mink to sheep scrapie. Science 172:859-861.
Hansough, G.R. and Burger, D. 1965. Encephalopathy of mink. I. Epizoociologic and
clinical observations. 3. Infec. Dis. 115:387-392.
Marsh, R.F. and Hanson, R.P. 1969. Physical and chemical properties of the
transmissible mink encephalopathy agent. 3. ViroL 3:176-180.
Marsh, R.F. and Hanson, R.P. 1979. On the origin of transmissible mink
encephalopathy. In Hadlow, W.J. and Prusiner, S.P. (eds.) Slow transmissible
diseases of the nervous system. Vol. 1, Academic Press, New York, pp 451-460.
Marsh, R.F. and Hartsough, G.R. 1986. Is there a scrapie-like disease in cattle?
Proceedings of the Seventh Annual Western Conference for Food Animal Veterinary
Medicine. University of Arizona, pp 20.
Wells, G.A.H., Scott, A.C., Johnson, C.T., Cunning, R.F., Hancock, R.D., Jeffrey, M.,
Dawson, M. and Bradley, R. 1987. A novel progressive spongiform encephalopathy
in cattle. Vet. Rec. 121:419-420.

MARSH

http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf

TSS

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continued........


Last Modified: 06/09/2005

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BSE ROUND TABLE EVENTS

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TSS


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ALL ABOUT FREE TRADING OF ALL STAINS OF TSEs! commodities and futures$ to hell with human health.
not enough body bags yet. simply amazing what they can get away with, (murder), corporate homicide. they know and
have known for decades, but continued to spread the agent, via a multitude of proven routes and sources. now the
OIE supports this policy of free trading of all strains of TSEs. what next, BSE in sheep? who cares though? they will
trade that freely too. THE OIE told me over two years ago they were going to address the CWD issue. Never did
though. Well, seems GW et al got what they wanted, I hope the administration (both parties that wanted it), i hope
they all choke on it, while they all hide behind there junk science designed for free trade. ...TSS




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