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From: TSS ()
Subject: TRANSCRIPT OF REMARKS FROM AG SEC JOHANNS (MORE BSe) THE WESTERN GOVERNORS ASS. BRECKENRIDGE, COLORADO JUNE 13, 2005
Date: June 16, 2005 at 8:56 am PST

TRANSCRIPT


Release No. 0211.05
Contact:
Office of Communications (202) 720-4623



Transcript of remarks by Agriculture Secretary Mike Johanns The Western Governors Association Breckenridge, Colorado

June 13, 2005


"Well, it's good to see you. In my job you have to be fleet of foot, and today is no exception. I thought maybe the best way for me to talk today would be to deal with the issue that we talked a lot about over the last months but maybe especially in the last couple of days, and that's BSE.

"I didn't come out here planning to talk on this, but after the events of late last week I thought well I better change the speech a little bit because all of the folks at the table here come from cattle country and you're going to go home and folks are going to say, what did the Secretary tell you about BSE? So I thought I'd better address that, and then I'm going to talk about trade issues.

"Well, where do I start? Today I would like to just simply take the subject head-on because I know it's critically important, and I want to make sure that you have the facts.

"I know that many of you do represent very strong cattle producing and processing states, and your constituents turn to you for accurate information. And I know we have Premiers here from Canada who of course are very interested in this issue also.

"I will be more than willing to take questions after I'm done, really on any topic. But this is a perfect opportunity for me to get started and offer some answers. So I'm going to walk through step by step what's occurred, what's next, and the very important role that each of you play in this issue.

"So let me start with a brief history, bring us all up to date. Since the USDA began an enhanced surveillance program for BSE in June of 2004 we've tested about 375,000 animals. And I might mention that these animals come from what we regard as high-risk population of cattle.

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

BUT, the first mad cow _documented_ in the USA, the one old Dave capped in Washington, was NOT a DOWNER...TSS

Saturday, January 24, 2004 - Page updated at 12:00 A.M.


Worker says discovery of infected cow was 'a fluke'

By Carol M. Ostrom
Seattle Times staff reporter










Dave Louthan says he remembers her well: an old dairy cow with specks of blood on her tail, spooky about going down the ramp into the slaughterhouse.

The government says the discovery that the Holstein had mad-cow disease proves its surveillance program, which focuses on "downer" or nonambulatory cows, works. After last month's discovery, the U.S. Department of Agriculture banned downer cows in the food supply.

But Louthan says it was "a fluke" that the Holstein, a cow he describes as "a good walker," was tested.

And even if it had been deemed a downer, under emergency rules enacted earlier this month it would have been sent to a rendering plant, where tests are not done at all.

Louthan, who killed the Holstein at Vern's Moses Lake Meat Co. on Dec. 9, says he has no doubt he remembers the right cow. "Every cow that comes in there, I kill. That kind of puts us in a relationship," said Louthan, who killed cows at Vern's for four years before he was laid off earlier this month after his bosses told him business had slowed. The plant manager, Tom Ellestad, has also confirmed that the cow was walking.

If he'd done what he should have, Louthan said, he would have taken the cow out of the truck and herded her around to a holding pen with other ambulatory animals.

But, he said, it was late in the day, the cow looked balky, and "I was cutting corners." So he shot a bolt through her head, scooped out a bit of brain, put it in a bag, labeled it with her number, and hung it on the wall with samples from others in the truckload. Later, he checked records to confirm that the "mad cow" was the cow he remembered, the balky Holstein from the Sunny Dene Ranch in Mabton, Yakima County.

If the Holstein had walked into the slaughterhouse, it probably would have been examined carefully, because it had apparent calving injuries and the veterinarian on site had tagged it for inspection.

But experts in the disease, formally known as bovine spongiform encephalopathy (BSE) say the inspector likely wouldn't have found anything, because the tiny protein particles implicated in the disease aren't visible to the naked eye.

Quite likely, the Holstein wouldn't have been tested for BSE, and no one would have known that the disease had been transported across the border in cows sent from Canada. Or that her meat, which was recalled Dec. 24, had found its way into the food chain.

The disease, which causes Swiss-cheese-like holes to form in a cow's brain, is fatal for humans who contract a related illness from eating infected meat.

Felicia Nestor, food-safety project director at the Government Accountability Project, a citizens' watchdog group, said investigation by her office confirms Louthan's account.

Even more troubling, said Nestor, is that the testing program is totally voluntary, and that the industry — not inspectors — chooses which animals are tested for BSE.

"Had this cow not given birth, and had a birthing injury, that cow would still be out in the field with BSE," Nestor said.

In another twist, emergency rules now in place would have let the Holstein fall through the surveillance net.

On Jan. 12, the U.S. Department of Agriculture (USDA) took emergency action banning all downer cows — no matter what the cause of their inability to walk — from the food supply.

Now, they're sent directly to rendering plants — where, in this state, they're not being tested for the disease.

USDA spokesman Nolan Lemon said all resources in Washington are being used to track down the remaining cows that came with the Holstein from Canada.

"Right now, we're evaluating how our surveillance program will have to change," Lemon said. Setting up testing at rendering plants "is a possibility," he said.

If current rules had been in place when the Holstein came through, "we may not have caught that cow," said Frank Hendrix, a cattleman and Washington State University extension agent in Yakima.

But, Hendrix added, the USDA is well aware of the problem.

"I'm sure in the next couple of months, the government will get it straightened out, and start testing at rendering plants as well," he said.

Whether the infected Holstein was a downer is important, because the government's surveillance system has long concentrated on downers, deemed to be more likely to have BSE than cows that can walk.

"Downers weren't the only source of samples, but they were a high source of it," Lemon said. Out of a total of 20,277 tests last fiscal year, ending Sept. 30, 16,560 were "downers" and 3,090 were cows that had died before they arrived at the slaughterhouse.

According to USDA records, Vern's began testing in early October, gathering samples from 258 cows through December.

The veterinarian's notes from Dec. 9 at Vern's show the Holstein as "alert" but lying down on its sternum. Notes made after it was slaughtered show it had pelvic injuries, which indicate difficulties in calving, not BSE.

The department's surveillance was designed to catch the 1-in-a-million case that statisticians said would be a tip-off that there were perhaps 45 other cases in the U.S. adult cattle population of about 45 million, Lemon said.

Before the Holstein tested positive, the USDA had determined that the tests should increase to 40,000 a year to catch that 1-in-a-million case, he added.

Nestor, at the Government Accountability Project, said much of the voluntary sampling of livestock has been done at smaller facilities. "Thank goodness for us all that Vern's stepped up to the plate and was willing to take the responsibility to sample these animals," she said. "If they had not been willing to do this, then we would never have found this cow."

But, she added, such an event is financially traumatic for a plant owner, who is not protected from the economic fallout resulting from discovery of the disease. "There is no incentive for a plant to find BSE," she said.

Louthan, 44, said he's sorry to lose his job, because he enjoyed the work. "I did it because I liked to kill cows," he said. "I don't care if I'm hauling them, feeding them or killing them. As long as I'm around livestock, I'm happy. I'm a cowboy."

Carol M. Ostrom: 206-464-2249 or costrom@seattletimes.com

http://seattletimes.nwsource.com/html/health/2001842920_madcow24m.html

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

"Three of these animals in all that testing tested 'inconclusive' using something that we refer to as a 'rapid test.' So once we had that inconclusive on the three animals, USDA followed protocols and followed up by conducting a test known as IHC, which is internationally recognized as a method of confirming BSE. And in many countries, actually it's the preferred test for BSE, and in this country it is the test that is used overwhelmingly. I don't know the exact percentage, but this is the test that we use in this country. Again it's internationally accepted.

"All three inconclusive samples when subjected to IHC testing showed up negative. So let me fast-forward now to this year.

"USDA's Office of Inspector General, and that would be like an auditor in your organizations, has been reviewing BSE-related activities throughout the process and reached the conclusion that further testing was warranted. The Inspector General recommended that all three of these samples be subjected to a second internationally recognized test, and that second test was called the Western blot test.

"Last Friday evening we received the results of those tests. Again all three of those were tested; of the three samples two were negative. And one came back reactive. I'll talk a bit more about what that means.

"It is critically important to note that all three of these animals though were kept away from the food and feed supplies as the protocols dictated. The carcasses from the animals in question were incinerated, again just as the protocols dictate. So in other words, the safeguards worked. We were able to protect both human and animal health. They never found their way into the food or feed chain.

"So what we have really is a scientific pursuit. We know that there's no public health risk related to this case. And we know that the protocols were kept throughout. So the additional examination represents an effort to better understand the disease.

"Because of the conflicting results between the IHC and Western blot test, the USDA will send a sample from this animal to a laboratory in Weybridge, England. This lab is internationally recognized for BSE testing.

"We expect the results on that within about two weeks. That could give or take two days on either side. Regardless of the outcome, one thing is very clear, and again I emphasize our firewalls did work. We put in place a system of interlocking safeguards, not just one safeguard but many, to protect human and animal health from BSE. And the system performed as it should, as we hoped it would.

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

According to a statement released Wednesday by Inspector General Phyllis Fong's office, auditors noticed "an unusual pattern of conflicting test results" while reviewing the government's program of testing for mad cow disease. ...TSS

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

"The safeguards are extensive. The ban on specified risk materials, we call them SRMs, from the human food supply. This animal went to a facility that handles only animals that are not suitable for human consumption, and the remains were incinerated as I mentioned.

"Our feed ban is another safeguard that has been in place since 1997 and ensures that a disease does not get passed from animal to animal. We have learned that's how the disease is transmitted, ruminant-to-ruminant feeding, which is banned in our country and I might add in Canada at the same time.

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

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


GAO ON USA BSE 2002

http://www.gao.gov/new.items/d02183.pdf

GAO 2003

http://www.gao.gov/new.items/d04259t.pdf

http://www.gao.gov/cgi-bin/getrpt?GAO-04-588T


October 2004 FOOD SAFETY
USDA and FDA Need
to Better Ensure
Prompt and Complete
Recalls of Potentially
Unsafe Food

snip...

Page 38 GAO-05-51 Food Recall Programs
To examine the voluntary recall of beef products associated with the
December 2003 discovery of an animal infected with BSE, we analyzed the
distribution lists USDA collected from companies and the verification
checks it conducted to develop a diagram illustrating the location and
volume of recalled beef that reached different levels of the distribution
chain. We compared the distribution lists and verification checks to
identify how many customers listed on the distribution lists did not receive
the recalled beef and the number of customers not listed on distribution
lists that received the recalled beef. We interviewed USDA and FDA staff
involved with the recall to understand the timing of recall actions and the
challenges encountered during the recall.
To develop information on the 2002 recall of ground beef by a ConAgra
plant in Greeley, Colorado, we reviewed USDA’s recall file and other
documents on the recall. We also met with the department’s Office of
Inspector General and reviewed the Inspector General’s September 2003
report.1
We conducted our review from May 2003 through August 2004 in
accordance with generally accepted government auditing standards.
1U.S. Department of Agriculture, Office of Inspector General, Great
Plains Region Audit
Report: Food Safety and Inspection Service: Oversight of Production
Process and Recall at
ConAgra Plant (Establishment 969), Report No. 24601-2-KC (September 2003).
Page 39 GAO-05-51 Food Recall Programs
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE Appendix II
On December 23, 2003, USDA announced that a cow in the state of
Washington had tested positive for BSE—commonly referred to as mad
cow disease. This appendix describes the actions USDA took to recall the
meat and the actions FDA took with respect to FDA-regulated products,
such as animal feed and cosmetics, made from rendered parts of the
animal.
Beef Recall Was
Triggered by a BSEPositive
Sample from
One Cow
On December 9, 2003, the recalling company slaughtered 23 cows. USDA,
in accordance with its BSE surveillance policy at the time, took a sample of
1 cow that was unable to walk, although the condition of the tested cow is
now disputed. USDA did not process the sample in its Ames, Iowa National
Veterinary Services Laboratory in an expedited manner because the cow
did not show symptoms of neurological disorder. USDA test results
indicated a presumptive positive for BSE on December 23, 2003.
Recall Begun in
December 2003 Was
Completed in March
2004
On December 23, 2003, after learning about the positive BSE test, USDA
headquarters notified the Boulder District Office, which is the field office
with jurisdiction over the recalling firm. The Boulder District began
gathering information about the recalling company’s product distribution.
Field staff telephoned the recalling company and were on-site at 7:00 p.m.
The Boulder District initially thought 3 days of the recalling company’s
production would have to be recalled, but further examination of facility
cleanup and shipping records revealed that it was only necessary to recall 1
day of production. USDA recall staff convened at 9:15 p.m. and discussed
the science related to BSE and whether the recalling company’s cleanup
practices were sufficient to limit the recall to 1 day of production.
Following USDA’s determination to conduct a Class II recall—that is, the
beef posed a remote possibility of adverse health consequences—USDA
contacted the recalling company to discuss recall details and the press
release. The press release and Recall Notification Report were released
that evening.
On December 24, 2003, USDA’s Food Safety and Inspection Service (FSIS)
sent inspectors to the recalling company’s primary customers to obtain
secondary customer distribution lists and product shipping records. USDA
conducted 100 percent verification checks for this recall—it contacted
every customer that received the recalled meat. This level of verification
checks is well above the percentage of checks conducted by USDA district
offices for the Class I recalls we reviewed.
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 40 GAO-05-51 Food Recall Programs
On December 26, 2003, USDA began checking the primary and secondary
customers of the recalling company that it was aware of, although the
entire product distribution chain was unknown.


snip...

REPORTS

1. Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete
Recalls of Potentially Unsafe Food. GAO-05-51, October 7.tss
http://www.gao.gov/cgi-bin/getrpt?GAO-05-51
Highlights - http://www.gao.gov/highlights/d0551high.pdf


GAO faults FDA handling of BSE-linked feed ban

Robert Roos * News Editor

Apr 26, 2005 (CIDRAP News) – Despite some improvements since 2002, the Food and Drug Administration's (FDA's) enforcement of rules to keep bovine spongiform encephalopathy (BSE) from spreading through cattle feed still has serious gaps, the Government Accountability Office (GAO) reported recently.

Some feed businesses have never been inspected, while others have not been inspected in more than 5 years, according to the GAO report, issued in March. In addition, the FDA does not usually test cattle feed for banned material, and the agency has not always alerted other federal agencies and the states when it learned that cattle might have been given feed containing such material.

"We believe that the problems described in this report are serious and that, given the fact that BSE has been discovered in North American cattle, breaches in FDA's oversight of the feed-ban rule place US cattle at risk for BSE," the report states. But the FDA said the problems are not significant enough to pose a serious risk.

BSE, or mad cow disease, spreads when cattle eat feed containing the remains of infected animals. To prevent this, in 1997 the FDA banned the use of most proteins from mammals in feed for cattle and other ruminant animals. (However, cattle blood, milk, restaurant plate waste, and gelatin can still be used in cattle feed.)

The sole US case of BSE so far was discovered in December 2003 in a Canadian born cow in Washington state. The discovery promoted the US Department of Agriculture (USDA) to add some new rules to keep infective material out of the food supply and to greatly increase testing of cattle for the disease. The USDA and FDA banned the use of specified-risk materials—high-risk cattle parts such as the brain, spinal cord, and tonsils—in human food, but they can still be used in feed for nonruminant animals and pets.

Under the FDA feed ban, firms must clearly label feed and feed ingredients that may contain banned proteins with the statement "Do not feed to cattle or other ruminants." Firms also must have methods for preventing mixing if they handle feed for both nonruminant animals (whose feed is still allowed to contain cattle protein) and ruminants.

Sens. Tom Harkin, D-Iowa, and Dick Durbin, D-Ill., requested the GAO report. To gather information, the agency reviewed 404 FDA inspection reports, interviewed FDA officials, and watched FDA and state inspectors conduct 19 feed-facility inspections in 12 states, the report says. The GAO also surveyed state agency officials in 38 states that inspected feed facilities under contracts with the FDA last year.

The report says the FDA has remedied some problems that the GAO had described in a report in early 2002. The agency now has uniform methods for inspecting feed facilities and training both FDA and state inspectors, plus better methods for tracking inspection results.

However, the GAO finds that the enforcement program still has serious weaknesses:

* About 14,800 feed manufacturers and other feed-industry businesses have been inspected so far, but the FDA knows there are others that have not been inspected, and it has no "uniform approach" for finding them.
* The FDA has not reinspected about 2,800 feed businesses in the past 5 years. Many of those were farms that are considered low-risk, but about 400 were feed mills, where the risk of violations is deemed higher.
* The FDA's inspection guidelines do not call for routine testing of cattle feed for banned material. FDA officials said the presence of exempt items such as cattle blood in feed makes such testing useless, but officials in some states said such testing would be useful at firms that say they don't use exempt items.
* The FDA has not always alerted the USDA and states when it learned that cattle might have been given feed containing banned material, even though the FDA's guidelines call for such notifications. In one case, an inspector found that a firm had been using banned material for nearly a year; the firm issued a recall, but the FDA did not notify the USDA or the state.
* The FDA has given incomplete information about feed-ban compliance to Congress and the public. For example, in January 2004 the agency reported a 99% compliance rate but failed to note that the rate was based on inspections of only about 570 firms. And in some cases, FDA has counted firms as being in compliance even when the firms have placed no warning labels on feeds that contain prohibited material.

The report says that in commenting on a draft version, the FDA said it believed "that the weaknesses we identified are not sufficiently material to place U.S. cattle at risk for BSE and that its risk-based inspection approach assures adequate oversight of the feed-ban rule."

The report includes nine recommendations to correct the various problems. The FDA disagreed with four of the recommendations, including the advice that the FDA should test feed samples when it inspects feed businesses. Tests cannot detect the prions that cause BSE, but they can detect animal material, which would help in verifying inspection results, the GAO contends.

See also:

GAO report "Mad cow disease: FDA's management of the feed ban has improved, but oversight weaknesses continue to limit program effectiveness"
http://www.gao.gov/new.items/d05101.pdf

Feb 28, 2002, CIDRAP News story "GAO says US barriers to mad cow disease are full of holes"
http://www.cidrap.umn.edu/cidrap/content/other/bse/news/gaorept.html


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


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


suppressed peer review of Harvard study October 31, 2002


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


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

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

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

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

TSS

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


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

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

TSS

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

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

TSS

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

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

NOT to forget those antibiotics in cattle for human consumption and the
fact they damn near killed me in 2001/02 with the MRSA (7 weeks vancomycin straight through the heart via long PIC line) after refusing
cadaver bone and blood for fear of CJD and in turn my neurosurgeon
did use a few disposable instruments and a bone grinder that would never
be used on anyone else due to my mom death from hvCJD.

GOTTA LOVE THOSE USDA TRIPLE FIREWALLS ;-(

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
2005-DT-02

November 23, 2004

Mr. Daniel W. Thuemmel, President
Thuemmel Dairy, Inc.
8774 Thuemmel Road
Port Austin, Michigan 48467

Dear Mr. Thuemmel,

An inspection of your dairy operation located at 8774 Thuemmel Road, Port Austin, Michigan, 48467, conducted by a Food and Drug Administration (FDA) investigator on June 29, 2004, confirmed that you offered at least two animals for sale for human food in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act). You also caused the new animal drug gentamicin sulfate to become adulterated within the meaning of Section 501(a)(5) of the Act, because the drug was used in a manner that does not conform with the extralabel use regulations in Title 21 Code of Federal Regulations (21 CFR) Part 530.

On May 12, 2004, you sold an adult dairy cow identified with back tag #[redacted] and neck chain #[redacted] to [redacted] and the animal was in turn sold to [redacted] for slaughter as human food. This cow was slaughtered on this same day and United States Department of Agriculture (USDA) analysis of tissue samples collected from that same animal identified the presence of [redacted] of gentamicin in the kidney and [redacted] gentamicin in the liver.

In addition, on June 1, 2004, you sold an adult dairy cow identified with back tag #[redacted] and neck chain #[redacted] to [redacted] where it was in turn sold to [redacted] for slaughter as human food. This cow was slaughtered on June 2, 2004, and USDA analysis of tissue samples collected from that same animal identified the presence of [redacted] of gentamicin in the kidney.

There is no approved tolerance level for gentamicin in dairy cattle. The presence of this drug in edible tissue from these animals causes the food to be adulterated.

Our investigation also found that you hold animals under conditions which are inadequate in that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain adequate medication/treatment records to identify the animal, date of medication, the drug dosage administered, and the drug pre-slaughter withdrawal time. Two examples of this are that there were no drug treatment records for the two dairy cows involved in the violative gentamicin tissue residues, identified with back tags #[redacted] and #[redacted], which were offered for sale and subsequently slaughtered for human food use. Food from animals held under such conditions are adulterated under Section 402(a)(4) of the Act.

You also adulterated the drug gentamicin sulfate within the meaning of Section 501(a)(5) of the Act when you used this drug in dairy cattle, a species for which it is not approved. The extralabel use of an approved animal drug is allowed if the use complies with Sections 512(a)(4) and 512(a)(S) of the Act and 21 CFR Part 530. However, your use of the drug was not in compliance with the extralabel use regulations because you administered it without the benefit of a valid veterinarian client-patient relationship, 21 CFR 530.10(a), and your use of gentamicin resulted in the presence of drug residue in edible tissue that might present a risk to public health, 21 CFR 530.11(c).

The above is not intended to be an all-inclusive list of violations. As a producer of dairy cows that are offered for use as food, you are responsible for assuring that your overall operation and the food you distribute are in compliance with the law. You should take prompt action to correct these violations and to establish procedures to prevent their recurrence. Failure to promptly correct these violations may result in regulatory sanctions without further notice. These sanctions include, but are not limited to, seizure and/or injunction. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies.

It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Federal Food, Drug and Cosmetic Act. The fact that you caused the adulteration of an animal that was sold and subsequently offered for sale in interstate commerce by a slaughter facility is sufficient to hold you responsible for violation of the Act.

You should notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 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.

Your response should be directed to Ms. Judith A. Jankowski, Compliance Officer, at the above address.

Sincerely yours,

/s/

Joann M. Givens
District Director
Detroit District Office

http://www.fda.gov/foi/warning_letters/g5082d.htm


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

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

######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html ##########

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

PRODUCT
a) Product is 9 Mile Steer Feed, packaged in white poly weaved
bags, each containing 100 lbs. A white label tied to the
inlet of each bag with twine identifies the product. Recall
# V-187-4;
b) Product is 9 Mile Pig and Sow Feed, packaged in white poly
weaved bags, each bag containing 100 lbs. A white label tied
to the inlet of each bag with twine identifies the product.
Recall # V-188-4.
CODE
The products contain no code date.
RECALLING FIRM/MANUFACTURER
Farmers Elevator, Co., Houston, OH, by telephone and letters dated
September 8, 2004. Firm initiated recall is ongoing.
REASON
Products may contain protein derived from mammalian tissues which is
prohibited in ruminant (steer) feed. FDA regulation, if the feed is
intended for non-ruminants (pigs), the bag labels must bear the
statement ìDo not feed to cattle or other ruminantsî.
VOLUME OF PRODUCT IN COMMERCE
700 lbs. Steer feed and 1,500 lb. Pig and sow fed.
DISTRIBUTION
OH.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00869.html

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

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

Department of Health and Human Services

Public Health Service
Food and Drug Administration

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


VIA FEDERAL EXPRESS

Our Reference: 3004508183

April 6, 2005

Priscilla D. Shaw
Owner
A&A Services
92-353 Laaloa St.
Kapolei, HI 96707

WARNING LETTER

Dear Ms. Shaw:

On January 10 and 11, 2005, we inspected your animal feed distribution operation located at 92-353 Laaloa St., Kapolei, HI 96707, 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).

Products that contain or may contain protein derived from mammalian tissues and that are intended for use in animal feed (prohibited material) must be labeled with the cautionary statement, "Do not feed to cattle or other ruminants" [21 C.F.R. 589.2000(d)(1) and (cx1)(i)]. Our inspection found that you are not labeling the products you are distributing to swine farms, which contain food waste from restaurants and hospital cafeterias, with this caution statement. As a result, these products are misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(a)(1)).

Our inspection also found that you use the same containers to hold both prohibited materials [redacted] waste to be used for feed for non-ruminants and non-prohibited materials [redacted] waste to be used for feed for ruminants). However, you failed to provide written procedures specifying clean-out procedures or other measures to avoid cross-contamination of the feed products to be used for ruminants [21 C.F.R. 589.2000(e)(1)(iv)]. You also failed to make copies of distribution records available for FDA inspection and copying (21 C.F.R. 589.2000(c)(1)(ii)].

At the conclusion of the inspection, these and other observations were listed on Form FDA 483, Inspectional Observations, which was issued to and discussed with you at the close of the inspection . A copy of this form is enclosed for your ready reference.

The above is not meant to be an a11-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all of your products 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 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 being taken to correct the violations, and prevent their recurrence. If corrective actions cannot be completed in fifteen (15) days, state the mason 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.

Your reply should be directed to Paul A. Peterson, Compliance Officer, Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, you may contact Mr. Peterson at (510) 337-6856.

Sincerely,

/S/

Barbara J. Cas
District Director
San Francisco District

http://www.fda.gov/foi/warning_letters/g5272d.htm

TSS

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

Public Health Service
Food and Drug Administration

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


June 15, 2004

Ref: 2004-DAL-WL-18

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Patrick ORay, CEO & President
Specialty Brands, Inc.
P.O. Box 51467
Ontario, CA 91761-1057

Dear Mr. ORay:

An inspection of your food manufacturing facility located at 601 E. 3rd
Street, Lampasas, Texas, was conducted on February 26 and March 1, 2004
by Investigators from the Food and Drug Administration (FDA). The
inspection found significant deviations from the requirements set forth
in Title 21, Code of Federal Regulations, Section 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 your firm sells its reduction stream waste
for use as animal feed and that it contracted with [redacted] to dispose
of this manufacturing process stream waste. [redacted] used this process
stream waste as animal feed for ruminants.

At the close of the inspection, a list of inspectional observations (FDA
483) was issued to your firm and discussed with Mr. Anthony E. Rocz,
Plant Manager. The following violation was observed during the inspection:

Products that contain protein derived from mammalian tissues and that
are intended for use in animal feed must be labeled with the cautionary
statement, Do not feed to cattle or other ruminants, as required by 21
CFR 589.2000(d)(1). For example, your firm manufactures Mexican
specialty food products such as tortillas, taquitos, and burritos that
contain beef. The production process stream waste includes ground corn,
product shells, and filling material, it is then placed in a
transportable bin for disposal by feeding to livestock. This
transportable waste bin did not bear the cautionary statement Do Not
Feed to Cattle or Other Ruminants.

Because your manufacturing stream waste did not bear this cautionary
statement, these products are misbranded within the meaning of section
403(a)(1) of the Federal Food, Drug, and Cosmetic Act.

You should know that this serious violation 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 injunction.

We are in receipt of a letter from Mr. Anthony E. ROCZ, Plant Manager,
dated March 2, 2004, in which he stated that your factory was under a
contract with [redacted] to remove and dispose of the production stream
waste generated at the factory since April 15, 2003. Our investigators
conveyed to Specialty Brands, Inc., on February 24, 2004, that the
disposal container was not properly labeled to indicate that the
material is not to be fed to cattle or other ruminants in accordance
with the BSE regulation. On February 26, 2004, our investigators
returned to your plant and conveyed to Mr. Rocz that earlier that
morning they observed cattle consuming the manufacturing stream waste
supplied by your firm to [redacted] The practice of supplying process
stream waste to [redacted] was indefinitely suspended on February 26,
2004. At that time, an alternative waste removal service was obtained to
dispose of the process stream waste in a sanitary landfill facility and
each load would be logged, a manifest detailing the pounds of process
waste disposed would be generated, and a certification of proper
disposal is to be provided for the record. This alternative stream waste
disposal process appears to be acceptable. Your letter also states that
your corporate Food Safety and Quality Assurance department is in the
process of drafting a corporate wide policy to ensure that all of your
factories are in compliance with the BSE regulation.

It is necessary for you to take prompt action on this matter now. Please
notify this office in writing within fifteen (15) working days from the
date you receive this letter of the specific actions you have taken to
prevent the recurrence of the violations, and when those actions were
taken or will be taken at your other corporate facilities having similar
disposal plans. Your reply should be sent to Edwin Ramos, Compliance
Officer, at the above stated address. If you have any questions
concerning this letter, you may contact Mr. Ramos at 214-253-5218.

Sincerely,

/s/

Michael A. Chappell
Dallas District Director

cc:
Specialty Brands, Inc.
Mr. Anthony E. Rocz, Plant Manager
601 E Third Street
Lampasas, TX 76550-2903

http://www.fda.gov/foi/warning_letters/g4898d.htm

Public Health Service
Food and Drug Administration

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


June 10, 2004

Ref: 2004-DAL-WL-17

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Jack Chapman, Owner
Chapman Ranch
11071 CR 1255
Lampasas, TX 76550

Dear Mr. Chapman:

An inspection of your ruminant feeding operation located at 11071 CR
1255, Lampasas, Texas, was conducted on February 26 and March 1, 2004 by
Investigators from the Food and Drug Administration (FDA). The
inspection found significant deviations from the requirements set forth
in Title 21, Code of Federal Regulations, Section 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 589.2000(a), to ruminants. This prohibited material consists of
manufacturing process stream waste from [redacted] a manufacturer of
products such as fully cooked tacos, burritos, and taquitos that contain
beef. This manufacturing process stream waste contains meat products
that have been cooked and offered for human food but that have not been
further heat processed for feed. This failure to further heat process
the material causes the feed to be adulterated under section
402(a)(2)(C)(i) because it contains an unapproved food additive (i.e.,
the meat products that have not been further heat processed for feed).

At the close of the inspection, copies of the BSE Guidance documents 69,
70 and 76 were provided to you and further discussed. Also, you
previously received a copy of 21 CFR 589.2000, the BSE regulation, which
was again explained in more specific detail. You should know that this
serious violation 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 injunction.

It is necessary for you to take action on this matter now. Please send a
written response to this office within fifteen (15) working days from
the date you receive 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 this letter, you may contact Mr.
Ramos at 214-253-5218.

Sincerely,

/s/

Michael A. Chappell
Dallas District Director

horizonal rule

http://www.fda.gov/foi/warning_letters/g4899d.htm


Public Health Service
Food and Drug Administration

Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309


June 10, 2004

VIA FEDERAL EXPRESS

WARNING LETTER
(04-ATL-13)

M. Dennis Burroughs
President
B & G Seed Company
591 Beck Road
Hull, Georgia 30646

Dear Mr. Burroughs:

An inspection of your feed mill was conducted by a Food and Drug
Administration (FDA) investigator on March 30, 2004. Our investigator
determined that you manufacture various products, including ruminant
feeds, which are animal feeds within the meaning of section 201(w) of
the Federal Food, Drug, and Cosmetic Act (the Act}. The inspection
revealed significant deviations from the requirements set forth in Title
21, Code of Federal Regulations (21 CFR), Part 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 feed being
manufactured and distributed by your facility to be misbranded within
the meaning of sections 403(a)(1) of the Act.

The inspection revealed that not all of your feeds that contain protein
derived from mammalian tissues and that are intended for use in animal
feed (prohibited material) were labeled with the statement Do not feed
to cattle or other ruminants, as required by 21 CFR 589.2000(d)(1) and
(c)(1)(i). An example is your B & G Pig Grower. In addition, you have
routinely provided scrap or salvage dog food containing prohibited
material to be used as pig feed that was not labeled with the required
statement. In the case of bulk feed ingredients, the statement could
appear on the placard and invoice that accompany the shipment. The lack
of the required statement causes these feeds to be misbranded as defined
in section 403(a)(1) of the Act.

Our investigator also noted that you had failed to provide for adequate
measures to avoid commingling or cross-contamination of products that
contain or may contain prohibited material into feeds that may be used
for ruminants, as required under 21 CFR 589.2000(e)(1)(iii). You also
failed to establish written procedures for separating products which may
contain prohibited material from all other protein products from the
time of receipt until the time of shipment, as required under 21 CFR
589.2000(e)(1)(iv).

The above is not intended as an all-inclusive list of violations at your
firm. As a manufacturer of animal feeds, you are responsible for
ensuring that your overall operation and the products you manufacture
and distribute are in compliance with the law. We have included a copy
of the FDA Guidance for Industry 68 - Small Entities Compliance Guide -
Protein Blenders, Feed Manufacturers, and Distributors.

You should take prompt action to correct the above violations, and you
should establish procedures 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 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 being taken to correct the violations and
prevent their recurrence. We do note that you initiated some corrective
actions during the inspection, including a feed recall and printing new
labels. If corrective action cannot be completed within 15 working days,
state the reason for the delay and date by which the corrections will be
completed. Include copies of any available documentation demonstrating
that corrections have been made. Your response should be directed to
Philip S. Campbell, Compliance Officer, at the address noted in the
letterhead.

Sincerely,

/s/

Mary Woleske, Director
Atlanta District

http://www.fda.gov/foi/warning_letters/g4900d.htm

TSS

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

PRODUCT
Product is custom made deer feed packaged in 100 lb. poly bags. The
product has no labeling. Recall # V-003-5.
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 6 tons.
DISTRIBUTION
OH.

END OF ENFORCEMENT REPORT FOR October 20, 2004

http://www.fda.gov/TSS

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

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

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

######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html ##########


PLEASE NOTE, .1 GRAM LETHAL...TSS


GIVE it time, and we will all become resistant to these antibiotics due to the
overuse in cattle for human consumption...

A FEW other mad cow feed ban violations and antibiotic violations ;

Menu Foods, Inc.
5/19/04

New Jersey District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No

Millstone Agri Distributors
5/22/03

Nashville District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No

Specialty Brands, Inc.
6/15/04

Dallas District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No

Zephyr Feed Company
5/28/03

Florida District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No

All American Feed & Tractor
4/01/02

Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No

Chapman Ranch
6/10/04

Dallas District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No

Fresno Farming LLC
6/23/04

San Francisco District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No

Sunnymead Ranch, Inc.
11/07/02

Dallas District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No

Van Dyke Grain Elevators Inc
4/17/02

Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No

Halter Feed & Grain, Inc.
4/08/04

Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF]
[HTML]
No

Horn's Feed Mill, Inc.
9/26/03

Chicago District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF]
[HTML]
No

Parrish & Heimbecker Limited
11/18/04

Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF]
[HTML]
No

B & G Seed Company
6/10/04

Atlanta District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No

Bakery Trading Company
7/29/02

Kansas City District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No

Bardstown Mill, Inc.
4/08/04

Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No

Barr Animal Foods
5/06/03

Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No

Darling International, Inc.
5/07/02

Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No

Illini Feeds, Inc.
7/12/04

Chicago District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No

Lincoln Land Livestock Co., Inc.
8/25/03

Chicago District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No

Premium Nutritional Products, Inc.
4/15/04

Kansas City District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No


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

"We have verified that the animal was born before the feed ban was instituted. This is a very important point that I need to point out to you. As you know, BSE is transmitted through contaminated feed. Our feed ban prohibited feeding practices that could pose a risk. The fact that this animal was born before the ban tells us that we can remain confident in the feed ban.

"I'd like to offer a thought about the possibility that the additional tests will come back positive. USDA has said since the very start of the enhanced surveillance program that we expected additional cases of BSE. You would find that statement on many records. We've said that from the very beginning.

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

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

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

"The key is whether we protected the food supply and the feed supply from the disease. And the answer very clearly is that we have. We have done that. The American consumer has the utmost faith in the safety of beef, and their confidence is well placed, and I'm committed to making sure that that continues.

"So you might be asking yourselves why the Secretary of Agriculture called a news conference to announce the results of a test when we specifically said that we haven't identified another case of BSE. All we have is the test that at best can be described as a weak positive, but even we acknowledge that we want to get the lab in England to take a look.

"Let me answer, I believe it is apparent-- I believe transparency is essential. Not only is it essential to government as a whole but it's essential when we talk about consumer confidence. You know all about this. You're elected leaders. I don't need to tell you about the devastating impact of false rumors and misinformation. And when it comes to BSE I think the history of this, there's been plenty of that. So my goal is to make sure that the American people and for that matter our friends across the globe know exactly what is happening, what the significance is, and what happens next.

"That incidentally is the reason why I led the roundtable discussion in Minnesota last week. We presented the facts and brought together representatives with very differing views, and we are articulated our position. So our goal is to do everything we can to get the information out. That was the reason for the Friday news conference.

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

Protesters have beef with Mad Cow
Wednesday 15 June @ 14:55:07
Government summit on cattle disease meets with skepticism

by Adrienne Urbanski

Grown women dressed as cows and horror movie-like splatters of cows’ blood were among the sights outside the USDA’s first and only Mad Cow roundtable discussion in St. Paul, where a group of scientists and activists protested the U.S. government’s approach to the disease.

The protest/press conference was held by the Wisconsin-based Center for Media and Democracy and the Organic Consumer Association, cleverly staged on a green dotted with large cow sculptures on the University of Minnesota’s St. Paul campus. In addition to the donning of furry cow costumes, the group dumped commercially purchased calf feed containing slaughterhouse waste and cow blood, to demonstrate how Mad Cow disease is passed on.

The re-feeding of dead cows and cow blood to other cows, a not-uncommon practice in modern ranching, spreads Mad Cow disease or BSE (Bovine Spongiform Encephalopathy), a neurological disorder which has been transmitted to humans primarily in Britain.

“The cows are basically eating themselves,” said Molly Riordan, a member of the Center for Media and Democracy and a participant in the dumping.

While the roundtable focused on industry leaders and, for the most part, nixed the inclusion of scientists or leaders of health organizations, the protest staged prior to it included scientists such as the Center for Media and Democracy’s senior researcher and molecular biologist Diane Farsetta.

While the roundtable discussion was meant to focus on the problem of Mad Cow, concern seemed directed more at restoring consumer trust in beef than the issue of whether Mad Cow is indeed a national health risk. Despite being open to the public and to the media, only members of the roundtable were able to ask questions and address concerns.

“Given that the roundtable was announced just three weeks before the event, and was only promoted in meat industry publications, I would say the USDA did a remarkably poor job, if their objective was to better inform the public,” Farsetta said.

The Center for Media and Democracy called the roundtable a “dog-and-pony show,” and consider it part of the USDA’s public-relations campaign to avoid policy changes while opening up foreign markets to U.S. beef.

The audience at the roundtable did seem to be comprised more of industry members than the local public. The room was dotted with cowboy hats, cowboy boots, and southern drawls.

John Peck, executive director of the group Family Farm Defenders, also sees the conference as a PR move.

“It’s a joke really, they’re just putting a spin on things, trying to make things seem better than they really are,” he said. “They even invited Japanese TV crews here so they’ll want to trade with us again.” Japan was the biggest importer of American beef until the discovery of Mad Cow in the U.S. in December of 2003.

One scientist taking the side of the cattle industry was Ron DeHaven of the Animal and Plant Health Inspection Service (APHIS), who assured the audience that current preventative measures would “prevent the disease from becoming established and spreading.”

Most of the speeches were concerned with restoring consumer confidence. Roundtable member Mike John of the National Cattleman’s Beef Association used his allotted time to assert that “beef is a delicious and wholesome food” and that “America is a great brand name.”

Kelli Ludlum of the American Farm Bureau Federation compared the number of fatalities related to BSE to the number of automobile fatalities, declaring that in comparison Mad Cow poses little threat.

Farsetta sees this industry-only panel as an attempt to weed out any potential criticism.

“Completely absent were criticisms even by government institutions such as the Government Accountability Office, the USDA’s Office of Inspector General, the USDA’s TSE Advisory Panel, or the International Review Subcommittee. While the Harvard Center for Risk Analysis report on Mad Cow disease was mentioned as justification for current policies, the Harvard team’s criticisms of the USDA somehow were forgotten.”

Apparently, the USDA anticipated some negative reaction from the public, as the level of security rivaled that of a presidential appearance. Police officers routinely patrolled the campus building’s hallways, and stood watch in the media’s overflow room. USDA Secretary Mike Johanns’ open time with the public and media was also only a few short minutes, and went unrecorded.

One of the key arguments reiterated by each roundtable member was the importance of the importation of Canadian cattle. In May of 2003 Canada discovered BSE in its cattle. While the United States halted the importing of Canadian beef during that summer, it began importing boneless beef in the fall of 2003.

Keith Collins, the Chief Economist of the USDA, defended the importing during his address.

“Without access to Canadian cattle, U.S. slaughter will remain below capacity, forcing some meatpackers to curtail slaughter operations.”

In his opening statements, Johanns addressed the importance of allowing the importation of Canadian cattle, and of Japan allowing the importation of American beef. “We are here to show that opening both the Japanese and the Canadian borders is absolutely safe and absolutely necessary for the health of our beef industry,” he said.

Repeatedly the panel referred to its “99 percent” success rate in compliance with the USDA safety mandates that prevent the spread of BSE through limiting the parts of dead cows that are put into feed, declaring it “a higher compliance rate than any other government agency.” According to Farsetta, however, that statistic is inaccurate.

“In March 2005, the Government Accountability Office, the nonpartisan, investigative arm of the U.S. Congress, reported on numerous problems with how compliance with the feed regulations is monitored. They revealed that the 99 percent figure is based on a small subset of feed producers that likely does not include many likely to have contamination problems.”

Coincidentally or not, Johanns announced the day following the roundtable discussion that preliminary tests found the existence of Mad Cow disease in three U.S. cows.

Farsetta suspects that the timing of these two events is more than just a coincidence.

“[In his announcement,] Secretary Johanns said that he was only handed the positive test result 10 minutes before the Friday evening news conference,” she said. “That may be true, but the USDA Inspector General’s Office reportedly asked that the “inconclusive” cows be retested at least a week previous. So Johanns at the very least knew about the retesting —but didn’t mention it—during the St. Paul event.”

According to the public record, Farsetta said, the USDA did announce their St. Paul event before the Inspector General’s Office asked them to retest the animals in question.

“But the timing and goals of the event, as I mentioned before, definitely raise questions for me,” she said. “And, with hindsight, it is certainly is convenient for the USDA—as it faces many questions about the likely new case of Mad Cow—to be able to point to the St. Paul event as evidence of a strong industry/government consensus on U.S. Mad Cow policies.” ||


http://www.pulsetc.com/article.php?sid=1887

http://www.p2preactor.com/article6593-protesters-beef.html

http://www.commondreams.org/views04/0105-10.htm

http://www.commondreams.org/cgi-bin/print.cgi?file=/views04/0105-10.htm

http://enews.primediabusiness.com/enews/beef/cowcalf_weekly/current

USDA 2003

We have to be careful that we don't get so set in the way we do things that
we
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.
Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS
.

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


snip.............


Dr. Detwiler: It seems a good idea, but I'm not aware of it.
Another important thing to get across to the public is that the negatives
do not guarantee absence of infectivity. The animal could be early in the
disease and the incubation period. Even sample collection is so important.
If you're not collecting the right area of the brain in sheep, or if
collecting lymphoreticular tissue, and you don't get a good biopsy, you
could miss the area with the PRP in it and come up with a negative test.
There's a new, unusual form of Scrapie that's been detected in Norway. We
have to be careful that we don't get so set in the way we do things that we
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.

Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS
.

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


snip...


FULL TEXT;


Completely Edited Version
PRION ROUNDTABLE


Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado


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

"I will offer an observation. Seventy-two hours later thereabouts the result is a relatively calm reporting of the situation. And I might add with commendable accuracy. For the most part media accounts that I've heard and read about have been very straightforward and very factual. I suspect the outcome might have been different had we waited for rumors to build over the weekend, and again that's why we talked Friday night.

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

ALSO, so the market players can have the weekend to get there money plays ready to go ...TSS

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

"You might also be wondering what implications this has in the area of exports or imports. I would submit this should have no impact, absolutely no impact if our trading partners make decisions based upon science and based upon facts.

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

WHAT Johanns meant was if our trading partners make decisions base upon JUNK SCIENCE, based soley on commodities and futures...TSS

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

"The fact is, that the safeguards did work. The fact is, the animal in question ran into those safeguards and it never entered the feed or food supply, and there was no public threat.

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

THOSE inconclusives would have never been retested if not for the OIG. HEADS NEED TO ROLL OVER THIS ONE...TSS

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

"There is no legitimate reason why our willingness to go above and beyond internationally accepted standards for testing should impact the acceptance of our product in other countries especially when several of these countries have confirmed multiple cases of BSE within the their own borders. The key here is that our safeguards are in place, and they did make the difference.

"With that said, I don't see how testing is relevant to the ongoing discussion with Japan, Korea, South Korea or any other trading partner. Our beef is in fact safe. We will be diligent in ensuring that we have the right protocols in place, protocols that are solidly grounded on science and consistently followed.

"For your part, you have a role also. My hope is that you will take the information, which we're going to hand out to you. We have packets for everybody -- and reinforce the citizens of your state, your confidence in our beef and indicate that consumer confidence is well-placed.

"You're welcome to direct anyone and everybody to our USDA website, and that is http://www.usda.gov . All of the information that I'm sharing with you is available there today.

snip...

"With that, let me just wrap up and say again, it's a pleasure to be here. I'd be happy to take any questions that you might have. Thank you."

[Applause.]

[NO QUESTIONS FROM MEDIA LISTED...TSS]

http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/1/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2005%2F06%2F0211.xml&PC_7_2_5JM_navtype=RT&PC_7_2_5JM_parentnav=TRANSCRIPTS_SPEECHES&PC_7_2_5JM_navid=NEWS_RELEASE#7_2_5JM

TSS




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