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From: TSS ()
Subject: January 3, 2006 — FDA Veterinarian Newsletter -July/August 2005, Volume XX, No. IV
Date: January 4, 2006 at 10:20 am PST


January 3, 2006 — FDA Veterinarian Newsletter -July/August 2005, Volume XX, No. IV

snip...

FDA Proposes Tighter Feed Ban to Prevent BSE


The Food and Drug Administration on October 6 proposed banning certain high-risk cattle material from all animal feeds, including pet food, to strengthen safeguards against bovine spongiform encephalopathy (BSE).

The proposed rule would add requirements to the 1997 feed rule, which bans most mammalian protein from use in feed for cattle and other ruminants. The rule proposes to eliminate 90 percent of all potentially infectious material from the feed supply.

The proposed rule would ban from all feed:

Brains and spinal cord of cattle 30 months old or older.

Brains and spinal cord of cattle not inspected and passed for human consumption.

The entire carcass of cattle not inspected and passed for human consumption if the brain and spinal cord has not been removed.

Tallow, if it is derived from the material that would be prohibited under this rule and contains more than 0.15 percent insoluble impurities.

Mechanically separated beef derived from material that would be prohibited under this rule.

The proposed rule is designed to prevent any possible “leakage” of potential infectious material into cattle feed. The 1997 rule prohibits the use of most mammalian protein in feed for cattle and other ruminants, but allows the use of the protein, including the brain and spinal cord, in feeds for swine and poultry. The proposed rule would prevent the highest risk material from entering any part of the feed chain. Therefore, it is unlikely to find its way, by accident or deliberately, into feed for cattle.

FDA believes that the 1997 feed rule has been extremely effective. However, with the discovery of BSE in the United States, FDA officials decided to further strengthen the measures already in place.

Earlier position

In January 2004, FDA announced it was planning to take other steps to address the BSE situation, including banning the use of poultry litter, plate waste, and blood and blood products in cattle feed. FDA also said it was planning to require dedicated facilities for handling feed and feed ingredients for ruminant animals.

However, after further consideration, including recommendations from an International Review team convened by USDA to assess the controls in place to prevent the spread of BSE, FDA concluded that banning plate waste, poultry litter, and blood and requiring dedicated facilities are not needed if high risk tissues are excluded from animal feed channels. By keeping the high-risk material out of all feed, none could be spilled into poultry litter, so that route would be blocked. BSE rules by USDA’s Food Safety Inspection Service (FSIS) and FDA’s Center for Food Safety and Applied Nutrition (CFSAN) address food safety by keeping potentially infectious material out of food, thus eliminating plate waste as a possible vehicle. Blood has not been shown to be a vehicle for BSE infection, so it was not included in the proposed rule. (In addition, international standard setting agencies believe blood products are as safe for use in animal feed as milk and milk products.) And separate, dedicated facilities would not be needed because the proposed rule would eliminate the high-risk material, thus eliminating the concern for contamination of cattle feed.

The proposal would cost the industry approximately $14 million to $24 million per year, annualized over a 10-year period. This estimate includes the cost of complying and the cost of substitute feeds.

The comment period for the rule closes December 20, 2005. Comments should be identified by Docket Number 2002N-0273, or RIM 0901-AF46. They can be submitted electronically through the Federal eRulemaking Portal: http://www.regulations.gov, or through the Agency website at http://www.fda.gov/dockets/ecomments.

Written comments can be submitted via fax at 301-827-6870; or mailed, hand delivered, or sent by courier as a paper copy, on a disk or a CD-ROM, to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20852. The comments may be posted publicly on FDA’s dockets, including any personal information submitted with the comment.

U.S. Completes Investigation of BSE-Infected Cow in Texas


After investigating the report of a cow in Texas found in June to be infected with bovine spongiform encephalopathy (BSE), Federal officials reported that appropriate safeguards were in place and working, which prevented the further spread of the disease.

The infected animal was destroyed and did not get into the food, feed, or pet food supply, officials said. This was the first native born cow in the United States found to be infected with BSE.

The U.S. Department of Agriculture (USDA), which is in charge of tracking and preventing animal disease, reported the infected animal to the Food and Drug Administration (FDA) on June 24, 2005. To determine if any other animals or offspring of animals from the herd of the infected animal were infected with BSE, USDA tracked down as many as it could of the 200 adult and 213 calves associated with the infected animals. No additional BSE was found.

Meanwhile, FDA officials, along with the Texas Animal Health Commission and the Texas Feed and Fertilizer Control Service, investigated the sources of feed given the infected animal to see if they could discover the source of the infectious material. In addition, the Federal and State authorities tracked the disposition of all animals associated with the infected cow to be sure the provisions of FDA’s 1997 BSE rule were followed.

The investigation concluded that the 1997 feed rule, which prohibits the feeding of most mammalian protein to cattle and other ruminants, was being followed. At an August 30 press teleconference, Dr. Stephen Sundlof, director of FDA’s Center for Veterinary Medicine, said that the investigation revealed that all companies involved were complying with the 1997 BSE feed rule.

FDA’s investigation identified 21 feed products used on the farm. FDA and State investigators went to three retail feed stores that had supplied the feed, and to nine feed mills that made the feed. According to Dr. Sundlof, “This investigation found no feed products used on the farm since 1997 had been formulated to contain prohibited mammalian protein.”

According to Dr. Sundlof, the infected cow, which was approximately 12 years old, had “very likely consumed contaminated feed well before 1997….”

The animals associated with the infected cow were properly handled during slaughter and disposition under the feed rule, Dr. Sundlof said: “The investigation into the disposition of herd-mates from this farm involved visits to nine slaughter plants and eight rendering plants. The investigation found that all rendering plants were operating in compliance with the BSE ruminant feed rule. A review of the inspection history of each of these rendering firms found no violation.”

On October 6, FDA announced proposed rules to further reduce the risk of BSE in the United States. The proposal would ban certain high risk cattle material from use in all feeds and pet foods. (See related story on page 1, “FDA Proposes Tighter Feed Ban to Prevent BSE.”)

http://www.fda.gov/cvm/FdaVetJulAug2005.htm

> The investigation concluded that the 1997 feed rule, which prohibits the feeding of

> most mammalian protein to cattle and other ruminants, was being followed.

FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

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

Note: On Dec. 23, 2003, the U.S. Department of Agriculture reported that a cow in Washington state had tested positive for bovine spongiform encephalopathy (BSE, or mad cow disease). As a result, information on this Web page stating that no BSE cases had been found in the United States is now incorrect. However, because other information on this page continues to have value, the page will remain available for viewing.

FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT


Today the Food and Drug Administration announced the results of tests taken on feed used at a Texas feedlot that was suspected of containing meat and bone meal from other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in feed for other ruminants. Results indicate that a very low level of prohibited material was found in the feed fed to cattle.

FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.

It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly low, even if the feed were contaminated.

According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections, to keep American cattle free of BSE."

Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from those animals will not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material are unaffected by this incident, and should be handled in the beef supply clearance process as usual.

FDA believes that Purina Mills has behaved responsibly by first reporting the human error that resulted in the misformulation of the animal feed supplement and then by working closely with State and Federal authorities.

This episode indicates that the multi-layered safeguard system put into place is essential for protecting the food supply and that continued vigilance needs to be taken, by all concerned, to ensure these rules are followed routinely.

FDA will continue working with USDA as well as State and local officials to ensure that companies and individuals comply with all laws and regulations designed to protect the U.S. food supply.


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


http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html


NEWS RELEASE

Texas Animal Health Commission

Box l2966 •Austin, Texas 78711 •(800) 550-8242• FAX (512) 719-0719

Linda Logan, DVM, PhD• Executive Director

For info, contact Carla Everett, information officer, at 1-800-550-8242, ext. 710,

or ceverett@tahc.state.tx.us

For Immediate Release--

Feed Contamination Issue Resolved by FDA

Although many of you may have heard the latest regarding the resolution of the cattle feed

contamination situation in Texas, I wanted to ensure that you received this statement issued

by the Food and Drug Administration (FDA), the agency in charge of regulating feed

components. The FDA has said the cattle involved are to be rendered and the material will not

enter ruminant or human food channels. The Texas Animal Health Commission (TAHC) will

provided assistance to the FDA as requested and needed.

FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT

Today (Tuesday, Jan. the Food and Drug Administration announced the results of tests taken

on feed used at a Texas feedlot that was suspected of containing meat and bone meal from

other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in

feed for other ruminants. Results indicate that a very low level of prohibited material was

found in the feed fed to cattle.

FDA has determined that each animal could have consumed, at most and in total,

five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These

animals weigh approximately 600 pounds.

It is important to note that the prohibited material was domestic in origin (therefore not likely

to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very

low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly

low, even if the feed were contaminated.

According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The

challenge to regulators and industry is to keep this disease out of the United States. One

important defense is to prohibit the use of any ruminant animal materials in feed for other

ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA)

ban on the importation of live ruminant animals from affected countries, these steps represent

a series of protections, to keep American cattle free of BSE."

Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily

purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed

containing the prohibited material. Therefore, meat from those animals will not enter the

human food supply. FDA believes any cattle that did not consume feed containing the

prohibited material are unaffected by this incident, and should be handled in the beef supply

clearance process as usual.

FDA believes that Purina Mills has behaved responsibly by first reporting the human error

that resulted in the misformulation of the animal feed supplement and then by working

closely with State and Federal authorities.

This episode indicates that the multi-layered safeguard system put into place is essential for

protecting the food supply and that continued vigilance needs to be taken, by all concerned, to

ensure these rules are followed routinely.

FDA will continue working with USDA as well as state and local officials to ensure that

companies and individuals comply with all laws and regulations designed to protect the U.S.

food supply.

---30--

http://www.tahc.state.tx.us/news/pr/2001/101FEED_ISSUE_RESOLVED.pdf

as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE

Risk of oral infection with bovine spongiform

encephalopathy agent in primates

Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia,

Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys

The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)—which can lead to variant

Creutzfeldt-Jakob disease (vCJD)—is compounded by incomplete knowledge about the efficiency of oral infection

and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral

transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a

BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the

other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a

preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public

health measures can prevent transmission of BSE to man.

snip...

BSE bovine brain inoculum

100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg

Primate (oral route)* 1/2 (50%)

Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)

RIII mice (icip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)

PrPres biochemical detection   

The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was

inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of

bioassays is generally judged to be about plus or minus 1 log. icip=intracerebral and intraperitoneal.

Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula

snip...

www.thelancet.com Published online January 27, 2005 http://image.thelancet.com/extras/05let1056web.pdf

#1 TEJAS MAD COW THAT WAS NOT TESTED AT ALL!

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.


OOPS!..........TSS


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

Statement by Chief Veterinary Medical Officer John Clifford Animal and Plant Health Inspection Service Regarding Non-Definitive BSE Test Results
July 27, 2005

snip...


The veterinarian treated the sample with a preservative, which readies it for testing using the immunohistochemistry (IHC) test —an internationally recognized confirmatory test for BSE. Neither the rapid screening test nor the Western blot confirmatory test can be conducted on a sample that has been preserved.


snip...

I would note that the sample was taken in April, at which time the protocols allowed for a preservative to be used (protocols changed in June 2005). The sample was not submitted to us until last week, because the veterinarian set aside the sample after preserving it and simply forgot to send it in.


http://www.aphis.usda.gov/lpa/news/2005/07/bsestatement_vs.html

"Earlier this week, USDA's Office of the Inspector General (OIG), which has been partnering with the Animal and Plant Health Inspection Service, the Food Safety and Inspection Service, and the Agricultural Research Service by impartially reviewing BSE-related activities and making recommendations for improvement, recommended that all three of these samples be subjected to a second internationally recognized confirmatory test, the OIE-recognized SAF immunoblot test, often referred to as the Western blot test. We received final results a short time ago. Of the three samples, two were negative, but the third came back reactive.

"Because of the conflicting results on the IHC and Western blot tests, a sample from this animal will be sent to the OIE-recognized reference laboratory for BSE in Weybridge, England. USDA will also be conducting further testing, which will take several days to complete.


http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2005/06/0206.xml

"Each was then followed up with an IHC test. Each confirmatory IHC test was negative. The Inspector General, in reviewing our surveillance system that we have in place, decided to retest with a second confirmatory test which is called the Western Blot. We have received test results showing a positive on one animal for the Western Blot.


http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2005/06/0207.xml

ONE YEAR LATER, not 24 to 96 hours (this is what i call mad cow market timing)


STATEMENT BY DR. JOHN CLIFFORD REGARDING FURTHER ANALYSIS OF BSE TEST RESULTS IN WEYBRIDGE, ENGLAND
June 16, 2005

"Today, an official with USDA's National Veterinary Services Laboratory departed for Weybridge, England, hand-carrying samples for further testing.

http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2005/06/0218.xml

"So let me start first with the test results. As you are aware, last November we had an inconclusive report from a rapid screening test. USDA then conducted two IHC confirmatory tests, and both came out negative. A few weeks ago an additional confirmatory test was conducted, and that test is referred to as the Western blot test.

"On June 10 I learned that test was reactive and shared those results at that time.

"We now have the test results from the lab in Weybridge, England, as well as the results from additional testing in our own lab, and again I am here today to share those results with you.

"The results confirm the presence of BSE in this animal, an animal that was blocked from entering the food supply thanks to the firewalls that are in place. It is critically important to note that this animal was identified as a high risk animal. A sample was taken, and the carcass was incinerated.


http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2005/06/0233.xml


06/09/05
BSE Roundtable Discussion Transcript


http://www.aphis.usda.gov/lpa/issues/bse/BSE_roundtable_6_9_05.pdf

NOW, let us look at another BSE ROUNDTABLE DISCUSSION by USDA et al in the year 2003, please note the BSE science on IHC testing then, and then compare to now, and then ponder those other 9,200 cattle of the infamous June 2004 BSE cover-up program, that did not have rapid testing or WB, just IHC, the lease likely to find BSE/TSE ;

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


2005


National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC) Testing Summary

The BSE enhanced surveillance program involves the use of a rapid screening test, followed by confirmatory testing for any samples that come back "inconclusive." The weekly summary below captures all rapid tests conducted as part of the enhanced surveillance effort. It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing.


http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html


Office of Inspector General OIG

Semiannual Report to Congress FY - 2005 - First Half

snip...


Stopping BSE at the Border—USDA Needs To

Strengthen Controls Over Canadian Beef Imports

Following the detection of a Canadian cow with bovine

spongiform encephalopathy (BSE or “mad cow disease”)

in May 2003, we examined the Animal and Plant Health

Inspection Service’s (APHIS) oversight of the importation

of beef products from Canada. Following requests from

four U.S. Senators, we began several reviews in June

2004 to explore whether USDA did not follow appropriate

safety measures, beginning sometime in the fall of 2003,

in allowing expanded Canadian beef imports into the

United States.

After the initial halt of imports, in August 2003 the

Secretary announced a list of low-risk products that would

be allowed from Canada. APHIS also allowed an

expansion in the type of Canadian facilities that could

produce items for export to the United States. The

gradual expansion occurred because agency employees

included products similar to those on the published lowrisk

list, but APHIS did not communicate this broadly.

As a result, from August 2003 to April 2004, APHIS issued

permits for products with questionable eligibility. Contrary

to publicly stated policy, the agency allowed the import of

products from Canadian facilities that produced both

eligible and ineligible products, increasing the possibility

that higher-risk product could be inadvertently imported.

APHIS also issued permits to allow the import of more

than 63,000 pounds of beef cheek meat with questionable

eligibility because the agency did not establish a clear

definition for “boneless beef.” Further, we found that

FSIS did not always communicate effectively about the

eligibility status of beef cheek meat, specifically to import

inspectors. In addition, APHIS issued 1,155 permits for

the importation of ruminant (e.g., cow, goat) products

from Canada without ensuring that the agency had an

appropriate system of internal controls to manage the

process for a suddenly overwhelming volume of requests.

From May through September 2004, we identified more

than 42,000 pounds of product with questionable

eligibility.

APHIS generally agreed to institute procedures for

communicating changes in policy and monitoring the

consistency between agency practice and publicly stated

policy, as well as to strengthen controls and finalize

procedures to issue and monitor permits. FSIS generally

agreed to implement controls to communicate the specific

eligibility of product when its eligibility status changes and

to implement an edit check in its import information

system to identify ineligible product. (Audit Report No.

33601-1-Hy, APHIS Oversight of the Importation of Beef

Products from Canada)


snip...


Restaurant Owner Sentenced for Smuggling Beef

from Japan, Importation of Which Is Prohibited Due

to Disease Concerns

In January 2005, a Los Angeles restaurant owner was

placed on probation for 60 months, to include 800 hours

of community service, after he pled guilty to smuggling

beef from Japan. Under 9 Code of Federal Regulations

(C.F.R.) § 94, beef from Japan is a prohibited product

for United States importation due to disease. On two

occasions in 2001 and 2002, inspectors in Anchorage,

Alaska, intercepted shipments sent from Japan that

were manifested as “book,” but upon inspection by

USDA and the United States Customs Service, were

found to contain approximately 25 kilograms of beef

inside a Styrofoam ice chest. Both shipments were

addressed to the restaurant owner. Shipping records

showed that the restaurant owner had received 13

shipments manifested as “book” from the same sender

in Japan in 2001 and 2002. All but one of the shipments

were in the same weight range as the two intercepted

shipments. The shipper and the restaurant owner were

subsequently indicted for various charges including

conspiracy and smuggling. An arrest warrant was

issued for the shipper, who is still in Japan.


http://www.usda.gov/oig/webdocs/SarcFirstHalf05.pdf


GAO-06-157R FDA Feed Testing Program

October 11, 2005


SNIP...FULL TEXT 29 PAGES ;


http://www.gao.gov/new.items/d06157r.pdf


Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA
Implemented in 2003 With Recommendations for Making the Program a Better
Oversight Tool. GAO-06-157R, October 11

http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R


CVM Update
November 2005 Update on Feed Enforcement Activities to Limit the Spread of
BSE

To help prevent the establishment and amplification of BSE through feed in
the United States, FDA implemented a final rule that prohibits the use of
most mammalian protein in feeds for ruminant animals. This rule, Title 21
Part 589.2000 of the Code of Federal Regulations, here called the Ruminant
Feed Ban, became effective on August 4, 1997.

This is an update on FDA enforcement activities regarding the ruminant feed
regulation. FDA's CVM has assembled data from the inspections that have been
conducted AND whose final inspection report has been recorded in the FDA's
inspection database as of November 26, 2005. As of November 26, 2005, FDA
had received over 41,000 inspection reports. The majority of these
inspections (around 68%) were conducted by State officials under contract to
FDA, with the remainder conducted by FDA officials.

Inspections conducted by FDA or State investigators are classified to
reflect the compliance status at the time of the inspection based upon the
objectionable conditions documented. These inspection conclusions are
reported as Official Action Indicated (OAI), Voluntary Action Indicated
(VAI), or No Action Indicated (NAI).

An OAI inspection classification occurs when significant objectionable
conditions or practices were found and regulatory sanctions are warranted in
order to address the establishment's lack of compliance with the regulation.
An example of an OAI inspection classification would be findings of
manufacturing procedures insufficient to ensure that ruminant feed is not
contaminated with prohibited material. Inspections classified with OAI
violations will be promptly re-inspected following the regulatory sanctions
to determine whether adequate corrective actions have been implemented.

A VAI inspection classification occurs when objectionable conditions or
practices were found that do not meet the threshold of regulatory
significance, but do warrant advisory actions to inform the establishment of
findings that should be voluntarily corrected. Inspections classified with
VAI violations are more technical violations of the Ruminant Feed Ban. These
include provisions such as minor recordkeeping lapses and conditions
involving non-ruminant feeds.

An NAI inspection classification occurs when no objectionable conditions or
practices were found during the inspection or the significance of the
documented objectionable conditions found does not justify further actions.

The results to date are reported here both by ?segment of industry? and ?in
total?. NOTE ? A single firm can operate as more than one firm type. As a
result, the categories of the different industry segments are not mutually
exclusive.

RENDERERS

These firms are the first to handle and process (i.e., render) animal
proteins and to send these processed materials to feed mills and/or protein
blenders for use as a feed ingredient.

Number of active firms whose initial inspection has been reported to FDA ?
274

Number of active firms handling materials prohibited from use in ruminant
feed ? 185 (68% of those active firms inspected)

Of the 185 active firms handling prohibited materials, their most recent
inspection revealed that:

1 firm (0.5%) was classified as OAI

11 firms (5.9%) were classified as VAI

LICENSED FEED MILLS

FDA licenses these feed mills to produce medicated feed products. The
license is required to manufacture and distribute feed using certain potent
drug products, usually those requiring some pre-slaughter withdrawal time.
This licensing has nothing to do with handling prohibited materials under
the feed ban regulation. A medicated feed license from FDA is not required
to handle materials prohibited under the Ruminant Feed Ban.

Number of active firms whose initial inspection has been reported to FDA ?
1,079

Number of active firms handling materials prohibited from use in ruminant
feed ? 426 (39% of those active firms inspected)

Of the 426 active firms handling prohibited materials, their most recent
inspection revealed that:

0 firm (0%) was classified as OAI

8 firms (1.9%) were classified as VAI

FEED MILLS NOT LICENSED BY FDA

These feed mills are not licensed by the FDA to produce medicated feeds.

Number of active firms whose initial inspection has been reported to FDA ?
5,165

Number of active firms handling materials prohibited from use in ruminant
feed ? 2,036 (39% of those active firms inspected)

Of the 2,036 active firms handling prohibited materials, their most recent
inspection revealed that:

2 firms (0.1%) were classified as OAI

24 firms (1.2%) were classified as VAI

PROTEIN BLENDERS

These firms blend rendered animal protein for the purpose of producing
quality feed ingredients that will be used by feed mills.

Number of active firms whose initial inspection has been reported to FDA --
340

Number of active firms handling materials prohibited from use in ruminant
feed ? 147 (43% of those active firms inspected)

Of the 147 active firms handling prohibited materials, their most recent
inspection revealed that:

0 firms (0%) were classified as OAI

7 firms (4.8%) were classified as VAI

RENDERERS, FEED MILLS, AND PROTEIN BLENDERS

This category includes only those firms that actually use prohibited
material to manufacture, process, or blend animal feed or feed ingredients.

Number of active renderers, feed mills, and protein blenders whose initial
inspection has been reported to FDA ? 6,576

Number of active renderers, feed mills, and protein blenders processing with
prohibited materials ? 539 (8.2% of those active firms inspected)

Of the 539 of active renderers, feed mills, and protein blenders processing
with prohibited materials, their most recent inspection revealed that:

3 firms (0.6%) were classified as OAI

23 firms (4.3%) were classified as VAI

OTHER FIRMS INSPECTED

Examples of such firms include ruminant feeders, on-farm mixers, pet food
manufacturers, animal feed salvagers, distributors, retailers, and animal
feed transporters.

Number of active firms whose initial inspection has been reported to FDA ?
13,477

Number of active firms handling materials prohibited from use in ruminant
feed ? 3,748 (28% of those active firms inspected)

Of the 3,748 active firms handling prohibited materials, their most recent
inspection revealed that:

8 firms (0.2%) were classified as OAI

95 firms (2.5%) were classified as VAI

TOTAL FIRMS

Note that a single firm can be reported under more than one firm category;
therefore, the summation of the individual OAI/VAI firm categories will be
more than the actual total number of OAI/VAI firms, as presented below.

Number of active firms whose initial inspection has been reported to FDA ?
16,476

Number of active firms handling materials prohibited from use in ruminant
feed ? 4,553 (27% of those active firms inspected)

Of the 4,553 active firms handling prohibited materials, their most recent
inspection revealed that:

9 firms (0.2%) were classified as OAI

107 firms (2.4%) were classified as VAI


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

Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm


http://www.fda.gov/cvm/5580.htm


[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle

03-025IFA
03-025IFA-2
Terry S. Singeltary


Page 1 of 17

From: Terry S. Singeltary Sr. [flounder9@verizon.net]

Sent: Thursday, September 08, 2005 6:17 PM

To: fsis.regulationscomments@fsis.usda.gov

Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified
Risk Materials for Human Food and Requirements

for the Disposition of Non-Ambulatory Disabled Cattle

Greetings FSIS,

I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS
Prohibition of the Use of Specified Risk Materials for Human Food and

Requirements for the Disposition of Non-Ambulatory Disabled Cattle

THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle

Broken bones and such may be the first signs of a sub clinical BSE/TSE
Non-Ambulatory Disabled Cattle ;

snip...FULL TEXT ;


http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1]
RIN 0579-AB93 TSS SUBMISSION


http://docket.epa.gov/edkfed/do/EDKStaffItemDetailView?objectId=090007d48099
3808


http://docket.epa.gov/edkfed/do/EDKStaffAttachDownloadPDF?objectId=090007d48
0993808


http://docket.epa.gov/edkfed/do/EDKStaffCollectionDetailView?objectId=0b0007
d48096b40d


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

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

OLD TSS SUBMISSIONS;


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

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08
d?OpenDocument


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


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


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

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

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

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


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


PART 2


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


PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

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

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


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


Asante/Collinge et al, that BSE transmission to the 129-methionine

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;


http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm





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