• If you are having problems logging in please use the Contact Us in the lower right hand corner of the forum page for assistance.

AFIA finalizes comments to FDA on proposed BSE feed rule

Help Support Ranchers.net:

flounder

Well-known member
Joined
Sep 3, 2005
Messages
2,631
Reaction score
0
Location
TEXAS
----- Original Message -----
From: "Terry S. Singeltary Sr." <[email protected]>
To: <[email protected]>
Sent: Tuesday, December 20, 2005 10:17 AM
Subject: AFIA finalizes comments to FDA on proposed BSE feed rule AFIA still insists on spreading more BSE


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

AFIA finalizes comments to FDA on proposed BSE feed rule

(World-Grain.com, December 19, 2005)


ARLINGTON, VIRGINIA, U.S. — A task force for the American Feed Industry Association has finalized comments to the U.S. Feed and Drug Administration for the FDA’s proposed bovine spongiform encephalopathy feed rule published Oct. 6, AFIA said late last week.

The comments will be filed before the comment period closes Tuesday. In general, AFIA agrees that the proposed rule will reduce the already very small risk of BSE in the U.S.

AFIA thinks the agency should not require the removal of brains and spinal cords from animals 30 months of age or younger that are dead or non-ambulatory, since FDA is not requiring such removal from animals that are slaughtered. Moreover, BSE is not found in animals under 30 months of age.

AFIA recommended to FDA that renderers only should keep records of brain/spinal cord removal, that tests should be developed for brain/spinal cord presence and that the federal government must address the excess disposal of carcasses likely to result from the proposed rule. The affected industries should be part of the disposal discussions.

FDA’s economic impact analysi is a matter of some dispute, and AFIA believes the agency should review additional analyses that are submitted for comment.

Finally, AFIA applauded the agency and industries’ actions to maintain a near perfect rate of compliance and agreed to continue to support education, surveillance, compliance and enforcement actions regarding this rule.

A copy of AFIA’s comments is available on the association’s web site at http://www.afia.org/img/assets/30/AFIA_BSE_comments12-15-05.pdf.

http://www.world-grain.com/feature_stories.asp?ArticleID=77151






December 19, 2005

Division of Dockets Management VIA ELECTRONIC MAIL

(HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket No. 2002N-0273, Proposed Rule Substances Prohibited From Use in Animal Food or Feed

Dear Sir/Madam:

The American Feed Industry Association (AFIA) is the national trade association representing feed and pet food manufacturers, ingredient manufacturers and suppliers, equipment manufacturers and other firms which supply goods and services to the feed industry. AFIA’s nearly 600 corporate members manufacture more than 75% of the nation’s primary feed. In addition, AFIA’s membership includes 21 state and eight national trade associations representing feed manufacturers and ingredient suppliers. Many AFIA members are subject to the current BSE feed regulation (21 CFR § 589.2000), and AFIA offers these comments on their behalf.

AFIA believes there is no FDA regulation with a higher level of industry compliance than this BSE feed rule, and applauds the agency’s continuing industry education and compliance efforts. Continuing programs to promote education about, compliance with, surveillance for and enforcement of this rule are essential to insuring BSE does not establish and amplify in the U.S., as well as for maintaining high level of confidence in the U.S. beef supply by consumers and global trading partners.

AFIA renews its commitment to support FDA’s efforts, and to seek adequate funding for continued education and compliance efforts at the state and federal levels. Only through this cooperative industry-government effort can we be effective in assuring the consuming public and our trading partners of the safety of the U.S. beef supply, while insuring continued animal health.

AFIA Supports FDA’s Proposed Rulemaking; But Believes One Change is Needed

AFIA generally supports the proposed changes to the BSE feed rule (21 CFR §589.2000) and creation of a new subsection 21 CFR § 589.2001. The approach proposed significantly reduces the already very low risk of BSE in the U.S. and is less costly than the approach proposed by FDA in January 2004.

American Feed Industry Association Comments to FDA on Docket 2002N-0273 2 December 19, 2005

However, AFIA remains very concerned about the costs of carcass disposal from animals excluded from this proposed rule, as well as carcasses and materials that must be disposed of due to the consequences of this rule, i.e. significant changes in the rendering industry brought on by

the proposed brain/spinal cord (B/SC) exclusions, including B/SC from all dead and nonambulatory animals regardless of age to be legal for rendering and feeding.

AFIA agrees with FDA’s proposal to remove from the entire feed supply chain a limited list of certain tissues from cattle to prevent the inadvertent commingling of prohibited mammalian protein with ruminant feed. The rationale FDA puts forward for making this proposal is scientifically defensible -- with one exception.

AFIA urges the agency to reduce the potential amount of unrenderable product that will likely result from the exclusion of SRMs and nonambulatory and dead animals for which B/SC is impractical or impossible. We believe the agency is being inconsistent in its application of risk reduction science by proposing to require the removal of B/SC in all dead or nonambulatory cattle, while allowing the feed use of B/SC from cattle less than 30 months of age for cattle which have been inspected and slaughtered.

AFIA asserts the even-handed application of science dictates the retention of the B/SC in the feed chain from cattle less than 30 months of age provided the age of the animal can be verified. This approach is consistent with the generally accepted principle that cattle under 30 months of age have been rarely, if ever, diagnosed with BSE. This position, however, is dependent on a verifiable method of determining age. For dairy operations, we believe herd records would justify that requirement. Feedlot calves would also clearly meet this requirement. Amending this portion of the proposal will further reduce the expected amount of material to be disposed of with no expected risk elevation. The cost savings would be significant and is detailed in comments by the National Renderers Association.

A Federal Government Task Force Should be Developed to Address Carcass Disposal

AFIA’s primary concern, however, is the lack of a coordinated federal program -- or even guidance to industry for carcass and SRM disposal resulting from this proposal. FDA can reduce a significant amount of this material by amending the proposal to adopt AFIA’s suggestion allowing use in non-ruminant feed of B/SC from dead and nonambulatory cattle less than 30 months of age.

At the same time, AFIA strongly urges the federal government to form a high-level state-federal task force to address the disposal issue. At the very least, this task force should include veterinary public health officials from each state. The task force should develop disposal options, and identify funding mechanisms to effect these options. The affected industries would be pleased to host roundtables, technical conferences or other meetings to address this issue.

The failure of the federal government to address responsible and environmentally responsible disposal of the increased amount of cattle material and animals requiring options

American Feed Industry Association Comments to FDA on Docket 2002N-0273 3 December 19, 2005

may lead to potential zoonootic disease transmission and further possibility of contamination of soil and water. AFIA believes FDA should promulgate a rule with the least amount of disposal issues and the maximum amount of risk reduction and the Federal Government agencies responsible for these issues should begin work when or if FDA finalizes this rule.

Lack of a B/SC Test Method is a Concern, as Well as FDA’s Potential for Using PCR

FDA raises the issue of a lack of analytical tests for detecting B/SC in rendered product. AFIA shares this concern, and believes if and when FDA finalizes this rule, it should fund analytical method development. Although recordkeeping is an important tool, the development of a definitive, sensitive test for cattle B/SC will greatly assist in compliance efforts.

AFIA is aware the agency has developed an enhanced polymerase chain reaction (PCR) analytical test for bovine material in feed product. Of concern is the relative sensitivity of such a test that detects bovine protein that is airborne in or near feed milling operations. Before,

FDA implements the regulatory testing of feed products, the agency needs to seriously consider the impact of airborne particles on the detection limits of this test method. AFIA does not support the use of such extremely sensitive methods that could result in positive findings for feed mills which do not handle prohibited mammalian protein in their manufacturing operations.

Additional Recordkeeping Should be Required Only for Rendering Operations

FDA asks for comments on extending recordkeeping requirements for this proposed regulation to industry segments beyond rendering operations. FDA explained the agency believes this would be redundant and therefore of little use. This proposed rule would require the removal of B/SC in certain cattle prior to rendering any tissue. The documentation (or testing, if developed) to insure this action has been taken must necessarily be done at the rendering operation. After the product is rendered, it would seem of little value to require records downstream from rendered product customers. Therefore, AFIA supports FDA’s position that recordkeeping at the rendering operation should be required to document the removal of B/SC from applicable cattle, and no other operations should be required to maintain additional, new records.

FDA Should Compare Any Submitted, Relevant Comprehensive Economic Analysis Against FDA’s Published Ones To Insure the Full Magnitude is Addressed

The economic impact of the proposed regulation on the rendering and animal production industries may be significant. AFIA believes the FDA should reevaluate the economic analysis of this rule prior to finalizing. Such an analysis should consider the overall economic impact of the proposed rule on all affected parties and be based on submitted, relevant data derived from a broad segment of the affected industries.

Finally, AFIA cannot stress strongly enough that this and future notices and rulemaking should be directed to animal health, as USDA and FDA have removed as many human health

American Feed Industry Association Comments to FDA on Docket 2002N-0273 4 December 19, 2005

concerns as are scientifically justified through previous actions banning the use of SRMs and downers in the food supply and related products.

In summary, AFIA generally supports FDA’s proposed rule, but believes the proposal should be amended to allow in animal feed brains and spinal cords from dead and non-ambulatory cattle less than 30 month of age. FDA should pursue testing methodologies to detect

B/SC in feed. The rendering industry should be required to keep additional records, and rendering industry customers should not have a duplicative recordkeeping burden. FDA and other federal agencies, in concert with state and industry interests, must address and develop practical and responsible alternatives and funding for disposal of additional carcasses and SRM material produced under this proposal.

AFIA appreciates the opportunity to offer these comments.

Sincerely,

Richard Sellers

Vice President, Feed Control & Nutrition

American Feed Industry Association

1501 Wilson Blvd., Suite 1100

Arlington, VA 22209

703/524-0810


http://www.afia.org/img/assets/30/AFIA_BSE_comments12-15-05.pdf


>>>AFIA thinks the agency should not require the removal of brains and spinal cords from animals 30 months of age or younger that are dead or non-ambulatory, since FDA is not requiring such removal from animals that are slaughtered. Moreover, BSE is not found in animals under 30 months of age.<<<



the youngest age of BSE case to date is 20 months old; As at: 31 May
2003 Year of onset Age youngest case (mnths) Age 2nd youngest case
(mnths) Age 2nd oldest case (yrs.mnths) Age oldest case (yrs.mnths) 1986
30 33 5.03 5.07 1987 30 31 9.09 10.00 1988 24 27 10.02 11.01(2) 1989 21
24(4) 12.00(2) 15.04 1990 24(2) 26 13.03 14.00 1991 24 26(3) 14.02 17.05
1992 20 26 15.02 16.02 1993 29 30(3) 14.10 18.10 1994 30(2) 31(2) 14.05
16.07 1995 24 32 14.09 15.05 1996 29 30 15.07 17.02 1997 37(7) 38(3)
14.09 15.01 1998 34 36 14.07 15.05 1999 39(2) 41 13.07 13.10 2000 40 42
17.08 19.09 2001 48(2) 56 14.10 14.11 2002 51 52 15.08 15.09(2) 2003 50
62 11.11 14.11


http://www.defra.gov.uk/animalh/bse/bse-statistics/bse/yng-old.html

http://www.defra.gov.uk/animalh/bse/index.html


The implications of the Swiss result for Britain, which has had the most
BSE, are complex. Only cattle aged 30 months or younger are eaten in
Britain, on the assumption, based on feeding trials, that cattle of that
age, even if they were infected as calves, have not yet accumulated
enough prions to be infectious. But the youngest cow to develop BSE on
record in Britain was 20 months old, showing some are fast incubators.
Models predict that 200-300 cattle under 30 months per year are infected
with BSE and enter the food chain currently in Britain. Of these 3-5
could be fast incubators and carrying detectable quantities of prion.


http://www.sare.org/htdocs/hypermail/html-home/28-html/0359.html



snip...


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


Muscle tissue has recently been detected with PrPSc
in the peripheral nerves (sciatic nerve, tibial nerve, vagus nerve) of the 11th BSE
cow in Japan (Yoshifumi Iwamaru et al). also recently, Aguzzi et al Letter to the Editor
Vet Pathol 42:107-108 (2005), Prusiner et al CDI test is another example of detection
of the TSE agent in muscle in sCJD, Herbert Budka et al CJD and inclusion body myositis:
Abundant Disease-Associated Prion Protein in Muscle, and older studies from Watson
Meldrum et al Scrapie agent in muscle - Pattison I A (1990), references as follow ;


PrPSc distribution of a natural case of bovine
spongiform encephalopathy

Yoshifumi Iwamaru, Yuka Okubo, Tamako Ikeda, Hiroko Hayashi, Mori-
kazu Imamura, Takashi Yokoyama and Morikazu Shinagawa

Priori Disease Research Center, National Institute of Animal Health, 3-1-5
Kannondai, Tsukuba 305-0856 Japan [email protected]

Abstract

Bovine spongiform encephalopathy (BSE) is a disease of cattle that causes
progressive neurodegeneration of the central nervous system. Infectivity
of BSE agent is accompanied with an abnormal isoform of prion protein
(PrPSc).

The specified risk materials (SRM) are tissues potentially carrying BSE
infectivity. The following tissues are designated as SRM in Japan: the
skull including the brain and eyes but excluding the glossa and the masse-
ter muscle, the vertebral column excluding the vertebrae of the tail, spinal
cord, distal illeum. For a risk management step, the use of SRM in both
animal feed or human food has been prohibited. However, detailed
PrPSc distribution remains obscure in BSE cattle and it has caused con-
troversies about definitions of SRM. Therefore we have examined PrPSc
distribution in a BSE cattle by Western blotting to reassess definitions of
SRM.

The 11th BSE case in Japan was detected in fallen stock surveillance.
The carcass was stocked in the refrigerator. For the detection of PrPSc,
200 mg of tissue samples were homogenized. Following collagenase
treatment, samples were digested with proteinase K. After digestion,
PrPSc was precipitated by sodium phosphotungstate (PTA). The pellets
were subjected to Western blotting using the standard procedure.
Anti-prion protein monoclonal antibody (mAb) T2 conjugated horseradish
peroxidase was used for the detection of PrPSc.

PrPSc was detected in brain, spinal cord, dorsal root ganglia, trigeminal
ganglia, sublingual ganglion, retina. In addition, PrPSc was also detected
in the peripheral nerves (sciatic nerve, tibial nerve, vagus nerve).

Our results suggest that the currently accepted definitions of SRM in
BSE cattle may need to be reexamined. ...

179

T. Kitamoto (Ed.)
PRIONS
Food and Drug Safety
================


ALSO from the International Symposium of Prion Diseases held in Sendai, October 31, to
November 2, 2004;


Bovine spongiform encephalopathy (BSE) in Japan


snip...


"Furthermore, current studies into transmission of cases of BSE that are
atypical or that develop in young cattle are expected to amplify the BSE
prion"


NO. Date conf. Farm Birth place and Date Age at diagnosis


8. 2003.10.6. Fukushima Tochigi 2001.10.13. 23


9. 2003.11.4. Hiroshima Hyogo 2002.1.13. 21


Test results


# 8b, 9c cows Elisa Positive, WB Positive, IHC negative, histopathology
negative


b = atypical BSE case


c = case of BSE in a young animal


b,c, No PrPSc on IHC, and no spongiform change on histology


International Symposium of Prion Diseases held in Sendai, October 31, to
November 2, 2004.

The hardback book title is 'PRIONS' Food and Drug Safety
T. Kitamoto (Ed.)


Tetsuyuki Kitamoto
Professor and Chairman
Department of Prion Research
Tohoku University School of Medicine
2-1 SeiryoAoba-ku, Sendai 980-8575, JAPAN
TEL +81-22-717-8147 FAX +81-22-717-8148
e-mail; [email protected]
Symposium Secretariat
Kyomi Sasaki
TEL +81-22-717-8233 FAX +81-22-717-7656
e-mail: [email protected]


snip...end


THIS brings up about another 9,200 points of concern. IF you look above at these two atypical TSE cows from Japan, (of which we could very well export more just like it), please notice the testing protocol;


>>># 8b, 9c cows Elisa Positive, WB Positive, IHC negative, histopathology
negative <<<


9,200 points of mad cow concern is the fact the USDA et al DID NOT use rapid TSE test OR WB test to test for BSE/TSE on 9,200 cattle, they used the least likely to find the agent only, the IHC, of which, DID NOT show up on two of those very young atypical positive Japanese cows, PLUS, like the one TEXAS cow they did finally confirm after 7+ months of trying to cover up. besides this, we have some 500,000 bse/tse test, the infamous June 2004 enhanced BSE/TSE surveillance (cover-up) program, where here the testing protocol was terribly flawwed on all these cows, where only IHC and rapid testing was used, no WB. Dr. Detwiler warned of this problem way back;


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


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. This was done to ensure that samples inappropriate for the rapid screen test were still tested, and also to monitor and improve upon IHC testing protocols. Of those 9,200 routine tests, one test returned a non-definitive result on July 27, 2005. That sample underwent additional testing at NVSL, as well as at the Veterinary Laboratories Agency in Weybridge, England, and results were negative. ...


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


APHIS et al forgets to add here that on that one additional non-definitive test of July 27, 2005, here again they could not use WB due to samples being preserved. Here in 2005 we have still not gotten the proper BSE/TSE testing protocol done correctly, after being told that we did since 1997.


hey, but its not about 'sound science' or 'human health'. GWs enhanced SRM program was nothing more than commodities and futures in action;


Our analysis suggests that if all slaughter animals are tested, but

there is no increase in access to either the Japanese or

South Korean markets, the result would be a net loss of

$17.50 (the estimated cost of testing) per head. Alternatively,

if full access to the Japanese and South Korean

markets is regained without implementing a broad

based BSE testing program, the potential revenue gain

ranges from about $45 to $66 per head (Figure 1).


http://www.oznet.ksu.edu/library/agec2/MF2679.pdf


GW seems to get his cake and eat it too $

nothing like 'sound science' in this administration, to hell with human health.


>>>Then you do a comparison of the countries. We have a herd size of about 90 million. We process about 30 million animals a year, thereabouts, probably a little bit more than that. We've been able to identify since the enhanced surveillance started one case that was actually so difficult to find we had to test and test and test to find it even. <<<


IN TEXAS we feed our cattle 5.5 grams of potentially BSE/TSE tainted protein, and that's o.k. per the FDA;


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


WE know what happens to most stumbling and staggering suspect mad cows in TEXAS too. THERE tissue samples either sit up on a shelf for 7+ months waiting for everyone to forget about, OR ;


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


WE know now, and we knew decades ago, that 5.5 grams of suspect feed in TEXAS was enough to kill 100 cows.


look at the table and you'll see that 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
Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.


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


Published online January 27, 2005

http://www.thelancet.com/journal/journal.isa

It is clear that the designing scientists must

also have shared Mr Bradley’s surprise at the results because all the dose

levels right down to 1 gram triggered infection.


http://www.bseinquiry.gov.uk/files/ws/s145d.pdf


2

6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100

grams) was probably given with the benefit of hindsight; particularly if one

considers that later in the same answer Mr Bradley expresses his surprise that it

could take as little of 1 gram of brain to cause BSE by the oral route within the

same species. This information did not become available until the "attack rate"

experiment had been completed in 1995/96. This was a titration experiment

designed to ascertain the infective dose. A range of dosages was used to ensure

that the actual result was within both a lower and an upper limit within the study

and the designing scientists would not have expected all the dose levels to trigger

infection. The dose ranges chosen by the most informed scientists at that time

ranged from 1 gram to three times one hundred grams. It is clear that the designing

scientists must have also shared Mr Bradley’s surprise at the results because all the

dose levels right down to 1 gram triggered infection.


http://www.bseinquiry.gov.uk/files/ws/s147f.pdf


Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts

[BBC radio 4 FARM news]

http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram

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


2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion)

http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml


SADLY, DEC 2005 SHOWS THAT WE STILL HAVE A SERIOUS PROBLEM WITH BSE/TSE MAD COW DISEASE FEED


GAO


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


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. [[email protected]]

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

To: [email protected]

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


AND WHOM HAVE THE FEEDERS PROTECTED IN THE PAST FROM MAD COW DISEASE AND WHAT WAS THERE MAJOR CONCERNS $

STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995

snip...

To minimise the risk of farmers' claims for compensation from feed
compounders.

To minimise the potential damage to compound feed markets through adverse publicity.

To maximise freedom of action for feed compounders, notably by
maintaining the availability of meat and bone meal as a raw
material in animal feeds, and ensuring time is available to make any
changes which may be required.

snip...

THE FUTURE

4..........

MAFF remains under pressure in Brussels and is not skilled at
handling potentially explosive issues.

5. Tests _may_ show that ruminant feeds have been sold which
contain illegal traces of ruminant protein. More likely, a few positive
test results will turn up but proof that a particular feed mill knowingly
supplied it to a particular farm will be difficult if not impossible.

6. The threat remains real and it will be some years before feed
compounders are free of it. The longer we can avoid any direct
linkage between feed milling _practices_ and actual BSE cases,
the more likely it is that serious damage can be avoided. ...

SEE full text ;

http://www.bseinquiry.gov.uk/files/yb/1995/08/24002001.pdf


THIS is what happens when you have the industry run the government. ...


TSS


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

flounder

Well-known member
Joined
Sep 3, 2005
Messages
2,631
Reaction score
0
Location
TEXAS
----- Original Message -----
From: "Terry S. Singeltary Sr." <[email protected]>
To: "Bovine Spongiform Encephalopathy" <[email protected]>
Cc: <[email protected]>; <[email protected]>
Sent: Tuesday, December 20, 2005 11:30 AM
Subject: Re: AFIA finalizes comments to FDA on proposed BSE feed rule AFIA
still insists on spreading more BSE


> Greetings BSE-L et al,
>
> now might be a good time to go over the PET FOOD manufactures in relations
> to BSE/TSE. ...TSS
>
>
>
> FOR IMMEDIATE RELEASE
> Statement
> May 26, 2003
> Media Inquiries: 301-827-6242
> Consumer Inquiries: 888-INFO-FDA
>
>
>
> FDA BSE Update - Pet Food from Canadian Manufacturer
> The Food and Drug Administration (FDA) has learned from the government of
> Canada that rendered material from a Canadian cow that last week tested
> positive for bovine spongiform encephalopathy (BSE, also known as “mad cow
> disease”) may have been used to manufacture pet food, specifically dry dog
> food, some of which was reported to have been shipped to the United
States.
> The Canadian government prevented the BSE positive cow from being
processed
> for human food. Therefore, consumers can be assured that their food does
not
> contain any remnants of the BSE positive cow.
>
> It is also important to stress that there is no scientific evidence to
date
> that dogs can contract BSE or any similar disease. In addition there is no
> evidence that dogs can transmit the disease to humans.
>
> FDA notified the U.S. pet food firm, The Pet Pantry International, of
Carson
> City, Nevada, when FDA learned that the pet food that the firm received
may
> have included rendered material from the BSE positive cow. The
manufacturer
> of the pet food is Champion Pet Food, Morinville, Alberta. Even though
there
> is no known risk to dogs from eating this dog food, as a prudent measure
to
> help assure that the U.S. stays BSE free The Pet Pantry International is
> asking its customers who may have purchased the suspect product to hold it
> for pickup by the distributor so that the dog food will not mistakenly be
> mixed into cattle or other feeds if any of the dog food is discarded or
> otherwise not used to feed dogs. The suspect dog food was produced by
> Champion Pet Food between February 4, 2003, and March 12, 2003.
>
> The Pet Pantry products were packaged in 50 lb bags, distributed to
> franchises around the country, and sold by home delivery only. There was
no
> retail distribution of the product. Consumers purchase Pet Pantry products
> by phone or email orders. The product is then delivered by the nearest
> franchisee directly to the consumer’s home.
>
> The product subject to this notification includes “Maintenance Diet”
labeled
> with a use by date of “17FEB04” and “Beef with Barley” with a use by date
of
> “05MAR04”. Consumers who have purchased dog food from The Pet Pantry since
> February of this year are asked to check their present supplies and see if
> any match the description of the product being removed. If so, consumers
are
> asked to contact The Pet Pantry at 1-800-381-7387 for further information
on
> how to return the product to The Pet Pantry for proper disposal. Consumers
> are asked not to destroy or discard the product themselves. The Pet Pantry
> will also use its sales records to contact consumers who purchased the
> affected product.
>
> FDA is working closely with the Pet Pantry International to assure for
> proper disposal of the recovered product.
>
> FDA will continue to provide updates on this case of BSE in Canada as
> additional information becomes available.
>
> ###
>
>
>
>
>
> http://www.fda.gov/bbs/topics/NEWS/2003/NEW00910.html
>
>
>
>
>
>
> U.S. Food and Drug Administration
> FDA Consumer magazine
> May-June 2001
> Table of Contents
>
>
>
> Pet Food: The Lowdown on Labels
> By Linda Bren
>
>
>
> snip...
>
>
>
>
>
>
> Pet Food and the Risk of 'Mad Cow Disease'
> No evidence of bovine spongiform encephalopathy (BSE), commonly known as
> "Mad Cow Disease," ever has been detected in horses, dogs, and other pets,
> such as birds, reptiles, and gerbils. However, a feline version of BSE,
> first identified in 1989, has been documented in domestic cats in Europe,
> mostly in the United Kingdom, according to the U.K.'s Ministry of
> Agriculture, Fisheries and Food.
>
> No cases of BSE or similar forms of the disease in cats, cows, or humans
> ever have been found in the United States. "The same precautions that the
> U.S. government is taking to keep BSE out of this country's cattle are
also
> protecting our pets," says William Burkholder, D.V.M., Ph.D., the FDA's
pet
> food specialist.
>
> Scientists believe BSE is transmitted through animal feed containing
certain
> animal proteins that may harbor the BSE agent. Since 1991, the United
States
> has banned the import of animal foods, including pet food, containing
> ruminant (such as cattle or sheep) materials from countries with BSE. In
> 1997, the United States extended the ban to most of Europe.
>
> In December 2000, the U.S. banned imports of animal proteins--from any
> species--from 31 countries that either are known to have BSE in their
cattle
> herds or are considered at high risk for having it. This means that no
> meat-containing pet food can legally be imported from a country at risk
for
> BSE.
>
> - -L.B.
>
>
>
> snip...
>
>
>
> http://www.fda.gov/fdac/features/2001/301_pet.html
>
>
>
>
>
> >>>it is also important to stress that there is no scientific evidence to
> date that dogs can contract BSE or any similar disease.
>
>
>
> THIS is not exactly correct. please see data below ;
>
>
>
> It was thought likely that at least some, and probably all, of the cases
> in zoo animals were caused by the BSE agent. Strong support for this
> hypothesis came from the findings of Bruce and others (1994)
> ( Bruce, M.E., Chree, A., McConnell, I., Foster, J., Pearson, G. &
> Fraser, H. (1994) Transmission of bovine spongiform encephalopathy and
> scrapie to mice: strain variation and species barrier. Philosophical
> Transactions of the Royal Society B 343, 405-411: J/PTRSL/343/405
> ), who demonstrated that the pattern of variation in incubation period
> and lesion profile in six strains of mice inoculated with brain
> homogenates from an affected kudu and the nyala, was similar to that
> seen when this panel of mouse strains was inoculated with brain from
> cattle with BSE. The affected zoo bovids were all from herds that were
> exposed to feeds that were likely to have contained contaminated
> ruminant-derived protein and the zoo felids had been exposed, if only
> occasionally in some cases, to tissues from cattle unfit for human
> consumption.
>
>
> snip...
>
>
> http://www.bseinquiry.gov.uk/files/ws/s324.pdf
>
>
>
>
> page 7...
>
>
> http://www.bseinquiry.gov.uk/files/ws/s067.pdf
>
>
>
> 6. As animal protein is a key ingredient in prepared pet food, particular
> attention has always
>
> been paid to animal health issues and meat hygiene controls. PFMA has
always
> advised
>
> its members in detail of any legal requirements and liaised closely with
> MAFF to
>
> understand how they should be met. In addition, PFMA members also have in
> place
>
> extensive quality control procedures of their own. The safety and
> reliability of a
>
> company’s products are always of paramount importance. Any policies
adopted
> in
>
> advance of legislation have been considered to be prudent measures with
the
> knowledge
>
> and experience available at that time. An example of this is the PFMA
policy
> only to use
>
> raw materials from animals which have been inspected and passed as fit for
> human
>
> consumption. This policy was adopted by PFMA in 1984, although it only
> became law in
>
> 1992 through the enactment of the Animal By-Products Order.
>
>
>
> http://www.bseinquiry.gov.uk/files/ws/s164.pdf
>
>
>
> 2. The Parliamentary Secretary said that he was concerned about the
> possibility that countries in which BSE had not yet been detected could be
> exporting raw meat materials (in particular crushed heads) contaminated
with
> the disease to the UK for use in petfood manufacture. ... YOU explained
that
> imported CRUSHED HEADS were extensively used in petfood industry ...
>
>
>
> http://www.bseinquiry.gov.uk/files/yb/1989/04/14001001.pdf
>
>
>
> ''creating'' problems which do not exist. Worse still, there is serious
risk
> that the media would get to hear of such a meeting and might then begin to
> ask questions along the lines of why were were apperently concerned that
> cats and dogs should not be fed ruminant meat and offal when we were
content
> that these should continue to form part of the adult human diet. ...
>
> Ruminant offals are, of course an important raw material in the
manufacture
> of ALL types of pet food, especially tripes and spleen. Thymus is also
used,
> as are oxtails and prime offals such as heart, liver, kidney and lungs,
but
> to a lesser extent because of their relative expense. CRUSHED HEADS (which
> inevitably involve BRAIN AND SPINAL CORD MATERIAL) are used to a limited
> extent but will also form one of the constituent raw materials of meat and
> bone, which IS used extensively in pet food manufacture - particularly of
> the dried and compound biscuit type of product. Despite this inclusion as
a
> major ingredient of all those offals in which the Southwood Committee
> concludedd the scrapie agent was most active, the pet food industry (which
> has an extensive research commitment;-) has had no reports of any
developing
> pattern of spongiform encephalopathies in dogs and cats. Accordingly
whilst
> they are alert to the need to keep the issue under scrutiny the pet food
> industry does not at present see cause for concern.
>
>
>
> http://www.bseinquiry.gov.uk/files/yb/1989/03/17007001.pdf
>
>
>
> MAD COW/DOG/CAT RECIPE
>
> http://www.bseinquiry.gov.uk/files/yb/1989/05/16001001.pdf
>
> http://www.bseinquiry.gov.uk/files/yb/1989/03/17007001.pdf
>
>
>
>
>
> STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995
>
> snip...
>
> To minimise the risk of farmers' claims for compensation from feed
> compounders.
>
> To minimise the potential damage to compound feed markets through adverse
> publicity.
>
> To maximise freedom of action for feed compounders, notably by
> maintaining the availability of meat and bone meal as a raw
> material in animal feeds, and ensuring time is available to make any
> changes which may be required.
>
> snip...
>
> THE FUTURE
>
> 4..........
>
> MAFF remains under pressure in Brussels and is not skilled at
> handling potentially explosive issues.
>
> 5. Tests _may_ show that ruminant feeds have been sold which
> contain illegal traces of ruminant protein. More likely, a few positive
> test results will turn up but proof that a particular feed mill knowingly
> supplied it to a particular farm will be difficult if not impossible.
>
> 6. The threat remains real and it will be some years before feed
> compounders are free of it. The longer we can avoid any direct
> linkage between feed milling _practices_ and actual BSE cases,
> the more likely it is that serious damage can be avoided. ...
>
> SEE full text ;
>
> http://www.bseinquiry.gov.uk/files/yb/1995/08/24002001.pdf
>
>
>
> Diagnosis of BSE in other species
>
> 102. On 1st May, 1990 I visited the University of Bristol at the request
of
> Dr Geoff Pearson to consult on
>
> the diagnosis of a spongiform encephalopathy in a cat. I agreed the
findings
> that Miss Janet Wyatt
>
> and Dr Pearson presented and confirmed that my view was that this was a
> scrapie-like spongiform
>
> encephalopathy. This was to be the first recorded case of what was later
> called feline spongiform
>
> encephalopathy ("FSE"). The findings from this case are summarised in my
> minute to the Directorate
>
> of the CVL and Mr Bradley dated 8th May, 1990 (YB90/5.8/3.1). On 10th May,
> 1990 I collaborated
>
> with colleagues at the Pathology Department, Bristol Veterinary School to
> prepare a letter reporting
>
> the occurrence of the SE in a cat to the Veterinary Record
(YB90/5.10/6.1).
>
> 103. I received a copy of a minute from Mr A Lebrecht (Principal Private
> Secretary to the Minister) dated
>
> 10th May addressed to the CVO, Mr Meldrum (YB90/5.10/7.1). This reported a
> meeting between Mr
>
> Meldrum, the Secretary, a Mr Dugdale, a Mr Gueterbock, the Minister and
the
> Parliamentary
>
> Secretary (Mr David Maclean), which discussed how to make public the
> information that a cat had
>
> been diagnosed as suffering from spongiform encephalopathy. I had some
> concerns at the time that
>
> the potential importance of this incident was not being recognised which I
> recorded in a draft minute
>
> dated 11th May, 1990 to Mr Bradley (YB90/5.11/1.1). Although the findings
> were preliminary, it
>
> was clear that they had potential importance for an association with BSE.
> Even at this early stage of
>
> investigations the indications were that this was unlikely to be an
isolated
> incident. It suggested that
>
> cats were susceptible to a scrapie-like disease, apparently by a natural
> route of infection (no entirely
>
> hereditary forms of TSE have been recorded in animal species), and that
the
> origin of infection was
>
> likely to be cattle or sheep. In view of what was known about BSE at the
> time, it also had
>
> implications for the products of the rendering industry and the prepared
pet
> food and fresh meat
>
> trades. The temporal occurrence of this incident was also consistent with
> possible exposure to the
>
> BSE agent during the period of recycling of carcasses of clinically
affected
> cattle. It would appear
>
> from my manuscript note on the draft filed that, on reflection, I did not
> send this minute. I recall that
>
> Mr Meldrum telephoned me at home on a Sunday evening in May to discuss the
> implications of the
>
> occurrence of FSE and that I expressed my personal view that discovery of
> FSE was probably of
>
> profound significance in relation to BSE and should lead to a complete ban
> on meat and bonemeal
>
> entering the animal food chain.
>
> 28
>
> 104. The University of Bristol was subsequently granted a MAFF contract,
for
> a study in collaboration with
>
> the NPU, to ascertain whether the condition in cats was transmissible to
> mice and, if so, to undertake
>
> strain typing of the agent. I was appointed "Project Officer" to monitor
> this study. The study was
>
> completed and showed that the disease in cats was indeed transmissible and
> that similarities in the
>
> biological characteristics of FSE and BSE on transmission to mice
indicated
> that the two diseases
>
> probably arose from a common source. An account of this study was
published
> in April 1994 (H.
>
> Fraser et al (1994) Transmission of feline spongiform encephalopathy to
> mice. Veterinary Record
>
> 134, 449: J/VR/134/449).
>
> 105. In their report dated June 1989 (IBD 4), the Tyrrell Committee had
> recommended that the health of
>
> animals fed offal, carcasses or meat and bonemeal (principally pigs,
> domestic cats and dogs and
>
> poultry) should be monitored. I was informed by Mr Bradley on 28th June,
> 1990 (YB90/6.28/8.1) that
>
> the VIS had been asked by Mr Meldrum to conduct a 'hound mortality survey'
> which would employ a
>
> similar protocol as was in place for the examination of the brains of cats
> with suspect FSE referred
>
> from VI Centres. The rationale was that hound packs represented a group of
> animals which were
>
> often fed bovine/ovine offals and meat and could therefore have been
> inadvertently exposed to the
>
> BSE agent in recent years. I only undertook a consultative role in this
> study. Brains with possible
>
> changes suggestive of an SE were to be forwarded to me for a second
opinion.
> My report dated 4th
>
> January, 1991 (YB91/1.4/4.1) records my examination of 10 hound brains
with
> vacuolar changes. A
>
> problem inherent in the design of this study was that failure to ensure
> optimum fixation of the brain
>
> had led to a number of changes which were attributable to post-mortem
> artefacts. This weakness in
>
> the survey's design, and the fact that there were no established specific
> diagnostic criteria for
>
> characterising scrapie-like spongiform encephalopathies in dogs, presented
> considerable difficulty in
>
> assessing the significance of the changes. Mr Bradley's minute of 4th
> October, 1991 (YB91/10.4/3.1)
>
> requested a situation report on the pathology findings in the survey. My
> reply of 17th October, 1991
>
> (YB91/10.17/1.1) included the view, with which Mr Wilesmith concurred (see
> his minute dated 18th
>
> October, 1991: YB91/10.18/1.1), that there was no satisfactory outcome of
> the survey.
>
> 106. The results of the survey were contained in a report in March 1992 by
> Mr Robert Higgins from the VI
>
> Centre at Thirsk (Bundle M11A, tab 8). The survey found no evidence of a
> pathologically overt SE
>
> similar to that reported in the domestic cat. 54.3% of brains examined
were
> considered negative for
>
> any changes of significance and 10.1% inconclusive, due to autolysis or
> damage to important brain
>
> sites. However, "vacuolar" changes involving certain anatomic nuclei in
the
> medulla were commonly
>
> observed but were impossible to interpret because of the sub-optimal
tissue
> preservation. The changes
>
> may have been artefact or instead represented intercurrent
neurodegenerative
> changes of unknown
>
> pathogenesis. As a result, 34.9% of cases had to be classified as
> histopathologically unresolved. On
>
> 6th December, 1993 I attended a meeting to consider possible further work
in
> relation to the hound
>
> 29
>
> survey (YB93/12.6/1.1). Options, and how they might be presented to the
> Tyrrell Committee, were
>
> discussed.
>
> 107. I was later requested to outline possible approaches to investigating
> further the anomalous results
>
> posed by the survey which I did in a concept note research proposal which
I
> sent to Mr T Eddy at
>
> Animal Health (Disease Control) on 9th February, 1995 (YB95/2.9/1.1). This
> was discussed but it
>
> was considered that the further work would not definitively resolve the
> unanswered questions which
>
> the survey had posed. This was a view with which I concurred.
>
> 108. In mid 1991 I became aware that a proposed survey of 300 deer brains
> would proceed...............
>
>
>
> http://www.bseinquiry.gov.uk/files/ws/s065a.pdf
>
>
>
> AGRICULTURE, FISHERIES AND FOOD
> BSE
>
> Mr. Campbell-Savours: To ask the Minister of Agriculture, Fisheries and
Food
> what evidence he has evaluated on the incidence of BSE-related conditions
in
> animals other than cattle. [9]
>
>
>
> Mr. Rooker: The following table gives the number of confirmed
Transmissible
> Spongiform Encephalopathy (TSE) cases in animals other than cattle in
Great
> Britain as at 30 April 1997. Species Number of cases
> Ankole cow 2
> Bison 1
> Cheetah(22) 3
> Domestic cat 77
> Eland 6
> Gemsbok 1
> Kudu 6
> Nyala 1
> Ocelot 2
> Oryx (Arabian) 1
> Oryx (scimitar horned) 1
> Puma 3
> Tiger(23) 1
>
>
>
>
>
>
>
>
> (22) Plus two litter mates that died in zoos abroad.
>
> (23) Plus another positive but clinically normal.
>
>
>
>
>
> Until November 1994, with the exception of BSE and scrapie, none of the
> other TSEs were notifiable. On the other hand, the Government believe that
> most cases of TSE have been reported to Agriculture Departments and
> epidemiological investigations have been carried out where possible. With
> respect to exotic ruminants, risk of infection was primarily associated
with
> consumption of feed, often produced for cattle, which contained meat and
> bone meal (MBM). With respect to exotic felines and domestic cats, the
risk
> was considered to be associated with consumption of central nervous system
> tissue which could legally be fed to them until it was banned in September
> 1990.
>
> No cases of TSE have been found confirmed in canines, although a case of
> spongiform encephalopathy in a Norwegian dog showing a spongiform change
in
> the brain is under investigation. This is not yet confirmed and
speculation
> about its origin delayed until results are available.
>
>
>
>
http://www.parliament.the-stationery-office.co.uk/pa/cm199798/cmhansrd/vo970
> 602/text/70602w28.htm
>
>
>
>
>
> Hound studies
>
> This largely started after it was found that dogs were being reported with
a
> spongiform encephalopathy and ataxia. The condition seemed to take place
in
> older dogs and was being reported from various parts of the UK. There was
> never any proof that it was caused by a TSE. One of the most difficult
> prblems to get around in all this was the outbreak of the disease that was
> seen in a large pack of game dogs. It was as if all the animals developed
> the disease concurrently..as would be expected if an infection was
involved.
> The animals were not very young and no specific infective cause or toxic
> cause was found.
>
> The documents below became clear during the Phillips Inquiry and represent
> documents passed around in the UK Ministry of Agriculture and Central
> Veterinary Laboratory:
> http://www.bseinquiry.gov.uk/files/yb/1991/10/18001001.pdf
> http://www.bseinquiry.gov.uk/files/yb/1993/12/06001001.pdf
> From these various documents:
>
> 37.Putative TSE in hounds - work started 1990 -(see para 41)
>
> Robert Higgins, a Veterinary Investigation Officer at Thirsk,
> had been working on a hound survey in 1990. Gerald Wells
> and I myself received histological sections from this survey
> along with the accompanying letter (YB90/11.28/1.1) dated
> November 1990. This letter details spongiform changes found
> in brains from hunt hounds failing to keep up with the rest of
> the pack, along with the results of SAF extractions from
> fresh brain material from these same animals. SAFs were not
> found in brains unless spongiform changes were also present.
> The spongiform changes were not pathognomonic (ie.
> conclusive proof) for prion disease, as they were atypical,
> being largely present in white matter rather than grey matter in
> the brain and spinal cord. However, Tony Scott, then head of
> electron microscopy work on TSEs, had no doubt that these
> SAFs were genuine and that these hounds therefore must have
> had a scrapie-like disease. I reviewed all the sections
> myself (original notes appended) and although the pathology
> was not typical, I could not exclude the possibility that this was
> a scrapie-like disorder, as white matter vacuolation is seen
> in TSEs and Wallerian degeneration was also present in the
> white matter of the hounds, another feature of scrapie.
>
> 38. Terry Singletary reviewed the literature on hound neuropathology, and
> discovered that micrographs and descriptive neuropathology from
> papers on 'hound ataxia' mirrored those in material from
> Robert Higgins' hound survey. Dr Tony Palmer (Cambridge) had
> done much of this work, and I obtained original sections
> from hound ataxia cases from him. This enabled me provisionally to
> conclude that Robert Higgins had in all probability detected
> hound ataxia, but also that hound ataxia itself was possibly a
> TSE. Gerald Wells confirmed in 'blind' examination of single
> restricted microscopic fields that there was no distinction
> between the white matter vacuolation present in BSE and
> scrapie cases, and that occurring in hound ataxia and the hound
> survey cases.
>
> 39.Hound ataxia had reportedly been occurring since the 1930's,
> and a known risk factor for its development was the feeding
> to hounds of downer cows, and particularly bovine offal.
> Circumstantial evidence suggests that bovine offal may also be
> causal in FSE, and TME in mink. Despite the inconclusive
> nature of the neuropathology, it was clearly evident that this
> putative canine spongiform encephalopathy merited further
> investigation.
>
> 40.The inconclusive results in hounds were never confirmed,
> nor was the link with hound ataxia pursued. I telephoned Robert
> Higgins six years after he first sent the slides to CVL.
> I was informed that despite his submitting a yearly report to the
> CVO including the suggestion that the hound work be continued,
> no further work had been done since 1991. This was
> surprising, to say the very least.
>
> 41.The hound work could have provided valuable evidence
> that a scrapie-like agent may have been present in cattle offal long
> before the BSE epidemic was recognised. The MAFF hound
> survey remains unpublished. Histopathological support to various other
> published
> MAFF experiments
>
> 42.These included neuropathological examination of material
> from experiments studying the attempted transmission of BSE to
> chickens and pigs (CVL 1991) and to mice (RVC 1994).
>
> http://www.bseinquiry.gov.uk/files/ws/s067.pdf
> nothing to offer scientifically;
> http://www.bseinquiry.gov.uk/files/yb/1991/10/17001001.pdf
> maddogs and Englishman
> http://www.bseinquiry.gov.uk/files/yb/1990/11/28001001.pdf
>
> Editorial: Things are really not as clear with dogs and TSE as you might
> think. The first thing was that the MAFF in the UK decided to do no
> scientific work investigating the cases (e.g. by inoculating them into
> animals), and that they were really not happy about discussing this with
the
> public. I was contacted by an Member of the UK Parliament in 1994
> concerning the possibility that a series of dogs near Doncaster had gone
> down with a similar condition that sounded very similar to BSE. The
animals
> were roughly the same age, and had been fed collectively by the owner.
The
> other main possibility was that the condition was due to a poisoning
element
> present in the food. A second group was in contact in around 1995 in
which
> the animals were considered to have been poisoned with heavy metals but no
> proof (or even investigation) seems to have taken place. This
determination
> by MAFF not to carry out any studies of inoculating BSE into dogs was
indeed
> strange at the time. The reason for this being so odd is that dogs are
> commonly available for experimental animals and it would be looked on as
> being a low cost experiment. However politically it is always extremely
bad
> to do experiments with loveable domestic dogs by inoculating them with a
> disease that could, to some degree be blamed on the incompitence of the
> government of the time.
>
>
>
> --------------------------------------------------------------------------
--
> ----
>
>
>
http://priondata.org/data/A_deerdog.html?PHPSESSID=33882364997e69974b09aba35
> 639be19
>
>
> Updated: 05 August 2004
> Contact: Stephen M. Apatow
> Director of Research & Development
> Humanitarian Resource Institute Legal Resource Center
> Biodefense Reference Library
> Eastern USA: (203) 668-0282 Western USA: (775) 884-4680
> Internet: http://www.humanitarian.net/law/biodefense
> Email: [email protected]
>
> Transmissible Spongiform Encephalopathies in North America
>
> Veterinarians question Transmissible Spongiform Encephalopathies (TSE) and
> infected feed as a link to CDS (Cognitive Disorder, Alzheimer's), the most
> common degenerative neurological disease in dogs and cats in the U.S.
>
> http://www.humanitarian.net/law/biodefense/bse_12004.html
>
>
>
>
>
> 2005
>
>
> DEFRA
> Department for Environment,
> Food & Rural Affairs
>
> Area 307, London, SW1P 4PQ
> Telephone: 0207 904 6000
> Direct line: 0207 904 6287
> E-mail: h.mcdonagh.defra.gsi.gov.uk
>
> GTN:
> FAX:
>
> Mr T S Singeltary
> P.O. Box 42
> Bacliff
> Texas
> USA 77518
>
> 21 November 2001
>
> Dear Mr Singeltary TSE IN HOUNDS
>
> Thank you for e-mail regarding the hounds survey. I am sorry for the long
> delay in responding.
>
> As you note, the hound survey remains unpublished. However the Spongiform
> Encephalopathy Advisory Committee (SEAC), the UK Government's independent
> Advisory Committee on all aspects related to BSE-like disease, gave the
> hound study detailed consideration at their meeting in January 1994. As a
> summary of this meeting published in the BSE inquiry noted, the Committee
> were clearly concerned about the work that had been carried out,
concluding
> that there had clearly been problems with it, particularly the control on
> the histology, and that it was more or less inconclusive. However was
agreed
> that there should be a re-evaluation of the pathological material in the
> study.
>
> Later, at their meeting in June 95, The Committee re-evaluated the hound
> study to see if any useful results could be gained from it. The Chairman
> concluded that there were varying opinions within the Committee on further
> work. It did not suggest any further transmission studies and thought that
> the lack of clinical data was a major weakness.
>
> Overall, it is clear that SEAC had major concerns about the survey as
> conducted. As a result it is likely that the authors felt that it would
not
> stand up to r~eer review and hence it was never published. As noted above,
> and in the detailed minutes of the SEAC meeting in June 95, SEAC
considered
> whether additional work should be performed to examine dogs for evidence
of
> TSE infection. Although the Committee had mixed views about the merits of
> conducting further work, the Chairman noted that when the Southwood
> Committee made their recommendation to complete an assessment of possible
> spongiform disease in dogs, no TSEs had been identified in other species
and
> hence dogs were perceived as a high risk population and worthy of study.
> However subsequent to the original recommendation, made in 1990, a number
of
> other species had been identified with TSE ( e.g. cats) so a study in
hounds
> was less
>
>
>
> critical. For more details see-
> http://www.bseinquiry, gov.uk/files/yb/1995/06/21005001 .pdf
>
> As this study remains unpublished, my understanding is that the ownership
of
> the data essentially remains with the original researchers. Thus
> unfortunately, I am unable to help with your request to supply information
> on the hound survey directly. My only suggestion is that you contact one
of
> the researchers originally involved in the project, such as Gerald Wells.
He
> can be contacted at the following address.
>
> Dr Gerald Wells, Veterinary Laboratories Agency, New Haw, Addlestone,
> Surrey, KT 15 3NB, UK
>
> You may also wish to be aware that since November 1994 all suspected cases
> of spongiform encephalopathy in animals and poultry were made notifiable.
> Hence since that date there has been a requirement for vets to report any
> suspect SE in dogs for further investigation. To date there has never been
> positive identification of a TSE in a dog.
>
> I hope this is helpful
>
> Yours sincerely 4
>
> HUGH MCDONAGH
> BSE CORRESPONDENCE SECTION
>
>
>
> ===========================TSS PERSONAL COMMUNICATION
>
>
>
> Recycled pets and potential for TSE amplification
> Assuming that a tiny fraction of cats with BSE-FSE ever get diagnosed as
> such (vestibular disorder more likely, no diagnosis at all likliest),
there
> would be a potential for re-cycling the disease should these infected cats
> be non-discriminately rendered for pet food:
> From Summer 1996 Earth Island Journal v11, #3 pg 27-31:
>
> "The rendering plant floor is piled high with raw product. Thousands of
dead
> dogs and cats; head and hooves from cattle, sheep, pigs and horses; whole
> skunks; rats and raccoons -- all waiting to be processed. In the 90-degree
> heat, the piles of dead animals seem to have a life of their own as
millions
> of maggots swarm over the carcassess."
> "Rendering plants process decomposing animal carcasses, large roadkill and
> euthanized dogs and cats into a dry protein product that is sold in the
pet
> food industry. One small plant in Quebec renders 22,000 pounds of dogs and
> cats per week... The fur is not removed and dead animals are cooked
together
> with viscera, bones and fat at 115 C for 20 minutes."
>
> "Each year in the US, 286 rendering plants quietly dispose of more than
> 12,500,000 tons of dead animals, fat and meat wasts. ... Baltimore's
Valley
> Proteins "hogger" vat contained an eclectic mix of body parts ranging from
> dead dogs, cats, raccoons, possums, deer, foxes, snakes, a baby circus
> elephant, and a police quarterhorse.... In an average year, Baltimore's
> pound hands over 21,888 dead animals to Valley Proteins [which] sells
> inedible animal parts and rendered material to Alpo, Heinz, and
> Ralston-Purina [US pet food manufactureres]"
>
> "Valley Protein maintains two production lines -- one for clean meat and
> bons and a second line for dead pets and wildlife. However, VP President
> Smith reported, that the [final] protein material is a mix from both
> production lines. Thus the meat and bone meal made at the plant includes
> materials from pets and wildlife, and are about five percent of that
product
> goes to dry-pet-food manufacturers."
>
>
>
> --------------------------------------------------------------------------
--
> ----
>
> Valley Protein responds
> Gerald F. Smith, Jr., President of Valley Proteins, Inc. responds to your
> Wednesday, October 23, 1996 transmission at 10:45 a.m. as follows:
>
> "I was misquoted in the article you referenced. Our plant in Baltimore, MD
> does indeed process dead domestic house pets which have been euthanized by
> veterinarians, animal control officials, humane societies and other animal
> protection organizations. This represents less than one-half of 1% of our
> Baltimore plant's business on an annual basis. Valley Proteins has a total
> of nine rendering plants in five states. Except for one pet food producer
> which purchased approximately 10 tons from our Baltimore plant on three
> different occasions during the last 12 months, we only sell animal
proteins
> to pet food manufacturers from our facilities which are capable of
recycling
> poultry by-products from poultry slaughter facilities. This pet food
> producer purchased less than one -half of 1% of our total Baltimore Meat
> Meal production. Therefore, during the last 12 months approximately 300
> pounds of our animal protein containing by-products from dead domestic
house
> pets entered the pet food market."
>
> --------------------------------------------------------------------------
--
> ----
>
> Listserve commentary 10.31.96
> Since the renderer (Valley Proteins) mentioned is in the U.S., presumably
> the meat and bone meal so generated (if the story is true) must be used in
> pet food in a manner consistent with FDA and USDA regulations.
> First of all, the pet food made must specifically reference the species
name
> on the label. E.g., "chicken byproducts", etc. I personally have never
seen
> "opossum byproducts" or "raccoon meat" or "cat byproducts" listed on ANY
> petfood I have ever seen.
>
> Secondly, any diseased tissue is inelgible for use in petfood.
>
> IF the story described is true, then most likely any recycled
pets/roadkill
> would be used in fertilizer meat and bone meal. While this might the
direct
> closed-loop feedback suggested.
>
> --------------- The label on Hill's Feline Senior Science Diet includes
> among the more specific ingredients, "animal fat (preserved with BHA,
propyl
> gallate and citric acid)" and "natural flavor".
>
>
> --------------------------------------------------------------------------
--
> ----
>
> Cats and BSE: the body count
> 1994: 16 1995: 8 1996: 6 so far
>
> The first FSE case was reported already in 1990
> (Wyatt et al (1990) Vet.Rec. 126, 513).
>
> Wyatt and coworkers reported 5 more cases in 1991 (Vet Rec.129,233) and
> sometime during 1992 the number of confirmed cases had reached 24.
>
> "Since the first report <..> a further 23 cases have been confirmed
> histologically (J.W. Wilesmith, personal communication).."
> (quote from Journal of small animal practise (1992),33,10,471)
>
> This leaves only a plausible discrepancy (of 28 cases) --
> for further cases confirmed in 1992 and cases from 1993.
>
> Maybe the single case reported from Norway is included in
> the total count mentioned in Devins' article in THE INDEPENDENT?
>
> Total count 72 diagnosed FSE cases can't be far off.
> This leaves only a plausible discrepancy (of 28 cases) --
> for further cases confirmed in 1992 and cases from 1993.
>
> --------------------------------------------------------------------------
--
> ----
> BSE in muscle and blood: see the article of I.H.Pattison and G.C.Millson,
> Distribution of the scrapie agent in the Tissue of experimentally
inoculated
> goats, Journal of Comparative Pathology and Therapeutics 1962; 72: 233-44.
> It demonstrated the scrapie agent in blood and muscle.
> D.H.Adams and W.M.Edgar described the transfer of scrapie with gingival in
> "Transmission of agent of Creutzfeldt-Jakob disease, British Medical
Journal
> 1978; 1(6118): 987".
>
>
>
> http://www.mad-cow.org/~tom/cats_bse_rend.html
>
>
>
>
> Information - [17.07.2001]
> Spongiform Encephalopathy in a Cat
> A 6-year-old cat from the canton Vaud was confirmed to have a so-called
> feline spongiform encephalopathy (FSE). FSE belongs to the group of
> transmissible spongiform encephalopathies similar to BSE. This is the
first
> case of FSE reported in Switzerland. Though the cause of the infection is
> unknown it is very likely that the cat was fed infectious food many years
> ago. Humans are not exposed to any danger by FSE.
> The cat born in 1995 was put to sleep due to strong disorders in the
central
> nervous system. The diagnosis was made by the Swiss Reference Center for
> Spongiform Encephalopathies of Animals at the Animal Neurology Institute
of
> the University Bern.
>
> FSE was first recognized in a cat in Great Britain in 1990. Up until today
> about 90 cases have been confirmed in domestic cats there. One case was
also
> reported in 1995 in Norway - so far a BSE-free country - and another as
well
> in the Principality of Liechtenstein in 1996. Further incidents have
> occurred in exotic wild cats (puma, ocelot, cheetah, lion, tiger) kept in
> zoos. Those animals had been fed raw slaughtered carcass scraps. According
> to the current knowledge the FSE agent is very much similar to the one of
> BSE. The average incubation period (the interval between the time of
> infection and time of emergence of the disease symptoms) of about 5 years
is
> also comparable to the BSE in cattle. Though FSE is one of the
transmissible
> infectious diseases, cats infected with FSE do not cause humans any danger
> because the infection takes place only through the food chain. A similar
> disease has never been observed in dogs and its kind yet.
>
> As the cause of the infection the feeding of raw or insufficiently heated
> brain- or spinal cord materials is considered in this case as well. It is
> most likely that the infection took place many years ago.
>
> The so-called risk materials (brain, spinal cord of cows) as well as
> carcasses of died or killed domestic animals and livestock have to be
> incinerated in Switzerland since 1996. The same regulations for feed
> produced in Switzerland apply to imported feed. Imported feed may not be
> made of animal body parts or risk materials.
>
> Bern, July 17, 2001
>
> The Federal Veterinary Office
> Communication
>
>
> Information
>
> Lukas Perler
> Implementation support
> ++41 31 322 01 56
> © Swiss Federal Veterinary Office (SFVO) 11.11.2004
>
>
http://www.bvet.admin.ch/news/mitteilungen/00040/index.html?lang=en&PHPSESSI
> D=33911231e291c5abfa483ea99b5b8900
>
>
>
> While pet food manufacturing may involve the application of heat to raw
> materials, pet food manufacturing operations are not generally considered
as
> rendering, unless the purpose of the process is to produce product that
> contains a stable protein ingredient. Cooking is not necessarily
synonymous
> with rendering. As such, collectors or firms distributing animal waste
> materials directly to pet food manufacturers should not seek to avoid the
> requirements of 21 CFR §589.2000(d) by claiming that the pet food
> manufacture destination solely consists of rendering operations.
>
>
>
>
>
> http://www.fda.gov/cvm/Documents/InspectPriorities
>
>
>
>
>
>
>
> http://www.fda.gov/cvm/Documents/7371-009.doc#AttachRegd
>
>
>
>
>
> 63. Is dog food that contains prohibited mammalian protein required to
carry
> cautionary statements at the retail level?
>
> Geyer:
>
> No.
>
> 64. Do stores that sell dog food have to maintain customer purchase
records?
>
> Geyer:
>
> No.
>
>
>
> snip...
>
>
>
> Questions concerning BSE not asked during the June 24 Satellite
> Teleconference
>
> The following questions were sent in during the BSE satellite
> teleconference, but were not answered during the broadcast. The source of
> the following answers is CVM.
>
> 1. Comment on use in cattle feed of waste from extrusion plants that make
> dog food.
>
> Answer:
>
> Cattle producers need to exercise caution in using such waste. If
prohibited
> material has been used in the production of the dog food, then the waste
> "may contain" prohibited material that cannot be fed to cattle. The pet
food
> manufacturer has a responsibility of labeling the waste material as
> prohibited material if the waste contains or may contain such material.
> However, the cattle producer also needs to take the initiative to be
assured
> that the product does not contain prohibited material by reviewing the
label
> or other information from the supplier. As a practical matter, it may be
> difficult to obtain the needed assurance unless the manufacturer does not
> use any prohibited material in the processing plant.
>
> 2. Are grocery stores required to know the name and address of each
> purchaser of pet food?
>
> Answer:
>
> FDA is not requiring grocery stores to keep the names and addresses of
each
> purchaser of pet foods. Pet food offered for sale and sold as pet food,
such
> as through the grocery store, ordinarily enters the home and is not likely
> to be available to be mistakenly fed to ruminant animals.
>
>
>
> http://www.fda.gov/cvm/bsetrans.htm
>
>
>
> TSS
>
>
>
> ----- Original Message -----
> From: "Terry S. Singeltary Sr." <[email protected]>
> To: <[email protected]>
> Sent: Tuesday, December 20, 2005 10:17 AM
> Subject: AFIA finalizes comments to FDA on proposed BSE feed rule AFIA
still
> insists on spreading more BSE
>
>
> ##################### Bovine Spongiform Encephalopathy
> #####################
>
> AFIA finalizes comments to FDA on proposed BSE feed rule
>
> (World-Grain.com, December 19, 2005)
>


snip...end...TSS
 
Top