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From: TSS ()
Subject: AFIA finalizes comments to FDA on proposed BSE feed rule AFIA still insists on spreading more BSE
Date: December 20, 2005 at 7:56 am PST


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 gan@affrc.go.jp

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; kitamoto@mail.tains.tohoku.ac.jp
Symposium Secretariat
Kyomi Sasaki
TEL +81-22-717-8233 FAX +81-22-717-7656
e-mail: kvomi-sasaki@mail.tains.tohoku.ac.ip


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. [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

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




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