Docket No. FDA2002N0031 (formerly Docket No. 2002N0273)

Thursday, April 09, 2009



Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed

[email protected].

Greetings FDA et al,

I kindly wish to comment on the following ;

[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46

[Federal Register: April 9, 2009 (Volume 74, Number 67)] [Proposed Rules] [Page 16160-16161] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ap09-18]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46

Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed delay of effective date.


http://edocket.access.gpo.gov/2009/E9-8127.htm



MY COMMENT AS FOLLOWS ;

I find it deeply disturbing, that with the science to date, especially with the science to date, transmission studies, the more virulent atypical strains of the BSE i.e. h-BSE and l-BSE, both of which have now been documented in North America, that we are even still discussing this most important topic. The industry involved has beat this mad cow feed ban to death, and still refuse to comply. IF they would have adhered to policy, rules and regulations put forth August 4th, 1997, when the partial, and voluntary ruminant to ruminant feed ban was first put in place, they would not still be crying the same tune. WE need not only to enforce the present ban, but strengthen it, especially to include blood in the ban. WE (the consumer), was promised this would happen years ago. For Pete's sake, this will be the third president to have to address these same questions, and I pray that this one has the guts to finally do something. We need NOT discuss this for one more second. We had 8 years that President Bush literally covered up mad cow disease, and let literally millions and millions of pounds of mad cow feed into commerce to be fed out. IN one feed ban recall alone in 2007, 10 MILLION PLUS POUNDS was fed out into commerce. and under this same President, we now millions of kids across our Nation that have been needlessly exposed to the mad cow agent via the infamous USDA CERTIFIED DOWNER COW DEAD STOCK SCHOOL LUNCH PROGRAM. if you think for one moment that the largest meat recall in the history of the USA was because a few animals were filmed being abused, your only kidding yourself. that meat was recalled because dead stock downer cows are at the highest risk to carry mad cow disease, and they had been feeding our children this stuff for years. AND then had the nerve to lie to us about THE GREAT BSE FIREWALL IN THE USA THAT WOULD PROTECT THE CONSUMER I.E. THE BSE FEED BAN, that never was nothing more than ink on paper. who will monitor these children in the years and decades to come for a human form of Transmissible Spongiform Encephalopathy? who can with a CJD/TSE surveillance system and CJD Questionnaire set up the way it is now? you can't.


ENOUGH already $ NO MORE DISCUSSION PLEASE, WE NEED ACTION !


I strenuously urge President Obama to NOT discuss this for one more moment, actions must be put forth now, and enforce such actions.

I strenuously urge President Obama to ENHANCE the feed ban to include blood, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban the use of "poultry litter" and the use of all mammalian and poultry protein in ruminant feed,as a feed ingredient for ruminant animals, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban the use of "plate waste" as a feed ingredient for ruminants, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban from human food (including dietary supplements please see latest May 2009 CDC warning on these type supplements, CWD, and Elk Antler Velvet), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates, and enforce such actions, based on sound science.

I strenuously urge President Obama to further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination, and enforce said regulations, based on sound science.


LET's take a look back at past promises and discussions on this issue, and then for a breath of fresh air, let's look at some sound science, and why no further discussion is warranted, and why action is needed ASAP ;



snip...full text here ;


Thursday, April 9, 2009


Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed




http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html




TSS

old Bullard really cracks me up. he is either as corrupt as the day is long, or just plain stupid. Bullard and r-calf et al, should stop worrying about Canada, and worry about their own back yard. stop covering up mad cow disease and using the SSS policy. if they would have taken care of business back in 1997, we would not be discussing this. Until a BSE Inquiry is addressed here in the USA against the USDA/FDA et al, and a true enhanced BSE Surveillance and testing program be put forth, we still will never no how many mad cows the USA really have $$$ the last enhanced BSE surveillance program was put forth, even the top prion Scientist said it was terribly flawed, and still is.

i said it a long time ago, ALL CATTLE FOR HUMAN AND ANIMAL CONSUMPTION SHOULD BE TESTED FOR 5 YEARS IN A ROW, before we know to a true extent, just what kind of problem we have. and all the rules and regulations on the mad cow feed ban will not work, unless they are strongly enforced, with severe ramifications when the rules are broke. stupidity is not acceptable anymore. ...


terry




4/10/2009 10:11:00 AM

R-CALF: Producers, Consumers Urged To Do What's Right To Protect Against BSE

Washington, D.C. – In a highly unusual move, the U.S. Food and Drug Administration (FDA) on Thursday published in the Federal Register a last-minute notice regarding the agency's intent to postpone its April 27, 2009, implementation of the final rule (published one year ago) that would enhance the U.S. feed ban to better protect against the spread of bovine spongiform encephalopathy (BSE, or mad cow disease). The FDA is providing the public with only seven days – through April 16, 2009 – to submit comments on whether the enhanced feed ban should be delayed for 60 days.

The U.S. Department of Agriculture (USDA) increased the risk of BSE in the United States by allowing into the U.S. millions of Canadian cattle, particularly Canadian cattle over 30 months (OTM) of age, which are of higher-risk for the disease. USDA states that the prevalence of BSE in the Canadian cattle herd is between three cases per million to eight cases per million cattle. The U.S. Centers for Disease Control and Prevention (CDC) states that the level of BSE prevalence in the Canadian cattle herd is up to 48-fold higher than the prevalence estimated in the U.S. cattle herd.

Just in 2008, nearly 1.6 million Canadian cattle, including OTM cattle, were imported into the United States. A recent USDA risk assessment model that incorporated a BSE prevalence rate for Canada of fewer than four cases per million head of cattle predicted the U.S. would import more than 100 BSE-infected cattle from Canada over the next 20 years.

The current U.S. feed ban, implemented in 1997, is actually weaker than Canada's initial feed ban because it does not ban the feeding of plate waste and poultry litter to cattle. Canada's feed ban has proved ineffective in controlling the spread of BSE in Canadian cattle, and after Canada began detecting multiple cases of BSE in animals born years after the feed ban, it relented to the repeated urging of international scientists and then enhanced its feed ban. Canada's enhanced feed ban, implemented in July 2007, now protects Canadian consumers against the spread of BSE from Canadian cattle by closing known transmission routes, including cross-contamination and inadvertent feeding of contaminated cattle parts. The FDA now plans to delay providing U.S. consumers with the same level of protection afforded Canadian consumers against these same Canadian cattle that are now being imported into the United States.

"This last-minute proposal to postpone the new FDA feed ban, needed to minimize the heighted BSE risk from Canadian cattle, is designed to position the U.S. cattle industry between a rock and a hard place, and we hope that U.S. producers and U.S. consumers will see through this manipulative tactic and force USDA and the FDA to do what's right," said R-CALF USA CEO Bill Bullard.

The fact is that USDA has purposely exposed U.S. consumers and the U.S. cattle herd to an unacceptable risk of BSE by allowing Canada's OTM cattle to freely enter the U.S. food supply, feed supply and cattle herd. USDA should not have allowed these higher-risk cattle into the U.S. until after it determined whether it was feasible to assume the additional costs necessary to mitigate this increased risk – the cost of upgrading the FDA feed ban.

"Like the original Canadian feed ban, the current U.S. feed ban is insufficient to address the heightened BSE risk in Canadian cattle," Bullard emphasized. "Either USDA must immediately eliminate the source of this heightened BSE risk by prohibiting the importation of OTM Canadian cattle, or FDA must immediately implement the 2008 BSE final rule to mitigate this heightened risk. There are no responsible alternatives."

R-CALF USA encourages U.S. consumers and U.S. cattle producers to submit comments on the FDA's proposal before midnight Eastern, April 16, 2009. For information on how to submit a public comment and to see a sample comment letter, go to www.r-calfusa.com and click on "Food Safety."

http://www.cattlenetwork.com/Content.asp?ContentID=305985

BSE MRR TSS, R-CALF ON CANADA VS USA

Bill Rancher

Joined: 10 Feb 2005 Posts: 1418 Location: GWN Posted: Fri Jan 05, 2007 9:49 am Post subject:

Texan wrote:

Hey Terry, I'd like to get a little further clarification on something if/when you have time. I'm not sure if I'm reading you correctly....

flounder wrote:

This is what sank my battleship in regards to testifying for r-calf. they actually appoached me about it, but i told them i would be glad to testify, but i was not stopping at the Canadian border, my testimony was to come south as well if given the opportunity. and that ended that, but i did supply them with a load of data, for whatever that was worth.

I highlighted the parts that confuse me. This almost makes it seem as if R-CALF was asking you to testify for them, but changed their mind when they found out that you were going to tell the WHOLE truth, instead of just the truth as regards Canadian imports.

I thought that R-CALF was only interested in the WHOLE truth - not just the selected parts of the truth that fit their protectionist agenda? After reading your post, it makes a person wonder. Maybe I read it wrong...

Am I reading this correctly, Terry? That can't be right, can it? Thanks.

I was wondering exactly the same thing Texan.

_________________

Canadian Beef....A cut above the rest!

my answer to big muddy from canada ;

hello there Texan,

yep, you read it right. don't know what ya'll gonna do without me. you know i plan on retiring from this mess soon. the pay is simply too excessive ;-( i fed them all i had at the time, and they shot the teacher. then hired old stanley i heard, go figure, must have been all those PhDs i had ;-)

as with the fuji-tv, when they came here and interviewed me for a BSE show, that i don't know what happened too, or the madcowboy documentary i was asked to proofread, and did, assured i would get some credit for, to never hear from again, to the speech in south Korea i was to make Nov. 23, but was shipwrecked somehow there too, and that might have been a good thing considering all the riots, and they did get the information anyway, to the TSS documentary, that too fell apart for good reasons i suppose, to helping creekstone, and finally to the NIH attempted destruction of an historical bank of donated tissue from CJD victims, and that one i think i did manage to stop, and that thanks to a Republican John Cornyn, i simply think it's time to let you fellars and gals clear this mess up. i have wasted enough time. it will be a decade next Christmas. i just would hate to keep kicking the same old mad cow. i know what happened for the most part, and the ones that don't get it now, never will.

now there Texan, as far as your question, and confusion ;-) i bet you thought i was not going to answer it, or, maybe hoping i would ;

flounder wrote:

This is what sank my battleship in regards to testifying for r-calf. they actually appoached me about it, but i told them i would be glad to testify, but i was not stopping at the Canadian border, my testimony was to come south as well if given the opportunity. and that ended that, but i did supply them with a load of data, for whatever that was worth.

I highlighted the parts that confuse me. This almost makes it seem as if R-CALF was asking you to testify for them, but changed their mind when they found out that you were going to tell the WHOLE truth, instead of just the truth as regards Canadian imports.

I thought that R-CALF was only interested in the WHOLE truth - not just the selected parts of the truth that fit their protectionist agenda? After reading your post, it makes a person wonder. Maybe I read it wrong...

Am I reading this correctly, Terry? That can't be right, can it? Thanks.

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

hello again there Texan,

i don't guess it matters anymore, i don't think ill be testifying for anyone, unless it is my own execution.

i was willing to participate in good faith, and sound science, that is why i think i was never sent to testify,

because in my opinion, R-Calf only wanted to cherry-pick the science, to use to there advantage, to try and

claim that Canada had a worse BSE problem than the USA, and i could not conceed to that. the science did

not confirm this. all one has to do is read the BSE GBR risk assessments, and that is why GW/OIE et al revised

there own risk assessments ;-) the BSE MRR policy.

i don't know, maybe i misinterpreted it all, maybe not, you can be the judge ;

oh what tangled webs we weave, when all we do is practice to deceive. ...TSS

SNIP...END... SEE FULL TEXT ;


*** http://ranchers.net/forum/viewtopic.php?t=15704&postdays=0&postorder=asc&start=12


http://ranchers.net/forum/viewtopic.php?t=15704&postdays=0&postorder=asc&start=24


http://ranchers.net/forum/viewtopic.php?t=15704&postdays=0&postorder=asc&start=36


http://ranchers.net/forum/viewtopic.php?t=15704&postdays=0&postorder=asc&start=48


THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ;

CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006

The U.S. Department of Agriculture was quick to assure the public earlier this week that the third case of mad cow disease did not pose a risk to them, but what federal officials have not acknowledged is that this latest case indicates the deadly disease has been circulating in U.S. herds for at least a decade.

The second case, which was detected last year in a Texas cow and which USDA officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a picture of the disease having been here for 10 years or so, since it is thought that cows usually contract the disease from contaminated feed they consume as calves. The concern is that humans can contract a fatal, incurable, brain-wasting illness from consuming beef products contaminated with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of other undetected cases," Dr. Paul Brown, former medical director of the National Institutes of Health's Laboratory for Central Nervous System Studies and an expert on mad cow-like diseases, told United Press International. "The question was, 'How many?' and we still can't answer that."

Brown, who is preparing a scientific paper based on the latest two mad cow cases to estimate the maximum number of infected cows that occurred in the United States, said he has "absolutely no confidence in USDA tests before one year ago" because of the agency's reluctance to retest the Texas cow that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end

http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r

CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...

Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central Nervous System ...

Address for correspondence: Paul Brown, Building 36, Room 4A-05, ...

http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm

O.I.E. .......... ??? GOD HELP US!

sample survey via oie for bse is about 400 test via 100 million cattle, if i am not mistaken. MOST countries that went

by these OIE guidelines all eventually went down with BSE. ...TSS

http://www.oie.int/downld/SC/2005/bse_2005.pdf

THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.

AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country

makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they

should do everyone a favor and dissolve there organization. ...

Page 95 of 98

8/3/2006


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3412&disposition=attachment&contentType=crtext


Thursday, April 09, 2009

Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed

[email protected].

Greetings FDA et al,

I kindly wish to comment on the following ;

[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46

[Federal Register: April 9, 2009 (Volume 74, Number 67)] [Proposed Rules] [Page 16160-16161] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ap09-18]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46

Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed delay of effective date.

http://edocket.access.gpo.gov/2009/E9-8127.htm

MY COMMENT AS FOLLOWS ;

I find it deeply disturbing, that with the science to date, especially with the science to date, transmission studies, the more virulent atypical strains of the BSE i.e. h-BSE and l-BSE, both of which have now been documented in North America, that we are even still discussing this most important topic. The industry involved has beat this mad cow feed ban to death, and still refuse to comply. IF they would have adhered to policy, rules and regulations put forth August 4th, 1997, when the partial, and voluntary ruminant to ruminant feed ban was first put in place, they would not still be crying the same tune. WE need not only to enforce the present ban, but strengthen it, especially to include blood in the ban. WE (the consumer), was promised this would happen years ago. For Pete's sake, this will be the third president to have to address these same questions, and I pray that this one has the guts to finally do something. We need NOT discuss this for one more second. We had 8 years that President Bush literally covered up mad cow disease, and let literally millions and millions of pounds of mad cow feed into commerce to be fed out. IN one feed ban recall alone in 2007, 10 MILLION PLUS POUNDS was fed out into commerce. and under this same President, we now millions of kids across our Nation that have been needlessly exposed to the mad cow agent via the infamous USDA CERTIFIED DOWNER COW DEAD STOCK SCHOOL LUNCH PROGRAM. if you think for one moment that the largest meat recall in the history of the USA was because a few animals were filmed being abused, your only kidding yourself. that meat was recalled because dead stock downer cows are at the highest risk to carry mad cow disease, and they had been feeding our children this stuff for years. AND then had the nerve to lie to us about THE GREAT BSE FIREWALL IN THE USA THAT WOULD PROTECT THE CONSUMER I.E. THE BSE FEED BAN, that never was nothing more than ink on paper. who will monitor these children in the years and decades to come for a human form of Transmissible Spongiform Encephalopathy? who can with a CJD/TSE surveillance system and CJD Questionnaire set up the way it is now? you can't.

ENOUGH already $ NO MORE DISCUSSION PLEASE, WE NEED ACTION !

I strenuously urge President Obama to NOT discuss this for one more moment, actions must be put forth now, and enforce such actions.

I strenuously urge President Obama to ENHANCE the feed ban to include blood, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban the use of "poultry litter" and the use of all mammalian and poultry protein in ruminant feed,as a feed ingredient for ruminant animals, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban the use of "plate waste" as a feed ingredient for ruminants, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban from human food (including dietary supplements please see latest May 2009 CDC warning on these type supplements, CWD, and Elk Antler Velvet), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates, and enforce such actions, based on sound science.

I strenuously urge President Obama to further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination, and enforce said regulations, based on sound science.

LET's take a look back at past promises and discussions on this issue, and then for a breath of fresh air, let's look at some sound science, and why no further discussion is warranted, and why action is needed ASAP ;

see full text ;

Thursday, April 9, 2009

Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed


http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html


TSS

r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada



Greetings cjdvoice,

don't be fooled cjdvoice. r-calf jumped on the mad cow band wagon only after a federal judge ordered a temporary halt to the shipment of bone-in cuts of meat to the United States. the mad cow was out of the barn in North America, they knew it, and jumped on that to better surve themselves to block Canadian beef. it had nothing to do with consumer safety, and it had everything to do with r-calf closing the Canadian border so USA cattle ranchers would have a closed market here. it's all about money$ r-calf whines about Canada and it's feed ban, and it's mad cows, while the USA has been covering up mad cow disease, this is fact. it took the OIG and an act of congress to finally document that Texas mad cow. this beside the one they did succeed in covering up in Texas. then you had 9,200 suspect mad cows that were ONLY TESTED with the least likely test to detect mad cow disease.

USDA: In 9,200 cases only one type of test could be used

WASHINGTON (AP)--The U.S. Department of Agriculture acknowledged Aug. 17 that its testing options for bovine spongiform encephalopathy were limited in 9,200 cases despite its effort to expand surveillance throughout the U.S. herd.

In those cases, only one type of test was used--one that failed to detect the disease in an infected Texas cow.

The department posted the information on its website because of an inquiry from The Associated Press.

Conducted over the past 14 months, the tests have not been included in the department's running tally of BSE tests since last summer. That total reached 439,126 on Aug. 17.

"There's no secret program," the department's chief veterinarian, John Clifford, said in an interview. "There has been no hiding, I can assure you of that."

Officials intended to report the tests later in an annual report, Clifford said.

These 9,200 cases were different because brain tissue samples were preserved with formalin, which makes them suitable for only one type of test--immunohistochemistry, or IHC.

In the Texas case, officials had declared the cow free of disease in November after an IHC test came back negative. The department's inspector general ordered an additional kind of test, which confirmed the animal was infected.

Veterinarians in remote locations have used the preservative on tissue to keep it from degrading on its way to the department's laboratory in Ames, Iowa. Officials this year asked veterinarians to stop using preservative and send fresh or chilled samples within 48 hours.

The department recently investigated a possible case of BSE that turned up in a preserved sample. Further testing ruled out the disease two weeks ago.

Scientists used two additional tests--rapid screening and Western blot--to help detect BSE in the country's second confirmed case, in a Texas cow in June. They used IHC and Western blot to confirm the first case, in a Washington state cow in December 2003.

"The IHC test is still an excellent test," Clifford said. "These are not simple tests, either."

Clifford pointed out that scientists reran the IHC several times and got conflicting results. That happened, too, with the Western blot test. Both tests are accepted by international animal health officials.

Date: 8/25/05

http://www.hpj.com/archives/2005/aug05/aug29/BSEtestoptionswerelimited.cfm

""These 9,200 cases were different because brain tissue samples were preserved with formalin, which makes them suitable for only one type of test--immunohistochemistry, or IHC."

THIS WAS DONE FOR A REASON!

THE IHC test has been proven to be the LEAST LIKELY to detect BSE/TSE in the bovine, and these were probably from the most high risk cattle pool, the ones the USDA et al, SHOULD have been testing. ...TSS

USDA 2003

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

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

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

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

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

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

snip...

FULL TEXT;

Completely Edited Version PRION ROUNDTABLE

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

2005

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

CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006

The U.S. Department of Agriculture was quick to assure the public earlier this week that the third case of mad cow disease did not pose a risk to them, but what federal officials have not acknowledged is that this latest case indicates the deadly disease has been circulating in U.S. herds for at least a decade.

The second case, which was detected last year in a Texas cow and which USDA officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a picture of the disease having been here for 10 years or so, since it is thought that cows usually contract the disease from contaminated feed they consume as calves. The concern is that humans can contract a fatal, incurable, brain-wasting illness from consuming beef products contaminated with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of other undetected cases," Dr. Paul Brown, former medical director of the National Institutes of Health's Laboratory for Central Nervous System Studies and an expert on mad cow-like diseases, told United Press International. "The question was, 'How many?' and we still can't answer that."

Brown, who is preparing a scientific paper based on the latest two mad cow cases to estimate the maximum number of infected cows that occurred in the United States, said he has "absolutely no confidence in USDA tests before one year ago" because of the agency's reluctance to retest the Texas cow that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end

http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r

CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ... Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central Nervous System ... Address for correspondence: Paul Brown, Building 36, Room 4A-05, ...

http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm

In this context, a word is in order about the US testing program. After the discovery of the first (imported) cow in 2003, the magnitude of testing was much increased, reaching a level of >400,000 tests in 2005 (Figure 4). Neither of the 2 more recently indigenously infected older animals with nonspecific clinical features would have been detected without such testing, and neither would have been identified as atypical without confirmatory Western blots. Despite these facts, surveillance has now been decimated to 40,000 annual tests (USDA news release no. 0255.06, July 20, 2006) and invites the accusation that the United States will never know the true status of its involvement with BSE.

In short, a great deal of further work will need to be done before the phenotypic features and prevalence of atypical BSE are understood. More than a single strain may have been present from the beginning of the epidemic, but this possibility has been overlooked by virtue of the absence of widespread Western blot confirmatory testing of positive screening test results; or these new phenotypes may be found, at least in part, to result from infections at an older age by a typical BSE agent, rather than neonatal infections with new "strains" of BSE. Neither alternative has yet been investigated.

http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm

http://madcowtesting.blogspot.com/2009/02/report-on-testing-ruminants-for-tses-in.html

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

USDA: In 9,200 cases only one type of test could be used

WASHINGTON (AP)--The U.S. Department of Agriculture acknowledged Aug. 17 that its testing options for bovine spongiform encephalopathy were limited in 9,200 cases despite its effort to expand surveillance throughout the U.S. herd.

In those cases, only one type of test was used--one that failed to detect the disease in an infected Texas cow.

The department posted the information on its website because of an inquiry from The Associated Press.

Conducted over the past 14 months, the tests have not been included in the department's running tally of BSE tests since last summer. That total reached 439,126 on Aug. 17.

"There's no secret program," the department's chief veterinarian, John Clifford, said in an interview. "There has been no hiding, I can assure you of that."

Officials intended to report the tests later in an annual report, Clifford said.

These 9,200 cases were different because brain tissue samples were preserved with formalin, which makes them suitable for only one type of test--immunohistochemistry, or IHC.

In the Texas case, officials had declared the cow free of disease in November after an IHC test came back negative. The department's inspector general ordered an additional kind of test, which confirmed the animal was infected.

Veterinarians in remote locations have used the preservative on tissue to keep it from degrading on its way to the department's laboratory in Ames, Iowa. Officials this year asked veterinarians to stop using preservative and send fresh or chilled samples within 48 hours.

The department recently investigated a possible case of BSE that turned up in a preserved sample. Further testing ruled out the disease two weeks ago.

Scientists used two additional tests--rapid screening and Western blot--to help detect BSE in the country's second confirmed case, in a Texas cow in June. They used IHC and Western blot to confirm the first case, in a Washington state cow in December 2003.

"The IHC test is still an excellent test," Clifford said. "These are not simple tests, either."

Clifford pointed out that scientists reran the IHC several times and got conflicting results. That happened, too, with the Western blot test. Both tests are accepted by international animal health officials.

Date: 8/25/05

http://www.hpj.com/archives/2005/aug05/aug29/BSEtestoptionswerelimited.cfm

""These 9,200 cases were different because brain tissue samples were preserved with formalin, which makes them suitable for only one type of test--immunohistochemistry, or IHC."

THIS WAS DONE FOR A REASON!

As for lowering standards, R-CALF has referenced the OIE (World Organization for Animal Health) as the authority on animal health issues. That's fine, as far as it goes. Trouble is, the OIE does not set standards, as R-CALF has claimed. Further, the OIE does not recommend countries ban meat imported - with SRMs removed - from countries with low or high BSE risk, contrary to R-CALF's implication.

In addition, there are no standards recognized for importing meat from minimal- or low-risk BSE countries. The U.S. is trying to set standards as precedent for trade, based on nearly 20 years of science. R-CALF wants trade only with countries who have never had a BSE case. They have not explained how many years they want the rest of the world to sit around and wait until it's okay to trust science and begin trading. Or how they would justify keeping imports out if ever a BSE case was discovered in the U.S. or export again ever.

http://www.mad-cow-facts.com/News-Commentary/r-calf-bullard-4-4-05.htm

JUST ABOUT EVERY COUNTRY THAT WENT BY THOSE FAILED OIE BSE GUIDELINES WENT DOWN WITH BSE. ...TSS

OH, NOT TO FOGET ;

Owner and Corporation Plead Guilty to Defrauding Bovine Spongiform Encephalopathy (BSE) Surveillance Program

An Arizona meat processing company and its owner pled guilty in February 2007 to charges of theft of Government funds, mail fraud, and wire fraud. The owner and his company defrauded the BSE Surveillance Program when they falsified BSE Surveillance Data Collection Forms and then submitted payment requests to USDA for the services. In addition to the targeted sample population (those cattle that were more than 30 months old or had other risk factors for BSE), the owner submitted to USDA, or caused to be submitted, BSE obex (brain stem) samples from healthy USDA-inspected cattle. As a result, the owner fraudulently received approximately $390,000. Sentencing is scheduled for May 2007.

snip...

4 USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half

http://www.usda.gov/oig/webdocs/sarc070619.pdf

AND WHILE R-CALF PREACHES THE MAD COW FEED GOSPEL ABOUT CANADA, WHAT'S R-CALFERS BEEN FEEDING USA HERDS ???


In 2007, in one weekly enforcement report, the fda recalled 10,000,000+ pounds of BANNED MAD COW FEED, 'in commerce', and i can tell you that most of it was fed out ;

10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007

Date: March 21, 2007 at 2:27 pm PST REASON Blood meal used to make cattle feed was recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.

VOLUME OF PRODUCT IN COMMERCE 42,090 lbs. DISTRIBUTION WI

REASON Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.

VOLUME OF PRODUCT IN COMMERCE 9,997,976 lbs. DISTRIBUTION ID and NV

END OF ENFORCEMENT REPORT FOR MARCH 21, 2007

http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html

Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL, TN, AND WV Date: September 6, 2006 at 7:58 am PST

snip...

see listings and references of enormous amounts of banned mad cow protein 'in commerce' in 2006 and 2005 ;

see full text ;

Friday, April 25, 2008 Substances Prohibited From Use in Animal Food or Feed [Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46

http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html

SPECIFIED RISK MATERIALS

http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html

SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS

http://cjdmadcowbaseoct2007.blogspot.com/2008/04/srm-mad-cow-recall-406-thousand-pounds.html

DO YOU SEE A PATTERN YET $$$

R-CALF, consumer groups demand public BSE hearings

The battle between the National Cattlemen's Beef Association and the upstart Rancher's Cattlemen's Action Legal Fund intensified this week as differences over trade issues and consumer safety were brought to a boil. Specifically, R-CALF joined three consumer activist groups in a press conference denouncing the USDA's handling of BSE prevention and detection policies, implying that American consumers are at risk from the disease. The groups joining R-CALF were Public Citizen, Consumer Federation of America and Consumers Union. R-CALF and the consumer groups called on the USDA to "maintain the current ban on Canadian beef and cattle imports until a scientific analysis can be conducted by a balanced panel of experts under the auspices of the Institute of Medicine and the National Academy of Sciences." NCBA president Jan Lyons called R-CALF's actions "shocking," and said "These groups are apparently willing to destroy consumer confidence in our products to achieve their partisan political gains, such as damaging the reputation of the Bush Administration and blocking international trade."

"It is inexcusable for cattle producers to align themselves with consumer activist groups that have for decades tried to destroy the favorability of beef in the American diet. NCBA and its members are committed to building consumer demand for beef and ensuring that our consumers have the safest product in the world for their families," Lyons said. To read more, click here.

INCREDIBLE! Just three weeks ago, R-CALF CEO Bill Bullard rocked the beef industry by saying "USDA was playing fast and loose with the safety and health of U.S. consumers," after a federal judge ordered a temporary halt to the shipment of bone-in cuts of meat to the United States. Now, the organization that claims to represent independent cattle ranchers and feeders saddles up with three anti-beef activist groups to prevent the USDA from continuing trade with Canada. R-CALF has now lost all claim to the "independent" flag they so proudly wave. And this week's actions prove they will use any tactic to further their isolationist , anti-trade policies. -Greg Henderson, Drovers editor-Drovers Alert Thursday, May 27, 2004, Vol. 4, Issue 21

R-CALF USA offers the following proposed framework that will (A) strengthen our resistance to BSE, (B) maintain long-term consumer confidence in our U.S. beef supply, and (C) conform to existing law, without necessitating new legislation. Immediately following our suggested framework is a narrative demonstrating the seriousness of this specific BSE threat as well as identifying the weaknesses associated with both the United States? and Canada?s initial response. Specifically, the narrative following our proposed framework will demonstrate: 1. The World Organization for Animal Health established a seven-year waiting period following a confirmed BSE case in native cattle before a BSE Free status is reinstated. 2. Past experience shows that the finding of only a single case of BSE within a year?s time provides little assurance that the disease is contained. 3. The frequency of BSE outbreaks outside the United Kingdom has increased significantly and BSE has spread to 12 new countries, including Canada, since 2000. 4. The USDA has maintained public confidence in its ability to protect its citizens from BSE by assuring the public that it has prohibited the importation of ruminant animals from countries where BSE is known to exist in native cattle since 1989. 5. The United States does not now have the ability to identify all foreign livestock within the United States or to recall or otherwise segregate foreign meat products should the need arise to do so. 6. The current BSE detection and notification procedures of our trading partners need to be tightened. Our proposed framework recognizes the foregoing facts and weakness in our current system and is designed to bolster our logistical ability to resist BSE.

snip...

Narrative in Support of R-CALF USA?s Proposed Framework R-CALF USA?s proposed framework is a measured response to the following facts, concerns, and questions arising from the single case of BSE discovered in Canada on or before May 20, 2003. The World Organization for Animal Health (OIE) sets international standards for managing the human and animal health risks associated with BSE. The OIE uses seven years as the period in which a country or zone must have no case of BSE in indigenous cattle in order to achieve a BSE Free status, representing the lowest level of risk.9 The OIE defines a zone as a ?clearly defined part of the territory of a country with a distinct animal health statues. The following types of zones are recognized: free zone, infected zone, surveillance zone and buffer zone.?10

snip...

Strengthening the United State?s Resistance to BSE 6 May 30, 2003 Moreover, BSE has been rapidly spreading to new countries since 2000. In 1999 only 12 countries in addition to the U.K. had reported one or more cases of BSE. By end of year 2002, there were 22 countries in addition to the U.K. reporting one or more cases of BSE, representing an 80 percent increase in the geographical distribution of the disease.13 While the United States acted properly to ban the feeding of meat and bone meal to ruminants in 199714, thus ensuring that BSE would not spread within the U.S. cattle herd, the concern remains that BSE could be introduced into the U.S. from imported cattle or beef. The worldwide spread of BSE is not yet contained. Just since 2000, the countries of Austria, Canada, Czech Republic, Denmark, Finland, Greece, Israel, Italy, Japan, Poland, Slovakia, Slovenia, and Spain have all had one or more confirmed cases of BSE originating from native cattle.15

http://www.r-calfusa.com/BSE/2004-06/030530-LetterToCongressBSEPlan.pdf

R-CALF, consumer groups demand public BSE hearings

The battle between the National Cattlemen's Beef Association and the upstart Rancher's Cattlemen's Action Legal Fund intensified this week as differences over trade issues and consumer safety were brought to a boil. Specifically, R-CALF joined three consumer activist groups in a press conference denouncing the USDA's handling of BSE prevention and detection policies, implying that American consumers are at risk from the disease. The groups joining R-CALF were Public Citizen, Consumer Federation of America and Consumers Union. R-CALF and the consumer groups called on the USDA to "maintain the current ban on Canadian beef and cattle imports until a scientific analysis can be conducted by a balanced panel of experts under the auspices of the Institute of Medicine and the National Academy of Sciences." NCBA president Jan Lyons called R-CALF's actions "shocking," and said "These groups are apparently willing to destroy consumer confidence in our products to achieve their partisan political gains, such as damaging the reputation of the Bush Administration and blocking international trade."

"It is inexcusable for cattle producers to align themselves with consumer activist groups that have for decades tried to destroy the favorability of beef in the American diet. NCBA and its members are committed to building consumer demand for beef and ensuring that our consumers have the safest product in the world for their families," Lyons said. To read more, click here.

INCREDIBLE! Just three weeks ago, R-CALF CEO Bill Bullard rocked the beef industry by saying "USDA was playing fast and loose with the safety and health of U.S. consumers," after a federal judge ordered a temporary halt to the shipment of bone-in cuts of meat to the United States. Now, the organization that claims to represent independent cattle ranchers and feeders saddles up with three anti-beef activist groups to prevent the USDA from continuing trade with Canada. R-CALF has now lost all claim to the "independent" flag they so proudly wave. And this week's actions prove they will use any tactic to further their isolationist , anti-trade policies. -Greg Henderson, Drovers editor-Drovers Alert Thursday, May 27, 2004, Vol. 4, Issue 21

http://sfbfp.ifas.ufl.edu/nlDS6-04.html

R-CALF, founded about a decade ago, has feuded with American meat-packing giants who back the integration of the Canadian and U.S. beef industries.

It's a group that's appealed to a certain element down there that are highly protectionist,? said Mr. Laycraft.

R-CALF sued U.S. packers to force up prices and fought unsuccessfully to impose anti-dumping and countervailing duties on Canadian beef.

They've been promoting a whole range of policies to obstruct trade with Canada,? said Mr. Laycraft.

The BSE-spurred ban on Canadian beef was a godsend to American producers, driving up domestic cattle prices as the free flow of Canadian animals to U.S. packing plants stopped.

The border has reopened to processed Canadian-packed products ? know as boxed beef ? but not to live animals.

No one from R-CALF was available to comment but the group contends in its legal submissions there's no evidence Canadian screening procedures and rules regarding contamination of cattle feed will eliminate the BSE risk.

It claims the number of Canadian cases found so far suggest there are still undiscovered BSE-infected animals in the Canadian herd. It has also proffered scientific experts who argue young cattle still present a risk.

R-CALF's argument may have been sideswiped by the recent discovery of BSE in an older Texas animal, says Darcy Davis, president of the Alberta beef producers.

All R-CALF's arguments about different levels of risk all fall away with the finding of that cow,? he says, noting Canada has not closed its border in reaction to the Texas case.

The trade position of the U.S. government that they're provisionally free (of BSE), that falls away. Now we need to discuss how best to go back to trading all different kinds of cattle.?

The impasse concerns the U.S. agriculture secretary, Mr. Lloyd said.

It sends an inconsistent signal to our trading partners when we're asking Japan and other trading nations to open their markets to us, yet we're not opening our market to Canada for the same reason,? he said.

Mr. Lloyd said he sees R-CALF's position as hypocritical and self-defeating.

http://www.madcowblog.com/2005/07/articles/mad-cow-updates/mad-cow-dispute-before-the-courts/

Also concerning the effectiveness of the U.S. feed ban, the Complaint points out that without prohibiting the current use of cattle protein in poultry feed, and without prohibiting the use of poultry litter in cattle feed, the Final Rule creates a risk of transmission of BSE from Canadian cattle imported into the U.S. to domestic cattle, USDA improperly moved forward with lifting the ban on importing Canadian cattle while still considering the necessary measures to address poultry feed and wastes.

http://www.southdakotastockgrowers.org/r-calf%20lawsuit%201-11-05.htm

r-calf talks the talk NOW, but they need to practice what they preach at home. clean up their own backyards, stop worrying about Canada. the USA and Canadian cattle market, feed market, import and export between the two, were so intertwined, it was one market. Canada is just being honest, they are testing to find, and finding. the USDA et al did just the opposite, and or years and years that was o.k. with R-CALF. Canada's feed ban is stronger that the USA's feed ban. the only reason the USA is not finding mad cow cases of any phenotype is because of the SSS policy of shoot, shovel, and shut the hell up. ...

BSE MRR TSS, R-CALF ON CANADA VS USA

Bill Rancher

Joined: 10 Feb 2005 Posts: 1418 Location: GWN Posted: Fri Jan 05, 2007 9:49 am Post subject:

Texan wrote:

Hey Terry, I'd like to get a little further clarification on something if/when you have time. I'm not sure if I'm reading you correctly....

flounder wrote:

This is what sank my battleship in regards to testifying for r-calf. they actually appoached me about it, but i told them i would be glad to testify, but i was not stopping at the Canadian border, my testimony was to come south as well if given the opportunity. and that ended that, but i did supply them with a load of data, for whatever that was worth.

I highlighted the parts that confuse me. This almost makes it seem as if R-CALF was asking you to testify for them, but changed their mind when they found out that you were going to tell the WHOLE truth, instead of just the truth as regards Canadian imports.

I thought that R-CALF was only interested in the WHOLE truth - not just the selected parts of the truth that fit their protectionist agenda? After reading your post, it makes a person wonder. Maybe I read it wrong...

Am I reading this correctly, Terry? That can't be right, can it? Thanks.

I was wondering exactly the same thing Texan.

_________________

Canadian Beef....A cut above the rest!

my answer to big muddy from canada ;

hello there Texan,

yep, you read it right. don't know what ya'll gonna do without me. you know i plan on retiring from this mess soon. the pay is simply too excessive ;-( i fed them all i had at the time, and they shot the teacher. then hired old stanley i heard, go figure, must have been all those PhDs i had ;-)

as with the fuji-tv, when they came here and interviewed me for a BSE show, that i don't know what happened too, or the madcowboy documentary i was asked to proofread, and did, assured i would get some credit for, to never hear from again, to the speech in south Korea i was to make Nov. 23, but was shipwrecked somehow there too, and that might have been a good thing considering all the riots, and they did get the information anyway, to the TSS documentary, that too fell apart for good reasons i suppose, to helping creekstone, and finally to the NIH attempted destruction of an historical bank of donated tissue from CJD victims, and that one i think i did manage to stop, and that thanks to a Republican John Cornyn, i simply think it's time to let you fellars and gals clear this mess up. i have wasted enough time. it will be a decade next Christmas. i just would hate to keep kicking the same old mad cow. i know what happened for the most part, and the ones that don't get it now, never will.

now there Texan, as far as your question, and confusion ;-) i bet you thought i was not going to answer it, or, maybe hoping i would ;

flounder wrote:

This is what sank my battleship in regards to testifying for r-calf. they actually appoached me about it, but i told them i would be glad to testify, but i was not stopping at the Canadian border, my testimony was to come south as well if given the opportunity. and that ended that, but i did supply them with a load of data, for whatever that was worth.

I highlighted the parts that confuse me. This almost makes it seem as if R-CALF was asking you to testify for them, but changed their mind when they found out that you were going to tell the WHOLE truth, instead of just the truth as regards Canadian imports.

I thought that R-CALF was only interested in the WHOLE truth - not just the selected parts of the truth that fit their protectionist agenda? After reading your post, it makes a person wonder. Maybe I read it wrong...

Am I reading this correctly, Terry? That can't be right, can it? Thanks.

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

hello again there Texan,

i don't guess it matters anymore, i don't think ill be testifying for anyone, unless it is my own execution.

i was willing to participate in good faith, and sound science, that is why i think i was never sent to testify,

because in my opinion, R-Calf only wanted to cherry-pick the science, to use to there advantage, to try and

claim that Canada had a worse BSE problem than the USA, and i could not conceed to that. the science did

not confirm this. all one has to do is read the BSE GBR risk assessments, and that is why GW/OIE et al revised

there own risk assessments ;-) the BSE MRR policy.

i don't know, maybe i misinterpreted it all, maybe not, you can be the judge ;

oh what tangled webs we weave, when all we do is practice to deceive. ...TSS

SNIP...END... SEE FULL TEXT ;

*** http://ranchers.net/forum/viewtopic.php?t=15704&postdays=0&postorder=asc&start=12

http://ranchers.net/forum/viewtopic.php?t=15704&postdays=0&postorder=asc&start=24

http://ranchers.net/forum/viewtopic.php?t=15704&postdays=0&postorder=asc&start=36

http://ranchers.net/forum/viewtopic.php?t=15704&postdays=0&postorder=asc&start=48

Saturday, April 11, 2009 CJD FOUNDATION SIDES WITH R-CALFERS NO BSE OR HUMAN TSE THERE OF IN USA 'don't be fooled'

http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html

FOR all these reasons, is why i oppose the CJD Foundation decission to side with a cattle company that over the years, was as responsible for exposing the USA consumer to mad cow disease as was Canada, and then submit a letter that was written and in support of blaming only Canada. This letter the CJD Foundation supports and ask you to write, is only in support of R-CALF and a closed market to Canada beef, ALL THE WHILE IGNORING AND NOT SAYING A WORD OF PAST AND PRESENT FAILLURES OF THE SAME THING HERE IN THE USA. don't be fooled CJDVOICE. if you support this letter the way it was written, you are only fooling yourselves. you are being played like a pawn. write your own letter/comment, tell them the rest of the story. THIS IS NOT ABOUT CANADA ! the only reason we don't find mad cow disease in the USA, is because they did everything they could do in NOT finding BSE in those some 800,000 cattle that were tested. even Paul Brown called it flawed. dont be fooled cjdvoice and cjd foundation members, don't be fooled. ...

CJD FOUNDATION AND R-CALF LETTER

Sample Comment Letter for Your Use (You are free to use all or part of this letter):

April 9, 2009 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061Rockville, MD 20852

Re: Docket Number: FDA-2002-N-0031 (formerly Docket No. 2002N-0273)

Dear Administrator,

As the family member of a loved one who has died of a Creutzfeldt-Jakob Disease (CJD), one form of which can be acquired by ingesting BSE contaminated beef, I want to express my outrage at the recent announcement of the U.S. Food and Drug Administration's (FDA) delay of its April 17, 2009 scheduled implementation of the final rule titled "Substances Prohibited from Use in Animal Food or Feed," commonly referred to as the 2008 BSE final rule. They have made this announcement with full knowledge that the U.S. Department of Agriculture (USDA) continues to subject U.S. consumers and the U.S. cattle herd to a heighted risk of bovine spongiform encephalopathy (BSE) from imports of live Canadian cattle, particularly imports of Canadian cattle over 30 months (OTM) of age.

In Canada the disease occurrence is between three cases per million to eight cases per million cattle. The U.S. Centers for Disease Control and Prevention (CDC) states the level of BSE prevalence in the Canadian cattle herd is 18-fold to 48-fold higher than the prevalence estimated in the U.S. cattle herd. Just in 2008, nearly 1.6 million Canadian cattle were imported into the United States. By delaying the implementation of the Feed Ban the FDA risks yet another break in an already severely compromised food safety firewall.

When USDA reopened the U.S. border in 2007 to Canada's highest-risk cattle population – OTM cattle – its risk modeling based on a Canadian BSE prevalence of fewer than 4 cases per million predicted that the U.S. would import over 100 head of BSE-infected cattle from Canada over the next 20 years. In addition, the risk modeling showed that human exposure to BSE would increase. However, as the CDC explained, the BSE prevalence in Canada could well be 8 cases per million, meaning that USDA likely has grossly underestimated the risk of introducing BSE-infected cattle into the U.S. as a result of allowing OTM Canadian cattle imports. Canada already has detected 16 native cases of BSE in its OTM cattle herd, 10 of which were born after the 1997 feed ban. The most recent of these cases was detected just last November. Nine of Canada's BSE-infected cattle met USDA's age requirements to be exported to the United States, as they were born after March 1, 1999, the date after which USDA erroneously claims BSE-infectivity was no longer circulating in Canada.

The current U.S. feed ban implemented in 1997 is comparable to the initial Canadian feed ban also implemented in 1997. Canada's feed ban proved ineffective at preventing the spread of BSE in Canada. Despite the repeated urging of international scientists, Canada resisted any upgrades to its feed ban until after it detected multiple BSE cases in cattle born years after its 1997 feed ban. Canada's July 2007 upgraded feed ban now protects Canadian consumers against the spread of BSE from Canadian cattle by closing known transmission routes, including cross-contamination and inadvertent feeding of contaminated cattle parts. It is unthinkable that the FDA would not afford U.S. consumers the same level of protection against these same Canadian cattle that are imported into the United States.

The FDA cannot legitimately argue that its current feed ban implemented in 1997, which is nearly identical to Canada's original feed ban also implemented in 1997, is any more effective at mitigating Canada's heightened BSE risk within U.S. borders than it was in mitigating Canada's heightened BSE risk in Canada. Nor can FDA ignore the scientific evidence that overwhelmingly shows that the current U.S. feed ban is insufficient to mitigate the heightened BSE risk associated with OTM cattle imported from Canada. These higher-risk OTM Canadian cattle are entering the U.S. at the rate of several thousand per week, are being commingled in the U.S. cattle herd where some would be expected to die, and are entering both the U.S. food system as well as the U.S. animal feed system. The U.S. already is accepting Canada's higher BSE risk without the protections necessary to mitigate that higher risk.

The FDA cannot bury its head in the sand and pretend the upgraded feed ban contained in the 2008 BSE final rule is not urgently needed to mitigate the increased BSE risk associated with the importation of millions of Canadian cattle. In fact, the FDA already has failed to timely implement an upgraded feed ban, which should have been implemented before USDA began to expose U.S. consumers and the U.S. cattle herd to Canada's heightened BSE risk.

The FDA has an absolute responsibility to protect the health and safety of U.S. consumers and the U.S. cattle herd against this foreign animal disease which is always 100% fatal, and has been known to cross the species barrier infecting humans with variant Creutzfeldt-Jakob Disease (vCJD), the human form of BSE. We need only look to the United Kingdom's recent tragic experience when it was discovered that BSE had crossed the species barrier to humans. Thus far this preventable disease has caused the deaths of 168 young adults. The long incubation period (which can be up to 40 years), means that tragically, there could be many more cases in the future. The FDA must break away from the manipulative actions by corporate-controlled, self-serving trade associations that have caused both FDA and USDA to endanger the health and safety of U.S. consumers and the U.S. cattle herd by exposing them to an unnecessary and avoidable risk of BSE.

The USDA must immediately eliminate the source of this heightened BSE risk by prohibiting the importation of OTM Canadian cattle, and the FDA must immediately implement the 2008 BSE final rule to mitigate this heightened risk. There are no responsible alternatives.

http://cjdadvocacy.blogspot.com/2009/04/fda-food-ban.html

http://www.cjdfoundation.org/

CANADA DID NOT KILL MY MOTHER, AND HER DEATH WAS NO SPONTANEOUS EVENT, OR HAPPENSTANCE OF BAD LUCK. ...

Thursday, April 9, 2009

Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed

http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html

TSS



Sunday, April 12, 2009


r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada


http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html

flounder, you mentioned, "thanks to John Cornyn". Can you clarify what you were saying here because it was a little ambiguous. Did Cornyn help save the tissue amples or was he trying to get rid of it?

Thanks in advance,

Tex

Tex said:

flounder, you mentioned, "thanks to John Cornyn". Can you clarify what you were saying here because it was a little ambiguous. Did Cornyn help save the tissue amples or was he trying to get rid of it?

Thanks in advance,

Tex

Click to expand...

Hello there Tex,



Senator Cornyn HELPED me SAVE the tissues. it was a long battle, but here is my letter, and his reply to me, and the news stories from the beginning to end. other folks were mad too. seems that when the atypical BSEs started showing up, and some of the pathology there of was pointing to some sub-types of sporadic CJD, they saw the writing on the wall and were going to destroy all the brain and tissue samples that was at the NIH cjd brain bank. even the primate brains and tissues Gibbs et al used to test, their tissues were to be destroyed too. I was furious, they have my mothers brain, and we did not donate these tissues for them to ignore and discard. were still waiting on answers and it's 2009, were still feeding cows to cows and still just talking about doing something about it. the mad cows are and have been out of the barn in the USA, and nobody testing to find. i suppose it's easier to continue to sell mad cow beef here in the USA, and then just continue to blame Canada. it's like we will have our own closed market on USA mad cow disease. course we will never know to what true extent it really is, until we do an extensive TRUE enhanced BSE surveillance and testing program. not one that covers up mad cow disease, but one that documents the true extent of TSE in the USA bovine, we will never really know will we. ...terry




JOHN CORNYN

TEXAS

UNITED STATES SENATE

WASHINGTON, DC 20510-4305

April 26,2005

Mr. Terry Singeltary P.O. Box 42 Bacliff, Texas 77518

Dear Mr. Singeltary:

In response to your recent request for my assistance, I have contacted the National Institutes ofHealth. I will write you again as soon as I receive a reply.

I appreciate having the opportunity to represent you in the United States Senate and to be of service in this matter.

Sincerely,

JOHN CORNYN United States Senator JC:djl

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

JOHN CORNYN

TEXAS

UNITED STATES SENATE

WASHINGTON, DC 20510-4305

May 18,2005

Mr. Terry Singeltary P.O. Box 42 Bacliff, Texas 77518

Dear Mr. Singeltary:

Enclosed is the reply I received from the Department of Health and Human Services in response to my earlier inquiry on your behalf. I hope this will be useful to you. I appreciate having the opportunity to represent you in the United States Senate.

Thank you for taking time to contact me.

Sincerely,

JOHN CORNYN United States Senate JC:djl Enclosure

DEPARTMENT OF HEALTH & HUMAN SERVICES

National Institutes of HealthNational Institute of NeurologicalDisorders and Stroke NINDS Building 31, Room 8A52 31 Center Dr., MSC 2540 Bethesda, Maryland 20892-2540 Phone: 301-496-9746 Fax: 301-496-0296 Email: [log in to unmask]

May 10, 2005

The Honorable John Cornyn United States Senator Occidental Tower5005 LBJ Freeway, Suite 1150 Dallas, Texas 75244-6199

Dear Senator Cornyn:

Your letter to the National Institutes of Health (NIH) forwarding correspondence from Mr. Terry S. Singeltary, Sr., has been forwarded to me for reply. Mr. Singeltary is concerned about thepreservation of Creutzfeldt-Jakob disease (CJD) brain samples that have been maintained by theNational Institute of Neurological Disorders and Stroke (NINDS) Intramural Research programfor many years.

I am sorry to learn that Mr. Singeltary's mother died of CJD and can certainly understand hisdesire that any tissues that could help investigators unravel the puzzle of this deadly disease arepreserved. I hope he will be pleased to learn that all the brains and other tissues with potential tohelp scientists learn about CJD are, and will continue to be, conserved. (The tissues that arediscarded are those that have either decayed to an extent that renders them no longer appropriatefor research or those for which we do not have sufficient identification.)

The purpose of gathering these brains and tissues is to help scientists learn about CJD. To that end, some of the NINDS-held samples are distributed to investigators who can demonstrate thatthey have a compelling research or public health need for such materials. For example, sampleshave been transferred to NIH grantee Dr. Pierluigi Gambetti, who heads the National PrionDiseases Pathology Surveillance Center at Case Western Reserve University in Ohio and workswith the Centers for Disease Control and Prevention to monitor all cases of CJD in the UnitedStates. Dr. Gambetti studies the tissues to learn about the formation, physical and chemicalproperties, and pathogenic mechanisms of prion proteins, which are believed to be involved inthe cause of CJD. Samples have also been transferred to Dr. David Asher, at the U.S. Food andDrug Administration, for use in assessing a potential diagnostic test for CJD.

Page 2 - The Honorable John Cornyn

in closing, we know that donating organs and tissue from loved ones is a very difficult andpersonal choice that must often be made at the most stressful of times. We at the NINDS aregrateful to those stalwart family members who make this choice in the selfless hope that it willhelp others afflicted with CJD. We also know the invaluable contribution such donations maketo the advancement of medical science, and we are dedicated to the preservation of all of thetissue samples that can help in our efforts to overcome CJD.

I hope this information is helpful to you in responding to Mr. Singeltary. Sincerely,

Story C. Landis, Ph.D. Director, National Institute ofNeurological Disorders and Stroke

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


NIH says it will preserve CJD brains By STEVE MITCHELL

WASHINGTON, May 31 (UPI) -- The National Institutes of Health apparently has reversed its position on the fate of an invaluable collection of brains from people afflicted with a condition similar to mad cow disease, saying in a letter to a U.S. senator it will not destroy the collection.

An NIH official had told United Press International previously that the brain collection, which consists of samples from hundreds of people who died from the brain-wasting illness called Creutzfeldt Jakob disease, could be discarded if another entity does not claim them.

That sparked an outcry from patient-advocacy groups, consumer watchdogs and scientists, and the agency now appears to have backed away from that course.

"All the brains and other tissues with potential to help scientists learn about CJD are, and will continue to be, conserved," Story Landis, director of the National Institute of Neurological Disorders and Stroke, which oversees the brain collection, wrote in a May 10 letter to Sen. John Cornyn, R-Texas.

Cornyn had inquired about the status of the collection in April.

Last March, Eugene Major, acting director of the basic neuroscience program at the NIH, told UPI the useful portions of the collection had been doled out to scientists and the remaining samples had "very little remaining value" and could be destroyed.

Landis could not be reached for comment Tuesday. NINDS spokesman Paul Girolami told UPI he had been unable to locate her.

Scientists think the collection, which dates back to 1963, is invaluable for research on CJD and similar diseases and could even provide insight into treatments. There is no cure for CJD and patients typically die within a year after symptoms begin.

"Absolutely, the collection is worth keeping," Bruce Johnson, a former NIH scientist who said he had been told the collection would be destroyed in two years if no one took the samples from the agency, told UPI.

The Memorial Institute for Neurodegenerative Diseases Inc., a non-profit organization consisting of more than 40 researchers from several countries, offered to take the collection off of NIH's hands more than a year ago and so far has not heard anything from the agency, Harry Peery, MIND's executive director, told UPI.

CJD belongs to a group of incurable and fatal diseases collectively known as transmissible spongiform encephalopathies, or TSEs, that includes mad cow disease in cows, chronic wasting disease in deer and elk, and scrapie in sheep.

Variant CJD, or vCJD, is a relatively new TSE, which people can contract from consuming beef products infected with the mad cow pathogen.

Despite Landis' assurance the collection will be preserved, some family members of the patients who donated their brains to the NIH are still skeptical. This is because the wording Landis used in the letter leaves open the possibility that some brain samples are being destroyed.

"The tissues that are discarded are those that have either decayed to an extent that renders them no longer appropriate for research or those for which we do not have sufficient identification," Landis wrote.

"Which ones" are being destroyed? asked Terry Singeltary, who is involved with several CJD patient groups.

"With a system like this, they could destroy whatever and whenever they wanted, for whatever reason they wanted," Singeltary, whose mother died of CJD in 1997, told UPI.

"It's a perfect excuse to discard some suspicious tissue resembling vCJD or some atypical TSE related to animal TSEs in the USA," he added.

Although the collection includes samples from CJD patients as young as 16 that could make them candidates for possible vCJD, the brains have never been screened for evidence of the disease. The only confirmed vCJD case in the United States occurred in a Florida woman who is thought to have contracted the disease in England.

Johnson said he along with renowned CJD expert Paul Brown were in the process of sorting through the samples to match them up with patient identification documents until they both retired. Some of the samples may prove impossible to identify, he said, but he and Brown are the only ones familiar enough with the collection to organize it and neither has been asked back by the agency to aid in the identification process.

Steve Mitchell is UPI's Medical Correspondent. E-mail: [log in to unmask]

Copyright 2005 by United Press International. All Rights Reserved.

http://washingtontimes.com/

http://www.sciencedaily.com/



NIH may destroy human brain collection


By Steve Mitchell
Medical Correspondent

Washington, DC, Mar. 24 (UPI) -- The National Institutes of Health may discard part or all of a rare collection that includes hundreds of human brain samples from patients that suffered from a disorder similar to mad cow disease -- unless another researcher or institution takes them on, United Press International has learned.

Several scientists said the collection, which is held by the NIH's National Institute for Neurological Disorders and Stroke in Bethesda, Md. -- and includes brains and other tissue samples from people afflicted with the brain-wasting illness Creutzfeldt Jakob disease -- is irreplaceable and could even provide insight into treatments for the fatal disorder. Currently, there is no cure for CJD and patients typically die within a year after symptoms begin.

However, NIH officials in control of the collection's fate told UPI the remaining samples are of little scientific value and may be disposed of if researchers outside the agency do not claim it. That position stands in sharp contrast with CJD experts who thought the collection should be preserved.

"It's invaluable," said Dr. Paul Brown, former medical director of the NIH's Laboratory for Central Nervous System Studies, whose expertise is in CJD and mad cow disease (also known as bovine spongiform encephalopathy, or BSE).

The collection is badly in need of organization and no one is certain how many brains or other tissue samples it contains, said Brown, who worked with the collection since its inception in the 1960's until his retirement last year. There could be brains, blood, spinal fluid and various other tissues from 1,000 people or more, he said. Some of the specimens would be of scientific use today, he said.

"This collection has the unique value of stretching back to the beginning of when these diseases were discovered," Brown told UPI, noting that the first samples were obtained in 1963. "It would be as though you had in your hands the possibility of finding out when AIDS started."

Bruce Johnson, a former technician at the CNSS lab who worked extensively with the collection before he retired in 2003, told UPI he was told "in two years they (NIH officials)are going to destroy it, if nobody wants it."

Eugene Major, acting director of the basic neuroscience program at the NIH, said no specific timeframe had been established.

"We have not set a firm deadline date," Major told UPI. "We are working very hard with investigators that we know in order to be able to make sure that whatever we deem is valuable is potentially kept here." Some samples already have been determined not to have any research value and have been "removed and disposed of," he said.

Others samples have been given out to Dr. David Asher at the Food and Drug Administration and Pierluigi Gambetti at the National Prion Disease Pathology Surveillance Center in Cleveland, Ohio.

Major maintained the remaining collection was not particularly valuable for research. "Whatever had been collected here that has not already been distributed to responsible investigators who could use them really has very little remaining value," he said.

Neither Asher nor Gambetti returned phone calls from UPI, but Brown said he thought Asher had received only a dozen or two samples at most and Gambetti had not received much at all.

Neil Cashman, a brain-disease researcher at the University of Toronto's Center for Research in Neurodegenerative Diseases -- who has tried to obtain the collection from the NIH -- said it was priceless.

"It would be like destroying an art museum," Cashman told UPI. "There's all this information and insight that's locked up in these tissues and if it's destroyed it will be lost forever."

The Memorial Institute for Neurodegenerative Diseases Inc., a non-profit organization consisting of more than 40 university and institute researchers from the United States, Canada, United Kingdom and France, also thinks the brain collection is invaluable.

"It is the opinion of the Board of Directors ... of The MIND Inc., that the ... brain bank should not be broken up nor destroyed," said Harry E. Peery, MIND's executive director, in a letter to UPI. "We believe that this collection is of inestimable research value and should be kept intact."

The institute, at the University of Saskatchewan in Saskatoon, applied for possession of the collection in early 2004, but received a letter from the NINDS indicating the fate of the collection had not yet been determined.

"We have heard nothing further since that time" and continue to be interested in acquiring the complete collection, Peery said.

CJD belongs to a group of rare, brain-wasting disorders that are little understood, incurable and fatal. This includes mad cow disease in cows, chronic wasting disease in deer and elk. The most infamous of these illnesses in humans is variant CJD, which people can contract from eating beef products infected with the mad-cow pathogen.

Although vCJD has infected more than 154 people worldwide, only one case has ever been detected in the United States -- in a Florida woman who is thought to have contracted the disease while living in the United Kingdom. However, the NIH brain samples have never been screened for vCJD -- something Johnson thinks is critically important.

"No one has ever looked to see if any American (in the collection) in the past had variant CJD," Johnson said. "You think it would be required that they do that. You think it would be a Congressional mandate that they test these brains: 'Let's see if we've got this disease in our country.'"

Johnson noted at least one brain in the collection he personally had examined -- from a French woman collected in 1971 -- showed evidence of possible vCJD infection, but the sample needed further study to be sure.

Other samples in the collection include the brains of patients who were only 16 years old when they were diagnosed with CJD. This would be unusual for sporadic CJD, because generally it strikes those over age 60. Variant CJD, on the other hand, typically occurs in patients in their 20s or younger.

"I thought it was absolutely vital (to test these brains)," Johnson said. "Maybe there's a dozen cases in there of variant CJD."

Major disagreed. "There's really no reason to do that," he said. "The effort it would take to screen those samples ... would not give us any new insights into variant CJD beyond what it is we already know."

Johnson said he was frustrated with the NIH administration's lack of interest in preserving the collection or testing for vCJD. "They don't understand," he said, "they honest-to-god don't understand what it's all about."

Patient advocates also objected to the possible destruction of the brains.

Terry Singeltary, whose mother died of a type of CJD called Heidenhain variant in 1997, said he is outraged and families of other CJD victims probably will be, too.

"A lot of these families went through a lot of heartache and a lot of trouble to get these brain samples to the NIH," Singeltary told UPI. "Now they're just going to discard them because they're not of scientific use? That's just asinine. That stuff is valuable information."

Graham Steel, vice-chair of the Human BSE Foundation in the United Kingdom, told UPI, "The potential loss of such important tissue samples would be a massive blow for TSE (the group of diseases that includes CJD and BSE) research in the United States. This should not be allowed to happen."

Singeltary noted there currently is no cure for these diseases. "If you don't have any answers yet, why would you throw these specimens away?" he asked.

He added that more sensitive tests are just becoming available and could help determine the origin of some of the CJD cases. "We've all been sitting around waiting for more sensitive tests to get validated because we want answers," he said.

"You know, it must be an embarrassment," Johnson said. "Some Senator is going to eventually say 'What is NIH doing about mad cow disease?' And people are going to scratch their heads and say 'not much'." He added, "What's going to happen (is) one of these senators or their wife is going to develop spontaneous CJD one day and ... there's going to be hell raised and they're going to ask, 'Why isn't NIH working on this?'"

--

E-mail [email protected]


http://www.washtimes.com/upi-breaking/20050323-053919-8481r.htm



NIH sends mixed signals on CJD brains

By Steve Mitchell
Medical Correspondent


Washington, DC, Apr. 7 (UPI) -- A National Institutes of Health official who told United Press International the agency might destroy its collection of brains from human patients afflicted with a condition similar to mad cow disease reportedly has told the head of a patient-advocate group the collection would be preserved.


The official, Eugene Major, acting director of the basic neuroscience program at the NIH, has not responded to e-mail or a phone call from UPI seeking clarification of his remarks, and the official status of the collection remains unknown.

As reported by UPI on March 24, the collection is stored in freezers by the NIH's National Institute for Neurological Disorders and Stroke in Bethesda, Md. It contains brains and other tissue samples from hundreds of people who died from the brain-wasting illness Creutzfeldt Jakob disease, as well as tissues from an untold number of experimental animals.

The consensus of scientists in this field is the collection, which dates back to 1963, is invaluable for research and could even provide insight into treatments for the fatal disorder. Currently, there is no cure for CJD and patients typically die within a year after symptoms begin.

Florence Kranitz, president of the non-profit advocacy group CJD Foundation, told UPI she had "a very long conversation" with Major, in which he told her the remaining tissues in the collection would not be destroyed.

"He reassured me in no uncertain terms," Kranitz said, noting constituents of the foundation and other CJD advocacy groups had been expressing concerns to her the tissues would be destroyed.

Kranitz, who has personal reasons for wanting the collection preserved -- her husband died of CJD in 2000 -- said she plans to meet with Major at the end of April to discuss the issue further.

CJD belongs to a group of diseases collectively known as transmissible spongiform encephalopathies, or TSEs, that includes mad cow disease in cows, chronic wasting disease in deer and elk, and scrapie in sheep. All TSEs are incurable and fatal.

Major previously told UPI some samples already have been destroyed and others have been given to researchers at the Food and Drug Administration and the National Prion Disease Pathology Surveillance Center in Cleveland.

Major said the remaining collection "has very little remaining value" and could be destroyed if another entity does not claim them.

Bruce Johnson, a former NIH scientist who retired at the end of 2003, said he had been told the collection would be destroyed in two years if no one took the samples from the NIH.

In response to hearing that Major had failed to confirm to UPI the brain collection would not be destroyed, Patricia Ewanitz, who lives in Port Jefferson Station, N.Y., and is founder of the advocacy group CJD Voice, said, "The brain tissue might not be indispensable to the National Institutes of Health but it is absolutely necessary to the families who thought enough of science to donate the brains, brain tissue and blood in hopes of someday finding an answer to why their loved one died."

Ewanitz, whose husband died of CJD in 1997, added, "It now seems like such a joke."

Terry Singeltary, whose mother passed away from a type of CJD in 1997, said the NIH should use the samples for scientific research, not just store them in freezers.

Both Singeltary and Ewanitz said they would feel more reassured if Major verified in writing the collection will not be destroyed.

"I would go further and ask Major what he plans to do with them," Singeltary said. "If the samples are just going to sit up there and go bad, then they should give them out to researchers looking for cause and cure."

The revelation the NIH might destroy part or all of the collection sparked an outcry from patient advocates, consumer groups and scientists.

Advocates have been contacting their members of Congress, urging them to investigate and prevent the NIH from destroying the brains. Consumer groups also have gotten involved and scientists have taken steps to obtain the collection or have urged Major not to destroy the samples.

Felicia Nestor, who serves as a consultant to Public Citizen, told UPI she had contacted certain legislators and at least one was considering looking into the situation. Nestor asked the legislator's name be withheld.

Kranitz said Major also told her he plans "to advertise in professional neurological journals and by whatever means necessary to make it known" to researchers in the field the tissues are available.

Major previously said, however, that efforts to inform researchers of the availability of the collection were already underway and included informing NIH grantees. He added he had personally notified researchers at scientific meetings, but no TSE researcher contacted by UPI was aware of this.

"I was never informed," said Laura Manuelidis, an expert on these diseases and section chief of surgery in the neuropathology department at Yale University. She said the first she had heard of the situation was in UPI's March 24 report.

Manuelidis also said she contacted Major, expressing interest in the specimens, but so far has not received a response.

"I sent a letter to (Major) on (March 25) about our interest in these specimens, but he has not replied," she told UPI in an e-mail.

Neil Cashman, a TSE expert at the University of Toronto, who said he was not aware the samples might be destroyed, has lobbied colleagues at the University of British Columbia -- where Cashman is scheduled to move to this summer -- to help draft a letter requesting the collection.

The Memorial Institute for Neurodegenerative Diseases Inc., a non-profit organization consisting of more than 40 university and institute researchers from the United States, Canada, the United Kingdom and France, requested the collection in January, 2004. So far, the institute has not been informed of a decision by the NIH.

Asked if Major had told him whether the collection would be preserved, MIND Executive Director Harry Peery said, "We have heard nothing further from Eugene Major or anyone else at the NIH regarding the brain collection."

--

E-mail: [email protected]


http://washingtontimes.com/upi-breaking/20050407-110535-2570r.htm



Sunday, April 12, 2009

TRANSMISSION OF ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN HUMANIZED MOUSE MODELS

http://bse-atypical.blogspot.com/2009/04/transmission-of-atypical-bovine.html



Sunday, April 12, 2009


r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada


http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html



Thursday, April 9, 2009

Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed

http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html


TSS

FDA2002N0031


r-calf


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480952081&disposition=attachment&contentType=pdf



CJD FOUNDATION


http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648094d9f9




i don't think i interpreted anything about USA mad cow problem, and or USA mad cow feed problem, of which is what this docket was for. in 2007, in one fda warning letter week, two warning letters, where 10,000,000 pounds of suspect banned mad cow feed went into commerce to be fed out. and 2006 was a banner year as well for USA MAD COW FEED that was banned, that went into commerce to be fed out. why does r-calf not mention this $$$ or the failed, flawed, and corrupt 2004 ENHANCED BSE SURVEILLANCE PROGRAM, that was nothing more of another mad cow cover-up. we all know it. OIG said it, in it's own way, and Paul Brown of CDC said it in plain terms. hmmm, no mention there either by r-calf$ that's what the r-calf is all about. they are playing some like a deck of cards.

nothing more of the same, big, big, denial, and that' s what anyone that signed that letter with r-calf ET AL supported, a big denial. ...TSS




Research Project: Study of Atypical Bse Location: Virus and Prion Diseases of Livestock

Project Number: 3625-32000-086-05 Project Type: Specific Cooperative Agreement

Start Date: Sep 15, 2004 End Date: Sep 14, 2009

Objective: The objective of this cooperative research project with Dr. Maria Caramelli from the Italian BSE Reference Laboratory in Turin, Italy, is to conduct comparative studies with the U.S. bovine spongiform encephalopathy (BSE) isolate and the atypical BSE isolates identified in Italy. The studies will cover the following areas: 1. Evaluation of present diagnostics tools used in the U.S. for the detection of atypical BSE cases. 2. Molecular comparison of the U.S. BSE isolate and other typical BSE isolates with atypical BSE cases. 3. Studies on transmissibility and tissue distribution of atypical BSE isolates in cattle and other species.

Approach: This project will be done as a Specific Cooperative Agreement with the Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance program to analyze the effectiveness of the U.S diagnostic tools for detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE isolate with atypical BSE isolates will provide further characterization of the U.S. BSE isolate. Transmission studies are already underway using brain homogenates from atypical BSE cases into mice, cattle and sheep. It will be critical to see whether the atypical BSE isolates behave similarly to typical BSE isolates in terms of transmissibility and disease pathogenesis. If transmission occurs, tissue distribution comparisons will be made between cattle infected with the atypical BSE isolate and the U.S. BSE isolate. Differences in tissue distribution could require new regulations regarding specific risk material (SRM) removal.

http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490




P26

TRANSMISSION OF ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN HUMANIZED MOUSE MODELS

Liuting Qing1, Fusong Chen1, Michael Payne1, Wenquan Zou1, Cristina Casalone2, Martin Groschup3, Miroslaw Polak4, Maria Caramelli2, Pierluigi Gambetti1, Juergen Richt5*, and Qingzhong Kong1 1Department of Pathology, Case Western Reserve University, Cleveland, OH 44106, USA; 2CEA, Istituto Zooprofilattico Sperimentale, Italy; 3Friedrich-Loeffler-Institut, Germany; 4National Veterinary Research Institute, Poland; 5Kansas State University, Diagnostic Medicine/Pathobiology Department, Manhattan, KS 66506, USA. *Previous address: USDA National Animal Disease Center, Ames, IA 50010, USA

Classical BSE is a world-wide prion disease in cattle, and the classical BSE strain (BSE-C) has led to over 200 cases of clinical human infection (variant CJD). Two atypical BSE strains, BSE-L (also named BASE) and BSE-H, have been discovered in three continents since 2004. The first case of naturally occurring BSE with mutated bovine PrP gene (termed BSE-M) was also found in 2006 in the USA. The transmissibility and phenotypes of these atypical BSE strains/isolates in humans were unknown. We have inoculated humanized transgenic mice with classical and atypical BSE strains (BSE-C, BSE-L, BSE-H) and the BSE-M isolate. We have found that the atypical BSE-L strain is much more virulent than the classical BSE-C. The atypical BSE-H strain is also transmissible in the humanized transgenic mice with distinct phenotype, but no transmission has been observed for the BSE-M isolate so far.

III International Symposium on THE NEW PRION BIOLOGY: BASIC SCIENCE, DIAGNOSIS AND THERAPY 2 - 4 APRIL 2009, VENEZIA (ITALY)

http://www.istitutoveneto.it/prion_09/Abstracts_09.pdf



Research Project: GENETIC AND BIOLOGICAL DETERMINANTS OF RESPIRATORY DISEASE SUSCEPTIBILITY Location: Animal Health Systems Research

Title: Association of a bovine prion gene haplotype with atypical BSE

Author

Clawson, Michael

Submitted to: Meeting Abstract Publication Type: Abstract Publication Acceptance Date: December 2, 2008 Publication Date: January 1, 2009 Citation: Clawson, M.L. 2009. Association of a bovine prion gene haplotype with atypical BSE [abstract]. Plant and Animal Genomes XVII Conference. Abstract No. W091. Available: http://www.intl-pag.org/17/abstracts/

Technical Abstract: Transmissible spongiform encephalopathies (TSEs), also known as prion diseases, are a class of fatal neurodegenerative disorders that occur in humans, ruminants, cats, and mink. Three distinct TSEs afflict cattle: classical bovine spongiform encephalopathy (BSE), atypical H-type BSE, and atypical L-type BSE. Classical BSE was identified in the 1980s and is acquired by cattle through the consumption of feed contaminated with the infectious prion agent. Atypical BSEs have only recently been recognized as distinct cattle prion diseases and are extremely rare. The full extent of genetic susceptibilities to atypical BSEs is unknown; however, one atypical H-type case identified in the United States (2006) was most likely caused by a genetic mutation in the prion gene, E211K. We have identified an association of a bovine prion DNA haplotype with atypical BSE that is independent of E211K. The haplotype spans a portion of the prion gene that includes part of intron 2, the entire coding region of exon 3, and part of the three prime untranslated region of exon 3 (13 kb). Despite the low frequency of this haplotype among general cattle populations, it was present in a majority of H- and L-type atypical BSE cases from Canada, France, and the United States. This result indicates that there is a genetic component to atypical BSE susceptibility in addition to E211K.

http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=234699

I ask Professor Kong ;

Thursday, December 04, 2008 3:37 PM Subject: RE: re--Chronic Wating Disease (CWD) and Bovine Spongiform Encephalopathies (BSE): Public Health Risk Assessment

''IS the h-BSE more virulent than typical BSE as well, or the same as cBSE, or less virulent than cBSE? just curious.....''

Professor Kong reply ;

.....snip

''As to the H-BSE, we do not have sufficient data to say one way or another, but we have found that H-BSE can infect humans. I hope we could publish these data once the study is complete. Thanks for your interest.''

Best regards, Qingzhong Kong, PhD Associate Professor Department of Pathology Case Western Reserve University Cleveland, OH 44106 USA

END...TSS

I look forward to further transmission studies, and a true ENHANCED BSE/atypical BSE surveillance program put forth testing all cattle for human and animal consumption for 5 years. a surveillance program that uses the most sensitive TSE testing, and has the personnel that knows how to use them, and can be trusted. I look forward to a stringent mad cow feed ban being put forth, and then strictly enforced. we need a forced, not voluntary feed ban, an enhanced feed ban at that, especially excluding blood. we need some sort of animal traceability. no more excuses about privacy. if somebody is putting out a product that is killing folks and or has the potential to kill you, then everybody needs to know who they are, and where that product came from. same with hospitals, i think medical incidents in all states should be recorded, and made public, when it comes to something like a potential accidental transmission exposure event. so if someone is out there looking at a place to go have surgery done, if you have several hospitals having these type 'accidental exposure events', than you can go some place else. it only makes sense. somewhere along the road, the consumer lost control, and just had to take whatever they were given, and then charged these astronomical prices. some where along the line the consumer just lost interest, especially on a long incubating disease such as mad cow disease i.e. Transmissible Spongiform Encephalopathy. like i said before, there is much more to the mad cow story than bovines and eating a hamburger, we must start focusing on all TSE in all species. ...TSS

Month Number of Tests

Feb 2009 -- 1,891

Jan 2009 -- 4,620

http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/ongoing_surv_results.shtml

P02.35

Molecular Features of the Protease-resistant Prion Protein (PrPres) in H-type BSE

Biacabe, A-G1; Jacobs, JG2; Gavier-Widén, D3; Vulin, J1; Langeveld, JPM2; Baron, TGM1 1AFSSA, France; 2CIDC-Lelystad, Netherlands; 3SVA, Sweden

Western blot analyses of PrPres accumulating in the brain of BSE-infected cattle have demonstrated 3 different molecular phenotypes regarding to the apparent molecular masses and glycoform ratios of PrPres bands. We initially described isolates (H-type BSE) essentially characterized by higher PrPres molecular mass and decreased levels of the diglycosylated PrPres band, in contrast to the classical type of BSE. This type is also distinct from another BSE phenotype named L-type BSE, or also BASE (for Bovine Amyloid Spongiform Encephalopathy), mainly characterized by a low representation of the diglycosylated PrPres band as well as a lower PrPres molecular mass. Retrospective molecular studies in France of all available BSE cases older than 8 years old and of part of the other cases identified since the beginning of the exhaustive surveillance of the disease in 20001 allowed to identify 7 H-type BSE cases, among 594 BSE cases that could be classified as classical, L- or H-type BSE. By Western blot analysis of H-type PrPres, we described a remarkable specific feature with antibodies raised against the C-terminal region of PrP that demonstrated the existence of a more C-terminal cleaved form of PrPres (named PrPres#2 ), in addition to the usual PrPres form (PrPres #1). In the unglycosylated form, PrPres #2 migrates at about 14 kDa, compared to 20 kDa for PrPres #1. The proportion of the PrPres#2 in cattle seems to by higher compared to the PrPres#1. Furthermore another PK-resistant fragment at about 7 kDa was detected by some more N-terminal antibodies and presumed to be the result of cleavages of both N- and C-terminal parts of PrP. These singular features were maintained after transmission of the disease to C57Bl/6 mice. The identification of these two additional PrPres fragments (PrPres #2 and 7kDa band) reminds features reported respectively in sporadic Creutzfeldt-Jakob disease and in Gerstmann-Sträussler-Scheinker (GSS) syndrome in humans.

http://www.neuroprion.com/pdf_docs/conferences/prion2007/abstract_book.pdf




Wednesday, February 11, 2009

Atypical BSE North America Update February 2009

Both of the BSE cases ascertained in the US native-born cattle were atypical cases (H-type), which contributed to the initial ambiguity of the diagnosis. 174, 185 In Canada, there have been 2 atypical BSE cases in addition to the 14 cases of the classic UK strain of BSE2: one was the H-type, and the other was of the L-type.198

snip...end

source :

Enhanced Abstract Journal of the American Veterinary Medical Association January 1, 2009, Vol. 234, No. 1, Pages 59-72

Bovine spongiform encephalopathy

Jane L. Harman, DVM, PhD; Christopher J. Silva, PhD

http://avmajournals.avma.org/doi/ref/10.2460/javma.234.1.59

Atypical BSE North America Update February 2009

http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html

Thursday, April 9, 2009

Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed

http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html



full text ;


Sunday, April 12, 2009 TRANSMISSION OF ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN HUMANIZED MOUSE MODELS

http://bse-atypical.blogspot.com/2009/04/transmission-of-atypical-bovine.html





TSS

Docket ID FDA-2002-N-0031 Docket Title Animal Proteins Prohibited in Ruminant Feed Document ID FDA-2002-N-0031-0132 Document Title Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date




Completely Edited Version

PRION ROUNDTABLE

2003

page 29

Dr. Linda Detwiler

The UK imports into the US.

There were 496 total, and 173 of the UK imports could have entered the US feed system. People don't like to hear this, but it's possible that one of the UK imports in the US entered the animal feed system and was exported to Canada. That's a possibility, because they import 50% of their feed from the US.

From 1994, we imported 11 million head of cattle from Canada. Most of these were feedlot animals for slaughter, but there were about 500,000 breeding animals. A number of Canada's cull cows were slaughtered here and could have introduced infectivity into our system. Even today we have Canadian imports in the country, breeding animals that were brought in prior to the ban and reside here.

We have feed ban exemptions: plate waste, poultry litter. We still allow that if it comes off a human plate, or if it's trimmings, it can be palletized and fed to ruminants. That might be a small amount, but it could allow spinal cord in certain cuts to be fed back to ruminants. Poultry litter or feather meal could be significant. Poultry is getting quite a bit of ruminant material in the US because it cannot go back to ruminants. Poultry and pigs are getting a substantial amount. Poultry litter is not only what passes through the chicken, but think about how chickens eat. They spill a lot on the floor. That stuff is still allowed to be fed back to cattle. That's a direct break in the ban, except that it's legal. Ruminants are getting ruminant material.

Unfiltered tallow: tallow is a lipid material. However, if it's not filtered, there are protein residues. That's meat and bone meal. That's allowed to be fed, so that's another legal exception where you can feed ruminant meat and bone meal through unfiltered tallow. We don't have an SRM ban and the 40 animals are the ones that if you have the agent, they introduce the most infectivity back into the animal food chain when they're rendered.

What's our on-farm compliance? We really don't know. ...snip...end...Dr. Linda Detwiler



UK EXPORTS OF MBM TO WORLD

http://www.bseinquiry.gov.uk/files/mb/m11g/tab05.pdf

OTHERS

BEEF AND VEAL

http://www.bseinquiry.gov.uk/files/mb/m11f/tab08.pdf

http://www.bseinquiry.gov.uk/files/mb/m11f/tab09.pdf

http://www.bseinquiry.gov.uk/files/mb/m11f/tab10.pdf

LIVE CATTLE

http://www.bseinquiry.gov.uk/files/mb/m11f/tab11.pdf

FATS

http://www.bseinquiry.gov.uk/files/mb/m11g/tab01.pdf

EMBRYOS

http://www.bseinquiry.gov.uk/files/mb/m11g/tab03.pdf

GELATIN ETC

http://www.bseinquiry.gov.uk/files/mb/m11g/tab02.pdf

SEMEN

http://www.bseinquiry.gov.uk/files/mb/m11g/tab04.pdf

MEAT

http://www.bseinquiry.gov.uk/files/mb/m11g/tab05.pdf

CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf

USA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf

MEXICO

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf

Wednesday, April 16, 2008 MBM, greaves, meat offal, live cattle, imports from UK to USA vs Canada "Three of four possible manufacturers supplying a protein supplement likely fed to the animal could have included meat and bone meal (MBM) as an ingredient in its formulation. One of these manufacturers was able to confirm usage of meat and bone meal in supplements and confirm a source of MBM to be one common to previous BSE investigations."

USA AND CANADA IMPORTS OF UK CATTLE BETWEEN 1981 - 1989

USA = 496

CANADA = 198

*add 14 to 198 as last UK import to Canada, 14 in 1990

http://www.inspection.gc.ca/english/sci/ahra/bseris/bserise.pdf

HERE is another look at all the imports for both the USA and Canada of UK live cattle and greaves exports ;

UK Exports of Live Cattle by Value 1986-96

USA 697 LIVE CATTLE

CANADA 299 LIVE CATTLE

http://www.bseinquiry.gov.uk/files/mb/m11f/tab11.pdf

UK TABLE of Exports of meal of meat and meat offal; greaves 1979 - 1995

USA 24 TONS

CANADA 83 TONS

http://www.bseinquiry.gov.uk/files/mb/m12/tab12.pdf

HOWEVER, my files show 44 tons of greaves for USA. ...TSS

Subject: Re: exports from the U.K. of it's MBM to U.S.??? From: [email protected]. Date: Tue, 8 Feb 2000 14:03:16 +0000 To: [email protected] (Receipt Notification Requested) (Non Receipt Notification Requested)

Terry

Meat and bonemeal is not specifically classified for overseas trade purposes. The nearest equivalent is listed as flours and meals of meat or offals (including tankage), unfit for human consumption; greaves. UK exports of this to the US are listed below:

Country Tonnes

1980 1981 12 1982 1983 1984 10 1985 2 1986 1987 1988 1989 20 1990

Data for exports between 1975 and 1979 are not readily available. These can be obtained (at a charge) from data retailers appointed by HM Customs and Excise: BTSL (Tel: 01372 463121) or Abacus (01245 252222). Best wishes Simon Pearsall Overseas trade statistics Stats (C&F)C

============ END...TSS...2008============

P04.27

Experimental BSE Infection of Non-human Primates: Efficacy of the Oral Route

Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3; Ingrosso, L3; Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6; Löwer, J1 1Paul-Ehrlich-Institut, Germany; 2Commissariat à l´Energie Atomique, France; 3Instituto Superiore di Sanità, Italy; 4Swedish Institute for Infectious Disease control, Sweden; 5Georg August University, Germany; 6German Primate Center, Germany

Background:

In 2001, a study was initiated in primates to assess the risk for humans to contract BSE through contaminated food. For this purpose, BSE brain was titrated in cynomolgus monkeys.

Aims:

The primary objective is the determination of the minimal infectious dose (MID50) for oral exposure to BSE in a simian model, and, by in doing this, to assess the risk for humans. Secondly, we aimed at examining the course of the disease to identify possible biomarkers.

Methods:

Groups with six monkeys each were orally dosed with lowering amounts of BSE brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).

Results:

In an ongoing study, a considerable number of high-dosed macaques already developed simian vCJD upon oral or intracerebral exposure or are at the onset of the clinical phase. However, there are differences in the clinical course between orally and intracerebrally infected animals that may influence the detection of biomarkers.

Conclusions:

Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route using less than 5 g BSE brain homogenate. The difference in the incubation period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years). However, there are rapid progressors among orally dosed monkeys that develop simian vCJD as fast as intracerebrally inoculated animals.

The work referenced was performed in partial fulfilment of the study "BSE in primates" supported by the EU (QLK1-2002-01096).

http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf

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 (ic ip 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. ic ip=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

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

TSS

http://madcowtesting.blogspot.com/2008/04/mbm-greaves-meat-offal-live-cattle.html



Thursday, April 09, 2009

Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed

[email protected].

Greetings FDA et al,

I lost my Mother to the Heidenhain Variant Creutzfeldt Jakob disease (confirmed see autopsy below).

I kindly wish to comment on the following ;

[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46

[Federal Register: April 9, 2009 (Volume 74, Number 67)] [Proposed Rules] [Page 16160-16161] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ap09-18]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46 TSS SUBMISSION # 5


Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed delay of effective date.

http://edocket.access.gpo.gov/2009/E9-8127.htm

MY COMMENT AS FOLLOWS ;

I find it deeply disturbing, that with the science to date, especially with the science to date, transmission studies, the more virulent atypical strains of the BSE i.e. h-BSE and l-BSE, both of which have now been documented in North America, that we are even still discussing this most important topic. The industry involved has beat this mad cow feed ban to death, and still refuse to comply. IF they would have adhered to policy, rules and regulations put forth August 4th, 1997, when the partial, and voluntary ruminant to ruminant feed ban was first put in place, they would not still be crying the same tune. WE need not only to enforce the present ban, but strengthen it, especially to include blood in the ban. WE (the consumer), was promised this would happen years ago. For Pete's sake, this will be the third president to have to address these same questions, and I pray that this one has the guts to finally do something. We need NOT discuss this for one more second. We had 8 years that President Bush literally covered up mad cow disease, and let literally millions and millions of pounds of mad cow feed into commerce to be fed out. IN one feed ban recall alone in 2007, 10 MILLION PLUS POUNDS was fed out into commerce. and under this same President, we now millions of kids across our Nation that have been needlessly exposed to the mad cow agent via the infamous USDA CERTIFIED DOWNER COW DEAD STOCK SCHOOL LUNCH PROGRAM. if you think for one moment that the largest meat recall in the history of the USA was because a few animals were filmed being abused, your only kidding yourself. that meat was recalled because dead stock downer cows are at the highest risk to carry mad cow disease, and they had been feeding our children this stuff for years. AND then had the nerve to lie to us about THE GREAT BSE FIREWALL IN THE USA THAT WOULD PROTECT THE CONSUMER I.E. THE BSE FEED BAN, that never was nothing more than ink on paper. who will monitor these children in the years and decades to come for a human form of Transmissible Spongiform Encephalopathy? who can with a CJD/TSE surveillance system and CJD Questionnaire set up the way it is now? you can't.

R-CALF and the CJD Foundation, seem oblivious to the fact that the USA has a mad cow problem. THIS IS NOT ABOUT THE CANADIAN BORDER. this is about feeding cows to cows in the USA, USA RUMINANT MAD COW FEED IN COMMERCE, and the fact the USA has had a mad cow problem for years.

all R-CALF wants to do is blame it on Canada, close the border, and then continue to feed ruminant feed to USA cattle, and ignore the TSE problem in the USA bovine, read closely what Bullard says from R-CALF ;

"We either implement this feed ban without any further delay or we stop the source of this problem by removing and reversing the Canadian cattle that continues to enter this country" said Bullard

http://www.montanasnewsstation.com/Global/story.asp?S=10171123

ENOUGH already $ NO MORE DISCUSSION PLEASE, WE NEED ACTION !

STOP ALL MAD COW FEED REGARDLESS !!!

I strenuously urge President Obama to NOT discuss this for one more moment, actions must be put forth now, and enforce such actions.

I strenuously urge President Obama to ENHANCE the feed ban to include blood, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban the use of "poultry litter" and the use of all mammalian and poultry protein in ruminant feed,as a feed ingredient for ruminant animals, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban the use of "plate waste" as a feed ingredient for ruminants, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban from human food (including dietary supplements please see latest May 2009 CDC warning on these type supplements, CWD, and Elk Antler Velvet), and cosmetics a wide range of bovine- derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates, and enforce such actions, based on sound science.

I strenuously urge President Obama to further minimize the possibility of cross- contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination, and enforce said regulations, based on sound science.

Sunday, April 12, 2009

BSE MAD COW TESTING USA 2009 FIGURES

Month Number of Tests

Feb 2009 -- 1,891

Jan 2009 -- 4,620

http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/ongoing_surv_results.shtml

http://madcowtesting.blogspot.com/2009/04/bse-mad-cow-testing-usa-2009-figures.html



PLEASE SEE MY FULL COMMENT SUBMISSION IN THE PDF ATTACHMENT, OR GO HERE


Thursday, April 9, 2009

Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed

http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html

http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html#comments

Sunday, April 12, 2009 r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada

http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html

http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html#comments





Thank you. Your comment on Document ID: FDA-2002-N-0031-0132 has been sent.

Your Comment tracking number is XXXXX

Attachments:

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----- Original Message ----- From: "TERRY SINGELTARY" <[email protected]> To: "Bovine Spongiform Encephalopathy" <[email protected]>; <[email protected]> Cc: <[email protected]>; <[email protected]>; <[email protected]>; <[email protected]>; <[email protected]> Sent: Wednesday, April 22, 2009 8:30 PM Subject: Re: [BSE-L] FDA-2002-N-0031-0132 Document Title Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date


Miracles do happen, i did not think i would live long enough to see this.
THANKS!


tss



CVM Update <<Back April 22, 2009

FDA Announces Confirmation of the Effective Date of the BSE Final Rule

The Food and Drug Administration today announced that the final rule
entitled ''Substances Prohibited From Use in Animal Food or Feed,'' will
become effective on April 27, 2009. However, to allow renderers additional
time to comply with the new requirements, the Agency has established a
compliance date of October 26, 2009. The additional 6 months will provide
time for those affected to identify appropriate methods for disposing of
material prohibited from use in animal feed by this rule. FDA is
encouraging affected parties who are able to begin complying with the rule
to do so as soon as possible.

In the April 9, 2009, Federal Register FDA proposed to delay the effective
date of the final rule for 60 days and provided a period of 7 days for
public comment. The agency received over 400 comments from state and
national cattle producer organizations, individual cattle producers,
renderers, meat processors, dairy organizations, State agriculture agencies,
and consumers.

Many of the comments indicated that certain entities were not adequately
prepared to comply with the final rule and that adequate alternative carcass
disposal methods had not been developed. However, a significant number of
comments received opposed delaying the effective date of the final rule due
to public and animal health concerns.

In consideration of all comments received, FDA believes the most appropriate
action is to confirm the April 27, 2009, effective date, and establish a
compliance date of October 26, 2009, for those who need additional time to
address compliance and implementation concerns.

FDA will conduct outreach to affected stakeholders to help them comply with
the rule. The Agency will hold a 50-state call to discuss the disposal
issues in various states or regions and will engage others affected by the
rule to assist as much as possible with meeting challenging carcass disposal
issues by the October 26, 2009 compliance date. FDA also plans on
finalizing the Small Entities Compliance Guide #195 for Renderers to provide
additional information specific to the concerns of the rendering industry.
Questions may be directed to Burt Pritchett, Center for Veterinary Medicine
(HFV-22), FDA, 7519 Standish Place, Rockville, MD 20855, 240-453-6860,
[email protected]..

For additional information, please see
http://www.federalregister.gov/OFRUpload/OFRData/2009-09466_PI.pdf and
http://www.fda.gov/cvm/bsetoc.html.



http://www.fda.gov/cvm/CVM_Updates/BSEFinalRule042209.htm




Tuesday, April 21, 2009


Docket No. FDA-2002-N-0031 CACTUS FEEDER INC.


http://madcowfeed.blogspot.com/


Monday, April 20, 2009


National Prion Disease Pathology Surveillance Center Cases Examined1
(December 31, 2008)


http://prionunitusaupdate2008.blogspot.com/2009/04/national-prion-disease-pathology.html


Thursday, April 9, 2009


Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46
Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed


http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html



http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html#comments


Sunday, April 12, 2009 r-calf and the USA mad cow problem, don't look, don't
find, and then blame Canada


http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html


http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html#comments



Wednesday, April 22, 2009


FDA Announces Confirmation of the Effective Date of the BSE Final Rule of
October 26, 2009



http://madcowfeed.blogspot.com/2009/04/fda-announces-confirmation-of-effective.html


i remember another 50 state emergency BSE conference call back in 2001 ;-)



Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 Date: Tue, 9 Jan 2001 16:49:00 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: [email protected]

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

Greetings List Members,

I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.

I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.

"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."

and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick.

(understand, these are taken from my notes for now. the spelling of names and such could be off.)

[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.

[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]

[host Richard] could you repeat the question?

[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

[not sure whom ask this] what group are you with?

[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.

[not sure who is speaking] could you please disconnect Mr. Singeltary

[TSS] you are not going to answer my question?

[not sure whom speaking] NO

from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;

[unknown woman] what group are you with?

[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now?

at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference.

IF i were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from;

[email protected] 301-827-6906

he would be glad to give you one ;-)

Rockville Maryland, Richard Barns Host

BSE issues in the U.S., How they were labelling ruminant feed? Revising issues.

The conference opened up with the explaining of the U.K. BSE epidemic winding down with about 30 cases a week.

although new cases in other countries were now appearing.

Look at Germany whom said NO BSE and now have BSE.

BSE increasing across Europe.

Because of Temporary Ban on certain rendered product, heightened interest in U.S.

A recent statement in Washington Post, said the New Administration (old GW) has a list of issues. BSE is one of the issues.

BSE Risk is still low, minimal in U.S. with a greater interest in MBM not to enter U.S.

HOWEVER, if BSE were to enter the U.S. it would be economically disastrous to the render, feed, cattle, industries, and for human health.

(human health-they just threw that in cause i was listening. I will now jot down some figures in which they told you, 'no need to write them down'. just hope i have them correct. hmmm, maybe i hope i don't ???)

80% inspection of rendering

*Problem-Complete coverage of rendering HAS NOT occurred.

sizeable number of 1st time FAILED INITIAL INSPECTION, have not been reinspected (70% to 80%).

Compliance critical, Compliance poor in U.K. and other European Firms.

Gloria Dunason Major Assignment 1998 goal TOTAL compliance. This _did not_ occur. Mixed level of compliance, depending on firm.

Rendering FDA license and NON FDA license

system in place for home rendering & feed 76% in compliance 79% cross contamination 21% DID NOT have system 92% record keeping less than 60% total compliance

279 inspectors 185 handling prohibited materials

Renderer at top of pyramid, significant part of compliance. 84% compliance

failed to have caution statement render 72% compliance & cross contamination caution statement on feed, 'DO NOT FEED TO CATTLE'

56 FIRMS NEVER INSPECTED

1240 FDA license feed mills 846 inspected

"close to 400 feed mills have not been inspected"

80% compliance for feed.

10% don't have system.

NON-FDA licensed mills There is NO inventory on non licensed mills. approximately 6000 to 8000 Firms ??? 4,344 ever inspected. "FDA does not have a lot of experience with"

40% do NOT have caution statement 'DO NOT FEED'.

74% Commingling compliance

"This industry needs a lot of work and only half gotten to"

"700 Firms that were falitive, and need to be re-inspected, in addition to the 8,000 Firms."

Quote to do BSE inspection in 19 states by end of January or 30 days, and other states 60 days. to change feed status??? Contract check and ask questions and pass info.

At this time, we will take questions.

[I was about the third or fourth to ask question. then all B.S.eee broke loose, and i lost my train of thought for a few minutes. picked back up here]

someone asking about nutritional supplements and sourcing, did not get name. something about inspectors not knowing of BSE risk??? the conference person assuring that Steve Follum? and the TSE advisory Committee were handling that.

Some other Dr. Vet, whom were asking questions that did not know what to do???

[Dennis Wilson] California Food Agr. Imports, are they looking at imports?

[Conference person] they are looking at imports, FDA issued imports Bulletin.

[Linda Singeltary ??? this was a another phone in question, not related i don't think] Why do we have non-licensed facilities?

(conference person) other feed mills do not handle as potent drugs???

Dennis Blank, Ken Jackson licensed 400 non FDA 4400 inspected of a total of 6000 to 8000,

(they really don't know how many non licensed Firms in U.S. they guess 6000 to 8000??? TSS)

Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not'

Warren-Maryland Dept. Agr. Prudent to re-inspect after 3 years. concerned of Firms that have changed owners.

THE END

TSS

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

Subject: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 Date: Wed, 10 Jan 2001 14:04:21 -0500 From: "Gomez, Thomas M." Reply-To: Bovine Spongiform Encephalopathy To: [email protected]

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

USDA/APHIS would like to provide clarification on the following point from Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.

[Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not']

Dr. Detwiler was responding to an announcement made during the call to use the FDA emergency number if anyone wanted to report a cow with signs suspect for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants to use the FDA emergency number as a last resort to report cattle suspect for BSE. What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement. Surveillance for BSE in the United States is a cooperative effort between states, producers, private veterinarians, veterinary hospitals and the USDA. The system has been in place for over 10 years. Each state has a system in place wherein cases are reported to either the State Veterinarian, the federal Veterinarian in Charge or through the veterinary diagnostic laboratory system. The states also have provisions with emergency numbers. Dr. Detwiler asked participants to use the systems currently in place to avoid the possibility of a BSE-suspect report falling through the cracks. Use of the FDA emergency number has not been established as a means to report diseased cattle of any nature.

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

Subject: Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan.9, 2001 Date: Wed, 10 Jan 2001 13:44:49 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: [email protected] References: 1

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

Hello Mr. Thomas,

What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement.

would you and the USDA/APHIS be so kind as to supply this list with a full text version of the conference call and or post on your web-site? if so when, and thank you. if not, why not?

The system has been in place for over 10 years.

that seems to be a very long time for a system to be in place, and only test 10,700 cattle from some 1.5 BILLION head (including calf crop). Especially since French are testing some 20,000 weekly and the E.U. as a whole, are testing many many more than the U.S., with less cattle, same risk of BSE/TSEs.

Why does the U.S. insist on not doing massive testing with the tests which the E.U. are using? Why is this, please explain?

Please tell me why my question was not answered?

U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

It was a very simple question, a very important question, one that pertained to the topic of BSE/feed, and asked in a very diplomatic way. why was it not answered?

If all these years, we have been hearing that pharmaceutical grade bovines were raised for pharmaceuticals vaccines etc. But yet the USA cannot comply with feed regulations of the ruminant feed ban, PLUS cannot even comply with the proper labelling of the feed, cross contamination etc. Then how in the world can you Guarantee the feed fed to pharmaceutical grade bovine, were actually non ruminant feed?

Before i was ask to be 'disconnected', i did hear someone in the background say 'we can't'-- have him ask the question again.

could you please be so kind, as to answer these questions?

thank you, Terry S. Singeltary Sr. Bacliff, Texas USA

P.S. if you will also notice, i did not post that emergency phone number and do not intend on passing it on to anyone. I was joking when i said i should call and report the whole damn U.S. Herd. So please pass that on to Dr. Detwiler, so she can rest easily.

BUT, they should be reported, some are infected with TSE. The U.S. is just acting as stupid as Germany and other Countries that insist they are free of BSE.

TSS

Subject: Report on the assessment of the Georgraphical BSE-risk of the USA July 2000 (not good) Date: Wed, 17 Jan 2001 21:23:51 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: [email protected]

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

Greetings List Members and ALL EU Countries,

Because of this report, and the recent findings of the 50-state BSE Conference call, I respectfully seriously suggest that these Countries and the SSC re-evaluate the U.S.A. G.B.R. to a risk factor of #3.

I attempted to post this to list in full text, but would not accept...

thank you, kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA

Report on the assessment of the Geographical BSE-risk of the USA July 2000

PART II

REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE RISK OF THE UNITED STATES OF AMERICA

- 29 -

Report on the assessment of the Geographical BSE-risk of the USA July 2000

EXECUTIVE SUMMARY

OVERALL ASSESSMENT

The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.

Stability: Before 1990 the system was extremely unstable because feeding of MBM to cattle happened, rendering was inappropriate with regard to deactivation of the BSE-agent and SRM and fallen stock were rendered for feed. From 1990 to 1997 it improved to very unstable, thanks to efforts undertaken to trace imported animals and exclude them from the feed chain and intensive surveillance. In 1998 the system became neutrally stable after the RMBM-ban of 1997.

External challenges: A moderate external challenge occurred in the period before 1990 because of importation of live animals from BSE-affected countries, in particular from the UK and Ireland. It cannot be excluded that some BSE-infected animals have been imported by this route and did enter the US rendering and feed production system. The efforts undertaken since 1990 to trace back UK-imported cattle and to exclude them from the feed chain reduced the impact of the external challenge significantly.

Interaction of external challenges and stability: While extremely unstable, the US system was exposed to a moderate external challenge, mainly resulting from cattle imports from the UK. It can not be excluded that BSE-infectivity entered the country by this route and has been recycled to domestic cattle. The resulting domestic cases would have been processed while the system was still very unstable or unstable and would hence have initiated a number of second or third generation cases. However, the level of the possible domestic prevalence must be below the low detection level of the surveillance in place.

As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent will remain at the current level.

JUSTIFICATION

1. DATA

The available information was suitable to carry out the GBR risk assessment.

- 30 -

Report on the assessment of the Geographical BSE-risk of the USA July 2000

2. STABILITY

2.1 Overall appreciation of the ability to identify BSE-cases and to eliminate animals at risk of being infected before they are processed

· Before 1989, the ability of the system to identify (and eliminate) BSE cases was limited. · Since 1990 this ability is significantly improved, thanks to a good BSE-surveillance and culling system (contingency plan). · Today the surveillance should be able to detect clinical BSE-cases within the limits set by an essential passive surveillance system, i.e. some cases might remain undetected.

2.2 Overall appreciation of the ability to avoid recycling BSE-infectivity, should it enter processing

· Before 1997 the US rendering and feed producing system would not have been able to avoid recycling of the BSE agent to any measurable extent. If the BSE-agent was introduced the feed chain, it could probably have reached cattle. · After the introduction of the RMBM-to-ruminants-ban in August 1997 the ability of the system to avoid recycling of BSE-infectivity was somewhat increased. It is still rather low due to the rendering system of ruminant material (including SRM and fallen stock) and the persisting potential for cross-contamination of cattle feed with other feeds and hence RMBM.

2.3 Overall assessment of the Stability

· Until 1990 the US BSE/cattle system was extremely unstable as RMBM was commonly fed to cattle, the rendering system was not able to reduce BSE-infectivity and SRM were rendered. This means that incoming BSE infectivity would have been most probably recycled to cattle and amplified and the disease propagated. · Between 1990 and 1995 improvements in the BSE surveillance and the efforts to trace back and remove imported cattle gradually improved the stability but the system remained very unstable. In 1998 the system became unstable because of an RMBM-ban introduced in 1997. After 1998 the ban was fully implemented and the system is regarded to be neutrally stable since 1998. The US system is therefore seen to neither be able to amplify nor to reduce circulating or incoming BSE-infectivity.

3. CHALLENGES

A moderate external challenge occurred in the period 1980-1989 because of importation of live animals from the UK. imports from other countries are regarded to have been negligible challenges. · As a consequence of this external challenge, infectivity could have entered the feed cycle and domestic animals could have been exposed to the agent. These domestic BSE-incubating animals might have again entered processing, leading to an internal challenge since 1991. · This internal challenge could have produced domestic cases of BSE, yet prevalence levels could have been below the detection limits of the surveillance system until now. (According to US calculations, the current surveillance

-31 -

Report on the assessment of the Geographical BSE-risk of the USA July 2000

system could detect clinical incidence of 1-3 cases per year per million adult cattle, i.e. in absolute numbers 43-129 cases per year). Between 1990 und 1995, with the exclusion of the imported animals from Europe from the feed chain, the effect of the external challenges decreased.

4. CONCLUSION ON THE RESULTING RISKS

4.1 Interaction of stability and challenqe

· In the late 80s, early 90s a moderate external challenges met an extremely unstable system. This would have amplified the incoming BSE-infectivity and propagated the disease. · With the exclusion of the imported animals from Europe from the feed chain between 1990 and 1995 the effect of the external challenge decreased. · Before 1998 an internal challenge, if it developed, would have met a still unstable system (inappropriate rendering, no SRM ban, RMBM ban only after 1997) and the BSE-infectivity could have been recycled and amplified. · After 1998 the neutrally stable system could still recycle the BSE-agent but due to the RMBM-ban of 1997 the BSE-infectivity circulating in the system would probably not be amplified.

4.2 Risk that BSE-infectivity enters processing

· A very low processing risk developed in the late 80s when the UK-imports were slaughtered or died. It increased until 1990 because of the higher risk to be infected with BSE of cattle imported from the UK in 1988/89, as these animals could have been processed prior to the back-tracing of the UK-imports in 1990. · From 1990 to 1995 a combination of surviving non-traced UK imports and some domestic (pre-)clinical cases could have arrived at processing resulting in an assumed constant low but non-negligible processing risk. · After 1995 any processing risk relates to assumed domestic cases arriving at processing. · The fact that no domestic cases have been shown-up in the BSE-surveillance is reassuring - it indicates that BSE is in fact not present in the country at levels above the detection limits of the country's surveillance system. This detection level has been calculated according to US-experts to be between 1 & 3 clinical cases per million adult cattle per year.

Note: The high turnover in parts of the dairy cattle population with a young age at slaughter makes it unlikely that fully developed clinical cases would occur (and could be detected) or enter processing. However, the theoretical infective load of the pre-clinical BSE-cases that under this scenario could be processed, can be assumed to remain relatively low.

4.3 Risk that BSE-infectivity is recycled and propagated

· During the period covered by this assessment (1980-1999) the US-system was not able to prevent propagation of BSE should it have entered, even if this ability was significantly improved with the MBM-ban of 1997. · However, since the likelihood that BSE-infectivity entered the system is regarded to be small but non-negligible, the risk that propagation of the disease took place is also small but not negligible.

- 32 -

Report on the assessment of the Geographical BSE-risk of the USA July 2000

5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK

5.1 The current GBR

The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.

5.2 The expected development of the GBR

As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent remains at the current level.

5.3 Recommendations for influencin.q the future GBR

· As long as the stability of the US system is not significantly enbanced above neutral levels it remains critically important to avoid any new external challenges. · All measures that would improve the stability of the system, in particular with regard to its ability to avoid recycling of the BSE-agent should it be present in the cattle population, would reduce, over time, the probability that cattle could be infected with the BSE-agent. Possible actions include: removal of SRMs and/or fallen stock from rendering, better rendering processes, improved compliance with the MBM-ban including control and reduction of cross-contamination. · Results from an improved intensive surveillance programme, targeting at risk sub-populations such as adult cattle in fallen stock or in emergency slaughter, could verify the current assessment.

snip... end...TSS

From: Terry S. Singeltary Sr. [[email protected]] Sent: Tuesday, July 29, 2003 1:03 PM To: [email protected] Cc: [email protected]; [email protected].; BSE-L Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION TO DOCKET 2003N-0312]

Greetings FDA,

snip...

PLUS, if the USA continues to flagrantly ignore the _documented_ science to date about the known TSEs in the USA (let alone the undocumented TSEs in cattle), it is my opinion, every other Country that is dealing with BSE/TSE should boycott the USA and demand that the SSC reclassify the USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the SSC to _flounder_ any longer on this issue, should also be regarded with great suspicion as well. NOT to leave out the OIE and it's terribly flawed system of disease surveillance. the OIE should make a move on CWD in the USA, and make a risk assessment on this as a threat to human health. the OIE should also change the mathematical formula for testing of disease. this (in my opinion and others) is terribly flawed as well. to think that a sample survey of 400 or so cattle in a population of 100 million, to think this will find anything, especially after seeing how many TSE tests it took Italy and other Countries to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to find 102 BSE cases), should be proof enough to make drastic changes of this system. the OIE criteria for BSE Country classification and it's interpretation is very problematic. a text that is suppose to give guidelines, but is not understandable, cannot be considered satisfactory. the OIE told me 2 years ago that they were concerned with CWD, but said any changes might take years. well, two years have come and gone, and no change in relations with CWD as a human health risk. if we wait for politics and science to finally make this connection, we very well may die before any decisions or changes are made. this is not acceptable. we must take the politics and the industry out of any final decisions of the Scientific community. this has been the problem from day one with this environmental man made death sentence. some of you may think i am exaggerating, but you only have to see it once, you only have to watch a loved one die from this one time, and you will never forget, OR forgive...yes, i am still very angry... but the transmission studies DO NOT lie, only the politicians and the industry do... and they are still lying to this day...TSS

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

Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Last updated: 19 July 2005 Adopted July 2004 (Question N° EFSA-Q-2003-083)

Report Summary Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90's when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.

Publication date: 20 August 2004

USA BSE GBR


http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620779461.htm


http://www.efsa.europa.eu/EFSA/Scientific_Document/sr03_biohaz02_usa_report_annex_en1.pdf?ssbinary=true


http://www.efsa.europa.eu/EFSA/Scientific_Document/sr03_biohaz02_usa_report_v2_en1.pdf?ssbinary=true


http://www.efsa.europa.eu/EFSA/Scientific_Document/sr03_biohaz02_usa_report_summary_en1.pdf?ssbinary=true



2005-2006

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE QUARTERLY ENFORCEMENT REPORT October 1, 2005 through December 31, 2005

snip....

CARGILL MEAT SOLUTIONS 00086K M DODGE CITY, KS X X On 10/11/05, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.

EXCEL CORP 00086R M FORT MORGAN, CO 2/22/05 X X On 8/11/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8. On 12/22/04, plant appealed the withholding action. Appeal was denied on 1/25/05.

00245L M LEXINGTON, NE 3/12/04 3/18/04 X 5/4/05 X X On 3/10/05, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.

9/16/05 9/29/05 X X TYSON FRESH MEATS INC. 09268 M PASCO, WA X X On 7/28/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.

TYSON FRESH MEATS INC. X X 00245D M EMPORIA, KS On 12/23/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.

DESERET MEAT 04852 M SPANISH FORK, UT 7/20/05 8/1/05 X X 12/29/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

NORTHERN PACKING COMPANY INC. 00571 M BRIAR HILL, NY 12/9/05 12/23/05 X X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

A.J. CEKAK'S MEAT MARKET 9/1/05 9/20/05 X X X On 9/1/05, an enforcement action 21562 M concerning failure to meet regulatory ORD, NE requirements for Escherichia coli Biotype 1 (E. coli) was taken. The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

ALTA VISTA LOCKER 10/5/05 10/26/05 X X The enforcement action included, as a 31931 M basis, failure of the establishment toALTA VISTA, KS comply with Agency requirements concerning specified risk material.

BROWN'S PROCESSING 13100 M13100 P ELSBERRY, MO 8/8/05 8/16/05 X X X 11/16/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

CHAMPLAIN BEEF INC 2/28/05 3/4/05 3/8/05 X X X 08547 M WHITEHALL, NY 10/17/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

FIVE STAR PACK INC. 9/1/05 9/9/05 X X 12/29/05 On 9/1/05, an enforcement action 08725 M08725 P concerning failure to meet regulatory GOLDEN CITY, MO requirements for Escherichia coli Biotype 1 (E. coli) was taken. The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material. FRESH FARMS BEEF 12/16/05 12/28/05 X X X The enforcement action included, as a 18579 M basis, failure of the establishment toRUTLAND, VT comply with Agency requirements concerning specified risk material.

GOETZ AND SONS WESTERN 11/15/05 11/23/05 12/1/05 X X MEATS INC 06245 M06245 P EVERETT, WA 12/17/05 12/28/05 X X X On 12/17/05, firm violated a regulatory control action by selling U.S.D.A retained product.

H AND P MEATS 21352 M SOUTH PITTSBURG, TN 7/28/05 8/8/05 8/17/05 8/19/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

HOPKINS PACKING COMPANY 11069 M BLACKFOOT, ID 7/28/05 8/1/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

NORTHWEST PREMIUM MEATS LLC 11032 M11032 P NAMPA, ID 7/26/05 7/29/05 X X 11/15/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

PARADISE LOCKER MEATS 31865 M31865 P TRIMBLE, MO 9/21/05 10/7/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material. PARAGON SPRAY DRYING, LLC 31762 M31762 P WAUKON, IA 9/6/05 9/12/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

RANDALL MEAT COMPANY 10669 M HOT SPRINGS, AR 7/1/05 7/28/05 10/12/05 10/24/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

S & S MEAT COMPANY 01046 M01046 P KANSAS CITY, MO 8/4/05 8/19/05 X X 11/16/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

STEAK MASTER 21159 M21159 P ELWOOD, NE 11/4/05 11/17/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

THE MEAT SHOP 31561 M BENSON, VT 8/18/05 9/6/05 9/9/05 X X X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

THEURER'S QUALITY MEATS, INC 31647 M31647 P LEWISTON, UT 7/27/05 7/29/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

TOOELE VALLEY MEATS 20594 M20594 P GRANTSVILLE, UT 7/25/05 8/1/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

WALNUT VALLEY PACKING LLC 32007 M32007 P EL DORADO, KS 12/15/05 12/30/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

YODER BROTHERS MEAT PROCESSING 17301 M PARIS, TN 10/3/05 10/12/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.

full text 54 pages ;

http://www.fsis.usda.gov/PDF/QER_Q1_FY2006.pdf

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE QUARTERLY ENFORCEMENT REPORT July 1, 2005 through September 30, 2005

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52 pages

http://www.fsis.usda.gov/PDF/QER_Q4_FY2005.pdf

TSS