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USDA Ignores Latest Scientific Evidence

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HAY MAKER

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USDA Ignores Latest Scientific Evidence,

Reverses BSE Protection Measures,

Adopts Weakest Int’l. Standards for Japanese Beef Imports



(Billings, Mont.) – “The U.S. Department of Agriculture (USDA) does not have a coherent BSE protection policy and is making trade deals with BSE-affected countries based on politics, not science,” said R-CALF USA president Leo McDonnell, in response to USDA’s final rule that allows Japan to export boneless beef from cattle of any age into the United States.



The rule (Japan Import Rule) is titled “Importation of Whole Cuts of Boneless Beef from Japan,” and was published Dec. 14 in the Federal Register (Docket No. 05-004-2).



Japan’s bovine spongiform encephalopathy (BSE) epidemic continues to grow, with seven new cases reported so far in 2005, and it reported its 21st case just last week. In 2004, Japan recorded five BSE cases; 2003, four cases; 2002, two cases; and, in 2001, three cases of BSE.



“Japan’s adult cattle population is only 2.05 million head, and with 21 reported BSE cases, it is obvious Japan has a significant BSE problem,” McDonnell explained. “Despite these facts, this Japan Import Rule immediately allows Japan to start shipping the U.S. boneless beef, no matter how old the animal was that those beef products came from.



“This sets a dangerous precedent for the U.S. cattle industry as it makes the U.S. the only major beef-consuming country in the world to accept beef from a BSE-infected cattle herd – regardless of the scope of the disease problem in that country and without requiring the more stringent BSE risk mitigation measures recommended by the OIE (World Organization for Animal Health),” he warned.



Less than a year ago, USDA published a rule on BSE and minimal-risk regions (Final Rule) to establish conditions under which the U.S. would accept beef from countries where BSE is known to exist. The agency claimed its policy was based on the latest scientific knowledge and USDA stated that several conditions must be met before the risk of importing beef from BSE-affected countries would be reduced to an acceptable level.



Among the conditions USDA stated were necessary to protect the U.S. from the introduction of BSE was the requirement that countries must have had in place – prior to the detection of BSE – risk mitigation measures adequate to prevent the establishment of the disease.



USDA explained that because of BSE’s lengthy incubation period, in countries that did not have risk mitigation measures such as a ruminant-to-ruminant feed ban prior to the detection of BSE, “by the time BSE was diagnosed in such countries and control measures were implemented, the chances that the disease had significantly spread were great.”



“This is precisely the case with Japan, which did not even implement a mandatory ruminant-to-ruminant feed ban until after late 2001, when it first discovered BSE in its native herd,” McDonnell pointed out. “With 21 cases of BSE, Japan’s rate of BSE is now over 10 cases per million head of cattle.



“Based on USDA’s own conclusions regarding BSE, Japan’s BSE epidemic is not expected to peak until 5 years after Japan implemented its feed ban, putting the expected peak during 2006 or beyond,” he continued. “So, despite Japan’s failure to implement timely prevention measures, USDA now says that this criterion doesn’t apply to Japan. And, despite the higher inherent risk of BSE in the Japanese cattle herd, the U.S. will, nonetheless, begin importing Japanese beef.”



USDA supports its newly relaxed position based on the same scientific knowledge the agency had when the agency established the condition in the first place – simply that BSE has not been detected in the muscle tissues of cattle.



But this isn’t all.



In addition, and again, based also on the agency’s ‘latest scientific knowledge,’ USDA defended its decision in the Final Rule to allow imports only from countries that met the condition of a BSE minimal-risk country, based on the agency’s implementation of what the USDA calls a series of interlocking and overlapping mitigation measures to minimize the risk of introducing BSE into the United States.



“This series of barriers included a requirement that only cattle and beef from cattle under 30 months of age would be allowed from minimal-risk countries – a recognition that the BSE risk is inherently higher in animals over 30 months of age,” McDonnell explained. “However, USDA has tossed this important mitigation measure out the window by allowing imports of Japanese beef from animals over 30 months of age, and the agency is now attempting to defend its action by claiming that age doesn’t matter after all.



“Unfortunately, however, USDA is accepting this over-30-month (OTM) Japanese beef from cattle of all breeds, including Holstein and Wagyu cattle, while imposing only the least stringent of all the risk mitigation measures recommended by the OIE,” McDonnell cautioned.



“The Japan Import Rule does not require the removal of high-risk tissues such as the brains, spinal cord and vertebral columns from Japanese cattle over 12 months of age, which is the minimal practice in every other country in the world, except Canada, with multiple cases of BSE,” McDonnell pointed out.



“USDA has not used any new scientific findings to support its relaxation of restrictions on Japanese imports,” noted veterinarian and R-CALF USA Vice President-Elect Max Thornsberry. “Instead, the agency has merely changed its conclusions drawn from the same scientific evidence it previously used to require much more stringent mitigation measures.”



In fact, Thornsberry pointed out, when R-CALF USA presented USDA with new scientific research (conducted on a naturally infected BSE cow by German researchers Anne Buschmann and Martin Groschup and published in the September 2005 issue of The Journal of Infectious Diseases) which not only reinforced previous findings but also revealed new findings showing BSE infectivity in new tissues – an obvious argument for proceeding with far more caution – USDA selectively dismissed the new scientific evidence on the basis the agency has not adequately confirmed that the scientific findings are correct.



“In other words,” stressed Thornsberry, “USDA is radically abandoning its scientific risk mitigation measures and is dismissing cutting-edge science without first confirming if such actions are unnecessarily increasing the risk of BSE.”

Moreover, Thornsberry said, the Japan Import Rule contradicts the agency’s previous conclusions on measures needed to mitigate the BSE risk. Just months ago, USDA considered BSE surveillance testing as an essential BSE mitigation measure. However, in the Japan Import Rule – which imposes no testing requirements on Japan – USDA now reverses its position and states that surveillance is not a mitigation measure.



Thornsberry explained that Japan currently conducts what is called an ELISA screening test followed by a confirmation test using the Western blot method on all older slaughtered cattle. This testing allows Japan to remove infected cattle from the food chain, particularly older cattle. But, because the U.S. does not require imports to be subject to such testing, Japanese beef from even older, high-risk cattle may be exported to the U.S. without undergoing a screening test to ensure that beef from older, BSE-infected animals is not exported to the United States, he said.



“U.S. consumers and U.S. cattle producers deserve the utmost in protections from USDA, and this action of relaxing important heath and safety standards in order to meet political ends – despite new scientific evidence – shows the agency has lost sight of its statutory responsibilities,” Thornsberry emphasized. “USDA could not be more inconsistent than is demonstrated by this rule.



In another clear example of inconsistency in the Japan Import Rule, USDA has ignored OIE’s requirement that beef products not be derived from cattle that may have been fed animal feed containing ruminant byproducts. Because the Japan Import Rule does not restrict cattle that were born before Japan’s 2001 feed ban, there is no provision or other assurance that cattle or beef products from cattle born and fed before the implementation of Japan’s feed ban would not be exported to the United States.



“One of the most frustrating things about this to cattle producers is USDA taking this action without regard to whether this relaxation of BSE standards will adversely affect our ability to restore the other export markets that were closed to us after the December 2003 discovery in Washington state of a Canadian cow with BSE,” he explained.



“What’s happening here is that USDA is hoping no one will object to this radical relaxation of health standards because they want to get into the Japanese market so badly,” McDonnell warned. “But USDA will now use this industry silence to support equally relaxed standards for Canada and other countries with BSE, opening the U.S. market to older cows and bulls that present a greater risk of introducing BSE.”



Note: To view the Japan Import Rule in its entirety, visit www.r-calfusa.com and go to “News Releases.” Find the link to this particular news release, and you can access the pdf file there.



# # #



R-CALF USA (Ranchers-Cattlemen Action Legal Fund, United Stockgrowers of America) represents thousands of U.S. cattle producers on domestic and international trade and marketing issues. R-CALF USA, a national, non-profit organization, is dedicated to ensuring the continued profitability and viability of the U.S. cattle industry. R-CALF USA’s membership consists primarily of cow/calf operators, cattle backgrounders, and feedlot owners. Its members – over 18,000 strong – are located in 47 states, and the organization has over 60 local and state association affiliates, from both cattle and farm organizations. Various main street businesses are associate members of R-CALF USA. For more information, visit www.r-calfusa.com or, call 406-252-2516.
 

PORKER

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Unfortunately, however, USDA is accepting this over-30-month (OTM) Japanese beef from cattle of all breeds, including Holstein and Wagyu cattle, while imposing only the least stringent of all the risk mitigation measures recommended by the OIE,” **** REASON, they have BEEN BSE TESTED FREE.
 

Silver

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PORKER said:
Unfortunately, however, USDA is accepting this over-30-month (OTM) Japanese beef from cattle of all breeds, including Holstein and Wagyu cattle, while imposing only the least stringent of all the risk mitigation measures recommended by the OIE,” **** REASON, they have BEEN BSE TESTED FREE.

And by my way of thinking that would make their beef safer than ours. What we should be irritated about is our lack of latitude to test our own beef, and advertise it as such.
 

flounder

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SRM Guidance Material
FSIS provides assistance to inspection program personnel in performing their verification activities as outlined in the interim final rule issued to amend 9 CFR 310.22(a)(3) of its regulations for the removal, segregation, and disposition of specified risk materials (SRMs).
Photograph 1 - Basic anatomical features to help determine the location of the most distal point of the distal ileum portion of the small intestine. (PDF only)
http://www.fsis.usda.gov/PDF/TSC_SRM_Cecum_Ileum.pdf
Photograph 2 - View of the ileocecal junction. (PDF only)
http://www.fsis.usda.gov/PDF/TSC_SRM_Ileocecal_Junction.pdf
Photograph 3 - View the uncoiling and trimming of the distal ileum proximal to the ileocecal junction. (PDF only)
http://www.fsis.usda.gov/PDF/TSC_SRM_Trimmed_Uncoiled_Ileum.pdf



BSE Guidance Material
Using Dentition to Age Cattle
Despite individual differences, when the age of an animal is not known, examination of the teeth serves as the best and most practical method of age determination.
Information and diagrams on the acceptable removal of tonsils from cattle for purposes of 9 CFR 310.22.
Visual diagrams and information provided in support of FSIS Notice 50-04



http://www.fsis.usda.gov/About_FSIS/Technical_Service_Center/index.asp


http://www.usda.gov/Newsroom/0264.04.html


http://www.usda.gov/Newsroom/0273.04.html


http://www.usda.gov/Newsroom/0289.04.html



Greetings,

i am trying to refrain in the new year, from having any opinion at all, one of a few of my new years resolutions. just go with the flow i suppose. the wife is estatic about it, her mom and dad have a bet. i even plan to expand this into my ongoing search for answers into TSE. so if i become boring, it's because i have no opinion on anything,
i will say nothing. it's going to be a quiet 2006. the betting lines are open at;
1-800-dontgiva ;-)

however, i suppose it does not hurt to ponder. i only ponder why they have ignored there own science there at USDA for all these years ;



Section
Title
File Format
Updated
Complete Manual The Complete BSE Surveillance Manual pdf 9.3mb 10/01/04 What's New Changes from the previous version html 17kb
10/01/04

Title Page
Contents

pdf 30kb
pdf 32kb
10/01/04
08/24/04
Procedure Manual Procedure Manual for BSE Surveillance pdf 420kb 10/01/04 Appendix A Procedures for investigations and
surveillance of targeted cattle for bovine spongiform encephalopathy (BSE) pdf 1.14mb 08/24/04 Appendix B BSE Surveillance Plan pdf 67kb 08/24/04 Appendix C State-level Surveillance Plan Templates pdf 80kb 08/24/04 Appendix D Sampling Job Aid pdf 1.6mb 08/24/04 Appendix E Taking a Quality Sample pdf 346kb 08/24/04 Appendix F AVIC Directory pdf 27kb 09/09/04 Appendix G Forms pdf 953kb 08/24/04 Appendix H Barcodes pdf 99kb 08/24/04 Appendix I Determining the Age of the Cattle pdf 888kb 08/24/04 Appendix J Background on BSE pdf 31kb 08/24/04 Appendix K FSIS Documents pdf 1.3mb 08/24/04 Appendix L Outreach Materials pdf 357kb 08/24/04 Appendix M Veterinary Services Memorandum NO. 580.4 – Procedures for Investigating a Suspected Foreign Animal Disease/Emerging Disease Incident (FAD/EDI) pdf 2.4mb 08/24/04


http://www.aphis.usda.gov/vs/nvsl/BSE/specimencollectionbse.htm



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

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


Page 1 of 17

From: Terry S. Singeltary Sr. [[email protected]]

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

To: [email protected]

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

for the Disposition of Non-Ambulatory Disabled Cattle

Greetings FSIS,

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

Requirements for the Disposition of Non-Ambulatory Disabled Cattle

THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle

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

snip...FULL TEXT ;


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


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



USA BSE RED BOOK

> October 1998
>
> BSE Red Book 2.1-36
>

> 7.2.1.7 Laboratory Coordination--The Laboratory Coordination Officer
> will advise the READE(3 Director concerning laboratory capabilities and
> appropriate laboratory examinations to be conducted to provide needed
> results as rapidly as possible. This individual will assist with
> interpretation of results.


> BSE Red Book 2.1-39
>
> 7.6 Depopulation Procedures
>
> Under no
> circumstances may BSE suspects be sent fo slaughhter or rendering.


snip...

> BSE Red Book 2.1-40
>
> 7.7 Disposal
> Under no circumstances may BSE suspects be sent to slaughter or
> rendering. Notify FDA, CVM if you suspect that the carcass of a
> BSE-confirmed animal has moved to rendering or animal feed
> manufacturing. Field personel should arrange for the carcass to be
> transported to and examined by a qualified veterinary pathologist or
> field veterinary medical officer. After the pathologic examination has
> been completed and the necessary diagnostic specimens have been
> obtained, field personnel should arrange for disposal of the carcass.
> Before a method of disposal is selected, there are many factors that
> must be considered, and often other State and Federal agencies must be
> consulted. The environmental and legal impacts of the operation must be
> considered. Upon recommendation of the State or Federal agencies, VS may
> consider other disposal methods.
>
snip...

> 7.7.3 Rendering
> Because BSE is spread by rendered animal protein, BSE-suspect and
> confirmed carcasses must not be rendered, unless the rendered material
> is incinerated. Notify FDA, CVM if you suspect that dead BSE animals or
> carcasses have moved to rendering or animal feed manufacturing.
>

snip...

> 7.10.11 Prevention--Suspects and animals confirmed to have BSE must not
> be rendered. Producers, feed mills, and rendering establishments should
> adhere to U.S. State and local rendering policies and FDA regulations
> concerning the feeding of rendered animal protein to ruminants.


snip...


If additional tests do suggest a
presumptive diagnosis of BSE, an NVSL pathologist will hand carry the
sample to the United Kingdom for confirmation. It is at this critical
point, when NVSL suggests a diagnosis of BSE and is preparing to send
the sample to the United Kingdom, that this BSE Response Plan is
initiated. The Plan begins the preliminary notification from NVSL to
APHIS. Preliminary Notification The director of NVSL is responsible for
immediately notifying the APHIS, Veterinary Services (VS) deputy
administrator when tests suggest a presumptive diagnosis of BSE. Once
NVSL has made a presumptive diagnosis of BSE, APHIS and FSIS field
activities will also be initiated. APHIS will receive notification
(either confirming or not confirming NVSL's diagnosis) from the United
Kingdom anywhere between 24 and 96 hours. (The international animal
health community has recognized the United Kingdom's Central Veterinary
Laboratory {CVL} as the world's reference laboratory for diagnosing BSE.
Other countries, including Belgium, France, Ireland, Luxembourg, the
Netherlands, Portugal, and Switzerland, have all sent samples to this
lab to confirm their first case of BSE).

snip...


https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument



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. ...



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



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

snip...


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


snip...



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


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



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

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


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



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


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



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


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

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



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



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

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

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

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


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


06/09/05
BSE Roundtable Discussion Transcript


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



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



USDA 2003

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

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


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


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

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

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


snip...


FULL TEXT;


Completely Edited Version
PRION ROUNDTABLE


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


2005


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

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


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



Office of Inspector General OIG

Semiannual Report to Congress FY - 2005 - First Half

snip...


Stopping BSE at the Border—USDA Needs To

Strengthen Controls Over Canadian Beef Imports

Following the detection of a Canadian cow with bovine

spongiform encephalopathy (BSE or “mad cow disease”)

in May 2003, we examined the Animal and Plant Health

Inspection Service’s (APHIS) oversight of the importation

of beef products from Canada. Following requests from

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

2004 to explore whether USDA did not follow appropriate

safety measures, beginning sometime in the fall of 2003,

in allowing expanded Canadian beef imports into the

United States.

After the initial halt of imports, in August 2003 the

Secretary announced a list of low-risk products that would

be allowed from Canada. APHIS also allowed an

expansion in the type of Canadian facilities that could

produce items for export to the United States. The

gradual expansion occurred because agency employees

included products similar to those on the published lowrisk

list, but APHIS did not communicate this broadly.

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

permits for products with questionable eligibility. Contrary

to publicly stated policy, the agency allowed the import of

products from Canadian facilities that produced both

eligible and ineligible products, increasing the possibility

that higher-risk product could be inadvertently imported.

APHIS also issued permits to allow the import of more

than 63,000 pounds of beef cheek meat with questionable

eligibility because the agency did not establish a clear

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

FSIS did not always communicate effectively about the

eligibility status of beef cheek meat, specifically to import

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

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

from Canada without ensuring that the agency had an

appropriate system of internal controls to manage the

process for a suddenly overwhelming volume of requests.

From May through September 2004, we identified more

than 42,000 pounds of product with questionable

eligibility.

APHIS generally agreed to institute procedures for

communicating changes in policy and monitoring the

consistency between agency practice and publicly stated

policy, as well as to strengthen controls and finalize

procedures to issue and monitor permits. FSIS generally

agreed to implement controls to communicate the specific

eligibility of product when its eligibility status changes and

to implement an edit check in its import information

system to identify ineligible product. (Audit Report No.

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

Products from Canada)


snip...


Restaurant Owner Sentenced for Smuggling Beef

from Japan, Importation of Which Is Prohibited Due

to Disease Concerns

In January 2005, a Los Angeles restaurant owner was

placed on probation for 60 months, to include 800 hours

of community service, after he pled guilty to smuggling

beef from Japan. Under 9 Code of Federal Regulations

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

for United States importation due to disease. On two

occasions in 2001 and 2002, inspectors in Anchorage,

Alaska, intercepted shipments sent from Japan that

were manifested as “book,” but upon inspection by

USDA and the United States Customs Service, were

found to contain approximately 25 kilograms of beef

inside a Styrofoam ice chest. Both shipments were

addressed to the restaurant owner. Shipping records

showed that the restaurant owner had received 13

shipments manifested as “book” from the same sender

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

were in the same weight range as the two intercepted

shipments. The shipper and the restaurant owner were

subsequently indicted for various charges including

conspiracy and smuggling. An arrest warrant was

issued for the shipper, who is still in Japan.


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





Working Group Report on

the Assessment of the Geographical BSE-Risk (GBR) of

CANADA

2004


snip...


- 2 -

2. EXTERNAL CHALLENGES

2.1 Import of cattle from BSE-Risk2 countries

An overview of the data on live cattle imports is presented in table 1 and is based on

data as provided in the country dossier (CD) and corresponding data on relevant exports

as available from BSE risk countries that exported to Canada. Only data from risk

periods are indicated, i.e. those periods when exports from a BSE risk country already

represented an external challenge, according to the SSC opinion on the GBR (SSC July

2000 and updated January 2002).

• According to the CD, 231 cattle were imported from UK during the years 1980 to

1990 and no cattle imports from UK were recorded after 1990.

• According to Eurostat, altogether 198 cattle have been imported from the UK during

the years 1980 to 1990, Additionally 500 were recorded in 1993; this import is

1 For the purpose of the GBR assessment the abbreviation "MBM" refers to rendering products, in particular

the commodities Meat and Bone Meal as such; Meat Meal; Bone Meal; and Greaves. With regard to imports

it refers to the customs code 230110 "flours, meals and pellets, made from meat or offal, not fit for human

2 BSE-Risk countries are all countries already assessed as GBR III or IV or with at least one confirmed

Annex to the EFSA Scientific Report (2004) 2, 1-14 on the Assessment of the

Geographical BSE Risk of Canada

- 3 -

mentioned in Eurostat and the updated UK export statistic as male calves, but not

mentioned in the original UK export statistics. According to the CD, detailed

investigations were carried out and it is very unlikely that the 500 calves have been

imported. Therefore, they were not taken into account.

• According to the CD, in 1990 all cattle imported from UK and Ireland since 1982

were placed in a monitoring program.

• Following the occurrence of the BSE index case in 1993 (imported from UK in 1987

at the age of 6 months), an attempt was made to trace all other cattle imported from

UK between 1982 and 1990.

• Of the 231 cattle imported from the UK between 1980 and 1990, 108 animals had

been slaughtered and 9 had died. From the remaining, 37 were exported, 76 were

sent to incineration and one was buried; these were not entering the rendering system

and therefore not taken into account.

• According to the CD, 16 cattle were imported from Ireland (according to Eurostat

20), of which 9 were slaughtered, 3 died. The remaining 4 were incinerated and did

therefore not enter the rendering system. According to the CD, the 6 animals which

were imported in 1990 according to Eurostat, were never imported.

• Moreover 22 cattle have been imported from Japan (through USA), of which 4 were

exported (excluded from the table) and 14 were destroyed and therefore not entering

the rendering system, 4 were slaughtered.

• Of 28 imported bovines from Denmark, 1 was destroyed and 1 was exported. Of the

19 buffalos imported in 2000, 1 was incinerated and the others were ordered to be

destroyed.

• Additionally in total 264 cattle according to the CD (276 according to other sources)

were imported from Austria, France, Germany, Hungary, Italy, The Netherlands and

Switzerland.

• The numbers imported according to the CD and Eurostat are very similar. Some

discrepancies in the year of import can be explained by an extended quarantine;

therefore it is likely that imports according to Eurostat in 1980 and imports

according to the CD in 1981 are referring to the same animals.

• Additionally, between 16.000 and 340.000 bovines have annually been imported

from US, almost all are steers and heifers. In total, between 1981 and 2003,

according to the CD more than 2.3 million, according to other sources 1.5 million

cattle have been imported.

• According to the CD, feeder/slaughter cattle represent typically more than 90% of

the imported cattle from the USA; therefore, only 10% of the imported cattle have

been taken into account.


snip...


Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

2.2 Import of MBM or MBM-containing feedstuffs from BSE-Risk

countries

An overview of the data on MBM imports is presented in table 2 and is based on data

provided in the country dossier (CD) and corresponding data on relevant exports as

available from BSE risk countries that exported to Canada. Only data from risk periods

are indicated, i.e. those periods when exports from a BSE risk country already

represented an external challenge, according to the SSC opinion on the GBR (SSC, July

2000 and updated January 2002).

According to the CD, no imports of MBM took place from UK since 1978 (initially

because of FMD regulations).

• According to Eurostat data, Canada imported 149 tons MBM from the UK in the

period of 1993 to 2001. According to up-dated MBM statistics from UK (August

2001) no mammalian MBM was exported to Canada from 1993 – 1996. As it was

illegal to export mammalian meat meal, bone meal and MBM from UK since

27/03/1996, exports indicated after that date should only have included nonmammalian

MBM. Therefore, these imports were not taken into account.

• According to the CD, imports of MBM have taken place from Denmark, Germany,

France, Japan and US.

• According to Eurostat Canada imported MBM from Denmark, Belgium, France and

Ireland.

• According to the CD further investigations concluded that all imported MBM from

Denmark consisted of pork and poultry origin and was directly imported for

aquaculture, the imported MBM from France was feather meal, the imported MBM

from Germany was poultry meal for aquaculture and the imported MBM from

Belgium was haemoglobin; therefore these imports were not taken into account.

• The main imports of MBM were of US origin, according to the CD around 250.000

tons, according to other sources around 310.000 tons between 1988 and 2003.


snip...


2.3 Overall assessment of the external challenge

The level of the external challenge that has to be met by the BSE/cattle system is

estimated according to the guidance given by the SSC in its final opinion on the GBR of

July 2000 (as updated in January 2002).

Live cattle imports:

In total the country imported according to the CD more than 2.3 million, according to

other data 1.5 million live cattle from BSE risk countries, of which 231 (CD)

respectively 698 (other sources) came from the UK. The numbers shown in table 1 are

the raw import figures and are not reflecting the adjusted imports for the assessment of

the external challenge. Broken down to 5 year periods the resulting external challenge is

as given in table 3. This assessment takes into account the different aspects discussed

above that allow to assume that certain imported cattle did not enter the domestic

BSE/cattle system, i.e. were not rendered into feed. In the case of Canada, the 500 cattle

imported from UK according to Eurostat were not taken into account and it is assumed

that all incinerated, buried, exported animals and the animals still alive did not enter the

rendering system and were therefore excluded from the external challenge.

MBM imports:

In total the country imported according to the CD around 300.000 tons, according to

other sources nearly 360.000 tons of MBM from BSE risk countries, of which 149 tons

came from the UK. The majority consisted of MBM imported from the US. The

numbers shown in table 2 are the raw import figures and are not reflecting the adjusted

imports for the assessment of the external challenge. Broken down to 5 year periods the

resulting external challenge is as given in table 3. This assessment takes into account

the different aspects discussed above that allow to assume that certain imported MBM

did not enter the domestic BSE/cattle system or did not represent an external challenge

for other reasons. As it was illegal to export mammalian meat meal, bone meal and

MBM from UK since 27/03/1996, exports indicated after that date should only have

included non-mammalian MBM. In the case of Canada all imported MBM from UK,

Germany, Belgium, Denmark and France was not taken into account.


snip...


3. STABILITY

3.1 Overall appreciation of the ability to avoid recycling of BSE

infectivity, should it enter processing

Feeding

The annual Canadian production of MBM is approximately 575,000 tons of which

approx. 40,000 tons are exported each year, mainly to USA.

Use of MBM in cattle feed

• Before the feed ban, dairy cattle received supplementary feed containing MBM

during their productive life (maximum 200-400 g MBM per day). Beef cattle in the

western part of the country do not usually receive complementary feed. Beef cattle

in the eastern part receive normally no supplement protein but the calves could have

access to creep feeds containing MBM, after weaning the ratios may have contained

supplemental protein containing MBM (100-400 g per day).

• According to the CD, MBM is mainly fed to pigs and poultry and included in pet

food.

• According to the CD, only a proportion of dairy cattle may have received MBM.

Feed bans

• Before 1997, there was no legal restriction to include MBM into cattle feed.

• An MBM-ban was introduced in August 1997; it is forbidden since to feed

mammalian MBM to ruminants except if of pure porcine, equine and non

mammalian origin, i.e. in practice a ruminant-to-ruminant ban (RMBM-ban).

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

- 9 -

Potential for cross-contamination and measures taken against

• Cross-contamination in the about 600 feed mills is assumed to be possible as long as

cattle and pig feed is produced in the same production lines, and premises.

• Cross-contamination during transport is possible, particularly if the same trucks are

used for transporting ruminant MBM (RMBM) and non-ruminant MBM (porcine or

poultry MBM which still might be included into cattle feed) or for transporting

pig/poultry feed and cattle feed.

• On-farm cross-contamination is regarded to be possible.

• Cross-contamination of cattle feed with RMBM can not be excluded. Hence, as

reasonable worst case scenario, it has to be assumed that cattle, in particular dairy

cattle, can still be exposed to RMBM and hence to BSE-infectivity, should it enter

the feed chain.

Control of Feed bans and cross-contamination

• With the introduction of the RMBM ban (1997) the feed mills (approximately 600)

were checked for compliance with the ban, including good manufacturing practices

(GMP) and record keeping, i.e. the separation in production of MBM containing

ruminant material (RMBM) from non-ruminant MBM.

• The feed mills had previously – since 1983 – been regularly checked in relation to

production of medicated feed.

• No examinations are performed to assess cross-contamination with RMBM of the

protein (e.g. non ruminant MBM) that enters cattle feed. Differentiation would

anyway be difficult.

Rendering

Raw material used for rendering

• Ruminant material is rendered together with material from other species, but

according to the CD only in the production of MBM prohibited for use in ruminant

feeds.

• Slaughter by-products, including specified risk material (SRM) and fallen stock are

rendered.

• The country expert estimated that 20% of the rendering plants, processing 20% of

the total amount of raw material, are connected to slaughterhouses. Their raw

material is more than 98 % animal waste from these slaughterhouses while less than

2 % is fallen stock. No estimation was given for the remaining 80% of the rendering

capacity.

• There are 32 rendering plants of which 3 are processing blood exclusively.

Rendering processes

• The rendering systems (parameters) were specified for 6 plants producing mixed

MBM, none of these fulfilled the 133/20/3 standard. Of these, 5 have dedicated

facilities to produce products for use in ruminant feed and products not permitted for

use in ruminant feed.

• The remaining plants process porcine or poultry material exclusively.

SRM and fallen stock

• There is an SRM ban for human food in place since 2003.

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

- 10 -

• However, SRM are rendered together with other slaughter waste and fallen stock.

However, according to the CD, MBM with SRM is not permitted to be fed to

ruminants.

Conclusion on the ability to avoid recycling

• Between 1980 and 1997 the Canadian system would not have been able to avoid

recycling of the BSE-agent to any measurable extent. If the BSE-agent was

introduced into the feed chain, it could have reached cattle.

• Since 1997 this ability gradually improved with the introduction of the ruminant

MBM ban and its implementation.

• Since cross-contamination cannot be excluded, and as SRM is still rendered by

processes unable to significantly reduce BSE-infectivity, the system is still unable to

avoid recycling of BSE-infectivity already present in the system or incoming.

3.2 Overall appreciation of the ability to identify BSE-cases and to

eliminate animals at risk of being infected before they are processed

Cattle population structure

• Cattle population: 12.15 Million in 1988 increasing to 14.6 Million in 2001;

• Of the total cattle population, 2.2 million are dairy cattle and 12.4 million are beef.

• The cattle population above 24 months of age: approx. 6.0 Million.

• Of the approximately 2.2 Million dairy cattle 2 Million are located in the two eastern

provinces Ontario and Quebec.

• Mixed farming (cattle and mono-gastric species) is usually not practiced; the

country expert estimated the proportion of mixed farming to be less than 1%.

• Individual regions traditionally have ID systems under provincial authorities. Brand

inspectors are present when cattle are assembled. It is estimated by the Canadians

that the level of a national, uniform ID for cattle is less than 10%; most of those

individual pedigree animals. Mandatory ID for the milk-fed veal sector was

implemented in Quebec in 1996, but does not contain information on the herd of

origin. An agreement of the relevant industries to develop a national cattle ID and

trace back strategy was reached on 1 May 1998 (starting in 2001).Since 2002, a

national identification program is existing. Al cattle leaving any farm premises must

be uniquely identified by ear tag.

BSE surveillance

• BSE was made notifiable in 1990.

• Every cow over one year of age exhibiting central nervous system signs suggestive

of BSE submitted to a laboratory or presented at an abattoir is subjected to a BSE

laboratory diagnostic test (histology and over the past years also PrPSc-based

laboratory tests).

• In addition, cattle submitted for rabies examination and found rabies negative are

examined for BSE. Samples are prepared immediately upon arrival to the federal

laboratory responsible for the rabies diagnostic for possible later BSE examination,

i.e. formalin fixation.

• Since the 1940’s, a rabies control program has been in place, where farmers,

veterinarians and the general public are well educated about this neurological

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

- 11 -

disease. In 1990, when BSE was made notifiable, this awareness was extended to

suspicions of BSE.

• Since 1993 the number of brains examined per year did exceed the number

recommended by OIE (300 - 336 for countries with a cattle population over 24

months of age of 5.0 to 7.0 Million) in all years, except in 1995 (table 4).

year 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003

samples 225 645 426 269 454 759 940 895 1´020 1´581 3´377 3´361

Table 4: Number of bovine brains annually examined for CNS diseases, including BSE.

• According to the CD approx. 98% of the examined cattle were older than 24 months

and approx. 90% exhibited neurological symptoms. Although the identification

system of Canada does not document the birth date or age of the animals, according

to the CD, examination of the dentition is used to ascertain the maturity of the

animals.

• The list of neurological differential diagnoses for the 754 brains examined in 1997

included encephalitis (70 cases), encephalomalacia (19), hemophilus (7),

hemorrhage (2), listeriosis (38), meningoencephalitis (36), rabies (22), tumors (2),

other conditions (135) and no significant findings (423).

• Compensation is paid for suspect BSE cases as well as for animals ordered to be

destroyed (90-95% of market value with a maximum of 2,500 Can$ per cow).

• Diagnostic criteria developed in the United Kingdom are followed at ADRI,

Nepean. According to the very detailed protocol for the collection, fixation and

submission of Bovine Spongiform Encephalopathy (BSE) specimens at abattoirs

under inspection by the Canadian Food Inspection Agency, the specimen shall be

shipped to National Center for Foreign Animal Disease, Winnipeg, Manitoba.

• In 2003, around 3000 animals from risk populations have been tested.

• According to the CD, it is aimed to test a minimum of 8000 risk animals (animals

with clinical signs consistent with BSE, downer cows, animals died on farm animals

diseased or euthanized because of serious illness) in 2004 and then continue to

progressively increase the level of testing to 30,000.

• In May 2003, Canada reported its first case of domestic BSE. A second case was

detected in the US on 23 December 2003 and traced back to Canadian origin. Both

were born before the feed ban and originated from Western Canada.

3.3 Overall assessment of the stability

For the overall assessment of the stability, the impact of the three main stability factors

(i.e. feeding, rendering and SRM-removal) and of the additional stability factor,

surveillance, has to be estimated. Again, the guidance provided by the SSC in its

opinion on the GBR of July 2000 (as updated January 2002) is applied.

Feeding

Until 1997, it was legally possible to feed ruminant MBM to cattle and a certain fraction of

cattle feed (for calves and dairy cattle) is assumed to have contained MBM. Therefore

feeding was "Not OK". In August 1997 a ruminant MBM ban was introduced but feeding

of non-ruminant MBM to cattle remained legal as well as feeding of ruminant MBM to

non-ruminant animals. This makes control of the feed ban very difficult because laboratory

differentiation between ruminant and non ruminant MBM is difficult if not impossible.

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

Due to the highly specialised production system in Canada, various mammalian MBM

streams can be separated. Such a feed ban would therefore be assessed as "reasonably

OK", for all regions where this highly specialised system exists. However, several areas

in Canada do have mixed farming and mixed feed mills, and in such regions, an RMBM

ban would not suffice. Additionally, official controls for cattle feeds to control for the

compliance with the ban were not started until the end of 2003. Thus, for the whole

country, the assessment of the feeding after 1997 remains "Not OK".

Rendering

The rendering industry is operating with processes that are not known to reduce infectivity.

It is therefore concluded that the rendering was and is "Not OK".

SRM-removal

SRM and fallen stock were and are rendered for feed. Therefore SRM-removal is assessed

as "Not OK"


snip...


4.2 Risk that BSE infectivity entered processing

A certain risk that BSE-infected cattle entered processing in Canada, and were at least

partly rendered for feed, occurred in the early 1990s when cattle imported from UK in

the mid 80s could have been slaughtered. 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.

4.3 Risk that BSE infectivity was recycled and propagated

A risk that BSE-infectivity was recycled and propagated exists since a processing risk

first appeared; i.e. in the early 90s. Until today this risk persists and increases fast

because of the extremely unstable BSE/cattle system in Canada.

5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK

5.1 The current GBR as function of the past stability and challenge

The current geographical BSE-risk (GBR) level is III, i.e. it is confirmed at a lower level

that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.

This assessment deviates from the previous assessment (SSC opinion, 2000) because at

that time several exporting countries were not considered a potential risk.

snip...

full text;



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



EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Publication date: 20 August 2004
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.


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html

SUMMARY

Summary of Scientific Report
http://www.efsa.eu.int
1 of 1
Scientific Report of the European Food Safety Authority
on the Assessment of the Geographical BSE-Risk (GBR) of
United States of America (USA)
Question N° EFSA-Q-2003-083
Adopted July 2004
Summary of 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.
Key words: BSE, geographical risk assessment, GBR, USA, third countries

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573/sr03_biohaz02_usa_report_summary_en1.pdf

REPORT (6 PAGES)

snip...

EFSA Scientific Report (2004) 3, 1-6 on the Assessment of the Geographical BSE Risk of
Conclusions
The European Food Safety Authority concludes:
1. The BSE agent was probably imported into USA and could have reached domestic
cattle in the middle of the eighties. This 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 meat and bone meal (MBM) imported into the USA
reached domestic cattle and lead to an internal challenge in the early nineties.
2. 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.
3. The current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed
that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
4. This assessment deviates from the previous assessment (SSC opinion, 2000) because
at that time several exporting countries were not considered a potential risk.
5. It is also worth noting that the current GBR conclusions are not dependent on the large
exchange of imports between USA and Canada. External challenge due to exports to
the USA from European countries varied from moderate to high. These challenges
indicate that it was likely that BSE infectivity was introduced into the North American
continent.
6. EFSA and its Scientific Expert Working group on GBR are concerned that the
available information was not confirmed by inspection missions as performed by the
Food and Veterinary office (FVO – DG SANCO) in Member States and other third
countries. They recommend including, as far as feasible, BSE-related aspects in
future inspection missions.
Expected development of the GBR
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.
A table summarising the reasons for the current assessment is given in the table below

snip...

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573/sr03_biohaz02_usa_report_v2_en1.pdf


EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Mexico
Last updated: 08 September 2004
Adopted July 2004 (Question N° EFSA-Q-2003-083)

Report

http://www.efsa.eu.int
3 of 6
Conclusions
The European Food Safety Authority concludes:
1. The BSE agent was probably imported into Mexico and could have reached domestic
cattle. These cattle imported could have been rendered and therefore led to an internal
EFSA Scientific Report (2004) 4, 1-6 on the Assessment of the Geographical BSE Risk of
challenge in the mid to late 1990’s. It is possible that imported MBM into Mexico
reached domestic cattle and leads to an internal challenge around 1993.
2. It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’
MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late
1990s). The high level of external challenge is maintained throughout the reference
period, and the system has not been made stable. Thus it is likely that BSE infectivity
was recycled and propagated from approximately 1993. The risk has since grown
consistently due to a maintained internal and external challenge and lack of a stable
system.
3. The current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed
that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
4. EFSA and its Scientific Expert Working group on GBR are concerned that the
available information was not confirmed by inspection missions as performed by the
Food and Veterinary office (FVO – DG SANCO) in Member States and other third
countries. They recommend including, as far as feasible, BSE-related aspects in
future inspection missions.

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/565/sr04_biohaz02_mexico_report_v2_en1.pdf

Summary

Summary of Scientific Report
http://www.efsa.eu.int
1 of 2
Scientific Report of the European Food Safety Authority
on the Assessment of the Geographical BSE-Risk (GBR) of
MEXICO
Question N° EFSA-Q-2003-083
Adopted July 2004
SUMMARY OF 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 Mexico, i.e. the likelihood of the presence of one or more cattle being infected
with BSE, pre-clinically as well as clinically, in Mexico. This scientific report addresses the
GBR of Mexico as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into Mexico and could have reached domestic cattle.
These cattle imported could have been rendered and therefore led to an internal challenge in
the mid to late 1990s. It is possible that imported meat and bone meal (MBM) into Mexico
reached domestic cattle and leads to an internal challenge around 1993.
It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM
(1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990s). The
high level of external challenge is maintained throughout the reference period, and the system
has not been made stable. Thus it is likely that BSE infectivity was recycled and propagated
from approximately 1993. The risk has since grown consistently due to a maintained internal
and external challenge and lack of a stable system.
EFSA concludes that the current geographical BSE risk (GBR) level is III, i.e. it is likely
but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSEagent.
The GBR is likely to increase due to continued internal and external challenge, coupled
with a very unstable system.
Key words: BSE, geographical risk assessment, GBR, Mexico, third countries
Summary of Scientific Report
http://www.efsa.eu.int
2 of 2


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/565/sr04_biohaz02_mexico_report_summary_en1.pdf


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 Mexico, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in Mexico. This scientific report addresses the GBR of Mexico as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into Mexico and could have reached domestic cattle. These cattle imported could have been rendered and therefore led to an internal challenge in the mid to late 1990s. It is possible that imported meat and bone meal (MBM) into Mexico reached domestic cattle and leads to an internal challenge around 1993.

It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990s). The high level of external challenge is maintained throughout the reference period, and the system has not been made stable. Thus it is likely that BSE infectivity was recycled and propagated from approximately 1993. The risk has since grown consistently due to a maintained internal and external challenge and lack of a stable system.

EFSA concludes that the current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. The GBR is likely to increase due to continued internal and external challenge, coupled with a very unstable system.

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/565_en.html


ONE YEAR PREVIOUSLY ;

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



DO all these accolades by Johanns USDA et al sound familiar? lets compare;


>>>And I can tell you, right now, with the BSE safeguards in place, American and Canadian beef and beef products are safe for consumption. <<<


compared to;


>>>Brownie, your doing a heck of a job<<<


no comment here, i have vowed a New Year resolution, i have no opinion anymore. ...TSS

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flounder

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re-OIE risk mitigation on BSE ???



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. With Science like this, Japan would be fully justified in declining to be a member. ...


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




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

C H A P T E R 2 . 3 . 1 3 .

BOVINE SPONGIFORM ENCEPHALOPATHY

Article 2.3.13.1.

The recommendations in this Chapter are intended to manage the human and animal health risks

associated with the presence of the bovine spongiform encephalopathy (BSE) agent in cattle (Bos taurus

and B. indicus) only.

1) When authorising import or transit of the following commodities and any products made from these

commodities and containing no other tissues from cattle, Veterinary Administrations should not

require any BSE related conditions, regardless of the BSE risk status of the cattle population of the

exporting country, zone or compartment:

a) milk and milk products;

b) semen and in vivo derived cattle embryos collected and handled in accordance with the

recommendations of the International Embryo Transfer Society;

c) hides and skins;

d) gelatin and collagen prepared exclusively from hides and skins;

e) protein-free tallow (maximum level of insoluble impurities of 0.15% in weight) and derivatives

made from this tallow;

f) dicalcium phosphate (with no trace of protein or fat);

g) deboned skeletal muscle meat (excluding mechanically separated meat) from cattle 30 months of

age or less, which were not subjected to a stunning process, prior to slaughter, with a device

injecting compressed air or gas into the cranial cavity, or to a pithing process, and which were

subject to ante- and post-mortem inspection and were not suspect or confirmed BSE cases; and

which has been prepared in a manner to avoid contamination with tissues listed in

Article 2.3.13.13.;

h) blood and blood by-products, from cattle which were not subjected to a stunning process,

prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a

pithing process.

2) When authorising import or transit of other commodities listed in this chapter, Veterinary

Administrations should require the conditions prescribed in this Chapter relevant to the BSE risk

status of the cattle population of the exporting country, zone or compartment.

Standards for diagnostic tests are described in the Terrestrial Manual.

Article 2.3.13.2.

The BSE risk status of the cattle population of a country, zone or compartment should be determined on the

basis of the following criteria:

1) the outcome of a risk assessment (which is reviewed annually), based on Section 1.3., identifying all

potential factors for BSE occurrence and their historic perspective:

2005 OIE Terrestrial Animal Health Code

2

a) Release assessment

Release assessment consists of assessing the likelihood that a transmissible spongiform

encephalopathy (TSE) agent has been introduced into the cattle population from a pre-existing

TSE in the indigenous ruminant population or via commodities potentially contaminated with a

TSE agent, through a consideration of the following:

i) the presence or absence of animal TSE agents in the country or zone or compartment and, if

present, their prevalence based on the outcomes of surveillance;

ii) meat-and-bone meal or greaves from the indigenous ruminant population;

iii) imported meat-and-bone meal or greaves;

iv) imported live animals;

v) imported animal feed and feed ingredients;

vi) imported products of ruminant origin for human consumption, which may have contained

tissues listed in Article 2.3.13.13. and may have been fed to cattle;

vii) imported products of ruminant origin for in vivo use in cattle.

Surveillance and other epidemiological investigations (especially surveillance for BSE conducted

on the cattle population) relevant to the above should be taken into account in carrying out the

assessment.

b) Exposure assessment

If the release assessment identifies a risk factor, an exposure assessment should be conducted,

consisting of assessing the likelihood of exposure of the BSE agent to cattle, through a

consideration of the following:

i) recycling and amplification of the BSE agent through consumption by cattle of meat-andbone

meal or greaves of ruminant origin, or other feed or feed ingredients contaminated with

these;

ii) the use of ruminant carcasses (including from fallen stock), by-products and slaughterhouse

waste, the parameters of the rendering processes and the methods of animal feed

manufacture;

iii) the feeding or not of ruminants with meat-and-bone meal and greaves derived from ruminants,

including measures to prevent cross-contamination of animal feed;

iv) the level of surveillance for BSE conducted on the cattle population to that time and the

results of that surveillance.

2) on-going awareness programme for veterinarians, farmers, and workers involved in transportation,

marketing and slaughter of cattle to encourage reporting of all cases showing clinical signs consistent

with BSE in target sub-populations as defined in Appendix 3.8.4.;

2005 OIE Terrestrial Animal Health Code

3

3) the compulsory notification and investigation of all cattle showing clinical signs consistent with BSE;

4) the examination in an approved laboratory of brain or other tissues collected within the framework

of the aforementioned surveillance and monitoring system.

When the risk assessment (which takes into account the surveillance referred to in the release and

exposure assessments above) demonstrates non-negligible risk, the country should conduct Type A

surveillance in accordance with Appendix 3.8.4.

When the risk assessment (which takes into account the surveillance referred to in the release and

exposure assessments above) demonstrates negligible risk, the country should conduct Type B surveillance

in accordance with Appendix 3.8.4.

Article 2.3.13.3.

Negligible BSE risk

Commodities from the cattle population of a country, zone or compartment pose a negligible risk of

transmitting the BSE agent should the following conditions be met:

1) a risk assessment, as described in point 1) of Article 2.3.13.2., has been conducted in order to identify

the historical and existing risk factors and the country has been demonstrated that appropriate

generic measures have been taken for the relevant period of time defined below to manage all risk

identified;

2) the country has demonstrated that Type B surveillance in accordance with Appendix 3.8.4. is in place,

3) EITHER:

a) there has been no case of BSE, or any case of BSE has been demonstrated to have been imported

and has been completely destroyed, and:

i) the criteria in points 2) to 4) of Article 2.3.13.2. have been complied with for at least

7 years; and

ii) it has been demonstrated, through an appropriate level of control and audit, that for at least

8 years meat-and-bone meal or greaves derived from ruminants has not been fed to ruminants;

OR

b) the last indigenous case of BSE was reported more than 7 years ago; and

i) the criteria in points 2) to 4) of Article 2.3.13.2. have been complied with for at least

7 years; and

ii) it has been demonstrated, thorough an appropriate level of control and audit, that for at

least 8 years meat-and-bone meal and greaves derived from ruminants has not been fed to

ruminants; and

iii) all BSE cases, as well as:

- all the progeny of female cases, born within 2 years prior to or after clinical onset of

the disease, and

2005 OIE Terrestrial Animal Health Code

4

- all cattle which, during their first year of life, were reared with the BSE cases during

their first year of life, and which investigation showed consumed the same potentially

contaminated feed during that period, or

- if the results of the investigation are inconclusive, all cattle born in the same herd as,

and within 12 months of the birth of, the BSE cases,

if alive in the country, zone or compartment, are permanently identified, and their movements

controlled, and when slaughtered or at death, are completely destroyed.

Article 2.3.13.4.

Controlled BSE risk

Commodities from the cattle population of a country, zone or compartment pose a controlled risk of

transmitting the BSE agent, should the following conditions be met:

1) a risk assessment, as described in point 1) of Article 2.3.13.2., has been conducted in order to identify

the historical and existing risk factors, and the country has not demonstrated that appropriate generic

measures have been taken for the relevant period of time defined below to manage all risks identified;

2) the country has demonstrated that Type A surveillance in accordance with Appendix 3.8.4. is in

place;

3) EITHER

a) there has been no case of BSE or any case of BSE has been demonstrated to have been imported

and has been completely destroyed, the criteria in points 2) to 4) of Article 2.3.13.2. are

complied with, and it can be demonstrated, through an appropriate level of control and audit,

that meat-and-bone meal and greaves derived from ruminants has not been fed to ruminants, but at

least one of the following two conditions applies:

i) the criteria in points 2) to 4) of Article 2.3.13.2. have not been complied with for 7 years;

ii) it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves

derived from ruminants to ruminants have been in place for 8 years;

OR

b) there has been an indigenous case of BSE reported, the criteria in points 2) to 4) of

Article 2.3.13.2. are complied with, and it can be demonstrated, through an appropriate level of

control and audit that meat-and-bone meal and greaves derived from ruminants have not been fed

to ruminants, but at least one of the following two conditions applies:

i) the criteria in points 2) to 4) of Article 2.3.13.2. have not been complied with for 7 years;

ii) it cannot be demonstrated that controls over the feeding of meat-and-bone meal and greaves

derived from ruminants to ruminants have been in place for 8 years;

AND

iii) all BSE cases, as well as:

- all the progeny of female cases, born within 2 years prior to or after clinical onset of

the disease, and

2005 OIE Terrestrial Animal Health Code

5

- all cattle which, during their first year of life, were reared with the BSE cases during

their first year of life, and which investigation showed consumed the same potentially

contaminated feed during that period, or

- if the results of the investigation are inconclusive, all cattle born in the same herd as,

and within 12 months of the birth of, the BSE cases,

if alive in the country, zone or compartment, are permanently identified, and their movements

controlled, and when slaughtered or at death, are completely destroyed.

Article 2.3.13.5.

Undetermined BSE risk

The cattle population of a country, zone or compartment poses an undetermined BSE risk if it cannot be

demonstrated that it meets the requirements of another category.

Article 2.3.13.6.

When importing from a country, zone or compartment posing a negligible BSE risk, Veterinary

Administrations should require:

for all commodities from cattle not listed in point 1) of Article 2.3.13.1.

the presentation of an international veterinary certificate attesting that the country or zone/compartment

complies with the conditions in Article 2.3.13.3.

Article 2.3.13.7.

When importing from a country, zone or compartment posing a controlled BSE risk, Veterinary

Administrations should require:

for cattle

the presentation of an international veterinary certificate attesting that:

1) the country, zone or compartment complies with the conditions in Article 2.3.13.4.;

2) cattle selected for export are identified by a permanent identification system enabling them to be

traced back to the dam and herd of origin, and are not exposed cattle as described in point 2) c) iii) of

Article 2.3.13.4.;

3) in the case of a country, zone or compartment with an indigenous case, cattle selected for export were

born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and

greaves derived from ruminants had been effectively enforced.

Article 2.3.13.8.

When importing from a country, zone or compartment with an undetermined BSE risk, Veterinary

Administrations should require:

for cattle

the presentation of an international veterinary certificate attesting that:

1) the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been banned

and the ban has been effectively enforced;

2005 OIE Terrestrial Animal Health Code

6

2) all BSE cases, as well as:

a) all the progeny of female cases, born within 2 years prior to or after clinical onset of the disease,

and

b) all cattle which, during their first year of life, were reared with the BSE cases during their first

year of life, and, which investigation showed consumed the same potentially contaminated feed

during that period, or

c) if the results of the investigation are inconclusive, all cattle born in the same herd as, and within

12 months of the birth of, the BSE cases,

if alive in the country, zone or compartment, are permanently identified, and their movements controlled,

and when slaughtered or at death, are completely destroyed;

3) cattle selected for export:

a) are identified by a permanent identification system enabling them to be traced back to the dam

and herd of origin and are not the progeny of BSE suspect or confirmed females;

b) were born at least 2 years after the date from which the ban on the feeding of ruminants with

meat-and-bone meal and greaves derived from ruminants was effectively enforced.

Article 2.3.13.9.

When importing from a country, zone or compartment posing a negligible BSE risk, Veterinary

Administrations should require:

for fresh meat and meat products from cattle (other than that listed in point 1) of Article 2.3.13.1.)

the presentation of an international veterinary certificate attesting that:

1) the country, zone or compartment complies with the conditions in Article 2.3.13.3.;

2) ante-mortem and post-mortem inspections were carried out on all cattle from which the fresh meat or

meat products originate.

Article 2.3.13.10.

When importing from a country, zone or compartment posing a controlled BSE risk, Veterinary

Administrations should require:

for fresh meat and meat products from cattle (other than those listed in point 1) of Article 2.3.13.1.)

the presentation of an international veterinary certificate attesting that:

1) the country, zone or compartment complies with the conditions in Article 2.3.13.4.;

2) ante-mortem and post-mortem inspections were carried out on all cattle from which the fresh meat

and meat products originate;

3) cattle from which the fresh meat and meat products destined for export originate were not subjected to a

stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial

cavity, or to a pithing process;

4) the fresh meat and meat products do not contain:

a) the tissues listed in Article 2.3.13.13.,

b) mechanically separated meat from the skull and vertebral column from cattle over 30 months of

age,

all of which have been completely removed in a manner to avoid contamination of the fresh meat and

meat products.

2005 OIE Terrestrial Animal Health Code

7

Article 2.3.13.11.

When importing from a country, zone or compartment with an undetermined BSE risk, Veterinary

Administrations should require:

for fresh meat and meat products from cattle (other than those listed in point 1) of Article 2.3.13.1.)

the presentation of an international veterinary certificate attesting that:

1) the cattle from which the fresh meat and meat products originate:

a) are not suspect or confirmed BSE cases;

b) have not been fed meat-and-bone meal or greaves;

c) were subjected to ante-mortem and post-mortem inspections;

d) were not subjected to a stunning process, prior to slaughter, with a device injecting compressed

air or gas into the cranial cavity, or to a pithing process;

2) the fresh meat and meat products do not contain:

a) the tissues listed in Article 2.3.13.13.,

b) nervous and lymphatic tissues exposed during the deboning process,

c) mechanically separated meat from the skull and vertebral column from cattle over 12 months of

age,

all of which have been completely removed in a manner to avoid contamination of the fresh meat and

meat products.

Article 2.3.13.12.

Ruminant-derived meat-and-bone meal or greaves, or any commodities containing such products, which

originate from a country, zone or compartment defined in Articles 2.3.13.4. and 2.3.13.5. should not be traded

between countries.

Article 2.3.13.13.

1) From cattle of any age originating from a country, zone or compartment defined in Articles 2.3.13.4. and

2.3.13.5., the following commodities, and any commodity contaminated by them, should not be

traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals,

or medical devices: tonsils and distal ileum, and protein products derived thereof. Food, feed,

fertilisers, cosmetics, pharmaceuticals or medical devices prepared using these commodities should

also not be traded.

2) From cattle that were at the time of slaughter over 30 months of age originating from a country, zone

or compartment defined in Article 2.3.13.4., the following commodities, and any commodity

contaminated by them, should not be traded for the preparation of food, feed, fertilisers, cosmetics,

pharmaceuticals including biologicals, or medical devices: brains, eyes, spinal cord, skull, vertebral

column and derived protein products. Food, feed, fertilisers, cosmetics, pharmaceuticals or medical

devices prepared using these commodities should also not be traded.

3) From cattle that were at the time of slaughter over 12 months of age originating from a country, zone

or compartment defined in Article 2.3.13.5., the following commodities, and any commodity

contaminated by them, should not be traded for the preparation of food, feed, fertilisers, cosmetics,

pharmaceuticals including biologicals, or medical devices: brains, eyes, spinal cord, skull, vertebral

column and derived protein products. Food, feed, fertilisers, cosmetics, pharmaceuticals or medical

devices prepared using these commodities should also not be traded.

2005 OIE Terrestrial Animal Health Code

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Article 2.3.13.14.

Veterinary Administrations of importing countries should require:

for gelatin and collagen prepared from bones and intended for food or feed, cosmetics, pharmaceuticals

including biologicals, or medical devices

the presentation of an international veterinary certificate attesting that the commodities came from:

1) a country, zone or compartment posing a negligible BSE risk; or

2) a country, zone or compartment posing a controlled BSE risk; and

a) skulls and vertebrae (except tail vertebrae) have been excluded;

b) the bones have been subjected to a process which includes all the following steps:

i) pressure washing (degreasing),

ii) acid demineralisation,

iii) prolonged alkaline treatment,

iv) filtration,

v) sterilisation at =138°C for a minimum of 4 seconds,

or to an equivalent process in terms of infectivity reduction.

Article 2.3.13.15.

Veterinary Administrations of importing countries should require:

for tallow and dicalcium phosphate (other than protein-free tallow as defined in Article 2.3.13.1.) intended

for food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals, or medical devices

the presentation of an international veterinary certificate attesting that it originates from:

1) a country, zone or compartment posing a negligible BSE risk; or

2) a country, zone or compartment posing a controlled BSE risk, and it originates from cattle which have

been subjected to ante-mortem and post-mortem inspection and has not been prepared using the

tissues listed in point 2 of Article 2.3.13.13.

Article 2.3.13.16.

Veterinary Administrations of importing countries should require:

for tallow derivatives (other than those made from protein-free tallow as defined in Article 2.3.13.1.)

intended for food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals, or medical devices

the presentation of an international veterinary certificate attesting that:

1) they originate from a country, zone or compartment posing a negligible BSE risk measures; or

2) they have been produced by hydrolysis, saponification or transesterification using high temperature

and pressure.

2005 OIE Terrestrial Animal Health Code

9

APPENDI X 3 . 8 . 4 .

SURVEILLANCE FOR BOVINE SPONGIFORM

ENCEPHALOPATHY

Article 3.8.4.1.

Introduction

1) Depending on the bovine spongiform encephalopathy (BSE) risk category of a country, zone or

compartment, surveillance for BSE may have one or more goals:

a) detecting BSE, to a pre-determined design prevalence, in a country, zone or compartment;

b) monitoring the evolution of BSE in a country, zone or compartment;

c) monitoring the effectiveness of a feed ban and/or other risk mitigation measures, in

conjunction with auditing, etc;

d) supporting a claimed BSE status;

e) gaining or regaining a higher BSE status.

2) When the BSE agent is present in a country or zone, the cattle population will comprise the following

sectors, in order of decreasing size:

a) cattle not exposed to the infective agent;

b) cattle exposed but not infected;

c) infected cattle, which may lie within one of three stages in the progress of BSE:

i) the majority will die or be killed before reaching a stage at which BSE is detectable by

current methods;

ii) some will progress to a stage at which BSE is detectable by testing before clinical signs

appear;

iii) the smallest number will show clinical signs.

3) The BSE status of a country, zone or compartment cannot be determined only on the basis of a

surveillance programme but should be determined in accordance with all the factors listed in

Article 2.3.13.2. The surveillance programme should take into account the diagnostic limitations

associated with the above sectors and the relative distributions of infected cattle among them.

4) With respect to the distribution and expression of the BSE agent within the sectors described above,

the following four subpopulations of cattle have been identified for surveillance purposes:

a) cattle over 30 months of age displaying behavioural or clinical signs consistent with BSE;

b) cattle over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk

without assistance; cattle over 30 months of age sent for emergency slaughter or condemned at

ante-mortem inspection (casualty, emergency slaughter or downer cattle);

2005 OIE Terrestrial Animal Health Code

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c) cattle over 30 months of age which are found dead on farm, during transport or at an abattoir

(fallen stock).

d) cattle over 36 months of age at routine slaughter.

5) A gradient is used to describe the relative value of surveillance applied to each subpopulation.

Surveillance should focus on the first subpopulation, but investigation of other subpopulations will

help to provide an accurate assessment of the BSE situation in the country, zone or compartment. All

countries should sample at least three of the four subpopulations. This approach is consistent with

Appendix 3.8.1. on surveillance and monitoring of animal health.

Article 3.8.4.2.

Description of cattle subpopulations

1) Cattle over 30 months of age displaying behavioural or clinical signs consistent with BSE

Cattle affected by illnesses that are refractory to treatment, and displaying progressive behavioural

changes such as excitability, persistent kicking when milked, changes in herd hierarchical status,

hesitation at doors, gates and barriers, as well as those displaying progressive neurological signs

without signs of infectious illness are candidates for examination. These behavioural changes, being

very subtle, are best identified by those who handle animals on a daily basis. Since BSE causes no

pathognomonic clinical signs, all countries with cattle populations will observe individual animals

displaying clinical signs consistent with BSE. It should be recognised that cases may display only

some of these signs, which may also vary in severity, and such animals should still be investigated as

potential BSE affected animals. The rate at which such suspicious cases are likely to occur will differ

among epidemiological situations and cannot therefore be predicted reliably.

This subpopulation, particularly cattle over 30 months of age, is the one exhibiting the highest

prevalence. The recognition greatly depends on the owner's awareness and observation of suspect

animals. The reporting of these suspect animals when at the farm will depend on the owner's

motivation based on cost and socio-economic repercussions.

2) Cattle over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without

assistance; cattle over 30 months of age sent for emergency slaughter or condemned at ante-mortem

inspection (casualty or emergency slaughter, or downer cattle)

These cattle may have exhibited some of the clinical signs listed above which were not recognised as

being consistent with BSE. Experience in countries where BSE has been identified indicates that this

subpopulation is the one demonstrating the second highest prevalence. For that reason, it is the

second most appropriate population to target in order to detect BSE.

3) Cattle over 30 months of age which are found dead on farm, during transport or at an abattoir (fallen

stock)

These cattle may have exhibited some of the clinical signs listed above prior to death, but were not

recognised as being consistent with BSE. Experience in countries where BSE has been identified

indicates that this subpopulation is the one demonstrating the third highest prevalence.

4) Cattle over 36 months of age at routine slaughter

Experience in countries where BSE has been identified indicates that this subpopulation is the one

demonstrating the lowest prevalence. For that reason, it is the least appropriate population to target

in order to detect BSE. However, sampling in this subpopulation may be an aide in monitoring the

progress of the epizootic and the efficacy of control measures applied, because it offers continuous

access to a cattle population of known class, age structure and geographical origin. Testing of routine

slaughter cattle younger than 36 months is of relatively very little value (Table 2).

2005 OIE Terrestrial Animal Health Code

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Within each of the above subpopulations, countries may wish to target cattle identifiable as imported

from countries or zones not free from BSE, cattle which have consumed potentially contaminated

feedstuffs from countries or zones not free from BSE, offspring of BSE affected cows and cattle

which have consumed feedstuffs potentially contaminated with other TSE agents.

When establishing a surveillance strategy, authorities must take into account inherent difficulties of

obtaining samples on farm. These difficulties include higher cost, necessity for education and

motivation of owners, counteracting potentially negative socio-economic implication. Authorities

must find ways to overcome these difficulties.

Article 3.8.4.3.

1) Implementation of type A surveillance

In order to implement efficiently a surveillance strategy for BSE, a country must use good quality

data (or reliable estimates) concerning the age distribution of its adult cattle population and the

number of cattle tested for BSE stratified by age and by subpopulation. The application of the

following procedure will allow the detection of BSE prevalence of at least one case per 100,000 in the

adult cattle population, at a confidence level of 95% in the country, zone or compartment of concern.

This Appendix utilises Tables 1 and 2 to determine a desired surveillance point target and the point

values of surveillance samples collected.

The approach assigns 'point values' to each sample, based on the subpopulation from which it was

collected and the likelihood of detecting infected cattle in that subpopulation. The number of points

a sample is assigned is determined by the subpopulation from which the sample is collected and the

age of the animal sampled. The total points accumulation is then periodically compared to the target

number of points for a country, zone or compartment.

A country should design its surveillance strategy to ensure that samples are representative of the herd

of the country, zone or compartment, and include consideration of demographic factors such as

production type and geographic location, and the potential influence of culturally unique husbandry

practices. The approach used and the assumptions made should be fully documented, and the

documentation retained for 7 years.

The points targets and surveillance point values in the appendix were obtained by applying the

following factors to a statistical model:

a) a prevalence of either at least one case per million or one case per 100,000 of the adult cattle

population;

b) a confidence level of 95%;

c) the pathogenesis, and pathological and clinical expression of BSE:

i) sensitivity of diagnostic methods used;

ii) relative frequency of expression by age;

iii) relative frequency of expression within each subpopulation;

iv) interval between clinical pathological change and clinical expression;

d) demographics of the cattle population, including age distribution;

e) influence of BSE on culling or attrition of animals from the cattle population via the four

subpopulations;

f) percentage of infected animals in the cattle population which are not detected.

2005 OIE Terrestrial Animal Health Code

12

Although the procedure accepts very basic information about a cattle population, and can be used

with estimates and less precise data, careful collection and documentation of the data significantly

enhance their value. Since samples from clinical suspect animals provide many times more

information than samples from healthy or dead-of-unknown-cause animals, careful attention to the

input data can substantially decrease the procedure's cost and the number of samples needed. The

essential input data are:

g) cattle population numbers stratified by age;

h) the number of cattle tested for BSE stratified by age and by subpopulation.

2) Maintenance (type B) surveillance

For countries which have demonstrated through risk assessment (including surveillance) that they

meet the requirements for 'negligible risk without commodity-specific risk mitigation measures',

surveillance should continue at a reduced, maintenance level.

In order to implement efficiently a maintenance surveillance strategy for BSE, a country must use

good quality data (or reliable estimates) concerning the age distribution of its adult cattle population

and the number of cattle tested for BSE stratified by age and by subpopulation. The application of

the following procedure will allow the detection of BSE prevalence of at least one case per 50,000 in

the adult cattle population, at a confidence level of 95% in the country, zone or compartment of

concern. This Appendix utilises Tables 1 and 2 to determine a desired surveillance point target and

the point values of surveillance samples collected.

Maintenance surveillance should focus on the higher prevalence subpopulations (especially clinical

suspects). The number of clinical suspect samples taken annually should approximate the number of

samples taken annually from clinical suspect cases during the time taken to reach the country, zone or

compartment's BSE status (to a maximum of seven years).

Article 3.8.4.4.

1) Selecting the points target

The desired surveillance points target is selected from Table 1, which shows target points for adult

cattle populations of different sizes. A country's adult cattle population size may be estimated or may

be set at one million because, for statistical reasons, one million is the point beyond which sample

size does not further increase with population size. The target depends on the design prevalence

chosen by the country.

2005 OIE Terrestrial Animal Health Code

13

Table 1 Points targets for different adult cattle population sizes in a country, zone or compartment which

has not identified any BSE cases

Target points for country, zone or compartment

with 0 cases, 95% confidence

Adult Cattle Population Size

(24 months and older)

*DP

1/100,000

*DP

1/50,000

= 1,000,000 300,000 150,000

800,000 - 1,000,000 240,000 120,000

600,000 - 800,000 180,000 90,000

400,000 - 600,000 120,000 60,000

200,000 - 400,000 60,000 30,000

100,000 - 200,000 30,000 15,000

50,000 - 100,000 15,000 7,500

*DP is the maximum possible prevalence or "design prevalence".

2) Determining the point values of samples collected

Table 2 can be used to determine the point values of the surveillance samples collected. The

approach assigns point values to each sample according to the likelihood of detecting infection based

on the subpopulation from which the sample was collected and the age of the animal sampled. This

approach takes into account the general principles of surveillance described in Appendix 3.8.1. and

the epidemiology of BSE.

Because precise aging of the animals that are sampled may not be possible, Table 2 combines point

values into five age categories. The point estimates for each category were determined as an average

for the age range comprising the group. The age groups were selected on their relative likelihoods of

expressing BSE according to scientific knowledge of the incubation of the disease and the world BSE

experience. Samples may be collected from any combination of subpopulations and ages but should

reflect the demographics of the cattle herd of the country, zone or compartment. In addition, countries

should sample at least three of the four subpopulations.

The total points for samples collected may be accumulated over a period of a maximum of

7 consecutive years to achieve the target number of points determined in Table 1.

2005 OIE Terrestrial Animal Health Code

14

Table 2 Surveillance point values for samples collected from animals in the given subpopulation and

age category

Surveillance subpopulation

Routine

slaughter

*

Fallen

stock

**

Casualty

slaughter

***

Clinical

suspect

****

age = 1 year and < 2 years

0.01 0.2 0.4 N/A

Age = 2 years and < 4 years (young adult)

0.1 0.2 0.4 260

Age = 4 years and < 7 years (middle adult)

0.2 0.9 1.6 750

Age = 7 years and < 9 years (older adult)

0.1 0.4 0.7 220

Age = 9 years (aged)

0.0 0.1 0.2 45

* Article 3.8.4.2 4 ** Article 3.8.4.2 3

*** Article 3.8.4.2 2 **** Article 3.8.4.2 1

Surveillance points remain valid for 7 years (the 95th percentile of the incubation period).

Article 3.8.4.5.

To monitor the evolution of BSE in a country, zone or compartment once it is detected

To monitor the evolution of BSE in a country, zone or compartment once it is detected, a more intensive

sampling method needs to be used to determine disease prevalence. For countries that have determined

that BSE exists within their cattle population, the goal of surveillance shifts from one of detection to one

of monitoring the extent and evolution of the disease, and monitoring the effectiveness of control

measures such as feed bans and SRM removal policies.

2005 OIE Terrestrial Animal Health Code

15

APPENDI X 3 . 6 . 3 .

P R O C E D U R E S F O R T H E R E D UC TI O N O F I N F E C T I V I T Y O F

T R A N S M I S S I B L E S P O N G I F O R M E N C E P H A L O P A T H Y A G E N T S

Article 3.6.3.1.

Meat-and-bone meal

The following procedure should be used to reduce the infectivity of any transmissible spongiform

encephalopathy agents which may be present during the production of meat-and-bone meal containing

ruminant proteins:

1. The raw material should be reduced to a maximum particle size of 50 mm before heating.

2. The raw material should be heated under saturated steam conditions to a temperature of not less

than 133°C for a minimum of 20 minutes at an absolute pressure of 3 bar.

2005 OIE Terrestrial Animal Health Code


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



EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Publication date: 20 August 2004
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.


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html


CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_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


What GAO Found
United States Government Accountability Office
Why GAO Did This Study
Highlights
Accountability Integrity Reliability
www.gao.gov/cgi-bin/getrpt?GAO-05-101.
To view the full product, including the scope
and methodology, click on the link above.
For more information, contact Robert A.
Robinson at (202) 512-3841 or
[email protected]
Highlights of GAO-05-101, a report to
congressional requesters
February 2005
MAD COW DISEASE
FDA's Management of the Feed Ban Has
Improved, but Oversight Weaknesses
Continue to Limit Program Effectiveness
FDA has made needed improvements to its management and oversight of the
feed-ban rule in response to GAO's 2002 report, but program weaknesses
continue to limit the effectiveness of the ban and place U.S. cattle at risk of
spreading BSE. Improvements made include FDA establishing a uniform
method of conducting compliance inspections and training FDA inspectors,
as well as state inspectors who carry out inspections under agreements with
FDA, on the new method. FDA also implemented new data-entry procedures
that are designed to more reliably track feed-ban inspection results.
Consequently, FDA has a better management tool for overseeing compliance
with the feed-ban rule and a data system that better conforms to standard
database management practices. However, various program weaknesses
continue to undermine the nation's firewall against BSE. For example:
. FDA acknowledges that there are more feed manufacturers and
transporters, on-farm mixers, and other feed industry businesses that are
subject to the feed ban than the approximately 14,800 firms inspected to
date; however, it has no uniform approach for identifying additional
firms.
. FDA has not reinspected approximately 2,800, or about 19 percent, of
those businesses, in 5 or more years; several hundred are potentially
high risk. FDA does not know whether those businesses now use
prohibited material in their feed.
. FDA's feed-ban inspection guidance does not include instructions to
routinely sample cattle feed to test for potentially prohibited material as
part of the compliance inspection. Instead, it includes guidance for
inspectors to visually examine facilities and equipment and review
invoices and other documents.
. Feed intended for export is not required to carry a caution label "Do not
feed to cattle or other ruminants," when the label would be required if
the feed were sold domestically. Without that statement, feed containing
prohibited material could be inadvertently or intentionally diverted back
to U.S. cattle or given to foreign cattle.
. FDA has not always alerted USDA and states when it learned that cattle
may have been given feed that contained prohibited material. This lapse
has been occurring even though FDA's guidance calls for such
communication.
. Although research suggests that cattle can get BSE from ingesting even a
small amount of infected material, inspectors do not routinely inspect or
review cleanout procedures for vehicles used to haul cattle feed.
More than 5 million cattle across
Europe have been killed to stop the
spread of bovine spongiform
encephalopathy (BSE), commonly
called mad cow disease. Found in
26 countries, including Canada and
the United States, BSE is believed
to spread through animal feed that
contains protein from BSE-infected
animals. Consuming meat from
infected cattle has also been linked
to the deaths of about 150 people
worldwide. In 1997, the Food and
Drug Administration (FDA) issued
a feed-ban rule prohibiting certain
animal protein (prohibited
material) in feed for cattle and
other ruminant animals. FDA and
38 states inspect firms in the feed
industry to enforce this critical
firewall against BSE. In 2002, GAO
reported a number of weaknesses
in FDA's enforcement of the feed
ban and recommended corrective
actions. This report looks at FDA's
efforts since 2002 to ensure
industry compliance with the feed
ban and protect U.S. cattle.
What GAO Recommends
GAO recommends FDA, among
other things, develop procedures
for finding additional firms subject
to the feed-ban and using tests to
augment inspections. FDA said the
study was thorough but disagreed
on four of nine recommendations.
GAO continues to believe that,
given the discovery of BSE in North
America and the oversight gaps
described in the report, the
recommended actions are needed
to protect U.S. cattle from BSE.


3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,
but Oversight Weaknesses Continue to Limit Program Effectiveness.
GAO-05-101, Feb. 25.
http://www.gao.gov/cgi-bin/getrpt?GAO-05-101
Highlights - http://www.gao.gov/highlights/d05101high.pdf


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

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

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

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


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


PART 2


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



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


Gerald Wells: Report of the Visit to USA, April-May 1989

snip...

The general opinion of those present was that BSE, as an
overt disease phenomenon, _could exist in the USA, but if it did,
it was very rare. The need for improved and specific surveillance
methods to detect it as recognised...

snip...

It is clear that USDA have little information and _no_ regulatory
responsibility for rendering plants in the US...

snip...

3. Prof. A. Robertson gave a brief account of BSE. The US approach
was to accord it a _very low profile indeed_. Dr. A Thiermann showed
the picture in the ''Independent'' with cattle being incinerated and thought
this was a fanatical incident to be _avoided_ in the US _at all costs_...

snip...

http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf

To be published in the Proceedings of the
Fourth International Scientific Congress in
Fur Animal Production. Toronto, Canada,
August 21-28, 1988

Evidence That Transmissible Mink Encephalopathy
Results from Feeding Infected Cattle

R.F. Marsh* and G.R. Hartsough

.Department of Veterinary Science, University of Wisconsin-Madison, Madison,
Wisconsin 53706; and ^Emba/Creat Lakes Ranch Service, Thiensville, Wisconsin 53092

ABSTRACT
Epidemiologic investigation of a new incidence of
transmissible mink encephalopathy (TME) in Stetsonville, Wisconsin
suggests that the disease may have resulted from feeding infected
cattle to mink. This observation is supported by the transmission of
a TME-like disease to experimentally inoculated cattle, and by the
recent report of a new bovine spongiform encephalopathy in
England.

INTRODUCTION

Transmissible mink encephalopathy (TME) was first reported in 1965 by Hartsough
and Burger who demonstrated that the disease was transmissible with a long incubation
period, and that affected mink had a spongiform encephalopathy similar to that found in
scrapie-affecied sheep (Hartsough and Burger, 1965; Burger and Hartsough, 1965).
Because of the similarity between TME and scrapie, and the subsequent finding that the
two transmissible agents were indistinguishable (Marsh and Hanson, 1969), it was
concluded that TME most likely resulted from feeding mink scrapie-infecied sheep.
The experimental transmission of sheep scrapie to mink (Hanson et al., 1971)
confirmed the close association of TME and scrapie, but at the same time provided
evidence that they may be different. Epidemiologic studies on previous incidences of
TME indicated that the incubation periods in field cases were between six months and
one year in length (Harxsough and Burger, 1965). Experimentally, scrapie could not be
transmitted to mink in less than one year.
To investigate the possibility that TME may be caused by a (particular strain of
scrapie which might be highly pathogenic for mink, 21 different strains of the scrapie
agent, including their sheep or goat sources, were inoculated into a total of 61 mink.
Only one mink developed a progressive neurologic disease after an incubation period of
22 mon..s (Marsh and Hanson, 1979). These results indicated that TME was either caused
by a strain of sheep scrapie not yet tested, or was due to exposure to a scrapie-like agent
from an unidentified source.

OBSERVATIONS AND RESULTS

A New Incidence of TME. In April of 1985, a mink rancher in Stetsonville, Wisconsin
reported that many of his mink were "acting funny", and some had died. At this time, we
visited the farm and found that approximately 10% of all adult mink were showing
typical signs of TME: insidious onset characterized by subtle behavioral changes, loss of
normal habits of cleanliness, deposition of droppings throughout the pen rather than in a
single area, hyperexcitability, difficulty in chewing and swallowing, and tails arched over
their _backs like squirrels. These signs were followed by progressive deterioration of
neurologic function beginning with locomoior incoordination, long periods of somnolence
in which the affected mink would stand motionless with its head in the corner of the
cage, complete debilitation, and death. Over the next 8-10 weeks, approximately 40% of
all the adult mink on the farm died from TME.
Since previous incidences of TME were associated with common or shared feeding
practices, we obtained a careful history of feed ingredients used over the past 12-18
months. The rancher was a "dead stock" feeder using mostly (>95%) downer or dead dairy
cattle and a few horses. Sheep had never been fed.

Experimental Transmission. The clinical diagnosis of TME was confirmed by
histopaihologic examination and by experimental transmission to mink after incubation
periods of four months. To investigate the possible involvement of cattle in this disease
cycle, two six-week old castrated Holstein bull calves were inoculated intracerebrally
with a brain suspension from affected mink. Each developed a fatal spongiform
encephalopathy after incubation periods of 18 and 19 months.

DISCUSSION
These findings suggest that TME may result from feeding mink infected cattle and
we have alerted bovine practitioners that there may exist an as yet unrecognized
scrapie-like disease of cattle in the United States (Marsh and Hartsough, 1986). A new
bovine spongiform encephalopathy has recently been reported in England (Wells et al.,
1987), and investigators are presently studying its transmissibility and possible
relationship to scrapie. Because this new bovine disease in England is characterized by
behavioral changes, hyperexcitability, and agressiveness, it is very likely it would be
confused with rabies in the United Stales and not be diagnosed. Presently, brains from
cattle in the United States which are suspected of rabies infection are only tested with
anti-rabies virus antibody and are not examined histopathologically for lesions of
spongiform encephalopathy.
We are presently pursuing additional studies to further examine the possible
involvement of cattle in the epidemiology of TME. One of these is the backpassage of
our experimental bovine encephalopathy to mink. Because (here are as yet no agent-
specific proteins or nucleic acids identified for these transmissible neuropathogens, one
means of distinguishing them is by animal passage and selection of the biotype which
grows best in a particular host. This procedure has been used to separate hamster-
adapted and mink-udapted TME agents (Marsh and Hanson, 1979). The intracerebral
backpassage of the experimental bovine agent resulted in incubations of only four months
indicating no de-adaptation of the Stetsonville agent for mink after bovine passage.
Mink fed infected bovine brain remain normal after six months. It will be essential to
demonstrate oral transmission fiom bovine to mink it this proposed epidemiologic
association is to be confirmed.

ACKNOWLEDGEMENTS
These studies were supported by the College of Agricultural and Life Sciences,
University of Wisconsin-Madison and by a grant (85-CRCR-1-1812) from the United
States Department of Agriculture. The authors also wish to acknowledge the help and
encouragement of Robert Hanson who died during the course of these investigations.

REFERENCES
Burger, D. and Hartsough, G.R. 1965. Encephalopathy of mink. II. Experimental and
natural transmission. J. Infec. Dis. 115:393-399.
Hanson, R.P., Eckroade, R.3., Marsh, R.F., ZuRhein, C.M., Kanitz, C.L. and Gustatson,
D.P. 1971. Susceptibility of mink to sheep scrapie. Science 172:859-861.
Hansough, G.R. and Burger, D. 1965. Encephalopathy of mink. I. Epizoociologic and
clinical observations. 3. Infec. Dis. 115:387-392.
Marsh, R.F. and Hanson, R.P. 1969. Physical and chemical properties of the
transmissible mink encephalopathy agent. 3. ViroL 3:176-180.
Marsh, R.F. and Hanson, R.P. 1979. On the origin of transmissible mink
encephalopathy. In Hadlow, W.J. and Prusiner, S.P. (eds.) Slow transmissible
diseases of the nervous system. Vol. 1, Academic Press, New York, pp 451-460.
Marsh, R.F. and Hartsough, G.R. 1986. Is there a scrapie-like disease in cattle?
Proceedings of the Seventh Annual Western Conference for Food Animal Veterinary
Medicine. University of Arizona, pp 20.
Wells, G.A.H., Scott, A.C., Johnson, C.T., Cunning, R.F., Hancock, R.D., Jeffrey, M.,
Dawson, M. and Bradley, R. 1987. A novel progressive spongiform encephalopathy
in cattle. Vet. Rec. 121:419-420.

MARSH

http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf


Greetings,


SO, the already terribly flawwed OIE BSE surveillance system is too burdensome for trade.
Aint that just too bad. SO, they decide to make it even weaker. The damn thing never worked
anyway. ALL one has to do is look at the documented BSE Countries that went by it. Did them
a lot of good.

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...

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

http://brain.hastypastry.net/forums/archive/index.php/t-54550.html


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. With Science like this, Japan would be fully justified in declining to be a member. ...


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


a.. BSE OIE


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

Kathy

Well-known member
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My recommended reading for EVERYONE this new year, is a book by:

Dr. Ernest Sternglass called "SECRET FALLOUT"

While we work and worry about our own personal situations, (which is perfectly OK); this man has spent a half a century uncovering lies bigger and more sinister than the BSE fiasco.

This book can be read on-line at the link:

http://www.ratical.com/radiation/SecretFallout/SF.html#TOC

It is a biography of his research and investigation into the damaging effects of man-made ionizing radiation from, nuclear weapons testing, power plants, etc.

I am hoping that you will read this, and pass on the link and name to more people. The more we are aware of this problem, the better prepared we can be to manage our own health, and to stop any further "fallout". There are difinitive agriculture connections which demand our attention.

Since this book came to my knowledge, another study by the prominent chronic wasting disease scientist "Elizabeth Williams" (now deceased), has come to my attention. She must have been working on several research projects before her and her husbands tragic death last year, and they are still in the publishing processes, posthumously.

This CWD expert, had two papers published on ionizing radiation in 2005.

Radiat Res. 2005 Oct;164(4 Pt 2):497-504.

Suppression of DNA-PK by RNAi has different quantitative effects on telomere dysfunction and mutagenesis in human lymphoblasts treated with gamma rays or HZE particles.

Zhang Q, Williams ES, Askin KF, Peng Y, Bedford JS, Liber HL, Bailey SM.

Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado 80523, USA.

Basic to virtually all relevant biological effects of ionizing radiation is the underlying damage produced in DNA and the subsequent cellular processing of such damage. The damage can be qualitatively different for different kinds of radiations, and the genetics of the biological systems exposed can greatly affect damage processing and ultimate outcome--the biological effect of concern. The accurate repair of DNA double-strand breaks (DSBs) is critical for the maintenance of genomic integrity and function. Incorrect repair of such lesions results in chromosomal rearrangements and mutations that can lead to cancer and heritable defects in the progeny of irradiated parents. We have focused on the consequent phenotypic effects of faulty repair by examining connections between cellular radiosensitivity phenotypes relevant for carcinogenesis after exposure to ionizing radiation, and deficiencies in various components of the non-homologous end-joining (NHEJ) system. Here we produced deficiencies of individual components of the DNA-dependent protein kinase (DNA-PK) holoenzyme (Ku86 and the catalytic subunit, DNA-PKcs), both singly and in combination, using RNA interference (RNAi) in human lymphoblastoid cell lines. Exposure of cells exhibiting reduced protein expression to either gamma rays or 1 GeV/nucleon iron particles demonstrated differential effects on telomere dysfunction and mutation frequency as well as differential effects between radiation qualities.


Cancer Res. 2005 Jul 1;65(13):5544-53.

NBS1 knockdown by small interfering RNA increases ionizing radiation mutagenesis and telomere association in human cells.

Zhang Y, Lim CU, Williams ES, Zhou J, Zhang Q, Fox MH, Bailey SM, Liber HL.

Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado 80523, USA. [email protected]

Hypomorphic mutations which lead to decreased function of the NBS1 gene are responsible for Nijmegen breakage syndrome, a rare autosomal recessive hereditary disorder that imparts an increased predisposition to development of malignancy. The NBS1 protein is a component of the MRE11/RAD50/NBS1 complex that plays a critical role in cellular responses to DNA damage and the maintenance of chromosomal integrity. Using small interfering RNA transfection, we have knocked down NBS1 protein levels and analyzed relevant phenotypes in two closely related human lymphoblastoid cell lines with different p53 status, namely wild-type TK6 and mutated WTK1. Both TK6 and WTK1 cells showed an increased level of ionizing radiation-induced mutation at the TK and HPRT loci, impaired phosphorylation of H2AX (gamma-H2AX), and impaired activation of the cell cycle checkpoint regulating kinase, Chk2. In TK6 cells, ionizing radiation-induced accumulation of p53/p21 and apoptosis were reduced. There was a differential response to ionizing radiation-induced cell killing between TK6 and WTK1 cells after NBS1 knockdown; TK6 cells were more resistant to killing, whereas WTK1 cells were more sensitive. NBS1 deficiency also resulted in a significant increase in telomere association that was independent of radiation exposure and p53 status. Our results provide the first experimental evidence that NBS1 deficiency in human cells leads to hypermutability and telomere associations, phenotypes that may contribute to the cancer predisposition seen among patients with this disease.
 

Silver

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Flounder, me'n Haymaker have neither the time nor the inclination to read through that whole post. We'd really rather just cut straight to the name calling if you don't mind. :lol:
 

flounder

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no problem at all there silver, im just a flounder in the mud, hunkered down, looken up, watchen. fire at will :lol:
 

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