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From: TSS ()
Subject: BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01 TSS COMMENT SUBMISSION
Date: January 28, 2007 at 6:57 pm PST

January 28, 2007

Greetings APHIS,


I would kindly like to submit the following to ;


BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01

[Federal Register: January 9, 2007 (Volume 72, Number 5)]
[Proposed Rules]
[Page 1101-1129]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja07-21]


[[Page 1101]]

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Part III

Department of Agriculture

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


Animal and Plant Health Inspection Service


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


9 CFR Parts 93, 94, 95, and 96


Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of
Live Bovines and Products Derived From Bovines; Proposed Rule


[[Page 1102]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, 95, and 96

[Docket No. APHIS-2006-0041]
RIN 0579-AC01


Bovine Spongiform Encephalopathy; Minimal-Risk Regions;
Importation of Live Bovines and Products Derived From Bovines

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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

SUMMARY: We are proposing to amend the regulations regarding the
importation of animals and animal products to establish conditions for
the importation of the following commodities from regions that present
a minimal risk of introducing bovine spongiform encephalopathy (BSE)
into the United States: Live bovines for any use born on or after a
date determined by APHIS to be the date of effective enforcement of a
ruminant-to-ruminant feed ban in the region of export; blood and blood
products derived from bovines; and casings and part of the small
intestine derived from bovines. We are proposing these amendments after
conducting a risk assessment and comprehensive evaluation of the issues
that concluded that such bovines and bovine products can be safely
imported under the conditions described in this proposed rule.

DATES: We will consider all comments that we receive on or before March
12, 2007.

ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov
, select ``Animal and Plant Health Inspection

Service'' from the agency drop-down menu, then click ``Submit.'' In the
Docket ID column, select APHIS-2006-0041 to submit or view public
comments and to view supporting and related materials available
electronically. Information on using Regulations.gov, including
instructions for accessing documents, submitting comments, and viewing
the docket after the close of the comment period, is available through
the site's ``User Tips'' link.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. APHIS
2006-0041, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. APHIS 2006-0041.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.


FOR FURTHER INFORMATION CONTACT: For information regarding ruminant
products, contact Dr. Karen James-Preston, Director, Technical Trade
Services, Animal Products, National Center for Import and Export, VS,
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.
For information concerning live ruminants, contact Dr. Lee Ann
Thomas, Director, Technical Trade Services, Animals, Organisms and
Vectors, and Select Agents, National Center for Import and Export, VS,
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.
For other information concerning this proposed rule, contact Dr.
Lisa Ferguson, Senior Staff Veterinarian, National Center for Animal
Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD
20737-1231; (301) 734-6954.

SUPPLEMENTARY INFORMATION:

I. Background ............... snip .................... full text ;


http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/07-17.htm


MY COMMENTS are as follows ;


WITH the new BASE mad cow in the USA bovine, on top of the regular BSE mad cow, I urgently stress that our borders be sealed and that no bovine or ovine, or cervids be traded. THE BSE MRR policy should be repealed, and the old BSE GBR risk assessments be adhered too, and strengthened to include all TSE. ...TSS

18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...


ITEM 9 - ANY OTHER BUSINESS

snip...


64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.
Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.


http://www.seac.gov.uk/minutes/95.pdf

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


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


EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)


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.europa.eu/en/science/tse_assessments/gbr_assessments/573.html

http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/573.Par.0004.File.dat/sr03_biohaz02_usa_report_v2_en1.pdf


EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Canada


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

The BSE agent was probably imported into the country middle of the eighties and could have reached domestic cattle in the early nineties. 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 90s. It is possible that imported meat and bone meal (MBM) into Canada reached domestic cattle and led to an internal challenge in the early 90s.

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.

EFSA concludes that the current GBR level of Canada is III, i.e. it is confirmed at a lower level that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as the system remains unstable, it is expected that the GBR continues to grow, even if no additional external challenges occur.


http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/564.html

http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/564.Par.0001.File.dat/sr02_biohaz02_canada_report_v2_en1.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Mexico


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.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/565.Par.0003.File.dat/sr04_biohaz02_mexico_report_summary_en1.pdf


http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/565.Par.0004.File.dat/sr04_biohaz02_mexico_report_v2_en1.pdf

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


CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006


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

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

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

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

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

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

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


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

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


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

PAUL BROWN COMMENT TO ME ON THIS ISSUE

Tuesday, September 12, 2006 11:10 AM


"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."


O.I.E. .......... ??? GOD HELP US! most every country that went by the flawed OIE BSE guidelines, most all became BSE infected countries. ...TSS


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

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

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


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

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

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

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


Page 95 of 98

8/3/2006

WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO SRMs ???

a.. BSE OIE

see full text ;


http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic

IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the

USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence of these agencies are so inept,

either through ignorance and or just too overweight with industry reps., they then should be all done away with and a

single agency brought forth, and if not, how will you correct this ongoing problem ?


http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf

http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=20678

http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&I=-3&P=3381

Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)


http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf

BRITISH MEDICAL JOURNAL


BMJ


http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2


BMJ


http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1


[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

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


[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)


http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf

THE SEVEN SCIENTIST REPORT ***


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf


PAUL BROWN M.D.

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf


9 December 2005
Division of Dockets Management (RFA-305)

SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf

Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm

Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of
Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm


03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf


03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf


Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf


In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf

Volume 12, Number 12–December 2006


PERSPECTIVE

On the Question of Sporadic

or Atypical Bovine SpongiformEncephalopathy and

Creutzfeldt-Jakob Disease

Paul Brown,* Lisa M. McShane,† Gianluigi Zanusso,‡ and Linda Detwiler§

Strategies to investigate the possible existence of sporadic

bovine spongiform encephalopathy (BSE) require

systematic testing programs to identify cases in countries

considered to have little or no risk for orally acquired disease,

or to detect a stable occurrence of atypical cases in

countries in which orally acquired disease is disappearing.

To achieve 95% statistical confidence that the prevalence

of sporadic BSE is no greater than 1 per million (i.e., the

annual incidence of sporadic Creutzfeldt-Jakob disease

[CJD] in humans) would require negative tests in 3 million

randomly selected older cattle. A link between BSE and

sporadic CJD has been suggested on the basis of laboratory

studies but is unsupported by epidemiologic observation.

Such a link might yet be established by the discovery

of a specific molecular marker or of particular combinations

of trends over time of typical and atypical BSE and various

subtypes of sporadic CJD, as their numbers are influenced

by a continuation of current public health measures that

exclude high-risk bovine tissues from the animal and

human food chains.


SNIP...


http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm?s_cid=eid06_0965_e

3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the Exhibit
Hall


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years. ***These results indicate that BASE is
transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.

6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp

SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html


There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf


Calves were challenged by mouth with homogenised brain from confirmed cases of BSE. Some received 300g (3 doses of 100g), some 100g, 10g or 1g. They were then left to develop BSE, but were not subjected to the normal stresses that they might have encountered in a dairy herd. Animals in all four groups developed BSE. There has been a considerable spread of incubation period in some of the groups, but it appears as if those in the 1 and 10g challenge groups most closely fit the picture of incubation periods seen in the epidemic. Experiments in progress indicate that oral infection can occur in some animals with doses as low as 0.01g and 0.001g. .........


http://www.defra.gov.uk/animalh/bse/science-research/pathog.html#dose


and i think, with time, and testing becomes more and more sensitive, we will all be surprised at just how much is too much, and just how young one might be to spread the agent, even as sub-clinical.


IF i remember correctly, the infamous PURINA FEED MILL incident in Gonzales TEXAS,
where at one feeding, those cows could not have consumed more than......or no more than 5.5 grams...etc. so, how many feedings does a feeder and or dairy calf have in there lifespan ? wouldn't you multiply that by those figures by that ??? be a lot of potential mad cow protein IN COMMERCE, and still is in 2006......tss


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


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


http://www.fda.gov/ora/about/enf_story/archive/2001/ch5/default.htm

Subject: DOCUMENTATION RELATED TO SPECIFIED RISK MATERIALS (SRMs) AND OTHER REGULATIONS FSIS NOTICE 01-07 1/8/07
Date: January 8, 2007 at 9:28 am PST

FSIS NOTICE 01-07 1/8/07

DOCUMENTATION RELATED TO SPECIFIED RISK MATERIALS (SRMs)
AND OTHER REGULATIONS


This notice clarifies how inspection program personnel are to document regulatory noncompliance related to 9 CFR 310.22 for controlling specified risk materials, as well as other regulations

Inspection program personnel are to cite 9 CFR 310.22 in the Relevant Regulation section of every noncompliance report (NR) for an establishment that does not meet the regulatory requirements for controlling SRMs. In addition to selecting 9 CFR 310.22, inspection program personnel are to select all other regulations with which there has been noncompliance.

For example, while performing the 03C02 procedure, the Inspector-in-Charge (IIC) sees spinal cord material on previously cut T-bone steaks that had passed the Critical Control Point (CCP). The IIC cites 9 CFR 417.2(c)(4) and 310.22(b) in the Relevant Regulations section on the Procedure Results NR screen. The IIC notifies the appropriate establishment official of the finding. The IIC also verifies that the corrective actions implemented by the establishment meet the requirements of 9 CFR 417.3(a) before issuing the NR.

Inspection program personnel are to describe the noncompliances in the Narrative Section, block 10, of the NR. The narrative should include a complete description of the SRM noncompliance, including the type of SRM and any other information relevant to the noncompliance. The narrative should also address each of the other regulations that inspection program personnel cite in the Relevant Regulations section on the NR screen. The statements in block 10 of the NR are to support completely and adequately the regulatory noncompliances cited.

For every NR that inspection program personnel issue, it is important that they cite all relevant regulations. These citations provide data that are the basis for critical, risk-based decisions that the FSIS must regularly make when working to ensure that meat and poultry products are safe. Thus, it is not appropriate for inspection program personnel to cite only one regulation if other regulations are also violated by the noncompliance that is the subject of the NR.

Inspection program personnel with technical questions related to the use of PBIS, or who experience technical problems, should contact the FAIM Help Desk at 1-800-473-9135. They should contact the Technical Service Center at 1-800-233-3935 for policy-related questions.


Philip S. Derfler /s/


Assistant Administrator
Office of Policy, Program, and Employee Development

DISTRIBUTION: Inspection Offices; T/A Inspectors; Plant Mgt; TRA; ABB; TSC; Import Offices NOTICE EXPIRES: 2/1/08 OPI: OPPED


http://www.fsis.usda.gov/regulations_&_policies/Notice_01-07/index.asp

> This notice clarifies how inspection program personnel are to document regulatory noncompliance

> related to 9 CFR 310.22 for controlling specified risk materials, as well as other regulations


SO, it's Monday Jan. 8, 2007, in 2006 ALONE, the FDA allowed literally 100s of 1,000s of TONS of ruminant protein to be fed to not only USA cattle and livestock, but it also exported this poison to other parts of the globe as well, and the FSIS is just NOW clarifying how it's inspectors handle SRMs ??? and no SRMs are being fed to cattle in the USA ???


LIKE i said,


IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the
USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence
of these agencies are so inept, either through ignorance and or just too overweight with industry reps.,
they then should be all done away with and a single agency brought forth, and if not, how will you
correct this ongoing problem ?


http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf

http://www.prwatch.org/node/4624


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


2006 (partial list of) highly potential mad cow protein in commerce USA


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

PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
CODE
None
RECALLING FIRM/MANUFACTURER
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based
protein.
VOLUME OF PRODUCT IN COMMERCE
477.72 tons
DISTRIBUTION
AL
______________________________
PRODUCT
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV


http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html


Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY

______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY

______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS

______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS

______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
87 tons
DISTRIBUTION
MS

______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-120-6
CODE
None
RECALLING FIRM/MANUFACTURER
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
350 tons
DISTRIBUTION
AL and MS

______________________________
PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN

END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006

###


http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html


Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI


END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125
TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST
PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL


END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


CJD WATCH MESSAGE BOARD
TSS
MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR July 12, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html


Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration

New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217

Telephone: 615-781-5380
Fax: 615-781-5391


May 17, 2006

WARNING LETTER NO. 2006-NOL-06

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).

Our investigation found you failed to provide measures, including sufficient
written procedures, to prevent commingling or cross-contamination and to
maintain sufficient written procedures [21 CFR 589.2000(e)] because:

You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.

You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from
mammalian tissues into feeds which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
Act.

This letter is not intended as an all-inclusive list of violations at your
facility. As a manufacturer of materials intended for animal feed use, you
are responsible for ensuring your overall operation and the products you
manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or
injunction, without further notice.

You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.

Sincerely,

/S

Carol S. Sanchez
Acting District Director
New Orleans District


http://www.fda.gov/foi/warning_letters/g5883d.htm


look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused
7% (1 of 14) of the cows to come down with BSE;


Risk of oral infection with bovine spongiform encephalopathy agent in
primates

Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to
non-human primates. We gave two macaques a 5 g oral dose of brain homogenate
from a BSE-infected cow. One macaque developed vCJD-like neurological
disease 60 months after exposure, whereas the other remained free of disease
at 76 months. On the basis of these findings and data from other studies, we
made a preliminary estimate of the food exposure risk for man, which
provides additional assurance that existing public health measures can
prevent transmission of BSE to man.


snip...


BSE bovine brain inoculum

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

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

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

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

PrPres biochemical detection

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

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

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

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


Published online January 27, 2005

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


Feb 06, 2004 Washington State Investigation—Final Epidemiology Report


http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/WashingtonState_epi_final3-04.pdf


Secretary's Advisory Committee Recommendations


Feb 13, 2004 Secretary’s Advisory Committee Report

http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/SAC-Report2-13-04.pdf


Feb 02, 2004 International Review Team (IRT) Report

http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/US_BSE_Report2-2-04.pdf


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

Information on the Washington State Investigation of the BSE-positive Cow

This Office of Inspector General (OIG)


http://www.usda.gov/oig/webdocs/TestimonyBlurb2.pdf

http://www.usda.gov/oig/webdocs/Testimony7-2004.pdf

http://www.usda.gov/oig/webdocs/50601-9-final.pdf


OIG REPORT ON IMPORTS FROM CANADA

http://www.usda.gov/oig/webdocs/33601-01-HY.pdf


Final Case Summeries


May 02, 2006 Alabama BSE Investigation—Final Epidemiology Report

http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/EPI_Final5-2-06.pdf

http://www.scienceblog.com/cms/feds_confirm_mad_cow_in_alabama_10204.html

http://www.prwatch.org/node/4624

http://www.microbes.info/forums/index.php?showtopic=306

Aug 30, 2005 USDA Texas BSE Investigation—Final Epidemiology Report

http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/bse_final_epi_report8-05.pdf


TSS REPORT ON 2ND TEJAS MAD COW Mon, 22 Nov 2004 17:12:15 -0600 (the one
that did NOT get away, thanks to the Honorable Phyllis Fong)


-------- Original Message --------


Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Mon, 22 Nov 2004 17:12:15 -0600
From: "Terry S. Singeltary Sr."
To: Carla Everett
References: <[log in to unmask]>
<[log in to unmask] us>


Greetings Carla,still hear a rumor;

Texas single beef cow not born in Canada no beef entered the food chain?

and i see the TEXAS department of animal health is ramping up forsomething,
but they forgot a url for update?I HAVE NO ACTUAL CONFIRMATION YET...can you
confirm???terry


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


-------- Original Message --------


Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Fri, 19 Nov 2004 11:38:21 -0600
From: Carla Everett
To: "Terry S. Singeltary Sr."
References: <[log in to unmask]>


The USDA has made a statement, and we are referring all callers to the USDA
web site. We have no informationabout the animal being in Texas. CarlaAt
09:44 AM 11/19/2004, you wrote:>Greetings Carla,>>i am getting
unsubstantiated claims of this BSE 'inconclusive' cow is from>TEXAS. can you
comment on this either way please?>>thank you,>Terry S. Singeltary Sr.>>


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


-------- Original Message --------


Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Mon, 22 Nov 2004 18:33:20 -0600
From: Carla Everett
To: "Terry S. Singeltary Sr."
References: <[log in to unmask]>
<[log in to unmask] us>
<[log in to unmask]> <[log in to unmask]
us> <[log in to unmask]>


our computer department was working on a place holder we could post USDA's
announcement of any results. There are no results to be announced tonight by
NVSL, so we are back in a waiting mode and will post the USDA
announcementwhen we hear something.At 06:05 PM 11/22/2004, you wrote:>why
was the announcement on your TAHC site removed?>>Bovine Spongiform
Encephalopathy:>November 22: Press Release title here >>star image More BSE
information>>>>terry>>Carla Everett wrote:>>>no confirmation on the U.S.'
inconclusive test...>>no confirmation on location of
animal.>>>>>>


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


THEN, 7+ MONTHS OF COVER-UP BY JOHANN ET AL! no doubt about it now $$$


NO, it's not pretty, hell, im not pretty, but these are the facts, take em
or leave em, however, you cannot change them.

with kindest regards,

I am still sincerely disgusted and tired in sunny Bacliff, Texas USA 77518

Terry S. Singeltary Sr.


FULL 130 LASHINGS TO USDA BY OIG again


http://www.usda.gov/oig/webdocs/50601-10-KC.pdf


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=23557

Feb 06, 2004 Washington State Investigation—Final Epidemiology Report


http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/WashingtonState_epi_final3-04.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

ALSO, now with the 4th documented transmission of vCJD via transfusion, from such a small donor pool, we must ban blood from feed for animal and human consumption ;


Fourth case of transfusion-associated vCJD infection in the United Kingdom

Editorial team (eurosurveillance.weekly@hpa.org.uk), Eurosurveillance
editorial office

A suspected case of variant Creutzfeldt-Jakob disease (vCJD) has recently
been diagnosed in a patient in the United Kingdom (UK), who received a blood
transfusion from a donor who later developed vCJD [1]. This is the fourth
case of probable transfusion transmission of vCJD infection in the UK. Three
of the four recipients developed symptoms of vCJD.
The first symptomatic case of vCJD associated with blood transfusion was
identified in December 2003. This individual developed vCJD six and a half
years after transfusion of red cells donated by an individual who developed
symptoms of vCJD three and a half years after donation.

A second case of vCJD 'infection' was identified a few months later in a
person who had received red cells from a donor who developed symptoms of
vCJD 18 months after donation. This patient (the second case) died from
causes unrelated to vCJD five years after transfusion. Post-mortem
investigations found abnormal prion protein in the spleen and a cervical
lymph node., However, prion protein was not found in the brain, and no
pathological features of vCJD were found.

A third case developed symptoms of vCJD six years after receiving a
transfusion of red blood cells, and died two years and eight months later.
The donor of the blood involved developed vCJD about 20 months after
donating it.

These three cases have been published as case reports and in the findings of
the ongoing collaborative study between the National Blood Services, the
National CJD Surveillance Unit, and the Office for National Statistics. This
study aims to collect evidence about transmission of CJD or vCJD via the
blood supply [2,3,4,5].

The new, fourth case is in a patient who developed symptoms of vCJD eight
and a half years after receiving a transfusion of red blood cells from a
donor who developed vCJD about 17 months after this blood was donated [1].
The donor to this case also donated the vCJD-implicated blood transfused to
the third case. As for all other reported clinical vCJD cases that have been
tested for genotype, this patient is a methionine homozygote at codon 129 of
the prion protein gene. The patient is currently alive.

All four cases had received transfusions of non-leucodepleted red blood
cells between 1996 and 1999. Since October 1999, leucocytes have been
removed from all blood used for transfusion in the UK. The effect of
leucodepletion on the reduction of the risk of transmission of vCJD from an
infective donation is uncertain.

This fourth case of vCJD infection associated with blood transfusion further
increases the level of concern about the risk of vCJD transmission between
humans by blood transfusion, although much remains unknown. This reinforces
the importance of the existing precautions that have been introduced to
reduce the risk of transmission of vCJD infection by blood and blood
products [6]. No cases of vCJD have been associated with fractionated plasma
products. The small group of living recipients of vCJD-implicated blood
transfusion in the UK have been informed of their potential exposure to vCJD
by blood transfusion, asked to take certain precautions to reduce the risk
of onward person-to-person transmission of vCJD during health care, and
offered specialist neurological evaluation and advice.

This article has been adapted from reference 1


References:
Health Protection Agency. Fourth case of variant CJD associated with blood
transfusion (press release). Press release, 18 January 2007.
(http://www.hpa.org.uk/hpa/news/articles/press_releases/2007/070118_vCJD.htm
)
Llewelyn CA, Hewitt PE, Knight RSG, Amar K, Cousens S, Mackenzie J, et al.
Possible transmission of variant CJD disease by blood transfusion. Lancet
2004; 363:417-21.
Peden AH, Head MW, Ritchie DL, Bell JE, Ironside JW. Preclinical vCJD after
blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 2004 ;
364: 527-9.
Wroe SJ, Pal S, Siddique D, Hyare H, Macfarlane R, et al Clinical
presentation and pre-mortem diagnosis of blood transfusion-associated
variant CJD. Lancet 2006;368:2061-67.
Hewitt PE, Llewelyn CA, Mackenzie J, Will RG. Creutzfeldt-Jakob disease and
blood transfusion: results of the UK Transfusion Medicine Epidemiology
review study. Vox Sang. 2006;91(3):221-230.
Department of Health [London]. Further precautions to protect blood supply.
Press release 2004/0104, 16 March 2004.
(http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesN
otices/fs/en?CONTENT_ID=4076608&chk=MTwE%2Bl)

http://www.eurosurveillance.org/ew/2007/070118.asp#4


THE last time a country decided it was o.k. to poison the rest of the world, I thought we had learned something from it, I suppose we have not. that is all in the world the BSE MRR policy is, a legal tool to poison the globe, just for commodities and futures. THIS time however, we are dealing with a more virulent strain of mad cow disease i.e. BASE, and it's been here in the USA for some time if you go back and look at the studies of Mission, Texas from the Scrapie transmission studies there. So I failed to see the logic of this BSE MRR policy, there is nothing science based about it. ...


CONFIDENTIAL BSE POLICY

http://www.bseinquiry.gov.uk/files/yb/1994/05/20002001.pdf

RESTRICTED

MINISTER'S MEETING ON BSE (EXPORTS AND TRIPE) AND ANTHRAX, 14, JULY 1989


http://www.bseinquiry.gov.uk/files/yb/1989/07/14006001.pdf


England worried briefly about infecting other countries


27 Aug 00 confidential correspondence obtained by Terry S. Singeltary Sr.


BSE11/2 020;

SC1337p

DEPARTMENT OF HEALTH AND SOCIAL SECURITY
Richmond House, 79 Whitehall, London SWIA 2NS
Telephone 01-210 3000
From the Chief Medical Officer
Sir Donald Achson KBE DM DSc FRCP FFCM FFOM

Mr K C Meldrum
Chief Veterinary Officer
Ministry of Agriculture, Fisheries and Food
Government Buildings
Hook Rise South
Tolworth
Surbiton
Surrey
KT6 7NG 3 January 1990

Dear Mr Meldrum

BOVINE SPONGIFORM ENCEPHALOPATHY

You will recall that we have previously discussed the potential risks of
BSE occurring in other countries as a result of the continuing export
from the UK of meat and bone that may be contaminated by scrapie or
possibly BSE.

I remain concerned that we are not being consistent in our attempts to
contain the risks of BSE. Having banned the feeding of meat and bone
meal to ruminamts in 1988, we should take steps to prevent these UK
products being fed to ruminants in other countries. This could be
achieved either through a ban on the export of meat and bone meal,
or at least by the proper labelling of these products to make it
absolutely clear they should not be fed to ruminants
[or zoo animals, including rare and endangered primates -- webmaster].
Unless some such action is taken the difficult problems we have faced with BSE
may well occur in other countries who import UK meat and bone meal.
Surely it is short sighted for us to risk being seen in future as
having been responsible for the introduction of BSE to the food chain
in other countries.

I would be very interested to hear how you feel this gap in the present
precautionary measures to eliminate BSE should be closed. We should be
aiming at the global elimination of this new bovine disense. The export
of our meat and bone meal is a continuing risk to other countries.

Yours Sincerely
Donald Acheson

Copy:
Dr Metters
Dr Pickles

90/1.03/1.1
============
BSE13/3 0083

Dr Pickles
From: Dr J S Metters DCM0
International, Prevention and Community Services
7 June 1990
Copies to: Dr McInnes Miss Pease Mr Otley

BSE

1. I spoke to Mr Capstick yesterday. Among other things, he told me
that MAFF are now considering the labelling of animal foodstuffs, and
in particular what detail would be required if such labelling was made
compulsory. Apparently our freedom of action is constrained by EC
Directives [total garbage, MAFF wants to keep exporting -- webmaster], and there is also concern about the level of detail that
should be included in any foodstuff labels.

2. Mr Capstick suggested that this was not an area that DH had a
particular interest. I countered by saying that we supported the
principle of labelling of animal foodstuffs, particularly when these
were going for export.

3. I also thanked him for keeping us informed, in a way that I hope
encourage further communication of MAFF's internal deliberations.


J S METTERS
Room 509
Richmond House
Ext. 5591 92/YdeS 90/6.7/5.1


http://www.mad-cow.org/00/aug00_last_news.html#fff

http://www.bseinquiry.gov.uk/files/yb/1990/01/03001001.pdf

> Transmission Studies
>
> Mule deer transmissions of CWD were by intracerebral inoculation and
> compared with natural cases
>
> {the following was written but with a single line marked through it
''first
> passage (by this route)}...TSS
>
> resulted in a more rapidly progressive clinical disease with repeated
> episodes of synocopy ending in coma. One control animal became affected,
it
> is believed through contamination of inoculum (?saline). Further CWD
> transmissions were carried out by Dick Marsh into ferret, mink and
squirrel
> monkey. Transmission occurred in ALL of these species with the shortest
> incubation period in the ferret.
>
> snip...
>
> Appendix 3
>
> VISIT TO USA - DR A E WRATHALL - INFO OH BSE AND SCRAPIE
>
> 1. Dr Clark lately of the Scrapie Research Unit, Mission Texas has
> successfully transmitted ovine and caprine scrapie to cattle. The
> experimental results have not been published but there are plans to do
> this. This work was initiated in 1978. A summary of it is:-
>
> Expt A
> 6 Her x Jer calves born in 1978 were inoculated as follows with
> a 2nd Suffolk scrapie passage:-
>
>
> i/c 1ml; i/m, 5ml; s/c 5ml; oral 30ml.
> 1/6 went down after 48 months with a scrapie/BSE-like disease.
>
> Expt B
> 6 Her or Jer or HxJ calves were inoculated with angora Goat
> virus 2/6 went down similarly after 36 months.
>
> Expt C
> Mice inoculated from brains of calves/cattle in expts A • B
> were resistant, only 1/20 going down with scrapie and this was the
> reason given for not publishing.
>
> Diagnosis in A, B, C was by histopath. No reports on SAT were given.
>
> 2. Dr Warren Foote indicated success so far in eliminating scrapie in
> offspring from experimentally- (and naturally) infected sheep by ET.
> He had found difficulty in obtaining embryos from naturally infected
> sheep (cf SPA).
>
> 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.
> BSE was not reported in USA.
>
>
> 4. Scrapie incidents (ie affected flocks) have shown a dramatic increase
> since 1978. In 1953 when the National Control Scheme was started
> there were 10-14 incidents, in 1978 - 1 and in 1988 so far 60.
>
> 5. Scrapie agent was reported to have been isolated from a solitary
> fetus.
>
> 6. A western blotting diagnostic technique (? on PrP) shows some promise.
>
> 7. Results of a questionnaire sent to 33 states on the subject of the
> national sheep scrapie programme survey indicated
>
>
> 17/33 wished to drop it
>
> 6/33 wished to develop it
>
> 8/33 had few sheep and were neutral
>
>
> Information obtained from Dr Wrathall's notes of a meeting of the U.S.
> Animal Health Association at Little Rock, Arkansas Nov. 1988.
>
>
>
> 33
>
> end...TSS
>
>
> >> Differences in tissue distribution could require new regulations
> >> regarding specific risk material (SRM) removal.
>
>
> snip...end
>
> full text 33 PAGES ;
>
>
> http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf
>
> http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf
>
>
> It was, however, performed in the USA in 1979, when it was shown that
cattle
> inoculated with the scrapie agent endemic in the flock of Suffolk sheep at
> the United States Department of Agriculture in Mission, Texas, developed a
> TSE quite unlike BSE. 32 The findings of the initial transmission, though
> not of the clinical or neurohistological examination, were communicated in
> October 1988 to Dr Watson, Director of the CVL, following a visit by Dr
> Wrathall, one of the project leaders in the Pathology Department of the
CVL,
> to the United States Department of Agriculture. 33 The results were not
> published at this point, since the attempted transmission to mice from the
> experimental cow brain had been inconclusive. The results of the clinical
> and histological differences between scrapie-affected sheep and cattle
were
> published in 1995. Similar studies in which cattle were inoculated
> intracerebrally with scrapie inocula derived from a number of
> scrapie-affected sheep of different breeds and from different States, were
> carried out at the US National Animal Disease Centre. 34 The results,
> published in 1994, showed that this source of scrapie agent, though
> pathogenic for cattle, did not produce the same clinical signs of brain
> lesions characteristic of BSE.
>
> http://www.bseinquiry.gov.uk/
>
>
>
> 1: J Infect Dis. 1994 Apr;169(4):814-20.
>
>
> Intracerebral transmission of scrapie to cattle.
>
> Cutlip RC, Miller JM, Race RE, Jenny AL, Katz JB, Lehmkuhl HD, DeBey BM,
> Robinson MM.
>
> USDA, Agriculture Research Service, National Animal Disease Center, Ames,
IA
> 50010.
>
> To determine if sheep scrapie agent(s) in the United States would induce a
> disease in cattle resembling bovine spongiform encephalopathy, 18 newborn
> calves were inoculated intracerebrally with a pooled suspension of brain
> from 9 sheep with scrapie. Half of the calves were euthanatized 1 year
after
> inoculation. All calves kept longer than 1 year became severely lethargic
> and demonstrated clinical signs of motor neuron dysfunction that were
> manifest as progressive stiffness, posterior paresis, general weakness,
and
> permanent recumbency. The incubation period was 14-18 months, and the
> clinical course was 1-5 months. The brain from each calf was examined for
> lesions and for protease-resistant prion protein. Lesions were subtle, but
a
> disease-specific isoform of the prion protein was present in the brain of
> all calves. Neither signs nor lesions were characteristic of those for
> bovine spongiform encephalopathy.
>
> MeSH Terms:
> Animals
> Brain/microbiology*
> Brain/pathology
> Cattle
> Cattle Diseases/etiology*
> Cattle Diseases/pathology
> Encephalopathy, Bovine Spongiform/etiology*
> Encephalopathy, Bovine Spongiform/pathology
> Immunoblotting/veterinary
> Immunohistochemistry
> Male
> Motor Neurons/physiology
> Prions/analysis
> Scrapie/pathology
> Scrapie/transmission*
> Sheep
> Sleep Stages
> Time Factors
>
> Substances:
> Prions
>
>
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8133096&dopt=Citation
>
>
> Intracerebral transmission of scrapie to cattle FULL TEXT PDF;
>
> SNIP...
>
>
> Discussion
>
>
> WE conclude that American sources of sheep scrapie are transmissible to
> cattle by direct intracerebral inoculation but the disease induced is NOT
> identical to BSE as seen in the United Kingdom. While there were
> similarities in clinical signs between this experimental disease and BSE,
> there was no evidence of aggressiveness, hyperexcitability, hyperesthesia
> (tactile or auditory), or hyperemetria of limbs as has been reported for
BSE
> (9). Neither were there extensive neurologic lesions, which are primary
for
> BSE, such as severe vacuolation of neurons and neuropil or neuronal
necrosis
> and gliosis. Although some vacuolation of neuropil, chromotolysis in
> neurons, and gliosis were seen in the brains of some affected calves,
these
> were industinguishable from those of controls. Vacuolated neurons in the
red
> nucleus of both challenged and normal calves were considered normal for
the
> bovines as previously described (50).
>
>
> PrP-res was found in ALL CHALLENGED CALVES REGARDLESS OF CLINCIAL SIGNS,
and
> the amount of PrP-res positively related to the length of the incubation.
> ...
>
>
> snip...
>
>
> WE also conclude from these studies that scrapie in cattle MIGHT NOT BE
> RECOGNIZED BY ROUTINE HISTOPATHOLOGICAL EXAMINATION OF THE BRAIN AND
SUGGEST
> THAT DETECTION OF PrP-res by immunohistochemistry or immunoblotting is
> necessary to make a definitive diagnosis. THUS, undiagnosed scrapie
> infection could contribute to the ''DOWNER-COW'' syndrome and could be
> responsible for some outbreaks of transmissible mink encephalopathy
proposed
> by Burger and Hartsough (8) and Marsh and harsough (52). ...
>
>
> snip...
>
>
> Multiple sources of sheep affected with scrapie and two breeds of cattle
> from several sources were used inthe current study in an effort to avoid a
> single strain of either agent or host. Preliminary results from mouse
> inoculations indicate multiple strains of the agent were present in the
> pooled inoculum (unpublished data). ...
>
>
> Transmission of the sheep scrapie to cattle was attempted in 1979 by using
> intracerebral, intramuscular, subcutaneous, and oral routes of inoculation
> of 5, 8- to 11-month old cattlw with a homologous mixture of brain from 1
> affected sheep (61, 62). ONE of the 5 cattle develped neurologic signs 48
> months after inoculation. Signs were disorientation, incoordination, a
> stiff-legged stilted gait, progressive difficulty in rising, and finally
in
> terminal recumbency. The clinical course was 2.5 months. TWO of the 5
cattle
> similarly inoculated with brain tissue from a goat with scrapie exhibited
> similar signs 27 and 36 months after incoluation. Clinical courses were 43
> an 44 days. Brain lesions of mild gliosis and vacuolation and mouse
> inoculation data were insufficient to confirm a diagnosis of scrapie. This
> work remained controversial until recent examination of the brains
detected
> PrP-res in all 3 cattle with neurologic disease but in none of the
> unaffected cattle (62). Results of these studies are similar to ours and
> underscore the necessity of methods other than histopathology to diagnose
> scrapie infection in cattle. We believe that immunologic techniques for
> detecting PrP-res currently provide the most sensitive and reliable way to
> make a definitive diagnosis...
>
>
> http://www.bseinquiry.gov.uk/files/sc/seac17/tab03.pdf
>
>
> Visit to USA ... info on BSE and Scrapie
>
> http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf
>

snip...

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


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0610&L=sanet-mg&D=0&T=0&P=19406


2006-2007 USA AND OIE POISONING GLOBE WITH BSE MRR POLICY

***These results indicate that BASE is
transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.

6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp

18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...


***$$$***

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.
Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.


http://www.seac.gov.uk/minutes/95.pdf

THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been
rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted products from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone. These are the facts as I have come to know through daily and extensive research of TSE over 9 years, since 12/14/97.
I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many
more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species.

MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ???

go figure. ...


Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518

Comment Submitted
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Thank you. Your comment on Document ID: APHIS-2006-0041-0001 has been sent. Comment Tracking Number: APHIS-2006-0041-DRAFT-0028

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If you wish to retain a copy of the receipt, use the following link to print a copy for your files. Print

http://www.regulations.gov/fdmspublic/component/main

funny how you never heard of this bse mrr policy until AFTER the USA was finally forced to document there first case of mad cow disease. ...tss



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