SEARCH VEGSOURCE:

 

 

Follow Ups | Post Followup | Back to Discussion Board | VegSource
See spam or
inappropriate posts?
Please let us know.
  




From: TSS ()
Subject: STATEMENT BY DR. RON DEHAVEN REGARDING OIE RISK RECOMMENDATION
Date: March 9, 2007 at 12:13 pm PST

Karen Eggert (301) 734-7280
Jerry Redding (202) 720-4623

STATEMENT BY DR. RON DEHAVEN REGARDING OIE RISK RECOMMENDATION

March 9, 2007

“In October 2006, the U.S. Department of Agriculture submitted an application and supporting documents to the World Organization for Animal Health (OIE) to formally request country classification for bovine spongiform encephalopathy (BSE) risk. The OIE undertakes a thorough review process before recommending a risk classification, and then provides an opportunity for all delegate countries to review the recommendations and present comments prior to final adoption of a country’s classification at the OIE’s General Assembly meeting in May.

“While we recognize that a final classification decision will not be made by the OIE until May, we feel it is important to be responsive to questions we are now being asked about the risk classification recommended for the United States. The OIE Scientific Commission has endorsed the recommendation from an OIE expert panel that the United States be classified as “controlled risk” for BSE.

“The controlled risk classification recognizes that OIE-recommended, science-based mitigation measures are in place to effectively manage any possible risk of BSE in the cattle population. This recommendation provides strong support that U.S. regulatory controls are effective and that U.S cattle and products from cattle of all ages can be safely traded in accordance with international guidelines, due to our interlocking safeguards.

“The OIE risk classification process is an essential step in promoting trade and understanding of this disease. We appreciate OIE’s review of our application, as well as its leadership in developing sound, science-based guidelines that will help countries standardize regulations and import requirements. We look forward to the final adoption of this classification, which will be announced at the OIE meeting in May.”

#

http://www.aphis.usda.gov/newsroom/content/2007/03/OIE_statement3-9-07.shtml

BSE/BASE UPDATE USA


In Reply to: MAD COW TISSUE SAMPLING FOR TESTING CONSISTS OF USDA CERTIFIED CATTLE posted by TSS on February 17, 2007 at 7:48 am:

United States District Court, District of Arizona


USA v Roland Emerson Farabee
2: 07-wi-0001-01-EHC

Proceeding Type: Waiver/Plea


Judge: Honorable Earl H Carroll
Courtroom: Phoenix Courtroom #501, 5th Floor


Date: 01/17/2007 Court Reporter: Candy Potter
Time: 01:30 PM Courtroom Deputy: Bobbi Hightower


Counts:
(may not reflect
all counts) 18:641 and 2 (Theft of Government Money and Adiding and Abetting) 1
18: 1341 and 2 (Mail Fruad and Aiding and Abetting) 2
18:1343 and 2 (Wire Fraud and Aiding and Abetting) - 3

U.S. Attorney: Long, Robert

--------------------------------------------------------------------------------
Defense Attorney(s): Attorney Phone: Attorney Designation:
McDonald, Jr., A. Melvin retained


http://www.azd.uscourts.gov/azd/callive.nsf/552b822403e5434a07256d6c007cc3ef/256244d68b5f47780725725e006aac31?OpenDocument&Click=

if my siphering is correct, that would be about another 2600 potential mad cows that went into the food chain. add that to these ;

>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.<


AND we know IHC is the least likely to find TSE.


and not to forget that one little old mad cow in TEXAS they rendered without any test at ALL.


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

REMINDER, CATTLE ON FEED IN TEXAS


IN TEXAS, cattle on feed for decades, fda says 5.5 grams ruminant protein,
if tainted with TSE, is not enough to kill a cow. actually, it's enough to
kill 100+ cows ;-)

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


and add these in ;


UPI previously reported that from 2001 to 2003 the USDA collected the wrong part of the brain in more than 200 cows that were being screened as part of its BSE surveillance program.

The USDA documents also indicate the agency never was able to identify or test 52 cows that came into the United States in 2001 along with the Washington cow that tested positive in 2003. Of these, 11 were considered to be "high risk" because they were born within a year and on the same premises as the infected cow.

These cows may have gone into the food supply and been consumed by people. The concern is humans can contract a fatal brain disease from eating beef products contaminated with the mad cow pathogen.


http://www.terradaily.com/upi/2005/WWN-UPI-20050721-17422400-bc-us-madcow.html


NOT to forget what Paul Brown TSE expert at CDC said ;


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."


OR, what the Honorable Phyllis Fong of the OIG found ;


Audit Report

Animal and Plant Health Inspection Service

Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II

and

Food Safety and Inspection Service

Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III

Report No. 50601-10-KC January 2006

Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain


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

Greetings list members,

IF you remember correctly, i posted this ;

Subject: Re: USDA/APHIS JUNE 2004 'ENHANCED' BSE/TSE COVER UP UPDATE
DECEMBER 19, 2004 USA
Date: Thu, 30 Dec 2004 12:27:06 -0600
From: "Terry S. Singeltary Sr.


BSE-L

snip...

>
> OH, i did ask Bio-Rad about this with NO reply to date;
>
>
> -------- Original Message --------
> Subject: USA BIO-RADs INCONCLUSIVEs
> Date: Fri, 17 Dec 2004 15:37:28 -0600
> From: "Terry S. Singeltary Sr."
> To: susan_berg@bio-rad.com
>
>
>
> Hello Susan and Bio-Rad,
>
> Happy Holidays!
>
> I wish to ask a question about Bio-Rad and USDA BSE/TSE testing
> and there inconclusive. IS the Bio-Rad test for BSE/TSE that complicated,
> or is there most likely some human error we are seeing here?
>
> HOW can Japan have 2 positive cows with
> No clinical signs WB+, IHC-, HP- ,
> BUT in the USA, these cows are considered 'negative'?
>
> IS there more politics working here than science in the USA?
>
> What am I missing?
>
>
>
> -------- Original Message --------
> Subject: Re: USDA: More mad cow testing will demonstrate beef's safety
> Date: Fri, 17 Dec 2004 09:26:19 -0600
> From: "Terry S. Singeltary Sr."
> snip...end
>
>
> Experts doubt USDA's mad cow results

snip...END

WELL, someone did call me from Bio-Rad about this,
however it was not Susan Berg.
but i had to just about take a blood oath not to reveal
there name. IN fact they did not want me to even mention
this, but i feel it is much much to important. I have omitted
any I.D. of this person, but thought I must document this ;

Bio-Rad, TSS phone conversation 12/28/04

Finally spoke with ;


Bio-Rad Laboratories
2000 Alfred Nobel Drive
Hercules, CA 94547
Ph: 510-741-6720
Fax: 510-741-5630
Email: XXXXXXXXXXXXXXXXXX

at approx. 14:00 hours 12/28/04, I had a very pleasant
phone conversation with XXXX XXXXX about the USDA
and the inconclusive BSE testing problems they seem
to keep having. X was very very cautious as to speak
directly about USDA and it's policy of not using WB.
X was very concerned as a Bio-Rad official of retaliation
of some sort. X would only speak of what other countries
do, and that i should take that as an answer. I told X
I understood that it was a very loaded question and X
agreed several times over and even said a political one.

my question;

Does Bio-Rad believe USDA's final determination of False positive,
without WB, and considering the new
atypical TSEs not showing positive with -IHC and -HP ???

ask if i was a reporter. i said no, i was with CJD Watch
and that i had lost my mother to hvCJD. X did not
want any of this recorded or repeated.

again, very nervous, will not answer directly about USDA for fear of
retaliation, but again said X tell
me what other countries are doing and finding, and that
i should take it from there.
"very difficult to answer"

"very political"

"very loaded question"

outside USA and Canada, they use many different confirmatory tech. in
house WB, SAF, along with
IHC, HP, several times etc. you should see at several
talks meetings (TSE) of late Paris Dec 2, that IHC- DOES NOT MEAN IT IS
NEGATIVE. again, look what
the rest of the world is doing.
said something about Dr. Houston stating;
any screening assay, always a chance for human
error. but with so many errors (i am assuming
X meant inconclusive), why are there no investigations, just false
positives?
said something about ''just look at the sheep that tested IHC- but were
positive''. ...


TSS

-------- Original Message --------
Subject: Your questions
Date: Mon, 27 Dec 2004 15:58:11 -0800
From: To: flounder@wt.net

Hi Terry:

............................................snip Let me know your phone
number so I can talk to you about the Bio-Rad BSE test.
Thank you

Regards

Bio-Rad Laboratories
2000 Alfred Nobel Drive
Hercules, CA 94547
Ph: 510-741-6720
Fax: 510-741-5630
Email: =================================


END...TSS


######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########


THE SEVEN SCIENTIST REPORT ***


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


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


[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

9/13/2005

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


Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA 11/03/2003 01:19 PM

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


Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS 07/11/2004 09:34 PM

https://web01.aphis.usda.gov/regpublic.nsf/168556f5aa7a82ba85256ed00044eb1f/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument


Importation of Whole Cuts of Boneless Beef From Japan

[Docket No. 05-004-2] RIN 0579-AB93


snip...


Peripheral Nerves

Issue: Two commenters stated that the underlying assumption of the
proposed rule, that whole cuts of boneless beef from Japan will not
contain tissues that may carry the BSE agent, is no longer valid
because researchers have found peripheral nervous system tissues,
including facial and sciatic nerves, that contain BSE infectivity.\2\
One of these commenters requested APHIS to explain whether and what
additional mitigation measures are needed to reduce the risks that
these tissues may be present in Japanese beef. This commenter further
requested an additional comment period to obtain public comment
regarding the manner by which APHIS intends to treat this new
scientific finding.
---------------------------------------------------------------------------

\2\ Bushmann, A., and Gruschup, M.; Highly Bovine Spongiform
Encephalopathy-Sensitive Transgenic Mice Confirm the Essential
Restriction of Infectivity to the Nervous System in Clinically
Diseased Cattle. The Journal of Infectious Diseases, 192: 934-42,
September 1, 2005.
---------------------------------------------------------------------------

Response: APHIS is familiar with the results of the study mentioned
by the commenters in which mice, genetically engineered to be highly
susceptible to BSE and to overexpress the bovine prion protein, were
inoculated with tissues from a BSE-infected cow. This study
demonstrated low levels of infectivity in the mouse assay in the facial
and sciatic nerves of the peripheral nervous system. APHIS has
evaluated these findings in the context of the potential occurrence of
infectivity in the peripheral nerves of cattle and the corresponding
risks of the presence of infectivity in such tissues resulting in
cattle or human exposure to the BSE agent. The results from these
experiments in genetically engineered mice should be interpreted with
caution, as the findings may be influenced by the overexpression of
prion proteins and may not accurately predict the natural distribution
of BSE infectivity in cattle. Further, the overexpression of prion
proteins in transgenic mice may not accurately mimic the natural
disease process because the transgenic overexpressing mice have been
shown to develop spontaneous lethal neurological disease involving
spongiform changes in the brain and muscle degeneration.\3\ In
addition, the route of administration to the mice was both
intraperitoneal and intracerebral, which are two very efficient routes
of infection as compared to oral consumption. Given these factors,
APHIS has determined that the finding of BSE infectivity in facial and
sciatic nerves of the transgenic mice is not directly applicable to
cattle naturally infected with BSE. Therefore, we do not consider it
necessary to make any adjustments to the risk analysis for this
rulemaking or to extend the comment period to solicit additional public
comment on this issue.
---------------------------------------------------------------------------

\3\ Westaway, D., et al.; (1994) Degeneration of Skeletal
Muscle, Peripheral Nerves, and the Central Nervous System in
Transgenic Mice Overexpressing Wild-type Prion Proteins. Cell 76, 117-129.
---------------------------------------------------------------------------

Blood

Issue: Two commenters expressed concern that there has been a
limited amount of research conducted on BSE infectivity in blood. One
of these commenters cited a report that discussed, among other things,
the detection of infectivity in sheep experimentally infected with BSE
via blood transfusions.\4\ This commenter also stated that the agent
that causes Creutzfeldt-Jakob disease (CJD), a chronic and fatal
neurodegenerative disease of humans, was detected in blood, and
questioned whether the BSE agent could be detected in blood as well.
The other commenter cited a study that detected infectivity in hamsters
experimentally infected with scrapie.\5\ This commenter requested that
APHIS ban the use of blood in cattle feed.
---------------------------------------------------------------------------

\4\ Pattison, J., et al.; UK Strategy for Research and
Development on Human and Animal Health Aspects of Transmissible
Spongiform Encephalopathies, 2005-2008. Available at
http://www.mrc.ac.uk/pdf-about-tse_uk_strategy_june2005.pdf.
\5\ Castilla, J., et al.; Detection of Prions in Blood. Nature
Medicine, doi: 10.1038/nm1286, August 28, 2005, at 3.
---------------------------------------------------------------------------

Response: As stated in our risk analysis, the pathogenesis studies
of naturally and experimentally infected cattle have not detected BSE
infectivity in blood.
The first study mentioned by the commenter above demonstrated
transmission of disease from sheep experimentally infected with BSE to
another sheep via blood transfusions. We note that there are widely
acknowledged differences between the distribution of BSE infectivity in
the tissues of cattle and sheep. In addition, there is a significant
difference in susceptibility to infection based on the route of
transmission. Infection via oral consumption may be 10,000 times less
efficient than infection via intravenous injection, such as a blood
transfusion.
Both the United Kingdom's Department for Environment, Food and
Rural Affairs' Spongiform Encephalopathy Advisory Committee (SEAC) and
the European Commission's Scientific Steering Committee (SSC), which
are scientific advisory committees, evaluated the findings of
transmission of infectivity via blood transfusions in sheep
experimentally infected with BSE and concluded that

[[Page 73907]]

these findings did not indicate that additional mitigation measures
were necessary to protect public health.\6\ Therefore, based on
currently available information, APHIS considers it unlikely that the
experimental observations in sheep reflect a biologically significant
event for cattle or affect the safety of whole cuts of boneless beef
derived from cattle born, raised, and slaughtered in Japan.
---------------------------------------------------------------------------

\6\ Spongiform Encephalopathy Advisory Committee, Oct. 19, 2000,
Summary of SEAC Committee Meeting 29 September 2000. Available at
http://www.defra.gov.uk/news/seac/seac500.htm.
European Commission Scientific Steering Committee; The
Implications of the Recent Papers on Transmission of BSE by Blood
Transfusion in Sheep (Houston et al., 2000; Hunter et al., 2002),
Adopted by the SSC at its Meeting of 12-13 September. Available at
http://europa.eu.int/comm/food/fs/sc/ssc/out280_en.pdf.

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

The study on scrapie-infected hamsters noted by the commenter
describes a process by which the abnormal prion protein can be
amplified and detected using current testing methods, such as a Western
blot. In this study, blood from hamsters experimentally infected with a
scrapie strain was collected when the animals demonstrated clinical
signs of disease. These blood samples were incubated with excess normal
prion protein from brain tissue for multiple cycles. If abnormal
protein is present in blood, it will convert the normal brain prion to
abnormal prion, yielding an increased amount of abnormal prion that can
be more easily detected. In this manner, the presence of abnormal prion
protein in the initial blood samples, which was present in levels too
low to detect using routine test methods, was demonstrated. While this
finding has many possibilities related to the development of diagnostic
tests, it does not demonstrate BSE infectivity in blood. We also note
that the international community largely considers that studies using
transmissible spongiform encephalopathies (TSEs) other than BSE in non-
bovine animals cannot be directly extrapolated to BSE in cattle because
of the significant interactions between the host species and the prion
strain involved.
Feed regulations in the United States are under the authority of
the Food and Drug Administration (FDA), not APHIS. Therefore, the
commenter's request that APHIS ban the use of blood in cattle feed
falls outside the scope of this rulemaking. For these reasons, we are
not making any changes to the rule based on these comments.


snip...


Issue: Two commenters raised questions regarding the origin of CJD
in humans. One commenter noted that there are different strains of TSEs
being discovered in ruminants, and that new atypical strains of TSE in
cattle look similar to sporadic CJD in humans. Another commenter asked
if APHIS has considered whether sporadic CJD in humans might be caused
by atypical cases of TSEs that have been found in animals. This
commenter further questioned whether blood and other tissues may carry
BSE infectivity in cattle infected with atypical strains of the BSE
agent or other TSE agents.
Response: Sporadic CJD is the most common form of CJD. It has been
found in every country in the world where it has been looked for
including countries that are generally considered by the international
scientific community to be free of BSE and other TSEs (for example,
Australia and New Zealand). In general, it affects about one person per
million. No association between sporadic CJD and consumption of animal
products in general and/or infected or contaminated bovine products has
ever been documented. It is currently believed that sporadic CJD arises
through the spontaneous conversion of PrPC (normal cellular
prion protein) to PrPSC in an individual.\13\ In contrast,
atypical cases of BSE in cattle are rare and have been reported in only
few countries that experience BSE, such as Italy, Belgium, Japan, and
France. It has been speculated that the spontaneous or sporadic form of
BSE could exist in cattle, as well as humans.\14\
---------------------------------------------------------------------------

\13\ Stahl, N. and Prusiner, S.B.; (1991) FASEB-J. 5: 2799-807.
\14\ Biacabe; 2004 EMBO reports, Vol. 5, No. 1.

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

[[Page 73916]]

APHIS agrees with the commenter that reports indicate that some of
the atypical BSE cases, in particular the bovine amyloidotic spongiform
encephalopathy (BASE), and sporadic CJD have similar PrPSC
patterns. APHIS evaluated the findings in the context of risk of
exposure to cattle and humans. Currently, the relevance of the atypical
cases is unknown, but at this time there is no indication that any
control measures--such as feed bans or SRM requirements--should be
modified based on these cases. Additionally, although atypical cases of
BSE and sporadic CJD share similarities at this point, there is no
evidence that they are linked.
Issue: One commenter expressed concern over the number of citations
issued for various SRM violations during the June 2004 enhanced BSE
surveillance program in the United States. This commenter questioned
whether these incidents of noncompliance may have led to infective
materials entering the human or animal food chains. This commenter
cited the case of BSE detected in a 12-year-old cow in Texas as
evidence that infective materials may have entered the food chain. The
commenter suggested that noncompliance reports should be made more
easily available to the public in the future.
Response: FSIS inspectors are responsible for verifying the
effectiveness of an establishment's procedures. If FSIS personnel
determine that an establishment's procedures are ineffective in
preventing cross-contamination, the inspectors will take appropriate
action. We note that none of the meat from the 12-year-old BSE-infected
cow in Texas mentioned by the commenter entered the human food or
animal feed chains.


snip...full text ;

http://www.epa.gov/fedrgstr/EPA-IMPACT/2005/December/Day-14/i24057.htm


Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1] RIN 0579-AB93 TSS SUBMISSION


http://docket.epa.gov/edkfed/do/EDKStaffItemDetailView?objectId=090007d480993808


http://docket.epa.gov/edkfed/do/EDKStaffAttachDownloadPDF?objectId=090007d480993808


http://docket.epa.gov/edkfed/do/EDKStaffCollectionDetailView?objectId=0b0007d48096b40d

Docket No. 05-004-1 RIN 0579-AB93 BSE TSS was Received


I would kindly like to comment on [Docket No. 05-004-1] RIN 0579-AB93 ;

PROPOSED RULES
Exportation and importation of animals and animal products:
Whole cuts of boneless beef from-
Japan,
48494-48500 [05-16422]


[Federal Register: August 18, 2005 (Volume 70, Number 159)]
[Proposed Rules]
[Page 48494-48500]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au05-7]

========================================================================
Proposed Rules
Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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


[[Page 48494]]


DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 05-004-1]
RIN 0579-AB93


Importation of Whole Cuts of Boneless Beef from Japan

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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

SUMMARY: We are proposing to amend the regulations governing the
importation of meat and other edible animal products by allowing, under
certain conditions, the importation of whole cuts of boneless beef from
Japan. We are proposing this action in response to a request from the
Government of Japan and after conducting an analysis of the risk that
indicates that such beef can be safely imported from Japan under the
conditions described in this proposal.

DATES: We will consider all comments that we receive on or before
September 19, 2005.

ADDRESSES: You may submit comments by any of the following methods:
EDOCKET: Go to http://www.epa.gov/feddocket to submit or


snip...


BSE infectivity has never been demonstrated in the muscle tissue of
cattle experimentally or naturally infected with BSE at any stage of
the disease. Studies performed using TSEs other than BSE in non-bovine
animals have detected prions in muscle tissue. However, the
international scientific community largely considers that these studies
cannot be directly extrapolated to BSE in cattle because of the
significant interactions between the host species and the prion strain
involved.
Pathogenesis studies of naturally and experimentally infected
cattle have not detected BSE infectivity in blood. However,
transmission of BSE was demonstrated in sheep that received a
transfusion of a large volume of blood drawn from other sheep that were
experimentally infected with the BSE agent. The United Kingdom's
Department for Environment, Food and Rural Affairs' Spongiform
Encephalopathy Advisory Committee (SEAC) and the European Commission's
Scientific Steering Committee (SSC), which are scientific advisory
committees, evaluated the implication of this finding in relation to
food safety.\5\ The SEAC concluded that the finding did not represent
grounds for recommending any changes to the current control measures
for BSE. The SSC determined that the research results do not support
the hypothesis that bovine blood or muscle meat constitute a risk to
human health.\6\


snip...


BSE Risk Factors for Whole Cuts of Boneless Beef


The most significant risk management strategy for ensuring the
safety of whole cuts of boneless beef is the prevention of cross-
contamination of the beef with SRMs during stunning and slaughter of
the animal. Control measures that prevent contamination of such beef
involve the establishment of procedures for the removal of SRMs,
prohibitions on air-injection stunning and pithing, and splitting of
carcasses. These potential pathways for contamination and the control
measures that prevent contamination are described in detail in the risk
analysis for this rulemaking.
SRM Removal. Research has demonstrated that SRMs from infected
cattle may contain BSE infectivity. Because infectivity has not been
demonstrated in muscle tissue, the most important mitigation measure
for whole cuts of boneless beef is the careful removal and segregation
of SRMs. Removal of SRMs in a manner that avoids contamination of the
beef with SRMs minimizes the risk of exposure to materials that have
been demonstrated to contain the BSE agent in cattle.

snip...


Variant Creutzfeldt-Jakob disease (vCJD), a chronic and fatal
neurodegenerative disease of humans, has been linked since 1996 through
epidemiological, neuropathological, and experimental data to exposure
to the BSE agent, most likely through consumption of cattle products
contaminated with the agent before BSE control measures were in place.
To date, approximately 170 probable and confirmed cases of vCJD have
been identified worldwide. The majority of these cases have either been
identified in the United Kingdom or were linked to exposure that
occurred in the United Kingdom, and all cases have been linked to
exposure in countries with native cases of BSE. Some studies estimate
that more than 1 million cattle may have been infected with BSE
throughout the epidemic in the United Kingdom. This number of infected
cattle could have introduced a significant amount of infectivity into
the human food supply. Yet, the low number of cases of vCJD identified
to date indicates that there is a substantial species barrier that
protects humans from widespread illness due to exposure to the BSE
agent.


snip...


International Guidelines on BSE

International guidelines for trade in animal and animal products
are developed by the World Organization for Animal Health (formerly
known as the Office International des Epizooties (OIE)), which is
recognized by the World Trade Organization (WTO) as the international
organization responsible for the development of standards, guidelines,
and recommendations with respect to animal health and zoonoses
(diseases that are transmissible from animals to humans). The OIE
guidelines for trade in terrestrial animals (mammals, birds, and bees)
are detailed in the Terrestrial Animal Health Code (available on the
internet at http://www.oie.int). The guidelines on BSE are contained in

Chapter 2.3.13 of the Code and supplemented by Appendix 3.8.4 of the
Code.


snip...end


http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/05-16422.htm

http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-16422.pdf

Greetings again APHIS ET AL,


THIS is not correct. IN fact, there are several factors i would like to kindly address. .......


SNIP...


WE MUST ADHERE TO THE BSE GBR RISK ASSESSMENTS, WE MUST WORK TO ENHANCE THOSE BSE GBR RISK ASSESSMENTS TO INCLUDE ALL ANIMAL TSEs, USDA/APHIS/GW ET ALs BSE MRR (Minimal Risk Region) should be REPEALED/DISBANDED/TRASHED/NADA and done away with for good. The BSE MRR policy is nothing more than a legal tool to trade all strains of TSEs globally...


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518


Your Comment with Title "[Docket No. 05-004-1] RIN 0579-AB93 BSE TSS " was Received.
The Identifier Assigned is "APHIS-2005-0073-0009".
An Electronic File was Attached to this Submission.

Please note that it may take between 24 and 72 hours for the EDOCKET staff to process your comment before it is available publicly through EDOCKET. You can use the identifier noted above to find your comment through the Quick or Advanced Search pages when it is available. ...........


http://www.aphis.usda.gov/lpa/news/2005/08/japanbeef_vs.html


EPA: Federal Register: Importation of Whole Cuts of Boneless Beef ...Importation of Whole Cuts of Boneless Beef From Japan , Federal Register document. ... we published in the Federal Register (70 FR 48494-48500, Docket No. ...


http://www.epa.gov/fedrgstr/EPA-IMPACT/2005/December/Day-14/i24057.htm


Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1] RIN 0579-AB93 TSS SUBMISSION

next 3 urls now dead ;


http://docket.epa.gov/edkfed/do/EDKStaffItemDetailView?objectId=090007d480993808


http://docket.epa.gov/edkfed/do/EDKStaffAttachDownloadPDF?objectId=090007d480993808


http://docket.epa.gov/edkfed/do/EDKStaffCollectionDetailView?objectId=0b0007d48096b40d

"[Docket No. 05-004-1] RIN 0579-AB93 BSE TSS " was Received

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

APHIS-2006-0041-0006 Comment from Terry S Singletary Sr 01/09/2007 PUBLIC SUBMISSIONS

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


APHIS-2006-0041-0006.1 Attachment to Singletary comment 01/09/2007 PUBLIC SUBMISSIONS

http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8


P.S.


----- Original Message -----
From: Terry S. Singeltary Sr.
To: Boyd.Rutherford@usda.gov
Sent: Sunday, February 25, 2007 12:35 PM
Subject: FOIA REQUEST FOR ATYPICAL TSE INFORMATION ON VERMONT SHEEP


Greetings USDA,


I respectfully request the final results of the mouse bio-assays test that were to have supposedly began 2+ years late, 5 years ago, on the imported sheep from Belgium ?


WHAT happened to the test results and MOUSE BIO-ASSAYS of those imported sheep from Belgium that were confiscated and slaughtered from the Faillace's, what sort of TSE did these animals have ?


WERE they atypical scrapie, BSE, and or typical scrapie ?


HOW much longer will you refuse to give us this information ? and for what reason ?


WHY is it that the Farm of the Mad Sheep of Mad River Valley were quarantined for 5 years, but none of these farms from Texas and Alabama with Atypical TSE in the Bovine, they have not been quarantined for 5 years, why not, with the real risk of BSE to sheep, whom is to say this was not BSE ?


snip.

full text ;


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


https://web01.aphis.usda.gov/regpublic.nsf/168556f5aa7a82ba85256ed00044eb1f/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument


FURTHERMORE, I respectfully request up front, that any fees for this FOIA be wavered due to the fact this information should be free to the public and is in the best interest for the public to have these final results, no financial gain from this FOIA information is to be made either. ...


Thank You,


kind regards,

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


Imported

Belgium/Netherlands

Sheep Test Results

Background

Factsheet

Veterinary Services April 2002

APHIS

snip.

Additional tests will be conducted to determine

exactly what TSE the animals have BSE or scrapie.

These tests involve the use of bioassays that consist

of injecting mice with tissue from the infected animals

Page 15 of 98

8/3/2006

and waiting for them to develop disease. This testing

may take at least 2 to 3 years to complete.

http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/fs_ahvtsheeptr.pdf

DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E.

(PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=fr20jy00-31

DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E

(PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES [2]

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=fr20jy00-32


--- Original Message ---


Subject: Sheep
Date: Sat, 12 Jun 2004 14:26:04 EDT
From: LAVET22@aol.com
To: flounder@wt.net

Mr. Singeltary.

I hope this finds you well. As you are aware I left the USDA last
year. I can only update you on the sheep before that time. Contact was
established with the UK on doing the bioassay studies. They agreed.
However, we were prioritized after their own needs, hence the delay. I
am aware that there are now additional labs in Europe running the mouse
bioassay strain typing. You will have to contact USDA for further word.

Linda Detwiler
=========

My reply to Dr. Detwiler;

--- Original Message ---
Subject: Re: Sheep
Date: Sat, 12 Jun 2004 13:53:57 -0500
From: "Terry S. Singeltary Sr."
To: LAVET22@aol.com
References:

hello Dr. Detwiler,

thanks for your kind reply.

> However, we were prioritized after their own needs, hence the delay.

not sure i understand that?

> You will have to contact USDA for further word.

already done that, and there answer was;


--- Original Message ---


Subject: Re: hello Dr. Sutton.question please.scrapie.TSS
Date: Thu, 20 May 2004 14:36:09 -0400
From: Jim.D.Rogers@aphis.usda.gov
To: flounder@wt.net

Dear Mr. Singeltary,

The Western blot tests on these animals were completed in April of this
year. That means that we can begin the mouse inoculations. To get the
results of the Western blot tests, you will need to submit a Freedom of
Information Act request through our FOIA office. The FAX number there is
301-734-5941.

Have a nice day,

Jim Rogers
APHIS LPA

--- Original Message ---


Subject: re-85th Meeting of SEAC - 30.11.04
Date: Tue, 21 Dec 2004 16:56:55 -0000
From: "Barlow, Tom (SEAC)"
To: "'flounder@wt.net'"

Dear Mr Singeltary

Thank you for you enquiry to the SEAC secretariat about mouse bioassays
commissioned by the USDA to investigate TSE cases in imported sheep.

After making a number of enquiries, it appears that Defra were not involved
with this work. However, it is possible that a UK research laboratory was
contacted by the USDA about such tests but I have been unable to find out
any further information. You may wish to make further enquiries with the
USDA.

Yours sincerely

Tom Barlow

Dr Tom Barlow
Spongiform Encephalopathy Advisory Committee (SEAC) Secretariat
Area 108, 1A Page Street, London SW1P 4PQ

Tel: 0207 904 6267


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


https://web01.aphis.usda.gov/regpublic.nsf/168556f5aa7a82ba85256ed00044eb1f/eff9eff1f7c5cf2b87256ecf000df08d?

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


[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

9/13/2005

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


THE SEVEN SCIENTIST REPORT ***


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

Suppressed peer review of Harvard study October 31, 2002.
http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf


USDA/OIG-A/50601-10-KC

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

Subject: Re: OIE WEAKENS BSE GUIDELINES EVEN MORE FOR TRADE PURPOSES, putting humans further 'at risk' globally
Date: May 25, 2006 at 7:08 am PST
In Reply to: OIE WEAKENS BSE GUIDELINES EVEN MORE FOR TRADE PURPOSES, putting humans further 'at risk' globally posted by TSS on May 24, 2006 at 7:17 pm:

Under the previous guidelines of the World Organization for Animal Health, known commonly as OIE, the U.S. would have had to wait until 2013 before it could be recognized as a "negligible risk" country. Under the new guidelines, approved Wednesday by unanimous vote, there will be little or no waiting. "For the U.S., this is much better," said Alex Thiermann, an OIE chairman.......snip.........end


Alex Thiermann, "an OIE chairman" is an employee of APHIS, USDA.


Quote:
Alejandro B. Thiermann

International Organisations Coordinator

U.S. Department of Agriculture USDA, APHIS

Dr. Thiermann is serving as International Organisations Coordinator in Paris, France, where he represents APHIS at relevant standard setting organisations dealing with animal health and international trade. This recent appointment in Paris resulted in response to his current leadership position in the standard setting committee of the OIE, as well as his past experience as twice chairman of the World Trade Organisation's Sanitary and Phytosanitary Committee (WTO-SPS).

During 1997 to 1999 he was elected Chairman of the World Trade Organisation, Sanitary and Phytosanitary Committee (WTO-SPS). From 1994 he served as the vice-president of the OIE' Code Commission and since 2000 he has served as president of this important standard-setting committee.

He served as a member of the U.S. delegations to the negotiation of the WTO, the IPPC, as well as serving as U.S. Coordinator for the Codex Alimentarius.

He joined APHIS in 1989 as the Deputy Administrator for International Services. Before joining APHIS, he served as the National Program Leader for animal health research under the USDA's Agriculture Research Service (ARS).

A native of Chile, he received his DVM degree from the University of Chile, and a PhD degree from the School of Medicine at Wayne State University in Detroit, Michigan. .............


disturbing......TSS


Subject: OIE WEAKENS BSE GUIDELINES EVEN MORE FOR TRADE PURPOSES, putting humans further 'at risk' globally
Date: May 24, 2006 at 7:17 pm PST


Intl Decision On BSE Standards Seen Helping US Trade Case

WASHINGTON (Dow Jones)--The U.S. will now have a much stronger case to make that there is virtually no mad-cow disease risk here thanks to a decision Wednesday by the Paris-based World Organization for Animal Health to relax country standard requirements. Previously, a country had to wait seven years after its discovery of mad-cow disease, or bovine spongiform encephalopathy, before it could be considered in the "negligible risk" category -- the category for countries with the least BSE risk.

That has now been changed and countries must wait until 11 years after birth date of the last native-born cow discovered with the disease. The U.S. reported finding its latest BSE case in March, but U.S. Department of Agriculture officials say the infected cow was more than 10 years old when it died.

Under the previous guidelines of the World Organization for Animal Health, known commonly as OIE, the U.S. would have had to wait until 2013 before it could be recognized as a "negligible risk" country. Under the new guidelines, approved Wednesday by unanimous vote, there will be little or no waiting. "For the U.S., this is much better," said Alex Thiermann, an OIE chairman.

He also called the new age-based guideline more "realistic." Ron DeHaven, head of USDA's Animal and Plant Health Inspection Service, called the new guidelines "a significant change," in a telephone interview with Dow Jones Newswires, prior to the OIE vote. DeHaven who is currently in Paris for the OIE annual meeting, said, "When we found the (BSE) case is not nearly as relevant as when that animal was born."

Michael David, head of USDA's National Center for Import and Export, agreed and explained that an infected cow's age can point to when there was a spread of the disease. There are three OIE risk categories: "negligible," "controlled" and "undetermined." The U.S. would prefer to be considered "negligible" because it provides negotiators with a stronger case for countries to reopen borders to U.S. beef. A "negligible" standing also carries with it fewer costly safety restrictions than the other categories.

The U.S. has reported finding three cases of BSE in cattle -- one in December 2003, a second in June 2005 and a third in March 2006. However, USDA officials said only the two latest cases count under the new OIE guidelines. The first BSE case, officials said, was in an animal about 6 years old, but that animal was born and infected in Canada before being sent to the U.S. David said that first BSE discovery "was an imported case and it really doesn't matter because we can show that it came from Canada.

The two that mattered to us are two native cases and one was born 12 years ago ... and the second one is at least 10 years old." Despite the infected animal's origin, the December 2003 BSE discovery was and still is very important to many beef-importing nations. Most importing countries, including Japan, South Korea and China, shut their borders to U.S. beef in December 2003.

Japan has since eased its ban and then reinstated it, but even when the country resumes importing again it will maintain restrictions on U.S. beef that are far stricter than OIE guidelines. The USDA's David said Japan registered an official objection with the OIE on the BSE standard changes approved Wednesday, but the country did not vote against them.

China and the U.S. are in negotiations now to resume beef trade, but China's refusal to accept USDA claims that it is a "negligible risk" country complicated talks held in mid-May. USDA officials now have a much stronger argument that U.S. beef products are among the least risky for BSE in the world, but an official OIE confirmation of "negligible" status for the U.S. could be as much as two years away, David said. The process is long and complex, requiring well detailed explanations of such things as a country's BSE surveillance program.

-By Bill Tomson; Dow Jones Newswires; 202-646-0088; bill.tomson@dowjones.com


http://www.cattlenetwork.com/content.asp?contentid=39753


Bse Oie Chapter 2.3.13

##################### 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:

snip...

2005 OIE Terrestrial Animal Health Code


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

Subject: Re: OIE WEAKENS BSE GUIDELINES EVEN MORE FOR TRADE PURPOSES, putting humans further 'at risk' globally
Date: May 26, 2006 at 12:59 pm PST

In Reply to: Re: OIE WEAKENS BSE GUIDELINES EVEN MORE FOR TRADE PURPOSES, putting humans further 'at risk' globally posted by TSS on May 25, 2006 at 7:08 am:


74th Annual General Session
of the International Committee
of the World Organisation for Animal Health (OIE)
21 – 26 May 2006

The 74th Annual General Session of the International Committee of the World Organisation for Animal Health (OIE) was held in Paris from 21 to 26 May 2006 .

The General Session notably brings together representatives appointed by the Governments of the 167 OIE Member Countries.

Approximately 600 participants representing Member Countries, intergovernmental organisations (FAO, WHO, World Bank, WTO etc.) took part in the event. The Session was honoured by the presence, alongside the President and the Director General, of high-ranked authorities, including numerous Ministers of OIE Member Countries.

Member Countries praised the role played by the OIE in the global fight against avian influenza. They particularly saluted the agreement reached with the World Bank and key donors to support developing and in transition countries to invest in programmes aimed at bringing their Veterinary Services in line with OIE standards.

The main points dealt with during the Session were as follows:

- The session accredited the application of a new Collaborating Centre - the Centre for Disease Control (CDC in Atlanta ) - with the aim of better preventing and controlling animal diseases transmittable to human beings. It also recognized the crucial role played by the OIE network of 170 reference laboratories and collaborating centres in reaching the organization's objectives ;

- Member Countries welcomed the new World Animal Health Information System (WAHIS) that will strengthen OIE's actions in terms of transparency on state of animal diseases worldwide;

- Consistent with the framework of its usual standard-setting activities, the Committee adopted new and updated international standards aimed at providing better safeguards for the sanitary safety of world trade in terrestrial and aquatic animals and their products as well as guidelines to better implement surveillance of animal diseases and zoonoses on their territory.

- Member countries also voted new improvements to chapters about animal welfare and food safety in production phase;

- They adopted policy lines on identification and animal traceability;

- Special attention was given to updating the chapter on BSE in the Terrestrial Animal Health Code. Adopted texts highlighted global surveillance methods that will allow the OIE to propose willing Member Countries a new procedure for an official recognition of their status on the disease;

- The Session approved the lists of countries or zones recognized by the OIE as being free from foot and mouth disease, rinderpest, contagious bovine pleuropneumonia and bovine spongiform encephalopathy;

- Member Countries also decided that notification to the OIE of any detection of highly pathogenic avian influenza (HPAI) in wildlife was to be compulsory;

- The list of Veterinary Critically Important Antimicrobials (VCIA) defined by OIE was published;

- The worldwide zoosanitary situation has been examined in detail ;

- Two technical items of biggest interest were presented and debated during the Session and gave rise to Resolutions passed by the International Committee:

- Economic and social justification of investment in animal health and zoonoses;

- Future approaches needed to ensure veterinary education meets societal demands.

The high level of scientific expertise of the speakers and the quality of the debates that followed the presentation of each technical item will have served to promote the global application of concepts that are essential for improved control of animal diseases and zoonoses.

The International Committee undertook the election of the new OIE President. Dr Barry O'Neil was elected for a three-year mandate. Members of the Administrative Commission, Regional Commissions and Specialist Commissions were also elected by the General Assembly.


May 2006


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

http://www.oie.int/eng/press/en_060526.htm

Canadian import rule progresses
TSCRA has received several calls asking when the U.S. border will be reopened to imports of live Canadian cattle.
The U. S. Department of Agriculture is currently developing rules for importing cattle from regions at minimal risk for bovine spongiform encephalopathy.
According to guidelines of the world organization for animal health (OIE), a minimal risk country can have up to two cases of BSE per million head of cattle diagnosed each year. Since Canada has approximately 14 million head of cattle and only two confirmed cases of BSE, it is a minimal risk country.
The rulemaking process is complex and must, by law, follow a number of prescribed steps. The rule has already gone through a number of these steps:
· The rule has been drafted by USDA.
· It has been given a first legal review by the Office of Management and Budget.
· It has been published in the Federal Register for public comment.
· Comments have been reviewed by USDA.
· The rule has been re-drafted by USDA taking into account comments received.
· It has been sent to OMB for final legal review.
· It has been determined by OMB to be economically significant, giving OMB up to 90 days to complete its final legal review.
· OMB will complete its final legal review in 90 days or less (90 days from the date the rule moved to OMB is Feb. 17, 2005).
· If approved, the final rule will be published in the Federal Register.
· The rule will take effect 60 days after being published in the Federal Register.

http://www.thecattlemanmagazine.com/newsDesk/news_update_12.04_tscra_Texas_cattle.asp#TSCRA%20urges%20APHIS%20to%20revise%20BSE%20surveillance%20plan

Updated :09-Jan-2004

The OIE standards on BSE: a guide for understanding and proper implementation

The World Organization for Animal Health (OIE) has become increasingly concerned about reports of international trade disruptions involving the misinterpretation of OIE standards. Recent published information on categorization of countries by the OIE indicates there are some apparent misunderstandings about the nature and purpose of the OIE international standards and guidelines, and their interpretation and implementation by Member countries.

The OIE Terrestrial Animal Health Code (the Code) contains standards, guidelines and recommendations to be used by national veterinary authorities to prevent the introduction of infectious agents pathogenic for animals and humans into the importing country during trade of animals and animal products, while avoiding unjustified sanitary barriers.

While the Code describes conditions for the classification of countries into one of five BSE risk categories, the OIE itself does not assign countries to all these categories. These are used by importing countries when determining the specific conditions for trade. However, the OIE has been recently requested to examine country submissions, made on a voluntary basis, for determining whether they meet the conditions to be officially classified by an OIE decision as "BSE free" or "BSE provisionally free". For the moment the OIE does not give an opinion on the further 3 categories existing in the Code. So far no country has been given such recognition by the OIE. Furthermore, the OIE has been requested by Member countries to reduce the current number of categories.

The Code also draws attention to the obligations under the provisions of the World Trade Organization-Sanitary and Phytosanitary Agreement (WTO-SPS), whereby the importing country cannot be more trade restrictive than necessary to achieve the desired national level of protection, and that its measures must not be different from those applied to products within the domestic market.

The OIE chapter on BSE currently describes five levels of exporting country status based on their determined risk level (free, provisionally free, minimal risk, moderate risk and high risk). It then addresses trade conditions for various commodities through an increasing degree of restrictions commensurate with the risks presented. For example, fresh meat may be imported safely from a country of any BSE status but with increasing restrictions so that, for countries presenting a high BSE risk, more severe measures are applied to the cattle and to the meat itself. The experts consider that, if these measures are followed, the meat is safe.

For some commodities however, the experts have determined that particular commodities should not be exported even from countries presenting a low BSE risk. For example, meat and bone meal, or any commodity containing such products, which originate from countries with minimal, moderate or high BSE risk should not be traded.

It is apparent that some Member Countries are applying trade bans when an exporting country reports the presence of BSE, without consulting the recommendations in the Code or conducting a risk analysis in accordance with its OIE and WTO obligations. While the Code provides increasingly restrictive recommendations which are commensurate with the level of BSE risk in each of the country status categories, it does not recommend any other ban than the above mentioned on trade of animals or specific animal products.

Regarding the BSE situation in the European Union and more recently in Japan, Canada and the US, the existence of valid up-to-date standards did not prevent major trade disruptions due to a failure by many countries to apply the international standard when establishing or revising their import policies. This has been particularly evident in the case of commodities for which the Code recommends that no restrictions be applied, regardless of the BSE status of the exporting country.

Except for short trade suspensions during investigation period following a new epidemiological event, it is of particular concern to the OIE that many countries apply trade bans when an exporting country reports its first case of BSE, without having conducted a risk analysis as described in the Code. Such situations penalise countries with a good and transparent surveillance system for animal diseases and zoonoses, and which have demonstrated their ability to control the risks identified. This may result in a reluctance to report future cases and an increased likelihood of disease spread internationally.


January 2004

http://www.oie.int/eng/press/en_040109.htm

Our third general concern has to do with these rules being less stringent than international

standards. We are aware that OIE standards for a minimal risk BSE country do not necessarily

require 7 years since the last case. OIE does have certain requirements for regions to qualify as

minimal risk regions in countries where BSE was identified less than 7 years ago. However, a

reading of the OIE Standards reveals that, when applied to the present case, Canada fails to meet

those standards.

This is where this proposed rule is more lenient than OIE standards. The OIE standard requires

that, in countries where BSE was identified less than 7 years ago, there has been a feed ban in

place for 8 years. Canada’s feed ban went into effect in 1997. Therefore, the Canadian feed ban

went into effect approximately 6 ½ years ago.

The OIE standard for a Minimal Risk BSE country or zone is quoted below:

b) the last indigenous case of BSE has been reported less than 7 years ago, and the BSE

incidence rate, calculated on the basis of indigenous cases, has been less than one case

per million during each of the last four consecutive 12- month periods within the cattle

population over 24 months of age in the country or zone (Note: For countries with a

population of less than one million adult cattle, the maximum allowed incidence should

be expressed in cattle-years.), and:

i) the ban on feeding ruminants with meat-and-bone meal and greaves

derived from ruminants has been effectively enforced for at least 8 years;

http://www.agdepartment.com/Testimony/CommentsBSE1-2-04.pdf


Question 35, IfFSIS were to exempt "BSE free" countries from the provisions ofthe SRM

rule, what standards should the Agency apply to determine a country's BSE status?

As stated above, strong precedents and justification exist for US authorities granting

exemptions from BSE-related measures for counties which do not pose a BSE risk. This

ability to grant exemptions should not be restricted to FSIS measures as implied by question

35, but should be applied across all relevant US authorities. Various options exist for

standards that could be applied to determine a country's BSE status. Some of these are

canvassed below.

As a matter of principle, a country, other than one that is recognised as posing a BSE risk

under current US regulation 9 C.F.R. 5 94.18, should not have new FSIS or FDA measures

applied to it until any new determination of BSE status that may be required under other US

Statutes is made. As long as they remain BSE free, these countries should be allowed to trade

under pre-existing conditions that applied under USDA and FDA rules and regulations,

pending the completion of any additional BSE status assessment that is required.

Some options for determining a country's BSE status include:

Option 1 : An assessment of BSE status of relevant counties is already conducted under

current US regulation 9 C.F.R. 5 94.18. FDA and FSIS rules and regulations could recognise

equivalence for counties that are recognised as BSE fiee under this rule, using whatever

standards are already in place for these assessments.

Option 2: The US could formally adopt its own criteria. We suggest that these should be

based on those promulgated by the OIE for BSE free and BSE provisionally free countries.

Such an approach is consistent with that in the proposed rule, BSE Minimal Risk Regions and

Importation ofCommodities. This proposed rule suggests a list of factors that has been

determined by APHIS to evaluate the BSE risk from a region and classify a region as a BSE

minimal-risk. These factors appear to be largely based on OIE recommendations for this

category of country or region.

As an example of how OIE recommendations can be applied, the Canadian Food and Drug

regulations that entered into force in 2003 define SRMs similarly to the FSIS Interim Final

Rule and prohibit the sale or importation of food that contains sRMs.' However, the Canadian

regulation also states that the prohibition "does not apply in respect of food that originates

from a country that is designated as being free from BSE . . . . "2 Under a related provision in

Canada's Health of Animals regulations, the government may utilize various criteria to

designate countries which the government considers to be free from the diseases that pose

certain risks.3 Pursuant to its regulatory authority, the Canadian government issued an

announcement in 2003 regarding its revised BSE import policies that sets forth the criteria by

which Canada determines whether a country is free.^ US authorities could decide to

adopt an assessment system that incorporates the Canadian (or similar) criteria. As stated

verbatim in the announcement, these criteria include:

Either

a. For the preceding seven (7) years, the country of origin must have

reported no cases of BSE in indigenous bovines, AND

b. no cases of BSE have been attributed to the country of origin from

another country through epidemiological investigation, OR

c all cases of BSE have been clearly demonstrated to originate

directly from the importation of live cattle from a BSE affected country

and no cases of BSE have been attributed to the country of origin from

another country through epidemiological investigation.

AND (all of the following)

d. The country of origin must have the animal health legislative

authority to regulate BSE and the zoosanitary infrastructure to enforce

surveillance, monitoring, eradication and import controls for BSE.

e. BSE must have been made a nationally notifiable disease in the

country of origin for the preceding seven (7) years.

f. The country of origin must have an eradication policy for BSE that

includes the investigation of suspect animals and, if confirmed positive,

their slaughter and destruction and the depopulation of any bovine

animal that epidemiological investigation identifies as potentially

having been exposed to the disease agent or common risk factor.

Animals to be disposed of must be excluded from both the human and

animal food chain.

C.R.C., C. 870, s. B.01.047.1.

Id.

' C.R.C., C. 296, s.7.

Canadian Food Inspection Agency, Canadian Bovine Spongifom Encephalopathy (BSE) Import Policies (June

16,2003), available at http://www.inspection.gc.cdenglish/animdheasapolicy/ie-2OOl-l7-42.shl (last

viewed Mar. 19, 2004).

http://www.fsis.usda.gov/OPPDE/Comments/04-021ANPR/04-021ANPR-63.pdf



Subject: BSE CANADA IMPORTANT NOTICE IMPORTANT NOTICE - Revised Policy Regarding Gelatin in Natural Health Products July 4, 2006
Date: July 6, 2006 at 1:30 pm PST

Electronic Bulletins
2006

IMPORTANT NOTICE - Revised Policy Regarding Gelatin in Natural Health Products
Date: July 4, 2006


Subject: EFSA RISK ASSESSMENT FOR ONLY BSE by Bovine Vertebral Column including Dorsal Root Ganglia to humans
Date: June 16, 2006 at 8:54 am PST
Summary of Opinion

www.efsa.eu.int 1

Opinion of the Scientific Panel on Biological Hazards of the European Food

Safety Authority on the “Quantitative assessment of the Human BSE risk

posed by Bovine Vertebral Column including Dorsal Root Ganglia with

respect to residual BSE risk”1

(Question N° EFSA-Q-2003-099)

Adopted on 18 May 2006

SUMMARY

1.1. Residual BSE risk due to Bovine Vertebral Column

The European Food Safety Authority (EFSA) quantitative risk assessment (QRA) guidance

document gives residual Bovine Spongiform Encephalopathy (BSE) risk assessments for byproducts

– tallow, gelatine and calcium phosphates – used in human food obtained from cattle

fit for human consumption (EFSA QRA report, 2004). The effect of including vertebral

column in the batch of raw materials used for the production of the by-products was

calculated as part of separate risk assessments for these materials. The Commission Mandate

to EFSA asked the Panel to review the “Opinion and report, assessment of the human BSE

risk posed by bovine vertebral column including dorsal root ganglia (adopted on 16 May

2002)” in the light of their QRA on residual BSE risk and, if appropriate, revise the 2002

Opinion accordingly. This revision covers the by-products, tallow and gelatine, but does not

consider the human risk from consumption of meat on the bone or the inclusion of bovinederived

phosphates as food additives, or the effect of changing the age limit for regarding

vertebral column as specified risk material.

The EFSA Opinions on tallow and gelatine give descriptions of manufacturing processes, the

various assumptions relating to their QRA and the background considerations relating to the

interpretation of the output values. In this document we simply reproduce the relevant

conclusions and recommendations of those opinions relating to the inclusion of vertebral

column and the production of these by-products.

1

For citation purposes: Opinion of the Scientific panel on Biological Hazards on “Quantitative assessment of

the Human BSE risk posed by Bovine Vertebral Column including Dorsal Root Ganglia with respect to

residual BSE risk”, The EFSA Journal (2006), 359, 1-3

Summary of Opinion

www.efsa.eu.int 2

Some illustrative data is shown below for the range of median (P50) exposure estimates

(units, Cattle oral infectious dose 50%, CoID50/person/week)2. For detailed results see table 1

further in this document.

GBR II† GBR III GBR IV

Tallow De-Greasing bones * * 10-12 to 10-11

Mixture of tissues * * 10-12 to 10-10

Gelatine Acid & Alkaline * * 10-9 to 10-8

Heat & Pressure * * 10-11 to 10- 10

The logic of interpreting the CoID50 units of exposure in terms of human risk is essentially

that assuming a species barrier of 1, and all the other assumptions, an exposure value > 10-8

per time period may result in one or more cases of vCJD per time period. The only scenario in

which the P50 values approach the 10-8 level is in the production of gelatine from bovine

bones by the acid and alkaline method. Referring back to the gelatine opinion, this is a worst

case consumption scenario where all the daily human dose of gelatine is assumed to be bovine

bone derived (when it is more likely to be 1-5%). Similarly, for more realistic sourcing

scenarios such as a GBR III country with reliable surveillance, even the P97.5 values only

approach 10-8 for gelatine produced from bovine bones by the acid and alkaline method (and a

worst case consumption input).

1.2. Conclusion of this revision

• Inclusion of vertebral column in the raw materials used to produce tallow and gelatine

from bones or a mixture of tissues increases the level of human exposure by ~ 3-10 fold.

However, the levels of residual BSE risk for these products calculated in the QRA are low

and the increased risk factor due to inclusion of vertebral column is unlikely to translate

into further cases of vCJD in the population. Therefore, in the case of tallow and gelatine,

there appears to be no rationale for imposing an age-limit above which to exclude

vertebral column from the batches of raw materials used to produce these by-products.

• The human risk from consumption of meat on the bone or the inclusion of bovine-derived

phosphates as food additives could be estimated using the QRA model if the appropriate

input data for human consumption were available.

1.3. Further recommendations of the BIOHAZ Panel during the adoption of this

report at their Plenary Meeting, 17-18th May, 2006

• This is the final Report to be revised in the light of the EFSA BSE QRA guidance

document (EFSA QRA report, 2004), and joins a series covering a range of residual BSE

risk assessments on the cattle by-products : tallow, gelatin, and calcium phosphates. Each

revision considers the separate effects of the QRA on the risk of exposure to human and/or

cattle population for each by-product. The Panel recognised the need to evaluate the

cumulative effect of each incremental change in exposure to the populations calculated in

2 * in this Table is defined as an exposure level of < 10-13 CoID50 units/person/per week.

† GBR: Geographical BSE Risk

Summary of Opinion

www.efsa.eu.int 3

these revisions, and recommended that this “total” exposure assessment be carried out in

the near future.

• “Gaps” in these residual risk assessments were inevitable due to the restricted scope of

the original EFSA BSE QRA guidance document, and the Panel recommended that these

gaps should be addressed by future Panel members using their “self-tasking mandate”

option. For example, in the context of this vertebral column document, the QRA model

could be used to estimate the human risk from consumption of meat on the bone or the

inclusion of bovine-derived phosphates as food additives.

• The EFSA BSE QRA guidance document was written almost four years ago, and although

some parts have been revised since then to accommodate new research findings, the

methodology and nomenclature for defining the geographical BSE risk (GBR) input to the

model is no longer appropriate. New methodology, under the auspices of the OIE, is

under construction within the EU and EFSA and the Panel recommended that once these

classifications had been finalised they should harmonised with those used in the EFSA

BSE QRA guidance document. The Panel anticipated that this harmonisation may have a

knock-on impact on the QRA calculations, conclusions and recommendations and that,

again, future Panel members should review this, and other, inputs of the QRA and address

this impact using their “self-tasking mandate” option.


http://www.efsa.eu.int/science/biohaz/biohaz_opinions/1540/biohaz_op_ej359_qra_vertebral_column_summary_en1.pdf

OPINION


http://www.efsa.eu.int/science/biohaz/biohaz_opinions/1540/biohaz_op_ej359_qra_vertebral_column_en1.pdf


>>>New methodology, under the auspices of the OIE, is

under construction within the EU and EFSA and the Panel recommended that once these

classifications had been finalised they should harmonised with those used in the EFSA

BSE QRA guidance document. The Panel anticipated that this harmonisation may have a

knock-on impact on the QRA calculations, conclusions and recommendations and that,

again, future Panel members should review this, and other, inputs of the QRA and address

this impact using their “self-tasking mandate” option.<<<


GOD HELP US!


sample survey via oie for bse is about 400 test via 100 million cattle, if i am not mistaken. MOST countries that went by these OIE guidelines all eventually went down with BSE. ...TSS


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


THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.
AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they should do everyone a favor and dissolve there organization. ...

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


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


a.. BSE OIE

see full text ;


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

II. Summary of APHIS’ regulatory standards for Minimal Risk regions

In the November 4, 2003, proposed rulemaking (APHIS 2003c), APHIS proposed to define standards for a Minimal Risk region and establish import requirements that imposed additional risk mitigation measures on animals and animal products imported from Minimal Risk regions. The minimal risk standards incorporated the broad elements of the Office International des Epizooties (OIE) guidelines for Minimal Risk regions (OIE 2004a). Below, we provide a discussion of the final standards and a more explicit discussion of how OIE guidelines were incorporated into our considerations in the development of the standards.

In the final rule, the APHIS standards for a BSE Minimal Risk region define it as a region that:


(1) Maintains, and, in the case of regions where BSE was detected, had in place prior to the detection of BSE in an indigenous ruminant, risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease. Such measures include the following:


(i) Restrictions on the importation of animals sufficient to minimize the possibility of infected ruminants being imported into the region, and on the importation of animal products and animal feed containing ruminant protein sufficient to minimize the possibility of ruminants in the region being exposed to BSE;


(ii) Surveillance for BSE at levels that meet or exceed recommendations of the World Organization for Animal Health (Office International des Epizooties) for surveillance for BSE; and


(iii) A ruminant-to-ruminant feed ban that is in place and effectively enforced.


(2) In regions where BSE was detected, conducted an epidemiological investigation following detection of BSE sufficient to confirm the adequacy of measures to prevent the further introduction or spread of BSE, and continues to take such measures.


(3) In regions where BSE was detected, took additional risk mitigation measures, as necessary, following the BSE outbreak based on risk analysis of the outbreak, and continues to take such measures.

In developing each of these standards for a BSE Minimal Risk region, APHIS based its standards on the guidelines established by the OIE for determining the BSE status of a region. The OIE guidelines, contained in Chapter 2.3.13 of the Terrestrial Animal Health Code (OIE 2004a) and supplemented by Appendix 3.8.4 of the Code (OIE 2004b), currently provide for five possible BSE classifications for regions. For each classification, the guidelines recommend different export conditions for live animals and products, based on the risk presented by the region. This framework not only recognizes different levels of risk among regions, but also provides for trade in live animals and products under certain conditions even from regions considered high-risk under the OIE guidelines. In the discussion that

2Analysis of Risk - Update for the Final Rule: Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of Commodities: Animal and Plant Health Inspection Service, December 2004

follows, we provide a more detailed discussion of the application of each of these standards with relevance to the OIE guidelines.

(1) Measures in place

A Minimal Risk region must have had in place risk mitigation measures and apply additional measures as appropriate. Such measures are based on risk considerations identified in the OIE Terrestrial Animal Health Code Article 2.3.13.2 and embodied in the Article 2.3.13.5, point 1, requirement that a "risk assessment … has been conducted and it has been demonstrated that appropriate measures have been taken for the relevant period of time to manage any risk identified."

OIE measures include (but are not limited to): a broad eradication program and extensive surveillance following the detection of BSE; effective epidemiological investigations with appropriate tracing, control and destruction of risk animals; measures to identify and effectively control pathways for amplification of BSE; continuing risk considerations with corresponding revisions of existing mitigations; processing methodologies; appropriate awareness programs; effective detection and control measures; and veterinary infrastructure sufficient to define and implement these programs. Under APHIS regulations (see (1)(i)-(1)(iii) above), these measures must include: import restrictions, surveillance, and an effective feed ban.

(1)(i) Import Restrictions

APHIS will evaluate the stringency and effectiveness of import restrictions to prevent the importation of BSE infected animals and BSE contaminated products. Our approach reflects the emphasis in the Terrestrial Animal Health Code on the evaluation of risk from imports and the need to take appropriate steps to address any identified risk. Specifically, the OIE Terrestrial Animal Health Code Article 2.3.13.2 identifies the need to assess the likelihood that a transmissible spongiform encephalopathy (TSE) agent has been introduced via imports and, as mentioned above, Article 2.3.13.5, point 1, emphasizes the need to demonstrate that appropriate measures have been taken.

(1)(ii) Surveillance

An APHIS evaluation of the surveillance program in place within a region will consider whether a region has in place a level of surveillance and monitoring which meets or exceeds the recommendations of OIE Terrestrial Animal Health Code Appendix 3.8.4 (OIE 2004b). The OIE recommendations specify approaches to determine whether BSE is present in the country, and, if present, to monitor the extent or evolution of the disease spread. Issues addressed include general principles for examination for clinical signs in relation to statistical approaches to sampling. The recommendations specify the minimum number of cattle exhibiting one or more clinical signs of BSE that should be subjected to diagnostic tests according to the total cattle population over 30 months of age and include recommendations for active targeted surveillance. With respect to the number of samples that must be taken over the preceding 7 years based on the national census of cattle over 30 months of age, APHIS will consider a region to have exceeded the OIE recommendations if the region

3Analysis of Risk - Update for the Final Rule: Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of Commodities: Animal and Plant Health Inspection Service, December 2004

samples a larger number of animals than those recommended by OIE over the appropriate period of time. APHIS will also assess policies and practices for active targeted surveillance.

(1)(iii) Feed Ban

APHIS will also consider the effectiveness of a feed ban in place within a region. Determining whether a feed ban has been effectively enforced will involve a review of a number of interrelated factors, including: the existence of a program to gather compliance information and statistics; whether appropriate regulations are in place in the region; the adequacy of enforcement activities (e.g., whether sufficient resources and commitment are dedicated to enforcing compliance); a high level of facility inspections and compliance; accountability of both inspectors and inspected facilities; and adequate recordkeeping. Another indication of an effective feed ban can be derived from epidemiologic investigations of diagnosed cases. Cases of BSE found in animals born after the feed ban was implemented would suggest either that the feed ban was ineffective or that there were noncompliance issues.

Because of the variability in the incubation period of BSE, APHIS chose not to follow the specifications of the OIE Terrestrial Animal Health Code (Article 2.3.13.5, point 2) that require a "ban on feeding ruminants with meat-and-bone meal (MBM) and greaves derived from ruminants has been effectively enforced for at least 8 years" [unless the last indigenous case of BSE was reported more than 7 years ago]. Rather, APHIS chose to consider the length of time a feed ban has been in place within the context of the sum total of the control measures in place at the time of the diagnosis of BSE and the actions taken subsequently, recognizing that measures taken with regard to other factors (e.g., inspection practices and level of compliance with the feed ban) may provide more positive evidence than simply the length of the feed ban.

APHIS will consider the factors above as well as region-specific factors—as a combined and integrated evaluation tool—to determine the overall effectiveness of control mechanisms and to analyze the residual risk. In determining whether the measures in place are adequate, APHIS will also consider the BSE incidence within a region with reference to the specific incidence criteria set forth in OIE Terrestrial Animal Health Code, Article 2.3.13.5 – i.e., "the BSE incidence rate, calculated on the basis of indigenous cases, has been less than 2 cases per million adult cattle during each of the last 4 consecutive 12-month periods within the cattle population over 24 months of age in the country or zone." In this way, APHIS will examine a combination of factors in a manner that allows us to evaluate an individual country’s specific situation, to acknowledge enhanced risk reduction effects of one or more factors that may compensate for other factors, and thereby, to analyze risk based on the overall effectiveness of actions taken by the country to prevent the entry and spread of BSE.

(2) Epidemiological Investigations

APHIS will assess the adequacy and results of any epidemiological investigation conducted by authorities of the region to establish that the standard has been met satisfactorily. Consistent with Article 2.3.13.5, point 2.b. iii of the OIE Code, we will assess whether risk

4Analysis of Risk - Update for the Final Rule: Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of Commodities: Animal and Plant Health Inspection Service, December 2004

animals have been identified and controlled and whether the risk animals have been destroyed as appropriate. Appropriate destruction means the animals are prevented from entering the ruminant feed chain—either through controls and restrictions on carcass disposal or through traceback efforts.

(3) Additional Risk Mitigation Measures

During its evaluation, APHIS will determine whether programs such as the ones identified in the OIE guideline are in place and assess their effectiveness. If a region has had a case of BSE within the preceding 7 years or a region has not had a case within the preceding 7 years but has not had an effective feed ban in place for 8 years, the OIE Terrestrial Animal Health Code, Article 2.3.13.5 indicates a region should demonstrate compliance with the measures in points 2 to 5 of Article 2.3.13.2. Points 2 to 5 include an ongoing awareness program for veterinarians, farmers, and workers involved in transportation, marketing, and slaughter of cattle; compulsory notification and investigation of all suspected cases of BSE; a BSE surveillance and monitoring program; and examination in an approved laboratory of brain and other tissues collected within the framework of the surveillance and monitoring system. In addition to consideration of the effectiveness of any of these measures, APHIS will also evaluate factors such as slaughtering and rendering practices, including specified risk materials (SRM) removal; evidence of a broad eradication program; increased surveillance; and additional import restrictions.

III. Release assessment

A release assessment requires consideration of country of origin factors (e.g., incidence/prevalence, surveillance and control programs), biologic factors (e.g., age of animals, agent predilection sites), and commodity factors (e.g., ease of contamination, effect of processing) (OIE Article 1.3.2.4). We considered a number of specific risk factors in the original release assessment, including: incidence of disease in the region of origin; levels of infectious agent; tissue localization; and feed source and exposure. Below, we provide an expanded discussion of these factors as they relate to our evaluation of Canada as a minimal risk region.

III.A. Considerations Related to Country of Origin Factors

Country of origin factors encompass a variety of factors such as disease incidence as well as risk mitigation measures. In its previous analyses (APHIS 2003b, 2004a), APHIS observed that the two cases of BSE in Canadian-origin animals, one in May 2003 in Canada and one in the United States in December 2003, satisfied the OIE incidence criterion for a minimal BSE-risk country, currently, less than two cases per million cattle over 24 months of age during each of the preceding 4 consecutive 12-month periods. While we recognize that the number of detected cases does not, by itself, allow for the determination of prevalence, evaluation of existing control measures within a country, including the level of surveillance, provides sufficient information from which to determine the magnitude of the risk. This

5Analysis of Risk - Update for the Final Rule: Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of Commodities: Animal and Plant Health Inspection Service, December 2004

section contains more detailed information on several of the factors we considered in making our determination.

III.A.1. Canadian import restrictions

Canada has implemented effective methods for preventing BSE introduction and subsequent potential for spread within Canada in order to minimize the possibility that infected ruminants or contaminated feedstuffs enter the country. The potential for introduction of the BSE agent into Canada has been limited by import restrictions on MBM and live animals. Canada’s Animal Disease and Protection Regulations (1978) and Health of Animals Regulations (1991) prohibited importation of MBM from countries other than the United States and, later, from Australia and New Zealand. These rules were first initiated in response to foot-and-mouth disease (FMD) and later extended to address BSE issues.

The Canadian Food Inspection Agency (CFIA) has extensively reviewed its history of imported commodities. CFIA examined transaction records obtained from Canada Customs and Revenue Agency (CCRA) for imports that occurred between 1990 and 2000. Of 4,000 records, 400 potentially represented prohibited material and required further investigation. No records of hazardous imports were discovered and transactions relating to ruminant feed were found to be either misclassifications or incorrectly identified. Further investigation focused on review of Eurostat data (Eurostat 2004) and the import trade data tables provided by Statistics Canada for the period of 1980-2000. References to potential MBM importations from Denmark, France, Belgium, Germany, and Japan, were reviewed in CCRA records and evaluated for MBM and related high risk material. The conclusion of the investigations was that Canada had not imported MBM for use in livestock feed from any country other than the United States, Australia, and New Zealand (CFIA 2002).

In addition, in 2000, Canada conducted a review of products imported from countries of the EU, Scandinavia, and Eastern Europe. The review period covered imports for the years between 1990 and 2000. Original documents with descriptions and volumes held by CFIA veterinary inspectors at ports of entry were investigated. The review concluded that MBM used for livestock feed had only been imported from the United States, Australia, and New Zealand (CFIA 2002).

Canada has not imported live cattle from the United Kingdom (UK) since 1990. In 1994, an import ban was imposed on all countries where BSE had been detected in native cattle, and from 1996 live cattle could only be imported from countries that Canada designated as free from BSE following a comprehensive risk assessment (CFIA 2003a). After detection of BSE in an imported animal in 1993, Canada traced and destroyed and incinerated or repatriated all surviving cattle imported from the UK (Kellar and Lees 2003).

III.A.2. Surveillance in Canada

Canada steadily increased its level of BSE surveillance between 1992 and 2003 (See Figure 1, information provided by CFIA). In calendar year 2003, Canada tested 5,727 cattle. Through

6Analysis of Risk - Update for the Final Rule: Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of Commodities: Animal and Plant Health Inspection Service, December 2004

December 1, 2004, a total of more than 15,800 samples had been obtained in 2004 alone, thus exceeding the goal of 8,000. The Canadian surveillance system is ramping up to test 30,000 animals per year in 2005. CFIA officials have stated that this surveillance program is designed to detect one case of BSE in one million adult cattle (CFIA 2004c).

http://www.aphis.usda.gov/lpa/issues/bse/risk_assessment/03-080-3_risk_doc.pdf

http://www.aphis.usda.gov/lpa/issues/bse/03-080-3_final_rule.pdf

Q: What pre-import safeguards does USDA have in place in Canada to ensure

that ineligible live animals are not shipped to the United States?

A: In order to ensure that only eligible animals are shipped to the United States,

USDA has been working very closely with Canadian officials to develop pre-import

safeguards.

These safeguards include the following:

• Each eligible animal must be individually identified by an official

Canadian eartag, applied before the animal arrives at the port of entry;

• Canadian officials will provide an official health certificate that verifies

the following information for each shipment of animals:

o Name and address of the importer;

o Species, breed, and number of bovine, sheep, or goats to be

imported;

o Purpose of importation;

o Individual identification for each animal, which includes eartag

number, and any other identification present on the animal,

including registration number (if any);

o Description of the bovine, sheep, or goats, including name, age in

months, color, and markings (if any);

o Region/country of origin;

o Address or other means of identifying the premises of origin and

any other premises where the bovines, sheep, or goats resided

immediately prior to export;

o Specific address of slaughter establishment, including FSIS

establishment number, for animals going to slaughter;

o Physical location of feedlot for animals that are to be moved to a

feedlot after importation;

o Name and address of exporter;

o Port of embarkation in Canada, the mode of transportation, route of

travel, and port of entry in the United States; and

o Identification numbers of the Canadian seals that have been

applied to each vehicle in the shipment.

There are additional pre-shipment requirements for shipments of live animals,

depending on whether or not the animal is for feeding or for immediate slaughter. Please

refer to the importer memos on the APHIS web site www.aphis.usda.gov.

http://www.aphis.usda.gov/lpa/issues/bse/CAN-ImportQ&A.pdf


Final Rule on BSE and Minimal-Risk Regions
December 2004

Veterinary Services

On Jan. 4, 2005, after a careful and thorough science-based risk assessment and a comprehensive rulemaking process, the U.S. Department of Agriculture (USDA) published a final rule amending its regulations to provide for the importation of certain ruminants, ruminant products and byproducts from regions that pose a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States. The rule establishes criteria for regions to be recognized as presenting minimal risk of introducing BSE into the United States. This rule ensures the continued protection of the U.S. food and feed supply from BSE, while removing unnecessary prohibitions on the importation of certain commodities from minimal-risk regions.

A minimal-risk region could include:
• A region in which BSE-infected animals have been diagnosed, but sufficient regulatory measures have been put in place that would make the introduction of BSE into the United State unlikely; or
• A region that has taken effective regulatory measures to prevent BSE, has never detected the disease, but cannot be considered BSE free.

By establishing criteria for minimal-risk regions, the United States has taken a leadership role in fostering trade of low-risk products with countries that have a low incidence of BSE and historically strong risk mitigation measures. Such a move is consistent with the World Organization for Animal Health (OIE) recommendations for the trade in animals and animal products from BSE-affected countries.

Classification of Canada as Minimal-Risk Region

In addition to defining the standards for minimal-risk regions, this rule places Canada in the minimal-risk category and defines the requirements that must be met to allow the import of certain ruminants and ruminant products from Canada.

USDA conducted a thorough risk analysis to evaluate the risk of resuming the importation of Canadian ruminants and ruminant products in view of the two BSE cases of Canadian origin. This risk analysis included careful consideration of the risk mitigation measures Canada has in place to detect and prevent BSE within Canadian cattle and also the risk mitigation measures imposed in this final rule. USDA determined that allowing the importation of certain Canadian ruminants and ruminant products under the conditions imposed by the rule will continue to protect against introducing additional cases of BSE into the United States.

USDA has determined that Canada meets the requirements for a minimal-risk region. The minimal-risk standards that Canada has met include, among other things:
• Import restrictions sufficient to minimize exposure to BSE. Since 1990, Canada has maintained stringent import restrictions preventing the entry of live ruminants and ruminant products, including rendered protein products, from countries that have found BSE in native cattle or that are considered to be at significant risk for BSE.
• Surveillance for BSE at levels that meet or exceed international guidelines. Canada has conducted active surveillance for BSE since 1992 and exceeded the level recommended in international guidelines for at least the past seven years.
• Ruminant-to-ruminant feed ban in place and effectively enforced. Canada has had a ban on the feeding of ruminant proteins to ruminants since August 1997, with compliance monitored through routine inspections.
• Appropriate epidemiological investigations, risk assessment, and risk mitigation measures imposed as necessary. Canada has conducted extensive investigations of BSE cases and has taken additional risk mitigation measures in response to these cases. These risk mitigation measures include among others, prohibiting specified risk materials in human food.

Commodities Eligible for Import from Canada

The final rule is effective March 7, 2005. Certain live ruminants and ruminant products and byproducts are eligible for importation from Canada as of that date under specified conditions. The following commodities are allowed to be imported as long as they meet applicable criteria specified in the regulations:
• Bovines, for feeding or immediate slaughter, as long as they are slaughtered at less than 30 months;
• Sheep and goats (ovines and caprines), for feeding or immediate slaughter, as long as they are slaughtered at less than 12 months of age;
• Meat from bovines, ovines, caprines and cervids (deer, elk, caribou, moose, and reindeer); and
• Certain other products and byproducts, including bovine livers and tongues, gelatin, and tallow.

USDA is also specifying that there are no import restrictions because of BSE for live cervids or camelids (i.e., llamas, alpacas, guanacos and vicunas) from a BSE-minimal risk region.

Additional Requirements for Canadian Imports

USDA is confident that the animal and public health measures that Canada has in place to prevent BSE, combined with existing U.S. domestic safeguards and additional safeguards provided in the final rule provide the utmost protections to U.S. consumers and livestock. The final rule provides the following additional requirements for live Canadian feeder cattle designed to ensure they are slaughtered before they reach 30 months of age:
• Feeder cattle must be permanently marked with a brand to identify the BSE minimal-risk region of origin before entering the United States. Feeder cattle exported from Canada will be branded with "C/\N;"
• Cattle must be individually identified with an ear tag before entering the United States. This ear tag allows the animal to be traced back to the premises of origin (birth herd);
• Information must be included on the cattle's animal health certification, relating to animal identification, origin, destination, and responsible parties;
• Cattle must be moved to feedlots in sealed containers and cannot go to more than one feedlot; and
• SRM's will be removed from Canadian cattle slaughtered in the United States in accordance with FSIS regulations.

The final rule provides the following additional requirements for live Canadian sheep and goats designed to ensure they are slaughtered before they reach 12 months of age:
• Sheep and goats must be permanently marked with a brand to identify the BSE minimal-risk region of origin before entering the United States. Sheep and goats exported from Canada will be branded with a "C;"
• Sheep and goats must be individually identified with an ear tag before entering the United States. This ear tag allows the animal to be traced back to the premises of origin;
• Information must be included on the sheep's and goat's animal health certification, relating to animal identification, origin, destination, and responsible parties;
• Sheep and goats must be moved to feedlots in sealed containers and cannot go to more than one feedlot.

USDA first proposed changes to its regulations regarding establishing minimal-risk regions and conditions for safely importing live ruminants and ruminant products from such regions on November 4, 2003, and the comment period was still under way when the United States announced its first case of BSE on December 23, 2003. To allow additional time for commenters to evaluate the proposal in the context of the first U.S. finding of the disease, USDA reopened the comment period and accepted comments until April 7, 2004.

Other countries or regions that meet the minimal-risk conditions will be considered in the future. The designation of any future countries as minimal-risk regions will be accomplished through rulemaking procedures following completion of an appropriate risk assessment.

Economic Impact

Prior to detection of BSE in Canada in May 2003, the United States and Canada engaged in significant trade in feeder cattle and slaughter cattle. This rule will reestablish mutually beneficial trade in live animals between the two countries. Because the United States has permitted imports from Canada of boneless beef from animals less than 30 months of age since mid-2003, this rule is expected to have little impact on U.S. beef imports.

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDAís TARGET Center at (202) 720-2600 (voice and TDD).

To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326-W, Whitten Building, 1400 Independence Avenue, SW, Washington, DC 20250-9410 or call (202) 720-5964 (voice and TDD). USDA is an equal opportunity provider and employer

http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/fs_ahbse_minrisk.html

Bush nominates new ag secretary
President Bush has nominated Nebraska Gov. Mike Johanns to serve as Secretary of Agriculture during his second term.
Johanns was born in Iowa and raised on a dairy farm. Since taking office in 1999, he has championed several issues important to cattle producers, including property tax relief and reducing the size of government. Major accomplishments include:


snip...end

http://www.thecattlemanmagazine.com/newsDesk/news_update_12.04_tscra_Texas_cattle.asp#Bush%20nominates%20new%20ag%20secretary

nuff said. IN my opinion the WOAH/OIE is nothing more than a organized bunch of lobbyist for the members Countries in support of there INDUSTRY, bound together as one, with the only purpose of open trade for there precious commodities and futures. Speaking only of BSE, they failed at every corner, and then just said to hell with it, well just trade all strains of TSE globally.

ALL IN ALL, it's a terribly failed system of TSE surveillance and attempted erradication of this agent in the USA, a failed policy driven by industry greed and ignorance. ...

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





Follow Ups:



Post a Followup

Name:
E-mail: (optional)
Subject:

Comments:

Optional Link URL:
Link Title:
Optional Image URL: