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From: TSS ()
Subject: 2006 -- 2007 BSE RESOLUTIONS AND POSITION STATEMENTS
Date: January 10, 2007 at 10:16 am PST

2006 -- 2007 BSE RESOLUTIONS AND POSITION STATEMENTS


snip...


Approved: 2003 | Amended: 2004 | Reaffirmed: 2005

42. Bovine spongiform encephalopathy (BSE) Risk Assessment

BACKGROUND: Bovine spongiform encephalopathy (BSE) is a chronic, degenerative disorder affecting the

nervous system of cattle. It is associated with consumption of animal proteins contaminated with specific risk

materials containing the infective agent.

A prudent, scientifically sound, risk-based approach to regulation is essential to control risk of transmission of

BSE in North America.

The quantitative BSE risk assessment prepared by the Harvard Center for Risk Analysis (the Harvard model)

indicates that an amplification of the BSE agent is unlikely in the U.S. due to Federal feed regulations.

The Harvard model is a useful tool in evaluating the potential effectiveness of regulatory changes proposed by

USDA and the Food and Drug Administration (FDA).

Since the confirmation of BSE in North America, USDA has initiated an enhanced BSE surveillance effort. In

addition, both USDA and FDA have implemented or proposed new regulations designed to reduce the risk of

transmission of BSE.

RESOLUTION: The National Institute for Animal Agriculture (NIAA) encourages FDA and USDA to utilize appropriate

risk assessment tools, including the Harvard model and results of the enhanced BSE surveillance effort,

in evaluating changes to regulations regarding BSE. Results of these evaluations should be used in determining

the utility of regulations.

NIAA continues to encourage USDA and FDA to utilize science as a basis for public policy decisions regarding

BSE. Prior to initiating regulations affecting the US livestock industry, greater emphasis needs to be placed on

utilizing World Organization for Animal Health (OIE) standards as well as negotiating North American minimum

regulatory standards that will better harmonize regulations and facilitate trade from minimum risk regions

based on science.

Continued emphasis on building collaboration with all affected state and industry partners is critical to longterm

success of the National BSE Surveillance program.

Further regulatory efforts to implement a mammalian-to-mammalian protein ban or total Specified Risk Mate14

NATIONAL INSTITUTE FOR ANIMAL AGRICULTURE

rial (SRM) ban in all animal feed must be based on cost/risk reduction benefit analysis and comprehensive

SRM, dead stock disposal planning.

Approved: 2004 | Amended: 2005

43. Use of Bovine Blood

BACKGROUND: Bovine spongiform encephalopathy (BSE) is a chronic, degenerative disorder affecting the

nervous system of cattle. It is associated with consumption of animal proteins contaminated with Specific

Risk Materials (SRM) containing the infective agent.

Fifteen years of scientific research has demonstrated no detectable BSE agent in Bovine blood and no transmission

of BSE from cow to cow through blood. The World Organization does not classify bovine blood as an

SRM for Animal Health.

Plasma, serum and fractions thereof contain biologically important components, including immunoglobulins,

which may be used in colostrum supplements, colostrum replacers and feed supplements to reduce risk of

transmission of Johne’s disease, brucellosis and other economically important diseases transmitted via colostrum.

RESOLUTION: The National Institute for Animal Agriculture (NIAA), based on current science, encourages the

Food and Drug Administration (FDA) to retain the current bovine blood and blood products exemption to the

ruminant feed ban, including plasma, serum and fractions thereof for diets used in ruminants and non-ruminants.

Approved: 2004 | Amended: 2005

http://www.animalagriculture.org/aboutNIAA/Resolutions/2006%202007%20Resolution%20and%20Position%20Statements.pdf

>>>NIAA continues to encourage USDA and FDA to utilize science as a basis for public policy decisions regarding

BSE. Prior to initiating regulations affecting the US livestock industry, greater emphasis needs to be placed on

utilizing World Organization for Animal Health (OIE) standards as well as negotiating North American minimum

regulatory standards that will better harmonize regulations and facilitate trade from minimum risk regions

based on science. <<<

IN other words, commodities and futures, to hell with sound science, and human health.


strange, BSE to humans as nvCJD, nvCJD blood transmits to humans (3 documented cases to date) ??? and no BSE blood transmission to cows ???

BSE BLOOD transmits to sheep too ;

The Lancet 2000; 356:999-1000

DOI:10.1016/S0140-6736(00)02719-7

Research Letters

Transmission of BSE by blood transfusion in sheep
F Houston PhD a, JD Foster BSC b, Angela Chong BSC b, N Hunter PhD b and CJ Bostock PhD a

Summary
We have shown that it is possible to transmit bovine spongiform encephalopathy (BSE) to a sheep by transfusion with whole blood taken from another sheep during the symptom.free phase of an experimental BSE infection. BSE and variant Creutzfeldt-Jakob disease (vCJD) in human beings are caused by the same infectious agent, and the sheep-BSE experimental model has a similar pathogenesis to that of human vCJD. Although UK blood transfusions are leucodepleted—a possible protective measure against any risk from blood transmission—this report suggests that blood donated by symptom—free vCJD-infected human beings may represent a risk of spread of vCJD infection among the human population of the UK.

Affiliations

a. Institute for Animal Health, Compton, Newbury, UK
b. Institute for Animal Health, Neuropathogenesis Unit, Edinburgh, EH9 3JF, UK

Correspondence to: Dr N Hunter

http://www.thelancet.com/journals/lancet/article/PIIS0140673600027197/abstract

http://www.whale.to/v/singeltary3.html

http://vir.sgmjournals.org/cgi/reprint/83/11/2897.pdf

http://www.blackwell-synergy.com/doi/abs/10.1046/j.1537-2995.2002.00098.x?cookieSet=1&journalCode=trf

New case of transfusion-associated vCJD in the United Kingdom

Editorial team (eurosurveillance.weekly@hpa.org.uk), Eurosurveillance
editorial office
A new case of probable variant Creutzfeldt-Jakob disease (vCJD) has recently
been diagnosed in a patient in the United Kingdom (UK) who received a blood
transfusion from a donor who later developed vCJD [1]. This patient, who is
still alive and is under the care of doctors at the National Prion Clinic,
is the third case of vCJD infection in the UK associated with transfusion
[2].

The first case of vCJD disease associated with blood transfusion was
identified in December 2003 [3]. This patient developed vCJD six and a half
years after receiving a transfusion of red blood cells donated by an
individual who developed symptoms of vCJD three and a half years after
donation [4].

Another case of vCJD 'infection' was identified a few months later in a
recipient of red blood cells from a donor who developed symptoms of vCJD 18
months after the donation [5]. This second patient died from causes
unrelated to vCJD five years after transfusion. Postmortem investigations
found abnormal prion protein in the spleen and a cervical lymph node, but
not in the brain, and no pathological features of vCJD were found [6].

The most recent patient developed vCJD almost eight years after receiving a
transfusion of red blood cells from a donor who developed vCJD about 20
months after donating this blood [1]. Each of the three infected recipients
received blood from different donors.

To date, 160 cases of vCJD have been identified in the UK. Of these, 23 are
known to have donated blood before the diagnosis of vCJD. A collaborative
study (the Transfusion Medicine Epidemiology Review) between the National
Blood Services, the National CJD Surveillance Unit and the Office for
National Statistics has been conducted since 1997 to collect evidence about
transmission of CJD or vCJD via the blood supply [7]. Blood donations have
been traced for 18 of the 23 known donors, and 66 recipients of these
vCJD-implicated blood donations have been identified. Forty of these 66
recipients have died, including the two previous patients with probable
transfusion-associated vCJD [4,6]. The small group of living recipients of
vCJD-implicated blood transfusion have been informed of their potential
exposure to vCJD by blood transfusion. Some were contacted in late 2003 and
early 2004, and some in 2005. They were asked to take certain precautions to
reduce the risk of onward person-to-person transmission of vCJD during
medical procedures.

All three infected recipients identified to date received non-leucodepleted
red blood cells. Since October 1999, leucocytes have been removed from all
blood used for transfusion in the UK. The effect of leucodepletion on the
reduction of the risk of transmission of vCJD from an infected donor is
uncertain.

The risk of vCJD infectivity in blood has also resulted in certain other
groups of individuals being categorised as ‘at risk of vCJD for public
health purposes’. These groups have been informed and asked to take public
health precautions. The groups include certain recipients of plasma products
[8], individuals who have donated blood to patients who developed vCJD [9]
and certain recipients of blood from donors to patients who developed vCJD
[10]. To date, there have been no vCJD cases associated with receipt of
plasma products, or in these other groups of individuals that have been
categorised as ‘at risk’.

This third case of vCJD infection associated with blood transfusion provides
further evidence that vCJD can be transmitted between humans by blood
transfusion, although much remains unknown. This reinforces the importance
of the existing precautions that have been introduced to reduce the risk of
transmission of vCJD infection by blood and blood products [11].

Numbers of vCJD cases countries other than the UK remain small: by January
2006, there had been 15 cases reported in France, 4 in Ireland, 2 in the
United States, and 1 each in Canada, Italy, Japan, the Netherlands,
Portugal, Saudi Arabia and Spain [12].

This article has been adapted from reference 2

References:

1. Health Protection Agency. New case of variant CJD associated with blood
transfusion. Press release 9 February 2006.
(http://www.hpa.org.uk/hpa/news/articles/press_releases/2006/060209_cjd.htm)
2. HPA. New case of transfusion-associated variant-CJD. Commun Dis Rep CDR
Wkly [serial online] 2006; 16(6): News. (http://www.hpa.org.uk/cdr)
3. CDR editorial team. Possible case of transfusion-associated variant CJD
in the United Kingdom. Eurosurveillance Weekly 2003; 7(51): 030128.
(http://www.eurosurveillance.org/ew/2003/031218.asp#2)
4. Llewelyn CA, Hewitt PE, Knight RSG, Amar K, Cousens S, Mackenzie J, Will
RG. Possible transmission of variant CJD disease by blood transfusion.
Lancet 2004; 363:417-421.
5. Eurosurveillance. Possible second case of variant CJD prion protein
transmission from blood transfusion in the UK. Eurosurveillance Weekly 2004;
8(31): 040729. (http://www.eurosurveillance.org/ew/2004/040729.asp#2)
6. Peden AH, Head MW, Ritchie DL, Bell JE, Ironside JW. Preclinical vCJD
after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet
2004; 364:527-529.
7. Transfusion Medicine Epidemiology Review (TMER) website.
(http://www.cjd.ed.ac.uk/TMER/TMER.htm)
8. Department of Health [London].Patient Notification Exercise Begins. Press
release 2004/0329, 9 September 2004.
(http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesN
otices/fs/en?CONTENT_ID=4088953&chk=4BSn4F)
9. Department of Health [London]. Notification exercise begins to reduce
risk of vCJD transmission. Press release 2005/0256, 20 July 2005.tss
(http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesN
otices/fs/en?CONTENT_ID=4116206&chk=4YsTe9)
10. Department of Health [London]. Next stage of notification exercise to
reduce risk of variant CJD transmission begins. Press release 2005/0404, 17
November 2005.
(http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesN
otices/fs/en?CONTENT_ID=4123496&chk=UnGWvb)
11. Department of Health [London]. Further precautions to protect blood
supply. Press release 2004/0104, 16 March 2004.
(http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesN
otices/fs/en?CONTENT_ID=4076608&chk=MTwE%2Bl)
12. Molesworth AM, Andrews NJ. Variant Creutzfeldt-Jakob disease in the
United Kingdom and elsewhere: situation at the end of 2005. Eurosurveillance
2006; 11(1): 060126. (http://www.eurosurveillance.org/ew/2006/060126.asp#5)


http://www.eurosurveillance.org/ew/2006/060209.asp#2


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

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


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


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

THE SEVEN SCIENTIST REPORT ***


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


PAUL BROWN M.D.

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


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

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

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

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


Subject: BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01
Date: January 9, 2007 at 9:08 am PST


http://disc.server.com/discussion.cgi?disc=236650;article=157;title=CJD%20DISCUSSION%20BOARD

TSS



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