flatfish
10-17-2006, 05:18 PM
CORRECT AS OF 21ST SEPTEMBER 2006
17
Medical Implants Containing Bovine Material
At SEAC 91 (February 2006) the Medicines and Healthcare products
Regulatory Agency (MHRA) asked the committee to consider the
potential BSE risks to humans from medical implants using bovine
material from the USA.
The regulations on medical devices containing animal materials are
based on the principle that TSE risks must be eliminated or reduced as
much as possible and residual risks must be acceptable when weighed
against the benefits to patients. Currently no guidance exists on the
acceptability of TSE risk control measures applied to animal material in
medical devices.
The MHRA requested advice on three 3 issues. (i) can TSE risk
associated with medical implants using USA sourced bovine material be
estimated given that it might vary over time? (ii) is there, or has there
been a significant risk that might warrant action in addition to that
already taken? (iii) can the standards that support the regulations be
altered to facilitate a consistent approach about the acceptability of
products?
The committee concluded that:
• a risk assessment should be conducted on each device because
of the large number of variables that influence associated TSE
risks.
Key factors which should be considered when assessing risks are:
• the animal source. Use of material from closed herds or from
herds that are managed carefully to prevent the introduction of
the BSE agent.
• use of material from young animals would markedly lower risk
compared with older animals.
• the geographical risk of BSE. The geographical BSE risk
status of a country gives an imprecise indication of BSE risk. It
would be better to use an estimated prevalence of BSE in a
country based on data from a robust surveillance system.
• the potential TSE infectivity of the source tissue(s) based on a
careful assessment of the available data on tissue infectivity.
CORRECT AS OF 21ST SEPTEMBER 2006
18
• the site of implantation. Sites with contact with the blood supply
or CNS may increase risk.
• whether TSE testing is undertaken on the source animal(s).
• the number of source animals used for each device.
http://www.seac.gov.uk/pdf/issue_summary.pdf
CONFIDENTIAL BSE AND VACCINES 1989
http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy
#########
Greetings List Members,
I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.
I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly
so.
"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."
and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.
(understand, these are taken from my notes for now.
the spelling of names and such could be off.)
[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.
[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]
[host Richard]
could you repeat the question?
[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[not sure whom ask this]
what group are you with?
[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.
[not sure who is speaking]
could you please disconnect Mr. Singeltary
[TSS]
you are not going to answer my question?
[not sure whom speaking]
NO
from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;
[unknown woman]
what group are you with?
[TSS]
CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?
at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.
IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;
RBARNS@ORA.FDA.GOV
301-827-6906
he would be glad to give you one ;-)
Rockville Maryland,
Richard Barns Host
snip...end
[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
03-025IFA
03-025IFA-2
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
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
17
Medical Implants Containing Bovine Material
At SEAC 91 (February 2006) the Medicines and Healthcare products
Regulatory Agency (MHRA) asked the committee to consider the
potential BSE risks to humans from medical implants using bovine
material from the USA.
The regulations on medical devices containing animal materials are
based on the principle that TSE risks must be eliminated or reduced as
much as possible and residual risks must be acceptable when weighed
against the benefits to patients. Currently no guidance exists on the
acceptability of TSE risk control measures applied to animal material in
medical devices.
The MHRA requested advice on three 3 issues. (i) can TSE risk
associated with medical implants using USA sourced bovine material be
estimated given that it might vary over time? (ii) is there, or has there
been a significant risk that might warrant action in addition to that
already taken? (iii) can the standards that support the regulations be
altered to facilitate a consistent approach about the acceptability of
products?
The committee concluded that:
• a risk assessment should be conducted on each device because
of the large number of variables that influence associated TSE
risks.
Key factors which should be considered when assessing risks are:
• the animal source. Use of material from closed herds or from
herds that are managed carefully to prevent the introduction of
the BSE agent.
• use of material from young animals would markedly lower risk
compared with older animals.
• the geographical risk of BSE. The geographical BSE risk
status of a country gives an imprecise indication of BSE risk. It
would be better to use an estimated prevalence of BSE in a
country based on data from a robust surveillance system.
• the potential TSE infectivity of the source tissue(s) based on a
careful assessment of the available data on tissue infectivity.
CORRECT AS OF 21ST SEPTEMBER 2006
18
• the site of implantation. Sites with contact with the blood supply
or CNS may increase risk.
• whether TSE testing is undertaken on the source animal(s).
• the number of source animals used for each device.
http://www.seac.gov.uk/pdf/issue_summary.pdf
CONFIDENTIAL BSE AND VACCINES 1989
http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy
#########
Greetings List Members,
I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.
I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly
so.
"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."
and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.
(understand, these are taken from my notes for now.
the spelling of names and such could be off.)
[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.
[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]
[host Richard]
could you repeat the question?
[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[not sure whom ask this]
what group are you with?
[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.
[not sure who is speaking]
could you please disconnect Mr. Singeltary
[TSS]
you are not going to answer my question?
[not sure whom speaking]
NO
from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;
[unknown woman]
what group are you with?
[TSS]
CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?
at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.
IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;
RBARNS@ORA.FDA.GOV
301-827-6906
he would be glad to give you one ;-)
Rockville Maryland,
Richard Barns Host
snip...end
[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
03-025IFA
03-025IFA-2
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
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518