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From: TSS ()
Subject: FDA Proposes Barring Certain Cattle Material From Medical Products As BSE Safeguard
Date: January 12, 2007 at 8:39 am PST

FOR IMMEDIATE RELEASE
P07-04
January 11, 2007
Media Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Proposes Barring Certain Cattle Material From Medical Products As BSE Safeguard

The U.S. Food and Drug Administration is proposing to limit the materials used in some medical products in order to keep them free of the agent thought to cause mad cow disease, also known as bovine spongiform encephalopathy or BSE.

This is the latest in a series of BSE safeguards that would bar material that has been found to harbor the highest concentrations of this fatal agent in infected cattle. These materials would be prohibited from use as ingredients in medical products or elements of product manufacturing.

The proposed rule would cover drugs (prescription, over-the-counter, and homeopathic), biologics (such as vaccines) and medical devices intended for use in humans as well as drugs intended for use in ruminant animals like cattle and sheep. Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie.

"These measures build on a series of barriers FDA and the U.S. Department of Agriculture have erected to further protect humans from exposure to the fatal agent linked to BSE," said Andrew von Eschenbach, M.D., Commissioner Food and Drugs. "This proposed rule adds one more safeguard that will reduce the risk of transmission even further."

The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and include:

the brain, skull, eyes and spinal cords from cattle 30 months and older;
the tonsils and a portion of the small intestines from all cattle regardless of their age or health;
any material from "downer" cattle--those that cannot walk;
any material from cattle not inspected and passed for human consumption;
fetal calf serum if appropriate procedures have not been followed to prevent its contamination with materials prohibited by this proposed rule;
tallow that contains more than 0.15 percent insoluble impurities if the tallow is derived from materials prohibited by this proposed rule and;
mechanically separated beef.
To ensure that companies comply with these prohibitions, FDA proposes to require that records be kept to demonstrate that any cattle material used as an ingredient in these medical products or as part of their manufacturing process meet the rule’s requirements.

Since 1996, strong evidence has accumulated for a causal relationship between ongoing outbreaks of mad cow disease in Europe and a disease in humans called variant Creutzfeldt-Jakob (vCJD) disease. Both disorders, which are thought to be caused by an unconventional transmissible agent, are invariably fatal brain diseases with incubation periods typically measured in years. Transmission of the BSE agent to humans, leading to vCJD, is believed to occur via ingestion of cattle products contaminated with the BSE agent; however the specific products associated with this transmission are unknown.

About 200 cases of vCJD have been identified worldwide, including three cases in the U.S. However, there is no evidence that those three patients contracted the BSE agent in the U.S.

FDA and USDA’s efforts to help protect the public from vCJD have included several other significant steps such as the FDA’s 1997 ruminant feed regulation, which forbids the use of certain mammalian-origin proteins in ruminant feed. Also, a 2005 interim final rule bans the use of certain high-risk cattle material in food, dietary supplements and cosmetics.

####

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01545.html

Subject: U.S.A. - 50 STATE BSE CONFERENCE CALL JAN. 9, 2001 (my notes)
Date: January 10, 2001 at 1:36 pm PST

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

BSE issues in the U.S.,
How they were labelling ruminant feed?
Revising issues.

The conference opened up with the explaining of
the U.K. BSE epidemic winding down with about 30
cases a week.

although new cases in other countries were now
appearing.

Look at Germany whom said NO BSE and now have BSE.

BSE increasing across Europe.

Because of Temporary Ban on certain rendered product,
heightened interest in U.S.

A recent statement in Washington Post, said the
New Administration (old GW) has a list of issues.
BSE is one of the issues.

BSE Risk is still low, minimal in U.S. with a greater
interest in MBM not to enter U.S.

HOWEVER, if BSE were to enter the U.S.
it would be economically disastrous
to the render, feed, cattle, industries,
and for human health.

(human health-they just threw that in cause i was listening. I will now
jot down some figures in
which they told you, 'no need to write them down'.
just hope i have them correct. hmmm, maybe i hope
i don't ???)

80% inspection of rendering

*Problem-Complete coverage of rendering HAS NOT
occurred.

sizeable number of 1st time FAILED INITIAL INSPECTION,
have not been reinspected (70% to 80%).

Compliance critical, Compliance poor in U.K.
and other European Firms.

Gloria Dunason
Major Assignment 1998 goal TOTAL compliance.
This _did not_ occur. Mixed level of compliance,
depending on firm.

Rendering FDA license and NON FDA license

system in place for home rendering & feed
76% in compliance
79% cross contamination
21% DID NOT have system
92% record keeping
less than 60% total compliance

279 inspectors
185 handling prohibited materials

Renderer at top of pyramid, significant
part of compliance.
84% compliance

failed to have caution statement render
72% compliance & cross contamination
caution statement on feed, 'DO NOT FEED TO CATTLE'

56 FIRMS NEVER INSPECTED

1240 FDA license feed mills
846 inspected

"close to 400 feed mills have not been inspected"

80% compliance for feed.

10% don't have system.

NON-FDA licensed mills
There is NO inventory on non licensed mills.
approximately 6000 to 8000 Firms ???
4,344 ever inspected.
"FDA does not have a lot of experience with"

40% do NOT have caution statement 'DO NOT FEED'.

74% Commingling compliance

"This industry needs a lot of work and only half
gotten to"

"700 Firms that were falitive, and need to be
re-inspected, in addition to the 8,000 Firms."

Quote to do BSE inspection in 19 states by end
of January or 30 days, and other states 60 days.
to change feed status??? Contract check and ask
questions and pass info.

At this time, we will take questions.

[I was about the third or fourth to ask question.
then all B.S.eee broke loose, and i lost my train
of thought for a few minutes. picked back up here]

someone asking about nutritional supplements and
sourcing, did not get name. something about inspectors
not knowing of BSE risk??? the conference person assuring that Steve
Follum? and the TSE advisory Committee were
handling that.

Some other Dr. Vet, whom were asking questions
that did not know what to do???

[Dennis Wilson]
California Food Agr.
Imports, are they looking at imports?

[Conference person]
they are looking at imports,
FDA issued imports Bulletin.

[Linda Singeltary ??? this was a another phone in
question, not related i don't think]
Why do we have non-licensed facilities?

(conference person)
other feed mills do not handle as potent drugs???

Dennis Blank, Ken Jackson
licensed 400
non FDA 4400 inspected of a total of 6000 to 8000,

(they really don't know how many non licensed Firms
in U.S. they guess 6000 to 8000??? TSS)

Linda Detwiler
asking everyone (me) not to use emergency BSE number,
unless last resort.
(i thought of calling them today, and reporting the
whole damn U.S. cattle herd ;-) 'not'

Warren-Maryland Dept. Agr.
Prudent to re-inspect after 3 years.
concerned of Firms that have changed
owners.

THE END

TSS

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############

From:

Sent:

To:

Subject:

Terry S. Singeltary Sr. [flounder@wt.net]

Monday, January 08,200l 3:03 PM

freas@CBS5055530.CBER.FDA.GOV

CJDIBSE (aka madcow) Human/Animal TSE’s--U.S.--Submission To Scientific Advisors and

Consultants Staff January 2001 Meeting (short version)

Greetings again Dr. Freas and Committee Members,

I wish to submit the following information to the

Scientific Advisors and Consultants Staff

2001 Advisory Committee (short version).

snip...

To think of Scrapie as the prime agent to compare CJD,

but yet overlook the Louping-ill vaccine event in 1930's

of which 1000's of sheep where infected by scrapie

from a vaccine made of scrapie infected sheep brains,

would be foolish. I acquired this full text version of the

event which was recorded in the Annual Congress of 1946

ational Vet. Med. Ass. of Great Britain and Ireland.

snip...

THEN think of vaccineCJD in children and the bovine tissues

used in the manufacturing process, think of the FACT that

this agent surviving 6OO*C.

PNAS -- Brown et al. 97 (7): 3418 scrapie agent live at 600*C

Then think of the CONFIDENTIAL documents of what was known of

human/animal TSE and vaccines in the mid to late 8Os, it was all about

depletion of stock, to hell with the kids, BUT yet they knew.

To think of the recall and worry of TSE's from the polio vaccine,

(one taken orally i think?), but yet neglect to act on the

other potential TSE vaccines (inoculations, the most effective mode to

transmit TSEs) of which thousands of doses were kept and used,

to deplete stockpile, again would be foolish.

--Oral polio; up to 1988, foetal calf serum was used from UK and

New Zealand (pooled); since 1988 foetal calf serum only from New

Zealand. Large stocks are held.

--Rubella; bulk was made before 1979 from foetal calf serum from UK

and New Zealand. None has been made as there are some 15 years stock.

--Diphtheria; UK bovine beef muscle and ox heart is used but since the

end of 1988 this has been sourced from Eire. There are 1,250 litres of

stock.

. .

--Tetanus; this involves bovine material from the UK mainly Scottish.

There are 21,000 litres of stock.

--Pertussis; uses bovine material from the UK. There are 63,000 litres

of stock.

--They consider that to switch to a non-UK source will take a minimum of

6-18 months and to switch to a non-bovine source will take a minimum of

five years.

3. XXXXXXXXXXX have measles, mumps, MMR, rubella vaccines. These

are sourced from the USA and the company believes that US material only

is used.

89/2.14/2.1

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

BSE3/1 0251

4. XXXXXXXXXXX have a measles vaccine using bovine serum from the UK.

there are 440,000 units of stock. They have also got MMR using bovine

serum from the UK.

5. XXXXXXXXXXX have influenza, rubella, measles,' MMR vaccines

likely to be used in children. Of those they think that only MMR

contains bovine material which is probably a French origin.

6. XXXXXXXXXXX have diphtheria/tetanus and potasses on clinical trial.

hese use veal material, some of which has come from the UK and has been

ade by XXXXXXXXXXX (see above).

I have documents of imports from known BSE Countries,

of ferments, whole blood, antiallergenic preparations,

2

snip....

http://www.fda.gov/OHRMS/DOCKETS/AC/01/slides/3681s2_09.pdf

http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm

http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm

http://www.microbes.info/forums/lofiversion/index.php/t377.html

http://www.whale.to/v/cjd1.html

http://www.mad-cow.org/00/may00_news.html

http://www.mad-cow.org/00/feb01_news_mid.html

TSS




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