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From: TSS ()
Subject: Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (TSS comment submission 07/11/2004 09:34 PM)
Date: February 24, 2005 at 2:14 pm PST

-------- Original Message --------
Subject: Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (TSS comment submission 07/11/2004 09:34 PM)
Date: Thu, 24 Feb 2005 15:01:41 -0600
From: "Terry S. Singeltary Sr."
To: BSE-L
CC: CJDVOICE

"Terry S. Singeltary Sr."

07/11/2004 09:34 PM


To:

fdadockets@oc.fda.gov

cc:

regulations@aphis.usda.gov, burt.pritchett@fda.gov

bcc:


Subject:

Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW
BSE SAFEGUARDS (comment submission)

Docket

No. 04-047-l

No. 04-021ANPR

No. 2004N-0264

NEW BSE SAFEGUARDS

Federal Measures to Mitigate BSE Risks: Considerations for Further Action

http://www.fda.gov/cvm/index/updates/bseanprm.htm

Greetings FDA, USDA and APHIS et al,

I would kindly like to comment on the continued delay of the regulations
that
have been proposed for years to reduce the risk of BSE/TSE in the USA.
Each day that is wasted debating this issue allows this agent to spread,
and many many more humans and animals become needlessly exposed to
this agent via a multitude of potential routes and sources right here in the
USA. TO continue to ignore the new findings from several scientists
about the
fact that BSE is not the only strain of TSE in cattle, the fact that
new atypical strains of TSE are showing up in not only cattle, but
sheep and the fact that the new strain of TSE in cattle seems to be
more similar to sporadic CJD as opposed to the nv/v CJD, to continue
to ignore these findings will only further spread this agent.

CWD and Scrapie have been running rampant in the USA for decades.
BOTH of which have been rendered and fed back to animals for
human/animal consumption for decades. All of which transmits to primates
by the natural and non-forced
oral consumption of TSE scrapie, CJD, Kuru agent (and CWD by inoculation).

Strong Scientific evidence discovered
back in the 80s support the fact that a TSE has been prevalent in the
USA bovine for decades, either undetected or ignored. IF you consider
the recent
stumbling and staggering TEXAS cow that was showing all signs of a CNS/TSE
disorder that was ordered to be rendered without BSE/TSE test, brains,
spinal cord, head and all (as to no possible evidence left of TSE), I
would think the 'ignored'
or 'covered up' to be the better terminology. Then you have the Downer
in Washington state that was actually a good walker and then all the
banned Canadian products that some how found it's way across the
border into the USA, considering all this, it is very difficult for me to
believe that the FDA/USDA/APHIS et al are doing everything
possible to protect the 'consumer'. Hardly the case;

Congressman Henry Waxmans Letter to the Honorable Ann Veneman
http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_may_13_let.pdf


-------- Original Message --------
Subject: Re: Congressman Henry Waxmans Letter to the Honorable Ann
Veneman on failure by USDA/APHIS TO TEST TEXAS MAD COW
Date: Wed, 9 Jun 2004 16:48:31 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
References: <40A8CD52.1070308@wt.net>

######## Bovine Spongiform Encephalopathy #########

USA BSE RED BOOK

> October 1998
>
> BSE Red Book 2.1-36
>

> 7.2.1.7 Laboratory Coordination--The Laboratory Coordination Officer
> will advise the READE(3 Director concerning laboratory capabilities and
> appropriate laboratory examinations to be conducted to provide needed
> results as rapidly as possible. This individual will assist with
> interpretation of results.


seems that if the 'enhanced BSE/TSE testing program' is to test some
400,000+ animals in 1 1/2 years, they better hurry up, times a wasting.

> BSE Red Book 2.1-39
>
> 7.6 Depopulation Procedures
>
> Under no
> circumstances may BSE suspects be sent fo slaughhter or rendering.


snip...

> BSE Red Book 2.1-40
>
> 7.7 Disposal
> Under no circumstances may BSE suspects be sent to slaughter or
> rendering. Notify FDA, CVM if you suspect that the carcass of a
> BSE-confirmed animal has moved to rendering or animal feed
> manufacturing. Field personel should arrange for the carcass to be
> transported to and examined by a qualified veterinary pathologist or
> field veterinary medical officer. After the pathologic examination has
> been completed and the necessary diagnostic specimens have been
> obtained, field personnel should arrange for disposal of the carcass.
> Before a method of disposal is selected, there are many factors that
> must be considered, and often other State and Federal agencies must be
> consulted. The environmental and legal impacts of the operation must be
> considered. Upon recommendation of the State or Federal agencies, VS may
> consider other disposal methods.
>
snip...

> 7.7.3 Rendering
> Because BSE is spread by rendered animal protein, BSE-suspect and
> confirmed carcasses must not be rendered, unless the rendered material
> is incinerated. Notify FDA, CVM if you suspect that dead BSE animals or
> carcasses have moved to rendering or animal feed manufacturing.
>

snip...

> 7.10.11 Prevention--Suspects and animals confirmed to have BSE must not
> be rendered. Producers, feed mills, and rendering establishments should
> adhere to U.S. State and local rendering policies and FDA regulations
> concerning the feeding of rendered animal protein to ruminants.


snip...

USDA/APHIS ET AL MUST GET BSE/TSE TESTING DONE CORRECTLY

THE recent findings of positive 'inconclusives' that turned up negative
was not only a nightmare to the consumer, but also to the farmers and
industry as well. Using Prionics or Bio-Rad or whatever rapid TSE test
will never eliminate the potential for human error. IF we look at the
recent discovery of the BSE in Switzerland in the Zoo Zebu, the testing
they perform would have eliminated this mix-up;

Diagnosis:

A. Laboratory where diagnosis was made: Institute of Animal Neurology,
University of Bern (OIE Reference Laboratory for bovine spongiform
encephalopathy).

B. Diagnostic tests used:

- histology;

- immunohistochemistry;

- ELISA (two different kits);

- western blot.

All tests gave positive results.


http://www.oie.int/eng/info/hebdo/AIS_38.HTM#Sec9


ALSO, if we look at the USA BSE EMERGENCY RESPONSE PLAN, where it states;

Subject:
U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary
Date: Tue, 4 May 1999 18:25:12 -0500 From: "Terry S. Singeltary Sr."
Reply-To: BSEL To: BSEL snip... If additional tests do suggest a
presumptive diagnosis of BSE, an NVSL pathologist will hand carry the
sample to the United Kingdom for confirmation. It is at this critical
point, when NVSL suggests a diagnosis of BSE and is preparing to send
the sample to the United Kingdom, that this BSE Response Plan is
initiated. The Plan begins the preliminary notification from NVSL to
APHIS. Preliminary Notification The director of NVSL is responsible for
immediately notifying the APHIS, Veterinary Services (VS) deputy
administrator when tests suggest a presumptive diagnosis of BSE. Once
NVSL has made a presumptive diagnosis of BSE, APHIS and FSIS field
activities will also be initiated. APHIS will receive notification
(either confirming or not confirming NVSL's diagnosis) from the United
Kingdom anywhere between 24 and 96 hours. (The international animal
health community has recognized the United Kingdom's Central Veterinary
Laboratory {CVL} as the world's reference laboratory for diagnosing BSE.
Other countries, including Belgium, France, Ireland, Luxembourg, the
Netherlands, Portugal, and Switzerland, have all sent samples to this
lab to confirm their first case of BSE). snip...end...TSS

WHY is the UK not going to verify the findings of BSE/TSE in tissue samples
as the original BSE emergency response plan told them too?

I think that having several different rapid TSE test kits (Prionics, Bio-Rad etc.)
along with the IHC and finally the OIE reference laboratory for confirmation is
the best possible answer. Prusiner et al have a test that is some 1,000 times more
sensitive and I only ponder why we are not using it? My fear is that once testing
becomes more sensitive, more tissue/organ will become known to hold infectivity
of some titre of the TSE agent. THEN we must ponder if _accumulation_ may play
a role? With the threat from new atypical TSEs in many species and the real threat
from iatrogenic CJD, the fact that we do not yet know how these new 'atypical'
phenotpyes will transmit and how infectious there tissues may be, we must act now,
we cannot flounder any longer...

snip...

FULL TEXT ;


https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument

TSS





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