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From: TSS ()
Subject: Re: Docket No. 2004N-0081 Use of Materials Derived From Cattle in Human Food and Cosmetics [TSS SUBMISSION]
Date: September 15, 2005 at 8:52 am PST

In Reply to: Re: Docket No. 2004N-0081 Use of Materials Derived From Cattle in Human Food and Cosmetics [TSS SUBMISSION] posted by TSS on September 7, 2005 at 7:35 pm:

----- Original Message -----
From: Terry S. Singeltary Sr.
To: fdadockets@oc.fda.gov
Sent: Thursday, September 15, 2005 11:00 AM
Subject: Re: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47

ADDITIONAL EVIDENCE FOR MY SUBMISSION TO
[Docket No. 2004N-0081] RIN 0910-AF47

LETTER
High levels of disease related prion protein in the ileum in variant Creutzfeldt-Jakob disease
S Joiner, J M Linehan, S Brandner, J D F Wadsworth and J Collinge
MRC Prion Unit and Department of Neurodegenerative Disease, Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery, London, UK


Correspondence to:
Professor J Collinge
MRC Prion Unit and Department of Neurodegenerative Disease, Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery, Queen Square, London WC1N 3BG, UK; j.collinge@prion.ucl.ac.uk


Keywords: prion; prion protein; ileum; variant Creutzfeldt-Jakob disease

The first 150 words of the full text of this article appear below.


Disease related prion protein (PrPSc) is readily detectable in lymphoreticular tissues in variant Creutzfeldt-Jakob disease (vCJD) but not in other forms of human prion disease.1–5 This distinctive pathogenesis together with the unknown population prevalence of asymptomatic vCJD infection1,5,6 has led to significant concerns that secondary transmission of vCJD prions will occur through a wide range of surgical procedures.1,3,7 Risk assessment for intestinal endoscopy, biopsy, and surgery is currently limited by a lack of knowledge about relative PrPSc levels and prion titres within intestinal tissues in vCJD patients. Because of its high content of lymphoid follicles, terminal ileum is regarded as the intestinal tissue having the highest potential for iatrogenic transmission of vCJD prions.8,9 Here we provide the first report of relative PrPSc concentrations in vCJD terminal ileum.

Tissues were obtained at autopsy with consent from relatives . . . [Full text of this article]

http://gut.bmjjournals.com/cgi/content/extract/54/10/1506-a

TSS


----- Original Message -----
From: Terry S. Singeltary Sr.
To: fdadockets@oc.fda.gov
Sent: Wednesday, September 07, 2005 9:44 PM
Subject: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47


Greetings FDA,

I would kindly like to comment on ;

Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47

SUMMARY: The Food and Drug Administration (FDA) is amending the interim
final rule on use of materials derived from cattle in human food and
cosmetics published in the Federal Register of July 14, 2004. In the
July 14, 2004, interim final rule, FDA designated certain materials
from cattle, including the entire small intestine, as ``prohibited
cattle materials'' and banned the use of such materials in human food,
including dietary supplements, and in cosmetics. FDA is taking this
action in response to comments received on the interim final rule.
Information was provided in comments that persuaded the agency that the
distal ileum, one of three portions of the small intestine, could be
consistently and effectively removed from the small intestine, such
that the remainder of the small intestine, formerly a prohibited cattle
material, could be used for human food or cosmetics. We (FDA) are also
clarifying that milk and milk products, hide and hide-derived products,
and tallow derivatives are not prohibited cattle materials. Comments
also led the agency to reconsider the method cited in the interim final
rule for determining insoluble impurities in tallow and to cite instead
a method that is less costly to use and requires less specialized
equipment. FDA issued the interim final rule to minimize human exposure
to materials that scientific studies have demonstrated are highly
likely to contain the bovine spongiform encephalopathy (BSE) agent in
cattle infected with the disease. FDA believes that the amended
provisions of the interim final rule provide the same level of
protection from human exposure to the agent that causes BSE as the
original provisions. ...

I would kindly like to submit the following ;

I find it very very disturbing that FDA now takes the position;

>>>Information was provided in comments that persuaded the agency that the
distal ileum, one of three portions of the small intestine, could be
consistently and effectively removed from the small intestine, such
that the remainder of the small intestine, formerly a prohibited cattle
material, could be used for human food or cosmetics. <<<

TSE science is emerging and the old testing techniques for TSEs are becoming much more sensitive than when some of these old BSE tissue bio-assays were done in the distant past. I urge once again for the FDA and the USDA to put forth sound science instead of the political and corporate science they have floundered with for the last 3 decades. THERE is much new data out that dispute the position the FDA/USDA have taken on SRMs.

SNIP...END...TSS



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