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From: TSS ()
Subject: Re: FDA 50 STATE EMERGENCY BSE CONFERENCE CALL JANUARY 9, 2001
Date: November 1, 2006 at 2:00 pm PST

In Reply to: Re: FDA 50 STATE EMERGENCY BSE CONFERENCE CALL JANUARY 9, 2001 posted by TSS on October 31, 2006 at 5:12 pm:

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

* * * * *

MEETING

WEDNESDAY,

APRIL 15, 1998

SNIP...

The important message from this study, remembering that it was brain material that was used rather than meat and bone meal, that assuming the rendering procedure produced -- or the drawing procedure produced no reduction in titre, the actual amount, the physical volume to look at, of the amount of tissue necessary to produce BSE in about three years, or three to four years after all dosage of, let's say, about .1 of a gram of the dried brain material -- well, it is .1 of a gram. In other words, if you reckon that brain when you dry it weighs about -- nine-tenths of it is gone and reduced to .1 of a gram of dried product, this very small amount is not something that anybody could control under farming conditions. When you would be talking about we need 2.5 kilograms to infect a cow, then this would be readily possible to control. But such a small amount which is presumed from the study showing that one gram will produce BSE three to four years later, it's quite a remarkable piece of information. Of course, we don't know the dose of meat and bone meal that will do that, only raw brain material.

SNIP...

Then with regard to injectables containing gelatins, we have probably more than two dozen products out there containing gelatins approved. Then we have a number of high investigational drugs. So, after we have the guidance argument published, we have communicated with the companies and asked them to provide us with information where the source material comes from. So, we're working with the company to amend our applications to assure the sourcing will not be from BSE countries. So, we're in the processing of doing that. (PAGE 168)

SNIP...


http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3406t1.rtf


TSS




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