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From: TSS ()
Subject: Re: Nutritional Supplements and TSEs i.e. MAD COW disease's BSE/BASE and CJDs
Date: February 11, 2007 at 10:28 am PST

In Reply to: Nutritional Supplements and TSEs i.e. MAD COW disease's BSE/BASE and CJDs posted by TSS on February 9, 2007 at 11:03 am:

1st. let's go back in time, before GW, the USDA et al, and the OIE sold
there soul to the devil, all for a buck.


what was, what is, and what ain't. ...tss


Summary of ORA BSE Import Bulletin 99B-14

The Food and Drug Administration (FDA) has alerted its import field offices
to the potential importation of human food products and nutritional
supplements containing ruminant material from BSE-affected or at-risk
countries as determined by United States Department of Agriculture
(USDA)/Animal, Plant Health and Inspection Service (APHIS). The current
action is a followup to an earlier FDA alert issued in January 2000
regarding bulk shipments of high risk bovine tissues from these same
countries. An expanded list of products at issue and a list of the current
BSE-affected countries is set out below.

USDA/APHIS has prohibited the importation into the United States of all
edible ruminant products from Europe, Oman, and other BSE-affected
countries. The Import Bulletin will facilitate FDA's careful review of all
imports of FDA-regulated products to ensure coordination with APHIS on the
prohibitions. FDA's review will include evaluation of product ingredient
lists to determine whether the products offered for import contain certain
ruminant materials. Products that appear to contain ruminant material from
the identified countries will be referred to APHIS for disposition.

PRODUCTS
Any products containing ruminant material such as (but not limited to):
Cheese products containing meat of ruminant origin
Ruminant meat products
Poultry products containing or processed with ruminant products
Rennet from ruminant animals
Pie fillings containing or processed with ruminant products
Multiple ingredient food products (soups, stews, sandwiches, mixed dinners,
etc.) containing or processed with ruminant products
Baby foods, geriatric foods, and dietary foods containing or processed with
ruminant products
Vitamins, minerals, proteins, and other dietary supplements that contain or
have been processed with ruminant material
Food additives (emulsifiers, enzymes, flavor enhancers, etc.) containing or
processed with ruminant materials
Botanicals containing or processed with ruminant materials
Animal by-products and extracts for human use
BSE-AFFECTED OR AT-RISK COUNTRIES
ALBANIA (AL)
ANDORRA (AD)
AUSTRIA (AT)
BELGIUM (BE)
BOSNIA-HERZEGOVINA (BA)
BULGARIA (BG)
CANADA (CA)
CROATIA (HR)
CZECH REPUBLIC (CS)
DENMARK (DK)
FEDERAL REPUBLIC OF YUGOSLAVIA (YU)
FINLAND (FI)
FRANCE (FR)
GERMANY (DE)
GREECE (GR)
HUNGARY (HU)
IRELAND, REPUBLIC of (IE)
ISRAEL (IL)
ITALY (IT)
JAPAN (JP)
LIECHTENSTEIN
LUXEMBOURG (LU)
MACEDONIA, the former YUGOSLAV REPUBLIC of (MK)
MONACO (MC)
NETHERLANDS (NL)
NORWAY (NO)
OMAN (OM)
POLAND (PL)
PORTUGAL (PT)
ROMANIA (RO)
SAN MARINO (SM)
SLOVAK REPUBLIC (SLOVAKIA) (SK)
SLOVENIA (SI)
SPAIN (ES)
SWEDEN (SE)
SWITZERLAND (CH)
UNITED KINGDOM (Great Britain including Northern Ireland, and Falkland
Islands) (GB)

http://www.cfsan.fda.gov/~comm/bseimpor.html

Suppressed peer review of Harvard study October 31, 2002

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf

NOW, reality setting in ;


EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR)
of the United States of America (USA)


Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working Group
on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE)
Risk (GBR) were asked by the European Commission (EC) to provide an
up-to-date scientific report on the GBR in the United States of America,
i.e. the likelihood of the presence of one or more cattle being infected
with BSE, pre-clinically as well as clinically, in USA. This scientific
report addresses the GBR of USA as assessed in 2004 based on data covering
the period 1980-2003.

The BSE agent was probably imported into USA and could have reached domestic
cattle in the middle of the eighties. These cattle imported in the mid
eighties could have been rendered in the late eighties and therefore led to
an internal challenge in the early nineties. It is possible that imported
meat and bone meal (MBM) into the USA reached domestic cattle and leads to
an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle imports
from BSE risk countries were slaughtered or died and were processed (partly)
into feed, together with some imports of MBM. This risk continued to exist,
and grew significantly in the mid 90’s when domestic cattle, infected by
imported MBM, reached processing. Given the low stability of the system, the
risk increased over the years with continued imports of cattle and MBM from
BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is likely
but not confirmed that domestic cattle are (clinically or pre-clinically)
infected with the BSE-agent. As long as there are no significant changes in
rendering or feeding, the stability remains extremely/very unstable. Thus,
the probability of cattle to be (pre-clinically or clinically) infected with
the BSE-agent persistently increases.


http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html

http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/573.Par.0004.File.dat/sr03_biohaz02_usa_report_v2_en1.pdf


USA BSE OIG 2006


http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006


The U.S. Department of Agriculture was quick to assure the public earlier
this week that the third case of mad cow disease did not pose a risk to
them, but what federal officials have not acknowledged is that this latest
case indicates the deadly disease has been circulating in U.S. herds for at
least a decade.

The second case, which was detected last year in a Texas cow and which USDA
officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a
picture of the disease having been here for 10 years or so, since it is
thought that cows usually contract the disease from contaminated feed they
consume as calves. The concern is that humans can contract a fatal,
incurable, brain-wasting illness from consuming beef products contaminated
with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of
other undetected cases," Dr. Paul Brown, former medical director of the
National Institutes of Health's Laboratory for Central Nervous System
Studies and an expert on mad cow-like diseases, told United Press
International. "The question was, 'How many?' and we still can't answer
that."

Brown, who is preparing a scientific paper based on the latest two mad cow
cases to estimate the maximum number of infected cows that occurred in the
United States, said he has "absolutely no confidence in USDA tests before
one year ago" because of the agency's reluctance to retest the Texas cow
that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven
months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005
suspect," Brown said. ...snip...end


http://www.upi.com/


CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central
Nervous System ... Address for correspondence: Paul Brown, Building 36, Room
4A-05, ...


http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm

PAUL BROWN COMMENT TO ME ON THIS ISSUE

Tuesday, September 12, 2006 11:10 AM


"Actually, Terry, I have been critical of the USDA handling of the mad cow
issue for some years,
and with Linda Detwiler and others sent lengthy detailed critiques and
recommendations to both the
USDA and the Canadian Food Agency." snip...end...tss

NOW, back in time again ;

FOR IMMEDIATE RELEASE
Statement
May 4, 2004


Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

Statement on Texas Cow With Central Nervous System Symptoms

On Friday, April 30 th , the Food and Drug Administration learned that a cow
with central nervous system symptoms had been killed and shipped to a
processor for rendering into animal protein for use in animal feed.

FDA, which is responsible for the safety of animal feed, immediately began
an investigation. On Friday and throughout the weekend, FDA investigators
inspected the slaughterhouse, the rendering facility, the farm where the
animal came from, and the processor that initially received the cow from the
slaughterhouse.

FDA's investigation showed that the animal in question had already been
rendered into "meat and bone meal" (a type of protein animal feed). Over the
weekend FDA was able to track down all the implicated material. That
material is being held by the firm, which is cooperating fully with FDA.

Cattle with central nervous system symptoms are of particular interest
because cattle with bovine spongiform encephalopathy or BSE, also known as
"mad cow disease," can exhibit such symptoms. In this case, there is no way
now to test for BSE. But even if the cow had BSE, FDA's animal feed rule
would prohibit the feeding of its rendered protein to other ruminant animals
(e.g., cows, goats, sheep, bison).

FDA is sending a letter to the firm summarizing its findings and informing
the firm that FDA will not object to use of this material in swine feed
only. If it is not used in swine feed, this material will be destroyed. Pigs
have been shown not to be susceptible to BSE. If the firm agrees to use the
material for swine feed only, FDA will track the material all the way
through the supply chain from the processor to the farm to ensure that the
feed is properly monitored and used only as feed for pigs.

To protect the U.S. against BSE, FDA works to keep certain mammalian protein
out of animal feed for cattle and other ruminant animals. FDA established
its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that
the disease spreads by feeding infected ruminant protein to cattle.

Under the current regulation, the material from this Texas cow is not
allowed in feed for cattle or other ruminant animals. FDA's action
specifying that the material go only into swine feed means also that it will
not be fed to poultry.

FDA is committed to protecting the U.S. from BSE and collaborates closely
with the U.S. Department of Agriculture on all BSE issues. The animal feed
rule provides crucial protection against the spread of BSE, but it is only
one of several such firewalls. FDA will soon be improving the animal feed
rule, to make this strong system even stronger.

####

http://www.fda.gov/bbs/topics/news/2004/NEW01061.html


TEXAS BOVINE DISEASE CARCASS DISPOSAL METHOD


“Anthrax is under-reported, because many ranchers in this area automatically
dispose
of carcasses and vaccinate livestock when they find dead animals that are
bloated or
bloody--common signs of the disease,” said Dr. Fancher.


http://www.tahc.state.tx.us/news/pr/2005/2005Jul_Anthrax_Confirmed_in_SuttonCty.pdf

OIG REPORT ON USDA AND HOW NOT TO FIND BSE
Submitted by flounder on Tue, 06/06/2006 - 13:05.

USDA 2004 ENHANCED BSE SURVEILLANCE PROGRAM AND HOW NOT TO FIND BSE CASES
(OFFICIAL DRAFT OIG REPORT)

snip...

CATTLE With CNS Symptoms Were NOT Always Tested

snip...

Between FYs 2002 and 2004, FSIS condemned 680 cattle of all ages due to CNS
symptoms. About 357 of these could be classified as adult. We could validate
that ONLY 162 were tested for BSE (per APHIS records. ...

snip...

WE interviewed officials at five laboratories that test for rabies. Those
officials CONFIRMED THEY ARE NOT REQUIRED TO SUBMIT RABIES-NEGATIVE SAMPLES
TO APHIS FOR BSE TESTING. A South Dakota laboratory official said they were
not aware they could submit rabies-negative samples to APHIS for BSE
testing. A laboratory official in another State said all rabies-negative
cases were not submitted to APHIS because BSE was ''NOT ON THEIR RADAR
SCREEN." Officials from New York, Wisconsin, TEXAS, and Iowa advised they
would NOT submit samples from animals they consider too young. Four of the
five States contacted defined this age as 24 months; Wisconsin defined it as
30 months. TEXAS officials also advised that they do not always have
sufficient tissue remaining to submit a BSE sample. ...

snip...

FULL TEXT 54 PAGES OF HOW NOT TO FIND BSE IN USA ;


http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_july_13_ig_rep.pdf


REMINDER, CATTLE ON FEED IN TEXAS


IN TEXAS, cattle on feed for decades, fda says 5.5 grams ruminant protein,
if tainted with TSE, is not enough to kill a cow. actually, it's enough to
kill 100+ cows ;-)

http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html

USA CJD 2006, reality setting in again ;


3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the Exhibit
Hall


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western
Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years. ***These results indicate that BASE is
transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.

6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp

SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html


There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf


18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...


64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.

Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...


http://www.seac.gov.uk/minutes/95.pdf

NOW, back in time again ;


Press Release
FOR IMMEDIATE RELEASE
Monday, Jan. 26, 2004
FDA Press Office
301-827-6242


Expanded "Mad Cow" Safeguards Announced
to Strengthen Existing Firewalls Against BSE Transmission
HHS Secretary Tommy G. Thompson today announced several new public health
measures, to be implemented by the Food and Drug Administration (FDA), to
strengthen significantly the multiple existing firewalls that protect
Americans from exposure to the agent thought to cause bovine spongiform
encephalopathy (BSE, also known as mad cow disease) and that help prevent
the spread of BSE in U.S. cattle.

The existing multiple firewalls, developed by both the U.S. Department of
Agriculture (USDA) and HHS, have been extremely effective in protecting the
American consumer from exposure to BSE. The first firewall is based on
import controls started in 1989. A second firewall is surveillance of the
U.S. cattle population for the presence of BSE, a USDA firewall that led to
the finding of the BSE cow in December. The third firewall is FDA's 1997
animal feed ban, which is the critical safeguard to help prevent the spread
of BSE through cattle herds by prohibiting the feeding of most mammalian
protein to ruminant animals, including cattle. The fourth firewall, recently
announced by USDA, makes sure that no bovine tissues known to be at high
risk for carrying the agent of BSE enter the human food supply regulated by
USDA. The fifth firewall is effective response planning to contain the
potential for any damage from a BSE positive animal, if one is discovered.
This contingency response plan, which had been developed over the past
several years, was initiated immediately upon the discovery of a BSE
positive cow in Washington State December 23.

The new safeguards being announced today are science-based and further
bolster these already effective safeguards.

******************************************

Specifically, HHS intends to ban from human food (including dietary
supplements), and cosmetics a wide range of bovine-derived material so that
the same safeguards that protect Americans from exposure to the agent of BSE
through meat products regulated by USDA also apply to food products that FDA
regulates.


******************************************

FDA will also prohibit certain currently allowed feeding and manufacturing
practices involving feed for cattle and other ruminant animals. These
additional measures will further strengthen FDA's 1997 "animal feed" rule.

"Today's actions will make strong public health protections against BSE even
stronger," Secretary Thompson said. "Although the current animal feed rule
provides a strong barrier against the further spread of BSE, we must never
be satisfied with the status quo where the health and safety of our animals
and our population is at stake. The science and our own experience and
knowledge in this area are constantly evolving. Small as the risk may
already be, this is the time to make sure the public is protected to the
greatest extent possible."

"Today we are bolstering our BSE firewalls to protect the public," said FDA
Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening
our animal feed rule, and we are taking additional steps to further protect
the public from being exposed to any potentially risky materials from
cattle. FDA's vigorous inspection and enforcement program has helped us
achieve a compliance rate of more than 99 percent with the feed ban rule,
and we intend to increase our enforcement efforts to assure compliance with
our enhanced regulations. Finally, we are continuing to assist in the
development of new technologies that will help us in the future improve even
further these BSE protections. With today's actions, FDA will be doing more
than ever before to protect the public against BSE by eliminating additional
potential sources of BSE exposure."

To implement these new protections, FDA will publish two interim final rules
that will take effect immediately upon publication, although there will be
an opportunity for public comment after publication.

The first interim final rule will ban the following materials from
FDA-regulated human food, (including dietary supplements) and cosmetics:

Any material from "downer" cattle. ("Downer" cattle are animals that cannot
walk.)
Any material from "dead" cattle. ("Dead" cattle are cattle that die on the
farm (i.e. before reaching the slaughter plant);
Specified Risk Materials (SRMs) that are known to harbor the highest
concentrations of the infectious agent for BSE, such as the brain, skull,
eyes, and spinal cord of cattle 30 months or older, and a portion of the
small intestine and tonsils from all cattle, regardless of their age or
health; and
The product known as mechanically separated beef, a product which may
contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system
for cutting meat from bones), may be used since USDA regulations do not
allow the presence of SRMs in this product.
The second interim final rule is designed to lower even further the risk
that cattle will be purposefully or inadvertently fed prohibited protein. It
was the feeding of such protein to cattle that was the route of disease
transmission that led to the BSE epidemic in United Kingdom cattle in the
1980's and 1990's.

This interim final rule will implement four specific changes in FDA's
present animal feed rule. First, the rule will eliminate the present
exemption in the feed rule that allows mammalian blood and blood products to
be fed to other ruminants as a protein source. Recent scientific evidence
suggests that blood can carry some infectivity for BSE.

Second, the rule will also ban the use of "poultry litter" as a feed
ingredient for ruminant animals. Poultry litter consists of bedding, spilled
feed, feathers, and fecal matter that are collected from living quarters
where poultry is raised. This material is then used in cattle feed in some
areas of the country where cattle and large poultry raising operations are
located near each other. Poultry feed may legally contain protein that is
prohibited in ruminant feed, such as bovine meat and bone meal. The concern
is that spillage of poultry feed in the chicken house occurs and that
poultry feed (which may contain protein prohibited in ruminant feed) is then
collected as part of the "poultry litter" and added to ruminant feed.

Third, the rule will ban the use of "plate waste" as a feed ingredient for
ruminants. Plate waste consists of uneaten meat and other meat scraps that
are currently collected from some large restaurant operations and rendered
into meat and bone meal for animal feed. The use of "plate waste" confounds
FDA's ability to analyze ruminant feeds for the presence of prohibited
proteins, compromising the Agency's ability to fully enforce the animal feed
rule.

Fourth, the rule will further minimize the possibility of
cross-contamination of ruminant and non-ruminant animal feed by requiring
equipment, facilities or production lines to be dedicated to non-ruminant
animal feeds if they use protein that is prohibited in ruminant feed.
Currently, some equipment, facilities and production lines process or handle
prohibited and non-prohibited materials and make both ruminant and
non-ruminant feed -- a practice which could lead to cross-contamination.

To accompany these new measures designed to provide a further layer of
protection against BSE, FDA will in 2004 step up its inspections of feed
mills and renderers. FDA will itself conduct 2,800 inspections and will make
its resources go even further by continuing to work with state agencies to
fund 3,100 contract inspections of feed mill and renderers and other firms
that handle animal feed and feed ingredients. Through partnerships with
states, FDA will also receive data on 700 additional inspections, for a
total of 3,800 state contract and partnership inspections in 2004 alone,
including annual inspections of 100 percent of all known renderers and feed
mills that process products containing materials prohibited in ruminant
feed.

"We have worked hard with the rendering and animal feed production
industries to try and achieve full compliance with the animal feed rule,"
said Dr. McClellan, "and through strong education and a vigorous enforcement
campaign, backed by additional inspections and resources, we intend to
maintain a high level of compliance."

Dr. McClellan also noted that, in response to finding a BSE positive cow in
Washington state December 23, FDA inspected and traced products at 22
facilities related to that positive cow or products from the cow, including
feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat
processors, transfer stations, and shipping terminals. Moreover, FDA has
conducted inspections at the rendering facilities that handled materials
from the positive cow, and they were found to be fully in compliance with
FDA's feed rule.

To further strengthen protections for Americans, FDA/HHS intends to work
with Congress to consider proposals to assure that these important
protective measures will be implemented as effectively as possible.

FDA is also continuing its efforts to assist in the development of better
BSE science, to achieve the same or greater confidence in BSE protection at
a lower cost. For example, to enhance the ability of our public health
system to detect prohibited materials in animal feed, FDA will continue to
support the development and evaluation of diagnostic tests to identify
prohibited materials. These tests would offer a quick and reliable method of
testing animal feeds for prohibited materials and for testing other products
for contamination with the agent thought to cause BSE.

FDA has publicly discussed many of the measures being announced today with
stakeholders in workshops, videoconferences, and public meetings. In
addition, FDA published an Advance Notice of Proposed Rulemaking in November
2002 (available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm
concerning possible changes to the animal feed rule.

Comprehensive information about FDA's work on BSE and links to other related
websites are available at http://www.fda.gov.

###


http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html

For Immediate Release
July 9, 2004
FSIS Press Office
APHIS Press Office
FDA Media Relations

(202) 720-9113
(202) 734-7799
(301) 827-6242


USDA and HHS Strengthen Safeguards Against
Bovine Spongiform Encephalopathy
WASHINGTON, July 9, 2004--HHS Secretary Tommy G. Thompson and Agriculture
Secretary Ann M. Veneman today announced three actions being taken to
further strengthen existing safeguards that protect consumers against the
agent that causes bovine spongiform encephalopathy (BSE, also known as "mad
cow disease").

The three documents on display today include:

A joint USDA Food Safety & Inspection Service (FSIS), USDA Animal and Plant
Health Inspection Service (APHIS) and Food and Drug Administration (FDA)
notice that asks for public comment on additional preventive actions that
are being considered concerning BSE;

*****************************************************

An interim final FDA rule that prohibits the use of certain cattle-derived
materials in human food (including dietary supplements) and cosmetics; and
A proposed FDA rule on recordkeeping requirements for the interim final rule
relating to this ban.

*****************************************************

"Today's actions continue our strong commitment to public health protections
against BSE," Secretary Thompson said. "Although our current rules are
strong, when it comes to public health and safety we cannot be content with
the status quo. We must continue to make sure the public is protected to the
greatest extent possible."

"This Administration is committed to science-based measures to enhance and
protect public health," Veneman said. "The advance notice of proposed
rulemaking will allow the public the opportunity to provide their input."

"The series of firewalls already in place offer excellent protection against
BSE," said Acting Commissioner of the Food and Drug Administration, Dr.
Lester M. Crawford. "With these additional measures, we will make a strong
system even stronger by putting into effect the most comprehensive,
science-based improvements possible."

snip...end


HHS news releases are available online at www.hhs.gov; FDA news releases can
be found at www.fda.gov, which will also provide links to the documents
discussed in this release.

####


http://www.fda.gov/bbs/topics/news/2004/NEW01084.html

STATEMENT
BY
LESTER M. CRAWFORD, D.V.M., PH.D.
DEPUTY COMMISSIONER OF FOOD AND DRUGS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
BEFORE
THE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY
UNITED STATES SENATE
JANUARY 27, 2004


http://www.fda.gov/ola/2004/bse0127.html

Yesterday, Department Secretary Tommy Thompson and FDA Commissioner Mark
McClellan announced several additional public health measures to further
strengthen the current robust safeguards that help protect Americans from
exposure to the agent that causes BSE and help prevent the spread of BSE in
U.S. cattle. These measures relate to both protections for foods intended
for human consumption as well as additional measures to strengthen FDA’s
1997 final rule regulating animal feed. With respect to human foods, FDA
announced that it will extend to FDA-regulated foods, dietary supplements
and cosmetics, restrictions on using specified risk materials that would
complement the recent USDA announcements. Concerning animal feed, the Agency
announced a series of measures designed to lower even further the risk that
cattle will be purposefully or inadvertently fed “ruminant” proteins,
including, eliminating an exemption in the feed rule that allows mammalian
blood and blood products at slaughter to be fed to ruminants as a protein
source; banning the use of “poultry litter” as a feed ingredient for cattle
and other ruminants; prohibiting the use of “plate waste” as a feed
ingredient for ruminants, including cattle; and taking steps to further
minimize the possibility of cross-contamination of animal feed via
equipment, facilities or production lines.


http://www.fda.gov/ola/2004/bse0127.html


DARLING INT. INC. $$$


http://www.fda.gov/ohrms/dockets/dailys/04/aug04/081704/04n-0264-c00107-vol20.pdf


NATIONAL BY-PRODUCTS, LLC $$$


http://www.fda.gov/OHRMS/DOCKETS/dailys/04/aug04/081104/04n-0264-emc00534.txt


GRIFFIN INDUSRIES INC. $$$

http://www.fsis.usda.gov/OPPDE/Comments/04-021ANPR/04-021ANPR-65.pdf

FDA Week

August 12, 2005

SECTION: Vol. 11 No. 32

LENGTH: 368 words


HEADLINE: FDA BACKS OFF PROMISE TO BAN BLOOD, POULTRY LITTER FROM ANIMAL
FEED

BODY:

FDA is backing off its previous promise to ban animal blood, poultry litter
and plate waste from animal feed to protect against the spread of mad cow
disease.

FDA Commissioner Lester Crawford unveiled the change Monday (Aug. at the
51st International Congress on Meat Science and Technology.

"Earlier last year we had announced other potential changes being
considered, including the prohibition of mammalian blood and blood products
in ruminant feed, the prohibition of poultry litter, and the prohibition of
plate waste," according to the printed version of Crawford's speech. "But we
are now focusing our efforts on specified risk materials."

House Democrats asked Crawford about the feed ban at an Appropriations
Committee late last month, but Crawford danced around the questions. He told
lawmakers FDA was going to issue an interim final rule on the feed ban, but
at the meat industry conference he said the agency is issuing a proposed
rule. Another FDA official also said the agency is issuing a proposed rule,
not an interim final rule.

Crawford told the meat conference attendees that the feed ban proposed rule
could call for prohibiting brains and spinal cords from cattle older than 29
months.

On Jan. 26, 2004, then-HHS Secretary Tommy Thompson said FDA was going to
ban the practice of feeding cattle animal blood, poultry litter and plate
waste. FDA issued a press release the same day providing details about the
interim final rules.

FDA was following the lead of the U.S. Agriculture Department, which had
announced weeks earlier that it was tightening regulations to prevent the
spread of bovine spongiform encephalopathy (BSE), or mad cow disease.

However, a Public Citizen source says the Office of Management and Budget
(OMB) kept FDA from banning blood from animal feed by refusing to give FDA
the emergency designation needed to quickly put the rules into effect (see
FDA Week, July 13). Although the USDA implemented its new regulations within
weeks, FDA waited months before finally issuing an "advanced notice of
proposed rule making" that requested suggestions on how, or if, it should
change the feed ban.

The proposed rule FDA is expected to issue also will have to pass through
OMB.

LOAD-DATE: August 12, 2005

Subject: BSE FDA MAD COW SAFEGUARDS LESTER CRAWFORD SOLD OUT TO THE HIGHEST
BIDDER
Date: October 18, 2006 at 7:44 am PST

Former FDA Commissioner Pleads Guilty to Conflict of Interest and Making
False Financial Disclosures


WASHINGTON, Oct. 17, 2006 - Lester M. Crawford, a former Commissioner of the
Food and Drug Administration (FDA), has pled guilty to a Conflict of
Interest charge and Making False Financial Disclosures to the U.S. Senate
and the Executive Branch, announced U.S. Attorney Jeffrey A. Taylor and
Inspector General Daniel Levinson, U.S. Department of Health and Human
Services.

Crawford entered his guilty plea to the two misdemeanor charges this
afternoon in the U.S. District Court for the District of Columbia before
U.S. Magistrate Judge Deborah Robinson. Crawford is scheduled to be
sentenced on January 22, 2007. He faces a sentence of up to one year in
prison on each charge.


"One of the most important principles of our ethics laws is that public
officials cannot have a financial interest in any decision that they make,”
stated U.S. Attorney Taylor. “Lester Crawford, who held one of the most
important jobs in government, blatantly violated these principles. Today, he
is being held accountable for his actions."

Inspector General Levinson stated, "Any Government official's disregard of
the conflict of interest laws undermines the integrity of the rules of
conduct established for all those in Government. Taxpayers must have
confidence that administrators of Government programs will be objective and
free from improper influences in carrying out their official duties."

Crawford, 68, of Chevy Chase, Maryland, held some of the most senior
positions in the FDA. He served as Deputy Commissioner between February 25,
2002 and March 26, 2004, when he became Acting Commissioner. On February 15,
2005, Crawford was nominated to become Commissioner. On July 18, 2005, the
U.S. Senate confirmed Crawford, who remained Commissioner until September
30, 2005.

As a senior FDA employee, Crawford was required to file regular Public
Financial Disclosure Reports, known as Standard Form SF 278s. Schedule A of
the SF 278 required the filer to list all investment assets having a value
exceeding $1,000 that were held by the filer or the filer's spouse, as well
as sources of income exceeding $200 earned by the filer during the
applicable reporting period.

Each year, ethics officials at the Department of Health and Human Services
reviewed Crawford's SF 278s to ensure that he and his wife were not holding
stocks or stock options of companies that were "significantly regulated
organizations," which federal regulations defined as organizations for which
the sales of products regulated by the FDA constitute ten percent or more of
annual gross sales in the organization's previous fiscal year. Any FDA
employee who was required to file an SF 278 could not hold a "financial
interest," such as stock or stock options, in a significantly regulated
organization.

Crawford's nomination as Commissioner required confirmation by the U.S.
Senate and was considered by the Senate Committee on Health, Education,
Labor, and Pensions. As a nominee, Crawford was required to submit two
financial disclosure documents to the Committee: an SF 278 and a Statement
for Completion by Presidential Nominees. Crawford filed both forms in
February 2005.

Crawford’s plea to Making False Writings is based on his failure to disclose
his and his wife’s ownership of stock in “significantly regulated
organizations” to the Senate Committee and to the Executive Branch.

During the relevant time periods, Crawford and/or his wife owned forbidden
stocks in the following “significantly regulated organizations”: Pepsico,
Sysco, Kimberly-Clark, and Embrex.

Crawford filed a number of disclosure forms and other false writings in
which he did not declare his and his wife’s ownership of forbidden stocks
and stock options. Specifically,

•July 1, 2004. In this SF 278, Crawford disclosed ownership of Sysco and
Kimberly-Clark stock. When an HHS ethics official inquired about Crawford’s
ownership of this stock, Crawford responded in a December 28, 2004 email
that the stocks in "Sysco and Kimberly-Clark have in fact been sold." That
statement was false.

• February 23, 2005. Crawford did not disclose on this SF 278 his income
from a November 17, 2004 exercise of Embrex stock options or the Crawfords'
ownership of Kimberly-Clark or Sysco stock.

• February 25, 2005. Crawford failed to disclose in his nominee Statement to
the Senate Committee his income from the exercise of Embrex stock options in
October 2003 and November 2004. Crawford also did not disclose his remaining
Embrex stock options.

Crawford’s ownership of Sysco and Pepsico stock and his role as Chairman of
the FDA’s Obesity Working Group (“OWG”) gave rise to the Conflict of
Interest charge, to which he has also pled guilty. On February 11, 2004,
Crawford and the OWG's Vice Chairman submitted the OWG's final report and
recommendations, entitled "Calories Count: Report of the Working Group on
Obesity," to then-FDA Commissioner Mark McClellan. The report contained many
recommendations, including encouraging manufacturers to re-label serving
sizes, noting as an example that "a 20 oz bottle of soda that currently
states 110 calories per serving and 2.5 servings per bottle could be labeled
as 275 calories per bottle." The FDA publicly released "Calories Count" on
March 12, 2004.

On June 3, 2004, Crawford testified before the House of Representatives
Committee on Government Reform about the government's role in combating
obesity. In his testimony, Crawford outlined the OWG's recommendations and
again stressed the importance of re-labeling serving sizes for sodas.

During the entire period from the formation of the OWG to the date of
Crawford's congressional testimony, Crawford and his wife owned 1,400 shares
of Pepsico stock, worth a minimum of about $62,000, and 2,500 shares of
Sysco stock, worth a minimum of about $78,000. Pepsico, a leading
manufacturer of soft drinks and snack foods, and its shareholders had a
financial interest in the OWG's conclusions and recommendations. Sysco, a
leading manufacturer of food products, and its shareholders had a financial
interest in the OWG's conclusions and recommendations.

There is no evidence that the OWG's conclusions were altered because of the
Crawfords' ownership of Pepsico or Sysco stock.

Following the announcement of Crawford’s departure from office, Senators
Mike Enzi and Edward Kennedy and Representatives Maurice Hinchey, Marcy
Kaptur, Lynn Woolsey, Raúl Grijalva, and Sam Farr asked that the Inspector
General investigate this matter.

In announcing today’s guilty plea, U.S. Attorney Taylor and Inspector
General Levinson commended Inspector Thomas Sowinski of the Inspector
General’s office for his outstanding investigation of this case. They also
thanked the Senate Legal Counsel’s Office for the help that it provided in
the investigation. Finally, they commended Assistant U.S. Attorneys Howard
Sklamberg and Timothy Lynch, who prosecuted the case, and intern Vi Do, who
assisted in the investigation.

For Information, Contact Public Affairs
Channing Phillips (202) 514-6


http://www.pharmalive.com/News/index.cfm?articleid=382127&categoryid=30

FOR IMMEDIATE RELEASE
P05-58
September 6, 2005
Media Inquiries:
Michael Herndon, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Amends Interim Final Rule "Use of Materials Derived from Cattle in Human
Food and Cosmetics"

The U.S. Food and Drug Administration today published several amendments to
the July 2004 interim final rule, "Use of Materials Derived from Cattle in
Human Food and Cosmetics," that will allow the use of certain cattle-derived
material in human foods and cosmetics.

The rule prohibits the use of cattle-derived materials that can carry the
infectious agent for bovine spongiform encephalopathy (BSE), or mad cow
disease, in human foods, dietary supplements, and in cosmetics. Based on the
scientific information provided during the interim final rule's comment
period, which demonstrates that a part of the cow's digestive tract called
the distal ileum can be consistently and effectively removed from the other
sections of the small intestine, it is no longer necessary to designate the
entire small intestine as a prohibited cattle material.

As a result, FDA is amending the rule to allow use of the small intestine in
human food and cosmetics, provided that the distal ileum has been removed.
The U.S. Department of Agriculture is publishing today a similar amendment
to its interim final rule on BSE.

The amendments also clarify that milk and milk products, hides and
hide-derived products, and tallow derivatives are not prohibited for use in
human food and cosmetics.

Finally, FDA has reconsidered the recommended method for determining
insoluble impurities in a type of solid fat known as tallow, in response to
information submitted to the agency, to cite 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 studies have demonstrated are highly likely to contain the BSE agent in
cattle with the disease. The amended interim final rule provides the same
level of protection against the agent that causes BSE as the original
provisions.

The amendments to the interim final rule are effective on October 7, 2005
and comments are being are accepted on the amendments through November 7,
2005.

####


http://www.fda.gov/bbs/topics/news/2005/NEW01229.html


[Federal Register: October 11, 2006 (Volume 71, Number 196)]
[Rules and Regulations]
[Page 59653-59669]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11oc06-3]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 189 and 700

[Docket No. 2004N-0257]
RIN 0910-AF48


Recordkeeping Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing, Material
From Cattle

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.


http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-16830.htm

WAY back in time ;


U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
November 14, 2000


Letter to Reiterate Certain Public Health and Safety Concerns to Firms
Manufacturing or Importing Dietary Supplements that Contain Specific Bovine
Tissues
To: Manufacturers and Importers of Dietary Supplements and Dietary
Supplement Ingredients:

The Food and Drug Administration (FDA) is taking this opportunity to
reiterate certain public health and safety concerns to firms manufacturing
or importing dietary supplements that contain specific bovine tissues. The
safety concerns about bovine-derived dietary supplement ingredients,
including extracts or substances derived from such tissues, are a result of
the fact that bovine-derived ingredients from cattle born, raised, or
slaughtered in certain countries present a risk of transmitting the
infectious agent that causes bovine spongiform encephalopathy (BSE) to
humans consuming such products. FDA strongly recommends that firms should
consider the public health consequences of this disease in taking whatever
steps are necessary to assure themselves and the public that such
ingredients do not come from cattle born, raised, or slaughtered in
countries where BSE exists.

Background

BSE is a transmissible neurologic disorder of cattle and is prevalent in
certain parts of the world. This neurological disease is one of a number of
transmissible spongiform encephalopathies (TSE) known and is similar to
other TSEs such as scrapie in sheep and Creutzfeldt-Jakob disease (CJD) in
humans. It is believed that the spread of BSE in cattle in some countries,
particularly Great Britain, was caused by the feeding of infected cattle and
sheep tissues to cattle. While transmission of the causative agent of BSE to
humans has not been definitively documented to date, inter-species transfer
has been demonstrated (e.g., mice can be infected by exposure to infected
bovine tissues). BSE has never been diagnosed in cattle in the United
States. However, although steps have been taken to control the spread of BSE
in cattle, new cases of BSE continue to be identified in certain European
countries. This fact illustrates that serious public health risks associated
with the consumption of animal-derived ingredients from animals sourced from
BSE-positive countries remain because such tissues may contain the causative
agent of BSE.

Recommendations

Although there is still no definitive evidence that the consumption of
bovine tissues that contain the transmissible agent for BSE cause CJD in
humans, FDA is concerned that appropriate measures to eliminate the use of
bovine tissues from BSE-countries be instituted by firms that use
bovine-derived ingredients in their products. The list of countries where
BSE is known to exist is maintained by the U.S. Department of Agriculture
(USDA) and codified in Title 9, Code of Federal Regulations, Part 94.18.
Currently, the list of countries in which BSE is know to exist includes
Great Britain, France, The Netherlands, Portugal, Luxembourg, Ireland,
Switzerland, Oman, and Belgium.

We strongly recommend that firms manufacturing or importing dietary
supplements which contain specific bovine tissues (see enclosure), including
extracts or substances derived from such tissues, take all steps necessary
to assure themselves and the public that such ingredients do not come from
cattle born, raised, or slaughtered in countries where BSE exists. FDA
believes that any firm using BSE-derived ingredients should take immediate
and continued actions to minimize the potential risk of human exposure to
the infectious agent that causes BSE in cattle.

We appreciate your attention to and cooperation in this matter. If you need
more information or have questions, please contact the Director, Division of
Compliance and Enforcement (HFS-810), Office of Nutritional Products,
Labeling, and Dietary Supplements, 200 C St., SW, Washington, DC 20204
(telephone 202-205-5229) or your local FDA District Office.


Sincerely,
Christine J. Lewis, Ph.D.
Director
Office of Nutritional Products, Labeling, and Dietary Supplements
Center for Food Safety and Applied Nutrition


----------------------------------------------------------------------------
----
Enclosure
List of Tissues with Suspected Infectivity(1)

Category I (High infectivity)

brain
spinal cord
Category II (Medium infectivity)

ileum
lymph nodes
proximal colon
spleen
tonsil
dura mater
pineal gland
placenta
cerebrospinal fluid
pituitary gland
adrenal gland
Category III (Low infectivity)

distal colon
nasal mucosa
sciatic nerve
bone marrow
liver
lung
pancreas
thymus gland
List taken from Report of a WHO Consultation on Public Health Issues Related
to Animal and Human Spongiform Encephalopathies, World Health Organization,
Office of Interantional Epizootics, Geneva, Switzerland, November 12-14,
1991.

----------------------------------------------------------------------------
----

The absence of a specific tissue, organ, or gland from this list does not
mean that such tissue, organ, or gland cannot contain the infectious agent
responsible for BSE. It only means that there was not adequate information
available at the time to assign the tissue, organ, or gland to a specific
category.

http://www.cfsan.fda.gov/~dms/dspltr05.html

1 FDA concern about the need for vigilance in the documentation and handling
of bovine-derived ingredients from countries with cattle infected with
bovine spongiform encephalopathies (BSE) is a matter of record (See FDA
Action Plan April 24, 2001.
http://www.fda.gov/oc/oca/roundtable/bse/fda_actionplan.html). The group of
human and animal diseases known as transmissible spongiform encephalopathies
(TSEs) is characterized by a sponge-like appearance of the brain and is
associated with deposits in the brain of unique proteins called prions. The
prions can be transmitted from one host to another, not only between members
of a single species, but also from one species to another. In the mid-1980s,
a new TSE, bovine spongiform encephalopathy (BSE), was first described in
cattle in the United Kingdom. Humans are also susceptible to TSEs, one form
of which is Creutzfeldt-Jakob disease (CJD). In 1996, a new variant of CJD
(vCJD) was described in patients in the United Kingdom. Epidemiological data
implicate the consumption of beef products contaminated with the agent of
BSE as the probable cause of vCJD in humans. Unfortunately, there is no
sensitive, specific pre-mortem diagnostic test in either humans or animals.
Diagnosis is confirmed only by post-mortem examination of brain tissue. At
present, animal and human TSEs have no treatments or preventative vaccines.
All are invariably fatal. Routine materials and processes that destroy
traditional human and animal pathogens do not appear to destroy prions, and
no established methods can reliably decontaminate or sterilize articles
contaminated with prions. For all these reasons, FDA recommends that firms
that manufacture or import dietary supplements or dietary ingredients
containing specific bovine tissues, including extracts or substances derived
from such tissues, take all necessary steps to ensure that such ingredients
do not come from cattle born, raised, or slaughtered in countries where BSE
exists. (See letter from FDA to Manufacturers and Importers of Dietary
Supplements and Dietary Supplement Ingredients, November 14, 2000, or visit
http://www.cfsan.fda.gov/~dms/dspltr05.html).

What is a dietary supplement?
Congress defined the term "dietary supplement" in the Dietary Supplement
Health and Education Act (DSHEA) of 1994. A dietary supplement is a product
taken by mouth that contains a "dietary ingredient" intended to supplement
the diet. The "dietary ingredients" in these products may include: vitamins,
minerals, herbs or other botanicals, amino acids, and substances such as
enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can
also be extracts or concentrates, and may be found in many forms such as
tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be
in other forms, such as a bar, but if they are, information on their label
must not represent the product as a conventional food or a sole item of a
meal or diet. Whatever their form may be, DSHEA places dietary supplements
in a special category under the general umbrella of "foods," not drugs, and
requires that every supplement be labeled a dietary supplement.........

see full text ;

http://www.cfsan.fda.gov/~dms/ds-oview.html#what

Questions for the TSE Advisory Committee

October 26, 2001


TOPIC 3

What is the public health risk to consumers that would warrant consideration
of prohibiting the sale of bovine brain and products containing brain for
human use?
Is there a consistent and appreciable difference in infectivity of various
sections/areas of bovine brain? If so, what are the differences in relative
degrees of infectivity of these areas?
Are there other bovine neurological tissues that, if used in consumer
products (such as foods, dietary supplements, cosmetics, and certain
non-application drugs), could also pose a significant health hazard? If so,
what are the differences in relative degrees of infectivity of these
tissues?
What physical, chemical, or biological factors of tissues and/or processes
should FDA consider in reviewing procedures that may have the ability to
reduce infectivity of bovine neurological tissues and products containing
bovine neurological tissues?
What tests are available to ascertain changes in infectivity in products
containing bovine neurological tissues as a result of processing?
What level of reduction in infectivity is necessary to consider products
containing bovine neurological tissues non-infective or "safe" for human
use?


http://www.fda.gov/ohrms/dockets/ac/01/questions/3796q2_14TSEACQuestions%20Final%20101201.htm

PRELIMINARY SUMMARY

TSEAC MEETING

October 25 & 26, 2001

(revised 11/2/01)

TOPIC 1. FDA’s Draft Guidance on Revised Preventive Measures to Reduce the
Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant
Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products (published in
the Federal Register on August 29, 2001

Dr. Dorothy Scott, Medical Reviewer, OBRR, FDA, presented a summary of the
previous committee discussion on donor deferral issues from the June 28 & 29
TSEAC meeting. She then gave an overview of FDA’s draft guidance, focusing
upon the new donor deferrals for risk of vCJD, as recommended by the TSEAC
on June 28, 2001. Dr. Scott briefly reviewed the rationale for not deferring
donors who lived in the U.K. since 1996, which is based upon effective
measures to prevent entry of BSE into the human food chain. She mentioned
the recent finding of BSE in Japan, which is under discussion at FDA. In
addition, she reviewed the rationale for deferring blood, but not Source
plasma donors who have lived in Europe, for vCJD exposure risk. This draft
recommendation is based upon scientific studies, which suggest that plasma
derivative manufacturing removes TSE agents, and upon concerns about the
impact of such a deferral upon availability of products such as IGIV and
Factor VIII. Finally, she reviewed efforts which are being made, within the
guidance, and without, to attenuate the impact of new deferrals on the blood
supply. A more comprehensive review of this issue by the TSEAC is
anticipated in the near future. The draft guidance will be open for public
comment until October 28, 2001.

Next the Committee received a report from Dr. Stephen Nightingale,
(Executive Secretary DHHS Advisory Committee on Blood Safety and
Availability) on DHHS ‘s recent monitoring program for blood supply and
current plans to extend this monitoring program to the supply of plasma
derivatives and their recombinant analogs. He then gave a summary of the
DHHS meeting held on September 24, 2001 to discuss the Department’s BSE/TSE
Action plan (draft summary on web site). The committee then heard
presentations from America’s Blood Centers, American Red Cross, New York
Blood Center and the Department of Defense. As a result of the open public
hearing and these presentations the committee received suggestions for
improving the DHHS monitoring program, and suggestions for FDA’s
consideration on their Draft Guidance. The committee chair stated that it
would be nice to have a uniform set of blood donor deferral criteria, but
that two sets of criteria can exist and that the two sets of criteria may
eventually evolve and the differences may be reduced.

TOPIC 2. Discussion of Amino Acid Sourcing and Production, and the
Theoretical Risk of Transmission of the BSE Agent Through Their Use in
Biopharmaceutical Products

The committee heard presentations from major amino acid manufacturers on
their current and previous sourcing of amino acids and their production
processes.

The committee’s discussion focused on reducing risk of TSE transmission as a
result of the use of amino acids as reagents or excipients in other CBER
regulated compounds. They discussed the possibility of requiring
manufacturers to validate their process if they choose to use bovine derived
material (with the exception of milk and hair). They suggested that although
the risk of TSE transmission was low, that manufactures should avoid using
bovine material and if used, it should be sourced from a BSE-free country.
However, they acknowledged that the designation of BSE free countries was
difficult and constantly changing and in most cases the manufacturers had
already switched from bovine to vegetable sources. They emphasized that due
to the amino acid production processes which included hydrolysis,
purification, chromatography and filtration that the risk of TSE
transmission was very small.

It should be noted that the committee stated that the potential risk posed
by amino acids for production of products already on the market is so
minimal that no effort need be made in constraining use or availability of
these products.

The committee then voted on the following three questions.

Questions

Does the committee think that the current manufacturing process and control
methods utilized by the manufacturers of amino acids can minimize the risk
to allow bovine-derived amino acids from BSE countries to be used as
reagents and excipients for the production of pharmaceutical products?
The committee voted: 1 yes vote, 18 no votes, and 0 abstentions.

The committee then voted on a recommendation formulated by the chair:

That the committee should recommend to FDA not to allow ruminant source
material (with the exception of material such as milk as milk gelatin and
and hair) to be used from BSE countries.

The committee voted: 18 yes votes, 1 no vote (one member changed his vote to
this "no" vote after the initial count, but before the meeting adjourned)
and 0 abstentions.

The committee modified this question to - Does the committee think that in
all circumstances the risk:benefit ratio would still be in favor of a
subject receiving any product where suspect amino acids had been used during
manufacture of that product?
The committee voted: 19 yes votes, 0 no votes, and 1 abstention.

If not, does the committee think that the current manufacturing process and
control methods utilized by the manufacturers of amino acids can minimize
the risk to allow other ruminant-derived amino acids from BSE countries to
be used as reagents and excipients for the production of pharmaceutical
products?
Based on the other answers this question is now a "moot point".

Question 4 in the briefing packet was not discussed.


TOPIC 3: Bovine Brain, Spinal Cord, and Other Neurological Tissue in Foods,
Drugs, and Cosmetics for Human Use

The Committee received an over view and background information from Dr.
Robert Brackett of CFSAN, followed by a presentation on "Opportunities to
Prevent Contamination of Edible Products in a Slaughter Plant with the BSE
Agent" from Dr. William James of the Food Safety Inspection Service, USDA.
Dr. James particularly described procedures in slaughtering (e.g., stunning,
splitting heads and carcasses) and in mechanical recovery of meat from bones
that may, if not performed properly, result in contamination of muscle meat
with CNS tissue. There was discussion also of the wide variety of products
that bovine CNS and recovered meat may be used in, often without labeling to
inform the consumer.

Questions

The committee modified the FDA presented questions to read:

1A. Is there a public health risk to consumers that would warrant
consideration of prohibiting the sale of bovine brain for human use?

The committee stated that the presence of undiagnosed or pre-clinical BSE
should be considered a health risk. Risks can also be due to products coming
from countries that were considered to be BSE free which later detected the
existence of BSE. And the risk to the consumer of un-knowingly purchasing
products that contain brain and CNS tissue should also be considered

The committee voted: 17 yes votes, 1 no votes, and 0 abstentions.

1B. Is there a public health risk to consumers that would warrant
consideration of prohibiting the sale of products containing brain for human
use?

The committee voted: 18 yes votes, 0 no votes, and 0 abstentions

2. Is there a consistent and appreciable difference in infectivity of
various sections/areas of bovine brain? If so, what are the differences in
relative degrees of infectivity of these areas?

There are differences in infectivity in different areas of the brain, but
those differences are not reproducible and therefore should not be used to
rank the relative risk of using various sections of a BSE-infected brain.
The committee requested information on the current state of surveillance and
Dr. Lisa Ferguson gave a short presentation on USDA surveillance program.
The committee stated that the surveillance data are imperfect and that
surveillance should be increased.

The committee voted: 0 yes votes, 17 no votes, and 0 abstentions.

3. Are there other bovine neurological tissues that, if used in consumer
products (such as foods, dietary supplements, cosmetics, and certain
non-application drugs), could also pose a significant health hazard? If so,
what are the differences in relative degrees of infectivity of these
tissues?

The committee voted: 17 yes votes, 0 no votes, and 0 abstentions. The
committee passed on the second part of the question and referenced their
answer to #2.

4. What physical, chemical, or biological factors of tissues and/or
processes should FDA consider in reviewing procedures that may have the
ability to reduce infectivity of bovine neurological tissues and products
containing bovine neurological tissues?

Everything should be considered on a product by product case. One committee
member stated that most processing steps would not affect the infectivity of
prion protein. It was stated that this question is too complicated and needs
a separate meeting, ideally with presentations on different processes which
may be used to process these tissues and manufacture products from them.

5. What tests are available to ascertain changes in infectivity in products
containing bovine neurological tissues as a result of processing?

There are two to three types of assays, bioassays including those in
transgenic mice, cell culture models and in vitro conversion assays also
test for the abnormal PRP protein. Confirmation dependent immunoassay was
mentioned. A member said that the best way to confirm infectivity is through
Western Blot, although it was stated earlier that getting a representative
sample is a problem with Western blotting procedures. There are really no
‘practical’ tests available to measure infectivity. It was stated that, like
question 4, this is a very complex question which may warrant a separate
meeting (perhaps in conjunction with question 4), ideally with presentations
on how these tissues are processed.

6. What level of reduction in infectivity is necessary to consider products
containing bovine neurological tissues non-infective or "safe" for human
use?

There are multiple levels of reduction depending on the origin and the
sourcing of the material. Since we do not know the infective dose for humans
and the infective dose may vary based on individual genetic composition, we
should have a zero tolerance for the infectious unit because any level of
infectivity may be unacceptable.

One committee member stated that bovine brain, spinal cord, distal ileum,
and eye should not be allowed for use in products in the U.S.

http://www.fda.gov/OHRMS/DOCKETS/ac/01/minutes/3796m1.htm

TSS



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