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From: TSS ()
Subject: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47
Date: April 17, 2008 at 2:41 pm PST

[Federal Register: April 17, 2008 (Volume 73, Number 75)]
[Rules and Regulations]
[Page 20785-20794]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17ap08-7]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 189 and 700

[Docket No. 2004N-0081]
RIN 0910-AF47


Use of Materials Derived From Cattle in Human Food and Cosmetics

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule and request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations on the use of materials derived from cattle in human food
and cosmetics. In these regulations, FDA has designated certain
materials from cattle as ``prohibited cattle materials'' and has banned
the use of such materials in human food, including dietary supplements,
and in cosmetics. Prohibited cattle materials include specified risk
materials (SRMs), the small intestine of all cattle unless the distal
ileum is removed, material from nonambulatory disabled cattle, material
from cattle not inspected and passed for human consumption, or
mechanically separated (MS) (Beef). Specified risk materials include
the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral
column (excluding the vertebrae of the tail, the transverse processes
of the thoracic and lumbar vertebrae, and the wings of the sacrum), and
dorsal root ganglia of cattle 30 months of age and older, and the
tonsils and distal ileum of the small intestine of all cattle. FDA is
amending its regulations so that FDA may designate a country as not
subject to certain bovine spongiform encephalopathy (BSE)-related
restrictions applicable to FDA regulated human food and cosmetics. A
country seeking to be so designated must send a written request to the
Director of FDA's Center for Food Safety and Applied Nutrition,
including information about the country's BSE case history, risk
factors, measures to prevent the introduction and transmission of BSE,
and any other relevant information.

DATES: This interim final rule is effective July 16, 2008. Submit
written or electronic comments on this interim final rule by July 16,
2008. Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 by May 19, 2008 (see the ``Paperwork
Reduction Act of 1995'' section of this document).


snip...


Table 1.--Top 10 Countries Exporting Specified North American Industry
Classification System (NAICS) Code Products to United States for 2006
NAICS 311611\1\--Meat Products (Excluding Quantity (thousands of
Poultry) kilograms)\2\
いいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいい
Canada 681,899
------------------------------------------------------------------------
Australia 376,585
------------------------------------------------------------------------
New Zealand 211,873
------------------------------------------------------------------------
Uruguay 103,305
------------------------------------------------------------------------
Brazil 83,897
------------------------------------------------------------------------
Denmark 46,652
------------------------------------------------------------------------
Mexico 35,553
------------------------------------------------------------------------
China 28,530
------------------------------------------------------------------------
Argentina 22,353
------------------------------------------------------------------------
Nicaragua 21,303
いいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいい
NAIC 311613--Animal Fats, Oils, & By- (thousands of
Products kilograms)\3\
いいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいい
Canada 94,306
------------------------------------------------------------------------
New Zealand 32,550
------------------------------------------------------------------------
China 7,809
------------------------------------------------------------------------
Australia 6,807
------------------------------------------------------------------------
Brazil 6,589
------------------------------------------------------------------------
Mexico 2,130
------------------------------------------------------------------------
Colombia 1,826
------------------------------------------------------------------------
Germany 1,642
------------------------------------------------------------------------
Ecuador 1,149
------------------------------------------------------------------------
Japan 1,138
------------------------------------------------------------------------
\1\ The NAIC code 31161 covers the animal slaughtering and processing
industry. The industry is composed of establishments that are
primarily engaged in one or more of the following: (1) Slaughtering
animals, (2) preparing processed meats and meat by-products, and (3)
rendering and refining animal fat, bones, and meat scraps. The
subcategory 311611 comprises those establishments primarily engaged in
slaughtering animals (except poultry and small game). Establishments
that slaughter and prepare meats are included in this classification.
(Ref. 5) We use this data as an indicator of the countries that are
most likely to petition FDA regarding their BSE status.
\2\ These figures do not include exports measured in ``clean yield
kilograms'' and ``pieces.''
\3\ These figures do not include exports measured in ``grams,''
``liters,'' ``metric tons,'' and ``pieces.''

We do not know how many countries might petition the FDA. However,
taking into consideration the previous information on countries
officially recognized as having a negligible BSE risk or being
provisionally free of BSE under OIE, as well as the information in
table 1 on countries that export large amounts of meat products and
animal fats, oils, and byproducts to the United States, we are
estimating for this analysis that 10 countries may be interested in
petitioning FDA to be excepted from certain BSE-related restrictions
applicable to human food and cosmetics. Our estimate is not intended to
suggest that all of these countries would be able to qualify for a
designation under Sec. Sec. 189.5(e) and 700.27(e).
3. Costs and Benefits of Exemption Provision


snip...$$$


http://edocket.access.gpo.gov/2008/08-1142.htm

http://edocket.access.gpo.gov/2008/pdf/08-1142.pdf


GWs BSE MRR policy, the legal trading of all strains of TSE globally $$$

February 18, 2004

Preeminent Scientists Protest Bush Administration's Misuse of Science
Nobel Laureates, National Medal of Science Recipients, and Other Leading Researchers Call for End to Scientific Abuses


Call (2MB mp3)
Washington, D.C.Today, more than 60 leading scientistsincluding Nobel laureates, leading medical experts, former federal agency directors and university chairs and presidentsissued a statement calling for regulatory and legislative action to restore scientific integrity to federal policymaking. According to the scientists, the Bush administration has, among other abuses, suppressed and distorted scientific analysis from federal agencies, and taken actions that have undermined the quality of scientific advisory panels.
Across a broad range of issues, the administration has undermined the quality of the scientific advisory system and the morale of the governments outstanding scientific personnel, said Dr. Kurt Gottfried, emeritus professor of physics at Cornell University and Chairman of the Union of Concerned Scientists. Whether the issue is lead paint, clean air or climate change, this behavior has serious consequences for all Americans.

Science, to quote President Bush's father, the former president, relies on freedom of inquiry and objectivity, said Russell Train, head of the Environmental Protection Agency under Nixon and Ford, who joined the scientists in calling for action. But this administration has obstructed that freedom and distorted that objectivity in ways that were unheard of in any previous administration.

The statement notes that while scientific input to the government is rarely the only factor in public policy decisions, this input should be weighed from an objective and impartial perspective. However, the administration of George W. Bush has disregarded this principle.

The Earth system follows laws which scientists strive to understand, said Dr. F. Sherwood Rowland a Nobel laureate in chemistry. The public deserves rational decisionmaking based on the best scientific advice about what is likely to happen, not what political entities might wish to happen.

We are not simply raising warning flags about an academic subject of interest only to scientists and doctors, said Dr. Neal Lane, a former director of the National Science Foundation and a former Presidential Science Advisor. In case after case, scientific input to policymaking is being censored and distorted. This will have serious consequences for public health.

In conjunction with the statement, the Union of Concerned Scientists today released a report Scientific Integrity in Policymaking that investigates numerous allegations in the scientists statement involving censorship and political interference with independent scientific inquiry at the Environmental Protection Agency, the Food and Drug Administration, and the Departments of Health and Human Services, Agriculture, Interior and Defense.

One example cited in the statement and report involves the suppression of an EPA study that found the bipartisan Senate Clear Air bill would do more to reduce mercury contamination in fish and prevent more deaths than the administration's proposed Clear Skies Act. This is akin to the White House directing the National Weather Service to alter a hurricane forecast because they want everyone to think we have clear skies ahead, said Kevin Knobloch, president of the Union of Concerned Scientists The hurricane is still coming, but without factual information no one will be ready for it.

Comparing President Bush with his father, George H.W. Bush and former president Richard M. Nixon, the statement warned that had these former presidents similarly dismissed science in favor of political ends, over 200,000 deaths and millions of respiratory and cardiovascular disease cases would not have been prevented with the signing of the original Clean Air Act and the 1990 amendments to that Act.

The statement demands that the Bush administrations distortion of scientific knowledge for partisan political ends must cease and calls for Congressional oversight hearings, guaranteed public access to government scientific studies and other measures to prevent such abuses in the future. The statement further calls on the scientific, engineering and medical communities to work together to reestablish scientific integrity in the policymaking process.

# # #
Among the statement signers are:

Philip W. Anderson*
David Baltimore*
Paul Berg*
Lewis Branscomb
Thomas Eisner*
Jerome Friedman
Richard Garwin*
Walter Kohn*
Neal Lane
Leon Lederman*
Mario Molina
W.H.K. Panofsky*
F. Sherwood Rowland
J. Robert Schrieffer*
Richard Smalley
Harold E. Varmus
Steven Weinberg*
E.O Wilson*

* National Medal of Science
Nobel laureate


http://www.ucsusa.org/news/press_release/preeminent-scientists-protest-bush-administrations-misuse-of-science.html


-------- Original Message --------
Subject: Docket No. 2004N-0081 and or RIN number RIN-0910-AF47 Use of
Materials Derived From Cattle in Human Food and Cosmetics [comment
submission]
Date: Tue, 13 Jul 2004 16:08:38 -0500
From: "Terry S. Singeltary Sr."
To: fdadockets@oc.fda.gov
CC: burt.pritchett@fda.gov, Agriculture@mail.house.gov


COMMENT SUBMISSION
[Docket No. 2004N-O081]
RIN-0910--AF47
Use of Materials Derived From Cattle in Human Food and Cosmetics
http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0081-nir0001.pdf

Greetings FDA,

I would kindly like to comment on the potential for TSE transmission from
cosmetics to humans and why I think that ALL animal by-products should be
excluded from cosmetics. IF we look at the TSE 'KURU'. Kuru is a
transmissible spongiform encephalopathy that was identified in Papua New
Guinea in the late 1950s. Several thousand cases of the disease occurred
during a period of several decades. Epidemiologic investigations
implicated ritual endocannibalistic funeral feasts as the likely route
through which the infectious agent was spread. The incubation period in
females was estimated to be shorter than that in males. The shortest
incubation periods were estimated in adult women, who may have been
exposed to the largest doses of infectious material.
MY question is, was the woman exposed to larger doses, are was it the
route of the
agent that may have been the factor of shorter incubation in woman, or both?

What is Kuru?
Kuru is a rare and fatal brain disorder that occurred at epidemic levels
during the 1950s-60s among the Fore people in the highlands of New
Guinea. The disease was the result of the practice of ritualistic
cannibalism among the Fore, in which relatives prepared and consumed the
tissues (including brain) of deceased family members. Brain tissue from
individuals with kuru was highly infectious, and the disease was
transmitted either through eating or by contact with open sores or
wounds. Government discouragement of the practice of cannibalism led to
a continuing decline in the disease, which has now mostly disappeared.

snip...

PLEASE NOTE the later ''or by contact with open sores or wounds.''

> and the disease was transmitted either through eating or by contact
> with open sores or wounds.


http://www.ninds.nih.gov/health_and_medical/disorders/kuru.htm

> the Fore women would scoop the brains of their dead relatives out of
> their skulls by hand before cooking. They then wiped the residual
> liquid and cadaver tissue over their paint-daubed bodies, leaving it
> caked in their hair and on their bodies for weeks after a mortuary feast.


Jennifer Cooke: kuru deaths continue in 1999

Sydney Morning Herald, Saturday, August 28, 1999


TSE INFECTION does takes place when the skin surface has been broken by
scarification (Taylor et al, 1996).

The transmission of KURU into animals supported the belief that the disease
had
been transmitted through ceremonial cannibalistic rituals in New Guinea with
a
possible route of spread involving handling fresh tissue and inoculation
through
mucous membranes and wounds including skin abrasions (Gajdusek, 1977)

Masters, C.J., Gajdusek, D.C. and Gibbs, C.J., (1980). The spongiform
encephalopathies: the natural history of CJD and its relationship to
kuru and scrapie.


* Gajdusek D.C. (1996). Kuru: From the New Guinea field journals
1957-1962. Grand Street, 15:6-33


* Gajdusek D.C. (1973). Kuru in the New Guinea Highlands. In
Spillane JD (ed): Tropical Neurology. New York, Oxford University
Press.


* Gajdusek D.C., Gibbs C.J., and M. Alpers (1966). Experimental
transmission of a kuru-like syndrome to chimpanzees. Nature, 209:794.


* Lindenbaum S. (1979). Kuru Sorcery. Mountain View, Ca, Mayfield
Publishing Company.


SCCNFP/0724/03, final
THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS
INTENDED FOR CONSUMERS
OPINION
CONCERNING
USE OF SPECIFIED RISK MATERIAL IN COSMETICS
CLARIFICATION FOR TALLOW DERIVATIVES
adopted by the SCCNFP on 30 July 2003
by means of the written procedure
SCCNFP/0724/03, final
Opinion on the Use of specified risk material in cosmetics -
Clarification for tallow derivatives
____________________________________________________________________________
_________________
2
1. Background

snip...

http://europa.eu.int/comm/health/ph_risk/committees/sccp/documents/out229_en.pdf

> 4. For GBR-C III and IV countries, tallow derivatives are safe if, in
> addition to the above
> (3), the specific risk materials have been removed and are not used
> for the production of
> tallow/tallow derivatives.


PLEASE NOTE, under the old BSE GBR, the USA would be re-classified as at
least a GBR III
risk assessment, if not a GBR IV in my opinion due to the misgivings from
USDA/APHIS et al,
some documented below in my references from Docket No, 04-047-l Regulatory
Identification
No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission).

Report on the
Assessment of the Geographical BSE - Risk of USA (July 2000) (220kb)

http://europa.eu.int/comm/food/fs/sc/ssc/out137_en.pdf

snip...end


-------- Original Message --------
Subject: Docket No, 04-047-l Regulatory Identification No. (RIN)
091O-AF46 NEW BSE SAFEGUARDS (comment submission)
Date: Sun, 11 Jul 2004 21:34:22 -0500
From: "Terry S. Singeltary Sr."
To: fdadockets@oc.fda.gov
CC: regulations@aphis.usda.gov, burt.pritchett@fda.gov


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

snip...

From: TSS ()
Subject: Re: Docket No. 2004N-0081 Use of Materials Derived From Cattle in
Human Food and Cosmetics [TSS SUBMISSION]
Date: September 7, 2005 at 7:35 pm PST

In Reply to: Docket No. 2004N-0081 Use of Materials Derived From Cattle in
Human Food and Cosmetics posted by TSS on September 7, 2005 at 7:07 am:


----- 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.


STATEMENT ON INFECTIVITY IN BOVINE TONSIL

Background

1. The views of the Committee were sought on unpublished results from an

ongoing long-term study of the pathogenesis of BSE in cattle. This study is

being carried out by the Veterinary Laboratory Agency and is funded by the

Food Standards Agency (FSA).

2. In this study, cattle were orally dosed with 100g of BSE-infected bovine

brain material. At various times after oral dosing, cattle were killed and

different tissues tested for infectivity. In the first instance, the
presence of

infectivity was assessed by injection of various tissues into inbred mice

("mouse bioassay "). In this research infectivity was detected in:

distal ileum (the earliest infectivity was detected at 6 months after

inoculation.)

brain and spinal cord and closely associated nervous tissue

(infectivity was detected in the months just prior to the clinical onset

of BSE in cattle)

at a single time point (around the time of clinical onset) bone marrow

was also found to contain infectivity. ...snip


http://www.seac.gov.uk/statements/tonsil211002.pdf


UPDATE OF THE OPINION ON

TSE INFECTIVITY DISTRIBUTION IN RUMINANT TISSUES

INITIALLY ADOPTED BY

THE SCIENTIFIC STEERING COMMITTEE

AT ITS MEETING OF 10-11 JANUARY 2002

AND AMENDED AT ITS MEETING OF 7-8 NOVEMBER 2002

following the submission of (1) a risk assessment by the German Federal
Ministry of

Consumer Protection, food and Agriculture and (2) new scientific evidence

regarding BSE infectivity distribution in tonsils


http://europa.eu.int/comm/food/fs/sc/ssc/out296_en.pdf


3. New work, work still in progress and future work

The infectivity of neural and non-neural tissues by intracerebral
inoculation of cattle is being

assayed in projects M03006 and M03007. These studies are important since it
is possible

that some tissues may not yet have been found to be infective, due to the
fact that

infectivity in these tissues is below the detection limits of the tests
applied so far. To date,

this study has shown infectivity in CNS tissues, the distal ileum, tonsil
tissue and the

nictitating membrane (the nictitating membrane is also known as the third
eyelid). Other

challenged and control cattle continue to be closely monitored for clinical
signs of BSE.

Research is ongoing to determine the susceptibility of other food animal
species to TSEs.

These include a project to determine the susceptibility of pigs to scrapie
through oral

exposure (M03005) and a project to further study the transmission of BSE to
pigs (M03010).

Project M03024 aims to determine whether UK red deer are susceptible to BSE
by oral

exposure. These studies are important since it is highly probable that pigs
and deer were

historically exposed to ruminant derived meat and bone meal (MBM). ...


http://www.food.gov.uk/multimedia/pdfs/annualresearchrpt04.pdf


TSEs And The Environment

The LANCET
Volume 351, Number 9110 18 April 1998

BSE: the final resting place

snip...


The first matter to consider is the distribution of infectivity in the
bodies of infected animals. The brain (and more generally, the central
nervous system) is the primary target in all transmissible spongiform
encephalopathies (TSE), and it contains by far the highest concentration
of the infectious agent. In naturally occuring disease, infectivity may
reach levels of up to about one million lethal doses per gram of brain
tissue, whether the disease be kuru, CJD, scrapie, or BSE. The
infectious agent in BSE-infected cattle has so far been found only in
brain, spinal cord, cervical and thoracic dorsal root ganglia,
trigeminal ganglia, distal ileum, and bone marrow.4 However, the much
more widespread distribution of low levels of infectivity in human
beings with kuru or CJD, and in sheep and goats with scrapie, suggests
that caution is advisable in prematurely dismissing as harmless other
tissues of BSE-infected cattle.


snip...end...TSS


snip...


BY reducing or weakening the SRM list due to the Economic Impact of BSE on
the U.S. Beef Industry and while doing so, ignoring all 'sound science',
again the FDA/USDA et al are willing to put every human and animal out there
at risk to further exposure to this TSE agent, all for a buck. this is not
'sound science' this is what i call 'corporate science', and it is and will
continue to expose people. some of these people will die from this agent
either directly or indirectly via a multitude of scientific proven routes
and sources. WE must remove all political and corporate science from TSE
research.


I find it disturbing that products that carry SRMs are still on the market
for humans such as nutritional supplements ;


ODD, I just picked up a catalog from STANDARD PROCESS INC. 2003 - 2004
Product Catalog
(a chiropractor had just left this catalog in my wife's foot doctors office
4/5/05)
and it's full of THOSE SRMS FOR HUMANS. I wonder how much is still left on
the market,
and how much is still in production, how much crosses the borders? 5 pages
of products
full of SRMs for humans. THIS is a really fine catalog, i am just now going
over.
LOADED with SRMs for humans. NO wonder my neighbors mom died from CJD while
taking
these damn mad cow pills. THEY even have a candy bars loaded with SRMs. HERE
is one ;

NATURAL COCOA STANDARDBAR (mad cow candy bar)
(i will just list animal organs)

bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

NATURAL PEANUT BUTTER STANDARDBAR

bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

USF (MAD COW) OINTMENT (RUB A DUB DUB, KURU ETC) ;

bovine orhic glandular extract

UTROPHIN PMG

bovine uterus PMG

VASCULIN

bovine heart PMG extract, veal bone PMG extract, bovine liever, porcine
duodenum,
bovine adrenal Cytosol extract, bovine spleen, ovine spleen (some yummy
stuff)

IPLEX (neighbors mom died from CJD while taking these pills for years)

bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach, bovine
adrenal,
bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN, bovine bone,
veal bone
meal

MYO-PLUS

bovine heart PMG, bovine liver, porcine stomach, bovine orchic extract,
bovine
spleen, ovine spleen, bovine adrenal Cytosol extract, BOVINE BRAIN

NEUROPLEX

bovine orchic Cytosol extract, bovine spleen, BOVINE BRAIN PMG EXTRACT,
BOVINE ANTERIOR PITUITARY, bovine liver, BOVINE PITUITARY PMG EXTRACT,
AND MORE BOVINE BRAIN... HOLY MAD COW IN A PILL !!!

NEUROTROPHIN PMG

BOVINE BRAIN PMG

NIACINAMIDE B6 VM

bovine liver, porcine stomach, bovine spleen ovine spleen,
BOVINE BRAIN

OCULOTROPHIN PMG
BOVINE EYE PMG

ORCHEX

bovine liver, bovine orchic Cytosol extract, porcine stomch,
bovine spleen, ovine spleen, BOVINE BRAIN

OSTARPLEX

veal bone PMG extract, veal bone PMG extract, bovine liver,
porcine stomach, bovine adrenal, bovine spleen, ovine spleen,
BOVINE BRAIN

PARAPLEX

bovine pancreas PMG extract, porcine duodenum, bovine adrenal PMG,
BOVINE PITUITARY PMG EXTRACT, bovine thyroid PMG extract

PITUITROPHIN PMG

RUMAPLEX

BOVINE BRAIN, veal bone PMG extract, bovine adrenal, bovine prostate
Cytosol extract, veal bone meal, bovine liver PMG extract, bovine spleen,
ovine spleen, bovine liver

SENAPLEX

bovine liver PMG extract, bovine adrenal, BOVNE BRAIN, veal bone meal,
bovine
kidney, bovine orchic extract, bovine spleen, ovine spleen ..........

THESE are just a few of MANY of just this ONE COMPANY.

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7


253 1 DR. BOLTON:

I have an additional question about 2 that. What is the assurance that
additional locally sourced 3 tracheas are not added into that manufacturing
process, thus 4 boosting the yield, if you will, but being returned to the 5
U.S. as being produced from U.S.-sourced raw material? 6 DR. McCURDY: Are
there data to indicate how many 7 grams, or whatever, of infected brain are
likely to infect 8 an organism, either animal or man, when taken orally? 9
DR. BROWN: If I am not mistaken, and I can be 10 corrected, I think a half a
gram is enough in a cow, orally; 11 in other words, one good
dietary-supplement pill. 12 DR. McCURDY: What I am driving at is the
question 13 we are asked is really not do we wish to regulate these 14
things coming in. I think the statements about difficulties 15 in regulating
things in the future or near future for new 16 regulations were probably
accurate. 17 But I think that we could exhibit some quite 18 reasonable
concern about blood donors who are taking dietary 19 supplements that
contain a certain amount of unspecified- 20 origin brain, brain-related,
brain and pituitary material. 21 If they have done this for more than a
sniff or something 22 like that, then, perhaps, they should be deferred as
blood 23 donors. 24 That is probably worse than spending six months in 25
the U.K. 254 1 DR. BROWN: That is exactly right. I think that 2 is why the
discussion has apparently been on things that are 3 not directly related to
these questions because, in order to 4 think about deferrals for blood
donors who are taking 5 dietary supplements with things like bovine brain in
them, 6 it is very important that we know that those products are 7 safe. 8
I think we have heard enough to suggest that they 9 may not be. 10 DR.
McCURDY: There is one other item that needs 11 to be considered and that is
what proportion of blood donors 12 are doing this; that is, how many blood
donors would you 13 lose, and I don't know what the demographics--there is
14 fairly good information on the demography of blood donors. 15 I have no
idea what the demography of people who take these 16 supplements is. Maybe
they are old men like me and aren't 17 going to be blood donors anymore. 18
DR. BROWN: The wording of the question is not as 19 demanding as the wording
of other deferral questions; that 20 is, the question here is consider
recommending. We are 21 not even recommending at this point. We are saying
to the 22 FDA, please think about this. It is worth thinking about. 23 DR.
DETWILER: One point about brain from Europe, 24 and Jean Philippe is still
here, those are considered 25 specified risk material and it is not correct
to be 255 1 incinerated; correct? Or destroyed? Brain and spinal cord 2 and
other high-risk tissues in Europe? 3 DR. NORTON: In tomorrow morning's
British Medical 4 Journal, which has appeared on-line today, there is an 5
article called U.S. Takes Precautions against BSE. One 6 paragraph says,
Even though the U.S. and U.K. governments 7 ban the practice of feeding
cattle products to cows, in the 8 early 1990s, some U.K. renderers continued
to manufacture 9 and ship contaminated meat and bonemeal around the world.
10 British export statistics show that thirty-seven tons of 11 meal made
from offal was sent to the United States in 1997, 12 well after the U.S.
government banned imports of such risky 13 meat. The ultimate use of these
imports has not been 14 identified. 15 That will appear tomorrow morning. 16
DR. DETWILER: That actually was in The New York 17 Times. That is a direct
quote out of The New York Times 18 article. We called the reporter on that.
That statement, 19 the thirty-seven tons, was taken out of the U.S. 20
Geographical BSE Risk Assessment. What they didn't put in 21 there, in the
statement, was the remainder of the GBR is at 22 that time, the big labeling
for that category in the U.K., 23 because it was illegal for them to ship it
to us from their 24 own regs. It is illegal for us to get that. 25 We did go
and try and trace that so that wasn't [FULL TEXT ABOUT 600 PAGES] 3681t2.rtf
http://www.fda.gov/ohrms/dockets/ac/cber01.htm

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm


IN fact, we are now finding that as little as 1 mg (or 0.001 gm) caused 7%
(1 of 14) of the cows to come down with BSE ;


Published online

January 27, 2005

Risk of oral infection with bovine spongiform

encephalopathy agent in primates

Corinne Ida Lasmzas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frdric Auvr, Evelyne Correia,

Nathalie Lescoutra-Etchegaray, Nicole Sals, Gerald Wells, Paul Brown,
Jean-Philippe Deslys

The uncertain extent of human exposure to bovine spongiform encephalopathy
(BSE)which can lead to variant

Creutzfeldt-Jakob disease (vCJD)is compounded by incomplete knowledge about
the ef.ciency of oral infection

and the magnitude of any bovine-to-human biological barrier to transmission.
We therefore investigated oral

transmission of BSE to non-human primates. We gave two macaques a 5 g oral
dose of brain homogenate from a

BSE-infected cow. One macaque developed vCJD-like neurological disease 60
months after exposure, whereas the

other remained free of disease at 76 months. On the basis of these .ndings
and data from other studies, we made a

preliminary estimate of the food exposure risk for man, which provides
additional assurance that existing public

health measures can prevent transmission of BSE to man.


snip...


BSE bovine brain inoculum

100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 01 mg 001 mg

Primate (oral route)* 1/2 (50%)

Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)

RIII mice (icip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)

PrPres biochemical detection   

The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was

inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the .rst positive animal (%). The accuracy of

bioassays is generally judged to be about plus or minus 1 log.
icip=intracerebral and intraperitoneal.

Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula


snip...end


www.thelancet.com Published online January 27, 2005


THEN you must consider cross contamination at feed mills and such. this has
been well proven in both the UK and the USA to date via r-to-r feed ban
violations. IT was proven in the UK that they indeed put profits before
human health;

[PDF] The BSE Inquiry / Statement No. 14 Issued 20 March 1998 THE ...


The BSE Inquiry / Statement No. 14. Issued 20 March 1998 ... number of feed
compounders and it became clear that cross contamination of feeds could
occur. ...

http://www.bseinquiry.gov.uk/files/ws/s014.pdf

[PDF] The BSE Inquiry / Statement No 76F (Supplementary) Mr Alan ...


But the mainbut the main problem was probably cross-contamination. ...

http://www.bseinquiry.gov.uk/files/ws/s076f.pdf


STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995

snip...

To minimise the risk of farmers' claims for compensation from feed
compounders.

To minimise the potential damage to compound feed markets through adverse
publicity.

To maximise freedom of action for feed compounders, notably by
maintaining the availability of meat and bone meal as a raw
material in animal feeds, and ensuring time is available to make any
changes which may be required.

snip...

THE FUTURE

4..........

MAFF remains under pressure in Brussels and is not skilled at
handling potentially explosive issues.

5. Tests _may_ show that ruminant feeds have been sold which
contain illegal traces of ruminant protein. More likely, a few positive
test results will turn up but proof that a particular feed mill knowingly
supplied it to a particular farm will be difficult if not impossible.

6. The threat remains real and it will be some years before feed
compounders are free of it. The longer we can avoid any direct
linkage between feed milling _practices_ and actual BSE cases,
the more likely it is that serious damage can be avoided. ...

SEE full text ;

http://www.bseinquiry.gov.uk/files/yb/1995/08/24002001.pdf


snip...


From: TSS ()
Subject: Inspector to file charges against USDA for them charging him with
misconduct on telling the truth about SRM mad cow violations
Date: September 7, 2005 at 1:37 pm PST

Consumer Health


Inspector to file charges against USDA
By Steve Mitchell Sep 6, 2005, 22:46 GMT


WASHINGTON, DC, United States (UPI) -- The federal meat inspector who was
charged with misconduct by the U.S. Department of Agriculture after he
claimed mad cow disease safeguards were being violated at slaughterhouses
told United Press International he plans to file charges against the agency.

Stan Painter, a USDA inspector and chair of the National Joint Council of
Food Inspection Locals, the inspectors union, notified the agency`s
management in a letter last December he was aware of instances where the
riskiest parts of older cows were not being marked or removed from
processing.

Painter worried these risky parts -- known as specified risk materials, or
SRMs -- could enter the food supply and infect people, causing a fatal brain
illness called variant Creutzfeldt Jakob disease.

Two cases of mad cow have been detected in U.S. herds, and some suspect
there are more. The USDA put the SRM safeguards in place in 2004 to protect
the public from mad cow disease -- also known as bovine spongiform
encephalopathy or BSE -- if more cases are detected.

The USDA did not respond to Painter`s concerns until he made his letter
known to news outlets.

On Dec. 28, 2004, the agency charged Painter with personal misconduct for
not revealing the names of the inspectors who told him of the SRM
violations. Officials also told him he was under a formal investigation,
which was dropped last month after the release of internal documents
revealing more than 1,000 violations of the USDA`s SRM regulations.

Painter said he thinks the USDA was attempting 'to harass and intimidate him
(and) to have a chilling effect' on other inspectors.

'I plan to file charges against the agency,' he told UPI, adding he has not
yet decided if he will go through the legal system, through internal USDA
procedures or another avenue.

Asked about Painter`s intent to bring charges, agency spokesman Steven Cohen
told UPI the documents -- called noncompliance reports, or NRs --
demonstrate 'that BSE safeguard regulations are being enforced and
prohibited materials did not reach the public.'

Mad cow disease remains a sensitive topic for the USDA because it can have
significant economic ramifications. The U.S. beef industry lost billions of
dollars because more than 60 nations closed their borders in 2003 to
American beef after the report of the first detected case in U.S. herds.
Japan, formerly the largest importer of American beef, still has not
reopened its borders.

For months, USDA officials denied Painter`s allegations in media reports,
saying they had investigated and found no evidence to substantiate his
claims. The NRs released last month under the Freedom of Information Act,
however, showed 1,036 violations of SRM regulations in at least 35 states,
Puerto Rico and the Virgin Islands, with some plants being cited repeatedly
for infractions. The USDA delayed releasing the documents for eight months
despite a federal law mandating a response within 30 days.

Patty Lovera, of the watchdog group Public Citizen, which requested the USDA
documents, said some of the violations cited in the NRs are egregious. In
one, an employee at a plant in Michigan was not properly marking older cows
to have their SRMs removed because he did not have a pencil. In another, an
employee in a Missouri plant was loading cow heads onto his pickup truck to
take home to feed to his dog.

Lovera charged the USDA with attempting to silence Painter and failing to
address problems with the SRM ban.

'Their behavior through this whole thing is appalling,' she told UPI. 'Stan
brought them concerns about a policy and instead of investigating the
policy, they investigated him.'

Last December, after Painter made his letter known publicly, the USDA sent
an officer to Painter`s house while he was on leave to question him about
the allegations in his letter. Later, USDA officials interrogated Painter
twice, asking him for the names of the inspectors who told him about the
violations.

Painter said he intentionally was kept ignorant of the inspectors` names
because he feared the agency would retaliate against them. Painter also said
USDA officials did not need the inspectors` names because they could
determine where the infractions were occurring by looking at their database
of NRs.

Sometime around June the U.S. Embassy in Japan posted a notice on its Web
site stating USDA officials had found no evidence to substantiate Painter`s
claims and had requested a criminal investigation into his actions. The
notice was removed in July after UPI reported its existence.

Although Cohen acknowledged more than 1,000 NRs were written by USDA
inspectors, he minimized their significance, saying they 'amount to less
than one-half of one percent of the total written for all reasons by (USDA)
inspection program personnel.'

Lovera said any infraction of mad cow safeguards should be of concern,
because this disease always is fatal in humans and cooking does not destroy
the pathogen.

'You have very little margin of error for something you don`t want to get
because you can`t cook it away and you can`t disinfect it,' she said.

Painter said his concern now is what the agency will do to fix what he sees
as shortcomings in the SRM policy.

'It`s a failed policy,' he said. 'It doesn`t protect the consumer.'

Cohen did not respond to whether the USDA planned to change the SRM
regulations.

The USDA`s Office of Inspector General has launched an investigation to
determine whether the regulations are being implemented effectively, and
results are due out soon.

E-mail: sciencemail@upi.com

Copyright 2005 by United Press International


http://washingtontimes.com/upi/20050906-050340-6793r.htm


***makes no difference, GW will change the SRM rules like he has the BSE GBR
risk assessment to the terribly flawed BSE MRR policy, the legal trading of
all strains of TSE, the 'gold card'. ...TSS


IN a time when FDA/USDA et al should be strengthening the TSE regulations,
it seems corporate interest has won out again over sound science and
consumer protection from an agent that is 100% fatal for the ones that go
clinical. With the many different atypical TSEs showing up in different
parts of the world, and with GWs BSE MRR policy (the legal policy of trading
all strains of TSEs), the battle that has waged for the last 25 years to
eradicate this agent from this planet will be set back decades, if not lost
for good. ...TSS


snip...

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm

http://www.fas.usda.gov/info/fr/2004/071404BSEFDA1.htm

http://www.fda.gov/ohrms/DOCKETS/dockets/04n0081/04n-0081-ref0001-Tab-A-vol6.pdf


APHIS-2006-0041-0006 TSE advisory committee for the meeting December 15,
2006


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8


Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)

http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf


[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle

9/13/2005

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES
[Docket No. APHIS-2006-0041] RIN 0579-AC01

[Federal Register: January 9, 2007 (Volume 72, Number 5)]
[Proposed Rules]
[Page 1101-1129]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja07-21]

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f8152

BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS
DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01
Date: January 9, 2007 at 9:08 am PST


http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f3412


Sunday, March 16, 2008

MAD COW DISEASE terminology UK c-BSE (typical), atypical BSE H or L, and or
Italian L-BASE

http://bse-atypical.blogspot.com/2008/03/mad-cow-disease-terminology-uk-c-bse.html


SCHOOL LUNCH PROGRAM FROM DOWNER CATTLE UPDATE

http://downercattle.blogspot.com/


SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS

http://cjdmadcowbaseoct2007.blogspot.com/2008/04/srm-mad-cow-recall-406-thousand-pounds.html


SPECIFIED RISK MATERIALS

http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html


*Acquired in UK
** Acquired in Saudi Arabia
*** Includes 17 inconclusive and 9 pending (1 from 2006, 8 from 2007.
**** Includes 17 non-vCJD type unknown (2 from 1996, 2 from 1997, 1
from 2001, 1 from 2003, 4 from 2004, 3 from 2005, 4 from 2006) and 36
type pending (2 from 2005, 8 from 2006, 26 from 2007).

Notes:

-- Cases are listed based on the year of death when available. If the
year of death is not available, the year of sample receipt is used.

-- Referrals: Cases with possible or probable prion disease from
which brain tissue or blood in the case of familial disease were submitted.

-- Inconclusive: Cases in which the samples were not sufficient to
make a diagnosis.

-- Non-vCJD type unknown are cases in which the tissue submitted was
adequate to establish the presence but not the type; in all cases,
vCJD could be excluded.

--
Communicated by:
Terry S. Singeltary Sr.

[In submitting these data, Terry S. Singeltary Sr. draws attention to
the steady increase in the "type unknown" category, which, according
to their definition, comprises cases in which vCJD could be excluded.
The total of 26 cases for the current year (2007) is disturbing,
possibly symptomatic of the circulation of novel agents.
Characterization of these agents should be given a high priority. - Mod.CP]


http://www.promedmail.org/pls/askus/f?p=2400:1001:6833194127530602005::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1010,39963

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

ALL animals for human/animal consumption must be tested for TSE.

ALL human TSEs must be made reportable Nationally and Internationally,
OF ALL AGES. ...TSS


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518





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