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From: TSS (216-119-143-91.ipset23.wt.net)
Subject: Re: Neuroinvasion by Scrapie following Inoculation via the Skin Is Independent of Migratory Langerhans Cells
Date: January 18, 2005 at 2:23 pm PST

In Reply to: Re: Neuroinvasion by Scrapie following Inoculation via the Skin Is Independent of Migratory Langerhans Cells posted by TSS on January 13, 2005 at 2:11 pm:

2004N-0257: Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed with, or Otherwise Containing Material from Cattle
------------------------------------------------------------------------


Document #
Received Date
Filed Date
Submitter Code
Submitter
FR Date
FR Page
Comment Date
Files
Remarks

BKG1 07/09/2004 07/09/2004 Federal Government
Background Material
Refs 1-8
Signature: Background Material Refs 1-8

NPR1 07/09/2004 FDA FDA 07/14/2004 42275-42285 08/13/2004 pdf http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0257-npr0001.pdf
Signature: LESTER M. CRAWFORD

EMC1 07/09/2004 07/09/2004 Health Professional T. Thomas,PE,PhD txt http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000001.txt

Signature: Theodore James Thomas,PE,PhD
REF1 07/16/2004 07/16/2004 Federal Government
OMB Review for July 14, 2004


Signature: OMB Review for July 14, 2004

EMC2 07/14/2004 07/14/2004 Individual Consumer T. Singeltary, Sr.

Signature: Terry S. Singeltary Sr. [SEE TSS SUBMISSION BELOW]

EMC3 07/19/2004 07/19/2004 Individual Consumer C. VerPault
Signature: Craig VerPault

EMC4 07/19/2004 07/19/2004 Individual Consumer B. Sachau
Signature: B. Sachau

EMC5 07/20/2004 07/20/2004 Individual Consumer A. Carter
Signature: Anna Carter

EXT1 08/06/2004 08/06/2004 International Industry
China WTO/TBT
Signature: Guo Lisheng

EMC6 08/05/2004 08/05/2004 Individual Consumer W. Majerus
Signature: Warren Majerus

EMC7 08/06/2004 08/06/2004 Private Industry World Trade Organization txt http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000007.txt, Attachments: doc1 http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000007-01.doc, pdf1 http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000007-01.pdf | doc2 http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000007-02.doc, pdf2 http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000007-02.pdf

Signature: Guo Lisheng
EMC8 08/06/2004 08/06/2004 Private Industry The Dow Chemical Company txt http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000008.txt, Attachment doc http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000008-01.doc, pdf http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000008-01.pdf

Signature: Mark Duvall
EMC9 08/12/2004 08/12/2004 Private Industry Gelatin Manufacturers Institute of America, Inc. txt http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000009.txt, Attachment doc http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000009-01.doc, pdf http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000009-01.pdf

Signature: Karen J. Elam & Michael J. Dunn

EMC10 08/12/2004 08/12/2004 Private Industry Kraft Foods Global, Inc. txt http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000010.txt, Attachment http://www.fda.gov/ohrms/dockets/dockets/04n0257/04N-0257_emc-000010-01.pdf
Signature: Susan R. Eickhoff

C1 08/09/2004 08/09/2004 Private Industry The Dow Chemical Company pdf http://www.fda.gov/ohrms/dockets/dockets/04n0257/04n-0257-c000001-01-vol2.pdf
Signature: Mark Duvall

C2 08/11/2004 08/10/2004 Private Industry American Dairy Products Institute pdf http://www.fda.gov/ohrms/dockets/dockets/04n0257/04n-0257-c000002-01-vol2.pdf
Signature: James J. Page

C3 08/11/2004 08/11/2004 Private Industry National Food Processors Association pdf http://www.fda.gov/ohrms/dockets/dockets/04n0257/04n-0257-c000003-vol2.pdf
Signature: John R. Cady

C4 08/12/2004 08/12/2004 Private Industry Gelatin Manufacturers of Europe pdf http://www.fda.gov/ohrms/dockets/dockets/04n0257/04n-0257-c000004-vol2.pdf
Signature: Daniel R. Dwyer

C5 08/12/2004 08/12/2004 Private Industry Gelatin Manufacturers of Europe pdf http://www.fda.gov/ohrms/dockets/dockets/04n0257/04n-0257-c000005-vol2.pdf

Signature: Daniel R. Dwyer

http://www.fda.gov/ohrms/dockets/dockets/04n0257/04n0257.htm

TSS SUBMISSION ;

-------- Original Message --------
Subject: Docket No. 2004N-0257 Recordkeeping Requirements for Human Food and Cosmetics [comment submission]]]
Date: Wed, 14 Jul 2004 14:11:36 -0500
From: "Terry S. Singeltary Sr."
To: fdadockets@oc.fda.gov
CC: "burt.pritchett"


Docket No. 2004N-0257

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

Greetings FDA,

ONCE again I must comment on TSE and cosmetics.

FOR the reasons below, there would be NO reason for record keeping for
cosmetics
due to SRMS or any by-product from cattle or any other species. FOR the
reasons
stated below, ALL animal by-products should be removed from cosmetics;

-------- 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 1. Entry n° 419 stipulates that Bovine, ovine and
caprine tissues and fluids from the encephalon, the spinal cord and the
eyes, and ingredients derived therefrom must not form part of the
composition of cosmetic products, was first added to Annex II to
Cosmetics Directive 76/768/EEC1 by Commission Directive 97/1/EC2
following an opinion of the Scientific Committee on Cosmetology. 2.
Entry n° 419 was further amended by Commission Directives 98/16/EC3, and
2000/6/EC4 in order to align the list of prohibited animal materials to
that contained in Commission Decisions defining Specified Risk Materials
(SRM) as regards transmissible spongiform encephalopathies (TSEs). 3.
Entry n° 419 stipulates that From the date referred to in Article 22 of
Regulation (EC) No 999/2001 (8) of the European Parliament and of the
Council, the specified risk materials as designated in Annex V to that
Regulation, and ingredients derived therefrom. Until that date, the
specified risk materials as designated in Annex XI Part A to Regulation
(EC) no 999/2001 and ingredients derived therefrom. However, tallow
derivatives may be used provided that the following methods have been
used and strictly certified by the producer: - transesterification or
hydrolysis at least: 200 °C, 40 bars (40,000 hPa) for 20 minutes
(glycerol and fatty acids and esters), - saponification with NaOH 12M
(glycerol and soap) : batch process: at 95 °C for 3 hours or continuous
process: at 140 °C, 2 bars (2 000 hPa) for 8 minutes or equivalent
conditions. 4. Based on the opinions of the SSC5 and on Commission
Decision 2001/2/EC6 regulating the use of material presenting risks as
regards TSEs, the SCCNFP adopted 2 further opinions on the amendment to
entry n° 419 (SCCNFP/0451/01 of 12 June 2001 and SCCNFP/0521/01 of 25
September 2001). 5. Consequently, the SCCNFP recommended that the list
referred to in Regulation n° 999/2001 should be supplemented by the
ingredients derived therefrom and that no exceptions should be made
regarding tallow derivatives. 1 OJ L 262, 27.09.1976, p. 169 2 OJ L 16,
18.01.1997, p. 85 3 OJ L 77, 14.03.1998, p. 44 4 OJ L 56, 1.03.2000, p.
42 5 Opinion of the SSC on TSE infectivity distribution in ruminant
tissues (state of knowledge December 2001), adopted 10-11 January 2002 6
OJ L 001, 4.01.2001, p. 21 SCCNFP/0724/03, final Opinion on the Use of
specified risk material in cosmetics - Clarification for tallow
derivatives
_____________________________________________________________________________________________
3 6. In its opinion adopted by the SCCNFP during the 22nd Plenary
Meeting of 17 December 2002 the SCCNFP (SCCNFP/0612/02) stated that the
exceptions made for tallow derivatives in its latest opinion concerning
the amendment to entry n° 419 of Annex II to Directive 76/768/EEC on
cosmetic products (SCCNFP/0552/02 of 27 February 2002) are no longer
scientifically consistent with the scientific opinions of the Scientific
Steering Committee on the safety of tallow. 7. Recently the SSC adopted
on its last meeting on 10 - 11 April 2003 an opinion on the safety of
tallow derivatives from cattle tallow based on an updated report by
the European Oleochemicals and Allied Products Group (APAG) on The
safety of tallow derivatives with respect to Bovine Spongiform
Encephalopathy 8. Due to the cosmetic applications of tallow
derivatives the SSC stated that it is justified to modulate the risk
reduction according to the source of the tallow used for the production
of the derivatives and the geographical BSE risk level. 2. Terms of
Reference Commission Decision 2001/2/EC was repealed by Commission
Regulation (EC) n° 1326/2001/EC7 of 29.6.2001 laying down transitional
measures to permit the changeover to the Regulation (EC) No 999/20018 of
the European Parliament and of the Council of 22 May 2001 laying down
rules for the prevention, control and eradication of certain
transmissible spongiform encephalopathies. The current definition for
Specified Risk Material is found in Annex V of the latter legislative
text and according to Article 3 1(g) does not include products
containing or derived from those tissues unless indicated otherwise.
There is also no exception made for tallow derivatives that may be used
if defined methods have been used to prepare. Because the designation of
specified risk material is dynamic progress and in order to avoid the
systematic consultation of the SCCNFP each time the designation of
specified risk material is updated, the SCCNFP was asked to give advice
on the following questions: 1. Are tallow derivatives safe for use in
cosmetic products with regard to BSE risk regardless of the production
process if they are derived from food- or feed- grade tallow and if
cross contamination is prevented? 2. Are tallow derivatives safe for use
in cosmetic products with regard to BSE risk regardless of the
production process if they are derived cattle from GBR-C I countries9
and fallen stock are excluded? 3. For GBR-C II countries, are tallow
derivatives safe for use in cosmetic products if fallen stock are
excluded, the animals from which the tallow is sourced are fit for human
7 OJ L 177, 30.6.2001, p. 60 8 OJ L 147, 31.5.2001, p.1 9 GBR-C stays
for Geographical BSE risk in cattle. SCCNFP/0724/03, final Opinion on
the Use of specified risk material in cosmetics - Clarification for
tallow derivatives
_____________________________________________________________________________________________
4 consumption, the raw tallow is produced according to the standards
indicated in the SSC opinion of 28-29 June 2001 on the safety of tallow
(including filtration), and the following processing conditions have
been used: to obtain glycerol and fatty acids and esters:
transesterification or hydrolysis at at least 200°C and an appropriate
corresponding pressure for 20 minutes, followed by a purification to
remove (insoluble) impurities; to obtain glycerol and soap:
saponification with NaOH 12M : batch process: at 95°C for 3 hours; or:
continuous process: at 140°C, 2 bars (2000 hPa) for 8 minutes or
equivalent conditions, followed by a purification to remove (insoluble)
impurities; and cross contamination is prevented? 4. For GBR-C III and
IV countries, are tallow derivatives safe for use in cosmetic products
if, in addition to the conditions described under (3), the specified
risk materials have been removed and are not used for the production of
tallow / tallow derivatives? 3. Opinion of the SCCNFP Based on the
information presented in the last opinion adopted by the Scientific
Steering Committee and in the respective EU legislative texts concerning
specified risk material (SMR) and concerning certain transmissible
spongiform encephalophathies, the SCCNFP is of the opinion that tallow
derivatives are safe for use as ingredients in cosmetic products. It is
justified to modulate the risk reduction according to the source of the
tallow used for the production of the derivatives and the geographical
BSE risk level. 1. Tallow derivatives are safe with regard to BSE risk
regardless of the production process if they are derived from food- or
feed- grade tallow and if cross contamination is prevented. The criteria
for food- and feed- grade tallow are detailed in the SSC opinion of
28-29 June 2001 on the safety of tallow obtained from ruminant slaughter
by products. 2. Tallow derivatives are safe with regard to BSE risk
regardless of the production process if they are derived from cattle
from GBR-C I countries and fallen stock are excluded. 3. For GBR-C II
countries, tallow derivatives are safe if fallen stock are excluded, the
animals from which the tallow is sourced are fit for human consumption,
the raw tallow is produced according to the standards indicated in the
SSC opinion of 28-29 June 2001 on the safety tallow (including
filtration), the processing conditions described in the mandate have
been used and cross contamination is preserved. 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.
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 NOW, with these
findings and the fact I will probably never live long enough to know
exactly what the source of infection that killed my mother from the
Heidenhain Variant of Creutzfeldt Jakob Disease, I only ponder if the
potential route of infection could have come from cosmetics. My mother
used those expensive facial creams all her life. SHE was an avid
fisherwoman and would layer herself with these creams for wrinkles, all
over her face and around her eyes. WITH these creams containing SRMs
i.e. 'brain, eyes, pituitary, CNS' tissues, the fact that the hvCJD is a
TSE that manifests itself directly behind the eyes (occipital brain
region), in the front part of the brain, the fact it is an exceedingly
rare strain/phenotype of the CJD, I only ponder the potential for
cosmetics as to be a potential source of some human TSE? I also ponder
the thought of accumulation of the TSE agent over a period of time from
a multitude of routes and sources, and finally after a long period of
time and accumulation, the 'threshold' is met (whatever that may be),
and one becomes clinical with TSE? WITH new studies showing the TSE
agent in muscle tissue, the fact that the sensitivity of TSE testing is
'not that sensitive', and the fact that Prusiner et al have a test that
they claim is some 1000 times more sensitive than existing TSE test. The
fact that new 'atypical' cases of TSEs are showing in in cattle and
sheep in different parts of the globe, with the new 'atypical' TSE in
cattle called 'BASE' being very similar to sporadic CJD as opposed to
nv/v CJD, I think it paramount that we act now and ban ALL animal TSEs
in Cosmetics. AS testing becomes more sensitive, change the rules as
applicable. TO wait and continue to expose millions and millions and
then later on, after finding out the worse case scenario is correct,
then to act, will be much too late. WE MUST ACT NOW! How many humans are
the Industry/Gov. willing to expose to this agent that is 100% fatal,
all for money, just to come up years or decades later saying, ''oops,
sorry, we wish to submit the following docket to discuss further BSE/TSE
precautions to remove all animal Tissues from cosmetics etc." due to all
reasons I have stated in these federal dockets over the years? WE must
act now to remove all animal TSEs from cosmetics! SEE more relevant
references pertaining to new atypical TSEs in cattle and sheep very
similar to sporadic CJD in humans and new studies on TSE infectivity in
muscle tissue below in my previous submission to Docket No, 04-047-l
Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS
(comment submission) and why it is paramount to BAN ALL ANIMAL TISSUES
IN COSMETICS; -------- 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......END.......TSS




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