From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Tuesday, July 29, 2003 1:03 PM
To: fdadockets@oc.fda.gov
Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

my name is Terry S. Singeltary Sr., i lost my mother to hvCJD
(Heidenhain Variant Creutzfeldt Jakob Disease).

i would kindly like to comment on the proposed HACCP method of
detecting and or preventing TSEs in the human/animal feed supply.

it seems to me by implementing something that was designed for Astronauts
instead of cattle, something that the GAO has already stated is terribly
flawed (HACCP), i find it very disturbing to continue to insist on refusing
to use rapid TSE TESTING in sufficient numbers to find TSEs, as with
other Countries that they too once thought they were BSE free. for example,
it took Italy 1 MILLION rapid TSE tests since 2001 to find 102 cases of
BSE. THE USA has only tested 48,000 cattle in the 14 years of surveillance.
there is documented proof that indeed the USA cattle have been infected
with a TSE for decades, but the FDA/USDA and other USA Gov. agencies
continue to conveniently ignore these findings. YOU must not ignore
what Richard Marsh found. Plus, you must not ignore Asante/Collinge new
findings that BSE transmission to the 129-methionine genotype can lead 
to an
alternate phenotype that is indistinguishable from type 2 PrPSc, the 
commonest
_sporadic_ CJD. The USA has been feeding ruminant by-products back to
cattle, deer, elk and sheep for decades, and TSEs in these species have been
recycled for feed for decades in the USA. The rendering process here in the
USA will not kill this agent. to implement any HACCP over massive rapid
TSE testing is only prolonging the inevitable, and will only allow the 
agent to
spread further. it is simply a band-aid approach to something that needs a
tourniquet...

3. Meat and Poultry: Better USDA Oversight and Enforcement of Safety

Rules Needed to Reduce Risk of Foodborne Illnesses. GAO-02-902, August
30.

FSIS Is Not Ensuring that Plants' HACCP Plans Meet Regulatory
Requirements

snip...

According to FSIS's food safety systems correlation reviews, inspectors
are not consistently identifying and documenting failures of plants'
HACCP plans to meet regulatory requirements. Furthermore, FSIS does
not expect its inspectors to determine whether HACCP plans are based on
sound science--the cornerstone of an effective plan. While in-depth
verification reviews examine the scientific aspects of HACCP plans, they
have been conducted in very few plants, and consumer safety officers
hired to review the scientific soundness of HACCP plans may take several
years to assess the plans at all plants. Moreover, inspectors in 55
percent of the 5,000 plants nationwide did not document any HACCP
violations during fiscal year 2001. When we brought this information to
the attention of FSIS officials, they were surprised that so many plants
had no HACCP violations for an entire year.

snip...

2. USDA believes that the title of the report is misleading. We
disagree. We believe the title accurately reflects the concerns detailed
throughout the body of the report.

snip...

http://www.gao.gov/cgi-bin/getrpt?GAO-02-902

http://www.gao.gov/new.items/rc00255.pdf

FDA acknowledges that it has not yet identified and inspected
all firms subject to the ban pg. 3 ;

http://www.gao.gov/new.items/d02183.pdf

The report concludes that federal actions do not sufficiently ensure 
that all
BSE-infected animals or products are kept out or that if BSE were found it
would be detected promptly and not spread to other cattle through animal
feed or enter the human food chain italics added pg. 3 ;

http://www.gao.gov/new.items/d02183.pdf

and why does everybody conveniently ignore these findings;

Asante/Collinge et al, that BSE transmission to the 129-methionine genotype
can lead to an alternate phenotype that is indistinguishable from type 2 
PrPSc,
the commonest _sporadic_ CJD;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm

To be published in the Proceedings of the
Fourth International Scientific Congress in
Fur Animal Production. Toronto, Canada,
August 21-28, 1988

Evidence That Transmissible Mink Encephalopathy
Results from Feeding Infected Cattle

R.F. Marsh* and G.R. Hartsough

Department of Veterinary Science, University of Wisconsin-Madison, Madison,
Wisconsin 53706; and ^Emba/Creat Lakes Ranch Service, Thiensville, 
Wisconsin 53092

ABSTRACT
Epidemiologic investigation of a new incidence of
transmissible mink encephalopathy (TME) in Stetsonville, Wisconsin
suggests that the disease may have resulted from feeding infected
cattle to mink. This observation is supported by the transmission of
a TME-like disease to experimentally inoculated cattle, and by the
recent report of a new bovine spongiform encephalopathy in
England.

INTRODUCTION

Transmissible mink encephalopathy (TME) was first reported in 1965 by 
Hartsough
and Burger who demonstrated that the disease was transmissible with a 
long incubation
period, and that affected mink had a spongiform encephalopathy similar 
to that found in
scrapie-affecied sheep (Hartsough and Burger, 1965; Burger and 
Hartsough, 1965).
Because of the similarity between TME and scrapie, and the subsequent 
finding that the
two transmissible agents were indistinguishable (Marsh and Hanson, 
1969), it was
concluded that TME most likely resulted from feeding mink 
scrapie-infecied sheep.
The experimental transmission of sheep scrapie to mink (Hanson et al., 1971)
confirmed the close association of TME and scrapie, but at the same time 
provided
evidence that they may be different. Epidemiologic studies on previous 
incidences of
TME indicated that the incubation periods in field cases were between 
six months and
one year in length (Harxsough and Burger, 1965). Experimentally, scrapie 
could not be
transmitted to mink in less than one year.
To investigate the possibility that TME may be caused by a (particular 
strain of
scrapie which might be highly pathogenic for mink, 21 different strains 
of the scrapie
agent, including their sheep or goat sources, were inoculated into a 
total of 61 mink.
Only one mink developed a progressive neurologic disease after an 
incubation period of
22 mon..s (Marsh and Hanson, 1979). These results indicated that TME was 
either caused
by a strain of sheep scrapie not yet tested, or was due to exposure to a 
scrapie-like agent
from an unidentified source.

OBSERVATIONS AND RESULTS

A New Incidence of TME. In April of 1985, a mink rancher in 
Stetsonville, Wisconsin
reported that many of his mink were "acting funny", and some had died. 
At this time, we
visited the farm and found that approximately 10% of all adult mink were 
showing
typical signs of TME: insidious onset characterized by subtle behavioral 
changes, loss of
normal habits of cleanliness, deposition of droppings throughout the pen 
rather than in a
single area, hyperexcitability, difficulty in chewing and swallowing, 
and tails arched over
their _backs like squirrels. These signs were followed by progressive 
deterioration of
neurologic function beginning with locomoior incoordination, long 
periods of somnolence
in which the affected mink would stand motionless with its head in the 
corner of the
cage, complete debilitation, and death. Over the next 8-10 weeks, 
approximately 40% of
alt the adult mink on the farm died from TME.
Since previous incidences of TME were associated with common or shared 
feeding
practices, we obtained a careful history of feed ingredients used over 
the past 12-18
months. The rancher was a "dead stock" feeder using mostly (>95%) downer 
or dead dairy
cattle and a few horses. Sheep had never been fed.

Experimental Transmission. The clinical diagnosis of TME was confirmed by
histopaihologic examination and by experimental transmission to mink 
after incubation
periods of four months. To investigate the possible involvement of 
cattle in this disease
cycle, two six-week old castrated Holstein bull calves were inoculated 
intracerebrally
with a brain suspension from affected mink. Each developed a fatal 
spongiform
encephalopathy after incubation periods of 18 and 19 months.

DISCUSSION
These findings suggest that TME may result from feeding mink infected 
cattle and
we have alerted bovine practitioners that there may exist an as yet 
unrecognized
scrapie-like disease of cattle in the United States (Marsh and 
Hartsough, 1986). A new
bovine spongiform encephalopathy has recently been reported in England 
(Wells et al.,
1987), and investigators are presently studying its transmissibility and 
possible
relationship to scrapie. Because this new bovine disease in England is 
characterized by
behavioral changes, hyperexcitability, and agressiveness, it is very 
likely it would be
confused with rabies in the United Stales and not be diagnosed. 
Presently, brains from
cattle in the United States which are suspected of rabies infection are 
only tested with
anti-rabies virus antibody and are not examined histopathologically for 
lesions of
spongiform encephalopathy.
We are presently pursuing additional studies to further examine the possible
involvement of cattle in the epidemiology of TME. One of these is the 
backpassage of
our experimental bovine encephalopathy to mink. Because (here are as yet 
no agent-
specific proteins or nucleic acids identified for these transmissible 
neuropathogens, one
means of distinguishing them is by animal passage and selection of the 
biotype which
grows best in a particular host. This procedure has been used to 
separate hamster-
adapted and mink-udapted TME agents (Marsh and Hanson, 1979). The 
intracerebral
backpassage of the experimental bovine agent resulted in incubations of 
only four months
indicating no de-adaptation of the Stetsonville agent for mink after 
bovine passage.
Mink fed infected bovine brain remain normal after six months. It wili 
be essential to
demonstrate oral transmission fiom bovine to mink it this proposed 
epidemiologic
association is to be confirmed.

ACKNOWLEDGEMENTS
These studies were supported by the College of Agricultural and Life 
Sciences,
University of Wisconsin-Madison and by a grant (85-CRCR-1-1812) from the 
United
States Department of Agriculture. The authors also wish to acknowledge 
the help and
encouragement of Robert Hanson who died during the course of these 
investigations.

REFERENCES
Burger, D. and Hartsough, G.R. 1965. Encephalopathy of mink. II. 
Experimental and
natural transmission. J. Infec. Dis. 115:393-399.
Hanson, R.P., Eckroade, R.3., Marsh, R.F., ZuRhein, C.M., Kanitz, C.L. 
and Gustatson,
D.P. 1971. Susceptibility of mink to sheep scrapie. Science 172:859-861.
Hansough, G.R. and Burger, D. 1965. Encephalopathy of mink. I. 
Epizoociologic and
clinical observations. 3. Infec. Dis. 115:387-392.
Marsh, R.F. and Hanson, R.P. 1969. Physical and chemical properties of the
transmissible mink encephalopathy agent. 3. ViroL 3:176-180.
Marsh, R.F. and Hanson, R.P. 1979. On the origin of transmissible mink
encephalopathy. In Hadlow, W.J. and Prusiner, S.P. (eds.) Slow transmissible
diseases of the nervous system. Vol. 1, Academic Press, New York, pp 
451-460.
Marsh, R.F. and Hartsough, G.R. 1986. Is there a scrapie-like disease in 
cattle?
Proceedings of the Seventh Annual Western Conference for Food Animal 
Veterinary
Medicine. University of Arizona, pp 20.
Wells, G.A.H., Scott, A.C., Johnson, C.T., Cunning, R.F., Hancock, R.D., 
Jeffrey, M.,
Dawson, M. and Bradley, R. 1987. A novel progressive spongiform 
encephalopathy
in cattle. Vet. Rec. 121:419-420.

http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf

02N-0273 - Substances Prohibited From ... [PART 1 TSS SUBMISSION]
... compare search on 8/8/01...tss =====ANIMAL PROTEIN ... had
to request to the FOIA >>for the USA madcow feed ban warning letters. ...
www.fda.gov/ohrms/dockets/dailys/ 03/Jan03/012403/8004be07.html - 68k -

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

Docket Management Docket: 02N-0273 - Substances Prohibited From ...
[PART 2 TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html


SNIP...

The problem is diminishing in most of the 15 EU nations, but in Britain 
there were
260 positive tests between January and May, compared with 156 for the same
period last year.

The higher number could be explained partly by the greater number of 
tests carried
out this year in Britain: 198,143 compared with 122,801.

The European Commission carried out about 4.1 million tests across 
member states -
about 10% of cattle in the bloc.

It found 591 positive cases of bovine spongiform encephalopathy in the 
first five months
of the year, down from 603 over the same period last year.

snip...

http://icberkshire.icnetwork.co.uk/0100news/nationalnews/content_objectid=13206973_method=full_siteid=50102_headline=-Britain-has-highest-mad-cow-results-name_page.html 



USA TEST ONLY 48,000 CATTLE IN 14 YEARS, from 100 MILLION
CATTLE IN ANY GIVEN YEAR, to 2003, TOTAL TSE TEST EVER IN
USA BOVINE;

As of April 30, 2003, over 48,000 brains have been examined for BSE or
another form of a TSE in cattle (figure 3
<http://www.aphis.usda.gov/lpa/issues/bse/surveillance/figure3.html>).
No evidence of either condition has been detected by histopathology or
immunohistochemistry.

http://www.aphis.usda.gov/lpa/issues/bse/surveillance/figure3.html


For the USA to continue to _flounder_ with these TSEs, as they have done 
for the past
30 years or so, will only allow the agent to spread. to continue to 
ignore what every other
Country around the globe has dealt with and is still dealing with, and 
to think that the USA
is any different, should be taken with great suspicion $

PLUS, if the USA continues to flagrantly ignore the _documented_ science 
to date about
the known TSEs in the USA (let alone the undocumented TSEs in cattle), 
it is my opinion,
every other Country that is dealing with BSE/TSE should boycott the USA 
and demand that
the SSC reclassify the USA BSE GBR II risk assessment to BSE/TSE GBR III 
'IMMEDIATELY'.
for the SSC to _flounder_ any longer on this issue, should also be 
regarded with great suspicion
as well. NOT to leave out the OIE and it's terribly flawed system of 
disease surveillance.
the OIE should make a move on CWD in the USA, and make a risk assessment 
on this as
a threat to human health. the OIE should also change the mathematical 
formula for testing
of disease. this (in my opinion and others) is terribly flawed as well. 
to think that a sample survey
of 400 or so cattle in a population of 100 million, to think this will 
find anything, especially after
seeing how many TSE tests it took Italy and other Countries to find 1 
case of BSE (1 million rapid
TSE test in less than 2 years, to find 102 BSE cases), should be proof 
enough to make drastic
changes of this system. the OIE criteria for BSE Country classification 
and it's
interpretation is very problematic. a text that is suppose to give 
guidelines, but
is not understandable, cannot be considered satisfactory. the OIE told me 2
years ago that they were concerned with CWD, but said any changes might
take years. well, two years have come and gone, and no change in relations
with CWD as a human health risk. if we wait for politics and science to
finally make this connection, we very well may die before any decisions
or changes are made. this is not acceptable. we must take the politics and
the industry out of any final decisions of the Scientific community. 
this has
been the problem from day one with this environmental man made death
sentence. some of you may think i am exaggerating, but you only have to see
it once, you only have to watch a loved one die from this one time, and you
will never forget, OR forgive...yes, i am still very angry...but the 
transmission
studies DO NOT lie, only the politicians and the industry do...and they are
still lying to this day...

Terry S. Singeltary Neurology Online, 27 Jan 2003 [Full text]

Re: RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob
disease in the United States

Email Terry S. Singeltary:
flounder@wt.net

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to
comment on the CDC's attempts to monitor the occurrence of emerging
forms of CJD. Asante, Collinge et al [1] have reported that BSE
transmission to the 129-methionine genotype can lead to an alternate
phenotype that is indistinguishable from type 2 PrPSc, the commonest
sporadic CJD. However, CJD and all human TSEs are not reportable
nationally. CJD and all human TSEs must be made reportable in every
state and internationally. I hope that the CDC does not continue to
expect us to still believe that the 85%+ of all CJD cases which are
sporadic are all spontaneous, without route/source. We have many TSEs in
the USA in both animal and man. CWD in deer/elk is spreading rapidly and
CWD does transmit to mink, ferret, cattle, and squirrel monkey by
intracerebral inoculation. With the known incubation periods in other
TSEs, oral transmission studies of CWD may take much longer. Every
victim/family of CJD/TSEs should be asked about route and source of this
agent. To prolong this will only spread the agent and needlessly expose
others. In light of the findings of Asante and Collinge et al, there
should be drastic measures to safeguard the medical and surgical arena
from sporadic CJDs and all human TSEs. I only ponder how many sporadic
CJDs in the USA are type 2 PrPSc?

http://www.neurology.org/cgi/eletters/60/2/176#535

# Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob
disease in the United States [FULL TEXT] - TSS 2/22/03 (0)

http://www.vegsource.com/talk/madcow/messages/9912538.html

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

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Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
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Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

BRITISH MEDICAL JOURNAL

SOMETHING TO CHEW ON

BMJ

http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2

BMJ

http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1

Full Text
Diagnosis and Reporting of Creutzfeldt-Jakob Disease
Singeltary, Sr et al. JAMA.2001; 285: 733-734.

http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama

Docket Management Docket: 02D-0073 - Guidance: Validation of Procedures 
for Processing of Human Tissues Intended for Transplantation
Comment Number: EC -4
Accepted - Volume 1

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfc.html

Docket Management Docket: 02D-0371 - Class II Special Controls Guidance 
Document: Human Dura Mater
Comment Number: EC -1
Accepted - Volume 1

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfe.html

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be11.html

PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

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

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

MAD COW NEWS...TSEs...TSS

http://www.vegsource.com/talk/madcow/index.html

CJD WATCH

http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm

CJD Watch message board

http://disc.server.com/Indices/167318.html

>>>6. What is the potential burden (increased cost and manpower) of a 
comprehensive, risk-based Federal feed safety program, and what options 
are available to minimize the burden?<<<

WHO CARES !!!

Moms death from hvCJD

http://www.vegsource.com/talk/lyman/messages/7252.html

MANY FACES

http://www.fortunecity.com/healthclub/cpr/798/cjd.htm

'A SON'S LOVE'

http://www.fortunecity.com/healthclub/cpr/798/terry.htm

'MOMS AUTOPSY REPORT'

http://www.vegsource.com/talk/lyman/messages/7548.html

anything less than 1 million rapid TSE test in USA cattle
annually for 5 years, anything less than that, simply put,
they don't want to find... 

Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, TEXAS USA 77518
<flounder@wt.net>