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From: Terry S. Singeltary Sr. (216-119-139-248.ipset19.wt.net)
Subject: Guidance for Industry: Use of Material from Bovine Spongiform Encephalopathy-Positive Cattle in Animal Feed; Availability [Docket No. 2004D-0438]
Date: September 30, 2004 at 7:30 am PST

-------- Original Message --------
Subject: Guidance for Industry: Use of Material from Bovine Spongiform Encephalopathy-Positive Cattle in Animal Feed; Availability [Docket No. 2004D-0438]
Date: Thu, 30 Sep 2004 09:36:56 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
CC: burt.pritchett@fda.gov, fdadockets@oc.fda.gov


[Federal Register: September 30, 2004 (Volume 69, Number 189)]
[Notices]
[Page 58448]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se04-93]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0438]


Guidance for Industry: Use of Material from Bovine Spongiform
Encephalopathy-Positive Cattle in Animal Feed; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry (174) entitled ``Use
of Material from BSE-Positive Cattle in Animal Feed.'' This guidance
document describes FDA's current thinking regarding the use in all
animal feed of all material from cattle that test positive for BSE
(bovine spongiform encephalopathy).

DATES: Submit written or electronic comments on agency guidances at any
time.

ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments on the
guidance via the Internet at http://www.fda.gov/dockets/ecomments .

Comments should be identified with the full title of the guidance and
the docket number found in brackets in the heading of this document.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
document.
Submit written requests for single copies of the guidance to the
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your
requests.

FOR FURTHER INFORMATION CONTACT: Burt Pritchett, Center for Veterinary
Medicine (HFV-222), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6860, e-mail: burt.pritchett@fda.gov .

SUPPLEMENTARY INFORMATION:

I. Background

BSE belongs to a family of animal and human diseases called
transmissible spongiform encephalopathies (TSEs). These include BSE or
``mad cow'' disease in cattle; scrapie in sheep and goats; and
classical and variant Creutzfeldt-Jakob diseases (CJD and vCJD) in
humans. There is no known treatment for these diseases, and there is no
vaccine to prevent them. In addition, although validated postmortem
diagnostic tests are available, there are no validated diagnostic tests
for BSE or other TSEs that can be used to test for the disease in live
animals or humans.
Under FDA's BSE feed regulation (21 CFR 589.2000) any protein-
containing portion of mammalian animals is prohibited for use in feed
for ruminant animals with the exception of certain products. FDA took
this action to minimize the potential for any undetected BSE
infectivity in animal feed to spread to ruminants via their feed. This
guidance document describes FDA's recommendations regarding the use in
all animal feed of all material from cattle that test positive for BSE.

II. Paperwork Reduction Act of 1995

FDA concludes that this guidance contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.

III. Significance of Guidance

This level 1 guidance is being issued consistent with FDA's good
guidance practices (GGPs) regulation in Sec. 10.115(21 CFR 10.115). It
is being implemented immediately without prior public comment, under
Sec. 10.115(g)(2), because FDA believes that, in light of the
increased BSE testing activities by the U.S. Department of Agriculture,
it is of public health importance to clarify that cattle that test
positive for BSE are adulterated and are not to be used in any animal
feed.
This guidance represents the agency's current thinking on the
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternate method may be
used as long as it satisfies the requirements of applicable statutes
and regulations.

IV. Comments

As with all of FDA's guidance, the public is encouraged to submit
written or electronic comments with new data or other new information
pertinent to this guidance. FDA periodically will review the comments
in the docket and, where appropriate, will amend the guidance. The
public will be notified of any such amendments through a document in
the Federal Register.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

V. Electronic Access

Copies of this guidance document may be obtained from the Center
for Veterinary Medicine home page (http://www.fda.gov/cvm ) and from
the Division of Dockets Management Web site
(http://www.fda.gov/ohrms/dockets/default.htm ).


Dated: September 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22014 Filed 9-29-04; 8:45 am]

BILLING CODE 4160-01-S

http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-22014.htm

Greetings,

PRETTY damn disgusting is it not? seems the 8/4/97 partial
and voluntary r-to-r feed ban that was put into place
worked so well, we are still discussing this issue
on Sept. 30, 2004. why are we still discussing this
issue? i find it a waste of time to submit anything
else to these IMBECILES. they do not listen to anyone
but there donors. this now has nothing to do
with science, but just how far the industry will go
to protect there commodity. seems the industry has
won, and the agent will continue to spread for decades
to come, many more exposed, and many more will die and
the BSeee will continue and i am tired. 7 years and this
is as far as we have gotten (even longer for others).
SADLY, i see no hope under this present regime...


Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]


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,

snip...

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...TSS

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt


Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA [takes a few minutes to load]


https://web01.aphis.usda.gov/BSEcom.nsf/BSEFrameset?OpenFrameSet&Frame=BottomFrame&Src=_25t156hb3dtmisrjjconjcc9n6ph6ccr66oqjgdpo74qm6e1l68qjcp9hc4o30dhgckq34phfc8rjgoj16orjep9ic8o66c9i64s3achl6pi68cpg60r38eb675i3ujrgcln48rr3elmmarjk4p0nat3f8pp62rb5cg0_


Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt


Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10
Accepted - Volume 2

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

PART 2

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


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


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


[PDF] Appendices to PL107-9 Inter-agency Working Group Final Report 1-1

File Format: PDF/Adobe Acrobat - View as HTML
Agent, Weapons of Mass Destruction Operations Unit Federal Bureau of
those who provided comments in response to Docket No. ...
Meager 8/18/01 Terry S. Singeltary Sr ...


http://www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf


Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt


# Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of

2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] -
TSS 1/27/03 (0)

Docket Management

Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm


Dockets Entered On October 2, 2003 Table of Contents, Docket #,

Title, 1978N-0301,

OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr.
Vol #: 1, ...


http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm


Daily Dockets Entered on 02/05/03

DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2.
... Vol#: 1.


03N-0009 Federal Preemption of State & Local Medical Device Requireme. ...

http://www.fda.gov/ohrms/dockets/dailys/03/Feb03/020503/020503.htm


Docket Management

Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater

Comment Number: EC -1
Accepted - Volume 1


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

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

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

Daily Dockets - 04/10/03


... 00D-1662 Use of Xenotransplantation Products in Humans.

EMC 98 Terry S. Singeltary Sr. Vol#: 3. 01F ...

http://www.fda.gov/ohrms/dockets/dailys/03/Apr03/041003/041003.htm - 05-20-2003
- Cached
http://www.fda.gov/ohrms/dockets/dailys/03/Apr03/041003/041003.htm


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed
EMC 1

Terry S. Singeltary Sr.
Vol #:1

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

EMC 7
Terry S. Singeltary Sr.
Vol #: 1
2003D-0186


http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm


01N-0423 Substances Prohibited from use in animal food/Feed Ruminant
APE 5 National Renderers Association, Inc. Vol#: 2
APE 6 Animal Protein Producers Industry Vol#: 2
APE 7 Darling International Inc. Vol#: 2
EMC 1 Terry S. Singeltary Sr. Vol#: 3

http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm


Docket No: 03-080-1 Title: Bovine Spongiform Encephalopathy ...


Terry S. Singeltary Sr. 11/4/03 Bacliff, TX


Docket No: 03-080-1

Title: Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of
Commodities


http://www.aphis.usda.gov/ppd/rad/LPOC/03-080-1.txt

Appendices to PL107-9 Inter-agency Working Group Final Report 1-1


comments.aphis.usda.gov Stanley G. Meager 8/18/01 Terry S. Singeltary
Sr. ...

http://www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf

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


LANCET INFECTIOUS DISEASE JOURNAL
Volume 3, Number 8 01 August 2003

Newsdesk

Tracking spongiform encephalopathies in North America

Xavier Bosch

My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost
my mom to hvCJD (Heidenhain variant CJD) and have been searching for
answers ever since. What I have found is that we have not been told the
truth. CWD in deer and elk is a small portion of a much bigger problem.

49-year-old Singeltary is one of a number of people who have remained
largely unsatisfied after being told that a close relative died from a
rapidly progressive dementia compatible with spontaneous
Creutzfeldt-Jakob disease (CJD). So he decided to gather hundreds of
documents on transmissible spongiform encephalopathies (TSE) and
realised that if Britons could get variant CJD from bovine spongiform
encephalopathy (BSE), Americans might get a similar disorder from
chronic wasting disease (CWD)the relative of mad cow disease seen among
deer and elk in the USA. Although his feverish search did not lead him
to the smoking gun linking CWD to a similar disease in North American
people, it did uncover a largely disappointing situation.

Singeltary was greatly demoralised at the few attempts to monitor the
occurrence of CJD and CWD in the USA. Only a few states have made CJD
reportable. Human and animal TSEs should be reportable nationwide and
internationally, he complained in a letter to the Journal of the
American Medical Association (JAMA 2003; 285: 733). I hope that the CDC
does not continue to expect us to still believe that the 85% plus of all
CJD cases which are sporadic are all spontaneous, without route or source.

snip...full text LANCET;

http://infection.thelancet.com/journal/journal.isa


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


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


THE PATHOLOGICAL PROTEIN

BY Philip Yam

Yam Philip Yam News Editor Scientific American
http://www.sciam.com
http://www.thepathologicalprotein.com/

IN light of Asante/Collinge et al 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;


-------- Original Message --------
Subject: re-BSE prions propagate as either variant CJD-like
or sporadic CJD Date: Thu, 28 Nov 2002 10:23:43-0000
From: "Asante, Emmanuel A"
To:"'flounder@wt.net'"


Dear Terry,


I have been asked by Professor Collinge to respond to your request. I am
a Senior Scientist in the MRC Prion Unit and the lead author on the
paper. I have attached a pdf copy of the paper for your attention. Thank
you for your interest in the paper.

In respect of your first question, the simple answer is, yes. As you
will find in the paper, we have managed to associate the alternate
phenotype to type 2 PrPSc, the commonest sporadic CJD.

It is too early to be able to claim any further sub-classification in
respect of Heidenhain variant CJD or Vicky Rimmer's version. It will
take further studies, which are on-going, to establish if there are
sub-types to our initial finding which we are now reporting. The main
point of the paper is that, as well as leading to the expected new
variant CJD phenotype, BSE transmission to the 129-methionine genotype
can lead to an alternate phenotype which is indistinguishable from type
2 PrPSc.

I hope reading the paper will enlighten you more on the subject. If I
can be of any further assistance please to not hesitate to ask.

est wishes.

Emmanuel Asante

<>
____________________________________

Dr. Emmanuel A Asante MRC Prion Unit & Neurogenetics Dept. Imperial
College School of Medicine (St. Mary's) Norfolk Place, LONDON W2 1PG
Tel: +44 (0)20 7594 3794 Fax: +44 (0)20 7706 3272 email:
e.asante@ic.ac.uk (until 9/12/02)

New e-mail: e.asante@prion.ucl.ac.uk (active from now)

____________________________________


snip...


full text ;

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


AND the new findings of BASE in cattle in Italy of Identification of a
second bovine amyloidotic spongiform encephalopathy: Molecular
similarities with sporadic

Creutzfeldt-Jakob disease

http://www.pnas.org/cgi/content/abstract/0305777101v1


Adaptation of the bovine spongiform encephalopathy agent to primates

and comparison with Creutzfeldt- Jakob disease: Implications for

human health


THE findings from Corinne Ida Lasmézas*, [dagger] , Jean-Guy Fournier*,
Virginie Nouvel*, Hermann Boe*, Domíníque Marcé*, François Lamoury*, Nicolas Kopp [Dagger] ,
Jean-Jacques Hauw§, James Ironside¶, Moira Bruce [||] , Dominique Dormont*,
and Jean-Philippe Deslys* et al,

THAT The agent responsible for French iatrogenic growth hormone-linked CJD
taken as a control is very different from vCJD but is similar to that found
in one case of sporadic CJD and one sheep scrapie isolate;

http://www.pnas.org/cgi/content/full/041490898v1

Characterization of two distinct prion strains
derived from bovine spongiform encephalopathy
transmissions to inbred mice


Sarah E. Lloyd, Jacqueline M. Linehan, Melanie Desbruslais,
Susan Joiner, Jennifer Buckell, Sebastian Brandner,
Jonathan D. F. Wadsworth and John Collinge


Correspondence
John Collinge
j.collinge@prion.ucl.ac.uk


MRC Prion Unit and Department of Neurodegenerative Disease, Institute of Neurology,
University College, London WC1N 3BG, UK

Received 9 December 2003

Accepted 27 April 2004


Distinct prion strains can be distinguished by differences in incubation period, neuropathology

and biochemical properties of disease-associated prion protein (PrPSc) in inoculated mice.

Reliable comparisons of mouse prion strain properties can only be achieved after passage in

genetically identical mice, as host prion protein sequence and genetic background are known

to modulate prion disease phenotypes. While multiple prion strains have been identified in

sheep scrapie and CreutzfeldtJakob disease, bovine spongiform encephalopathy (BSE) is

thought to be caused by a single prion strain. Primary passage of BSE prions to different lines

of inbred mice resulted in the propagation of two distinct PrPSc types, suggesting that two

prion strains may have been isolated. To investigate this further, these isolates were

subpassaged in a single line of inbred mice (SJL) and it was confirmed that two distinct prion

strains had been identified. MRC1 was characterized by a short incubation time (110±3 days),

a mono-glycosylated-dominant PrPSc type and a generalized diffuse pattern of PrP-immunoreactive

deposits, while MRC2 displayed a much longer incubation time (155±1 days),

a di-glycosylated-dominant PrPSc type and a distinct pattern of PrP-immunoreactive deposits

and neuronal loss. These data indicate a crucial involvement of the host genome in modulating

prion strain selection and propagation in mice. It is possible that multiple disease phenotypes

may also be possible in BSE prion infection in humans and other animals.


http://vir.sgmjournals.org/cgi/content/abstract/85/8/2471

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

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


Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518






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