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From: TSS ()
Subject: R-CALF VS USDA STATE COURT OF APPEALS NINTH CIRCUIT JULY 14, 2005
Date: July 14, 2005 at 6:12 pm PST


NOT FOR PUBLICATION

STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

RANCHERS CATTLEMEN ACTION

LEGAL FUND UNITED

STOCKGROWERS OF AMERICA,

Plaintiff - Appellee,

v.

UNITED STATES DEPARTMENT OF

AGRICULTURE, Animal and Plant Health

Inspection Service; MIKE JOHANNS, in

his capacity as the Secretary of

Agriculture,

Defendants - Appellants.

No. 05-35264

DC No. CV 05-006 RFC

D. Mont.

ORDER

Before: TASHIMA, PAEZ, and CALLAHAN, Circuit Judges.

The court, after consideration of the briefs of the parties and the various

amici curiae, and oral argument, has determined that the order of the United States

District Court for the District of Montana of March 5, 2005, granting a preliminary

injunction enjoining the enforcement of a final rule issued by the Animal and Plant

Health Inspection Service, United States Department of Agriculture, published on

January 4, 2005, entitled "Bovine Spongiform Encephalopathy, Minimal Risk

FILED

JUL 14 2005

CATHY A. CATTERSON, CLERK

U.S. COURT OF APPEALS

2

Regions and Importation of Commodities; Final Rule and Notice" (the "Preliminary

Injunction Order"), 70 Fed. Reg. 460, must be reversed.

It is therefore ORDERED:

1. Pursuant to Fed. R. App. P. 8(a), the court sua sponte hereby stays the

Preliminary Injunction Order, effective immediately, pending the final resolution of

this appeal.

2. An opinion setting forth the reasons for the court’s reversal of the

Preliminary Injunction Order shall be issued expeditiously and in due course.

http://www.ca9.uscourts.gov/ca9/Documents.nsf/54dbe3fb372dcb6c88256ce50065fcb8/134c98ea28ef26cd88256fcb007db929/$FILE/R-CALF_stayord.pdf

R-CALF Cattle Update: Disappointment In Court Ruling

“We are disappointed in today’s ruling by the 9th S. Circuit Court of Appeals. The 9th Circuit gave no reasons for their action, so there isn’t much we can do until we see those reasons.

“R-CALF USA remains confident that USDA’s Final Rule was not justified, and that USDA did not provide significant justification for overturning a longstanding policy that protected both the U.S. cattle herd and U.S. consumers from the introduction of BSE.

“USDA’s Final Rule is based merely on a reinterpretation of existing science that has been around for years. USDA is motivated by political considerations of wanting to resume trade with Canada.

“R-CALF is confident that when we have a full hearing on the merits of the case, we will demonstrate to the district court that USDA’s actions are premature and unjustified.

“This decision makes mandatory COOL all the more important so consumers will know where their beef comes from.”

http://www.cattlenetwork.com/content.asp?contentid=5940

United States Court of Appeals for the Ninth Circuit

Office of the Clerk of Court

July 8, 2005

NOTICE

Re: Oral Arguments in Seattle, Washington, July 13, 2005

• Ranchers Cattlemen v. USDA, CA# 05-35214 etc. ("the beef case")

• National Wildlife Federation v. National Marine Fisheries,CA# 05-35569, 70

("the salmon case")

Two of the cases on the July 13, 2005 oral argument calendar in Seattle have generated

media interest. Oral argument will take place at The Park Place Building, 1200 Sixth Avenue,

21st Floor, Seattle, Washington.

The first case, the "beef" case, is scheduled for oral argument Wednesday morning, July

13, 2005 before the panel of Ninth Circuit Judges A. Wallace Tashima, Richard Paez, and

Consuelo Callahan. The calendar for that day starts at 9:00 a.m. The "beef" case is scheduled

fourth on the morning calendar; argument is expected to start at approximately 11:00am and last

one hour.

Seating for the lawyers in the cases on the calendar will be reserved, along with a limited

number of seats for the media. The media seats are available on a first come basis. An

overflow courtroom with a video connection is available on the fourth floor. The courtroom

doors will be opened at 8:00am. Picture identification is required to enter the courtroom.

The second cases generating media interest is the "salmon" case, scheduled for argument

in the same courtroom at 2:00 p.m. before the Ninth Circuit panel of Judges A. Wallace Tashima,

Sidney Thomas and Richard Paez. That case is the only case on the afternoon calendar. Oral

argument is scheduled to take approximately forty minutes.

The panel is not expected to rule from the bench. The Court’s decisions will be posted

on the court’s web page as soon as they are available. Digital audio recordings of all oral

arguments before the Court are available the next day on the court’s web page. Pleadings filed

in both these cases are also available on the web page. www.ca9.uscourts.gov.

Seattle Clerk’s Office: 206/553-2937 San Francisco Clerk’s Office: 415/556-9800

http://www.ca9.uscourts.gov/ca9/Documents.nsf/54dbe3fb372dcb6c88256ce50065fcb8/3bd4a626371607c588257038006023ec/$FILE/OralArgSeattle.pdf


Click to view: http://www.usda.gov/2005/07/0258.xml

Release No. 0258.05
Contact:
USDA Press Office (202) 720-4623

SECRETARY JOHANNS STATEMENT ON NINTH CIRCUIT COURT RULING

July 14,2005

"I applaud today's ruling by the Ninth Circuit Court of Appeals to lift the preliminary injunction that blocked implementation of the BSE minimal risk regions rule. Because the ruling is effective immediately, we are immediately taking steps to resume the importation of cattle under 30 months of age from Canada.

"USDA's Animal and Plant Health Inspection Service is already in contact with the Canadian Food Inspection Agency to prepare to certify cattle for shipment. We have been safely importing boneless boxed beef from Canada since September 2003, and now we will use the scientific approach laid-out in our minimal risk rule to once again safely import live Canadian cattle for processing.

"This is great news for the future of the U.S. beef industry, specifically the many ranchers, feeders, and processing plants that have been struggling to make ends meet due to the closed border. It also bolsters our position with other international trading partners by following the very advice we have given them to base trade decisions on sound science."


#
USDA News
oc.news@usda.gov
202 720-4623
==============

GW's BSE/TSE MRR POLICY IS A LEGAL TRADING POLICY
TO MAKE LEGAL THE TRADING OF ALL STRAINS OF HUMAN/ANIMAL

TSEs. A POLICY FOR SUICIDE OF LONG INCUBATION. IT'S ABOUT

NOTHING MORE THAN COMMODITIES AND FUTURES $$$

TSS


>DATA Charmaine's HD:BSE - AUGUST 95-fill in bse position paper spec<


FROM THE DIRECTOR GENERAL

24 August, 1995

STRICTLY PRIVATE AND CONFIDENTIAL


Dear •salutation

UKASTA POLICY ON BSE

At the President's suggestion in the light of recent events, I have
reviewed the history of our policy on BSE so as to ensure that it fully
reflects the needs of our supporters In the feed Industry.

The paper enclosed with this letter is the result. For obvious reasons,
this is being circulated only to an extremely small circle within
UKASTA - basically, the National Executive Council.

If you have any comments on the policy, or the paper, I should be glad
to receive them under Private & Confidential cover.

Yours sincerely,

J.W. REED

JWR/cg

copied to SMT members - IJD; JN; JAS; REW


95/8.24/2.1


STRICTLY PRIVATE AND CONFIDENTIAL

UKASTA INTERNAL POSITION STATEMENT
BOVINE SPONGIFORM ENCEPHALOPATHY

POLICY AIMS

1. These have been consistent, although unstated except In FEC discussions, since at least 1989:-

• 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.


STRATEGY ADOPTED/SUCCESS ACHIEVED

2. Strategy has depended upon the situation at a particular time.
UKASTA has sought to anticipate criticism from other industry sectors
and action by Government/Brussels as the epidemic has developed
and knowledge of the disease increased. Through dose liaison with
MAFF. we have to date avoided public statements seriously damaging
to the feed Industry and the adoption of policies likely to lead to such
damage.

3. Successful examples of this strategy include:

• "Voluntary Ban" on SBO's In all MBM purchase contracts from
November 1989. matching the Government ban on SBO'S in
human food but anticipating the statutory ban on SBO's in feed
which came in only from September 1990;

• Pressing Government for full compensation to farmers, which was
finally conceded in February 1990;

• evidence (not Just on BSE) to the Lamming Committee in 1991/92
resulted in their recommending tighter controls over home
mixers/integrated operations, and over the processing of fallen
animals. Government eventually tightened the fallen animals
legislation in December 1992. Other Lamming recommendations
could yet be useful to us.

continued.....

95/8.24/2.2

2

• UKASTA pressure dissuaded MAFF from publicly linking voluntary
ELISA tests of feed on farms with BAB's to (possibly compulsory)
tests at compounders' premises in June/July 1994:

• in August 1995. while tightening the SBO Order and responding
to the EU Decision requiring introduction of a testing programme.
MAFF has accepted UKASTA proposals for the presentation of the
changes to a wider audience, including farmers, and accepted our
help in preparing for an EU Commission visit to inspect
procedures and controls.


THE FUTURE

4. BSE has for more than seven years posed the greatest single potential
threat to feed compounders' profitability. Although the epidemic is in
sharp decline (275 cases per week compared to 1000 at the peak).
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. In issue management
terms, the aims and the strategy remain valid, but must be kept
under review in the light of further events.

JWR/cg/23.8.95

95/8.24/2.3


SEE full text ;

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


Last Updated: 07/14/2005

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

Subject: Pleadings related to Rancher's Cattlemen Action, et al v. US Dept of Agriculture


Attachment:
Double click icon to view.

Date Posted

Document
Topic
Filesize (Kbytes)






07/14/05



Order

8.6


07/11/05



Reply Brief for the Proposed Intervenors-Appellants

3,175.8


07/07/05



Appellee's Brief

7,574.6


07/05/05



Answering Brief for Plaintiff-Appellee

3,453.8


07/05/05



Order

78.2


07/01/05



On Appeal from the United States District Court for the District of Montana

957.2


06/28/05



Brief of Amici Curiae Supporting Appellee R-Calf

2,625.8


06/28/05



June 28, 2005

68.5


06/21/05



Intervenors-Appellants' Brief


3,629.6


06/16/05



Reply Brief Appellants

2,527.9


06/16/05



Amicus Brief Appellee

9,946.3


06/16/05



Appellants' Brief

7,751.5


06/16/05



Amicus Brief R-Calf

2,563.2


06/16/05



Amicus Brief Government of Canada

3,060.2


06/16/05



Amicus Brief National Beef Cattlemens Association

2,539.3


06/16/05



Amicus Brief Alberta Beef Producers

1,738.7


06/16/05



Amicus Brief Tyson Foods

3,278.3


06/16/05



Amicus Brief Pioneer

1,753.0


06/16/05



Amicus Brief Montana, et al.

1,942.2


06/16/05



Amicus Brief Easterday Ranches

4,636.6


06/16/05



Amicus Brief American Meat Institute

3,381.7


06/16/05



Amicus Brief Pioneer

1,753.0


06/16/05



Order

91.6


06/16/05



Order

160.4


06/01/05



Motion of Proposed Amici Curiae for Leave to File Brief

426.4


06/01/05



Order

6.6


05/23/05



Order

48.6


05/12/05



Reply in Support of Motion for Leave to File Amici Curiae Brief


179.0


05/12/05



Replacement Brief of Amicus Brief In Support of Appellants and Reversal of The District Court's Preliminary Injunction Order

1,931.9


05/12/05



Motion of Amicus Curiae For Leave To File Replacement Brief in Support of Appellant's and Reversal of The District Court's Preliminary Injunction Order

1,891.9


05/12/05



Reply To Opposition To Motions For Leave To File Amici Curiae Briefs

314.4


05/12/05



Opposition of Amicus Curiae To Plaintiff-Appellee's Motion to Strike

254.6


05/12/05



Reply of the Government to Opposition To Motions For Leave To File Amicus Briefs

323.9


05/12/05



Amicus Curiae Reply To Opposition To Motion For Leave To File Amicus Brief

273.2


05/12/05



Order

104.8


05/12/05



Reply in Support of Motion For Leave To File a Brief Amicus Curiae

256.5


05/06/05



Related Case - Order

45.6


05/03/05



Opposition to Motions for Leave to File Briefs as Amici Curiae

987.6


04/04/05



Order

85.8


03/25/05



Order

87.4


03/21/05



Order of Preliminary Injunction

66.5


03/21/05



Opinion

1,254.6


03/21/05



Notice of Preliminary Injunction Appeal


212.2









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

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



http://www.ca9.uscourts.gov/ca9/Documents.nsf/54DBE3FB372DCB6C88256CE50065FCB8/134C98EA28EF26CD88256FCB007DB929?OpenDocument


Agency blamed for mad cow fallout

By DENNIS BUECKERT


OTTAWA (CP) - Canada's $8-billion mad cow disaster can be squarely attributed the failure of the Canadian Food Inspection Agency to assess economic consequences of even a single infection, says a leading expert.

William Leiss of the University of Ottawa, who is also a past president of the Royal Society of Canada, said the CFIA assessed the risk of mad cow to animal health and human health, but not the risk of losing export markets. Yet Canada was party to an international agreement providing for a ban on exports from any country with even a single case of the disease. The policy was known as "one cow and you're out."

"What would be the economic impact of one or just a few cases of BSE (bovine spongiform encepalopathy) in the Canadian herd?" Leiss asked at a World Health Organization conference on risk management.

"We failed completely to manage or even to recognize this risk at our great cost."

He said Canada followed U.S. policies in adopting a minimal testing program. But Canada's risk profile is completely different from that of the United States.

At the time, Canada exported 75 per cent of beef production while the United States exported only 10 per cent. Losing export markets was not a serious problem for the Americans, he said.

"In food issues we are cursed with the political attitude that we've just got to be onside with the U.S. and nothing else matters."

He said the CFIA also followed the U.S. lead in making a half-hearted effort to stop recycling infected protein in ruminant food, which is widely believed to be the cause of mad cow disease.


Leiss said the CFIA ban on feeding proteins from ruminants to ruminants remains "full of holes."

Leiss said the United States conducted a full risk assessment in 1997-98, but Canada did not do one until six years later.

CFIA spokesman Marc Richard said the agency didn't include economic consequences in its assessment because that is not the agency's mandate.

"We don't usually address the economic stuff," said Richard in an interview. "The risk assessment was based strictly on the disease. Overall we're the administrators of the Animal Health Act.

"The CFIA's risk assessments have to do with animal disease. That is our mandate and in our mandate we specifically don't address economics."

But another CFIA official, senior veterinarian Darcy Undseth, said economic consequences of a mad cow infection in Canada were considered in a 2002 risk assessment even though they were not quantified.

He said the consequences were described in that assessment as "extreme."

Undseth said the CFIA's response was "very successful because of the proactive steps taken since 1990 and the very measured response taken in a North American context.

"BSE has not established and amplified in North America but was captured on its way to eradication."

Asked about the estimated $8 billion in economic losses to date, Undseth said animal diseases do have economic impact but the BSE response "has been a successful program."

http://cnews.canoe.ca/CNEWS/Canada/2005/07/12/1128444-cp.html


USA BSE GBR RAISED TO BSE GBR III

Working Group Report on the Assessment of the Geographical BSE-Risk (GBR
III) of USA 2004 ''extremely/very unstable BSE/cattle system''

USA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf>

CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf

MEXICO

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf


Canada and the United States have been raised to level III (presence of BSE likely but not confirmed, or confirmed at a lower level) following a new assessment taking into account the most recent evidence. EFSAs Scientific Expert Working Group on geographic BSE risk assessment also evaluated the status of Mexico and South Africa which were classified as level III.

http://www.efsa.eu.int/press_room/press_release/575_en.html


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

Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA


From: TSS ()
Subject: MAD COW FEED BAN WARNING LETTER USA June 9, 2005
Date: July 5, 2005 at 8:46 am PST

Department of Health and Human Services Public Health Service
Food and Drug Administration

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7119
FAX: (612) 334-4142


June 9, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 05-15

Michael J. Langenhorst
President
Anamax Corporation
P.O. Box 10067
Green Bay, WI 54307

Dear Mr. Langenhorst:

Our inspection of your rendering plant located at 505 Hardman Avenue South, South St. Paul, Minnesota, from January 12-20, 2005, revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations , Part 589 .2000 (21 CFR 589 .2000), Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow the requirements of this regulation, products being manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], and misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)].

Our investigation found that you failed to provide for measures to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] in that:

1. You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.

2. You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.

Our investigation also found that you failed to label products that may contain protein derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants." For example, your Feather Meal and Stabilized Poultry By-Product Meal lack this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues. Because your products do not bear this caution statement, they are misbranded under Section 403(a)(1) of the Act [21 U.S .C. 343(a)(1)).

The above is not intended as an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.

You should acknowledge this letter within 15 working days of receiving and include any additional corrective actions concerning your facility. We have received your letter dated January 31, 2005, which replies to the Form FDA-483 issued on January 20, 2005, and your letter dated February 25, 2005, that states all corrections have been implemented. The corrections you have reported appear to be adequate but will be evaluated further during our follow-up inspection.

Your response should be directed to Compliance Officer Jane E . Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District


http://www.fda.gov/foi/warning_letters/g5373d.pdf
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA


https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed

Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument


Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA


https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed


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 ...


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, ...

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. ...


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


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
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1


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

Send Post-Publication Peer Review to journal:


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.


Until recently, CWD was thought to be confined to the wild in a small

region in Colorado. But since early 2002, it has been reported in other

areas, including Wisconsin, South Dakota, and the Canadian province of

Saskatchewan. Indeed, the occurrence of CWD in states that were not

endemic previously increased concern about a widespread outbreak and

possible transmission to people and cattle.


To date, experimental studies have proven that the CWD agent can be

transmitted to cattle by intracerebral inoculation and that it can cross

the mucous membranes of the digestive tract to initiate infection in

lymphoid tissue before invasion of the central nervous system. Yet the

plausibility of CWD spreading to people has remained elusive.


Part of the problem seems to stem from the US surveillance system. CJD

is only reported in those areas known to be endemic foci of CWD.

Moreover, US authorities have been criticised for not having performed

enough prionic tests in farm deer and elk.


Although in November last year the US Food and Drug Administration

issued a directive to state public-health and agriculture officials

prohibiting material from CWD-positive animals from being used as an

ingredient in feed for any animal species, epidemiological control and

research in the USA has been quite different from the situation in the

UK and Europe regarding BSE.


Getting data on TSEs in the USA from the government is like pulling

teeth, Singeltary argues. You get it when they want you to have it,

and only what they want you to have.


Norman Foster, director of the Cognitive Disorders Clinic at the

University of Michigan (Ann Arbor, MI, USA), says that current

surveillance of prion disease in people in the USA is inadequate to

detect whether CWD is occurring in human beings; adding that, the

cases that we know about are reassuring, because they do not suggest the

appearance of a new variant of CJD in the USA or atypical features in

patients that might be exposed to CWD. However, until we establish a

system that identifies and analyses a high proportion of suspected prion

disease cases we will not know for sure. The USA should develop a

system modelled on that established in the UK, he points out.

Ali Samii, a neurologist at Seattle VA Medical Center who recently

reported the cases of three hunterstwo of whom were friendswho died

from pathologically confirmed CJD, says that at present there are

insufficient data to claim transmission of CWD into humans; adding that

[only] by asking [the questions of venison consumption and deer/elk

hunting] in every case can we collect suspect cases and look into the

plausibility of transmission further. Samii argues that by making both

doctors and hunters more aware of the possibility of prions spreading

through eating venison, doctors treating hunters with dementia can

consider a possible prion disease, and doctors treating CJD patients

will know to ask whether they ate venison.


CDC spokesman Ermias Belay says that the CDC will not be investigating

the [Samii] cases because there is no evidence that the men ate

CWD-infected meat. He notes that although the likelihood of CWD

jumping the species barrier to infect humans cannot be ruled out 100%

and that [we] cannot be 100% sure that CWD does not exist in humans&

the data seeking evidence of CWD transmission to humans have been very

limited.


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


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.<<<

actually, that quote was from a more recent article in the Journal of

Neurology (see below), not the JAMA article...

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

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 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. Best 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

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,
OF ALL AGES. ...

TSS






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