From: TSS ()
Subject: STATEMENT BY AGRICULTURE SECRETARY MIKE JOHANNS REGARDING THE FREE TRADE AGREEMENT WITH KOREA
Date: April 6, 2007 at 8:40 am PST
FORCE FEEDING S KOREA USDA CERTIFIED MAD COW BEEF AND BUSH'S MAD COW POLICY DON'T LOOK, DON'T FIND
Release No. 0090.07
Contact:
Office of Communications (202) 720-4623
STATEMENT BY AGRICULTURE SECRETARY MIKE JOHANNS REGARDING THE FREE TRADE AGREEMENT WITH KOREA
April 5, 2007
snip...
"While the agreement includes many beneficial provisions for U.S. agricultural products, I am confident in saying that it will not be ratified unless Korea opens its market to U.S. beef in accordance with science-based international guidelines."
snip...
http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/1/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2007%2F04%2F0090.xml&PC_7_2_5JM_parentnav=LATEST_RELEASES&PC_7_2_5JM_navid=NEWS_RELEASE#7_2_5JM
Information on the Washington State Investigation of the BSE-positive Cow
This Office of Inspector General (OIG)
http://www.usda.gov/oig/webdocs/TestimonyBlurb2.pdf
http://www.usda.gov/oig/webdocs/Testimony7-2004.pdf
http://www.usda.gov/oig/webdocs/50601-9-final.pdf
OIG REPORT ON IMPORTS FROM CANADA
http://www.usda.gov/oig/webdocs/33601-01-HY.pdf
Final Case Summeries
May 02, 2006 Alabama BSE Investigation-Final Epidemiology Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/EPI_Final5-2-06.pdf
http://www.scienceblog.com/cms/feds_confirm_mad_cow_in_alabama_10204.html
http://www.prwatch.org/node/4624
http://www.microbes.info/forums/index.php?showtopic=306
Aug 30, 2005 USDA Texas BSE Investigation-Final Epidemiology Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/bse_final_epi_report8-05.pdf
TSS REPORT ON 2ND TEJAS MAD COW Mon, 22 Nov 2004 17:12:15 -0600 (the one
that did NOT get away, thanks to the Honorable Phyllis Fong)
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Mon, 22 Nov 2004 17:12:15 -0600
From: "Terry S. Singeltary Sr."
To: Carla Everett
References: <[log in to unmask]>
<[log in to unmask] us>
Greetings Carla,still hear a rumor;
Texas single beef cow not born in Canada no beef entered the food chain?
and i see the TEXAS department of animal health is ramping up forsomething,
but they forgot a url for update?I HAVE NO ACTUAL CONFIRMATION YET...can you
confirm???terry
==============================
==============================
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Fri, 19 Nov 2004 11:38:21 -0600
From: Carla Everett
To: "Terry S. Singeltary Sr."
References: <[log in to unmask]>
The USDA has made a statement, and we are referring all callers to the USDA
web site. We have no informationabout the animal being in Texas. CarlaAt
09:44 AM 11/19/2004, you wrote:>Greetings Carla,>>i am getting
unsubstantiated claims of this BSE 'inconclusive' cow is from>TEXAS. can you
comment on this either way please?>>thank you,>Terry S. Singeltary Sr.>>
===================
===================
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Mon, 22 Nov 2004 18:33:20 -0600
From: Carla Everett
To: "Terry S. Singeltary Sr."
References: <[log in to unmask]>
<[log in to unmask] us>
<[log in to unmask]> <[log in to unmask]
us> <[log in to unmask]>
our computer department was working on a place holder we could post USDA's
announcement of any results. There are no results to be announced tonight by
NVSL, so we are back in a waiting mode and will post the USDA
announcementwhen we hear something.At 06:05 PM 11/22/2004, you wrote:>why
was the announcement on your TAHC site removed?>>Bovine Spongiform
Encephalopathy:>November 22: Press Release title here >>star image More BSE
information>>>>terry>>Carla Everett wrote:>>>no confirmation on the U.S.'
inconclusive test...>>no confirmation on location of
animal.>>>>>>
==========================
==========================
THEN, 7+ MONTHS OF COVER-UP BY JOHANN ET AL! no doubt about it now $$$
NO, it's not pretty, hell, im not pretty, but these are the facts, take em
or leave em, however, you cannot change them.
with kindest regards,
I am still sincerely disgusted and tired in sunny Bacliff, Texas USA 77518
Terry S. Singeltary Sr.
FULL 130 LASHINGS TO USDA BY OIG again
http://www.usda.gov/oig/webdocs/50601-10-KC.pdf
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=23557
Feb 06, 2004 Washington State Investigation-Final Epidemiology Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/WashingtonState_epi_final3-04.pdf
NOT TO FORGET about the other TEXAS MAD COW they did succeed in covering up ;
FOR IMMEDIATE RELEASE
Statement
May 4, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
Statement on Texas Cow With Central Nervous System Symptoms
On Friday, April 30 th , the Food and Drug Administration learned that a cow with central nervous system symptoms
had been killed and shipped to a processor for rendering into animal protein for use in animal feed.
FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout
the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came
from, and the processor that initially received the cow from the slaughterhouse.
FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of
protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being
held by the firm, which is cooperating fully with FDA.
Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform
encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way
now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered
protein to other ruminant animals (e.g., cows, goats, sheep, bison).
FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of
this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown
not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all
the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used
only as feed for pigs.
To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other
ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the
disease spreads by feeding infected ruminant protein to cattle.
Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant
animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry.
FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture
on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of
several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger.
Page 79 of 98
8/3/2006
####
http://www.fda.gov/bbs/topics/news/2004/NEW01061.html
OR THE TEXAS PURINA MAD COW FEED INCIDENT ;
FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
--------------------------------------------------------------------------------
Note: On Dec. 23, 2003, the U.S. Department of Agriculture reported that a cow in Washington state had tested
positive for bovine spongiform encephalopathy (BSE, or mad cow disease). As a result, information on this Web page
stating that no BSE cases had been found in the United States is now incorrect. However, because other information on
this page continues to have value, the page will remain available for viewing.
FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT
Today the Food and Drug Administration announced the results of tests taken on feed used at a Texas feedlot that was
suspected of containing meat and bone meal from other domestic cattle -- a violation of FDA's 1997 prohibition on
using ruminant material in feed for other ruminants. Results indicate that a very low level of prohibited material was
found in the feed fed to cattle.
FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams -
approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.
It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected
material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential
risk of BSE to such cattle is therefore exceedingly low, even if the feed were contaminated.
According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and
industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant
animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's
(USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of
protections, to keep American cattle free of BSE."
Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily purchasing all 1,222 of
the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from
those animals will not enter the human food supply. FDA believes any cattle that did not consume feed containing the
prohibited material are unaffected by this incident, and should be handled in the beef supply clearance process as usual.
Page 80 of 98
8/3/2006
FDA believes that Purina Mills has behaved responsibly by first reporting the human error that resulted in the
misformulation of the animal feed supplement and then by working closely with State and Federal authorities.
This episode indicates that the multi-layered safeguard system put into place is essential for protecting the food supply
and that continued vigilance needs to be taken, by all concerned, to ensure these rules are followed routinely.
FDA will continue working with USDA as well as State and local officials to ensure that companies and individuals
comply with all laws and regulations designed to protect the U.S. food supply.
http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
BUT yet they knew at that time 5.5 grams would be enough to kill 100 cows ;
look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused
7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in
primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to
non-human primates. We gave two macaques a 5 g oral dose of brain homogenate
from a BSE-infected cow. One macaque developed vCJD-like neurological
disease 60 months after exposure, whereas the other remained free of disease
at 76 months. On the basis of these findings and data from other studies, we
made a preliminary estimate of the food exposure risk for man, which
provides additional assurance that existing public health measures can
prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
It is clear that the designing scientists must
also have shared Mr Bradley’s surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
2
6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100
grams) was probably given with the benefit of hindsight; particularly if one
considers that later in the same answer Mr Bradley expresses his surprise that it
could take as little of 1 gram of brain to cause BSE by the oral route within the
same species. This information did not become available until the "attack rate"
experiment had been completed in 1995/96. This was a titration experiment
designed to ascertain the infective dose. A range of dosages was used to ensure
that the actual result was within both a lower and an upper limit within the study
and the designing scientists would not have expected all the dose levels to trigger
infection. The dose ranges chosen by the most informed scientists at that time
ranged from 1 gram to three times one hundred grams. It is clear that the designing
scientists must have also shared Mr Bradley’s surprise at the results because all the
dose levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
2) Infectious dose:
To cattle: 1 gram of infected brain material (by oral ingestion)
http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml
MADCOW Postcard from … Seoul
(READ AND SKROLL ALL THE WAY TO BOTTOM OF PAGE. ...TSS
Name: Terry S. Singeltary Sr. Date: Jan 26, 2007
Dear Terry S. Singeltary Sr.
My name in Seoungwon Lee and I work for National Assemblywoman (MP) Sang-Jeong Sim, in South Korea. Below is a message from Mr. Kwon. Please get back to us regarding the letter.
Thank you.
Seoungwon Lee
Legislative Assistant
National Assembly
Republic of Korea
Dear Terry S. Singeltary Sr.
Greetings from Korea.
I have learned about what you and your family have been through a internet. Being the father of a small family, I can only imagine the sense of loss that you and your family still must feel regarding your mother.
SNIP...FULL TEXT ;
http://www.fpif.org/fpiftxt/3940
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling’s 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007. Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI – 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J – PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A-BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html
Thursday, March 15, 2007
Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD)
From Plasma-Derived Products
In recent years, questions have been raised concerning the potential risk of variant Creutzfeldt-Jakob disease (vCJD - a rare but fatal brain infection) for recipients of plasma- derived clotting factors, including United States (US) licensed Factor Eight (pdFVIII), Factor Nine (pdFIX), and other plasma-derived products such as immune globulins and albumin. In response to these questions, FDA conducted a risk assessment. Based on the risk assessment, the US Public Health Service believes that the risk of vCJD to patients who receive US licensed pdFVIII products is most likely to be extremely small, although we do not know the risk with certainty. vCJD risk from other plasma derived products, including Factor IX, is likely to be as small or smaller.
This web page provides FDA’s risk assessment for US licensed pdFVIII and risk communication materials for this product and other plasma derivatives. Included are Key Points, and Questions and Answers. Additional links are provided to FDA’s current guidance documents on deferral of blood and plasma donors who may be at increased risk of vCJD, and to other sources of information regarding vCJD.
Documents Regarding US Licensed pdFVIII, and Other US Licensed Plasma Derivatives Including pdFIX
Potential vCJD Risk From US Licensed Plasma-Derived Factor VIII (pdFVIII, Antihemophilic Factor) Products: Summary Information, Key Points
Risk Assessment (PDF, 582 KB)
Risk Assessment Appendix (PDF, 623 KB)
Questions and Answers on vCJD and pdFVIII
Questions and Answers on vCJD and Plasma Derivatives Other than pdFVIII
Guidance on Donor Deferral Related to CJD and vCJD
Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products" - 8/2006
Questions and Answers on FDA Guidance: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob (CJD) Disease and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products - 1/22/2004
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products - 1/2002
Other Sources of Information
Transmissible Spongiform Encephalopathies Advisory Committee
Blood Products Advisory Committee Meeting – Summary of Recent TSEAC Meeting and Statement about FXI from the UK, on October 21, 2004
Information on vCJD: Centers for Disease Control and Prevention
Information on Bovine Spongiform Encephalopathy (“Mad Cow Disease”): US Department of Agriculture
Patient Organizations:
Committee of Ten Thousand
Hemophilia Federation of America
National Hemophilia Foundation and/or HANDI
World Federation of Hemophilia
http://www.fda.gov/cber/blood/vcjdrisk.htm
PRODUCT
Recovered Plasma, Recall # B-0854-07
CODE
Unit: V10665
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by email on August 25, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
END OF ENFORCEMENT REPORT FOR MARCH 14, 2007
###
http://www.fda.gov/bbs/topics/enforce/2007/ENF00995.html
nvCJD mad cow blood recalls ENFORCEMENT REPORT FOR MARCH 7, 2007
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0805-07;
b) Platelets, Recall # B-0806-07;
c) Recovered Plasma, Recall # B-0807-07
CODE
a) Units: 4759943, 4677574, 4555912;
b) Units: 4759943, 4555912;
c) Units: 4677574, 4555912
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MA, OK, TX, and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0808-07;
b) Platelets, Recall # B-0809-07;
c) Recovered Plasma, Recall # B-0810-07
CODE
a), b), and c) Unit: 5249546
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N, Goldman Center, Oklahoma City, OK, by facsimile on August 1, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OK, NB, and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0811-07;
b) Recovered Plasma, Recall # B-0812-07
CODE
a) and b) Unit: 5218775
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N, Goldman Center, Oklahoma City, OK, by facsimile on July 7, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0826-07;
b) Platelets, Recall # B-0827-07;
c) Fresh Frozen Blood, Recall # B-0828-07;
d) Recovered Plasma, Recall # B-0829-07
CODE
a) Units: 5250527, 4901850, 4517058;
b) Units: 4901850, 4517058;
c) Unit: 4517058;
d) Units: 5250527, 4901850
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 27, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
OK, TX, Austria, and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0843-07;
b) Recovered Plasma, Recall # B-0844-07
CODE
a) and b) Units: 5738052, 5275313, 4801421
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on January 22, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TX, OK, and Switzerland
END OF ENFORCEMENT REPORT FOR MARCH 7, 2007
###
http://www.fda.gov/bbs/topics/enforce/2007/ENF00994.html
4th CASE VCJD VIA BLOOD TRANSFUSION, BSE, BASE, AND SPORADIC CJD
By Terry S Singeltary
Bacliff, Texas USA Jan 24, 07
http://bloodindex.org/view_news_zone.php?id=206
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
----- Original Message -----
From: Terry S. Singeltary Sr.
To: Terry S. Singeltary Sr. ; [log in to unmask]
Cc: [log in to unmask] ; [log in to unmask]
Sent: Thursday, November 30, 2006 1:47 PM
Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION PART II]
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&P=16159
USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN
18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.
snip...
64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.
Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.
snip...
http://www.seac.gov.uk/minutes/95.pdf
3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse
Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University
Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.
***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.***
6:30 Close of Day One
http://www.healthtech.com/2007/tse/day1.asp
SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...
http://www.cjdsurveillance.com/resources-casereport.html
There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.
He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf
THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ;
CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006
The U.S. Department of Agriculture was quick to assure the public earlier
this week that the third case of mad cow disease did not pose a risk to
them, but what federal officials have not acknowledged is that this latest
case indicates the deadly disease has been circulating in U.S. herds for at
least a decade.
The second case, which was detected last year in a Texas cow and which USDA
officials were reluctant to verify, was approximately 12 years old.
These two cases (the latest was detected in an Alabama cow) present a
picture of the disease having been here for 10 years or so, since it is
thought that cows usually contract the disease from contaminated feed they
consume as calves. The concern is that humans can contract a fatal,
incurable, brain-wasting illness from consuming beef products contaminated
with the mad cow pathogen.
"The fact the Texas cow showed up fairly clearly implied the existence of
other undetected cases," Dr. Paul Brown, former medical director of the
National Institutes of Health's Laboratory for Central Nervous System
Studies and an expert on mad cow-like diseases, told United Press
International. "The question was, 'How many?' and we still can't answer
that."
Brown, who is preparing a scientific paper based on the latest two mad cow
cases to estimate the maximum number of infected cows that occurred in the
United States, said he has "absolutely no confidence in USDA tests before
one year ago" because of the agency's reluctance to retest the Texas cow
that initially tested positive.
USDA officials finally retested the cow and confirmed it was infected seven
months later, but only at the insistence of the agency's inspector general.
"Everything they did on the Texas cow makes everything USDA did before 2005
suspect," Brown said. ...snip...end
http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r
CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central
Nervous System ... Address for correspondence: Paul Brown, Building 36, Room
4A-05, ...
http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm
PAUL BROWN COMMENT TO ME ON THIS ISSUE
Tuesday, September 12, 2006 11:10 AM
"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."
OR, what the Honorable Phyllis Fong of the OIG found ;
Audit Report
Animal and Plant Health Inspection Service
Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II
and
Food Safety and Inspection Service
Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III
Report No. 50601-10-KC January 2006
Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain
http://www.usda.gov/oig/webdocs/50601-10-KC.pdf
EXPORTATION AND IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS:
BSE; MRR AND IMPORTATION OF COMMODITIES, 65758-65759 [E6-19042]
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&T=0&P=3854
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&P=3381
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=498
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0702&L=sanet-mg&T=0&P=10277
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&T=0&P=9972
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=4492
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=2583
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=2470
Subject: Re: Docket No. 2005N-0373 RIN number 0910-AF54 TSS SUBMISSION
Date: March 30, 2007 at 10:57 am PST
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=19128
O.I.E. SELLS THERE SOUL TO THE DEVIL AND WILL REPEAT WHAT THE
U.K. DID, POISON THE WORLD LEGALLY WITH MAD COW DISEASEs
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=498
Re: UK's first case of H-type BSE confirmed by DEFRA
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=8125
UNITED STATES DOCUMENTS FIRST CASE RARE NOR98 SCRAPIE STRAIN
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=10928
DeHaven to leave APHIS
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=15937
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=2583
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=187
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=13149
A special form of PrPSc in muscles of a BSE-infected cow ''PRION 2005''
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=4492
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle 03-025IFA 03-025IFA-2 9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
PAUL BROWN M.D.
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf
9 December 2005
Division of Dockets Management (RFA-305)
SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf
Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm
Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of
Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm
03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf
03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf
Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf
In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf
3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,
but Oversight Weaknesses Continue to Limit Program Effectiveness.
GAO-05-101, Feb. 25.
www.gao.gov/cgi-bin/getrpt?GAO-05-101
Highlights - www.gao.gov/highlights/d05101high.pdf
TSS
