Tuesday, April 21, 2015

Transmissible Spongiform Encephalopathy Advisory Committee TSEAC MEETING SCHEDULED FOR June 1, 2015

Transmissible Spongiform Encephalopathy Advisory Committee TSEAC MEETING SCHEDULED FOR June 1, 2015

 

 

2015 Advisory Committee Tentative Meetings

 

The tentatively scheduled advisory committee meetings will provide both advisory committee members and the public with the opportunity, in advance, to schedule attendance at FDA's upcoming advisory committee meetings. Changes to this list will be posted on this site on a monthly basis with meetings occurring in the upcoming 6 months. FDA will continue to publish a Federal Register notice 15 days in advance of each upcoming advisory committee meeting, to announce the meeting (21 CFR 14.20).

 

The following list announces FDA's tentatively scheduled advisory committee meetings for 2015. You may also obtain up-to-date information by calling the Advisory Committee Information Line 1-800-741-8138 (301-443-0572 in the Washington, DC area).

 

Transmissible Spongiform Encephalopathies Advisory Committee June 1.

 


 


 

 

There should be a great deal to be concerned about in relations to the TSE prion disease, blood, tissue, and surgical arenas in the USA.

 

In my opinion, with the available science and history of the TSE prion in North America, in many different species, the history on mad cows in Texas, the history mad cow feed in Texas, the history on CJD in humans in Texas, the assumption that the latest nvCJD case in Texas was from British Beef as the number one assumption, is preposterous. There is as much, if not more risk factor for this gentleman to have acquired the nvCJD from a USA/TEXAS source, as there is anywhere else in the world. In fact, I believe the BSE TSE Prion disease originated in the USA.

 

I would kindly like to evaluate the latest science on the Transmissible Spongiform Encephalopathy TSE sporadic Creutztfeldt Jakob Disease sCJD, and Bovine Spongiform Encephalopathy BSE, and it’s many different variants or phenotypes i.e. the atypical TSE prion, and the history of mad cows and the unusual cases of CJD TSE Prioin disease in Texas. ...

 

Thank You,

 

kind regards, terry



p.s. update April 29, 2015 TSEAC posted ;


June 1, 2015: Transmissible Spongiform Encephalopathies Advisory Committee Meeting Announcement

 

Center

 

Date

 

Time

 

Location

 

CBER June 1, 2015 June 1, 2015 from 8:00 a.m. to approximately 5:00 p.m. 10903 New Hampshire Avenue., Building 31 Conference Center, The Great Room, room 1503 Silver Spring, MD 20993-0002

 

Agenda

 

On June 1, 2015, the Transmissible Spongiform Encephalopathies Advisory Committee will meet in open session to hear update presentations on the following topics: 1) the variant Creutzfeldt-Jakob Disease (vCJD) situation worldwide and an update on the United Kingdom’s Transfusion Medicine Epidemiological Review; 2) vCJD in the United States; and 3) the bovine spongiform encephalopathy (BSE) situation worldwide and the United States Department of Agriculture’s regulatory approaches to reduce the risk of food-borne exposure of BSE. Following the update presentations, in open session, the committee will hear presentations from FDA on current measures to reduce risk of vCJD from transfusion in the US, and a mathematical model of the risk reduction achievable under the current and alternative geographically based donor deferral policies in conjunction with leukocyte reduction of blood components. The Committee will then discuss FDA’s geographically based donor deferral policies and other strategies, including leukocyte reduction of blood components, to reduce the risk of transfusion-transmitted vCJD.

 

Meeting Materials

 

Materials for this meeting will be available on the 2015 Meeting Materials, Transmissible Spongiform Encephalopthies Advisory Commitee page.

 

Public Participation Information

 

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. •Written submissions may be made to the contact person on or before May 25, 2015 •Oral presentations on June 1, 2015 from the public will be scheduled between approximately 2:30 p.m. and 3:30 p.m. •Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 15, 2015. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 18, 2015. •For those unable to attend in person, the meeting will also be Web cast. The Web cast will be available at the following link. Transmissible Spongiform Encephalopathies Advisory Committee meeting June 1, 2015: https://collaboration.fda.gov/cbertseac/

 

Contact Information •Bryan Emery or Rosanna Harvey 10903 New Hampshire Ave., Bldg. 71, rm. 6132, Silver Spring, MD 20993-0002, 240-402-8054 e-mail: Bryan.Emery@fda.hhs.gov or email: Rosanna.Harvey@fda.hhs.gov •FDA Advisory Committee Information Line 1-800-741-8138 (301-443-0572 in the Washington, DC, area). Please call the Information Line for up-to-date information on this meeting.

 

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

 

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

 

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. Seating for this meeting may be limited, so the public is encouraged to watch the free webcast if you are unable to attend. The link for the webcast will be available at 8 a.m. June 1, 2015 at the links above. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Bryan Emery or Rosanna Harvey at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

 

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Official FR Notice

 


 

 

Saturday, April 18, 2015

 

*** vCJD TEXAS CDC Emerging Infectious Diseases May 2015 Baylor College of Medicine Neuroscience 2014 case of human form of “mad cow disease” highlights need for continued surveillance

 


 

 

>>> Variant CJD and blood transfusion: are there additional cases?

 

 

TSE Prion and blood transfusion: will there be additional cases?  this should be the concern. ...TSS

 

Thursday, March 26, 2015

 

Variant CJD and blood transfusion: are there additional cases?

 

Vox Sanguinis (2014) 107, 220–225 ORIGINAL PAPER © 2014 International Society of Blood Transfusion DOI: 10.1111/vox.12161

 


 

Tuesday, December 30, 2014

 

TSEAC USA Reason For Recalls Blood products, collected from a donors considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed END OF YEAR REPORT 2014

 


 

 Sunday, March 09, 2014

 

 A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease

 

 FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES

 


 

 Sunday, June 9, 2013

 

 TSEAC March 14, 2013: Transmissible Spongiform Encephalopathies Advisory Committee Meeting Webcast

 


 

 Wednesday, June 29, 2011

 

 TSEAC Meeting August 1, 2011 donor deferral Saudi Arabia vCJD risk blood and blood products

 


 

 Wednesday, June 29, 2011 TSEAC JUNE 2, 1999 Welcome to the FDA traveling road show From: TSS

 

 Subject: TSEAC JUNE 2, 1999 Welcome to the FDA traveling road show

 

 Date: October 15, 2007 at 3:18 pm PST

 

 TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE MEETING Thursday, June 2, 1999

 


 

 Wednesday, March 2, 2011

 

 Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript Posted: 3/2/2011 Posted: 3/2/2011

 

 October 28, 2010

 

 Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript Posted: 3/2/2011

 


 

 Monday, February 7, 2011

 

 FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???

 


 

 October 29, 2010

 

 Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript Posted: 3/2/2011

 


 

 Monday, October 18, 2010

 

 TSEAC Transmissible Spongiform Encephalopathies Advisory Committee Draft Agenda and Meeting Materials,

 

 Posted: 10/18/2010

 

 Meeting of the Transmissible Spongiform Encephalopathies Advisory Committee Center Date Time Location

 


 

 Tuesday, September 14, 2010

 

 Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)

 


 

 Saturday, September 5, 2009

 

 TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS

 


 

 Sunday, May 10, 2009

 

 Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)

 

 TO : william.freas@fda.hhs.gov

 

 May 8, 2009

 

 Greetings again Dr. Freas, TSEAC et al,

 

 I would kindly, once again, wish to comment at this meeting about the urgent actions that need to be taken asap, to the Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009. Due to my disability from my neck injury, I will not be attending this meeting either, however I hope for my submission to be read and submitted. ...

 

 IN reply to ;

 


 

 snip...see full text ;

 

 Sunday, May 10, 2009

 

 Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)

 

 TO : william.freas@fda.hhs.gov

 


 

 Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 INTRODUCTION The United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) held a public meeting on July 25, 2006 in Washington, D.C. to present findings from the Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 (report and model located on the FSIS website:

 


 

 Comments on technical aspects of the risk assessment were then submitted to FSIS. Comments were received from Food and Water Watch, Food Animal Concerns Trust (FACT), Farm Sanctuary, R-CALF USA, Linda A Detwiler, and Terry S. Singeltary. This document provides itemized replies to the public comments received on the 2005 updated Harvard BSE risk assessment. Please bear the following points in mind:

 


 

 From: Terry S. Singeltary Sr.

 

 To: FREAS@CBER.FDA.GOV

 

 Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov

 

 Sent: Friday, December 01, 2006 2:59 PM

 

 Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION

 

 snip...

 

 ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)

 

 THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone.

 

 These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ...

 

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

 

 snip... 48 pages...

 


 

 Wednesday, October 17, 2007

 

TSEAC MEETINGS

 

----- Original Message -----

 

 From: Terry S. Singeltary Sr.

 

 To: FREAS@CBER.FDA.GOV

 

 Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov

 

 Sent: Wednesday, November 29, 2006 1:24 PM

 

 Subject: TSE advisory committee for the meeting December 15, 2006 [TSSSUBMISSION]November 29, 2006

 

 Greetings FDA, DHH, Dr. Freas, and Dr. Harvey et al,

 

 a kind and warm Holiday Greetings to you all.i kindly wish to submit the following to the TSE advisory committee for the meeting December 15, 2006, about the assessment for potential exposure to vCJD in human plasma-derivedantihemophilic factor (FVIII) productsmanufactured from U.S. plasma donors and related communication material ;

 


 

 i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;

 


 

 however, i seem to disagree. from my primitive ciphering, i see it another way. this is a huge catastrophic risk. 3 in 160 is 1.9%. so call that 2% which is 1 in 50 or twenty per thousand or 20,000 per million. also, wha tabout the mixed genotypes/mixed susceptibility?

 

 what about the silent carriers that donated tainted blood?

 

 what about the sporadic CJDs of UNKNOWN strain or phenotype?

 

 this risk assessment is just more BSe to me. just another in a long line of industry fed crap. i pray that my assessment is the one that is wrong. but it is THEY who roll the dice with your life. it is THEY who refuse to regulate an industry that has run amok. just from are call aspect of potentially tainted blood, and these are just recent recalls ;

 

 PRODUCT

 

 Source Plasma, Recall # B-0054-7CODEUnits: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891,03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969,03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588,03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228,03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628,03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707,03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189,03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979,03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707,04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719,04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816,04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063,04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485,04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930,04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578

 

 RECALLING FIRM/MANUFACTURER

 

 BioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004.

 

 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

 

 89 units

 

 DISTRIBUTION

 

 CA and Austria

 

 END OF ENFORCEMENT REPORT FOR October 25, 2006

 

 ###

 


 

 USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

 

 ______________________________

 

 PRODUCTSource Plasma, Recall # B-1708-6CODEUnits: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140,MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855,MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136,MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343,04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504,05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874,05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236,05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336,05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907,05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277,05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355,05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892,05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962

 

 RECALLING FIRM/MANUFACTURER

 

 BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, collected from unsuitable donors based on risk factors for Creutzfeldt-Jakob Disease (CJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 80 units

 

 DISTRIBUTION CA, NC, and MD

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;b) Fresh Frozen Plasma, Recall # B-1715-6;c) Platelets, Recall # B-1716-6CODEa),

 

 b), and c) Unit: 2443732RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by letters dated November 11, 2003 and December 18, 2003. 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

 

 TX and WI

 

 END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006

 

 ###

 


 

 PRODUCT

 

 Fresh Frozen Plasma, Recall # B-1751-6

 

 CODE

 

 Unit: 4936623

 

 RECALLING FIRM/MANUFACTURER

 

 Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated September 16, 2005.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 1 unit

 

 DISTRIBUTION

 

 TX

 

 END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006

 

 ###

 


 

 Mon Aug 7, 2006 10:2471.248.132.189

 

 PRODUCT

 

 a) Red Blood Cells, Recall # B-1587-6;b) Cryoprecipitated AHF, Recall # B-1588-6;c) Recovered Plasma, Recal # B-1589-6

 

 CODE

 

 a), b) and c)

 

 Unit: 2016719

 

 RECALLING FIRM/MANUFACTURER

 

 Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on March 13, 2003.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 3 units

 

 DISTRIBUTION

 

 GA and Germany

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;b) Fresh Frozen Plasma, Recall # B-1591-6

 

 CODE

 

 a) and b)

 

 Unit: 2443595

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June30, 2004.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;b) Fresh Frozen Plasma, Recall # B-1593-6

 

 CODEa) and b)

 

 Unit: 2545596

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 14, 2004 and January 3, 2005.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX

 

 ______________________________

 


 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;b) Fresh Frozen Plasma, Recall # B-1551-6

 

 CODEa) and b)

 

 Unit 2395371

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20,2003.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6;b) Platelets, Recall # B-1553-6;c) Fresh Frozen Plasma, Recall # B-1554-6

 

 CODE

 

 a), b) and c)

 

 Unit 2438702

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29,2003.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 3 units

 

 DISTRIBUTION

 

 TX

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6;b) Fresh Frozen Plasma, Recall # B-1556-6

 

 CODEa) and b)

 

 Unit 2454970

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 and December 11. 2003.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells, Recall # B-1494-6b) Cryoprecipitated AHF, Recall # B-1495-6

 

 CODEa) and b)

 

 Unit 5013100

 

 RECALLING FIRM/MANUFACTURER

 

 Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May17, 2005. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 GA

 

 ______________________________

 

 PRODUCT

 

 Source Plasma, Recall # B-1450-6

 

 CODE

 

 Unit numbers ST0824313 and ST0824764

 

 RECALLING FIRM/MANUFACTURER

 

 Stillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003.

 

 Firm initiated recall is complete.REASON

 

 Blood products, which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 UK

 

 ______________________________

 

 PRODUCT

 

 Plasma Frozen, Recall # B-1422-6;Recovered Plasma, Recall # B-1423-6

 

 CODE

 

 a) Unit 03E42218;

 

 b) Unit 03E38153

 

 RECALLING FIRM/MANUFACTURER

 

 American Red Cross Blood Services, Atlanta, GA, by telephone, e-mail orletter on February 20 or 21, 2004. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 GA and Switzerland

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6;

 

 b) Recovered Plasma, Recall # B-1375-6CODEa) and b) unit 2453906

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31 and November 5, 2003. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX and Austria

 

 ______________________________

 

 PRODUCT

 

 Source Plasma.

 

 Recall # B-1295-6

 

 CODE

 

 Units: NG0046551, NG0045950

 

 RECALLING FIRM/MANUFACTURERD

 

 CI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002, Firm initiated recall is complete.

 

 REASON

 

 Blood products, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire appropriately, were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 KY

 

 ______________________________

 

 PRODUCT

 

 Source Plasma. Recall # B-1296-6

 

 CODE

 

 Unit: NG 0044520RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 12, 2002. Firm initiated recall is complete.

 

 REASON

 

 Blood product, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, was distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 1 unit

 

 DISTRIBUTION

 

 KY

 

 ______________________________

 

 PRODUCT

 

 Source Plasma. Recall # B-1297-6

 

 CODE

 

 Units: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020,NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002. Firm initiated recall is complete.

 

 REASON

 

 Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 13 units

 

 DISTRIBUTION

 

 KY

 

 ______________________________

 

 PRODUCT

 

 Source Plasma, Recall # B-1298-6

 

 CODE

 

 Units: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG0042525, NG 0042341RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002. Firm initiated recall is complete.

 

 REASON

 

 Blood products, collected from a donor who answered questions on the variant Creutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 7 units

 

 DISTRIBUTION

 

 KY

 

 ______________________________

 

 PRODUCT

 

 Recovered Plasma, Recall # B-1299-6CODEUnit: 4357117

 

 RECALLING FIRM/MANUFACTURER

 

 Department of the Navy, Naval Medical Center, San Diego, CA, by fax and letter on September 25, 2003. Firm initiated recall is complete.

 

 REASON

 

 Blood product, collected from a donor considered to be at risk of exposure to Creutzfeldt-Jacob Disease (CJD), was distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 1 unit

 

 DISTRIBUTION

 

 Germany

 

 END OF ENFORCEMENT REPORT FOR July 12, 2006

 

 ###

 


 

 CJD WATCH MESSAGE BOARD

 

 TSS

 

 FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY Fri Jul 7, 2006 09:3770.110.83.160

 

 FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1379-6;

 

 b) Platelets, Recall # B-1380-6;

 

 c) Fresh Frozen Plasma, Recall # 1381-6;

 

 d) Recovered Plasma, Recall # B-1382-6

 

 CODE

 

 a) Unit numbers: 2343106, 2377779, and 2403533;

 

 b) and c) Unit numbers: 2377779;

 

 d) Unit numbers: 2343106 and 2403533

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June12, 2003. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 7 units

 

 DISTRIBUTIONTX and Austria

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6;

 

 b) Recovered Plasma, Recall # B-1468-6

 

 CODE

 

 a) and b)

 

 Unit numbers: 2329380

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8,2003. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTIONTX and Switzerland

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6;

 

 b) Cryoprecipitated AHF, Recall # B-1480-6;

 

 c) Recovered Plasma, Recall # B-1481-6

 

 CODE

 

 a), b), and c)

 

 Unit numbers: 2383280

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July23 and 29, 2004. Firm initiated recall is complete.

 

 REASONBlood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 3 units

 

 DISTRIBUTION

 

 TX and Switzerland

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6;

 

 b) Fresh Frozen Plasma, Recall # B-1483-6

 

 CODE

 

 a) and b)

 

 Unit number: 2501452

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile onOctober 5, 2004. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX and NY

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6;

 

 b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6;

 

 c) Recovered Plasma, Recall # B-1486-6

 

 CODE

 

 a) and c)

 

 Unit number: 2554077;

 

 b) Unit number: 2415708

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August13, 2004. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 3 units

 

 DISTRIBUTION

 

 TX and Austria

 

 _____________________________________

 

 END OF ENFORCEMENT REPORT FOR July 5, 2006

 

 ###

 


 

 Greetings again Dr. Freas et al at FDA,

 

 WITH new atypical TSE in the bovine, in the sheep, goat, and humans, and the fact that the new BASE TSE in cattle being very very similar to sporadic CJD, rather than the nvCJD, the fact that now science showing the TSE agent of the atypical cattle in Japan showing infectivity other than CNS tissue, the fact that the latest Texas mad cow and the recent Alabama mad cow both being of the atypical strain, it would seem prudent to include all human TSE in the blood ban, in my opinion. with sporadic CJD, you have many strains and or phenotypes, some of which are 'UNKNOWN', so we do not know how this will transmit, what tissues are infectious and or if blood transmits. that's the bottomline, however it has been reported that the BASE is more virulent to humans.With this, and the fact that sporadic CJD has tripled in the past few years or so, i see itas being prudent to take serious and immediate action ;

 

 snip...see full text ;

 

 Wednesday, October 17, 2007 TSEAC MEETINGS ----- Original Message -----

 

 From: Terry S. Singeltary Sr.

 

 To: FREAS@CBER.FDA.GOV

 

 Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov

 

 Sent: Wednesday, November 29, 2006 1:24 PM

 

 Subject: TSE advisory committee for the meeting December 15, 2006 [TSSSUBMISSION]November 29, 2006

 

 Greetings FDA, DHH, Dr. Freas, and Dr. Harvey et al,

 

 a kind and warm Holiday Greetings to you all.i kindly wish to submit the following to the TSE advisory committee for the meeting December 15, 2006, about the assessment for potential exposure to vCJD in human plasma-derivedantihemophilic factor (FVIII) productsmanufactured from U.S. plasma donors and related communication material ;

 


 

 i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;

 


 

 however, i seem to disagree. from my primitive ciphering, i see it another way. this is a huge catastrophic risk. 3 in 160 is 1.9%. so call that 2% which is 1 in 50 or twenty per thousand or 20,000 per million. also, wha tabout the mixed genotypes/mixed susceptibility?

 

 what about the silent carriers that donated tainted blood?

 

 what about the sporadic CJDs of UNKNOWN strain or phenotype?

 

 this risk assessment is just more BSe to me. just another in a long line of industry fed crap. i pray that my assessment is the one that is wrong. but it is THEY who roll the dice with your life. it is THEY who refuse to regulate an industry that has run amok. just from are call aspect of potentially tainted blood, and these are just recent recalls ;

 

 PRODUCT

 

 Source Plasma, Recall # B-0054-7CODEUnits: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891,03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969,03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588,03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228,03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628,03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707,03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189,03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979,03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707,04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719,04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816,04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063,04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485,04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930,04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578

 

 RECALLING FIRM/MANUFACTURER

 

 BioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004.

 

 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

 

 89 units

 

 DISTRIBUTION

 

 CA and Austria

 

 END OF ENFORCEMENT REPORT FOR October 25, 2006

 

 ###

 


 

 USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

 

 ______________________________

 

 PRODUCTSource Plasma, Recall # B-1708-6CODEUnits: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140,MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855,MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136,MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343,04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504,05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874,05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236,05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336,05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907,05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277,05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355,05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892,05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962

 

 RECALLING FIRM/MANUFACTURER

 

 BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, collected from unsuitable donors based on risk factors for Creutzfeldt-Jakob Disease (CJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 80 units

 

 DISTRIBUTION CA, NC, and MD

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;b) Fresh Frozen Plasma, Recall # B-1715-6;c) Platelets, Recall # B-1716-6CODEa),

 

 b), and c) Unit: 2443732RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by letters dated November 11, 2003 and December 18, 2003. 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

 

 TX and WI

 

 END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006

 

 ###

 


 

 PRODUCT

 

 Fresh Frozen Plasma, Recall # B-1751-6

 

 CODE

 

 Unit: 4936623

 

 RECALLING FIRM/MANUFACTURER

 

 Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated September 16, 2005.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 1 unit

 

 DISTRIBUTION

 

 TX

 

 END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006

 

 ###

 


 

 Mon Aug 7, 2006 10:2471.248.132.189

 

 PRODUCT

 

 a) Red Blood Cells, Recall # B-1587-6;b) Cryoprecipitated AHF, Recall # B-1588-6;c) Recovered Plasma, Recal # B-1589-6

 

 CODE

 

 a), b) and c)

 

 Unit: 2016719

 

 RECALLING FIRM/MANUFACTURER

 

 Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on March 13, 2003.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 3 units

 

 DISTRIBUTION

 

 GA and Germany

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;b) Fresh Frozen Plasma, Recall # B-1591-6

 

 CODE

 

 a) and b)

 

 Unit: 2443595

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June30, 2004.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;b) Fresh Frozen Plasma, Recall # B-1593-6

 

 CODEa) and b)

 

 Unit: 2545596

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 14, 2004 and January 3, 2005.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX

 

 ______________________________

 


 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;b) Fresh Frozen Plasma, Recall # B-1551-6

 

 CODEa) and b)

 

 Unit 2395371

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20,2003.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6;b) Platelets, Recall # B-1553-6;c) Fresh Frozen Plasma, Recall # B-1554-6

 

 CODE

 

 a), b) and c)

 

 Unit 2438702

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29,2003.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 3 units

 

 DISTRIBUTION

 

 TX

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6;b) Fresh Frozen Plasma, Recall # B-1556-6

 

 CODEa) and b)

 

 Unit 2454970

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 and December 11. 2003.

 

 Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells, Recall # B-1494-6b) Cryoprecipitated AHF, Recall # B-1495-6

 

 CODEa) and b)

 

 Unit 5013100

 

 RECALLING FIRM/MANUFACTURER

 

 Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May17, 2005. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 GA

 

 ______________________________

 

 PRODUCT

 

 Source Plasma, Recall # B-1450-6

 

 CODE

 

 Unit numbers ST0824313 and ST0824764

 

 RECALLING FIRM/MANUFACTURER

 

 Stillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003.

 

 Firm initiated recall is complete.REASON

 

 Blood products, which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 UK

 

 ______________________________

 

 PRODUCT

 

 Plasma Frozen, Recall # B-1422-6;Recovered Plasma, Recall # B-1423-6

 

 CODE

 

 a) Unit 03E42218;

 

 b) Unit 03E38153

 

 RECALLING FIRM/MANUFACTURER

 

 American Red Cross Blood Services, Atlanta, GA, by telephone, e-mail orletter on February 20 or 21, 2004. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 GA and Switzerland

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6;

 

 b) Recovered Plasma, Recall # B-1375-6CODEa) and b) unit 2453906

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31 and November 5, 2003. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX and Austria

 

 ______________________________

 

 PRODUCT

 

 Source Plasma.

 

 Recall # B-1295-6

 

 CODE

 

 Units: NG0046551, NG0045950

 

 RECALLING FIRM/MANUFACTURERD

 

 CI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002, Firm initiated recall is complete.

 

 REASON

 

 Blood products, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire appropriately, were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 KY

 

 ______________________________

 

 PRODUCT

 

 Source Plasma. Recall # B-1296-6

 

 CODE

 

 Unit: NG 0044520RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 12, 2002. Firm initiated recall is complete.

 

 REASON

 

 Blood product, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, was distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 1 unit

 

 DISTRIBUTION

 

 KY

 

 ______________________________

 

 PRODUCT

 

 Source Plasma. Recall # B-1297-6

 

 CODE

 

 Units: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020,NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002. Firm initiated recall is complete.

 

 REASON

 

 Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 13 units

 

 DISTRIBUTION

 

 KY

 

 ______________________________

 

 PRODUCT

 

 Source Plasma, Recall # B-1298-6

 

 CODE

 

 Units: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG0042525, NG 0042341RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002. Firm initiated recall is complete.

 

 REASON

 

 Blood products, collected from a donor who answered questions on the variant Creutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 7 units

 

 DISTRIBUTION

 

 KY

 

 ______________________________

 

 PRODUCT

 

 Recovered Plasma, Recall # B-1299-6CODEUnit: 4357117

 

 RECALLING FIRM/MANUFACTURER

 

 Department of the Navy, Naval Medical Center, San Diego, CA, by fax and letter on September 25, 2003. Firm initiated recall is complete.

 

 REASON

 

 Blood product, collected from a donor considered to be at risk of exposure to Creutzfeldt-Jacob Disease (CJD), was distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 1 unit

 

 DISTRIBUTION

 

 Germany

 

 END OF ENFORCEMENT REPORT FOR July 12, 2006

 

 ###

 


 

 CJD WATCH MESSAGE BOARD

 

 TSS

 

 FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY Fri Jul 7, 2006 09:3770.110.83.160

 

 FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1379-6;

 

 b) Platelets, Recall # B-1380-6;

 

 c) Fresh Frozen Plasma, Recall # 1381-6;

 

 d) Recovered Plasma, Recall # B-1382-6

 

 CODE

 

 a) Unit numbers: 2343106, 2377779, and 2403533;

 

 b) and c) Unit numbers: 2377779;

 

 d) Unit numbers: 2343106 and 2403533

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June12, 2003. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 7 units

 

 DISTRIBUTIONTX and Austria

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6;

 

 b) Recovered Plasma, Recall # B-1468-6

 

 CODE

 

 a) and b)

 

 Unit numbers: 2329380

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8,2003. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTIONTX and Switzerland

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6;

 

 b) Cryoprecipitated AHF, Recall # B-1480-6;

 

 c) Recovered Plasma, Recall # B-1481-6

 

 CODE

 

 a), b), and c)

 

 Unit numbers: 2383280

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July23 and 29, 2004. Firm initiated recall is complete.

 

 REASONBlood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 3 units

 

 DISTRIBUTION

 

 TX and Switzerland

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6;

 

 b) Fresh Frozen Plasma, Recall # B-1483-6

 

 CODE

 

 a) and b)

 

 Unit number: 2501452

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile onOctober 5, 2004. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 2 units

 

 DISTRIBUTION

 

 TX and NY

 

 ______________________________

 

 PRODUCT

 

 a) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6;

 

 b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6;

 

 c) Recovered Plasma, Recall # B-1486-6

 

 CODE

 

 a) and c)

 

 Unit number: 2554077;

 

 b) Unit number: 2415708

 

 RECALLING FIRM/MANUFACTURER

 

 South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August13, 2004. Firm initiated recall is complete.

 

 REASON

 

 Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

 

 VOLUME OF PRODUCT IN COMMERCE

 

 3 units

 

 DISTRIBUTION

 

 TX and Austria

 

 _____________________________________

 

 END OF ENFORCEMENT REPORT FOR July 5, 2006

 

 ###

 


 

 Greetings again Dr. Freas et al at FDA,

 

 WITH new atypical TSE in the bovine, in the sheep, goat, and humans, and the fact that the new BASE TSE in cattle being very very similar to sporadic CJD, rather than the nvCJD, the fact that now science showing the TSE agent of the atypical cattle in Japan showing infectivity other than CNS tissue, the fact that the latest Texas mad cow and the recent Alabama mad cow both being of the atypical strain, it would seem prudent to include all human TSE in the blood ban, in my opinion. with sporadic CJD, you have many strains and or phenotypes, some of which are 'UNKNOWN', so we do not know how this will transmit, what tissues are infectious and or if blood transmits. that's the bottomline, however it has been reported that the BASE is more virulent to humans.With this, and the fact that sporadic CJD has tripled in the past few years or so, i see itas being prudent to take serious and immediate action ;

 


 

 2001 Singeltary Submission to FDA on blood related risk factors from TSE prion aka mad cow type disease

 

 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 08,2001 3:03 PM freas ...

 


 

 

 U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001

 


 

 

Transmissible Spongiform Encephalopthy TSE Prion Disease

 

*** Kuru Video

 

Kuru: The Science and The Sorcery

 


 

 

*** Scrapie Video

 


 

 

*** Human Mad Cow Video

 


 

 

*** USA sporadic CJD MAD COW DISEASE HAS HUGE PROBLEM Video

 


 

 

2014

 

***Moreover, L-BSE has been transmitted more easily to transgenic mice overexpressing a human PrP [13,14] or to primates [15,16] than C-BSE.

 

***It has been suggested that some sporadic CJD subtypes in humans may result from an exposure to the L-BSE agent.

 

*** Lending support to this hypothesis, pathological and biochemical similarities have been observed between L-BSE and an sCJD subtype (MV genotype at codon 129 of PRNP) [17], and between L-BSE infected non-human primate and another sCJD subtype (MM genotype) [15].

 

snip...

 


 

 

Monday, October 10, 2011

 

EFSA Journal 2011 The European Response to BSE: A Success Story

 

snip...

 

EFSA and the European Centre for Disease Prevention and Control (ECDC) recently delivered a scientific opinion on any possible epidemiological or molecular association between TSEs in animals and humans (EFSA Panel on Biological Hazards (BIOHAZ) and ECDC, 2011). This opinion confirmed Classical BSE prions as the only TSE agents demonstrated to be zoonotic so far

 

*** but the possibility that a small proportion of human cases so far classified as "sporadic" CJD are of zoonotic origin could not be excluded.

 

*** Moreover, transmission experiments to non-human primates suggest that some TSE agents in addition to Classical BSE prions in cattle (namely L-type Atypical BSE, Classical BSE in sheep, transmissible mink encephalopathy (TME) and chronic wasting disease (CWD) agents) might have zoonotic potential.

 

snip...

 


 


 

 

Thursday, August 12, 2010

 

Seven main threats for the future linked to prions

 

First threat

 

The TSE road map defining the evolution of European policy for protection against prion diseases is based on a certain numbers of hypotheses some of which may turn out to be erroneous. In particular, a form of BSE (called atypical Bovine Spongiform Encephalopathy), recently identified by systematic testing in aged cattle without clinical signs, may be the origin of classical BSE and thus potentially constitute a reservoir, which may be impossible to eradicate if a sporadic origin is confirmed.

 

*** Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans.

 

*** These atypical BSE cases constitute an unforeseen first threat that could sharply modify the European approach to prion diseases.

 

Second threat

 

snip...

 


 

*** Creutzfeldt-Jakob Disease Public Health Crisis VIDEO

 


 


 


 


 

 

Tuesday, December 16, 2014

 

Evidence for zoonotic potential of ovine scrapie prions

 

Hervé Cassard,1, n1 Juan-Maria Torres,2, n1 Caroline Lacroux,1, Jean-Yves Douet,1, Sylvie L. Benestad,3, Frédéric Lantier,4, Séverine Lugan,1, Isabelle Lantier,4, Pierrette Costes,1, Naima Aron,1, Fabienne Reine,5, Laetitia Herzog,5, Juan-Carlos Espinosa,2, Vincent Beringue5, & Olivier Andréoletti1, Affiliations Contributions Corresponding author Journal name: Nature Communications Volume: 5, Article number: 5821 DOI: doi:10.1038/ncomms6821 Received 07 August 2014 Accepted 10 November 2014 Published 16 December 2014 Article tools Citation Reprints Rights & permissions Article metrics

 

Abstract

 

Although Bovine Spongiform Encephalopathy (BSE) is the cause of variant Creutzfeldt Jakob disease (vCJD) in humans, the zoonotic potential of scrapie prions remains unknown. Mice genetically engineered to overexpress the human ​prion protein (tgHu) have emerged as highly relevant models for gauging the capacity of prions to transmit to humans. These models can propagate human prions without any apparent transmission barrier and have been used used to confirm the zoonotic ability of BSE. Here we show that a panel of sheep scrapie prions transmit to several tgHu mice models with an efficiency comparable to that of cattle BSE. The serial transmission of different scrapie isolates in these mice led to the propagation of prions that are phenotypically identical to those causing sporadic CJD (sCJD) in humans. These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions.

 

Subject terms: Biological sciences• Medical research At a glance

 


 

 

why do we not want to do TSE transmission studies on chimpanzees $

 

5. A positive result from a chimpanzee challenged severly would likely create alarm in some circles even if the result could not be interpreted for man. I have a view that all these agents could be transmitted provided a large enough dose by appropriate routes was given and the animals kept long enough. Until the mechanisms of the species barrier are more clearly understood it might be best to retain that hypothesis.

 

snip...

 

R. BRADLEY

 


 

 

Suspect symptoms

 

What if you can catch old-fashioned CJD by eating meat from a sheep infected with scrapie?

 

28 Mar 01 Most doctors believe that sCJD is caused by a prion protein deforming by chance into a killer. But Singeltary thinks otherwise. He is one of a number of campaigners who say that some sCJD, like the variant CJD related to BSE, is caused by eating meat from infected animals. Their suspicions have focused on sheep carrying scrapie, a BSE-like disease that is widespread in flocks across Europe and North America.

 

Now scientists in France have stumbled across new evidence that adds weight to the campaigners' fears. To their complete surprise, the researchers found that one strain of scrapie causes the same brain damage in mice as sCJD.

 

"This means we cannot rule out that at least some sCJD may be caused by some strains of scrapie," says team member Jean-Philippe Deslys of the French Atomic Energy Commission's medical research laboratory in Fontenay-aux-Roses, south-west of Paris. Hans Kretschmar of the University of Göttingen, who coordinates CJD surveillance in Germany, is so concerned by the findings that he now wants to trawl back through past sCJD cases to see if any might have been caused by eating infected mutton or lamb...

 

2001

 

Suspect symptoms

 

What if you can catch old-fashioned CJD by eating meat from a sheep infected with scrapie?

 

28 Mar 01

 

Like lambs to the slaughter

 

31 March 2001

 

by Debora MacKenzie Magazine issue 2284.

 

FOUR years ago, Terry Singeltary watched his mother die horribly from a degenerative brain disease. Doctors told him it was Alzheimer's, but Singeltary was suspicious. The diagnosis didn't fit her violent symptoms, and he demanded an autopsy. It showed she had died of sporadic Creutzfeldt-Jakob disease.

 

Most doctors believe that sCJD is caused by a prion protein deforming by chance into a killer. But Singeltary thinks otherwise. He is one of a number of campaigners who say that some sCJD, like the variant CJD related to BSE, is caused by eating meat from infected animals. Their suspicions have focused on sheep carrying scrapie, a BSE-like disease that is widespread in flocks across Europe and North America.

 

Now scientists in France have stumbled across new evidence that adds weight to the campaigners' fears. To their complete surprise, the researchers found that one strain of scrapie causes the same brain damage in mice as sCJD.

 

"This means we cannot rule out that at least some sCJD may be caused by some strains of scrapie," says team member Jean-Philippe Deslys of the French Atomic Energy Commission's medical research laboratory in Fontenay-aux-Roses, south-west of Paris. Hans Kretschmar of the University of Göttingen, who coordinates CJD surveillance in Germany, is so concerned by the findings that he now wants to trawl back through past sCJD cases to see if any might have been caused by eating infected mutton or lamb.

 

Scrapie has been around for centuries and until now there has been no evidence that it poses a risk to human health. But if the French finding means that scrapie can cause sCJD in people, countries around the world may have overlooked a CJD crisis to rival that caused by BSE.

 

Deslys and colleagues were originally studying vCJD, not sCJD. They injected the brains of macaque monkeys with brain from BSE cattle, and from French and British vCJD patients. The brain damage and clinical symptoms in the monkeys were the same for all three. Mice injected with the original sets of brain tissue or with infected monkey brain also developed the same symptoms.

 

As a control experiment, the team also injected mice with brain tissue from people and animals with other prion diseases: a French case of sCJD; a French patient who caught sCJD from human-derived growth hormone; sheep with a French strain of scrapie; and mice carrying a prion derived from an American scrapie strain. As expected, they all affected the brain in a different way from BSE and vCJD. But while the American strain of scrapie caused different damage from sCJD, the French strain produced exactly the same pathology.

 

"The main evidence that scrapie does not affect humans has been epidemiology," says Moira Bruce of the neuropathogenesis unit of the Institute for Animal Health in Edinburgh, who was a member of the same team as Deslys. "You see about the same incidence of the disease everywhere, whether or not there are many sheep, and in countries such as New Zealand with no scrapie." In the only previous comparisons of sCJD and scrapie in mice, Bruce found they were dissimilar.

 

But there are more than 20 strains of scrapie, and six of sCJD. "You would not necessarily see a relationship between the two with epidemiology if only some strains affect only some people," says Deslys. Bruce is cautious about the mouse results, but agrees they require further investigation. Other trials of scrapie and sCJD in mice, she says, are in progress.

 

People can have three different genetic variations of the human prion protein, and each type of protein can fold up two different ways. Kretschmar has found that these six combinations correspond to six clinical types of sCJD: each type of normal prion produces a particular pathology when it spontaneously deforms to produce sCJD.

 

But if these proteins deform because of infection with a disease-causing prion, the relationship between pathology and prion type should be different, as it is in vCJD. "If we look at brain samples from sporadic CJD cases and find some that do not fit the pattern," says Kretschmar, "that could mean they were caused by infection."

 

There are 250 deaths per year from sCJD in the US, and a similar incidence elsewhere. Singeltary and other US activists think that some of these people died after eating contaminated meat or "nutritional" pills containing dried animal brain. Governments will have a hard time facing activists like Singeltary if it turns out that some sCJD isn't as spontaneous as doctors have insisted.

 

Deslys's work on macaques also provides further proof that the human disease vCJD is caused by BSE. And the experiments showed that vCJD is much more virulent to primates than BSE, even when injected into the bloodstream rather than the brain. This, says Deslys, means that there is an even bigger risk than we thought that vCJD can be passed from one patient to another through contaminated blood transfusions and surgical instruments.

 


 

 

Thursday, March 20, 2014

 

CHRONIC WASTING DISEASE CWD TSE PRION OF CERVID AND THE POTENTIAL FOR HUMAN TRANSMISSION THEREFROM 2014

 


 

 

Tuesday, July 01, 2014

 

*** CHRONIC WASTING DISEASE CWD TSE PRION DISEASE, GAME FARMS, AND POTENTIAL RISK FACTORS THERE FROM ***

 


 

 

Thursday, July 03, 2014

 

*** How Chronic Wasting Disease is affecting deer population and what’s the risk to humans and pets? ***

 


 

 

Thursday

 

CWD TO HUMANS, AND RISK FACTORS THERE FROM (see latest science)

 

Tuesday, November 04, 2014

 

*** Six-year follow-up of a point-source exposure to CWD contaminated venison in an Upstate New York community: risk behaviours and health outcomes 2005–2011

 


 

 

Friday, January 30, 2015

 

*** Scrapie: a particularly persistent pathogen ***

 


 

 

Sunday, April 12, 2015

 

*** Research Project: Transmission, Differentiation, and Pathobiology of Transmissible Spongiform Encephalopathies 2014 Annual Report ***

 


 

 

Saturday, April 11, 2015

 

***  ISU veterinary researchers study retinal scans as early detection method for mad cow disease

 


 

 

Wednesday, April 15, 2015

 

KURU Transmissible Spongiform Encephalopthy TSE Prion Disease

 


 

 

 

Comment from Terry Singeltary


This is a Comment on the Food and Drug Administration (FDA) Notice: Draft Guidance for Industry on Ensuring Safety of Animal Feed Maintained and Fed On-Farm; Availability
For related information, Open Docket Folder  Docket folder icon

Comment



Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180 Singeltary Comment

Greetings FDA et al,

I wish to comment on Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180.

Once again, I wish to kindly bring up the failed attempt of the FDA and the ruminant to ruminant mad cow feed ban of August 4, 1997. This feed ban is still failing today, as we speak. Even more worrisome, is the fact it is still legal to feed cervids to cervids in the USA, in fact, the FDA only _recommends_ that deer and elk considered to be of _high_ risk for CWD do not enter the animal food chain, but there is NO law, its only voluntary, a recipe for a TSE prion disaster, as we have seen with the ruminant to ruminant feed ban for cattle, where in 2007, one decade post August 1997 mad cow feed ban, where in 2007 10,000,000 POUNDS OF BANNED BLOOD LACED MEAT AND BONE MEAL WHEN OUT INTO COMMERCE, TO BE FED OUT. Since 2007, these BSE feed ban rules have been breached time and time again. tons and tons of mad cow feed went out in Alabama as well, where one of the mad cows were documented, just the year before in 2006, and in 2013 and 2014, breaches so bad (OAI) Official Action Indicated were issued. those are like the one issued where 10 million pounds of banned blood laced meat and bone meal were fed out.

What is the use of having a Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180, if it cannot be enforced, as we have seen with a mandatory ruminant to ruminant feed ban?

I strenuously once again urge the FDA and its industry constituents, to make it MANDATORY that all ruminant feed be banned to all ruminants, and this should include all cervids as soon as possible for the following reasons...

======

In the USA, under the Food and Drug Administrations BSE Feed Regulation (21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from deer and elk is prohibited for use in feed for ruminant animals. With regards to feed for non-ruminant animals, under FDA law, CWD positive deer may not be used for any animal feed or feed ingredients. For elk and deer considered at high risk for CWD, the FDA recommends that these animals do not enter the animal feed system.

***However, this recommendation is guidance and not a requirement by law.

======

31 Jan 2015 at 20:14 GMT

*** Ruminant feed ban for cervids in the United States? ***

31 Jan 2015 at 20:14 GMT

http://www.plosone.org/annotation/listThread.action?root=85351



19 May 2010 at 21:21 GMT

*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics of BSE in Canada Singeltary reply ;

http://www.plosone.org/annotation/listThread.action;jsessionid=635CE9094E0EA15D5362B7D7B809448C?root=7143



Tuesday, December 23, 2014

FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2014 BSE TSE PRION

http://madcowusda.blogspot.com/2014/12/fda-part-589-substances-prohibited-from.html


2013

Sunday, December 15, 2013

FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2013 UPDATE

http://madcowusda.blogspot.com/2013/12/fda-part-589-substances-prohibited-from.html

DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal Feed; Availability
Date: Fri, 16 May 2003 11:47:37 0500
EMC 1 Terry S. Singeltary Sr. Vol #: 1

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


10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007

Date: March 21, 2007 at 2:27 pm PST

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

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/Safety/Recalls/EnforcementReports/2007/ucm120446.htm


Terry S. Singeltary Sr.

*** See attached file(s)

Attachments

  (1)

Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed On-Farm Terry Singeltary Comment

View Attachment:
 
 
 
Sunday, April 5, 2015
 
*** Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180 ***
 
 
 

Sunday, November 23, 2014

 

*** Confirmed Variant Creutzfeldt-Jakob Disease (variant CJD) Case in Texas in June 2014 confirmed as USA case NOT European ***

 


 

Monday, November 3, 2014

 

USA CJD TSE PRION UNIT, TEXAS, SURVEILLANCE UPDATE NOVEMBER 2014

 

National Prion Disease Pathology Surveillance Center Cases Examined1 (October 7, 2014)

 

***6 Includes 11 cases in which the diagnosis is pending, and 19 inconclusive cases;

 

***7 Includes 12 (11 from 2014) cases with type determination pending in which the diagnosis of vCJD has been excluded.

 

***The sporadic cases include 2660 cases of sporadic Creutzfeldt-Jakob disease (sCJD),

 

***50 cases of Variably Protease-Sensitive Prionopathy (VPSPr)

 

***and 21 cases of sporadic Fatal Insomnia (sFI).

 


 

Thursday, January 15, 2015

 

41-year-old Navy Commander with sporadic Creutzfeldt–Jakob disease CJD TSE Prion: Case Report

 


 

Subject: *** Becky Lockhart 46, Utah’s first female House speaker, dies diagnosed with the extremely rare Creutzfeldt-Jakob disease aka mad cow type disease

 

what is CJD ? just ask USDA inc., and the OIE, they are still feeding the public and the media industry fed junk science that is 30 years old.

 

why doesn’t some of you try reading the facts, instead of rubber stamping everything the USDA inc says.

 

sporadic CJD has now been linked to BSE aka mad cow disease, Scrapie, and there is much concern now for CWD and risk factor for humans.

 

My sincere condolences to the family and friends of the House Speaker Becky Lockhart. I am deeply saddened hear this.

 

with that said, with great respect, I must ask each and every one of you Politicians that are so deeply saddened to hear of this needless death of the Honorable House Speaker Becky Lockhart, really, cry me a friggen river. I am seriously going to ask you all this...I have been diplomatic for about 17 years and it has got no where. people are still dying. so, are you all stupid or what??? how many more need to die ??? how much is global trade of beef and other meat products that are not tested for the TSE prion disease, how much and how many bodies is this market worth?

 

Saturday, January 17, 2015

 

*** Becky Lockhart 46, Utah’s first female House speaker, dies diagnosed with the extremely rare Creutzfeldt-Jakob disease

 


 

*** ALERT new variant Creutzfeldt Jakob Disease nvCJD or vCJD, sporadic CJD strains, TSE prion aka Mad Cow Disease United States of America Update December 14, 2014 Report ***

 


 

Tuesday, November 04, 2014

 

Towards an Age-Dependent Transmission Model of Acquired and Sporadic Creutzfeldt-Jakob Disease

 


 

Thursday, January 22, 2015

 

Transmission properties of atypical Creutzfeldt-Jakob disease: a clue to disease etiology?

 


 


 

Sunday, July 06, 2014

 

Dietary Risk Factors for Sporadic Creutzfeldt-Jakob Disease: A Confirmatory Case-Control Study

 

Conclusions—The a priori hypotheses were supported.

 

*Consumption of various meat products may be one method of transmission of the infectious agent for sCJD.

 


 

PLEASE REMEMBER ;

 

The Akron, Ohio-based CJD Foundation said the Center for Disease Control revised that number in October of 2004 to about one in 9,000 CJD cases per year in the population group age 55 and older.

 

HAVE YOU GOT YOUR CJD QUESTIONNAIRE ASKING REAL QUESTIONS PERTAINING TO ROUTE AND SOURCE OF THE TSE AGENT THAT KILLED YOUR LOVED ONE ???

 

if not, why not...

 

Friday, November 30, 2007

 

CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION

 


 


 

Friday, January 10, 2014

 

vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial type prion disease, what it ???

 


 


 

Self-Propagative Replication of Ab Oligomers Suggests Potential Transmissibility in Alzheimer Disease

 

Received July 24, 2014; Accepted September 16, 2014; Published November 3, 2014

 


 

Singeltary comment ;

 


 

Saturday, December 13, 2014

 

Terry S. Singeltary Sr. Publications TSE prion disease

 

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

 

Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA

 

snip...

 


 

 

 

TSS