Plasma & Serum Proteins Receive Continued FDA Approval
Posted Apr 09 2009 7:13pm
Plasma & Serum Proteins Receive Continued FDA Approval
4/25/2008 APC, Inc. is pleased to advise our customers and industry partners that as anticipated, the Food and Drug Administration (FDA) will continue to allow the use of bovine blood, plasma and serum proteins in ruminant feeds. In April 2008 FDA announced the publication of its Final Rule for 21 CFR Part 589.2001 – Substances Prohibited From Use in Animal Food or Feed. FDA specifically stated in their opinion that, "FDA is not prohibiting the use of blood and blood products in animal feed because we believe such a prohibition would do very little to reduce the risk of BSE transmission." Known as a leader in developing nutritional products for the swine industry, where 95% of pig starter diets in the United States contain functional proteins, APC has more recently developed their line of colostrum replacers, supplements, feed additives and milk replacer ingredients for calves. Products include plasma, serum and immunoglobulin concentrate based Acquire®, Lifeline®, Gammulin® and Nutrapro® used to optimize the health and performance of calves. To view the full report for Final Rule 21 CFR Part 589.2001 visit: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2002-N-0031-nfr.pdf To view the complete Feed Rule 21 CFR Part 589 visit: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
----- Original Message ----- From: Terry S. Singeltary Sr.To: FREAS@CBER.FDA.GOVCc: firstname.lastname@example.org; email@example.com Sent: Wednesday, November 29, 2006 1:24 PMSubject: 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-derived antihemophilic factor (FVIII) products manufactured from U.S. plasma donors and related communication material ; http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/200 i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them; http://www.newsday.com/news/health/ats-ap_health14nov27,0,7955259.story?coll=ny- 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, what about 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 a recall aspect of potentially tainted blood, and these are just recent recalls ; PRODUCTSource 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, 04MMNC1578RECALLING FIRM/MANUFACTURERBioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004.Firm initiated recall is complete.REASONBlood products, collected from a donor who was at increased risk for newvariant Creutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE89 unitsDISTRIBUTIONCA and AustriaEND OF ENFORCEMENT REPORT FOR October 25, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00975.htmlUSA 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 05MIND2962RECALLING FIRM/MANUFACTURERBioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.Firm initiated recall is complete.REASONBlood products, collected from unsuitable donors based on risk factors forCreutzfeldt-Jakob Disease (CJD), were distributed.VOLUME OF PRODUCT IN COMMERCE80 unitsDISTRIBUTIONCA, NC, and MD______________________________PRODUCTa) 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/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by letters datedNovember 11, 2003 and December 18, 2003. Firm initiated recall is complete.REASONBlood products, co lected from a donor who was at increased risk for newvariant Creutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONTX and WIEND OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.htmlPRODUCTFresh Frozen Plasma, Recall # B-1751-6CODEUnit: 4936623RECALLING FIRM/MANUFACTURERGulf Coast Regional Blood Center, Houston, TX, by facsimile dated September16, 2005. Firm initiated recall is complete.REASONBlood product, which was collected from an unsuitable donor based on riskfactors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONTXEND OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006###http://ww .fda.gov/bbs/topics/enforce/2006/ENF00968.htmlMon Aug 7, 2006 10:24184.108.40.206PRODUCTa) Red Blood Cells, Recall # B-1587-6;b) Cryoprecipitated AHF, Recall # B-1588-6;c) Recovered Plasma, Recal # B-1589-6CODEa), b) and c) Unit: 2016719RECALLING FIRM/MANUFACTURERWalter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile onMarch 13, 2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONGA and Germany______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;b) Fresh Frozen Plasma, Recall # B-1591-6CODEa) and b) Unit: 2443595RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June30, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;b) Fresh Frozen Plasma, Recall # B-1593-6CODEa) and b) Unit: 2545596RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile onDecember 14, 2004 and January 3, 2005. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________http://www.fda.gov/bbs/topics/e TEXT ; http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&dihttp://creutzfeldt-jakob-disease.blogspot.com/2008/10/cber-2007-annual-report-ashttp://www.fda.gov/OHRMS/DOCKETS/ac/06/transcripts/2006-4271t1.pdf Friday, October 24, 2008CBER 2007 Annual Report Assessing the Potential Risk of variant Creutzfeldt-Jakob Disease from Blood Products http://creutzfeldt-jakob-disease.blogspot.com/2008/10/cber-2007-annual-report-as Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0006.1 Public Submission Title Attachment to Singletary comment http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3412&dihttp://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=APHIShttp://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&di TSSTuesday, November 11, 2008 SaBTO Summary of 1st Public Meeting - variant CJD and blood Tuesday 21st October 2008, 2pm-4pm http://vcjdblood.blogspot.com/2008/11/sabto-summary-of-1st-public-meeting.html
Friday, November 21, 2008 Amarillo-area (suspect sporadic CJD) case linked to mad cow disease Rumor in Texas
Review on the epidemiology and dynamics of BSE epidemics
Cases of atypical BSE have only been found in countries having implemented large active surveillance programs. As of 1st September 2007, 36 cases (16 H, 20 L) have been described all over the world in cattle: Belgium (1 L) , Canada (1 H)15, Denmark (1 L)16, France (8 H, 6 L)17, Germany (1 H, 1 L) , Italy (3 L)18, Japan (1 L) , Netherlands (1 H, 2 L)19, Poland (1 H, 6 L)20, Sweden (1 H)21, United Kingdom (1 H)22, and USA (2 H)23. Another H-type case has been found in a 19 year old miniature zebu in a zoological park in Switzerland . It is noteworthy that atypical cases have been found in countries that did not experience classical BSE so far, like Sweden, or in which only few cases of classical BSE have been found, like Canada or the USA.
And last but not least, similarities of PrPres between Htype BSE and human prion diseases like CJD or GSS have been put forward , as well as between L-type BSE and CJD . These findings raise questions about the origin and inter species transmission of these prion diseases that were discovered through the BSE active surveillance.
Please remember, the last two mad cows documented in the USA i.e. Alabama and Texas, both were of the 'atypical' BSE strain, and immediately after that, the USDA shut down the testing from 470,000 to 40,000 in the U.S. in 2007 out of about 35 million cattle slaughtered. also, science is showing that some of these atypical cases are more virulent to humans than the typical UK BSE strain ;
***Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD.***
Progress Report from the National Prion Disease Pathology Surveillance Center
An Update from Stephen M. Sergay, MB, BCh & Pierluigi Gambetti, MD
In this context, a word is in order about the US testing program. After the discovery of the first (imported) cow in 2003, the magnitude of testing was much increased, reaching a level of >400,000 tests in 2005 (Figure 4). Neither of the 2 more recently indigenously infected older animals with nonspecific clinical features would have been detected without such testing, and neither would have been identified as atypical without confirmatory Western blots. Despite these facts, surveillance has now been decimated to 40,000 annual tests (USDA news release no. 0255.06, July 20, 2006) and invites the accusation that the United States will never know the true status of its involvement with BSE.
In short, a great deal of further work will need to be done before the phenotypic features and prevalence of atypical BSE are understood. More than a single strain may have been present from the beginning of the epidemic, but this possibility has been overlooked by virtue of the absence of widespread Western blot confirmatory testing of positive screening test results; or these new phenotypes may be found, at least in part, to result from infections at an older age by a typical BSE agent, rather than neonatal infections with new "strains" of BSE. Neither alternative has yet been investigated.