tag:blogger.com,1999:blog-3763568913308811352.post1522059942205287246..comments2020-02-27T23:20:36.269-08:00Comments on FDA Strengthens BSE Safeguards Animal Feed: Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: ProposedTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.comBlogger1125tag:blogger.com,1999:blog-3763568913308811352.post-38958558788220693922009-04-17T07:34:00.000-07:002009-04-17T07:34:00.000-07:00-------------------- BSE-L@LISTS.AEGEE.ORG -------...-------------------- BSE-L@LISTS.AEGEE.ORG --------------------<br /><br /><br />TSS COMMENT SUBMISSION # 5 <br /><br /><br />Docket ID FDA-2002-N-0031 Docket Title Animal Proteins Prohibited in Ruminant Feed Document ID FDA-2002-N-0031-0132 Document Title Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date<br /><br /><br /><br /><br />Completely Edited Version<br /><br />PRION ROUNDTABLE<br /><br />2003<br /><br />page 29<br /><br />Dr. Linda Detwiler<br /><br />The UK imports into the US.<br /><br />There were 496 total, and 173 of the UK imports could have entered the US feed system. People don't like to hear this, but it's possible that one of the UK imports in the US entered the animal feed system and was exported to Canada. That's a possibility, because they import 50% of their feed from the US.<br /><br />From 1994, we imported 11 million head of cattle from Canada. Most of these were feedlot animals for slaughter, but there were about 500,000 breeding animals. A number of Canada's cull cows were slaughtered here and could have introduced infectivity into our system. Even today we have Canadian imports in the country, breeding animals that were brought in prior to the ban and reside here.<br /><br />We have feed ban exemptions: plate waste, poultry litter. We still allow that if it comes off a human plate, or if it's trimmings, it can be palletized and fed to ruminants. That might be a small amount, but it could allow spinal cord in certain cuts to be fed back to ruminants. Poultry litter or feather meal could be significant. Poultry is getting quite a bit of ruminant material in the US because it cannot go back to ruminants. Poultry and pigs are getting a substantial amount. Poultry litter is not only what passes through the chicken, but think about how chickens eat. They spill a lot on the floor. That stuff is still allowed to be fed back to cattle. That's a direct break in the ban, except that it's legal. Ruminants are getting ruminant material.<br /><br />Unfiltered tallow: tallow is a lipid material. However, if it's not filtered, there are protein residues. That's meat and bone meal. That's allowed to be fed, so that's another legal exception where you can feed ruminant meat and bone meal through unfiltered tallow. We don't have an SRM ban and the 40 animals are the ones that if you have the agent, they introduce the most infectivity back into the animal food chain when they're rendered.<br /><br />What's our on-farm compliance? We really don't know. ...snip...end...Dr. Linda Detwiler<br /><br /><br /><br />UK EXPORTS OF MBM TO WORLD<br /><br />http://www.bseinquiry.gov.uk/files/mb/m11g/tab05.pdf<br /><br />OTHERS<br /><br />BEEF AND VEAL<br /><br />http://www.bseinquiry.gov.uk/files/mb/m11f/tab08.pdf<br /><br />http://www.bseinquiry.gov.uk/files/mb/m11f/tab09.pdf<br /><br />http://www.bseinquiry.gov.uk/files/mb/m11f/tab10.pdf<br /><br />LIVE CATTLE<br /><br />http://www.bseinquiry.gov.uk/files/mb/m11f/tab11.pdf<br /><br />FATS<br /><br />http://www.bseinquiry.gov.uk/files/mb/m11g/tab01.pdf<br /><br />EMBRYOS<br /><br />http://www.bseinquiry.gov.uk/files/mb/m11g/tab03.pdf<br /><br />GELATIN ETC<br /><br />http://www.bseinquiry.gov.uk/files/mb/m11g/tab02.pdf<br /><br />SEMEN<br /><br />http://www.bseinquiry.gov.uk/files/mb/m11g/tab04.pdf<br /><br />MEAT<br /><br />http://www.bseinquiry.gov.uk/files/mb/m11g/tab05.pdf<br /><br />CANADA<br /><br />http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf<br /><br />USA<br /><br />http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf<br /><br />MEXICO<br /><br />http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf<br /><br />Wednesday, April 16, 2008 MBM, greaves, meat offal, live cattle, imports from UK to USA vs Canada "Three of four possible manufacturers supplying a protein supplement likely fed to the animal could have included meat and bone meal (MBM) as an ingredient in its formulation. One of these manufacturers was able to confirm usage of meat and bone meal in supplements and confirm a source of MBM to be one common to previous BSE investigations."<br /><br />USA AND CANADA IMPORTS OF UK CATTLE BETWEEN 1981 - 1989<br /><br />USA = 496<br /><br />CANADA = 198<br /><br />*add 14 to 198 as last UK import to Canada, 14 in 1990<br /><br />http://www.inspection.gc.ca/english/sci/ahra/bseris/bserise.pdf<br /><br />HERE is another look at all the imports for both the USA and Canada of UK live cattle and greaves exports ;<br /><br />UK Exports of Live Cattle by Value 1986-96<br /><br />USA 697 LIVE CATTLE<br /><br />CANADA 299 LIVE CATTLE<br /><br />http://www.bseinquiry.gov.uk/files/mb/m11f/tab11.pdf<br /><br />UK TABLE of Exports of meal of meat and meat offal; greaves 1979 - 1995<br /><br />USA 24 TONS<br /><br />CANADA 83 TONS<br /><br />http://www.bseinquiry.gov.uk/files/mb/m12/tab12.pdf<br /><br />HOWEVER, my files show 44 tons of greaves for USA. ...TSS<br /><br />Subject: Re: exports from the U.K. of it's MBM to U.S.??? From: S.J.Pearsall@esg.maff.gsi.gov.uk Date: Tue, 8 Feb 2000 14:03:16 +0000 To: flounder@wt.net (Receipt Notification Requested) (Non Receipt Notification Requested)<br /><br />Terry<br /><br />Meat and bonemeal is not specifically classified for overseas trade purposes. The nearest equivalent is listed as flours and meals of meat or offals (including tankage), unfit for human consumption; greaves. UK exports of this to the US are listed below:<br /><br />Country Tonnes<br /><br />1980 1981 12 1982 1983 1984 10 1985 2 1986 1987 1988 1989 20 1990<br /><br />Data for exports between 1975 and 1979 are not readily available. These can be obtained (at a charge) from data retailers appointed by HM Customs and Excise: BTSL (Tel: 01372 463121) or Abacus (01245 252222). Best wishes Simon Pearsall Overseas trade statistics Stats (C&F)C<br /><br />============ END...TSS...2008============<br /><br />P04.27<br /><br />Experimental BSE Infection of Non-human Primates: Efficacy of the Oral Route<br /><br />Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3; Ingrosso, L3; Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6; Löwer, J1 1Paul-Ehrlich-Institut, Germany; 2Commissariat à l´Energie Atomique, France; 3Instituto Superiore di Sanità, Italy; 4Swedish Institute for Infectious Disease control, Sweden; 5Georg August University, Germany; 6German Primate Center, Germany<br /><br />Background:<br /><br />In 2001, a study was initiated in primates to assess the risk for humans to contract BSE through contaminated food. For this purpose, BSE brain was titrated in cynomolgus monkeys.<br /><br />Aims:<br /><br />The primary objective is the determination of the minimal infectious dose (MID50) for oral exposure to BSE in a simian model, and, by in doing this, to assess the risk for humans. Secondly, we aimed at examining the course of the disease to identify possible biomarkers.<br /><br />Methods:<br /><br />Groups with six monkeys each were orally dosed with lowering amounts of BSE brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).<br /><br />Results:<br /><br />In an ongoing study, a considerable number of high-dosed macaques already developed simian vCJD upon oral or intracerebral exposure or are at the onset of the clinical phase. However, there are differences in the clinical course between orally and intracerebrally infected animals that may influence the detection of biomarkers.<br /><br />Conclusions:<br /><br />Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route using less than 5 g BSE brain homogenate. The difference in the incubation period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years). However, there are rapid progressors among orally dosed monkeys that develop simian vCJD as fast as intracerebrally inoculated animals.<br /><br />The work referenced was performed in partial fulfilment of the study "BSE in primates" supported by the EU (QLK1-2002-01096).<br /><br />http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf<br /><br />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;<br /><br />Risk of oral infection with bovine spongiform encephalopathy agent in primates<br /><br />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.<br /><br />snip...<br /><br />BSE bovine brain inoculum<br /><br />100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg<br /><br />Primate (oral route)* 1/2 (50%)<br /><br />Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)<br /><br />RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)<br /><br />PrPres biochemical detection<br /><br />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<br /><br />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<br /><br />bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal.<br /><br />Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula<br /><br />Published online January 27, 2005<br /><br />http://www.thelancet.com/journal/journal.isa<br /><br />It is clear that the designing scientists must<br /><br />also have shared Mr Bradley's surprise at the results because all the dose<br /><br />levels right down to 1 gram triggered infection.<br /><br />http://www.bseinquiry.gov.uk/files/ws/s145d.pdf<br /><br />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"<br /><br />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.<br /><br />http://www.bseinquiry.gov.uk/files/ws/s147f.pdf<br /><br />TSS<br /><br />http://madcowtesting.blogspot.com/2008/04/mbm-greaves-meat-offal-live-cattle.html<br /><br /><br /><br />Thursday, April 09, 2009<br /> <br />Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed<br /> <br />burt.pritchett@fda.hhs.gov<br /> <br />Greetings FDA et al,<br /> <br />I lost my Mother to the Heidenhain Variant Creutzfeldt Jakob disease (confirmed see autopsy below).<br /> <br />I kindly wish to comment on the following ;<br /> <br />[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46<br /> <br />[Federal Register: April 9, 2009 (Volume 74, Number 67)] [Proposed Rules] [Page 16160-16161] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ap09-18]<br /> <br />DEPARTMENT OF HEALTH AND HUMAN SERVICES<br /> <br />Food and Drug Administration<br /> <br />21 CFR Part 589<br /> <br />[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46 TSS SUBMISSION # 5<br /><br /> <br />Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date<br /> <br />AGENCY: Food and Drug Administration, HHS.<br /> <br />ACTION: Notice of proposed delay of effective date.<br /> <br />http://edocket.access.gpo.gov/2009/E9-8127.htm<br /> <br />MY COMMENT AS FOLLOWS ;<br /> <br />I find it deeply disturbing, that with the science to date, especially with the science to date, transmission studies, the more virulent atypical strains of the BSE i.e. h-BSE and l-BSE, both of which have now been documented in North America, that we are even still discussing this most important topic. The industry involved has beat this mad cow feed ban to death, and still refuse to comply. IF they would have adhered to policy, rules and regulations put forth August 4th, 1997, when the partial, and voluntary ruminant to ruminant feed ban was first put in place, they would not still be crying the same tune. WE need not only to enforce the present ban, but strengthen it, especially to include blood in the ban. WE (the consumer), was promised this would happen years ago. For Pete's sake, this will be the third president to have to address these same questions, and I pray that this one has the guts to finally do something. We need NOT discuss this for one more second. We had 8 years that President Bush literally covered up mad cow disease, and let literally millions and millions of pounds of mad cow feed into commerce to be fed out. IN one feed ban recall alone in 2007, 10 MILLION PLUS POUNDS was fed out into commerce. and under this same President, we now millions of kids across our Nation that have been needlessly exposed to the mad cow agent via the infamous USDA CERTIFIED DOWNER COW DEAD STOCK SCHOOL LUNCH PROGRAM. if you think for one moment that the largest meat recall in the history of the USA was because a few animals were filmed being abused, your only kidding yourself. that meat was recalled because dead stock downer cows are at the highest risk to carry mad cow disease, and they had been feeding our children this stuff for years. AND then had the nerve to lie to us about THE GREAT BSE FIREWALL IN THE USA THAT WOULD PROTECT THE CONSUMER I.E. THE BSE FEED BAN, that never was nothing more than ink on paper. who will monitor these children in the years and decades to come for a human form of Transmissible Spongiform Encephalopathy? who can with a CJD/TSE surveillance system and CJD Questionnaire set up the way it is now? you can't.<br /> <br />R-CALF and the CJD Foundation, seem oblivious to the fact that the USA has a mad cow problem. THIS IS NOT ABOUT THE CANADIAN BORDER. this is about feeding cows to cows in the USA, USA RUMINANT MAD COW FEED IN COMMERCE, and the fact the USA has had a mad cow problem for years.<br /> <br />all R-CALF wants to do is blame it on Canada, close the border, and then continue to feed ruminant feed to USA cattle, and ignore the TSE problem in the USA bovine, read closely what Bullard says from R-CALF ;<br /> <br />"We either implement this feed ban without any further delay or we stop the source of this problem by removing and reversing the Canadian cattle that continues to enter this country" said Bullard<br /> <br />http://www.montanasnewsstation.com/Global/story.asp?S=10171123<br /> <br />ENOUGH already $ NO MORE DISCUSSION PLEASE, WE NEED ACTION !<br /> <br />STOP ALL MAD COW FEED REGARDLESS !!!<br /> <br />I strenuously urge President Obama to NOT discuss this for one more moment, actions must be put forth now, and enforce such actions.<br /> <br />I strenuously urge President Obama to ENHANCE the feed ban to include blood, and enforce said regulations, based on sound science.<br /> <br />I strenuously urge President Obama to ban the use of "poultry litter" and the use of all mammalian and poultry protein in ruminant feed,as a feed ingredient for ruminant animals, and enforce said regulations, based on sound science.<br /> <br />I strenuously urge President Obama to ban the use of "plate waste" as a feed ingredient for ruminants, and enforce said regulations, based on sound science.<br /> <br />I strenuously urge President Obama to ban from human food (including dietary supplements please see latest May 2009 CDC warning on these type supplements, CWD, and Elk Antler Velvet), and cosmetics a wide range of bovine- derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates, and enforce such actions, based on sound science.<br /> <br />I strenuously urge President Obama to further minimize the possibility of cross- contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination, and enforce said regulations, based on sound science.<br /> <br />Sunday, April 12, 2009<br /> <br />BSE MAD COW TESTING USA 2009 FIGURES<br /> <br />Month Number of Tests<br /> <br />Feb 2009 -- 1,891<br /> <br />Jan 2009 -- 4,620<br /> <br />http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/ongoing_surv_results.shtml<br /> <br />http://madcowtesting.blogspot.com/2009/04/bse-mad-cow-testing-usa-2009-figures.html<br /> <br /><br /><br />PLEASE SEE MY FULL COMMENT SUBMISSION IN THE PDF ATTACHMENT, OR GO HERE <br /><br /><br />Thursday, April 9, 2009<br /> <br />Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed<br /> <br />http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html<br /> <br />http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html#comments<br /> <br />Sunday, April 12, 2009 r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada<br /> <br />http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html<br /> <br />http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html#comments<br /><br /><br /><br /><br /><br />Thank you. 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