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From: TSS ()
In Reply to: Mad cow disease found in Russia near the EU border posted by TSS on October 17, 2006 at 12:23 pm:
>>>"The two people who had contact with the animal have received vaccinations," it added,<<< http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf CORRECT AS OF 21ST SEPTEMBER 2006 17 Medical Implants Containing Bovine Material At SEAC 91 (February 2006) the Medicines and Healthcare products Regulatory Agency (MHRA) asked the committee to consider the potential BSE risks to humans from medical implants using bovine material from the USA. The regulations on medical devices containing animal materials are based on the principle that TSE risks must be eliminated or reduced as much as possible and residual risks must be acceptable when weighed against the benefits to patients. Currently no guidance exists on the acceptability of TSE risk control measures applied to animal material in medical devices. The MHRA requested advice on three 3 issues. (i) can TSE risk associated with medical implants using USA sourced bovine material be estimated given that it might vary over time? (ii) is there, or has there been a significant risk that might warrant action in addition to that already taken? (iii) can the standards that support the regulations be altered to facilitate a consistent approach about the acceptability of products? The committee concluded that: • a risk assessment should be conducted on each device because of the large number of variables that influence associated TSE risks. Key factors which should be considered when assessing risks are: • the animal source. Use of material from closed herds or from herds that are managed carefully to prevent the introduction of the BSE agent. • use of material from young animals would markedly lower risk compared with older animals. • the geographical risk of BSE. The geographical BSE risk status of a country gives an imprecise indication of BSE risk. It would be better to use an estimated prevalence of BSE in a country based on data from a robust surveillance system. • the potential TSE infectivity of the source tissue(s) based on a careful assessment of the available data on tissue infectivity. CORRECT AS OF 21ST SEPTEMBER 2006 18 • the site of implantation. Sites with contact with the blood supply or CNS may increase risk. • whether TSE testing is undertaken on the source animal(s). • the number of source animals used for each device. http://www.seac.gov.uk/pdf/issue_summary.pdf Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 ######### Bovine Spongiform Encephalopathy Greetings List Members, I was lucky enough to sit in on this BSE conference I submitted a version of my notes to "They tell me it is a closed meeting and and i would have been doing just fine, (understand, these are taken from my notes for now. [host Richard Barns] [TSS] [no answer, you could hear in the back ground, [host Richard] [TSS] [not sure whom ask this] [TSS] [not sure who is speaking] [TSS] [not sure whom speaking] from this point, i was still connected, got to listen [unknown woman] [TSS] at this point the conference was turned back up, IF i were another Country, I would take heed to my RBARNS@ORA.FDA.GOV he would be glad to give you one ;-) Rockville Maryland, BSE issues in the U.S., The conference opened up with the explaining of although new cases in other countries were now Look at Germany whom said NO BSE and now have BSE. BSE increasing across Europe. Because of Temporary Ban on certain rendered product, A recent statement in Washington Post, said the BSE Risk is still low, minimal in U.S. with a greater HOWEVER, if BSE were to enter the U.S. (human health-they just threw that in cause i was listening. I will now 80% inspection of rendering *Problem-Complete coverage of rendering HAS NOT sizeable number of 1st time FAILED INITIAL INSPECTION, Compliance critical, Compliance poor in U.K. Gloria Dunason Rendering FDA license and NON FDA license system in place for home rendering & feed 279 inspectors Renderer at top of pyramid, significant failed to have caution statement render 56 FIRMS NEVER INSPECTED 1240 FDA license feed mills "close to 400 feed mills have not been inspected" 80% compliance for feed. 10% don't have system. NON-FDA licensed mills 40% do NOT have caution statement 'DO NOT FEED'. 74% Commingling compliance "This industry needs a lot of work and only half "700 Firms that were falitive, and need to be Quote to do BSE inspection in 19 states by end At this time, we will take questions. [I was about the third or fourth to ask question. someone asking about nutritional supplements and Some other Dr. Vet, whom were asking questions [Dennis Wilson] [Conference person] [Linda Singeltary ??? this was a another phone in (conference person) Dennis Blank, Ken Jackson (they really don't know how many non licensed Firms Linda Detwiler Warren-Maryland Dept. Agr. THE END TSS ############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html FROM New York TIMES Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Hi terry -- thanks for all your help. I know it made a difference with ----- Original Message ----- > http://www.vegsource.com/talk/madcow/messages/8219.html >From the New York Times NYTimes.com, January 11, 2001 Many Makers of Feed Fail to Heed Rules on Mad Cow Disease Large numbers of companies involved in manufacturing animal feed are not The widespread failure of companies to follow the regulations, adopted But much more needs to be done to ensure that mad cow disease does not The regulations state that feed manufacturers and companies that render All products that contain rendered cattle or sheep must have a label Under the regulations, F.D.A. district offices and state veterinary Among 180 large companies that render cattle and another ruminant, Then there are some 6,000 to 8,000 feed mills so small they do not On the other hand, fewer than 10 percent of companies, big and small, The American Feed Industry Association in Arlington, Va., did not return http://www.nytimes.com/2001/01/11/science/11COW.html Subject: ######### Bovine Spongiform Encephalopathy USDA/APHIS would like to provide clarification on the following point [Linda Detwiler asking everyone (me) not to use emergency BSE number, Dr. Detwiler was responding to an announcement made during the call to ############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html Subject: ######### Bovine Spongiform Encephalopathy Hello Mr. Thomas, > What Mr. Singeltary failed to do was provide would you and the USDA/APHIS be so kind as to supply > The system has been in place for over 10 years. that seems to be a very long time for a system to be in Why does the U.S. insist on not doing massive testing Please tell me why my question was not answered? > U.S. cattle, what kind of guarantee can you It was a very simple question, a very important If all these years, we have been hearing that Before i was ask to be 'disconnected', could you please be so kind, as to answer these thank you, P.S. if you will also notice, i did not post that BUT, they should be reported, some are infected with TSE. TSS Subject: Report on the assessment of the Georgraphical BSE-risk of the ######### Bovine Spongiform Encephalopathy Greetings List Members and ALL EU Countries, Because of this report, and the recent findings I attempted to post this to list in full text, thank you, Report on the assessment of the Geographical BSE-risk of the USA PART II REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE - 29 - Report on the assessment of the Geographical BSE-risk of the USA EXECUTIVE SUMMARY OVERALL ASSESSMENT The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely Stability: Before 1990 the system was extremely unstable because feeding External challenges: A moderate external challenge occurred in the Interaction of external challenges and stability: While extremely As long as there are no changes in stability or challenge the JUSTIFICATION 1. DATA The available information was suitable to carry out the GBR risk - 30 - Report on the assessment of the Geographical BSE-risk of the USA 2. STABILITY 2.1 Overall appreciation of the ability to identify BSE-cases and to · Before 1989, the ability of the system to identify (and 2.2 Overall appreciation of the ability to avoid recycling · Before 1997 the US rendering and feed producing system would not 2.3 Overall assessment of the Stability · Until 1990 the US BSE/cattle system was extremely unstable as 3. CHALLENGES A moderate external challenge occurred in the period 1980-1989 because -31 - Report on the assessment of the Geographical BSE-risk of the USA July system could detect clinical incidence of 1-3 cases per year per million 4. CONCLUSION ON THE RESULTING RISKS 4.1 Interaction of stability and challenqe · In the late 80s, early 90s a moderate external challenges met an 4.2 Risk that BSE-infectivity enters processing · A very low processing risk developed in the late 80s when the Note: The high turnover in parts of the dairy cattle population with a 4.3 Risk that BSE-infectivity is recycled and propagated · During the period covered by this assessment (1980-1999) the - 32 - Report on the assessment of the Geographical BSE-risk of the USA 5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK 5.1 The current GBR The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely 5.2 The expected development of the GBR As long as there are no changes in stability or challenge the 5.3 Recommendations for influencin.q the future GBR · As long as the stability of the US system is not significantly snip... FULL TEXT about 16 pages snip...end EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Report The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003. The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties. A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries. EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases. Publication date: 20 August 2004 Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL, Date: September 6, 2006 at 7:58 am PST PRODUCT Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA, RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II PRODUCT ______________________________ PRODUCT ______________________________ ______________________________ PRODUCT ______________________________ PRODUCT ______________________________ PRODUCT ______________________________ PRODUCT END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006 ### ### ### ### PRODUCT END OF ENFORCEMENT REPORT FOR July 12, 2006 ### http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html New Orleans District Telephone: 615-781-5380 May 17, 2006 WARNING LETTER NO. 2006-NOL-06 FEDERAL EXPRESS Mr. William Shirley, Jr., Owner Dear Mr. Shirley: On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration Our investigation found you failed to provide measures, including sufficient You failed to use clean-out procedures or other means adequate to prevent You failed to maintain written procedures specifying the clean-out As a result . the poultry meal you manufacture may contain protein derived This letter is not intended as an all-inclusive list of violations at your You should notify this office in writing within 15 working days of receiving Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Sincerely, /S Carol S. Sanchez Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, 100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg Primate (oral route)* 1/2 (50%) Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%) PrPres biochemical detection The comparison is made on the basis of calibration of the bovine inoculum inoculated into mice and cattle.8 *Data are number of animals bioassays is generally judged to be about plus or minus 1 log. ic Table 1: Comparison of transmission rates in primates and cattle infected http://www.thelancet.com/journal/journal.isa also have shared Mr Bradley's surprise at the results because all the dose levels right down to 1 gram triggered infection. To cattle: 1 gram of infected brain material (by oral ingestion) [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf 03-025IFA P.O. Box 42 Bacliff, Texas USA 77518
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