meanwhile, back at the ranch with larry, curly, and mo at USDA ET AL ON BSE ALABAMA STYLE

Subject: SEAC DRAFTS MINUTES 91st meeting held on 24th February 2006 ITEM 5 – MEDICAL IMPLANTS CONTAINING BOVINE MATERIAL OF USA ORIGIN BSE GBR III Date: March 29, 2006 at 9:44 am PST SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE Draft minutes of the open session of the 91st meeting held on 24th February 2006 snip... Members agreed that this third case indicates that there is relatively high risk of transmission of vCJD by blood transfusion. It was not known whether a tonsil biopsy had been conducted in this case. Such a biopsy was considered important to help ascertain whether tonsil biopsy could be used as a diagnostic test for clinical iatrogenic vCJD. It also was considered important to conduct autopsies on these remaining individuals on the event of their death to determine, amongst other things, the prevalence of infection in this group. Professor John Collinge (MRC – Prion Unit) considered it very important that these individuals had access to best practice care and counselling and be informed about clinical trials and the development of potential therapies. Members agreed that active approaches to obtaining tissues for testing and clinical monitoring of these patients was important both to ensure best practice clinical care and for enhancing understanding of risks. • Interviews had taken place for two new members for SEAC. The recommendations of the interview panel would be submitted to Ministers shortly. snip... ITEM 5 – MEDICAL IMPLANTS CONTAINING BOVINE MATERIAL (SEAC 91/2) 12. The Chair explained that the Medicines and Healthcare products Regulatory Agency (MHRA) asked the committee to consider issues around potential BSE risks to humans from medical implants using bovine material from USA animals. SEAC was also asked to comment on a scheme developed by a British Standards Institution (BSI) committee to assess whether BSE risks associated with medical devices are minimised. 13. MrJeremy Tinkler (MHRA) summarised the regulations on medical devices containing animal materials in relation to TSE risks. The regulations 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. About 100 medical devices containing bovine material, which have tissue contact with the recipient, are available in Europe. They tend to be used to treat serious conditions and confer significant clinical benefit, such as heart valves for paediatric cases. At present there are no alternatives to the animal-derived materials used in these products. 14. MrTinkler explained that, although regulations are in place, no guidance exists on the acceptability of TSE risk control measures applied to animal material in medical devices. Careful sourcing of animal material tends to be the most practicable way of reducing the TSE risk. The lack of guidance has led to inconsistent interpretation of the regulations across Europe. This was recently highlighted by the certification by a Notified Body in one Member State of -cardiovascular implants sourced from open cattle herds in the USA, recently reclassified as a Geographical BSE Risk (GBR) level III country. Certification was on the grounds of a lack of alternatives. However, the MHRA took the view that the TSE risk associated with these devices had not been minimised since it should be possible to source the material from another country or from closed herds. Therefore, the MHRA felt that it was inappropriate to market such products freely in Europe, and their use should only be permitted on humanitarian grounds until the risk had been minimised. 15. The MHRA wished SEAC to advise upon 3 issues. First, can the TSE risk associated with medical implants utilising bovine material sourced from USA cattle be estimated, given that it might vary over time? Second, is there, or has there been a significant risk from the use of such products that might warrant action in addition to that already taken to limit use of the products? Third, can the standards that support the regulations be altered to facilitate more consistent decisions about the acceptability of products? To address this third issue, a BSI committee has proposed a scheme, outlined in SEAC paper 91/2, that consists of additional requirements for acceptability of TSE risks in relation to medical devices. 16. A member noted that there are a number of variables that influence the overall risks and benefits from medical devices containing bovine material. The presence of TSE agents in the implant is influenced by the type of tissue used. The site of implantation also affects TSE risk, implantation sites in contact with central nervous system (CNS) or the blood supply could raise transmission risks. In addition, the number of animals used per device would influence transmission risks. The potential benefit to patients is also influenced by the type of device, with the benefit ranging from life saving (cardiovascular implants) to enhancement of quality of life (orthopaedic footware). The range of availability of alternatives may also vary considerably depending on the device. Taking all these factors together there is likely to be a wide range in the risk : benefit ratio between medical devices and a ‘one rule fits all’ approach was unlikely to be meaningful. Mr Tinkler noted that sourcing, availability and safety measures for skin contact devices, such as orthopaedic footwear tended to be similar to those for consumer products, whereas more stringent safety and quality assurance measures were employed for medical implants (including collagen). 17. Members noted that the number of animals needed to source material for implants such as heart valves was likely to be small. It should be possible to reduce risks by sourcing these materials from closed herds or herds managed carefully to prevent the introduction of the BSE agent. Mr Tinkler agreed that it should be possible to use closed herds. Additionally, it was suggested that it may be possible to source materials from other species, such as pigs. Mr Tinkler responded that heart valves from pigs had been used in medical implants but porcine pericardium was too thin and so bovine pericardium was used in most cases. Dr Matthews explained that the cost of using animals from closed herds for some devices may be prohibitively expensive, noting the material for many devices is sourced from animals slaughtered for human consumption. A member noted that if relatively few animals are required this should not be prohibitive for potentially life-saving devices. 18. Members asked about the age of the source cattle, noting that use of material from younger animals would markedly reduce risks. Mr Tinkler explained that animal age depended on the quality of the tissue required for the intended use. For example, 6 month old animals would be used to source pericardium or heart valves, however collagen would be obtained from older animals. Members suggested that age of animal be used as a risk reduction criterion. TSE testing of the source animal could also be used as a risk reduction measure, although such testing would not definitively prove an animal to be uninfected. Mr Tinkler noted that BSE testing had not been included as a requirement in the standard. 19. Members suggested that, because of the wide range of variables that influence the risk in relation to medical devices, it is more appropriate to conduct independent risk assessments on each device. The characteristics of the device, the tissue and source animal all influence the risk to varying extents. 20. Members considered that GBR status gives a very imprecise indication of BSE risk. In relative terms, the BSE risk was likely to be lower in a GBR I country compared with a GBR III country, but the difference in risk cannot be quantified. In terms of a more robust risk analysis, it is important to obtain a more reliable estimate of the prevalence of BSE in a country than simply GBR status, and have confidence in the quality of the surveillance data. Since all the necessary BSE surveillance data from the USA are not publicly available, it is not possible to accurately determine the prevalence of BSE in the USA. Dr Matthews noted that at the time the standard was developed, GBR status, while crude, was the only tool available to assess risk and that it reflected the uncertainties in the data available. In the future, the GBR categorisation would to be replaced by a simplified classification in line with an Office International des Epizooties (OIE) categorisation. He pointed out that such schemes took into account of exposure to the BSE agent from the UK or other countries and that they were developed in the context of uncertainty about the infectivity of particular tissues. 21. Dr Matthews noted that data are now available on the infectivity of a wide range of bovine tissues. In September 2005, the World Health Organisation had updated its assessment of the risk of TSE infectivity in tissues. These data, although incomplete, should increase confidence in the safety of particular tissues, particularly if the age of the source animal is also considered. As a result, less reliance need now be placed on the status of the country of origin. Members agreed, but noted that it would be important to assess the quality of the data on which assessments are based. As it seems highly likely that blood, at least from humans infected with vCJD, can be infectious, tissues and organs with a significant blood supply may also confer higher risk. 22. Members noted that some of the definitions used in the BSI scheme were poorly defined and non-quantitative. Furthermore, there was no quantitation of the maximum acceptable risk - it was not appropriate to consider that just because a risk has been minimised by available techniques, the absolute risk was acceptably low. In addition, the scheme appeared to attach similar importance to each risk reduction method and selectively apply them to each GBR status, which may be inappropriate. 23. In summary, 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. When assessing the geographical risk of BSE, the GBR 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. • 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. snip... http://www.seac.gov.uk/minutes/draft91.pdf Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 Date: Tue, 9 Jan 2001 16:49:00 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de ######### Bovine Spongiform Encephalopathy ######### Greetings List Members, I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started. I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so. "They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating." and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick. (understand, these are taken from my notes for now. the spelling of names and such could be off.) [host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch. [TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds? [no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.] [host Richard] could you repeat the question? [TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds? [not sure whom ask this] what group are you with? [TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide. [not sure who is speaking] could you please disconnect Mr. Singeltary [TSS] you are not going to answer my question? [not sure whom speaking] NO from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again; [unknown woman] what group are you with? [TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now? at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference. IF i were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from; RBARNS@ORA.FDA.GOV 301-827-6906 he would be glad to give you one ;-) Rockville Maryland, Richard Barns Host SNIP...END...TSS ============================================ Freas, William Monday, January 08,200l 3:03 PM Consultants Staff January 2001 Meeting (short version) Last, but not least. The illegal/legal harvesting of body parts and tissues will come back to haunt you. Maybe not morally, but due to NO background checks and human TSEs, again it will continue to spread. Stupidity, Ignorance and Greed is what fuels this disease. You must stop all of this and ACT AT ONCE... http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf 40,000 human heart valves a year from BSE herds Sun, 3 Sep 2000. Unpublished Inquiry documents obtained by CJD activist Terry S. Singeltary Sr. of Bacliff, Texas http://www.mad-cow.org/00/sep00_news.html#hhh The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts. TIP740203/l 0424 CONFIDENTIAL http://www.mad-cow.org/00/may00_news.html From: Terry S. Singeltary Sr. (216-119-138-152.ipset18.wt.net) Subject: COMMERCIAL IN CONFIDENCE/BSE/SURGICAL IMPLANTS/BLOOD CONTACT DEVICES (1989) Date: August 31, 2000 at 1:46 pm PST Greetings, thought i would make a comment on some of these old documentsi have been posting, still more to come. But i am trying to showthe pattern of deceipt and lies that surround this pendingenvironmental worldwide human/animal catastrophe. If i have not proven it yet, to EVERYONE, i will, just give me a little more time, my scanner and myself can only go so fast.... thanks, Terry S. Singeltary Sr., Bacliff, Texas USA ============================================ COMMERCIAL IN CONFIDENCE Miss M Duncan From: Dr E HoxeyDate: 29 January 1990cc: Mr R BurtonDr N RichardsonMs K TurnerMs J DhellMr N WeatherheadBOVINE SPONGIFORM ENCEPHALOPATHY1. In your absence on sick leave, I chaired the STD BSE group meetingon 26th January 1990.2. The minutes of the meeting will be circulated shortly but I was askedto bring to your attention the concerns of the group regarding the BMSheart valve.3. This concern arose from a number of points on the agenda:-i) the______________decision to source all raw material for sutures from Australasia from January 1990.ii) the major cleandown and decontamination proposed for thefactory and the possibility of press interest that this may generate.iii) the indication in the Tyrell Report on Research that theinfective agent may be induced to cross the species barrier byintracerebral, intraperitoneal or intravenous injection.4. As you are aware, the____________situation has been a model which wehave observed closely.5. Reviewing the BMS situatien, we considered the incidence of BSE inthe herds used for materials, the processing received by the materialand the age of the cattle used. Given the number of uncertainties andlack of definitive information on BSE, the_______________model wasstill considered as a good one. The group were uncomfortable with theposition of BMS as the only company using UK sourced material.6. The group considered that it may be worthwhile arranging a furthermeeting with___________to confidentially make them aware that theywould now be the only company using UK sourced bovine material forproducts of this type.7. Clearly, __________and__________ are now in an exposed position inthis area and all the implications need te be considered. Could we haveyour news on this proposal please?Dr E V HoxeyPD STD PG1A716 RSQExt 335690/01.29/19.1==============B.S.E. GUIDELINES ON BOVINE IMPLANTS & BLOOD CONTACT DEVICES -MEETING WITH MANUFACTURERSDATE: 8 DECEMBER 1989DH REPRESENTATIVES Nigel RichardsonWill BurtonEammon HoxeyJeremy TinklerHelen CampbellCarol BleakleyBill WaineThe main purpose of the meeeting is to discuss the companies currentmanufacturing procedures, future plans and their compliance with theBSE guidelines. Their views were also sought as to the practicalfeasibility of the guidelines with respect to the manufacturingprocess, and any improvements that could be suggested.The meetings were held separately with each company. Neither hadreceived any queries concerning BSE from countries to which theirproducts are exported.CURRENT POSITION1.__________ have brought in a microbiologist as a technical scientificadviser, initially to inform them of the current understanding ofBSE. He is still available to them and keeps them up to date with newdevelopments.2. At present they produce bovine pericardial heart valves, & (a sistercompany) produces heparin coated products (from a porcine source). Inthe future it is possible that they will introduce a bovine patchproduced from bovine pericardium from the same source. They will keepthe Department informed of any progress in this area.SOURCE MATERIAL3. The source material for the manufacture of heart valves is bovinepericardial sacs. The cows used are 18-24 months old when slaughtered,the majority around 18 months. BMS have no knowledge of the actualage.4. The cows are killed using brain penetration. Dr Bleakley made thepoint that as far as she was aware this was the only method used inthis country. Meat inspectors are paid to obtain the bovinepericardium. They are paid a set rate but bonuses are given forincreased yields. Mr Burton expressed concern as to the conflict ofinterests that may arise as a result of this. Dr Bleakley did notbelieve that this was the case because of the relationship BMS haddeveloped with the inspectors.89/12.12/8.1============COMMENTS ON THE GUIDELINES14. Dr. Bleakley believed that the pericardium would not allow thereplication of the causative agent, and does not present a risk.15. She suggested that the guidelines were impossible to implementfrom the point of view of the manufacturing process for the followingreasons:--It is not possible to use closed herds simply because of the numbersof cattle involved. This is up to 800 each week.-Calves under 6 months old cannot be used as the pericardium is toothin to be incorporated into a valve.-For cows this in the age group used brain penetration is the onlymethod of slaughtering used in this country.PROPOSALS PUT FORWARD BY DR BLEAKLEY16. The goverment should fund research in this area. For example,investigating the presence or absence of the infectious agent inother parts of the body, such as the pericardium. Also to look at howthe slaughtering process affects the spread of the disease.17. Ideally the answer would be to take random tissue samples inorder to detect contaminated material. This is not currently feasiblewith the length of time required to conduct titre testing.COMMENTS ON THE REVIEW ON METHODS OF STERILIZATION FOR BSE18. Everything present reflected the published material, but thevalidity of some of this is questionable. It was pointed out that:--it was stated that different strains display different heatsensitivity, but this does not appear to be chemically related-the claim to be "effective' would depend on the type of material thatwas being used and the time involved.CURRENT POSITION19.____________ manufacture porcine valves and bovine pericardialpatches. The possibility of producing porcine conduits is currentlybeing investigated. This has not yet progressed.20. The material is obtained from 2 abattoires in this country:--Dorchester, where veal calves under 18 weeks are slaughtered forsourcing pericardium for ________________. These are used to producesmall patches of less than 90mm diameter, this may be divided into 4quadrants. This represents 80-90% of sales.-Fairham where cows between 5 and 10 years old are slaughtered toproduce larger patches and strips of 100mm by 45mm.89/12.12/8.2=============32. As a result of the concern voiced of direct inoculation of BSEvia sectioning instruments it was stated that it would be feasible touse new blades with each carcass.COMMENTS ON THE GUIDELINES33. Dr Waine was not convinced of the need for sterile sectioningequipment and separate packaging from the abattoire. He felt thatthis would merely have a cosmetic effect.34. He suggested that the possibility of bovine-human cross-infectionwas very remote.35. He did not believe that it was possible for manufacturers tofollow the guidelines as they stand.PROPOSALS36. Dr Waine felt that the steps taken by the Government had beenrealistic to control the outbreak.REVIEW37. Dr Waine did not believe that any sterilization treatmentproposed would retain the surgical usage of the pericardium.VALVES38. The response has been that this problem is restricted to the U.K.Thier material is obtained from the same Italian source as thepatches. There is no age specification on the cows but the preferenceis for the larger valves which would therefore come from the olderanimals.PORCINE VALVES39. There was a small discussion as to whether these products do fallunder the issued guidelines. The assumption had been made by thecompany that they are not included as pigs are not known to besusceptible to infection by a Scrapie-like agent. This was confirmedby Dr Hoxey.40. The pigs are electrocuted and the heart and pericardium obtainedprior to inspection.41. One abattoire supplies them with most of their porcine requirments.H CampbellPG2CRoom 312 RSQExt. 321212 December 198989/12.12/8.3============TIP740203/3 0241Bovine Spongiform Meeting Held On Friday 26th January 1990Present Dr E Hoxey {chairman)Mr W BurtonDr N RichardsonMrs J DhellMs K TurnerMS H CambellMr N Weatherhead (secretary)copies: Miss Duncan1.ApologiesApologies were received from Miss Duncan2.Minutes of the last meeting.The previous minutes were accepted.3.Matters arising not on the agenda.As agreed at the previous meeting the paper on "Inactivation ofScrapie-like Agents" was sent with a Covering letter drafted byDr Hoxey to all companies that use Bovine or Porcine materiais.4.Report on the STD meeting with ___________________The minutes of the meeting were discussed by the committee it wasnoted that:-a} _____________ now meet DH Guidelines as the devices produced fromthe calf material comply as that they are obtained from animals lessthan 6 months old.The company had written to confirm that they nowsource older animals from overseas.b) _____________ are unable to meet the DH Guidelines.and will not be doing so in the foreseeable future. The panel showedconcern over the stance that BMS are taking. The committee felt that itwas important to arrange a further meeting to inform them that theyare now the only company using UK sourced material. [see minutes of themeeting dated 8/12/89 attached). Dr Hoxey agreed to write separateyto Miss Duncan on this issue.action: Dr Hoxey5. Report on the CSM/MCA BSE working party meeting 10/1/90Mr Burton had produced a note of the above meeting as the minutes hadas yet not been distributed. The committee noted that:-90/01.26/20.1=============TIP740203/3 02421) _______________ has exceeded all expectations tn complyingwith DH Guidelines. They will be sourcing all raw material fromAustralasia from January 1990.2) _______________ are using an international expert _______________to advise them on factory decontamination at the change over of source.3) The use of Dr Taylor and the factory decontamination may qeneratepress interest.4) The offal ban has not yet been expanded to include Scotland.5) The CSM/MCA BSE working group agrees with the approach that STDare taking to Tissue Harvesting and wished to be kept updated.The note of the meeting is attached for reference.6. STD Database updatingMr Burton drafted a minute for signature by Mr Worroll.The object ofthe minute was to enable STD to keep a check on companies that useanimal material in their products.The control manual committee amended the minute and agreed that theaudit report procedure should include (if it does not already) astatement to the effect that the company information section shouldinclude details of raw materials used.The CMC suggested a sentence to the effect "Team leaders visitingBlue Guide companies should additionally take account of Mr Worroll'sminute of Jan 1990." The committee agreed with this sentence and passedit back for inclusion in the Base-line Documents.action N Weatherhead7. Review of the 'Interim Report of the Consultative Committee onResearch into BSE" (Tyrell committee report.)Mrs Dhell presented a summarized Version of the above document to thecommittee. It was noted that only the research studies catorqorisedhigh/medium priority would all somehow receive funding. The committeeexpressed a wish to find out:-1) Areas which have not been prioritised which have relevance toSTDS area of interest.2) Has any party taken up the study "Investigation into the fate ofbovine and ovine tissues and product that could lead to infection byas yet unrecognised routes."90/01.26/20.2==============TIP740203/3 02433. The protocol of work being carried out by the Clinical ResearchLaboratory in Harrow add proposed by the Neuropathogenesis unit inEdinburgh:a) Have they any plans to include pericardium. If not could PD suggestthat they miqht include it.b) What controls are they using.c) Will it be possible to arrange a visit.4) It was suggested that Dr Pickles be contacted as the DHrepresentitive on the Tyrell committee, to enquire if comments onthis document were being sought by the committee, as PD has a numberof points it wishes to raise.8. Incorporation of Guidance into Chemical Methods for the sterilizationof animal tissue Used in medical Devices.The draft paper on methods of validation in chemical sterilization wasshown to the BGRP for comments, these were later received. A copy wasalso forwarded to MCA and despite numerous reminders no reply had asyet been received.The committee recommended that the paper on "Chemical Methods for theSterilization of Animal Tissue Used in Medical Devices" should beamended include Tissue Harvesting. The BGRP will be informed of thisand a copy of tbe document will be presented to the next CMS/MCA BSEworking group which is to be held on 4th July l99O.Mrs Dhell to arrange a meeting to draft this ammendment.Mrs Turneraction:Hr TinklerMrs DhellDr Hoxey9. Possibility of sending STD paper 'Inactivation of Scrapie-likeAgents" to Dr Taylor and Dr Kimberlin for their comments.The committee felt that the paper should be sent to Dr Taylor andDr Klmberlin and that they should be invited to comment. If theysubsequently required payment for this work the committee felt thatthe Department should finance it if necessary.Mrs Dhell will draft a letter to accompany the report for Miss Duncanto sign.action: Mrs Dhell90/01.26/20.3==============TIP740203/3 024410. - presentation on current situationMiss Duncan's report was passed over until the next meeting.1l. Oral discussion on relevant media interest and media reports.The discussion mainly revolved around _____________ and the exposedposition PD would be in if the media became involved. The possiblepress coverage expected in relation to events at ___________ could alsoraise the profile of BSE in "medical" products.Mr Burton to obtain copies of any defensive briefings draftedby MCA in responce to the ______________ situation.N Weatherhead90/01.26/20.4############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############ i recieved the 1947 report of the Louping-ill vaccine incident and posted on www here; Louping-ill vaccine (scrapie transmission by vaccine) THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946 NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND ANNUAL CONGRESS, 1946 snip... The enquiry made the position clear. Scrapie was developing in the sheep vaccinated in 1935 and it was only in a few instances that the owner was associating the occurrence with louping-ill vaccination. The disease was affecting all breeds and it was confined to the animals vaccinated with batch 2. This was clearly demonstrated on a number of farms on which batch 1 had been used to inoculate the hoggs in 1935 and batch 2 to inoculate the ewes. None of the hoggs, which at this time were three- year-old ewes. At this time it was difficult to forecast whether all of the 18,000 sheep which had received batch 2 vaccine would develop scrapie. It was fortunate, however, that the majority of the sheep vaccinated with batch 2 were ewes and therfore all that were four years old and upwards at the time of vaccination had already been disposed of and there only remained the ewes which had been two to three years old at the time of vaccination, consequently no accurate assessment of the incidence of scrapie could be made. On a few farms, however, where vaccination was confined to hoggs, the incidence ranged from 1 percent, to 35 percent, with an average of about 5 percent. Since batch 2 vaccine had been incriminated as a probable source of scrapie infection, an attempt was made to trace the origin of the 112 sheep whose tissues had been included in the vaccine. It was found that they had been supplied by three owners and that all were of the Blackface or Greyface breed with the exception of eight which were Cheviot lambs born in 1935 from ewes which had been in contact with scrapie infection. Some of these contact ewes developed scrapie in 1936-37 and three surviving fellow lambs to the eight included in the batch 2 vaccine of 1935 developed scrapie, one in September, 1936, one in February, 1937, and one in November, 1937. There was, therefore, strong presumptive evidence that the eight Cheviot lambs included in the vaccine althought apparently healthy were, in fact, in the incubative stage of a scrapie infection and that in their tissues there was an infective agent which had contaminated the batch 2 vaccine, rendering it liable to set up scrapie. If that assumption was correct then the evidence indicated that:- (1) the infective agent of scrapie was present in the brain, spinal cord and or spleen of infected sheep: (2) it could withstand a concentration of formalin of 0-35 percent, which inactivated the virus of louping-ill: (3) it could be transmitted by subcutaneous inoculation; (4) it had an incubative period of two years and longer. Two Frenchmen, Cuille & Chelle (1939) as the result of experiments commenced in 1932, reported the successful infection of sheep by inoculation of emulsions of spinal cord or brain material by the intracerebral, epidural, intraocular and subcutaneous routes The incubation period varied according to the route employed, being one year intracerebrally, 15 months intraocularly and 20 months subcutaneously. They failed to infect rabbits but succeeded in infecting goats. Another important part of their work showed that the infective agent could pass throught a chamberland 1.3 filter, thus demonstrating that the infective agent was a filtrable virus. It was a curious coincidence that while they were doing their transmission experiments their work was being confirmed by the unforeseeable infectivity of a formalinized tissue vaccine. As a result of this experience a large-scale transmision experiment involving the ue of 788 sheep was commenced in 1938 on a farm specially taken for the purpose by the Animal Diseases Research Association with funds provided by the Agricultural Research Council. The experiment was designed to determine the nature of the infective agent and the pathogenesis of the disease. It is only possible here to give a summary of the result which showed that (1) saline suspensions of brain and spinal cord tissue of sheep affected with scrapie were infective to normal sheep when inoculatted intracerebrally or subcutaneously; (2) the incubation period after intracerebral inoculation was seven months and upwards and only 60 percent of the inoculated sheep developed scrapie during a period of four and a half years; (3) the incubation period after subcutaneous inoculation was 15 months and upwards and only about 30 percent of the inoculated sheep developed the disease during the four and a half years: (4) the infective agent was of small size and probably a filtrable virus. The prolonged incubative period of the disease and the remarkable resistance of the causal agent to formalin are features of distinct interest. It still remains to determine if a biological test can be devised to detect infected animals so that they can be killed for food before they develop clinical symptoms and to explore the possibilities of producing an immunity to the disease... 8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients). http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf although 176 products do _not_ conform to the CSM/VPC guidelines. http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf Super-ovulate cattle. (Not to forget about the potential for some BSE cases to come from vaccinations containing pituitary-derived SRMs.) TWA LITTLE minute http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf COMMERCIAL IN CONFIDENCE http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf NOT FOR PUBLICATION http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE snip... I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use. snip... The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out... http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf more on the 1968 medicine act, they forgot to follow http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer) http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf (It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.) http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf TWA LITTLE STATEMENT 331 http://www.bseinquiry.gov.uk/files/ws/s331.pdf 25 Apr 2002 : Column WA58 Bovine Embryos and Live Cattle: Imports from North America The Earl of Caithness asked her Majesty's Government: When the ban on the importation of embryos and live cattle from North America will be lifted; and [HL3912] What is the scientific evidence for the imposition of a ban on the importation of embryos and live cattle from North America. [HL3913] Lord Whitty: Her Majesty's Government have not imposed a ban on imports of bovine embryos and live cattle from North America. The European Parliament and European Council introduced legislation in May last year laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (TSEs). The legislation was introduced in response to the recommendations of the Office International des Epizooties (OIE—the international animal health organisation) and advice from the Commission's scientific comittees. The legislation (and the transitional measures which came into effect in October last year) includes requirement that imports into the EU of bovine embryos and live cattle must be accompanied by certification confirming that the feeding of ruminants with protein derived from mammals has been banned and that the ban has been effectively enforced. Some exporting countries, such as Canada and the USA, are currently unable to meet these new requirements. http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds02/text/20425w04.htm BSE: US Export of Specified Risk Material Lord Kennet asked Her Majesty's Government: Whether the United States contends that under the provisions enforceable by the World Trade Organisation the European Union may not ban the import into Europe from the United States of "specified risk material" (that is, material at possible risk of BSE infection). Lord Donoughue: Yes. But their position on the Specified Risk Material legislation is based on the assumption that the United States can safely be regarded as a "BSE free" country. Their case for such treatment has not been accepted by the EU Commission's Scientific Veterinary Committee. http://www.publications.parliament.uk/pa/ld199798/ldhansrd/vo971215/text/71215w02.htm Baroness Masham of Ilton: My Lords, as blood products which infected haemophiliacs with HIV came from the USA, is the Minister confident that something else nasty may not come again from imported blood from the USA? Is he aware that there are ways of cleaning blood to make it safer? I know that that is done in Vienna, in Austria. Will the Minister look into that? Following the question asked by the noble Lord, Lord Clement-Jones, about people using their own blood, I am sure that, when this Statement goes out into the wider community, people will want to know that information. http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds03/text/31217-09.htm However, the Bio Products Laboratory who produce plasma products did export surplus products, under the Income Generation Regulations for the NHS, and used the income for the benefit of the health service.[21] http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/20703.htm#n21 43. Do you sell any of it abroad at all? (Mr Gorham) No. The only circumstances in which we would export blood would be if there was an approach to the British Government and the British Government felt that it was appropriate to support an international emergency or something like that. We do supply the British Forces. We occasionally help out our colleagues in Wales and Scotland and they would reciprocate with us if that was appropriate. At the moment it is more or less totally contained within the United Kingdom. http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/1012904.htm Blood and Blood Products Mr. Hinchliffe: To ask the Secretary of State for Health what estimate he has made of the number of persons who have been inoculated with blood or blood products over the past three years in the United Kingdom. [61681] Ms Jowell [holding answer 2 December 1998]: It is estimated that about one million people in the United Kingdom receive blood and blood products every year. http://www.parliament.the-stationery-office.co.uk/pa/cm199899/cmhansrd/vo990210/text/90210w02.htm Human vaccine prepared in animal brains http://www.mad-cow.org/00/nov00_late_news.html#fff http://www.whale.to/v/singeltary7.html http://www.mad-cow.org/00/may00_news.html http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I _______________________________ PRODUCTHuman Tissue for Transplantation, Recall # B-0432-6:a) Tricortical Wedge (R) 1.5 x 2.5 cm,Freeze Dried Irradiated;b) Tricortical Wedge ( L ) 1.7 x 3.0 cm,Fresh Frozen Irradiated;c) Cancellous Crushed 60.0 cc, Freeze Dried,Irradiated;d) Cancellous Crushed 30.0 cc Freeze Dried,Irradiated;e) Achilles Tendon OA ( R ) Fresh FrozenIrradiated;f) Achilles Tendon OA ( L ) Fresh FrozenIrradiated;g) Lumbar;h) Cancellous Crushed 30.0 cc Fresh Frozen,IrradiatedCODEa) Tissue 04091-002;b) Tissue 04113-003;c) Tissues 04091-008, 04101-008, 04103-002,04103-003, 04105-003;d) Tissues 04091-005, 04091-006, 04091-007,04101-006, 04101-007, 04102-004, 04102-005,04104-003, 04104-004, 04104-005, 04105-002,04109-003, 04109-004, 04120-004, 04124-003,04124-004, 04138-002, 04138-003, 04140-002,04143-002, 04143-003, 04146-001, 04152-001;e) Tissues 04101-003, 04123-004;f) Tissues 04101-004, 04123-003;g) Tissues 03049-001, 03051-001, 04091-001,04102-001, 04103-001, 04104-001, 04105-001,04106-001, 04107-001, 04108-001, 04109-001,04113-001, 04120-001, 04122-001, 04123-001,04124-001;h) Tissue 04108-002RECALLING FIRM/MANUFACTURER Recalling Firm: Central Texas Regional Blood & Tissue Center, Austin, TX, bytelephone on October 4, 2005, and by letter dated October 11, 2005.Manufacturer: Biomedical Tissue Services, Fort Lee, NJ, firm initiatedrecall is ongoing. REASON Human tissues, procured from donors without adequate donor eligibility determinations, were distributed. VOLUME OF PRODUCT IN COMMERCE 51 allografts DISTRIBUTION TX and CO PRODUCT Human Corneal Tissues for Transplantation, Recall # B-0380-6CODETissues: CI044108 OD and CI044108 OSRECALLING FIRM/MANUFACTURERMichigan Eye Bank, Ann Arbor, MI, by letter dated November 22, 2005, and byfacsimile dated November 28, 2005. Firm initiated recall is complete. REASON Human Corneas, collected from an ineligible donor, were distributed.VOLUME OF PRODUCT IN COMMERCE2 tissuesDISTRIBUTIONMI, CA and Germany _______________________________ PRODUCTa) Red Blood Cells Leukocytes Reduced,Recall # B-0617-6;b) Red Blood Cells (Apheresis) Leukocytes Reduced(distributed as split product), Recall # B-0618-6;c) Platelets Leukocytes Reduced, Recall # B-0619-6;d) Fresh Frozen Plasma, Recall # B-0620-6;e) Cryoprecipitated AHF, Recall # B-0621-6;f) Plasma Cryoprecipitate Reduced, Recall # B-0622-6;g) Recovered Plasma, Recall # B-0623-6CODEa) Unit numbers: 1136792, 1040212, 1011245;b) Unit numbers: 1048247-1, 1048247-2;c) Unit numbers: 1040212, 1011245;d) Unit number: 1136792;e) Unit numbers: 1040212, 1011245;f) Unit number: 1040212;g) Unit number: 1011245RECALLING FIRM/MANUFACTURERHoxworth Blood Center, Cincinnati, OH, by letter dated September 6, 2005.Firm initiated recall is complete.REASONBlood products, collected from a donor considered to be at increased riskfor variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE12 unitsDISTRIBUTIONOH and FL _______________________________ END OF ENFORCEMENT REPORT FOR MARCH 1, 2006### http://www.fda.gov/bbs/topics/enforce/2006/ENF00941.html RE-REASON Human Corneas, collected from an ineligible donor, were distributed http://www.mad-cow.org/dec99_news.html#bbb PRODUCTRecovered Plasma, Recall # B-0643-6CODEUnit numbers: R170537, R165863, and R158308RECALLING FIRM/MANUFACTURERPuget Sound Blood Center, Seattle, WA, by facsimile on October 7, 2003. Firminitiated recall is complete.REASONBlood products, which were collected from an unsuitable donor based on riskfactors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION Austria END OF ENFORCEMENT REPORT FOR FEBRUARY 22, 2006### http://www.fda.gov/bbs/topics/enforce/2006/ENF00940.html PRODUCTa) Product is 1.0 cc Regenaform® RT. SINGLE PATIENTUSE ONLY. Recall # Z-0481-06;b) OPTEFORM Allografts of varying sizes. SINGLE PATIENTUSE ONLY. Recall # Z-0482-06;c) Product is OPTEFORM Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0483-06;d) OPTEFORM® RT Moldable Allograft of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0484-06;e) Osteofil + RT Allograft Paste in varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0485-06;f) Osteofil Allograft Paste (Bio) of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0486-06;g) Osteofil IC Syringeable of varying sizes. SINGLEPATIENT USE ONLY. Recall # 0487-06;h) Osteofil ICM Moldable Strip of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0488-06;i) Osteofil RT, ICM Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0489-06;j) OSTEOFIL® DBM Paste of varying sizes. SINGLEPATIENT USE ONLY. Recall # Z-0490-06;k) OsteoPack 3 FZ 22cc. SINGLE PATIENT USE ONLY.Recall # Z-0491-06;l) Regenafil IC. SINGLE PATIENT USE ONLY.Recall # Z-0492-06;m) REGENAFORM RT Allograft Paste, 1cc. SINGLEPATIENT USE ONLY. Recall # Z-0493-06;n) Product is REGENAFORM® Allograft Moldable Blocks,of varying sizes. SINGLE PATIENT USE ONLY.Recall # Z-0494-06;o) Product is RTI Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0495-06;p) Product is REGENAFIL® Allograft Paste, Syringe,0.5cc. SINGLE PATIENT USE ONLY. Recall # 0496-06;q) Product is 1.0cc flowable paste from donorapproved for distribution in Italy. SINGLEPATIENT USE ONLY. Recall # Z-0497-06;r) Product is OPTEFIL Allograft Paste of varyingsizes. SINGLE PATIENT USE ONLY. Recall# Z-0498-06;s) Product is OPTEFIL Allograft Paste, Syringeof varying sizes. SINGLE PATIENT USE ONLY.Recall # Z-0499-06;t) Product is OPTEFORM® Allograft Full Disc,5 x 90mm, 32cc, Frozen. SINGLE PATIENT USEONLY, Recall # Z-0500-06;u) Product is 2.0 cc Opteform® RT. SINGLEPATIENT USE ONLY. Recall # Z-0501-06CODE2879130 2879131 2879132 2879133 2879134 2879135 2879136 2879137 28791382879139 2879350 2879351 2879352 2879353 2879354 2879355 2879440 28794412879442 2879443 2879444 2879445 2879446 2879447 2879448 2879449 28794502879451 2879452 2879453 2879454 2879455 2879456 2879457 2879458 snip...literally 100s and 100s and 100s, much to many recalls to post here, first few and last few lines posted here... TSS 2667981 2667983 2667984 2667985 26679872667988 2667989 2669552 2669553 2669554 2669556 2669559 2669633 26696362669639 2669640 2669965 2669967 2669968 2669969 2669981 2669983 2669985 RECALLING FIRM/MANUFACTURERRegeneration Technologies, Inc., Alachua, FL, by letter on October 14, 2005.Firm initiated recall is ongoing. REASON The tissue was collected from donors for whom there is ___no verifiableidentity or consent___. The medical records and social histories of the donorscannot be ascertained. The devices which incorporate these donor bonetissues undergo processing, including sterilization, which has beenvalidated to inactivate and/or remove all viral diseases for which humantissue donors are tested. VOLUME OF PRODUCT IN COMMERCE 5,320 DISTRIBUTION Nationwide and Internationally END OF ENFORCEMENT REPORT FOR FEBRUARY 15, 2006### http://www.fda.gov/bbs/topics/enforce/2006/ENF00939.html _______________________________ PRODUCTSource Plasma, Recall # B-0584-6CODEUnits VL53767, ZZ031076, ZZ030881, ZZ03046, VL151413, VL151144, VL50837RECALLING FIRM/MANUFACTURERBioLife Plasma Services LP, Shreveport, LA, by facsimile dated October 6,2003. Firm initiated recall is complete.REASONSource Plasma, collected from a donor who was at increased risk for variantCreutzfeldt-Jakob Disease (vCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE 7 units DISTRIBUTION NC END OF ENFORCEMENT REPORT FOR FEBRUARY 1, 2006### http://www.fda.gov/bbs/topics/enforce/2006/ENF00937.html _______________________________ PRODUCTRed Blood Cells, Recall # B-0552-6CODEUnit number: 4426304RECALLING FIRM/MANUFACTURERFlorida's Blood Center, Inc., St. Petersburg, FL, by facsimile on July 8,2005. Firm initiated recall is complete.REASONBlood product, collected from a donor who may have been at increased riskfor new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONFLEND OF ENFORCEMENT REPORT FOR JANUARY 25, 2006### http://www.fda.gov/bbs/topics/enforce/2006/ENF00936.html RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I _______________________________ PRODUCTHuman Tissue for Transplantation, Recall # B-0322-6a) Alloquent CC Allograft (8, 9 & 10 mm);b) Achilles Tendon;c) Cancellous Bone 4-10 mm (15 & 30 cc);d) Patella Tendon-Hemi;e) Iliac Crest Wedge (14-17mm, 11-13mm,<10mm, and 18+mm);f) Tibialis TendonCODEa) Code: BS30-4008, BS30-4009, BS30-4010;b) Code: LATM;c) Code: LCISM & LCIPM;d) Code: LTTM;e) Code: LIWXLM, LIWLM, LIWMM, LIWSM;f) Code: LTTMRECALLING FIRM/MANUFACTURERRecalling Firm: Lost Mountain Tissue Bank, Kennesaw, GA, by letters datedOctober 12, and October 21, 2005.Manufacturer: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm initiatedrecall is ongoing.REASONHuman tissues, procured from donors without adequate donor eligibilitydeterminations, were distributed.VOLUME OF PRODUCT IN COMMERCE283 tissuesDISTRIBUTIONNationwide and Turkey _______________________________ PRODUCTPUROS Allograft Bone;Suspend Tutoplast Processed Fascia Lata,Recall # B-0375-6CODEa) U00000000045293 U00000000045294 U00000000045295 U00000000045296U00000000045297 U00000000045298 U00000000045299 U00000000045300U00000000045301 U00000000045302 U00000000045303 U00000000045368U00000000045369 snip...literally 100s and 100s and 100s, much to many recalls to post here, first few and last few lines posted here... TSS BM04A11221A024041204BM03K10421A045031504 BM03K12121A045020904 BM03L10421A045020904BM03L10621A045020904 BM03L11621A045031504 BM03L11621B045031504BM03L12121A045031504 BM03J11421A048011904 BM03J11421B048011904BM03K12121A048020904 BM03L10621A048020904 BM03L10621B048020904BM03L11221A048020904 BM03L11521A048020904 BM03L11521B048020904 RECALLING FIRM/MANUFACTURER Recalling Firm: Tutogen Medical, Inc., Alachua, FL, by telephone, facsimileand letter on October 14, 2005 and by letter dated October 24, 2005.Responsible Firm: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firminitiated recall is ongoing. REASON Human Tissues, procured from donors __without adequate donor eligibility determinations__, were distributed. VOLUME OF PRODUCT IN COMMERCE a) 5,676 allografts; b) 48 allografts DISTRIBUTION Nationwide, and Canada _______________________________ PRODUCTa) Red Blood Cells, LeukocytesReduced, Recall # B-0492-6;b) Recovered Plasma, Recall # B-0497-6CODEa) and b) Unit number: 4101212RECALLING FIRM/MANUFACTURERNorthwest Florida Blood Center, Inc., Pensacola, FL, by telephone andfacsimile on March 7, 2003. Firm initiated recall is complete.REASONBlood products, collected from an unsuitable donor due to a history oftravel to an area considered at increased risk of exposure to variantCreutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION FL _______________________________ END OF ENFORCEMENT REPORT FOR JANUARY 18, 2006### http://www.fda.gov/bbs/topics/enforce/2006/ENF00935.html PRODUCTSource Plasma, Recall # B-0391-6CODEUnit number: 7030260750RECALLING FIRM/MANUFACTURERZLB Bioplasma, Inc., San Antonio, TX, by facsimile and telephone onSeptember 29, 2003. Firm initiated recall is complete.REASONBlood product, which was collected from a donor who was deferred due to riskfactors associated with variant Creutzfeldt-Jakob disease (vCJD) travel, wasdistributed.VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION FL _____________________________________________________________ PRODUCTa) Red Blood Cells, Leukocytes ReducedRecall # B-0456-6;b) Recovered Plasma, Recall # B-0457-6CODEa) Unit number: 06FR39967;b) Unit numbers: 06FR37676, 06FR39967RECALLING FIRM/MANUFACTURERAmerican National Red Cross, Southern California Region, Pomona, California,by telephone on June 2, 2002, and by letter dated, June 20, 2002, and byfacsimile transmission dated June 19, 2002. Firm initiated recall iscomplete.REASONBlood products, collected from a donor who was at increased risk of variantCreutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 units DISTRIBUTION CA and Switzerland _______________________________ END OF ENFORCEMENT REPORT FOR JANUARY 4, 2006### http://www.fda.gov/bbs/topics/enforce/2006/ENF00933.html EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Last updated: 19 July 2005 Adopted July 2004 (Question N° EFSA-Q-2003-083) Report Summary Summary of the Scientific 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 http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_it.html http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02_usa_report_summary_en1.pdf http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02_usa_report_v2_en1.pdf UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE QUARTERLY ENFORCEMENT REPORT July 1, 2005 through September 30, 2005 snip... Administrative Actions Pending or Taken at Small HACCP Plants [includes actions initiated in prior quarters] snip... DESERET MEAT 04852 M SPANISH FORK, UT 07/27/05 08/01/05 X X On 7/27/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3. snip... 52 pages http://www.fsis.usda.gov/PDF/QER_Q4_FY2005.pdf Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”): Current and Proposed Safeguards Updated October 13, 2005 Geoffrey S. Becker Specialist in Agricultural Policy Resources, Science and Industry Division Sarah A. Lister Specialist in Public Health and Epidemiology Domestic Social Policy Division SNIP... snip... http://www.ncseonline.org/NLE/CRSreports/05oct/RL32199.pdf Suppressed peer review of Harvard study October 31, 2002 http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf 03-025IFA 03-025IFA-2 Terry S. Singeltary Page 1 of 17 From: Terry S. Singeltary Sr. [flounder9@verizon.net] Sent: Thursday, September 08, 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle Greetings FSIS, I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ; SUB CLINICAL PRION INFECTION MRC-43-00 Issued: Monday, 28 August 2000 NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH FINDINGS RELEVANT TO CJD AND BSE Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 9/13/2005 http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518