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From: TSS ()
In Reply to: Texas BSE Investigation Final Epidemiology Report August 2005 (PART 1) posted by TSS on August 31, 2005 at 11:08 am:
Greetings, I must say, i was much to angry yesterday to put forth a good sound based scientific approach to a thorough critic of the facts. This investigation is another great example of federal, state, and local partners cooperating to help protect livestock health in this country. <<< And also internationally and in the research community, while it's never been proven that offspring can get this disease through maternal transmission -- it's never been proven or disproven actually -- but it's thought very much from the international experts and the research it is extremely rare if it does happen. Both of these calves were born very well prior to this animal being slaughtered. This animal did not show any clinical signs typical of BSE -- sampled and destroyed. This animal did not show any clinical signs or evidence of BSE which would make it even more unlikely that these two offspring would have any risk of having BSE. The other 200 head that were traced were retraced as a result also of a lack of records. We were looking at cattle of interest over a five-year period of time of which this animal was born. Her approximate age was 12. We expanded one year of that and made her 11 to 13, and then we'd go another year beyond that. So we looked at animals basically in the age range of 10 to 15 years of age to remove those from the herd. And we traced every adult animal that we could from 1990. Many of those animals would not even be of concern because they would not have received any feed at the time that she was in the herd or would have not been a birth cohort and born at the same time that she was. So of those, 143 were reported as slaughtered, and we confirmed that 131 were definitely slaughtered; 34 were presumed dead, and 20 of those were untraceable. So again, we feel that the risk is extremely small. We do not feel that the public or our pet food industry should have any concerns relative to this issue. <<< FACTS; Maternal transmission 7. There is evidence from animal studies for low level maternal A BSE case born in September 2001 http://www.defra.gov.uk/animalh/bse/controls-eradication/barbinfo/28-09-2001.pdf CATTLE ON FEED IN TEXAS Note: On Dec. 23, 2003, the U.S. Department of Agriculture reported that a FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT FDA has determined that each animal could have consumed, at most and in It is important to note that the prohibited material was domestic in origin According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing FDA believes that Purina Mills has behaved responsibly by first reporting This episode indicates that the multi-layered safeguard system put into FDA will continue working with USDA as well as State and local officials to http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Published online January 27, 2005 http://www.thelancet.com/journal/journal.isa For personal use. Only reproduce with permission from Elsevier Ltd It is clear that the designing scientists must also have shared Mr Bradley's surprise at the results because all the dose levels right down to 1 gram triggered infection. 6. It also appears to me that Mr Bradley's answer (that it would take less grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise could take as little of 1 gram of brain to cause BSE by the oral route same species. This information did not become available until the "attack 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 that the actual result was within both a lower and an upper limit within the and the designing scientists would not have expected all the dose levels to infection. The dose ranges chosen by the most informed scientists at that ranged from 1 gram to three times one hundred grams. It is clear that the scientists must have also shared Mr Bradley's surprise at the results dose levels right down to 1 gram triggered infection. [BBC radio 4 FARM news] http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm To cattle: 1 gram of infected brain material (by oral ingestion) http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml In addition, USDA cannot rely on the Food and Drug Administrations The 2002 GAO report found that, (C)oncerning the feed ban, FDA has not We also believe that USDA should act to ensure that no CNS tissue is B. Investigation of Handling of CNS-Suspect Cow in San Angelo, Texas Overview On May 4, 2004, the FSIS Acting Regional Director in Dallas, Texas reported that a cow identified as having Central Nervous System (CNS) symptoms by an FSIS veterinarian at Lone Star Beef Processors (Lone Star Beef), a beef processing facility in San Angelo, Texas was not tested for BSE after it had been slaughtered. The initial decision by the FSIS Veterinary Medical Officer (VMO) on-site at Lone Star Beef to have the cow tested for BSE was overturned by a senior APHIS official and the cow’s carcass was sent to a rendering plant. FSIS regulations at the time of the incident required VMOs to contact the APHIS Assistant Area Veterinarian in Charge (AAVIC) to allow APHIS to collect a BSE surveillance sample from suspect cattle. OIG initiated an investigation to determine if the AAVIC in Austin, Texas, provided a false statement to USDA FSIS investigators during their inquiry of his decision not to test the animal at Lone Star Beef. To conduct our investigation, OIG reviewed previously obtained statements, various documents and USDA regulations, and interviewed APHIS, FSIS, beef processing facility, and rendering company personnel. Summary of OIG Findings The OIG investigation found no substantive evidence that the USDA official(s) responsible for the decision not to take brain tissue samples from the cow for BSE testing, or any other USDA personnel, provided false information or engaged in intentional misconduct. We determined that a misjudgment was made by at least one USDA veterinary official in the handling of the suspect cow. Sworn statements provided by the two responsible USDA veterinary officials involved differ as to whether both concurred in this decision. The suspect cow’s carcass was sent to a rendering plant in San Angelo on April 27, 2004 for processing as inedible by-product. APHIS then utilized its "Indemnity Plan" 10 procedures to purchase the by-products as a preventative safety measure, and disposed of it at a local landfill in accordance with applicable environmental standards. Evidence shows that at the time of this incident, communication problems occurred between the APHIS and FSIS employees involved. Taken together, the statements of both APHIS and FSIS personnel and other evidence indicate inconsistencies in their understanding of procedures for BSE tissue sampling of CNS suspect cattle in certain circumstances, and the handling of the carcass pending test results. It is apparent from the sworn statements provided to OIG that APHIS and FSIS personnel and Lone Star Beef officials could not resolve how best to proceed, and that confusion existed about how to properly handle the CNS-suspect carcass. On May 5, 2004, FSIS and APHIS Veterinary Services announced a new joint policy regarding BSE sampling of condemned cattle at slaughter plants. The policy establishes protocols for the agencies’ responsibilities to obtain samples from condemned cattle exhibiting signs of CNS disorders, regardless of age. ... snip... http://www.usda.gov/oig/webdocs/Testimony7-2004.pdf USDA Office of Inspector General Statement on Audit Work Related to the BSE Test Result Announced on June 10, 2005 In August 2004, the Department of Agriculture’s (USDA) Office of Inspector General (OIG) issued an audit report on USDA’s BSE Surveillance Program—Phase I. (See OIG’s website at: http://www.usda.gov/oig/webdocs/50601-9-final.pdf.) OIG made a number of recommendations to improve the Department’s BSE Surveillance Plan in the Phase I audit report. Based on our audit findings, we recommended that USDA fully disclose the assumptions behind its sampling plan, clarify the limitations, and ensure that all high-risk animals are sampled and tested in accordance with USDA policy and the 2004 Surveillance Plan. We also recommended that USDA expedite development of a new system to track and report accomplishments, and implement performance measures and a continuous risk assessment. Currently, OIG has two audits in progress pertaining to BSE. In our BSE Surveillance Program—Phase II audit, OIG is monitoring the Department’s implementation of its BSE Expanded Surveillance Program, involving both APHIS and FSIS. This audit will evaluate the following: the effectiveness of USDA’s expanded BSE Surveillance program; the performance of BSE laboratories in meeting their objectives and complying with program policies and procedures for conducting tests on submitted BSE samples and reporting test results to APHIS and stakeholders; and the corrective actions taken by USDA in response to recommendations in the BSE Surveillance Program—Phase I audit report cited above. In our Phase III audit, we are evaluating whether the USDA enforcement of the ban on specified risk materials (SRMs) in meat products and controls to prevent central nervous system (CNS) tissue in advanced meat recovery (AMR) product have been effectively implemented. The review also covers FSIS ante mortem condemnation procedures and procedures for obtaining brain tissue samples from condemned cattle for BSE testing. In the course of reviewing voluminous records and information gathered during the BSE Surveillance Program—Phase II audit, OIG auditors noted an unusual pattern of conflicting test results on one sample and initiated additional testing of that sample. As announced by USDA on June 10, the sample subsequently rendered a positive result under the OIE (World Organization for Animal Health) recognized SAF immunoblot test. OIG’s fieldwork on these audits is ongoing. Once the audits are completed, OIG will report on the specific BSE Enhanced Surveillance Program issues and procedures we examined, our corresponding findings and recommendations, and USDA’s response thereto. We anticipate completing and publicly releasing the reports late this summer. http://www.usda.gov/oig/webdocs/BSEStatement050615.pdf MAD COW DISEASE Improvements in the Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts snip... Results in Brief While BSE has not been found in the United States, federal actions do not sufficiently ensure that all BSE-infected animals or products are kept out or that if BSE were found, it would be detected promptly and not spread to other cattle through animal feed or enter the human food supply. With regard to imports, the United States had imported about 125 million pounds of beef (0.35 percent of total imported) and about 1,000 cattle (0.003 percent of total imported) from countries that later discovered BSE—during the period when BSE would have been incubating. In addition, weaknesses in USDA’s and FDA’s import controls, such as inspection capacity that has not kept pace with the growth in imports, may allow BSE-infected products to enter the country. With regard to animal testing to detect BSE, although USDA has steadily increased the number of animals it tests, it does not include many animals that die on farms. Experts consider these animals a high-risk population. Concerning the feed ban, FDA has not acted promptly to compel firms to keep prohibited proteins out of cattle feed and to label animal feed that cannot be fed to cattle. We identified some noncompliant firms that had not been reinspected for 2 or more years and instances when no enforcement action had occurred even though the firms had been found noncompliant on multiple inspections. Moreover, FDA’s data on inspections are severely flawed and, as a result, FDA does not know the full extent of industry compliance. FDA acknowledges that it has not yet identified and inspected all firms subject to the ban. In terms of the public health risk, consumers do not always know when foods and other products they use may contain central nervous system tissue, which, according to scientific experts, could pose a health risk if taken from diseased animals. The economic impacts of a BSE outbreak in the United States could be severe, according to federal economists. However, scientific experts believe the health risks are uncertain. In terms of the economic impacts, if BSE were discovered in U.S. cattle, beef exports and domestic beef consumption would drop. The severity and duration of the economic impact would depend largely on the number of animals affected, the U.S. response, and the public’s reaction. We could not extrapolate the potential impact on the U.S. economy by looking at the experiences of countries Page 3 GAO-02-183 Mad Cow Disease with BSE because perceptions about food safety risks vary from country to country, and the economic impacts of BSE on one country might not be applicable to another. Nonetheless, if BSE were found here, the economic impact on the $56 billion beef industry could be devastating. Many consumers might refuse to buy domestic beef; beef exports could decline dramatically and sales in related industries—such as hamburger chains and soup and frozen dinner manufacturers—could be similarly affected. Concerning the health risks, if BSE-infected cattle were to enter the food supply, some people might develop vCJD. However, experts disagree about the number of people who would be affected. While many believe that vCJD is very difficult to contract, so that relatively few people would develop it, some experts believe that, because of the long incubation period, no one can predict whether few or many might contract vCJD. The United States acted as many as 5 years earlier than other countries to impose controls over imports of animals and animal feed ingredients from countries that had experienced BSE. Similarly, U.S. surveillance efforts to test cattle brains for BSE met internationally recommended testing targets earlier than other countries. However, the United States has a more permissive feed ban than other countries—one that allows cattle feed to contain proteins from horses and pigs. FDA is reviewing whether these ingredients should continue to be allowed in cattle feed. Finally, as in most countries that are BSE-free, including the United States, cattle brains and other central nervous system tissue can be sold as human food. This report makes recommendations to USDA and FDA to, among other things, strengthen enforcement of the feed ban, develop a coordinated strategy to identify resources needed to increase inspections of imported goods, and alert consumers when products may contain central nervous system tissue. In commenting on a draft of this report, FDA and Customs concurred with our recommendations. USDA largely concurred but said that labeling and warning statements should be reserved for known hazards. ... snip...full text 63 pages; http://www.gao.gov/new.items/d02183.pdf For Release on Delivery Expected at 3:00 p.m. EST Tuesday, March 30, 2004 FEDERAL FOOD SAFETY AND SECURITY SYSTEM Fundamental Restructuring Is Needed to Address Fragmentation and Overlap Statement of Lawrence J. Dyckman, Director Natural Resources and Environment snip... Page 12 GAO-04-588T Multiple agencies must respond when serious food safety challenges emerge. Inconsistent food safety authorities result in the need for multiple agencies to respond to emerging food safety challenges. This was illustrated recently with regard to ensuring that animal feed is free of diseases, such as bovine spongiform encephalopathy (BSE), or mad cow disease. A fatal human variant of the disease is linked to eating beef from cattle infected with BSE. As we reported in 2002, four federal agencies are responsible for overseeing the many imported and domestic products that 6USDA officials report that rulemaking for shell eggs will be separate from rulemaking for egg products because shell egg packing facilities lack the capacity to respond to a Hazard Analysis and Critical Control Point (HACCP) rule at present. USDA officials explain that they will likely propose HACCP and sanitation performance standard regulations for egg product plants, while shell egg facilities will likely receive guidance and training materials related to HACCP and sanitation standards. Page 13 GAO-04-588T pose a risk of BSE. One, the U.S. Customs and Border Protection, screens all goods entering the United States to enforce its laws and the laws of 40 other agencies. The second, USDA’s Animal and Plant Health Inspection Service (APHIS), protects livestock from animal diseases by monitoring the health of domestic and imported livestock.7 The third, USDA’s FSIS, monitors the safety of imported and domestically produced meat and, at slaughterhouses, tests animals prior to slaughter to determine if they are free of disease and safe for human consumption. Finally, FDA monitors the safety of animal feed—animals contract BSE through feed that contains protein derived from the remains of diseased animals. During the recent discovery of an infected cow in Washington state, FDA investigated facilities that might have handled byproducts from the infected animal to make animal feed. Figure 6 illustrates the fragmentation in the agencies’ authorities. 7On March 1, 2003, APHIS’s Agriculture Quarantine and Inspection force became part of the Department of Homeland Security. Page 14 GAO-04-588T Figure 6: Federal Government Agencies Involved in Bovine Spongiform Encephalopathy (BSE) Oversight When we issued our report in 2002, BSE had not been found in U.S. cattle. However, we found a number of weaknesses in import controls. Because of those weaknesses and the disease’s long incubation period—up to 8 years—we concluded that BSE might be silently incubating somewhere in the United States. Then, in May 2003, an infected cow was found in Canada, and in December 2003, another was found in the state of Washington. USDA’s Animal and Plant Health Inspection Service operates the surveillance program that found the infected U.S. cow, while FDA must ensure that the disease cannot spread by enforcing an animal feed ban that prohibits the use of cattle brains and spinal tissue, among other things, in cattle feed. With regard to the meat from the BSE-infected Page 15 GAO-04-588T animal found in Washington state, FSIS conducted a recall of meat distributed in markets in six states. Both USDA and FDA have reported that meat from the cow was not used in FDA-regulated foods. However, had the meat been used, for example, in canned soups that contained less than 2 percent meat, FDA—not FSIS—would have been responsible for working with companies to recall those foods. (As app. II shows, the agencies’ oversight responsibilities for food products vary depending on the amount of beef or poultry content.) Neither FDA nor USDA has authority under existing food safety laws to require a company to recall food products.8 Both agencies work informally with companies to encourage them to initiate a recall, but our ongoing work shows that each agency has different approaches and procedures. This can be confusing to food processors involved in a recall. Overlapping responsibilities in responding to mad cow disease highlight the challenges that government and industry face when responding to the need to remove contaminated food products from the market. As part of work currently underway, we are looking at USDA and FDA food recalls—including USDA’s oversight of the BSE-related recall and FDA’s oversight of the feed ban. We are also monitoring both USDA’s and FDA’s BSE-response activities. There are undoubtedly other federal food safety activities where overlap and duplication may occur. For example, in the areas of food safety research, public outreach, or both FDA, and USDA’s Economic Research Service, FSIS and the Cooperative State Research, Education and Extension Service have all received funding to develop food safety-related educational materials for the public. In addition, responsibility for regulating genetically modified foods is shared among FDA, USDA, and the Environmental Protection Agency (EPA). However, we have not yet examined the extent to which these and other areas of overlap and duplication impact the efficiency of the food safety system. 8FDA, however, does have legislative authority to require recalls that involve infant formula. The fragmented legal and organizational structures of the federal food safety system are now further challenged by the realization that American farms and food are vulnerable to potential attack and deliberate contamination. As we recently reported in a statement for the record before the Senate Committee on Governmental Affairs,9 bioterrorist attacks could be directed at many different targets in the farm-to-table continuum, including crops, livestock, food products in the processing and Emerging Terrorist Threats Highlight the Need to Reorganize the Federal Food Safety System snip... http://www.gao.gov/new.items/d04588t.pdf Statement on Texas Cow With Central Nervous System Symptoms FDA, which is responsible for the safety of animal feed, immediately began FDA's investigation showed that the animal in question had already been Cattle with central nervous system symptoms are of particular interest FDA is sending a letter to the firm summarizing its findings and informing To protect the U.S. against BSE, FDA works to keep certain mammalian protein Under the current regulation, the material from this Texas cow is not FDA is committed to protecting the U.S. from BSE and collaborates closely #### ooops! PLEASE NOTE, the Harvard BSE risk assessment was proven to be a sham, just like the June 2004 Enhanced BSE Surveillance Program was. THOSE 500,000 cattle that were suppose to be tested with proper up to date BSE/TSE testing protocols were terrible flawed. IN essence, the testing was meaningless. some 9,200 of those tests did not even include rapid testing or WB, only IHC, the least likely to find BSE/TSE, as Dr. Detwiler tried to point out in 2003 ; We have to be careful that we don't get so set in the way we do things that Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't Dr. Keller: Tissues are routinely tested, based on which tissue provides an Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't FACTS ; Feb 28, 2002 (CIDRAP News) – Congress's General Accounting Office (GAO) concludes in a new report that the United States remains vulnerable to bovine spongiform encephalopathy (BSE), or mad cow disease, because of inadequate import barriers and weak enforcement of rules to contain any BSE-contaminated products that might reach US shores. "The continuing absence of BSE in the United States today cannot be sufficiently ensured by current federal prevent efforts," states the report, released Feb 26. "The introduction and spread of BSE in the United States could stem from cattle and cattle-derived products from countries that subsequently developed BSE and from gaps in import controls, animal testing, and feed ban enforcement. As a result of these problems, consumers may unknowingly eat foods that contain central nervous system tissue from a diseased animal." The report says that about 1,000 cattle and 125 million pounds of beef entered the United States from countries that later found cases of BSE. Further, hundreds of firms have violated a ban on putting meat and bone meal in cattle feed, and the Food and Drug Administration (FDA) has done little to enforce the ban, the GAO says. The GAO investigated the government's BSE prevention efforts at the request of Sens. Tom Harkin, D-Iowa, Richard Lugar, R-Ind., and Dick Durbin, D-Ill. Durbin promised to introduce a bill to strengthen BSE prevention efforts. "We can't have the world's most reliable food supply without an equally reliable system of regulation and oversight," Durbin said in a Feb 26 news release. Agriculture Secretary Ann Veneman took issue with the report on several counts, saying the GAO didn't fully consider recent actions that federal agencies have taken to strengthen BSE safeguards. She also said the GAO didn't appropriately recognize a Harvard University report issued last year that determined the risk of BSE in the United States to be very low. Eating meat from animals with BSE is considered a risk factor for variant Creutzfeldt-Jakob disease in humans. BSE prevention steps in the United States began in 1989 with a ban on the importation of live ruminants (cattle, sheep, and goats) and ruminant meat and bone meal from the United Kingdom and other countries with BSE. In 1997 the ban was extended to the rest of Europe, and the FDA banned the use of most mammalian protein in feed for ruminants the same year. In addition, the FDA and the US Department of Agriculture (USDA) screen cattle-derived, FDA-regulated products imported from countries where BSE exists, the GAO report says. Over the past 20 years, the nation imported about 1,000 cattle, 125 million pounds of beef, and 23 million pounds of inedible meat byproducts from countries where BSE was later found, the GAO determined. Some contaminated animals or products may have entered the country because BSE's incubation period is up to 8 years, the report says. In particular, the nation imported 242 cattle from Japan between 1993 and 1999. After Japan reported its first BSE cases in September 2001, the USDA managed to locate most of the imported cattle, but 24 animals had already gone to slaughter or rendering. "In addition to the BSE risk posed by past imports, a small but steady stream of BSE-risk material may still be entering the United States through international bulk mail," the GAO says. USDA inspectors at international bulk mail facilities can spot organic matter with special x-ray scanners, but inspectors are not on duty at all times and they can screen only a fraction of the stream of incoming packages, the report states. In a 6-month period last year, 570 of 116,000 packages screened at one facility contained "at-risk beef or beef-derived products." Risky items also can slip through federal ports of entry when shipments are inaccurately labeled or through lack of inspection, the GAO reported. For example, sampling by the US Customs Service in fiscal 1999 showed that information on beef shipments was wrong in over 21% of cases. Further, in fiscal year 2000 the FDA inspected only 1% of the 4 million imported food entries under its jurisdiction and less than 1% of the 146,000 shipments of animal drugs and feeds. BSE prevention efforts also include USDA testing of cattle tissue. The GAO says the USDA has increased its testing program but does not test many cattle that die on farms, which are assumed to pose an increased risk because they are usually older and often die of unknown causes. Some cattle that die on farms are collected and rendered into products that include animal feed, the report says. The GAO finds serious fault with the FDA's enforcement of the ban on mammalian protein in cattle feed. Since 1997, FDA and state personnel have conducted more than 12,000 inspections at more than 10,576 firms (eg, renderers, feed mills) and found 364 firms in violation, the report states. The FDA estimates that at least another 1,200 firms that should be subject to the ban have not been identified. "FDA did not take prompt enforcement action to compel firms to comply with the feed ban," the GAO says. By April 2001 (when the GAO investigation began), the agency's only enforcement steps had been to issue two warning letters, though the pace picked up after that. Several firms repeatedly violated the rules but did not receive warning letters. Further, the FDA has no overall enforcement strategy that sets penalties and deadlines. "Even if FDA were to actively enforce the federal ban, its inspection database is so severely flawed that—until corrected—it should not be used to assess compliance," the report says. It includes a long list of problems with the database; for example, entries for about 45% of all inspections lack information to uniquely identify the firms inspected. In other findings, the GAO concluded that the United States acted as much as 5 years earlier than other countries to bar imports of animals and animal feed ingredients from countries with BSE cases. However, the nation has a "more permissive" feed ban than other countries in that cattle feed can contain protein from horses and pigs. The FDA is currently reviewing this provision, the report notes. The report recommends a number of steps to address the problems it describes. Among other things, it suggests that the secretary of agriculture consider using public service announcements or labels to inform consumers that certain beef cuts and products may contain central nervous system (CNS) tissue. The GAO also suggests that the FDA consider requiring labeling of regulated products, including food, cosmetics, and drugs, that contain CNS tissue. Agriculture Secretary Veneman critiqued the GAO report in a statement released the same day (Feb 26). "The report fails to appropriately recognize the conclusions and recommendations made last year by Harvard University in its comprehensive, 3-year study on BSE," she said. "The Harvard Risk Analysis showed that the risk of BSE occurring in the Untied States is extremely low and that early government protection systems have been largely responsible for keeping BSE out of the United States and would prevent it from spreading if it ever did enter the country." Veneman also said that despite extensive USDA comments on the draft report, "scientific and technical errors" survived in the final report. Further, the report "does not appropriately consider the additional actions that have been taken by federal agencies to strengthen BSE programs," she added. The USDA described a number of recent actions related to BSE in a separate news release (see link below). That release says the FDA has "significantly improved" its database on firms' compliance with the animal feed rule. The improved database will be fully operational in April and will allow the FDA to track compliance more effectively, officials said. In addition, the FDA is receiving an extra $15 million for BSE prevention efforts this year, bringing the total to $19 million, and is hiring 115 people this year to help in those efforts. The USDA also issued a set of responses to the recommendations in the GAO report. The agency rejected the idea of labeling beef and beef products that may contain CNS tissue, stating, "The presence of CNS tissue does not mean that the product is infectious for BSE. Labeling and warning statements should be reserved for known hazards." In response to another GAO recommendation, the USDA said it is already increasing its testing of tissue samples from animals that die on farms. The agency said that the number of cattle brains tested this year will be more than double last year's total, and that "A focus of this increased surveillance is to obtain more samples from animals that die on farms." Regarding the Harvard study of BSE risk in the United States, the GAO report says the agency did not try to validate the model or assumptions used by the Harvard researchers. However, the report says the Harvard authors acknowledged that their conclusions "could be influenced by a number of model assumptions that could not be verified with confidence—including assumptions about US measures to prevent the introduction and spread of BSE." The Harvard researchers also noted that compliance with the animal feed ban is the leading source of uncertainty in their assessment, the GAO report states. ... http://www.cidrap.umn.edu/cidrap/content/other/bse/news/gaorept.html -------- Original Message -------- Greetings, I was doing a bit of digging this morning and can not for the life > BSE JAN. 9, 2001 EMERGENCY 50 STATE CONFERENCE CALL IF you go here ; http://www.fda.gov/cvm/bse_updates.htm skroll down to ; UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES http://www.fda.gov/cvm/bseup.htm YOU will see (above url) the 'day after' report, once the NY TIMES > On Thursday, the Food and Drug Administration reported that hundreds > On Jan. 9, the F.D.A.'s Center for Veterinary Medicine held a snip... IMPORTANT NOTICE: 50 STATE CONFERENCE CALL - BSE TUESDAY, JANUARY 9, 2001 A special "50 STATE CONFERENCE CALL" to discuss BSE The 50 State call is scheduled for Tuesday, January We request that you forward this message to your The agenda will be as follows: 1. Center For Veterinary Medicine (FDA) - Discussion 2. Office of Regional Operations (FDA) - Discussion 3. Questions and answers. ____________________________________________________________ Date: Fri, 12 Jan 2001 03:34:26 +0000 (GMT) Of interest...don't repeat. On Jan 9, was somewhere snip....... Another piece of information for you only: Ray ____________________________________________________________ Confidential: What a mess! Seems like the time is ripe for everyone You need to watch your back........but keep picking at ____________________________________________________________ MY question I suppose is, WHERE is the official TRANSCRIPT in full, of the WHY is this transcipt not easily available for the public on some URL, ######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ########## ######### 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 > http://www.vegsource.com/talk/madcow/messages/8220.html > http://www.vegsource.com/talk/madcow/messages/8221.html > http://www.vegsource.com/talk/madcow/messages/8222.html > http://www.vegsource.com/talk/madcow/messages/8230.html > hi sandy, >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, 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 http://www.vegsource.com/talk/madcow/messages/8278.html http://www.vegsource.com/talk/madcow/messages/8279.html http://www.vegsource.com/talk/madcow/index.html to keep up with this epidemic in both humans and animals, BSE NEWS http://www.vegsource.com/talk/madcow/messages/7252.html http://www.vegsource.com/talk/madcow/messages/7548.html http://www.whale.to/v/cjd2.html http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2 http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1 http://www.InsideTheWeb.com/messageboard/mbs.cgi?acct=mb172420&MyNum=978977689&P=No&TL=978977689 this message will self destruct in 10 seconds ;-) Terry S. Singeltary Sr., http://vegancowboy.org/TSS-part1of8.htm NOW, just what about that Harvard BSE risk assessment, the IHC gold standard of BSE immunity in the USA (more BSeee) ; HARVARD PEER REVIEW OF BSE RISK ASSESSMENT October 31, 2002 Final Report snip... Introduction snip... 2.2 OVERALL WEAKNESSES OF THE MODEL snip... 3.2 HAVE THE DATA BEEN CORRECTLY snip... Mad-Cow Rule Breaches By BILL TOMSON WASHINGTON -- Federal documents show U.S. meat packers sometimes failed to follow procedures to prevent the spread of mad-cow disease, including leaving spinal cords in cattle, miscalculating cattle ages and not sanitizing equipment. Most of the 1,036 "noncompliance records" released by the Department of Agriculture appear to show record-keeping or other paperwork infractions. And a violation recorded Aug. 3, 2004, said a USDA inspector stopped plant operations after watching employees fail to remove spinal cords from carcasses. Spinal cords are thought to carry the mad-cow disease, or bovine spongiform encephalopathy. The inspector said as a result the facility pledged to retain more than 500 carcasses and inspect them. A "similar" violation for the same establishment had been written up about three months earlier, the report said. No company's name could be seen on the document that had sections blacked out, but it was accompanied by a letter from Tyson Fresh Meats Inc., a unit of Tyson Foods Inc. Tyson wrote that employees who should have been removing spinal cords were chastised for "poor work performance." Gary Mickelson, a Tyson spokesman, said, "We view this particular incident as more of a procedural issue than a food-safety concern because of the additional measures we take after this point in the production process to make sure nervous-system materials don't enter the food supply." An unrelated violation said a factory wasn't correctly determining cattle ages. An inspector said when he tried to verify records that four cattle were younger than 30 months, he found three of the animals were older. USDA maintains that, for the most part, mad-cow infection can only be found in cattle 30 months and older so most tissue capable of carrying the disease -- called specified risk material, or SRM -- only needs to be removed from older animals. If an animal is younger, those parts don't need to be removed. Some parts, such as tonsils and distal ileum, are considered SRM in cattle of all ages and must be removed. After the first case of mad-cow disease was found in the U.S. in December 2003, USDA began requiring the removal of spinal-cord, brain and other tissues from older cattle. Several other food-safety rules were implemented, including a ban on "downer" or dead animals from the food supply. Humans are believed to be susceptible to the disease through consumption of some beef products if they contain infected tissue. A slaughterhouse, owned by Smithfield Foods Inc. subsidiary Moyer Packing Co., was written up July 15, 2004, for mishandling an animal that was dead-on-arrival and slated to be tested in USDA's federal BSE surveillance program. The program focuses on downer cattle that are too sick or injured to walk or cattle that died before slaughter. USDA considers those cattle more likely to be infected. The USDA inspector said he observed "abdominal fluids and tissues" from the dead animals "scattered throughout the unloading and livestock scale areas." Moyer said in a response letter to USDA that the "entire affected area ... was hosed with high-pressure water and debris were removed." Smithfield spokesman Jerry Hostetter said: "The dead animal in question was nowhere near a food-production or processing area. It was in the cattle receiving yards ... prior to being taken into the plant. No parts of the animal got anywhere near the food supply." Write to Bill Tomson at bill.tomson@osterdowjones.com From: TSS () Daily Update On August 17, 2005, no inconclusive test results were reported. National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC) Testing Summary The BSE enhanced surveillance program involves the use of a rapid screening test, followed by confirmatory testing for any samples that come back "inconclusive." The weekly summary below captures all rapid tests conducted as part of the enhanced surveillance effort. It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing. This was done to ensure that samples inappropriate for the rapid screen test were still tested, and also to monitor and improve upon IHC testing protocols. Of those 9,200 routine tests, one test returned a non-definitive result on July 27, 2005. That sample underwent additional testing at NVSL, as well as at the Veterinary Laboratories Agency in Weybridge, England, and results were negative. Weekly Summary Cumulative Total from June 1, 2004: 439,126 THE USA BSE GBR RISK ASSESSMENT SHOULD BE IMMEDIATELY REASSESSED TO BSE GBR IV. >>>"There's no secret program," the department's chief veterinarian, John Clifford, said in an interview. "There has been no hiding, I can assure you of that."<<< r i g h t ... The investigators visited these establishments to collect information on formulation, shipping invoices, and the use of ruminant meat and bonemeal on the premises, both before the 1997 feed ban and after the 1997 feed ban. This investigation found no feed products used on the farm since 1997 had been formulated to contain prohibited mammalian protein. The investigation identified one feed which contained an animal protein source that could not be identified and the investigation also found one feed mill that supplied feed to the farm and that used ruminant meat and bonemeal in feed formulations for nonruminant species after the BSE ruminant feed rule went into effect, and this was permitted under the rule. And there were several feed mills that had used ruminant meat and bonemeal prior to the 1997 feed ban but had ceased to use that material after the 1997 feed ban. The investigation into the disposition of herd-mates from this farm involved visits to nine slaughter plants and eight rendering plants. The investigation found that all rendering plants were operating in compliance with the BSE ruminant feed rule. A review of the inspection history of each of these rendering firms found no violation. <<< The animal was then shipped to a pet food plant where it was sampled for BSE. The plant did not use the animal in its product, and the carcass was destroyed. <<< by USDA Chief Veterinarian John Clifford Regarding the Epidemiological Investigation into the recently confirmed BSE case June 29, 2005 http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/07/0280.xml IN CONFIDENCE PERCEPTION OF UNCONVENTENTIONAL SLOW VIRUS DISEASES OF ANIMALS IN THE USA 1985 The Stetsonville outbreak (farmer's name: Brecke). In addition to the downer cows and horses Brecke's mink recieved a cereal supplement. Hartsough's view was that this would contain bone meal and would be from a commercial source. If this were so and it was contaminated with a TME agent why were no other ranches affected? Many mink ranches now feed a commerical pelleted diet. Brecke was equipped to process LARGE CARCASSES USING A CRUSHER/MIXER WHICH COULD ACCOMMODATE A WHOLE COW! snip... Dead mink go for rendering but are used only in poultry feed. In the fall at pelting time the skinned carcasses of the mink are placed in large barrels which are left in the open to freeze. When full, a renderer collects ''for use in poultry feeds''. Sections from the brains of the two Brecke TME inoculated cattle were examined and Marsh provided all the blocks from the 2nd steer for study at CVL and comparison with BSE. In general the vacuolar changes were more severe than in most cases of BSE but very similar in distribution. Unfortunately material aken fro histopathology from those anials omitted representaion of most of the brain stem. ........... Wilbur Clarke (reference the Mission, Texas scrapie transmission transmission to cattle study) is now the State Veterinarian for Montana based at Helena. I was given confidential access to sections from the Clarke scrapie-cattle transmission experiment. Details of the experimental design were as supplied previously by Dr. Wrathall (copy of relevant information appended). Only 3 animals (2 inoculated with 2nd pass Suffolk scrapie and 1 inoculated with Angora goat passaged scrapie) showed clinical signs. Clinical signs were characterised by weakness, ''a stilted hindlimb gait'', disorientation, ataxia and, terminally, lateral recumbency. The two cattle from which I examined material were inocluated at 8 months of age and developed signs 36 months pi (goat scrapie inoculum) and 49 months pi (one of the Suffolk scrapie inoculated) respectively. This latter animal was killed at 58 months of age and so the clinical duration was only 1 month. The neuropathology was somewhat different from BSE or the Stetsonville TME in cattle. Vacuolar changes were minimal, to the extent that detection REQUIRED CAREFUL SEARCHING. Conversely astrocyte hypertrophy was a widespread and prominent feature. The material requires DETAILED NEUROPATHOLOGICAL ASSESSMENT BUT WHETHER OR NOT THIS WILL BE DONE REMAINS A QUESTION. Transmission Studies Mule deer transmissions of CWD were by intracerebral inoculation and compared with natural cases {the following was written but with a single line marked through it ''first passage (by this route)}...TSS resulted in a more rapidly progressive clinical disease with repeated episodes of synocopy ending in coma. One control animal became affected, it is believed through contamination of inoculum (?saline). Further CWD transmissions were carried out by Dick Marsh into ferret, mink and squirrel monkey. Transmission occurred in ALL of these species with the shortest snip... Appendix 3 VISIT TO USA - DR A E WRATHALL - INFO OH BSE AND SCRAPIE 1. Dr Clark lately of the Scrapie Research Unit, Mission Texas has Expt A Expt B Expt C Diagnosis in A, B, C was by histopath. No reports on SAT were given. 2. Dr Warren Foote indicated success so far in eliminating scrapie in 3. Prof. A Robertson gave a brief account of BSE. The US approach was to 5. Scrapie agent was reported to have been isolated from a solitary 6. A western blotting diagnostic technique (? on PrP) shows some promise. 7. Results of a questionnaire sent to 33 states on the subject of the 6/33 wished to develop it 8/33 had few sheep and were neutral 33 end...TSS full text 33 PAGES ; http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf http://www.bseinquiry.gov.uk/ 1: J Infect Dis. 1994 Apr;169(4):814-20. Cutlip RC, Miller JM, Race RE, Jenny AL, Katz JB, Lehmkuhl HD, DeBey BM, Robinson MM. USDA, Agriculture Research Service, National Animal Disease Center, Ames, IA 50010. To determine if sheep scrapie agent(s) in the United States would induce a disease in cattle resembling bovine spongiform encephalopathy, 18 newborn calves were inoculated intracerebrally with a pooled suspension of brain from 9 sheep with scrapie. Half of the calves were euthanatized 1 year after inoculation. All calves kept longer than 1 year became severely lethargic and demonstrated clinical signs of motor neuron dysfunction that were manifest as progressive stiffness, posterior paresis, general weakness, and permanent recumbency. The incubation period was 14-18 months, and the clinical course was 1-5 months. The brain from each calf was examined for lesions and for protease-resistant prion protein. Lesions were subtle, but a disease-specific isoform of the prion protein was present in the brain of all calves. Neither signs nor lesions were characteristic of those for bovine spongiform encephalopathy. MeSH Terms: Substances: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8133096&dopt=Citation SNIP... http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf 12/10/76 snip... A The Present Position with respect to Scrapie Scrapie is a natural disease of sheep and goats. It is a slow The field problem has been reviewed by a MAFF working group It is clear that scrapie in sheep is important commercially and Recently the question has again been brought up as to whether Whether true or not. the hypothesis that these agents might be snip... 76/10.12/4.6 http://www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf sCJD in a young Dutch valine homozygote: atypical molecular Sporadic Creutzfeldt-Jakob disease in a young Dutch valine homozygote: Head MW, Tissingh G, Uitdehaag BM, Barkhof F, Bunn TJ, Ironside JW, Department of Pathology, University of Edinburgh, Western General Hospital, A case of sporadic Creutzfeldt-Jakob disease (sCJD) is described in a young Publication Types: PMID: 11506411 [PubMed - indexed for MEDLINE] -------- Original Message -------- Subject: re-BSE prions propagate as either variant CJD-like or sporadic CJD Date: Thu, 28 Nov 2002 10:23:43 -0000 From: "Asante, Emmanuel A" To: Dear Terry, I have been asked by Professor Collinge to respond to your request. I am a Senior Scientist in the MRC Prion Unit and the lead author on the paper. I have attached a pdf copy of the paper for your attention. Thank you for your interest in the paper. In respect of your first question, the simple answer is, yes. As you will find in the paper, we have managed to associate the alternate phenotype to type 2 PrPSc, the commonest sporadic CJD. It is too early to be able to claim any further sub-classification in respect of Heidenhain variant CJD or Vicky Rimmer's version. It will take further studies, which are on-going, to establish if there are sub-types to our initial finding which we are now reporting. The main point of the paper is that, as well as leading to the expected new variant CJD phenotype, BSE transmission to the 129-methionine genotype can lead to an alternate phenotype which is indistinguishable from type 2 PrPSc. I hope reading the paper will enlighten you more on the subject. If I can be of any further assistance please to not hesitate to ask. Best wishes. Emmanuel Asante <> ____________________________________ Dr. Emmanuel A Asante MRC Prion Unit & Neurogenetics Dept. Imperial College School of Medicine (St. Mary's) Norfolk Place, LONDON W2 1PG Tel: +44 (0)20 7594 3794 Fax: +44 (0)20 7706 3272 email: e.asante@ic.ac.uk (until 9/12/02) New e-mail: e.asante@prion.ucl.ac.uk (active from now) ____________________________________ snip... full text ; http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm Creutzfeldt-Jakob disease THE findings from Corinne Ida Lasmézas*, [dagger] , Jean-Guy Fournier*, Hermann Boe*, Domíníque Marcé*, François Lamoury*, Nicolas Kopp [Dagger ] , Jean-Jacques Hauw§, James Ironside¶, Moira Bruce [||] , Dominique Dormont*, and Jean-Philippe Deslys* et al, that The agent responsible http://www.pnas.org/cgi/content/full/041490898v1 Characterization of two distinct prion strains http://vir.sgmjournals.org/cgi/content/abstract/85/8/2471 Diagnosis and Reporting of Creutzfeldt-Jakob Disease Singeltary, Sr et al. JAMA.2001; 285: 733-734. http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama BRITISH MEDICAL JOURNAL SOMETHING TO CHEW ON BMJ http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2 BMJ http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1 https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt Docket Management Docket: 02N-0273 - Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed Comment Number: EC -10 Accepted - Volume 2 PART 2 PDF]Freas, William TSS SUBMISSION File Format: PDF/Adobe Acrobat - Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ... http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf Asante/Collinge et al, that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest _sporadic_ CJD; http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt # Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of Docket Management Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305 http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr. www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2. 03N-0009 Federal Preemption of State & Local Medical Device Requireme. ... Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater Comment Number: EC -1 Accepted - Volume 1 ... 00D-1662 Use of Xenotransplantation Products in Humans. http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm 2003D-0186 01N-0423 Substances Prohibited from use in animal food/Feed Ruminant APE 5 National Renderers Association, Inc. Vol#: 2 APE 6 Animal Protein Producers Industry Vol#: 2 APE 7 Darling International Inc. Vol#: 2 EMC 1 Terry S. Singeltary Sr. Vol#: 3 http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm ALL animals for human/animal consumption must be tested for TSE. From: TSS () Release No. 0339.05 SEC. MIKE JOHANNS: Thank you very much, and good afternoon everyone, and thank you for joining us. I will begin today with an announcement about the National Animal Identification System, and then what I'd like to do from there is ask Dr. John Clifford to report on the conclusion of the investigation related to the cow that tested positive for BSE in June of this year. Many of you have heard me say before that I am deeply committed to the spirit of public service that involves listening, really listening, to the people whom we serve. We may not always agree with each other, but as public servants it is important that we listen. That's why I've been traveling around the country doing a Farm Bill listening tour to hear from the entire ag community about what's on their mind, what we're doing right, and what we might do better. Well, today I'd like to tell you about some of the listening we've done on the National Animal Identification System. That's a good place for me to start. The system is one of the most important infrastructure initiatives in animal agriculture today. Our goal is to work hand-in-hand with producers and the states to enhance our collective ability to quickly identify animals that may be of concern in a disease outbreak. When this system is fully implemented, we expect to be able to identify all potentially affected animals and premises within 48 hours of a disease detection. You'd be hard-pressed to find anyone working in animal agriculture today who doesn't believe that's a worthy objective and an important investment for us to make. After all, the faster we identify affected animals and premises, the faster we are able to contain the disease. But as with any major initiative touching so many segments of the industry, there are differing views on some pretty fundamental questions like whether data in the system should be publicly or privately held, how can we protect confidentiality of the data, and whether the data collection should be a voluntary system or a mandatory system. Last year the USDA held a series of listening sessions around the country, some 16 in all as a matter of fact, to hear what folks around the country had to say. We also formed a special subcommittee under the Secretary's Advisory Committee on Foreign Animal and Poultry Diseases that has widespread producer representation. And in May as you know we published a detailed thinking paper outlining our proposed strategy for getting a mandatory system in place and framing some additional questions for stakeholders to contemplate. In their responses, producers expressed concern about confidentiality when it comes to animal movement information. Without question, the participation of producers is absolutely essential to the success of an animal identification system. That's why we paid attention when producers asked that animal movement data be privately held. Based on the feedback, I'm putting forth guiding principles today that allow animal movement data to be maintained in a private system that can be readily accessed when necessary by state and federal animal health authorities. This allows the industry to continue developing databases that house animal movement information, and we envision those databases feeding a single, privately-held animal tracking repository that we can access. This initiative, or innovative approach, addresses producers' concerns while at the same time enabling federal and state officials to access information that we may need for disease control purposes. There are a number of concepts being discussed in the private sector about how this should work and how it should be funded. USDA is not favoring any one of them over the other. USDA will be scheduling a stakeholder meeting this fall to clarify expectations for the private tracking system and discuss user requirements in system specifications. In the meantime, USDA will be finalizing and releasing the program standards that were presented in the thinking paper. Beyond that, we will be looking to industry to come together to drive this leg of the journey. I believe strongly this is the right approach. This system has always been about government and private partnership. USDA has invested a great deal, nearly $19 million in 2004, to get the infrastructure started. Most of that went to cooperative agreements with states and with tribes. For Fiscal Year 2005, we've invested another $33 million with about half of that going to additional cooperative agreements. And there's another $33 million in the President's 2006 Budget for additional infrastructure building. We are making great progress in the area of premise registration with 100,000 premises now registered and plans to begin later this year allocating blocks of animal identification numbers to tag manufacturers. With today's announcement, we begin work on the next step in developing the animal identification system, tracking animal movements. The only way the system will work is if stakeholders have a role in designing it, if all are truly, fully invested. The piece of the system that is the most producer-dependent is this piece dealing with tracking animal movements, and so it simply makes good sense for producers to design and to maintain that piece of the system. Ultimately we know we will end up with a system that embodies the best that the private system and government have to offer. I would be happy to answer your questions about the National Animal Identification System in just a moment. But just briefly while we're speaking of tracing animals, I did want to mention that we've completed our epidemiological investigation related to the BSE animal identified in June. This very thorough investigation has been a tremendous example of partnership at the federal, state, and, I might add, the industry level. And we appreciate that. It's worth nothing that this investigation would have taken far less than two months if we had the National Animal Identification System in place. That delay is not significant in terms of human or animal health because BSE is not a contagious disease. But the time it has taken to identify, locate, and test animals of interest is significant to our efforts to reopen export markets, because a number of trading partners have been reluctant to make decisions until the investigation is complete. I am pleased that we are now in a position to close the investigation, communicate this information to our trading partners, and then move forward. I have with me today Dr. John Clifford, our chief veterinarian, along with Dr. Steve Sundlof of the Food and Drug Administration, to provide you with information about their conclusions. So I'll now turn the microphone to Dr. Clifford. DR. JOHN CLIFFORD: Thank you, Mr. Secretary. As you said, the announcement of the guiding principles for the future of a public/private partnership for animal ID is a giant step forward for a national animal identification system. Because it was developed through the integration of premises registration, animal registration, and animal tracking, the NAIS has always been viewed as a government/industry partnership. Today's announcement affirms our commitment and eagerness to work with the industry to achieve the goals of the NAIS. Now I want to turn to the completion of the epidemiological investigation that was conducted following the BSE detection in Texas in June. Many people worked very hard on the investigation, and I'd like to thank the Veterinary Services employees involved, our colleagues from the Food and Drug Administration, the owners of the animals, along with the Texas Animal Health Commission and the Texas Feed and Fertilizer Control Service for their outstanding work. This investigation is another great example of federal, state, and local partners cooperating to help protect livestock health in this country. I'll now summarize our findings. Our results indicate that the positive animal, called the "index animal." was born and raised on a ranch, termed the "index farm," in Texas. It was a cream-colored Brahma cross, approximately 12 years of age at the time of its death. It was born prior to the implementation of FDA's mandatory ruminant-to-ruminant feed ban in the U.S., and that ban was implemented in August 1997. The animal was sold through a livestock sale in November of 2004 and transported to a packing plant. The animal was dead upon arrival. The animal was therefore refused by the packing plant. This refusal was consistent with USDA's safeguards to protect the meat supply from BSE. The animal was then shipped to a pet food plant where it was sampled for BSE. The plant did not use the animal in its product, and the carcass was destroyed. APHIS's epidemiological investigation attempted to trace all adult animals that left the index farm after 1990. The investigation also attempted to trace all progeny born within two years of the index animal's death. Together these animals are called "animals of interest." These steps are consistent with the guidance for epidemiological investigations and to detections of BSE issued by the International Animal Health governing body or the OIE. During the course of this investigation, USDA removed and tested a total of 67 animals of interest from the farm where the index animal's herd originated. All of these animals tested negative for BSE. A total of 200 additional adult animals of interest were determined to have left the index farm. Of these 200, APHIS determined that 143 animals were slaughtered, 2 animals were found alive but one was determined not to be of interest because of its age, and the other tested negative for BSE. 34 animals were presumed dead, 1 is known dead, and the remaining 20 are classified as "untraceable." In addition to the adult animals, we also looked for two calves born to the index animal. Due to record-keeping and identification issues, we had to trace 213 calves. Of these 213, 208 entered feeding and slaughter channels, 4 are presumed to have entered feeding and slaughter channels, and 1 calf was untraceable. As you know, BSE is not a contagious animal disease. This disease is spread through contaminated feed. To determine whether contaminated feed could have played a role in the index animal's infection, FDA and the Texas Feed and Fertilizer Control Service conducted a thorough feed investigation. For a summary of the findings of the feed investigation, we have Dr. Steve Sundlof here from the FDA. Before I turn things over, though, I will say that we are extremely pleased with the results of the epidemiological investigation. It shows there was no widespread problem associated with the index herd, and as you will hear more about in a moment, that the ruminant feed ban in the United States is solid. It also affirms that USDA's interlocking system of safeguards to prevent BSE from entering the food chain is working as it should. We remain vigilant, as well, as in our efforts to determine the prevalence of BSE in the United States. To date there have been only 2 BSE-positive animals found in this country in more than 452,000 animals tested in the last 14 months. All evidence is that the prevalence is extremely low and continues to decline given the length of time the ruminant feed ban has been in effect. With that, I will turn things over to Dr. Steve Sundlof from the Food and Drug Administration. DR. STEVE SUNDLOF: Thank you, Dr. Clifford. I will read an opening statement as well. On June 24, 2005, the USDA informed the FDA that a cow in Texas tested positive for bovine spongiform encephalopathy. The animal was disposed of by incineration and did not enter the human food or animal feed chains. Although the animal posed no risk to the animal feed supply, FDA, along with USDA's Animal and Plant Health Inspection Service, the Texas Animal Health Commission, and the Texas Feed and Fertilizer Control Service conducted a feed investigation with two main objectives. The first objective was to identify all protein sources in the animal's feed history that could potentially have been the source of the BSE agent. The second objective was to verify that cattle of interest leaving the herd after 1997 were rendered at facilities that were in compliance with the 1997 regulation that prohibits most mammalian protein in the feed for ruminants, which hereafter we will call the BSE Ruminant Feed Rule. The feed history investigation identified 21 products that had been used on the farm since 1990. These feed products were purchased from three retail feedstores and had been manufactured at nine different feed mills. The investigators visited these establishments to collect information on formulation, shipping invoices, and the use of ruminant meat and bonemeal on the premises, both before the 1997 feed ban and after the 1997 feed ban. This investigation found no feed products used on the farm since 1997 had been formulated to contain prohibited mammalian protein. The investigation identified one feed which contained an animal protein source that could not be identified and the investigation also found one feed mill that supplied feed to the farm and that used ruminant meat and bonemeal in feed formulations for nonruminant species after the BSE ruminant feed rule went into effect, and this was permitted under the rule. And there were several feed mills that had used ruminant meat and bonemeal prior to the 1997 feed ban but had ceased to use that material after the 1997 feed ban. The investigation into the disposition of herd-mates from this farm involved visits to nine slaughter plants and eight rendering plants. The investigation found that all rendering plants were operating in compliance with the BSE ruminant feed rule. A review of the inspection history of each of these rendering firms found no violation. And those are my prepared comments. SEC. JOHANNS: Very good. Thank you, both of you. And with that I think we're ready to open it up to some questions. OPERATOR: Thank you. If you have a question you can do so by pressing *1 on your touchtone phone. Anytime you wish to cancel your question you can do so by pressing *2. Please be mindful to record your name as well as your affiliation when announced. First question comes from Libby Quaid. REPORTER: Hi. Thank you. A question for Dr. Sundlof with FDA. Your agency promised more than a year and a half ago to close loopholes in the feed ban. When will FDA act on that promise, and what will FDA do to close the loopholes? DR. SUNDLOF: Thank you. Yes, we have been working on the proposed rule. We announced July 14 of 2004, in an advanced notice of proposed rulemaking, that we intended to move forward with a modification of the feed rule that would prohibit specified risk materials in all animal feeds. I can report that there's been quite a great deal of progress on that, and that we hope that a rule will be forthcoming within the next month or two. REPORTER: Can you say what that rule will entail? Will it be different from what the ANPR was? DR. SUNDLOF: It will -- well, the ANPR dealt with a whole lot of issues. And so I can't say it will be different, but I think you'll find it's consistent with what we announced in the ANPR. MR. JIM ROGERS: Next question, please? OPERATOR: Next question comes from Daniel Goldstein of Bloomberg News. REPORTER: Yeah, hi. This question is for the Secretary. Last month or earlier this month the USDA released about 1,000 incidents where there was a case of meat plants not following the rules or violations for specified risk materials. And you spoke of some reluctance on the part of trading partners to reopen trade while there was a BSE investigation happening. Has there been any reluctance on the part of these trading partners to reopen because of some of these violations? SEC. JOHANNS: There hasn't been. They've asked for information. We supply that information, we answer whatever questions they have. There's an interest in it, I can say that, but I haven't had any trading partner say, 'We're not going to open the border,' or 'We're considering closing the border if they've opened it already.' So at least at this stage it's been more of a situation where they were interested and we provided the information. MR. ROGERS: Next question, please? OPERATOR: Next question comes from Ron Hays of Clear Channel. REPORTER: Yes. I guess my question is regards to some of the comments that have been made by the Japanese in recent days, Japanese Food Safety Commission. Seemingly some of their panel members questioning our feed ban and saying they're fearful that we might have as "bad of a situation as they had in Britain" is one quote we saw from the Japanese media. You know. Can anybody address-- what assurances can we make to them and to folks in this country that we are effective on our feed ban and right across the board? SEC. JOHANNS: I'll ask Dr. Sundlof to address that in just a second, but I would just offer a thought. That's just simply not the case. I mean, it just simply is not, not the case. We've worked very intensely, as you know, with the Japanese over many, many months now to deal with their questions and to address whatever concerns they raised. With the Japanese we've even gone beyond what international rules require. We agreed that we would start trading with animals at 20 months and under, and even the international standards don't require that. In 452,000 animals tested in the last 14 months we've had two BSE-positive animals. So again, we'll respectfully address their question, but quite honestly I don't see any scientific basis for the issue they're raising. Doctor, you can offer a thought if you would. DR. SUNDLOF: Thank you, Mr. Secretary. Well, let me just say that we've had a very effective feed ban in place since 1997. It's been over eight years now this month. And we have really focused our efforts on enforcing the ban and making sure that compliance with the feed ban was high. And we reported on several occasions that compliance when we go out and investigate -- we did over 6,800 inspections in the last year and are projecting to do even more in the upcoming years -- that their physical inspections, where inspectors go out and do a physical examination of the feed plants or the renderers, in all cases we find the compliance by the industries affected is greater than 99 percent. So it's an extremely high compliance rate. It's hard to get any better than that. The fact that both of these cattle that were BSE-positive in the United States were born at or before the feed ban and probably very likely consumed contaminated feed well before 1997-- there's just no indication the feed rule is not effective. MR. ROGERS: Our next question, please? OPERATOR: Next question comes from Steve Kay of Cattle Buyers Weekly. REPORTER: Gentlemen, I want to go back to the proposed rule by AFDA because the question of Ron Hayes mentioned what members of Japan's Prion Subcommittee were referring to in part, and one of their concerns that we were still, we the U.S. are still allowing meat and bonemeal to be fed to nonruminants. Now the advanced notice by FDA Dr. Sundlof suggests or proposes a ban on SRMs from all animal feed. Can you tell me, if you proceed with that, is that going to satisfy Japan, do you think? How is USDA going to convey to Japan that we might be moving in this way, because if this rule becomes a final rule but doesn't take effect for another year or more is Japan going to say, Well, we'll reopen our border in a year when this takes effect? I mean, how is all this going to play out? SEC. JOHANNS: Well, I'll offer another thought and then Dr. Sundlof, I'd ask you to offer your thoughts. Japan would not be justified under any science, any view of the world, to adopt that viewpoint. Again I point out with Japan we at the USDA, actually before I arrived, but made a decision to agree with Japan that we would start with the trade of animals 20 months and under. In the history of the world we haven't found an animal that tested positive for BSE 20 months and under. They just simply have no risk here. So that approach would not be justified by international standards, it would not be justified by scientific standards. It really is time for Japan, in my opinion, to step up here and go through a science-based process and reopen the border, and hopefully we're nearing the end of that very kind of process. Doctor, any thoughts? DR. SUNDLOF: Thank you again, Mr. Secretary. I don't have the insight to know what the Japanese government is going to do, based on what the feed rule or the proposed feed rule will convey. But the rule is very much risk-based. It uses the Harvard Risk Assessment to actually quantitate the risk and the risk reduction of the proposed measures that we will be publishing soon. And so I would agree with the Secretary that on the basis of science, the science is clearly laid out in the proposed rule and under a risk assessment that has undergone significant peer review by the scientific community. So I think if the decisions are going to be based in science then I think we will have a very defensible position. MR. ROGERS: Next question, please. OPERATOR: Next question comes come from Kerry Young of Bloomberg. REPORTER: Hi. I just had a question on why it's taking so long to get the revised feed ban out there. SEC. JOHANNS: Dr. Sundlof, if you could address that? DR. SUNDLOF: Okay, thank you again. Well, one of the reasons was -- there's actually a number of reasons. Back in January 2004 when, within a month after the first case in the U.S. was reported, the Secretary of Health and Human Services at that point made a statement that the FDA would propose modifications to the feed rule that would eliminate plate waste, poultry litter, cattle blood and require that all facilities that manufacture with ruminant meat and bonemeal be dedicated to non-ruminants and not prepare any ruminant feed in those mills. Within a week after the Secretary's announcement, the International Review Team that was advisory to the Secretary of Agriculture made recommendations that were very much different than that which the Secretary had announced the week prior. Based on that, we decided at that point to go through an advanced notice of proposed rulemaking to get all the information out, all the recommendations that the International Review Team has made, and discuss those from a risk basis. And as a result of that, we are now into rulemaking. One other thing that was a reason for the delay is that during this time USDA was in the middle of their intense surveillance activity to try and determine the prevalence of BSE in U.S. cattle. And that was done, the questions that were before us were--the International Review Team based their recommendations on assumptions that there was significant infectivity in the U.S. cattle herd. The results of the USDA surveillance tend to cast doubt on that assumption, and so it had a major effect on which was the correct regulation or what were the correct measures that would be commensurate with the real risk? So those are some of the reasons it has been delayed. It's a complicated regulation. It involves a lot of material that will have to be disposed of in some environmentally friendly way, and so we have to be very thoughtful about how we propose a rule that has minimal environmental impacts but yet does the greatest amount to reduce the actual risk to BSE in cattle. SEC. JOHANNS: If I could just add something that obviously is very, very relevant and very important. Again, that's to point out that in the last 14 months we've tested 452,000 high-risk animals. These are the animals, that present themselves for testing, that experience would show from other countries would have the highest chance of being a BSE situation. We've had two out of that identify as positive. And both of those animals were born before the feed ban. So it's obviously the decision, some years ago now, to impose the first generation of feed ban was the right decision. MR. ROGERS: Next question, please. OPERATOR: Next question comes from Sally Schuff from Feedstuffs. REPORTER: Yes. This is Sally Schuff at Feedstuffs. Thank you for taking the question. The question is a two-part question for Dr. Clifford and Dr. Sundlof. Dr. Clifford, you said when the second case was announced the test results were more similar to the Western blot test, was more similar to results found in France than in the United Kingdom, leading to some question about what strain of BSE she might have. My question to you is, has that been resolved yet? Do you have any more positive identification on the strain? My question for Dr. Sundlof is, have you identified the source of the meat and bonemeal that was fed prior to the feed ban? Was it domestic or imported? DR. CLIFFORD: This is John Clifford. I'll answer the first part. From a regulatory standpoint, this is a case of BSE. Looking from a molecular standpoint, there's further work that's being done internationally on some of these cases. And--but from our standpoint, this is a case of traditional BSE that we would find. So that's the way we're approaching this. OPERATOR: Next question comes from Karen Robinson of Dallas Morning News. REPORTER: Hello, this is Karen Robinson Jacobs with the Dallas Morning News. I wanted to go back to the Texas cow, and if you could tell us maybe a little more slowly how much cattle or meat from this particular index ranch got into the human food chain, how much got into the pet food chain, and how concerned should consumers be that they may have eaten something already before the test even began? DR. CLIFFORD: This is John Clifford. I'd begin by saying if you look at what we know internationally, it's not very common at all. In fact it's rare to have more than one single case of BSE found within a herd. So from that standpoint alone, the risk is extremely small. In addition you have other safeguards in place. We have had a feed ban in place since 1997. It's been in place for 8 years, and then there's other cross-cutting protections as well from the food safety side that Dr. Ken Peterson's on if he wants to address as well. But as far as actual poundage, I don't think it's possible for us to give you that actual number. There was two calves of interest that we traced. Due to the lack of appropriate records at the time, we actually traced 213 calves. Of those, it's estimated that 212 of those animals went into the feeding and slaughter channels. Those animals would have been slaughtered likely prior to 30 months of age, which we know that it's extremely small risk of having BSE prior to 30 months of age. And also internationally and in the research community, while it's never been proven that offspring can get this disease through maternal transmission -- it's never been proven or disproven actually -- but it's thought very much from the international experts and the research it is extremely rare if it does happen. Both of these calves were born very well prior to this animal being slaughtered. This animal did not show any clinical signs typical of BSE -- sampled and destroyed. This animal did not show any clinical signs or evidence of BSE which would make it even more unlikely that these two offspring would have any risk of having BSE. The other 200 head that were traced were retraced as a result also of a lack of records. We were looking at cattle of interest over a five-year period of time of which this animal was born. Her approximate age was 12. We expanded one year of that and made her 11 to 13, and then we'd go another year beyond that. So we looked at animals basically in the age range of 10 to 15 years of age to remove those from the herd. And we traced every adult animal that we could from 1990. Many of those animals would not even be of concern because they would not have received any feed at the time that she was in the herd or would have not been a birth cohort and born at the same time that she was. So of those, 143 were reported as slaughtered, and we confirmed that 131 were definitely slaughtered; 34 were presumed dead, and 20 of those were untraceable. So again, we feel that the risk is extremely small. We do not feel that the public or our pet food industry should have any concerns relative to this issue. MR. ROGERS: Next question, please. OPERATOR: Next question comes from Chuck Abbott of Reuters. REPORTER: Good afternoon. I'm curious -- what, Mr. Secretary, what you're going to do about the downer ban which is still now a preliminary rather than a permanent rule. When will you decide on the downer ban? How sweeping will it be? And what's going to happen to the surveillance testing program? It has run some months beyond its originally envisioned lifetime. I'll stop there. SEC. JOHANNS: The surveillance program, as you know, was really open-ended. So I might debate with you a little bit on your last thought there. But here's what I would say. I am not prepared to bring the surveillance program to a conclusion, have not made a final decision on the downer ban. As you know, we've started now with the testing of the 20,000 healthy animals. We hope to have that done in the next 60 days. Dating from the time of my confirmation hearing really until now, my view was to get the surveillance program in the kind of shape that we wanted, make sure that we'd touched all the bases. And then, in addition to that, do the additional testing of the 20,000 healthy animals and then, once we have all the information together, make a decision on some of those pending issues. So that's where it's at. MR. ROGERS: All right. I'd like to thank everyone for calling today. If you have further questions for the U.S. Department of Agriculture, you can call me, Jim Rogers, at 202-690-4755. If you have questions for the Food and Drug Administration, please contact my counterpart Ray Jones at 301-827-6246. This concludes the call for today, and I thank you all for participating. I only pray that the world does not buy into this phony BSE MRR policy and June 2004 Enhanced BSE surveillance program. none of it was based on sound science. Working Group Report on the Assessment of the Geographical BSE-Risk (GBR) of MEXICO 2004 There is no SRM-ban. SRM is normally destined for human consumption. According to the CD, fallen stock from pasture and diseased animals are incinerated and not rendered. Conclusion on the ability to avoid recycling In light of the above information, it has to be assumed that the BSE agent, should it have entered Mexico, could have been recycled and potentially amplified. high external challenges with a very unstable system makes the occurrence of an internal challenge likely in Mexico from approximately 1993 onwards. 4.2 Risk that BSE infectivity entered processing It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990’s). The high level of external challenge is maintained throughout the reference period, and the system has not been made stable, leading to increased internal 4.3 Risk that BSE infectivity was recycled and propagated It is likely that BSE infectivity was recycled and propagated from approximately 1993. The risk has since grown consistently due to a maintained internal and external challenge and lack of a stable system. 5. CONCLUSION ON THE GEOGRAPHICAL BSE - RISK 5.1 The current GBR as function of the past stability and challenge The current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. snip...end Report Summary 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. http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html Greetings FDA, snip... PLUS, if the USA continues to flagrantly ignore the _documented_ science to date about the known TSEs in the USA (let alone the undocumented TSEs in cattle), it is my opinion, every other Country that is dealing with BSE/TSE should boycott the USA and demand that the SSC reclassify the USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the SSC to _flounder_ any longer on this issue, should also be regarded with great suspicion as well. NOT to leave out the OIE and it's terribly flawed system of disease surveillance. the OIE should make a move on CWD in the USA, and make a risk assessment on this as a threat to human health. the OIE should also change the mathematical formula for testing of disease. this (in my opinion and others) is terribly flawed as well. to think that a sample survey of 400 or so cattle in a population of 100 million, to think this will find anything, especially after seeing how many TSE tests it took Italy and other Countries to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to find 102 BSE cases), should be proof enough to make drastic changes of this system. the OIE criteria for BSE Country classification and it's interpretation is very problematic. a text that is suppose to give guidelines, but is not understandable, cannot be considered satisfactory. the OIE told me 2 years ago that they were concerned with CWD, but said any changes might take years. well, two years have come and gone, and no change in relations with CWD as a human health risk. if we wait for politics and science to finally make this connection, we very well may die before any decisions snip... The general opinion of those present was that BSE, as an snip... It is clear that USDA have little information and _no_ regulatory snip... 3. Prof. A. Robertson gave a brief account of BSE. The US approach snip... http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf To be published in the Proceedings of the Evidence That Transmissible Mink Encephalopathy R.F. Marsh* and G.R. Hartsough •Department of Veterinary Science, University of Wisconsin-Madison, Madison, ABSTRACT INTRODUCTION Transmissible mink encephalopathy (TME) was first reported in 1965 by Hartsough OBSERVATIONS AND RESULTS A New Incidence of TME. In April of 1985, a mink rancher in Stetsonville, Wisconsin Experimental Transmission. The clinical diagnosis of TME was confirmed by DISCUSSION ACKNOWLEDGEMENTS REFERENCES MARSH http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf WITH all said, the following is probably the most ignoramus statement about the Texas mad cows and ----- Original Message ----- From: TSS () Texas BSE Investigation Final Epidemiology Report August 2005 2 Table of Contents Executive Summary............................................................................................................. 3 Background of the Investigation......................................................................................... 3 BSE Response Plan .............................................................................................................. 3 Definition of At-Risk Cattle.................................................................................................... 3 Definition of Cattle of Interest ............................................................................................... 4 Definition of Feed Cohort...................................................................................................... 4 Definition of Birth Cohort...................................................................................................... 4 Definition of At-Risk Progeny................................................................................................ 4 Epidemiology Investigation of Index Herd: Farm A....................................................... 5 Background........................................................................................................................... 5 Progeny................................................................................................................................. 6 Birth Cohort ........................................................................................................................... 6 Feed Cohort ........................................................................................................................... 6 Removal of Cattle from the Index Farm............................................................................ 7 Tracing of Progeny .............................................................................................................. 7 Tracing of Birth Cohorts..................................................................................................... 8 Tracing of Cattle of Interest................................................................................................ 9 Calculation of Minimum Estimated Ages .............................................................................. 9 Trace Herds ........................................................................................................................ 10 Trace Herd 1........................................................................................................................ 10 Trace Herd 2........................................................................................................................ 10 Trace Herd 4........................................................................................................................ 11 Trace Herd 5........................................................................................................................ 11 Trace Herd 6........................................................................................................................ 11 Trace Herd 7........................................................................................................................ 12 Trace Herd 8........................................................................................................................ 12 Analysis of Data on Presumed Dead and Untraceable Animals.................................... 12 Appendix 1 – Final Trace-Out Diagram.............................................................................. 13 3 Executive Summary In June 2005, an inconclusive bovine spongiform encephalopathy (BSE) sample from November 2004, that had originally been classified as negative on the immunohistochemistry test, was confirmed positive on SAF immunoblot (Western blot). The U.S. Department of Agriculture (USDA) identified the herd of origin for the index cow in Texas; that identification was confirmed by DNA analysis. USDA, in close cooperation with the Texas Animal Health Commission (TAHC), established an incident command post (ICP) and began response activities according to USDA’s BSE Response Plan of September 2004. Response personnel removed at-risk cattle and cattle of interest (COI) from the index herd, euthanized them, and tested them for BSE; all were negative. USDA and the State extensively traced all at-risk cattle and COI that left the index herd. The majority of these animals entered rendering and/or slaughter channels well before the investigation began. USDA’s response to the Texas finding was thorough and effective. Background of the Investigation On June 10, 2005, USDA announced that the November 2004 inconclusive BSE sample tested positive on SAF immunoblot. The SAF immunoblot was run at USDA’s National Animal Disease Center (NADC) upon the recommendation of USDA’s Office of the Inspector General. Samples were sent to a World Organization for Animal Health (OIE) reference laboratory for BSE in Weybridge, England, for confirmatory tests. Farm A, located in Texas, was the suspected farm of origin for the index cow and was placed under hold order on June 20, 2005 pending confirmation of the positive results and DNA analysis of the herd. Weybridge confirmed the BSE positive on June 24, 2005. The carcass of the index cow had been disposed of by incineration in November 2004. Cattle from several units on Farm A were bled for DNA testing (a unit is a part of the business entity of a farm. For example, a pasture on which a group resides may be a unit). Farm A was confirmed as the farm of origin for the index cow on June 29, 2005, and an ICP was established in Texas to coordinate the response. Removal of at-risk cattle from the index herd, and tracing of atrisk cattle and COI that had left the index herd, commenced immediately. BSE Response Plan The September 2004 BSE Response Plan outlines the necessary tracing and removal of atrisk cattle and, in some cases, COI, in response to the identification of a BSE-positive animal. Response personnel removed at-risk animals from the index farm and traced atrisk animals and COI in accordance with the response plan. Definition of At-Risk Cattle At-risk cattle were cattle that were confirmed to be: part of the birth cohort; part of the feed cohort; or progeny of the positive cow born within 2 years prior to the positive test. Response personnel removed at-risk cattle from the herd, euthanized them, and tested them for BSE; all were negative. 4 Definition of Cattle of Interest In many cases, at-risk cattle could not be definitively identified. Response personnel then analyzed herd inventories and herd records to identify a group of cattle that include all potential at-risk cattle and any other cattle that could not be distinguished from at-risk cattle. All of these cattle (at-risk cattle and any additional cattle as necessary) were defined as COI. COI that fell into the appropriate age range and could be part of the birth or feed cohort were removed from the herd, euthanized, and tested for BSE; all were negative. Definition of Feed Cohort The feed cohort consisted of all cattle which, during their first year of life, were reared with the positive animal during its first year of life and consumed the same feed during that period. In the index herd, this definition applied to cattle in any unit that were weaned and fed with calves from the other units for a short period of time and then later returned to their respective units of origin from 1991-1995 (the range of years that could have coincided with the first year of life of the index cow). Definition of Birth Cohort In most cases, it was impractical or impossible to definitively determine which cattle were exposed to a feed source. Accordingly, response personnel used a birth cohort to determine which cattle to consider at-risk. The birth cohort included all cattle born on the positive animal’s birth premises within 1 year before or after the BSE-positive animal’s date of birth. Since the index cow was approximately 12 years of age, but an exact date of birth did not appear in the herd records, response personnel used a potential age range of 12 years with 1 year added to each end of that age (age 11 to 13) to sufficiently cover the most likely age range of the animal. In addition, if the positive animal moved from the birth premises to any other premises during its first year of life, all cattle of less than 1 year of age that were present on such additional premises were also considered to be at-risk. Using the age range of the index animal, all cattle born on the index premises from 1990-1995 were part of the birth cohort of the index animal. Definition of At-Risk Progeny Since the index cow was not confirmed to have been exhibiting clinical signs of BSE prior to her positive test results, the at-risk progeny as defined by the OIE were those offspring that were born within the 2 years prior to the positive test result. Those 2 years prior to the positive test result would have included her calves from 2002, 2003, and 2004. According to the owner, the index cow produced her last calf either in Fall 2003 or Spring 2004, and the calf prior to that was born either in Fall 2002 or Spring 2003. Tracing activities focused on these two calves as at-risk progeny. 5 Epidemiology Investigation of Index Herd: Farm A Background The index cow was an approximately 12-year-old yellow or cream-colored Brahma cross that originated from Farm A located in Texas. The cow was sold through a livestock sale on 11/11/04, purchased by an order buyer, and was transported to a packing plant on Monday, 11/15/04. When the truck arrived at the packing plant during the late afternoon of 11/15/04, the index cow and one other were found dead on the truck and were transported to a pet food plant later that day where they were sampled for BSE testing as part of the enhanced BSE surveillance. DNA analysis of blood samples taken from five of the six units of cattle that comprise Farm A yielded four animals from two different units that were genetically related to the index cow and confirmed Farm A as her herd of origin. The herd on Farm A consisted of mixed breed beef cattle that are traditionally not used as seedstock replacement animals. Market records and preliminary tracing indicated that most animals that left the index herd either went to slaughter within a few days of sale or, in the case of younger animals, entered into known rendering and slaughter channels immediately following sale. There were only 11 cows identified during the investigation that were traced from Farm A into other herds where they had been used as replacement cows. The owner of Farm A raised this cow from birth and stated that the cow had never been off the premises prior to its sale. She was marketed because of poor body condition (the animal’s condition had not improved despite the early weaning of her 2003/2004 calf). The owner stated that the cow had always been excitable and had fallen while she was being loaded to go to the market, but that this was not unusual behavior for her in his opinion. In addition there was a report of this cow being down in the alley at the livestock market on 11/11/04, but she apparently got up again and was able to be loaded onto the truck to go to the packing plant. When questioned about any previous history of neurological signs in cattle on the farm, the owner reported that no cattle on the farm had ever shown any neurological signs, nor had there been any cases of rabies on the index farm. Index Herd Census Farm A consisted of 6 units (Units A through F) containing a total of about 217 adult cattle and approximately 100 to 120 calves. Early in the investigation, response personnel discovered that an additional unit belonging to the owner’s son and located adjacent to Unit F could also contain COI. This group, Unit G, contained 16 adult cattle and made a seventh unit that became included in the investigation. On 6/22/05, the first three of the original six units were sampled for DNA testing to confirm the herd of origin of the index cow. Those first three units consisted of: Unit A contained 62 head with some older cattle (more likely than the other units to provide a DNA match); Unit B with 28 head (3-year-old unit); and Unit C with 25 head (2-year-old unit). Two additional units were sampled for DNA on 6/23/05; Unit D with 31 head and Unit E with 30 head, both of which contained older animals. 6 The sixth unit, Unit F, containing 41 head, was purchased in 1993 from another source. Because it did not have animals that were genetically related to the other 5 units, this unit was not sampled for DNA testing. Unit F, and adjacent Unit G, contained COI because the weaned heifers from those units were commingled and fed with weaned heifers from the other units for a short period of time before they were returned to their respective units of origin. This practice of weaning and feeding together fit the definition of a feed cohort. Progeny The owner did keep some replacement heifers and, although he was relatively sure that he had not kept any offspring from the yellow cow because of her excitable demeanor, DNA analysis of the herd revealed several animals in the herd that may have been older offspring of the index cow. While the owner sold 12 calves at the sale with the index cow on 11/11/04, her last calf was not in that group. According to the owner, the index cow’s last calf was born either in Fall 2003 or Spring 2004, weaned early, and sold through the livestock market some time between February and October 2004. The calf prior to that would have been born either in Fall 2002 or Spring 2003 and was sold at the livestock market sometime between January and December 2003. Birth Cohort The owner of Farm A kept very few herd records; this made finding documentation on this cow’s birth cohort difficult. The birth cohort, by definition, included all cattle born on the positive animal’s birth premises within 1 year, before or after, the positive animal’s date of birth. The index cow was approximately 12 years of age in November 2004, but there was no exact birth date in the herd records. A potential age range of 11 to 13 years was used to sufficiently cover the animal’s most likely age. Using this range, all cattle born on the index premises between 1990 and 1995 were considered part of the birth cohort. In lieu of the owner’s records, herd records from Veterinary Services’ Generic Database (GDB) were used to compile a list of brucellosis calfhood vaccination (CV) tag numbers from the index herd that corresponded to animals to be included in the birth cohort. There were 121 animals identified through GDB as having been calfhood vaccinated on the index farm between 1991 and 1994. The owner of Farm A did not calfhood vaccinate after 1994. Moreover, calfhood vaccinates include only heifers. Therefore, the list of 121 animals was not a complete list of all birth cohorts. However the tracing that response personnel conducted on other COI was designed to account for the remainder of the birth cohorts. Feed Cohort Animals in Units A, D, and E, that were weaned and fed with the positive cow between 1991-1995, were already considered at-risk as part of the defined birth cohort. Animals in Units B and C were 3-year-olds and 2-year-olds, respectively, and were too young to be either birth or feed cohorts. Although Unit F was purchased separately and did not contain animals genetically related to the other units, calves from Unit F were weaned and fed for a short period of time with weaned calves from other units and all calves were later returned to their respective units of origin. Since Unit F was not purchased until 1993, the feed cohort consisted of those animals in Unit F that could have been weaned and fed with the index cow in 1993 or 1994. Additionally, Unit G contained possible feed cohorts that could have been weaned and fed with the index cow between the years of 1991 and 1995. 7 Feed The feeding regimen for the cattle in this herd consisted of natural pasture, hay, mineral supplement, syrup tubs occasionally, and a breeder’s supplement (predominantly a name brand manufactured breeder’s cube). The Food and Drug Administration (FDA) investigated all sources of feed and supplements used on Farm A. In-depth investigations and site visits were conducted by FDA involving retail feed stores, feed manufacturers, slaughter plants, renderers, and brokers. A more detailed account of the investigation is contained in FDA’s final report. Removal of Cattle from the Index Farm Any animal still present within the index herd that could have been a possible birth cohort or feed cohort of the index cow was targeted for removal as an at-risk animal. Units A, D, E, F, and G, all of which were known to contain older animals, were inventoried. Identification tags, tattoos, and brands were recorded, and all animals were aged based on their dentition and any man-made identification. Cattle whose estimated age indicated that they could have been part of the index cow’s birth or feed cohort were removed from the herd, euthanized, and tested for BSE; all were negative. Units B and C were exempt from the cohort removal process because they contained only 3-year-old and 2-year-old animals respectively. Although the DNA analysis of animals in Units A through E determined that there were 2 animals present that could have been offspring of the index cow, their estimated age by dentition revealed that they were not of the appropriate age to be at-risk progeny. This verified the owner’s claim that he had sold the index cow’s last two calves at the livestock market and they were not currently present in the index herd. After sorting by age, response personnel identified and removed the following numbers of cows from the herd on 7/6/05: Unit A, 11 cows; Unit D, 11 cows; Unit E, 7 cows. The same process was applied to Units F and G and the following numbers of cows were identified and removed from the herd on 7/7/05: Unit F, 28 cows; Unit G, 10 cows. Of the 67 animals removed from the herd as possible birth cohorts and/or feed cohorts of the index cow, 42 were definitively identified as belonging to the birth cohort due to the presence of a calfhood vaccination tag or tattoo that corresponded to the appropriate birth cohort years. All 67 animals were euthanized on 7/6/05 and 7/7/05 and samples were subsequently sent to USDA’s National Veterinary Services Laboratories (NVSL) for BSE testing. All samples were run on the ELISA test and confirmed negative on 7/8/05 and 7/9/05. Upon confirmation of negative results, disposal of carcasses was completed by burial in an approved landfill facility. The index farm was released from hold order on 7/11/05. Tracing of Progeny The 2003/2004 progeny of the index cow was known to have left the farm through a specific livestock market sometime between February and October 2004. The 2002/2003 progeny of the index cow left the farm through the same market sometime between January 8 and December 2003. Response personnel learned early in the investigation that animals from the index farm were sold not only under the index farm owner’s name and that of his wife, but also by other members of the owner’s immediate family. Additionally, there were no herd records to indicate the gender of the two at-risk progeny. Therefore, market records for February through October 2004 and January through December 2003 were obtained for all calves sold both by Farm A’s owner and by members of his immediate family; response personnel traced all such calves to determine their disposition. With the index herd being composed of mixed breed beef cattle, the calves that left the farm were genetically unsuitable for use as replacement animals or for sale as breeding stock, a fact that was confirmed by the trace work and the documentation of the final disposition of the calves of interest. Response personnel ultimately identified 213 calves of interest to be traced. Of these, 208 were confirmed to have entered known rendering/slaughter channels, 4 were presumed to have entered rendering/slaughter channels, and 1 was purchased in cash through a livestock market with no buyer name or contact information (this animal was classified as untraceable. See Appendix 1). A calf was categorized as presumed to have entered rendering/slaughter channels if it passed through at least one livestock market subsequent to its original sale and could not be individually traced due to unknown resale date and new backtag, but all calves resold matching that description during an appropriate date range were purchased by known rendering/slaughter order buyers. It was not possible to DNA test the calves that entered known rendering and slaughter channels – most were of an age in which they were likely to have been slaughtered prior to the time of the investigation. There were no calves traced to farms outside of rendering and slaughter channels. Tracing of Birth Cohorts Since there were essentially no records maintained on the index farm, it was necessary to compile the list of known birth cohorts using brucellosis CV tag numbers for this herd from the period 1991 to 1994. The calves vaccinated during that time period were part of the index cow’s birth cohort and tracing activities centered on finding those animals. There were 121 animals whose CV tag number and/or tattoo included them as part of the birth cohort. Of those 121 animals, 67 animals were definitively accounted for (42 were found in the index herd, removed, and tested BSE negative; 25 were identified as having left Farm A through the market system and were traced, 11 of those were reported slaughtered, 13 were classified as presumed dead, and 1 was found alive, euthanized, and tested BSE negative). Of the remaining 54 animals from the birth cohort, there may have been several that died within the index herd, but the majority likely left the herd without identification and would have been either re-tagged at the livestock market or consigned directly to slaughter without identification. To account for these remaining birth cohorts, all adult cattle that left the index farm since 1990 were traced as COI. 9 Tracing of Cattle of Interest The investigation revealed that many animals left Farm A, arrived at markets without any identification tags, and were subsequently re-tagged at the market. Due to lack of farm records, it is unknown which of these re-tagged animals may have belonged to the birth cohort. As a result, all animals that may have left Farm A since 1990 were traced as COI. Additionally, animals from the index farm were sold not only under the index farm owner’s name and that of his wife, but also by other members of the owner’s immediate family; therefore, cattle sold from the index farm by all pertinent family members were traced. There were some older animals that left the index farm but were able to be excluded from further trace work because they were known not to have been part of the birth cohort or feed cohort of the index cow despite their being of the appropriate age. The index farm owner’s late father had maintained a herd of cattle separate from the index farm but which was added to the index farm in 1997. Complete herd test data and CV data from the GDB was obtained for the father’s herd and those animals were excluded from the tracing activities. There were a total of 200 COI traced: 143 were reported to have been slaughtered (131 of those were confirmed as having been slaughtered), 1 is known to have died previously and was buried, 2 were found alive (1 was a known birth cohort that tested negative, 1 was determined not to be one of the cattle of interest due to her young age), 34 were classified as presumed dead, 20 were classified as untraceable. (See Appendix 1). Animals were confirmed at slaughter using GDB slaughter testing data or the hard copies of slaughter testing Form 4-54. An animal was classified as presumed dead if records that could be used to advance the tracing of the animal were exhausted or did not exist, and the age of the animal at the time of the investigation was estimated to be at least 11 years old or older. Since the index herd was not a purebred or seedstock operation, and animals leaving the herd were unlikely to be purchased as replacement cattle, standard industry practices indicated that most adult animals that had left the herd would have been culled and slaughtered by the time they were in this age group. Additionally, this age cutoff was arrived at through review of market records and the specific years in which Farm A sold cattle through the market. An animal was classified as untraceable if all records to advance the tracing of the animal were exhausted or did not exist, and the age of the animal at the time of the investigation was estimated to be less than 11 years of age (the animal, therefore, could not be presumed dead). Calculation of Minimum Estimated Ages Throughout the tracing process, personnel used minimum estimated ages of the 200 COI to evaluate whether those individuals could be old enough to be part of the birth or feed cohort of the index cow. Since Farm A’s owner maintained no records on the ages of animals, GDB data assisted in assigning minimum estimated ages. Animals that were wearing brucellosis CV eartags could be aged quite accurately because the exact CV date was recorded in the GDB and those animals would have been vaccinated between 4 to 12 months of age. The GDB also contained lists of individual eartags for all animals on the 10 index farm that were included in complete herd brucellosis testing in 1991, 1993, and 1994. Cattle included in those herd tests would have been at least 18 months of age at the time of the test and their minimum age today could be extrapolated from that data. Finally, the GDB also contained livestock market testing data that could also be used to assign a minimum age because the animal would have been at least 18 months of age on date the earliest brucellosis market test was conducted. The minimum ages calculated for the cattle of interest were used later in an analysis by USDA’s Centers for Epidemiology and Animal Health (CEAH) to determine the probable disposition of untraceable and presumed dead animals based on their age. Trace Herds Response personnel made every attempt to trace COI to their final dispositions (which, in most cases, was slaughter). If an animal was traced to a herd owner and the owner could not provide information that indicated that the animal of interest was not currently present within his/her herd, the owner’s herds were placed under hold order pending a herd inventory to determine whether or not the animal of interest had been retained. There were eight herds identified as the last traceable location of the animal of interest and were, therefore, subjected to herd inventories in an attempt to locate the animal. When an animal of interest was located within a herd, the age of the animal was estimated using dentition and any man-made identification. If the animal fell into the appropriate age range to be a possible birth cohort or feed cohort of the index cow, the animal was removed from the herd and tested. If an animal of interest was located within the herd and fell into the appropriate age range to be a possible at-risk progeny of the index cow, the animal was sampled for DNA testing. Trace Herd 1 The owner of Trace Herd 1 was identified as having received one of the adult COI from the index herd. Trace Herd 1 contained 909 head of cattle in multiple pastures and was placed under hold order on 7/21/05. Upon completion of herd inventory, the animal of interest was not found within the herd. A GDB search of all recorded herd tests conducted on Trace Herd 1 and all market sales by the owner failed to locate the identification tag of the animal of interest and she was subsequently classified as untraceable. The hold order on Trace Herd 1 was released on 8/8/05. Trace Herd 2 Trace Herd 2 was identified as having received one of the adult COI from the index herd. Trace Herd 2 contained 19 head of cattle on one pasture and was placed under hold order on 7/25/05. The owner of Trace Herd 2 identified the animal of interest by her eartag while he was feeding his cattle out of a bucket and individually penned her for inspection by field personnel. While the cow was identified as one of the animals that had left the index farm, her age by dentition was estimated to be only 5 years old, which was too young to have placed her as part of the birth or feed cohort of the index animal. She was classified as found alive but determined not to be one of the COI; the hold order on Trace Herd 2 was released on 7/26/05. 11 Trace Herd 3 The owner of Trace Herd 3 was identified as possibly having received an animal of interest. The herd was placed under hold order on 7/27/05. The herd inventory was conducted on 7/28/05. The animal of interest was not present within the herd, and the hold order was released on 7/28/05. The person who thought he sold the animal to the owner of Trace Herd 3 had no records and could not remember who else he might have sold the cow to. Additionally, a search of GDB for all cattle sold through the markets by that individual did not result in a match to the animal of interest. The animal of interest traced to this herd was classified as untraceable because all leads were exhausted. Trace Herd 4 The owner of Trace Herd 4 was identified as having received one of the COI through an order buyer. Trace Herd 4 was placed under hold order on 7/29/05. A complete herd inventory was conducted on 8/22/05 and 8/23/05. There were 233 head of cattle that were examined individually by both State and Federal personnel for all man-made identification and brands. The animal of interest was not present within the herd. Several animals were reported to have died in the herd sometime after they arrived on the premises in April 2005. A final search of GDB records yielded no further results on the eartag of interest at either subsequent market sale or slaughter. With all leads having been exhausted, this animal of interest has been classified as untraceable. The hold order on Trace Herd 4 was released on 8/23/05. Trace Herd 5 The owner of Trace Herd 5 was identified as having received two COI and was placed under hold order on 8/1/05. Trace Herd 5 is made up of 67 head of cattle in multiple pastures. During the course of the herd inventory, the owner located records that indicated that one of the COI, a known birth cohort, had been sold to Trace Herd 8 where she was subsequently found alive. Upon completion of the herd inventory, the other animal of interest was not found within the herd. A GDB search of all recorded herd tests conducted on Trace Herd 5 and all market sales by the owner failed to locate the identification tag of the animal of interest and she was subsequently classified as untraceable due to all leads having been exhausted. The hold order on Trace Herd 5 was released on 8/8/05. Trace Herd 6 The owner of Trace Herd 6 was identified as possibly having received an animal of interest and was placed under hold order on 8/1/05. This herd is made up of 58 head of cattle on two pastures. A herd inventory was conducted and the animal of interest was not present within the herd. The owner of Trace Herd 6 had very limited records and was unable to provide further information on where the cow might have gone after he purchased her from the livestock market. A search of GDB for all cattle sold through the markets by that individual did not result in a match to the animal of interest. Additionally, many of the animals presented for sale by the owner of the herd had been re-tagged at the market effectually losing the traceability of the history of that animal prior to re-tagging. The animal of interest traced to this herd was classified as untraceable due to all leads having been exhausted. The hold order on Trace Herd 6 was released on 8/3/05. 12 Trace Herd 7 The owner of Trace Herd 7 was identified as having received an animal of interest and was placed under hold order on 8/1/05. Trace Herd 7 contains 487 head of cattle on multiple pastures in multiple parts of the State, including a unit kept on an island. The island location is a particularly rough place to keep cattle and the owner claimed to have lost 22 head on the island in 2004 due to liver flukes. Upon completion of the herd inventory, the animal of interest was not found present within Trace Herd 7. A GDB search of all recorded herd tests conducted on Trace Herd 7 and all market sales by the owner failed to locate the identification tag of the animal of interest. The cow was subsequently classified as untraceable. It is quite possible though that she may have died within the herd, especially if she belonged to the island unit. The hold order on Trace Herd 7 was released on 8/8/05. Trace Herd 8 Trace Herd 8 received an animal of interest, which happened to be a known birth cohort of the index cow, from Trace Herd 5. Trace Herd 8 consists of 146 head of cattle that were placed under hold order on 8/4/05. A herd inventory was conducted, the birth cohort was found alive in the herd, and she was purchased and euthanized. The hold order on Trace Herd 8 was released on 8/4/05. The cow was sampled on 8/5/05 and BSE tested by ELISA at NVSL. Results were negative (as reported on 8/6/05); carcass disposal was completed by alkaline digestion. Analysis of Data on Presumed Dead and Untraceable Animals CEAH performed an analysis of the minimum estimated ages of those COI that were classified as either presumed dead or untraceable to determine the likely disposition of those animals based on their ages. Moreover, CEAH performed an analysis of the likely disposition of the one calf that was classified as untraceable during the investigation. 13 Appendix 1 – Final Trace-Out Diagram TSS
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