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BSE USDA MAD COW PROTOCOLS, OIG $ GAO [cover up until caught, then cover up some more] NO SPANK POLICY Printable version "We know there is absolutely no risk to animal or human health related to 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 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 January 2002 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 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 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 October 31, 2002 Review of the Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States Conducted by the Harvard Center for Risk Analysis, Harvard School of Public Health and Center for Computational Epidemiology, College of Veterinary Medicine, Tuskegee University Final Report Prepared for U.S. Department of Agriculture Food Safety and Inspection Service Office of Public Health and Science Prepared by RTI Health, Social, and Economics Research Research Triangle Park, NC 27709 RTI Project Number 07182.024 RTI Project Number 07182.024 Review of the Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States Conducted by the Harvard Center for Risk Analysis, Harvard School of Public Health & Center for Computational Epidemiology, College of Veterinary Medicine, Tuskegee University Final Report October 31, 2002 Prepared for U.S. Department of Agriculture Food Safety and Inspection Service Office of Public Health and Science Prepared by RTI Health, Social, and Economics Research Research Triangle Park, NC 27709 snip... 9.1 KEY SOURCES OF VARIABILITY AND UNCERTAINTY 1) In Section 3.2 of the H-T BSE study report, the authors list 15 sources of uncertainty that they evaluated individually for influences on the model predictions for two outcomes: Z the total number of cattle that become infected after the introduction of 10 infected animals at the beginning of the period, and Z the amount of BSE infectivity (quantified in terms of the number of cattle oral ID50s) in food produced for human consumption over that period. In addition to varying the parameters to reflect a best case and worse case, the authors considered the impact of different sources of infection on the model’s predictions, described in Section 3, Pages 71-79 and compared the model’s predictions with alternative 9-1 Review of the Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States — Final Report scenarios. The parameters evaluated in the sensitivity (uncertainty) analysis are listed in detail in the synopsis. 2) The method used for evaluating the contributions of uncertainty in inputs to uncertainty in model predications has key shortcomings. The chosen method in the BSE risk assessment model is to evaluate the influence of one individual uncertainty source while setting all of the other assumptions or uncertainty sources to their base-case values. For example, when considering the impact of the uncertainty in maternal BSE transmission rate on the model prediction, the other 14 uncertainty sources are set to their basecase point estimates. This kind of analysis should be referred to as "sensitivity analysis," not as "uncertainty analysis" as described in the report. Although uncertainty analysis and sensitivity analysis are closely related, they are two different disciplines. Uncertainty analysis assesses the uncertainty in model outputs that derives from uncertainty in all inputs when simulated simultaneously. Sensitivity Analysis assesses the contributions of the inputs to the total uncertainty in analysis outcomes (Cullen and Frey, 1999). Therefore, the results from the BSE model "uncertainty analysis" do not represent the full range of uncertainty in the risk of animal or human exposed to BSE associated with simultaneous contributions from all uncertainty inputs. Instead, what is reported is an individual contribution of one uncertainty input to the partial uncertainty in the model output, the risk such as associated with animal or human exposure to BSE. 3) Variability refers to the heterogeneity of values with respect to time, space, or a population. For example, in exposure assessment, variable quantities include the rate at which individuals consume specific dietary items and the body weights of the individuals (Cullen and Frey, 1999). Variability can be represented by a frequency distribution showing the variation in a characteristic of interest over time, space. Uncertainty arises due to lack of knowledge regarding the true value of a quantity. For example, there may be uncertainty regarding the proportion of animals that die on the farm that are rendered. Uncertainty can be quantified as a probability distribution representing the likelihood that the unknown quantity falls within a given range of values (Frey, 1997). Although the BSE model evaluates the impact of how comparison of various uncertainty sources influences the model predication, there 9-2 Section 9 — Identification and Characterization of Variability, Uncertainty, Critical Assumptions, and Data Gaps is no distinction between variability and uncertainty in the model inputs or outputs. In typical practice, in an exposure or risk assessment model, the model inputs can be divided into those that are variable, those that are uncertain, and those with some aspects of each (Bogen and Spear, 1987; IAEA, 1989; Morgan and Henrion, 1990; Finkel, 1990; Frey, 1992). For example, in the BSE model, maternal BSE transmission rate is variable across different mothers, but it is also uncertain because there is no knowledge regarding its true value. It is not possible to determine whether there are variables that are misspecified as uncertain that instead should have been arranged distribution for variability because there is not enough description of the characteristics of most of the input variables. Therefore, based upon the information presented in the model documentation, it is not possible to determine which inputs should be arranged distributions for variability and/or uncertainty. Variability and uncertainty have different ramifications for decisionmakers (Cullen and Frey, 1999). Uncertainty forces decisionmakers to judge how probable it is that risks will be overestimated or underestimated for every member of the exposed population, whereas variability forces them to cope with the certainty that different individuals will be subjected to risks both above and below any reference point one chooses (NRC, 1994). Therefore, it is recommended that both sources of variability and uncertainty be identified and distinguished and that variability and uncertainty analysis be done in the BSE risk assessment model. 4) In Section 2, at the beginning of Page 26, the authors state the uncertainty in ascertaining the potential risk posed by oral exposure to Chronic Wasting Disease (CWD): Ascertaining the potential risk posed by oral exposure to CWD is further complicated by the following sources of uncertainty. First, there are no accurate statistics documenting the number or type of deer and elk killed by hunters. Second, the type of deer and elk that can be hunted in different geographic areas varies. Third, the disposition of deer and elk remains after slaughter is uncertain. Finally, the prevalence of the disease in all but the highest risk areas is unknown. The authors have found no data for key sources of uncertainty. 9-3 Review of the Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States — Final Report 5) On Page 55 at the end of the first paragraph, the authors state, "Our base case assumes that clinical BSE cases would be detected at AM inspection 90 percent of the time. Because this value is highly uncertain, our uncertainty analysis evaluates the impact of using a wide range of values on the results of our simulation (see Section 3.2.2)." However, it was found that only two values were evaluated. 6) Table 2.18-1 (Appendix 1, Page 31) specifies joint probability as a percentage but Table 2.2.2.3 (Appendix 2, Page 8) specifies it as a probability. (Also, the reviewers wonder if the decimal point is in the correct place.) Consistency among the units or measures of the probability would be nice. 7) The authors have done a sensitivity analysis where they altered the parameter values one at a time to determine the effect on the model’s predictions, varied values defining the source of infectivity to determine the effect on the model’s predictions, and compared the model’s prediction for other scenarios. These are all important means to determine the model’s behavior and reliability. The sources of variability are largely only considered individually, so synergistic effects cannot be assessed. The authors have been careful to select "reasonable" values for the best and worst cases, but allowing a greater range of variability would provide a better understanding of the behavior of the model and its stability. 8) Key sources of variability that have been omitted are accidents that can sometimes happen and the intentional introduction of prions to feed or water; and a long-term change in practices by producers, processing establishments, and/or renderers that might result in prolonged exposure. Because of these omissions, one may wonder whether a more parsimonious model might be as predictive. 9) In the case of variability and uncertainty, the risk of infection through imported animals is addressed in a defensible manner, even though the probability of this incursion is not estimated. However, the age at infection ignores the information and the uncertainty of the incubation period and is not addressed. The summary of these aspects, perhaps somewhat harshly, is that the synthesis and critical review of the literature needs more attention. 9-4 Section 9 — Identification and Characterization of Variability, Uncertainty, Critical Assumptions, and Data Gaps 10) Little information regarding the distributions of BSE model inputs and simulation techniques was provided for the so-called "uncertainty analysis." Therefore, key questions that should be addressed include the following: (1) How was the value of an input altered? (2) What sampling techniques were used? It is necessary to clearly list the distribution assumptions and parameters (if used) and to clearly describe related simulation techniques when doing uncertainty analysis. The description in the report regarding the "uncertainty analysis" of the BSE model is not clear enough for users or reviewers to understand how the "uncertainty analysis" (if any) is done. 9.2 CRITICAL ASSUMPTIONS 1) Surveillance efficiency, recognition rate of "clinical cases," and level of inactivation by local rendering are overestimated. Also, with respect to recognition rate (where only the very typical cases will be recognized), it is assumed that 90 percent (in the case of worst case, 50 percent) of the BSE clinical cases will be detected in the ante-mortem inspection, which is way off from the general feeling in the EU on this topic. 2) In discussing fracContaminate on Page 16, Appendix 1, the authors state that flushing and cleaning leave only 0.1 percent of the prohibited material behind. This cross-contamination as compared to European demonstrated rates is grossly underestimated, unless flushing and cleaning are done in a very different (and probably uneconomical) way. 3) The readability of the report could be improved by tabulating all assumptions, as was done for the slaughter process assumptions (Table 3-8, Page 68) and the render and feed production assumptions (Table 3-9, Page 69). On Page 67 (second paragraph, first line), the authors refer to 15 sets of assumptions, but present only seven bullets (does a bullet represent a set?). If each item within a bullet is summed, 17 assumptions can be identified. Also, the authors set parameters to three values: base case, best case, and worst case. But the justification for the specific values assigned is weak, because little data are available. Without hard data, the detailed list of assumptions for this process has heuristic 9-5 Review of the Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States — Final Report value but does not particularly strengthen the predictive value of the model. 4) The authors assume that "conditions affecting the spread of BSE in the U.S. would remain unchanged for the 20 years following its introduction" (Executive summary, Page i, third paragraph, sixth line). This is a huge assumption and probably unrealistic. As with most agents of disease, especially newly discovered agents (emerging diseases), prevalence increases over time largely because of more and improved testing over time. This has not been incorporated into the model. Often, agents, once thought rare, are found to be ubiquitous (e.g., E. coli O157:H7). The public health goal then is to prevent the agents from spreading or accumulating in critical locations, including animals, during critical periods of time. 9.3 IMPORTANT DATA GAPS 1) The authors state, "There exist considerable data gaps for many important model assumptions" (Page 87). The authors have done a commendable job of incorporating the available data, but this also has limited the scope of the model and/or has resulted in giving certain factors more weight (a larger contribution to the results) than perhaps is warranted. 2) On Pages 22 and 23 the introduction risks are discussed. The import of risk material from the UK is assessed properly, but the import of risk material from third countries seems largely ignored. The EU concluded long ago that lots of risk material from the UK was transported via third countries. Switzerland, for example, mainly got infected via France not directly from the UK. Thus, the introduction risk is probably underestimated, although it is plausible that this risk still remains very low. 3) An analysis of all imported MBM and feed in the 1980s would be welcomed. Confirming evidence that imported MBM was only used in pet food would also be useful. 4) "Tallow" at least deserves some more comments (Page 34), given the fact that traces of protein are certainly in there and that international flow of these products is even more difficult to quantify. 9-6 ... snip... full text 132 pages of what USDA DID NOT TELL YOU AND DID NOT WANT YOU TO KNOW; SUPPRESSED PEER REVIEW OF HARVARD STUDY OCTOBER 31, 2002 http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf a February 2005 MAD COW DISEASE FDA’s Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness GAO-05-101 What GAO Found United States Government Accountability Office Why GAO Did This Study Highlights Accountability Integrity Reliability www.gao.gov/cgi-bin/getrpt?GAO-05-101. To view the full product, including the scope and methodology, click on the link above. For more information, contact Robert A. Robinson at (202) 512-3841 or robinsonr@gao.gov. Highlights of GAO-05-101, a report to congressional requesters February 2005 MAD COW DISEASE FDA’s Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness FDA has made needed improvements to its management and oversight of the feed-ban rule in response to GAO’s 2002 report, but program weaknesses continue to limit the effectiveness of the ban and place U.S. cattle at risk of spreading BSE. Improvements made include FDA establishing a uniform method of conducting compliance inspections and training FDA inspectors, as well as state inspectors who carry out inspections under agreements with FDA, on the new method. FDA also implemented new data-entry procedures that are designed to more reliably track feed-ban inspection results. Consequently, FDA has a better management tool for overseeing compliance with the feed-ban rule and a data system that better conforms to standard database management practices. However, various program weaknesses continue to undermine the nation’s firewall against BSE. For example: • FDA acknowledges that there are more feed manufacturers and transporters, on-farm mixers, and other feed industry businesses that are subject to the feed ban than the approximately 14,800 firms inspected to date; however, it has no uniform approach for identifying additional firms. • FDA has not reinspected approximately 2,800, or about 19 percent, of those businesses, in 5 or more years; several hundred are potentially high risk. FDA does not know whether those businesses now use prohibited material in their feed. • FDA’s feed-ban inspection guidance does not include instructions to routinely sample cattle feed to test for potentially prohibited material as part of the compliance inspection. Instead, it includes guidance for inspectors to visually examine facilities and equipment and review invoices and other documents. • Feed intended for export is not required to carry a caution label "Do not feed to cattle or other ruminants," when the label would be required if the feed were sold domestically. Without that statement, feed containing prohibited material could be inadvertently or intentionally diverted back to U.S. cattle or given to foreign cattle. • FDA has not always alerted USDA and states when it learned that cattle may have been given feed that contained prohibited material. This lapse has been occurring even though FDA’s guidance calls for such communication. • Although research suggests that cattle can get BSE from ingesting even a small amount of infected material, inspectors do not routinely inspect or review cleanout procedures for vehicles used to haul cattle feed. More than 5 million cattle across Europe have been killed to stop the spread of bovine spongiform encephalopathy (BSE), commonly called mad cow disease. Found in 26 countries, including Canada and the United States, BSE is believed to spread through animal feed that contains protein from BSE-infected animals. Consuming meat from infected cattle has also been linked to the deaths of about 150 people worldwide. In 1997, the Food and Drug Administration (FDA) issued a feed-ban rule prohibiting certain animal protein (prohibited material) in feed for cattle and other ruminant animals. FDA and 38 states inspect firms in the feed industry to enforce this critical firewall against BSE. In 2002, GAO reported a number of weaknesses in FDA’s enforcement of the feed ban and recommended corrective actions. This report looks at FDA’s efforts since 2002 to ensure industry compliance with the feed ban and protect U.S. cattle. What GAO Recommends GAO recommends FDA, among other things, develop procedures for finding additional firms subject to the feed-ban and using tests to augment inspections. FDA said the study was thorough but disagreed on four of nine recommendations. GAO continues to believe that, given the discovery of BSE in North America and the oversight gaps described in the report, the recommended actions are needed to protect U.S. cattle from BSE. snip...full text ; http://www.gao.gov/new.items/d05101.pdf What GAO Found May 17, 2005 Steps Should Be Taken to Reduce USDA and FDA have primary responsibility for overseeing the safety of the GAO has issued many reports OIG same old song and dance until 2008 ; Safety and Security: Increasingly we have all come to realize that the world presents greater threats to our well being as individuals and a citizenry in terms of health and resources. Challenges such as those related to maintaining a safe food supply and protecting America’s plants and animals from invasive pests are critical. Thus, we have established as a strategic goal "Support USDA in the enhancement of safety and security measures to protect USDA and agricultural resources and in related public health concerns." ... http://www.usda.gov/oig/webdocs/rptstrategicplan.pdf THE TEXAS GONZALES/PURINA INCIDENT SHOWED THAT 5.5 GRAMS OF FOR IMMEDIATE RELEASE FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT Today the Food and Drug Administration announced the results of tests 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 According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Despite this negligible risk, Purina Mills, Inc., is nonetheless FDA believes that Purina Mills has behaved responsibly by first This episode indicates that the multi-layered safeguard system put into FDA will continue working with USDA as well as State and local officials http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram Risk of oral infection with bovine spongiform encephalopathy agent in primates Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys Published online January 27, 2005 http://www.thelancet.com/journal/journal.isa Neurobiology * Commissariat à l'Energie Atomique, Service de Neurovirologie, Direction des Sciences du Vivant/Département de Recherche Medicale, Centre de Recherches du Service de Santé des Armées 60-68, Avenue du Général Leclerc, BP 6, 92 265 Fontenay-aux-Roses Cedex, France; Hôpital Neurologique Pierre Wertheimer, 59, Boulevard Pinel, 69003 Lyon, France; § Laboratoire de Neuropathologie, Hôpital de la Salpêtrière, 83, Boulevard de l'Hôpital, 75013 Paris, France; ¶ Creutzfeldt-Jakob Disease Surveillance Unit, Western General Hospital, Crewe Road, Edinburgh EH4 2XU, United Kingdom; and Institute for Animal Health, Neuropathogenesis Unit, West Mains Road, Edinburgh EH9 3JF, United Kingdom Edited by D. Carleton Gajdusek, Centre National de la Recherche Scientifique, Gif-sur-Yvette, France, and approved December 7, 2000 (received for review October 16, 2000) There is substantial scientific evidence to support the notion that bovine spongiform encephalopathy (BSE) has contaminated human beings, causing variant Creutzfeldt-Jakob disease (vCJD). This disease has raised concerns about the possibility of an iatrogenic secondary transmission to humans, because the biological properties of the primate-adapted BSE agent are unknown. We show that (i) BSE can be transmitted from primate to primate by intravenous route in 25 months, and (ii) an iatrogenic transmission of vCJD to humans could be readily recognized pathologically, whether it occurs by the central or peripheral route. Strain typing in mice demonstrates that the BSE agent adapts to macaques in the same way as it does to humans and confirms that the BSE agent is responsible for vCJD not only in the United Kingdom but also in France. The agent responsible for French iatrogenic growth hormone-linked CJD taken as a control is very different from vCJD but is similar to that found in one case of sporadic CJD and one sheep scrapie isolate. These data will be key in identifying the origin of human cases of prion disease, including accidental vCJD transmission, and could provide bases for vCJD risk assessment. Conclusions From BSE and vCJD transmissions in nonhuman primates, a number of conclusions can be drawn that are of major importance for human health: (i) human-adapted BSE appears to be a variant of the BSE agent that is more virulent for humans than cattle BSE and is efficiently transmitted by the peripheral route; (ii) the detection of vCJD in unusually young patients is probably not because of a lack of diagnosis of cases in older patients, thus raising the question of the source of human contamination with BSE early in life; and (iii) iatrogenic transmissions from patients with vCJD would be readily recognized by using the same diagnostic criteria as those applied to vCJD [clinical and pathological criteria (27) comprising neuronal loss and gliosis in the thalamus correlated with high MRI signal (28, 29)], whether such contaminations had occurred by the central or i.v. route. Primary and iatrogenic cases of vCJD could be distinguished on the basis of the patient's clinical history. The risk assessment of biological products of human origin, notably those derived from blood, has been deeply modified by the appearance of vCJD. We confirm that the BSE agent has contaminated humans not only in the U.K. and the Republic of Ireland but also in France, and we show that its pathogenic properties for primates are being enhanced by a primary passage in humans. Considering the flow of potentially contaminated bovine-derived products between 1980 and 1996, it is obvious that further vCJD cases may occur outside the U.K. Thus, and in the light of the present study, it is necessary to sustain worldwide CJD surveillance regardless of national BSE incidence and to take all precautionary measures to avoid iatrogenic transmissions from vCJD. http://www.pnas.org/cgi/content/full/041490898v1 ANOTHER ONE OF FDAs infamous UNTITLED DOCUMENTS TSEs; Tissue distribution of bovine spongiform encephalopathy agent in primates after intravenous or oral infection C Herzog, N Saks, N Etchegaray, A Charbonnier, S Freire, D Dormont, J-P Deslys, C I Lasmezas http://www.fda.gov/ohrms/dockets/dockets/04n0081/04n-0081-bkg0001-Tab-02-vol2.pdf BASE in cattle in Italy of Identification of a Creutzfeldt-Jakob disease Adaptation of the bovine spongiform encephalopathy agent to primates 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 Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC. Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation. PMID: 6997404 greetings, BLATANT enhancement of lies, deceit, secrecy and cover-up ? SADLY, we can expect more of the same through 2008. ... HOW many times are they allowed to change protocols every time they get caught before OIG calls it for what it 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 TSS
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