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From: TSS ()
Release No. 0362.06 Animal identification has been another one of my priorities, and we are making progress. We now have more than 300,000 premises registered. States and organizations are just doing a great job getting it underway, and we're working to get systems in place for animal identification. We're approving private and state animal tracking databases for producers. We're approving identification devices such as ear tags for cattle. But I've heard concerns about the confidentiality of the data, and so if I could I'd like to address that. Identification of animals in the system is a critical tool in safeguarding the health of agricultural animals from disease. When it comes to an outbreak, time is money. The ID system enables health officials to stop the spread of the disease and lessen the economic and other social impacts. Everyone in this room understands the consequences of an outbreak-- the loss of breeding stock and labor and time and animal pain and suffering and money. Quick identification of infected animals means less exposure. The faster we can assure our consumers and trading partners that our animals are healthy, well it is critical. Premises registration is our top priority. Without this foundation, the system would not work. And it's this kind of competitive system that we're trying to achieve. Those who have expressed concern that the system is bureaucratic and administrative should note the strong private sector involvement. From the time I held the first conference on animal ID, as governor of Nebraska, I felt I had two clear opinions I was working with. The best of those is voluntary, and the system should be driven by the private sector. I firmly believed then and continue to believe today that the best innovation, the best price competition, the best opportunity for producers is the voluntary system that is in the private sector. I understand that the disclosure of information affects a producer's ability to bargain for a best price. As someone born and raised on a dairy farm in Iowa, I can tell you we are going to do all we can to protect the confidentiality of this information. That's why I've directed our Animal and Plant Health Inspection Service to create an animal ID system that will hold the information about animal movements in the private sector or state databases. Animal movement information registered in a private animal tracking database is private. They're not USDA records. USDA doesn't own the data, and therefore we have no control over it. With that, let me wrap up by saying it's a fascinating time to be in agriculture, an exhilarating time to be Secretary of Agriculture. .....snip......end; http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/3/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2006%2F09%2F0362.xml&PC_7_2_5JM_parentnav=TRANSCRIPTS_SPEECHES&PC_7_2_5JM_navid=TRANSCRIPT#7_2_5JM HOW NOT TO FIND BSE TSE ANIMALS AND THERE COHORTS IN THE USA 2006 As part of its ongoing efforts to safeguard U.S. animal health, USDA initiated the implementation of the National Animal Identification System (NAIS) in 2004. NAIS is a cooperative State-Federal-industry partnership to standardize and expand animal identification programs and practices to all livestock species and poultry. NAIS is being developed through the integration of three components—premises identification, animal identification, and animal tracking. The long-term goal of the NAIS is to provide animal health officials with the capability to identify all livestock and premises that have had direct contact with a disease of concern within 48 hours after discovery. NAIS is currently a voluntary program. To ensure the participation requirements of NAIS not only provide the results necessary to maintain the health of the national herd but also is a program that is practical for producers and all others involved in production, USDA has adopted a phased-in approach to implementation. Although the draft strategic plan references mandatory requirements in 2008 and beyond, to date no actions have been initiated by USDA to develop regulations to require participation in NAIS. APHIS will publish updates to the implementation plan as recommendations are received and evaluated by the NAIS Subcommittee and the Secretary's Advisory Committee on Foreign Animal and Poultry Diseases. http://animalid.aphis.usda.gov/nais/index.shtml ANIMAL IDENTIFICATION AND REGISTRATION 1994 UK http://www.bseinquiry.gov.uk/files/yb/1994/02/09002001.pdf O.I.G. ON B.S.E. U.S.A. 2006 Executive Summary Animal and Plant Health Inspection Service - Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II and Food Safety and Inspection Service - Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III Results in Brief This report evaluates elements of the interlocking safeguards in place to protect United States (U.S.) beef from Bovine Spongiform Encephalopathy, widely known as BSE or "mad cow disease." Since 1990, the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), has led a multi-agency effort to monitor and prevent BSE from entering the food supply. After discovering a BSE-positive cow in December 2003, APHIS expanded its BSE surveillance program. To further protect the food supply, USDA banned materials identified as being at risk of carrying BSE (specified risk materials (SRM)), such as central nervous system tissue. As part of this effort, USDA’s Food Safety and Inspection Service (FSIS) required beef slaughter and processing facilities to incorporate controls for handling such materials into their operational plans. Onsite FSIS inspectors also inspect cattle for clinical signs in order to prevent diseased animals from being slaughtered for human consumption. To evaluate the effectiveness of the safeguards, we assessed APHIS’ implementation of the expanded surveillance program, as well as FSIS’ controls to prevent banned SRMs from entering the food supply. In June 2004, APHIS implemented its expanded surveillance program; participation by industry in this surveillance program is voluntary. As of May 2005, over 350,000 animals were sampled and tested for BSE. To date, two animals tested positive for BSE; one tested positive after implementation of the expanded surveillance program. USDA made significant efforts to implement the expanded BSE surveillance program. Much needed to be done in a short period of time to establish the necessary processes, controls, infrastructure, and networks to assist in this effort. In addition, extensive outreach and coordination was undertaken with other Federal, State, and local entities, private industry, and laboratory and veterinary networks. This report provides an assessment as to the progress USDA made in expanding its surveillance effort and the effectiveness of its controls and processes. This report also discusses the limitations of its program and data in assessing the prevalence of BSE in the U.S. herd. Surveillance Goals and Objectives In March 2004, USDA published its plan to expand the BSE surveillance program. The plan’s goal was to collect samples from as many adult1 cattle from the high-risk population as possible in 12-18 months while ensuring that there was statistically appropriate geographical representation of the adult cattle population in the United States. Overall, USDA designed the program to define whether BSE was actually present in the U.S. cattle population and if so, to what level. When USDA published its plan, Office of Inspector General (OIG) was examining the pre-expansion program. In anticipation of the coming changes, we reviewed the plan in order to determine if its design would allow the Department to reach statistically valid conclusions about the presence and level of BSE. Since the implementation plan had not been finalized, we provided recommendations for USDA to consider as they moved forward with implementing an expanded surveillance program. In August 2004, we released our report, Animal and Plant Health Inspection Service and Food Safety and Inspection Service, Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase I (Report No. 50601-9-KC), which discussed our observations of the challenges USDA faced in meeting its stated goals and made 19 recommendations for USDA to consider as it moved forward with implementation. Our prior report primarily focused on (1) the potential for unwarranted statistical conclusions to be drawn from the data USDA planned to collect, and (2) the challenges in identifying and testing high-risk cattle. In response to our report, APHIS agreed to disclose the limitations of the data and the assumptions made and its impact on any statistical representations regarding the prevalence of BSE in order to obviate misinterpretation. We reviewed the specific corrective actions APHIS and FSIS agreed to take in response to prior audit recommendations during this audit. In this report, we discuss the specific areas where corrective actions were not fully effective in addressing our concerns in the following areas: obtaining representative samples, identifying and obtaining samples from the high-risk surveillance streams, and completeness and accuracy of program data. APHIS has provided OIG unpublished drafts of its preliminary analysis, which included various statistical approaches to determining the prevalence of BSE. In general, each approach mitigates some, but not all of the limitations associated with its data and underlying assumptions in the design and implementation of its surveillance program. Some of the approaches also 1 FSIS considers bulls and cows to be mature cattle with cows ordinarily having given birth to one or more calves. FSIS defines SRMs to be present in cattle 30 months of age or older, while APHIS defines its target population for BSE sampling to be over 30 months of age. Dentition is used to estimate the age ranges of cattle. Dentition is the development of teeth and their arrangement in the mouth. USDA/OIG-A/50601-10-KC/ Page iii introduce new challenges because any conclusions are extremely sensitive to the accuracy of the underlying data. The accuracy of the underlying data is also critical to the development of a future maintenance surveillance program. We cannot fully assess any of the approaches being considered by APHIS since it has not finalized its analysis. In Finding 1, however, we do offer several observations for APHIS to consider as it develops its conclusions about the prevalence of BSE in the U.S. cattle population. Inherent Limitations in Identifying and Testing High-Risk Cattle APHIS obtained significantly more samples for testing than they originally anticipated would be needed to achieve its stated level of confidence in estimating the prevalence of BSE in the U.S. herd. Because of the voluntary nature of its program, however, we could not determine how successful APHIS was in obtaining a representative proportion of high-risk cattle for testing. Our prior report recognized the significant challenges for APHIS to obtain samples from the high-risk population because of the inherent problems with obtaining voluntary compliance and transporting carcasses for testing. APHIS took steps to obtain facilitated pathways, by entering into over 100 agreements, to collect and test brain samples for BSE. However, using USDA published data that estimates the distribution of the cattle population, as well as those that died or became nonambulatory, we could not determine whether APHIS achieved either geographical representation or representation of the desired surveillance stream (clinical suspects, fallen stock, casualty slaughter fallen stock, and routine slaughter). Findings 1 and 2 present the conditions noted that impact this evaluation. USDA Testing Protocols and Quality Assurance Procedures In November 2004, USDA announced that its rapid screening test produced an inconclusive BSE test result. A contract laboratory ran its rapid screening test on a brain sample collected for testing and produced three high positive reactive results. As required, the contract laboratory forwarded the inconclusive sample to APHIS’ National Veterinary Services Laboratories (NVSL) for confirmation. NVSL repeated the rapid screening test, which again produced three high positive reactive results. Following established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE. Faced with conflicting results between the rapid screening and IHC tests, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded that no further testing was necessary since testing protocols were followed and the confirmatory test was negative. In our discussions with APHIS officials, they justified their decision to not do additional testing because the IHC test is internationally recognized as the "gold standard" of testing. Also, they believed that USDA/OIG-A/50601-10-KC/ Page iv conducting additional tests would undermine confidence in USDA’s testing protocols. OIG obtained evidence that indicated additional testing was prudent. We came to this conclusion because the rapid screening tests produced six high positive reactive results, the IHC tests conflicted, and various standard operating procedures were not followed. Also, our review of the relevant scientific literature, other countries’ protocols, and discussions with experts led us to conclude that additional confirmatory testing should be considered in the event of conflicting test results. To maintain objectivity and independence, we requested that USDA’s Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) immunoblot test. The additional testing produced positive results. To confirm, the Secretary of Agriculture requested that an internationally recognized BSE laboratory in Weybridge, England (Weybridge) perform additional testing. Weybridge conducted various tests, including their own IHC tests and three Western blot tests. The tests confirmed that the cow was infected with BSE. The Secretary immediately directed USDA scientists to work with international experts to develop new protocols that include performing dual confirmatory tests in the event of an inconclusive BSE screening test. We attribute the failure to identify the BSE positive sample to rigid protocols, as well as the lack of adequate quality assurance controls over its testing program. Details of our concerns are discussed in Findings 3 and 4. Controls (Firewalls) to Prevent BSE in the Food Supply USDA instituted proactive procedures to prevent tissues and products that could possibly contain the infective agent for BSE from entering the food supply. FSIS performs inspections on cattle before slaughter (ante mortem) to observe clinical signs that may indicate a central nervous system disorder or other signs that may be associated with BSE. Such animals are condemned and prohibited from slaughter for human consumption. FSIS also identified high-risk beef tissue and products as SRMs, and banned them from the food supply. FSIS inspects slaughter processes to verify that slaughterhouses have incorporated controls for handling SRMs into their operational plans; adequate procedures must be in place for removing, segregating, and disposing of SRMs. OIG reviewed the SRM plans of several establishments, observed FSIS inspection procedures, and evaluated the effectiveness of controls during the slaughter process. We did not identify SRMs entering the food supply. However, due to the lack of adequate records, we could not determine whether SRM procedures were followed and/or were adequate in 9 of 2 For purposes of this report, the term renderers also includes pet food manufacturers and plants that handle dead, dying, disabled, or diseased livestock. 3 9 CFR 320.5, states that every person that engages in business in or for commerce, as a meat broker, renderer, or animal food manufacturer … shall register with the Administrator [of FSIS]. 12 establishments visited during the audit. There is no requirement in the United States for the age of animals to be recorded, therefore, APHIS and FSIS rely on meat establishments to determine the age of cattle slaughtered using documentation or dentition. SRM restrictions apply predominantly to cattle 30 months of age or older. FSIS periodically checks the accuracy of age determinations through dentition; however, we could not determine how often these checks are made. We found that improvements can be made in the following areas. • Several of the establishments did not comply with their SRM plans and/or maintain records to support that they follow their plans. FSIS has addressed the specific cases of noncompliance identified during the audit. Findings 5 through 9 discuss our assessment of the effectiveness of USDA’s firewalls. Other Program Administration Issues FSIS and APHIS did not maintain current and comprehensive listings of renderers2 and related businesses. These entities are required to register with FSIS as a condition of engaging in business.3 As a result, should serious animal diseases be detected in the United States, USDA’s ability to quickly determine and trace the source of infections to prevent the spread of the disease could be impaired. Also, APHIS could not use the registrations to identify potential sources to mitigate geographical gaps in BSE testing. We discuss the details of this issue in Finding 11. We also determined that an APHIS area office paid costs for sampling and carcass transportation, storage, and disposal that exceeded national cost recovery guidelines and/or that were ineligible for reimbursement. The area office entered into 10 reimbursable agreements before national office cost recovery guidelines had been issued but did not adjust the agreements afterwards although instructed to do so by the national office. Instead, the area office included the questionable costs in amounts proposed (by USDA/OIG-A/50601-10-KC/ Page vi third parties) in other allowable cost categories. The area office official stated he changed supporting records because he believed he should honor the prior negotiated costs. As a result, at least $1.2 million of about $11.2 million paid were unsupported program costs. Finding 12 more fully examines the unsupported costs and why they went undiscovered. The expanded stage of USDA’s BSE surveillance program is nearing its end. Accordingly, it is vital that the conditions summarized above be considered as USDA uses the data gathered to design an effective BSE surveillance maintenance program and to report its assessment of the prevalence of BSE in the U.S. herd. In particular, APHIS must develop testing protocols which are grounded in science and flexible enough to adapt to changing circumstances. For its part, FSIS must ensure that it effectively monitors SRM handling practices to ensure they comply with Federal regulations. Implemented, these management controls will help USDA continue to effectively safeguard the U.S. beef supply for consumers. Recommendations • Perform additional outreach to emphasize the age of the target animals and to ensure laboratory personnel understand procedures for submitting the desired samples; and followup with laboratories that appear to be providing an insufficient number of samples. • Verify compliance with its SRM control procedures through its Performance Based Inspection System, which should also be modified to allow for timely analysis of violation trends and tracking corrective action. • Determine whether FSIS and/or APHIS need additional authorities to perform inspection and BSE sampling activities in pre-screening areas immediately adjacent, or contiguous to, official slaughter establishments. SNIP...FULL TEXT 130 PAGES ; http://www.usda.gov/oig/webdocs/50601-10-KC.pdf March 30, 2006 - Senate Passes Animal ID Bill (BSE) Today, the Alabama State Senate passed HB 254 with a vote of 20-6. This bill will provide for the confidentiality of information initially gathered by the Alabama Department of Agriculture and Industries as the department implements and maintains a database for Animal Identification in accord and consistent with the United States Department of Agriculture's National Animal Identification System. Premises ID Registration has been implemented in the last year and Animal ID Registration is not far behind. The information on premises and animals, gathered at the request of Commissioner Sparks, is to protect the interest of public health, safety, and welfare. As of today, 14 locations and 44 movements of cattle have been examined with 39 of those being substantially completed. Additional investigations of locations and herds will continue. This process is to eliminate herds from the ongoing investigation. A flow chart showing how the traceback process is progressing has been posted on the Alabama Department of Agriculture & Industries website www.agi.alabama.gov. As the chart illustrates, the investigation has broadened to include many farms and stockyards. The farms are where the index cow may have lived previously or where her immediate family members may have lived. The stockyards are places where investigators have reviewed records of transactions and conducted interviews. Each link is being thoroughly examined and then, based on the information collected the link will either continue on to another location or be closed. Federal and state officials have stressed that it may not be possible to trace the index cow to her herd of origin due to the primitive traceback methods being used in the investigation. Eventually, leads in the case may be exhausted despite their best efforts. The next update from ADAI will be sent Monday, April 3rd. March 30, 2006 snip...full text; i dont believe them. you can do test on the teeth to determine how old they are, better than detention. where is the head??? show me the data, this is what others should be asking. ... TSS THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ; CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006 The U.S. Department of Agriculture was quick to assure the public earlier The second case, which was detected last year in a Texas cow and which USDA These two cases (the latest was detected in an Alabama cow) present a "The fact the Texas cow showed up fairly clearly implied the existence of Brown, who is preparing a scientific paper based on the latest two mad cow USDA officials finally retested the cow and confirmed it was infected seven "Everything they did on the Texas cow makes everything USDA did before 2005 CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ... Possible contamination of dairy feeds with ruminant derived meat and bone meal. Possible contamination of animal feed ingredients, including ingredients The feed was manufactured from materials that may have been contaminated Animal and fish feeds which were possibly contaminated with ruminant based [GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has [2] [GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.88&filename=d05101.txt&directory=/diskb/wais/data/gao THE SEVEN SCIENTIST REPORT *** Marie A. Vodicka, PhD Assistant Vice President Biologics & Blotechnology Scientlflc & Regulatory Affairs SCIENCE & REG AFFAIRS Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rrn . 1061 Rackville, MD 20862 No. 2002N-0273 February 14, 2006 Dear Sir or Madam : The Pharmaceutical Research and Manufacturers of America (PhRMA) is comment to the proposed rules issued. ...... Johanns et al at the USDA are the very reason that animal TSEs are rampant in the USA, and give it time, so will human TSE. ...TSS
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