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NCBA, R-CALF, COOL, USDA (No Politics!)
CANADA FINDS ANOTHER 'SUSPECT' BSE CASE ...USA ???
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<blockquote data-quote="flounder" data-source="post: 241487" data-attributes="member: 3519"><p>Subject: CANADA FINDS ANOTHER 'SUSPECT' BSE CASE while USA is simply not looking to find (as of July 10, 2006 - 13:00 EST)</p><p>Date: July 10, 2006 at 11:07 am PST </p><p></p><p>Latest Information (as of July 10, 2006 - 13:00 EST)</p><p>The Canadian Food Inspection Agency (CFIA) is currently conducting confirmatory testing at the National Reference Laboratory in Winnipeg of samples from a cow from Alberta suspected of having bovine spongiform encephalopathy (BSE). Preliminary screening tests were not able to rule out BSE. Therefore, consistent with established CFIA protocol, additional analysis is underway.</p><p>The animal, reported to be a 50-month old dairy cow, died and was retained on farm. No part of the carcass entered the human food or animal feed systems, and the entire carcass has been placed under control.</p><p>The CFIA has launched an investigation to collect additional information about the affected animal. In addition, the CFIA will identify other animals of equivalent risk, namely cattle born on the same farm within 12 months before and after the affected animal. Any live animals found from this group will be segregated and tested. </p><p>As testing and the investigation progress, the CFIA will provide Canadians and trading partners with regular updates. Information will be posted to the CFIA's Website as it becomes available. </p><p></p><p></p><p><a href="http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/situatione.shtml" target="_blank">http://www.inspection.gc.ca/english/ani ... ione.shtml</a> </p><p></p><p></p><p></p><p>no wonder USA is not documenting any young cattle yet with mad cow disease,</p><p>hell, its a miracle USDA et al have documented any mad cow at all at this</p><p>rate ; </p><p></p><p></p><p>Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle</p><p>Still Remain Our prior report identified a number of inherent problems in</p><p>identifying and testing high-risk cattle. We reported that the challenges in</p><p>identifying the universe of high-risk cattle, as well as the need to design</p><p>procedures to obtain an appropriate representation of samples, was critical</p><p>to the success of the BSE surveillance program. The surveillance program was</p><p>designed to target nonambulatory cattle, cattle showing signs of CNS disease</p><p>(including cattle testing negative for rabies), cattle showing signs not</p><p>inconsistent with BSE, and dead cattle. Although APHIS designed procedures</p><p>to ensure FSIS condemned cattle were sampled and made a concerted effort for</p><p>outreach to obtain targeted samples, industry practices not considered in</p><p>the design of the surveillance program reduced assurance that targeted</p><p>animals were tested for BSE. In our prior report, we recommended that APHIS</p><p>work with public health and State diagnostic laboratories to develop and</p><p>test rabies-negative samples for BSE. This target group is important for</p><p>determining the prevalence of BSE in the United States because rabies cases</p><p>exhibit clinical signs not inconsistent with BSE; a negative rabies test</p><p>means the cause of the clinical signs has not been diagnosed. Rabies</p><p>Negative Samples APHIS agreed with our recommendation and initiated an</p><p>outreach program with the American Association of Veterinary Laboratory</p><p>Diagnosticians, as well as State laboratories. APHIS also agreed to do</p><p>ongoing monitoring to ensure samples were obtained from this target</p><p>population. Although APHIS increased the samples tested from this target</p><p>group as compared to prior years, we found that conflicting APHIS</p><p>instructions on the ages of cattle to test resulted in inconsistencies in</p><p>what samples were submitted for BSE testing. Therefore, some laboratories</p><p>did not refer their rabies negative samples to APHIS in order to maximize</p><p>the number tested for this critical target population. In addition, APHIS</p><p>did not monitor the number of submissions of rabies negative samples for BSE</p><p>testing from specific laboratories. According to the Procedure Manual for</p><p>BSE Surveillance, dated October 2004, the target population includes:</p><p>Central nervous system (CNS) signs and/or rabies negative - sample animals</p><p>of any age (emphasis added): a. Diagnostic laboratories –samples submitted</p><p>due to evidence of CNS clinical signs.</p><p>USDA/OIG-A/50601-10-KC Page 19</p><p>USDA/OIG-A/50601-10-KC Page 20</p><p>b. Public health laboratories – rabies negative cases. c. Slaughter</p><p>facilities – CNS ante mortem condemned at slaughter, sampled by FSIS. d.</p><p>On-the-farm – CNS cattle that do not meet the criteria for a foreign animal</p><p>disease investigation. For FYs 2002, 2003, and 2004 (through February 2004),</p><p>NVSL received 170, 133, and 45 rabies-negative samples, respectively.</p><p>Between June 1, 2004, and May 29, 2005, the number of samples received for</p><p>testing increased to 226 rabies suspect samples. The collection sites</p><p>submitting these samples follow. Collection Site Number of Rabies Suspect</p><p>Submissions * Slaughter Plant 0 Renderer 2 On-Farm 11 Public Health Lab 94</p><p>Diagnostic Lab 81 3D-4D 8 Other 4 Total 200 * 26 were tested but not counted</p><p>by APHIS towards meeting the target goals because the obex was not</p><p>submitted. We obtained a copy of a memorandum, dated July 13, 2004, that</p><p>APHIS sent to diagnostic and public health laboratories providing them</p><p>instructions on submitting samples for cattle showing signs of CNS diseases,</p><p>but testing negative for rabies. The letter was sent to about 170 State</p><p>veterinary diagnostic and public health laboratories and discussed the need</p><p>to submit specimens to NVSL of all adult cattle (emphasis added) that showed</p><p>signs of CNS diseases, but tested negative for rabies. This directive did</p><p>not specify the age of the cattle. The Procedure Manual for BSE</p><p>Surveillance, dated October 2004, specified samples of cattle of any age</p><p>should be submitted. We contacted laboratories in six States to determine if</p><p>it was standard procedure to submit all negative rabies samples to NVSL. We</p><p>found that, because of the lack of specificity in the APHIS letter and</p><p>inadequate followup by APHIS, there were inconsistencies in the age of</p><p>cattle samples submitted for BSE testing. For those States contacted, the</p><p>following samples were submitted versus tested as negative for rabies.</p><p>USDA/OIG-A/50601-10-KC Page 21</p><p>Rabies Negative Tests Not Sent for BSE Testing Since June 1, 2004 State</p><p>Negative Rabies Tests Sent for BSE Testing Not Sent for BSE Testing</p><p>Pennsylvania a/ 33 15 18 Kansas b/ 85 69 16 Wisconsin c/ 12 1 11 South</p><p>Dakota d/ 7 0 7 Arizona e/ 5 5 0 Mississippi e/ 4 4 0 Total 146 94 52 a/ A</p><p>Pennsylvania laboratory official said only rabies negative cattle over 20</p><p>months of age were submitted for BSE testing. The laboratory did not submit</p><p>18 samples for BSE testing because the animals were less than 20 months of</p><p>age. b/ Kansas laboratory officials said early in the expanded surveillance</p><p>program, there was confusion as to the cattle ages that should be submitted</p><p>for BSE testing. They did not know if cattle should be submitted that were</p><p>above 20 months or 30 months of age. Of the 16 animals not submitted for BSE</p><p>testing, 14 were under 20 months of age from early in the expanded</p><p>surveillance program. The other two animals were not tested due to internal</p><p>laboratory issues. The Kansas and Nebraska area office officials contacted</p><p>the laboratory and told the officials to submit rabies negative cattle of</p><p>any age for BSE testing. The laboratory now submits all rabies negative</p><p>cattle for BSE testing. c/ A Wisconsin laboratory official said only rabies</p><p>negative cattle samples 30 months of age or older are submitted for BSE</p><p>testing. Of the 11 animals not submitted for BSE testing, 8 were less than</p><p>30 months of age. Wisconsin laboratory officials were not certain why the</p><p>other three samples were not submitted. d/ Laboratory officials from South</p><p>Dakota said they did not receive notification from APHIS regarding the</p><p>submission of rabies negative cases for BSE testing. The section supervisor</p><p>and laboratory director were not aware of any letter sent to the laboratory.</p><p>The section supervisor said most bovine rabies tests at the laboratory are</p><p>performed on calves. We confirmed the laboratory's address matched the</p><p>address on APHIS' letter distribution list. However, there was no evidence</p><p>that the South Dakota area office contacted the laboratory. The laboratory</p><p>was not listed on the documentation from the APHIS regional office detailing</p><p>the area office contacts with laboratory personnel. We contacted the South</p><p>Dakota area office and were advised that while some contact had been made</p><p>with the laboratory, the contact may have involved Brucellosis rather than</p><p>BSE. On May 4, 2005, the area office</p><p>advised us they recently contacted the laboratory regarding the submission</p><p>of rabies negative samples for BSE testing. e/ Arizona and Mississippi</p><p>laboratory officials said they submitted all rabies negative samples for BSE</p><p>testing regardless of the age of the animal. An NVSL official stated that</p><p>APHIS is not concerned with rabies negatives samples from cattle less than</p><p>30 months of age. This position, however, is contrary to APHIS' published</p><p>target population. Our prior audit recognized the significant challenge for</p><p>APHIS to obtain samples from some high-risk populations because of the</p><p>inherent problems with obtaining voluntary compliance and transporting the</p><p>carcasses for testing. USDA issued rules to prohibit nonambulatory animals</p><p>(downers) from entering the food supply at inspected slaughterhouses. OIG</p><p>recommended, and the International Review Subcommittee33 emphasized, that</p><p>USDA should take additional steps to assure that facilitated pathways exist</p><p>for dead and nonambulatory cattle to allow for the collection of samples and</p><p>proper disposal of carcasses. Between June 1, 2004, and May 31, 2005, the</p><p>APHIS database documents 27,617 samples were collected showing a reason for</p><p>submission of nonambulatory and 325,225 samples were collected with reason</p><p>of submission showing "dead." Downers and Cattle that Died on the Farm APHIS</p><p>made extensive outreach efforts to notify producers and private</p><p>veterinarians of the need to submit and have tested animals from these</p><p>target groups. They also entered into financial arrangements with 123</p><p>renderers and other collection sites to reimburse them for costs associated</p><p>with storing, transporting, and collecting samples. However, as shown in</p><p>exhibit F, APHIS was not always successful in establishing agreements with</p><p>non-slaughter collection sites in some States. APHIS stated that agreements</p><p>do not necessarily reflect the entire universe of collection sites and that</p><p>the presentation in exhibit F was incomplete because there were many</p><p>collection sites without a payment involved or without a formal agreement.</p><p>We note that over 90 percent of the samples collected were obtained from the</p><p>123 collection sites with agreements and; therefore, we believe agreements</p><p>offer the best source to increase targeted samples in underrepresented</p><p>areas. We found that APHIS did not consider industry practices in the design</p><p>of its surveillance effort to provide reasonable assurance that cattle</p><p>exhibiting possible clinical signs consistent with BSE were tested.</p><p>Slaughter facilities do not always accept all cattle arriving for slaughter</p><p>because of their business requirements. We found that, in one State visited,</p><p>slaughter facilities pre-screened and rejected cattle (sick/down/dead/others</p><p>not meeting business</p><p>USDA/OIG-A/50601-10-KC Page 22</p><p>33 Report from the Secretary's Advisory Committee on Foreign Animal and</p><p>Poultry Diseases, February 13, 2004.</p><p>USDA/OIG-A/50601-10-KC Page 23</p><p>standards) before presentation for slaughter in areas immediately adjacent</p><p>or contiguous to the official slaughter establishment. These animals were</p><p>not inspected and/or observed by either FSIS or APHIS officials located at</p><p>the slaughter facilities. FSIS procedures state that they have no authority</p><p>to inspect cattle not presented for slaughter. Further, APHIS officials</p><p>stated they did not believe that they had the authority to go into these</p><p>sorting and/or screening areas and require that the rejected animals be</p><p>provided to APHIS for BSE sampling. Neither APHIS nor FSIS had any process</p><p>to assure that animals left on transport vehicles and/or rejected for</p><p>slaughter arrived at a collection site for BSE testing. FSIS allows</p><p>slaughter facilities to designate the area of their establishment where</p><p>federal inspection is performed; this is designated as the official</p><p>slaughter establishment.34 We observed animals that were down or dead in</p><p>pens outside the official premises that were to be picked up by renderers.</p><p>Animals that were rejected by plant personnel were transported off the</p><p>premises on the same vehicles that brought them to the plant.35 A policy</p><p>statement36 regarding BSE sampling of condemned cattle at slaughter plants</p><p>provided that effective June 1, 2004, FSIS would collect BSE samples for</p><p>testing: 1) from all cattle regardless of age condemned by FSIS upon ante</p><p>mortem inspection for CNS impairment, and 2) from all cattle, with the</p><p>exception of veal calves, condemned by FSIS upon ante mortem inspection for</p><p>any other reason. FSIS Notice 28-04, dated May 20, 2004, informed FSIS</p><p>personnel that, "FSIS will be collecting brain samples from cattle at</p><p>federally-inspected establishments for the purpose of BSE testing." The</p><p>notice further states that, "Cattle off-loaded from the transport vehicle</p><p>onto the premises of the federally-inspected establishment (emphasis added),</p><p>whether dead or alive, will be sampled by the FSIS Public Health</p><p>Veterinarian (PHV) for BSE after the cattle have been condemned during ante</p><p>mortem inspection. In addition, cattle passing ante mortem inspection but</p><p>later found dead prior to slaughter will be condemned and be sampled by the</p><p>FSIS PHV." 34 FSIS regulations do not specifically address the designation</p><p>of an establishment's "official" boundaries; however, FSIS Notices 29-04</p><p>(dated May 27, 2004) and 40-04 (dated July 29, 2004) make it clear that FSIS</p><p>inspection staff are not responsible for sampling dead cattle that are not</p><p>part of the "official" premises. 35 APHIS' area office personnel stated that</p><p>it was their understanding that some establishments in the State were not</p><p>presenting cattle that died or were down on the transport vehicle to FSIS</p><p>for ante mortem inspection. The dead and down cattle were left in the</p><p>vehicle, if possible. In rare circumstances, dead cattle may be removed from</p><p>the trailer by plant personnel to facilitate the unloading of other animals.</p><p>36 A May 20, 2004, Memorandum between the Administrators of APHIS and FSIS.</p><p>USDA/OIG-A/50601-10-KC Page 24</p><p>APHIS has the responsibility for sampling dead cattle off-loaded onto</p><p>plant-owned property that is adjoining to, but not considered part of, the</p><p>"official premises.37 FSIS procedures38 provide that "Dead cattle that are</p><p>off-loaded to facilitate the off-loading of live animals, but that will be</p><p>re-loaded onto the transport vehicle, are not subject to sampling by FSIS.</p><p>While performing our review in one State, we reviewed the circumstances at</p><p>two slaughter facilities in the State that inspected and rejected unsuitable</p><p>cattle before the animals entered the official receiving areas of the</p><p>plants. This pre-screening activity was conducted in areas not designated by</p><p>the facility as official premises of the establishment and not under the</p><p>review or supervision of FSIS inspectors. The plant rejected all</p><p>nonambulatory and dead/dying/sick animals delivered to the establishment.</p><p>Plant personnel refused to offload any dead or downer animals to facilitate</p><p>the offloading of ambulatory animals. Plant personnel said that the driver</p><p>was responsible for ensuring nonambulatory animals were humanely euthanized</p><p>and disposing of the carcasses of the dead animals. Plant personnel informed</p><p>us that they did not want to jeopardize contracts with business partners by</p><p>allowing unsuitable animals on their slaughter premises. In the second case,</p><p>one family member owned a slaughter facility while another operated a</p><p>livestock sale barn adjacent to the slaughter facility. The slaughter</p><p>facility was under FSIS' supervision while the sale barn was not. Cattle</p><p>sometimes arrived at the sale barn that were sick/down/dead or would die or</p><p>go down while at the sale barn. According to personnel at the sale barn,</p><p>these animals were left for the renderer to collect. The healthy ambulatory</p><p>animals that remained were marketed to many buyers including the adjacent</p><p>slaughter facility. When the slaughter facility was ready to accept the</p><p>ambulatory animals for processing, the cattle would be moved from the sale</p><p>barn to the slaughter facility where they were subject to FSIS' inspection.</p><p>We requested the slaughter facilities to estimate the number of cattle</p><p>rejected on a daily basis (there were no records to confirm the estimates).</p><p>We visited a renderer in the area and found that the renderer had a contract</p><p>with APHIS to collect samples for BSE testing. In this case, although we</p><p>could not obtain assurance that all rejected cattle were sampled, the</p><p>renderer processed a significant number of animals, as compared to the</p><p>slaughter plants' estimates of those rejected. Due to the close proximity</p><p>(less than 5 miles) of the renderer to the slaughter facilities, and the</p><p>premium it paid for dead cattle that were in good condition, there was a</p><p>financial incentive for transport drivers to dispose of their dead animals</p><p>at this renderer. 37 FSIS Notice 40-04, dated July 29, 2004. 38 FSIS Notice</p><p>29-04, dated May 27, 2004.</p><p>USDA/OIG-A/50601-10-KC Page 25</p><p>In our discussions with APHIS officials in Wisconsin and Iowa, they</p><p>confirmed that there were plants in their States that also used</p><p>pre-screening practices. On May 27, 2005, we requested APHIS and FSIS to</p><p>provide a list of all slaughter facilities that pre-screened cattle for</p><p>slaughter in locations away from the area designated as the official</p><p>slaughter facility. Along with this request, we asked for information to</p><p>demonstrate that either APHIS or FSIS confirmed there was a high likelihood</p><p>that high-risk animals were sampled at other collection sites. In response</p><p>to our request, the APHIS BSE Program Manager stated that APHIS did not have</p><p>information on slaughter plants that pre-screen or screen their animals for</p><p>slaughter suitability off their official plant premises. To their knowledge,</p><p>every company or producer that submits animals for slaughter pre-sorts or</p><p>screens them for suitability at various locations away from the slaughter</p><p>facility. For this reason, USDA focused its BSE sample collection efforts at</p><p>other types of facilities such as renderers, pet food companies, landfills,</p><p>and dead stock haulers. Further, in a letter to OIG on June 14, 2005, the</p><p>administrators of APHIS and FSIS noted the following: "…we believe that no</p><p>specific actions are necessary or appropriate to obtain reasonable assurance</p><p>that animals not presented for slaughter are being tested for BSE. There are</p><p>several reasons for our position. First, we do not believe that the practice</p><p>is in fact causing us to not test a significant enough number of animals in</p><p>our enhanced surveillance program to invalidate the overall results. Second,</p><p>OIG has concluded that because of the geographical proximity and business</p><p>relationships of the various entities involved in the case investigated,</p><p>there is reasonable assurance that a majority of the rejected cattle had</p><p>been sampled. Third, it is also important to remember that the goal of the</p><p>enhanced surveillance program is to test a sufficient number of animals to</p><p>allow us to draw conclusions about the level of BSE (if any) in the American</p><p>herd…We believe that the number we may be not testing because of the</p><p>"pre-sorting" practice does not rise to a significant level. The number of</p><p>animals tested to date has far exceeded expectations, so it is reasonable to</p><p>infer that there are few of the animals in question, or that we are testing</p><p>them at some other point in the process…APHIS estimated…there were</p><p>approximately 446,000 high risk cattle…[and APHIS has]…tested over 375,000</p><p>animals in less than 1 year. This indicated that we are missing few animals</p><p>in the high-risk population, including those that might be pre-sorted before</p><p>entering a slaughter facility's property." We obtained 123 APHIS sampling</p><p>agreements and contracts with firms and plotted their locations within the</p><p>United States (see exhibit F). We also analyzed the samples tested to the</p><p>BSE sampling goals allocated to each State under the prior surveillance</p><p>program. This analysis showed that there are</p><p>USDA/OIG-A/50601-10-KC Page 26</p><p>sampling gaps in two large areas of the United States where APHIS did not</p><p>have contracts with collection sites. These two areas are shown in the</p><p>following chart (Montana, South Dakota, North Dakota and Wyoming – Group 1</p><p>and Louisiana, Oklahoma, Arkansas, and Tennessee – Group 2): State Original</p><p>Sampling Goal Based on (268,500 sampling goal) Samples collected as of May</p><p>31, 2005 Deficit No. of BSE Sampling Agreements/ Contracts39MT 5,076 182</p><p>4,894 2 SD 6,938 2,792 4,146 1 ND 3,616 174 3,442 0 WY 2,513 61 2,452 0 AREA</p><p>TOTAL 14,934 OK 7,792 2,407 5,385 1 AR 3,672 353 3,319 0 TN 4,938 3,050</p><p>1,888 1 LA 2,312 452 1,860 1 AREA TOTAL 12,452 APHIS notes that for the</p><p>current surveillance program, it had established regional goals and APHIS</p><p>was not trying to meet particular sampling levels in particular States.</p><p>However, we believe that it would be advantageous for APHIS to monitor</p><p>collection data and increase outreach when large geographical areas such as</p><p>the above States do not provide samples in proportion to the numbers and</p><p>types of cattle in the population. We also disagree with APHIS/FSIS'</p><p>contention that because they have tested over 375,000 of their 446,000</p><p>estimate of high risk cattle, few in the high-risk population are being</p><p>missed, including those that might be pre-screened before entering a</p><p>slaughter facility's property. In our prior audit, we reported that APHIS</p><p>underestimated the high-risk population; we found that this estimate should</p><p>have been closer to 1 million animals (see Finding 1). We recognize that BSE</p><p>samples are provided on a voluntary basis; however, APHIS should consider</p><p>industry practice in any further maintenance surveillance effort. Animals</p><p>unsuitable for slaughter exhibiting symptoms not inconsistent with BSE</p><p>should be sampled and their clinical signs recorded. However, this cited</p><p>industry practice results in rejected animals not being made available to</p><p>either APHIS or FSIS veterinarians for their observation and identification</p><p>of clinical signs exhibited ante mortem. Although these animals may be</p><p>sampled later at other collection sites, the animals are provided post</p><p>mortem without information as to relevant clinical signs exhibited ante</p><p>mortem. For these reasons, we believe APHIS needs to 39APHIS noted that</p><p>sites with agreements do not necessarily reflect the entire universe of</p><p>collection sites and at some sites APHIS collects samples with no payment</p><p>involved and no agreement in place. OIG agrees that not all collection sites</p><p>are reflected in our presentation of the 123 sites with reimbursable</p><p>agreements. OIG believes obtaining sampling agreements is one of the primary</p><p>methods available to increase sample numbers in areas with sampling gaps.</p><p>USDA/OIG-A/50601-10-KC Page 27</p><p>observe these animals ante mortem when possible to assure the animals from</p><p>the target population are ultimately sampled and the clinical signs</p><p>evaluated. Recommendation 3....... </p><p></p><p><a href="http://www.usda.gov/oig/webdocs/50601-10-KC.pdf" target="_blank">http://www.usda.gov/oig/webdocs/50601-10-KC.pdf</a></p><p></p><p> </p><p></p><p>TSS</p></blockquote><p></p>
[QUOTE="flounder, post: 241487, member: 3519"] Subject: CANADA FINDS ANOTHER 'SUSPECT' BSE CASE while USA is simply not looking to find (as of July 10, 2006 - 13:00 EST) Date: July 10, 2006 at 11:07 am PST Latest Information (as of July 10, 2006 - 13:00 EST) The Canadian Food Inspection Agency (CFIA) is currently conducting confirmatory testing at the National Reference Laboratory in Winnipeg of samples from a cow from Alberta suspected of having bovine spongiform encephalopathy (BSE). Preliminary screening tests were not able to rule out BSE. Therefore, consistent with established CFIA protocol, additional analysis is underway. The animal, reported to be a 50-month old dairy cow, died and was retained on farm. No part of the carcass entered the human food or animal feed systems, and the entire carcass has been placed under control. The CFIA has launched an investigation to collect additional information about the affected animal. In addition, the CFIA will identify other animals of equivalent risk, namely cattle born on the same farm within 12 months before and after the affected animal. Any live animals found from this group will be segregated and tested. As testing and the investigation progress, the CFIA will provide Canadians and trading partners with regular updates. Information will be posted to the CFIA's Website as it becomes available. [url=http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/situatione.shtml]http://www.inspection.gc.ca/english/ani ... ione.shtml[/url] no wonder USA is not documenting any young cattle yet with mad cow disease, hell, its a miracle USDA et al have documented any mad cow at all at this rate ; Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain Our prior report identified a number of inherent problems in identifying and testing high-risk cattle. We reported that the challenges in identifying the universe of high-risk cattle, as well as the need to design procedures to obtain an appropriate representation of samples, was critical to the success of the BSE surveillance program. The surveillance program was designed to target nonambulatory cattle, cattle showing signs of CNS disease (including cattle testing negative for rabies), cattle showing signs not inconsistent with BSE, and dead cattle. Although APHIS designed procedures to ensure FSIS condemned cattle were sampled and made a concerted effort for outreach to obtain targeted samples, industry practices not considered in the design of the surveillance program reduced assurance that targeted animals were tested for BSE. In our prior report, we recommended that APHIS work with public health and State diagnostic laboratories to develop and test rabies-negative samples for BSE. This target group is important for determining the prevalence of BSE in the United States because rabies cases exhibit clinical signs not inconsistent with BSE; a negative rabies test means the cause of the clinical signs has not been diagnosed. Rabies Negative Samples APHIS agreed with our recommendation and initiated an outreach program with the American Association of Veterinary Laboratory Diagnosticians, as well as State laboratories. APHIS also agreed to do ongoing monitoring to ensure samples were obtained from this target population. Although APHIS increased the samples tested from this target group as compared to prior years, we found that conflicting APHIS instructions on the ages of cattle to test resulted in inconsistencies in what samples were submitted for BSE testing. Therefore, some laboratories did not refer their rabies negative samples to APHIS in order to maximize the number tested for this critical target population. In addition, APHIS did not monitor the number of submissions of rabies negative samples for BSE testing from specific laboratories. According to the Procedure Manual for BSE Surveillance, dated October 2004, the target population includes: Central nervous system (CNS) signs and/or rabies negative - sample animals of any age (emphasis added): a. Diagnostic laboratories –samples submitted due to evidence of CNS clinical signs. USDA/OIG-A/50601-10-KC Page 19 USDA/OIG-A/50601-10-KC Page 20 b. Public health laboratories – rabies negative cases. c. Slaughter facilities – CNS ante mortem condemned at slaughter, sampled by FSIS. d. On-the-farm – CNS cattle that do not meet the criteria for a foreign animal disease investigation. For FYs 2002, 2003, and 2004 (through February 2004), NVSL received 170, 133, and 45 rabies-negative samples, respectively. Between June 1, 2004, and May 29, 2005, the number of samples received for testing increased to 226 rabies suspect samples. The collection sites submitting these samples follow. Collection Site Number of Rabies Suspect Submissions * Slaughter Plant 0 Renderer 2 On-Farm 11 Public Health Lab 94 Diagnostic Lab 81 3D-4D 8 Other 4 Total 200 * 26 were tested but not counted by APHIS towards meeting the target goals because the obex was not submitted. We obtained a copy of a memorandum, dated July 13, 2004, that APHIS sent to diagnostic and public health laboratories providing them instructions on submitting samples for cattle showing signs of CNS diseases, but testing negative for rabies. The letter was sent to about 170 State veterinary diagnostic and public health laboratories and discussed the need to submit specimens to NVSL of all adult cattle (emphasis added) that showed signs of CNS diseases, but tested negative for rabies. This directive did not specify the age of the cattle. The Procedure Manual for BSE Surveillance, dated October 2004, specified samples of cattle of any age should be submitted. We contacted laboratories in six States to determine if it was standard procedure to submit all negative rabies samples to NVSL. We found that, because of the lack of specificity in the APHIS letter and inadequate followup by APHIS, there were inconsistencies in the age of cattle samples submitted for BSE testing. For those States contacted, the following samples were submitted versus tested as negative for rabies. USDA/OIG-A/50601-10-KC Page 21 Rabies Negative Tests Not Sent for BSE Testing Since June 1, 2004 State Negative Rabies Tests Sent for BSE Testing Not Sent for BSE Testing Pennsylvania a/ 33 15 18 Kansas b/ 85 69 16 Wisconsin c/ 12 1 11 South Dakota d/ 7 0 7 Arizona e/ 5 5 0 Mississippi e/ 4 4 0 Total 146 94 52 a/ A Pennsylvania laboratory official said only rabies negative cattle over 20 months of age were submitted for BSE testing. The laboratory did not submit 18 samples for BSE testing because the animals were less than 20 months of age. b/ Kansas laboratory officials said early in the expanded surveillance program, there was confusion as to the cattle ages that should be submitted for BSE testing. They did not know if cattle should be submitted that were above 20 months or 30 months of age. Of the 16 animals not submitted for BSE testing, 14 were under 20 months of age from early in the expanded surveillance program. The other two animals were not tested due to internal laboratory issues. The Kansas and Nebraska area office officials contacted the laboratory and told the officials to submit rabies negative cattle of any age for BSE testing. The laboratory now submits all rabies negative cattle for BSE testing. c/ A Wisconsin laboratory official said only rabies negative cattle samples 30 months of age or older are submitted for BSE testing. Of the 11 animals not submitted for BSE testing, 8 were less than 30 months of age. Wisconsin laboratory officials were not certain why the other three samples were not submitted. d/ Laboratory officials from South Dakota said they did not receive notification from APHIS regarding the submission of rabies negative cases for BSE testing. The section supervisor and laboratory director were not aware of any letter sent to the laboratory. The section supervisor said most bovine rabies tests at the laboratory are performed on calves. We confirmed the laboratory’s address matched the address on APHIS’ letter distribution list. However, there was no evidence that the South Dakota area office contacted the laboratory. The laboratory was not listed on the documentation from the APHIS regional office detailing the area office contacts with laboratory personnel. We contacted the South Dakota area office and were advised that while some contact had been made with the laboratory, the contact may have involved Brucellosis rather than BSE. On May 4, 2005, the area office advised us they recently contacted the laboratory regarding the submission of rabies negative samples for BSE testing. e/ Arizona and Mississippi laboratory officials said they submitted all rabies negative samples for BSE testing regardless of the age of the animal. An NVSL official stated that APHIS is not concerned with rabies negatives samples from cattle less than 30 months of age. This position, however, is contrary to APHIS’ published target population. Our prior audit recognized the significant challenge for APHIS to obtain samples from some high-risk populations because of the inherent problems with obtaining voluntary compliance and transporting the carcasses for testing. USDA issued rules to prohibit nonambulatory animals (downers) from entering the food supply at inspected slaughterhouses. OIG recommended, and the International Review Subcommittee33 emphasized, that USDA should take additional steps to assure that facilitated pathways exist for dead and nonambulatory cattle to allow for the collection of samples and proper disposal of carcasses. Between June 1, 2004, and May 31, 2005, the APHIS database documents 27,617 samples were collected showing a reason for submission of nonambulatory and 325,225 samples were collected with reason of submission showing “dead.” Downers and Cattle that Died on the Farm APHIS made extensive outreach efforts to notify producers and private veterinarians of the need to submit and have tested animals from these target groups. They also entered into financial arrangements with 123 renderers and other collection sites to reimburse them for costs associated with storing, transporting, and collecting samples. However, as shown in exhibit F, APHIS was not always successful in establishing agreements with non-slaughter collection sites in some States. APHIS stated that agreements do not necessarily reflect the entire universe of collection sites and that the presentation in exhibit F was incomplete because there were many collection sites without a payment involved or without a formal agreement. We note that over 90 percent of the samples collected were obtained from the 123 collection sites with agreements and; therefore, we believe agreements offer the best source to increase targeted samples in underrepresented areas. We found that APHIS did not consider industry practices in the design of its surveillance effort to provide reasonable assurance that cattle exhibiting possible clinical signs consistent with BSE were tested. Slaughter facilities do not always accept all cattle arriving for slaughter because of their business requirements. We found that, in one State visited, slaughter facilities pre-screened and rejected cattle (sick/down/dead/others not meeting business USDA/OIG-A/50601-10-KC Page 22 33 Report from the Secretary’s Advisory Committee on Foreign Animal and Poultry Diseases, February 13, 2004. USDA/OIG-A/50601-10-KC Page 23 standards) before presentation for slaughter in areas immediately adjacent or contiguous to the official slaughter establishment. These animals were not inspected and/or observed by either FSIS or APHIS officials located at the slaughter facilities. FSIS procedures state that they have no authority to inspect cattle not presented for slaughter. Further, APHIS officials stated they did not believe that they had the authority to go into these sorting and/or screening areas and require that the rejected animals be provided to APHIS for BSE sampling. Neither APHIS nor FSIS had any process to assure that animals left on transport vehicles and/or rejected for slaughter arrived at a collection site for BSE testing. FSIS allows slaughter facilities to designate the area of their establishment where federal inspection is performed; this is designated as the official slaughter establishment.34 We observed animals that were down or dead in pens outside the official premises that were to be picked up by renderers. Animals that were rejected by plant personnel were transported off the premises on the same vehicles that brought them to the plant.35 A policy statement36 regarding BSE sampling of condemned cattle at slaughter plants provided that effective June 1, 2004, FSIS would collect BSE samples for testing: 1) from all cattle regardless of age condemned by FSIS upon ante mortem inspection for CNS impairment, and 2) from all cattle, with the exception of veal calves, condemned by FSIS upon ante mortem inspection for any other reason. FSIS Notice 28-04, dated May 20, 2004, informed FSIS personnel that, “FSIS will be collecting brain samples from cattle at federally-inspected establishments for the purpose of BSE testing.” The notice further states that, “Cattle off-loaded from the transport vehicle onto the premises of the federally-inspected establishment (emphasis added), whether dead or alive, will be sampled by the FSIS Public Health Veterinarian (PHV) for BSE after the cattle have been condemned during ante mortem inspection. In addition, cattle passing ante mortem inspection but later found dead prior to slaughter will be condemned and be sampled by the FSIS PHV.” 34 FSIS regulations do not specifically address the designation of an establishment’s “official” boundaries; however, FSIS Notices 29-04 (dated May 27, 2004) and 40-04 (dated July 29, 2004) make it clear that FSIS inspection staff are not responsible for sampling dead cattle that are not part of the “official” premises. 35 APHIS’ area office personnel stated that it was their understanding that some establishments in the State were not presenting cattle that died or were down on the transport vehicle to FSIS for ante mortem inspection. The dead and down cattle were left in the vehicle, if possible. In rare circumstances, dead cattle may be removed from the trailer by plant personnel to facilitate the unloading of other animals. 36 A May 20, 2004, Memorandum between the Administrators of APHIS and FSIS. USDA/OIG-A/50601-10-KC Page 24 APHIS has the responsibility for sampling dead cattle off-loaded onto plant-owned property that is adjoining to, but not considered part of, the “official premises.37 FSIS procedures38 provide that “Dead cattle that are off-loaded to facilitate the off-loading of live animals, but that will be re-loaded onto the transport vehicle, are not subject to sampling by FSIS. While performing our review in one State, we reviewed the circumstances at two slaughter facilities in the State that inspected and rejected unsuitable cattle before the animals entered the official receiving areas of the plants. This pre-screening activity was conducted in areas not designated by the facility as official premises of the establishment and not under the review or supervision of FSIS inspectors. The plant rejected all nonambulatory and dead/dying/sick animals delivered to the establishment. Plant personnel refused to offload any dead or downer animals to facilitate the offloading of ambulatory animals. Plant personnel said that the driver was responsible for ensuring nonambulatory animals were humanely euthanized and disposing of the carcasses of the dead animals. Plant personnel informed us that they did not want to jeopardize contracts with business partners by allowing unsuitable animals on their slaughter premises. In the second case, one family member owned a slaughter facility while another operated a livestock sale barn adjacent to the slaughter facility. The slaughter facility was under FSIS’ supervision while the sale barn was not. Cattle sometimes arrived at the sale barn that were sick/down/dead or would die or go down while at the sale barn. According to personnel at the sale barn, these animals were left for the renderer to collect. The healthy ambulatory animals that remained were marketed to many buyers including the adjacent slaughter facility. When the slaughter facility was ready to accept the ambulatory animals for processing, the cattle would be moved from the sale barn to the slaughter facility where they were subject to FSIS’ inspection. We requested the slaughter facilities to estimate the number of cattle rejected on a daily basis (there were no records to confirm the estimates). We visited a renderer in the area and found that the renderer had a contract with APHIS to collect samples for BSE testing. In this case, although we could not obtain assurance that all rejected cattle were sampled, the renderer processed a significant number of animals, as compared to the slaughter plants’ estimates of those rejected. Due to the close proximity (less than 5 miles) of the renderer to the slaughter facilities, and the premium it paid for dead cattle that were in good condition, there was a financial incentive for transport drivers to dispose of their dead animals at this renderer. 37 FSIS Notice 40-04, dated July 29, 2004. 38 FSIS Notice 29-04, dated May 27, 2004. USDA/OIG-A/50601-10-KC Page 25 In our discussions with APHIS officials in Wisconsin and Iowa, they confirmed that there were plants in their States that also used pre-screening practices. On May 27, 2005, we requested APHIS and FSIS to provide a list of all slaughter facilities that pre-screened cattle for slaughter in locations away from the area designated as the official slaughter facility. Along with this request, we asked for information to demonstrate that either APHIS or FSIS confirmed there was a high likelihood that high-risk animals were sampled at other collection sites. In response to our request, the APHIS BSE Program Manager stated that APHIS did not have information on slaughter plants that pre-screen or screen their animals for slaughter suitability off their official plant premises. To their knowledge, every company or producer that submits animals for slaughter pre-sorts or screens them for suitability at various locations away from the slaughter facility. For this reason, USDA focused its BSE sample collection efforts at other types of facilities such as renderers, pet food companies, landfills, and dead stock haulers. Further, in a letter to OIG on June 14, 2005, the administrators of APHIS and FSIS noted the following: “…we believe that no specific actions are necessary or appropriate to obtain reasonable assurance that animals not presented for slaughter are being tested for BSE. There are several reasons for our position. First, we do not believe that the practice is in fact causing us to not test a significant enough number of animals in our enhanced surveillance program to invalidate the overall results. Second, OIG has concluded that because of the geographical proximity and business relationships of the various entities involved in the case investigated, there is reasonable assurance that a majority of the rejected cattle had been sampled. Third, it is also important to remember that the goal of the enhanced surveillance program is to test a sufficient number of animals to allow us to draw conclusions about the level of BSE (if any) in the American herd…We believe that the number we may be not testing because of the “pre-sorting” practice does not rise to a significant level. The number of animals tested to date has far exceeded expectations, so it is reasonable to infer that there are few of the animals in question, or that we are testing them at some other point in the process…APHIS estimated…there were approximately 446,000 high risk cattle…[and APHIS has]…tested over 375,000 animals in less than 1 year. This indicated that we are missing few animals in the high-risk population, including those that might be pre-sorted before entering a slaughter facility’s property.” We obtained 123 APHIS sampling agreements and contracts with firms and plotted their locations within the United States (see exhibit F). We also analyzed the samples tested to the BSE sampling goals allocated to each State under the prior surveillance program. This analysis showed that there are USDA/OIG-A/50601-10-KC Page 26 sampling gaps in two large areas of the United States where APHIS did not have contracts with collection sites. These two areas are shown in the following chart (Montana, South Dakota, North Dakota and Wyoming – Group 1 and Louisiana, Oklahoma, Arkansas, and Tennessee – Group 2): State Original Sampling Goal Based on (268,500 sampling goal) Samples collected as of May 31, 2005 Deficit No. of BSE Sampling Agreements/ Contracts39MT 5,076 182 4,894 2 SD 6,938 2,792 4,146 1 ND 3,616 174 3,442 0 WY 2,513 61 2,452 0 AREA TOTAL 14,934 OK 7,792 2,407 5,385 1 AR 3,672 353 3,319 0 TN 4,938 3,050 1,888 1 LA 2,312 452 1,860 1 AREA TOTAL 12,452 APHIS notes that for the current surveillance program, it had established regional goals and APHIS was not trying to meet particular sampling levels in particular States. However, we believe that it would be advantageous for APHIS to monitor collection data and increase outreach when large geographical areas such as the above States do not provide samples in proportion to the numbers and types of cattle in the population. We also disagree with APHIS/FSIS’ contention that because they have tested over 375,000 of their 446,000 estimate of high risk cattle, few in the high-risk population are being missed, including those that might be pre-screened before entering a slaughter facility’s property. In our prior audit, we reported that APHIS underestimated the high-risk population; we found that this estimate should have been closer to 1 million animals (see Finding 1). We recognize that BSE samples are provided on a voluntary basis; however, APHIS should consider industry practice in any further maintenance surveillance effort. Animals unsuitable for slaughter exhibiting symptoms not inconsistent with BSE should be sampled and their clinical signs recorded. However, this cited industry practice results in rejected animals not being made available to either APHIS or FSIS veterinarians for their observation and identification of clinical signs exhibited ante mortem. Although these animals may be sampled later at other collection sites, the animals are provided post mortem without information as to relevant clinical signs exhibited ante mortem. For these reasons, we believe APHIS needs to 39APHIS noted that sites with agreements do not necessarily reflect the entire universe of collection sites and at some sites APHIS collects samples with no payment involved and no agreement in place. OIG agrees that not all collection sites are reflected in our presentation of the 123 sites with reimbursable agreements. OIG believes obtaining sampling agreements is one of the primary methods available to increase sample numbers in areas with sampling gaps. USDA/OIG-A/50601-10-KC Page 27 observe these animals ante mortem when possible to assure the animals from the target population are ultimately sampled and the clinical signs evaluated. Recommendation 3....... 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