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From: TSS ()
In Reply to: Re: cattletoday.com CENSORS TSS ON BSE AKA MAD COW posted by TSS on March 21, 2006 at 10:28 am:
“Mad Cow Disease”): Current and Proposed Safeguards Updated October 13, 2005 Geoffrey S. Becker Specialist in Agricultural Policy Resources, Science and Industry Division Sarah A. Lister Specialist in Public Health and Epidemiology Domestic Social Policy Division In August 2003, the United States had announced that it, Canada, and Mexico were entering into discussions at the OIE to develop new guidance for with countries that have reported BSE, under certain conditions. The basis proposal, according to U.S. officials, was that conditions for trade should not simply on the number of “mad cow” cases a country has reported. Rather, conditions should better reflect the adequacy of a country’s safeguards in whatever level of risk is found through a scientifically valid risk words, countries with strong safeguards should not be penalized because testing has found an acceptably low number of BSE cases, whereas another with inadequate protections may simply not be testing for and/or reporting disease. On May 26, 2005, the OIE agreed to new BSE trade guidelines. is a simplified hierarchy of risk: ! Category 1 countries are those with negligible risk, and thus subject to the least restrictive conditions for exporting ruminants and ruminant products; ! Category 2 are those countries with controlled risk; and ! Category 3 are those where the risks are unknown. In another guideline change, OIE decided that trade in boneless muscle beef from cattle under 30 months of age should be considered to be safe, their exporting country’s BSE risk profile, so long as that country has controls in place. For example, one control would be an acceptable method determining these animals’ ages and for segregating them from older animals. The United States and Canada most likely fall within category 2, several analysts have observed. Again, as under the prior OIE guidelines for BSE, modified guidelines leave it up to the exporting countries to convince country authorities that their beef and cattle are safe. The importing might or might not accept these demonstrations of safety — and might not necessarily agree to observe the OIE guidelines. country’s risk mitigation measures as a whole, not as separate items on a example, Declaration of David Wilson, head of the OIE International Trade February 17, 2005, in the case Ranchers Cattlemen Action Legal Fund USA vs. 05-06-BLG-RFC). 13 U.S. Dept. of Agriculture, “Exportation and importation of animals and Bovine spongiform encephalopathy; minimal risk regions and importation of 68 Federal Register 62386, Nov. 4, 2003. If a bilateral trade disagreement over a country’s BSE safeguards were to an international dispute panel, presumably that panel would look to the OIE guidelines for direction in resolving it. However, a dispute resolution as under the Uruguay Round agreements administered by the World Trade Organization) can be lengthy and not always settled to the satisfaction of The U.S.-supported approach to BSE and trade has been put to the test by practical developments between the United States and its trading specifically, Canada has been seeking expansion of its permitted ruminant to the United States. Although the Administration and many in Congress agree Canada, several U.S. producer groups and their allies do not (see “Canadian Cattle Imports,” below). At the same time, the United States has been trying regain access to the Japanese, Korean, and other important export markets, have been closed since the United States found its first case of BSE in 2003. This is despite U.S. efforts to convince them that U.S. safeguards are scientifically sound, and that they equal or exceed the standards (see “Japan Beef Trade Issues” later in this section). 49 See FDA, “BSE — CVM Updates” page at 50 See, for example, FDA, “FDA Statement on Rendered Products Derived From in Washington State,” Dec. 27, 2003, at [http://www.fda.gov/bbs/topics/NEWS/ 2003/NEW01000.html]. 51 Such tests would determine only if prohibited materials were present in whether infectious BSE prions were present. No such prion test for feed 52 GAO, FDA’s Management of the Feed Ban Has Been Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness (GAO-05-101), Feb. 2005. GAO, Mad Cow Disease: Improvements in the Animal Feed Ban and Other Areas Would Strengthen U.S. Prevention Efforts, (GAO-02-183), Jan. 2002. Enforcement of the Feed Ban The FDA Center for Veterinary Medicine has since 2001 provided periodic updates of its feed ban enforcement activity on a public website.49 On June the agency reported that it had identified and conducted initial inspections renderers, feed mills, protein blenders and related establishments. The that 4,093 of them (26%) handled materials prohibited for use in ruminant this subset, FDA reported that the vast majority were within compliance. FDA has asserted on several occasions that feed industry compliance with the ban has reached 99%.50 FDA bases its compliance determinations on inspection facilities, practices, and records. At this time there is no certified test used on actual ruminant feed to determine if it contains prohibited July 2004 ANPR, FDA requested information on potential test methods for SRM in animal feed.51 The Government Accountability Office (GAO) has twice evaluated FDA’s oversight of the feed ban, in 2002 and 2005, and reported a number of administrative procedures, inspection, and enforcement.52 In its February report, GAO commented that FDA’s 99% reported compliance rate may be misleading because the rate was based on inspections of only about 570 added that FDA does not include all serious violations in its calculations reclassifies firms as being in compliance once they correct violations, no long a problem existed. For this and other reasons GAO said that FDA did not sufficient information to calculate a compliance rate and recommended the agency report enforcement information in its complete context. Also in its 2005 report, GAO concluded that FDA had made improvements in its management of the feed ban since the 2002 GAO report, but that “various program weaknesses continue to undermine the nation’s firewall against BSE.” of the weaknesses cited was the lack of a uniform approach to identify all additional feed manufacturers, on-farm mixers, and other feed industry beyond the approximately 14,800 firms the agency had identified. Among other concerns, GAO also commented that FDA had not reinspected approximately firms for several years and therefore does not know whether they use materials in their feed, that the agency had not required a warning label on export that is not intended for cattle and other ruminants, and that it had prohibited feed. The preamble to the October 6, 2005, proposed feed rule provides additional insights into compliance with the present ban. FDA stated that during FY2004 the first half of FY2005, federal and state inspections had identified 41 cross-contamination or commingling problems in firms that handle feeds prohibited mammalian protein. That number represented 0.4% of inspections. During the same period these inspectors found 165 instances of mislabeling and 604 instances of improper recordkeeping (6.3%). garnered considerable criticism. On February 17, 2004, the House Committee Government Reform held a hearing to question USDA officials and others, the Committee’s month-long investigation into the circumstances surrounding of the Washington state cow (December 2003). The Committee Chairman and Ranking Member released a letter to the Secretary of Agriculture the same which they questioned whether the cow was in fact non-ambulatory when it was selected for testing.65 The committee raised questions relevant to the improved surveillance program. If in fact the animal were not a downer but an apparently healthy cow with BSE, had the surveillance program been effectively, and could Congress be confident that the disease is very rare United States? On April 27, 2004, a cow showing signs of a central nervous system disease a Texas slaughter plant was condemned for human food use by FSIS, and the veterinarian on site recommended that it be tested for BSE. However, a APHIS official determined that it should not be tested, so the animal’s sent to a rendering plant for processing into inedible byproducts. This led critics to charge that the Department had “covered up” a possible case of Such testing concerns became subjects of investigations by USDA’s Inspector General (IG). She presented her preliminary findings at a joint hearing held 2004, by the House Government Reform and Agriculture Committees. The IG told the committees that in the case of the Washington state cow, her office had no instances where USDA personnel knowingly conveyed false or misleading information, or engaged in intentional misconduct.” The investigation, “...did reveal procedural errors and inconsistent descriptions that gave of the public concerns that the identification of the BSE-positive cow may mishandled.”66 concerning “Mad Cow” Disease, Feb. 17, 2004, and related documents, [http://reform.house.gov/GovReform/News/DocumentSingle.aspx?DocumentID=2497] 66 Testimony of Phyllis K. Fong, USDA Inspector General, “A Review of the Expanded BSE Cattle Surveillance Program,” joint hearing of the House Government Reform and the House Committee on Agriculture, July 14, 2004. 67 Ibid. 68 USDA, Office of Inspector General Audit Report, Animal and Plant Health Service and Food Safety and Inspection Service Bovine (BSE) Surveillance Phase I, Report No. 50601-9-KC, August 2004. The IG testified that her office also found “no substantive evidence” that officials provided any “false information or engaged in intentional the Texas case. However, the IG cited inconsistencies in officials’ BSE sampling and carcass handling procedures. As a result, FSIS and APHIS on May 5, 2004, had announced a new joint policy to clarify these procedures responsibilities, she observed.67 The IG also presented the preliminary results of an audit of the Department’ expanded surveillance plan, finding a number of inconsistences. For example, IG stated that surveillance findings may be unreliable because the plan: is random since participation is voluntary; assumes that BSE is confined only high-risk cattle population while other studies show that healthy-looking could have BSE; does not include a process for obtaining animals that die on cannot obtain a statistically appropriate geographical representation of the population; and does not allow APHIS to find and test enough cattle in the population. The final OIG report, issued in late August 2004, generally preliminary findings.68 The Secretary of Agriculture and other USDA officials at the July 2004 defended the surveillance program, noting among other things that the OIG observations were based on the plan before it was implemented and that many report’s recommendations had already been addressed. APHIS was receiving a representative mix of samples from all locations, reaching deeply into the cattle population, and the statistical basis for the sampling was sound, asserted. They added that adjustments had been made as the result of ongoing assessments of the program. The OIG has continued to assess the testing It was at the IG’s insistence that APHIS researchers re-tested tissue from a first was determined to be negative, and then ultimately positive for BSE “Inconclusive” Test Results. In June 2004, shortly after the enhanced surveillance program was begun, USDA announced two inconclusive findings for BSE which were later determined to be negative. The finding announced on 2004, was confirmed negative on June 30. The finding announced on June 29, was confirmed negative on July 2. USDA reported each inconclusive finding not provide information on the location or any other details about the According to policy instituted in December 2003, the carcasses of the two animals were held pending test results, and were later destroyed. Cattle market prices fell in response to news of the inconclusive findings, rebounded to varying degrees once the conclusive negative results were USDA was criticized both for releasing too much and too little information, some industry groups said the policy to release partial information struck balance. During the wait for final results, USDA officials repeated the rumors generated by withholding information while an inconclusive test were 68 USDA, Office of Inspector General Audit Report, Animal and Plant Health Service and Food Safety and Inspection Service Bovine (BSE) Surveillance Phase I, Report No. 50601-9-KC, August 2004. CRS-33 69 See for example “New mad cow case possible,” The Kansas City Star; and news again hits producers; As future prices fall, officials industry promote beef,” The Fort Worth Star Telegram, both November 19, 2004. 70 Statement by Clifford, John, APHIS Deputy Administrator, November 23, 71 “Market Rebounds With a Vengeance,” Cattle Buyers Weekly, November 29, pending would be just as damaging to markets as would the release of findings. They also reiterated that given the extent of the enhanced problem, some false positive screening tests were to be expected and, additional true cases of BSE could surface as well. APHIS’s policy had been to announce an inconclusive result if an initial screening test were positive. APHIS changed this policy after the market uncertainties which followed the first two inconclusive August 4, 2004, the agency stated that it would announce a result as (i.e., testing positive in the screen but not yet confirmed in follow-up a second screening test on the sample were also positive. Confirmatory Testing Methods. With this newer policy in place, APHIS announced another inconclusive finding on November 18, 2004. As with the previous two announcements, the agency did not provide details on the animal or location, although some unconfirmed press reports speculated that it was year-old cow in Texas. Cattle market prices again fell steeply, as did stock such chains as McDonald’s Corporation and Wendy’s International.69 Five days later, on November 23, APHIS reported that confirmatory testing at its Ames NVSL facility had found the sample to be negative for BSE. Ames had the immunohistochemistry (IHC) test, an internationally-recognized gold standard test.... Because the November 18 screening test results were reactive in first and second screens, NVSL scientists made the recommendation to run the IHC test a second time.... Negative results make us confident that the question is indeed negative for BSE.70 Following this announcement, live cattle prices rebounded dramatically, cattle producers to more than recoup their earlier losses at the expense of meat packers) who paid the higher prices, thus incurring their own operating When its November 2004 IHC test came back negative for BSE, USDA did not run the other OIE-recognized confirmatory test, the Western blot, or send the World Reference Laboratory in Weybridge, England, to evaluate the contrast, USDA did run the Western blot test and consult with Weybridge to the BSE-positive result in December 2003. In the spring of 2005, USDA’s IG asked APHIS to retest the samples from the three 2004 “inconclusives,” because of its concerns about the original example, the November 2004 sample should not have been frozen; and there paperwork reporting problems, it was reported. This OIG-requested retesting news again hits producers; As future prices fall, officials industry promote beef,” The Fort Worth Star Telegram, both November 19, 2004. 70 Statement by Clifford, John, APHIS Deputy Administrator, November 23, 71 “Market Rebounds With a Vengeance,” Cattle Buyers Weekly, November 29, 72 Transcript of media conference, June 24, 2005, at portal/usdahome]. For an explanation of the two OIE-approved tests, see the APHIS factsheet at [http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/ faq_BSE_confirmtests.pdf]. 73 Ibid. 74 Transcript of media conference, June 24, 2005. The APHIS website also has series of factsheets explaining in more detail the confirmatory testing were applied in this case. June 2005 was done by USDA scientists (reportedly without the direct of the Secretary of Agriculture) using the Western blot method. When this showed the presence of BSE in the November 2004 sample, the Secretary of Agriculture made the result public on June 10, calling it a “weak positive.” officials delivered a sample from the animal to Weybridge for further began their own additional testing. The Weybridge lab conducted a series of analyses on the sample. All but one detected BSE, including another IHC test. The Secretary of Agriculture that the positive IHC test by Weybridge used a different procedure than the in November 2004 by USDA at Ames. A Weybridge scientist, Dr. Danny Matthews, confirmed that “there are no two laboratories around the world that are identical IHC methods and not a single test that you can take off the tests may not perform comparably.72 USDA officials also revealed on June 24, 2005, that a USDA laboratory had actually found possible BSE in the animal when it applied an “experimental” of the IHC test back in November 2004. However, they asserted that the had not reported this result because the test method had not been validated regulatory use.73 This information, and the positive BSE confirmation by provoked strong criticism by consumer groups and several Members of They expressed renewed skepticism about the adequacy of USDA’s testing and procedures; about department officials’ efforts to communicate all information about BSE in the United States; and about earlier assurances IHC was “the gold standard.” Secretary Johanns, who replaced Ann Veneman as Secretary earlier in 2005, promised on June 24, 2005, that henceforth the Department would conduct two of confirmatory tests — the IHC and the Western blot — if any screening to yield an “inconclusive” result. If either confirmatory test is positive, result will be reported, he announced. But Secretary Johanns also defended surveillance program, stating, “Science is ever evolving. It is not static. learn more we apply the knowledge.” USDA is carefully reviewing its testing ensure that it is “in line with the very latest science,” he said, adding, most important thing to remember is that we’ve only needed this test three since our enhanced surveillance began.”74 In all three instances of “inconclusives,” the so-called Bio-Rad ELISA test used as the screening test. Bio-Rad Laboratories has previously said that detected a case of BSE in a 23-month old bull in Japan, shown to be positive portal/usdahome]. For an explanation of the two OIE-approved tests, see the APHIS factsheet at [http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/ faq_BSE_confirmtests.pdf]. 73 Ibid. 74 Transcript of media conference, June 24, 2005. The APHIS website also has series of factsheets explaining in more detail the confirmatory testing were applied in this case. 75 For more information, see OIE, Disease Information, “Bovine spongiform in Japan: atypical case,” Vol. 16, No. 41, Oct. 10 2003, at Rad Laboratories website, [http://www.bio-rad.com]. 76 “Second US cow tests positive for BSE,” NewScientist.com News Service, 77 USDA, “Statement by Bill Hawks, Undersecretary for Marketing and Programs Regarding a Request by Creekstone for Private BSE Testing,” press 9, 2004. 78 For information on these programs, see the website of USDA’s Agricultural Service at [http://www.ams.usda.gov/]. 79 A legal analysis of the Creekstone decision is available in CRS Report Private Testing of Mad Cow Disease: Legal Issues, by Stephen R. Vina. Western blot test, but negative on immunohistochemistry (IHC) — a case that reported to OIE as “atypical BSE.”75 It also has been reported that the screening test has been found to be “false positive” (i.e., positive in the but negative upon confirmatory testing) at a rate of about one in a thousand The variety of testing schemes for BSE and seemingly conflicting statements their accuracy illustrates that laboratory science itself, and international on it, continue to evolve. Private BSE Testing: The Creekstone Decision http://www.ncseonline.org/NLE/CRSreports/05oct/RL32199.pdf BSE GBR ASSESSMENTS EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) Report The European Food Safety Authority and its Scientific Expert Working Group The BSE agent was probably imported into USA and could have reached domestic A processing risk developed in the late 80s/early 90s when cattle imports EFSA concludes that the current GBR level of USA is III, i.e. it is likely http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf TSS #################### https://lists.aegee.org/bse-l.html
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