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From: TSS ()
CVM Update November 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, here called the Ruminant Feed Ban, became effective on August 4, 1997. This is an update on FDA enforcement activities regarding the ruminant feed regulation. FDA's CVM has assembled data from the inspections that have been conducted AND whose final inspection report has been recorded in the FDA's inspection database as of November 26, 2005. As of November 26, 2005, FDA had received over 41,000 inspection reports. The majority of these inspections (around 68%) were conducted by State officials under contract to FDA, with the remainder conducted by FDA officials. Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI). An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented. A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of the Ruminant Feed Ban. These include provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds. An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions. The results to date are reported here both by “segment of industry” and “in total”. NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive. RENDERERS These firms are the first to handle and process (i.e., render) animal proteins and to send these processed materials to feed mills and/or protein blenders for use as a feed ingredient. Number of active firms whose initial inspection has been reported to FDA – 274 Number of active firms handling materials prohibited from use in ruminant feed – 185 (68% of those active firms inspected) Of the 185 active firms handling prohibited materials, their most recent inspection revealed that: 1 firm (0.5%) was classified as OAI 11 firms (5.9%) were classified as VAI LICENSED FEED MILLS FDA licenses these feed mills to produce medicated feed products. The license is required to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time. This licensing has nothing to do with handling prohibited materials under the feed ban regulation. A medicated feed license from FDA is not required to handle materials prohibited under the Ruminant Feed Ban. Number of active firms whose initial inspection has been reported to FDA – 1,079 Number of active firms handling materials prohibited from use in ruminant feed – 426 (39% of those active firms inspected) Of the 426 active firms handling prohibited materials, their most recent inspection revealed that: 0 firm (0%) was classified as OAI 8 firms (1.9%) were classified as VAI FEED MILLS NOT LICENSED BY FDA These feed mills are not licensed by the FDA to produce medicated feeds. Number of active firms whose initial inspection has been reported to FDA – 5,165 Number of active firms handling materials prohibited from use in ruminant feed – 2,036 (39% of those active firms inspected) Of the 2,036 active firms handling prohibited materials, their most recent inspection revealed that: 2 firms (0.1%) were classified as OAI 24 firms (1.2%) were classified as VAI PROTEIN BLENDERS These firms blend rendered animal protein for the purpose of producing quality feed ingredients that will be used by feed mills. Number of active firms whose initial inspection has been reported to FDA -- 340 Number of active firms handling materials prohibited from use in ruminant feed – 147 (43% of those active firms inspected) Of the 147 active firms handling prohibited materials, their most recent inspection revealed that: 0 firms (0%) were classified as OAI 7 firms (4.8%) were classified as VAI RENDERERS, FEED MILLS, AND PROTEIN BLENDERS This category includes only those firms that actually use prohibited material to manufacture, process, or blend animal feed or feed ingredients. Number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA – 6,576 Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 539 (8.2% of those active firms inspected) Of the 539 of active renderers, feed mills, and protein blenders processing with prohibited materials, their most recent inspection revealed that: 3 firms (0.6%) were classified as OAI 23 firms (4.3%) were classified as VAI OTHER FIRMS INSPECTED Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters. Number of active firms whose initial inspection has been reported to FDA – 13,477 Number of active firms handling materials prohibited from use in ruminant feed – 3,748 (28% of those active firms inspected) Of the 3,748 active firms handling prohibited materials, their most recent inspection revealed that: 8 firms (0.2%) were classified as OAI 95 firms (2.5%) were classified as VAI TOTAL FIRMS Note that a single firm can be reported under more than one firm category; therefore, the summation of the individual OAI/VAI firm categories will be more than the actual total number of OAI/VAI firms, as presented below. Number of active firms whose initial inspection has been reported to FDA – 16,476 Number of active firms handling materials prohibited from use in ruminant feed – 4,553 (27% of those active firms inspected) Of the 4,553 active firms handling prohibited materials, their most recent inspection revealed that: 9 firms (0.2%) were classified as OAI 107 firms (2.4%) were classified as VAI Issued by: Mad Cow Cover Up Continues: Terry S. Singeltary. Sr. Shirley Wilkes Johnson "Like Paul Revere with e-mail, Terry Singeltary Sr. is on a mission to sound an alarm: Beware of mad cow disease. As is true of many crusaders, however, his pleas often fall on deaf ears. But since his mother's death in December 1997, the Galveston County man has been obsessed with possible connections between her deadly brain disorder, sporadic Creutzfeldt-Jakob Disease, and mad cow disease." --- Carol Christian, reporter, Houston Chronicle "I strongly suspect he (Terry Singeltary) is right in thinking the USA has had BSE cases. The American government is making the same mistake as the British in putting the short-term commercial interests of its farmers before health considerations. "It should start formal and widespread testing of cattle plus compulsory autopsies for all human CJD victims at the state's expense. If there is BSE, then leaving it to spread will kill people -- and that would eventually destroy the industry, too." "Terry has been helpful in providing contact information regarding suspect CJD cases so that the Health Department can initiate case investigations and learn more about CJD in Texas. I think we learn more from him than he does from us." (noting in the article that the department cannot release records on individual patients). "I wouldn't be so zealous in getting the word out if I wasn't convinced that someone is covering up the truth. They used to say BSE would never transmit to humans, and it has. They lied about the feed ban being in place. I've lost faith in the whole process. I've discovered too many things on my own." "I've been told by a lay researcher whose mother died of CJD that the unofficial word is that, short of a CJD case showing up in the US that looks *exactly* like the British strain, there will be no acknowledgement of a problem in this country, at least not with the current administration." “Food safety advocates argue that the U.S. record of testing 10 percent of all cows -- only those that show visible signs of disease -- looks shabby compared with Japan's requirement that all slaughtered beef cows 21 months or older be tested. Some local governments still test all cows. Japan can afford to claim ‘the customer is king.’ Japan's caloric consumption of meat, which stood at 15.4 percent of the diet in 2004, was a scant 3.7 percent back in 1960. ‘We didn't eat meat before, and we can always go back, said an agriculture ministry official involved in free-trade agreement negotiations.’ ” Strangely, one year before to the day, Terry's next door neighbor's mother, also, died of CJD. So, Terry has been studying this disease for nearly a decade and has become a respected "walking encyclopedia" for researchers, reporters and families with loved ones suffering with or dying from CJD. Most doctors believe that sCJD is caused by a prion protein deforming by chance into a killer. But Singeltary thinks otherwise. He is one of a number of campaigners in the world who say that some sCJD, like the variant CJD related to BSE, is caused by eating meat from infected animals. Terry said he became convinced that BSE is here as he watched his mother die. The rare, fatal brain disease is sometimes accompanied by severe jerking. His mother started seeing brown spots in September 1997 and was virtually blind within two weeks. By the eighth week of the illness she was bedridden, and in the 10th week she died. Before that she had been in good health, he said. Creutzfeldt-Jakob Disease CJD is a horrendous infectious rapidly progressive fatal brain-deteriorating disease for which there is no treatment or cure. One strain, nvCJD, is linked to bovine spongiform encephalopathy (i.e. Mad Cow Disease) in Great Britain. The personal story you will hear today and others on a website called Many Faces of CJD put a human face on this always fatal disease. Most of the stories tell of people who have died of CJD or currently have CJD. These stories describe the symptoms and progression of the disease as well as the problems in getting it correctly diagnosed Janice Blue Listen Live on www.GoVeganTexas.org Every animal you eat Contact for Today's Guest & Producer: Terry S. Singeltary. Sr.,guest Shirley Wilkes Johnson,producer Related Websites on Today's Topic: The Many Faces of CJD: CJD Voices: http://www.Voices.org Prion Surveillance Center USA MAD COW CJD UPDATE 12/5/05 TSS RADIO 90.1 FM KPFT MOM DOD 12/14/97 HEIDENHAIN VARIANT CREUTZFELDT JAKOB DISEASE From: TSS () GAO October 11, 2005 The Honorable Saxby Chambliss Chairman The Honorable Tom Harkin Ranking Democratic Member Committee on Agriculture, Nutrition, and Forestry United States Senate The Honorable Thad Cochran United States Senate The Honorable Richard J. Durbin United States Senate Subject: Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA Implemented in 2003 With Recommendations for Making the Program a Better Oversight Tool In 1997, the Food and Drug Administration (FDA) banned the use of most proteins derived from mammals (referred to as prohibited material) in feed intended for cattle and other ruminants.1 The feed-ban rule is one of the primary actions taken by the federal government to protect U.S. cattle from bovine spongiform encephalopathy (BSE),2 commonly known as mad cow disease, which is believed to be spread through feed that contains malformed protein found in certain tissue—particularly brain and central nervous system tissue—of BSE-infected animals.3 Earlier this year, mad cow disease was found for the first time in a 12-year old animal born and raised in the United States. In January 2002, we reported on the effectiveness of federal actions to prevent the introduction and spread of BSE in the United States and identified a number of areas where improvements were needed to strengthen FDA’s oversight of firms in the feed 1Ruminants are animals with four-chambered stomachs, including, but not limited to, cattle, buffalo, sheep, goats, deer, elk, and antelope. For the purpose of this report, "cattle" refers to cattle and all other ruminant animals and "cattle feed" refers to feed for cattle and other ruminant animals. 2 21 C.F.R. §589.2000. 3 Adding protein (derived from animals or plants) to feed is a common nutritional practice used to speed animal growth. United States Government Accountability Office Washington, DC 20548 2 GAO-06-157R FDA Feed Testing Program industry.4 In February 2005, we issued a follow-up report that examined the effectiveness of FDA’s actions since the 2002 report to ensure industry compliance with the feed-ban rule and protect U.S. cattle from BSE.5 Our report concluded that while FDA has taken a number of positive steps, its processes still have room for improvement. Our February 2005 report also noted that FDA had begun a small, discrete feed testing program in August 2003. We reported that we would provide information on this new feed testing program, which FDA described as a unique effort, once FDA provided us with data on the feed tests. FDA later gave us the information we required to examine those feed testing activities. Accordingly, this report assesses FDA’s small feed testing program and examines the extent to which this feed testing program helps FDA better assure industry compliance with the feed-ban rule. This report is the final component of our follow-up work on FDA’s BSE prevention efforts. FDA established the feed testing program in an assignment memorandum issued in August 2003, entitled Assignment Memorandum—Sample Assignment for Domestic Products, which contained instructions for implementing the program. The purpose of the feed testing program was to collect and analyze cattle and other types of animal feed and feed ingredients to determine whether feed that could be fed to cattle might contain material prohibited by FDA’s feed-ban rule. Under the program, FDA collected 641 feed samples through the end of fiscal year 2004 and planned to collect 900 feed samples during fiscal year 2005. The 2003 guidance gave FDA’s district offices responsibility for collecting samples and submitting them to an FDA laboratory where analysts test the samples using a procedure called feed microscopy—a visual (microscopic) examination for potentially prohibited material, such as particles of bone, hair, or muscle fiber from certain animals. If an analyst detects what appears to be prohibited material, the findings are confirmed by a second analyst. According to FDA officials, some samples were tested using a more specialized method called polymerase chain reaction (PCR), a test that FDA has been piloting, which can differentiate ruminant DNA from other animal DNA.6 The guidance noted that because FDA had designated a number of cattle-derived exemptions to the feed-ban rule, including blood, milk protein, and plate waste, the laboratory tests could not definitively determine violations but, rather, could identify potential violations. The guidance directs the districts to conduct follow-up reviews on each potential violation to determine whether the facility represented by the sample actually violates the feed ban. On the basis of the follow-up reviews, the districts assign final compliance determinations—that the facility where the sample was collected has complied with or has violated the feed-ban rule. In June 2005, FDA issued a directive that all feed sample analysis and follow-up actions 4GAO, Mad Cow Disease: Improvements in the Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts, GAO-02-183 (Washington, D.C.: Jan. 25, 2002). 5 GAO, Mad Cow Disease: FDA’s Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness, GAO-05-101, (Washington, D.C.: Feb. 25, 2005). 6The PCR test works by aiding in the differentiation of mitochondrial DNA between animal species. 3 GAO-06-157R FDA Feed Testing Program be recorded in FDA’s central data system—the Field Accomplishments and Compliance Tracking System (FACTS)—and that districts complete follow-up reviews of potential violations within 30 working days. In July 2005, FDA issued a revised assignment memorandum that, among other things, enhances the testing protocol by adopting the PCR test for sample retesting and directs districts to provide sufficient narrative explanation in FACTS to explain their final determination on samples that laboratories identify as potential violations. For the purpose of this report, we use the term "feed testing program" to distinguish the samples FDA collected for the feed-testing assignments from samples FDA and states collected in conjunction with routine BSE inspections. We included only the samples that FDA collected for the assignments. To examine the extent to which FDA’s feed testing program provides better assurance of industry compliance with the feed-ban rule, we reviewed FDA’s data on 1,206 samples collected through June 2005. We identified 989 feed samples collected by FDA’s district offices and analyzed by FDA laboratories between August 2003 and June 2005, under the feed testing assignment/program implemented under the August 2003 guidance document. We compared sample collection, analysis, and follow-up with the program instructions in the August 2003 assignment memorandum. In order to assess FDA’s timeliness in analyzing feed samples and to determine results of these analyses, we analyzed data on feed sample collection and laboratory analysis maintained in FACTS on the 989 feed samples. In order to assess the types of follow-up activities carried out by the districts and the basis for their final determinations on potential violations, we obtained and analyzed additional electronic files from FDA districts and discussed those activities and determinations with officials in the 19 FDA district offices. We also obtained detailed district-specific data and information on sample collection, follow-up, and enforcement activities in interviews with the officials in the 19 FDA district offices and discussed this information with FDA headquarters officials. To assess the reliability of the FACTS data, we analyzed the feed sample records in this database as of June 7, 2005. We analyzed the data to identify problems with completeness, accuracy, or timeliness of data entry, and reviewed system documentation on controls. We determined that the data were sufficiently reliable for the purposes of this report. The testing program data assessed for this report, including documentation in FACTS, spreadsheets maintained by individual district offices, documents describing district follow-up actions for individual samples, and all written guidance documents, were provided in response to our specific requests for all such documentation and data related to the feed testing program. Finally, we examined the feed testing program guidance that FDA provided in the June 2005 field management directive and the July 2005 assignment memorandum and compared it with the instructions and guidance FDA provided in the August 2003 memorandum. We performed our work from February through August 2005 in accordance with generally accepted government auditing standards. Our work included an assessment of FDA’s feed testing program data reliability and internal controls. Results in Brief The feed testing program is a small part of FDA’s BSE oversight effort and is one of several methods FDA uses to monitor for compliance with the feed-ban rule. However, 4 GAO-06-157R FDA Feed Testing Program several weaknesses in the design and implementation of the feed testing program need to be addressed to improve its effectiveness. Specifically, under the program guidance, • FDA did not require districts to document their follow-up reviews or the basis for their final determinations on samples that the laboratories identified as potentially containing banned protein products. Although the districts may have conducted rigorous follow-up and exercised sound judgment, the basis for their decisions cannot be reviewed and confirmed. • For nearly half the 989 samples, FDA took longer than 30 days from the date the sample was collected until the date the laboratory completed its analysis— including 21 samples that took longer than 100 days. This extended period does not include the time FDA’s districts would have spent following up on samples that indicated potential violations. FDA and industry agree that cattle feed is consumed very quickly. By the time FDA conducted its follow up to determine whether a violation had occurred, the feed may have been consumed. • FDA managers in headquarters did not adequately oversee the feed testing program. Specifically, FDA managers did not receive periodic reports or have other oversight controls in place to assure that the program was implemented correctly. Moreover, FDA did not identify intended program goals and, as a result, does not know whether or to what extent the feed testing program is contributing to the agency’s BSE oversight efforts. FDA’s June 2005 directive and July 2005 revised instructions—issued nearly 2 years into the program—includes (1) a requirement that follow-up actions and compliance determinations be fully documented in FDA’s centralized FACTS compliance tracking system with sufficient explanation to allow the reader to understand the basis for the decision and (2) a time limit for districts to complete follow-up reviews. To ensure that the feed testing program contributes to FDA’s BSE oversight efforts, we are recommending that FDA (1) fully implement the June 2005 field management directive and July 2005 assignment memorandum, (2) assure that districts and laboratories adhere to time limits on collecting samples, completing sample analysis, and carrying out follow-up activities to minimize cattle’s exposure to potentially contaminated feed, and (3) require sufficient oversight by headquarters managers to assure the program is achieving its intended goals. In commenting on a draft of this report, FDA expressed concern that GAO was issuing a report that focused on one small aspect of FDA’s BSE oversight efforts. We agree that it is a small component of FDA’s overall efforts, but it vies for FDA’s limited BSE oversight resources. Furthermore, as we pointed out in our more comprehensive February 2005 report, we looked at this small program separately because FDA did not provide program data in time for its inclusion in the broader report. FDA also disagreed with two of our recommendations in a draft of this report: that it set a time period for laboratories to complete sample analyses and that headquarters managers exercise sufficient oversight to assure the program operates as intended. FDA indicated that it had some target timeframes for laboratories. Because we could not pinpoint where delays were occurring, we revised our recommendation to address the need to minimize overall time—from sample collection through analysis and follow-up activities—in order to minimize cattle’s exposure to potentially dangerous feed. With regard to our recommendation for better management oversight, FDA disagreed with our assertion that the program was not sufficiently monitored and noted the activities its managers have undertaken. We modified that recommendation to clarify what we believe is needed in terms of management oversight. Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA Implemented in 2003 With Recommendations for Making the Program a Better Oversight Tool. GAO-06-157R, October 11 http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission) https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt Docket Management Docket: 02N-0273 - Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed Comment Number: EC -10 Accepted - Volume 2 File Format: PDF/Adobe Acrobat - Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ... genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest _sporadic_ CJD; 03-025IFA From: Terry S. Singeltary Sr. [flounder9@verizon.net] Sent: Thursday, September 08, 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle Greetings FSIS, I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ; snip...FULL TEXT ; http://docket.epa.gov/edkfed/do/EDKStaffAttachDownloadPDF?objectId=090007d480993808 http://docket.epa.gov/edkfed/do/EDKStaffCollectionDetailView?objectId=0b0007d48096b40d
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