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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. SNIP...FULL TEXT 29 PAGES ; http://www.gao.gov/new.items/d06157r.pdf https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt Docket Management Docket: 02N-0273 - Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed Comment Number: EC -10 Accepted - Volume 2 PART 2 PDF]Freas, William TSS SUBMISSION File Format: PDF/Adobe Acrobat - Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ... http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf Asante/Collinge et al, that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest _sporadic_ CJD; http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm Docket 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[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle03-025IFA03-025IFA-2Terry S. SingeltaryPage 1 of 17From: Terry S. Singeltary Sr. [flounder9@verizon.net]Sent: Thursday, September 08, 2005 6:17 PMTo: fsis.regulationscomments@fsis.usda.govSubject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirementsfor the Disposition of Non-Ambulatory Disabled CattleGreetings 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 andRequirements for the Disposition of Non-Ambulatory Disabled CattleTHE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled CattleBroken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;SUB CLINICAL PRION INFECTIONMRC-43-00Issued: Monday, 28 August 2000NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCHFINDINGS RELEVANT TO CJD AND BSEA team of researchers led by Professor John Collinge at the MedicalResearch Council Prion Unit1 report today in the Proceedings of theNational Academy of Sciences, on new evidence for the existence of a?sub-clinical? form of BSE in mice which was unknown until now. 9/13/2005
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