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: Published: Oct 11, 2005. Publicly Released: Nov 9, 2005.

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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. 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), 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. 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 industry. 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. 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.

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, 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.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: FDA implemented this recommendation. The directive and assignment memorandum were being implemented as the report was under final review. At recommendation follow up, FDA confirmed it was continuing implementation.

    Recommendation: To ensure that the feed testing program is a useful tool for helping FDA oversee industry compliance with the feed-ban rule, the Commissioner of FDA should fully implement the June 2005 field management directive and July 2005 assignment memorandum revising the feed testing program.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  2. Status: Closed - Not Implemented

    Comments: FDA did not implement this recommendation.

    Recommendation: To ensure that the feed testing program is a useful tool for helping FDA oversee industry compliance with the feed-ban rule, the Commissioner of FDA should assure that districts and laboratories adhere to time limits on collecting samples and completing sample analysis and follow-up activities to minimize cattle's exposure to potentially contaminated feed.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  3. Status: Closed - Not Implemented

    Comments: FDA did not implement this recommendation.

    Recommendation: To ensure that the feed testing program is a useful tool for helping FDA oversee industry compliance with the feed-ban rule, the Commissioner of FDA should require FDA headquarters managers to exercise sufficient oversight, with periodic reports from the Field Accomplishments and Compliance Tracking System or other management controls, and identify appropriate performance indicators for the feed testing program, to assure that the program operates as intended and achieves its intended goals.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

 

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