Mad Cow Disease:

FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness

GAO-05-101: Published: Feb 25, 2005. Publicly Released: Mar 15, 2005.

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More than 5 million cattle across Europe have been killed to stop the spread of bovine spongiform encephalopathy (BSE), commonly called mad cow disease. Found in 26 countries, including Canada and the United States, BSE is believed to spread through animal feed that contains protein from BSE-infected animals. Consuming meat from infected cattle has also been linked to the deaths of about 150 people worldwide. In 1997, the Food and Drug Administration (FDA) issued a feed-ban rule prohibiting certain animal protein (prohibited material) in feed for cattle and other ruminant animals. FDA and 38 states inspect firms in the feed industry to enforce this critical firewall against BSE. In 2002, GAO reported a number of weaknesses in FDA's enforcement of the feed ban and recommended corrective actions. This report looks at FDA's efforts since 2002 to ensure industry compliance with the feed ban and protect U.S. cattle.

FDA has made needed improvements to its management and oversight of the feed-ban rule in response to GAO's 2002 report, but program weaknesses continue to limit the effectiveness of the ban and place U.S. cattle at risk of spreading BSE. Improvements made include FDA establishing a uniform method of conducting compliance inspections and training FDA inspectors, as well as state inspectors who carry out inspections under agreements with FDA, on the new method. FDA also implemented new data-entry procedures that are designed to more reliably track feed-ban inspection results. Consequently, FDA has a better management tool for overseeing compliance with the feed-ban rule and a data system that better conforms to standard database management practices. However, various program weaknesses continue to undermine the nation's firewall against BSE. FDA acknowledges that there are more feed manufacturers and transporters, on-farm mixers, and other feed industry businesses that are subject to the feed ban than the approximately 14,800 firms inspected to date; however, it has no uniform approach for identifying additional firms. FDA has not reinspected approximately 2,800, or about 19 percent, of those businesses, in 5 or more years; several hundred are potentially high risk. FDA does not know whether those businesses now use prohibited material in their feed. FDA's feed-ban inspection guidance does not include instructions to routinely sample cattle feed to test for potentially prohibited material as part of the compliance inspection. Instead, it includes guidance for inspectors to visually examine facilities and equipment and review invoices and other documents. Feed intended for export is not required to carry a caution label "Do not feed to cattle or other ruminants," when the label would be required if the feed were sold domestically. Without that statement, feed containing prohibited material could be inadvertently or intentionally diverted back to U.S. cattle or given to foreign cattle. FDA has not always alerted USDA and states when it learned that cattle may have been given feed that contained prohibited material. This lapse has been occurring even though FDA's guidance calls for such communication. Although research suggests that cattle can get BSE from ingesting even a small amount of infected material, inspectors do not routinely inspect or review cleanout procedures for vehicles used to haul cattle feed.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: To further strengthen oversight and enforcement of the animal feed ban and better protect U.S. cattle and American consumers, the Commissioner of FDA should develop uniform procedures for identifying additional firms subject to the feed ban.

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

    Status: Closed - Implemented

    Comments: FDA has taken several actions that meet the intent of our recommendation for FDA to develop more uniform procedures to identify additional firms subject to the feed ban. FDA has taken action to increase its inventory of firms subject to the feed ban. In addition to ongoing efforts by FDA District Offices to work with their states to identify firms subject to the feed ban, the Center for Veterinary Medicine (CVM) issued an assignment to the District Offices in September 2006 to work with states to develop an inventory of salvage firms. A second CVM assignment issued in 2007 directed Districts to work with their states to develop an inventory of firms that transport feed and feed ingredients. To strengthen the inspection program related to BSE, FDA awarded grants for fiscal year 2006 to eight state feed regulatory agencies and to four additional state feed regulatory agencies in fiscal year 2008; most of the grant proposals explained how the states would earmark a portion of the funding to further develop their facility inventories. FDA is also working with USDA to identify new firms engaged in rendering-type activities.

    Recommendation: To further strengthen oversight and enforcement of the animal feed ban and better protect U.S. cattle and American consumers, the Commissioner of FDA should require firms that process with prohibited material to notify FDA. If FDA believes it does not have the necessary statutory authority, it should seek that authority from Congress.

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

    Status: Closed - Not Implemented

    Comments: The status of the recommendation implementation is unchanged from the response FDA provided following GAO's February 2005 Report. FDA said that the recommendation requires a statutory change by the Congress and would take significant resources to implement.

    Recommendation: To further strengthen oversight and enforcement of the animal feed ban and better protect U.S. cattle and American consumers, the Commissioner of FDA should develop guidance for inspectors to systematically use tests to verify the safety of cattle feed and to confirm the adequacy of firms' procedures for ridding equipment and vehicles of prohibited material before they are used for processing or transporting cattle feed or feed ingredients.

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

    Status: Closed - Not Implemented

    Comments: The status of the recommendation implementation is unchanged from the response FDA provided following GAO's February 2005 Report. FDA said that no test currently exists for the detection of the infectious prion agent in feed that causes BSE. In its FY 2007 accomplishment report for the Center for Veterinary Medicine, FDA said it is currently validating the "real time polymerase chain reaction" method for detecting prohibited animal proteins in animal feed but had not completed its validation. FDA said that when the method is validated, it will be used to detect prohibited proteins produced according to U.S. processing conditions. FDA said it did validate the method for use in detecting prohibited proteins processed according to European Union conditions, and can be used to detect these materials in imported products.

    Recommendation: To further strengthen oversight and enforcement of the animal feed ban and better protect U.S. cattle and American consumers, the Commissioner of FDA should collect feed test results from states that sample feed to help verify compliance with the feed ban.

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

    Status: Closed - Implemented

    Comments: FDA has taken action to collect feed test results from the states. FDA awarded grants to eight state feed regulatory agencies in fiscal year 2006 and four additional state feed regulatory agencies in fiscal year 2008. Under these grants, each state agency has purchased laboratory equipment, hired and trained analysts and inspectors, sampled and tested feed samples using FDA approved test methods, and submit midyear (June) and end of year (December) reports to FDA. FDA reports that the program has been successful overall. FDA met with the original 8 state grantees in January 2008 to review performance and gain feedback. These actions meet the intent of our recommendation.

    Recommendation: To further strengthen oversight and enforcement of the animal feed ban and better protect U.S. cattle and American consumers, the Commissioner of FDA should develop a sample design for FDA's inspectors to use for sampling finished feed and feed ingredients that will allow FDA to more accurately generalize about compliance with the feed ban from the test results.

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

    Status: Closed - Not Implemented

    Comments: The status of the recommendation implementation is unchanged from the response following GAO's February 2005 report. FDA said sampling of finished feed and feed ingredients cannot serve as a basis to generalize compliance with the feed ban. FDA said the currently available tests are not definitive for prohibited material and does not by itself prove the presence of prohibited material and a violation of the ruminant feed ban.

    Recommendation: To further strengthen oversight and enforcement of the animal feed ban and better protect U.S. cattle and American consumers, the Commissioner of FDA should seek authority from Congress to require the cautionary statement on feed and feed ingredients that are intended for export and that contain prohibited material.

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

    Status: Closed - Not Implemented

    Comments: The status of the recommendation implementation is unchanged from the response following GAO's February 2005 Report. FDA said that for the most part, it focuses its policies on matters under its regulatory authority. In addition, FDA said that before it could adopt a policy to encourage the use of the cautionary statement on exports, it would need to determine that such a statement would not be inconsistent with the laws of other countries.

    Recommendation: To further strengthen oversight and enforcement of the animal feed ban and better protect U.S. cattle and American consumers, the Commissioner of FDA should ensure that USDA and states are alerted when inspectors discover that feed or feed ingredients with prohibited material may have been fed to cattle.

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

    Status: Closed - Not Implemented

    Comments: FDA has not provided sufficient documentation to allow us to detemine what, if any, actions may have been taken.

    Recommendation: To further strengthen oversight and enforcement of the animal feed ban and better protect U.S. cattle and American consumers, the Commissioner of FDA should modify the BSE inspection form to include questions inspectors can use to document whether firms that process or handle cattle feed or feed ingredients have procedures to ensure the cleanliness of vehicles they use to transport cattle feed and feed ingredients.

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

    Status: Closed - Implemented

    Comments: FDA revised the BSE inspection form in October 2007 to include the recommended information. FDA added questions that FDA and state inspectors use to document whether firms that process or handle prohibited material have procedures to ensure the cleanliness of transportation vehicles to adequately prevent commingling or cross-contamination with cattle feed or feed ingredients.

    Recommendation: To further strengthen oversight and enforcement of the animal feed ban and better protect U.S. cattle and American consumers, the Commissioner of FDA should ensure that inspection results are reported in a complete and accurate context.

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

    Status: Closed - Not Implemented

    Comments: The status of the recommendation implementation is unchanged from the response following GAO's February 2005 Report. FDA believes that it is reporting inspections results in a complete and accurate context.

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