The remaining cases were discovered in 26 countries,  including Canada and the United States. According to our analysis, this new approach and data system are designed  to more reliably track feed-ban inspection results. As a result, 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. These problems should not occur with FDA’s new  system. Program Weaknesses Continue to Limit the Effectiveness of FDA’s Animal Feed Ban

While FDA has made many improvements to its oversight and enforcement  of the feed ban in response to our 2002 report recommendations, we found  a number of oversight weaknesses that limit the effectiveness of the ban  and could place U.S. cattle at risk for BSE. Specifically, we found that FDA  does not  have a uniform procedure to identify all firms subject to the feed ban,  require firms to notify FDA if they process with prohibited material,  routinely use tests to verify compliance with the feed ban,  alert USDA or states when cattle may have been fed with feed  containing prohibited material, and  adequately overseeing the procedures for cleaning vehicles that haul  cattle feed. We found that 2,833 or about 19 percent, of these firms FDA has identified  as subject to the feed-ban rule have not been reinspected in 5 or more  years. For example, the feed-ban inspection guidance  does not instruct inspectors to routinely sample cattle feed to verify firms’  claims that they do not use prohibited materials or exempt ingredients, or  to ensure that firms’ cleanout and flushing procedures to prevent  commingling are followed and are effective. Research suggests that  cattle can get BSE from ingesting even a small amount of infected  material—an amount that could be introduced in feed that was transported  in a poorly cleaned vehicle. This information has also been used to cite  high industry compliance. However, FDA  said the report did not identify material weaknesses to support our position  that oversight weaknesses limit FDA’s program effectiveness and place U.S.  cattle at risk of spreading BSE. Although FDA noted implementation concerns, it did not take issue on the  need for (1) developing uniform procedures for identifying firms subject to  the feed ban, (2) collecting test results from the states that sample feed, (3)  including a cautionary statement on feed and feed ingredients intended for  export, (4) notifying USDA and states when feed or feed ingredients  containing prohibited material may have been fed to cattle, and (5)  modifying the inspection form to include questions to better oversee the  cleanliness of vehicles used to transport cattle feed or feed ingredients. Scope and Methodology

As discussed below, to assess the effectiveness of the Food and Drug  Administration’s (FDA) actions to ensure industry compliance with the  feed ban and protect U.S. cattle from bovine spongiform encephalopathy  (BSE), we (1) analyzed 404 inspection reports for BSE inspections  performed during fiscal year 2003 and 2004; (2) observed 19 inspections in  12 states that were conducted by either FDA or state inspectors; (3)  assessed the reliability of FDA’s feed-ban inspection database; (4)  interviewed officials at FDA headquarters and district offices, state  agencies, and industry associations, as well as reviewed documents  provided by these officials concerning oversight of the animal feed ban;  and (5) surveyed state agency officials in 38 states. of animal feed to test for prohibited  materials as part of BSE inspections that  are done for FDA? A well enforced feed ban is even more critical now that BSE  has been discovered in cattle in North America. In fact, FDA acknowledges that there are  millions of firms potentially subject to the feed-ban rule. FDA has no  basis for that assertion.
Why GAO Did This Study

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.

What GAO Found

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.