Mad Cow Disease:

Improvements in the Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts

GAO-02-183: Published: Jan 25, 2002. Publicly Released: Feb 26, 2002.

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Bovine spongiform encephalopathy (BSE), also known as mad cow disease, has been found in cattle in 23 countries. Countries with BSE have suffered large economic losses because of declines in both beef exports and domestic beef sales. The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have primary responsibility for preventing the introduction of BSE-contaminated cattle, beef, and cattle-derived products into the United States. GAO found that FDA has not acted promptly to force firms to keep prohibited proteins out of cattle feed and to label animal feed that cannot be fed to cattle. FDA's data on inspections are severely flawed, and FDA is unaware of the full extent of industry compliance. If BSE was discovered in U.S. cattle, many consumers might refuse to buy domestic beef; beef exports could decline dramatically as could sales in related industries, such as hamburger chains and frozen dinner manufacturers. Furthermore, some people might develop mad cow disease if infected cattle were to enter the food supply. The United States acted as many as five years earlier than did other countries to impose controls over imports of animals and animal feed ingredients from countries that had experienced mad cow disease. Similarly, U.S. surveillance efforts to test cattle brains for mad cow disease met internationally recommended testing targets earlier than did other countries. However, the United States' feed ban is more permissive than that of other countries, allowing cattle feed to contain proteins from horses and pigs. FDA is reviewing whether these ingredients should continue to be allowed in cattle feed. Finally, as in most countries that are BSE-free, cattle brains and other central nervous system tissue can be sold as human food.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: To meet resource needs, FDA hired more than 655 food security personnel and increased port-of-entry food examinations, including imported animal feed and feed ingredients that could pose a risk of BSE. Further, under the Bioterrorism Act, FDA and Customs were required to integrate their information systems, which has allowed FDA to more efficiently evaluate and process import entries. Finally, FDA and Customs signed a memorandum-of-understanding under which FDA has commissioned over 8,000 Customs officers to conduct, on FDA's behalf, investigations and examinations of imported food and feed.

    Recommendation: In order to strengthen inspections of imported products that could pose a risk of BSE, the Secretaries of Health and Human Services and of Agriculture, in consultation with the Commissioner of Customs, should develop a coordinated strategy, including identifying resource needs.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: Under the Bioterrorism Act, a substantial number of APHIS border inspectors were transferred to DHS to provide additional Customs resources. In addition, FDA hired more than 655 food security personnel and increased port-of-entry food examinations, including imported animal feed and feed ingredients that could pose a risk of BSE. Further, under the Bioterrorism Act, FDA and Customs were required to integrate their information systems, which has allowed FDA to more efficiently evaluate and process import entries.

    Recommendation: In order to strengthen inspections of imported products that could pose a risk of BSE, the Secretaries of Health and Human Services and of Agriculture, in consultation with the Commissioner of Customs, should develop a coordinated strategy, including identifying resource needs.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: FDA developed and implemented a BSE inspection reporting form that provides guidance to inspectors on how to uniformly and completely document a firm's operations and assess compliance with the feed rule. The information is maintained in a new database that was designed to more reliably track results and catch errors. FDA provided training for FDA and state inspectors on conducting and documenting BSE inspections with the new form and worked with district and state coordinators to ensure that all inspectors use the reporting form. The BSE coordinator in each FDA district office is responsible for ensuring that inspection reports are accurate and completed in a timely fashion. The BSE district and state coordinators use inspection data on suppliers and customers of inspected firms to identify new firms subject to the feed ban rule.

    Recommendation: In order to strengthen oversight and enforcement of the animal feed ban, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop a strategy, working with states, to ensure that the information FDA needs to oversee compliance is collected and that all firms subject to the feed ban are identified and inspected in a timely fashion.

    Agency Affected: Department of Agriculture

  4. Status: Closed - Implemented

    Comments: With FDA's recently issued feed ban inspection guidance, FDA and state inspectors and program managers can determine whether, and to what extent, firms are in compliance with the feed ban rule and help ensure that BSE inspections and enforcement actions are conducted in a uniform fashion. The recently implemented BSE feed ban database and data entry procedures allow for more reliable tracking of inspection results and prompt more timely follow up on non-compliance. These actions largely address the intent of our recommendation.

    Recommendation: In order to strengthen oversight and enforcement of the animal feed ban, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop an enforcement strategy with criteria for actions to address firms that violate the ban and time frames for reinspections to confirm that firms have taken appropriate corrective actions.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Not Implemented

    Comments: FDA does not plan to track enforcement actions taken by states. Because states' standards for initiating enforcement actions may differ from FDA's standards, FDA believes enforcement actions would not be comparable and the information would be misleading if presented collectively. We believe FDA is not availing itself of valuable information.

    Recommendation: In order to strengthen oversight and enforcement of the animal feed ban, the Secretary of Health and Human Services should direct the Commissioner of FDA to track enforcement actions taken by states.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Implemented

    Comments: FDA implemented a newly designed feed ban database and data entry procedures in its agency-wide Field Accomplishment and Compliance Tracking System (FACTS). The new approach and data system, which better conform to standard database management practices, include unique firm identifiers and provide edit checks to detect incomplete and inaccurate information. As a result, FDA is able to report more reliable feed ban compliance information on its Web site.

    Recommendation: In order to strengthen oversight and enforcement of the animal feed ban, the Secretary of Health and Human Services should direct the Commissioner of FDA to ensure that, as contractors modify the inspection database, they incorporate commonly accepted data management and verification procedures so that the inspection data can be useful as a management and reporting tool.

    Agency Affected: Department of Health and Human Services

  7. Status: Closed - Implemented

    Comments: USDA now requires the complete removal of the spinal cord and other tissue at risk for carrying BSE.

    Recommendation: In order to help consumers identify foods that may contain central nervous system tissue, as USDA evaluates whether such tissue from cattle poses a health risk, the Secretary of Agriculture should consider whether some interim action, such as public service announcements or caution labels or signs, might be appropriate to advise consumers that certain beef cuts and beef products may contain central nervous system tissue.

    Agency Affected: Department of Health and Human Services

  8. Status: Closed - Implemented

    Comments: USDA implemented a regulation that bans the practice of using advanced meat recovery technology.

    Recommendation: In order to help consumers identify foods that may contain central nervous system tissue, as USDA evaluates whether such tissue from cattle poses a health risk, the Secretary of Agriculture should better enforce the existing labeling requirement for products that contain beef extracted using advanced meat recovery technology and contain central nervous system tissue.

    Agency Affected: Department of Agriculture

  9. Status: Closed - Implemented

    Comments: USDA agreed to, and has followed through on, targeting animals that die on farms in its expanded BSE surveillance program.

    Recommendation: In order to strengthen the BSE surveillance program, the Secretary of Agriculture should increase the number of tests from cattle that die on farms in the BSE surveillance program.

    Agency Affected: Department of Agriculture

  10. Status: Closed - Implemented

    Comments: FDA recently prohibited the use of certain cattle material, including central nervous system tissue from nonambulatory cattle, in food for humans, including dietary supplements, and in cosmetics. According to FDA, if, based on science, the presence of central nervous system tissue poses a human risk, it should not be allowed as an ingredient in products. The act of banning this cattle material achieves the intent of our recommendation for FDA to consider whether certain products should have warning labels.

    Recommendation: Additionally, to further help consumers identify foods or other products that may contain central nervous system tissue, the Secretary of Health and Human Services should consider whether the products it regulates, including food, cosmetics, and over-the-counter drugs, should be labeled to advise consumers that the products may contain central nervous system tissue.

    Agency Affected: Department of Agriculture

 

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