1. TSE Advisory Committee October 25, 2001 Center for Food Safety and Applied Nutrition Food and Drug Administration Washington, DC 20204 Topic 3

2. l Bovine Brain, Spinal Cord, and Other Neurological Tissue in Foods, Drugs, and Cosmetics for Human Use

3. Purpose l To determine the benefit, if any, of restricting the use of bovine neurological tissues and products derived from these tissues in foods, drugs, and cosmetics for human use

4. Background l Neurological tissues are the most highly infective tissues in BSE-infected cattle. l These tissues may be used as human food and may be used in a variety of FDA- regulated products. l FDA is not aware of any practical analytical tests for detecting the BSE agent in ingredients or products.

5. FDA Authorities l Public Health Service Act: Make and enforce regulations to prevent introduction, transmission, or spread of a communicable disease. l Federal Food, Drug, and Cosmetic Act: Ensure the safety of cosmetics, food (including dietary supplements) and feed, drugs (including animal drugs), vaccines, biologics, blood products, and medical devices.

6. USDA Regulates: l Most meat (beef, pork, lamb, horse, goat) l Poultry l Egg products (liquid, frozen, and dried)

8. Question 1

9. Question 2 l Is there a consistent and appreciable difference in infectivity of various sections/areas of bovine brain? If so, what are the differences in relative degrees of infectivity of these areas?

10. Question 3 l Are there other bovine neurological tissues that, if used in consumer products (such as foods, dietary supplements, cosmetics, and certain non-application drugs), could also pose a significant health hazard? If so, what are the differences in relative degrees of infectivity of these tissues?

11. Question 4 l What physical, chemical, or biological factors of tissues and/or processes should FDA consider in reviewing procedures that may have the ability to reduce infectivity of bovine neurological tissues and products containing bovine neurological tissues?

12. Question 5 l What tests are available to ascertain changes in infectivity in products containing bovine neurological tissues as a result of processing?

13. Question 6 l What level of reduction in infectivity is necessary to consider products containing bovine neurological tissues non-infective or "safe" for human use?