TSE Advisory CommitteeOctober 25, 2001

Center for Food Safety and Applied Nutrition Food and Drug Administration

Washington, DC 20204

Topic 3

Topic 3 Bovine Brain, Spinal Cord, and Other

Neurological Tissue in Foods, Drugs, and Cosmetics for Human Use

Purpose

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

Background

Neurological tissues are the most highly infective tissues in BSE-infected cattle.

These tissues may be used as human food and may be used in a variety of FDA-regulated products.

FDA is not aware of any practical analytical tests for detecting the BSE agent in ingredients or products.

FDA Authorities Public Health Service Act: Make and enforce

regulations to prevent introduction, transmission, or spread of a communicable disease.

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.

USDA Regulates:

Most meat (beef, pork, lamb, horse, goat) Poultry Egg products (liquid, frozen, and dried)

Question 1

What is the public health risk to consumers that would warrant consideration of prohibiting the sale of bovine brain and products containing brain for human use?

Question 2

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?

Question 3

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?

Question 4

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?

Question 5

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

Question 6

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