0910-AF54 200410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Use of Materials Derived From Cattle In Human and Animal Medical Products The regulation would prohibit the use of certain cattle material in the manufacture of human medical products and animal drugs. The rule would prohibit the same cattle material that is prohibited in the previous FDA IFR that applies to foods and cosmetics. These include certain high risk tissues (e.g., brain, skull, eyes, spinal cord, trigeminal ganglia, parts of the vertebral column, and dorsal root ganglia) from cattle 30 months and older, tonsils and the distal ileum as well as the rest of the small intestine of cattle of any age, mechanically separated beef, material from nonambulatory disabled cattle, and material from cattle not inspected and passed for human consumption. The prohibitions would apply only to materials derived from animals slaughtered after the effective dates of the rules. Other Significant First Time Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 116 21 CFR 226.60 21 CFR 300.200 21 CFR 500 21 CFR 600.16 21 CFR 895 21 CFR 1271.465 21 CFR 1271.470 Not Yet Determined Yes FDA is taking this action in response to the finding of an adult cow, imported from Canada, that tested positive for BSE in the State of Washington. This action will minimize human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. Undetermined. There were several alternatives considered to the rule. These same alternatives, plus any new ones presented in comments, will be considered for the final. • No new regulation. • Prohibit the use of prohibited cattle materials in human medical products and animal drugs and require access to existing records relevant to determine compliance. • Prohibit the use of prohibited cattle materials in human medical products and animal drugs and require establishment, maintenance, and access to records demonstrating that prohibited cattle materials are not used in human food and cosmetics. FDA expects minimal costs of compliance as this rule reflects current practices of most affected manufacturers. The costs of this rule are the costs to industry of assuring that prohibited materials are not used in the manufacture of medical products. By reducing exposure to potentially infective materials, this rule will provide an additional safeguard against a case of vCJD occurring in humans if cattle infected with BSE are used in the manufacture or processing of medical products. The benefits of the rule will be the value of the public and health benefits. The public and animal health benefit is the reduction in the risk of the human and ruminant illness associated with exposure to the agent that causes BSE. NPRM 02/00/2005 No No None No NA Not Collected Eric Flamm 0910 Food and Drug Administration FDA 301 796-4726 301 847-3541 eric.flamm@fda.hhs.gov Office of the Commissioner, WO1, Room 4315B, 10903 New Hampshire Ave., Silver Spring MD 20993