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HHS/FDA RIN: 0910-AF54 Publication ID: Fall 2004 
Title: ●Use of Materials Derived From Cattle In Human and Animal Medical Products 
Abstract: 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 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 
Legal Authority: Not Yet Determined 
Legal Deadline:  None

Statement of Need: 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.

Summary of the Legal Basis: Undetermined.

Alternatives: 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.

Anticipated Costs and Benefits: 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.

Risks: 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.

Timetable:
Action Date FR Cite
NPRM  02/00/2005   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
Agency Contact:
Eric Flamm
Senior Policy Advisor, Office of Policy
Department of Health and Human Services
Food and Drug Administration
Office of the Commissioner, WO1, Room 4315B, 10903 New Hampshire Ave.,
Silver Spring, MD 20993
Phone:301 796-4726
Fax:301 847-3541
Email: eric.flamm@fda.hhs.gov

 
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