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Statement of Need: FDA is proposing recordkeeping requirements because records documenting the absence of prohibited cattle materials are needed by manufacturers and processors of human medical products and animal drugs that contain or are manufactured with cattle material to ensure that these products do not contain prohibited cattle materials. Prohibited cattle materials are 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. FDA is proposing additional restrictions for higher risk human medical products and for ruminant drugs to address the greater disease risk posed by these products should they contain any infectious material from a BSE-positive animal.

Summary of the Legal Basis: Undetermined.

Alternatives: Alternatives were not specifically considered in the proposed rule with regard to recordkeeping requirements because it was a companion rulemaking to the interim final rule prohibiting the use of certain cattle material in human medical products and animal drugs. Recordkeeping alternatives were considered in the interim final rule. Those same alternatives, plus any new ones presented in comments, will be considered for the final rule. There were several alternatives considered to the proposed additional restrictions. These same alternatives, plus any new ones presented in comments, will be considered for the final. • No additional restrictions. • Prohibit the use in higher risk human medical products of listed neural tissues from cattle 12 months and older and all cattle material from countries listed by APHIS as having unacceptable risk or incidence of BSE, and prohibit the use in ruminant drugs of those materials that are prohibited in ruminant feed.

Anticipated Costs and Benefits: FDA believes 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 and of conforming with additional restrictions on the use of cattle material in certain medical products (implantable, etc.). In addition, affected manufacturers will incur costs associated with establishing and maintaining records to demonstrate compliance. 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 finalizing the proposed rule with respect to its recordkeeping requirements are derived from the benefits of the interim final rule, which are the value of the public and animal health benefits. The benefits of finalizing the proposed rule with respect to its additional requirements are also the value of the public and animal health benefits. The public and animal health benefit is the reduction in the risk of the human or animal illness associated with exposure to the agent that causes BSE.