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Statement of Need: FDA proposed recordkeeping requirements because records documenting the absence of prohibited cattle materials are needed by manufacturers and processors of human food and cosmetics that contain 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.

Summary of the Legal Basis: Because the rule is a companion rulemaking to the interim final rule prohibiting the use of certain cattle material in human food and cosmetics, we issued the proposed rule under the authorities cited in the interim final rule (21 U.S.C. sections 342(a)(2)(C), 342(a)(3), 342(a)(4), 342(a)(5), 361(c), and 371(a)) as well as sections 801(a) and 701(b) of the Federal Food, Drug, and Cosmetic Act (the Act). Without records documenting the absence of BSE risk materials in source materials, manufacturers and processors of human food and cosmetics cannot know whether they are adulterating their products by including BSE risk materials in their products. Therefore, a failure of manufacturers and processors to establish and maintain such records results in human food and cosmetics being prepared under unsanitary conditions whereby they may have been rendered injurious to health. Furthermore, without adequate records, FDA cannot know whether manufacturers and processors of human food and cosmetics have complied with the prohibitions against use of BSE risk materials. Therefore, the recordkeeping requirements are necessary for the efficient enforcement of the interim final rule. We are also issuing the provisions of this proposed rule related to records regarding imported human food and cosmetics under sections 801(a) and 701(b) of the Act. Section 801(a) (21 U.S.C. 381(a)) provides for refusal of admission into the United States of human food and cosmetics that appear to be adulterated. Section 701(b) (21 U.S.C. 371(b)) authorizes the Secretaries of Treasury and Health and Human Services to jointly prescribe regulations for the efficient enforcement of section 801. This proposed rule sets out requirements for imported human food and cosmetics to ensure that only products that fully comply with the requirements of the interim final rule are admitted into the United States.

Alternatives: Alternatives were not specifically considered in the proposed rule because it was a companion rulemaking to the interim final rule prohibiting the use of certain cattle material in human food and cosmetics. 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.

Anticipated Costs and Benefits: If the proposal is finalized, we expect that the costs will be to setup and then to maintain a recordkeeping system to document all cattle-derived ingredients, except tallow derivatives, used in FDA-regulated food and cosmetics. The setup costs are about $1 million, and the annual costs of maintaining the recordkeeping system are about $200,000. The benefit of the rule is that its requirements will--by requiring records that the provisions of the interim final rule have been followed--provide an additional safeguard against a case of vCJD occurring in humans.

Risks: The benefits of finalizing the proposed rule are derived from the benefits of the interim final rule, which are the value of the public health benefits. The public health benefit is the reduction in the risk of the human illness associated with consumption of the agent that causes BSE. The Harvard-Tuskegee risk assessment has stated that a ban on specified risk materials, including cattle brains, spinal cord and vertebral column, from inclusion in human and animal food would reduce the very few potential BSE cases in cattle by a further 88 percent and potential human exposure to infectivity in meat and meat products by a further 95 percent.