View Rule

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: FDA's legal basis for the IFR derived from the adulteration provisions in sections 402(a)(2)(C), 402(a)(3), 402(a)(4), 402(a)(5), 601(c), and under section 701(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. sections 342(a)(2)(C), 342(a)(3), 342(a)(4), 342(a)(5), 361(c), and 371(a)). Under section 402(a)(3) of the Act, a food is deemed adulterated "if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food." Because of the discovery of a BSE positive cow in the United States and the possibility of disease transmission to humans from exposure to material from infected cattle, BSE risk materials are unfit for food. Furthermore, some cattle are not inspected and passed because they have died before slaughter. Material from these cattle is adulterated under section 402(a)(5). The failure to ensure that food or cosmetics are prepared, packed, or held under conditions in which BSE risk materials do not contaminate the food or cosmetics constitutes an insanitary condition whereby the food or cosmetics may have been rendered injurious to health and thus renders the food or cosmetics adulterated under section 402(a)(4) or 601(c). We are also relying on the food additive provision in section 402(a)(2)(C). Because neither a food additive regulation nor an exemption is an effect for BSE risk materials intended for use in human food, such materials, with the exception of dietary ingredients in dietary supplements, are adulterated under section 402(a)(2)(C) of the act and their presence in food renders the food adulterated. Finally, requiring measures to prevent food and cosmetics from being adulterated allows for efficient enforcement of the act under section 701(a). Once material is removed from cattle, we may not be able to obtain the information necessary to determine whether it is BSE risk material. Therefore, the records access requirement is also necessary for the efficient enforcement of this rule.

Alternatives: There were several alternatives considered to the interim final 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 food and cosmetics and require access to existing records relevant to determine compliance. • Prohibit the use of prohibited cattle materials in human food and cosmetics 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: We expect the social cost of the final rule, which we approximate by multiplying the difference in ingredient prices by the preregulation quantity of ingredients, will be borne by producers and consumers of affected products. If demand is inelastic compared with supply, consumers will bear most of the social cost. If supply is inelastic compared with demand, producers will bear most of the social cost. The ready availability of alternatives for the prohibited ingredients, and the small number of products currently using them, implies that the social costs of this rule will likely be small for foods. The social costs for cosmetics will be greater. We estimate that the cost of ingredient switching for cosmetics will range from a lower bound of $0 to an upper bound of $18 million. The benefit of the final rule is that its requirements will-by reducing exposure to potentially infective materials-provide a safeguard against a case of vCJD occurring in humans if cattle infected with BSE enter the human food or cosmetic supply.

Risks: The benefits of the final rule will be 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.