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Statement of Need: In December 2003, the U.S. Department of Agriculture (USDA) announced a positive case of BSE in a dairy cow in Washington State. Subsequent epidemiological investigations confirmed that the infected cow was born and most likely became infected in Alberta, Canada, prior to Canada's 1997 implementation of a ban on feeding mammalian protein to ruminants. This case followed the identification of BSE in a single cow in Alberta, Canada, in May 2003. In response to the identification of these BSE cases in North America, FDA is proposing to amend its regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals. This measure will further strengthen existing safeguards designed to help prevent the spread of BSE in U.S. cattle. BSE belongs to a family of diseases known as transmissible spongiform encephalopathies (TSEs). TSE’s are fatal, progressively degenerative central nervous system diseases of man and other animals. TSE’s include, among other diseases, BSE in cattle, scrapie in sheep and goats, chronic wasting disease (CWD) in deer and elk, and Creutzfeldt-Jakob disease (CJD) in humans. There is no known treatment for these diseases, and there is no vaccine to prevent them. In addition, although validated postmortem diagnostic tests are available, there are no validated diagnostic tests for BSE that can be used to test for the disease in live animals. In the Federal Register of July 14, 2004 (69 FR 42288), FDA and USDA jointly published an advance notice of proposed rulemaking (ANPRM) to inform the public about the recommendations made by a team of international BSE experts (IRT) convened by the Secretary of Agriculture in January 2004 and to request comments on a number of issues related to possible regulatory measures. Among other recommendations, the IRT recommended that: 1) all specified risk materials (SRMs) be excluded from all animal feed including pet food; 2) cross contamination be prevented throughout thfeed chain; and 3) the use of all mammalian and poultry protein in ruminant feed be prohibited. FDA intends to consider all information received in response to the ANPRM prior to making a determination as to what measures are needed to further strengthen animal feed safeguards.

Summary of the Legal Basis: The agency is proposing these regulations under sections 402 and 701 of the Federal Food, Drug, and Cosmetics Act.

Alternatives: FDA has considered four other measures that are not included in the proposed rule. These measures include: 1) a requirement that those facilities handling both prohibited materials and ruminant feeds use dedicated facilities or equipment for each; 2) a ban on the use of poultry litter in ruminant feeds; 3) a ban on the use of blood and blood products in ruminant feeds; and 4) a ban on the use of what is commonly referred to as plate waste in ruminant feeds.

Anticipated Costs and Benefits: The proposed regulation may be expected to require the expenditure of over $100 million in any one year by the private sector and may have a significant impact on a substantial number of small entities. The estimated total annualized costs of the rule are the sum of the costs of prohibiting the list of cattle origin materials identified in the proposed rule. The benefit of the proposed rule includes the elimination of much of the remaining risk of spreading BSE in U.S. cattle. Assuming the hypothetical import of five infected cattle, FDA believes that the proposed rule would effectively remove about 95 percent of the remaining risk of human exposure to BSE infected material. The U.S. economy may also benefit from increased exports to the extent that the rule persuades foreign governments to import U.S. beef products. While we are unable to quantify these benefits, they are potentially large, given the significant loss of exports resulting from the discovery of an infected cow in Washington State.

Risks: BSE is an incurable disease that can affect cattle and certain other mammals that ingest infective material from BSE infected cattle. In 1996, a newly recognized form of the human disease, Creutzfeldt-Jakob disease (CJD), referred to as variant CJD (vCJD), was reported in the United Kingdom. Scientific and epidemiological studies have linked vCJD to exposure to the BSE agent, most likely through human consumption of beef products contaminated with the agent that causes BSE. The discovery of a BSE positive dairy cow in Washington State in December 2003, caused the Agency to review its policies for the prevention of the spread of BSE within the United States. The need for regulatory action in this case is related to the inability of the market and existing regulations to ensure that the risk of BSE exposure through animal feed is minimized to the extent possible, given that BSE could potentially have an enormous adverse impact on both animal and human health.