Mad Cow Disease is the commonly used name for Bovine Spongiform Encephalopathy (BSE), a slowly progressive, degenerative, fatal disease affecting the central nervous system of adult cattle. Since 1990, the U.S. Department of Agriculture (USDA) has conducted aggressive surveillance of the highest risk cattle going to slaughter in the United States. The exact cause of BSE is not known but it is generally accepted by the scientific community that the likely cause is infectious forms of a type of protein, prions, normally found in animals cause BSE. In cattle with BSE, these abnormal prions initially occur in the small intestines and tonsils, and are found in central nervous tissues, such as the brain and spinal cord, and other tissues of infected animals experiencing later stages of the disease. There is a disease similar to BSE called Creutzfeldt-Jacob Disease (CJD) that is found in people. A variant form of CJD (vCJD) is believed to be caused by eating contaminated beef products from BSE-affected cattle. To date, there have been 155 confirmed and probable cases of vCJD worldwide among the hundreds of thousands of people that may have consumed BSE-contaminated beef products. The one reported case of vCJD in the United States was in a young woman who contracted the disease while residing in the UK and developed symptoms after moving to the U.S. Since 1989, the FDA and other federal agencies have had ongoing regulatory measures in place to prevent BSE contamination of U.S. food and food products. Following the identification in a Washington state dairy herd of a BSE-positive cow imported from Canada, USDA issued new regulations containing additional safeguards to further minimize risk for introduction of the BSE agent into the U.S. food supply. See USDA's website www.usda.gov for further information. Similarly, FDA has prohibited the use of the cattle materials that carry the highest risk of BSE in human food, including dietary supplements, and in cosmetics. FDA's rule (and September 2005 amendments) prohibit use of the following cattle material in human food and cosmetics: * cattle material from non-ambulatory, disabled cattle, * cattle material from organs from cattle 30 months of age or older in which infectious prions are most likely to occur, and the tonsils and the distal ileum of the small intestine of cattle of all ages, * cattle material from mechanically separated (MS) (beef), and * cattle material from cattle that are not inspected and passed for human consumption FDA's rule also requires that food and cosmetics manufacturers and processors make available to FDA any existing records relevant to their compliance with these prohibitions. FDA has also published a proposal requiring manufacturers and processors of food and cosmetics made with cattle material to establish and maintain records demonstrating that their products do not contain prohibited cattle material. In September 2005, FDA amended the interim final rule to allow use of the small intestine in human food and cosmetics, provided the distal ileum has been removed. FDA also clarified that milk and milk products, hide and hide-derived products and tallow derivatives are not considered prohibited cattle materials. Finally, in response to comments the agency has reconsidered the method cited in the interim final rule for determining insoluble impurities in tallow and is citing a method that is less costly and requires less specialized equipment.