On March 18, 2016 the FDA issued its final rule prohibiting the use of certain cattle material in human foods, dietary supplements, and cosmetics. The rule is focused on reducing the risk of human exposure to bovine spongiform encephalopathy (BSE), a fatal neurological disorder sometimes known as “mad cow disease.” The rule will take effect on April 18, 2016.
Under the final rule, FDA prohibits the use of designated parts and organs referred to as “specified risk materials.” Studies have shown that when cattle are infected with BSE, the BSE agent resides in these parts and organs. The final rule also prohibits the use of the small intestine (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption by the appropriate regulatory authority, and mechanically separated beef. FDA has clarified that other materials can be used in foods and cosmetics and are not prohibited: milk and milk products, hides and hide-derived products, tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, and gelatin manufactured using customary industry practices.
Cattle materials inspected and passed from a country specifically designated under the rule are also carved out from the BSE-related restrictions. A country seeking to be designated must send a written request to the Director of FDA’s Center for Food Safety and Applied Nutrition, including information about the country’s BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other relevant information.
The final rule completes a rulemaking process that began with an interim final rule in 2004 and was followed by interim final rules in 2005 and 2008. In addition to the restrictions in this final rule, FDA has other specific requirements regarding record maintenance, retention, and accessibility, for manufacturers and processors of human foods or cosmetic products made with material from cattle.
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