The U.S. Food and Drug Administration (FDA) recently issued a final rule to address the risk of bovine spongiform encephalopathy (BSE) by prohibiting the use of certain cattle material in human food, dietary supplements and cosmetics. BSE is a terminal, neurological disease transmitted “when cattle ingest protein meal containing the BSE infectious agent.” Prohibited cattle materials include “Specified Risk Materials (SRMs), the small intestine from all cattle (unless the distal ileum has been removed), material from non-ambulatory disabled cattle not inspected and passed, or mechanically separated (MS) (Beef).” SRMs include “the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae, and the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), DRG of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine from all cattle.”
According to FDA, the final rule “completes a rulemaking process that began with an interim final rule (IFR) in 2004 and was followed by IFRs in 2005 and 2008. It also confirms that “milk and milk products, hides and hide-derived products, tallow that contains no more than 0.15 percent insoluble impurities, and tallow derivatives are not prohibited cattle materials.” It also amends “the final rule to provide a definition of gelatin and to clarify that gelatin is not considered prohibited cattle material under 21 CFR 189.5(a)(1) and 700.27 (a)(1) as long as it is manufactured using the customary industry processes specified.” Further, per the 2008 amendments, FDA proposed a process for designating a country as “not subject to certain BSE-related restrictions applicable to FDA regulated human food and cosmetics,” which is addressed in this final rule. See Federal Register, March 18, 2016.