FDA issues final rule related to BSE risk reduction.
- Bovine spongiform encephalopathy (BSE) — also called “mad cow disease” — is a fatal and progressive neurologic disease that affects cattle. BSE poses a risk to humans because people can get a version of the disease called variant Creutzfeldt-Jakob disease (vCJD). There is no known treatment for vCJD, and it is fatal. Infected individuals are believed to have contracted the disease from eating food made with cows sick with BSE. To protect Americans against BSE-related risks, FDA has taken measures to protect the food supply, such as by placing stringent restrictions on the use of high-risk cow parts in animal feed and by restricting the use of material derived from cattle in FDA-regulated products.
- FDA has issued a final rule prohibiting the use of certain cattle material to minimize the potential risk of BSE in human food (including dietary supplements) and cosmetics. The final rule designates the following items as prohibited cattle materials:
- Specified risk materials (SRMs ): brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia (DRG) of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine from all cattle
- The small intestine from all cattle unless the distal ileum has been properly removed
- Material from nonambulatory disabled cattle
- Material from cattle not inspected and passed, or mechanically separated (MS) (Beef).
- The final rule represents the long-awaited reaffirmation of an interim final rule dating back to 2004, as amended in 2005 and 2008. As useful clarifying points, the final rule confirms that the category of prohibited cattle materials does not include: milk and milk products, hide and hide-derived products, tallow that contains no more than 0.15 % insoluble impurities, and tallow derivatives. The final rule also defines “gelatin” and confirms — consistent with the industry’s general understanding — that gelatin is not a prohibited cattle material provided that it is manufactured using specified customary industry processes. The rule also provides a process for designating a country as not subject to BSE-related restrictions applicable to FDA regulated human food and cosmetics. The final rule is effective on April 18, 2016.