WASHINGTON – The US Food and Drug Administration released its final rule on bovine spongiform encephalopathy. The rule finalizes three interim rules from 2004, 2005 and 2008.

“The FDA is taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent,” FDA said in its announcement. “It is important to note that the US has long had measures in place to prevent the introduction and spread of BSE, including those affirmed in this rule; therefore the risk of human exposure to the BSE agent from FDA-regulated human food and cosmetics is negligible.”

In the rule, FDA finalized the process for designating a country as not subject to BSE-related restrictions applicable to products regulated by the agency. Also, FDA said cattle materials prohibited from use in human food, dietary supplements and cosmetics include:

Specified risk materials such as 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 non-ambulatory disabled cattle, and material from cattle not inspected and passed, or mechanically separated (MS) (beef).

Materials not prohibited include milk and milk products, hides and hide-derived products, tallow that contains no more than 0.15 percent insoluble impurities and tallow derivatives. Additionally, FDA defines gelatin and clarifies that gelatin is not considered a prohibited cattle material if it is manufactured using specified customary industry processes.

More information is available from the Federal Register.