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  1. CFSAN Constituent Updates

FDA Announces Final Rule on Bovine Spongiform Encephalopathy

Constituent Update

March 17, 2016

The U.S. Food and Drug Administration today issued a rule finalizing three previously-issued interim final rules designed to further reduce the potential risk of bovine spongiform encephalopathy (BSE), sometimes referred to as “mad cow disease,” in human food.

The final rule provides definitions for prohibited cattle materials and prohibits their use in human food, dietary supplements, and cosmetics, to address the potential risk of BSE. These materials include:

  • 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 rule additionally 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. The FDA also finalized the process for designating a country as not subject to BSE-related restrictions applicable to FDA regulated human food and cosmetics. 

Finally, the rule provides a definition of gelatin and clarifies that gelatin is not considered a prohibited cattle material if it is manufactured using the customary industry processes specified. Gelatin was never considered a prohibited cattle material, but FDA had never specifically defined gelatin in past IFRs.

The FDA is taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent. It is important to note that the U.S. 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. 

This rule finalizes three interim rules from 2004, 2005, and 2008.

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