The Food and Drug Administration last week issued a rule finalizing three 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 rule provides definitions for prohibited cattle materials and confirms that milk and milk products are not included in the prohibited list. 

BSE is a progressive neurologic disease that affects the cow’s central nervous system and gets worse over time. In the Frequently Asked Questions provided along with the final rule, FDA reaffirms that scientific research indicates that BSE cannot be transmitted in cow’s milk, even if the milk comes from a cow with BSE.

The United States 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 is negligible. The agency is taking this action to further minimize human exposure to specific cattle material that could potentially contain the BSE agent.

The items identified as prohibited cattle materials are “specified risk materials,” the small intestine from all cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated beef.

For more information, contact John Allan, IDFA vice president of regulatory affairs and international standards, at jallan@idfa.org.