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FDA Proposes BSE Safeguard in Medicines

A new rule proposed by the Food and Drug Administration would limit cattle materials used in certain medicines as a safeguard against bovine spongiform encephalopathy.

The rule would prohibit the use of certain cattle materials found to be most likely to harbor an agent thought to cause mad cow disease in medical products or elements of product manufacturing. The rule would cover drugs, biologics (including vaccines) and medical devices meant for use in humans or ruminant animals such as cattle or sheep. Sheep can get a disease similar to BSE called scrapie.

The materials prohibited in the proposed rule include:

• the brain, skull, eyes and spinal cords from cattle 30 months and older;
• the tonsils and a portion of the small intestines from all cattle regardless of their age or health;
• any material from cattle that cannot walk;
• any material from cattle not inspected and passed for human consumption;
• fetal calf serum if appropriate procedures have not been followed to prevent its contamination with materials prohibited by this proposed rule;
• tallow that contains more than 0.15% insoluble impurities if the tallow is derived from materials prohibited by this proposed rule and;
• mechanically separated beef.