The U.S. Food and Drug Administration is proposing to limit the materials used in some medical products in order to keep them free of the agent thought to cause mad cow disease, also known as bovine spongiform encephalopathy or BSE.
This is the latest in a series of BSE safeguards that would bar material that has been found to harbor the highest concentrations of this fatal agent in infected cattle. These materials would be prohibited from use as ingredients in medical products or elements of product manufacturing.
The proposed rule would cover drugs (prescription, over-the-counter, and homeopathic), biologics (such as vaccines) and medical devices intended for use in humans as well as drugs intended for use in ruminant animals like cattle and sheep. Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie.
“These measures build on a series of barriers FDA and the U.S. Department of Agriculture have erected to further protect humans from exposure to the fatal agent linked to BSE,” said Andrew von Eschenbach, M.D., Commissioner Food and Drugs. “This proposed rule adds one more safeguard that will reduce the risk of transmission even further.”
The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and 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 “downer” cattle–those 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 percent insoluble impurities if the tallow is derived from materials prohibited by this proposed rule and;
* mechanically separated beef.