FDA believes current regulation protects the public from BSE but reopens comment period due to new studies
March 4, 2013
The Food and Drug Administration (FDA) is reopening the comment period for the interim final rule entitled “Use of Materials Derived From Cattle in Human Food and Cosmetics.” The interim final rule protects consumers from exposure to bovine spongiform encephalopathy (BSE) by prohibiting the use of certain cattle parts in human food, including dietary supplements, and cosmetics. Under the interim final rule amended in 2005, the small intestine of cattle can be used in human food, dietary supplements, and cosmetics if the portion of the small intestine known as the distal ileum has been properly removed.
Since 2005, there have been scientific studies that found trace levels of infectivity in parts of cattle small intestine, other than the distal ileum, from animals with BSE. However, FDA believes that the levels of infectivity are so low that they do not pose a significant health risk to humans or ruminants in the U.S. Consistent with FDA’s position, the World Organization for Animal Health has not changed its definition of “specified risk material” to include any part of the small intestine other than the distal ileum.
Further, FDA does not believe there would be a measurable reduction in the risk from BSE to the American public by removing additional parts of the cattle small intestine and, as such, it would be appropriate to finalize the interim final rule without changing any provisions related to the small intestine. Nonetheless, FDA is reopening the comment period to give interested parties an opportunity to comment on the studies and on FDA’s tentative conclusion.