New research completed after an interim final rule on bovine spongiform encephalopathy (BSE) was completed in 2005 has the FDA reopening its comment period for the rule.
The FDA announced the decision Monday after scientific studies found trace levels of infectivity in parts of cattle small intestine, other than the already banned distal ileum, from animals with BSE. The 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.
The World Organization for Animal Health mirrors the FDA’s position and has not changed its definition of “specified risk material” to include any part of the small intestine other than the distal ileum.
The 2005 rule entitled “Use of Materials Derived From Cattle in Human Food and Cosmetics” allows the small intestine of cattle to 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.
The FDA does not believe there is a measurable reduction in the risk from BSE 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.
The FDA is reopening the comment period to give anyone an opportunity to comment on the studies and on FDA’s tentative conclusion.
The reopened comment period is posted in the Federal Register.