Cow intestines and BSE in the spotlight again
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” that was published in the Federal Register on July 14, 2004. The interim final rule prohibited the use of certain cattle material to address the potential risk of BSE in human food, including dietary supplements and cosmetics.
On Sept. 7, 2005, FDA amended the interim final rule to make changes, including providing that the small intestine of cattle, formerly prohibited cattle material, could be used in human food and cosmetics if the distal ileum was removed by a specified procedure or one that the establishment could demonstrate is equally effective in ensuring complete removal of the distal ileum. At the time, the distal ileum was known to be a potential reservoir for BSE, but other parts of the small intestine were considered safe.
According to FDA, research since 2005 has revealed traces of BSE in parts of the intestine currently allowed in human food and drugs. “Therefore, we are reopening the comment period for the interim final rule to give interested parties an opportunity to comment on the new studies concerning infectivity in parts of the small intestine other than the distal ileum,” FDA officials said.
FDA says the studies have found low levels of BSE in other parts of the cow’s intestine, including the proximal ileum, jejunum, ileocecal junction, and colon, prompting concerns that perhaps USDA and FDA should also prohibit these parts from use in human foods and cosmetics.
“The infectivity levels reported in these studies were much lower than the infectivity levels that were previously demonstrated in the distal ileum,” notes FDA.
FDA did say that it believes that the trace levels of infectivity found in these other parts of the intestine don’t pose a risk of human exposure to BSE in the U.S.
“We tentatively conclude that the effect of these traces of infectivity on the risk of human or ruminant exposure to BSE in the United States is negligible,” the agency wrote.
“We want to hear from other people,” says Sebastian Cianci, spokesperson for FDA. “From what we’re seeing, we’ve concluded that there wouldn’t be a measurable reduction of risk from removing other parts. However, we want other people to weigh in before a final determination is made.”
FDA has reopened the public comment period as they consider strengthening the rule in light of the new research. The comment period ends May 3.
The reopened comment period has been posted in the Federal Register. Comments can be submitted by clicking the “Submit a Formal Comment” button in the upper right hand corner of the page. — Traci Eatherton, WLJ Editor