FDA on bisphenol A
This article was originally published in The Gray Sheet
Executive Summary
Agency's decision to restrict its initial toxicity analysis of bisphenol A (BPA) to food-contact applications such as infant formula packaging "severely limits the usefulness" of the agency's draft 1assessment issued in August, says a subcommittee to FDA's Science Board in a 2report posted online Oct. 29. The report says FDA should have considered the "totality of exposures," including from medical devices used in the neonatal intensive care unit, to guide more accurate calculations. The observation is one of several critiques lodged at FDA's assessment, which the subcommittee says overlooks potentially informative data and comes to questionable conclusions about the safety margins for BPA levels in food packaging. FDA has said it plans to develop a separate assessment of BPA in medical products (3"The Gray Sheet" Oct. 20, 2008, In Brief). The subcommittee presented the report at an Oct. 31 Science Board meeting