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NTP Releases Draft Report on Bisphenol A for Public Comment

Bisphenol A (BPA) has been the subject of global controversy in recent years, with some jurisdictions restricting its use in children’s products and baby bottles due to concerns about potential exposure risks. FDA’s longstanding position on BPA is that BPA is safe at the current levels occurring in foods.

On February 23, 2018, the National Toxicology Program (NTP) released for public comment a pre-peer review draft report on the findings of a comprehensive two-year rodent study examining the potential effects of BPA on health. The study – conducted by senior scientists at the FDA’s National Center for Toxicological Research (NCTR) – is part of a collaborative effort called the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA).  CLARITY-BPA had two components: the core study conducted at NCTR according to FDA Good Laboratory Practice regulations and CLARITY-BPA academic studies of various health endpoints, conducted by grantees at academic institutions and using offspring of rodents derived from the core study.

The draft report includes data from the NCTR core study.  The core study analyzed the effects of several different doses of BPA evaluating chronic and early life exposure in two different groups of rodents. The doses ranged from low doses that would be comparable to typical human exposures, to doses that greatly exceed human exposures. The study found “minimal effects” for the BPA-dosed groups of rodents. The report did identify some areas that could merit further research, such as the increase in occurrence of mammary gland tumors at one of the five doses, in one of the groups. But the significance of these findings will be assessed through the peer review process.

Dr. Stephen Ostroff, Deputy Commissioner for Foods and Veterinary Medicine at FDA, issued a statement highlighting the fact that the draft report points towards “minimal effects” and supports FDA’s longstanding position that BPA, at current levels occurring in food is safe. A peer-review meeting is scheduled for April 26, 2018 and will be open to the public

© 2020 Keller and Heckman LLPNational Law Review, Volume VIII, Number 57


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...