FDA to review BPA safety after groups point to ‘sobering' European data

The U.S. Food and Drug Administration has agreed to formally review the safety of bisphenol A in polycarbonate, metal cans and other food-contact materials, accepting a petition from public health groups that say new data from European regulators points to the need for a rethink.

The Environmental Defense Fund and a coalition of other groups announced June 2 that the FDA had accepted their petition to review the safety of BPA in some common food-contact materials. They pointed to new data, including a December recommendation from an expert panel of the European Food Safety Authority, that governments set much lower levels for BPA migration and exposure in food.

"Based on studies not previously considered by FDA, the EFSA Expert Panel found that harmful effects from BPA exposure can occur at levels tens of thousands times lower than previously thought," said Maricel Maffini, a co-author of the petition and consultant.

Most people in the United States get 5,000 times more BPA in their daily diets than the EFSA expert panel considers safe, said Tom Neltner, EDF's senior director for safer chemicals.

The petitioners included the groups Breast Cancer Prevention Partners, Clean Water Action, Consumer Reports, the Endocrine Society and the Environmental Working Group.

A former senior federal government official working on chemical toxicity, Linda Birnbaum, also joined the petition and said that the EFSA panel's work points to the need for much lower BPA exposure levels migrating from plastics and other materials.

"The scientific evidence is now more than enough to require strict limits on the use of BPA in packaging and plastics that come in contact with our food," said Birnbaum, a former director of the National Institute of Environmental Health Sciences and the National Toxicology Program.

"The results are sobering, indicating that the harmful effects from BPA can occur at minuscule levels, far below what we're exposed to," she said.

Accepting the petition for review does not mean that FDA will agree with its conclusions, but it does subject BPA and its exposure levels to renewed formal scrutiny. Federal law requires the FDA to complete its review by Oct. 31, but the agency sometimes takes longer.

In an emailed statement, the American Chemistry Council's Polycarbonate/Bisphenol A Global Alliance said it's too soon to say if FDA would change its position on BPA.

"FDA's action indicates that Food Additive Petition No. 284831 is administratively complete, however it has not yet been technically evaluated for its merit," ACC said. "It is premature to conclude that FDA will modify its position on the safety of BPA."

ACC said "BPA is one of the most widely studied chemicals used today," and it pointed to a 2018 review by FDA, known as its Clarity Core Study, which it called the largest study ever conducted on potential health effects from BPA exposure.

"This study, along with many others, confirmed that BPA is safe at the very low levels to which consumers are exposed," the trade group said. "The PC/BPA Global Alliance strongly supports efforts to promote the responsible and safe use of BPA and stands behind its safety in food-contact applications."

In a February statement making formal comments to the EFSA review, ACC said that the European agency's new scientific review "does not provide a robust basis to significantly deviate" from a 2015 EFSA review that found BPA safe.

EFSA, for its part, said in a December news release that it was basing its scientific review on new data that had emerged. It said its science panel was recommending that the tolerable daily intake level of BPA be reduced from 4 micrograms per kilogram of body weight per day to 0.04 nanograms per kilogram per day.

EFSA said reviews it had done in 2006 and 2015 had only set temporary TDI levels, because of gaps and uncertainties in the data. But it said new studies emerged after 2013, indicating adverse effects on the immune system.

"The new scientific studies that have emerged in literature have helped us address important uncertainties about BPA's toxicity," EFSA said.