MILWAUKEE — An international consortium of industry, academic and government scientists has rejected as incomplete and unreliable the U.S. Food and Drug Administration’s case that a chemical found in food containers and other household products is safe.
The group, which met last month in Germany, is working to release a consensus statement in the next few weeks. The meeting was closed to the public, but the Milwaukee Journal Sentinel interviewed many scientists who attended the meeting and has seen working versions of their agreement.
The group raises questions about the two studies the FDA has used as its foundation to declare that bisphenol A is safe in food and beverage containers. It calls for a much broader look at the chemical than the FDA has given.
Speakers at the conference included Rochelle Tyl, the author of the two studies that are being used as the FDA’s benchmarks. Both of Tyl’s studies were paid for by the American Chemistry Council, a trade association for BPA-makers.
According to scientists at the meeting, Tyl conceded that there were errors and inconsistencies in the 2008 report that the FDA used as the foundation for its findings.
“It is becoming undeniable that BPA is dangerous,” said Laura Vandenberg, a developmental biologist at Tufts University, one of 58 scientists from around the world invited to the conference in Germany. “The FDA’s standard for safety is reasonable certainty. It is no longer reasonable to say that BPA is safe.”
The group’s conclusions also call into question the European Food Safety Authority’s assessment of BPA. The authority, which also relies on Tyl’s studies, sets policy for all countries in the European Union.
Tyl told the Journal Sentinel in an e-mail that her studies do not claim that BPA is safe. Her studies were not designed to cover all aspects of the chemical’s effects. They simply show no effects to the reproductive system of rats and mice that were exposed to the chemical at low doses, she said.
She has previously acknowledged inconsistencies in her data, particularly the age of some animals that were examined in the 2008 study for effects on the prostate.
The conference, held in late March, was called to reassess the safety of BPA for German regulators. But the agreements that were forged there are being closely watched by those worldwide with a stake in the future of the chemical, including BPA-makers, regulators and advocates who consider the chemical to be dangerous.
Laura Tarantino, director of the FDA’s Office of Food Additive Safety, said Tyl’s studies followed proper protocol. But she acknowledged some uncertainties about whether Tyl’s studies addressed all concerns about the chemical. Neither Tarantino nor any FDA scientists were invited to the meeting.
Tarantino said her agency would look at other studies that raise concerns about BPA.
What is it?
BPA, formally known as bisphenol A, was developed more than 100 years ago as a synthetic estrogen and is used in thousands of household products to make hard, clear plastic for things such as baby bottles and food containers. It also is used in many dental sealants and to line most food and beverage cans.
Some scientists think that long-term exposure to BPA is harmful to humans, but the European Union and the U.S. Food and Drug Administration say the chemical is safe.
Canada declared BPA to be toxic and has banned its use in baby bottles. Several states, including California, Oregon and Hawaii, are considering bans. Earlier this year, the six major baby bottle-makers promised to stop using BPA.
