April 12, 2009 in Nation/World

FDA challenged on food container safety

Scientists seek new assessment of chemical
Meg Kissinger And Susanne Rust Milwaukee Journal Sentinel
 

At a glance

Bisphenol A, developed more than 100 years ago as a synthetic estrogen, is used to make hard, clear plastic for things such as baby bottles and food containers. Recent studies have linked the chemical to heart disease and diabetes. The FDA declared BPA to be safe last August.

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 has interviewed many scientists who attended the meeting and has seen several 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 and 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. The scientists’ consensus statement will contradict claims by industry spokesmen who have been citing the FDA and European assessments as proof that BPA is safe.

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.

John Vandenbergh, a biologist at North Carolina State University who attended the conference in Germany, said the FDA risks losing credibility by relying on such flimsy evidence.

“We desperately need good judgment at the FDA,” Vandenbergh said. “For years, they did a superb job looking out for food safety. I hate to see something like this jeopardize all that.”

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.

The group agreed that Tyl’s studies were too limited in their scope to be considered benchmarks.


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