Food and Drug Administration Prepares BPA Decision

Published March 10, 2012

The U.S. Food and Drug Administration is preparing a decision on whether to ban bisphenol A, a chemical widely used in plastics and the linings of metal food containers. To settle a lawsuit filed by the Natural Resources Defense Council, FDA agreed to issue its decision by March 31.

The NRDC filed a petition with the FDA in 2008 requesting the agency ban BPA. When the FDA failed to respond to the petition in the time required by law, the NRDC filed a federal lawsuit to compel an FDA decision. FDA settled the suit with the NRDC by agreeing to issue a decision by March 31.

Studies Confirm Safe Use

Anti-BPA activists allege BPA exposure threatens reproductive health, can cause cancer, and increases the risk of child behavior problems. The assertions are based on some studies indicating rats may suffer these effects when they are fed mega-doses of BPA.

The asserted health risks to rats, however, have never been documented in humans. Also, the studies suggesting BPA may cause such negative health effects in rats have been criticized for their methodology and are dependent on huge doses that are not comparable to any foreseeable human exposure levels. 

In 2010 the FDA released a report finding, “Studies employing standardized toxicity tests have thus far supported the safety of current low levels of human exposure to BPA.”

“FDA is continuing to consider the low dose toxicity studies of BPA as well as other recent peer-reviewed studies related to BPA,” the FDA report added. 

Also in 2010, scientists with the U.S. Environmental Protection Agency published research finding rats do not suffer negative health consequences even when they are exposed to long-term mega-doses of BPA. 
Similarly, the European Food Safety Authority concluded in 2010 that BPA is safe for humans at real-world exposure levels.

‘Unequivocal and Robust’ Exoneration

At the time, the European Food Safety Authority study seemed to conclusively close the door on anti-BPA allegations.

“The results [of the study] are unequivocal and robust and are based on a valid and rational scientific foundation,” Richard Sharpe, a researcher at the Medical Research Council’s Centre for Reproductive Biology in Edinburgh, told the UK Independent.

“The study with many other studies, ‘more or less close the door’ on the possibility that bisphenol A has oestrogenic effects we need worry about,” said Sharpe.

Activists Continue Opposition

Despite the findings of these various studies, anti-BPA activists have been pushing for federal and state bans on the chemical. Independent of the NRDC’s legal challenge, Rep. Edward Markey (D-MA) is sponsoring a House bill that would ban BPA.

“Every day, millions of American consumers are exposed to this dangerous chemical, commonly used in packaging for canned foods, beverages and even baby formula,” said Sarah Janssen, a senior scientist in the Environment and Public Health program at the NRDC, in an NRDC press statement. “The FDA has an obligation to protect us from toxic food additives.”

Two Paths

“Not one of the more than 5,000 studies conducted on BPA worldwide has shown harm to humans of any age in normal consumer use,” said Henry I. Miller, a former FDA medical reviewer who now serves as the Robert Wesson Fellow in Scientific Philosophy at the Hoover Institution at Stanford University. 

“This was confirmed yet again in early 2011 when a group of German researchers analyzed the scientific literature. Their report in the journal Critical Reviews in Toxicology concluded, ‘The available evidence indicates that BPA exposure represents no noteworthy risk to the health of the human population, including newborns and babies,'” said Miller.

“The role of the FDA and the nature of the American regulatory process are at a crossroad, and the stakes are high,” Miller explained. “The FDA can take one of two paths. One would reaffirm the government’s commitment to a science-driven regulatory process that relies on empirical data and sound risk analysis. The other would actually compromise public health and would constitute capitulation to the NRDC, giving encouragement to every special interest and activist group that wants custom-drafted regulations based on ideology and speculation and that can afford expensive litigation.”

James M. Taylor ([email protected]) is managing editor of Environment & Climate News.