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FDA rejects call to ban bisphenol A but continues safety research

By Rory Harrington and Mark Astley , 02-Apr-2012
Last updated on 11-May-2012 at 09:37 GMT

US federal authorities said they dismissed a call from the Natural Resource Defense Council (NRDC) Friday to ban bisphenol A (BPA) in food packaging because the petition failed to provide concrete scientific evidence the chemical posed a health risk.

But the Food and Drug Administration (FDA) declared that the announcement was “not a final safety determination” on the substance and that it “continues to support research examining the safety of BPA”.  A further assessment on BPA safety is scheduled for completion later this year, it said.

The agency made its latest statement on the substance after a court ruling last year ordering it to respond to a NRDC petition by the end on March 2012. The environmental action group obtained the judgement after the FDA breached its own rules by failing to respond to the written 2008 petition within 180 days.

In the wake of the FDA statement, the NRDC accused the food safety body of getting its decision wrong and of being out of step with current research.

Flawed evidence

However, the FDA was at pains to stress that its pronouncement was based wholly on an evaluation of the scientific data that accompanied the NRDC petition.

In a 15-page letter sent to the campaigning group, the agency gave a detailed breakdown on why it considered the studies provided by the NRDC were flawed scientifically.

“In the response to the petition that while evidence from some studies have raised questions as to whether BPA may be associated with a variety of health effects, there remain serious questions about these studies, particularly as they relate to humans and the public health impact of BPA,” FDA spokesman Douglas Karas told FoodProductionDaily.com.

He added: “FDA has been studying and continues to study the effects of BPA and will make any necessary changes to BPA's status based on the science. FDA is working toward completion of another updated safety review on BPA this year to include all relevant studies and publications.”

Some $30m has been invested in a joint project between the FDA and the National Institute of Environmental Health Sciences (NIEHS) to design sound protocols and studies with a strong quantitative element and reproducible results “to predict and more fully characterize the risk are needed to provide results that are of value in determining whether there truly is a risk and in making regulatory decisions” said Karas.

The FDA said significant results from the collaborative research had found that human infant exposure to BPA is between 84% and 92% less than previously estimated and people of all ages metabolise and expel the chemical from their body faster than rodents used in studies, said the agency.

Levels of BPA from food that could be passed from pregnant rodents to its unborn offspring were so low they could not be measured. Rodents 100 to 1,000 times more BPA than people are exposed to through food, left no detectable active form of BPA in the foetus eight hours after the mother’s exposure, said Karas.

 

Out of step, failure to protect

 

The NRDC refused to back down as it slammed the FDA announcement.

“BPA is a toxic chemical that has no place in our food supply. We believe FDA made the wrong call,” said Dr Sarah Janssen, the group’s senior scientist in the public health programme.

She added: “The agency has failed to protect our health and safety ­ - in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in foetuses, babies and young children.

“The FDA is out-of-step with scientific and medical research. This illustrates the need for a major overhaul of how the government protects us against dangerous chemicals.”

The American Chemistry Council (ACC) welcomed the FDA announcement

“FDA has closed the book on NRDC’s 2008 petition and clearly resolved that there was no scientific evidence presented that would warrant any change in the food-contact applications of BPA," said Steven G. Hentges, who heads the ACC’s polycarbonate/BPA global group.

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