FDA denies ignoring harm in bottle chemical

WASHINGTON (Reuters) - U.S. regulators said on Wednesday they did not ignore evidence showing possible harm from a chemical used in many plastic products, including baby bottles and food containers.

A panel of outside experts convened by the Food and Drug Administration said on Tuesday the FDA failed to consider studies calling into question the safety of bisphenol A, a chemical used for decades to harden plastic products, when it issued a draft conclusion in August that BPA is safe.

But the FDA quickly issued a statement reiterating its view that "based on all available evidence" current levels of exposure to BPA through food packaging do not pose an immediate health risk to the public, including infants and babies.

"We need to get that clear -- we did not ignore studies. We looked at all the studies," Norris Alderson, FDA associate commissioner for science, said in a telephone interview.

"The committee gave us valuable guidance on how we can improve our assessment using the current data. But they did not say in any way that I can find that there is an immediate health risk," Alderson said.

The advisory panel's report concluded "the margins of safety defined by FDA as 'adequate' are, in fact, inadequate."

Some U.S. lawmakers said the advisory panel's report is more evidence the FDA has mishandled its assessment of BPA.

BPA is used in many food and beverage containers, the coating of food cans and some medical devices. It mimics the hormone estrogen in the body. People consume it when it leaches from plastic into baby formula, water or food in a container.

The panel, which formally presents its report to an FDA science committee on Friday, urged the agency to take into account other animal studies that have found health concerns and studies published since the draft assessment was made.

U.S. government toxicologists at the National Institutes of Health this year concluded BPA presents "some concern" for harmful effects on development of the prostate and brain and for behavioral changes in fetuses, infants and children.

A study by British researchers published in September showed that people with the highest levels of BPA in their body were much more likely to have heart disease, diabetes and liver-enzyme abnormalities than those with the lowest levels.

Canada said this month it will move to limit sales of baby bottles made with BPA due to health concerns.

Environmental activists and some U.S. lawmakers have accused the FDA of relying too heavily on two industry-funded animal studies to dismiss safety concerns about BPA.

Laura Tarantino of the FDA's Center for Food Safety and Applied Nutrition said those studies "were the best we had" in guiding safety conclusions on BPA. "What we're concerned about is the utility of the data that's produced, not who paid for the study," Tarantino said in a telephone interview.

Tarantino said she did not know when the FDA would make its final conclusion on BPA's safety, but this year is unlikely.

The American Chemistry Council industry group said in a statement: "If the agency (FDA) determines that existing margins of safety are insufficient in infant applications, our member companies that manufacture BPA will put processes in place to promptly phase out the use of materials containing BPA in baby bottles and infant formula packaging."

(Editing by Anthony Boadle)