FDA Reevaluating Position On BPA Compound in Plastics

Controversy has erupted over some plastic bottles, like these Nalgenes.
Controversy has erupted over some plastic bottles, like these Nalgenes. (By David Mcnew -- Getty Images)
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Tuesday, April 29, 2008

This excerpt is adapted from the Checkout blog:

Ever since the National Toxicology Program said two weeks ago that bisphenol A (BPA), a widely used compound in hard plastic food containers, poses "some concern" about neural and behavioral effects in fetuses, infants and children, one retailer after another has pledged to pull BPA from baby products, and consumers have been uneasily eyeing their water bottles, their kids' binkies and their Tupperware.

The Food and Drug Administration regulates the use of BPA in products that come into contact with food, such as baby bottles and baby formula cans. When my colleague Lyndsey Layton reported on the NTP's latest conclusions, the FDA was mum on the findings. (The agency has since given her an interview on a follow-up story.)

Inside the agency, however, BPA has been keeping officials busy. The American Chemistry Council, the trade group for the nation's largest chemical companies, recently asked the FDA to update its position on BPA. Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, and Rep. Bart Stupak (D-Mich.), chairman of the oversight and investigations subcommittee, have been looking into the government's position ever since environmental activists raised concerns last year that a contractor preparing a draft report on BPA risks for the NTP also worked for the chemical industry.

Last week, Michelle Twaroski, a supervisory toxicologist in the FDA's food-packaging division, agreed to chat with us about the agency's thinking on BPA and where it's headed.

QGiven what the NTP said recently, and the reaction of retailers such as Wal-Mart and Toys R Us, should consumers be freaking out? The science isn't totally conclusive. What are we supposed to think?

ARight now, the FDA doesn't recommend that anyone stop using these products. However, concerned consumers should know that several alternatives to polycarbonate baby bottles exist, including glass baby bottles.

Is the FDA going to take another look at its position on BPA?

The FDA has continuously monitored the data on BPA and has been actively evaluating BPA since 2007. Our review is in the process of evaluating the conclusions reached by the National Toxicology Program's expert advisory committee to the Center for the Evaluation of Risks to Human Reproduction (CERHR). That committee concluded that there is "some concern" about neural and behavioral developmental toxicity. This concern was reiterated in the NTP draft brief released in April, which also expressed "some concern" about developmental effects on the prostate gland, mammary gland, and an earlier age for puberty in females.

We consider these conclusions very seriously and are actively reviewing the concerns they've raised. In fact, the commissioner this month formed an agency task force on BPA. This task force will be developing recommendations for him with regard to FDA-regulated products containing BPA.

Dingell and Stupak have called into question FDA's reliance on two studies funded by the chemical industry to support its position on BPA. Can you respond to their concerns?

We are aware of the questions raised regarding the two studies. However, FDA's ongoing review of BPA has involved more than the two studies sponsored by industry. We have weighted the two industry studies as pivotal because they include regulatory protocols that were expanded to address the issues of concern at the time of their initiation. They included a large range of doses, including low doses, to allow for evaluation of a dose response, and all raw data was submitted to the agency for our independent evaluation.

Though these studies were sponsored by industry, they were conducted by a well-known laboratory, were developed in consultation with our European counterparts and the FDA was briefed on them. These studies were designed to answer questions that had arisen about BPA at the time they were initiated.

The new safety evaluations that were published by the NTP in April, Canada's warning, as well as evaluations performed by NTP's expert panel, raised questions from newly evolving areas of research. As mentioned, we were already in the process of reviewing one set of endpoints and, with the new task force, we will be reviewing all the concerns raised in our new evaluation of BPA.

So FDA is going to reevaluate its position on BPA?

Yes. The task force is performing a risk assessment on BPA and will submit its recommendations to the commissioner.

-- Annys Shin

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