Panel Rebukes FDA on Plastic Safety

Panel Rebukes F.D.A. on Plastic Safety

A scientific panel has issued a blistering report against the Food and Drug Administration, saying the agency ignored important evidence in reassuring consumers about the safety of the controversial chemical bisphenol-A.

The panel, in a report issued this week, did not draw any conclusions about the safety of the chemical, known as BPA. But it criticized the F.D.A. for ignoring crucial studies and using what it said were flawed methods in reaching its conclusions.

The drug agency’s evaluation of BPA “creates a false sense of security” and “overlooks a wide range of potentially-serious findings,” the panel’s report said.

In a statement, the F.D.A. said that the report “raised important questions” and that more study was needed, but it did not back away from its claim that the chemical is safe. The agency will review the report of the scientific advisory board on Friday.

BPA is widely used to make hard, clear plastic water and baby bottles, and it is found in the lining of nearly every soft drink and canned food product. The chemical appears to have estrogen-like effects, and in animal studies it appears to accelerate puberty and pose a cancer risk.

While most worries about BPA focus on children, some recent reports suggest BPA interferes with chemotherapy, and in adults the chemical has been linked to higher risk for heart disease and diabetes. The F.D.A. has maintained that the levels of BPA to which children and adults are exposed do not pose a meaningful risk.

This fall, the agency asked an independent panel of scientific advisers to review its conclusions. The seven-member panel includes environmental health, toxicology and statistics experts from three major universities, the Environmental Protection Agency and the Centers for Disease Control and Prevention.

These are among the concerns raised by the panel:

• The F.D.A. assessment does not have an adequate number of infant formula samples and relies too heavily on averages, rather than accounting for variability in the samples.

• The agency excluded several important animal studies that raised questions about the safety of BPA.

• New research on BPA in adult humans and animals was published after the F.D.A.’s draft report and should be included in its findings.

• The margins of safety for BPA exposure used by the agency are “inadequate.”

• The agency focused only on food-source exposures to BPA rather than the “totality of exposures” from other sources, which “severely limits the usefulness of the safety assessment.”

In its statement, the F.D.A. said consumers should know that “based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.”

The American Chemistry Council said it awaits direction from the F.D.A. once further BPA assessment is complete. “If the agency 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,” the group said in a statement.

For a PDF of the scientific group’s full report, click here.