FDA updates safety assessment of BPA
February 2, 2010
The Food and Drug Administration issued an update of its views related to the safety of bisphenol-A (B.P.A.) the chemical used to make a hard clear plastic used in many consumer products, including baby bottles and sipping cups, and that also is used as an ingredient in epoxy resins used to provide a protective lining on the inside of metal-based food and beverage cans. While the F.D.A. acknowledged B.P.A. at current levels of exposure has not been shown to harm either children or adults, it said recent research documenting subtle effects of low doses of B.P.A. in laboratory animals raised concerns and suggested the need for additional studies. In the meantime, the F.D.A. said it would continue to suggest “simple reasonable steps” families and parents may take to minimize exposure, particularly of infants, to B.P.A.
Based on results from recent studies using novel approaches to test for subtle effects of B.P.A., the National Toxicology Program (N.T.P.) at the National Institutes of Health expressed “some concern” about the potential effects of B.P.A. on the brains, behavior and prostate glands of fetuses, infants and young children.
Josh Sharfstein, the F.D.A.’s principal deputy commissioner, said during a telephone news conference, “Our safety assessment of B.P.A. is ongoing. At this time, the agency is informing the public that we share the perspective of the N.T.P. of some concern for the health effects of B.P.A. at low doses in the food supply.” Dr. Sharfstein said “some concern” meant “we need to know more.” He said the F.D.A. was partnering with the N.T.P. to conduct several key studies on the safety of B.P.A. during the next 18 to 24 months.
“In the interim, the F.D.A. is taking reasonable steps to help reduce human exposure to B.P.A.,” Dr. Sharfstein said. “These steps include supporting the industry’s action to stop producing B.P.A.-containing baby bottles and infant feeding cups for the U.S. market, facilitating the development of alternatives to B.P.A. for the linings of liquid infant formula cans and supporting efforts to replace B.P.A. or minimize B.P.A. levels in other food can linings.”
Dr. Sharfstein said the F.D.A. supported the recommendations of the U.S. Department of Health and Human Services for sound infant feeding and food preparation practices that also may help reduce exposure to B.P.A. At the same time, Dr. Sharfstein said, “F.D.A. is not recommending families change the use of infant formula or food as the benefit of a stable source of good nutrition outweighs the potential risk from B.P.A. exposure.”
Dr. Sharfstein said the F.D.A. supported a shift to a more robust regulatory framework for its oversight of B.P.A. so the agency would be able to act quickly, if necessary, in the event new information confirms a threat to safety.
Dr. Sharfstein noted oversight of B.P.A. currently is based on 40-year-old “inflexible” food additive regulation. He said the F.D.A. does not know when product manufacturers are using B.P.A. because manufacturers are not required to disclose the existence or nature of the formulations they’re using under the current regulation for the chemical.
“And if we wanted to change anything, like if we were to decide that it was necessary to revoke a major use of B.P.A., we would have to go through notice-and-comment rulemaking,” Dr. Sharfstein said.
He pointed out since 2000, the F.D.A. has regulated new food contact substances through a notification program.
“The way this works is F.D.A. receives notification from each manufacturer of the basis for safe use of the food contact substance detailing the condition of the substance’s use, allowing the agency and the public to know how much is being used and for what application.” The F.D.A. then is able to work with individual manufacturers to minimize exposure of the public to a substance if a potential or actual safety concern arises. Additionally, the F.D.A. is authorized to revoke certain uses of a substance it deemed injurious to public health simply through a notice published in the Federal Register, he said.
“So, F.D.A. is interested in treating B.P.A. within the modern framework for food contact substances,” Dr. Sharfstein said. He said the F.D.A. will speak with the industry about voluntary notification of B.P.A. use. The agency also will investigate whether it has the ability to require such notification under its current authority. A third way to bring about a more robust oversight for B.P.A. would be through legislation, he said.
Meanwhile, the Wisconsin state senate on Jan. 26 unanimously passed the B.P.A.-Free Kids Act that would ban the manufacture and wholesale in Wisconsin children’s bottles and cups containing B.P.A. Canada, Minnesota, Connecticut, the city of Chicago and Suffolk County in New York have similar bans in effect, and 10 other states are considering bans, according to the office of Wisconsin state senator Julia Lassa, who is the author of the Wisconsin bill.