Under an agreement between the Food and Drug Administration and the National Resources Defense Council and approved by U.S. District Judge Barbara S. Jones in New York on Dec. 7, the F.D.A. must decide before March 31, 2012, whether it will ban the use of the chemical bisphenol A (B.P.A.) in food packaging.
B.P.A. is a chemical used in the manufacture of hard clear plastic containers such as some water drinking bottles, baby bottles and sipping cups. It also is used in the manufacture of linings that seal most metal food containers.
In recent years, a number of mostly animal-based studies have raised concerns that B.P.A. may have adverse effects on human health. Some of the studies suggested B.P.A. may affect the brains, behavior and prostate glands of fetuses, infants and young children, and others linked exposure to the chemical to increased risk of cancer, diabetes, obesity and hyperactivity.
The N.R.D.C. in 2008 filed a petition with the F.D.A. requesting the agency ban the use of B.P.A. in food packaging, food containers and any material likely to come in contact with food. When the F.D.A. did not respond to the petition in the timeframe required by law, the N.R.D.C. sued in 2010 asking the federal district court to require the agency to respond.
Judge Jones in approving the agreement between the F.D.A. and the N.R.D.C. said the F.D.A. must issue a “final decision” on whether to ban the use of B.P.A., not a “tentative response.”
In its most recent safety assessment of B.P.A. issued in January 2010, the F.D.A. indicated B.P.A. at current levels of exposure has not been shown to harm either children or adults. But it also acknowledged research documenting subtle effects of low doses of B.P.A. in laboratory animals raised concerns and suggested the need for additional studies.
In its 2010 assessment, the F.D.A. said while the additional research was in progress, it would take “reasonable steps to help reduce human exposure to B.P.A.” The F.D.A. said those steps would 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.”
While awaiting F.D.A. action, several state governments banned the use of B.P.A. in the manufacture of baby bottles.
Also, Canada last year became the first nation to prohibit the importation, sale and advertising of baby bottles that contain B.P.A.
“It is discouraging that we had to ask the court to intervene just to get F.D.A. to do its job,” said Sarah Janssen, a senior scientist with the N.R.D.C. “The agency has been dragging its feet on making a decision about B.P.A. for far too long.”
The American Chemical Council in response to the settlement asserted B.P.A. is safe.
“The consensus of government regulatory bodies around the world, including the U.S. F.D.A. and the European Food Safety Authority, is that B.P.A. is safe for use in food-contact materials,” said Steven G. Hentges, a director of the council.
Scott Faber, vice-president of governmental affairs at the Grocery Manufacturers Association, said he expects the F.D.A.’s recent research on B.P.A. to support the industry’s position.
“Every other regulatory authority around the globe has concluded that B.P.A. is safe for use in food containers, and we expect F.D.A. will reconfirm this finding,” Mr. Faber said.
Indeed, the European Food Safety Authority on Dec. 1 indicated it will not revise the current tolerable daily intake level of B.P.A. in the European Union, which is 0.05 mg/kg body weight. The authority noted that since 2010 some studies on developing animals suggested certain B.P.A.-related effects, but they were not sufficiently convincing. The authority said uncertainties regarding the relevance to humans of these toxological effects noted in laboratory animals remain to be clarified.
Meanwhile, congressional pro-ponents of a ban on B.P.A. use in food packaging pointed to a study published in Pediatrics, the journal of the American Academy of Pediatrics, in October that suggested B.P.A. exposure in the womb may lead to behavioral problems in girls, including anxiety and depression.
Senator Dianne Feinstein of California, sponsor of S. 136, the Ban Poisonous Additives Act of 2011, said, “The Pediatrics study is another red flag and adds to the already mounting evidence that exposure to B.P.A., particularly at critical states of a child’s development, is linked to harmful health effects. With each new study, there is more cause for concern, yet the lobbying effort against getting this chemical out of products is powerful. Small steps have been taken by retailers, manufacturers, the industry, and at the state level, but we need to go further, and this study exemplifies why we need to be concerned.”