FDA rejects petition to ban bisphenol A
April 10, 2012
by Jay Sjerven
WASHINGTON— The Food and Drug Administration on March 30 rejected a petition to ban the use of bisphenol A in food and beverage packaging. In a letter to the petitioner, the Natural Resources Defense Council, David H. Horsey, an acting associate commissioner of the F.D.A., said, “The information provided in your petition was not sufficient to persuade F.D.A., at this time, to initiate rulemaking to prohibit the use of B.P.A. in human food and packaging.”
The F.D.A. was required to respond to the N.R.D.C. petition, which was filed in 2008, by March 31, 2012, under an agreement between the agency and the N.R.D.C. ordered by U.S. District Judge Barbara A. Jones in New York last December.
B.P.A. is a chemical used in the manufacture of hard plastic containers such as some water drinking bottles, baby bottles and sippy cups. It also has been used in the manufacture of linings that seal metal food containers.
In recent years, several mostly animal-based studies raised concerns 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 and young children, and others linked exposure to the chemical to increased risk of cancer, diabetes, obesity and hyperactivity.
But in a Consumer Health Information notice issued March 30, the F.D.A. said its assessment “is that the scientific evidence at this time does not suggest that the very low levels of human exposure to B.P.A. through the diet are unsafe.”
Dennis M. Keefe, director of the F.D.A.’s Office of Food Additive Safety, said the agency takes all concerns and studies about B.P.A. seriously and will continue to evaluate them, but the agency has yet to find convincing evidence suggesting B.P.A. at current exposure levels is harmful to humans.
“We make public health decisions based on a careful review of well performed studies, not based on claims or beliefs,” Dr. Keefe said. “We have to perform unbiased evaluation of the data.”
The F.D.A. said its National Center for Toxicological Research (N.C.T.R.) has been studying B.P.A. since 2008 in response to public concerns. The agency pointed to some of its findings.
Researchers from the N.C.T.R. have found the level of B.P.A. from food that could be passed from pregnant mothers to the fetus is so low that it could not be measured. They found exposure to B.P.A. in human infants is from 84% to 92% less than previously estimated. They indicated they were able to build mathematical models of what happens to B.P.A. once it’s in the human body, and these showed B.P.A. is rapidly metabolized and eliminated through feces and urine. The F.D.A. further said the center’s research has not found evidence of B.P.A. toxicity at low doses in rodent studies, including doses that are still above human exposure levels.
The F.D.A. said it would continue its research and monitoring of studies to address uncertainties and concerns raised about B.P.A.
The chemical and packaging industries applauded the F.D.A. response. Steven G. Hentges, speaking on behalf of the American Chemistry Council, said, “F.D.A.’s decision today, which has taken into consideration the best available science, again confirms that B.P.A. is safe for use in food-contact materials, as it has been approved and used safely for four decades.”
And John Rost, chairman of the North American Metal Packaging Alliance, said, “Given the serious implications on food safety from any action to ban B.P.A., we believe F.D.A. is pursuing a prudent course of action. A ban without conclusive scientific evidence of risk would compromise the safety of canned foods and beverages enjoyed by millions of Americans every day.”
But Sarah Jannsen, senior scientist in the public health program of the N.R.D.C., said, “B.P.A. is a toxic chemical that has no place in our food supply. We believe the F.D.A. made the wrong call.”
Congressional proponents of a federal ban on the use of B.P.A. expressed disappointment with the F.D.A. decision and indicated they would continue to seek legislation to eliminate the chemical’s use.
“Despite steps taken around the world to eliminate the use of this toxic chemical in food and beverage packaging, the F.D.A. continues to ignore safety concerns and allow B.P.A. in the household products American families use every day,” said Representative Edward Markey of Massachusetts. “Many manufacturers have already stopped using B.P.A. in their products due to public pressure, leading to the development of alternatives for this harmful chemical.”
Mr. Markey is sponsor in the House of the Ban Poisonous Additives Act that would establish a federal ban on B.P.A. use in baby bottles, sippy cups and baby food and infant formula containers. Mr. Markey in March, in advance of the F.D.A. decision, filed three separate petitions with the F.D.A. requesting the agency permanently remove regulatory approval for the use of B.P.A. in infant formula and baby and toddler food packaging, small reusable household food and beverage containers, and canned food packaging on the grounds that manufacturers have stopped using B.P.A. in the products due to consumer demand.
“I call on the F.D.A. to accept my petition and close the door on the use of this chemical in America’s food and beverage packaging and provide assurance that B.P.A. forever will be kept out of our bodies,” Mr. Markey said.
Senator Dianne Feinstein of California, sponsor of the Ban Poisonous Additives Act on the Senate side, said, “Today’s denial by the F.D.A. is disappointing and regrettable. The hundreds of scientific studies that link B.P.A. to harmful health effects — particularly at early stages of a child’s development — cannot be ignored. I won’t argue that more research might be needed on the effects of B.P.A., but in the meantime, our children should not be used as guinea pigs. I will continue to press ahead with my efforts to ban B.P.A. from children’s products at the federal level until B.P.A. is banned once and for all.”