FDA shifts stance on BPA, announces "some concern" about children's health

The FDA shifts its position on BPA, saying it has "some concern" about health of children exposed to the chemical in plastic bottles and cans.

 By Marla Cone
 Editor in Chief
  Environmental Health News

Jan. 15, 2010

 

In a major shift, the U.S. Food and Drug Administration announced Friday that it has “some concern” about the effects of bisphenol A on children’s health and is launching new research to answer key questions that may lead to regulation of the chemical.

The announcement basically puts the federal government’s regulatory agency in line with federal scientists when it comes to the controversial, estrogen-like chemical.

FDA Commissioner Margaret Hamburg said that her agency has embraced the conclusion of the National Toxicology Program, which announced two years ago after a review of the science that there is “some concern” about developmental and reproductive problems in infants and children exposed to BPA.

J.P. Myers.
The FDA warned against using BPA products with boiling liquids.

An ingredient of polycarbonate plastic, BPA is one of the most widely used synthetic chemicals in industry today. It can seep from hard plastic beverage containers such as baby bottles and sippy cups, as well as from liners in cans containing food and infant formula.

Hamburg said the FDA will not at this point ban or restrict BPA or recommend that consumers stop buying products that contain it.

But the agency, she said, will shift to a more robust oversight of the chemical so that it “can move quickly, if appropriate” once more questions about its possible effects are answered. She said FDA supports attempts by some manufacturers to remove BPA products from the market and search for alternatives in cans.

William Corr, Deputy Secretary of Health and Human Services, said that tests on laboratory animals show “subtle effects” and raise “concerns that we are now taking a much closer look at.” He said while BPA is not proven to be dangerous, it deserves a closer look by the FDA.

Friday’s announcement is a major shift for the FDA because in 2008 it concluded in a draft report that BPA was safe. The agency at that time agreed with the plastics industry, which maintained that the animal studies were flawed and that there was no evidence that human babies were in danger.

Dr. Joshua Sharfstein, the principal deputy commissioner of the FDA, stressed that they are not advising parents to stop using bottles and cans that contain BPA. But they are recommending that people use alternatives when available, throw out worn or scratched containers and avoid exposing the bottles to hot liquids or high temperatures, which can cause more BPA to leach out.

Environmental groups welcomed the shift at FDA, saying the agency original decision was out of step with the science. But they said Friday's announcement will not protect consumers.

"We agree with the FDA’s assessment that a complete overhaul of the regulatory framework that allowed BPA to be approved as a packaging additive is critically needed. But we are concerned that the announcement today does not go far enough to protect public health, and even sends a mixed message to consumers," said Shannon Coughlin of the Breast Cancer Fund.
 

Sarah Janssen, a staff scientist at the Natural Resources Defense Council, called it "too little, too late."

"More research is always a good idea but there comes a time when we know enough to act and that time has come for BPA," she wrote in a blog.

The chemical industry on Friday criticized the FDA's move, saying that  "some of the recommendations are likely to worry consumers and are not well-founded."

The announcement "confirms that exposure to BPA in food contact products has not been proven harmful to children or adults," the American Chemistry Council said in a statement, adding that “regulatory agencies around the world, which have recently reviewed the research, have reached conclusions that support the safety of BPA."

Nevertheless, many studies have found a variety of health effects in laboratory animals exposed to low levels of BPA. In addition, in 2008, scientists reported that people exposed to higher levels are more likely to develop cardiovascular disease and diabetes, according to the first large-scale study of BPA in human beings.

 Nearly two years ago, the National Toxicology Program, part of the National Institutes of Health, concluded after reviewing about 500 studies that there was "some concern" that fetuses, babies and children were in danger because BPA harmed animals at low levels found in nearly all human bodies.

 When animal fetuses or newborns are exposed, BPA "can cause changes in behavior and the brain, prostate gland, mammary gland and the age at which females attain puberty," the NTP’s report said.
 
"These studies only provide limited evidence for adverse effects on development and more research is needed to better understand their implications for human health," it said. "However, because these effects in animals occur at bisphenol A exposure levels similar to those experienced by humans, the possibility that bisphenol A may alter human development cannot be dismissed."
 
 That report put the two federal agencies at odds, since the FDA found no safety concerns.
 
Hamburg said the FDA’s original decision was based on “standard toxicological tests” but that after the NTP report, the  FDA—under a new administration—revisited the issue and looked at newer studies and sought feedback from scientists. An independent panel of advisors told the FDA that it had ignored important scientific evidence from animal tests when it concluded that BPA was safe.
 
As a result, Hamburg said the agency changed its mind and now “we share the perspective of the NTP" that there is enough evidence to justify "some concern. She added that “our safety assessment of BPA is ongoing.”
 
 The federal government has pledged $30 million in research over the next 18 to 24 months to answer questions about the safety of BPA.
 
Linda Birnbaum, director of the National Institute of Environmental Health Sciences and the National Toxicology Program, said the federal agencies plan to “learn as much as we can as fast as we can and share that information as quickly as we can.”
 

“There is a growing body of evidence that suggests BPA may be a concern,” Birnbaum said. She said there is a “wealth of data” but key questions remain about the risks to children.

Frederick vom Saal, a University of Missouri biologist who is a leading expert studying BPA's health effects, said the change in the FDA's stance is a major step forward. But he added that the recent research should provide ample evidence that the chemical should be banned.

"We will see if they are really able to respond to the huge amount of new science showing dangers not recognized two years ago. They should move quickly to restrict the use of BPA in products used by adults as well as infants," he said.

The FDA could regulate the chemical under a food additive regulation that dates back to the 1960s.

 Currently, industry does not have to report to the FDA when it is using the chemical in food and beverage containers. If FDA does choose to regulate it, manufacturers would have to notify the agency of its usage and the FDA could issue recommendations or requirements.
 
A bill authored by Sen. Dianne Feinstein, D-Calif., would ban BPA from baby bottles and other reusable food containers, and require warning labels on cans that contain BPA.
 
The chemical has been used as a building block in polycarbonate plastic for about 50 years. Many baby bottle and sports bottle manufacturers have stopped making products with BPA in response to consumer demand.
 
For more information about the FDA’s recommendations, go to http://www.hhs.gov/safety/bpa/