FDA says it's unable to regulate BPA
As 'indirect food additive,' substance is exempt from scrutiny
By Meg Kissinger of the Journal Sentinel
Posted: Jan. 17, 2010
U.S. Food and Drug Administration officials say they are powerless to regulate BPA, although they have declared the chemical to be a safety concern for fetuses, babies and young children.
A quirk in the rules allows BPA makers to skirt federal regulation.
"We may have to go after legislation to change it," Joshua Sharfstein, the FDA's principal deputy director, told the Journal Sentinel. The newspaper has been investigating the government's lack of regulation regarding BPA for three years.
FDA officials announced Friday that they had reversed their position that bisphenol A is safe. The chemical, used to line most food and beverage cans, has been found in the urine of 93% of Americans tested.
The agency now considers BPA to be of some concern for effects on the brain, behavior and prostate glands of fetuses and the very young. Scientific studies have raised concerns about the chemical's link to breast and prostate cancer, diabetes, obesity, heart disease, reproductive failures and behavioral problems.
The FDA did not ban the chemical, although top scientists, including Linda Birnbaum, director of the National Toxicology Program, say they consider the safety of BPA to be uncertain. An agency source says some from within the FDA wanted to follow Canada's lead and ban it from baby bottles - or from the lining of infant formula cans - but administration officials have resisted, concerned that babies who rely on bottled formula would be left without healthy alternatives.
"They couldn't take it off the shelves when there aren't substitutes in place," said the source, who asked not to be identified because the issue is so politically charged in the agency.
FDA officials - including Sharfstein; Lynn Goldmann, a consultant to the FDA; and Jesse Goodman, the FDA's acting chief scientist - told the Journal Sentinel they were frustrated by the antiquated framework of the FDA's regulatory process.
Officials say they would like chemical manufacturers to report information about the chemical to them, including how much BPA they produce and where and how it is used.
But because BPA was classified years ago as an indirect food additive, it is not subject to the kind of scrutiny that other chemicals are. Without critical data about BPA, it is impossible to regulate the chemical, officials said.
BPA, first manufactured in 1891, was later developed as a plasticizer in the early 1960s. It was classified in 1963 as an indirect food additive and is listed among some 3,000 chemicals that are "generally regarded as safe." That designation exempts them from scrutiny.
According to the FDA's regulations, a substance that is granted that status is not subject to FDA review.
So, while the agency can broadcast its opinion that the chemical is not safe, it can't compel companies to provide certain information about the chemical.
Given concern about BPA, and the ongoing evaluation and studies on its safety, the FDA thinks that the more modern framework is more robust and appropriate for oversight of BPA, agency officials say.
The FDA candidly explains the limitations on its Web site:
Current BPA food contact uses were approved under food additive regulations issued more than 40 years ago. This regulatory structure limits the oversight and flexibility of FDA.
Once a food additive is approved, any manufacturer of food or food packaging may use the food additive in accordance with the regulation. There is no requirement to notify FDA of that use.
For example, today there exist hundreds of different formulations for BPA-containing epoxy linings, which have varying characteristics. As currently regulated, manufacturers are not required to disclose to FDA the existence or nature of these formulations.
Furthermore, if FDA were to decide to revoke one or more approved uses, FDA would need to undertake what could be a lengthy process of rulemaking to accomplish this goal.
FDA Administrator Margaret Hamburg said the agency needs to overhaul its regulatory framework because the structure limits its ability to monitor BPA production.
"We need to be more nimble," she said.
Sharfstein, the deputy director, said the agency can try to get the companies to volunteer the information but might have to get a change in the law.
The FDA's admission of its inability to regulate the chemical should give muscle to legislative efforts for a ban, said Jon Peterson Myers, chief scientist for Environmental Health Sciences, who has advocated for a BPA ban.
"Industry always uses the argument that the chemical is regulated," Myers said. "This shows that it is not. State and federal lawmakers need to consider that. They can't rely on this agency to regulate it if they don't have the tools to do so."
Minnesota, Connecticut, the City of Chicago and two counties in New York have banned BPA in baby bottles. Other measures are being considered in 30 states and municipalities. A federal ban on BPA in all food contact has been proposed in Congress.
The Journal Sentinel obtained e-mails through the Freedom of Information Act that showed how the agency's look at BPA had been influenced by BPA makers.
The newspaper found that industry scientists wrote sections of the FDA's earlier draft declaring the chemical to be safe for all uses. It later obtained e-mails that showed industry lobbyists were given priority treatment in scrutinizing studies and that FDA regulators looked to them for advice on how to deal with the media.
The newspaper also uncovered documents that showed how BPA makers borrowed the same tactics and some of the same people as the tobacco industry to downplay the health risks of their products. In a meeting held in Washington, D.C., last May, food packaging executives mapped out a public relations strategy that included finding a pregnant woman to serve as a spokeswoman for the benefits of BPA. Notes referred to such a person as "the holy grail."
Last year, more than 6 billion pounds of BPA was made, representing nearly $7 billion in sales. U.S. companies that make BPA are Bayer Material Science; Dow Chemical Co.; SABIC Innovative Plastics (formerly GE Plastics); Hexion Specialty Chemicals; and Sunoco Chemicals.
Company officials have evaded questions about their product. Rep. John D. Dingell (D-Mich.) has written letters to BPA makers demanding information about their production levels but has gotten no reply.
"They absolutely stonewalled them, just like they stonewall anyone who wants information," said Fred vom Saal, a University of Missouri scientist who has advocated a ban of BPA. Vom Saal has debated against industry lobbyists at government hearings.
Chemical industry scientists maintain that BPA is safe. The American Chemistry Council, the lobby group for the chemical industry, issued a statement Friday saying that BPA is an important ingredient in preserving the integrity of food and drink.
The Obama administration committed $30 million to studies of BPA. The FDA's Sharfstein said the data is expected to be collected in the next 18 months to two years.
While the FDA considers how to deal with BPA makers, the market is moving away from using BPA in baby products. Last year, the six major baby bottle makers announced they would stop using the chemical in their products.
Susanne Rust, a former Journal Sentinel reporter involved in the paper's BPA investigation and now a freelance writer, contributed to this report.