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.