Bisphenol A: FDA Finds It Unsafe, But Can’t Regulate Its Use

The U.S. Food and Drug Administration says it is in no position to regulate BPA, although it has declared the chemical to be a safety concern for fetuses, babies and young children. Apparently the problem lies with some federal laws.

FDA officials announced last fortnight 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.

But whereto from there? 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.

"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.

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.

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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, wrote Meg Kissinger of the Journal Sentinel.

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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.

More than 6 billion pounds of the chemical are manufactured each year, accounting for nearly $7 billion in sales.

The chemical is used to line nearly all food and beverage cans. It is used to make hard clear plastic for baby bottles, tableware, eyeglasses, dental sealants, DVDs and hundreds of other household objects.

BPA, which leaches into food and drink when it is heated, has been linked to prostate and breast cancer, reproductive failure, obesity, heart disease, diabetes and behavioral problems.

Sarah Janssen, MD, PhD, staff scientist at Natural Resources Defense Council explains, "It's a small step in the right direction that FDA is working with other federal agencies to acknowledge the health concern, but we believe there is sufficient evidence about the health risks of BPA to support regulatory action now. We know that low dose exposure to BPA at critical stages of development is linked to health effects later in life."

Urvashi Rangan, PhD, toxicologist with Consumers Union, says, "Although food can linings is a relatively small use for BPA, it is a major source of exposure for most people and FDA needs to act as swiftly as possible to limit further exposure."

Mia Davis, BPA Coordinator for Clean Water Action says, "Major baby bottle manufacturers and retailers are already moving away from BPA, but it remains on store shelves in some bottles, sippy cups and in most canned goods. We are all exposed to BPA and other hormone disruptors from a myriad of sources, and our government agencies should be acting in our best interest to eliminate these exposures."

"It's good that FDA registered concern about BPA and is advising parents to reduce children's exposure," said Janet Nudelman of the Breast Cancer Fund. "But the announcement doesn't go far enough. Congress needs to step in and pass the bill currently under consideration, which would ban BPA from all food applications."

BPA manufacturers, however, have maintained it is safe - and they did so again Friday. Lobbyists for the chemical-makers have regularly pointed to the FDA's earlier ruling as proof for their stance.

In 2008, the FDA declared that BPA was safe for all uses based on two studies, both of which were paid for by the chemical industry.

The Journal Sentinel found that lobbyists for the chemical industry wrote entire sections of that decision.

The chemical has been banned for use in baby bottles in Canada, Minnesota, Connecticut, the city of Chicago and two counties in New York. Similar bills are being considered in Wisconsin, Pennsylvania and Washington. A federal ban for all food contact items has been proposed in Congress.

Source-Medindia
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