FDA Shifts Position on BPA but Says Its Hands are Tied

In its long-awaited decision on the dangers of bisphenol-A (BPA) exposure, the Food and Drug Administration (FDA) announced that it believes there is some concern about the effects of BPA on children. This is a shift from the agency's recent position that BPA is safe. The agency says its ability to regulate the chemical, however, is limited by FDA's outdated regulatory authority.

On Jan. 15, FDA announced [1] the results of a year-long review process of scientific studies on low-dose exposure to BPA. The agency expected to announce the results of that review in November 2009 but delayed the announcement until this month. FDA and other federal agencies are still assessing the dangers of exposure to the chemical, which is most commonly found in hard plastics and metal food containers. Products that can contain BPA [2] include baby and water bottles, medical equipment, non-metal dental fillings and sealants, thermal paper used for receipts, and more.

In its announcement of the policy shift, the agency said, "FDA shares the perspective of the National Toxicology Program that recent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children." As a result, FDA is taking several interim steps:

• Working with industry, FDA is supporting efforts to reduce exposure to BPA by searching for substitutes for its use and minimizing the amount of the chemical in use currently.
• FDA is seeking "a shift to a more robust regulatory framework for oversight of BPA."
• The agency is seeking more scientific information to help address the uncertainties it believes exist. According to the announcement, FDA will open a docket on Regulations.gov to ask for public comment and submissions for agency consideration.

In addition, the Department of Health and Human Services (HHS), the National Institutes of Health, and FDA announced a new website [3] for parents to learn more about BPA and its effects. The message provided on the website is confusing. It states, "While BPA is not proven to harm children or adults ... newer studies have led federal health officials to express some concern about the safety of BPA."

The website encourages parents to take several actions to "minimize your infant's exposure to BPA." Discarding scratched baby bottles and cups and avoiding the overheating of formula or food placed in polycarbonate containers are some of the steps suggested.

Several other government agencies are stepping up research on the effects of BPA. According to the HHS website, FDA and the Centers for Disease Control and Prevention (CDC) are conducting new research on the chemical's health effects. The U.S. Environmental Protection Agency is preparing action plans for a variety of chemicals, including BPA. The action plans will summarize scientific studies on BPA and propose a plan for addressing the risks associated with exposure to the chemical, according to a Dec. 17, 2009, BNA article [4] (subscription required).

The National Institute of Environmental Health Sciences [5] is providing $30 million over two years for private and public research. The agency also held an October 2009 meeting of scientists receiving government funding to launch an integrated research effort on BPA.

The federal research focus constitutes a change from prior years in which FDA argued, as recently as August 2008, that BPA was safe. Other research from multiple sources led other governments and private corporations to change their policies and practices regarding BPA. Bottle manufacturers like Nalgene and retailers such as Wal-Mart began to find alternatives to BPA-laced plastic and pulled products from commerce. Health Canada conducted a risk assessment [6] that concluded there was concern about neurological development problems from exposure of infants and small children to BPA. As a result, Canada banned the use of BPA in baby bottles and infant formula cans.

According to FDA's Jan. 15 announcement, BPA is considered a food additive and is subject to regulations issued more than 40 years ago. Under this framework, "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," the announcement adds.

If FDA wished to regulate BPA, it would have to initiate a new rulemaking. Any regulatory decision would have to be based on clearer scientific evidence than the agency believes exists currently. Although FDA cannot compel industry to submit data on the chemical, it intends to ask manufacturers to voluntarily submit information about food contact uses. For years, industry has ignored questions from Congress and refused to turn over information to FDA, according to a Jan. 17 Milwaukee Journal Sentinel article [7].

Dr. Joshua Sharfstein, Principle Deputy Commissioner of FDA, told the Journal Sentinel that the agency may need to ask Congress to provide it with the necessary authority to collect data on BPA uses and impacts before the agency issues standards. There is frustration within the agency with the antiquated regulatory framework that applies to BPA, especially when the agency has had the ability to regulate new food additives since 2000.

According to the Journal Sentinel, the agency's inability to regulate should help convince Congress to pass new legislation. The article quotes John Peterson Myers, Chief Scientist of Environmental Health Sciences, who favors banning BPA, as saying, "Industry always uses the argument that the chemical is regulated … 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."

Several bills have been introduced in Congress either to ban BPA in certain uses or to label products containing BPA so that consumers are free to choose which products to buy. The bills remain in committee.