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EPA joins the FDA in investigation of BPA

The Environmental Protection Agency (EPA) will add polycarbonate (PC) precursor bisphenol A (BPA) to its chemicals of concern list and require testing related to environmental effects as part of a new action plan. The EPA will not examine BPA within food packaging, leaving that to the U.S. Food and Drug Administration (FDA), which in January announced that it had "concerns" about the potential human health impacts of BPA. Those concerns have led the FDA to study the potential effects and ways to reduce exposure to BPA in food packaging.

In a statement, Steve Owens, assistant administrator of the EPA's Office of Prevention, Pesticides and Toxic Substances, stressed that while the EPA shares the FDA's concern about potential health impacts from BPA, food packaging falls under the purview of the FDA. The EPA will instead focus on the potential environmental impacts of BPA, over which it has authority, saying that releases of BPA to the environment exceed 1 million lb/yr. In December, the EPA announced for the first time that it would use its authority under the Toxic Substances Control Act (TSCA) to list chemicals that may present an unreasonable risk of injury to health or the environment.

In a statement released on the same day as the EPA announcement, Cal Dooley, president and CEO of the American Chemistry Council (ACC), stressed that he believes the EPA is not proposing any regulatory action regarding human health. Dooley also said that the ACC would cooperate with the EPA on its action plan, and also work to modernize the agency's Toxic Substances Control Act (TSCA).

In response to questions from PlasticsToday, the ACC said that similar to the EPA Action Plan, the FDA's interim update in January described actions the agency is taking regarding BPA and human health concerns. A key aspect of that ongoing activity is to conduct research that will help answer key scientific questions and address uncertainties, with much of this research will occur over the next 18-24 months. "For the same reasons, [the ACC] also has an ongoing program to sponsor research and testing on BPA," an ACC spokesperson said. "Although the FDA did not announce a timeline, further updates and decisions will presumably be based on the research they and others are conducting."

For the last 10 years, the EPA has focused on protecting citizens from existing chemicals by making basic screening-level toxicity information on them publicly available. In 2008 it expanded those efforts through its Chemical Assessment and Management Program (ChAMP). More recently, EPA Administrator Lisa Jackson has launched what she calls a comprehensive effort to bolster the agency's chemical management program and assure the safety of chemicals. On March 10, the Senate Environment and Public Works Subcommittee on Superfund, Toxics, and Environmental Health held a hearing on modernizing TSCA, with testimony provided by DuPont, among others. In the next few weeks, Senator Frank Lautenberg (D-NJ) and Representative Bobby Rush (D-IL) are expected to introduce a TSCA reform bill. Of the 62,000 chemicals on the market at the time the original law passed in 1976, environmental groups say the EPA has only required testing on about 200, while regulating just five.

The new EPA action plan will also require information on concentrations of BPA in surface, ground, and drinking water. It will mandate that manufacturers provide test data to assist the agency in evaluating its possible impacts, including long-term effects on growth, reproduction, and development in aquatic organisms and wildlife. Additionally, using the EPA's Design for the Environment (DfE) program, it will look for ways to reduce unnecessary exposures, including assessing substitutes, while additional studies continue.

In late 2010, the agency's efforts could potentially include testing or monitoring data in the vicinity of landfills, manufacturing facilities, or similar locations to determine the potential for BPA to enter the environment, with the EPA anticipating publishing an advance notice of proposed rulemaking in late 2010. Products already affected include thermal and carbonless paper coatings used in receipts where BPA alternatives may be readily available. Additionally, the EPA intends to examine alternatives for BPA used in foundry castings, as well as BPA-based materials lining water and waste water pipes.

The EPA is working with the FDA, the Centers for Disease Control and Prevention, and the National Institute of Environmental Health Sciences to assess non-food packaging exposures that fall outside of the FDA's reach but within EPA's regulatory authority.

On March 30, the ACC's Dooley spoke on a TSCA Modernization panel at GlobalChem Conference and Expo in Baltimore, MD, saying, "[the ACC] is committed to developing a new, comprehensive chemical management law that puts the safety of the American consumer first, while ensuring the innovation that will lead to the development of essential new consumer products and high-paying American jobs."

Outside the same event, a coalition of 200 environmental and public health groups called on the chemical industry within the conference to deliver what they called "a substantive platform to reform our federal toxic chemicals policy." That coalition, Safer Chemicals, Healthy Families (SCHF), released a document outlining three differences they've discerned between how the chemical industry and public health groups are defining TSCA reform.

In particular, SCHF wants health and safety information released on all chemicals as a condition for entering or remaining on the market. The SCHF has also called for the EPA quickly reduce the impact of chemicals "already known to be dangerous", saying that complete risk assessments called for by the chemical industry would leave the EPA "wasting precious resources to reinvent the wheel." SCHF also believes that the EPA should investigate cumulative exposure to chemicals, such as they are experienced in the real world, not on an individual basis.

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