At both the federal and state level, 2010 has seen a potentially significant shift in the regulatory landscape regarding Bisphenol A use in consumer products.
Some of these efforts continue to be exploratory, recognizing that the case for regulation requires more thorough scientific analysis.
Others, however, particularly at the state level, raise greater concerns as they threaten to establish piecemeal, state-by-state regulation that imposes particular burdens on all companies in the distribution chain.
Much of the recent increased focus on BPA stems from pronouncements by the Food and Drug Administration and the Environmental Protection Agency in 2010; and the enactment in 2009 and 2010 of laws in several states banning the use of BPA in certain consumer products.
These and related developments are briefly summarized below.
The EPA's March 29, 2010, “Bisphenol A Action Plan” provides an informative overview of BPA-related regulatory developments in the U.S. and abroad. EPA notes that although food-contact uses comprise only about 5 percent of total BPA use, “most human exposure appears to come from food packaging materials.” Since these uses fall under the FDA's authority to regulate food-contact articles, the report acknowledges that “FDA has the lead in making human health judgments on BPA.”
With respect to environmental (i.e., non-FDA) concerns, EPA will consider initiating rulemaking under the Toxic Substances Control Act to identify BPA on the “Chemicals of Concern List” as well as other possible action under TSCA. The agency projects autumn 2010 as a possible date for issuing a notice of proposed TSCA rulemaking. On May 12, EPA submitted to the White House Office of Management and Budget a Chemicals of Concern List that includes BPA.
In its discussion of risk assessments and risk management, the EPA report states that while BPA has been evaluated as a chemical of potential concern in the U.S. and abroad since the early 1980's, “very little information is available on exposure from consumer products.” Significantly, the report contains the following summary observation:
“There is agreement among international regulatory authorities using generally accepted approaches to human health assessment that human exposures to BPA are below levels that would be associated with health effects, leading to determinations that current uses of BPA do not present human health risks warranting further regulatory controls.”
The report continues, however, that the “complicating factor” is the uncertainty surrounding the meaning and relevance of the effects observed in some novel low-dose studies, a factor also reflected in FDA's 2010 pronounce- ments.
In January, the FDA issued an update on BPA use in food-contact applications. It states that although “studies employing standardized toxicity tests have thus far supported the safety of current low levels of human exposure to BPA,” the FDA believes recent studies “provide reason for some concern” over the effects of BPA.
Noting the “uncertainties” associated with these studies, however, FDA said it will continue to review them, support additional studies, seek public and expert input, and generally pursue a “shift to a more robust regulatory framework for oversight of BPA.”
The FDA expects to have the results of this additional research in 18-24 months. Over roughly this same period, the National Institute of Environmental Health Sciences will invest about $30 million in BPA-related research.
Several bills were introduced in Congress in 2009 and 2010, ranging from proposed legislation to require BPA labeling to banning its use in food and beverage containers, unless exempted by FDA. The BPA-Free Kids Act of 2009, HR 4456, would treat any non-metal food or beverage container that contains BPA and is intended for children 3 or younger as a banned hazardous substance under the Federal Hazardous Substances Act.
Among other things, the bill also would require certifications of compliance with respect to such children's food or beverage containers, following the approach of the Consumer Product Safety Improvement Act of 2008, with respect to lead and phthalates in children's products. Significantly, as of this writing, the Food and Drug Administration Food Safety Modernization Act, passage of which was expected earlier this year, remains stalled as a result of Senator Dianne Feinstein's efforts to amend the measure to include BPA restrictions based on her 2009 bill, the Ban Poisonous Additives Act of 2009 (S. 593).
As of the end of July, seven states had enacted laws regarding BPA.
Wisconsin's law, effective June 15, bans use of BPA in baby bottles and “sippy” cups primarily intended for children 3 or younger. Minnesota's law, which took effect Jan. 1, similarly is aimed at BPA in products for children under 3. The Connecticut statute, which will take effect Oct. 1, 2011, broadly prohibits manufacture, sale, offer for sale, or distribution in Connecticut of any “reusable food or beverage containers” containing BPA, which expressly includes sports bottles. Vermont's statute imposes similar restrictions to take effect July 1, 2012. The Washington statute bans use of BPA in certain children's products, and also bans distribution or sale of non-metal sports bottles with BPA, effective July 1, 2012. In mid-April of this year, Maryland enacted a BPA law that would bar the manufacture, distribution or sale on or after Jan. 1, 2012, of empty bottles or cups intended for children under age 4 if the article contains BPA. On July 30, New York enacted its limited BPA ban, effective Dec. 1, 2010, on various child-care products, including baby bottles and drinking cups, intended for children under age 3.
Under the Obama Administration, the two principal federal agencies involved with BPA, the FDA and EPA, have taken a more aggressive posture regarding potential BPA regulation. At this point, however, such efforts remain largely research-oriented and are thus unlikely to generate binding regulation of consumer products in the near term. Similarly, pending federal legislation has been limited and largely confined to BPA in products for very young children. The same has been true for the several states that have enacted legislation regulating BPA.
The three exceptions are Connecticut, Washington, and Vermont, where the statutory restrictions extend beyond children's products to reusable beverage containers, including sports water bottles.
If other states enact similar bans, a fragmented, state-by-state regulatory patchwork will develop, independent of and potentially counterproductive to the continuing efforts of federal reg- ulators to assess the scientific justification for BPA regulation.
Paul Laurenza is an attorney in the Washington office of national law firm Dykema Gossett PLLC and is a member of its government policy and automotive industry groups.