The U.S. Environmental Protection Agency (EPA) issued on July 26, 2011, an advance notice of proposed rulemaking (ANPR) concerning testing of bisphenol A (BPA). The notice applies to EPA’s chemical action plan issued under the Toxic Substances Control Act (TSCA) on BPA in March 2010. The ANPR shows the EPA is moving forward, sending a strong message that the agency isn't backing off plans to regulate BPA under TSCA, or any other chemical action plans.
In EPA's action plan for BPA, the agency states the ANPR is directed only toward the environmental presence and effects of BPA. According to the notice, EPA is working with the U.S. Department of Health and Human Services (HHS) on potential human health issues, but isn't considering additional testing regarding human health issues at this time.
In the notice, EPA seeks input on the necessity and best approach to obtain environmental effects, exposure, and pathway information relevant to determining whether BPA does or doesn't present an unreasonable risk of injury to the environment. Due to the ubiquitous presence of BPA in the environment from many sources of production and use, the EPA is struggling with responding to this threshold question.
The ANPR includes the following questions for commenters:
1. Whether the EPA should propose requiring specific toxicity testing to characterize more fully the effects of BPA on environmental organisms at low concentrations;
2. Whether the EPA should propose requiring environmental testing consisting of sampling and monitoring — particularly in the vicinity of reported releases of BPA into the environment. What design and protocol should the EPA use for such sampling and monitoring to identify potential sources and pathways of exposure, and determine the extent to which environmental organisms may be exposed to BPA concentrations of concern (as determined by existing data and by additional studies that are either already underway or would be conducted under a test rule); and
3. Which TSCA Section 4(a)(1) finding authority would be most appropriate for proposing a BPA test rule and why (along with supporting information). Any proposal ultimately would be based on EPA’s assessment of relevant information available at the time of proposal.
EPA reaffirms that, as stated in the BPA Action Plan, it doesn't intend to initiate regulatory action under TSCA at this time on the basis of human health. EPA notes that most human exposure, including to children, comes through food packaging materials, which are under the jurisdiction of the U.S. Food and Drug Administration (FDA).
According to the EPA, the FDA, together with the Centers for Disease Control and Prevention (CDC) and the National Institute of Environmental Health Sciences (NIEHS), “is investing in important new health studies in both animals and humans to better determine and evaluate the potential health consequences of BPA exposures.” EPA will continue to coordinate closely with FDA, CDC, and NIEHS on this activity.
EPA states, to the extent that FDA may identify health concerns from BPA in food contact materials, EPA will work with the agency to identify and assess potential substitutes. Levels of exposure that may be identified as being of concern to human health will affect the extent to which the EPA would address potential risks to human health resulting from uses within TSCA jurisdiction.
In addition, the EPA requests comment on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related ones, in environmental organisms at low concentrations. The EPA also seeks comment on requiring environmental testing consisting of sampling and monitoring for BPA in the vicinity of expected BPA releases. This would determine whether environmental organisms may currently be exposed to concentrations of BPA that are at, or above, levels of concern for adverse effects, including endocrine-related ones.
Because BPA is used in many applications by many industries, this notice is important as it cuts across many sectors of the economy. Response to the EPA’s request is essential as it will greatly influence whether and, if so, how environmental testing of BPA will proceed. Comment is due by September 26, 2011.
Lynn L. Bergeson is Chemical Processing's Regulatory Editor. You can e-mail her at Lbergeson@putman.net.
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.