After the EPA extended the public comment period on its problem formulation documents for the first 10 chemicals that will receive risk evaluations under the amended Toxic Substances Control Act (TSCA), major stakeholders provided radically divergent views of both the documents and the EPA’s approach to developing them.
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The problem formulation documents refine the scope of risk evaluations for the first 10 chemicals. One of the more controversial decisions the EPA has taken concerns the conditions of use of the chemicals—that is, those uses that will be included in the risk evaluations because the Agency believes they present an unreasonable risk to people. Under the Trump administration, the Agency has made it clear that it will, “on a case-by-case basis, exclude certain activities that EPA has determined to be conditions of use in order to focus its analytical efforts on those exposures that are likely to present the greatest concern, and consequently merit an unreasonable risk determination.”
The risk evaluations for the first 10 chemicals must be completed by December 2019.
Approach Promotes Efficiency
This approach to conditions of use found favor with the American Chemistry Council (ACC) in its comments on the problem formulation documents. The ACC states that it is appropriate for the Agency to focus “on those conditions of use that raise the greatest potential for risk,” an approach that promotes efficiency.
“The problem formulation documents present a thoughtful approach to identifying current uses that are appropriate for inclusion within the scope of the risk evaluation,” said the ACC. The organization added that it would also like the Agency to develop a systematic approach to decisions regarding conditions of use decisions.
“As EPA gains more experience conducting TSCA risk evaluations for high priority chemicals, it would be useful if the Agency would develop a framework that articulates its process for deciding when conditions of use are in or out of scope,” wrote the ACC. “This would help EPA streamline future efforts, provide greater public understanding of EPA’s decisions, increase transparency and reproducibility, and enable industry to identify the types of information that may be most helpful for manufacturers, processors, and downstream users to develop and/or share with EPA. Developing a framework would also help industry anticipate which conditions of use will be the likely focus in future assessments so that they can direct resources efficiently to develop and/or gather information relevant to EPA’s potential risk evaluations and facilitate proactive data collection efforts.”
Approach Is Illegal
A radically different view was presented by the Environmental Defense Fund (EDF) as part of its 200 pages of comments on the problem.
The EDF argues that the TSCA amendments do not give the EPA the authority to leave certain conditions of use for certain chemicals out of the risk evaluations because exposures to those chemicals are or could be assessed under other statutes, such as the Clean Air Act or Clean Water Act. The EDF adds that the EPA cannot accurately evaluate risk to potentially exposed or susceptible subpopulations, such as fenceline communities, if it excludes the vast majority of exposure pathways leading to their greater exposure. Also, the Agency’s approach ignores the numerous problems with compliance, implementation, and enforcement under the other authorities the EPA seeks to rely on instead of TSCA, says the EDF.
“Instead, EPA should be guided by the statutory language and consider all of the conditions of use, exposures, and hazards related to a chemical substance,” asserts the EDF, which adds that the Agency “should not ignore evidence because of self-imposed blinders.”