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Final rules must ensure EPA focuses on conditions of use that warrant risk evaluations and bases its decisions on the best available science and weight of the evidence

WASHINGTON (March 21, 2017) – The American Chemistry Council (ACC) recently filed comments on the Environmental Protection Agency’s (EPA) proposed rules for Procedures for Prioritization of Chemicals and Risk Evaluation as required by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act):

“EPA is to be commended for its ongoing effort to meet the Lautenberg Chemical Safety Act’s statutory deadlines relating to the framework rules for prioritization and risk evaluation. High quality risk evaluations of chemicals prioritized for review are at the heart of a modernized Toxic Substances Control Act (TSCA) as amended by the Lautenberg Act. ACC has been an active participant in the implementation process for these two rulemakings, and will continue to offer constructive solutions on ways to improve these rules before they are finalized in June.

“The Lautenberg Act requires EPA to develop, by rule, a risk-based screening process to designate chemicals as low priority or high priority for subsequent risk evaluation. ACC urges EPA to clarify its proposed prioritization process in the rule, and in particular, to use tiered, risk-based screening tools and approaches to designate chemicals as high priority for risk evaluation in a measured and efficient manner. EPA’s rule should result in a small and focused queue of high priority chemicals with the remainder classified as low priority, in keeping with the need for the Agency to direct its resources to the highest priorities. EPA’s priority decisions must meet the science standard requirements of Section 26 of the Act and ACC urges EPA to reference these standards in the prioritization rule. We encourage EPA to establish a prioritization process that ensures that the chemicals and uses moving into risk evaluation are of the greatest importance to achieve EPA’s public health mission.

“In both the prioritization process and in risk evaluation, EPA should focus on the particular conditions of use of a chemical that deserve attention. A risk-based and efficient process means that the uses of a chemical that may present the greatest risk are the focus for the review.

“EPA’s expressed vision that “all” conditions of use for chemicals move to risk evaluation is not supported by the statute itself, is unworkable, and will impede EPA from achieving the throughput of high quality risk evaluations that Congress—and the public—expect. The Agency should follow the intent of the law and flexibly scope its work so that it evaluates not “all” conditions of use, but instead focuses on the most relevant, highest risk conditions of use that warrant risk evaluations. The rule should detail a risk evaluation process that consists of a tiered approach that includes an initial screening-level evaluation; when necessary, a more detailed evaluation to quantify potential risks would then be conducted.

“The Agency must clarify in the risk evaluation rule exactly how it will base its risk evaluations on the highest quality, most relevant scientific data and the weight of the scientific evidence as required by Section 26 of the law; this provision requires a new approach EPA must take when conducting risk assessments. Clear definitions are a necessity. Finally, criteria for both manufacturer-requested, and EPA-initiated, risk evaluations should align.

“We are committed to helping EPA refine its proposed rules for prioritization and risk evaluation to ensure that the amendments to TSCA achieve the goals of protections for human health and environment, while enabling our industry to continue to innovate, create jobs and grow the economy.”


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