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WASHINGTON (August 16, 2018) – The American Chemistry Council (ACC) today filed comments with EPA on the first 10 problem formulation documents under the amended Toxic Substances Control Act (TSCA) and on EPA’s systematic review approach document.

“ACC commends EPA’s dedicated staff for their continued efforts to meet the requirements of the law,” said ACC Vice President of Regulatory and Technical Affairs Michael Walls. “After fully reviewing and analyzing the problem formulation documents, it is clear that EPA is focused on the conditions of use that represent the greatest potential for risk and gathering the best available information to use in the risk evaluations.”

In its comments on the problem formulations for the first 10 chemicals, ACC makes several recommendations to the agency for its consideration in these and future scoping documents for TSCA risk evaluations. Among others, those include:

  • Systematic review: EPA’s development of a structured process to identify, evaluate and integrate evidence from both the hazard and exposure assessments developed during the TSCA risk evaluations is appropriate and will provide increased transparency into the TSCA risk evaluation process.
  • Conditions of use: EPA should develop a framework for its scoping approach that articulates its process for deciding when conditions of use will be in or out of scope of the risk evaluation. This would help streamline the agency’s future efforts, increase transparency and help industry anticipate EPA’s information needs in the risk evaluations.
  • Coordination with other appropriate federal executive departments or agencies: EPA should develop new or update existing memoranda of understanding with other federal agencies, in particular OSHA, to clarify how it will undertake its TSCA Section 9(d) consultation obligations. This coordination is essential to avoid duplicative and unnecessary regulation.
  • Tiered approaches to assessment: EPA should apply tiered approaches to hazard and exposure assessments throughout the risk evaluation process. This will enable EPA to meet TSCA’s deadlines, adhere to TSCA’s science standards and enable EPA and the regulated community to apply resources efficiently. For example, a roadmap showing EPA’s approach to tiered exposure assessments and guidance on the same would be useful.

“We believe the systematic review proposal has many positive attributes and that several areas of guidance are well developed. It focuses on fit-for-purpose evaluations and an iterative evaluation process, which allow for flexibility that is necessary given the wide array of chemical substances that will be reviewed under TSCA,” Walls continued. “However, the approach would benefit from additional explicit guidance, particularly related to evidence integration, which will help ensure objective, comprehensive, scientifically supported risk evaluations for TSCA chemicals.”

ACC will continue to support the efficient and effective implementation of TSCA. Successful implementation of this important bipartisan legislation is essential to ensuring protections for human health and environment while enabling our industry to continue to innovate, create jobs and grow the economy.

» To read the full comments on the first 10 problem formulations, click here
» To read the full comments on systematic review, click here

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