Meeting Minutes and Final Report for April 2022 SACC Meeting on Draft TSCA Systematic Review Protocol
Released on July 21, 2022
The meeting minutes and final report are now available for the April 19-21, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed draft Systematic Review Protocol Supporting Toxic Substances Control Act (TSCA) Risk Evaluations for Chemical Substance Version 1.0. The SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention and is structured to provide scientific advice, information and recommendations on the scientific basis for risk assessments, methodologies and pollution prevention measures and approaches for chemicals regulated under TSCA. The SACC meeting minutes and final report are available in docket EPA-HQ-OPPT-2021-0414 at www.regulations.gov. A link to the document is also posted on the SACC meeting webpage.
TSCA requires EPA to adhere to specific scientific standards including the use of the best available science and the weight of scientific evidence. A standardized and transparent approach to identifying, selecting, assessing, and synthesizing the relevant information is important in ensuring a sound scientific foundation for TSCA hazard and exposure assessments.
In 2018, the previous Administration released the Application of Systematic Review in TSCA Risk Evaluations to be used when conducting TSCA chemical risk evaluations. EPA contracted with the National Academies of Sciences, Engineering, and Medicine (NASEM) in December 2019 to conduct a peer review of this approach. The February 2021 report from the NASEM TSCA Committee found that the 2018 document contained incomplete and hard to follow documentation, did not meet the criteria of “comprehensive, workable, objective, and transparent” and did not meet the standards of systematic review methodology. NASEM recommended that EPA revise its approach, incorporating components from existing methodologies, including EPA’s Integrated Risk Information System (IRIS) program.
In response to recommendations made by the NASEM, other EPA offices including the Office of Research and Development (ORD), and the public, EPA has significantly updated the TSCA systematic review process, which was released in December 2021 for public comment and then peer reviewed by the SACC in April 2022. The process EPA submitted for SACC review was developed to strengthen EPA’s approach to reviewing and selecting the scientific studies that are used to inform TSCA chemical risk evaluations and ensure that EPA has the best tools under TSCA to protect human health and the environment.
Last year, NASEM also reviewed ORD’s handbook for developing IRIS assessments which identify and characterize the health hazards of chemicals found in the environment. EPA will continue to work with ORD to incorporate the NASEM recommendations on the IRIS handbook into its TSCA systematic review approach.
EPA is committed to following an open and transparent process to review and update the agency’s systematic review approach. The agency is in the process of reviewing feedback from the meeting and will modify the proposed approach, as appropriate. EPA intends to issue its response to the SACC’s recommendations along with any revisions to the approach in 2023.