The U.S. Environmental Protection Agency (USEPA) released a draft Toxic Substances Control Act (TSCA) Systematic Review Protocol. According to the USEPA, the protocol is intended to strengthen its approach to reviewing and selecting the scientific studies that are used to inform TSCA chemical risk evaluations and ensure that USEPA has the best tools under TSCA to protect human health and the environment.
The February 2021 report from the National Academies of Sciences, Engineering, and Medicine (NASEM) TSCA Committee found that the previous systematic review process contained incomplete and hard to follow documentation, did not meet the criteria of being “comprehensive, workable, objective, and transparent,” and did not meet the standards of systematic review methodology. NASEM recommended that USEPA revise its approach, incorporating components from existing methodologies, including USEPA’s Integrated Risk Information System (IRIS) program.
In response to recommendations made by the NASEM, as well as comments received from the TSCA Scientific Advisory Committee on Chemicals (SACC) and the public, the USEPA has significantly updated the TSCA systematic review process and developed a systematic review protocol. The draft TSCA Systematic Review Protocol will undergo peer review at a meeting of the SACC on April 19-21, 2022, and the USEPA will also use this feedback to further improve the document. The date, time, and registration instructions for the public peer review virtual meeting, including information on making oral comments, will be announced on the SACC website by early March 2022.
In the draft TSCA protocol, the USEPA streamlines the data evaluation of human health hazards by enabling the use of recent and future IRIS systematic reviews. The draft protocol also includes new methods to reduce bias and improve evaluation consistency between reviewers and across chemicals. These improvements include coordinated data evaluation training and calibration exercises for reviewers, the development of additional internal evaluation guidance, and improvement of evaluation forms.
The USEPA is accepting comments on the draft protocol in docket EPA-HQ-OPPT-2021-0414 until February 18, 2022.