Draft Protocol for Systematic Review in TSCA Risk Evaluations
In December 2021, EPA released a draft Toxic Substances Control Act (TSCA) Systematic Review Protocol. The protocol will 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.
In 2018, the previous Administration released the Application of Systematic Review in TSCA Risk EvaluationsIn 2019, EPA contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to review the approach included in that 2018 document.
The report from the NASEM TSCA Committee, released in February 2021, included several opportunities and recommendations to improve EPA’s systematic review process.
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 EPA has significantly updated the TSCA systematic review process and developed a systematic review protocol to address NASEM’s recommendations.
The draft TSCA Systematic Review Protocol includes key recommendations received from NASEM on the Application of Systematic Review in TSCA Risk Evaluations, is a product of collaboration with the Office of Research and Development’s IRIS program, and will continue to be improved by public feedback, examination of the recent NASEM report on the ORD Staff Handbook for Developing IRIS Assessments, and evolution of the state of the science in the field of systematic review.
EPA will accept comments in docket EPA-HQ-OPPT-2021-0414 for 60 days. The draft protocol will also undergo peer review by the TSCA SACC in April 2022. The TSCA SACC will hold a public peer review virtual meeting on April 19-21, 2022, from 10:00 AM to 5:00 PM EDT.
Previously, EPA’s initial work on systematic review was described in the supplemental files for each TSCA scope document, which included the Strategy for Conducting Literature Searches and the Bibliography for each chemical. The final document below contains the agency’s 2018 response to the comments received on these supplemental documents. While EPA is not using, and will not again use, the 2018 systematic review approach document, the documents are provided below for historical reference.
- 2018 Application of Systematic Review in TSCA Risk Evaluations (pdf)
- 2018 Response to Public Comments Related to the Supplemental Files Supporting the TSCA Scope Documents for the First Ten Risk Evaluations (pdf)