On February 16, 2021, the EPA announced it “will refine its approach to selecting and reviewing the scientific studies that are used to inform Toxic Substances Control Act (TSCA) chemical risk evaluations (known as systematic review).”

The announcement came in response to recommendations from the National Academies of Science, Engineering and Medicine (National Academies) in a report it published entitled “The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations.” This report was the result of the EPA’s contracting with the National Academies in December 2019  to conduct a peer review of the Agency’s 2018 Application of Systematic Review in TSCA Risk Evaluations.

According to the National Academies, changes to the TSCA systemic review process used by the EPA’s Office of Pollution Prevention and Toxics (OPPT) are necessary to ensure the process is comprehensive, workable, objective, and transparent.

“The report recognizes OPPT’s challenge in meeting the strict statutory schedule for completing assessments, but says OPPT’s systematic review does not meet state-of-practice standards,” according to the National Academies press release, which also offers the following summary of recommendations:

• “OPPT staff should engage in ongoing cross-sector efforts to develop and validate new tools and approaches for exposure, environmental health, and other areas where systematic review is applied. TSCA evaluation approaches would benefit from the substantial external expertise available as well as acceptance from outside stakeholders as the approaches are developed.”
• “The decision to develop a wholly original approach to hazard assessment, rather than starting with other extant protocols as a foundation, is one source of the process’s problems. OPPT should consider incorporating components of methodologies from the National Institute of Environmental Health Science’s Office of Health Assessment and Translation and EPA’s Integrated Risk Information System and Navigation Guide.”
• “Documentation of the process is incomplete and hard to follow. OPPT should assemble a handbook for TSCA review and evidence integration methodology to detail steps in the process.”
• “The terms ‘weight of evidence’ and ‘systematic review’ are used interchangeably. The report urges OPPT to use standard descriptors for the strength of evidence instead.”

The EPA acknowledges that the recommendations within the report are in line with the “Biden-Harris Administration’s commitment to making evidence-based decisions.”

The Agency will no longer be using the 2018 systematic review process reviewed by the National Academies. When that methodology was published, the Agency stated updates were planned based on the outcomes of its first 10 risk assessments. As such, it had already begun developing revisions to that approach. The EPA stated it “is committed to addressing (the National Academy’s) recommendations and ensuring strong science is the basis for all chemical risk evaluations.”

“High quality, best available scientific data and studies are the foundation of our chemical risk evaluations,” said Michal Freedhoff, acting assistant administrator for the Office of Chemical Safety and Pollution Prevention. “Strengthening the process used to select this information will improve chemical safety and ensure our risk evaluations protect human health and the environment.”

Later this year, the “EPA expects to publish and take public comment on a TSCA systematic review protocol that will adopt many of the recommendations in the Academies’ report,” according to the Agency’s press release.