WASHINGTON — The U.S. Environmental Protection Agency’s Office of Pollution Prevention and Toxics (OPPT) should make changes to its systematic review process under the Toxic Substances Control Act (TSCA) to ensure it is comprehensive, workable, objective, and transparent, says a new report from the National Academies of Sciences, Engineering, and Medicine.

Recent changes to TSCA require EPA to establish a standard process for chemical risk evaluations and complete those evaluations under a strict timetable. OPPT’s 2018 document Application of Systematic Review in TSCA Risk Evaluations details the agency’s new standard approach for systematic reviews used in TSCA chemical risk evaluations. The committee that wrote the National Academies report reviewed this document and other materials to analyze OPPT’s approach.

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. It offers recommendations to improve the process, including the following:

• 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 study — undertaken by the Committee to Review EPA’s TSCA Systematic Review Guidance Document — was sponsored by the U.S. Environmental Protection Agency. The National Academies are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.

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