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The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations (2021) / Chapter Skim
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3 Crosscutting Issues with the TSCA Approach
Pages 52-56

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From page 52...
... Risk Evaluations and associated materials to determine whether the process is comprehensive, workable, objective, and transparent." In summary, the committee finds that the process outlined in the 2018 guidance document, and as elaborated and applied in the example evaluations, does not meet the criteria of "comprehensive, workable, objective, and transparent." The committee's evaluation was made difficult by the incomplete and hardto-follow documentation of many details of the process -- adequacy of documentation is requisite for achieving transparency, objectivity, and replicability. The committee found that the systematic reviews within the draft risk evaluations considered did not meet the standards of systematic review methodology.
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From page 53...
... Without a clear definition of "a systematic review method," the committee inferred from the presentations by OPPT staff and the 2018 guidance document that the TSCA program interpreted the rule to mean "systematic review" as conventionally defined. With this interpretation of the rule in mind and considering the full set of requirements for what constitutes systematic review, the committee has found that OPPT has not been performing "systematic review" for the various evidence streams in a way that meets current standards.
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From page 54...
... Similarly, as described in Chapter 2, there are already established tools for assessing risk of bias and certainty that have been used extensively and that could be used in TSCA risk evaluations. The committee recommends that OPPT give full consideration to existing approaches related to all evidence streams before continuing on the track of developing new instruments that may not be needed.
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From page 55...
... . ENHANCING CLARITY OF DOCUMENTATION OF THE ASSESSMENT METHODS The committee carefully examined the 2018 guidance document, considered several TSCA evaluations, and was briefed by OPPT staff on multiple occasions, including with presentations and poster sessions.
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From page 56...
... The committee also suggests that OPPT evaluate the ways that existing OHAT, IRIS, and Nav igation Guide methods could be modified for the other evidence streams. In addition, OPPT should use existing guidance within the agency such as the Guidelines for Human Exposure Assessment, the Guidelines for Ecological Risk Assessment, and the operating procedures for the use of the ECOTOXicology knowledgebase, as following existing guidelines would improve transparency of the assessments.
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