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III.
EPA's Proposed Risk Evaluation Process Should Offer Greater Specificity
Regarding the Use of Systematic Review Approaches.
As discussed in further detail in Section IV of these comments, EPA should articulate a clear
regulatory definition of systematic review and commit to implementing a systematic review
approach throughout the risk evaluation process. Systematic review is a process to collect and
evaluate information in a transparent and reproducible manner. ACC cannot envision any
situation where a systematic review definition would unduly restrict the specific science that can
be used to conduct a risk evaluation. A systematic review process will allow EPA to be flexible
and to adapt with changing science, assuming that the new science meets the necessary high
quality standards that are required by LCSA. Articulating a regulatory definition for systematic
review is fully consistent with EPA's policy objectives.
RESPONSES TO SPECIFIC QUESTIONS RAISED BY EPA
IV. Responses to Specific Questions Raised by EPA
While EPA is seeking public comment on all aspects of the proposed rule, the Agency
specifically requests comments on seven topics. ACC's recommendations on each of these topics
are provided below.
Question 1. "Redefining" Scientific Terms
To ensure clarity and consistency, important scientific terms should be clearly defined in the
rulemaking." While many of these terms are not novel concepts and are already in use, multiple
definitions are in use and may mean different things to different stakeholders. Thus, there is a
need for clarity and consistency to ensure that the Agency and all stakeholder groups are using
uniform definitions.
For example, EPA notes that extensive descriptions for the phrases "best available science,"
"weight-of-the-evidence," and "sufficiency of information" can be found in EPA's Risk
Characterization Handbook" and other existing guidance. However, we are unable to find any
clear definitions for "best available science," "weight-of-the-evidence" and "sufficiency of
information" in EPA's Risk Characterization Handbook. While there are references to "weight of
evidence" and "sufficient information," neither term is clearly described.
22 See National Toxicology Program Fact Sheet on Systematic Review, available at
hips:/www.nichs. nih.gov/health/materials/systematic review. 508.pdf
See 82 Fed. Reg. at 7567 ("Due to the rapid advancement of the science of risk evaluation and the science and
technology that inform risk evaluation, this proposed rule seeks to balance the need for the risk evaluation
procedures to be transparent, without unduly restricting the specific science that will be used to conduct the
evaluations, allowing the Agency flexibility to adapt and keep current with changing science as it conducts TSCA
evaluations into the future.")
We do not suggest defining terms in a manner that deviates from accepted scientific understanding, and of course,
our suggestions are intended to align with best available science requirements set out in the statute itself.
See hups://www.epa.zov/sites/production/files/2015.
10/documents/osp fisk characterization handbook 2000.pdf.
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Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

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