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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
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response data and models. Rather, consistent with the applicability of this final rule, the EPA is finalizing a definition of dose-response data that is specific to the relationship between a dose or exposure and an effect.
4. Influential scientific information. In the 2020 SNPRM, the EPA proposed expanding the scope of the 2018
proposed rule to include influential scientific information and proposed to define influential scientific information as scientific information the Agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions, consistent with the definition of influential scientific information provided in the OMB Final Information Quality Bulletin for Peer Review Ref.
8.
The EPA received public comments in support of and against the Agencys proposed 40 CFR 30.2 definition of influential scientific information.
Some commenters believed that the proposed definition was too broad to be useful and, as a result, would apply to all scientific documents produced by the EPA. Other commenters believed that the proposed definition was too narrow and would not adequately capture the types of information that may be considered influential.
The EPA finds that these comments have merit, in part. The definition of influential scientific information at proposed 40 CFR 30.2 in the 2020
SNPRM is the same definition as in the OMB Final Information Quality Bulletin for Peer Review Ref. 8. The EPA
proposed to adopt this definition because it intended the scope to be consistent with how that term has been interpreted and applied in the context of peer review.10 Given that the definition is both established and has been routinely applied by the EPA, the EPA
disagrees with the suggestion that the term is inherently too narrow or too broad. Rather than modify the proposed 40 CFR 30.2 definition of influential scientific information, the EPA is modifying 40 CFR 30.3 in the final rule to clarify the Agencys intent that the requirements in 40 CFR 30.3 apply to influential scientific information, unless the influential scientific information is exempted from peer review requirements as described in Section IX
10 For example, see the Environmental Protection Agency Annual Report on Peer Review Fiscal Year 2017 October 1, 2016September 30, 2017 that the Agency submitted to OMB, https cfpub.epa.gov/
si/EPA%20FY%202017%20Annual%20Peer%20
Review%20Report.pdf. Each annual report identifies influential scientific information and highly influential scientific assessments.

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of the OMB Final Information Quality Bulletin for Peer Review Ref. 8.
Consistent with this approach, the EPA
is finalizing the definition of influential scientific information as proposed in the 2020 SNPRM.
5. Pivotal science. In the 2020
SNPRM, the EPA introduced the term pivotal science, defined in proposed 40 CFR 30.2 as the specific scientific studies or analyses that underly sic influential scientific information. This term was proposed as a parallel to pivotal regulatory science, defined in 40 CFR 30.2 of the 2018 proposed rule as the specific scientific studies or analyses that drive the requirements and/or quantitative analysis of EPA
significant regulatory decisions.
The EPA received comment on the use of regulatory in pivotal regulatory science. Some commenters contended that there is no such thing as science that is regulatory; rather, there is science used to support regulation.
Some commenters also noted that the terms pivotal science and pivotal regulatory science have similar scopes.
The EPA acknowledges that no scientific study is inherently regulatory;
rather, the EPA uses science to inform its significant regulatory actions. In order to increase the clarity of this final rule, to take into account the similarities between the two definitions, and to more accurately describe the science that the EPA uses, the EPA is removing the term pivotal regulatory science and combining the definitions of pivotal science and pivotal regulatory science under the single term pivotal science in 40 CFR 30.2.
The EPA is responding to comments on both terms together.
Some commenters noted that the scope of studies that could be considered pivotal science was unclear but appeared broad. Some commenters argued that since properly conducted science reviews the entire body of scientific evidence, nearly any study evaluated could be considered pivotal science. The EPAs SAB
suggested that the Agency clarify whether pivotal science refers to all the hazard characterization and doseresponse models that the EPA evaluates and captures in its analysis Ref. 27.
Other commenters asserted that if the EPA interprets pivotal science broadly to include all studies involved in the development of significant regulatory actions or influential scientific information, implementing this rule would be infeasible.
As discussed in Section III.B of this preamble, the EPA finds merit in comments that the proposed definition for pivotal science appeared too broad
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to feasibly implement in this rule.
Because of the EPAs commitment to basing its decisions on sound science, the EPA may review several hundred or thousands of scientific studies in the development of significant regulatory actions or influential scientific information. As such, the EPA agrees that determining data availability for all the studies EPA considers in significant regulatory actions and influential scientific information may be infeasible at this time. Future statute-specific rulemakings may be more expansive as the EPA continues to make incremental progress toward maximizing transparency.
Further, although this rulemaking does not require reanalysis of a studys underlying data, the EPA finds that limiting the scope of pivotal science will still provide meaningful and impactful opportunity for reanalysis.
Lewandowsky et al. 2020 evaluated the cost-effectiveness of reanalysis studies under various scenarios and concluded that reanalysis studies are most cost-effective when they are focused on studies of the greatest interest to the scientific community in this study, the number of citations was a surrogate for interest Ref. 38. This finding is consistent with results in other studies that found and encouraged narrowing the focus of attempted reanalysis studies to those studies of greater significance Refs. 37, 39, 40, 41.
In this final rule, rather than considering all studies that support the assessment of the relationship of a dose or exposure of a pollutant, contaminant, or substance to the magnitude of a predicted health or environmental impact as pivotal science, the EPA is balancing transparency and feasibility by focusing on those studies that inform the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and an effect.
Thus, pivotal science includes only those studies that are integral to characterizing dose-response relationships e.g., identifying candidate PODs. These are the studies that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. Although this rule takes an incremental approach and therefore does not include studies informing the dose-response modeling e.g., benchmark response selection, studies identifying data for toxicokinetic adjustments, or studies informing the selection of uncertainty factors do not drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific
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