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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
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is altering the final definition to increase clarity. For example, the EPA
notes that the proposed definition for regulatory science combined both general categories of scientific information, such as assessments and models, with specific examples of EPA
scientific products, such as criteria documents and regulatory impact analyses. The EPA acknowledges that this may increase confusion and is therefore limiting the final definition to general categories. As such, the EPA is altering the definition of science that serves as the basis for informing a significant regulatory action in 40 CFR
30.2 to mean studies, analyses, models, and assessments of a body of evidence that provide the basis for EPA
significant regulatory actions.
Examples of models include those used in regulatory impact analyses. Examples of assessments of a body of evidence include risk assessments, hazard identifications, Integrated Risk Information System IRIS assessments, and criteria documents.
Other commenters expressed confusion over the scope of what constitutes science that serves as the basis for informing a final significant regulatory action, as defined in the proposed rule. One commenter asserted that the phrase provides the basis means that science that serves as the basis for informing a final significant regulatory action could be all the science considered, relied upon, and included in the administrative record of a rulemaking by the EPA. The EPA
agrees with this and clarifies in the final rule that the scope of science that serves as the basis for informing a significant regulatory action is equivalent to the science included in the public docket as part of a rulemaking, but not all of that body of science would typically be considered pivotal science.
D. Applicability of the Rule In the 2018 proposed rulemaking, the EPA proposed to apply the requirements of this rulemaking on significant regulatory decisions. The EPA then solicited comment on whether the requirements of this rulemaking should apply to 1 other stages of the rulemaking process; 2 a narrower scope of coverage; and 3 certain categories of regulatory actions, such as individual party adjudications, enforcement activities, or permit proceedings or other agency actions. In the 2020 SNPRM, the EPA proposed to expand the applicability of this rulemaking to include influential scientific information.
The EPA received significant comment on the proposed applicability
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of this rulemaking to significant regulatory decisions and influential scientific information. Some commenters supported the proposed applicability, while other commenters disagreed with it.
A few commenters addressed the potential for expansion or narrowing of the scope of the rule to include other actions in addition to final significant regulatory decisions and influential scientific information. Of the few commenters that explicitly addressed potential expansion beyond the proposed rulemaking, a majority focused on recommendations to include the science underlying Integrated Science Assessments ISAs and IRIS
assessments. A few commenters expressed support to expand the proposed rulemaking to include one or more of the following: TSCA risk evaluations; CERCLA remedial actions;
RCRA corrective actions; as well as assessments and actions under the CWA. Additional comments recommended expansion of the scope of the proposed rulemaking to include enforcement and permitting actions, as well as agency guidance documents.
Some commenters supported applying the requirements of this rulemaking to proposed rules and advance notices of proposed rulemakings. Other commenters specifically opposed expanding the proposed rulemaking to include the aforementioned actions.
Additionally, some commenters recommended narrowing the scope to only rulemakings subject to the Congressional Review Act or economically significant regulatory actions under E.O. 12866 i.e., those rules that have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.
Some of the assessments that commenters suggested should be subject to the requirements of this rulemaking are categorized as influential scientific information. The EPA notes that many assessments categorized as influential scientific information support rulemakings and other actions under several environmental statutes that the EPA administers. For example, the ISA
for lead and the IRIS assessment for trichloroethylene have been used in a variety of actions including those that are not significant regulatory actions under TSCA, RCRA, and the CAA. IRIS
assessments are routinely used under the CAA, RCRA, and CERCLA. By finalizing the scope rule to include
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influential scientific information, the Agency is applying the applicability of the rule to an important category of scientific assessments that influence a wide range of EPA regulatory actions.
The EPA sees no need to include the proposed rule stage of final significant regulatory actions in the regulatory text because as a practical matter proposed rules must comply with this final rule before being finalized. As a general matter, the EPA does not introduce the studies and analyses it relies on for a rulemaking at the final rule stage. The scientific basis for a rulemaking is provided for public review and comment in the public docket when the proposed rule is issued or, if subsequently added to the docket, through a separate opportunity for public comment. Advance notices of proposed rulemakings are not consistent with the purpose of this rule, given their preliminary nature and frequent focus on soliciting comments on a regulatory issue or approach.
Transparency is important in ensuring that the decisions the EPA makes are based on sound science. The EPA is finalizing the applicability of this rule to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. The EPA is not applying this rulemaking to permit proceedings, site-specific actions, or enforcement actions because these actions are typically focused on individual regulated entities.
E. Availability of Dose-Response Data In the 2018 proposed rule, the EPA
proposed to require at 40 CFR 30.5 that when promulgating final significant regulatory decisions, the Agency shall ensure that dose-response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation. The EPA received a large number of comments stating that the approach in the 2018 proposed rule would likely preclude the use of valid data and models from consideration as pivotal science. The comments indicated that the proposed requirement to ensure data and models are publicly available in a manner sufficient for independent validation would prevent the use of data and models that include CBI, proprietary data, and PII that cannot be sufficiently de-identified to protect the data subjects, as well as many older studies. In response to such comments, in the 2020 SNPRM, the EPA
proposed a modified version of the 2018
proposed regulatory text at 40 CFR 30.5.
Proposed 40 CFR 30.5 would allow
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