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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations information. Future statute-specific rulemakings may interpret pivotal science more broadly.
This clarified definition of pivotal science in the final rule is also responsive to the SABs comments that pivotal science should be more focused Ref. 27. Consistent with the intent of this rulemaking, the EPA intends to clearly identify the studies considered pivotal in the documentation at the proposed rule stage for significant regulatory actions and when influential scientific information is disseminated for peer review.
Some commenters also expressed confusion regarding how pivotal science relates to best available science. One commenter recommended that if this rulemaking is intended to alter the EPAs definition and use of the best available science, the EPA should issue further guidance for public comment. To be clear, this rulemaking is not intended to modify the Agencys interpretations of best available science. The EPA will continue to consider all peer-reviewed science, consistent with existing study quality assessment factors and corresponding statutory mandates. The EPA will then identify and consider pivotal science in accordance with the provisions of this rule, unless the implementation of the rule conflicts with statutory requirements and associated implementing regulations.
6. Publicly available. In the 2018
proposed rule, the EPA used the term publicly available, but did not propose a definition at 40 CFR 30.2 or describe it in the preamble to the 2018
proposed rule. Some commenters on the 2018 proposed rule asked the EPA to explain what it meant by the term. In the 2020 SNPRM, the EPA proposed a definition for publicly available at 40
CFR 30.2.
One commenter stated that the proposed definition was vague because it did not make clear whether the study data itself would proactively be made available to members of the public by data holders in government sources, media sources, or other online sources.
The definition is not intended to describe the mechanism for making the information available i.e., whether the information is made available proactively or is made available upon request. Rather, the definition describes whether, given the nature of the information, it can be, must be, or is already generally available i.e., where the information can be made lawfully available from government records, is required to be made available by government law or regulation, or is
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information that is widely available to the general public.
Another commenter requested that the EPA consider data and models to be publicly available when they are available through restricted access when the data includes CBI, proprietary data, or PII that cannot be sufficiently deidentified to protect the data subjects.
The EPA disagrees with the commenter.
The plain meaning of publicly available does not include availability through restricted access to data that includes CBI or PII because there are laws that preclude the disclosure of CBI
or PII to those not authorized for its access. Thus, the general public cannot access the un-sanitized CBI data or nonanonymized PII data in a manner that will allow for independent validation through reanalysis. If the public cannot access such data, it is not publicly available.
Several commenters contended that the proposed definition of publicly available would introduce a bias favoring industry data submitted to the EPA. They asserted that industrygenerated studies submitted to the EPA
pursuant to FIFRA would be considered publicly available because they could be obtained by the public in response to a Freedom of Information Act FOIA
request. However, this does not mean that these are immediately or easily available to the public. Some commenters cited the EPAs Freedom of Information Act Annual Report Fiscal Year 2019 2020, which lists a median response time for expedited processing of FOIA requests by the EPA as 493 days Ref. 42. The EPA
finds that such comments have merit and is modifying the definition in the final rule to add the following at the end of the definition: the public must be able to access the information on the date of publication of the proposed rule for the significant regulatory action or dissemination of the draft influential scientific information for public review and comment.
7. Research data. Proposed 40 CFR
30.2 in the 2018 proposed rule included a definition of research data. In the 2020 SNPRM, the EPA deleted the proposed definition of research data.
While one commenter on the 2020
SNPRM noted that the exclusions in the proposed definition of research data of trade secrets and personal and medical information were not incorporated into the proposed definition of data, commenters did not request that the EPA maintain a definition of research data. The EPA
is not including a definition of research data in this final rule given
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that it is finalizing the definition of data.
8. Significant regulatory actions. In the 2018 proposed rule, the EPA defined the term regulatory decisions as final regulations determined to be significant regulatory actions under Executive Order E.O. 12866, Regulatory Planning and Review. Some commenters stated that the use of regulatory decisions was confusing given that the term was only intended to apply to a subset of regulations. The EPA agrees with these comments, and to clarify the definition, the Agency is changing the term from regulatory decisions to significant regulatory actions in the final rule.
9. Science that serves as the basis for informing a significant regulatory action. In the 2018 proposed rule, the EPA proposed to define the term regulatory science. A number of commenters expressed confusion over both the meaning and scope of this proposed term. One commenter noted that other Federal agencies have defined regulatory science. For example, the U.S. Food and Drug Administration FDA has described regulatory science as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products Ref. 43.This commenter suggested that a simplified definition would be regulatory science consists of the scientific segment of the regulatory process. The EPA acknowledges that the term regulatory science may be confusing because it suggests either that the term refers to a scientific discipline of regulatory decision-making akin to FDAs description, or that the EPA
considers some science inherently regulatory. Neither of these interpretations reflects the Agencys intent in defining this term. The EPA
considers the breadth of scientific evidence in its rulemakings; while this scientific evidence informs policy decisions, the EPAs consideration of the science does not make it regulatory science. To reflect this fact, in the final rule the EPA is changing the proposed term regulatory science to science that serves as the basis for informing a significant regulatory action.
In the 2018 proposed rule, the EPA
defined regulatory science as scientific information, including assessments, models, criteria documents, and regulatory impact analyses, that provide the basis for EPA final significant regulatory actions. Several commenters claimed that this definition was vague and without discernable meaning. The EPA disagrees with the assertion that the proposed definition was without meaning, but in response to comments
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