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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations finds that good cause exists under APA
section 553d3 to make this rule effective immediately upon publication.

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II. Background A. Summary of 2018 Proposed Rule In the 2018 proposed rule Ref. 5, the EPA proposed adding 40 CFR part 30, which would direct the EPA to ensure that the pivotal regulatory science underlying its actions is publicly available in a manner sufficient for independent validation. The EPA
proposed to take this action under the authority of the statutes it administers, including provisions providing general authority to promulgate regulations necessary to carry out the Agencys functions under these statutes and provisions specifically addressing the Agencys conduct of and reliance on scientific activity to inform those functions.
In the 2018 proposed rule, the EPA
defined dose-response data and models, pivotal regulatory science, regulatory decisions, regulatory science, and research data proposed 40 CFR 30.2.
Many of the provisions in proposed 40 CFR part 30 applied to dose-response models and data, regardless of the source of funding or identity of the party who developed the model or generated the data. Specifically, the EPA
proposed that the Agency would ensure that dose-response data and models underlying pivotal regulatory science were publicly available in a manner sufficient for independent validation, including releasing information necessary for the public to understand, assess, and replicate findings proposed 40 CFR 30.5. The public release of such information would be consistent with law; protect privacy, confidentiality, and confidential business information CBI; and be sensitive to national security interests.
In addition to proposing requirements for ensuring that dose-response data and models were publicly available in a manner sufficient for independent validation, the EPA proposed additional requirements pertaining to the use of dose-response data and models underlying pivotal regulatory science.
Proposed 40 CFR 30.6 would have required the EPA to: Describe and document any assumptions and methods used; clearly explain the scientific basis for each model assumption used and present analyses showing the sensitivity of the modeled results to alternative assumptions;
evaluate the appropriateness of using default assumptions e.g., assumptions of a linear, no-threshold dose-response
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on a case-by-case basis; and when available, give explicit consideration to high-quality studies that explore: A
broad class of parametric dose-response or concentration-response models, a robust set of potential confounding variables, nonparametric models that incorporate fewer assumptions, the use of various threshold models across the dose or exposure range, and models that investigate factors that might account for spatial heterogeneity.
The 2018 proposed rule also included requirements that pertained more broadly to the use of studies in Agency actions and pivotal regulatory science.
Proposed 40 CFR 30.4 would have required the EPA to clearly identify all studies relied upon when taking any final Agency action and make all such studies available to the public to the extent practicable. Proposed 40 CFR
30.7 would have required the EPA to conduct independent peer review of all pivotal regulatory science used to justify regulatory decisions. As part of the peer review, the EPA would have been required to ask peer reviewers to articulate the strengths and weaknesses of the Agencys justification for the assumptions applied and the implications of those assumptions for the results.
Finally, the 2018 proposed rule would have allowed for the EPA Administrator to grant exemptions to the requirements of the rule when the Administrator determined that compliance would be impracticable because it was not feasible to either 1 ensure that all doseresponse data and models underlying pivotal regulatory science were publicly available in a manner sufficient for independent validation, in a fashion consistent with law; protective of privacy, confidentiality, and CBI; and sensitive to national security interests;
or 2 conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions for reasons outlined in Section IX of the OMB
Bulletin for Peer Review Ref. 8.
The EPA solicited comment on the 2018 proposed rule generally and on specific provisions in the proposal, including the legal authority for the proposed rule, the scope of the proposal, public access to dose-response data and models, and how the proposed rule should be implemented.
B. Summary of 2020 Supplemental Notice of Proposed Rulemaking The 2020 SNPRM Ref. 7 included clarifications, modifications, and additions to certain provisions in the 2018 proposed rule. The 2020 SNPRM
also revised the authority cited in proposed 40 CFR part 30; revised
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proposed 40 CFR 30.2, 30.3, 30.5, 30.6, 30.7, and 30.9; and deleted proposed 40
CFR 30.10.
Through the 2020 SNPRM, the EPA
modified proposed 40 CFR part 30 to expand the scope of the 2018 proposed rule, clarified the intent of the 2018
proposed rule, and solicited public comment on two proposed approaches for how the Agency would consider data and model availability when evaluating studies. The 2020 SNPRM modified the scope of the 2018 proposed rule in two ways: 1 Expanded dose-response data and models to data and models, and 2 expanded the applicability of the proposed requirements to influential scientific information, which was defined in the 2020 SNPRM as the 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. As a result of the 2020 SNPRM, the provisions in proposed 40 CFR part 30 would have applied to data and models, regardless of the source of funding or identity of the party who developed the model or generated the data, underlying pivotal science or pivotal regulatory science.
The EPA modified proposed 40 CFR
30.2, 30.3, 30.6, and 30.9 to reflect this change in scope of the proposed rulemaking.
With the expanded scope, the EPA
proposed that data and models underlying pivotal regulatory science and pivotal science be available in a manner sufficient for independent validation. To clarify its intent, in the 2020 SNPRM the EPA modified and added proposed definitions for key terminology, including data, model, publicly available, and independent validation. Specifically, the EPA clarified that independent validation of data and models, as proposed, meant the reanalysis of study data by subject matter experts who have not contributed to the development of the study to demonstrate that the same analytic results reported in the study are capable of being substantially reproduced 2020 SNPRM proposed 40 CFR 30.2. In the 2020 SNPRM, the EPA also proposed definitions for reanalyze and capable of being substantially reproduced to further clarify the intent of the rulemaking.
In proposed 40 CFR 30.5, the EPA
solicited public comment on two approaches for how the Agency would consider data and model availability
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