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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
individual studies identified as pivotal science if the studies have already undergone journal peer review. If the Agency conducts peer review on pivotal science, the EPA shall ask peer reviewers to articulate the strengths and weaknesses of the justification for the assumptions applied in analyzing doseresponse data and the implications of those assumptions for the results.

with publicly available to improve specificity, since the latter term is defined. Together, these changes are meant to clarify that the requirements of 40 CFR 30.4 are consistent with the EPAs existing practice of making science that serves as the basis for informing a significant regulatory action available in the public docket as part of the rulemaking.

I. Changes to 40 CFR 30.4 What requirements apply to EPAs use of studies in significant regulatory actions?
In the 2018 proposed rule, the EPA
proposed to require at 40 CFR 30.4 that EPA shall clearly identify all studies or other regulatory science relied upon when it takes any final action. The EPA
should make all such studies available to the public to the extent practicable.
Some commenters expressed concern that proposed 40 CFR 30.4 would permit the Agency to exclude valid studies from consideration on the basis of the availability of underlying data or models. Another commenter noted that this section would apply to any final agency action, rather than regulatory decisions. In response to these comments, the EPA notes that this section does not require the EPA to exclude studies from consideration when developing final significant regulatory actions either on the basis of the availability of underlying data or models, or depending on the practicability of making these studies available to the public.
The EPA agrees with the commenter that the scope of 40 CFR 30.4 should be limited to significant regulatory actions, which are defined in 40 CFR 30.2 as final regulations determined to be significant regulatory actions by the Office of Management and Budget pursuant to Executive Order 12866.
The EPA is finalizing additional changes to the title and body of 40 CFR
30.4 by using terms defined in 40 CFR
30.2. In the title of 40 CFR 30.4, the EPA
is replacing taking final action with significant regulatory actions to improve clarity and specificity, since the latter term is defined. In the body of 40 CFR 30.4, the EPA is replacing all studies or other regulatory science relied upon when it takes any final agency action with science that serves as the basis for informing a significant regulatory action to improve specificity, since the latter language is defined; replacing should with shall; studies with science that serves as the basis for informing a significant regulatory action to improve specificity, since the latter term is defined; and available to the public
J. Benefits and Costs In the 2018 proposed rule, as part of its E.O. 12866 and E.O. 13563 reviews, the EPA stated that the benefits of the proposal justify the costs. The EPAs rationale was that the rule would facilitate expanded data sharing and exploration of key data sets, improve the ability to independently validate analyses underlying significant regulatory actions, and would be implemented in a cost-effective way.
The 2020 SNPRM did not provide additional characterizations of benefits and costs. A number of commenters noted that the EPA did not provide an economic assessment to support the Agencys benefit-cost claims.
Commenters also noted that the EPA did not characterize costs to the Agency, including administrative costs to ascertain the public availability of underlying data, costs for additional analyses required, and costs to ensure that PII and CBI are not disclosed. Other commenters noted that the EPA had not adequately explained the benefits of this rule, including enabling increased secondary analyses by third party researchers.
The EPA agrees that neither the 2018
proposed rule nor the 2020 SNPRM
included a characterization of costs to the Agency. The EPA emphasizes that this is a rule of internal procedure promulgated under the EPAs housekeeping authority. However, the EPA has identified some incremental costs that the Agency may incur as a result of this final rule. As stated in Section III.A.2 of this preamble, the EPA
will continue its current practice of conducting extensive review of scientific studies during the development of significant regulatory actions and influential scientific information. The additional procedures required by this rule apply only to pivotal science, which is a subset of the total number of studies that the EPA
would evaluate. Given the costs of the current robust process for identifying and reviewing scientific studies and documentation that are existing Agency practice, as well as that the determination of dose-response data availability is limited to pivotal science underlying significant regulatory actions
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and influential scientific information, the EPA anticipates that the incremental costs of this rule will be small. The Agency may also incur other administrative costs to perform analyses and evaluations to support activities such as exemption decisions made by the Administrator, and documenting these or other decisions made pursuant to the requirements of the final rule.
Again, the Agency anticipates that the incremental costs for these activities will be small relative to current administrative costs for developing significant regulatory actions or influential scientific information.
Finally, this final rule does not require the EPA to disclose or host data, but to determine if dose-response data are available and to give greater consideration to those studies for which such data are available. Hence, this rule does not impose costs on the EPA or any other party to make data available, including costs to ensure that PII and CBI are not disclosed. The Agency may opt, at its discretion, to incur the costs associated with making data available when it is in the public interest to do so, but that will be decided on a caseby-case basis and is not a requirement of the final rule.
The EPA also agrees that the benefits of the rule were not fully characterized in the 2018 proposed rule or the 2020
SNPRM. The EPA emphasizes, however, that this is a rule of internal procedure promulgated under the EPAs housekeeping authority. As discussed in Section III.A.1 of this preamble, the main benefits of this rule spring from greater transparency in significant regulatory actions and influential scientific information. By placing greater emphasis on the availability of dose-response data underlying pivotal science, the rule will allow for greater scientific scrutiny as EPA decision makers are developing significant regulatory actions and influential scientific information and increases the likelihood that any errors will be identified and corrected. Greater transparency is also inherently valuable as a principle of good government and provides benefits to the public at large, including reducing the risk of errors in EPA analyses and in the science such analyses rely upon. The ability for independent subject matter experts to validate pivotal science will facilitate more effective comment and engagement with the public during development of future significant regulatory actions and influential scientific information.
Some commenters further argued that the EPA failed to account for costs external to the EPA as consequence of
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