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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations under which the Administrator could grant an exception in the 2020 SNPRM:
Technological barriers render sharing of the data or models infeasible; the development of the data or model was completed or updated before the effective date of the final rule; or making the data and models available would conflict with laws governing privacy, confidentiality, CBI, or national security. Some commenters supported the condition that would allow the Administrator to grant an exemption based on the age of a study, noting that older studies may not have been conducted with the intention of providing access to underlying data and models for independent validation, particularly at the stage of data and models proposed in the 2020 SNPRM.
Other commenters opposed this condition, contending that exempting studies based on the age of the study is unnecessary and undermines the goal of increasing transparency in the development of regulatory decisions.
Some commenters noted it may be prohibitively expensive for researchers to make their data and models available.
The EPA finds that these comments have merit, in part. The Agency agrees with retaining the Administrators exemption provision because there are conditions under which compliance with the requirements in 40 CFR part 30
might be impracticable. For example, the underlying dose-response data for some studies, particularly older studies, may not be readily publicly available because of the technological barriers to data sharing e.g., differences in data storage devices or data retention practices that existed when they were developed. As a result, the EPA is finalizing the Administrators exemption provision as proposed in the 2020 SNPRM, with additional conditions described here. Due to other changes described in this preamble, the Administrators exemption provision, which was previously in 40 CFR 30.9 in the 2018 proposed rule and the 2020
SNPRM, is now 40 CFR 30.7 in the final rule.
The EPA does not agree with the comments regarding the role of the Administrator in determining whether to grant an exemption and finds that the Administrator is the appropriate decision maker in this context. To ensure that the Administrators decision is appropriately transparent, in the final rule the EPA has included a provision in 40 CFR 30.7 that requires the Agency to document the rationale for any exemptions granted by the Administrator in the significant regulatory action or influential scientific information. This documentation would
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typically be provided as part of the proposed rulemaking, given that it would be part of the decision concerning what is the pivotal science for the rule. Regardless of what is provided in the proposed rule stage of the rulemaking, the final rulemaking will provide clear documentation.
Some commenters and the EPAs SAB
Ref. 27 also requested that the EPA
include criteria that the Administrator will consider when determining whether to grant exemptions from the requirements in 40 CFR part 30. The EPA finds that these comments have merit and is including additional criteria in 30 CFR 30.7 that may be used by the Administrator when he or she is determining whether greater consideration should be afforded to pivotal science for which the underlying dose-response data are not available in a manner sufficient for independent validation. As a result, the Administrator may also determine that greater consideration is warranted when a third party has independently validated the underlying dose-response data through reanalysis or when the EPAs evaluation of the factors in 40
CFR 30.5d indicate that full consideration of the pivotal science is justified.
To assist the Administrator in determining whether to grant an exemption, the EPA program or Region responsible for the significant regulatory action or influential scientific information and public commenters can provide input when the Administrator is considering an exemption. The EPA
will document the rationale for the Administrators exemption in the significant regulatory action or influential scientific information. The EPA is confident that the above criteria provide sufficient clarity and boundaries for the Administrator to consider when granting an exemption under 40 CFR 30.7.
H. Peer Review In the 2018 proposed rule and the 2020 SNPRM, the EPA proposed to require independent peer review on pivotal regulatory science and pivotal science. The EPA also proposed to require that the Agency ask peer reviewers to opine on the strengths and weaknesses of the EPAs justifications for the assumptions used in models.
Some commenters on the 2018
proposed rule and 2020 SNPRM
specifically asked why the EPA would need to peer review health and scientific studies and scientific literature that had already undergone independent peer review. They stated that the EPA failed to explain why
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existing peer review requirements and mechanisms are insufficient. Such commenters also noted that in addition to being duplicative and unnecessary, the proposed requirement would cause unnecessary delays in the EPA actions and would result in increased costs for the Agency. One commenter noted that the EPA already has policies in place for peer review and referred to the EPAs Peer Review Handbook Ref. 44.
Another commenter stated that, while it is certainly best practice to consider only science that has been independently peer reviewed when making regulatory decisions, that does not necessitate independent peer review by the EPA. The commenter noted that most scientific bodies and publicationsincluding Nature, Science, the Bipartisan Policy Center, and Proceedings of the National Academy of Sciencesemploy some of the most robust peer review practices and that they already apply to the types of studies which the proposed rule would require the EPA to peer review anew. Some commenters also stated that the proposed peer review requirements specific to assumptions used in models suggest that the 40 CFR 30.7 regulatory text would require that the EPA conduct peer review of the proposed Agency action itself, rather than of the science underlying that action. One of the commenters contended that it is entirely unclear how peer review could be applied to EPAs reasoning itself, rather than the pivotal science supporting the regulatory decision.
The EPA finds that these comments have merit, in part. However, in this rule, the EPA is not changing the preexisting requirements of the OMB Final Information Quality Bulletin for Peer Review Ref 8. The preamble of the Bulletin states that the intensity of peer review is highly variable across journals and prior peer review and publication is not by itself sufficient grounds for determining that no further review is necessary Ref. 8. Peer review does not typically include reanalysis of the underlying data i.e., the proper stage of data where the data that are ready to be analyzed to extract relevant information and, thus, peer review is not considered a replacement for the data availability requirements of this rule.
The EPA is, therefore, finalizing the language at 40 CFR 30.6 formerly 40
CFR 30.7 in the 2018 proposed rule and the 2020 SNPRM to clarify that the Agency will evaluate whether or not to initiate peer review, consistent with the OMB Final Information Quality Bulletin for Peer Review Ref. 8 and the EPAs Peer Review Handbook Ref. 44, of
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