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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations CFR 30.5d. In this way, the EPA will balance the importance of transparency with the need to maintain a strong scientific basis for its assessments.
This final rule requires the consideration of the factors in 40 CFR
30.5d when assessing pivotal studies for which the dose-response data are not available for independent validation.
The EPA may adapt these factors in upcoming statute-specific rulemakings, as appropriate, for significant regulatory actions under the different environmental statutes that the EPA
administers. How scientific information is to be considered varies among the different environmental statutes and sometimes within an individual statute.
Interpretation of the assessment factors will be tailored to the specific circumstances and the specific environmental statutes.
Some commenters asserted that the 2018 proposed rule and the 2020
SNPRM failed to explain how historical data, which may have been collected under different policies and procedures, will be treated. These commenters noted that underlying dose-response data may have been lost for older studies due to record retention schedules. Some commenters also contended that a significant amount of work would be required to locate, curate, and retrospectively make datasets available for public access.
The EPA intends to determine the extent of the consideration that should be given to pivotal studies lacking available data on a case-by-case basis.
The EPA will consider the circumstances specific to each such study when it applies the factors listed in 40 CFR 30.5d to that study. The age of the data is not a consideration under 40 CFR 30.5d, but could be the basis for a 40 CFR 30.7 exemption request.
Some commenters stated that the EPA
should not have the rulemaking apply retrospectively to studies given the potential difficulty accessing, reviewing, and making data available that were not originally intended to be disseminated, as would be required by this rulemaking. These commenters requested that the EPA apply the rulemaking provisions only to data and models underlying studies generated after the promulgation of this rule.
This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on existing i.e., completed significant regulatory actions or influential scientific information. For future, significant regulatory actions and influential scientific information, the final rule applies equally to all dose-response data
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underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data.
Some commenters contended that a substantial amount of work would be required in order to make data underlying studies available for independent validation, but that the EPA has not identified a responsible party for this work, nor has it made clear the timelines, electronic data sharing mechanisms, or how public reporting of such availability would be achieved, archived, and maintained over time. The EPA would like to emphasize that this final rule does not impose requirements on any entity outside of the EPA. This is a rule of internal procedures and does not direct or require any outside entity or the EPA
to establish data sharing mechanisms.
Further, the final rule does not require the EPA to collect, store, or publicly disseminate dose-response data underlying pivotal science.
Some commenters asserted that reproducing findings across similar studies is more informative than reanalyzing the data from a single study.
Such commenters noted that confidence in the study findings is best gained when different groups are studying the same thing or are conducting similar studies. They asserted that the study results could then be averaged, compared, and further analyzed. One commenter noted that the ability to reanalyze the data from a study with very poor scientific quality does not strengthen the quality of the study.
Commenters contended that reproducing studies i.e., producing something that is very similar to that research, but it is in a different medium or context is generally viewed as a more informative and resource efficient approach to validation of research than reanalyzing the data of a particular study. Some commenters contended that reanalysis of the data and models underlying studies is not how to determine the quality of a study; rather, there are other key aspects of studies that are integral to assessing the quality of a study.
Other commenters supported the proposed requirement for independent validation by reanalysis of data and models underlying studies because they believe this is key to determining whether the science is accurate and of high quality. Some commenters contended that by reanalyzing the underlying data and models, independent researchers can evaluate the myriad of choices and assumptions
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the original researchers have made regarding the data and statistical models and the potential introduction of any sources of bias.
While the availability of doseresponse data underlying a study in a manner sufficient for independent validation is an important component of determining the level of consideration to afford a study, the EPA agrees that availability by itself is not sufficient to determine study quality. As explained in 40 CFR 30.5b, the EPA will use existing factors including soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review to evaluate study quality. Subsequently, after identifying the highest quality, most relevant studies that would inform a dose-response assessment and identifying the availability of pivotal science, the EPA would consider the additional applicable factors in 40 CFR
30.5d when determining the level of consideration to give pivotal science where the underlying dose-response data are not available for independent validation. Further, although the EPA
agrees with commenters that meaningful insights can be obtained through similar studies in different media or context, the EPA continues to find that independent validation of the study findings and conclusions driving the EPAs dose-response assessments would provide important information. As detailed in Section III.A.1 of this preamble, there is scientific support for the usefulness of reanalyzing data, and the EPA finds this to be especially true for data that drive the quantitative requirements or analyses of EPA
significant regulatory actions or influential scientific information.
Implementation of this rule will increase transparency and, thus, the opportunity for independent subject matter experts to validate pivotal science, and as the dose-response data are better understood the public will, if they so choose, be able to more effectively comment, engage, and hold the EPA accountable during the development of future significant regulatory actions and influential scientific information.
F. Proposed 40 CFR 30.6
In the 2018 proposed rule, the EPA
proposed requirements at 40 CFR 30.6
specific to dose-response data and models. These proposed requirements directed the EPA to describe and document the assumptions and methods it used; to evaluate the appropriateness of using default assumptions, including assumptions of a linear, no threshold dose-response; to explain the scientific
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