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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
research results and help identify and correct unintended errors, as well as reanalyze the data for new and different purposes, examine novel questions, provide new scientific insights, and improve model development. In its April 24, 2020, letter to EPA
Administrator Wheeler Ref. 27, the EPAs SAB noted that it
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recognizes the importance of this rule and its purpose, establishing transparency of the influential scientific information used for significant regulations and enhancing public access to scientific data and analytical methods to help ensure scientific integrity, consistency and robust analysis.
Strengthening transparency by improving access to data can lead to an increase in the quantity and the quality of evidence that informs important regulatory and policy decisions. The scientific community is moving toward adopting the precept of sharing accurate data and information to increase credibility, high-quality outcomes and public confidence in science. The SAB
supports the adoption of this precept. 9

The EPA also agrees with commenters that the scientific community and government agencies are making great strides in data transparency; however, improvements can still be made over existing policies and mechanisms. Many scientific publications, for example, require authors to make a data availability or data access statement, which discloses where and under what conditions the underlying study data are available. Yet the EPA cannot solely rely on data availability statements made in published research because initiatives toward greater data sharing and transparency amongst scientific journals and international organizations are still being implemented, are inconsistently enforced, and the true accessibility of data in a public repository is still limited Refs. 28, 29, 30, 31, 32, 33. For example, Christensen et al. 2019
evaluated 1,072 peer-reviewed articles and found that rates of data availability for empirical articles published after journals adopted data-sharing policies differ widely between journals, from 0
percent to 83 percent, with a mean of 35
percent Ref. 32. Stodden et al. 2018
noted they were only able to retrieve the dataset and code for 44 percent of the 204 computational studies published in Science in the 16 months after the publisher instituted its data availability requirements Ref. 34. Therefore, the rule requirements for the EPAs independent evaluation of the availability of data are necessary and critical to prioritizing data transparency in the pivotal science underlying its 9 The SAB also provided several constructive comments and recommendations, which have been considered in the development of this final rule.

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significant regulatory actions and influential scientific information.
Finally, focusing the final rule requirements on the underlying doseresponse data is intended to address public comments concerning clarity of the rule, potential unintended consequences, and the potential for farreaching impacts. The requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying doseresponse data, while balancing important technical considerations in order to ensure the Agency maintains a strong scientific basis for its decisionmaking. The incremental progress made possible by this rule provides an important step towards prioritizing transparency in particularly impactful EPA rules and assessments and will inform future statute-specific rulemakings.
2. Effect of this rule on the studies the EPA uses to support significant regulatory actions and influential scientific information. The EPA received significant comment on the effect of the 2018 proposed rule and 2020 SNPRM
on the studies the Agency would be able to consider and use to support significant regulatory actions and influential scientific information. Many commenters asserted that the EPAs action, if finalized, would limit the scientific studies the EPA could use because the EPA would exclude from consideration any studies where the underlying data and models could not be made publicly available or available in a manner sufficient for independent validation.
As discussed in Section III.B of this preamble, based on a consideration of the public comments on the 2018
proposed rule and the 2020 SNPRM, the EPA is finalizing internal procedural requirements for how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating a significant regulatory action or developing influential scientific information that relies on dose-response data. The EPA is also further clarifying how the Agency will determine the consideration to afford to pivotal science in either significant regulatory actions or influential scientific information.
Consistent with existing Agency practice Ref. 35, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information. The EPA will continue to use the following, established factors to assess the quality of studies used to develop significant
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regulatory actions and influential scientific information Refs. 36, 37:
SoundnessThe extent to which the scientific and technical procedures, measures, methods or models employed to generate the information are reasonable for, and consistent with, the intended application.
Applicability and UtilityThe extent to which the information is relevant for the Agencys intended use.
Clarity and CompletenessThe degree of clarity and completeness with which the data, assumptions, methods, quality assurance, sponsoring organizations and analyses employed to generate the information are documented.
Uncertainty and VariabilityThe extent to which the variability and uncertainty quantitative and qualitative in the information or in the procedures, measures, methods or models are evaluated and characterized.
Evaluation and ReviewThe extent of independent verification, validation and peer review of the information or of the procedures, measures, methods or models.
When evaluating potential links between exposure to a pollutant, contaminant, or substance and effects and the nature of the dose-response relationship, the EPA will follow best practices and rely on the highest quality, most relevant studies in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well-substantiated evidence consistent with Agency guidelines on hazard identification and dose-response assessment to support a relationship between exposure and effect, the EPA
will identify a subset of those studies for use in characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect.
This will be based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements, quantitative analyses, or both will be identified as pivotal science see Section III.E of this preamble.
Once the EPA has identified pivotal sciencefor either significant regulatory actions or influential scientific informationthe EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA
will give greater consideration to pivotal science for which the underlying doseresponse data are either publicly available in a manner sufficient for
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