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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations the Agency. Risk assessments and regulations that target emissions and risk reduction of one or more pollutants, contaminants, or substances are integral to the Agencys mission and the underlying dose-response data that inform the quantitative value used to evaluate and mitigate potential risk are critical to understanding the assessment or regulatory action. In addition, the data underlying the dose-response assessment are more distinct than the broad range of data informing an entire risk assessment. Therefore, the EPA is concentrating its current efforts to increase transparency on a well-defined step in the quantitative assessment of risk supporting specific Agency actions.
This final rule provides an important step in furthering the progress already being made toward maximizing transparency and will provide important insight for developing future statute-specific requirements.
Most public commenters on the purpose of the 2018 proposed rule and the 2020 SNPRM supported the concept of greater transparency, but questioned the problem the EPA was trying to fix.
Other commenters indicated that it was not clear how greater data availability would fix these perceived problems, given what they asserted were limited detail in the proposed rule. Some public commenters and members of the EPAs Science Advisory Board SAB also suggested that issues related to transparency are or may be fixed with existing guidance, mechanisms, and other requirements. Other commenters questioned the motivation for the rulemaking, asserting that the rulemaking was the result of political interests, rather than scientific need;
that it was biased to benefit industry; or that it was a deliberate attempt to suppress human health and climate studies. Some commenters contended that there was little evidence of a widespread reanalysis issue in science or, in particular, studies that would inform environmental policy. Other commenters contended that the rulemaking was at odds with the Agencys mission and would result in decreased environmental and human health protections. Some commenters asserted that the rule would lead to increased litigation and limit the publics trust in the EPA. Other commenters contended that the rule was inconsistent with practices in other Federal agencies and may adversely impact other Federal and state agencies that rely on EPA assessments.
Commenters supporting the rulemaking generally asserted that the greater transparency provided in the proposal and SNPRM was necessary and
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important for developing sound and scientifically robust regulations. Some commenters stated that transparency is a principle of good government. Some commenters noted specific benefits to greater transparency, including more effective public scrutiny and scientific debate, less political rhetoric, and clearer, more efficient regulations. Some commenters provided specific examples of EPA regulations or risk assessments that have relied on incorrect data or would have been improved with greater transparency. Other commenters contended that greater transparency was consistent or complementary with research and publishing policies, Federal Government policies, and the scientific method, while other commenters asserted that the rule would be an important improvement to transparency at the EPA.
The EPA continues to believe that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the opportunity for the public to access the EPAs scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agencys mission, and the publics health and safety. This rule is designed to build upon OMB M
1915 Ref. 18, which highlights the need to characterize the sensitivity of an agencys conclusions to analytic assumptions, as well as other Federal guidance documents that require greater data transparency Ref. 18. The EPAs attention to data transparency is also responsive to the broader interest in greater data and model transparency observed in the numerous transparency initiatives in the scientific community and Federal Government, as well as the criticism the EPA has received from members of the public, scientific community, and Congress on the transparency of the scientific basis for EPAs decisions in previous influential scientific information assessments and regulatory actions Refs. 19, 20, 21, 22, 23. The EPAs continued progress toward maximizing transparency is vital to building and maintaining trust with the public and credibility in the Agencys decisions.
The EPA disagrees with the contention that this rule is politically motivated, as transparency assumes no political ideology, nor is this rule likely to result in decreased human health or environmental protections, as the benefits of greater data transparency and the significance of reanalyzing and validating study results are welldocumented in scientific literature.
McNutt 2014 noted, reproducibility,
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rigor, transparency, and independent verification are cornerstones of the scientific method Ref. 24. The National Academies of Sciences, Engineering, and Medicine NAS
workshop on Reproducibility and Replicability in Science also noted that certainly, reproducibility and replicability play an important role in achieving rigor and transparency Ref.
16.8 Munafo et al. 2017 state, the credibility of scientific claims is rooted in the evidence supporting them, which includes the methodology applied, the data acquired, and the process of methodology implementation, data analysis and outcome interpretation.
Claims become credible by the community reviewing, critiquing, extending and reproducing the supporting evidence. However, without transparency, claims only achieve credibility based on trust in the confidence or authority of the originator. Transparency is superior to trust Ref. 25. The 2019 NAS
workshop on Reproducibility and Replicability in Science also concluded, the scientific enterprise depends on the ability of the scientific community to scrutinize scientific claims and to gain confidence over time in results and inferences that have stood up to repeated testing Ref. 16. Importantly, the workshop also concluded that researchers, funding institutions, and journals could make advancements to improve reproducibility, rigor, and transparency Ref. 16.
The EPA agrees that data transparency is vital for individuals who have not contributed to the study to be able to verify the quality and strength of published studies and agrees with commenters that the opportunity to independently validate the pivotal science that the EPA relies upon is important in furthering scientific understanding and the Agencys mission. A presenter in a 2016 NAS
workshop on Principles and Obstacles for Sharing Data from Environmental Health Research stated more directly that for environmental policy making to be legitimate, the scientific reasoning behind a given decisionincluding the data supporting itmust be transparent NAS Workshop Report, Ref. 26. When data are widely available, researchers can validate 8 The NAS workshop on Reproducibility and Replicability in Science defines reproducibility to mean the extent to which a researcher can obtain consistent computational results using the same input data, computational steps, methods, code, and conditions of analysis. The use of reproducibility by the NAS is consistent with the intent of the use of independent validation in this rule.

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