Je veux savoir à propos de…

jbell on DSKJLSW7X2PROD with RULES

Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations agency consideration of studies with restricted access to data and models that have CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects. For all other studies, data and models should be publicly available if the studies were to be used as pivotal regulatory science or pivotal science. In the 2020 SNPRM, the EPA also proposed an alternative. Under the alternative 40 CFR 30.5 proposal, when promulgating significant regulatory decisions or developing influential scientific information, the Agency would, other things equal, give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation either because the information is publicly available or available through tiered access when the data include CBI, proprietary data, or PII
and appropriate techniques have been used to reduce the risk of reidentification. In the 2020 SNPRM, the Agency proposed that in developing the final significant regulatory decision or influential scientific information, the EPA would identify those studies that were given greater consideration and provide a short description of why and how greater consideration was given.
A few commenters contended that 40
CFR 30.5 as proposed in the 2018
proposed rule was superior to proposed 40 CFR 30.5 in the 2020 SNPRM and the alternative proposed 40 CFR 30.5 in the 2020 SNPRM. The commenters asserted that privacy or confidentiality should not have priority over transparency.
They further asserted that the approaches in the 2020 SNPRM would impose substantial limits on the effect of the rule since privacy, confidentiality, and restricted access are all concepts and practices that inhibit full transparency.
Some commenters supported the categorical approach taken in proposed 40 CFR 30.5 in the 2020 SNPRM in which pivotal science would need to be available for independent validation. A
few commenters suggested that it be expanded to apply to all studies, not only those that are pivotal science.
Other commenters contended the proposed 2020 SNPRM approach was flawed because it would exclude from consideration valid scientific studies for which the underlying data at the stage required by this regulation are unavailable, regardless of whether the studies have been peer reviewed or would be considered part of the best available science under the environmental statutes that EPA
administers that require the use of best available science. These commenters stated that such a categorical exclusion
VerDate Sep<11>2014

16:19 Jan 05, 2021

Jkt 253001

is inconsistent with current scientific standards and the requirements of the environmental statutes that the EPA
administers. Other commenters noted that there are a variety of reasons, including the age of a study, why the underlying data at the stage required by this rulemaking would not be available, publicly or otherwise, for independent validation.
Some commenters supported and other commenters opposed alternate proposed 40 CFR 30.5 in which the Agency would, all else being equal, give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation. Some commenters stated that this was a reasonable way to consider transparency because studies would be assessed on a case-by-case basis and valid studies would not be categorically excluded.
Other commenters did not support alternate proposed 40 CFR 30.5 because they contended there is no scientific justification for a rule that directs the EPA to selectively give greater consideration to certain studies over others based on data availability.
Upon consideration of the comments, the EPA agrees that it is important not to categorically exclude any study because the data underlying a study at the stage required by this rulemaking may not be available for independent validation. Therefore, the EPA is not finalizing the primary proposal in the 2020 SNPRM that would have categorically required that for studies to be considered pivotal science, the underlying data would need to be available for independent validation.
However, given that transparency is an important aspect of EPAs regulatory actions and assessments, it should be an important consideration in how the Agency considers pivotal science. As described in 40 CFR 30.5 of the final rule, the EPA will rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well substantiated evidence to support a relationship between exposure and effect, the EPA
will identify those studiesbased on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpointsthat would inform a doseresponse assessment for those effect endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements or quantitative analyses of an EPA significant regulatory action or influential scientific
PO 00000

Frm 00045

Fmt 4700

Sfmt 4700

483

information will be identified as pivotal science.
Further, the EPA is finalizing the approach that gives greater consideration to pivotal science whose underlying dose-response data are publicly available or available through restricted access. Restricted or tiered access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism e.g., Data Use Agreements that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information.
Some commenters argued that the EPA did not sufficiently explain how it will identify pivotal science. For example, one commenter stated that the EPA did not explained what it means for a study to underly sic influential scientific information or to drive the requirements of final significant regulatory actions. Some commenters on the 2018 proposed rule asked for the EPA to clarify in what stage of the review process the Agency would identify pivotal science. In the 2020
SNPRM, the EPA explained, under this proposed regulation EPA would continue to use standard processes for identifying, evaluating, and reviewing available data, models, and studies.
When the Agency has potentially identified multiple key studies or models of similar quality that could drive its subsequent decisions, the Agency will investigate the availability of the underlying data. In response to the 2020 SNPRM, one commenter suggested the EPA provide a transparent explanation of how and why studies are determined to be pivotal science over others. A commenter also argued that if the EPA interprets pivotal science narrowly i.e., not as all the studies included in the weight of evidence, this would introduce risk of selecting pivotal science in a biased manner without sufficient accountability.
Another commenter recommended that the EPA establish criteria for designating studies as pivotal science.
The EPA disagrees with the proposition that designating a set of key studies as pivotal science will necessarily be biased or without accountability. The EPA follows an objective, unbiased process for identifying and evaluating scientific
E:FRFM06JAR1.SGM

06JAR1