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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation.
The EPA acknowledges, and agrees with commenters, that there may be pivotal science for which the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA
may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator see Section III.G of this preamble. See Section III.E of this preamble for a description of the factors the EPA will consider when determining the consideration to afford to pivotal science when the underlying dose-response data are not available for independent validation.
The EPA expects to identify pivotal science, and the consideration afforded to pivotal science, in proposed significant regulatory actions and external review drafts of influential scientific information, which will allow the subject matter experts, if they so choose, to independently validate the pivotal science and provide comment to the EPA. The EPA believes that this approach will allow the public to more effectively comment, engage, and hold the EPA accountable during the future development of specific significant regulatory actions and influential scientific information.
3. Effect of this rule on human health and environmental protection. Many commenters contended that the 2018
proposed rule and the 2020 SNPRM
would prevent the EPA from meeting its statutory obligations and performing its mission of protecting human health and the environment. Some commenters asserted that, by excluding studies based on data availability, the EPA
would develop regulatory decisions that are: 1 Not based on high-quality studies or the best available science; and 2 potentially biased towards regulated parties. As a result, these commenters argued that human health and environmental protections would decrease. Several commenters contended that decreased human health and environmental protections would disproportionately affect communities of color, indigenous communities, and low-income communities because these
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communities are more likely to live or work near sources of pollution.
The EPA considered these comments when finalizing this rule, and the EPA
does not agree that its approach will lead to systematic bias towards certain types of stakeholder goals. As described above, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
When characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect, the EPA will identify pivotal science and give greater consideration to pivotal science for which the underlying doseresponse data are available in a manner sufficient for independent validation.
Including this review of dose-response data availability for pivotal science is critical to the EPAs progress toward increased transparency and providing increased opportunity for scientific reanalysis and review by independent third parties. This approach will result in significant regulatory actions and influential scientific information that are based on high quality studies that maximize transparency, leading to human health and environmental protections consistent with the statutes the EPA administers.
In response to the 2018 proposed rule, the EPA received comments on perceived conflicts between the requirements included in the 2018
proposed rule and statutory requirements that direct EPA to consider certain data and information when developing Agency actions. For example, some commenters contended that the requirements in the 2018
proposed rule conflicted with the FIFRA
pesticide registration requirements and associated implementing regulations, which require registrants to submit data and information to the EPA to enable the Agency to make its unreasonable adverse effects determinations. These commenters argued that, under the 2018
proposed rule, the EPA would not be able to consider these data, which are often claimed as CBI, when evaluating the pesticide registrations because the data could not be made publicly available. In response to this comment and other similar comments, the EPA

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clarified in the 2020 SNPRM the relationship between this rulemaking, the environmental statutes and their implementing regulations by adding language to proposed 40 CFR 30.3
stating that statutory requirements and corresponding implementing regulations would control in the event of any conflicts.
With this final rule, the EPA is maintaining language from the 2020
SNPRM in 40 CFR 30.3 stating that statutory requirements and corresponding implementing regulations will control in the event of any conflict, and clarifying in this preamble that the requirements in this final rule set the overarching structure and principles for transparency in significant regulatory actions and influential scientific information. The EPA plans to promulgate either statutespecific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers.
B. Dose-Response Data The 2018 proposed rule focused on dose-response data and models, although not consistently. For example, some parts of the proposed regulatory text appear to limit applicability of certain provisions to only dose-response models. In others, the proposed requirements would apply more broadly. Commenters noted this variability. As a result, in the 2020
SNPRM, the EPA proposed a consistent, broader applicability to data and models.
The EPA received significant comment on this proposed expansion of the applicability of the rulemaking to data and models. While some commenters supported this expansion, other commenters contended that the applicability to dose-response data and models was already very broad, and that the broader applicability would significantly limit the information that the EPA could consider in a broad ranges of assessments e.g., bioaccumulation data, data on environmental releases, exposure estimates used by the EPA across the environmental statutes that it administers. Some commenters contended that the EPA did not provide sufficient rationale to support this expansion.
Based on the comments on the 2018
proposed rule and the 2020 SNPRM, taking into account the number of studies that would be subject to the rule, the EPA determined that the Agency
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