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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations this rule, including costs to third party researchers and their institutions to make their raw data available and protect PII/CBI through data-masking, de-identification, or deposition in public data repositories. The EPA
disagrees with the argument that this rule would impose costs on third-party researchers. This is a rule of internal procedure that does not impose requirements on any party other than the EPA. This rule imposes no costs on researchers or their institutions, and the EPA will consider and evaluate all relevant and appropriate science in its significant regulatory actions and influential scientific information. The EPA recognizes that researchers and other third parties may voluntarily consider the EPAs position on data availability, as described in this rule, as they make their own decisions about how to conduct research and the extent to which they make data and models available. Researchers may choose to make more data and models available, but the EPA recognizes that these parties will weigh their own benefits and costs and make choices that they deem appropriate.
Some commenters argued the 2018
proposed rule and the 2020 SNPRM
would impose costs on third parties because it would prohibit the EPA from using necessary science where the underlying data and models are not publicly available, which would prevent the EPA from meeting its statutory obligations and performing its mission of protecting human health and the environment. Some commenters also contended that the proposed rule requirements would impose costs to the public by delaying EPA regulatory actions that protect human health and the environment.
As described earlier, the EPA
acknowledges and agrees with commenters that there may be pivotal science where the underlying data are not publicly available or available through restricted access. The final rule is limited to dose-response data and, as no studies are categorically excluded from consideration, the EPA will continue to rely on the full body of the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Consistent with the requirements of this rule, the EPA will identify a subset of those studies based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints that would inform a dose-response assessment, and will give greater consideration to pivotal science for
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which the underlying dose-response data are available. The EPA disagrees with commenters that the requirements of this rule will result in any meaningful delay in promulgating regulations.
While this final rule requires the Agency to evaluate the availability of dose-response data for pivotal science, the incremental burden to the Agency to carry out these requirements is expected to be small given 1 the extensive scientific review the EPA already conducts regularly and 2 that the requirement is limited to pivotal science i.e., typically a small, though highly important, subset of the studies the EPA
would review. Further, with this final rule, the EPA is maintaining language in 40 CFR 30.3 stating that the statutes that the EPA administers, or their implementing regulations, will control in the event of any conflicts with the requirements of this rule. The Agency will continue to comply with and abide by the requirements in those statutes and implementing regulations, including regulatory deadlines.
K. Proposed 40 CFR 30.8 How is EPA
to account for cost under this subpart?
In 2018, the EPA proposed in 40 CFR
30.8 that EPA shall implement the provisions of this subpart in a manner that minimizes costs. A number of commenters argued that this statement was vague and that the 2018 proposed rule neither explained what costs this rule would incur, nor how they would be minimized. One commenter further raised concern that, in order to minimize costs, proposed 40 CFR 30.8
may require the EPA to exclude valid data from consideration rather than take potentially expensive steps to protect CBI, proprietary data, and PII. Still other commenters interpreted proposed 40
CFR 30.8 as requiring the EPA to base its final significant regulatory actions and influential scientific information on cost. Commenters expressed concern that this would be at the exclusion of considerations such as the best available science and public health. A commenter further argued that the EPA does not have the statutory authority to base its assessment of science on cost without consideration of public health and environmental costs and benefits and privacy-related costs and benefits, and that doing so would be irrational and arbitrary.
As explained in Section III.J of this preamble, this rule of internal procedure is anticipated to incur small incremental costs related to the additional review of data availability, as compared to the Agencys existing costs for extensive review and documentation as part of the development of significant regulatory
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actions and influential scientific information. In consideration of the public comments, however, the EPA is not finalizing proposed 40 CFR 30.8
How is EPA to account for cost under this subpart? This rule is not intended to require the EPA to exclude valid data from consideration on the basis of cost, nor interpret the EPAs statutory authority to consider costs in significant regulatory actions or influential scientific information. Given the EPAs existing commitment to fulfill its duties in a cost-effective manner, the EPA has determined not to finalize proposed 40
CFR 30.8.
IV. References The following is a listing of the documents that are specifically referenced in this notice. The docket includes these documents and other information considered by EPA, including documents referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket.
For assistance in locating these other documents, please consult the person listed under FOR FURTHER INFORMATION
CONTACT.
1. E.O. 13777, Enforcing the Regulatory Reform Agenda, 82 FR 12285 March 1, 2017, available at https
www.federalregister.gov/documents/
2017/03/01/2017-04107/enforcing-theregulatory-reform-agenda.
2. E.O. 13783, Promoting Energy Independence and Economic Growth, 82
FR 16093 March 31, 2017, available at https www.federalregister.gov/
documents/2017/03/31/2017-06576/
promoting-energy-independence-andeconomic-growth.
3. Office of Mgmt. & Budget, Exec. Office of the President, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 FR
8451 February 22, 2002, available at https www.federalregister.gov/
documents/2002/02/22/R2-59/
guidelines-for-ensuring-and-maximizingthe-quality-objectivity-utility-andintegrity-of-information.
4. Office of Mgmt. & Budget, Exec. Office of the President, Open Data Policy Managing Information as an Asset, OMB
M1313 May 9, 2013, available at https www.whitehouse.gov/sites/
whitehouse.gov/files/omb/memoranda/
2013/m-13-13.pdf.
5. U.S. EPA. Strengthening Transparency in Regulatory Science; Proposed Rule, 83
FR 18768 April 30, 2018 FRL9977
40, available at https
www.federalregister.gov/documents/
2018/04/30/2018-09078/strengtheningtransparency-in-regulatory-science.
6. U.S. EPA. Strengthening Transparency in Regulatory Science; Proposed Rule, 83
FR 24255 May 25, 2018 FRL997831,
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