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Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Rules and Regulations
corresponding update to the regulations, without providing the corresponding benefit underlying the 30-day delay.
Minimizing that time period would reduce the possibility of confusion for the public. Accordingly, EPA is making this rule effective immediately upon publication.
C. What is the Agencys authority for taking this action?
EPA promulgated the 2021 final rule pursuant to its housekeeping authority, which EPA gained through the Reorganization Plan No. 3 of 1970, 84
Stat. 2086 July 9, 1970, which created the EPA. The Reorganization Plan established the Administrator as head of the agency, transferred functions and authorities of various agencies and Executive departments to the EPA, including the authority to promulgate regulations to carry out the transferred functions. including a housekeeping authority to promulgate procedural, but not substantive, rules. However, the rule was vacated and remanded in light of the courts conclusion that the 2021
final rule constituted a substantive rule, and therefore the EPA lacked authorization to promulgate the 2021
final rule pursuant to its housekeeping authority. This action to implement the vacatur is being taken pursuant to the courts order Ref. 2.

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II. Background of the Vacated 2021
Final Rule A. Summary of the Key Requirements in the 2021 Final Rule The 2021 final rule established how the EPA would have considered the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information Ref.
1. When promulgating significant regulatory actions or developing influential scientific information for which the conclusions are driven by the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect, the 2021 final rule would have required that the EPA give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. The 2021 final rule also would have required the EPA
to identify and make publicly available the science that serves as the basis for informing a significant regulatory action at the proposed rule stage to the extent practicable; included additional requirements for the peer review of pivotal science; and provided criteria for the Administrator to exempt certain
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studies from the requirements of the rule.
B. Litigation, Vacatur and Court Mandate On January 11, 2021 the plaintiffs Environmental Defense Fund and others EDF filed a complaint in the U.S.
District Court for the District of Montana Ref. 3. Among other allegations, EDF
contended that the 2021 final rule was substantive and therefore unlawful to promulgate under the EPAs housekeeping authority, which only permits promulgation of procedural rules. The plaintiffs further argued that the EPA lacked good cause to make the rule effective immediately. On January 27, 2021, the court issued a partial summary judgment ruling that the 2021
final rule was substantive because it failed to provide the EPA with procedural direction but instead narrowly limited the agencys discretion to consider certain scientific research when conducting future rulemakings.
The court reasoned that by determining how the Agency weighs particular scientific evidence, the 2021 final rule determined outcomes rather than process. The court further ruled that EPA did not have good cause to make the 2021 final rule effective immediately and held that the effective date for the rule was 30 days after publication, or February 5, 2021 Ref. 4. Based on the district courts conclusion that the final rule constituted a substantive rather than a procedural rule, EPA lacked authority to promulgate the final rule under its housekeeping authority. Given the courts decision, the EPA filed an unopposed motion to vacate and remand the rule Ref. 5. On February 1, 2021, the court granted the motion vacating the 2021 final rule and remanding it to the EPA Ref. 2. This action effectuates the court order vacating the 2021 final rule.
III. Effective Date This final rule will become effective upon publication in the Federal Register.
IV. References 1. U.S. EPA. Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information; Rule, 86 FR 469 January 6, 2021 FRL1001907ORD, available at https www.federalregister.gov/
documents/2021/01/06/2020-29179/
strengthening-transparency-in-pivotalscience-underlying-significantregulatory-actions-and.
2. EDF vs. EPA, Case No. 4:21cv 00003BMM, United States District
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Court for the District of Montana, Order February 1, 2021, available at https
www.epa.gov/sites/production/files/
2021-02/documents/vacatur_and_
remand_final_order_case_421-cv-00003bmm.pdf.
3. EDF vs. EPA, Case No. 4:21cv 00003BMM, United States District Court for the District of Montana, Complaint January 11, 2021.
4. EDF vs. EPA, Case No. 4:21cv 00003BMM, United States District Court for the District of Montana, Order on Partial Motion January 27, 2021.
5. EDF vs. EPA, Case No. 4:21cv 00003BMMJTJ, United States District Court for the District of Montana, Defendants Unopposed Motion for Vacatur and Remand January 31, 2021.
V. Statutory and Executive Orders Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is a significant regulatory action that was submitted to the Office of Management and Budget OMB for review. Any changes made in response to OMB recommendations have been documented in the docket. The EPA
does not anticipate that this rulemaking will have an economic impact on regulated entities.
B. Paperwork Reduction Act PRA
This action does not contain any information collection activities and therefore does not impose an information collection burden under the PRA.
C. Regulatory Flexibility Act RFA
This action is not subject to the RFA.
The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act APA, 5 U.S.C. 553, or any other statute. This rule is not subject to notice and comment requirements because the Agency has invoked the APA good cause exemption under 5 U.S.C. 553b.
D. Unfunded Mandates Reform Act UMRA
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 15311538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
E. Executive Order 13132: Federalism This action does not have federalism implications. It will not have substantial direct effects on the states, on the
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