[Federal Register Volume 86, Number 104 (Wednesday, June 2, 2021)]
[Rules and Regulations]
[Pages 29515-29517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11317]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 30

[EPA-HQ-OA-2018-0259; FRL-10024-32-ORD]
RIN 2080-AA15


Strengthening Transparency in Pivotal Science Underlying 
Significant Regulatory Actions and Influential Scientific Information; 
Implementation of Vacatur

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is removing the 
regulatory provisions associated with the final rule Strengthening 
Transparency in Pivotal Science Underlying Significant Regulatory 
Actions and Influential Scientific Information. This action effectuates 
the vacatur of the final rule ordered by the United States District 
Court for the District of Montana. It is also responsive to the 
Executive order entitled ``Protecting Public Health and the Environment 
and Restoring Science to Tackle the Climate Crisis,'' signed on January 
20, 2021.

DATES: This final rule is effective May 28, 2021.

ADDRESSES: The EPA has established a docket for this action under 
Docket ID No. EPA-HQ-OA--2018-0259 All documents in the docket are 
listed on the http://www.regulations.gov website. Although listed in 
the index, some information may not be publicly available, e.g., CBI or 
other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available electronically 
through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Bennett Thompson, Office of Science 
Advisor, Policy and Engagement (8104R), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone 
number: (202) 564-1071; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action removes requirements for how the EPA considers the 
availability of dose-response data underlying its pivotal science used 
in its significant regulatory actions and influential scientific 
information. The EPA recognizes any entity interested in submitting 
studies to EPA or how EPA evaluates and considers science in EPA 
regulations may be interested in this final rule.

B. Why is EPA issuing this action?

    The EPA is removing the regulatory provisions associated with the 
final rule ``Strengthening Transparency in Pivotal Science Underlying 
Significant Regulatory Actions and Influential Scientific Information'' 
(86 FR 469, January 6, 2021), herein referred to as the ``2021 final 
rule'' (Ref. 1). This action effectuates the vacatur of the final rule 
ordered by the United States District Court for the District of Montana 
in Environmental Defense Fund et al. v. EPA, No. 21-cv-00003 (D. Mon. 
Feb. 1, 2021) (EDF v. EPA).
    Section 553 of the Administrative Procedure Act, 5 U.S.C. 
553(b)(B), provides that, when an agency for good cause finds that 
notice and public procedure are impracticable, unnecessary or contrary 
to the public interest, the agency may issue a rule without providing 
notice and an opportunity for public comment. EPA has determined that 
there is good cause under section 553(b)(B) to issue this final rule 
without prior proposal and opportunity for comment because this action 
undertakes the ministerial tasks of removing regulatory provisions 
vacated by the court in EDF v. EPA (Ref. 2).
    As a matter of law, the order issued by the court in EDF v. EPA on 
February 1, 2021 vacated the 2021 final rule. It is, therefore, 
unnecessary to provide notice and an opportunity for comment on this 
action, which carries out the court's orders by removing the 2021 final 
rule from 40 CFR part 30.
    In addition, EPA finds that it has good cause to make these 
revisions immediately effective upon publication under section 553(d) 
of the Administrative Procedure Act, 5 U.S.C. 553(d). Section 553(d) 
provides that final rules shall not become effective until 30 days 
after publication in the Federal Register ``except . . . as otherwise 
provided by the agency for good cause. '' The purpose of this provision 
is to ``give affected parties a reasonable time to adjust their 
behavior before the final rule takes effect.'' Omnipoint Corp. v. Fed. 
Commc'n Comm'n, 78 F.3d 620, 630 (D.C. Cir. 1996); see also United 
States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977) (quoting 
legislative history). Thus, in determining whether good cause exists to 
waive the 30-day delay, an agency should, ``balance the necessity for 
immediate implementation against principles of fundamental fairness 
which require that all affected persons be afforded a reasonable amount 
of time to prepare for the effective date of its ruling.'' Gavrilovic, 
551 F.2d at 1105. EPA has determined that there is good cause under 
section 553(d) for making this final rule effective immediately because 
this action merely implements the court order vacating the 2021 final 
rule. Delaying the effectiveness of this rule further would prolong the 
period of time between the change in the law (i.e., the court's 
vacatur) and the

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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 Agency's 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 
court's 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 court's order 
(Ref. 2).

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 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 EPA's 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 
agency's 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 
court's 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 court's 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) (FRL-10019-07-ORD), 
available at https://www.federalregister.gov/documents/2021/01/06/2020-29179/strengthening-transparency-in-pivotal-science-underlying-significant-regulatory-actions-and.
    2. EDF vs. EPA, Case No. 4:21-cv-00003-BMM, United States District 
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-00003-bmm.pdf.
    3. EDF vs. EPA, Case No. 4:21-cv-00003-BMM, United States District 
Court for the District of Montana, Complaint (January 11, 2021).
    4. EDF vs. EPA, Case No. 4:21-cv-00003-BMM, United States District 
Court for the District of Montana, Order on Partial Motion (January 27, 
2021).
    5. EDF vs. EPA, Case No. 4:21-cv-00003-BMM-JTJ, 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. 
553(b).

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in 
UMRA, 2 U.S.C. 1531-1538, 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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relationship between the National Government and the states, or on the 
distribution of power and responsibilities among the various levels of 
government.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that concern environmental health or safety risks 
that the EPA has reason to believe may disproportionately affect 
children, per the definition of ``covered regulatory action'' in 
section 2-202 of the Executive order. This action is not subject to 
Executive Order 13045 because it does not concern an environmental 
health risk or safety risk.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' within the 
meaning of Executive Order 13211. It is not likely to have a 
significant adverse effect on the supply, distribution or use of 
energy, and it has not otherwise been designated as a significant 
energy action by the Administrator of the Office of Information and 
Regulatory Affairs (OIRA).

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order 
12898 (59 FR 7629, February 16, 1994) because it does not establish an 
environmental health or safety standard.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule 
report to each House of the Congress and to the Comptroller General of 
the United States. This action is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 30

    Environmental protection, Administrative practice and procedure, 
Reporting and recordkeeping requirements.

Michael S. Regan,
Administrator.

PART 30--[REMOVED AND RESERVED]

0
For the reasons set forth in the preamble and under the authority of 
the court order in Environmental Defense Fund et al. v. EPA, No. 21-cv-
00003 (D. Mon. Feb. 1, 2021) (EDF v. EPA), the EPA removes and reserves 
40 CFR part 30.
[FR Doc. 2021-11317 Filed 5-28-21; 8:45 am]
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