[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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