Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information; Implementation of Vacatur, 29515-29517 [2021-11317]
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Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Rules and Regulations
TABLE 1 TO § 845.14—Continued
Points
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14,543
14,890
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8. In § 845.15, revise introductory text
of paragraph (b) to read as follows:
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§ 845.15 Assessment of separate
violations for each day.
*
*
*
*
*
(b) In addition to the civil penalty
provided for in paragraph (a) of this
section, whenever a violation contained
in a notice of violation or cessation
order has not been abated within the
abatement period set in the notice or
order or as subsequently extended
pursuant to section 521(a) of the Act, 30
U.S.C. 1271(a), a civil penalty of not less
than $2,596 will be assessed for each
day during which such failure to abate
continues, except that:
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PART 846—INDIVIDUAL CIVIL
PENALTIES
9. The authority citation for part 846
continues to read as follows:
■
Authority: 28 U.S.C. 2461, 30 U.S.C. 1201
et seq., and 31 U.S.C. 3701.
10. In § 846.14, revise the first
sentence of paragraph (b) to read as
follows:
■
§ 846.14
Amount of individual civil penalty.
*
*
*
*
*
(b) The penalty will not exceed $17,
314 for each violation. * * *
[FR Doc. 2021–11301 Filed 6–1–21; 8:45 am]
BILLING CODE 4310–05–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 30
[EPA–HQ–OA–2018–0259; FRL–10024–32–
ORD]
jbell on DSKJLSW7X2PROD with RULES
RIN 2080–AA15
Strengthening Transparency in Pivotal
Science Underlying Significant
Regulatory Actions and Influential
Scientific Information; Implementation
of Vacatur
Environmental Protection
Agency (EPA).
AGENCY:
VerDate Sep<11>2014
17:10 Jun 01, 2021
Jkt 253001
Final rule.
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 https://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 https://
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:
osp_staff@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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ACTION:
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
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29515
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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02JNR1
29516
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 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).
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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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17:10 Jun 01, 2021
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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 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-pivotalscience-underlying-significantregulatory-actions-and.
2. EDF vs. EPA, Case No. 4:21–cv–
00003–BMM, 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. 4:21–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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Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Rules and Regulations
List of Subjects in 40 CFR Part 30
relationship between the National
Government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
Environmental protection,
Administrative practice and procedure,
Reporting and recordkeeping
requirements.
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.
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.
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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).
Jkt 253001
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]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[[EPA–R07–OAR–2019–0711; FRL–10024–
22–Region 7]
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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).
17:10 Jun 01, 2021
PART 30—[REMOVED AND
RESERVED]
Air Plan Approval; Missouri;
Construction Permits By Rule
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution or Use
VerDate Sep<11>2014
Michael S. Regan,
Administrator.
The Environmental Protection
Agency (EPA) is approving selected
revisions to a Missouri State rule in the
State Implementation Plan (SIP) that
establishes a process and standardized
conditions under which certain types of
sources can construct and operate in
lieu of going through the State’s formal
construction permitting process. The
EPA is approving rule revisions that
include modifications to the operating
conditions for crematories and animal
incinerators, adjustments to sulfur
limits on Number 2 diesel oil for
consistency with Federal limits,
removal of ‘‘restrictive’’ words, addition
of definitions specific to the rule, and
other minor edits. At this time, the
agency is not acting on revisions that
conflict with an EPA regulation related
to disposal of pharmaceuticals collected
in drug take-back programs. The EPA’s
approval of the State’s other rule
revisions is being done in accordance
with the requirements of the Clean Air
Act (CAA).
DATES: This final rule is effective on July
2, 2021.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–R07–OAR–2019–0711. All
documents in the docket are listed on
SUMMARY:
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29517
the https://www.regulations.gov
website. Although listed in the index,
some information is not publicly
available, i.e., confidential business
information (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 through https://
www.regulations.gov or please contact
the person identified in the FOR FURTHER
INFORMATION CONTACT section for
additional information.
FOR FURTHER INFORMATION CONTACT:
Wendy Vit, Environmental Protection
Agency, Region 7 Office, Air Quality
Planning Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at
(913) 551–7697, or by email at
vit.wendy@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document ‘‘we,’’ ‘‘us,’’
and ‘‘our’’ refer to the EPA. This section
provides additional information by
addressing the following:
Table of Contents
I. What is being addressed in this action?
II. Have the requirements for approval of the
SIP revision been met?
III. The EPA’s Response to Comments
IV. What action is the EPA taking?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews
I. What is being addressed in this
action?
The EPA is taking final action to
approve selected revisions to 10 Code of
State Regulations (CSR) 10–6.062 in the
Missouri SIP. The revised State rule was
submitted by the State of Missouri on
March 7, 2019 and became effective on
March 30, 2019. The submission
requested revisions to the SIP that
include: (1) Expanding the materials
that crematories and animal incinerators
are allowed to burn from 100% human
and animal remains to 90% human and
animal remains with up to 10% illegal
and waste pharmaceutical drugs, (2)
modifying operating conditions for
crematories and animal incinerators, (3)
adjusting sulfur limits on Number 2
diesel oil for consistency with Federal
limits, (4) removing ‘‘restrictive’’ words,
(5) adding definitions specific to the
rule, and (6) making other minor edits.
The EPA is finalizing this action
because certain revisions to this State
rule meet the applicable requirements of
the Clean Air Act. EPA is not acting on
the State rule revisions that would allow
crematories and animal incinerators to
burn up to 10% by weight of illegal and
waste pharmaceuticals.
E:\FR\FM\02JNR1.SGM
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]]>Agencies
[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.
-----------------------------------------------------------------------
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 https://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 https://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
[[Page 29516]]
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]
BILLING CODE 6560-50-P
