Air Quality Implementation Plan; California; Northern Sierra Air Quality Management District; Stationary Source Permits, 59729-59732 [2020-19587]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 185 / Wednesday, September 23, 2020 / Proposed Rules
https://www.fda.gov/media/70844/
download), accessed February 5, 2020.
8. FDA, Draft Guidance for Industry,
‘‘Distributing Scientific and Medical
Publications on Unapproved New Uses—
Recommended Practices,’’ February 2014
(available at https://www.fda.gov/media/
88031/download), accessed February 5,
2020.
9. FDA, Draft Guidance for Industry,
‘‘Responding to Unsolicited Requests for
Off-Label Information About Prescription
Drugs and Medical Devices,’’ December
2011 (available at https://www.fda.gov/
media/82660/download), accessed
February 5, 2020.
10. Eguale, T., D.L. Buckeridge, A. Verma, et
al., ‘‘Association of Off-Label Drug Use
and Adverse Drug Events in an Adult
Population,’’ Journal of American
Medical Association Internal Medicine,
176(1):55–63, 2016.
3. The authority citation for part 801
continues to read as follows:
21 CFR Part 201
Drugs, Labeling, Reporting and
recordkeeping requirements.
Authority: 21 U.S.C. 321, 331, 351, 352,
360d, 360i, 360j, 371, 374.
21 CFR Part 801
Labeling, Medical devices, Reporting
and recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, we propose that 21
CFR parts 201 and 801 be amended as
follows:
PART 201—LABELING
1. The authority citation for part 201
is revised to read as follows:
■
Authority: 21 U.S.C. 321, 331, 343, 351,
352, 353, 355, 358, 360, 360b, 360ccc,
360ccc–1, 360ee, 360gg–360ss, 371, 374,
379e; 42 U.S.C. 216, 241, 262, 264.
2. Revise § 201.128 to read as follows:
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§ 201.128
Meaning of intended uses.
The words intended uses or words of
similar import in §§ 201.5, 201.115,
201.117, 201.119, 201.120, 201.122, and
1100.5 of this chapter refer to the
objective intent of the persons legally
responsible for the labeling of an article
(or their representatives). The intent
may be shown by such persons’
expressions, the design or composition
of the article, or by the circumstances
surrounding the distribution of the
article. This objective intent may, for
example, be shown by labeling claims,
advertising matter, or oral or written
statements by such persons or their
representatives. Objective intent may be
shown, for example, by circumstances
in which the article is, with the
knowledge of such persons or their
representatives, offered or used for a
purpose for which it is neither labeled
nor advertised; provided, however, that
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PART 801—LABELING
■
List of Subjects
■
a firm would not be regarded as
intending an unapproved new use for an
approved drug based solely on that
firm’s knowledge that such drug was
being prescribed or used by health care
providers for such use. The intended
uses of an article may change after it has
been introduced into interstate
commerce by its manufacturer. If, for
example, a packer, distributor, or seller
intends an article for different uses than
those intended by the person from
whom he or she received the article,
such packer, distributor, or seller is
required to supply adequate labeling in
accordance with the new intended uses.
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■
4. Revise § 801.4 to read as follows:
§ 801.4
Meaning of intended uses.
The words intended uses or words of
similar import in §§ 801.5, 801.119,
801.122, and 1100.5 of this chapter refer
to the objective intent of the persons
legally responsible for the labeling of an
article (or their representatives). The
intent may be shown by such persons’
expressions, the design or composition
of the article, or by the circumstances
surrounding the distribution of the
article. This objective intent may, for
example, be shown by labeling claims,
advertising matter, or oral or written
statements by such persons or their
representatives. Objective intent may be
shown, for example, by circumstances
in which the article is, with the
knowledge of such persons or their
representatives, offered or used for a
purpose for which it is neither labeled
nor advertised; provided, however, that
a firm would not be regarded as
intending an unapproved new use for an
approved or cleared device based solely
on that firm’s knowledge that such
device was being prescribed or used by
health care providers for such use. The
intended uses of an article may change
after it has been introduced into
interstate commerce by its
manufacturer. If, for example, a packer,
distributor, or seller intends an article
for different uses than those intended by
the person from whom he or she
received the article, such packer,
distributor, or seller is required to
supply adequate labeling in accordance
with the new intended uses.
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59729
Dated: September 8, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
[FR Doc. 2020–20437 Filed 9–22–20; 8:45 am]
BILLING CODE 4164–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2020–0418; FRL–10013–
74–Region 9]
Air Quality Implementation Plan;
California; Northern Sierra Air Quality
Management District; Stationary
Source Permits
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to approve a
revision to the Northern Sierra Air
Quality Management District (NSAQMD
or ‘‘District’’) portion of the California
State Implementation Plan (SIP). In this
action, we are proposing to approve a
rule submitted by the NSAQMD that
governs the issuance of permits for
stationary sources, which focuses on the
preconstruction review and permitting
of major sources and major
modifications under part D of title I of
the Clean Air Act (CAA or ‘‘the Act’’).
We are taking comments on this
proposal and a final action will follow.
DATES: Written comments must be
received on or before October 23, 2020.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R09–
OAR–2020–0418 at https://
www.regulations.gov, or via email to
R9AirPermits@epa.gov. For comments
submitted at Regulations.gov, follow the
online instructions for submitting
comments. Once submitted, comments
cannot be removed or edited from
Regulations.gov. For either manner of
submission, the EPA may publish any
comment received to its public docket.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information the disclosure of
which is restricted by statute.
Multimedia submissions (audio, video,
etc.) must be accompanied by a written
comment. The written comment is
considered the official comment and
should include discussion of all points
you wish to make. The EPA will
generally not consider comments or
comment contents located outside of the
primary submission (i.e., on the web,
cloud, or other file sharing system). For
SUMMARY:
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additional submission methods, please
contact the person identified in the FOR
FURTHER INFORMATION CONTACT section.
For the full EPA public comment policy,
information about CBI and multimedia
submissions, and general guidance on
making effective comments, please visit
https://www2.epa.gov/dockets/
commenting-epa-dockets. If you need
assistance in a language other than
English or if you are a person with
disabilities who needs a reasonable
accommodation at no cost to you, please
contact the person identified in the FOR
FURTHER INFORMATION CONTACT section.
FOR FURTHER INFORMATION CONTACT:
Amber Batchelder, EPA Region IX, 75
Hawthorne St., San Francisco, CA
94105; by phone: (415) 947–4174, or by
email to batchelder.amber@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document, the terms
‘‘we,’’ ‘‘us,’’ and ‘‘our’’ refer to the EPA.
III. Proposed Action and Public Comment
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews
Table of Contents
Table 1 lists the rule addressed by this
proposal, including the date on which it
was adopted by the District and the date
on which it was submitted to the EPA
by the California Air Resources Board
(CARB or ‘‘the State’’). The Northern
Sierra Air Quality Management District
(NSAQMD) is the air pollution control
agency for Nevada, Sierra, and Plumas
Counties.
I. The State’s Submittal
A. What rule did the State submit?
B. Are there other versions of this rule?
C. What is the purpose of the submitted
rule?
II. The EPA’s Evaluation
A. What is the background for this
proposal?
B. How is the EPA evaluating the rule?
C. Does the rule meet the evaluation
criteria?
I. The State’s Submittal
A. What rule did the State submit?
TABLE 1—SUBMITTED RULES
District
Rule No.
NSAQMD ....................
428
Rule title
NSR Requirements for New and Modified Major Sources in Nonattainment Areas.
For areas designated nonattainment
for one or more National Ambient Air
Quality Standards (NAAQS), the
applicable SIP must include
preconstruction review and permitting
requirements for new or modified major
stationary sources of such
nonattainment pollutant(s) under part D
of title I of the Act, commonly referred
to as Nonattainment New Source
Review (NNSR). The rule listed in Table
1 contains the District’s NNSR permit
program applicable to new and
modified major sources located in areas
within the District that are designated
nonattainment for any NAAQS for
ozone or particulate matter equal to or
less than 2.5 micrometers (PM2.5).
We find that the submittal for Rule
428 meets the completeness criteria in
40 CFR part 51 Appendix V, which
must be met before formal EPA review.
B. Are there other versions of this rule?
There are no previous versions of
NSAQMD Rule 428 in the California
SIP.
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C. What is the purpose of the submitted
rule?
NSAQMD Rule 428 is intended to
address the CAA’s statutory and
regulatory requirements for NNSR
permit programs for major sources
emitting nonattainment air pollutants
and their precursors.
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Submitted1
02/19/20
NAAQS.5 On December 3, 2012, the
EPA issued a final rule that determined
A. What is the background for this
that the western part of Nevada County
proposal?
had attained the 1997 ozone NAAQS by
6
Because a part of Nevada County(‘‘the the extended attainment date.
On
March
27,
2008,
the
EPA
issued a
western part’’) is a federal ozone
final rule revising the NAAQS for
nonattainment area and part of Plumas
ozone, reducing the standards to a level
County (‘‘the Portola area’’) is a federal
of 0.075 ppm.7 On May 21, 2012, the
2
PM2.5 nonattainment area, the CAA
EPA
issued a final rule designating the
requires the NSAQMD to have a SIPwestern
part of Nevada County as
approved NNSR program for new and
nonattainment for the 2008 8-hour
modified major sources in the ozone
ozone NAAQS, with a Marginal
and PM2.5 nonattainment areas that are
classification.8 On May 4, 2016, the EPA
under its jurisdiction. Below, we
issued a final rule that determined that
provide the area’s nonattainment
the western part of Nevada County had
designation history for the ozone and
not attained the 2008 ozone NAAQS by
PM2.5 NAAQS, which forms the basis for the attainment date and was therefore
the District’s NNSR program needed to
reclassified as a Moderate
satisfy the NNSR requirements
nonattainment area.9 On August 23,
applicable to Serious ozone
2019, the EPA issued a final rule that
nonattainment areas and Moderate
determined that the western part of
PM2.5 nonattainment areas.
Nevada County had not attained the
2008 ozone NAAQS by the attainment
On July 18, 1997, the EPA issued a
date and was therefore reclassified as a
final rule revising the primary and
Serious ozone nonattainment area.10
secondary NAAQS for ozone to
establish new 8-hour standards of 0.08
On October 26, 2015, the EPA issued
a final rule revising the NAAQS for
ppm.3 On April 30, 2004, the EPA
ozone, reducing the standards to a level
issued a final rule designating the
of 0.070 ppm.11 On June 4, 2018, the
western part of Nevada County as
EPA
issued a final rule designating the
nonattainment for the 1997 8-hour
western part of Nevada County as
ozone NAAQS.4 On May 14, 2012, this
nonattainment for the 2015 8-hour
area was reclassified as Moderate
nonattainment for the 1997 ozone
II. The EPA’s Evaluation
2 While
1 The submittal was transmitted to the EPA via a
letter from CARB dated February 6, 2020.
VerDate Sep<11>2014
Adopted
the NSAQMD includes all of Nevada,
Sierra, and Plumas Counties, only the western part
of Nevada County is nonattainment for ozone, and
only a specific part of Plumas County is
nonattainment for PM2.5. See 40 CFR part 81.305.
3 40 CFR 50.10; see 62 FR 38856, 38894–38895.
4 69 FR 23858, 23889.
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5 77 FR 28424; see also 77 FR 43521 (July 25,
2012); 40 CR 81.305.
6 77 FR 71551.
7 40 CFR 50.15; see 73 FR 16436, 16511.
8 77 FR 30088, 30103.
9 81 FR 26697.
10 84 FR 44238; see 40 CFR 81.305.
11 40 CFR 50.19; see 80 FR 65292, 65452–53.
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ozone NAAQS, with a Moderate
classification.12
On January 15, 2013, the EPA issued
a final rule revising the NAAQS for
PM2.5, reducing the primary annual
standard to 12.0 micrograms per cubic
meter.13 On January 15, 2015, the EPA
issued a final rule designating the
Portola area as nonattainment for the
2012 primary annual PM2.5 NAAQS,
with a Moderate classification.14
The designations of the western part
of Nevada County as a federal ozone
nonattainment area and the Portola area
as a federal PM2.5 nonattainment area
triggered the requirement for the
NSAQMD to develop and submit an
NNSR program to the EPA for approval
into the California SIP.15 The District’s
NNSR program must satisfy the NNSR
requirements applicable to Moderate
PM2.5 nonattainment areas and Serious
ozone nonattainment areas, as these are
the highest PM2.5 and ozone
nonattainment classifications to which
the District is subject.16
On February 19, 2020, CARB
submitted to the EPA for SIP approval,
via correspondence dated February 6,
2020, NSAQMD Rule 428, ‘‘NSR
Requirements for New and Modified
Major Sources in Nonattainment Areas,’’
which was adopted by the District on
November 25, 2019.
B. How is the EPA evaluating the rule?
The EPA reviewed NSAQMD Rule
428 for compliance with CAA
requirements for: (1) Stationary source
preconstruction permitting programs as
set forth in CAA part D, including CAA
sections 172(c)(5) and 173; (2) the
review and modification of major
sources in accordance with 40 CFR
51.160–51.165 as applicable in Serious
ozone and Moderate PM2.5
nonattainment areas; (3) the review of
new major stationary sources or major
modifications in a designated
nonattainment area that may have an
impact on visibility in any mandatory
Class I Federal Area in accordance with
40 CFR 51.307; (4) SIPs in general as set
forth in CAA section 110(a)(2),
including 110(a)(2)(A) and
12 83
FR 25776, 25788; see 40 CFR 81.305.
CFR 50.18; see 78 FR 3086, 3277.
14 80 FR 2206, 2218; see 40 CFR 81.305.
15 40 CFR 51.1003(a)(1), 51.1100(o)(14),
51.1105(a) and (f), 51.1114, 51.1314. We note that,
as a result of the EPA’s determination that an area
has attained a NAAQS by the attainment date, those
SIP elements related to attaining the NAAQS are
suspended for so long as the area continues to attain
the standard; however, the requirement for an
NNSR program is not one of the SIP elements
suspended as a result of such a determination. See,
e.g., 40 CFR 51.1118.
16 See 40 CFR 51.1003(a)(1), 51.1105(f), 51.1114.
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13 40
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59731
110(a)(2)(E)(i); 17 and (5) SIP revisions as
set forth in CAA section 110(l) 18 and
193.19 Our review evaluated the
submittals for compliance with the
NNSR requirements applicable to
nonattainment areas designated Serious
for ozone and nonattainment areas
designated Moderate for PM2.5, and
ensured that the submittals addressed
the NNSR requirements for the 1997,
2008 and 2015 ozone NAAQS, and the
2012 Annual PM2.5 NAAQS.
the EPA for SIP approval to be clear and
legally enforceable, and have
determined that the submittal
demonstrates in accordance with CAA
section 110(a)(2)(E)(i) that the District
has adequate personnel, funding, and
authority under state law to carry out
these proposed SIP revisions.
Our Technical Support Document,
which can be found in the docket for
this rule, contains a more detailed
discussion of our analysis of Rule 428.
C. Does the rule meet the evaluation
criteria?
III. Proposed Action and Public
Comment
With respect to procedural
requirements, CAA sections 110(a)(2)
and 110(l) require that revisions to a SIP
be adopted by the state after reasonable
notice and public hearing. Based on our
review of the public process
documentation included in the February
19, 2020 submittal of NSAQMD Rule
428, we find that the NSAQMD has
provided sufficient evidence of public
notice, opportunity for comment and a
public hearing prior to adoption and
submittal of these rules to the EPA.
With respect to the substantive
requirements found in CAA sections
172(c)(5) and 173, and 40 CFR 51.160–
51.165, we have evaluated NSAQMD
Rule 428 in accordance with the
applicable CAA and regulatory
requirements that apply to NNSR permit
programs under part D of title I of the
Act for all relevant ozone and PM2.5
NAAQS, including the 2015 ozone
NAAQS. We find that NSAQMD Rule
428 satisfies these requirements as they
apply to sources subject to NNSR permit
program requirements for ozone
nonattainment areas classified as
Serious and PM2.5 nonattainment areas
classified as Moderate. We have also
determined that this rule satisfies the
related visibility requirements in 40
CFR 51.307. In addition, we have
determined that Rule 428 satisfies the
requirement in CAA section 110(a)(2)(A)
that requires regulations submitted to
As authorized in section 110(k)(3) of
the Act, the EPA is proposing to
approve the submitted rule because it
fulfills all relevant CAA requirements.
We have concluded that our approval of
the submitted rule would comply with
the relevant provisions of CAA sections
110(a)(2), 110(l), 172(c)(5), 173, and 193,
and 40 CFR 51.160–51.165 and 40 CFR
51.307.
In support of this proposed action, we
have concluded that our action would
comply with section 110(l) of the Act
because approval of NSAQMD Rule 428
will not interfere with any applicable
requirement concerning attainment and
reasonable further progress, or any other
CAA applicable requirement. In
addition, our approval of Rule 428 will
not relax any pre-November 15, 1990
requirement in the SIP, and therefore
changes to the SIP resulting from this
action ensure greater or equivalent
emission reductions of ozone, PM2.5,
and their respective precursors in the
District; accordingly, we have
concluded that our action is consistent
with the requirements of CAA section
193.
If we finalize this action as proposed,
our action will be codified through
revisions to 40 CFR 52.220a
(Identification of plan-in part).
We will accept comments from the
public on this proposal until October
23, 2020.
17 CAA section 110(a)(2)(A) requires that
regulations submitted to the EPA for SIP approval
be clear and legally enforceable, and CAA section
110(a)(2)(E)(i) requires that states have adequate
personnel, funding, and authority under state law
to carry out their proposed SIP revisions.
18 CAA section 110(l) requires SIP revisions to be
subject to reasonable notice and public hearing
prior to adoption and submittal by states to EPA
and prohibits EPA from approving any SIP revision
that would interfere with any applicable
requirement concerning attainment and reasonable
further progress, or any other applicable
requirement of the CAA.
19 CAA section 193 prohibits the modification of
any SIP-approved control requirement in effect
before November 15, 1990 in a nonattainment area,
unless the modification ensures equivalent or
greater emission reductions of the relevant
pollutants.
IV. Incorporation by Reference
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In this rule, the EPA is proposing to
include in a final EPA rule regulatory
text that includes incorporation by
reference. In accordance with
requirements of 1 CFR 51.5, the EPA is
proposing to incorporate by reference
the rule listed in Table 1 of this
preamble. The EPA has made, and will
continue to make, this document
available electronically through https://
www.regulations.gov and in hard copy
at the EPA Region IX Office (please
contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of
this preamble for more information).
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V. Statutory and Executive Order
Reviews
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
Act and applicable federal regulations.
42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the
EPA’s role is to approve state choices,
provided that they meet the criteria of
the Act. Accordingly, this proposed
action merely proposes to approve state
law as meeting federal requirements and
does not impose additional
requirements beyond those imposed by
state law. For that reason, this proposed
action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• Is not an Executive Order 13771 (82
FR 9339, February 3, 2017) regulatory
action because SIP approvals are
exempted under Executive Order 12866;
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide the EPA with the
discretionary authority to address
disproportionate human health or
environmental effects with practical,
appropriate, and legally permissible
methods under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, the SIP is not approved
to apply on any Indian reservation land
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or in any other area where the EPA or
an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the rule does not have
tribal implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Volatile organic
compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: August 28, 2020.
John Busterud,
Regional Administrator, Region IX.
[FR Doc. 2020–19587 Filed 9–22–20; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
[Docket No. FWS–R4–ES–2018–0062;
FXES11130900000–189–FF0932000]
RIN 1018–BD02
Endangered and Threatened Wildlife
and Plants; Removal of the Nashville
Crayfish From the Federal List of
Endangered and Threatened Wildlife
Fish and Wildlife Service,
Interior.
ACTION: Proposed rule; reopening of
comment period and announcement of
public hearing.
AGENCY:
We, the U.S. Fish and
Wildlife Service (Service), proposed to
remove the Nashville crayfish
(Orconectes shoupi) from the Federal
List of Endangered and Threatened
Wildlife (List). This determination is
based on the best available scientific
and commercial data, which indicate
that the threats to the species have been
eliminated or reduced to the point that
the species has recovered and no longer
meets the definition of an endangered
species or a threatened species under
the Endangered Species Act of 1973, as
amended (Act). We announced a 60-day
public comment period on the proposed
rule, ending January 27, 2020. We now
reopen the public comment period on
the proposed rule to allow all interested
parties additional time to comment on
the proposed rule. Comments
SUMMARY:
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previously submitted need not be
resubmitted and will be fully
considered in preparation of the final
rule. We also announce a public
informational meeting and public
hearing on the proposed rule.
DATES:
Written comments: The comment
period on the proposed rule that
published November 26, 2019 (84 FR
65098), is reopened. We will accept
comments received or postmarked on or
before October 23, 2020. Please note that
comments submitted electronically
using the Federal eRulemaking Portal
(see ADDRESSES, below) must be
received by 11:59 p.m. Eastern Time on
the closing date, and comments
submitted by U.S. mail must be
postmarked by that date to ensure
consideration.
Public informational meeting and
public hearing: On October 8, 2020, we
will hold a public informational
meeting from 6 to 7 p.m., Central Time,
followed by a public hearing from 7 to
8:30 p.m., Central Time.
ADDRESSES:
Availability of documents: You may
obtain copies of the November 26, 2019,
proposed rule and associated
documents on the internet at https://
www.regulations.gov under Docket No.
FWS–R4–ES–2018–0062.
Written comments: You may submit
written comments by one of the
following methods:
(1) Electronically: Go to the Federal
eRulemaking Portal: https://
www.regulations.gov. In the Search box,
enter FWS–R4–ES–2018–0062, which is
the docket number for the proposed
rule. Then, click on the Search button.
On the resulting page, in the Search
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E:\FR\FM\23SEP1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 185 (Wednesday, September 23, 2020)]
[Proposed Rules]
[Pages 59729-59732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19587]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[EPA-R09-OAR-2020-0418; FRL-10013-74-Region 9]
Air Quality Implementation Plan; California; Northern Sierra Air
Quality Management District; Stationary Source Permits
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the Northern Sierra Air Quality Management
District (NSAQMD or ``District'') portion of the California State
Implementation Plan (SIP). In this action, we are proposing to approve
a rule submitted by the NSAQMD that governs the issuance of permits for
stationary sources, which focuses on the preconstruction review and
permitting of major sources and major modifications under part D of
title I of the Clean Air Act (CAA or ``the Act''). We are taking
comments on this proposal and a final action will follow.
DATES: Written comments must be received on or before October 23, 2020.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2020-0418 at https://www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be removed or edited from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information the disclosure of which is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For
[[Page 59730]]
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI and multimedia submissions, and
general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets. If you need assistance in
a language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.
FOR FURTHER INFORMATION CONTACT: Amber Batchelder, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105; by phone: (415) 947-4174, or by
email to [email protected].
SUPPLEMENTARY INFORMATION: Throughout this document, the terms ``we,''
``us,'' and ``our'' refer to the EPA.
Table of Contents
I. The State's Submittal
A. What rule did the State submit?
B. Are there other versions of this rule?
C. What is the purpose of the submitted rule?
II. The EPA's Evaluation
A. What is the background for this proposal?
B. How is the EPA evaluating the rule?
C. Does the rule meet the evaluation criteria?
III. Proposed Action and Public Comment
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews
I. The State's Submittal
A. What rule did the State submit?
Table 1 lists the rule addressed by this proposal, including the
date on which it was adopted by the District and the date on which it
was submitted to the EPA by the California Air Resources Board (CARB or
``the State''). The Northern Sierra Air Quality Management District
(NSAQMD) is the air pollution control agency for Nevada, Sierra, and
Plumas Counties.
Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
District Rule No. Rule title Adopted Submitted\1\
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NSAQMD........................ 428 NSR Requirements for New and 11/25/19 02/19/20
Modified Major Sources in
Nonattainment Areas.
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For areas designated nonattainment for one or more National Ambient
Air Quality Standards (NAAQS), the applicable SIP must include
preconstruction review and permitting requirements for new or modified
major stationary sources of such nonattainment pollutant(s) under part
D of title I of the Act, commonly referred to as Nonattainment New
Source Review (NNSR). The rule listed in Table 1 contains the
District's NNSR permit program applicable to new and modified major
sources located in areas within the District that are designated
nonattainment for any NAAQS for ozone or particulate matter equal to or
less than 2.5 micrometers (PM2.5).
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\1\ The submittal was transmitted to the EPA via a letter from
CARB dated February 6, 2020.
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We find that the submittal for Rule 428 meets the completeness
criteria in 40 CFR part 51 Appendix V, which must be met before formal
EPA review.
B. Are there other versions of this rule?
There are no previous versions of NSAQMD Rule 428 in the California
SIP.
C. What is the purpose of the submitted rule?
NSAQMD Rule 428 is intended to address the CAA's statutory and
regulatory requirements for NNSR permit programs for major sources
emitting nonattainment air pollutants and their precursors.
II. The EPA's Evaluation
A. What is the background for this proposal?
Because a part of Nevada County(``the western part'') is a federal
ozone nonattainment area and part of Plumas County (``the Portola
area'') is a federal PM2.5 nonattainment area,\2\ the CAA
requires the NSAQMD to have a SIP-approved NNSR program for new and
modified major sources in the ozone and PM2.5 nonattainment
areas that are under its jurisdiction. Below, we provide the area's
nonattainment designation history for the ozone and PM2.5
NAAQS, which forms the basis for the District's NNSR program needed to
satisfy the NNSR requirements applicable to Serious ozone nonattainment
areas and Moderate PM2.5 nonattainment areas.
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\2\ While the NSAQMD includes all of Nevada, Sierra, and Plumas
Counties, only the western part of Nevada County is nonattainment
for ozone, and only a specific part of Plumas County is
nonattainment for PM2.5. See 40 CFR part 81.305.
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On July 18, 1997, the EPA issued a final rule revising the primary
and secondary NAAQS for ozone to establish new 8-hour standards of 0.08
ppm.\3\ On April 30, 2004, the EPA issued a final rule designating the
western part of Nevada County as nonattainment for the 1997 8-hour
ozone NAAQS.\4\ On May 14, 2012, this area was reclassified as Moderate
nonattainment for the 1997 ozone NAAQS.\5\ On December 3, 2012, the EPA
issued a final rule that determined that the western part of Nevada
County had attained the 1997 ozone NAAQS by the extended attainment
date.\6\
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\3\ 40 CFR 50.10; see 62 FR 38856, 38894-38895.
\4\ 69 FR 23858, 23889.
\5\ 77 FR 28424; see also 77 FR 43521 (July 25, 2012); 40 CR
81.305.
\6\ 77 FR 71551.
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On March 27, 2008, the EPA issued a final rule revising the NAAQS
for ozone, reducing the standards to a level of 0.075 ppm.\7\ On May
21, 2012, the EPA issued a final rule designating the western part of
Nevada County as nonattainment for the 2008 8-hour ozone NAAQS, with a
Marginal classification.\8\ On May 4, 2016, the EPA issued a final rule
that determined that the western part of Nevada County had not attained
the 2008 ozone NAAQS by the attainment date and was therefore
reclassified as a Moderate nonattainment area.\9\ On August 23, 2019,
the EPA issued a final rule that determined that the western part of
Nevada County had not attained the 2008 ozone NAAQS by the attainment
date and was therefore reclassified as a Serious ozone nonattainment
area.\10\
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\7\ 40 CFR 50.15; see 73 FR 16436, 16511.
\8\ 77 FR 30088, 30103.
\9\ 81 FR 26697.
\10\ 84 FR 44238; see 40 CFR 81.305.
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On October 26, 2015, the EPA issued a final rule revising the NAAQS
for ozone, reducing the standards to a level of 0.070 ppm.\11\ On June
4, 2018, the EPA issued a final rule designating the western part of
Nevada County as nonattainment for the 2015 8-hour
[[Page 59731]]
ozone NAAQS, with a Moderate classification.\12\
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\11\ 40 CFR 50.19; see 80 FR 65292, 65452-53.
\12\ 83 FR 25776, 25788; see 40 CFR 81.305.
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On January 15, 2013, the EPA issued a final rule revising the NAAQS
for PM2.5, reducing the primary annual standard to 12.0
micrograms per cubic meter.\13\ On January 15, 2015, the EPA issued a
final rule designating the Portola area as nonattainment for the 2012
primary annual PM2.5 NAAQS, with a Moderate
classification.\14\
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\13\ 40 CFR 50.18; see 78 FR 3086, 3277.
\14\ 80 FR 2206, 2218; see 40 CFR 81.305.
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The designations of the western part of Nevada County as a federal
ozone nonattainment area and the Portola area as a federal
PM2.5 nonattainment area triggered the requirement for the
NSAQMD to develop and submit an NNSR program to the EPA for approval
into the California SIP.\15\ The District's NNSR program must satisfy
the NNSR requirements applicable to Moderate PM2.5
nonattainment areas and Serious ozone nonattainment areas, as these are
the highest PM2.5 and ozone nonattainment classifications to
which the District is subject.\16\
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\15\ 40 CFR 51.1003(a)(1), 51.1100(o)(14), 51.1105(a) and (f),
51.1114, 51.1314. We note that, as a result of the EPA's
determination that an area has attained a NAAQS by the attainment
date, those SIP elements related to attaining the NAAQS are
suspended for so long as the area continues to attain the standard;
however, the requirement for an NNSR program is not one of the SIP
elements suspended as a result of such a determination. See, e.g.,
40 CFR 51.1118.
\16\ See 40 CFR 51.1003(a)(1), 51.1105(f), 51.1114.
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On February 19, 2020, CARB submitted to the EPA for SIP approval,
via correspondence dated February 6, 2020, NSAQMD Rule 428, ``NSR
Requirements for New and Modified Major Sources in Nonattainment
Areas,'' which was adopted by the District on November 25, 2019.
B. How is the EPA evaluating the rule?
The EPA reviewed NSAQMD Rule 428 for compliance with CAA
requirements for: (1) Stationary source preconstruction permitting
programs as set forth in CAA part D, including CAA sections 172(c)(5)
and 173; (2) the review and modification of major sources in accordance
with 40 CFR 51.160-51.165 as applicable in Serious ozone and Moderate
PM2.5 nonattainment areas; (3) the review of new major
stationary sources or major modifications in a designated nonattainment
area that may have an impact on visibility in any mandatory Class I
Federal Area in accordance with 40 CFR 51.307; (4) SIPs in general as
set forth in CAA section 110(a)(2), including 110(a)(2)(A) and
110(a)(2)(E)(i); \17\ and (5) SIP revisions as set forth in CAA section
110(l) \18\ and 193.\19\ Our review evaluated the submittals for
compliance with the NNSR requirements applicable to nonattainment areas
designated Serious for ozone and nonattainment areas designated
Moderate for PM2.5, and ensured that the submittals
addressed the NNSR requirements for the 1997, 2008 and 2015 ozone
NAAQS, and the 2012 Annual PM2.5 NAAQS.
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\17\ CAA section 110(a)(2)(A) requires that regulations
submitted to the EPA for SIP approval be clear and legally
enforceable, and CAA section 110(a)(2)(E)(i) requires that states
have adequate personnel, funding, and authority under state law to
carry out their proposed SIP revisions.
\18\ CAA section 110(l) requires SIP revisions to be subject to
reasonable notice and public hearing prior to adoption and submittal
by states to EPA and prohibits EPA from approving any SIP revision
that would interfere with any applicable requirement concerning
attainment and reasonable further progress, or any other applicable
requirement of the CAA.
\19\ CAA section 193 prohibits the modification of any SIP-
approved control requirement in effect before November 15, 1990 in a
nonattainment area, unless the modification ensures equivalent or
greater emission reductions of the relevant pollutants.
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C. Does the rule meet the evaluation criteria?
With respect to procedural requirements, CAA sections 110(a)(2) and
110(l) require that revisions to a SIP be adopted by the state after
reasonable notice and public hearing. Based on our review of the public
process documentation included in the February 19, 2020 submittal of
NSAQMD Rule 428, we find that the NSAQMD has provided sufficient
evidence of public notice, opportunity for comment and a public hearing
prior to adoption and submittal of these rules to the EPA.
With respect to the substantive requirements found in CAA sections
172(c)(5) and 173, and 40 CFR 51.160-51.165, we have evaluated NSAQMD
Rule 428 in accordance with the applicable CAA and regulatory
requirements that apply to NNSR permit programs under part D of title I
of the Act for all relevant ozone and PM2.5 NAAQS, including
the 2015 ozone NAAQS. We find that NSAQMD Rule 428 satisfies these
requirements as they apply to sources subject to NNSR permit program
requirements for ozone nonattainment areas classified as Serious and
PM2.5 nonattainment areas classified as Moderate. We have
also determined that this rule satisfies the related visibility
requirements in 40 CFR 51.307. In addition, we have determined that
Rule 428 satisfies the requirement in CAA section 110(a)(2)(A) that
requires regulations submitted to the EPA for SIP approval to be clear
and legally enforceable, and have determined that the submittal
demonstrates in accordance with CAA section 110(a)(2)(E)(i) that the
District has adequate personnel, funding, and authority under state law
to carry out these proposed SIP revisions.
Our Technical Support Document, which can be found in the docket
for this rule, contains a more detailed discussion of our analysis of
Rule 428.
III. Proposed Action and Public Comment
As authorized in section 110(k)(3) of the Act, the EPA is proposing
to approve the submitted rule because it fulfills all relevant CAA
requirements. We have concluded that our approval of the submitted rule
would comply with the relevant provisions of CAA sections 110(a)(2),
110(l), 172(c)(5), 173, and 193, and 40 CFR 51.160-51.165 and 40 CFR
51.307.
In support of this proposed action, we have concluded that our
action would comply with section 110(l) of the Act because approval of
NSAQMD Rule 428 will not interfere with any applicable requirement
concerning attainment and reasonable further progress, or any other CAA
applicable requirement. In addition, our approval of Rule 428 will not
relax any pre-November 15, 1990 requirement in the SIP, and therefore
changes to the SIP resulting from this action ensure greater or
equivalent emission reductions of ozone, PM2.5, and their
respective precursors in the District; accordingly, we have concluded
that our action is consistent with the requirements of CAA section 193.
If we finalize this action as proposed, our action will be codified
through revisions to 40 CFR 52.220a (Identification of plan-in part).
We will accept comments from the public on this proposal until
October 23, 2020.
IV. Incorporation by Reference
In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the rule listed in Table 1 of this preamble. The EPA has
made, and will continue to make, this document available electronically
through https://www.regulations.gov and in hard copy at the EPA Region
IX Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).
[[Page 59732]]
V. Statutory and Executive Order Reviews
Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the Act. Accordingly, this
proposed action merely proposes to approve state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
Is not an Executive Order 13771 (82 FR 9339, February 3,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
organic compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: August 28, 2020.
John Busterud,
Regional Administrator, Region IX.
[FR Doc. 2020-19587 Filed 9-22-20; 8:45 am]
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