[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15161-15162]
[FR Doc No: 2018-07151]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1201]

Pregnant Women: Scientific and Ethical Considerations for
Inclusion in Clinical Trials; Draft Guidance; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Pregnant
Women: Scientific and Ethical Considerations for Inclusion in Clinical
Trials.'' This draft guidance discusses the ethical and scientific
issues when considering the inclusion of pregnant women in clinical
trials of drugs and biological products. This draft guidance is
intended to advance scientific research in pregnant women, and
discusses issues that should be considered within the framework of
human subject protection regulations.

DATES: Submit either electronic or written comments on the draft
guidance by June 8, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you

do not wish to be made available to the public, submit the comment as a
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1201 for ``Pregnant Women: Scientific and Ethical
Considerations for Inclusion in Clinical Trials; Draft Guidance;
Availability.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Denise Johnson-Lyles, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6469, Silver Spring, MD 20993, 301-796-
6169.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Pregnant Women: Scientific and Ethical Considerations for
Inclusion in Clinical Trials.'' Currently, collection of safety data on
prescription drugs and biological products used during pregnancy
usually occurs after approval, and clinicians and patients must
undertake a risk-benefit analysis for the use of such products in
pregnant women with limited human safety information. Historically,
pregnant women have been an understudied population and there have been
barriers to obtaining data from pregnant women in clinical trials,
including concerns about protecting women and their fetuses from
research-related risks. However, data are needed to inform safe and
effective treatment during pregnancy, and in certain situations, it is
ethically and scientifically appropriate to collect data in pregnant
women in clinical trials conducted during drug development.
    This draft guidance discusses the ethical and scientific issues
when considering the inclusion of pregnant women in clinical trials of
drugs and biological products. This draft guidance is intended to
advance scientific research in pregnant women, and discusses issues
that should be considered within the framework of human subject
protection regulations.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on scientific and
ethical considerations for inclusion of pregnant women in clinical
trials. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07151 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 236 (Monday, December 9, 2019)]
[Rules and Regulations]
[Pages 67191-67196]
[FR Doc No: 2019-26295]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2018-0072; FRL-10002-81-Region 5]

Air Plan Approval; Illinois; Sulfur Dioxide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a
request submitted by the Illinois Environmental Protection Agency
(IEPA) on February 6, 2018, to revise the Illinois State Implementation
Plan (SIP) under the Clean Air Act (CAA) for the 2010 1-hour sulfur
dioxide (SO2) National Ambient Air Quality Standard (NAAQS).
IEPA specifically requested EPA approval to amend the Illinois SIP for
the 2010 1-hour SO2 NAAQS to account for two variances
granted by the Illinois Pollution Control Board (IPCB) to Calpine
Corporation (Calpine) and Exelon Generation, LLC (Exelon). EPA

proposed to approve the state's submittal on June 12, 2019.

DATES: This final rule is effective on January 8, 2020.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2018-0072. All documents in the docket are listed in
the http://www.regulations.gov website. Although listed in the index,
some information is not publicly available, e.g., Confidential Business
Information 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 either through
http://www.regulations.gov, or please contact the person identified in
the For Further Information Contact section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Francisco J. Acevedo, Mobile Source
Program Manager, Control Strategies Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, wherever ``we'',
``us'' or ``our'' is used, we mean EPA.

I. What is being addressed by this document?

    In conjunction with Illinois' adoption of SO2 emission
limits for major sources, the state adopted rule revisions (Sulfur
Content Rule) to limit the sulfur content of distillate and residual
fuel oil combusted at stationary sources throughout the state. See 35
Ill. Adm. Code 214.161(b)(2) and 214.305(a)(2). The Sulfur Content Rule
specifically requires that the sulfur content of distillate fuel oil
combusted on or after January 1, 2017, not exceed 15 parts per million
(ppm). The rule applies to owners and operators of existing fuel
combustion emission and process emission sources that burn liquid fuel.
    Illinois' Sulfur Content Rule, containing 35 Ill. Adm. Code
214.161(b)(2) and 214.305(a)(2), was submitted to EPA as a SIP revision
on March 2, 2016, and EPA issued an approval in the Federal Register on
February 1, 2018 (83 FR 4591) and May 29, 2018 (83 FR 24406).
    On May 18, 2016, pursuant to Section 35(a) of the Illinois
Environmental Protection Act, 415 ILCS 5/34(a), and Part 104 of Title
35 of the Illinois Administrative Code, 35 Ill. Adm. Code 104.100,
Exelon filed a Petition for Variance with the IPCB regarding its Byron
(Ogle County), Clinton (DeWitt County), Dresden (Grundy County), and
LaSalle (LaSalle County) nuclear generation stations. See Exelon
Generation, LLC v. Illinois Environmental Protection Agency, PCB 16-
106. Section 35 of the Illinois Environmental Protection Act provides
that the IPCB, under state law, ``may grant individual variances . . .
whenever it is found, upon presentation of adequate proof, that
compliance with any rule or regulation . . . would impose an arbitrary
or unreasonable hardship.'' (IPCB's granting of such a variance under
state law, however, does not automatically revise what is federally
enforceable under the SIP; only if Illinois submits and EPA approves a
SIP revision reflecting the granting of the variance can the federally
enforceable SIP be revised.) Exelon requested temporary relief from the
15 ppm sulfur content limitation for distillate fuel oil set forth in
35 Ill. Adm. Code 214.161(b)(2). On September 8, 2016, the IPCB granted
the variance subject to a number of conditions.
    On June 16, 2016, Calpine also filed a Petition for Variance with
the IPCB regarding the Zion Energy Center. See Calpine Corporation
(Zion Energy Center) v. Illinois Environmental Protection Agency, PCB
16-112. On August 8, 2016, Calpine filed an Amended Petition for
Variance with the IPCB, requesting temporary relief from the 15 ppm
sulfur content limitation for distillate fuel oil set forth in 35 Ill.
Adm. Code 214.161(b)(2). On November 17, 2016, the IPCB granted the
variance from January 1, 2017, to December 31, 2021, subject to several
conditions. IPCB also granted the motion on August 17, 2017, amending
its order to correct the errors.
    The Petition for Variance sought relief from provisions that were
approved into the Illinois SIP. Those SIP provisions remain in effect
and enforceable unless and until EPA revises the SIP to incorporate the
variances. Thus, following the decision by IEPA to approve the
variances, IEPA submitted them to EPA for approval as SIP revisions.
    On February 6, 2018, IEPA formally submitted a request for EPA
approval to amend the Illinois SIP for the 2010 1-hour SO2
NAAQS to account for two variances granted by the IPCB to Calpine and
Exelon. The submittal included an analysis of the potential impact of
the variances on air quality, specifically with respect to the 2010 1-
hour SO2 NAAQS. This analysis was part of the variance
applications submitted by Calpine and Exelon to the IPCB.
    On June 12, 2019, at 84 FR 27212, EPA proposed to approve IEPA's
request to amend the Illinois SIP to reflect the variances granted by
the IPCB for Calpine and Exelon.

II. What comments did we receive on the proposed SIP revision?

    Our June 12, 2019 proposed rule provided a 30-day comment period.
The comment period closed on July 12, 2019. EPA received comments from
one party during the public comment period. In this section we are
responding to the comments received.
    Comment. The commenter generally states that EPA should not approve
the variances addressed in the proposal. The commenter specifically
notes that the sources' claim that they are economically burdened by
the imposition of the state's rule requiring compliance with sulfur
limits of no greater than 15 ppm is factually incorrect. In addition,
the commenter asserts that the facilities should not be allowed to
dilute the 15 ppm fuel with any remaining high sulfur fuel and that
they should immediately sell any remaining non-compliant fuel and stop
burning diluted fuel with non-compliant sulfur limits.
    Response. As discussed in more detail in the June 12, 2019 proposed
approval, both Exelon and Calpine considered several potential options
to comply with the Sulfur Content Rule as of January 1, 2017. Such
options included combusting all the non-compliant fuel; continuing to
dilute the fuel's sulfur content concentrations with ultra-low sulfur
diesel (ULSD); draining all the storage tanks and refilling them with
ULSD. According to the IPCB, both companies demonstrated that none of
the compliance alternatives evaluated were practicable for meeting the
15 ppm sulfur limit by January 1, 2017 and presented a substantial
hardship to the companies. EPA agrees with IPCB's evaluation that
substantial hardship exists based on review of support documentation
provided to the IPCB and included as part of the SIP revision submitted
to EPA. Exelon's plan for complying with the Sulfur Content Rule by the
end of the variance period outlined by the IPCB calls for continuing to
replenish the lower sulfur tanks with ULSD; and, as part of a
coordinated program, emptying the higher sulfur tanks and refilling
them with ULSD. Under Calpine's compliance plan, the facility would
comply with the Sulfur Content Rule by January 1, 2022 by continuing to
purchase only fuel with sulfur content

below 15 ppm. This ensures that the sulfur content of the fuel used at
the facility will continue to decrease. During the variance period, the
sulfur content of all distillate oil combusted by Calpine must not
exceed 115 ppm sulfur content. EPA believes that both compliance plans
provide enough flexibility to allow Exelon and Calpine to address their
hardship concerns while also requiring full compliance with the Sulfur
Content Rule at the end of the variance period. The commenter did not
submit any specific information for EPA review to substantiate its
claim that the companies' hardship concerns were factually incorrect.
    In addition, while hardship is a prerequisite for state variance
issuance in this case, hardship is not a prerequisite for Federal
approval. The state regulation under which it grants variances is not
part of the SIP. Hardship is a defensible criterion for the state to
use in allocating air quality resources, but it is not a criterion
under the CAA, nor is EPA obliged in this case to judge whether it
would have made the same determination as the state. EPA here needs
only to judge whether the approval of these variances into the SIP
interferes with attainment and reasonable further progress or any other
applicable CAA requirement.
    Comment. The commenter raises concerns that the state did not
perform an appropriate CAA section 110(l) analysis to determine what
effect these units would have on the 2010 1-hour SO2 NAAQS.
Further, the commenter states that EPA should evaluate situations when
all the engines are being used at the same time since they appear to be
emergency units that would likely be turned on at the same time.
    Response. Both Exelon and Calpine submitted an analysis of the
potential impact of their respective variances on air quality,
specifically with regard to the 2010 1-hour SO2 NAAQS. These
analyses were part of the variance applications submitted to the IPCB.
In addition, IEPA and EPA independently evaluated the impact of both
variances and concluded that the facilities would not contribute to
current SO2 nonattainment areas, and that they would not
cause any current attainment area to violate the SO2 NAAQS.
In addition, EPA concluded that the impact of these variances with
regards to section 110(l) do not result in emissions increases above
the levels of emissions that were in place when EPA designated these
counties as attainment/unclassifiable for the 2010 1-hour
SO2 NAAQS, but rather result in deferred emission reductions
during the variance period (unachieved emissions reductions). While
these variances delay the emission reductions provided by the approved
state rule, these reductions are not necessary to achieve attainment in
these areas, since EPA concluded that these areas were attaining the
standard even before the reductions required by Illinois' rule were to
commence. Specifically, as discussed in more detail in the June 12,
2019 proposed approval, EPA designated all of these counties as
attainment/unclassifiable on January 9, 2018, based on monitoring data
from 2014 to 2016 and emissions information that predated the January
1, 2017 compliance date of Illinois' fuel sulfur regulation.
    The information submitted by the state was sufficient to assess
whether the requirements of section 110(l) were met. For the Exelon
variance, the potentially affected geographic areas include portions of
the four counties in which the Exelon facilities are located. Each of
these counties is designated as attainment/unclassifiable for the 2010
1-hour SO2 NAAQS. This includes Ogle County for Byron
Station, LaSalle County for LaSalle Station, Grundy County for Dresden
Station and DeWitt County for Clinton Station. The combined backup
diesel storage capacity for the four Exelon stations which are part of
this variance is 782,668 gallons. Using the maximum capacity of diesel
fuel with a worst case 250 ppm sulfur content would result in 1.7 tons
of combined unachieved emissions reductions during the variance period
(0.443 tons at the Byron station; 0.238 tons at the Clinton station;
0.343 tons at the Dresden station; and 0.342 tons at the LaSalle
station). A calculation of expected unachieved emissions reductions
based on a more realistic projection, which uses a five-year average
annual fuel usage at each station and current sulfur concentrations of
the fuel in the pertinent tanks (based on the highest measure sulfur
content fuel in the largest tanks at the Byron, Clinton, and Dresden
stations and an average at the LaSalle station), would result in
unachieved emissions reductions on a yearly basis during the variance
period totaling less than one-tenth of one ton for all the stations
combined.
    The 2010 1-hour SO2 NAAQS (or standard) is 75 parts per
billion (ppb) based on the ``design value'' (the three-year average of
annual 99th percentile daily maximum 1-hour average concentrations).
IEPA maintains fifteen (15) SO2 air monitors throughout the
state. While these monitors are at a substantial distance from the
sources that were granted variances, none of the monitors closest to
the sources recorded any exceedances of the 75 ppb standard between
2014-2016, the design value timeframe immediately before Illinois
implemented its statewide Sulfur Content Rule requirement. The highest
1-hour design value (2014-2016) for the nearest SO2
monitoring sites to the Exelon sources ranged from 11 ppb to 44 ppb.
Also, as stated above, EPA concluded that the impact of this variance
with regards to section 110(l) does not result in emissions increases
above the levels of emissions that were in place when these counties
were designated as attainment/unclassifiable for the 2010 1-hour
SO2 NAAQS, but rather result in unachieved emission
reductions that are deferred during the variance period.
    For the Calpine variance, the backup distillate oil in the tank at
the Zion Energy Center would allow for approximately 68.6 hours of
turbine operation or approximately 22.8 hours for each of the three
combustion turbines at the facility. Using the remaining distillate oil
with 115 ppm sulfur content would result in actual unachieved emissions
of 0.77 tons of SO2 over the five-year term of the variance,
or 0.15 tons per year. The modeling conducted for this variance to
demonstrate the environmental impact of using distillate oil with 115
ppm sulfur content shows that the air quality in potentially impacted
areas will remain far below the 2010 1-hour SO2 NAAQS, and
the facility will not cause a modeled NAAQS exceedance.
    The nearest SO2 monitoring sites to Calpine did not
record any exceedances in 2013 (IEPA 2013) when Calpine had a permitted
sulfur limit of 480 ppm. The highest 1-hour monitored value in 2013 for
those sites are 14 ppb and 10 ppb (36.7 ug/m\3\ and 26.2 ug/m\3\).
Calpine is also approximately 90 kilometers from the nearest
nonattainment area for the 2010 1-hour SO2 NAAQS, Lemont
(AQS ID 17-031-16010). Based on available air quality modeling results,
Calpine is not contributing to these monitors.
    The commenter is concerned about the possibility that all of the
backup generators being granted variances might operate simultaneously.
Given the distances between the different affected facilities, air
quality near any one of these facilities would not reflect any
detectable impact from any level of operation of pertinent
SO2 sources at any of the other affected facilities. The
more germane question is whether full simultaneous usage of the
variance by the affected units at any one of these facilities would
cause air quality concerns. The available information demonstrates that
these areas are

attaining by sufficient margin and the impact of these variances is
sufficiently small that these variances would not interfere with
attainment or any other CAA requirement.
    Comment. The commenter does not believe the variances should be
approved because the Round 3 SO2 designations did not
account for these units burning non-compliant sulfur fuel. The
commenter believes that if these units were to turn on all at the same
time near a Round 3 or Round 4 SO2 designation source, the
2010 1-hour SO2 NAAQS could be violated. EPA must
affirmatively determine whether this is a possibility and whether the
sources could contribute to a violation of a 2010 1-hour SO2
NAAQS.
    Response. In fact, the Round 3 SO2 designations did
account for these emissions. These designations were based on actual
emissions in these areas. While the variances authorize the affected
sources to defer any decrease in emissions as soon as would otherwise
be required, the designation reflects available evidence indicating
that the areas were attaining the standard even before the emission
reductions from Illinois' low sulfur fuel oil rule took effect in these
areas.
    All the facilities that received these variances from IPCB are
located in separate counties that were designated by EPA as attainment/
unclassifiable for the 2010 1-hour SO2 NAAQS during the
Round 3 SO2 designations process. As part of its evaluation
of the variances, IEPA examined the locations of the affected
facilities in comparison to areas that were investigated and modeled
for future area designation recommendations (Round 2 and Round 3
SO2 designations process), and found that there was no
overlap; IEPA determined, and EPA concurs, that it did not believe that
the facilities associated with these variances would impact potential
future nonattainment areas or change the designation for any of the
counties where the facilities are located. Because of their relatively
low SO2 contribution levels, none of the facilities were
required by EPA's SO2 Data Requirement Rule (DRR) to be
discretely modeled during the Round 3 SO2 designations
process. However, EPA designated the pertinent counties as attainment
unclassifiable on the basis of 2014 to 2016 monitored air quality data
and emissions information, reflecting air quality before the January 1,
2017 compliance date for Illinois' fuel sulfur regulation. The
variances do not change this assessment because their impact does not
result in emissions increases above the levels of emissions that were
in place during the Round 3 designations process, but rather result in
unachieved emission reductions that are deferred during the variance
period. As outlined earlier, the design value for the closest monitors
to the facilities are sufficiently below the 2010 1-hour SO2
NAAQS and even assuming that the combined deferred emissions reduction
of 2.47 tons were to be considered an emission increase and were to
occur at one time, it would not trigger a violation of the 2010 1-hour
SO2 NAAQS. In addition, the impact of these variances is
minimized by the fact the all the facilities are located outside of
each other facility's reasonable modeling domain and would not have the
potential to cause any significant concentration gradients within an
area of analysis.
    Regarding Round 4 SO2 designations, Illinois installed
and began operation of a new monitoring network near a pair of DRR
sources in Macon County by January 1, 2017. Under a court-ordered
designation schedule, EPA is required by December 31, 2020, to
designate this area (Macon County) using three years (2017-2019) of
quality-assured data to be collected from this network. None of the
Exelon and Calpine units that are part of this variance request are in
Macon County or are within the reasonable modeling domain and would not
have the potential to cause any significant concentration gradients
within the area of analysis.
    Comment. The commenter states that even if EPA believes the
variance is appropriate, EPA should instead require the affected
facilities to utilize the non-compliant fuel first using a ``first in,
first out'' method, so that the non-compliant fuel is used up faster,
thereby reducing the time it takes for the facilities to come into
compliance with the state rule and the SIP. The commenter further
states that EPA should require the facilities to use up any non-
compliant fuel first without dilution so that the time in non-
compliance is limited and any violation of the SIP and state law is
limited to a short time period.
    Response. Requiring the affected facilities to utilize non-
compliant fuel using a ``first in, first out'' method is not
practicable in this situation because of the number of tanks that are
affected; the location of these tanks in the facilities; and because of
the legal and contractual restrictions that require both companies to
maintain a specified volume of fuel on hand. In Exelon's case, the
Nuclear Regulatory Commission regulations require that the facilities
store and maintain on-site enough fuel to power the emergency equipment
for up to seven days and ensure nuclear safety. As the fuel is
depleted, Exelon is obligated to replenish the tanks to maintain the
required seven-day supply, which would result in burning compliant
fuel, as well as non-compliant fuel. In addition, Exelon indicates that
the Federally Enforceable State Operating Permits for the facilities
restrict the usage of, and emissions from, the emergency equipment.
Similarly, some of the equipment is subject to Federal New Source
Performance Standards for ``Stationary Compression Ignition Internal
Combustion Engines'' (40 CFR part 60, subpart IIII) and the National
Emission Standards for Hazardous Air Pollutants for ''Stationary
Reciprocating Internal Combustion Engines'' (40 CFR part 63, subpart
ZZZZ), which also restrict the amount of time the emergency equipment
can be operated.
    In Calpine's case, the company is contractually obligated to
maintain 12 hours of backup fuel in case of emergency, so draining the
tanks would violate this obligation and risk public safety. In its
hardship assessment, Calpine argued that it cannot combust all its
distillate oil without violating its Clean Air Act Permit Program
permit that was reissued on October 16, 2014 (ID NO. 097200ABB,
Application No. 99110042). Under its permit, the facility may only
combust distillate oil for limited purposes including when natural gas
is unavailable or for shakedown, evaluation, and testing of the
turbines. Therefore, the facility's permit and economic conditions
prevented burning the entire supply of the distillate oil supply before
January 1, 2017. Additionally, Calpine argues that draining the storage
tanks would impose a substantial hardship. Draining the tanks would
entail purchasing and installing new equipment and revising facility
plans that safeguard fuel spills at a substantial cost. As part of
their variance agreement, both Exelon and Calpine are required to fully
comply with the Sulfur Content Rule and will incur the costs necessary
to achieve compliance. The companies only seek additional time to
comply with the requirements of the Sulfur Content Rule within their
current regulatory and contractual framework.

III. What action is EPA taking?

    EPA is approving the revision to the Illinois SIP submitted by the
IEPA on February 6, 2018, because the variances granted by the IPCB for
Calpine and Exelon meet all applicable requirements and would not
interfere with attainment of the 2010 1-hour SO2 NAAQS.

IV. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the IPCB
Opinion and Orders of the Board described in the amendments to 40 CFR
part 52 set forth below. EPA has made, and will continue to make, these
documents generally available through www.regulations.gov, and/or at
the EPA Region 5 Office (please contact the person identified in the
For Further Information Contact section of this preamble for more
information). Therefore, these materials have been approved by EPA for
inclusion in the SIP, have been incorporated by reference by EPA into
that plan, are fully federally enforceable under sections 110 and 113
of the CAA as of the effective date of the final rulemaking of EPA's
approval, and will be incorporated by reference in the next update to
the SIP compilation.\1\
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    \1\ 62 FR 27968 (May 22, 1997).
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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 CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this 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 2,
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 CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable 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 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).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 7, 2020. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2) of the CAA.)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Sulfur oxides.

    Dated: November 20, 2019.
Cathy Stepp,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
2. In Sec.  52.720 the table in paragraph (d) is amended by adding
entries in alphabetical order for ``Calpine Corporation (Zion Energy
Center)'' and ``Exelon Generation, LLC'' to read as follows:

Sec.  52.720  Identification of plan.

* * * * *
    (d) * * *

                               EPA-Approved Illinois Source-Specific Requirements
----------------------------------------------------------------------------------------------------------------
                                                      State effective
         Name of source           Order/permit  No.         date         EPA approval date         Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Calpine Corporation (Zion Energy         PCB 16-112         12/19/2016  12/09/2019, [insert  As amended on 8/17/
 Center).                                                                Federal Register     2017.
                                                                         citation].

                                                  * * * * * * *
Exelon Generation, LLC..........         PCB 16-106          9/13/2016  12/09/2019, [insert
                                                                         Federal Register
                                                                         citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 2019-26295 Filed 12-6-19; 8:45 am]
 BILLING CODE 6560-50-P