[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4070-4074]
[FR Doc No: 2021-00834]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2020-0005; FRL-10018-41-OW]

Draft National Pollutant Discharge Elimination System (NPDES)
Pesticide General Permit for Point Source Discharges From the
Application of Pesticides; Reissuance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of draft permit and request for public comment.

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SUMMARY: All ten Environmental Protection Agency (EPA) Regions are
proposing for public comment the draft 2021 National Pollutant
Discharge Elimination System (NPDES) pesticide general permit (PGP)--
the draft 2021 PGP. The draft 2021 PGP covers point source discharges
from the application of pesticides to waters of the United States. Once
finalized, the draft 2021 PGP will replace the existing permit, the
2016 PGP, which was issued for a five-year term in the Federal Register
on October 31, 2016, and expires October 31, 2021, at midnight. The
draft 2021 PGP has the same conditions and requirements as the 2016 PGP
and would authorize certain point source discharges from the
application of pesticides to waters of the United States in accordance
with the terms and conditions described therein. EPA proposes to issue
this permit for five (5) years in all areas of the country where EPA is
the NPDES permitting authority. EPA solicits public comment on all
aspects of the draft 2021 PGP. This Federal Register document describes
the draft 2021 PGP in general and seeks comment as described in Section
III.C, of this document. The Fact Sheet accompanying the permit
contains supporting documentation. EPA encourages the public to read
the Fact Sheet to understand the draft 2021 PGP better.

DATES: Comments on the draft 2021 PGP must be received on or before
March 16, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2020-0005, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Instructions: All submissions received must include the Docket ID
No. EPA-HQ-OW-2020-0005. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information, see the ``Public Participation'' heading of the
SUPPLEMENTARY INFORMATION section of this document. Out of an abundance
of caution for members of the public and our staff, EPA Docket Center
and Reading Room are closed to the public with limited exceptions, to
reduce the risk of transmitting COVID-19. Our Docket Center staff will
continue to provide remote customer service via email, phone, and
webform. We encourage the public to submit comments via https://www.regulations.gov or email, as there may be a delay in processing
mail and faxes. Hand deliveries and couriers may be received by
scheduled appointment only. For further information on EPA Docket
Center services and the current status, please visit us online at
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: EPA Regional Office listed in Section
I.D. of this document, or you can send an email to<EMAIL_ADDRESS>You may
also contact Chelsea Durant, EPA Headquarters, Office of Water, Office
of Wastewater Management at tel.:<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>Electronic versions of the draft 2021 PGP and
Fact Sheet are also available on

EPA's NPDES website at https://www.epa.gov/npdes/pesticide-permitting.

SUPPLEMENTARY INFORMATION: This section is organized as follows:

Table of Contents

I. General Information
    A. Does this action apply to me?
    B. Public Participation
    C. Finalizing the Draft 2021 PGP
    D. Who are the EPA regional contacts for this draft permit?
II. Background
III. Scope and Applicability
    A. Geographic Coverage
    B. Categories of Pesticide Use-Patterns Covered
    C. Summary of the Permit and Changes From the 2016 PGP
IV. Cost Impacts of the Draft 2021 PGP
V. Executive Orders 12866 and 13563
VI. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

I. General Information

A. Does this action apply to me?

    You may be affected by this action if you apply pesticides under
the use patterns in Section III.B of this document that result in a
discharge to waters of the United States in one of the geographic areas
identified in Section III.A of this document. Potentially affected
entities, as categorized in the North American Industry Classification
System (NAICS), may include, but are not limited to:

      Table 1--Entities Potentially Regulated by the Draft 2021 PGP
------------------------------------------------------------------------
                                                        Examples of
           Category                   NAICS         potentially affected
                                                          entities
------------------------------------------------------------------------
Agricultural entities--General  111 Crop           Producers of crops
 agricultural interests,         Production.        mainly for food and
 farmers/producers, forestry,                       fiber, including
 and irrigation.                                    farms, orchards,
                                                    groves, greenhouses,
                                                    and nurseries that
                                                    have irrigation
                                                    ditches requiring
                                                    pest control.
                                113110 Timber      The operation of
                                 Tract Operations.  timber tracts for
                                                    the purpose of
                                                    selling standing
                                                    timber.
                                113210 Forest      Growing trees for
                                 Nurseries          reforestation and/or
                                 Gathering of       gathering forest
                                 Forest Products.   products, such as
                                                    gums, barks, balsam
                                                    needles, rhizomes,
                                                    fibers, Spanish
                                                    moss, ginseng, and
                                                    truffles.
                                221310 Water       Operating irrigation
                                 Supply for         systems.
                                 Irrigation.
Pesticide parties (includes     325320 Pesticide   Formulation and
 pesticide manufacturers,        and Other          preparation of
 other pesticide users/          Agricultural       agricultural pest
 interests, and consultants).    Chemical           control chemicals.
                                 Manufacturing..
Public health parties           923120             Government
 (includes mosquito or other     Administration     establishments
 vector control districts and    of Public Health   primarily engaged in
 commercial applicators that     Programs.          the planning,
 service these).                                    administration, and
                                                    coordination of
                                                    public health
                                                    programs and
                                                    services, including
                                                    environmental health
                                                    activities.
Resource management parties     924110             Government
 (includes State departments     Administration     establishments
 of fish and wildlife, State     of Air and Water   primarily engaged in
 departments of pesticide        Resource and       the administration,
 regulation, State               Solid Waste        regulation, and
 environmental agencies, and     Management         enforcement of air
 universities).                  Programs.          and water resource
                                                    programs; the
                                                    administration and
                                                    regulation of water
                                                    and air pollution
                                                    control and
                                                    prevention programs;
                                                    the administration
                                                    and regulation of
                                                    flood control
                                                    programs; the
                                                    administration and
                                                    regulation of
                                                    drainage development
                                                    and water resource
                                                    consumption
                                                    programs; and
                                                    coordination of
                                                    these activities at
                                                    intergovernmental
                                                    levels.
                                924120             Government
                                 Administration     establishments
                                 of Conservation    primarily engaged in
                                 Programs.          the administration,
                                                    regulation,
                                                    supervision and
                                                    control of land use,
                                                    including
                                                    recreational areas;
                                                    conservation and
                                                    preservation of
                                                    natural resources;
                                                    erosion control;
                                                    geological survey
                                                    program
                                                    administration;
                                                    weather forecasting
                                                    program
                                                    administration; and
                                                    the administration
                                                    and protection of
                                                    publicly and
                                                    privately owned
                                                    forest lands.
                                                    Government
                                                    establishments
                                                    responsible for
                                                    planning,
                                                    management,
                                                    regulation and
                                                    conservation of
                                                    game, fish, and
                                                    wildlife
                                                    populations,
                                                    including wildlife
                                                    management areas and
                                                    field stations; and
                                                    other administrative
                                                    matters relating to
                                                    the protection of
                                                    fish, game, and
                                                    wildlife are
                                                    included in this
                                                    industry.
Utility parties (includes       221 Utilities....  Provide electric
 utilities).                                        power, natural gas,
                                                    steam supply, water
                                                    supply, and sewage
                                                    removal through a
                                                    permanent
                                                    infrastructure of
                                                    lines, mains, and
                                                    pipes.
------------------------------------------------------------------------

B. Public Participation

1. Written Comments
    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2020-
0005, at https://www.regulations.gov. Once submitted, comments cannot
be edited or removed from the docket. EPA may publish any comment
received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure 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. 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 additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

    EPA is temporarily suspending its Docket Center and Reading Room
for public visitors, with limited exceptions, to reduce the risk of
transmitting COVID-19. Our Docket Center staff will continue to provide
remote customer service via email, phone, and webform. We encourage the
public to submit comments via https://www.regulations.gov as there may
be a delay in processing mail and faxes. Hand deliveries or couriers
will be received by scheduled appointment only. For further information
and updates on EPA Docket Center services, please visit us online at
https://www.epa.gov/dockets.
    EPA continues to monitor information carefully and continuously
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID-19.
2. Will public hearings be held on this action?
    EPA has not scheduled any public hearings to receive public comment
concerning the draft 2021 PGP. However, interested persons may request
a public hearing concerning the draft 2021 PGP pursuant to 40 CFR
124.12. Requests for a public hearing must be sent or delivered in
writing to the same email address ([email protected]) as provided above for
public comments prior to the close of the comment period. Requests for
a public hearing must state the nature of the issues proposed to be
raised in the hearing. Pursuant to 40 CFR 124.12, EPA shall hold a
public hearing if it finds, on the basis of requests, a significant
degree of public interest in a public hearing on the draft 2021 PGP. If
EPA decides to hold a public hearing, a public notice of the date,
time, and place of the hearing will be made at least 30 days prior to
the hearing. Any person may provide written or oral statements and data
pertaining to the draft 2021 PGP at any such public hearing.
    To facilitate robust opportunities for public participation in the
permitting process during any interruptions caused by COVID-19, EPA
intends to utilize and encourages the use of electronic and telephonic
means of communication to the maximum extent possible under the law.
EPA will issue public notices and solicit comments on permit actions
via on-line tools and/or email. If public hearings are requested, EPA
will seek to conduct those hearings utilizing remote capabilities via
telephone and the internet.

C. Finalizing the Draft 2021 PGP

    EPA intends to issue a final 2021 PGP on or prior to October 31,
2021 (the expiration date of the 2016 PGP). The final 2021 PGP will be
issued after all public comments received during the public comment
period have been considered and any appropriate changes are made to the
draft 2021 PGP. EPA will include its response to significant comments
received in the docket as part of the final permit decision. Once the
final 2021 PGP becomes effective, eligible Operators may seek
authorization under the new PGP as outlined in the permit. To ensure
uninterrupted permit coverage from the 2016 PGP to the 2021 PGP,
Operators who are required to submit a Notice of Intent (NOI) must
submit their NOI for coverage under the new permit prior to discharge
as outlined in the permit (no later than 10 or 30 days before
discharge). See Part 1.2.4 of the draft 2021 PGP.

D. Who are the EPA regional contacts for this draft permit?

    For EPA Region 1, contact George Papadopoulos at tel.: (617) 918-
1579; or email at<EMAIL_ADDRESS>    For EPA Region 2, contact Stephen Venezia at tel.:<PHONE_NUMBER>;
or email at<EMAIL_ADDRESS>    For Puerto Rico, contact Sergio Bosques at tel.:<PHONE_NUMBER> or
<EMAIL_ADDRESS>    For EPA Region 3, contact Carissa Moncavage at tel.: (215) 814-
5798; or email at<EMAIL_ADDRESS>    For EPA Region 4, contact Sam Sampath at tel.:<PHONE_NUMBER>; or
email at<EMAIL_ADDRESS>    For EPA Region 5, contact John Colletti at tel.:<PHONE_NUMBER>; or
email at<EMAIL_ADDRESS>    For EPA Region 6, contact William F. Cooper at tel.:<PHONE_NUMBER>
or email at<EMAIL_ADDRESS>    For EPA Region 7, contact Alex Owutaka at tel.:<PHONE_NUMBER> or
email at<EMAIL_ADDRESS>    For EPA Region 8, contact Amy Clark at tel.:<PHONE_NUMBER> or
email at<EMAIL_ADDRESS>    For EPA Region 9, contact Pascal Mues at tel.:<PHONE_NUMBER> or
email at<EMAIL_ADDRESS>    For EPA Region 10, contact Bilin Basu at tel.:<PHONE_NUMBER> or
email at<EMAIL_ADDRESS>
II. Background

    Section 301(a) of the Clean Water Act (CWA) provides that ``the
discharge of any pollutant by any person shall be unlawful'' unless the
discharge is in compliance with certain other Sections of the Act. 33
U.S.C. 1311(a). The CWA defines ``discharge of a pollutant'' as ``(A)
any addition of any pollutant to navigable waters from any point source
and (B) any addition of any pollutant to the waters of the contiguous
zone or the ocean from any point source other than a vessel or other
floating craft.'' 33 U.S.C. 1362(12). A ``point source'' is any
``discernible, confined and discrete conveyance'' but does not include
``agricultural stormwater discharges and return flows from irrigated
agriculture.'' 33 U.S.C. 1362(14).
    The term ``pollutant'' includes among other things ``garbage . . .
chemical wastes, biological materials . . . and industrial, municipal,
and agricultural waste discharged into water.'' 33 U.S.C. 1362(6).
    A person may discharge a pollutant without violating the Section
301 prohibition by obtaining authorization to discharge (referred to
herein as ``coverage'') under a Section 402 NPDES permit (33 U.S.C.
1342). Under Section 402(a), EPA may ``issue a permit for the discharge
of any pollutant, or combination of pollutants, notwithstanding Section
1311(a)'' upon certain conditions required by the Act.
    EPA issued the first Pesticide General Permit (``2011 PGP'') on
October 31, 2011, in response to the United States Sixth Circuit Court
of Appeals ruling vacating EPA's 2006 Final Rule on Aquatic Pesticides.
National Cotton Council of America. v. EPA, 553 F.3d 927 (6th Cir.
2009). EPA developed the PGP to control point source discharges of
biological pesticides and chemical pesticides that leave a residue into
waters of the United States. The PGP provides coverage for certain
point source discharges of pollutants to waters of the United States in
areas where EPA is the NPDES permitting authority. In 2016, EPA issued
the second PGP (``2016 PGP''). The 2016 PGP will expire at midnight on
October 31, 2021.

III. Scope and Applicability

A. Geographic Coverage

    EPA provides permit coverage for classes of point source discharges
of pollutants that occur in areas where EPA is the NPDES permitting
authority. The geographic coverage of the draft 2021 PGP is listed in
Appendix C of the draft permit.

B. Categories of Pesticide Use-Patterns Covered

    The draft 2021 PGP has the same requirements and conditions as
EPA's 2016 PGP and regulates the same discharges of pollutants to
waters of the United States from the application of (1)

biological pesticides, and (2) chemical pesticides that leave a
residue. The draft 2021 PGP applies to the following same pesticide use
patterns:
     Mosquito and Other Flying Insect Pest Control--to control
public health/nuisance and other flying insect pests that develop or
are present during a portion of their life cycle in or above standing
or flowing water. Public health/nuisance and other flying insect pests
in this use category include mosquitoes and black flies.
     Weed and Algae Pest Control--to control weeds, algae, and
pathogens that are pests in water and at water's edge, including
ditches and/or canals.
     Animal Pest Control--to control animal pests in water and
at water's edge. Animal pests in this use category include fish,
lampreys, insects, mollusks, and pathogens.
     Forest Canopy Pest Control--application of a pesticide to
a forest canopy to control the population of a pest species (e.g.,
insect or pathogen) where, to target the pests effectively, a portion
of the pesticide unavoidably will be applied over and deposited to
water.
    The scope of activities encompassed by these pesticide use patterns
is described in greater detail in Part III.1.1 of the Fact Sheet for
the draft 2021 PGP.

C. Summary of the Permit and Changes From the 2016 PGP

    Once issued, the final 2021 PGP will replace the 2016 PGP, which
was issued for a five-year term in the Federal Register on October 31,
2016 (81 FR 75816), and expires October 31, 2021, at midnight. The
draft 2021 PGP is similar to the 2016 PGP, and is structured in the
same nine parts: (1) Coverage under This Permit, (2) Technology-Based
Effluent Limitations, (3) Water Quality-Based Effluent Limitations, (4)
Monitoring, (5) Pesticide Discharge Management Plan, (6) Corrective
Action, (7) Recordkeeping and Annual Reporting, (8) EPA Contact
Information and Mailing Addresses, and (9) Permit Conditions Applicable
to Specific States (including Territories) and Indian Country.
Additionally, as with the 2016 PGP, the draft 2021 PGP includes nine
appendices with additional conditions and guidance for permittees: (A)
Definitions, Abbreviations, and Acronyms, (B) Standard Permit
Conditions, (C) Areas Covered, (D) Notice of Intent (NOI) form, (E)
Notice of Termination (NOT) form, (F) Pesticide Discharge Evaluation
Worksheet (PDEW), (G) Annual Reporting Template, (H) Adverse Incident
Report Template, and (I) Endangered Species Procedures.
    The following is a summary of the draft 2021 PGP's proposed
requirements:
     The PGP defines ``Operator'' (i.e., the entity required to
obtain NPDES permit coverage for discharges) to include any (a)
Applicator who performs the application of pesticides or has day-to-day
control of the application of pesticides that results in a discharge to
waters of the United States, or (b) Decision-maker who controls any
decision to apply pesticides that results in a discharge to waters of
the United States. There may be instances when a single entity acts as
both an Applicator and a Decision-maker.
     All Applicators are required to minimize pesticide
discharges by using only the amount of pesticide and frequency of
pesticide application necessary to control the target pest, maintain
pesticide application equipment in proper operating condition, control
discharges as necessary to meet applicable water quality standards, and
monitor for and report any adverse incidents.
     All Decision-makers are required, to the extent not
determined by the Applicator, to minimize pesticide discharges by using
only the amount of pesticide and frequency of pesticide application
necessary to control the target pest. All Decision-makers are also
required to control discharges as necessary to meet applicable water
quality standards and monitor for and report any adverse incidents.
     Certain Decision-makers [i.e., any agency for which pest
management for land resource stewardship is an integral part of the
organization's operations, entities with a specific responsibility to
control pests (e.g., mosquito and weed control districts), local
governments or other entities that apply pesticides in excess of
specified annual treatment area thresholds, and entities that discharge
pesticides to Tier 3 waters (Outstanding National Resource Waters, 40
CFR 131.12(a)(3)) or to waters of the United States containing National
Marine Fisheries Service (NMFS) Listed Resources of Concern] are
required also to submit an NOI to obtain authorization to discharge and
to implement pest management options to reduce the discharge of
pesticides to waters of the United States. Within this group, certain
large Decision-makers (any (1) public entity that serves a population
greater than 10,000 or (2) private enterprise that exceeds the Small
Business Administration size standard as identified in 13 CFR 121.201)
must also develop a Pesticide Discharge Management Plan (PDMP), submit
annual reports, and maintain detailed records. Certain small Decision-
makers (any (1) public entity that serves a population of 10,000 or
less or (2) private enterprise that does not exceed the Small Business
Administration size standard as identified in 13 CFR 121.201) are
required to complete a pesticide discharge evaluation worksheet for
each pesticide application (in lieu of the more comprehensive PDMP), an
annual report, and detailed recordkeeping.
     Deadlines for submittal of a Notice of Intent to be
covered, if required, are provided in Part 1.2.3, Table 1-2, of the
draft 2021 PGP.
    EPA encourages the public to review and comment on all aspects and
provisions in the draft 2021 PGP. The draft 2021 PGP is similar to the
2016 PGP but includes minor changes which are listed below. See the
Fact Sheet accompanying the draft 2021 PGP for further discussion.
    (1) Removes the out of date NOI provision that provided automatic
coverage for all Operators until January 12, 2017.
    (2) Replaces the requirement to use EPA's eNOI system with EPA's
NPDES eReporting Tool (NeT) when preparing and submitting NOIs, NOTs,
and annual reports.
    (3) Updates Appendix A, Definitions, Abbreviations, and Acronyms to
include the terms ``Pesticide discharges to waters of the United States
from pesticide application'' and ``pesticide residue,'' as defined in
40 CFR 122.2.
    (4) Modifies Appendix B, Standard Permit Conditions, to ensure
consistency with 40 CFR 122.41.
    (5) Updates Appendix C, Areas Covered, to add Indian Country within
Virginia and Indian Country within Indiana, and to remove the State of
Idaho.

IV. Cost Impacts of the Draft 2021 PGP

    Based on the cost analyses performed for the 2011 PGP and 2016 PGP,
EPA expects the costs that covered entities, including small
businesses, will bear to comply with this permit will be minimal. Since
the draft 2021 PGP is similar to the 2016 PGP, EPA projects that the
draft 2021 PGP will have no incremental cost impacts on regulated
entities. Copies of EPA's cost impact analyses for the 2011 PGP and
2016 PGP are available in the docket for this permit. See the Fact
Sheet accompanying this draft permit for further discussion.

V. Executive Orders 12866 and 13563

    The draft 2021 PGP is not a significant regulatory action and was
therefore not

submitted to the Office of Management and Budget (OMB) for review.

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

    This action does not have tribal implications as specified in E.O.
13175. It will neither impose substantial direct compliance costs on
federally recognized tribal governments, nor preempt tribal law. EPA
directly implements the NPDES Program, including the 2021 PGP when it
is finalized, in Indian Country; therefore, in compliance with EPA
Policy on Consultation and Coordination with Indian Tribes, EPA
consulted with tribal officials early in the process to permit tribes
to have meaningful and timely input into the renewal of the PGP. To
gain an understanding of, and where necessary, to address tribal
implications of the draft 2021 PGP, EPA conducted the following
activities:
     May 8, 2020--EPA emailed notification letters to tribal
leaders initiating consultation and coordination on the renewal of the
PGP. The initiation letter was also posted on EPA's Tribal Consultation
Opportunities Tracking System (TCOTS) at https://tcots.epa.gov/.
     June 9, 2020--EPA held an informational webinar open to
all tribal representatives and reserved the last part of the webinar
for official consultation comments. Fourteen tribal representatives
participated in the webinar. No official comments were received during
the webinar. The presentation was posted on the tribal portal website
at http://tcots.epa.gov.
    EPA received no comments from tribes and tribal organizations
during the formal consultation period. Records of the tribal
informational webinar and a consultation summary are included in the
docket for this proposed action (Docket ID No. EPA-HQ-OW-2020-0005).

    Authority: Clean Water Act, 33 U.S.C. 1251 et seq.

    Dated: December 14, 2020.
Dennis Deziel,
Regional Administrator, EPA Region 1.

    Dated: December 14, 2020.
Javier Laureano,
Director, Water Division, EPA Region 2.

    Dated: December 14, 2020.
Carmen R. Guerrero-P[eacute]rez,
Director, Caribbean Environmental Protection Division, EPA Region 2
Caribbean Office.

    Dated: December 14, 2020.
Catherine A. Libertz,
Director, Water Division, EPA Region 3.

    Dated: December 14, 2020.
Jeaneanne M. Gettle,
Director, Water Division, EPA Region 4.

    Dated: December 14, 2020.
Tera L. Fong,
Director, Water Division, EPA Region 5.

    Dated: December 14, 2020.
Charles W. Maguire,
Director, Water Division, EPA Region 6.

    Dated: December 14, 2020.
Jeffery Robichaud,
Director, Water Division, EPA Region 7.

    Dated: December 14, 2020.
Judy Bloom,
Manager, Clean Water Branch, EPA Region 8.

    Dated: December 14, 2020.
Tom[aacute]s Torres,
Director, Water Division, EPA Region 9.

    Dated: December 14, 2020.
Daniel D. Opalski,
Director, Water Division, EPA Region 10.
[FR Doc. 2021-00834 Filed 1-14-21; 8:45 am]
BILLING CODE 6560-50-P


                 United States Environmental Protection Agency
                              Statement of Basis
                             Air Pollution Control
                     Part 71 Title V Permit to Operate for
                     Little Canyon Unit Compressor Station
                        Permit No. V-UO-000016-2022.00

The purpose of this document is to set forth the legal and factual basis for permit conditions, including references to applicable provisions of the Clean Air Act (CAA or Act) and implementing regulations of the CAA title V operating permit program at 40 C.F.R. part 71 (Part 71). This document also gives the derivation of conditions as required by 40 C.F.R. § 71.11(b).

EPA Authority to Issue Part 71 Permits

All major stationary sources of air pollution and certain other sources are required to apply for title V operating permits that include emission limitations and other conditions as necessary to assure compliance with applicable requirements of the CAA, including the requirements of the applicable State Implementation Plan (SIP). CAA §§ 502(a) and 504(a). The title V operating permit program does not generally impose new substantive air quality control requirements (referred to as "applicable requirements"), but does require permits to contain monitoring, recordkeeping, reporting and other requirements to assure source' compliance with applicable requirements. 57 FR 32250, 32251 (July 21, 1992). One purpose of the title V operating permit program is to "enable the source, States, EPA, and the public to understand better the requirements to which the source is subject, and whether the source is meeting those requirements." 57 FR 32251. Thus, the title V operating permit program is a vehicle for ensuring that air quality control requirements are appropriately applied to the source emission units and for assuring compliance with such requirements.

Part 71 programs for Indian country - The Administrator will implement and enforce an operating permits program in Indian country, as defined in § 71.2, when an operating permits program which meets the requirements of part 70 of this chapter has not been explicitly granted full or interim approval by the Administrator for Indian country.

Facility Information and Description

Applicant and Stationary Source Information

Table 1: Applicant Information
Owner/Operator
Facility (SIC Code: 1311)
Utah Gas Corporation
133 E 1000N
Roosevelt, Utah  84066
Little Canyon Unit Compressor Station: Latitude 39.896944N, Longitude 109.605556W
LCU 2-6GX Wellsite: Latitude 39.8948N, Longitude 109.6069W

Table 2: Stationary Source Information
Responsible Official(s)
Facility Contact
(1) Russ Knight, President
(2) April Mestas, Regulatory Manager

Utah Gas Corporation
760 Horizon Drive, Suite 400
Grand Junction, Colorado  81506
(970) 260-1864
Ken Secrest
Regulatory Coordinator
Utah Gas Corporation
133 E 1000N
Roosevelt, Utah  84066
(970) 675-4440 Ext. 7947

Facility Description
Utah Gas Corporation (UGC) Little Canyon Unit is a natural gas compressor station. Natural gas produced from area wells is sent to the compressor station through gathering flowlines. Once the gas enters the station, it flows through a two-phase separator to reduce water and condensable liquids content in the gas stream prior to entry into the compressor. The liquids produced from the on-site separator are then sent to two 400-barrel condensate tanks operating at atmospheric pressure for storage prior to being hauled offsite by truck. Following the inlet separator, the gas is compressed with a natural gas-fired internal combustion engine driven compressor to higher pressure of approximately 700 psig. The high-pressure gas leaving the compressor then passes into a triethylene glycol (TEG) natural gas dehydration system. The TEG natural gas dehydration system consists of a 25 MMscfd capacity process still vent, a 0.50 MMBtu/hr natural gas-fired process heater and a TEG regenerator. The natural gas dehydration system uses a Benzene, Toluene, Ethylbenzene, and Xylenes (BTEX) system that captures BTEX vapors from the still vent and sends the vapors to a thermal oxidizer for destruction.
Following dehydration, the dry natural gas stream leaves the station via a metered sales pipeline. The station has on-site electrical power supplied by a Capstone natural gas-fired microturbine-driven generator (insignificant emission unit). In addition, the station operates air-assisted pneumatic control devices with air supplied by the on-site electric-driven air compressor.
In addition, a natural gas wellsite (LCU 2-6GX) is located approximately 1,000 feet from Little Canyon Unit. Natural gas produced from the LCU 2-6GX wellsite flows into the common, Little Canyon Unit area gas gathering system. The LCU 2-6GX wellsite consists of a small (< 1 MMscfd) natural gas dehydration system with a 0.25 MMBtu/hr natural gas-fired process heater, one 300-barrel condensate storage tank with a 0.25 MMBtu/hr natural gas-fired process heater, one 400-barrel condensate storage tank with one (1) 0.50 MMBtu/hr process heater, truck loading operations and one 18 hp natural gas-fired pump engine.

Title V Major Source Status
The Part 71 Permit Program applies to major sources, as defined in 40 C.F.R. § 71.2. The title V major source thresholds, as determined by pollutant-specific PTE, for criteria pollutants are 100 tons per year (tpy) and for HAP are 10 tons/year for a single HAP or 25 tons/year for any combination of HAP.
According to the information provided by UGC in their Part 71 renewal application, uncontrolled emissions from dehydration unit, LCD-1, exceed the major source thresholds for HAP (55.74 tpy for benzene and 51.71 tpy for toluene). Therefore, the source is a title V source, per 40 C.F.R. § 71.3(a)(3). This facility has federally enforceable requirements under 40 C.F.R. part 63, subpart HH (maximum achievable control technology (MACT) HH) that limit the PTE of LCD-1.
Source Determination
At 40 C.F.R. § 71.2, a major source is generally defined as any stationary source (or any group of stationary sources that are located on one or more contiguous or adjacent properties and are under common control of the same person (or persons under common control)), belonging to a single major industrial grouping and that are a major source as described in the definition. On June 3, 2016, the EPA published a final rule clarifying when oil and natural gas sector equipment and activities must be deemed a single source when determining whether major source permitting programs prevention of significant deterioration (PSD) and New Source Review preconstruction permit programs, and the Part 71 permit program) apply (81 FR 35622). By clarifying the term "adjacent," the rule specifies that equipment and activities in the oil and natural gas sector that are under common control will be considered part of the same source if they are located on the same surface site or on individual surface sites that share equipment and are within (1/4) mile of each other.
According to information provided by UGC in their Part 71 renewal application, the LCU 2-6GX wellsite and Little Canyon Unit are located within a quarter mile of each other and share equipment. Therefore, the EPA has determined that the LCU 2-6GX wellsite is adjacent to Little Canyon Unit and thus part of the same stationary source.
Area Classification - Local Air Quality and Attainment Status
Little Canyon Unit is located within the exterior boundaries of Uintah and Ouray (U&O) Indian Reservation and within an area designated as Marginal nonattainment for the 2015 ozone National Ambient Air Quality Standard (NAAQS) of 70 parts per billion. The exact location for this source is Latitude 39.896944N, Longitude 109.605556W, in Uintah County, Utah.
Tribal Reservation Contact
Mike Natchees
Air Quality Program Director
Ute Indian Tribe
P.O. Box 70
Fort Duchesne, Utah  84026
(435) 725-4974 or<EMAIL_ADDRESS>
Identification of Emission Generating Activities
The Part 71 Permit Program allows the Permittee to separately list in the permit application units or activities that qualify as "insignificant" based on potential emissions below 2 tpy for all regulated pollutants that are not listed as HAP under section 112(b) and below 1,000 lbs/year or the de minimis level established under section 112(g), whichever is lower, for HAP. However, the application may not omit information needed to determine the applicability of or to impose, any applicable requirement. Units and activities that qualify as "insignificant" for the purposes of the Part 71 application are in no way exempt from applicable requirements or any requirements of the Part 71 permit. Tables 3 and 4 list emission units and emission generating activities, including any air pollution control devices.

Table 3: Emission Units and Emission Generating Activities
                               Emissions Unit ID
                                  Description
                               Control Equipment

LCC-4
Caterpillar 3516LE; 1,340 hp
4-Stroke Lean-Burn Reciprocating Internal Combustion Engine Natural Gas-Fired

Serial No. 4EK04146	Installed: 9/13/2022 Mfd: 8/25/2004

Oxidation Catalyst

LCU 2- 6GX PU
 Arrow C-96; 18 hp
4-Stroke Rich-Burn Internal Combustion Pumping Engine Natural Gas-Fired (LCU 2-6GX Wellsite)

Serial No. 210024-C	Installed: Pre-June 2006 Mfd: 12/13/2003

None
LCTO-1
 36" Thermal Oxidizer with TJ0200HV Burner
 Serial No. 28187 	Installed: 4/2/2009

None

LCD-1
25 MMscfd TEG Dehydration Unit

Serial No. Unknown	Installed: 12/9/2005

Thermal Oxidizer (LCTO-1)
LCU 2- 6GX D-1
0.2 MMscfd TEG Dehydration Unit (LCU 2-6GX Wellsite)

Serial No. Unknown	Installed: 2000

None

LCT-1
LCT-2
400 bbl Condensate Storage Tanks

Serial #: 8801801-3	Installed: 9/15/2005
Serial #: 8J01801-4	Installed: 9/15/2005

None
T-1
T-2
One 400 bbl and One 300 bbl Condensate Storage Tank (LCU 2-6GX Wellsite)

None
L-1
Condensate Loadout
None
ENGINEBD
Compressor Blowdowns
None
LCF-1
Fugitive Emissions
None
LCF-2
Fugitive Emissions (LCU 2-6GX Wellsite)
None

Table 4: Insignificant Emission Units[*]
                                  Description
            Capstone 65 kW Microturbine Genset (Little Canyon Unit)
                Pig Launcher and Receiver (Little Canyon Unit)
       0.50 MMBtu/hr TEG Dehydration Unit Reboiler (Little Canyon Unit)
               0.50 MMBtu/hr Tank Heater #1 (Little Canyon Unit)
               0.50 MMBtu/hr Tank Heater #2 (Little Canyon Unit)
     0.25 MMBtu/hr natural gas-fired separator heater (Little Canyon Unit)
         2.0 MMBtu/hr heater for Thermal Oxidizer (Little Canyon Unit)
                 Condensate Truck Loading (LCU 2-6GX Wellsite)
              Compressor Blowdown Emissions (Little Canyon Unit)
                0.50 MMBtu/hr Tank Heater (LCU 2-6GX Wellsite)
                0.25 MMBtu/hr Tank Heater (LCU 2-6GX Wellsite)
    0.25 MMBtu/hr TEG Dehydration Unit Reboiler Heater (LCU 2-6GX Wellsite)
              0.50 MMBtu/hr Separator Heater (LCU 2-6GX Wellsite)
*Insignificant emission units can change at the facility as long as the new or replacement units meet the criteria for
insignificance, and Utah Gas Corporation supplies information as required under 40 C.F.R. part 71 and this permit. The insignificant emission unit status does not exempt these emission units from the requirements of any NSPS and MACT standards that may apply.

Permitting, Construction and Compliance History

Little Canyon Unit Compressor Station, owned by UGC, was initially permitted on August 31, 2017, and operates under the Part 71 Operating Permit V-UO-000016-2006.00. The permit expired on August 31, 2022. A timely Part 71 renewal application was received by the EPA on February 7, 2022, and was deemed complete on April 7, 2022.

Emission Inventory

Pursuant to 40 C.F.R. § 52.21, PTE is defined as the maximum capacity of a stationary source to emit a pollutant under its physical and operational design. Any physical or operational limitation on the capacity of the source to emit a pollutant, including air pollution control equipment and restrictions on hours of operation or on the type or amount of material combusted, stored, or processed, shall be treated as part of its design if the limitation, or the effect it would have on emissions, is federally enforceable. Independently enforceable applicable requirements are considered enforceable to the extent that the source is in compliance with the standard. In addition, beneficial reductions in non-targeted pollutants resulting from compliance with an independently enforceable applicable requirement may be counted towards PTE provided the emission reduction of the non-targeted pollutant is enforceable as a practical matter and compliance is being met. See the 1995 guidance memo signed by John Seitz, Director of the Office of Air Quality Planning and Standards titled, "Options for Limiting Potential to Emit of a Stationary Source under Section 112 and Title V of the Clean Air Act."

UGC reported the controlled emission unit-specific PTE in their Part 71 renewal permit application. The controlled emissions in Table 5 are based on the legally and practicably enforceable requirements set forth in this draft permit.

Table 5: Potential-to-Emit with Legally and Practicably Enforceable Controls
                         Regulated Air Pollutants (tpy)

                                    Unit I.D.

                                      NOX

                                      CO

                                      VOC

                                       PM

                                      SO2

                                      CH2O
                                   Total HAPs
                                      LCC-4
                                     19.39
                                     33.10
                                      7.82
                                      0.50
                                       -
                                      3.57
                                       4.40
                                    LCU 2- 6GX
                                       PU

                                      2.06

                                     0.88

                                      0.05

                                      0.02

                                    <0.01

                                      0.02

                                       0.03
                                      LCTO-1
                                     4.35
                                     3.66
                                     0.05
                                     0.33
                                       -
                                       -
                                       -
                                      LCD-1
                                       -
                                        -
                                     10.12
                                       -
                                       -
                                       -
                                       5.58
                                     LCU 2-
                                     6GX D-1
                                       -
                                        -
                                      4.07
                                       -
                                       -
                                       -
                                       2.13
                                      LCT-1
                                      LCT-2
                                       -
                                        -
                                      4.78
                                       -
                                       -
                                       -
                                       0.43
                                       T-1
                                       T-2
                                       -
                                        -
                                      3.03
                                       -
                                       -
                                       -
                                       0.14
                                       L-1
                                       -
                                        -
                                      2.02
                                       -
                                       -
                                       -
                                       0.18
                                    ENGINEBD
                                       -
                                        -
                                      4.00
                                       -
                                       -
                                       -
                                       0.15
                                        LCF-1
                                       -
                                        -
                                      6.88
                                       -
                                       -
                                       -
                                       0.84
                                     LCF-2
                                       -
                                        -
                                      2.88
                                       -
                                       -
                                       -
                                       0.16
                                     IEUs[*]
                                      2.39
                                     3.60
                                      1.04
                                      0.20
                                      0.02
                                      0.04
                                       0.13
                                      TOTAL
                                     28.19
                                     41.24
                                     46.74
                                      1.05
                                      0.03
                                      3.63
                                      14.17

Regulatory Analysis

The discussions in the following sections are based on the information provided by UGC in their Part 71 renewal application, certified to be true and accurate by the Responsible Official of this facility.
PSD, 40 C.F.R. Part 52.21
The Prevention of Significant Deterioration Permit Program at 40 C.F.R. part 52 is a preconstruction review requirement of the CAA that applies to proposed projects that are sufficiently large (in terms of emissions) to be a "major" stationary source or "major" modification of an existing stationary source. Source size is defined in terms of "potential to emit," which is its capability at maximum design capacity to emit a pollutant, except as constrained by existing legally and practically enforceable conditions applicable to the source. A new stationary source or a modification to an existing minor stationary source is major if the proposed project has the PTE of any pollutant regulated under 40 C.F.R. part 52 in amounts equal to or exceeding specified major source thresholds, which are 100 tpy for 28 listed industrial source categories and 250 tpy for all other sources. PSD also applies to modifications at existing major sources that cause a "significant net emissions increase" at that source. Significance levels for each pollutant are defined in the PSD regulations at 40 C.F.R. § 52.21.
According to the information provided by UGC in their Part 71 renewal application, at the time of its construction, Little Canyon Unit was not a major source of emissions with respect to the PSD Permit Program as the PTE did not exceed the major source thresholds of any criteria pollutants regulated under PSD Permit Program. As such, the source was not subject to preconstruction permitting requirements of the PSD Permit Program.
NSR, 40 C.F.R. Part 49
40 C.F.R. § 49.166 - Federal Major New Source Review Program for Nonattainment Areas in Indian Country:
The Federal Major NSR Program for Nonattainment (NA) Areas in Indian Country (NNSR Permit Program) at 40 C.F.R. part 49 is a preconstruction review requirement of the CAA that applies to proposed projects that are sufficiently large (in terms of emissions) to be a "major" stationary source or "major modification" of an existing stationary source in an area that the EPA has designated nonattainment for a NAAQS (See 40 C.F.R. § 49.167). Similar to the PSD Permit Program, source size is defined in terms of PTE, but a new stationary source or a modification to an existing stationary source is major if the proposed project has the PTE for any pollutant regulated under the 40 C.F.R. part 49 requirements in amounts equal to or exceeding specified major source thresholds defined in 40 C.F.R. part 51, appendix S.
On April 30, 2018, the EPA designated portions of the Indian country lands within the U&O Reservation as marginal nonattainment for the 2015 ozone NAAQS effective on August 3, 2018. Little Canyon Unit is located within that Marginal ozone nonattainment area. Appendix S lists the marginal ozone nonattainment major source threshold for VOC or NOX emissions as 100 tpy. As explained previously, Little Canyon Unit was not considered a major source with respect to the PSD Permit Program at the time of construction and is also not a major source with respect to the NNSR Permit Program, as the PTE of VOC and NOX, precursor pollutants to ozone, are both below 100 tpy with respect to the Marginal ozone nonattainment area within which Little Canyon Unit is located.
40 C.F.R. § 49.151 - Federal Minor New Source Review Program in Indian Country:
The Federal Minor New Source Review (MNSR) Permit Program at 40 CFR part 49, subpart C (§§49.151 through 49.165), is a preconstruction review requirement of the CAA that applies to all new and modified minor sources, synthetic minor sources and minor modifications at major sources, located in Indian country where no EPA-approved program is in place. True minor sources and modifications and minor modifications at existing major sources are proposed projects that have PTE for any pollutant regulated under the MNSR Permit Program that are below the major source thresholds in the PSD Permit Program or the NNSR Permit Program at 40 CFR part 49, subpart C, and above the minor source thresholds in Table 1 of 40 CFR § 49.153 (thresholds differ depending on the pollutant). The MNSR Permit Program also provides the EPA authority to establish enforceable restrictions for an otherwise major source to establish that source as a synthetic minor source for NSR-regulated pollutants or HAP for the purposes of the PSD, NNSR or title V Permit Programs, or for the purposes of major source requirements of the NESHAP at 40 CFR part 63. Additionally, the MNSR Permit Program established a Federal Implementation Plan (FIP) (§§ 49.101 through 49.105) for true minor sources in the oil and natural gas production and natural gas processing segments that are in Indian country.
Little Canyon Unit is currently a true minor source and was originally constructed and commenced operations before August 30, 2011. As such, Little Canyon Unit was registered as an existing true minor source per 40 C.F.R. § 49.160 (registration number: REG-UO-000016-2013.001). No other pre-construction requirements applied to Little Canyon Unit under the MNSR Permit Program.
NSPS, 40 C.F.R. Part 60
40 C.F.R. Part 60, Subpart A: This subpart applies to the owner or operator of any stationary source which contains an affected facility, the construction or modification of which is commenced after the date of publication of any standard in 40 C.F.R. part 60 (Part 60). The general provisions under subpart A apply to sources that are subject to the specific subparts of Part 60.

As explained below, Little Canyon Unit is not subject to any specific subparts of Part 60; therefore, the General Provisions of Part 60 do not apply.

40 C.F.R. Part 60, Subpart GG: This rule applies to stationary gas turbines, with a heat input at peak load equal to or greater than 10.7 gigajoules per hour (10 MMBtu/hr), that commenced construction, modification or reconstruction after October 3, 1977.

Based on the information provided by UGC in their Part 71 renewal application, the stationary gas turbine located at Little Canyon Unit has a maximum heat input less than 10.7 gigajoules per hour; therefore, this rule does not apply. The maximum heat input for the Capstone Microturbine at the facility is 0.2 MMBtu/hr.

40 C.F.R. Part 60, Subpart Kb: This subpart establishes requirements for controlling VOC emissions from storage vessels with a capacity greater than or equal to 75 cubic meters (471.74 bbls) that are used to store volatile organic liquids for which construction, reconstruction or modification commenced after July 23, 1984.

Based on the information provided by UGC in their Part 71 renewal application, the condensate tanks (LCT-1, LCT-2, LCU 2-6GX Tank 1, and LCU 2-6GX Tank 2) at Little Canyon Unit and LCU 2-6GX wellsite are exempt from these requirements because they have a capacity of less than 471.74 bbls.

40 C.F.R. Part 60, Subpart KKK: This subpart establishes requirements for controlling fugitive VOC emissions from onshore natural gas processing plants. It applies to natural gas processing plants that commenced construction, reconstruction, or modification after January 20, 1984, and on or before August 23, 2011.

Based on the information provided by UGC in their Part 71 renewal application, Little Canyon Unit is not a natural gas processing plant, therefore the facility is not subject to this subpart.

40 C.F.R. Part 60, Subpart LLL: This subpart applies to sweetening units and sulfur recovery units at onshore natural gas processing facilities. As defined in this subpart, sweetening units are process devices that separate hydrogen sulfide (H2S) and CO2 from a sour natural gas stream. Sulfur recovery units are defined as process devices that recover sulfur from the acid gas (consisting of H2S and CO2) removed by a sweetening unit.

Based on the information provided by UGC in their Part 71 renewal application, neither sweetening nor sulfur recovery are performed at the facility. Therefore, Little Canyon Unit is not subject to this subpart.

40 C.F.R. Part 60, Subpart JJJJ: This subpart establishes emission standards and compliance requirements for the control of emissions from stationary spark ignition internal combustion engines that commenced construction, modification, or reconstruction after June 12, 2006, and are manufactured on or after specified manufacture trigger dates. The manufacture trigger dates are based on the engine type, fuel used and maximum engine horsepower.

Based on the information provided by UGC in their Part 71 application, the engines operating at the facility were manufactured prior to the manufacture trigger dates in the rule (January 1, 2008 for engines LCU-3 and LCU-4, and July 1, 2008 for the Arrow C-96 pump engine). Therefore, this subpart does not apply.

40 C.F.R. Part 60, Subpart KKKK: The rule applies to stationary combustion turbines with a heat input at peak load equal to or greater than 10.7 gigajoules (10 MMBtu) per hour.

Based on the information provided by UGC in their Part 71 renewal application, the stationary gas turbine located at Little Canyon has a maximum heat input less than 10.7 gigajoules per hour; therefore, this rule does not apply. The maximum heat input for the Capstone Microturbine at the facility is 0.2 MMBtu/hr.

40 C.F.R. Part 60, Subpart OOOO: This subpart establishes emission standards for the control of VOC and SO2 emissions from affected facilities that commence construction, modification, or reconstruction after August 23, 2011, and on or before September 18, 2015. Affected facilities include, but are not limited to well completions, centrifugal compressors, reciprocating compressors, pneumatic controllers, storage vessels and sweetening units.

Based on the information provided by UGC in their Part 71 renewal application, the current equipment at Little Canyon Unit and LCU 2-6GX wellsite that are affected facilities predate the applicability date for this subpart. Therefore, Little Canyon Unit and LCU 2-6GX wellsite are not subject to this subpart.

40 C.F.R. part 60, Subpart OOOOa: This subpart establishes emission standards for the control of VOC and SO2 emissions from affected facilities that commence construction, modification or reconstruction after September 18, 2015. Affected facilities include, but are not limited to well completions, centrifugal compressors, reciprocating compressors, pneumatic controllers, storage vessels and sweetening units.

Based on the information provided by UGC in their Part 71 renewal application, the current equipment at Little Canyon Unit and LCU 2-6GX wellsite that are affected facilities predate the applicability date for this subpart. Therefore, Little Canyon Unit and LCU 2-6GX wellsite are not subject to this subpart.

NESHAP, 40 C.F.R. Part 63
40 C.F.R. Part 63, Subpart A: The requirements of 40 C.F.R. part 63, subpart A apply to sources that are subject to the specific subparts of 40 C.F.R. part 63.
As explained below, Little Canyon Unit and LCU 2-6GX wellsite are subject to 40 C.F.R. part 63, subpart HH, National Emission Standards for Hazardous Air Pollutants from Oil and Natural Gas Production Facilities and subpart ZZZZ, National Emission Standards for Hazardous Air Pollutants for Stationary Reciprocating Internal Combustion Engines; therefore, the General Provisions of 40 C.F.R. part 63 apply.
40 C.F.R. Part 63, Subpart HH: This subpart establishes emission standards for the control of HAP emissions from affected units located at natural gas production facilities that process, upgrade or store natural gas prior to the point of custody transfer, or that process, upgrade or store natural gas prior to the point at which natural gas enters the natural gas transmission and storage source category or is delivered to a final end user. The affected units are glycol dehydration units, storage vessels with the potential for flash emissions (as defined in the rule) and the group of ancillary equipment and compressors intended to operate in volatile HAP service which are located at natural gas processing plants.
Based on the information provided by UGC in their Part 71 renewal application, Little Canyon Unit and LCU 2-6GX wellsite do not operate any storage vessels with the potential for flash emissions (as defined in the rule). Uncontrolled emissions from dehydration unit LCD-1 exceed the major source thresholds for HAP (55.74 tpy for benzene and 51.71 tpy for toluene). Therefore, dehydration unit LCD-1 is subject to the major source requirements of this subpart.
As defined in § 63.761, emissions from any oil and gas exploration or production well, and emissions from any pipeline compressor station shall not be aggregated with emissions from other similar units to determine whether such emission points are major sources. Therefore, the LCU 2-6GX wellsite is an area source under the rule and dehydration unit LCU 2-6GX D-1 is subject to the area source requirements of the rule. However, dehydration unit LCU 2-6GX D-1 meets the exemption criteria in § 63.764(e) because according to the information provided by UGC in their Part 71 renewal application the actual annual average flowrate of natural gas to the dehydration unit is less than 85 thousand standard cubic meters per day. UGC is subject to the recordkeeping requirements for the exemption criteria at § 63.774(d)(1).
40 C.F.R. Part 63, Subpart YYYY: This rule establishes national emission limitations and work practice standards for HAPs emitted from Stationary Combustion Turbines. The affected source includes the stationary combustion turbine located at a major source of HAP emissions.
As defined in § 63.6090(b)(3), an existing, new or reconstructed stationary combustion turbine with a rated peak power output of less than 1.0 megawatt (MW) does not have to meet the requirements of this subpart. Based on the information provided by UGC in their Part 71 renewal application, although Little Canyon Unit is a major source of HAP emissions, the 65 kw Capstone Microturbine Generator at the facility is exempt from the requirements of this subpart because according to UGC, it has a peak power output of less than 1.0 MW. The maximum heat input for the Capstone Microturbine at the facility is 0.2 MMBtu/hr.
40 C.F.R. Part 63, Subpart ZZZZ (Subpart ZZZZ or MACT): This subpart establishes emission standards and operating limitations for the control of HAP emissions from spark ignition and compression ignition reciprocating internal combustion engines.
According to the regulations at § 63.6585(b), a major source of HAP emissions is a plant site that emits or has the potential to emit any single HAP at a rate of 10 tons (9.07 megagrams) or more per year or any combination of HAP at a rate of 25 tons (22.68 megagrams) or more per year, except that for oil and gas production facilities, a major source of HAP emissions is determined for each surface site. Since the LCU 2-6GX wellsite and Little Canyon Unit are not located on the same surface site, neither the emissions from the wellsite nor the compressor station shall be aggregated for the purposes of determining a major source of HAP.
As defined in § 63.6675, for production field facilities, only HAP emissions from glycol dehydration units, storage vessels with the potential for flash emissions, combustion turbines and reciprocating internal combustion engines shall be aggregated to determine whether such emission points are major sources. Based on the information provided by UGC in their Part 71 renewal application and subsequent minor permit modification application, the replacement reciprocating internal combustion engine (LCC-4) at Little Canyon Unit is considered a "new" engine because it commenced construction after December 19, 2002. As a result, the replacement engine will be subject to Subpart ZZZZ as a "new" engine with a site rating of more than 500 hp located at a major source of HAP emissions.
The Arrow C-96 pump engine at the LCU 2-6GX wellsite (LCU 2-6GX PU) is subject to the area source requirements of Subpart ZZZZ.
40 C.F.R. Part 63, Subpart DDDDD (Boiler MACT): This rule establishes national emission limitations and operating limitations for HAP emitted from new and existing industrial boilers, institutional boilers, commercial boilers and process heaters that are located at major sources of HAP. For the purposes of this subpart, a major source of HAP is as defined in § 63.2, except that for oil and natural gas production facilities, a major source of HAP is as defined in § 63.761. Boilers or process heaters that combust natural gas for fuel or have a maximum designed heat input capacity less than 10 MMBtu/hr are subject to work practice standards in lieu of emission limits. For the purposes of this subpart, an affected unit is an existing unit if it was constructed prior to June 4, 2010.
The dehydration unit reboiler and heaters at Little Canyon Unit meet the definition of process heaters in the rule. However, because Little Canyon Unit is subject to the major source requirements of 40 C.F.R. part 63, subpart HH, UGC may account for the reductions of PTE achieved through compliance with previous MACT standards prior to the first compliance date of subsequent MACT standards. Based on the information provided by UGC in their Part 71 renewal application, the PTE at Little Canyon Unit with federally enforceable controls was below major source thresholds for HAPs as of the first compliance date of this subpart (January 1, 2016, for existing process heaters and April 1, 2013, for new process heaters). Therefore, Little Canyon Unit does not meet the definition of a major source under the rule and this subpart does not apply. This subpart does not apply to LCU 2-6GX wellsite because it does not meet the definition of a major source under the rule.
40 C.F.R. Part 63, Subpart JJJJJJ (Subpart JJJJJ or Boiler MACT (for area sources)): This rule establishes national emission standards and operating limitations for HAP emitted from new and existing industrial boilers, institutional boilers, and commercial boilers that are fueled by coal, biomass, or oil and are located at area sources of HAP. For the purposes of this subpart, an affected unit is an existing unit if it was constructed prior to June 4, 2010.
Based on the information provided by UGC in their Part 71 renewal application, there are no industrial, commercial, or institutional boilers located at Little Canyon Unit or LCU 2-6GX wellsite as defined in the rule. Therefore, Subpart JJJJJJ does not apply.
Compliance Assurance Monitoring (CAM) Rule
Pursuant to requirements concerning enhanced monitoring and compliance certification under the CAA, the EPA promulgated regulations to implement compliance assurance monitoring (CAM) for major stationary sources of air pollution, for purposes of title V permitting that are required to obtain operating permits under Part 71. The rule requires owners or operators of such sources to conduct monitoring that provide a reasonable assurance of compliance with applicable requirements under the CAA.
    CAM Applicability

According to § 64.2(a), CAM applies to each pollutant specific emission unit (PSEU) located at a major source which is required to obtain a Part 71 permit if the unit satisfies all of the following criteria:
 The unit is subject to an emission limitation or standard for the applicable regulated air pollutant other than an emissions limitation or standard that is exempt under § 64.2(b)(1);

 The unit uses a control device to achieve compliance with any such limit or standard; and

 The unit has pre-control device emissions of the applicable regulated pollutant that are equal to or greater than 100 percent of the amount, in tpy, required for a source to be classified as a major Title V source.

    CAM Plan Submittal Deadlines

 Large pollutant-specific emissions units. A CAM plan submittal for all PSEUs with the PTE (taking into account control devices) of any one regulated air pollutant in an amount equal to or greater than 100 percent of the amount, in tpy, required for a source to be classified as a major source, is due at the following times:

 On or after April 20, 1998, if by that date, a Part 71 application has either:

 Not been filed; or
 Not yet been determined to be complete.

 On or after April 20, 1998, if a Part 71 permit application for a significant modification is submitted with respect to those PSEUs for which the requested permit revision is applicable; or

 Upon application for a renewed Part 71 permit and a CAM plan has not yet been submitted with an initial or a significant modification application, as specified above.

 Other pollutant-specific emissions units. A CAM Plan must be submitted for all PSEUs that are not large PSEUs, but are subject to this rule, upon application for a Part 71 renewal permit.

Based on the information provided by UGC in their Part 71 renewal application, dehydration unit LCD-1 is a PSEU with pre-controlled emissions that equal or exceed 100 percent of major VOC and HAP thresholds. However, LCD-1 is subject to the major source requirements of 40 C.F.R. part 63, subpart HH and thus meets the exemption criteria of § 64.2(b)(1). Since no other PSEUs at the facility have pre-controlled emissions that exceed or equal 100 percent of major source thresholds, Little Canyon Unit is not subject to CAM requirements.

Chemical Accident Prevention Program
40 C.F.R. Part 68: Chemical Accident Prevention Provisions. This rule applies to stationary sources that manufacture, process, use, store or otherwise handle more than the threshold quantity of a regulated substance in a process. Regulated substances include 77 toxic and 63 flammable substances which are potentially present in the natural gas stream entering the facility and in the storage vessels located at the facility. The quantity of a regulated substance in a process is determined according to the procedures presented under § 68.115. Sections 68.115(b)(l) and (2)(i) indicate that toxic and flammable substances in a mixture do not need to be considered when determining whether more than a threshold quantity is present at a stationary source if the concentration of the substance is below one percent by weight of the mixture. Section 68.115(b)(2)(iii) indicates that prior to entry into a natural gas processing plant, regulated substances in naturally occurring hydrocarbon mixtures need not be considered when determining whether more than a threshold quantity is present at a stationary source. Naturally occurring hydrocarbon mixtures include condensate, field gas and produced water.
Based on the updated information provided in UGC's Part 71 renewal application, Little Canyon Unit and LCU 2-6GX wellsite do not have regulated substances above the threshold quantities in this rule; and therefore, are not subject to the requirement to develop and submit a risk management plan.
EPA Trust Responsibility  -  consultation requirements
Endangered Species Act (ESA),16 U.S.C. § 1531 et seq. (1973)
Under section 7(a)(2) of the ESA, federal agencies are required to ensure that actions they authorize, fund, or carry out are not likely to jeopardize the continued existence of any listed, threatened, or endangered species, or destroy or adversely modify the designated critical habitat of such species. 16 U.S.C. § 1536(a)(2). The U.S. Fish and Wildlife Service and National Marine Fisheries Service have promulgated ESA implementing regulations at 50 C.F.R. part 402.
The CAA title V permit program requires the EPA to issue a permit specifically describing the permittee's existing pollution control obligations under the CAA. A title V permit does not generally create any new substantive requirements, but rather simply incorporates all existing CAA requirements, called "applicable requirements," into a single unified operating permit applicable to a particular facility. The title V permit EPA is issuing to UGC does not authorize the construction of new emission units, or emission increases from existing units, nor does it otherwise authorize any physical modifications to the facility or its operations. The EPA has concluded that the permit appropriately incorporates all existing CAA requirements applicable to the facility. The EPA lacks discretion in this title V permitting decision to take action that could inure to the benefit of any listed species or their critical habitat. The EPA has concluded that issuance of this permit will have no effect on any listed species or their critical habitat. Accordingly, this permit action is consistent with the requirements of ESA section 7.
NHPA
National Historic Preservation Act (NHPA), Public Law 89-665; 54 U.S.C. 300101 et seq.
The title V permit the EPA is issuing to UGC does not authorize the construction of new emission units, or emission increases from existing units, nor does it otherwise authorize any physical modifications to the facility or its operations. The EPA has concluded that issuance of this permit will have no effect on any property under the NHPA of 1966 pursuant to Section 106 of the NHPA, which requires federal agencies to consider the impact of their actions on historic properties.
Environmental Justice (EJ)
Executive Order 12898 directs federal agencies "to the greatest extent practicable and permitted by law," to "make achieving environmental justice part of its mission by identifying and addressing as appropriate, disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minority populations and low-income populations." Executive Order 14008 further directs federal agencies to "to address the disproportionately high and adverse human health, environmental, climate-related and other cumulative impacts on disadvantaged communities, as well as the accompanying economic challenges of such impacts." In addition, Executive Order 13985 calls on each federal agency to "pursue a comprehensive approach to advancing equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality." Accordingly, advancing environmental justice and equity is one of EPA's highest priorities as set forth in the Agency's FY22-26 Strategic Plan.

The EPA defines "Environmental Justice" (EJ) to include the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and polices. The EPA's goal is to provide an opportunity for overburdened populations or communities to participate in the permitting process. "Overburdened" is used to describe the minority, low-income, tribal and indigenous populations or communities in the United States that potentially experience disproportionate environmental harms and risks due to exposures or cumulative impacts or greater vulnerability to environmental hazards.

As part of EPA's trust responsibility to the Ute Indian Tribe and the above noted Executive Orders, the EPA has kept the Tribe informed about this permit action by copying them on key communications such as the emailed application completeness determination and will provide a minimum 30-day public comment period, and opportunity for a public hearing if requested. The EPA does not routinely offer tribal consultation on title V renewal permits for existing operating sources that do not incorporate any significant changes from the previously issued permit unless there is a request or known interest from the Tribe.
Permit Content
Draft permit sections 1 - 4

The draft permit contains all of the required elements for Part 71 permits, as specified in            40 C.F.R. § 71.5, including, but not limited to:

 Emissions limitations and standards, including those operational requirements and limitations that assure compliance with all applicable requirements at the time of permit issuance, as identified and discussed in this Statement of Basis;

 The permit duration, not to exceed 5 years;

 Monitoring and related recordkeeping and reporting requirements sufficient to assure and demonstrate compliance with all applicable requirements;

 A severability clause to ensure the continued validity of the various permit requirements in the event of a challenge to any portions of the permit;

 Specific provisions stating that: (a) any noncompliance constitutes a violations of the CAA and is grounds for enforcement action; (b) it is not a defense for the Permittee in an enforcement action that it would have been necessary to halt or reduce the permitted activity in order to maintain compliance with the permit; (c) instructions for how the permit may be modified, revoked, reopened, reissued, or terminated for cause; (d) the permit does not convey and property rights or exclusive privilege; (e) and upon request, the Permittee shall furnish to the permitting authority copies of required records;

 A provision to ensure that the Permittee pays fees to the EPA consistent with the fee schedule approved in 40 C.F.R. § 71.9;

 A provision to ensure that the permit expires upon five years elapsing from the effective date; and

 An off-permit changes provision allowing changes that are not addressed or prohibited by the permit.
Changes Between the Previous Permit and Draft Permit
The permit has been reformatted using the EPA's new Part 71 permit and statement of basis templates. As a result, the permit condition numbering system has changed from the previous permit. For national consistency, the semi-annual reporting timeframe in the renewed permit (permit condition 45) is 30 days following the end of reporting period instead of 90 days listed in the previously issued permit. Also, the renewed permit reflects the removal of Emission Unit LCC-3 as it had been removed from the facility since the issuance of initial Part 71 permit.
Public Participation

Public Notice

As described in 40 C.F.R. § 71.11(a)(5), all Part 71 draft operating permits shall be publicly noticed and made available for public comment. The public notice of permit actions and public comment period is described in 40 C.F.R. § 71(d).

There will be a 30-day public comment period for actions pertaining to a draft permit. Notification will be given for this draft permit to the permit applicant, the affected tribe, the affected state, the tribal and local air pollution control agencies, the city and county executives, and the state and federal land managers which have jurisdiction over the area where the source is located. A notification will also be provided to all persons who have submitted a written request to be included on the notification list.

If you would like to be added to our notification list to be informed of future actions on this or other CAA permits issued in Indian country, please send an email using the link for Region 8 CAA permit public comment opportunities at http://www.epa.gov/caa-permitting/caa-permit-public-comment-opportunities-region-8.

Public notice will be provided at http://www.epa.gov/caa-permitting/caa-permit-public-comment-opportunities-region-8 giving opportunity for public comment on the draft permit and the opportunity to request a public hearing.

Opportunity to Comment

Members of the public will be given an opportunity to review a copy of the draft permit prepared by the EPA, the application, this Statement of Basis for the draft permit and all supporting materials for the draft permit. An electronic copy of the draft permit and related documents may be viewed online at the website cited below. Information is also available by emailing or speaking with the following contact:

Contact: Suman Kunwar, Environmental Engineer,<PHONE_NUMBER> or<EMAIL_ADDRESS>
Electronic copies of the draft permit, Statement of Basis and supporting permit record may be accessed for review at:
https://www.epa.gov/caa-permitting/caa-permit-public-comment-opportunities-region-8.

Any interested person may submit written comments on the draft Part 71 operating permit during the public comment period by email using the instructions on the public comment opportunities web site address listed above or through https://www.regulations.gov (Docket ID #EPA-R08-OAR-2022-0199). All comments will be considered and answered by the EPA in making the final decision on the permit. The EPA keeps a record of the commenters and of the issues raised during the public participation process.

Anyone, including the applicant, who believes any condition of the draft permit is inappropriate should raise all reasonable ascertainable issues and submit all arguments supporting their position by the close of the public comment period. Any supporting materials submitted must be included in full and may not be incorporated by reference, unless the material has already been submitted as part of the administrative record in the same proceeding or consists of state or federal statutes and regulations, EPA documents of general applicability or other generally available reference material.

The final permit will be a public record that can be obtained upon request. A statement of reasons for changes made to the draft permit and responses to comments received will be sent to all persons who comment on the draft permit. The final permit and response to comments document will also be available online at: https://www.epa.gov/caa-permitting/caa-permits-issued-epa-region-8. Anyone may request a copy of the final permit at any time by contacting the Tribal Air Permit Program at<PHONE_NUMBER> or by sending an email to<EMAIL_ADDRESS>

Opportunity to Request a Hearing

A person may submit a written request for a public hearing to the Part 71 Permitting Lead, U.S. EPA Region 8, by stating the nature of the issues to be raised at the public hearing. Based on the number of hearing requests received, the EPA will hold a public hearing whenever it finds there is a significant degree of public interest in a draft operating permit. The EPA will provide public notice of the public hearing. If a public hearing is held, any person may submit oral or written statements and data concerning the draft permit.

Appeal of Permits

Within 30 days after the issuance of a final permit decision, any person who filed comments on the draft permit or participated in the public hearing may petition to the Environmental Appeals Board (EAB) to review any condition of the permit decision. Any person who failed to file comments or participate in the public hearing may petition for administrative review, only if the changes from the draft to the final permit decision or other new grounds were not reasonably foreseeable during the public comment period. The 30-day period to appeal a permit begins with the EPA's service of the notice of the final permit decision.

The petition to appeal a permit must include a statement of the reasons supporting the review, a demonstration that any issues were raised during the public comment period, a demonstration that it was impracticable to raise the objections within the public comment period or that the grounds for such objections arose after such a period. When appropriate, the petition may include a showing that the condition in question is based on a finding of fact or conclusion of law which is clearly erroneous; or, an exercise of discretion, or an important policy consideration that the EAB should review.

The EAB will issue an order either granting or denying the petition for review, within a reasonable time following the filing of the petition. Public notice of the grant of review will establish a briefing schedule for the appeal and state that any interested person may file an amicus brief. Notice of denial of review will be sent only to the permit applicant and to the person requesting the review. To the extent review is denied, the conditions of the final permit decision become final agency action.

A motion to reconsider a final order shall be filed within ten days after the service of the final order. Every motion must set forth the matters claimed to have been erroneously decided and the nature of the alleged errors. Motions for reconsideration shall be directed to the Administrator rather than the EAB. A motion for reconsideration shall not stay the effective date of the final order unless it is specifically ordered by the EAB.

Petition to Reopen a Permit for Cause

Any interested person may petition the EPA to reopen a permit for cause, and the EPA may commence a permit reopening on its own initiative.

The EPA will only revise, revoke and reissue, or terminate a permit for the reasons specified in 40 C.F.R. § 71.7(f) or 71.6(a)(6)(i). All requests must be in writing and must contain facts or reasons supporting the request. If the EPA decides the request is not justified, it will send the requester a brief written response giving a reason for the decision. Denial of these requests is not subject to public notice, comment or hearings. Denials can be informally appealed to the EAB by a letter briefly setting forth the relevant facts.

Abbreviations and Acronyms

ASTM  		American Society for Testing and Materials
bbl			barrel
CAA  			Clean Air Act [42 U.S.C. § 7401, et seq.]
CEDRI		Compliance and Emission Reporting Data Interface
C.F.R.			Code of Federal Regulations
CH2O			Formaldehyde
CO			Carbon Monoxide
EPA  			U.S. Environmental Protection Agency, Region 8
EU  			Emission Unit
Facility  		 Little Canyon Unit Compressor Station: Latitude 39.896944N, Longitude 109.605556W and LCU 2-6GX Wellsite: Latitude 39.8948N, Longitude 109.6069W
gal  			gallon
g  			grams
HAP  			Hazardous Air Pollutant
hp			horsepower
hr  			hour
Id. No.		         	Identification Number
kg  			kilogram
kW			kilowatt
lb  			pound
MACT  		Maximum Achievable Control Technology
Mfd			Manufactured
Mg  			Megagram
MMBtu/hr  	Million British Thermal Units per Hour
MMscfd		Million Standard Cubic Feet per Day
NESHAP  		National Emission Standards for Hazardous Air Pollutants
NOX  			Nitrogen Oxides
NSPS  			New Source Performance Standards
NSR  			New Source Review
Operator	                 Utah Gas Corporation
Permittee	                 Utah Gas Corporation
PM  			Particulate Matter
PM10  			Particulate Matter less than 10 microns in diameter
ppm  			parts per million
PSD  			Prevention of Significant Deterioration
PTE   			Potential to Emit
SO2  			Sulfur Dioxide
TEG				Triethylene Glycol
VOC  			Volatile Organic Compounds


[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Notices]
[Pages 67409-67411]
[FR Doc No: 2015-27816]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Bioequivalence Recommendations for Progesterone; Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of Availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry on progesterone gel
entitled ``Draft Guidance on Progesterone.'' The recommendations
provide specific guidance on the design of bioequivalence (BE) studies
to support abbreviated new drug applications (ANDAs) for progesterone
gel.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 4, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2007-D-0369 for Bioequivalence Recommendations for Progesterone;
Draft Guidance for Industry; Availability. Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    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: Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002,
301-796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry, ``Bioequivalence
Recommendations for Specific Products,'' which explained the process
that would be used to make product-specific BE recommendations
available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As
described in that guidance, FDA adopted this process as a means to
develop and disseminate product-specific BE recommendations and provide
a meaningful opportunity for the public to consider and comment on
those recommendations. This notice announces the availability of draft
BE recommendations for progesterone gel.
    FDA initially approved new drug application 020701 for Crinone gel
in July 1997. There are no approved ANDAs for this product. We are now
issuing a draft guidance for industry on BE recommendations for generic
progesterone gel (``Draft Guidance on Progesterone'').
    In June 2013, Watson Laboratories, manufacturer of the reference
listed drug, Crinone, submitted a citizen petition requesting that FDA
require ANDA applicants to demonstrate bioequivalence to Crinone with
studies that include pharmacokinetic and clinical endpoint studies and
to issue a draft BE guidance identifying these studies. (FDA notes that
subsequent to submission of the petition, Watson Laboratories informed
FDA that the company has changed its name to Actavis Labs UT Inc.) FDA
has reviewed the issues raised in the petition and is responding to the
petition (Docket No. FDA-2013-P-0664, available at http://www.regulations.gov).
    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 Agency's current
thinking on the design of BE studies to support ANDAs for progesterone
gel. 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.

II. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27816 Filed 10-30-15; 8:45 am]
BILLING CODE 4164-01-P