[Federal Register Volume 80, Number 215 (Friday, November 6, 2015)]
[Proposed Rules]
[Pages 68808-68815]
[FR Doc No: 2015-28342]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 60

[EPA-HQ-OAR-2014-0866; FRL-9935-90-OAR]
RIN 2060-AS43

Standards of Performance for Stationary Compression Ignition
Internal Combustion Engines

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing
amendments to the standards of performance for stationary compression
ignition (CI) internal combustion engines to allow manufacturers to
design the engines so that operators can temporarily override
performance inducements related to the emission control system for
stationary CI internal combustion engines operating during emergency
situations where the operation of the engine or equipment is needed to
protect human life, and to require compliance with Tier 1 emission
standards during such emergencies. The EPA is also proposing to amend
the standards of performance for certain stationary CI internal
combustion engines located in remote areas of Alaska.

DATES: Comments must be received on or before December 21, 2015.
    Public hearing. If anyone contacts us requesting to speak at a
public hearing by November 13, 2015, a public hearing will be held on
November 23, 2015. If you are interested in attending the public
hearing, contact Ms. Melanie King at<PHONE_NUMBER> or
<EMAIL_ADDRESS>to verify that a hearing will be held.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2014-0866, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI) or other information 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. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e. on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    The EPA requests that you also submit a separate copy of your
comments to the contact person identified below (see FOR FURTHER
INFORMATION CONTACT). If the comment includes information you consider
to be CBI or otherwise protected, you should send a copy of the comment
that does not contain the information claimed as CBI or otherwise
protected.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. The EPA also relies on materials in Docket
ID Nos. EPA-HQ-OAR-2008-0708, EPA-HQ-OAR-2010-0295, and EPA-HQ-OAR-
2011-1032, and incorporates those dockets into the record for this
proposed rule.
    Although listed in the index, some information is not publicly
available (e.g., CBI or other information whose disclosure is
restricted by statute). Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically in
http://www.regulations.gov or in hard copy at the EPA Docket Center,
EPA WJC West Building, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding federal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the Air Docket is<PHONE_NUMBER>. Visit the EPA Docket
Center homepage at http://www.epa.gov/epahome/dockets.htm for
additional information about the EPA's public docket.
    In addition to being available in the docket, an electronic copy of
this proposed rule will be available on the World Wide Web (WWW).
Following signature, a copy of this proposed rule will be posted at the
following address: http://www.epa.gov/ttn/atw/icengines/.
    Public hearing: If anyone contacts the EPA requesting a public
hearing by November 13, 2015, the public hearing will be held on
November 23, 2015 at the EPA's campus at 109 T.W. Alexander Drive,
Research Triangle Park, North Carolina. Please contact Ms. Melanie King
at<PHONE_NUMBER> or at<EMAIL_ADDRESS>to register to speak at
the hearing or to inquire as to whether or not a hearing will be held.

FOR FURTHER INFORMATION CONTACT: Ms. Melanie King, Energy Strategies
Group, Sector Policies and Programs Division (D243-01), Environmental
Protection Agency, Research Triangle Park, North Carolina 27711;
telephone number:<PHONE_NUMBER>; facsimile number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Organization of this document. The information presented in this
preamble is organized as follows:

I. General Background
II. Temporary Override of Inducements in Emergency Situations
    A. Background
    B. Proposed Amendments
III. Remote Areas of Alaska
    A. Background
    B. Proposed Amendments
IV. Impacts of the Proposed Action
    A. Economic Impacts
    B. Environmental Impacts
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review, and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
    I. National Technology Transfer and Advancement Act (NTTAA)
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. General Background

    On July 11, 2006, the EPA promulgated standards of performance

for stationary CI internal combustion engines (71 FR 39154). These
standards, known as new source performance standards (NSPS), implement
section 111(b) of the Clean Air Act (CAA), and are issued for
categories of sources that cause, or contribute significantly to, air
pollution that may reasonably be anticipated to endanger public health
or welfare. The standards apply to new stationary sources of emissions,
i.e., sources whose construction, reconstruction, or modification
begins after a standard for those sources is proposed. The NSPS for
stationary CI internal combustion engines established limits on
emissions of particulate matter (PM), nitrogen oxides (NOX),
carbon monoxide (CO) and non-methane hydrocarbons (NMHC). The emission
standards are generally modeled after the EPA's standards for nonroad
and marine diesel engines. The nonroad CI engine standards are phased
in over several years and have Tiers with increasing levels of
stringency. The engine model year in which the Tiers take effect varies
for different size ranges of engines. The Tier 4 final standards for
new stationary non-emergency and nonroad CI engines generally begin
with either the 2014 or 2015 model year.
    In 2011, the EPA finalized revisions to the NSPS for stationary CI
engines that amended the standards for engines with a displacement
greater than 10 liters per cylinder, and also for engines located in
remote areas of Alaska (76 FR 37954). In this action, the EPA is
proposing amendments to the NSPS regarding performance inducements for
Tier 4 engines and the criteria for defining remote areas of Alaska.
The proposed amendments are discussed below.

II. Temporary Override of Inducements in Emergency Situations

A. Background

    Many Tier 4 final engines are equipped by the engine manufacturer
with selective catalytic reduction (SCR) to reduce emissions of
NOX. The consumable reactant in an SCR system is typically
supplied as a solution of urea in water known as diesel exhaust fluid
(DEF). Engines equipped with SCR generally include controls that limit
the function of the engines if they are operated without DEF, or if the
engine's electronic control module cannot otherwise confirm that the
SCR system is properly operating. Such controls are generally called
``inducements'' because they induce the operator to properly maintain
the SCR emission control system. In normal circumstances, if
inducements begin, the engine operator is expected to perform any
necessary maintenance to avoid shutdown. Manufacturers as well as
owners and operators of nonroad and stationary CI Tier 4 certified
engines have raised concerns regarding the inducements being triggered
and engines shutting down during emergency situations. Triggers could
include a temporary supply shortage of DEF, a freeze warning, a blocked
DEF hose, or a disconnected or faulty DEF pump or sensor. These
inducements can be triggered because of an actual emission problem
(such as a blocked DEF line or an empty DEF tank), or because of a
sensor problem that reports a false positive problem even though the
emission controls are still functioning properly. While the EPA is
confident that DEF is now widely available and easily obtainable across
the United States, the EPA is concerned that in emergency
circumstances, such as the aftermath of storms like Hurricane Sandy or
Hurricane Katrina, there may be a possibility of temporary disruptions
in DEF supply, disruptions in communications between operators and
service centers, or delays in response time for engine repair service.
In an emergency situation, allowing inducements to impact engine
performance may endanger human lives for engines that are providing
life-saving emergency service, such as engines providing emergency
power for a hospital. As an example, the Johns Hopkins Health System
indicated that the availability of emergency power ``can be the
difference between life and death for critically ill patients.
Disruption of emergency power for any reason could have catastrophic
results for patients in surgery, for patients on respirators, and for
patients receiving medical gases, to name a few.'' (See Docket ID No.
EPA-HQ-OAR-2014-0866.)
    The EPA's existing nonroad and stationary engine compliance
regulations in 40 CFR 1068.101(b)(1)(ii) allow operators to temporarily
disable or remove emission controls to address emergency situations,
with a limited exemption from the prohibition that normally applies for
tampering with certified engines.\1\ However, until recently, the
regulations did not allow manufacturers to design the emission controls
to be disabled or removed in emergency situations. With modern
electronically controlled engines, many emission controls are
integrated into the engine's control software, and there is no way for
the operator to selectively disable emission control software, while
maintaining engine function. In order to permit engine manufacturers to
design the emission controls to be disabled or removed in emergency
situations, the EPA amended the emission standards for nonroad CI
engines to allow manufacturers of nonroad CI engines to give operators
the means to temporarily override inducements while operating in
emergency situations (79 FR 46356, August 8, 2014). At that time, the
EPA indicated that the amendments did not apply to stationary CI
engines. Engine manufacturers and owners and operators of stationary CI
engines have indicated that it would be appropriate to extend the
provisions to stationary CI engines, since they can also be used in
emergency situations, and many engines are dual-certified for both
nonroad and stationary use. To address concerns about stationary CI
engines shutting down during emergency situations and endangering human
lives, the EPA is proposing in this action to allow manufacturers of
stationary CI engines certified to the Tier 4 standards to give
operators the means to temporarily override inducements while operating
in qualified emergency situations. The EPA is also proposing to require
engine operators to meet the Tier 1 emission standard in 40 CFR 89.112
that applies to the engine's rated power during the qualified emergency
situation. The specific amendments the EPA is proposing are discussed
in more detail below. If adopted, these provisions will make available
stationary engines that will allow operators to use the flexibility
already provided under 40 CFR 1068.101(b)(1)(ii) to ensure that
emission controls will not impede the engine from providing life-saving
emergency service. The flexibility the EPA is adopting is very narrow
and contains several provisions to ensure the need for the relief.
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    \1\ ``This [tampering] prohibition does not apply in any of the
following situations: . . . (ii) You need to modify the engine/
equipment to respond to a temporary emergency and you restore it to
proper functioning as soon as possible.'' 40 CFR 1068.101(b)(1)(ii).
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B. Proposed Amendments

    As discussed previously, on August 8, 2014, the EPA promulgated
provisions allowing manufacturers of nonroad engines certified to the
emission standards in 40 CFR part 1039 to give operators the means to
temporarily override emission control inducements while operating in
emergency situations, such as those where operation of the engine is
needed to protect human life (79 FR 46356). These provisions, which are
codified in 40 CFR 1039.665, allow for auxiliary emission control
devices (AECDs) that help to ensure proper function of

engines in emergency situations. AECDs are any element of design that
senses temperature, motive speed, engine revolutions per minute,
transmission gear, or any other parameter for the purpose of
activating, modulating, delaying, or deactivating the operation of any
part of the emission control system. The provisions of 40 CFR 1039.665
allow the engine manufacturer to include a dormant feature in the
engine's control software that could be activated to override emission
control inducements. In this action, the EPA is proposing to adopt
those same provisions for stationary CI engines certified to the
standards in 40 CFR part 1039 and used in qualified emergency
situations. It is important to emphasize that the EPA is confident that
Tier 4 engines will function properly in the vast majority of emergency
situations. Thus, the EPA expects that AECDs allowed under this
proposed provision will rarely be activated. The EPA is proposing this
provision merely as a precaution to ensure that stationary CI engines
can continue to operate in emergencies.
    The proposed amendments allow engine manufacturers to design into
their stationary CI engines a dormant AECD that can be activated for up
to 120 engine hours per use during a qualified emergency situation to
prevent emission controls from interfering with engine operation. The
EPA is proposing that engine manufacturers can offer, and operators can
request, re-activations of the AECD for additional time in increments
of 120 engine hours in cases of a prolonged emergency situation. During
the emergency situation, the engine must meet the Tier 1 emission
standard in 40 CFR 89.112 that applies to the engine's rated power.
Operators activating the AECD will be required to report the incident
to the engine manufacturers, and engine manufacturers will submit an
annual report to the EPA summarizing the use of these AECDs during the
prior year. These proposed amendments are discussed in more detail
below.
1. Definition of Qualified Emergency Situation
    The EPA is proposing to use the definition of qualified emergency
situation established in the August 8, 2014, amendments for nonroad
engines. This definition is found in the introductory text to 40 CFR
1039.665, and specifies that a qualified emergency situation is one in
which the condition of an engine's emission controls poses a
significant direct or indirect risk to human life. An example of a
direct risk would be an emission control condition that inhibits the
performance of an engine being used to rescue a person from a life-
threatening situation (for example, providing power to a medical
facility during an emergency situation). An example of an indirect risk
would be an emission control condition that inhibits the performance of
an engine being used to provide electrical power to a data center that
routes ``911'' emergency response telecommunications.
2. Basic AECD Criteria
    Section 1039.665 specifies provisions allowing for AECDs that are
necessary to ensure proper function of engines and equipment in
emergency situations. It also includes specific criteria that the
engine manufacturer must meet to ensure that any adverse environmental
impacts are minimized. These criteria are:
     The AECD must be designed so that it cannot be activated
more than once without the specific permission of the certificate
holder. Reactivation of the AECD must require the input of a temporary
code or equivalent security feature.
     The AECD must become inactive within 120 engine hours of
becoming active. The engine must also include a feature that allows the
operator to deactivate the AECD once the emergency is over.
     The manufacturer must show that the AECD deactivates
emission controls (such as inducement strategies) only to the extent
necessary to address the expected emergency situation.
     The engine controls must be configured to record in non-
volatile electronic memory the total number of activations of the AECD
for each engine.
     The manufacturer must take appropriate additional steps to
induce operators to report AECD activation and request resetting of the
AECD. The EPA recommends including one or more persistent visible and/
or audible alarms that are active from the point when the AECD is
activated to the point when it is reset.
     The manufacturer must provide purchasers with instructions
on how to activate the AECD in emergency situations, as well as
information about penalties for abuse.
3. Emission Standards During Qualified Emergency Situations
    The EPA is proposing to require stationary CI engines to meet
different emission standards for the very narrow period of operation
where there is an emergency situation with a risk to human life and the
owner or operator is warned that the inducement is about to occur. The
EPA is proposing that the emission standards that apply when the AECD
is activated during the qualified emergency situation are the Tier 1
standards in 40 CFR 89.112. Engine manufacturers indicated that meeting
the Tier 2 or 3 standards in 40 CFR 89.112 is not feasible because the
base engine used in Tier 4 configurations does not have exhaust gas
recirculation (EGR), which is the engine design technology used to meet
the Tier 2 and 3 standards. The EGR is not needed for Tier 4 because
NOX is controlled by the SCR.\2\ The Tier 1 requirement
applies only when there is a qualified emergency situation and bypass
of inducements is necessary to ensure continued operation of the
engine. Once the emergency situation has ended and the AECD is
deactivated, the engine must comply with the otherwise applicable
emission standard specified in 40 CFR 60.4202. Engine manufacturers
must provide data demonstrating that the engine complies with the Tier
1 standard when the AECD is activated when applying for certification
of an engine equipped with an AECD.
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    \2\ See Docket Id No. EPA-HQ-OAR-2014-0866.
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4. Approval, Recordkeeping and Reporting for Engine Manufacturers
    Manufacturers may ask for approval of the use of emergency AECDs at
any time; however, the EPA encourages manufacturers to obtain
preliminary approval before submitting an application for
certification. Otherwise, the EPA's review of the AECD, which may
include many unique features, may delay the approval of the application
for certification.
    The manufacturer is required to keep records to document the use of
emergency AECDs until the end of the calendar year 5 years after the
onset of the relevant emergency situation. The manufacturer must submit
an annual compliance report to the EPA within 90 calendar days of the
end of each calendar year in which it authorizes use of an AECD. The
annual report must include a description of each AECD activation and
copies of the reports submitted by owners or operators (or statements
that an owner or operator did not submit a report, to the extent of the
manufacturer's knowledge). If an owner or operator fails to report the
use of an emergency AECD to the manufacturer, the manufacturer, to the
extent it has been made aware of the AECD activation, must send written
notification to the operator that failure to meet the submission
requirements may subject the operator to penalties.

5. Engine Owner or Operator Requirements
    Owners or operators who purchase engines with this dormant feature
will receive instructions from the engine manufacturer on how to
activate the AECD in qualified emergency situations, as well as
information about penalties for abuse. The EPA would consider
appropriate use of this feature to be during a situation where
operation of a stationary CI engine is needed to protect human life (or
where impaired operation poses a significant direct or indirect risk to
human life), and temporarily overriding emission controls enables full
operation of the equipment. The EPA is adopting this provision to give
operators the means to obtain short-term relief one time without the
need to contact the engine manufacturer or the EPA. In a qualified
emergency situation, delaying the activation to obtain approval could
put lives at risk, and would be unacceptable. However, the EPA retains
the authority to evaluate, after the fact, whether it was reasonable to
judge that there was a significant risk to human life to justify the
activation of the AECD. Where the EPA determines that it was not
reasonable to judge (1) that there was a significant risk to human
life; or (2) that the emission control strategy was curtailing the
ability of the engine to perform, the owner or operator may be subject
to penalties for tampering with emission controls. The owner or
operator requirements also include a specific prohibition on operating
the engine with the AECD beyond the time reasonably needed for such
operation. The owner or operator may also be subject to penalties for
tampering if they continue to operate the engine with the AECD once the
emergency situation has ended or the problem causing the emission
control strategy to interfere with the performance of the engine has
been or can reasonably be fixed. Nevertheless, the EPA will consider
the totality of the circumstances when assessing penalties, and retain
discretion to reduce penalties where the EPA determines that an owner
or operator acted in good faith.
    The owner or operator must send a written report to the engine
manufacturer within 60 calendar days after activating an emergency
AECD. If any consecutive reactivations occur, this report is still due
60 calendar days from the first activation. The report must include:
     Contact name, mail and email addresses, and telephone
number for the responsible company or entity.
     A description of the emergency situation, the location of
the engine during the emergency, and the contact information for an
official who can verify the emergency situation (such as a county
sheriff, fire marshal, or hospital administrator).
     The reason for AECD activation during the emergency
situation, such as the lack of DEF, or the failure of an emission-
related sensor when the engine was needed to respond to an emergency
situation.
     The engine's serial number (or equivalent).
     A description of the extent and duration of the engine
operation while the AECD was active, including a statement describing
whether or not the AECD was manually deactivated after the emergency
situation ended.
    Paragraph 1039.665(g) specifies that failure to provide this
information to the engine manufacturer within the deadline is improper
use of the AECD and is prohibited.

III. Remote Areas of Alaska

A. Background

1. Original Request From the State of Alaska
    The 2006 final NSPS for CI internal combustion engines included a
provision that allowed the state of Alaska to submit for EPA approval
through rulemaking process an alternative plan for implementing the
requirements of the NSPS for public-sector electric utilities located
in rural areas of Alaska not accessible by the Federal Aid Highway
System (FAHS). The alternative plan was required to be based on the
requirements of section 111 of the CAA, including any increased risks
to human health and the environment, and was also required to be based
on the unique circumstances related to remote power generation,
climatic conditions, and serious economic impacts resulting from
implementation of the final NSPS.
    The EPA communicated with officials from the state of Alaska on
several occasions following the promulgation of the 2006 final rule. On
October 31, 2008, the EPA received Alaska's request for several
revisions to the NSPS as it pertained to engines located in the remote
part of Alaska not served by the FAHS.\3\ After reviewing the
information provided by the state of Alaska, the EPA agreed that the
circumstances in remote Alaska required special rules. On June 28,
2011, the EPA promulgated several amendments for engines used in remote
Alaska (76 FR 37954). The amendments of relevance for this action are
as follows:
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    \3\ Docket item No. EPA-HQ-OAR-2010-0295-0012.
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     Exempting all pre-2014 model year engines from diesel fuel
sulfur requirements;
     Allowing owners and operators of stationary CI engines
located in remote areas of Alaska to use engines certified to marine
engine standards, rather than land-based nonroad engine standards;
     Removing requirements to meet emission standards that
would necessitate the use of aftertreatment devices for NOX,
in particular, SCR, for engines used in remote Alaska (emission
standards that are not based on the use of aftertreatment devices for
NOX do apply);
     Removing requirements to meet emission standards that
would necessitate the use of aftertreatment devices for PM until the
2014 model year; and
     Allowing the blending of used lubricating oil, in volumes
of up to 1.75 percent of the total fuel, if the sulfur content of the
used lubricating oil is less than 200 parts per million (ppm) and the
used lubricating oil is ``on-spec,'' i.e., it meets the on-
specification levels and properties of 40 CFR 279.11.
    In support of its October 31, 2008, request, the state of Alaska
noted that remote communities in Alaska that are not accessible by the
FAHS rely on diesel engines and fuel for electricity. These communities
are scattered over long distances in remote areas and are not connected
to population centers by road or power grid. These communities are
located in the most severe arctic environments in the United States.
    The state of Alaska noted that remote villages in Alaska use
combined heat and power cogeneration plants, which are vital to their
economy, given the high cost of fuel and the substantial need for heat
in that climate. Heat recovery systems are used with diesel engines in
remote communities to provide heat to community facilities and schools.
Marine-jacketed diesel engines are used wherever possible because of
their superior heat recovery and thermal efficiency. The state of
Alaska indicated that they have noticed great reductions in heat
recovery when using Tier 3 non-marine engines. The state noted that
reductions in fuel efficiency will lead to greater fuel use and greater
emissions from burning extra heating oil. The EPA agreed with the state
that there are significant benefits from using marine engines, and
finalized a revision allowing engines in remote Alaska to use marine-
certified engines. However, as the state of Alaska noted, marine-
certified engines,

particularly those below 800 horsepower (HP), are not required to meet
more stringent requirements for reduction of PM emissions, which is the
most significant pollutant of concern in these areas. Therefore, the
EPA required that owners and operators of 2014 model year and later
engines in remote areas of Alaska must either be certified to Tier 4
standards (whether land-based nonroad or marine) or must install PM
reduction technologies on their engines to achieve at least 85 percent
reduction in PM.
    The original request from the state of Alaska noted particular
concern with NOX standards that would likely entail the use
of SCR in remote Alaska. NOX reductions are particularly
important in areas where ozone is a concern, because NOX is
a precursor to ozone. However, the state of Alaska, and remote Alaska
in particular, does not have any significant ozone problems. Moreover,
the use of SCR entails the supply, storage, and use of a DEF that needs
to be used properly in order to achieve the expected emissions
reductions, and that may have additional operational problems in remote
arctic climates. As noted above, these villages are scattered over long
distances in remote areas and are not connected to population centers
by road or power grid. The villages are located in the most severe
arctic environments in the United States and they rely on stationary
diesel engines and fuel for electricity and heating, and these engines
need to be in working condition, particularly in the winter. The
availability of DEF in remote villages may be an issue, which is
notable given the importance of the stationary engines in these
villages. Furthermore, the costs for the acquisition, storage, and
handling of the DEF are greater than for engines located elsewhere in
the United States due to the remote location and severe arctic climate
of the villages. In order to maintain proper availability of the DEF
during the harsh winter months, new heated storage vessels may be
needed at each engine facility, further increasing the compliance costs
for these remote villages. Given the issues that would need to be
addressed if SCR were required, and the associated costs of this
technology when analyzed under NSPS guidelines, the EPA agreed with the
state of Alaska's argument that it is inappropriate to require such
standards for stationary engines in remote Alaska \4\ and amended the
NSPS for stationary CI internal combustion engines to specify that
owners and operators of new stationary engines in remote areas of
Alaska do not have to meet the Tier 4 standards for NOX.
However, owners and operators of model year 2014 and later engines that
do not meet the Tier 4 p.m. standards would be required to use PM
aftertreatment that achieves PM reductions of at least 85 percent. The
use of PM aftertreatment will also achieve reductions in CO and NMHC.
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    \4\ Note that this action applies to stationary engines only; it
is unlikely that such an approach would be appropriate for mobile
engines, given that they are less permanent in a village and can
move in and out of areas as work requires.
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    Finally, regarding allowing owners and operators to blend up to
1.75 percent used oil into the fuel system, the state noted that there
are no permitted used oil disposal facilities in remote Alaskan
communities. The state has developed a cost-effective and reliable
used-oil blending system that is currently being used in many remote
Alaskan communities, disposing of the oil in an environmentally
beneficial manner and capturing the energy content of the used oil. The
absence of allowable blending would necessitate the shipping out of the
used oil and would risk improper disposal and storage, as well as
spills. According to the state, blending waste oil at 1.75 percent or
less will keep the fuel within American Society for Testing and
Materials (ASTM) specifications if the sulfur content of the waste oil
is below 200 ppm. The state acknowledged the need for engines equipped
with aftertreatment devices to use fuel meeting the sulfur
requirements. The EPA agreed that the limited blending of used oil into
the diesel fuel used by stationary engines in remote Alaska is an
environmentally beneficial manner of disposing of such oil and is of
little to no concern when kept within appropriate limits. Therefore,
the EPA finalized amendments that permit the blending of fuel oil at
such levels for engines in remote Alaska. The used oil must be ``on-
spec,'' i.e., it must meet the on-specification levels and properties
in 40 CFR 279.11.
2. New Request From the State of Alaska
    On November 28, 2014, the EPA received a new request from the state
of Alaska, which can be found in the docket for this rulemaking. The
request asked that the EPA revise the criteria for remote areas of
Alaska, which were established in the 2011 amendments as areas that are
not accessible by the FAHS, to also include areas that are accessible
by the FAHS, but face similar challenges to areas that are not
accessible. The letter recommended that the EPA adopt the same
definition for remote areas of Alaska in the NSPS that was adopted in
the 2013 amendments to the National Emission Standards for Hazardous
Air Pollutants (NESHAP) for Reciprocating Internal Combustion Engines
(RICE), which can be found at 40 CFR part 63, subpart ZZZZ. The RICE
NESHAP definition specifies that engines in areas that are accessible
by the FAHS can be considered remote if each of the following
conditions is met: (1) The only connection to the FAHS is through the
Alaska Marine Highway System, or the stationary CI engine operation is
within an isolated grid in Alaska that is not connected to the
statewide electrical grid referred to as the Alaska Railbelt Grid; (2)
at least 10 percent of the power generated by the engine on an annual
basis is used for residential purposes; and (3) the generating capacity
of the facility is less than 12 megawatts, or the engine is used
exclusively for backup power for renewable energy.\5\
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    \5\ See 40 CFR 63.6603(b).
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    The state of Alaska provided information in a March 2, 2015, letter
to the EPA to show that the communities in these additional FAHS-
accessible areas face similar challenges to the communities in areas
that are not accessible by the FAHS, and that the concerns that led to
the 2011 amendments to the NSPS are also valid for the additional
areas. As discussed previously, these challenges include
inaccessibility, expense for DEF transport and storage, risk of engine
shutdown, shortage of trained operators, and availability and cost of
Tier 4 engines. The state noted that some of the communities are only
accessible by road for a few months each year, or only by weekly ferry
service; the alternative travel method is by floatplane. Thus, the
delivery of DEF and the travel for engine service technicians to these
areas would be much more costly than for areas that are not remote. The
need to heat the DEF in the communities with a severe arctic climate
would divert heat that is routinely used for space heating. Communities
in these areas rely on diesel engines for electricity and heating,
similar to the communities that are in areas that are not accessible by
the FAHS, and failure of the engine to operate due to a shortage of DEF
could present a risk to human life. The communities also have
difficulty finding and retaining trained operators for the engines and
aftertreatment devices, according to the state of Alaska.\6\
---------------------------------------------------------------------------

    \6\ The state noted in its letter that nonroad engines are
typically brought in temporarily by contractors and, therefore, the
concerns raised for stationary engines are not necessarily
applicable for nonroad engines.

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

    Based on the information provided by the state, the EPA agrees that
the circumstances that warranted different emission standards for new
stationary CI internal combustion engines in areas of Alaska that are
not accessible by the FAHS are also present in the additional FAHS-
accessible remote areas identified in the RICE NESHAP definition.

B. Proposed Amendments

    The EPA is proposing an amendment to the NSPS for stationary CI
internal combustion engines that would align the definition of remote
areas of Alaska with the definition currently used in the RICE NESHAP.
The amendments specify that engines in areas that are accessible by the
FAHS can be considered remote if each of the following conditions is
met: (1) The only connection to the FAHS is through the Alaska Marine
Highway System, or the stationary CI engine operation is within an
isolated grid in Alaska that is not connected to the statewide
electrical grid referred to as the Alaska Railbelt Grid; (2) at least
10 percent of the power generated by the engine on an annual basis is
used for residential purposes; and (3) the generating capacity of the
facility is less than 12 megawatts, or the engine is used exclusively
for backup power for renewable energy. The Alaska Railbelt Grid is
defined as the service areas of the six regulated public utilities that
extend from Fairbanks to Anchorage and the Kenai Peninsula. These
utilities are Golden Valley Electric Association; Chugach Electric
Association; Matanuska Electric Association; Homer Electric
Association; Anchorage Municipal Light & Power; and the City of Seward
Electric System.
    The following provisions that are currently present in the NSPS for
stationary CI internal combustion engines for engines that are located
in areas of Alaska that are not accessible by the FAHS will be extended
to stationary CI internal combustion engines located in the areas
identified above:
     Exemption for all pre-2014 model year engines from diesel
fuel sulfur requirements;
     Allowance for owners and operators of stationary CI
engines to use engines certified to marine engine standards, rather
than land-based nonroad engine standards;
     No requirement to meet emission standards that would
necessitate the use of aftertreatment devices for NOX, in
particular, SCR (emission standards that are not based on the use of
aftertreatment devices for NOX will apply);
     No requirement to meet emission standards that would
necessitate the use of aftertreatment devices for PM until the 2014
model year; and
     Allowance for the blending of used lubricating oil, in
volumes of up to 1.75 percent of the total fuel, if the sulfur content
of the used lubricating oil is less than 200 ppm and the used
lubricating oil is ``on-spec,'' i.e., it meets the on-specification
levels and properties of 40 CFR 279.11.

IV. Impacts of the Proposed Action

A. Economic Impacts

    The EPA does not expect any significant economic impacts as a
result of this proposed rule. A significant economic impact for the
amendment allowing the temporary override of inducements in emergency
situations is not anticipated because AECDs are expected to be
activated rarely (if ever), and, thus, the impacts to affected sources
and consumers of affected output will be minimal.
    The economic impact from the change to the criteria for remote
areas of Alaska will be a cost savings for owners or operators of
engines that are located in the additional areas that will now be
considered remote. The precise savings depends on the number and size
of engines that will be installed each year. Information provided by
the Alaska Energy Authority indicated that one to two new engines are
expected to be installed each year. Information provided by the state
of Alaska indicated that the expected initial capital cost savings per
engine ranges from $28,000 to $163,000, depending on the size of the
engine. There will also be annual operating and maintenance cost
savings due to avoidance of the need to obtain and store DEF.

B. Environmental Impacts

    The EPA does not expect any significant environmental impacts as a
result of the proposed amendment to allow a temporary override of
inducements in emergency situations. The AECDs are expected to be
activated rarely (if ever) and will only affect emissions for a very
short period.
    The EPA also does not expect significant environmental impacts as a
result of the proposed amendments to the criteria for remote areas of
Alaska. As an example, allowing the use of a Tier 3 engine instead of a
Tier 4 engine would result in less reductions for a 250 HP stationary
CI engine of 5.4 tons per year (tpy) of NOX, 0.1 tpy of
NMHC, 1.6 tpy of CO, and 0.3 tpy of PM, assuming the engine operates
full time (8,760 hours per year).\7\ As stated previously, the state of
Alaska estimates that only one to two new engines will be installed
each year in the additional remote areas.
---------------------------------------------------------------------------

    \7\ Estimates are based on Tier 3 and Tier 4 emission factors
for a 175-300 HP engine provided in Table A4 of Exhaust and
Crankcase Emission Factors for Nonroad Engine Modeling--Compression-
Ignition. NR-009d. Assessment and Standards Division, Office of
Transportation and Air Quality. U.S. Environmental Protection
Agency. EPA-420-R-10-018. July 2010. http://www.epa.gov/otaq/models/nonrdmdl/nonrdmdl2010/420r10018.pdf.
---------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review, and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control number 2060-0590. The proposed regulatory relief for stationary
CI engines would be voluntary and optional.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden or otherwise has a positive economic effect on the small
entities subject to the rule. As mentioned earlier in this preamble,
the EPA is harmonizing the NSPS for stationary CI engines in this
action with an existing rule issued by the EPA for nonroad CI engines.
Thus, this action is reducing regulatory impacts to small entities as
well as other affected entities. The EPA is also including additional
remote areas of Alaska in the regulatory flexibility provisions already
in the rule for remote areas of Alaska, which further reduces the
burden of the existing rule on small entities and other

affected entities. We have, therefore, concluded that this action will
relieve regulatory burden for all directly regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local, or tribal governments or the private sector. This action does
not contain a federal mandate that may result in expenditures of $100
million or more for the private sector in any one year. Engine
manufacturers have the flexibility to choose whether or not to use
optional AECDs.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

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

    This action does not have tribal implications as specified in
Executive Order 13175. It will not have substantial direct effects on
tribal governments, on the relationship between the federal government
and Indian tribes, or on the distribution of power and responsibilities
between the federal government and Indian tribes, as specified in
Executive Order 13175. This proposed rule would impose compliance costs
primarily on engine manufacturers, depending on the extent to which
they take advantage of the flexibilities offered. The proposed
amendments to expand the areas that are considered remote areas of
Alaska would reduce the compliance costs for owners and operators of
stationary engines in those areas. Thus, Executive Order 13175 does not
apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes this action will not have potential
disproportionately high and adverse human health or environmental
effects on minority, low-income, or indigenous populations. The
provisions being proposed in this action are designed to eliminate
risks to human life and are expected to be used rarely, if at all, and
will only affect emissions for a very short period. Other changes the
EPA is proposing to make have minimal effect on emissions.

List of Subjects in 40 CFR Part 60

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.

    Dated: October 30, 2015.
Gina McCarthy,
Administrator.
    For the reasons stated in the preamble, title 40, chapter I, part
60 of the Code of the Federal Regulations is proposed to be amended as
follows:

PART 60--STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES

0
1. The authority citation for part 60 continues to read as follows:

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

Subpart IIII--Standards of Performance for Stationary Compression
Ignition Internal Combustion Engines

0
2. Amend Sec.  60.4201 by revising paragraph (f)(1) and adding
paragraph (h) to read as follows:

Sec.  60.4201  What emission standards must I meet for non-emergency
engines if I am a stationary CI internal combustion engine
manufacturer?

* * * * *
    (f) * * *
    (1) Remote areas of Alaska; and
* * * * *
    (h) Stationary CI ICE certified to the standards in 40 CFR part
1039 and equipped with auxiliary emission control devices (AECDs) as
specified in 40 CFR 1039.665 must meet the Tier 1 certification
emission standards for new nonroad CI engines in 40 CFR 89.112 while
the AECD is activated during a qualified emergency situation. When the
qualified emergency situation has ended and the AECD is deactivated,
the engine must resume meeting the otherwise applicable emission
standard specified in this section.
0
3. Amend Sec.  60.4202 by revising paragraph (g)(1) to read as follows:

Sec.  60.4202  What emission standards must I meet for emergency
engines if I am a stationary CI internal combustion engine
manufacturer?

* * * * *
    (g) * * *
    (1) Remote areas of Alaska; and
* * * * *
0
4. Amend Sec.  60.4204 by adding paragraph (f) to read as follows:

Sec.  60.4204  What emission standards must I meet for non-emergency
engines if I am an owner or operator of a stationary CI internal
combustion engine?

* * * * *
    (f) Owners and operators of stationary CI ICE certified to the
standards in 40 CFR part 1039 and equipped with AECDs as specified in
40 CFR 1039.665 must meet the Tier 1 certification emission standards
for new nonroad CI engines in 40 CFR 89.112 while the AECD is activated
during a qualified emergency situation. A qualified emergency situation
is defined in 40 CFR 1039.665. When the qualified emergency situation
has ended and the AECD is deactivated, the engine must resume meeting
the otherwise applicable emission standard specified in this section.
0
5. Amend Sec.  60.4210 by adding paragraph (j) to read as follows:

Sec.  60.4210  What are my compliance requirements if I am a stationary
CI internal combustion engine manufacturer?

* * * * *
    (j) Stationary CI ICE manufacturers may equip their stationary CI
internal combustion engines certified to the emission standards in 40
CFR part 1039 with AECDs for qualified emergency situations according
to the requirements

of 40 CFR 1039.665. Manufacturers of stationary CI ICE equipped with
AECDs as allowed by 40 CFR 1039.665 must meet all of the requirements
in 40 CFR 1039.665 that apply to manufacturers. Manufacturers must
provide data demonstrating that the engine complies with the Tier 1
standard in 40 CFR 89.112 when the AECD is activated when applying for
certification of an engine equipped with an AECD as allowed by 40 CFR
1039.665.
0
6. Amend Sec.  60.4211 by adding paragraph (h) to read as follows:

Sec.  60.4211  What are my compliance requirements if I am an owner or
operator of a stationary CI internal combustion engine?

* * * * *
    (h) The requirements for operators and prohibited acts specified in
40 CFR 1039.665 apply to owners or operators of stationary CI ICE
equipped with AECDs for qualified emergency situations as allowed by 40
CFR 1039.665.
0
7. Amend Sec.  60.4214 by adding paragraph (e) to read as follows:

Sec.  60.4214  What are my notification, reporting, and recordkeeping
requirements if I am an owner or operator of a stationary CI internal
combustion engine?

* * * * *
    (e) Owners or operators of stationary CI ICE equipped with AECDs
pursuant to the requirements of 40 CFR 1039.665 must report the use of
AECDs as required by 40 CFR 1039.665(e).
0
8. Amend Sec.  60.4216 by revising paragraphs (b) through (d) and (f)
as follows:

Sec.  60.4216  What requirements must I meet for engines used in
Alaska?

* * * * *
    (b) Except as indicated in paragraph (c) of this section,
manufacturers, owners and operators of stationary CI ICE with a
displacement of less than 10 liters per cylinder located in remote
areas of Alaska may meet the requirements of this subpart by
manufacturing and installing engines meeting the requirements of 40 CFR
parts 94 or 1042, as appropriate, rather than the otherwise applicable
requirements of 40 CFR parts 89 and 1039, as indicated in sections
Sec. Sec.  60.4201(f) and 60.4202(g) of this subpart.
    (c) Manufacturers, owners and operators of stationary CI ICE that
are located in remote areas of Alaska may choose to meet the applicable
emission standards for emergency engines in Sec. Sec.  60.4202 and
60.4205, and not those for non-emergency engines in Sec. Sec.  60.4201
and 60.4204, except that for 2014 model year and later non-emergency CI
ICE, the owner or operator of any such engine that was not certified as
meeting Tier 4 p.m. standards, must meet the applicable requirements
for PM in Sec. Sec.  60.4201 and 60.4204 or install a PM emission
control device that achieves PM emission reductions of 85 percent, or
60 percent for engines with a displacement of greater than or equal to
30 liters per cylinder, compared to engine-out emissions.
    (d) The provisions of Sec.  60.4207 do not apply to owners and
operators of pre-2014 model year stationary CI ICE subject to this
subpart that are located in remote areas of Alaska.
* * * * *
    (f) The provisions of this section and Sec.  60.4207 do not prevent
owners and operators of stationary CI ICE subject to this subpart that
are located in remote areas of Alaska from using fuels mixed with used
lubricating oil, in volumes of up to 1.75 percent of the total fuel.
The sulfur content of the used lubricating oil must be less than 200
parts per million. The used lubricating oil must meet the on-
specification levels and properties for used oil in 40 CFR 279.11.
0
9. Amend Sec.  60.4219 by adding in alphabetical order the definitions
for ``Alaska Railbelt Grid'' and ``Remote areas of Alaska'' to read as
follows:

Sec.  60.4219  What definitions apply to this subpart?

* * * * *
    Alaska Railbelt Grid means the service areas of the six regulated
public utilities that extend from Fairbanks to Anchorage and the Kenai
Peninsula. These utilities are Golden Valley Electric Association;
Chugach Electric Association; Matanuska Electric Association; Homer
Electric Association; Anchorage Municipal Light & Power; and the City
of Seward Electric System.
* * * * *
    Remote areas of Alaska means areas of Alaska that meet either
paragraph (1) or (2) of this definition.
    (1) Areas of Alaska that are not accessible by the Federal Aid
Highway System (FAHS).
    (2) Areas of Alaska that meet all of the following criteria:
    (i) The only connection to the FAHS is through the Alaska Marine
Highway System, or the stationary CI ICE operation is within an
isolated grid in Alaska that is not connected to the statewide
electrical grid referred to as the Alaska Railbelt Grid.
    (ii) At least 10 percent of the power generated by the stationary
CI ICE on an annual basis is used for residential purposes.
    (iii) The generating capacity of the source is less than 12
megawatts, or the stationary CI ICE is used exclusively for backup
power for renewable energy.
* * * * *
[FR Doc. 2015-28342 Filed 11-5-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40588-40591]
[FR Doc No: 2021-16057]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0698]

Outsourcing Facility Fee Rates for Fiscal Year 2022

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2022 rates for the establishment and reinspection fees
related to entities that compound human drugs and elect to register as
outsourcing facilities under the Federal Food, Drug, and Cosmetic Act
(FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual
establishment fee from outsourcing facilities, as well as a
reinspection fee for each reinspection of an outsourcing facility. This
document establishes the FY 2022 rates for the small business
establishment fee ($5,824), the non-small business establishment fee
($18,999), and the reinspection fee ($17,472) for outsourcing
facilities; provides information on how the fees for FY 2022 were
determined; and describes the payment procedures outsourcing facilities
should follow. These fee rates are effective October 1, 2021, and will
remain in effect through September 30, 2022.

FOR FURTHER INFORMATION CONTACT: For more information on human drug
compounding and outsourcing facility fees: Visit FDAs website at:
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm.
    For questions relating to this notice: Melissa Hurley, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., Rm. 61075, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 503B of the FD&C Act (21 U.S.C. 353b), a human drug
compounder can become an ``outsourcing facility.'' Outsourcing
facilities, as defined in section 503B(d)(4), are facilities that meet
all the conditions described in section 503B(a), including registering
with FDA as an outsourcing facility and paying an annual establishment
fee. If the conditions of section 503B are met, a drug compounded by or
under the direct supervision of a licensed pharmacist in an outsourcing
facility is exempt from three sections of the FD&C Act: (1) Section
502(f)(1) (21 U.S.C. 352(f)(1)) concerning the labeling of drugs with
adequate directions for use; (2) section 505 (21 U.S.C. 355) concerning
the approval of human drug products under new drug applications (NDAs)
or abbreviated new drug applications (ANDAs); and (3) section 582 (21
U.S.C. 360eee-1) concerning drug supply chain security requirements.
Drugs compounded in outsourcing facilities are not exempt from the
requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)) concerning current good manufacturing practice
requirements for drugs.
    Section 744K of the FD&C Act (21 U.S.C. 379j-62) authorizes FDA to
assess and collect the following fees associated with outsourcing
facilities: (1) An annual establishment fee from each outsourcing
facility and (2) a reinspection fee from each outsourcing facility
subject to a reinspection (see section 744K(a)(1) of the FD&C Act).
Under statutorily defined conditions, a qualified applicant may pay a
reduced small business establishment fee (see section 744K(c)(4) of the
FD&C Act).
    FDA announced in the Federal Register of November 24, 2014 (79 FR
69856), the availability of a final guidance for industry entitled
``Fees for Human Drug Compounding Outsourcing Facilities Under Sections
503B and 744K of the FD&C Act.'' The guidance provides additional
information on the annual fees for outsourcing facilities and
adjustments required by law, reinspection fees, how to submit payment,
the effect of failure to pay fees, and how to qualify as a small
business to obtain a reduction of the annual establishment fee. This
guidance can be accessed on FDA's website at: https://www.fda.gov/media/136683/download.

II. Fees for FY 2022

A. Methodology for Calculating FY 2022 Adjustment Factors

1. Inflation Adjustment Factor
    Section 744K(c)(2) of the FD&C Act specifies the annual inflation
adjustment for outsourcing facility fees. The inflation adjustment has
two components: One based on FDA's payroll costs and one based on FDA's
non-payroll costs for the first 3 of the 4 previous fiscal years. The
payroll component of the annual inflation adjustment is calculated by
taking the average change in FDA's per-full time equivalent (FTE)
personnel compensation and benefits (PC&B) in the first 3 of the 4
previous fiscal years (see section 744K(c)(2)(A)(ii) of the FD&C Act).
FDA's total annual spending on PC&B is divided by the total number of
FTEs per fiscal year to determine the average PC&B per FTE.
    Table 1 summarizes the actual cost and FTE data for the specified
fiscal years, and provides the percent change from the previous fiscal
year and the average percent change over the first 3 of the 4 fiscal
years preceding FY 2022. The 3-year average is 2.7383 percent.

                                 Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                Fiscal year                       2018              2019              2020        3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................    $2,690,678,000    $2,620,052,000    $2,875,592,000  ..............
Total FTE.................................            17,023            17,144            17,535  ..............
PC&B per FTE..............................          $158,061          $152,826          $163,992  ..............
Percent change from previous year.........            4.2206           -3.3120            7.3063          2.7383
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this
2.7383 percent should be multiplied by the proportion of PC&B to total
costs of an average FDA FTE for the same 3 fiscal years.

                      Table 2--FDA PC&Bs as a Percent of FDA Total Costs of an Average FTE
----------------------------------------------------------------------------------------------------------------
                Fiscal year                       2018              2019              2020        3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................    $2,690,678,000    $2,620,052,000    $2,875,592,000  ..............
Total Costs...............................    $5,370,935,000    $5,663,389,000    $6,039,321,000  ..............
PC&B Percent..............................           50.0970           46.2630           47.6145         47.9915
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.7383 percent multiplied by 47.9915
percent, or 1.3142 percent.
    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that the
portion of the inflation adjustment for non-payroll costs for FY 2022
is equal to the average annual percent change in the Consumer Price
Index (CPI) for urban consumers (U.S. City Average; Not Seasonally
Adjusted; All items; Annual Index) for the first 3 years of the
preceding 4 years of available data, multiplied by the proportion of
all non-PC&B costs to total costs of an average FDA FTE for the same
period.
    Table 2 provides the summary data for the percent change in the
specified CPI for U.S. cities. These data are published by the Bureau
of Labor Statistics and can be found on its website: https://data.bls.gov/cgi-bin/surveymost?cu. The data can be viewed by checking
the box marked ``U.S. city average, All items--CUUR0000SA0'' and then
selecting ``Retrieve Data.''

                   Table 3--Annual and 3-Year Average Percent Change in U.S. City Average CPI
----------------------------------------------------------------------------------------------------------------
                      Year                             2018            2019            2020       3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................................         251.107         255.657         258.811  ..............
Annual Percent Change...........................          2.4425          1.8120          1.2337          1.8294
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this
1.8294 percent should be multiplied by the proportion of all non-PC&B
costs to total costs of an average FTE for the same 3 fiscal years. The
proportion of all non-PC&B costs to total costs of an average FDA FTE
for FYs 2018 to 2020 is 52.0085 percent (100 percent minus 47.9915
percent equal 52.0085 percent). Therefore, the non-pay adjustment is
1.8294 percent times 52.0085 percent, or 0.9514 percent.
    The PC&B component (1.3142 percent) is added to the non-PC&B
component (0.9514 percent), for a total inflation adjustment of 2.2656
percent (rounded). Section 744K(c)(2)(A)(i) of the FD&C Act specifies
that one is added to that figure, making the inflation adjustment
1.022656.
    Section 744K(c)(2)(B) of the FD&C Act provides for this inflation
adjustment to be compounded after FY 2015. This factor for FY 2022
(2.2656 percent) is compounded by adding one to it, and then
multiplying it by one plus the inflation adjustment factor for FY 2021
(13.8991 percent), as published in the Federal Register on August 4,
2020 (85 FR 47225). The result of this multiplication of the inflation
factors for the 7 years since FY 2015 (1.022656 x 1.138991) becomes the
inflation adjustment for FY 2022. For FY 2022, the inflation adjustment
is 16.4796 percent (rounded). We then add one, making the FY 2022
inflation adjustment factor 1.164796.
2. Small Business Adjustment Factor
    Section 744K(c)(3) of the FD&C Act specifies that in addition to
the inflation adjustment factor, the establishment fee for non-small
businesses is to be further adjusted for a small business adjustment
factor. Section 744K(c)(3)(B) of the FD&C Act provides that the small
business adjustment factor is the adjustment to the establishment fee
for non-small businesses that is necessary to achieve total fees
equaling the amount that FDA would have collected if no entity
qualified for the small business exception in section 744K(c)(4) of the
FD&C Act. Additionally, section 744K(c)(5)(A) states that in
establishing the small business adjustment factor for a fiscal year,
FDA shall provide for the crediting of fees from the previous year to
the next year if FDA overestimated the amount of the small business
adjustment factor for such previous fiscal year.
    Therefore, to calculate the small business adjustment to the
establishment fee for non-small businesses for FY 2022, FDA must
estimate: (1) The number of outsourcing facilities that will pay the
reduced fee for small businesses for FY 2022 and (2) the total fee
revenue it would have collected if no entity had qualified for the
small business exception (i.e., if each entity that registers as an
outsourcing facility for FY 2022 were to pay the inflation-adjusted fee
amount of $17,472).
    With respect to (1), FDA estimates that 12 entities will qualify
for small business exceptions and will pay the reduced fee for FY 2022.
With respect to (2), to estimate the total number of entities that will
register as outsourcing facilities for FY 2022, FDA used data submitted
by outsourcing facilities through the voluntary registration process,
which began in December 2013. Accordingly, FDA estimates that 80
outsourcing facilities, including 12 small businesses, will be
registered with FDA in FY 2022.
    If the projected 80 outsourcing facilities paid the full inflation-
adjusted fee of $17,472, this would result in total revenue of
$1,397,760 in FY 2022 ($17,472 x 80). However, 12 of the entities that
are expected to register as outsourcing facilities for FY 2022 are
projected to qualify for the small business exception and to pay one-
third of the full fee ($5,824 x 12), totaling $69,888 instead of paying
the full fee ($17,472 x 12), which would total $209,664. This would
leave a potential shortfall of $139,776 ($209,664 minus $69,888).
    Additionally, section 744K(c)(5)(A) of the FD&C Act states that in
establishing the small business adjustment factor for a fiscal year,
FDA shall provide for the

crediting of fees from the previous year to the next year if FDA
overestimated the amount of the small business adjustment factor for
such previous fiscal year. FDA has determined that it is appropriate to
credit excess fees collected from the last completed fiscal year, due
to the inability to conclusively determine the amount of excess fees
from the fiscal year that is in progress at the time this calculation
is made. This crediting is done by comparing the small business
adjustment factor for the last completed fiscal year, FY 2020 ($2,208),
to what would have been the small business adjustment factor for FY
2020 ($1,671) if FDA had estimated perfectly.
    The calculation for what the small business adjustment would have
been if FDA had estimated perfectly begins by determining the total
target collections (15,000 x [inflation adjustment factor] x [number of
registrants]). For the most recent complete fiscal year, FY 2020, this
was $1,293,446 ($16,798 x 77). The actual FY 2020 revenue from the 77
total registrants (i.e., 67 registrants paying FY 2020 non-small
business establishment fee and 10 small business registrants) paying
establishment fees is $1,181,456. $1,181,456 is calculated as follows:
(FY 2020 Non-Small Business Establishment Fee adjusted for inflation
only) x (total number of registrants in FY 2020 paying Non-Small
Business Establishment Fee) + (FY 2020 Small Business Establishment
Fee) x (total number of small business registrants in FY 2020 paying
Small Business Establishment Fee). $16,798 x 67 + $5,599 x 10 =
$1,181,456. This left a shortfall of $111,990 from the estimated total
target collection amount ($1,293,446 minus $1,181,456). This amount
($111,990) divided by the total number of registrants in FY 2020 paying
Standard Establishment Fee (67) equals $1,671.
    The difference between the small business adjustment factor used in
FY 2020 and the small business adjustment factor that would have been
used had FDA estimated perfectly is $537 ($2,208 minus $1,671). The
$537 (rounded to the nearest dollar) is then multiplied by the number
of actual registrants who paid the standard fee for FY 2020 (67), which
provides us a total excess collection of $35,963 in FY 2020.
    Therefore, to calculate the small business adjustment factor for FY
2022, FDA subtracts $35,963 from the projected shortfall of $139,776
for FY 2022 to arrive at the numerator for the small business
adjustment amount, which equals $103,813. This number divided by 68
(the number of expected non-small businesses for FY 2022) is the small
business adjustment amount for FY 2022, which is $1,527 (rounded to the
nearest dollar).

B. FY 2022 Rates for Small Business Establishment Fee, Non-Small
Business Establishment Fee, and Reinspection Fee

1. Establishment Fee for Qualified Small Businesses \1\
---------------------------------------------------------------------------

    \1\ To qualify for a small business reduction of the FY 2022
establishment fee, entities had to submit their exception requests
by April 30, 2021. See section 744K(c)(4)(B) of the FD&C Act. The
time for requesting a small business exception for FY 2022 has now
passed. An entity that wishes to request a small business exception
for FY 2023 should consult section 744K(c)(4) of the FD&C Act and
section III.D of FDA's guidance for industry entitled ``Fees for
Human Drug Compounding Outsourcing Facilities Under Sections 503B
and 744K of the FD&C Act,'' which can be accessed on FDA's website
at https://www.fda.gov/media/136683/download.
---------------------------------------------------------------------------

    The amount of the establishment fee for a qualified small business
is equal to $15,000 multiplied by the inflation adjustment factor for
that fiscal year, divided by 3 (see section 744K(c)(4)(A) and (c)(1)(A)
of the FD&C Act). The inflation adjustment factor for FY 2022 is
1.164796. See section II.A.1 for the methodology used to calculate the
FY 2022 inflation adjustment factor. Therefore, the establishment fee
for a qualified small business for FY 2022 is one third of $17,472,
which equals $5,824 (rounded to the nearest dollar).
2. Establishment Fee for Non-Small Businesses
    Under section 744K(c) of the FD&C Act, the amount of the
establishment fee for a non-small business is equal to $15,000
multiplied by the inflation adjustment factor for that fiscal year,
plus the small business adjustment factor for that fiscal year, and
plus or minus an adjustment factor to account for over or under
collections due to the small business adjustment factor in the prior
year. The inflation adjustment factor for FY 2022 is 1.164796. The
small business adjustment amount for FY 2022 is $1,527. See section
II.A.2 for the methodology used to calculate the small business
adjustment factor for FY 2022. Therefore, the establishment fee for a
non-small business for FY 2022 is $15,000 multiplied by 1.164796 plus
$1,527, which equals $18,999 (rounded to the nearest dollar).
3. Reinspection Fee
    Section 744K(c)(1)(B) of the FD&C Act provides that the amount of
the FY 2022 reinspection fee is equal to $15,000, multiplied by the
inflation adjustment factor for that fiscal year. The inflation
adjustment factor for FY 2022 is 1.164796. Therefore, the reinspection
fee for FY 2022 is $15,000 multiplied by 1.164796, which equals $17,472
(rounded to the nearest dollar). There is no reduction in this fee for
small businesses.

C. Summary of FY 2022 Fee Rates

                   Table 4--Outsourcing Facility Fees
------------------------------------------------------------------------

------------------------------------------------------------------------
Qualified Small Business Establishment Fee..............          $5,824
Non-Small Business Establishment Fee....................          18,999
Reinspection Fee........................................          17,472
------------------------------------------------------------------------

III. Fee Payment Options and Procedures

A. Establishment Fee

    Once an entity submits registration information and FDA has
determined that the information is complete, the entity will incur the
annual establishment fee. FDA will send an invoice to the entity, via
email to the email address indicated in the registration file, or via
regular mail if email is not an option. The invoice will contain
information regarding the obligation incurred, the amount owed, and
payment procedures. A facility will not be registered as an outsourcing
facility until it has paid the annual establishment fee under section
744K of the FD&C Act. Accordingly, it is important that facilities
seeking to operate as outsourcing facilities pay all fees immediately
upon receiving an invoice. If an entity does not pay the full invoiced
amount within 15 calendar days after FDA issues the invoice, FDA will
consider the submission of registration information to have been
withdrawn and adjust the invoice to reflect that no fee is due.
    Outsourcing facilities that registered in FY 2021 and wish to
maintain their status as an outsourcing facility in FY 2022 must
register during the annual registration period that lasts from October
1, 2021, to December 31, 2021. Failure to register and complete payment
by December 31, 2021, will result in a loss of status as an outsourcing
facility on January 1, 2022. Entities should submit their registration
information no later than December 10, 2021, to allow enough time for
review of the registration information, invoicing, and payment of fees
before the end of the registration period.

B. Reinspection Fee

    FDA will issue invoices for each reinspection after the conclusion
of the reinspection, via email to the email address indicated in the
registration file

or via regular mail if email is not an option. Invoices must be paid
within 30 days.

C. Fee Payment Procedures

    1. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American Express). Secure electronic
payments can be submitted using the User Fees Payment Portal at--
https://userfees.fda.gov/pay. (Note: only full payments are accepted.
No partial payments can be made online.) Once you search for your
invoice, click ``Pay Now'' to be redirected to Pay.gov. Electronic
payment options are based on the balance due. Payment by credit card is
available for balances less than $25,000. If the balance exceeds this
amount, only the ACH option is available. Payments must be made using
U.S. bank accounts as well as U.S. credit cards.
    2. If paying with a paper check: Checks must be in U.S. currency
from a U.S. bank and made payable to the Food and Drug Administration.
Payments can be mailed to: Food and Drug Administration, P.O. Box
979033, St. Louis, MO 63197-9000. Include invoice number on check. If a
check is sent by a courier that requests a street address, the courier
can deliver the check to: U.S. Bank, Attn: Government Lockbox 979033,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only. If you have any questions
concerning courier delivery, contact the U.S. Bank at<PHONE_NUMBER>).
    3. When paying by wire transfer, the invoice number must be
included. Without the invoice number the payment may not be applied.
Regarding reinspection fees, if the payment amount is not applied, the
invoice amount will be referred to collections. The originating
financial institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required that the
outsourcing facility add that amount to the payment to ensure that the
invoice is paid in full. Use the following account information when
sending a wire transfer: U.S. Dept of the Treasury, TREAS NYC, 33
Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No.
021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number
is 53-0196965.

    Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16057 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-RO3-OAR-2008-0068; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans; Delaware;
Control of Stationary Combustion Turbine Electric Generating Unit
Emissions

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:  EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the State of Delaware. This revision pertains to
controlling nitrogen oxides emissions from stationary combustion turbine
electric generating units.  This action is being taken under the Clean
Air Act (CAA).

DATES: Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-RO3-OAR-2008-0068 by one of the following methods:

 www.regulations.gov.  Follow the on-line instructions for submitting
comments.

B.    E-mail<EMAIL_ADDRESS>
C.    Mail:   EPA-RO3-OAR-2008-0068, Cristina Fernandez, Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

     D.   Hand Delivery: At the previously-listed EPA Region III
address.  Such deliveries are only accepted during the Docket(s normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-RO3-OAR-2008-0068.  EPA's policy is that all comments received will
be included in the public docket without change, and may be made
available online at www.regulations.gov, including any personal
information provided, unless the comment includes information claimed to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.  Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov or
e-mail.  The www.regulations.gov website is an (anonymous access(
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment.  If you
send an e-mail comment directly to EPA without going through
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet.  If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit.  If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment.  Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute.  Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form.  Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Delaware Department of Natural Resources &
Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover, Delaware
19903.

FOR FURTHER INFORMATION CONTACT: Gerallyn Duke,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:  On September 11, 2007, the Delaware
Department of Natural Resources and Environmental Control (DNREC)
submitted to EPA a revision to its SIP for Regulation 1148 - Control of
Nitrogen Oxides (NOx) Emissions from Stationary Combustion Turbine
Electric Generating Units.

I.    Background

DNREC has identified large stationary combustion turbines (CTs) as
significant contributors to the release of NOx, which is a precursor to
the formation of ground-level ozone.  Ozone poses a significant threat
to human health especially to the young, the elderly, or anyone with
impaired ability to breathe, as ozone harms the lungs.

CTs normally operate at peak times for the demand for electricity.  In
Delaware, peak times are in the summer and coincide with hot and humid
weather conditions that are conducive to the formation of ozone.  By
reducing NOx emissions from CTs during the ozone season, the likelihood
that Delaware’s air quality will exceed the federal standards for
ozone is reduced.  This regulation will affect six existing CTs in
Delaware, each with an installed capacity of 1 megawatt (MW), none of
which currently operate with any NOx pollution control equipment.

These six CTs emitted 2.21 tons of NOx per day in 2002, which is the
most recent year for Delaware’s emissions inventory.  DNREC has
determined that use of water injection technology would reduce NOx
emissions by approximately 40 percent, or by 0.88 tons per day.  Water
injection reduces the combustion temperature and consequently reduces
NOx emissions.

Delaware is part of the Philadelphia-Wilmington-Atlantic City ozone
nonattainment area and it must take regulatory actions to improve air
quality to meet the 8-Hour Ozone National Ambient Air Quality Standard
(NAAQS) by 2010.  This regulation is one of many regulatory actions that
DNREC has undertaken in recent years as part of its SIP which is a
federal requirement to show that Delaware’s air quality will attain
compliance with the 8-Hour Ozone NAAQS by 2010.  No inconsistencies or
inadequacies regarding EPA policy and the Clean Air Act have been
identified.

II.   Summary of SIP Revision

Rregulation 1148 – Control of NOx Emissions from Stationary Combustion
Turbine Electric Generating Units requires that an owner or operator of
an existing stationary combustion turbine electric generating unit
located in Delaware with a base-load nameplate capacity of 1 MW or
greater must, by May 1, 2009, either demonstrate that the existing
stationary combustion turbine generating unit meets the emission limits
listed below or must install NOx emission controls

designed to meet these limits: for CTs that burn gaseous fuel – 42
parts per million volume (ppmv), corrected to 15 percent O2 dry basis
NOx,, and for CTs that burn liquid fuel – 88 ppmv NOx.  Design of
these limits was based on anticipated NOx emissions if water injection
pollution control equipment were installed.

The six CTs affected by this regulation operate without any NOx
pollution control equipment, although they are subject to regulations
designed to control NOx emissions.  DNREC determined that the six
sources could achieve significant reductions in their NOx emissions
through the use of water injection equipment.  Water injection is a
proven, feasible technology that has been used in other states to reduce
NOx emissions.

This revision will reduce NOx emissions from CTs by 40 percent, or by
0.88 tons per day to approximately 1.33 tons per day.  Such a reduction
will significantly improve air quality, particularly on days when CTs
normally operate, i.e., hot humid days and when weather conditions are
conducive to forming ground-level ozone, and is one of the many
regulatory steps taken to allow DNREC to attain the NAAQS by 2010.

Proposed Action

EPA is proposing to approve the Delaware SIP revision for Control of
Stationary Combustion Turbine Electric Generating Unit Emissions, which
was submitted on September 11, 2007.  This SIP revision will have a
beneficial effect on air quality in the Delaware portion of the

Philadelphia – Wilmington – Atlantic City ozone nonattainment area.
EPA is soliciting public comments on the issues discussed in this
document.  These comments will be considered before taking final action.

IV. Statutory and Executive Order Reviews

Under the Clean Air Act, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations.  42 U.S.C. 7410(k); 40 CFR 52.02(a).  Thus, in
reviewing SIP submissions, EPA’s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  Accordingly,
this action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law.  For that reason, this proposed action:

is not a "significant regulatory action” subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

does not impose an information collection burden under the provisions of
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);

does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4);

does not have Federalism implications as specified in Executive Order
13132 (64 FR 43255, August 10, 1999);

is not an economically significant regulatory action based on health or
safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997);

is not a significant regulatory action subject to Executive Order 13211
(66 FR 28355, May 22, 2001);

is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with the
Clean Air Act; and

does not provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994).

In addition, this proposed approval of Delaware’s Stationary
Combustion Turbine Engine emissions rule does not have tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements.

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

____July 1, 2008______________           ___________/s/_________________

Dated:                                                      Donald S.
Welsh,

Regional Administrator,

                                                                 Region
III.

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