[Federal Register Volume 85, Number 90 (Friday, May 8, 2020)]
[Notices]
[Page 27419]
[FR Doc No: 2020-09832]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5319]

Notice of Followup to Notice of Public Hearing and Request for
Comments on Devices Proposed for a New Use With an Approved, Marketed
Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a followup on a Federal Register document issued on
September 26, 2017, that announced a public hearing and requested
comments on a potential approach to enable device sponsors to obtain
marketing authorization for their products labeled for a new use with
an approved, marketed drug when the sponsor for the approved drug does
not wish to pursue or collaborate on the new use, referred to in the
notice as devices referencing drugs (DRDs). After further consideration
and in light of the comments received, FDA does not intend to pursue
the potential approach described in the referenced Federal Register
document at this time.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5130, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA issued a Federal Register document on
September 26, 2017 (82 FR 44803), entitled ``Devices Proposed for a New
Use With an Approved, Marketed Drug; Public Hearing; Request for
Comments''. The document announced a public hearing and requested
comments on a potential approach to enable device sponsors to obtain
marketing authorization for their products labeled for a new use with
an approved, marketed drug when the sponsor for the approved drug does
not wish to pursue or collaborate on the new use. Such new uses
generally involve a change in how the drug is used or administered,
such as a change in dose, route, or rate of administration, or use of
the approved drug for an indication for which it is not approved. As
discussed in the document, such DRDs raise unique public health,
scientific, regulatory, and legal issues, which the potential approach
was intended to address. However, after further consideration and in
light of the comments received during the public hearing and submitted
to the docket, FDA does not intend to pursue the potential approach
described in the document at this time.

    Dated: May 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09832 Filed 5-7-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Proposed Rules]
[Pages 65675-65680]
[FR Doc No: 2015-27168]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2015-0592; FRL-9936-14-Region 5]

Air Plan Approval; Minnesota; Revision to Visibility Federal
Implementation Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
revise the Minnesota Federal implementation plan (FIP) for visibility,
to establish emission limits for Northern States Power Company's
(NSP's) Sherburne County Generating Station (Sherco), pursuant to a
settlement agreement. The settlement agreement, signed by
representatives of EPA, NSP, and three environmental groups, was for
resolution of a lawsuit filed by the environmental groups for EPA to
address any contribution from Sherco to reasonably attributable
visibility impairment (RAVI) that the Department of Interior (DOI)
certified was occurring at Voyageurs and Isle Royale National Parks.

DATES: Comments must be received on or before November 27, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0592, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Douglas Aburano, Chief, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Douglas Aburano, Chief, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
Such deliveries are only accepted during the Regional Office normal
hours of operation, and special arrangements should be made for
deliveries of boxed information. The Regional Office official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2015-0592. 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 email. The
www.regulations.gov Web site 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 email comment
directly to EPA without going through www.regulations.gov your email
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 docket are listed in the
www.regulations.gov index. 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 in
www.regulations.gov or at the Environmental Protection Agency, Region
5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago,
Illinois 60604. This facility is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding Federal holidays. We recommend that
you telephone John Summerhays, Environmental Scientist, at (312) 886-
6067 before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: John Summerhays, Environmental
Scientist, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This supplementary information section is
arranged as follows:

I. What regulations apply to RAVI?

II. What is the history and content of the Sherco settlement
agreement?
III. What action is EPA taking?
IV. Statutory and Executive Order Reviews

I. What regulations apply to RAVI?

    Section 169A of the Clean Air Act provides for a visibility
protection program and sets forth as a national goal ``the prevention
of any future, and the remedying of any existing, impairment of
visibility in mandatory Class I Federal areas which impairment results
from manmade air pollution.'' \1\ Pursuant to these statutory
requirements, EPA promulgated regulations entitled ``Visibility
Protection'' in subpart P of Title 40 of the Code of Federal
Regulations (40 CFR), specifically in 40 CFR 51.300 et seq., which
include separate requirements addressing RAVI and regional haze. 45 FR
80084 (December 2, 1980). The term ``reasonably attributable visibility
impairment'' is defined in 40 CFR 51.301 to mean ``visibility
impairment that is caused by the emission of air pollutants from one,
or a small number of sources.'' These regulations at 40 CFR
51.302(c)(1) provide that ``[t]he affected Federal Land Manager may
certify to the State, at any time, that there exists reasonably
attributable impairment of visibility in any mandatory Class I Federal
area.''
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    \1\ In accordance with the mandate of section 169A(a)(2), 40 CFR
part 81 subpart D (40 CFR 81.400 to 81.437) specifies the mandatory
Class I Federal areas where visibility is an important value and the
visibility is impaired by manmade air pollution.
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    The visibility regulations also provide for periodic review, and
revision as appropriate, of the long-term strategy for making
reasonable progress toward the visibility goals, including review and
revision as appropriate within three years of receipt of certification
of RAVI from a Federal land manager (FLM). 40 CFR 51.306(c). The 36
affected states were required to submit revisions to their SIPs to
comply with these requirements by September 2, 1981. 40 CFR
51.302(a)(1) (1981). See 45 FR 80084, 80091.
    Most states did not meet the September 2, 1981 deadline for
submitting a SIP revision to address visibility protection. A number of
environmental groups sued EPA, alleging that the Agency had failed to
perform a nondiscretionary duty under section 110(c) of the Clean Air
Act to promulgate visibility FIPs. To settle the lawsuit, EPA agreed to
promulgate visibility FIPs according to a specified schedule. On July
12, 1985, EPA promulgated a FIP for the visibility monitoring strategy
and new source review (NSR) requirements at 40 CFR 51.304 and 51.307.
50 FR 28544. See also 51 FR 5504 (February 13, 1986) and 51 FR 22937
(June 24, 1986). These provisions have been codified at 40 CFR 52.26,
52.27 and 52.28. On November 24, 1987, EPA continued its visibility FIP
rulemaking by promulgating its plan for meeting the general visibility
plan requirements and long-term strategies of 40 CFR 51.302 and 51.306.
52 FR 45132. The long-term strategy provisions have been codified at 40
CFR 52.29; the provisions specifically pertaining to Minnesota are at
40 CFR 52.1236.
    In the proposed rulemaking for the general visibility plan and
long-term strategy requirements, EPA addressed certifications of
existing visibility impairment submitted by the FLMs. 52 FR 7802 (March
12, 1987). EPA found that the information provided by the FLMs was not
adequate to enable the Agency to determine whether the impairment was
traceable to a single source or small number of sources and therefore
addressable under the visibility regulations. For this reason, EPA
determined that the implementation plans did not need to require best
available retrofit technology (BART) or other control measures at that
time. EPA also acknowledged, however, that the FLMs may certify the
existence of visibility impairment at any time and that the FLMs
therefore might provide additional information in the future on
impairment that would allow EPA to attribute it to a specific source.
EPA stated that in such cases, the information regarding impairment and
the need for BART or other control measures would be reviewed and
assessed as part of the periodic review of the long-term visibility
strategy. 52 FR 7802, 7808. EPA affirmed these determinations in its
final rulemaking. 52 FR 45136 (November 24, 1987).
    Based on this history, unless and until Minnesota submits a plan
that EPA approves as satisfying the RAVI-related visibility planning
requirements, the current plan for addressing RAVI is a Federal plan,
and EPA has the authority and obligation to review the RAVI plan for
Minnesota periodically and to make any necessary revisions. The
adoption of the emission limits being proposed here is an element of
fulfilling that responsibility.
    As will be discussed below, the settlement agreement regarding
Sherco provides for the adoption of specified emission limits that
address DOI's concerns that led to a RAVI certification at Voyageurs
and Isle Royale National Parks. Because these emission limits will
address the concerns DOI raised in its RAVI certification, there is no
need for us to evaluate whether Sherco is the source of the impairment
in Voyageurs or Isle Royale or to determine the emission levels that
would be achieved by BART if BART were necessary.

II. What is the history and content of the Sherco settlement agreement?

    On October 21, 2009, DOI certified to EPA that RAVI was occurring
at the Voyageurs and Isle Royale National Parks, in Northern Minnesota
and Northern Michigan, respectively. DOI cited numerous results from an
analysis described in Minnesota's regional haze submittal, which in
DOI's view demonstrated that Sherco was the source of this RAVI.
    Separately, Minnesota submitted its regional haze plan on December
30, 2009, and submitted a proposed supplemental submission on January
5, 2012. In this plan as supplemented, Minnesota proposed no emission
limits for Sherco (or for other electric generating units (EGUs) in
Minnesota), relying instead on Federal trading program rules known as
the Transport Rule to satisfy pertinent requirements for BART.\2\ EPA
proposed to approve this element of Minnesota's plan on January 25,
2012, at 77 FR 3681, but stated that this proposal did not address
whether Minnesota had satisfied the requirements that applied as a
result of DOI's certification of RAVI.
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    \2\ This proposal was consistent with a proposed finding by EPA
that the Transport Rule provided better visibility protection than
source-specific BART on electric generating units, and consistent
with an associated proposed rule allowing states to rely on the
Transport Rule in lieu of source-specific BART for these sources.
This exemption applies only to NOX and SO2,
but Minnesota found that no control was necessary to satisfy BART
for other pollutants.
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    Minnesota submitted a final supplemental regional haze submittal on
May 8, 2012. In this submittal, Minnesota submitted source-specific
limits on sulfur dioxide (SO2) and nitrogen oxides
(NOX) emissions from Sherco, which it found to represent
BART. These limits applied to the stack serving Units 1 and 2, limiting
SO2 emissions to 0.12 pounds per million British Thermal
Units (lbs/MMBtu) and limiting NOX emissions to 0.15 lbs/
MMBtu. EPA approved these limits as ``an enhancement that make the
Minnesota's submission more stringent than it would be if it simply
relied on [the Transport Rule] to address'' BART requirements for EGUs,
thereby concluding that these limits in combination with the Transport
Rule satisfied pertinent BART requirements for EGUs in the state. 77 FR
34801, 34803 (June 12, 2012). EPA took no action during that rulemaking
as to

whether Minnesota's plan satisfied requirements triggered by DOI's
certification of RAVI.
    On December 5, 2012, with subsequent amendments on March 25, 2015,
the National Parks Conservation Association, Sierra Club, and the
Minnesota Center for Environmental Advocacy filed a lawsuit in the U.S.
District Court for the District of Minnesota seeking to compel action
by EPA to address DOI's RAVI certification. On July 24, 2014, pursuant
to action by the U.S. Court of Appeals for the Eighth Circuit, NSP
gained standing as an intervenor in this case. These parties engaged in
settlement discussions with EPA, leading to a draft settlement
agreement that the parties signed on May 15, 2015. EPA published a
notice soliciting comments on this settlement agreement on June 1,
2015, at 80 FR 31031. EPA received two sets of generally supportive
comments, and on July 24, 2015, the Department of Justice notified the
Eighth Circuit that the settlement agreement was final.
    The terms of this settlement agreement require EPA to propose new
SO2 emission limits for Units 1 and 2\3\ and for Unit 3 at
Sherco. Specifically, the settlement agreement requires EPA to propose
an emission limit for Units 1 and 2 of 0.050 lbs/MMBtu, expressed as a
rolling 30-day average. EPA anticipates that NSP will be able to meet
this limit through the use of low sulfur coal and the facility's
existing flue gas desulfurization equipment. The settlement agreement
requires EPA to propose an emission limit for Unit 3 of 0.29 lbs/MMBtu,
also expressed as a rolling 30-day average. EPA anticipates that
Northern States Power will be able to meet this limit with the
facility's existing flue gas desulfurization equipment and increased
use of desulfurizing reagent.
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    \3\ Because Units 1 and 2 vent through a shared stack, the
proposed emission limit applies to the combined emissions of these
two units.
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    The settlement agreement further states that compliance with these
emission limits must be determined on the basis of data obtained by a
continuous emission monitor operated in accordance with 40 CFR part 75.
Compliance with the limits, expressed as limits on 30-day average
emissions, must be determined by dividing the sum of the SO2
emissions over each period of 30 successive boiler-operating days by
the total heat input over that same period. The settlement agreement
provides that the data used to determine compliance shall reflect any
bias adjustments provided for in appendix A to 40 CFR part 75, but
shall not use substituted data provided for in 40 CFR part 75 subpart
D.\4\
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    \4\ The provisions of 40 CFR part 75 specify the requirements
for operation and data reporting for continuous emission monitoring
for facilities such as Sherco that are subject to the Acid Rain
Program. Under 40 CFR part 75, such facilities must conduct periodic
tests to determine whether the measurements underlying the reported
emission values are biased; if the results fail to meet the criteria
in 40 CFR part75 appendix A 7.6.4, reflecting sufficient
underestimation to warrant adjustment, the measured results are
multiplied times a bias adjustment factor computed in 40 CFR part 75
appendix A 7.6.5. For hours when the facility is operating but the
emission monitor is not generating valid data, the settlement
agreement specifies that data obtained by the ``Missing Data
Substitution Procedures'' required for Acid Rain Program purposes in
40 CFR part 75 subpart D shall not be used.
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    Finally, Paragraph 5 of the settlement agreement states that
``Sherco Units 1 and 2 will achieve [its SO2 emission limit]
starting October 1, 2015, . . . and . . . Sherco Unit 3 will achieve
[its SO2 emission limit] starting June 1, 2017.'' (Emphasis
added). Paragraph 5 continues, ``EPA agrees to propose such emission
limitations . . . with a compliance date for Units 1 and 2 of October
1, 2015, and a compliance date for Unit 3 of June 1, 2017.'' Attachment
A to the settlement agreement states, for Units 1 and 2, ``[i]nitial
compliance with [the] limit shall be demonstrated no later than October
1, 2015,'' and, for Unit 3, ``[i]nitial compliance with [the] limit
shall be demonstrated no later than June 1, 2017.''
    Accordingly, under the proposed rule, the first compliance
demonstration for Units 1 and 2 would be computed on October 1, 2015,
using data from the immediately preceding 30 boiler-operating days.
Similarly, the first compliance demonstration for Unit 3 would use data
from the 30 boiler-operating days immediately preceding June 1, 2017.
For example, under this proposed rule, if the boilers operate every
day, the first 30-day period for which compliance at Units 1 and 2 is
required is the period from September 1 to September 30, 2015, and the
first 30-day period for which compliance at Unit 3 is required is May 2
to May 31, 2017.
    EPA recognizes that the compliance deadline for Units 1 and 2
predates the prospective final rulemaking. Because NSP is a party to
the settlement agreement, however, the company has had adequate notice
that an initial demonstration of compliance with the limits for Units 1
and 2 would be required on October 1, 2015, notwithstanding provisions
in the settlement agreement that would allow EPA to sign a final
rulemaking as late as February 2016.
    On August 11, 2015, DOI wrote to EPA regarding the settlement
agreement. DOI recounted that its prior letter, dated October 21, 2009,
had ``identified visibility impairment at Voyageurs and Isle Royale
National Parks likely attributable to [Sherco],'' but noted that ``a
number of events have led or will lead to significant improvements in
visibility at these Parks,'' including the continued ``trend of
reducing sulfur dioxide emissions at Sherco'' resulting from the
settlement agreement. DOI concluded that ``[a]lthough the settlement
reaches a different result than the recommendation made in our [letter
certifying RAVI], once implemented, the settlement achieves an outcome
that addresses our visibility concerns at Voyageurs and Isle Royale
National Parks.''
    In light of this August 11, 2015 letter, EPA is proposing to find
that the incorporation of these SO2 emission limits into the
Minnesota visibility FIP satisfies any outstanding obligation EPA has
with respect to DOI's 2009 RAVI certification. Specifically, EPA
believes that the emission limits obviate the need for an analysis of
the magnitude or origins of visibility impairment at Voyageurs or Isle
Royale or potential BART control options at Sherco. While DOI's 2009
certification expressed particular concern with Sherco's NOX
emissions, modeling in Minnesota's regional haze plan (particularly in
the Sherco BART analysis) suggests that SO2 emissions have
comparable visibility impacts to NOX at these parks. As a
result, EPA anticipates that the visibility improvement that will
result from the proposed SO2 emission limits, when
considered in conjunction with the SO2 and NOX
reductions already achieved by the Minnesota regional haze SIP, will be
comparable to any improvement that might have resulted from additional
NOX limits. To be clear, EPA is not proposing to find that
the RAVI DOI certified in 2009 at Voyageurs or Isle Royale was
attributable to emissions from Sherco, that Sherco is currently a
source of RAVI, or that BART controls are necessary at Sherco. EPA is
instead proposing to find that such determinations are no longer
necessary in light of the significant emission reductions that will
occur at Sherco as a result of the settlement agreement, which
addresses the concerns DOI originally expressed in 2009.

III. What action is EPA taking?

    In accordance with the settlement agreement signed on May 15, 2015,
by representatives of EPA, three environmental groups, and NSP, EPA is

proposing to incorporate the emission limits identified in the
agreement into the Minnesota visibility FIP. Specifically, EPA is
proposing the following limits:

--For stack SV001, serving Units 1 and 2, a limit on SO2
emissions of 0.050 lbs/MMBtu, as a 30-day rolling average, determined
as the ratio of pounds of emissions divided by the heat input in MMBtu,
both summed over 30 successive boiler-operating days, beginning on the
30-boiler-operating-day period ending September 30, 2015. For purposes
of this limit, a boiler operating day is defined as a day in which fuel
is combusted in either Unit 1 or Unit 2 (or both).
--For Unit 3, a limit on SO2 of 0.29 lbs/MMBtu, as a 30-day
rolling average, also determined as the ratio of pounds of emissions
divided by the heat input in MMBtu, both summed over 30 successive
boiler-operating days, beginning on the 30-boiler-operating-day period
ending May 31, 2017.

    Additionally, in light of DOI's August 11, 2015 letter, EPA is
proposing to find that the incorporation of these SO2
emission limits into the Minnesota visibility FIP satisfies any
outstanding obligation EPA has with respect to DOI's 2009 RAVI
certification. EPA intends to conduct no analysis of the magnitude or
origins of visibility impairment at Voyageurs or Isle Royale or review
of potential BART control options at Sherco in response to this
certification.

IV. Statutory and Executive Order Reviews

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

    This proposed action is not a ``significant regulatory action''
under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993)
and is therefore not subject to review under Executive Orders 12866 and
13563 (76 FR 3821, January 21, 2011). As discussed in detail in section
IV.C below, the proposed FIP applies to only one source. It is
therefore not a rule of general applicability.

B. Paperwork Reduction Act

    This proposed action does not impose an information collection
burden under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq. Under the Paperwork Reduction Act, a ``collection of
information'' is defined as a requirement for ``answers to . . .
identical reporting or recordkeeping requirements imposed on ten or
more persons. . . .'' 44 U.S.C. 3502(3)(A). Because the proposed FIP
applies to just one facility, the Paperwork Reduction Act does not
apply. See 5 CFR 1320(c).
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid Office of Management and Budget (OMB) control number.
The OMB control numbers for EPA's regulations in 40 CFR are listed in
40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's proposed rule on
small entities, small entity is defined as: (1) A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of this proposed action on
small entities, I certify that this proposed action will not have a
significant economic impact on a substantial number of small entities.
EPA's proposal adds additional controls to a certain source. The
Regional Haze FIP revisions that EPA is proposing here would impose
Federal control requirements to resolve concerns that one power plant
in Minnesota is unduly affecting visibility at two national parks. The
power plant and its owners are not small entities.

D. Unfunded Mandates Reform Act (UMRA)

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and Tribal
governments and the private sector. Under section 202 of UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and Tribal governments, in
the aggregate, or to the private sector, of $100 million or more
(adjusted for inflation) in any one year. Before promulgating an EPA
rule for which a written statement is needed, section 205 of UMRA
generally requires EPA to identify and consider a reasonable number of
regulatory alternatives and adopt the least costly, most cost-
effective, or least burdensome alternative that achieves the objectives
of the rule. The provisions of section 205 of UMRA do not apply when
they are inconsistent with applicable law. Moreover, section 205 of
UMRA allows EPA to adopt an alternative other than the least costly,
most cost-effective, or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including Tribal governments, it must have developed under
section 203 of UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
    Under Title II of UMRA, EPA has determined that this proposed rule
does not contain a Federal mandate that may result in expenditures that
exceed the inflation-adjusted UMRA threshold of $100 million by State,
local, or Tribal governments or the private sector in any one year. In
addition, this proposed rule does not contain a significant Federal

intergovernmental mandate as described by section 203 of UMRA, nor does
it contain any regulatory requirements that might significantly or
uniquely affect small governments.

E. Executive Order 13132: Federalism

    Federalism (64 FR 43255, August 10, 1999) revokes and replaces
Executive Orders 12612 (Federalism) and 12875 (Enhancing the
Intergovernmental Partnership). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have Federalism implications.'' ``Policies that have Federalism
implications'' is defined in the Executive Order to include regulations
that 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.'' Under Executive Order 13132, EPA may not issue a
regulation that has Federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or EPA
consults with State and local officials early in the process of
developing the proposed regulation. EPA also may not issue a regulation
that has Federalism implications and that preempts State law unless the
Agency consults with State and local officials early in the process of
developing the proposed regulation.
    This rule 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, as specified in Executive Order 13132, because it
merely extends an existing FIP by promulgating emission limits for one
source in accordance with a settlement agreement. Thus, Executive Order
13132 does not apply to this action. In the spirit of Executive Order
13132, and consistent with EPA policy to promote communications between
EPA and State and local governments, EPA specifically solicits comment
on this proposed rule from State and local officials.

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

    Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 9, 2000), requires EPA
to develop an accountable process to ensure ``meaningful and timely
input by tribal officials in the development of regulatory policies
that have tribal implications.'' This proposed rule does not have
tribal implications, as specified in Executive Order 13175. It will not
have substantial direct effects on tribal governments. Thus, Executive
Order 13175 does not apply to this rule. However, EPA did discuss this
action in a July 16, 2015, conference call with Michigan and Minnesota
Tribes, and EPA invites further comment from tribes that may be
interested in this action.

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

    Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to
any rule that: (1) Is determined to be economically significant as
defined under Executive Order 12866; and (2) concerns an environmental
health or safety risk that we have reason to believe may have a
disproportionate effect on children. EPA interprets E.O. 13045 as
applying only to those regulatory actions that concern health or safety
risks, such that the analysis required under section 5-501 of the E.O.
has the potential to influence the regulation. This action is not
subject to E.O. 13045 because it is neither economically significant
nor pertinent to an environmental health or safety risk that might have
a disproportionate effect on children. However, to the extent this
proposed rule will limit emissions of SO2, the rule will
have a beneficial effect on children's health by reducing air
pollution.

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

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12 of the National Technology Transfer and Advancement Act
(NTTAA) of 1995 requires Federal agencies to evaluate existing
technical standards when developing a new regulation. To comply with
NTTAA, EPA must consider and use ``voluntary consensus standards''
(VCS) if available and applicable when developing programs and policies
unless doing so would be inconsistent with applicable law or otherwise
impractical.
    The EPA believes that VCS are inapplicable to this action. Today's
action does not require the public to perform activities conducive to
the use of VCS.

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

    Executive Order 12898 (59 FR 7629, February 16, 1994), establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    We have determined that this proposed rule, if finalized, will not
have disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Sulfur dioxide, Reporting and
recordkeeping requirements, visibility protection.

    Dated: October 9, 2015.
Susan Hedman,
Regional Administrator, Region 5.

    40 CFR part 52 is proposed to be amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

0
2. Section 52.1236 is amended by adding paragraph (e) to read as
follows:

Sec.  52.1236  Visibility protection.

* * * * *
    (e)(1) On and after the 30-boiler-operating-day period ending on
September 30, 2015, the owners and operators of the facility at 13999

Industrial Boulevard in Becker, Sherburne County, Minnesota, shall not
cause or permit the emission of SO2 from stack SV001
(serving Units 1 and 2) to exceed 0.050 lbs/MMBTU as a 30-day rolling
average.
    (2) On and after the 30-boiler-operating-day period ending on May
31, 2017, the owners and operators of the facility at 13999 Industrial
Boulevard in Becker, Sherburne County, Minnesota, shall not cause or
permit the emission of SO2 from Unit 3 to exceed 0.29 lbs/
MMBTU as a 30-day rolling average.
    (3) The owners and operators of the facility at 13999 Industrial
Boulevard in Becker, Sherburne County, Minnesota, shall operate
continuous SO2 emission monitoring systems in compliance
with 40 CFR part 75, and the data from this emission monitoring shall
be used to determine compliance with the limits in this paragraph (e).
    (4) For each boiler operating day, compliance with the 30-day
average limitations in paragraphs (e)(1) and (e)(2) of this section
shall be determined by summing total emissions in pounds for the period
consisting of the day and the preceding 29 successive boiler operating
days, summing total heat input in MMBTU for the same period, and
computing the ratio of these sums in lbs/MMBTU. Boiler operating day is
used to mean a 24-hour period between 12 midnight and the following
midnight during which any fuel is combusted at any time in the steam-
generating unit. It is not necessary for fuel to be combusted the
entire 24-hour period. A boiler operating day with respect to the
limitation in paragraph (e)(1) of this section shall be a day in which
fuel is combusted in either Unit 1 or Unit 2. Bias adjustments provided
for under 40 CFR part 75 appendix A shall be applied. Substitute data
provided for under 40 CFR part 75 subpart D shall not be used.

[FR Doc. 2015-27168 Filed 10-26-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 46 (Thursday, March 11, 2021)]
[Rules and Regulations]
[Pages 13816-13819]
[FR Doc No: 2021-05049]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2020-0102; FRL-10021-39-Region 4]

Air Plan Approval; KY; Jefferson County; Gasoline Loading
Facilities at Existing Bulk Terminals and New Bulk Plants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving
revisions to the Jefferson County portion of the Kentucky State
Implementation Plan (SIP), submitted by the Commonwealth of Kentucky,
through the Energy and Environment Cabinet (Cabinet) on September 5,
2019. The revisions were submitted by the Cabinet on behalf of the
Louisville Metro Air Pollution Control District (District) and include
amendments related to the standards for existing gasoline loading
facilities at bulk terminals and new gasoline loading facilities at
bulk plants. The amendments to these standards replace a requirement
for gasoline tank trucks to possess a valid Kentucky pressure vacuum
test sticker with a requirement for specific vapor tightness testing
and recordkeeping procedures, clarify rule applicability, and remove
language stating that a pressure measuring device will be supplied by
the District. EPA is approving the revisions because they are
consistent with the Clean Air Act (CAA or Act).

DATES: This rule is effective April 12, 2021.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2020-0102. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials can either
be retrieved electronically via www.regulations.gov or in hard copy at
the at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sarah LaRocca, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-8994. Ms. LaRocca can also be reached

via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. EPA's Action

    EPA is approving changes to Regulation 6.21, Standard of
Performance for Existing Gasoline Loading Facilities at Bulk Terminals,
and Regulation 7.20, Standard of Performance for New Gasoline Loading
Facilities at Bulk Plants, of the Jefferson County portion of the
Kentucky SIP, submitted by the Commonwealth of Kentucky on September 5,
2019. The amendments replace the requirement for tank trucks being
loaded at bulk terminals and plants to possess a valid Kentucky
pressure vacuum test sticker with specific vapor tightness testing and
recordkeeping requirements and make minor, non-substantive changes as
discussed in section II. These SIP revisions update the current SIP-
approved versions of Regulation 6.21 (Version 2) and Regulation 7.20
(Version 2) to Version 3.

II. EPA's Analysis of the Revisions

    The District's September 5, 2019, SIP revisions include changes to
Regulation 6.21 and Regulation 7.20 related to standards for existing
gasoline loading facilities at bulk terminals and standards for new
gasoline loading facilities at bulk plants, respectively, as described
below. The District notes that it enacted these regulations to control
volatile organic compound emissions from gasoline loading facilities
and that Regulations Parts 6 and 7 apply more stringent standards to a
broader cross-section of sources than the Federal New Source
Performance Standards (NSPS).\1\
---------------------------------------------------------------------------

    \1\ 40 CFR part 60, subpart XX, is the Federal NSPS containing
standards of performance for bulk gasoline terminals.
---------------------------------------------------------------------------

    The District has revised Regulation 6.21 and Regulation 7.20 to
discontinue the practice of requiring gasoline transport vehicles to
display a Kentucky pressure vacuum test sticker. Specifically, the
revisions to Regulation 6.21 and Regulation 7.20 delete the text of
subsection 3.6.4 and subsection 3.11.1, respectively, which provide
that no owner or operator of a bulk gasoline terminal or plant subject
to these regulations may allow a tank truck or trailer to be loaded
with gasoline unless the vehicle has ``a valid Kentucky pressure-vacuum
test sticker as required by Regulation 6.37 attached and visibly
displayed.'' \2\ This requirement is replaced with specific procedures
for assuring that tank trucks and their associated vapor collection
systems have passed the required vapor tightness test on an annual
basis. New subsection <IP_ADDRESS> of Regulation 6.21 and subsection
<IP_ADDRESS> of Regulation 7.20 state that no owner or operator of an
existing bulk gasoline terminal or a new bulk gasoline plant shall
allow loading unless the gasoline tank truck and its vapor collection
system has demonstrated a pressure change within specific parameters.
---------------------------------------------------------------------------

    \2\ The District has no record of ever having created
``Regulation 6.37'' (see email from Byron Gary, Louisville Air
Pollution Control District, to Sarah LaRocca, EPA Region 4, March
23, 2020), and the Jefferson County portion of the Kentucky SIP does
not contain ``Regulation 6.37.'' The District's September 5, 2019,
revisions rectify this discrepancy by removing the references to the
non-existent ``Regulation 6.37'' and adding new provisions (at
subsection 3.6.4 for Regulation 6.21 and subsection 3.11.1 for
Regulation 7.20) containing detailed, updated procedures that
explicitly state the vapor tightness and recordkeeping requirements.
---------------------------------------------------------------------------

    The SIP revision also adds a new subsection <IP_ADDRESS> of Regulation
6.21 and a new subsection <IP_ADDRESS> of Regulation 7.20 to specify the
testing procedures that must be used to assure compliance with the new
vapor tightness requirements. As approved for incorporation into the
SIP, these subsections require that EPA Method 27, ``Determination of
Vapor Tightness of Gasoline Delivery Tank Using Pressure Vacuum Test,''
as specified in 40 CFR part 60, appendix A, on July 1, 1991, shall be
used to determine compliance with subsection <IP_ADDRESS> of Regulation 6.21
and subsection <IP_ADDRESS> of Regulation 7.20.\3\ The new subsections also
require the owner or operator of a tank truck being loaded at an
affected facility to have this vapor tightness test completed annually
and to maintain all testing records (i.e., test data, date of testing,
identification of tank truck, type of repair, retest data and date) for
two years after the date of testing, and to make such records available
upon request by the District. EPA notes that the District's revised
tank truck vapor tightness standards, testing procedures, and
recordkeeping requirements as approved for incorporation into the SIP
are consistent with the Commonwealth of Kentucky's requirements at 401
KAR 63:031, Leaks from gasoline tank trucks, and also with EPA's
requirements applicable to gasoline cargo tanks under 40 CFR part 60,
subpart XX, Standards of Performance for Bulk Gasoline Terminals (see
40 CFR 60.505(b)) and 40 CFR part 63, subpart BBBBBB, National Emission
Standards for Hazardous Air Pollutants for Source Category: Gasoline
Distribution Bulk Terminals, Bulk Plants, and Pipeline Facilities (see
40 CFR 63.11092(f)(1) and 63.11094(b)).
---------------------------------------------------------------------------

    \3\ EPA is not acting on the phrase ``or an alternate procedure
approved by the District'' in the District's new subsection <IP_ADDRESS>
of Regulation 6.21 and subsection <IP_ADDRESS> of Regulation 7.20. The
District has withdrawn this phrase from the SIP revision. The
withdrawal letter is included in the docket for this action.
---------------------------------------------------------------------------

    The revisions also include minor changes to Regulation 6.21 and
Regulation 7.20. A non-substantive change to Section 1 of Regulation
6.21 clarifies that the rule applies to each affected facility that was
either existing or had a construction permit issued on or before June
13, 1979.\4\ The non-substantive changes to Regulation 7.20 clarify
that the rule applies to each affected facility which commenced
construction, modification, or reconstruction after June 13, 1979; \5\
remove language in subsection 3.11.3 such that a pressure measuring
device is no longer required to be supplied by the District; and
renumber subsections within Section 3.
---------------------------------------------------------------------------

    \4\ The prior version of the rule states that it applies to
``each affected facility which was in being or had a construction
permit issued by the District before June 13, 1979.'' ``Affected
facility'' is defined in Section 2.1 of the rule as ``facilities at
a bulk gasoline terminal for loading gasoline into tank trucks,
trailers, railroad tank cars, or other mobile, non-marine vessels.''
    \5\ The prior version of the rule states that it applies to
``each new affected facility which is commenced after the June 13,
1979.'' ``Affected facility'' is defined in Section 2.1 of the rule
as ``a bulk gasoline plant.''
---------------------------------------------------------------------------

    Because these rule revisions will not allow an increase in air
pollutant emissions, EPA has determined that these changes will not
interfere with attainment or maintenance of the NAAQS, reasonable
further progress, or any other applicable requirement of the CAA.
    In a notice of proposed rulemaking (NPRM) published on January 22,
2021 (86 FR 6589), EPA proposed to approve changes to the Jefferson
County portion of the Kentucky SIP, provided on September 5, 2019. The
January 21, 2021, NPRM provides additional detail regarding the
background and rationale for EPA's action. Comments on the NPRM were
due on or before February 22, 2021. One comment was received on the
NPRM and is addressed below.

III. Response to Comments

    EPA received one comment on its January 21, 2021, NPRM. The comment
is provided in the docket for this final action. EPA has summarized and
responded to the comment below.
    Comment: The commenter ``agree[s] with th[e] proposed rule because
the results will be beneficial to protecting air quality'' and states
that the rule would be impactful because automobile emissions are a
large contributor to air pollution. The commenter further states

that ``requiring tank trucks to have this vacuum stickers will help
ensure that less volatile emissions will be released into the air'' and
that ``tank drivers would have to update this sticker annually,
ensuring that the automobiles stay up to date with regulations.''
    Response: Although the commenter expresses agreement with the
proposed rule, they are mistaken regarding the nature of the action. As
discussed throughout the NPRM, the revisions to Regulation 6.21 and
Regulation 7.20 remove the requirement for gasoline transport vehicles
to display a Kentucky pressure vacuum test sticker in Jefferson County.
The revisions replace the sticker requirement with specific procedures
for assuring that tank trucks and their associated vapor collection
systems have passed the required vapor tightness test on an annual
basis. The revisions also require the owner or operator of a tank truck
being loaded at an affected facility to maintain all testing records
for two years after the date of testing and to make such records
available upon request by the District. EPA is approving the revisions
because the new testing requirements are as stringent as those that
would have been required to obtain a pressure vacuum test sticker, and
therefore will not allow an increase in air pollutant emissions, and
because the revisions are otherwise consistent with the CAA.

IV. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Louisville
Metro Air Pollution Control District Regulation 6.21, Standard of
Performance for Existing Gasoline Loading Facilities at Bulk Terminals,
Version 3, and Regulation 7.20, Standard of Performance for New
Gasoline Loading Facilities at Bulk Plants, Version 3, effective June
19, 2019, with the exception of the phrase ``or an alternate procedure
approved by the District'' in Regulation 6.21, subsection <IP_ADDRESS> and
Regulation 7.20, subsection <IP_ADDRESS>. The changes to these rules
replace a requirement for gasoline tank trucks to possess valid
pressure vacuum test sticker with a requirement for specific vapor
tightness testing and recordkeeping procedures, clarify rule
applicability, and remove language stating that a pressure measuring
device will be supplied by the District. EPA has made, and will
continue to make, these materials generally available through
www.regulations.gov and at the EPA Region 4 office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information). Therefore, these materials have
been approved by EPA for inclusion in the State implementation plan,
have been incorporated by reference by EPA into that plan, are fully
federally enforceable under sections 110 and 113 of the CAA as of the
effective date of the final rulemaking of EPA's approval, and will be
incorporated by reference in the next update to the SIP compilation.\6\
---------------------------------------------------------------------------

    \6\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

V. Final Action

    EPA is approving the revisions to Regulation 6.21, Standard of
Performance for Existing Gasoline Loading Facilities at Bulk Terminals,
Version 3, and Regulation 7.20, Standard of Performance for New
Gasoline Loading Facilities at Bulk Plants, Version 3 of the Jefferson
County portion of the Kentucky SIP, submitted on September 5, 2019, as
discussed above.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 10, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Volatile organic compounds.

    Dated: March 5, 2021.
John Blevins,
Acting Regional Administrator, Region 4.

    For the reason stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart S--Kentucky

0
2. Section 52.920(c), Table 2, is amended under ``Reg 6--Standards of
Performance for Existing Affected Facilities'' by revising the entry
for ``6.21'' and under ``Reg 7--Standards of Performance for New
Affected Facilities'' by revising the entry for ``7.20'' to read as
follows:

Sec.  52.920   Identification of plan.

* * * * *
    (c) * * *

                                             Table 2--EPA-Approved Jefferson County Regulations for Kentucky
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     EPA approval                               District
                 Reg                          Title/subject              date       Federal Register notice  effective date          Explanation
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                            Reg 6--Standards of Performance for Existing Affected Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
6.21................................  Standard of Performance for        3/11/2021  [Insert citation of           6/19/2019  Except for the phrase ``or
                                       Existing Gasoline Loading                     publication].                            an alternate procedure
                                       Facilities at Bulk                                                                     approved by the District''
                                       Terminals.                                                                             in subsection <IP_ADDRESS>.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Reg 7--Standards of Performance for New Affected Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
7.20................................  Standard of Performance for        3/11/2021  [Insert citation of             6/19/19  Except for the phrase ``or
                                       New Gasoline Loading                          publication].                            an alternate procedure
                                       Facilities at Bulk Plants.                                                             approved by the District''
                                                                                in subsection <IP_ADDRESS>.

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

* * * * *
[FR Doc. 2021-05049 Filed 3-10-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 95 (Tuesday, May 17, 2011)]
[Proposed Rules]
[Pages 28373-28376]
[FR Doc No: 2011-12015]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0472; Directorate Identifier 2011-NM-005-AD]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Model F.28 Mark
1000, 2000, 3000, and 4000 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing

airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    [T]he Federal Aviation Administration (FAA) has published
Special Federal Aviation Regulation (SFAR) 88, and the Joint
Aviation Authorities (JAA) has published Interim Policy INT/POL/25/
12. The review conducted by Fokker Services on the Fokker F28 Type
Design in response to these regulations revealed that, under certain
failure conditions, a short circuit may develop in the collector
tank level float switch wiring. Such a short circuit may result in
an ignition source in the tank vapour space.
    This condition, if not corrected, could result in a wing fuel
tank explosion and consequent loss of the aeroplane.
* * * * *
The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by July 1, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 231, 2150 AE
Nieuw-Vennep, the Netherlands; telephone +31 (0) 252-627-350; fax +31
(0) 252-627-211; e-mail<EMAIL_ADDRESS>
Internet http://www.myfokkerfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2011-0472;
Directorate Identifier 2011-NM-005-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2010-0194, dated September 29, 2010 (referred
to after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    [T]he Federal Aviation Administration (FAA) has published
Special Federal Aviation Regulation (SFAR) 88, and the Joint
Aviation Authorities (JAA) has published Interim Policy INT/POL/25/
12. The review conducted by Fokker Services on the Fokker F28 Type
Design in response to these regulations revealed that, under certain
failure conditions, a short circuit may develop in the collector
tank level float switch wiring. Such a short circuit may result in
an ignition source in the tank vapour space.
    This condition, if not corrected, could result in a wing fuel
tank explosion and consequent loss of the aeroplane.
    For the reasons described above, this [EASA] AD requires the
installation of a fuse packed in a jiffy junction [i.e., crimped
wire in-line junction device] in the collector tank level float
switch wiring.

The required actions also include revising the aircraft maintenance
program by incorporating critical design configuration control
limitations (CDCCLs). You may obtain further information by examining
the MCAI in the AD docket.
    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: Single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    The Joint Aviation Authorities (JAA) has issued a regulation that
is similar to

SFAR 88. (The JAA is an associated body of the European Civil Aviation
Conference (ECAC) representing the civil aviation regulatory
authorities of a number of European States who have agreed to co-
operate in developing and implementing common safety regulatory
standards and procedures.) Under this regulation, the JAA stated that
all members of the ECAC that hold type certificates for transport
category airplanes are required to conduct a design review against
explosion risks.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

Relevant Service Information

    Fokker Services B.V. has issued Service Bulletin SBF28-28-049,
dated June 23, 2010, including Fokker Drawing W57273, Sheet 002, Issue
C, dated June 23, 2010, Fokker Drawing W58048, Sheet 1, dated April 29,
2010, and Fokker Manual Change Notification MCNM-F28-035, dated June
23, 2010. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 4 products of U.S. registry. We also estimate that
it would take about 5 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $825 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these costs.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $5,000, or $1,250 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Fokker Services B.V.: Docket No. FAA-2011-0472; Directorate
Identifier 2011-NM-005-AD.

Comments Due Date

    (a) We must receive comments by July 1, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Fokker Services B.V. Model F.28 Mark
1000, 2000, 3000, and 4000 airplanes, certificated in any category,
all serial numbers.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new Critical Design Configuration
Control Limitations (CDCCLs). Compliance with these CDCCLs is
required by 14 CFR 91.403(c). For airplanes that have been
previously modified, altered, or repaired in the areas addressed by
this AD, the operator may not be able to accomplish the actions
described in the revisions. In this situation, to comply with 14 CFR
91.403(c), the operator must request approval for an alternative
method of compliance (AMOC) according to paragraph (j) of this AD.
The request should include a description of changes to the required
actions that will ensure the continued operational safety of the
airplane.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    [T]he Federal Aviation Administration (FAA) has published
Special Federal Aviation Regulation (SFAR) 88, and the Joint
Aviation Authorities (JAA) has published Interim Policy INT/POL/25/
12. The review conducted by Fokker Services on the Fokker F28 Type
Design in response to these regulations revealed that, under certain
failure conditions, a short circuit may develop in the collector
tank level float switch wiring. Such a short circuit may result in
an ignition source in the tank vapour space.
    This condition, if not corrected, could result in a wing fuel
tank explosion and consequent loss of the aeroplane.
* * * * *

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 24 months after the effective date of this AD,
install fuses packed in jiffy junctions [i.e., crimped wire in-line
junction device], in accordance with the Accomplishment Instructions
of Fokker Service Bulletin SBF28-28-049, dated June 23, 2010,
including Fokker Drawing W57273, Sheet 002, Issue C, dated June 23,
2010, Fokker Drawing W58048, Sheet 1, dated April 29, 2010, and
Fokker Manual Change Notification MCNM-F28-035, dated June 23, 2010.

Maintenance Program Revision

    (h) Before further flight after doing the modification required
in paragraph (g) of this AD: Revise the maintenance program by
incorporating the CDCCL specified in paragraph 1.L.(1)(c) of Fokker
Services Service Bulletin SBF28-28-049, dated June 23, 2010,
including Fokker Drawing W57273, Sheet 002, Issue C, dated June 23,
2010, Fokker Drawing W58048, Sheet 1, dated April 29, 2010, and
Fokker Manual Change Notification MCNM-F28-035, dated June 23, 2010.

No Alternative Critical Design Configuration Control Limitations
(CDCCLs)

    (i) After accomplishing the revision required by paragraph (h)
of this AD, no alternative CDCCLs may be used unless the CDCCLs are
approved as an alternative method of compliance (AMOC) in accordance
with the procedures specified in paragraph (j) of this AD.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: Although EASA Airworthiness Directive 2010-0194, dated
September 29, 2010, specifies both revising the maintenance program
to include limitations, and maintaining CDCCLs, this AD only
requires the revision. Requiring a revision of the maintenance
program, rather than requiring maintaining CDCCLs, requires
operators to record AD compliance only at the time the revision is
made. Maintaining CDCCLs specified in the airworthiness limitations
must be complied with in accordance with 14 CFR 91.403(c).

Other FAA AD Provisions

    (j) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested, using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be e-mailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (k) Refer to MCAI EASA Airworthiness Directive 2010-0194, dated
September 29, 2010; and Fokker Services Service Bulletin SBF28-28-
049, dated June 23, 2010, including Fokker Drawing W57273, Sheet
002, Issue C, dated June 23, 2010, Fokker Drawing W58048, Sheet 1,
dated April 29, 2010, and Fokker Manual Change Notification MCNM-
F28-035, dated June 23, 2010; for related information.

    Issued in Renton, Washington, on May 6, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-12015 Filed 5-16-11; 8:45 am]
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