[Federal Register: July 8, 2009 (Volume 74, Number 129)]
[Notices]
[Page 32620]
[DOCID:fr08jy09-85]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Blood Products Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 20, 2009, from 8
a.m. to 6 p.m. and on July 21, 2009, from 9 a.m. to 12 noon.
    Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD 20877,<PHONE_NUMBER>.
    Contact Person: William Freas or Pearline K. Muckelvene, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike (HFM-71), Rockville, MD 20852,<PHONE_NUMBER>, or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area), code<PHONE_NUMBER>. Please call the Information
Line for up-to-date information on this meeting. A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On July 20, 2009, in the morning, the committee will review
proposed strategies to demonstrate the effectiveness of new coral snake
antivenoms. In the afternoon, the committee will discuss alternative
clinical and surrogate endpoints for evaluating efficacy of Alpha-1
Proteinase Inhibitor (Human) augmentation therapy in Alpha-1
antitrypsin deficiency. Alpha-1 antitrypsin deficiency is a genetic
condition associated with decreased circulating levels of alpha-1
antitrypsin that significantly increases the risk of serious lung
disease (i.e. emphysemia) in adults. On July 21, 2009, the committee
will hear updates on the following topics: The April 30 to May 1, 2009,
meeting of the Department of Health and Human Services Advisory
Committee on Blood Safety and Availability (http://www.hhs.gov/ophs/
bloodsafety/index.html); the June 12, 2009, meeting of the FDA
Transmissible Spongiform Encephalopathies Advisory Committee (http://
www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
BloodVaccinesandOtherBiologics/
TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/
ucm129559.htm); and an overview of the epidemiology and virology of the
2009 A/H1N1 influenza virus and its impact on the U.S. blood system.
The committee will also hear informational presentations on recent
public and private hemovigilance efforts, including the pilot
hemovigilance module in the National Healthcare Safety Network.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm, scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
15, 2009. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. and 11 a.m. and between approximately 3:45
p.m. and 5 p.m. on July 20, 2009, and between approximately 11:30 a.m.
and 12 noon on July 21, 2009. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before July 13, 2009. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by July 8,
2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact William Freas or
Pearline K. Muckelvene at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    FDA regrets that it was unable to publish this notice 15 days prior
to the July 20, 2009, Blood Advisory Committee meeting. Because the
agency believes there is some urgency to bring these issues to public
discussion and qualified members of the Blood Advisory Committee were
available at this time, the Commissioner of Food and Drugs concluded
that it was in the public interest to hold this meeting even if there
was not sufficient time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: June 29, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-16101 Filed 7-7-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 161 (Tuesday, August 24, 2021)]
[Proposed Rules]
[Pages 47270-47275]
[FR Doc No: 2021-17953]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2021-0531; FRL-8843-01-R3]

Approval and Promulgation of Air Quality Plans; Pennsylvania;
Reasonably Available Control Technology (RACT) Determinations for Case-
by-Case Sources Under the 1997 and 2008 8-Hour Ozone National Ambient
Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve multiple state implementation plan (SIP) revisions submitted by
the Commonwealth of Pennsylvania. These revisions were submitted by the
Pennsylvania Department of Environmental Protection (PADEP) to
establish and require reasonably available control technology (RACT)
for twenty-three major sources of volatile organic compounds (VOC) and/
or nitrogen oxides (NOX) pursuant to the Commonwealth of
Pennsylvania's conditionally approved RACT regulations. In this
rulemaking action, EPA is proposing to approve source-specific RACT
determinations (case-by-case or alternative NOX emission
limits) for sources at twenty-three major NOX and VOC
emitting facilities submitted by PADEP. These RACT evaluations were
submitted to meet RACT requirements for the 1997 and 2008 8-hour ozone
national ambient air quality standards (NAAQS). This action is being
taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before September 23,
2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2021-0531 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, 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. 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, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Ms. Emily Bertram, Permits Branch
(3AD10), Air & Radiation Division, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
The telephone number is<PHONE_NUMBER>. Ms. Bertram can also be reached
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On May 7, 2020, PADEP submitted a revision
to its SIP to address source-specific NOX and/or VOC RACT
for sources at numerous major NOX and VOC emitting
facilities located in the Commonwealth, including the twenty-three
facilities in this action. This SIP revision is intended to address the
NOX and/or VOC RACT requirements under sections 182 and 184
of the CAA for the 1997 and 2008 8-hour ozone NAAQS. Table 1 of this
document lists the SIP submittal date and the facilities included in
PADEP's submittal. Although submitted in one SIP revision by PADEP, EPA
views each facility as a separable SIP revision and may take separate
final action on one or more facilities.
    For additional background information on Pennsylvania's
``presumptive'' RACT II SIP see 84 FR 20274 (May 9, 2019) and on
Pennsylvania's source-specific (case-by-case or alternative
NOX emission limits) RACT determinations see the appropriate
technical support document (TSD) which is available online at https://www.regulations.gov, Docket No. EPA-R03-OAR-2021-0531.

    Table 1--PADEP SIP Submittals for Major NOX and/or VOC Sources in
 Pennsylvania Subject to Source-Specific RACT Under the 1997 and 2008 8-
                           Hour Ozone Standard
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      SIP Submittal date                 Major source (county)
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5/7/2020.....................  AK Steel Corp (formerly Armco, Inc.
                                Butler Operations) (Butler).
                               Allegheny and Tsingshan Stainless LLC,
                                Midland Facility (formerly J & L
                                Specialty Steel Inc., Midland Facility)
                                (Beaver).
                               Alumax Mill Products (Lancaster).
                               American Craft Brewery LLC (Lehigh).
                               American Refining Group Inc (McKean).
                               American Zinc Recycling Corp (Horsehead
                                Resource Development Company, Inc.)
                                (Carbon).
                               Appvion Operations, Inc. (Blair).
                               ArcelorMittal Steelton LLC (formerly
                                Bethlehem Steel Corporation) (Dauphin).
                               Carpenter Technology Corporation, Reading
                                Plt (Berks).
                               Chestnut Ridge Foam Inc (formerly
                                Chestnut Ridge Foam, Inc., Latrobe)
                                (Westmoreland).
                               East Penn Manufacturing Company, Inc.,
                                Battery Assembly (Berks).
                               General Carbide Corporation
                                (Westmoreland).
                               Lord Corp Saegertown (Crawford).
                               NLMK Pennsylvania LLC, Farrell Plt
                                (formerly Caparo Steel Co.--Farrell)
                                (Mercer).
                               Omnova Solutions Inc.--Auburn Plant
                                (formerly Gencorp, Inc.) (Schuylkill).
                               Pixelle Specialty Solutions LLC--Spring
                                Grove Mill (York).
                               Sonneborn LLC (formerly Crompton
                                Corporation, Fairview Township; Witco
                                Corp, Petrolia Facility) (Butler).
                               Specialty Tires of America, Indiana Plant
                                (formerly Specialty Tires of America,
                                Inc.) (Indiana).
                               Standard Steel LLC (formerly Standard
                                Steel Division of Freedom Forge Corp.)
                                (Mifflin).
                               Tennessee Gas Pipeline Co., Mercer
                                Station 219 (Mercer).
                               Truck Accessories Group Milton Plant
                                (formerly Truck Accessories Group East)
                                (Northumberland).
                               United Refining Co (Warren).
                               Wheatland Tube Company (Mercer).
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I. Background

A. 1997 and 2008 8-Hour Ozone NAAQS

    Ground level ozone is not emitted directly into the air but is
created by chemical reactions between NOX and VOC in the
presence of sunlight. Emissions from industrial facilities, electric
utilities, motor vehicle exhaust, gasoline vapors, and chemical
solvents are some of the major sources of NOX and VOC.
Breathing ozone can trigger a variety of health problems, particularly
for children, the elderly, and people of all ages who have lung
diseases such as asthma. Ground level ozone can also have harmful
effects on sensitive vegetation and ecosystems.
    On July 18, 1997, EPA promulgated a standard for ground level ozone
based on 8-hour average concentrations. 62 FR 38856. The 8-hour
averaging period replaced the previous 1-hour averaging period, and the
level of the NAAQS was changed from 0.12 parts per million (ppm) to
0.08 ppm. EPA has designated two moderate nonattainment areas in
Pennsylvania under the 1997 8-hour ozone NAAQS, namely Philadelphia-
Wilmington-Atlantic City, PA-NJ-MD-DE (the Philadelphia Area) and
Pittsburgh-Beaver Valley (the Pittsburgh Area). See 40 CFR 81.339.
    On March 12, 2008, EPA strengthened the 8-hour ozone standards, by
revising its level to 0.075 ppm averaged over an 8-hour period (2008 8-
hour ozone NAAQS). On May 21, 2012, EPA designated five marginal
nonattainment areas in Pennsylvania for the 2008 8-hour ozone NAAQS:
Allentown-Bethlehem-Easton, Lancaster, Reading, the Philadelphia Area,
and the Pittsburgh Area. 77 FR 30088; see also 40 CFR 81.339.
    On March 6, 2015, EPA announced its revocation of the 1997 8-hour
ozone NAAQS for all purposes and for all areas in the country,
effective on April 6, 2015. 80 FR 12264. EPA has determined that
certain nonattainment planning requirements continue to be in effect
under the revoked standard for nonattainment areas under the 1997 8-
hour ozone NAAQS, including RACT.

B. RACT Requirements for Ozone

    The CAA regulates emissions of NOX and VOC to prevent
photochemical reactions that result in ozone formation. RACT is an
important strategy for reducing NOX and VOC emissions from
major stationary sources within areas not meeting the ozone NAAQS.
    Areas designated nonattainment for the ozone NAAQS are subject to
the general nonattainment planning requirements of CAA section 172.
Section 172(c)(1) of the CAA provides that SIPs for nonattainment areas
must include reasonably available control measures (RACM) for
demonstrating attainment of all NAAQS, including emissions reductions
from existing sources through the adoption of RACT. Further, section
182(b)(2) of the CAA sets forth additional RACT requirements for ozone
nonattainment areas classified as moderate or higher.
    Section 182(b)(2) of the CAA sets forth requirements regarding RACT
for the ozone NAAQS for VOC sources. Section 182(f) subjects major
stationary sources of NOX to the same RACT requirements
applicable to major stationary sources of VOC.\1\
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    \1\ A ``major source'' is defined based on the source's
potential to emit (PTE) of NOX or VOC, and the applicable
thresholds for RACT differs based on the classification of the
nonattainment area in which the source is located. See sections
182(c)-(f) and 302 of the CAA.
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    Section 184(b)(1)(B) of the CAA applies the RACT requirements in
section 182(b)(2) to nonattainment areas classified as marginal and to
attainment areas located within ozone transport regions established
pursuant to section 184 of the CAA. Section 184(a) of the CAA
established by law the current Ozone Transport Region (OTR) comprised
of 12 eastern states, including Pennsylvania. This requirement is
referred to as OTR RACT. As noted previously, a ``major source'' is
defined based on the source's potential to emit (PTE) of
NOX, VOC, or both pollutants, and the applicable thresholds
differ based on the classification of the nonattainment area in which
the source is located. See sections 182(c)-(f) and 302 of the CAA.
    Since the 1970's, EPA has consistently defined ``RACT'' as the
lowest emission limit that a particular source is capable of meeting by
the

application of the control technology that is reasonably available
considering technological and economic feasibility.\2\
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    \2\ See December 9, 1976 memorandum from Roger Strelow,
Assistant Administrator for Air and Waste Management, to Regional
Administrators, ``Guidance for Determining Acceptability of SIP
Regulations in Non-Attainment Areas,'' and 44 FR 53762 (September
17, 1979).
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    EPA has provided more substantive RACT requirements through
implementation rules for each ozone NAAQS as well as through guidance.
In 2004 and 2005, EPA promulgated an implementation rule for the 1997
8-hour ozone NAAQS in two phases (``Phase 1 of the 1997 Ozone
Implementation Rule'' and ``Phase 2 of the 1997 Ozone Implementation
Rule''). 69 FR 23951 (April 30, 2004) and 70 FR 71612 (November 29,
2005), respectively. Particularly, the Phase 2 Ozone Implementation
Rule addressed RACT statutory requirements under the 1997 8-hour ozone
NAAQS. See 70 FR 71652 (November 29, 2005).
    On March 6, 2015, EPA issued its final rule for implementing the
2008 8-hour ozone NAAQS (``the 2008 Ozone SIP Requirements Rule''). 80
FR 12264. At the same time, EPA revoked the 1997 8-hour ozone NAAQS,
effective on April 6, 2015.\3\ The 2008 Ozone SIP Requirements Rule
provided comprehensive requirements to transition from the revoked 1997
8-hour ozone NAAQS to the 2008 8-hour ozone NAAQS, as codified in 40
CFR part 51, subpart AA, following revocation. Consistent with previous
policy, EPA determined that areas designated nonattainment for both the
1997 and 2008 8-hour ozone NAAQS at the time of revocation, must retain
implementation of certain nonattainment area requirements (i.e., anti-
backsliding requirements) for the 1997 8-hour ozone NAAQS as specified
under section 182 of the CAA, including RACT. See 40 CFR 51.1100(o). An
area remains subject to the anti-backsliding requirements for a revoked
NAAQS until EPA approves a redesignation to attainment for the area for
the 2008 8-hour ozone NAAQS. There are no effects on applicable
requirements for areas within the OTR, as a result of the revocation of
the 1997 8-hour ozone NAAQS. Thus, Pennsylvania, as a state within the
OTR, remains subject to RACT requirements for both the 1997 8-hour
ozone NAAQS and the 2008 8-hour ozone NAAQS.
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    \3\ On February 16, 2018, the United States Court of Appeals for
the District of Columbia Circuit (D.C. Cir. Court) issued an opinion
on the 2008 Ozone SIP Requirements Rule. South Coast Air Quality
Mgmt. Dist. v. EPA, 882 F.3d 1138 (D.C. Cir. 2018). The D.C. Cir.
Court found certain parts reasonable and denied the petition for
appeal on those. In particular, the D.C. Cir. Court upheld the use
of NOX averaging to meet RACT requirements for 2008 8-
hour ozone NAAQS. However, the Court also found certain other
provisions unreasonable. The D.C. Cir. Court vacated the provisions
it found unreasonable.
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    In addressing RACT, the 2008 Ozone SIP Requirements Rule is
consistent with existing policy and Phase 2 of the 1997 Ozone
Implementation Rule. In the 2008 Ozone SIP Requirements Rule, EPA
requires RACT measures to be implemented by January 1, 2017 for areas
classified as moderate nonattainment or above and all areas of the OTR.
EPA also provided in the 2008 Ozone SIP Requirements Rule that RACT
SIPs must contain adopted RACT regulations, certifications where
appropriate that existing provisions are RACT, and/or negative
declarations stating that there are no sources in the nonattainment
area covered by a specific control technique guidelines (CTG) source
category. In the preamble to the 2008 Ozone SIP Requirements Rule, EPA
clarified that states must provide notice and opportunity for public
comment on their RACT SIP submissions, even when submitting a
certification that the existing provisions remain RACT or a negative
declaration. States must submit appropriate supporting information for
their RACT submissions, in accordance with the Phase 2 of the 1997
Ozone Implementation Rule. Adequate documentation must support that
states have considered control technology that is economically and
technologically feasible in determining RACT, based on information that
is current as of the time of development of the RACT SIP.
    In addition, in the 2008 Ozone SIP Requirements Rule, EPA clarified
that states can use weighted average NOX emissions rates
from sources in the nonattainment area for meeting the major
NOX RACT requirement under the CAA, as consistent with
existing policy.\4\ EPA also recognized that states may conclude in
some cases that sources already addressed by RACT determinations for
the 1979 1-hour and/or 1997 8-hour ozone NAAQS may not need to
implement additional controls to meet the 2008 8-hour ozone NAAQS RACT
requirement. See 80 FR 12278 and 12279 (March 6, 2015).
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    \4\ EPA's NOX RACT guidance ``Nitrogen Oxides
Supplement to the General Preamble'' (57 FR 55620; November 25,
1992) encouraged states to develop RACT programs that are based on
``area wide average emission rates.'' Additional guidance on area-
wide RACT provisions is provided by EPA's January 2001 economic
incentive program guidance titled ``Improving Air Quality with
Economic Incentive Programs,'' available at https://www.epa.gov/sites/production/files/2015-07/documents/eipfin.pdf. In addition, as
mentioned previously, the D.C. Cir. Court upheld the use of
NOX averaging to meet RACT requirements for 2008 8-hour
ozone NAAQS. South Coast Air Quality Mgmt. Dist. v. EPA, 882 F.3d
1138 (D.C. Cir. February 16, 2018).
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C. Applicability of RACT Requirements in Pennsylvania

    As indicated earlier, RACT requirements apply to any ozone
nonattainment areas classified as moderate or higher (serious, severe
or extreme) under CAA sections 182(b)(2) and 182(f). Pennsylvania has
outstanding ozone RACT requirements for both the 1997 and 2008 8-hour
ozone NAAQS. The entire Commonwealth of Pennsylvania is part of the OTR
established under section 184 of the CAA and thus is subject statewide
to the RACT requirements of CAA sections 182(b)(2) and 182(f), pursuant
to section 184(b).
    At the time of revocation of the 1997 8-hour ozone NAAQS (effective
April 6, 2015), only two moderate nonattainment areas remained in the
Commonwealth of Pennsylvania for this standard, the Philadelphia and
the Pittsburgh Areas. As required under EPA's anti-backsliding
provisions, these two moderate nonattainment areas continue to be
subject to RACT under the 1997 8-hour ozone NAAQS. Given its location
in the OTR, the remainder of the Commonwealth is also treated as a
moderate nonattainment area under the 1997 8-hour ozone NAAQS for any
planning requirements under the revoked standard, including RACT. The
OTR RACT requirement is also in effect under the 2008 8-hour ozone
NAAQS throughout the Commonwealth, since EPA did not designate any
nonattainment areas above marginal for this standard in Pennsylvania.
Thus, in practice, the same RACT requirements continue to be applicable
in Pennsylvania for both the 1997 and 2008 8-hour ozone NAAQS. RACT
must be evaluated and satisfied as separate requirements under each
applicable standard.
    RACT applies to major sources of NOX and VOC under each
ozone NAAQS or any VOC sources subject to CTG RACT. Which
NOX and VOC sources in Pennsylvania are considered ``major''
and are therefore subject to RACT is dependent on the location of each
source within the Commonwealth. Sources located in nonattainment areas
would be subject to the ``major source'' definitions established under
the CAA based on the area's current classification(s). In the case of
Pennsylvania, sources located outside of moderate or above ozone
nonattainment areas, as part of the OTR, shall be treated as if these
areas were moderate.

    In Pennsylvania, the SIP program is implemented primarily by the
PADEP, but also by local air agencies in Philadelphia County (the City
of Philadelphia's Air Management Services [AMS]) and Allegheny County,
(the Allegheny County Health Department [ACHD]). These agencies have
implemented numerous RACT regulations and source-specific measures in
Pennsylvania to meet the applicable ozone RACT requirements.
Historically, statewide RACT controls have been promulgated by PADEP in
Pennsylvania Code Title 25--Environmental Resources, Part I--Department
of Environmental Protection, Subpart C--Protection of Natural
Resources, Article III--Air Resources, (25 Pa. Code) Chapter 129. AMS
and ACHD have incorporated by reference Pennsylvania regulations, but
have also promulgated regulations adopting RACT controls for their own
jurisdictions. In addition, AMS and ACHD have submitted, through PADEP,
separate source-specific RACT determinations as SIP revisions for
sources within their respective jurisdictions, which have been approved
by EPA. See 40 CFR 52.2020(d)(1).
    States were required to make RACT SIP submissions for the 1997 8-
hour ozone NAAQS by September 15, 2006. PADEP submitted a SIP revision
on September 25, 2006, certifying that a number of previously approved
VOC RACT rules continued to satisfy RACT under the 1997 8-hour ozone
NAAQS for the remainder of Pennsylvania.\5\ PADEP has met its
obligations under the 1997 8-hour ozone NAAQS for its CTG and non-CTG
VOC sources. See 82 FR 31464 (July 7, 2017). RACT control measures
addressing all applicable CAA RACT requirements under the 1997 8-hour
ozone NAAQS have been implemented and fully approved in the
jurisdictions of ACHD and AMS. See 78 FR 34584 (June 10, 2013) and 81
FR 69687 (October 7, 2016). For the 2008 8-hour ozone NAAQS, states
were required to submit RACT SIP revisions by July 20, 2014. On May 16,
2016, PADEP submitted a SIP revision addressing RACT for both the 1997
and 2008 8-hour ozone NAAQS in Pennsylvania. Specifically, the May 16,
2016 SIP submittal intended to satisfy sections 182(b)(2)(C), 182(f),
and 184 of the CAA for both the 1997 and 2008 8-hour ozone NAAQS for
Pennsylvania's major NOX and VOC non-CTG sources, except
ethylene production plants, surface active agents manufacturing, and
mobile equipment repair and refinishing.\6\
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    \5\ The September 15, 2006 SIP submittal initially included
Pennsylvania's certification of NOX RACT regulations;
however, NOX RACT portions were withdrawn by PADEP on
June 27, 2016.
    \6\ EPA's conditional approval of PADEP's May 16, 2016 SIP
revision covered relevant sources located in both Philadelphia and
Allegheny County, Pennsylvania.
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D. EPA's Conditional Approval for Pennsylvania's RACT Requirements
Under the 1997 and 2008 8-Hour Ozone NAAQS

    On May 16, 2016, PADEP submitted a SIP revision addressing RACT for
both the 1997 and 2008 8-hour ozone NAAQS in Pennsylvania. PADEP's May
16, 2016 SIP revision intended to address certain outstanding VOC CTG
RACT and major NOX RACT requirements under the CAA for both
standards. The SIP revision requested approval of Pennsylvania's 25 Pa.
Code 129.96-100, Additional RACT Requirements for Major Sources of
NOX and VOCs (the ``presumptive'' RACT II rule). Prior to
the adoption of the RACT II rule, Pennsylvania relied on the
NOX and VOC control measures in 25 Pa. Code 129.92-95,
Stationary Sources of NOX and VOCs, (the RACT I rule) to
meet RACT for major sources of VOC and NOX. The requirements
of the RACT I rule remain in effect and continue to be implemented as
RACT.\7\ On September 26, 2017, PADEP submitted a supplemental SIP
revision which committed to address various deficiencies identified by
EPA in PADEP's May 16, 2016 ``presumptive'' RACT II rule SIP revision.
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    \7\ These requirements were initially approved as RACT for
Pennsylvania under the 1979 1-hour ozone NAAQS. The RACT I Rule was
approved by EPA into the SIP on March 23, 1998. 63 FR 13789.
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    On May 9, 2019, EPA conditionally approved the RACT II rule based
on PADEP's September 26, 2017 commitment letter.\8\ See 84 FR 20274. In
EPA's final conditional approval, EPA noted that PADEP would be
required to submit, for EPA's approval, SIP revisions to address any
facility-wide or system-wide NOX emissions averaging plan
approved under 25 Pa. Code 129.98 and any case-by-case RACT
determinations under 25 Pa. Code 129.99. PADEP committed to submitting
these additional SIP revisions within 12 months of EPA's final
conditional approval, specifically May 9, 2020.
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    \8\ On August 27, 2020, the Third Circuit Court of Appeals
issued a decision vacating EPA's approval of three provisions of
Pennsylvania's presumptive RACT II rule applicable to certain coal-
fired power plants. Sierra Club v. EPA, 972 F.3d 290 (3d Cir. 2020).
None of the sources in this proposed rulemaking are subject to the
three presumptive RACT II provisions at issue in that Sierra Club
decision.
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    Therefore, as authorized in CAA section 110(k)(3) and (k)(4),
Pennsylvania was required to submit the following as source-specific
SIP revisions, by May 9, 2020, for EPA's approval as a condition of
approval of 25 Pa. Code 128 and 129 in the May 16, 2016 SIP revision:
(1) All facility-wide or system-wide NOX emissions averaging
plans approved by PADEP under 25 Pa. Code 129.98 including, but not
limited to, any terms and conditions that ensure the enforceability of
the averaging plan as a practical matter (i.e., any monitoring,
reporting, recordkeeping, or testing requirements); and (2) all source-
specific RACT determinations approved by PADEP under 25 Pa. Code
129.99, including any alternative compliance schedules approved under
25 Pa. Code 129.97(k) and 129.99(i); the case-by-case RACT
determinations submitted to EPA for approval into the SIP should
include any terms and conditions that ensure the enforceability of the
case-by-case or source-specific RACT emission limitation as a practical
matter (i.e., any monitoring, reporting, recordkeeping, or testing
requirements). See May 9, 2019 (84 FR 20274). Through multiple
submissions between 2017 and 2020, PADEP has submitted to EPA for
approval various SIP submissions to implement its RACT II case-by-case
determinations and averaging plans. This proposed rulemaking is based
on EPA's review of one of these SIP revisions.

II. Summary of SIP Revisions

    In order to satisfy a requirement from EPA's May 9, 2019
conditional approval, PADEP has submitted to EPA, SIP revisions
addressing source-specific RACT requirements for major sources in
Pennsylvania subject to 25 Pa. Code 129.98 or 129.99. As noted in Table
1 of this document, on May 7, 2020, PADEP submitted to EPA, a SIP
revision pertaining to Pennsylvania's source-specific NOX
and/or VOC RACT determinations for sources located at numerous major
NOX and VOC emitting facilities located in the Commonwealth.
PADEP provided documentation in its SIP revisions to support its
source-specific RACT determinations for affected emission units at each
major NOX and VOC emitting facilities subject to 25 Pa. Code
129.98 or 129.99.
    In the Pennsylvania RACT SIP revision, PADEP included a case-by-
case RACT determination for the existing emissions units at each of
these major sources of NOX and/or VOC that required a
source-specific RACT determination pursuant to 25 Pa. Code 129.99. In
PADEP's RACT

determinations an evaluation was completed to determine if previously
SIP-approved, case-by-case RACT requirements (herein referred to as
RACT I) were more stringent and required to be retained in the sources
Title V air quality permit and subsequently, the Federally-approved
SIP, or if the new case-by-case RACT requirements are more stringent
and supersede the previous Federally-approved provisions.
    EPA, in this action, is taking action on sources at twenty-three
major NOX and/or VOC emitting facilities in Pennsylvania,
subject to Pennsylvania's source-specific RACT requirements, as
summarized in Table 2.

 Table 2--Twenty-Three Major NOX and/or VOC Sources in Pennsylvania Subject to Source-Specific RACT II Under the
                                        1997 and 2008 8-Hour Ozone NAAQS
----------------------------------------------------------------------------------------------------------------
                                     1-Hour ozone RACT source?    Major source pollutant       RACT II permit
       Major source (county)                  (RACT I)               (NOX and/or VOC)         (effective date)
----------------------------------------------------------------------------------------------------------------
AK Steel Corp (formerly Armco, Inc.  Yes......................  NOX and VOC..............  10-00001 (2/25/2020).
 Butler Operations) (Butler).
Allegheny and Tsingshan Stainless    Yes......................  NOX and VOC..............  04-00013 (2/24/2020).
 LLC, Midland Facility (formerly J
 & L Specialty Steel Inc., Midland
 Facility) (Beaver).
Alumax Mill Products (Lancaster)...  Yes......................  NOX and VOC..............  36-05014 (9/9/2019).
American Craft Brewery LLC (Lehigh)  Yes......................  NOX and VOC..............  39-00006F (10/23/
                                                                                2019).
American Refining Group Inc          Yes......................  NOX and VOC..............  42-00004 (1/15/2020)
 (McKean).                                                                                and 42-004K (9/24/
                                                                                2019).
American Zinc Recycling Corp         Yes......................  NOX......................  13-00001 (3/25/2019).
 (Horsehead Resource Development
 Company, Inc.) (Carbon).
Appvion Operations, Inc. (Blair)...  Yes......................  NOX and VOC..............  07-05001 (3/16/2020).
ArcelorMittal Steelton LLC           Yes......................  NOX and VOC..............  22-05012 (3/1/2020).
 (formerly Bethlehem Steel
 Corporation) (Dauphin).
Carpenter Technology Corporation,    Yes......................  NOX and VOC..............  06-05007 (3/10/2020).
 Reading Plt (Berks).
Chestnut Ridge Foam Inc (formerly    Yes......................  VOC......................  65-00181 (1/22/2020).
 Chestnut Ridge Foam, Inc.,
 Latrobe) (Westmoreland).
East Penn Manufacturing Company,     Yes......................  NOX and VOC..............  06-05069 (5/21/2019).
 Inc., Battery Assembly (Berks).
General Carbide Corporation          Yes......................  VOC......................  65-00622 (3/3/2020).
 (Westmoreland).
Lord Corp Saegertown (Crawford)....  Yes......................  VOC......................  20-00194 (4/12/2021).
NLMK Pennsylvania LLC, Farrell Plt   Yes......................  NOX and VOC..............  43-00310 (1/22/2020).
 (formerly Caparo Steel Co.--
 Farrell) (Mercer).
Omnova Solutions Inc.--Auburn Plant  Yes......................  VOC......................  54-00009 (6/26/2018).
 (formerly Gencorp, Inc.)
 (Schuylkill).
Pixelle Specialty Solutions LLC--    Yes......................  NOX and VOC..............  67-05004 (4/1/2020).
 Spring Grove Mill (York).
Sonneborn LLC (formerly Crompton     Yes......................  NOX and VOC..............  10-037I (9/17/2019).
 Corporation, Fairview Township;
 Witco Corp, Petrolia Facility)
 (Butler).
Specialty Tires of America, Indiana  Yes......................  VOC......................  32-00065 (1/16/2019).
 Plant (formerly Specialty Tires of
 America, Inc.) (Indiana).
Standard Steel LLC (formerly         Yes......................  NOX and VOC..............  44-05001 (8/16/2019).
 Standard Steel Division of Freedom
 Forge Corp.) (Mifflin).
Tennessee Gas Pipeline Co., Mercer   Yes......................  NOX and VOC..............  43-00272 (1/2/2019).
 Station 219 (Mercer).
Truck Accessories Group Milton       Yes......................  VOC......................  49-00020 (1/14/2020).
 Plant (formerly Truck Accessories
 Group East) (Northumberland).
United Refining Co (Warren)........  Yes......................  NOX and VOC..............  62-00017 (2/6/2020).
Wheatland Tube Company (Mercer)....  Yes......................  NOX......................  43-00182 (3/26/2019).
----------------------------------------------------------------------------------------------------------------

    The case-by-case RACT determinations submitted by PADEP consist of
an evaluation of all reasonably available controls at the time of
evaluation for each affected emissions unit, resulting in a PADEP
determination of what specific emission limit or control measures
satisfy RACT for that particular unit. The adoption of new or
additional controls or the revisions to existing controls as RACT were
specified as requirements in new or revised Federally enforceable
permits (hereafter RACT II permits) issued by PADEP to the source.
Similarly, the adoption of an alternative NOX emission limit through a
NOX emission averaging plan was specified in a RACT II permit. The RACT
II permits, which revise or adopt additional source-specific controls,
have been submitted as part of the Pennsylvania RACT SIP revisions for
EPA's approval in the Pennsylvania SIP under 40 CFR 52.2020(d)(1). The
RACT II permits submitted by PADEP are listed in the last column of
Table 2 of this document, along with the permit effective date, and are
part of the docket for this rulemaking, which is available online at
https://www.regulations.gov, Docket No. EPA-R03-OAR-2021-0531.\9\ EPA
is proposing to incorporate by reference in the Pennsylvania SIP, via
the RACT II permits, source-specific RACT determinations under the 1997
and 2008 8-hour ozone NAAQS for certain sources at major NOX
and VOC emitting facilities.\10\
---------------------------------------------------------------------------

    \9\ The RACT II permits included in the docket for this
rulemaking are redacted versions of the facility's Federally
enforceable permits. They reflect the specific RACT requirements
being approved into the Pennsylvania SIP via this rulemaking.
    \10\ While the prior SIP-approved RACT I permit will remain part
of the SIP, this RACT II rule will incorporate by reference the RACT
II requirements through the RACT II permit and clarify the ongoing
applicability of specific conditions in the RACT I permit.
---------------------------------------------------------------------------

III. EPA's Evaluation of SIP Revisions

    After thorough review and evaluation of the information provided by
PADEP for sources at twenty-three major NOX and/or VOC
emitting facilities in Pennsylvania included in its SIP revision
submittal, EPA finds that PADEP's case-by-case RACT determinations and
conclusions provided are reasonable and appropriately considered
technically and economically feasible controls,

while setting lowest achievable limits. EPA finds that the proposed
source-specific RACT controls for the sources subject to this
rulemaking action adequately meet the CAA RACT requirements for the
1997 and 2008 8-hour ozone NAAQS for the subject sources of
NOX and/or VOC in Pennsylvania, as they are not covered by
or cannot meet Pennsylvania's presumptive RACT regulation.
    EPA also finds that all the proposed revisions to previously SIP
approved RACT requirements, under the 1979 1-hour ozone standard (RACT
I), as discussed in PADEP's SIP revisions, will result in equivalent or
additional reductions of NOX and/or VOC emissions and should
not interfere with any applicable requirement concerning attainment of
the NAAQS, reasonable further progress or other applicable CAA
requirement under section 110(l) of the CAA.
    EPA's complete analysis of PADEP's source-specific RACT SIP
revisions is included in the TSD available in the docket for this
rulemaking action and available online at https://www.regulations.gov,
Docket number EPA-R03-OAR-2021-0531.

IV. Proposed Action

    Based on EPA's review, EPA is proposing to approve the Pennsylvania
SIP revisions for source-specific RACT determinations for individual
sources at twenty-three major NOX and VOC emitting
facilities listed in Table 2 of this document and incorporate by
reference in the Pennsylvania SIP, via the RACT II permits, source-
specific RACT determinations under the 1997 and 2008 8-hour ozone NAAQS
for those sources. EPA is soliciting public comments on the issues
discussed in this document. These comments will be considered before
taking final action. As EPA views each facility as a separable SIP
revision, should EPA receive comment on one facility but not others,
EPA may take separate, final action on the remaining facilities.

V. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference source-specific RACT determinations via the RACT II permits
as described in Sections II and III--Summary of SIP Revisions and EPA's
Evaluation of SIP Revisions in this document. EPA has made, and will
continue to make, these materials generally available through https://www.regulations.gov and at the EPA Region III Office (please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

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 CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rulemaking, addressing the
NOX and VOC RACT source-specific requirements for individual
sources at twenty-three facilities in Pennsylvania for the 1997 and
2008 8-hour ozone NAAQS, 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, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: August 11, 2021.
Diana Esher,
Acting Regional Administrator, Region III.
[FR Doc. 2021-17953 Filed 8-23-21; 8:45 am]
BILLING CODE P


[Federal Register: March 17, 2008 (Volume 73, Number 52)]
[Notices]
[Page 14242]
[DOCID:fr17mr08-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL08-44-000]

PJM Interconnection, L.L.C., Complainant, v. Accord Energy LLC,
BJ Energy LLC, Franklin Power LLC, GLE Trading LLC, Ocean Power LLC,
Pillar Fund LLC, Power Edge LLC, Tower Research Capital LLC, Tower
Research Capital Investments LLC, Respondents; Notice of Complaint

March 10, 2008.
    Take notice that on March 7, 2008, PJM Interconnection, LLC (PJM)
filed a formal complaint against Accord Energy LLC, BJ Energy LLC,
Franklin Power LLC, GLE Trading LLC, Ocean Power LLC, Pillar Fund LLC,
Power Edge LLC, Tower Research Capital LLC, and Tower Research Capital
Investments LLC (collectively, Respondents), pursuant to sections 206,
222, and 306 of the Federal Power Act, 16 U.S.C. 824e, 824v, and 825e
and 18 CFR 385.206, alleging that the Respondents engaged in conduct
and committed actions to manipulate the PJM market in violation of the
Commission's prohibitions against market manipulation, and that
Respondents should be required to disgorge unjust revenues and provide
refunds, and be investigated for civil penalties.
    PJM certifies that copies of the complaint were served on the
contacts for Respondents.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on March 27, 2008.

 Kimberly D. Bose,
Secretary.
 [FR Doc. E8-5235 Filed 3-14-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: December 20, 2007 (Volume 72, Number 244)]
[Notices]
[Page 72350-72351]
[DOCID:fr20de07-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13041-000]

BPUS Generation Development, LLC; Notice of Application Accepted
for Filing and Soliciting Motions To Intervene, Protests, and Comments

December 13, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 13041-000.
    c. Date filed: September 28, 2007.
    d. Applicant: BPUS Generation Development, LLC.
    e. Name of Project: Ross Barnett Hydroelectric Project.
    f. Location: Pearl River in Rankin County, Mississippi. It would
use the Pearl River Valley Water Supply District's Ross Barnett Dam.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Jeffrey M. Auser, P.E., BPUS Generation
Development, LLC, 225 Greenfield Parkway, Suite 201, Liverpool, NY
13088,<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-13041-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project using the Pearl
River Valley Water Supply District's Ross Barnett Dam and operated in a
run-of-river mode would consist of: (1) A new 100-foot long, 125-foot
wide, 50-foot high concrete powerhouse; (2) three 400-foot-long, 12-
foot-diameter steel penstocks; (3) a new intake east of the spillway
and a new tailrace on the east bank of the existing stilling basin; (4)
three turbine/generator units with a combined installed capacity of 24
megawatts; (5) a new 2.2-mile long above ground transmission line
extending northwest from the switchyard near the powerhouse to the
existing Church Street substation owned by Mississippi Power & Light;
and (6) appurtenant facilities. The proposed Ross Barnett Project would
have an average annual generation of 54 gigawatt-hours.
    l. This filing is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3676 or
e-mail<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy
is also available for inspection and reproduction at the address in
item h above.

    m. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    n. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    o. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    p. Proposed Scope of Studies Under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    q. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    r. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    s. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-24662 Filed 12-19-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 136 (Tuesday, July 16, 2019)]
[Notices]
[Pages 34044-34045]
[FR Doc No: 2019-15033]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket No. NHTSA-2019-0019]

Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Request for
Comment; Prevalence of Alcohol and Other Drug Use Among Motor Vehicle
Crash Victims Admitted to Select Trauma Centers.

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Notice and request for comments on a new information
collection.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Request (ICR)
abstracted below is being submitted to the Office of Management and
Budget (OMB) for review and approval. The ICR describes the nature of
the information collection and its expected burden. A Federal Register
notice with a 60-day comment

period soliciting comments on the information collection was published
on April 24, 2019. NHTSA received one comment, from the National
Transportation Safety Board (NTSB), that was supportive of the proposed
information collection.

DATES: Comments must be received on or before August 15, 2019.

ADDRESSES: Send comments regarding the burden estimate, including
suggestions for reducing the burden, to the Office of Management and
Budget, Attention: Desk Officer for NHTSA, 725 17th Street NW,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Amy Berning, Contracting Officer's
Representative, NHTSA-NPD-130, 1200 New Jersey Avenue SE, W44-237,
Washington, DC 20590. Ms. Berning's phone number is<PHONE_NUMBER>, and
her email address is<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Before a Federal agency can collect certain
information from the public, it must receive approval from the Office
of Management and Budget (OMB). In compliance with these requirements,
this notice announces that the following information collection request
has been forwarded to OMB.
    A Federal Register notice with a 60-day comment period soliciting
comments on the information collection was published on April 24,
2019.\1\ NHTSA received one comment,\2\ from the NTSB, that was
supportive of the information collection. NTSB stated that it found the
proposed collection of information to be necessary, proper, and useful;
the methodology to be valid; the quality and clarity of the proposed
collected information to be appropriate; and the collection techniques
to be suitable. The comment expressed NTSB's support for NHTSA's
research efforts to better understand the prevalence of alcohol and
other drug use among crash victims admitted to selected trauma centers
and morgues and stated that NHTSA's work on drugs and driving is
crucial to NHTSA's proper performance of its agency functions,
particularly addressing the safety hazards caused by driver impairment.
In further support, NTSB referenced its own safety recommendation to
NHTSA to develop and disseminate a common standard of practice for drug
toxicology testing.\3\ NTSB also noted that because the blood specimens
will be left over from those already drawn and used for medical care
and that demographic data will be deidentified, there will be no
evident burden placed on the public or the individuals involved in the
research. NHTSA is not making any changes to the information collection
based on the comment received.
---------------------------------------------------------------------------

    \1\ 84 FR 17233.
    \2\ The docket number for the 60-day notice was mistakenly used
twice, and the docket also included nine comments that were related
to a shoulder belt requirement for side-facing seats on
motorcoaches.
    \3\ See the NTSB's November 21, 2012, letter to NHTSA issuing
Safety Recommendations H-12-32 and -33. Safety Recommendation H-12-
33 is classified ``Open--Acceptable Response.''
---------------------------------------------------------------------------

    Title: Prevalence of Alcohol and Other Drug Use Among Motor Vehicle
Crash Victims Admitted to Select Trauma Centers.
    OMB Control Number: 2127--New.
    Affected Public: Seriously- or fatally-injured victims of motor
vehicle crashes presenting directly to the selected trauma centers or
morgues shortly after a crash.
    Form Number: No forms.
    Abstract: The National Highway Traffic Safety Administration
(NHTSA) seeks to examine the prevalence of legal and illegal drugs in
the systems of seriously- and fatally-injured drivers and other crash-
involved road users (e.g., passengers, pedestrians, bicyclists, and
scooter riders) presenting directly to the selected trauma centers or
morgues. The participating trauma centers and medical examiners will
provide the study with de-identified blood samples, when available,
that were already collected during their routine clinical treatment
activities. The study will then conduct independent drug toxicology
testing to determine the prevalence of alcohol and other drugs in the
systems of the participants. The trauma centers and medical examiners
will also provide the study with other de-identified participant
classification information such as patient demographics, cause of
injury, and injury severity. The trauma centers and medical examiners
will provide this already-collected and de-identified information to
the study in accordance with all applicable Federal, State, and local
regulations governing the sharing of such information and as approved
by the study IRB. The trauma centers and medical examiners at the
selected study sites universally draw patients' blood for clinical
treatment or autopsy purposes. The trauma centers and medical examiners
also collect other information such as patient demographics, cause of
injury, injury severity, and drugs administered during treatment as
part of their normal operating procedures. Therefore, there is no
estimated time burden on the participants as the trauma centers and
medical examiners will be providing the study with de-identified blood
samples already collected, but not used, during their routine clinical
procedures, and other de-identified information that was already
collected as part of their routine clinical documentation procedures.
    Total Estimated Annual Burden Hours: 0.00 hours per year.
    Estimated Number of Respondents: The study anticipates collecting
de-identified information on approximately 7,500 seriously- or fatally-
injured victims of crashes.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
department to enhance the quality, utility and clarity of the
information collection; and (d) ways that the burden could be minimized
without reducing the quality of the collected information.

    Authority: 44 U.S.C. 3506(c)(2)(A).

    Issued in Washington, DC.
Jon Krohmer,
Associate Administrator, Acting, Research and Program Development.
[FR Doc. 2019-15033 Filed 7-15-19; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 107 (Monday, June 4, 2018)]
[Rules and Regulations]
[Pages 25575-25577]
[FR Doc No: 2018-11877]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0157]
RIN 1625-AA00

Safety Zone for Fireworks Display; Severn River, Sherwood Forest,
MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain waters of the Severn River. This action is necessary to provide
for the safety of life on the navigable waters of the Severn River at
Sherwood Forest, MD, during a fireworks display on July 3, 2018 (with
alternate date of July 6, 2018). This action will prohibit persons and
vessels from entering the safety zone unless authorized by the Captain
of the Port Maryland-National Capital Region or a designated
representative.

DATES: This rule is effective from 8:30 p.m. on July 3, 2018, through
10 p.m. on July 6, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0157 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Ronald Houck, Sector Maryland-National Capital Region
Waterways Management Division, U.S. Coast Guard; telephone 410-576-
2674, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On January 16, 2018, the Sherwood Forest Club, Inc. of Sherwood
Forest, MD, notified the Coast Guard that from 9:20 p.m. to 9:50 p.m.
on July 3, 2018, it will be conducting a fireworks display launched
from the end of the Sherwood Forest Club main pier, located adjacent to
the Severn River, approximately 200 yards east of Brewer Pond in
Sherwood Forest, MD. In response, on April 4, 2018, the Coast Guard
published a notice of proposed rulemaking (NPRM) entitled ``Safety Zone
for Fireworks Display; Severn River, Sherwood Forest, MD'' (83 FR
14384). There we stated why we were issuing the NPRM, and invited
comments on our proposed regulatory action related to this fireworks
display. During the comment period that ended May 4, 2018, we received
2 comments.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Baltimore (COTP) has determined that
potential hazards associated with the fireworks to be used in the July
3, 2018, display will be a safety concern for anyone in the Severn
River near the fireworks discharge site. The purpose of this rule is to
ensure safety of vessels and the navigable waters in the safety zone
before, during, and after the scheduled event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received two comments on our NPRM published
April 4, 2018. Both comments provided support of this rulemaking. There
are no substantive changes in the regulatory text of this rule from the
proposed rule in the NPRM.
    This rule establishes a safety zone that will be enforced from 8:30
p.m. until 10:30 p.m. on July 3, 2018, and if necessary due to
inclement weather, from 8:30 p.m. until 10:30 p.m. on July 6, 2018. The
safety zone will cover all navigable waters of the Severn River, within
150 yards of a fireworks discharge site located at the end of Sherwood
Forest Club main pier in approximate position latitude 39[deg]01'54.0''
N, longitude 076[deg]32'41.8'' W, located at Sherwood Forest, MD. The
duration of the zone is intended to ensure the safety of life on these
navigable waters before, during, and after the scheduled 9:20 p.m.
fireworks display. While the zone is being enforced, no vessel or
person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative. To request
permission to transit the area, the Captain of the Port Maryland-
National Capital Region and or designated representatives can be
contacted at telephone number<PHONE_NUMBER> or on marine band radio VHF-
FM channel 16 (156.8 MHz). The Coast Guard vessels enforcing this
section can be contacted on marine band radio VHF-FM channel 16 (156.8
MHz). Upon being hailed by a U.S. Coast Guard vessel, or other Federal,
State, or local agency vessel, by siren, radio, flashing light, or
other means, the operator of a vessel must proceed as directed. If
permission is granted to enter the safety zone, all persons and vessels
must comply with the instructions of the Captain of the Port Maryland-
National Capital Region or designated representative and proceed as
directed while within the zone.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
will be able to safely transit around this safety zone, which would
impact a small designated area of the Severn River for 2 hours during
the evening when vessel traffic is normally low. The Coast Guard will
issue a Broadcast Notice to Mariners via VHF-FM marine band radio
channel 16 to provide information about the safety zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant

economic impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
a safety zone lasting 2 hours that would prohibit vessel movement
within a portion of the Severn River. It is categorically excluded from
further review under paragraph L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T05-0157 to read as follows:

Sec.  165.T05-0157   Safety Zone for Fireworks Display; Severn River,
Sherwood Forest, MD.

    (a) Location. The following area is a safety zone: All waters of
the Severn River, within 150 yards of a fireworks discharge site
located at the end of Sherwood Forest Club main pier in approximate
position latitude 39[deg]01'54.0'' N, longitude 076[deg]32'41.8'' W,
located at Sherwood Forest, MD. All coordinates refer to datum NAD
1983.
    (b) Definitions. As used in this section:
    (1) Captain of the Port Maryland-National Capital Region means the
Commander, U.S. Coast Guard Sector Maryland-National Capital Region.
    (2) Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port Maryland-National Capital Region to assist in enforcement of the
safety zone described in paragraph (a) of this section.
    (c) Regulations. The general safety zone regulations found in 33
CFR part 165, subpart C apply to the safety zone created by this
section.
    (1) All persons are required to comply with the general regulations
governing safety zones found in 33 CFR 165.23.
    (2) Entry into or remaining in this safety zone is prohibited
unless authorized by the Coast Guard Captain of the Port Maryland-
National Capital Region. All vessels underway within this safety zone
at the time it is implemented are to depart the zone.
    (3) Persons desiring to transit the area of the safety zone shall
obtain authorization from the Captain of the Port Maryland-National
Capital Region or designated representative. To request permission to
transit the area, the Captain of the Port Maryland-National Capital
Region and or designated representatives can be contacted at telephone
number<PHONE_NUMBER> or on marine band radio VHF-FM channel 16 (156.8
MHz). The Coast Guard vessels enforcing this section can be contacted
on marine band radio VHF-FM channel 16 (156.8 MHz). Upon being hailed
by a U.S. Coast Guard vessel, or other Federal, State, or local agency
vessel, by

siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed. If permission is granted to enter the safety
zone, all persons and vessels shall comply with the instructions of the
Captain of the Port Maryland-National Capital Region or designated
representative and proceed as directed while within the zone.
    (4) Enforcement officials. The U.S. Coast Guard may be assisted in
the patrol and enforcement of the zone by Federal, State, and local
agencies.
    (d) Enforcement period. This section will be enforced from 8:30
p.m. to 10:30 p.m. on July 3, 2018, and if necessary due to inclement
weather, from 8:30 p.m. to 10:30 p.m. on July 6, 2018.

    Dated: May 25, 2018.
Joseph B. Loring,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2018-11877 Filed 6-1-18; 8:45 am]
 BILLING CODE 9110-04-P


P-17-0396 Sanitized Support Documents Index:
 P-17-0396 Sanitized Determination Document (linked)
 P-17-0396 Sanitized CHEM Report (attached)
 P-17-0396 Sanitized ECO Report (attached)
 P-17-0396 Sanitized ENG Report (attached)
 P-17-0396 Sanitized EXP Report (attached)
 P-17-0396 Sanitized Fate Report (attached)
 P-17-0396 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


Docket Numbers OAR 2003   0048 ( Electronic) and A 98 44 ( Legacy)

The document National Emissions Standards for Hazardous Air Pollutants ( NESHAP) for the Miscellaneous Organic Chemical Manufacturing Industry: Summary of Response to Comments is filed in Docket OAR 2003 0121 as Docket ID 0036.


[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Proposed Rules]
[Pages 22749-22751]
[FR Doc No: 2019-10401]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101 and 102

[Docket No. FDA-2019-D-0892]

The Use of an Alternate Name for Potassium Chloride in Food
Labeling; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``The Use of an
Alternate Name for Potassium Chloride in Food Labeling.'' The draft
guidance, when finalized, will explain our intent to exercise
enforcement discretion for the declaration of the name ``potassium
chloride salt,'' as an alternative to ``potassium chloride,'' in the
ingredient statement on the labels of foods that contain potassium
chloride as an ingredient.

DATES: Submit either electronic or written comments on the draft
guidance by July 19, 2019 to ensure that we consider your comment on
the draft guidance before we begin work on the final version of the
guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-0892 for ``The Use of an Alternate Name for Potassium
Chloride in Food Labeling.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments

received, go to https://www.regulations.gov and insert the docket
number, found in brackets in the heading of this document, into the
``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Nutrition and Food Labeling, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Andrea Krause, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry
entitled ``The Use of an Alternate Name for Potassium Chloride in Food
Labeling.'' We are issuing the draft guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations. This draft
guidance is not subject to Executive Order 12866.
    This draft guidance, if finalized, is intended to explain to food
manufacturers our intent to exercise enforcement discretion for the
declaration of the name ``potassium chloride salt'' in the ingredient
statement on food labels as an alternative to the common or usual name
``potassium chloride.'' This flexibility in declaring potassium
chloride in the ingredient statement on food labels may help inform
consumers of the use of potassium chloride as at least a partial
substitute for sodium chloride, thereby leading to the selection of
foods with lower sodium content and decreasing the amount of sodium
consumed. This draft guidance is consistent with FDA's Nutrition
Innovation Strategy (accessed at https://www.fda.gov/food/labelingnutrition/ucm602651.htm) to reduce the burden of chronic
disease in the United States through improved nutrition, by empowering
consumers with information, and supporting and fostering industry
innovation in developing and promoting healthfulness of food options.
    Americans consume, on average, 3,400 milligrams (mg) of sodium per
day, nearly 50 percent more than the 2,300 mg/day limit recommended by
the ``2015-2020 Dietary Guidelines for Americans'' (Ref. 1). Over 70
percent of sodium consumed comes from processed and prepared foods,
which makes it difficult for consumers to control their sodium intake
(Ref. 2). High levels of sodium intake are associated with increased
blood pressure, which increases risk of cardiovascular disease (Refs. 3
to 6); researchers have estimated that reductions in sodium intake have
the potential to prevent tens of thousands of premature deaths and
illnesses each year (Ref. 7). Thus, associations between sodium intake
and health outcomes support the need to engage in population-based
efforts to lower excessive dietary sodium intakes. This draft guidance,
when finalized, may facilitate development of lower sodium food options
and is consistent with our previous actions to encourage stakeholders
to reduce sodium levels in food products.
    Sodium reduction techniques include the use of replacement
ingredients to replicate the taste and preservative function of sodium
chloride in foods. One such ingredient is potassium chloride. Potassium
chloride is an ingredient that is generally recognized as safe when
used under conditions specified in our regulations at 21 CFR 184.1622.
The food industry has used potassium chloride to reduce sodium chloride
in prepared and processed foods. In most instances, potassium chloride
is used as a partial substitute for sodium chloride. Adequate potassium
intake is beneficial in lowering blood pressure, and potassium intake
is generally low in comparison to Federal recommendations (Refs. 8 and
9).
    Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the
label of a food fabricated from two or more ingredients must bear the
common or usual name of each such ingredient (section 403(i)(2) of the
FD&C Act (21 U.S.C. 343(i)(2))). A common or usual name is the name by
which an article is known to the American public. Common or usual names
are generally established by common usage, though in some cases they
may be established by regulation. See 21 CFR 102.5(d). The common or
usual name of potassium chloride has been established by common usage
as ``potassium chloride.''
    The draft guidance takes into consideration a citizen petition from
NuTek Food Science, dated June 27, 2016 (Docket No. FDA-2016-P-1826),
requesting that we issue guidance recognizing ``potassium salt'' as an
additional common or usual name for potassium chloride (Ref. 10).
However, ``potassium salt'' is not a name in common usage for potassium
chloride, and we are unaware of evidence that would support a
regulation establishing ``potassium salt'' as the common or usual name.
    In contrast, the name ``potassium chloride salt'' may signal to
consumers that potassium chloride is a substitute for salt. Informing
consumers that potassium chloride is a substitute for sodium chloride
(salt) could result in consumers selecting food options with less
sodium. This, in turn, could encourage industry to continue to reduce
sodium levels in processed foods by substituting potassium chloride for
some sodium chloride, thereby decreasing overall sodium intake,
increasing potassium intake, and benefitting public health. Because
``potassium chloride salt'' includes the entire common or usual name of
the ingredient, we consider it unlikely that consumers will confuse it
with sodium chloride or other potassium-containing salts. Therefore, we
tentatively intend to exercise enforcement discretion for the
declaration of ``potassium chloride salt'' in the place of ``potassium
chloride'' in the ingredient statement on labels of foods containing
potassium chloride as an ingredient.

II. Other Issues for Consideration and Request for Information

    We will review any consumer data and other information that is
submitted to us to determine whether ``potassium chloride salt'' has
become an alternate common or usual name for potassium chloride in the
future.
    We invite comment on the following questions. Please provide the
reasoning behind your comments, including, where available, any data or
other supporting information.
    1. How would use of the name ``potassium chloride salt'' in the
ingredient statement as an alternative to ``potassium chloride''
improve consumer understanding of this ingredient? What other methods
or approaches could improve consumer understanding? Please provide any
relevant data or information to support your answer.

    2. What alternate names to ``potassium chloride salt'' would better
promote consumer understanding of potassium chloride? Please provide
any relevant data or information to support your answer.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

IV. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. U.S. Department of Health and Human Services and U.S. Department
of Agriculture, ``2015-2020 Dietary Guidelines for Americans,'' 8th
Ed., December 2015. http://health.gov/dietaryguidelines/2015/guidelines/, accessed December 10, 2018.*
2. Harnack, L.J., M.E. Cogswell, J.M. Shikany, et al., ``Sources of
Sodium in US Adults From 3 Geographic Regions.'' Circulation,
135:1775-1783, 2017.
3. Institute of Medicine, ``Dietary Reference Intakes for Water,
Potassium, Sodium Chloride and Sulfate.'' Washington DC: The
National Academies Press. 2005.
4. Sacks, F.M., L.P. Svetkey, W.M. Vollmer, et al., ``Effects on
Blood Pressure of Reduced Dietary Sodium and the Dietary Approaches
to Stop Hypertension (DASH) diet.'' DASH--Sodium Collaborative
Research Group. New England Journal of Medicine, 344(1): 3-10, 2001.
5. Graudal, N.A., T. Hubeck-Graudal, and G. J[uuml]rgens, ``Effects
of Low-Sodium Diet vs. High-Sodium Diet on Blood Pressure, Renin,
Aldosterone, Catecholamines, Cholesterol, and Triglyceride (Cochrane
Review).'' American Journal of Hypertension, 25(1):1-15, 2012. PMID:
22068710. http://www.ncbi.nlm.nih.gov/pubmed/22068710, accessed
December 10, 2018.
6. Eckel, R.H., J.M. Jakicic, J.D. Ard, et al., ``2013 AHA/ACC
Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A
Report of the American College of Cardiology/American Heart
Association Task Force on Practice Guidelines.'' Journal of the
American College of Cardiology, 63(25 Pt B):2960-2984, 2014. PMID:
24239922. http://www.ncbi.nlm.nih.gov/pubmed/24239922, accessed
December 10, 2018.
7. Coxson, P.G., N.R. Cook, M. Joffres, et al., ``Mortality Benefits
From US Population-wide Reduction in Sodium Consumption: Projections
from 3 Modeling Approaches.'' Hypertension, 61:564-570, 2013.
8. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. ``Scientific Report of the 2015 Dietary Guidelines
Advisory Committee,'' Part B, Chapter 6. http://www.health.gov/dietaryguidelines/2015-scientific-report/, accessed December 10,
2018.*
9. Jackson, S.L., M.E. Cogswell, L. Zhao, et al., ``Association
Between Urinary Sodium and Potassium Excretion and Blood Pressure
Among Adults in the United States: National Health and Nutrition
Examination Survey, 2014.'' Circulation, 137:237-246, 2018.
10. Petition from Brian L. Boor, President and Chief Operating
Officer, NuTek Food Science, LLC, to Division of Dockets Management,
Food and Drug Administration, Docket No. FDA-2016-P-1826, dated June
27, 2016.*

    Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10401 Filed 5-17-19; 8:45 am]
 BILLING CODE 4164-01-P