[Federal Register Volume 84, Number 114 (Thursday, June 13, 2019)]
[Proposed Rules]
[Pages 27566-27570]
[FR Doc No: 2019-12517]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R9-OAR-2018-0821 FRL-9995-11-Region 9]

Determination of Attainment by the Attainment Date for the 2008
Ozone National Ambient Air Quality Standards; Phoenix-Mesa, Arizona

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
determine that the Phoenix-Mesa ozone nonattainment area (``Phoenix
NAA''), which is classified as ``Moderate'' for the 2008 ozone National
Ambient Air Quality Standards (NAAQS or ``standards''), attained the
NAAQS by its Moderate area attainment date of July 20, 2018. This
determination is based on complete, quality-assured, and certified data
for 2015-2017. This proposed action is necessary to fulfill the EPA's
statutory obligation to determine whether ozone nonattainment areas
attained the NAAQS by the attainment date.

DATES: Any comments must arrive by July 15, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2018-0821 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, 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: Nancy Levin, EPA Region IX, 75
Hawthorne Street, San Francisco, CA 94105. By phone:<PHONE_NUMBER> or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to the EPA.

Table of Contents

I. What is the Background for this action?
    A. Ozone NAAQS, Area Designations, and Classifications
    B. Ambient Air Quality Monitoring Data
II. What is the EPA's analysis of the relevant air quality data?
    A. Monitoring Network and Data Considerations
    B. Evaluation of the Ambient Air Quality Data
III. Proposed Action
IV. Environmental Justice Considerations
V. Statutory and Executive Order Reviews

I. What is the background for this action?

A. Ozone NAAQS, Area Designations, and Classifications

    The Clean Air Act (CAA or ``Act'') requires the EPA to establish
national primary and secondary standards for certain widespread
pollutants, such as ozone, which cause or contribute to air pollution
that is reasonably anticipated to endanger public health or welfare.\1\
In

the 1970s, the EPA promulgated primary and secondary ozone standards
based on a 1-hour average. In 1997, we replaced the 1-hour ozone
standards with primary and secondary 8-hour ozone standards. In 2008,
we revised the 8-hour ozone standards to the level of 0.075 parts per
million (ppm), daily maximum 8-hour average.\2\ Since the primary and
secondary ozone standards are the same, we refer to them hereafter in
this document using the singular ``2008 ozone standard'' (or simply
``standard'') or NAAQS. The 2008 ozone standard is met at an ambient
air quality monitoring site when the design value is less than or equal
to 0.075 ppm, as determined in accordance with 40 CFR part 50, appendix
P.\3\ The design value is a statistic that describes the air quality
status of a given location relative to the level of the NAAQS. For the
purpose of comparison with the 2008 ozone standard, the design value
for a site is the 3-year average of the annual fourth-highest daily
maximum 8-hour average ozone concentrations.
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    \1\ CAA sections 108 and 109. Primary standards represent
ambient air quality standards the attainment and maintenance of
which the EPA has determined, including a margin of safety, are
requisite to protect the public health. Secondary standards
represent ambient air quality standards the attainment and
maintenance of which the EPA has determined are requisite to protect
the public welfare from any known or anticipated adverse effects
associated with the presence of such air pollutant in the ambient
air. CAA section 109(b).
    \2\ 73 FR 16436 (March 27, 2008); 40 CFR 50.15. In 2015, we
tightened the ozone National Ambient Air Quality Standards (NAAQS or
``standards'') even further and established 0.070 parts per million
(ppm), 8-hour average, as the new ozone NAAQS. 80 FR 65292 (October
26, 2015). While the 1979 1-hour ozone NAAQS and 1997 8-hour ozone
NAAQS have been revoked, the 2008 ozone NAAQS remains in effect.
    \3\ 40 CFR 50.15.
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    The EPA designated NAAs for the 2008 ozone standard on May 21,
2012, effective July 20, 2012.\4\ In that action, the EPA classified
(by operation of law) the Phoenix NAA as ``Marginal'' nonattainment.
The original attainment date for the 2008 ozone standard for this
Marginal ozone NAA was as expeditious as practicable but not later than
July 20, 2015.\5\
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    \4\ 77 FR 30088.
    \5\ 40 CFR 51.1103(a).
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    Section 181(b)(2)(A) of the CAA requires that within 6 months
following the applicable attainment date, the EPA must determine
whether an ozone NAA attained the ozone standard based on the area's
design value as of that date. In May 2016, the EPA determined that the
Phoenix NAA failed to attain the 2008 ozone standard by the applicable
attainment date of July 20, 2015, and reclassified the area to the next
higher classification, i.e., ``Moderate.'' Our determination was based
on complete, quality-assured, and certified data for 2012-2014.\6\
States with Moderate ozone areas are required to submit revisions to
the applicable state implementation plan (SIP) that comply with the
requirements set forth in subpart 2 of part D of title I of the CAA and
in the EPA's ozone implementation rule for the 2008 ozone NAAQS in 40
CFR part 51, subpart AA. The relevant SIP requirements include, among
other requirements, attainment demonstrations and associated reasonably
available control measures, reasonable further progress (RFP) plans,
and contingency measures for failure to attain or make RFP. The
applicable attainment date for areas classified as Moderate
nonattainment for the 2008 ozone NAAQS is as expeditious as practicable
but not later than July 20, 2018.\7\ Because the design value is based
on the three most recent, complete calendar years of data, attainment
must occur no later than December 31 of the year prior to the
attainment date (i.e., December 31, 2017, in the case of Moderate NAAs
for the 2008 ozone NAAQS).
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    \6\ 81 FR 26697 (May 4, 2016). The 2012-2014 design value for
the Phoenix NAA was 0.080 parts per million, which exceeded the 2008
ozone NAAQS of 0.075 ppm. We note that today's action is based on
the 2015-2017 design value.
    \7\ 40 CFR 51.1103.
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B. Ambient Air Quality Monitoring Data

    A determination of whether an area's air quality meets the 2008
ozone NAAQS is generally based upon three consecutive calendar years of
complete, quality-assured data measured at established State and Local
Air Monitoring Stations (SLAMS) in the NAA and entered into the EPA Air
Quality System (AQS) database. Data from ambient air monitoring sites
operated by state or local agencies in compliance with EPA monitoring
requirements must be submitted to AQS. Heads of monitoring agencies
annually certify that these data are accurate to the best of their
knowledge. Accordingly, the EPA relies primarily on data in AQS when
determining the attainment status of an area.\8\ All ozone data are
reviewed to determine the area's air quality status in accordance with
40 CFR part 50, appendix P.
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    \8\ 40 CFR 50.15; 40 CFR part 50, appendix P; 40 CFR part 53; 40
CFR part 58, appendices A, C, D and E.
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    When the design value is less than or equal to 0.075 ppm (based on
the rounding convention in 40 CFR part 50, appendix P) at each
monitoring site within the area, then the area is meeting the 2008
ozone NAAQS. To make the determination that an area attains the NAAQS,
each monitor must have a valid design value \9\ meeting the standard.
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    \9\ Design values attaining the 2008 ozone NAAQS also must meet
minimum data completeness requirements specified in 40 CFR part 50,
appendix P to be considered valid.
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II. What is the EPA's analysis of the relevant air quality data?

A. Monitoring Network and Data Considerations

    The Arizona Department of Environmental Quality (ADEQ or
``State''), Maricopa County Air Quality Department (MCAQD), Pinal
County Air Quality Control District (PCAQCD), and Salt River Pima-
Maricopa Indian Community (SRPMIC) operate a combined 24 ozone SLAMS in
the Phoenix NAA (see Table 1 for AQS identification number, site name,
design value, and completeness data for 2015-2017 (i.e., the design
value period)). MCAQD operates 18 of these ozone sites in the Phoenix
NAA, however one of these sites (AQS# 040139706, Rio Verde) was
approved by the EPA for closure in 2017.10 11 ADEQ operates
one ozone site in the Phoenix NAA (JLG Supersite). PCAQCD operates one
ozone site in the Phoenix NAA (AJ Maintenance Yard). SRPMIC operates
four ozone sites in the Phoenix NAA (Senior Center, Red Mountain, Lehi,
and High School).
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    \10\ Blue Point-Sheriff Station-Tonto NF-Salt River Rec. Area,
Buckeye, Cave Creek, Central Phoenix, Dysart, Falcon Field, Fountain
Hills, Glendale, Humboldt Mountain, Mesa, North Phoenix, Pinnacle
Peak, Rio Verde, South Phoenix, South Scottsdale, Tempe, West
Chandler, West Phoenix.
    \11\ Letter from Elizabeth J. Adams, Acting Director, Air
Division, EPA Region IX, to Ben Davis, Director, Air Monitoring
Manager, Maricopa County Air Quality Department (MCAQD), dated
September 15, 2017, approving MCAQD's closure of the Rio Verde ozone
SLAMS site.
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    State and local air monitoring agencies are required to submit
annual monitoring network plans to the EPA.\12\ Tribal monitoring
agencies may also submit such plans. An annual monitoring network plan
discusses the status of the air monitoring network, as required under
40 CFR 58.10. MCAQD, PCAQCD, ADEQ and SRPMIC submit annual monitoring
network plans for ozone SLAMS in the Phoenix NAA. Since 2007, the EPA
has regularly reviewed these annual monitoring network plans for
compliance with the applicable requirements in 40 CFR part 58. With
respect to ozone, the EPA has found that the area's annual monitoring
network plans for 2015 through 2017 meet the applicable requirements
under 40 CFR part 58.13 14 15 16 Furthermore,

the EPA concluded from its Technical Systems Audits (TSAs) of ADEQ,
MCAQD, and PCAQCD, that the combined ambient air monitoring network
currently meets or exceeds the requirements for the minimum number of
SLAMS in the Phoenix NAA for the 2008 ozone
standard.17 18 19 The EPA also conducted a TSA of SRPMIC,
but, as a tribal agency, minimum monitoring requirements do not apply
to SRPMIC.\20\
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    \12\ 40 CFR 58.10(a)(1).
    \13\ Letter from Gwen Yoshimura, Acting Manager, Air Quality
Analysis Office, EPA Region IX, to Philip A. McNeely, Director,
Maricopa County Air Quality Department (MCAQD), dated October 31,
2016, approving MCAQD's 2015 annual monitoring network plan; Letter
from Gwen Yoshimura, Manager, Air Quality Analysis Office, EPA
Region IX, to Philip A. McNeely, Director, Maricopa County Air
Quality Department (MCAQD), dated October 30, 2017, approving
MCAQD's 2016 annual monitoring network plan; Letter from Gwen
Yoshimura, Manager, Air Quality Analysis Office, EPA Region IX, to
Philip A. McNeely, Director, Maricopa County Air Quality Department
(MCAQD), dated October 30, 2018, approving MCAQD's 2017 annual
monitoring network plan.
    \14\ Letter from Gwen Yoshimura, Acting Manager, Air Quality
Analysis Office, EPA Region IX, to Michael Sundblom, Director, Pinal
County Air Quality Control District (PCAQCD), dated October 31,
2016, approving PCAQCD's 2015 annual monitoring network plan; Letter
from Gwen Yoshimura, Manager, Air Quality Analysis Office, EPA
Region IX, to Michael Sundblom, Director, Pinal County Air Quality
Control District (PCAQCD), dated October 30, 2016, approving
PCAQCD's 2016 annual monitoring network plan; Letter from Gwen
Yoshimura, Manager, Air Quality Analysis Office, EPA Region IX, to
Michael Sundblom, Director, Pinal County Air Quality Control
District (PCAQCD), dated October 30, 2018, approving PCAQCD's 2017
annual monitoring network plan.
    \15\ Letter from Gwen Yoshimura, Acting Manager, Air Quality
Analysis Office, EPA Region IX, to Timothy S. Franquist, Director,
Air Quality Division, Arizona Department of Environmental Quality
(ADEQ), dated November 3, 2016, approving ADEQ's 2015 annual
monitoring network plan; Letter from Gwen Yoshimura, Manager, Air
Quality Analysis Office, EPA Region IX, to Timothy S. Franquist,
Director, Air Quality Division, Arizona Department of Environmental
Quality (ADEQ), dated November 3, 2016, approving ADEQ's 2016 annual
monitoring network plan; Letter from Gwen Yoshimura, Manager, Air
Quality Analysis Office, EPA Region IX, to Timothy S. Franquist,
Director, Air Quality Division, Arizona Department of Environmental
Quality (ADEQ), dated October 30, 2017, approving ADEQ's 2017 annual
monitoring network plan.
    \16\ Letter from Gwen Yoshimura, Acting Manager, Air Quality
Analysis Office, EPA Region IX, to Christopher Horan, Division
Manager, Environmental Protection & Natural Resources Division, Salt
River Pima-Maricopa Indian Community (SRPMIC), dated October 31,
2016, approving SRPMIC's 2015 annual monitoring network plan; Letter
from Gwen Yoshimura, Manager, Air Quality Analysis Office, EPA
Region IX, to Christopher Horan, Division Manager, Environmental
Protection & Natural Resources Division, Salt River Pima-Maricopa
Indian Community (SRPMIC), dated October 30, 2017, approving
SRPMIC's 2016 annual monitoring network plan; Letter from Gwen
Yoshimura, Manager, Air Quality Analysis Office, EPA Region IX, to
Christopher Horan, Division Manager, Environmental Protection &
Natural Resources Division, Salt River Pima-Maricopa Indian
Community (SRPMIC), dated October 30, 2018, approving SRPMIC's 2017
annual monitoring network plan.
    \17\ Letter from Elizabeth J. Adams, Director, Air Division, EPA
Region IX, to Mr. Timothy Franquist, Director, Air Quality Division,
ADEQ, dated April 25, 2019, transmitting findings from the EPA's
2018 TSA of the ADEQ's ambient air monitoring program.
    \18\ Letter from Elizabeth J. Adams, Acting Director, Air
Division, EPA Region IX, to Mr. Michael Sundblom, Director, PCAQCD,
dated September, 28, 2016, transmitting findings from the EPA's 2016
TSA of the PCAQCD's ambient air monitoring program.
    \19\ Letter from Elizabeth J. Adams, Acting Director, Air
Division, EPA Region IX, to Philip A. McNeely, Director, MCAQD,
dated June 12, 2017, transmitting findings from the EPA's 2016 TSA
of the MCAQD's ambient air monitoring program.
    \20\ Letter from Elizabeth J. Adams, Acting Director, Air
Division, EPA Region IX, to Mr. Christopher Horan, Environmental
Director, SRPMIC, dated August 29, 2017, transmitting findings from
the EPA's 2016 TSA of the SRPMIC's ambient air monitoring program.
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    MCAQD, PCAQCD, ADEQ and SRPMIC oversee the quality assurance of
data collected from their sites and annually certify that their
respective data submitted to AQS are complete and quality-assured, and
have done so for each year relevant to our determination of attainment,
2015-2017.21 22 23 24
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    \21\ Letter from Timothy Franquist Jr, Deputy Director, Air
Quality Division, Arizona Department of Environmental Quality, to
Deborah Jordan, EPA Region IX, dated April 27, 2015 [correct date
was April 27, 2016], Certification of 2015 Ambient Air Data and Re-
Certification of 2014 Ambient Air Data in AQS Database Reported by
ADEQ; Letter from Timothy S. Franquist, Director, Air Quality
Division, Arizona Department of Environmental Quality, to Elizabeth
Adams, Acting Air Division Director, Air Division, EPA Region IX,
dated April 5, 2017, Certification of 2016 Ambient Air Data and Re-
Certification of 2015 Ambient Air Data in AQS Database Reported by
ADEQ; Letter from Timothy S. Franquist, Director, Air Quality
Division, to Elizabeth Adams, Air Division Director, EPA Region IX,
dated April 27, 2018, Certification of 2017 Ambient Air Data and Re-
Certification of 2016 Ambient Air Data in AQS Database Reported by
ADEQ.
    \22\ Letter from Philip A. McNeely, Director, Maricopa County
Air Quality Department, to Deborah Jordan, Air Division, EPA Region
IX, dated April 25, 2016, 2015 Data Certification Letter; Letter
from Philip A. McNeely, Director, Maricopa County Air Quality
Department, to Elizabeth Adams, Acting Director, Air Division, EPA
Region IX, dated April 7, 2017, 2016 Data Certification Letter;
Letter from Philip A. McNeely, Director, Maricopa County Air Quality
Department, to Elizabeth Adams, Acting Director, Air Division, EPA
Region IX, dated April 10, 2018, 2017 Data Certification.
    \23\ Letter from Josh DeZeeuw, Air Quality Manager, Pinal County
Air Quality Control District, to Deborah Jordan, dated April 29,
2016, AQS Data Certification--2015; Letter from Josh DeZeeuw, Air
Quality Manager, Pinal County Air Quality Control District, to
Elizabeth Adams, dated April 28, 2017, AQS Data Certification--2016;
Letter from Josh DeZeeuw, Air Quality Manager, Pinal County Air
Quality Control District, to Elizabeth Adams, dated April 30, 2018,
AQS Data Certification--2017.
    \24\ Letter from Christopher Horan, Environmental Protection &
Natural Resources Manager, Salt River Pima Maricopa Indian
Community, to Deborah Jordan, Director, Air Division, EPA Region IX,
dated April 27, 2016, 2015 AQS Data Certification of Ambient Air
Monitoring Data; Letter from Christopher Horan, Environmental
Protection & Natural Resources Manager, Salt River Pima Maricopa
Indian Community, to Elizabeth Adams, Acting Director, Air Division,
EPA Region IX, dated March 31, 2016 [correct date was March 31,
2017], 2016 AQS Data Certification of Ambient Air Monitoring Data;
Letter from Christopher Horan, Environmental Protection & Natural
Resources Manager, Salt River Pima Maricopa Indian Community, to
Elizabeth Adams, Acting Director, Air Division, EPA Region IX, dated
April 13, 2018, 2017 AQS Ambient Air Monitoring Data Certification.
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    Lastly, consistent with the requirements contained in 40 CFR part
50, the EPA has reviewed the quality-assured and certified ozone
ambient air monitoring data for completeness. The EPA reviewed the data
as recorded in AQS for the applicable monitoring period, collected at
the monitoring sites in the Phoenix NAA, and has determined that the
data are complete, except for the Tempe monitoring station.\25\
Monitoring at the Tempe station was temporarily suspended from April to
October in 2015 as a result of significant modifications by the
landowner to the site. MCAQD notified the EPA of this temporary closure
in MCAQD's 2015 annual ambient air monitoring plan.\26\ The Tempe
monitoring site was not the design value monitor in the Phoenix NAA for
the five previous valid design value years (2010-2014). In addition,
Tempe did not have the highest fourth-highest daily maximum 8-hour
ozone concentrations in the NAA in 2016 or 2017. For these reasons, the
temporary closure and invalid 2017 design value at the Tempe monitoring
site does not affect the EPA's ability to determine the design value
for the area. For the remaining ozone monitoring sites in the Phoenix
NAA, daily maximum 8-hour average concentrations are available for at
least 90 percent of the days within the ozone monitoring season, on
average for the 2015-2017 period, and daily maximum 8-hour average
concentrations are available for at least 75 percent of the days within
the ozone monitoring season for each individual year within that
period. Therefore, the remaining sites meet the data completeness
requirements of 40 CFR part 50, appendix P.\27\
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    \25\ See EPA, Air Quality System, Design Value Report, May 20,
2019.
    \26\ 2015 Air Monitoring Network Plan, Philip A. McNeely,
Director, MCAQD, submitted June 30, 2016.
    \27\ The Rio Verde Ozone SLAMS was approved for closure in 2017,
however, there were sufficient data for the monitor to still have a
valid 2015-2017 design value.
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B. Evaluation of the Ambient Air Quality Data

    As noted previously, the applicable attainment date for the Phoenix
NAA is July 20, 2018. We have reviewed the

data collected at the monitoring sites within that area during the
three-year period preceding the attainment date (2015-2017) to
determine whether the area attained the 2008 ozone standard by the
attainment date. Table 1 shows the fourth-highest daily maximum 8-hour
ozone concentrations for 2015 through 2017, 2015-2017 design values,
and data completness for ozone monitors within the Phoenix NAA. The
design value for a given area is based on the monitoring site in the
area with the highest design value.

                           Table 1--Phoenix NAA: 2015-2017 Monitoring Site-Level Design Values for the 2008 8-Hour Ozone NAAQS
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                                                                4th Highest daily maximum 8-                        Percent complete          2015-2017
                                                                 hour average value  (ppm)      2015-2017  ---------------------------------   Average
             AQS site ID                     Site name       ---------------------------------    Design                                       percent
                                                                 2015       2016       2017       value        2015       2016       2017      complete
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040130019...........................  West Phoenix..........       .074       .071       .077         .074        100        100        100          100
040131003...........................  Mesa..................       .072       .075       .078         .075        100        100        100          100
040131004...........................  North Phoenix.........       .074       .075       .077         .075        100         99        100          100
040131010...........................  Falcon Field..........       .072       .073       .078         .074        100         98         99           99
040132001...........................  Glendale..............       .067       .066       .068         .067         98         99         98           98
040132005...........................  Pinnacle Peak.........       .074       .074       .077         .075         99        100         98           99
040133002...........................  Central Phoenix.......       .071       .070       .071         .070        100        100         99          100
040133003...........................  South Scottsdale......       .068       .070       .070         .069         98         99         99           99
040134003...........................  South Phoenix.........       .070       .067       .072         .069        100        100         99          100
040134004...........................  West Chandler.........       .070       .069       .074         .071        100        100        100          100
040134005...........................  Tempe.................        N/A       .068       .065          N/A         12        100         99           76
040134008...........................  Cave Creek............       .069       .071       .071         .070        100        100         99           99
040134010...........................  Dysart................       .067       .063       .076         .068        100        100         89           95
040134011...........................  Buckeye...............       .060       .059       .070         .063         98         99         91           95
040139508...........................  Humboldt Mtn..........       .073       .072       .074         .073         97        100        100           99
040139702...........................  Blue Point............       .071       .071       .074         .072         99        100         99          100
040139704...........................  Fountain Hills........       .069       .068       .073         .070        100        100         97           99
040139706...........................  Rio Verde.............       .068       .070       .068         .068        100        100         83           92
040139997...........................  JLG Supersite.........       .075       .075       .076         .075         98         94         98           97
040137020...........................  Senior Center.........       .073       .070       .075         .072        100        100         99          100
040137021...........................  Red Mountain..........       .074       .071       .079         .074        100         99         99           99
040137022...........................  Lehi..................       .076       .072       .077         .075        100         99         97           99
040137024...........................  High School...........       .072       .070       .075         .072         96         98         98           98
040213001...........................  AJ Maintenance........       .073       .072       .079         .074         97         97         96           97
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    In the EPA's review of monitoring data for the 2008 ozone standard
for the Phoenix NAA, the EPA is excluding certain exceedances of the
standard from the attainment determination presented herein because
they were the result of exceptional events. ADEQ provided documentation
supporting requests for concurrence on wildfire ozone exceptional
events covering a total of 14 exceedances recorded on June 20, 2015,
and July 7, 2017, at monitors within the Phoenix NAA. The EPA reviewed
the documentation that ADEQ provided to demonstrate that these
exceedances meet the criteria for exceptional events under the EPA's
Exceptional Events Rule.\28\ The EPA concurred with ADEQ's requests for
determinations that, based on the weight of evidence, the exceedances
were caused by wildfire ozone exceptional events.\29\ Accordingly, the
EPA has determined that the monitored exceedances associated with these
exceptional events should be excluded from use in determinations of
exceedances and violations, including the evaluation of whether the
Phoenix NAA has attained by the attainment date in accordance with CAA
section 181(b)(2)(A).
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    \28\ 40 CFR 50.1(j), (k), (l), (m), (n), (o), (p), (q), (r);
50.14; 51.930. See also 40 CFR part 50, appendix P, section 1.a,
(determinations of whether to exclude, retain, or make adjustments
to the data affected by exceptional events is determined by the
requirements under 40 CFR 50.1, 50.14 and 51.930).
    \29\ See letters from Elizabeth J. Adams, Director, Air
Division, EPA Region IX, to Timothy S. Franquist, Director, Air
Quality Division, ADEQ, dated February 5, 2019, and May 7, 2019.
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    Our proposed determination that the area has attained the 2008
ozone NAAQS is based in part on our concurrence with ADEQ that the
exceedances monitored in the Phoenix NAA on June 20, 2015, and July 7,
2017, were caused by wildfire ozone exceptional events, and our related
exclusion of these exceedances from the attainment determination.

III. Proposed Action

    The EPA is proposing to determine that the Phoenix NAA has attained
the 2008 ozone standard by its Moderate area attainment date of July
20, 2018, based on complete, quality-assured, and certified ambient air
quality monitoring data for the 2015-2017 monitoring period. Based on
our proposed finding of attainment by the applicable attainment date,
we are also proposing to determine that the CAA requirement for the SIP
to provide for contingency measures to be implemented in the event the
area fails to attain (``attainment contingency measures'') will no
longer apply to the Phoenix NAA. Under CAA section 172(c)(9),
attainment contingency measures must be implemented only if the area
fails to attain by the attainment date. Therefore, if we finalize the
determination that the Phoenix NAA has attained the 2008 ozone
standard, attainment contingency measures for this NAAQS would never be
required to be implemented, regardless of whether the area continues to
attain the NAAQS. The State submitted contingency measures as part of
the Phoenix area 2008 Moderate ozone plan adopted in December 2016. We
will defer taking any action on these measures in light of this
proposed finding of attainment by the applicable attainment date and
resulting

determination that the attainment contingency measure requirement no
longer applies to the area. The State may elect to withdraw the
attainment contingency measures to lift the obligation on the EPA under
section 110(k) to act on these measures.
    We are not proposing to suspend the attainment-related requirements
for the Phoenix NAA under 40 CFR 51.1118 at this time because ozone
monitoring data for 2018 are not consistent with continued attainment
of the standard in the Phoenix NAA.
    We also note that, if finalized, this proposed determination that
the Phoenix ozone NAA has attained the 2008 ozone NAAQS would not
constitute a redesignation of the area to attainment for the 2008 ozone
standard. Under CAA section 107(d)(3)(E), redesignations to attainment
require states to meet a number of additional statutory criteria,
including the EPA's approval of a SIP revision demonstrating
maintenance of the standard for 10 years after redesignation. The
designation status of the Phoenix area will remain Moderate
nonattainment for the 2008 ozone NAAQS until such time as the EPA
determines that the area meets the CAA requirements for redesignation
to attainment.

IV. Environmental Justice Considerations

    The EPA believes that this proposed action will not have
disproportionately high or adverse human health or environmental
effects on minority, low-income, or indigenous populations.
    The purpose of this rule is to determine whether the Phoenix NAA
attained the 2008 ozone standard by its Moderate area attainment date,
which is required under the CAA for purposes of implementing the 2008
ozone standard. As such, this action does not directly affect the level
of protection provided for human health or the environment.

V. Statutory and Executive Order Reviews

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

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

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not expected to be an Executive Order 13771
regulatory action because this action is not significant under
Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This rule does not impose any new information collection burden
under the PRA not already approved by the OMB.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action imposes no enforceable duty on any
state, local or tribal governments, or the private sector.

F. Executive Order 13132: Federalism

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

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

    This action has tribal implications. However, it will neither
impose substantial direct compliance costs on federally recognized
tribal governments, nor preempt tribal law. Four tribes have areas of
Indian country within or directly adjacent to the Phoenix NAA: Fort
McDowell Yavapai Nation, Gila River Indian Community, Salt River Pima-
Maricopa Indian Community of the Salt River Reservation, and the Tohono
O'odham Nation of Arizona. The EPA intends to communicate with
potentially affected tribes located within or directly adjacent to the
boundaries of the Phoenix NAA as the agency moves forward in developing
a final rule.

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

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

I. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

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

J. National Technology Transfer Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

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

    The EPA believes the human health or environmental risk addressed
by this action will not have potential disproportionately high and
adverse human health or environmental effects on minority, low-income,
or indigenous populations. The results of this evaluation are contained
in the section of the preamble titled ``Environmental Justice
Considerations.''

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Oxides of nitrogen, Ozone,
Volatile organic compounds.

    Dated: May 31, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2019-12517 Filed 6-12-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Proposed Rules]
[Page 12531]
[FR Doc No: 2017-04188]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2017-C-0935]

DSM Biomedical; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by DSM Biomedical, proposing
that the color additive regulations be amended to provide for the safe
use of high purity carbon black for coloring ultra-high molecular
weight polyethylene sutures for use in general surgery.

DATES: The color additive petition was filed on January 27, 2017.

FOR FURTHER INFORMATION CONTACT: Joseph M. Thomas, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice
that we have filed a color additive petition (CAP 7C0310), submitted by
DSM Biomedical, 735 Pennsylvania Dr., Exton, PA 19341. The petition
proposes to amend the color additive regulations in 21 CFR part 73,
Listing of Color Additives Exempt From Certification, to provide for
the safe use of high purity carbon black for coloring ultra-high
molecular weight polyethylene sutures for use in general surgery.
    We have determined under 21 CFR 25.32(l) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

    Dated: February 28, 2017.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2017-04188 Filed 3-3-17; 8:45 am]
 BILLING CODE 4164-01-P


one or more patents or patent applications? If yes, please provide the
associated patent number or patent application number (or numbers) and
explain why the information should be treated as confidential.
    (iv) Is the claim of confidentiality intended to last less than 10
years (see TSCA section 14(e)(1)(B))? If yes, please indicate the
number of years (between 1 and 10 years) or the specific date after
which the claim is withdrawn.
    (v) Has EPA, another Federal agency, or court made any
confidentiality determination regarding information associated with
this chemical substance? If yes, please provide the circumstances
associated with the prior determination, whether the information was
found to be entitled to confidential treatment, the entity that made
the decision, and the date of the determination.
    (4) Additional substantiation questions for chemical identity-
related claims only. Unless otherwise specified in the relevant
electronic reporting form, answers to the following questions must be
provided for each chemical

identity-related confidentiality claim in a TSCA submission:
    (i) Is this chemical substance publicly known (including by your
competitors) to be in U.S. commerce? If yes, please explain why the
specific chemical identity should still be afforded confidential status
(e.g., the chemical substance is publicly known only as being
distributed in commerce for research and development purposes, but no
other information about the current commercial distribution of the
chemical substance in the United States is publicly available). If no,
please complete the certification statement:

    I certify that on the date referenced I searched the internet
for the chemical substance identity (i.e., by both chemical
substance name and CASRN). I did not find a reference to this
chemical substance and have no knowledge of public information that
would indicate that the chemical is being manufactured or imported
by anyone for a commercial purpose in the United States. [provide
date].

    (ii) Does this specific chemical substance leave the site of
manufacture (including import) in any form, e.g., as a product,
effluent, emission? If yes, please explain what measures have been
taken to guard against the discovery of its identity.
    (iii) If the chemical substance leaves the site in a form that is
available to the public or your competitors, can the chemical identity
be readily discovered by analysis of the substance (e.g., product,
effluent, emission), in light of existing technologies and any costs,
difficulties, or limitations associated with such technologies? Please
explain why or why not.
    (iv) Would disclosure of the specific chemical identity release
confidential process information? If yes, please explain.
    (5) Exemptions from the substantiation requirement. Information
described in paragraphs (b)(5)(i) and (b)(5)(ii) of this section is
exempt from the requirement to substantiate the claim at the time of
submission. EPA may identify on a reporting form certain information as
exempt from substantiation. Additional assertions of exemption from
substantiation may be asserted by the submitter. Each such assertion
must include a detailed explanation for why the information falls
within the claimed exemption. If the explanation is missing or
inadequate, and the claim is not otherwise substantiated, EPA will
place a hold on the submission, as described in paragraph (d) of this
section.
    (i) The following information types are exempt from the
substantiation requirement at the time of information submission:
    (A) Specific information describing the processes used in
manufacture or processing of a chemical substance, mixture, or article;
    (B) Marketing and sales information;
    (C) Information identifying a supplier or customer;
    (D) Details of the full composition of a mixture and the respective
percentages of constituents;
    (E) Specific information regarding the use, function, or
application of a chemical substance or mixture in a process, mixture,
or article; and
    (F) Specific production or import volumes.
    (ii) Exemption for chemical substances not yet offered for
commercial distribution.
    (A) A confidentiality claim for specific identity of a chemical
substance, where the submission is made prior to the date on which the
chemical substance whose identity is claimed as confidential is first
offered for commercial distribution, is exempt from the requirement to
substantiate confidentiality claims at the time of submission.
    (B) A specific chemical identity claim includes specific chemical
names, CAS numbers, molecular formulas, reactants (if required to be
reported as part of the identification of the chemical, such as for
Class 2 substances in Sec.  720.45(a)), and structural diagrams; or in
the case of microorganisms, genus and species name and genetic
construct.
    (C) This exemption applies where the submitter lacks information to
reasonably conclude that the chemical substance has been offered for
commercial distribution, where both:
    (1) The chemical substance is not on the TSCA Inventory, and
    (2) The substance is otherwise not publicly known to have been
offered for commercial distribution.
    (c) Public copies. All TSCA submissions and their accompanying
attachments that include a confidentiality claim must be accompanied,
at the time of submission, by a public version of the submission and
any attachments, with all information that is claimed as confidential
removed. In the case of documents collected by EPA or on behalf of EPA
in person at the site of a TSCA inspection under section 11 of the Act,
the affected company must provide such public copies at the same time
as it provides substantiation of its confidentiality claims in
accordance with paragraph (b)(1) of this section, within ten working
days after the inspection ends. Only information that is claimed as
confidential may be redacted or removed. Generally, a public copy that
removes all or substantially all of the information would not meet the
requirements of this paragraph (c) of this section and the submission
may be temporarily put on hold as deficient.
    (1) Where the applicable reporting form or electronic reporting
tool contains a checkbox or other means of designating with specificity
what information is claimed as confidential, no further action by the
submitter is required to satisfy this requirement.
    (2) For all other information claimed as confidential, including
but not limited to information in attachments and in substantiations
required under paragraph (b) of this section, the submitter must
prepare and attach a public copy. EPA may hold as deficient submissions
with public or sanitized copies that are entirely blank or that are
substantially reduced in length as compared to the CBI version (see
paragraph (e) of this section).
    (d) Generic name. Each confidentiality claim for specific chemical
identity must be accompanied by a structurally descriptive generic name
for that substance. This generic name must be consistent with guidance
on the determination of structurally descriptive generic names
developed in accordance with TSCA section 14(c)(4)(A) (e.g., Guidance
for Creating Generic Names for Confidential Chemical Substance Identity
Reporting under TSCA; available at https://www.epa.gov/tsca-inventory/guidance-creating-generic-names-confidential-chemical-substance-identity-reporting), and 15 U.S.C. 2613(c)(1)(C)(ii).
    (1) At a minimum, the generic name must either:
    (i) Be identical to the generic name for the same substance
included on the non-confidential portion of the TSCA Inventory (if the
substance is listed on the TSCA Inventory), or
    (ii) For substances that are not listed on the TSCA Inventory, mask
only the confidential portions of the specific chemical name. In most
cases, only one structural element of a specific chemical name may be
masked to protect a confidential chemical identity--if the submitter of
a proposed generic name wishes to mask more than one such element, the
submission must include an explanation of why masking only one element
is insufficient to protect the confidential identity.
    (2) Notwithstanding paragraph (d)(1) of this section, EPA may
conclude that a generic name provided with the submission and listed on
the current non-confidential version of the TSCA

Inventory does not comply with 15 U.S.C. 2613(c)(1)(C). In such cases,
EPA will notify the submitting company and proceed as described in
paragraph (c)(4) of this section.
    (3) A generic name that meets the requirements of section
14(c)(1)(C) of the Act prior to the date on which the chemical
substance is first offered for commercial distribution for the purposes
of a pre-market submission (e.g., a PMN) may not be sufficient for the
purposes of subsequent listing on the TSCA Inventory, as identified
upon review under section 14(g)(1)(C)(i) of the Act of a
confidentiality claim for specific chemical identity made in a Notice
of Commencement required under Sec.  720.102 or Sec.  725.190(f). In
such cases, EPA will notify the submitting company and proceed as
described in Sec.  720.102(f) or Sec.  725.190(f).
    (4) If EPA concludes that the proposed generic name does not comply
with 15 U.S.C. 2613(c)(1)(C), EPA will notify the submitter, and
provide 10 business days for the submitter to provide a revised generic
name. If EPA concludes that the revised generic name is still not
acceptable, EPA will hold the submission for an additional period of up
to 10 business days, and proceed as set out in paragraph (e) of this
section.
    (e) Deficient confidentiality claims. (1) A confidentiality claim
under TSCA is deficient if it meets one or more of the following
criteria:
    (i) The confidentiality claim is not accompanied by the supporting
statement and certification required by paragraph (a) of this section.
    (ii) The confidentiality claim is not accompanied by the
substantiation required by paragraph (b) of this section. If the
submitter claims an exemption from substantiation under paragraph
(b)(5) of this section and the exemption does not apply or an
explanation is not provided for the exemption pursuant to paragraph
(b)(5) of this section, the confidentiality claim is deficient.
    (iii) The confidentiality claim is not accompanied by a public copy
that meets the requirements of paragraph (c) of this section.
    (iv) The confidentiality claim is for a specific chemical identity
and is not accompanied by a generic name that meets the requirements of
paragraph (d) of this section.
    (2) A submission that is identified as deficient under paragraph
(e)(1) of this section will be held for a period of up to 10 business
days, and the submitter will be notified via CDX as described in
paragraph (h) of this section. During the hold, which commences on the
day the CDX notice is sent, any applicable review period for the
underlying submission will be suspended until either the deficiency is
corrected or the 10 business days elapse without such correction. Upon
the occurrence of the first of either of these events, the applicable
review period for the underlying submission commences or comes out of
suspension. If the deficiency is not remedied during the suspension,
EPA will proceed with review of the submission and may deny the CBI
claim(s).
    (f) Electronic reporting required. (1) Except in the case of
information subpoenaed under TSCA section 11(c) or materials collected
or requested by EPA as part of an inspection under TSCA section 11(a),
TSCA submissions bearing confidentiality claims must be submitted via
CDX.
    (2) You must use CISS to complete and submit TSCA submissions via
CDX. To access CISS go to https://cdx.epa.gov/ and follow the
appropriate links.
    (3) On receipt by EPA, each electronic TSCA submission will be
assigned a case number or document identifier, which will be available
to the submitter in their CDX account. This identifier may be used as a
reference in future communications that concern the substance, and may
be used by EPA in public communications (e.g., Federal Register
notices) that concern the submission, such as notices of receipt, final
confidentiality determination, pending confidentiality claim
expiration, or in other regulatory actions that concern the TSCA
submission.
    (g) Requirement to report health and safety studies using
templates. Submitters of health and safety studies or information from
such studies must provide such data in templated form, using an
appropriate OECD harmonized template, if such template is available for
the data type (https://www.oecd.org/ehs/templates/). Individual test or
data submission rules or orders may specify an appropriate template or
templates. Submission of templated data is not a substitute for
submitting a full study report where a specific TSCA rule or order
requires submission of the full study report (e.g., Sec.  720.50(a), or
according to the terms of a specific order under TSCA section 5(e)).
    (h) Requirement to maintain company contact information; electronic
notices concerning confidentiality claims. (1) To facilitate ongoing or
future communication concerning TSCA submissions, current contact
information for all of the individuals associated with a particular
TSCA submission must be maintained. Contact information for all the
individuals associated with a particular TSCA submission must be
updated by amending the submission via CDX, except that submissions
that are either no longer accessible to the submitting company or that
were not submitted via CDX (e.g., submissions that were originally
provided on paper or other physical media), updated company contact
must be provided via CDX using the appropriate EPA-provided electronic
reporting application in CISS. In circumstances where ownership of the
company or unit of a company has changed, such that contact information
for one or more prior TSCA submissions that include confidentiality
claims is affected, a notice of transfer of ownership must be directed
to EPA via CDX. Instructions for providing this notice and for
requesting access to copies of a prior TSCA submission are available at
https://cdx.epa.gov/.
    (2) When EPA contacts a TSCA submitter concerning confidentiality
claims (e.g., related to a pending or concluded confidentiality claim
review, a deficient submission, or in relation to the 10-year
expiration of a confidentiality claim (described in TSCA section
14(e)), EPA may provide notices and other correspondence to the
submitter via CDX, using the contact information provided in the most
recent version of the submission, or using the contact information
provided in a more recent notice of transfer of ownership relating to
that submission. The fact and date of delivery of such notice is
verified automatically by CDX.
    (3) In addition to individual notice described in paragraph (h)(2)
of this section, EPA will publish on its website, or other appropriate
platform, a list of TSCA submissions with confidentiality claims that
are approaching the end of the ten-year period of protection described
in TSCA section 14(e). Such TSCA submissions will be referred to by the
TSCA case or document identifier (as described in paragraph (f)(3) of
this section) that was assigned to the submission by EPA when it was
originally submitted. TSCA submissions will be added to this list at
least 60 days prior to the end of the ten-year period of protection,
along with instructions for reasserting and substantiating expiring
claims.
    (4) When a confidentiality claim is being reviewed pursuant to TSCA
section 14(f), EPA will provide, when necessary, notice of such review
and an opportunity to substantiate or resubstantiate the affected
confidentiality claim to the submitter using the contact information
for the authorized official or technical contact provided in the most
recent version of the submission or in a more recent

notice of transfer of ownership relating to that submission.
    (5) Where the submission with the relevant CBI claim was not
originally made via CDX, EPA will send the notice via courier or US
Mail to the company address provided in the most recent TSCA submission
made by that company, or via other means that allows verification of
the fact and date of receipt. The notice will provide instructions for
substantiating claims that were exempt from substantiation when the
confidentiality claim was asserted or for which the submitter was
otherwise not required to provide substantiation at the time of initial
submission, and for updating or re-substantiating as necessary any
claims that were previously substantiated.
    (i) Withdrawing confidentiality claims. TSCA confidentiality claims
may be voluntarily withdrawn by the submitter at any time.
    (1) Confidentiality claims in TSCA submissions that were originally
made via electronic submission may be withdrawn by reopening the
submission in CDX, removing confidentiality markings (e.g.,
confidential checkmarks or bracketing), revising sanitized attachments
or copies as appropriate, and then resubmitting the submission.
    (2) For submissions that were not originally made via CDX, or that
are no longer accessible to the submitting company via CDX,
confidentiality claims may also be withdrawn via CDX using the ``TSCA
Communications'' application or successor system. The withdrawal
correspondence must indicate the case or document number (or other
applicable document identifier or document identifying details) from
which CBI claims are being withdrawn, identify the submitting company,
and include a list or description of the information for which CBI
claims are being withdrawn, including page numbers where relevant.
Current contact information for the person withdrawing the claim must
also be provided, in the event EPA needs clarification concerning which
claim or claims are being withdrawn.
    (j) Amending public copy following confidentiality claim denial or
expiration. (1) Following the expiration or EPA's denial of a TSCA
confidentiality claim, the person who asserted the denied or expired
claim should prepare and submit a revised public copy of the submission
to EPA, following the procedures for voluntarily withdrawing claims
described in Sec.  703.5(i).
    (2) If the person who asserted the denied or expired claim declines
or fails to provide within 30 days a revised public copy of the
submission that includes the information for which the confidentiality
claim(s) were denied or expired, EPA may prepare an addendum to the
original public copy, as needed, in order to provide the newly
available information to the public.

Sec.  703.7  EPA review of confidentiality claims under TSCA Section
14(g)

    (a) Representative subset. (1) Definition. A representative subset
consists of at least 25% of confidentiality claims asserted under TSCA,
not including claims for specific chemical identity or for the
categories of information listed in section 14(c)(2) of TSCA. Excluded
from the representative subset are
    (i) Inquiries with respect to potential submission to EPA of a
notification under 40 CFR part 720, 721, 723 or 725 by a person who has
not submitted the notification at the time of the inquiry, including
inquiries under Sec.  720.25(b) or 721.11;
    (ii) Submissions or other communication not submitted to EPA via
CDX; and
    (iii) Amendments to previous TSCA submissions.
    (2) Selection of submissions for review. To satisfy its
confidentiality claim review obligations under section 14(g)(1)(C)(ii)
of TSCA, EPA may review all claims (except those exempt from
substantiation under TSCA section 14(c)(2)) in every fourth TSCA
submission submitted via CDX that is part of the representative subset,
in chronological order of receipt by EPA. For each submission selected
for review as part of the representative subset, EPA reviews and
approves or denies every individual confidentiality claim in that
submission (except claims that are exempt under TSCA sections 14(c)(2)
and 14(g)), including claims made in attachments and amendments
available to EPA at the time of the review.
    (b) Review of new and expiring confidentiality claims under TSCA
Section 14(g). (1) Under TSCA Section 14(g), EPA will review:
    (i) All chemical identity claims asserted in TSCA submissions
except those that are exempt from substantiation according to TSCA
Section 14(c)(2)(G), and
    (ii) A representative subset of other confidentiality claims as
provided in paragraph (a) of this section.
    (2) EPA will review all timely requests for extension of claims
under section 14(e) of TSCA within 30 days of receipt.
    (3) EPA will also review or re-review confidentiality claims under
certain other circumstances, as set out in TSCA section 14(f). TSCA
section 14(f) reviews are conducted in accordance with procedures set
out in Sec.  703.8.
    (c) Commencement of the review period and effect of amendments.
Subject to Sec.  703.5(e), the 90-day review period described in TSCA
section 14(g) begins on the day that EPA accepts a new TSCA submission
that includes confidentiality claims. For new information, other than
specific chemical identity, added to a submission after EPA first
accepts the submission, the review will take into account such
amendments to that submission that are made either up to 60 days from
the original submission date, or until the Agency issues a final
confidentiality determination for the submission, whichever comes
first. If a submission is amended to report an additional or different
chemical substance that includes a new specific chemical identity
claim, the TSCA section 14(g) review period for the added chemical
identity begins on the day EPA accepts the amendment including the new
claim.
    (d) Publication of final determinations. Final confidentiality
determinations will be published on EPA's website, or other platform,
periodically, in accordance with the requirements of TSCA section
26(j).
    (e) Claim denials and notice period. Final determinations will be
issued by the General Counsel or their designee, which may include
personnel outside of the Office of General Counsel. In the case that
EPA determines that a claim or part of a claim is not entitled to
confidential treatment, EPA will provide notice of the denial to the
person who made the claim and provide reasons for the denial or denial
in part. The notice will be provided electronically, as described in
Sec.  703.5(h)(2). The 30-day notice period described in TSCA section
14(g)(2)(B) begins on the next business day following the date the
notice is made available to the submitter in their CDX account.
    (f) Substantive criteria for use in confidentiality determinations.
Information claimed as confidential under TSCA section 14 will be
approved if:
    (1) The business has asserted a business confidentiality claim
which has not expired by its terms, nor been waived nor withdrawn;
    (2) The business has satisfactorily shown that it has taken
reasonable measures to protect the confidentiality of the information,
and that it intends to continue to take such measures for as long as
the claim is maintained;

    (3) The information is not, and has not been, reasonably obtainable
without the business's consent by other persons (other than
governmental bodies) by use of legitimate means (other than discovery
based on a showing of special need in a judicial or quasi-judicial
proceeding; e.g., the business has demonstrated a reasonable basis to
believe the information is not readily discoverable through reverse
engineering);
    (4) The business has demonstrated a reasonable basis to conclude
that disclosure of the information is likely to cause substantial harm
to the competitive position of the business; and
    (5) No statute denies confidential protection to the information.
Information from health and safety studies is not entitled to
confidential treatment, except that the following information may be
entitled to confidential treatment if it otherwise meets the remainder
of criteria in this paragraph (f):
    (i) Any information, including formulas (including molecular
structures) of a chemical substance or mixture, that discloses
processes used in the manufacturing or processing of a chemical
substance or mixture; or
    (ii) In the case of a mixture, the portion of the mixture comprised
by any of the chemical substances in the mixture.
    (g) Request for Reconsideration. Persons who received a denial or
partial denial notification under paragraph (e) of this section may
request reconsideration by the Office of General Counsel prior to the
end of the 30-day period specified in the notice and described under
paragraph (e) of this section. The business must make its request for
reconsideration electronically via CDX, following the instructions in
the notice. If a request for reconsideration is timely received, EPA
will suspend the 30-day notice period described in paragraph (e) of
this section while the Office of General Counsel reconsiders the
Agency's determination. Once the Office of General Counsel's
reconsideration is complete, the Agency will provide notification,
pursuant to Sec.  703.5(h), to the person of EPA's decision on the
request for reconsideration. If upon reconsideration the Agency upholds
the confidentiality determination, the 30-day notice period will
resume. The Office of General Counsel will perform its review de novo
and will only reconsider determinations based on the information
included with the original submission and amendments made up until the
time the final determination was issued.
    (h) Criteria to use in consideration of requests for extension
under TSCA section 14(e). Requests to extend the period of
confidentiality protection under TSCA section 14(e) use the same
criteria as described under Sec.  703.7(f). Requests for extension may
rely on a substantiation previously provided to EPA, but the submitter
must recertify that the substantiation is still true and correct.

Sec.  703.8  EPA Review of Confidentiality Claims Under TSCA Section
14(f).

    (a) Review of confidentiality claims initiated under TSCA Section
14(f). In accordance with the procedures described in this section, EPA
may review confidentiality claims that are subject to TSCA section
14(f)(1), and will review confidentiality claims subject to TSCA
section 14(f)(2) in the following situations:
    (1) In response to a request under the Freedom of Information Act
(5 U.S.C. 552) for TSCA information claimed confidential;
    (2) If EPA has reason to believe that information claimed
confidential does not qualify for protection from disclosure; or
    (3) For any chemical substance EPA determines under TSCA section
6(b)(4)(A) presents an unreasonable risk of injury to health or the
environment.
    (b) Substantiation exemptions not applicable. All confidentiality
claims asserted in submissions described by paragraph (a) of this
section are subject to the substantiation requirements, including those
that were initially exempt from substantiation according to section
14(c)(2) of TSCA.
    (c) Additional substantiation. If necessary, such as in the case
that substantiation has not previously been provided for
confidentiality claims under review, or in the case that EPA has reason
to believe the substantiation is incomplete or out of date, EPA will
request additional substantiation from the person(s) that claimed the
information as confidential.
    (d) Additional substantiation notice. If additional substantiation
is necessary, EPA will provide notice to the person that claimed the
information as confidential in the manner specified in Sec.
703.5(h)(4). The notice will provide the time allowed for additional
substantiation from the business and the method for requesting a time
extension if necessary. If the person does not make a timely response
or extension request, EPA will consider any existing substantiations in
its review of the claims or, in the case of any unsubstantiated claim,
EPA will construe this as a waiver of the claim and may make the
information public without any further notice to the submitter.
    (e) Substantive criteria for use in confidentiality determinations.
The criteria in Sec.  703.7(f) apply to confidentiality determinations
initiated under TSCA section 14(f). For determinations required to
respond to a FOIA request, the criteria in Sec.  703.7(f) are
supplemented with one additional criterion that must be satisfied: The
business adequately demonstrates that the information is commercial or
financial information obtained from a person and is confidential within
the meaning of FOIA Exemption 4 (5 U.S.C. 552(b)(4)).
    (f) Adverse determinations and notice period. Final determinations
will be issued by the General Counsel or their designee, including
personnel outside of the Office of General Counsel. Except for
instances where claims were waived, if EPA determines that information
claimed confidential does not qualify for protection from disclosure,
EPA will provide written notice to the person who asserted the claim.
The notice will be provided electronically, as described in Sec.
703.5(h)(2). The 30-day notice period described in TSCA section
14(g)(2)(B) begins on the next business day following the date the
notice is made available to the submitter in their CDX account.
    (g) Disclosure of Information. After a final determination has been
made by EPA to release some or all of the information claimed as
confidential, the Agency shall make the information available to the
public (in the absence of a court order prohibiting disclosure)
whenever:
    (1) The period provided for commencement by a business of an action
to obtain judicial review of the determination has expired without
notice to EPA of commencement of such an action; or
    (2) The court, in a timely-commenced action, has denied the
person's motion for a preliminary injunction, or has otherwise upheld
the EPA determination.
    (h) Notice relating to public requests for records. Any person
whose request for release of the information under 5 U.S.C. 552 is
pending at the time notice is given under paragraph (f) of this section
shall be furnished notice under 5 U.S.C. 552 either stating the
circumstances under which the some or all of the information will be
released or denying the request if all requested information was found
to be entitled to confidential treatment.

PART 704--REPORTING AND RECORDKEEPING REQUIREMENTS

0
6. The authority citation for part 704 continues to read as follows:

    Authority: 15 U.S.C 2607(a).

0
7. Revise Sec.  704.7 to read as follows:

Sec.  704.7  Confidential business information claims.

    Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.

PART 707--CHEMICAL IMPORTS AND EXPORTS

0
8. The authority citation for part 707 continues to read as follows:

    Authority: 15 U.S.C 2611(b) and 2612.

0
9. Amend Sec.  707.63 by redesignating paragraphs (a) through (d) as
paragraphs (b) through (e) and adding a new paragraph (a) to read as
follows:

Sec.  707.63  Definitions.

    (a) CDX or Central Data Exchange means EPA's centralized electronic
document receiving system, or its successor system.
0
10. Amend Sec.  707.65 by revising paragraphs (a)(1) and (2), removing
paragraph (a)(3), and revising paragraph (c) to read as follows:

Sec.  707.65  Submission to the Agency.

    (a) * * *
    (1)(i) The notice must be for the first export or intended export
by an exporter to a particular country in a calendar year when the
chemical substance or mixture is the subject of an order issued, an
action that is pending, or relief that has been granted under TSCA
section 5(f), a rule that has been proposed or promulgated under TSCA
section 6, or an action that is pending or relief that has been granted
under TSCA section 7.
    (ii) The notice must only be for the first export or intended
export by an exporter to a particular country when the chemical
substance or mixture is the subject of an order issued, an action that
is pending, or relief that has been granted under TSCA section 5(e), a
rule that has been proposed or promulgated under TSCA section 5(a)(2),
or when the submission of data is required under TSCA section 4 or
5(b). Under this paragraph (a)(1)(ii), notice of export to a particular
country is not required if an exporter previously submitted to EPA a
notice of export to that country prior to January 16, 2007.
    (2) The notice must be submitted to EPA within seven days of
forming the intent to export or on the date of export, whichever is
earlier. A notice of intent to export must be based on a definite
contractual obligation, or an equivalent intra-company agreement, to
export the regulated chemical.
* * * * *
    (c) Notices must be submitted via CDX, using the TSCA section 12(b)
Export Notification Application or its successor.
0
11. Amend Sec.  707.67 by revising paragraph (a) to read as follows:

Sec.  707.67  Contents of notice.

* * * * *
    (a) The name of the regulated chemical as it appears in the TSCA
section 4, 5, 6, and/or 7 action. For substances on the confidential
portion of the TSCA Inventory, this means that the substance must be
identified by generic name and accession number, or by any other non-
confidential identifier under which it is listed on the TSCA section
12(b) reporting list maintained by EPA and available in the TSCA
section 12(b) Export Notification Application described in Sec.
707.65(c). If a category is regulated, the name of the individual
regulated chemical within that category, as well as the category, must
be given. The name must be that which appears in the TSCA Inventory, if
the chemical appears there.
* * * * *
0
12. Amend Sec.  707.75 by revising paragraph (d) to read as follows:

Sec.  707.75  Confidentiality

* * * * *
    (d) Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.

PART 716--HEALTH AND SAFETY DATA REPORTING

0
12. The authority citation for part 716 continues to read as follows:

    Authority: 15 U.S.C 2607(d).

0
13. Revise Sec.  716.55 to read as follows:

Sec.  716.55  Confidentiality claims.

    Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.

PART 717--RECORDS AND REPORTS OF ALLEGATIONS THAT CHEMCIAL
SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE
ENVIRONMENT

0
14. The authority citation for part 717 continues to read as follows:

    Authority: 15 U.S.C 2607(c).

0
15. Amend Sec.  717.17 by revising paragraph (c) to read as follows:

Sec.  717.17  Inspection and reporting requirements.

* * * * *
    (c) How to Report. When required to report, firms must submit
copies of records via CDX https://cdx.epa.gov/ using the EPA provided
electronic reporting application.
0
16. Revise Sec.  717.19 to read as follows:

Sec.  717.19  Confidentiality.

    Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.

PART 720--PREMANUFACTURE NOTIFICATION

0
17. The authority citation for part 720 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2613.

0
18. Revise Sec.  720.80 to read as follows:

Sec.  720.80  General provisions.

    Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
* * * * *

Sec.  720.85  [Removed]

0
19. Remove Sec.  720.85.

Sec.  720.90  [Removed]

0
20. Remove Sec.  720.90.
0
21. Revise Sec.  720.95 to read as follows:

Sec.  720.95  Public file.

    All information submitted with a notice, including any health and
safety study and other supporting documentation, will become part of
the public file for that notice, unless such materials are claimed
confidential in accordance with procedures in 40 CFR 703.5. In
addition, EPA may add materials to the public file, subject to subpart
E of this part. Publicly available materials are available at the
docket addresses in Sec.  700.17(b)(1) and (2) of this chapter and on
EPA's website.
0
22. Amend Sec.  720.102 by revising paragraph (c)(2) and adding
paragraphs (e) and (f) to read as follows:

Sec.  720.102  Notice of commencement of manufacture or import.

* * * * *
    (c) * * *
    (2) If the submitter claims any information on the form as
confidential, the claim must be asserted and substantiated in
accordance with the requirements described in 40 CFR part 703 and must
be submitted via EPA Form 7710-56. If the submitter wants the chemical
identity to be listed on the confidential portion of the TSCA
Inventory, the chemical identity must be claimed as confidential and
the submitter must also follow the

certification, substantiation, and generic name requirements described
part 703 and paragraphs (e) and (f) of this section. Otherwise, EPA
will list the specific chemical identity on the public TSCA Inventory.
Submitters who did not claim the chemical identity, submitter identity,
or other information to be confidential in the PMN cannot claim this
information as confidential in the notice of commencement.
* * * * *
    (e) Confidentiality. (1) Any person who asserts a confidentiality
claim for chemical identity in a Notice of Commencement submitted under
Sec.  720.102 must:
    (i) Comply with generic name requirements described in part 703 and
as specified in paragraph (f) of this section.
    (ii) Agree that EPA may disclose to a person with a bona fide
intent to manufacture or import the chemical substance the fact that
the particular chemical substance is included on the confidential TSCA
Inventory for purposes of notification under section 5(a)(1)(A) of the
Act.
    (iii) Have available for the particular chemical substance, and
agree to furnish to EPA upon request:
    (A) An elemental analysis.
    (B) Either an X-ray diffraction pattern (for inorganic substances),
a mass spectrum (for most other substances), or an infrared spectrum of
the particular chemical substance, or if such data do not resolve
uncertainties with respect to the identity of the chemical substance,
additional or alternative spectra or other data to identify the
chemical substance.
    (2) Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
    (f) Generic Name. If a submitter asserts a claim of confidentiality
for chemical identity in a notice of commencement, they must provide a
structurally descriptive generic name.
    (1) Generic names must:
    (i) Be structurally descriptive (e.g., not a trade name);
    (ii) Describe the chemical structure of the chemical substance as
specifically as practicable while protecting only those features of the
chemical structure that are claimed as confidential and disclosure of
which would likely cause substantial harm to the competitive position
of the person--the generic name should generally only obscure one
structural feature, but in any case, should conceal only the feature(s)
necessary to avoid a likelihood of substantial competitive harm to the
submitter; and
    (iii) Be consistent with guidance on the determination of
structurally descriptive generic names, developed in accordance with
TSCA section 14(c)(4)(A) (e.g., Guidance for Creating Generic Names for
Confidential Chemical Substance Identity Reporting under TSCA;
available at https://www.epa.gov/tsca-inventory/guidance-creating-generic-names-confidential-chemical-substance-identity-reporting).
    (2) Generic names will be reviewed by EPA at the time of
submission. (i) If EPA concludes that a proposed generic name meets the
criteria in paragraph (f)(1) of this section, EPA will include that
generic name in the public TSCA Inventory listing for that substance.
    (ii) If the proposed generic name does not meet the criteria in
paragraph (f)(1) of this section, EPA will notify the submitter
concerning the deficiency via CDX, as described in 40 CFR 703.5(f). EPA
will provide 10 business days to correct the deficiency and provide an
alternative generic name that would be acceptable to EPA. If the
alternative generic name proposed by EPA is acceptable to the submitter
(or if the submitter does not respond within the 10-day period), EPA
will place that alternative generic name on the public TSCA Inventory.
If the alternative generic name proposed by EPA is not acceptable to
the submitter, the submitter must submit a revised generic name that
meets the criteria in paragraph (f)(1) of this section and an
explanation of how EPA's proposed generic name reveals confidential
information. If EPA concludes that the submitter's revised generic name
also does not meet the criteria in paragraph (f)(1) of this section,
EPA will hold the notice of commencement for a period of up to 10
business days. Reporting requirements will not be considered to have
been met and the substance will not be added to the TSCA Inventory
during this period. If the submission remains deficient after this 10-
day period, EPA will proceed with CBI review of the chemical identity
claim and will likely deny the claim.

PART 723--PREMANUFACTURE NOTICE EXEMPTIONS

0
23. The authority citation for part 723 continues to read as follows:

    Authority: 15 U.S.C. 2604.

0
24. Amend Sec.  723.50, by revising paragraph (l) to read as follows:

Sec.  723.50  Chemical substances manufactured in quantities of 10,000
kilograms or less per year, and chemical substances with low
environmental releases and human exposures.

* * * * *
    (l) Confidentiality. Claims of confidentiality must be made in
accordance with the procedures described in 40 CFR part 703.
* * * * *
0
25. In Sec.  723.250, revise the introductory text of paragraphs (f)
and (n) to read as follows:

Sec.  723.250  Polymers.

* * * * *
    (f) Exemption report for polymers manufactured under the terms of
this section. For substances exempt under paragraphs (e)(1), (e)(2),
and (e)(3) of this section a report of manufacture or import must be
submitted by January 31 of the year subsequent to initial manufacture.
The report and accompanying claims must be submitted via CDX (https://cdx.epa.gov/), using the TSCA Section 5 Notices and Supports--ePMN
application. See Sec.  720.40(a)(2)(ii) for information on how to
access e-PMN software. The notice must include:
* * * * *
    (n) Confidentiality. Claims of confidentiality must be made in
accordance with the procedures described in 40 CFR part 703.

PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR
MICROORGANISMS

0
26. The authority citation for part 725 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.

0
27. Revise Sec.  725.80 to read as follows:

Sec.  725.80  General provisions.

    Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703, except as modified in this
paragraph. In general, references to ``chemical'' or ``chemical
identity'' in part 703 are equivalent to ``microorganism'' or
``microorganism identity'' for the purposes of this part.
    (a) In place of Sec.  703.5(b)(3)(v), the following question
applies: Has EPA, another Federal agency, or court made any
confidentiality determination regarding information associated with
this microorganism? If yes, please provide the circumstances associated
with the prior determination, whether the information was found to be
entitled to confidential treatment, the entity that made the decision,
and the date of the determination.
    (b) In place of Sec.  703.5(b)(4), the following questions apply:
    (1) Has the identity of the microorganism been kept confidential to
the extent that competitors do not know it is being manufactured or
imported

into US commerce? If not, explain why the microorganism identity should
still be afforded confidential status (e.g., the microorganism is
publicly known only as being distributed in commerce for research and
development purposes, but no other information about the current
commercial distribution of the microorganism in the United States is
publicly available).
    (2) Does the microorganism leave the site of production or testing
in a form which is accessible to the public or to competitors? If yes,
please explain what measures have been taken to guard against the
discovery of its identity. Further, what is the cost to a competitor,
in time and money, to develop appropriate use conditions? What factors
facilitate or impede product analysis?

Sec.  725.85  [Removed]

0
28. Remove Sec.  725.85.

Sec.  725.92  [Removed]

0
29. Remove Sec.  725.92.

Sec.  725.94  [Removed]

0
30. Remove Sec.  725.94.
0
31. Revise Sec.  725.95 to read as follows:

Sec.  725.95  Public file.

    All information submitted, including any health and safety study of
a microorganism and other supporting documentation, will become part of
the public file for that submission, unless such materials are claimed
as confidential in accordance with this section. In addition, EPA may
add materials to the public file, subject to subpart C of this part.
Publicly available materials are available at the docket addresses in
Sec.  700.17(b)(1) and (2) of this chapter and on EPA's website.
0
32. Amend Sec.  725.190 by revising paragraph (c) and adding paragraphs
(e) and (f) to read as follows:

Sec.  725.190  Notice of Commencement of manufacture or import.

* * * * *
    (c) Information to be reported. The NOC must contain the following
information: Specific microorganism identity, MCAN number, and the date
when manufacture or import commences. If the person claims any
information on the form as confidential, the claim must be asserted and
substantiated in accordance with the requirements described in part 703
and Sec.  725.80, as indicated in EPA Form 7710-56. If the submitter
wants the microorganism identity to be listed on the confidential
portion of the TSCA Inventory, the microorganism identity must be
claimed as confidential and also follow the certification,
substantiation, and generic name requirements described in part 703 and
paragraph (e) and (f) of this section.
* * * * *
    (e) Requirements for assertion. Any person who asserts a
confidentiality claim for microorganism identity must:
    (i) Comply with the requirements of paragraph (f) of this section
regarding submission of a generic name.
    (ii) Agree that EPA may disclose to a person with a bona fide
intent to manufacture or import the microorganism the fact that the
particular microorganism is included on the confidential TSCA Inventory
for purposes of notification under section 5(a)(1)(A) of the Act.
    (iii) Have available and agree to furnish to EPA upon request the
taxonomic designations and supplemental information required by Sec.
725.12.
    (iv) Make claims of confidentiality in accordance with the
procedures described in 40 CFR part 703.
    (f) Generic Name. If a submitter asserts a claim of confidentiality
for microorganism identity in a notice of commencement, they must
provide a generic name.
    (1) Generic names must:
    (i) Be structurally descriptive (e.g., not a trade name); and
    (ii) Be consistent with guidance on the determination of
structurally descriptive generic names, developed in accordance with
TSCA section 14(c)(4)(A) (e.g., Guidance for Creating Generic Names for
Confidential Chemical Substance Identity Reporting under TSCA). Generic
names for microorganisms may only mask the portion of microorganism
identity that the submitter believes is proprietary (considering that
the identity of a microorganism to be listed on the TSCA Inventory must
include taxonomic designations (genus, species, and strain), key
phenotypic traits, key genotypic traits and modifications, genetic
material that has been introduced or modified, any vector constructs
used, cellular location of introduced or modified genes, number and
type of genes introduced or modified, and method of construction or
modification). Taxonomic designation (in most cases down to strain)
must be included in the generic name except where the submitter claims
the taxonomic designation confidential, in which case the person making
such claim must provide an explanation of why such masking is necessary
to protect proprietary information. Additionally, the generic
microorganism identity must include a statement regarding the function
and stability of the genetic construct. This includes an indication of
whether the introduced or modified genes are present on the chromosome
or extrachromosomal.
    (2) Generic names will be reviewed by EPA at the time of
submission.
    (i) If EPA concludes that a proposed generic name meets the
criteria in paragraph (f)(1) of this section, EPA will include that
generic name in the public TSCA Inventory listing for that substance.
    (ii) If the proposed generic name does not meet the criteria in
paragraph (f)(1) of this section, EPA will notify the submitter
concerning the deficiency via CDX, as described in Sec.  703.5(h). EPA
will provide ten business days to correct the deficiency and provide an
alternative generic name that would be acceptable to EPA. If the
alternative generic name proposed by EPA is acceptable to the submitter
(or if the submitter does not respond within the ten-day period), EPA
will place that alternative generic name on the public TSCA Inventory.
If the alternative generic name proposed by EPA is not acceptable to
the submitter, the submitter must submit a revised generic name that
meets the criteria in paragraph (f)(1) of this section and an
explanation of how EPA's proposed generic name reveals confidential
information. If EPA concludes that the revised generic name also does
not meet the criteria in paragraph (f)(1) of this section, EPA will
hold the notice of commencement for a period of up to 10 business days.
Reporting requirements will not be considered to have been met and the
microorganism will not be added to the TSCA Inventory during this
period. If the submission remains deficient after this 10-day period,
EPA will proceed with CBI review of the microorganism identity claim
and will likely deny the claim.

PART 790--PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST
RULES

0
33. The authority citation for part 790 continues to read as follows:

    Authority: 15 U.S.C. 2603.

0
32. Revise Sec.  790.7 to read as follows:

Sec.  790.7  Confidentiality.

    Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.

[FR Doc. 2022-09629 Filed 5-11-22; 8:45 am]
BILLING CODE 6560-50-P