[Federal Register Volume 85, Number 150 (Tuesday, August 4, 2020)]
[Notices]
[Pages 47217-47220]
[FR Doc No: 2020-16905]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1680]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; Isotonitazene; MDMB-
4en-PINACA; CUMYL-PEGACLONE; Flubromazolam; Clonazolam; Diclazepam; 3-
MeO-PCP; DIPHENIDINE; 2-MEO-DIPHENIDINE; 5-MEO-DALT; and 3-
FLUOROPHENMETRAZINE (3-FPM); Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
requesting interested persons to submit comments concerning abuse
potential, actual abuse, medical usefulness, trafficking, and impact of
scheduling

changes on availability for medical use of 11 drug substances. These
comments will be considered in preparing a response from the United
States to the World Health Organization (WHO) regarding the abuse
liability and diversion of these drugs. WHO will use this information
to consider whether to recommend that certain international
restrictions be placed on these drug substances. This notice requesting
comments is required by the Controlled Substances Act (CSA).

DATES: Submit either electronic or written comments by August 28, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 28, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 28, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2020-N-1680 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs;
Isotonitazene; MDMB-4en-PINACA; CUMYL-PEGACLONE; Flubromazolam;
Clonazolam; Diclazepam; 3-MeO-PCP; DIPHENIDINE; 2-MEO-DIPHENIDINE; 5-
MEO-DALT; and 3-FLUOROPHENMETRAZINE (3-FPM); Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on 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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic
Substances (Psychotropic Convention). Article 2 of the Psychotropic
Convention provides that if a party to the convention or WHO has
information about a substance, which in its opinion may require
international control or change in such control, it shall so notify the
Secretary-General of the United Nations (the U.N. Secretary-General)
and provide the U.N. Secretary-General with information in support of
its opinion.
    Paragraph (d)(2)(A) of the CSA (21 U.S.C. 811) (Title II of the
Comprehensive Drug Abuse Prevention and Control Act of 1970) provides
that when WHO notifies the United States under Article 2 of the
Psychotropic Convention that it has information that may justify adding
a drug or other substances to one of the schedules of the Psychotropic
Convention, transferring a drug or substance from one schedule to
another, or deleting it from the schedules, the Secretary of State must
transmit the notice to the Secretary of Health and Human Services
(Secretary of HHS). The Secretary of HHS must then publish the notice
in the Federal Register and provide opportunity for interested persons
to submit comments that will be considered by HHS in its preparation of
the scientific and medical evaluations of the drug or substance.

II. WHO Notification

    The Secretary of HHS received the following notice from WHO (non-
relevant text removed):
Ref.: C.L.22.2020

    The World Health Organization (WHO) presents its compliments to
Member States and Associate Members and in reference to C.L.14.2019
has the pleasure of informing

that the 43rd Expert Committee on Drug Dependence (ECDD) will meet
from 12 to 16 October 2020 in Geneva, Switzerland. In the event that
the meeting should be held virtually due to exceptional
circumstances, corresponding arrangements will be made. Given that
ECDD meetings are of a closed nature, this letter serves to notify
Member States of the substances under review at the 43rd ECDD, which
are in the Annex I for reference.
    WHO is mandated by the 1961 and 1971 International Drug Control
Conventions to make recommendations to the UN Secretary-General on
the need for and level of international control of psychoactive
substances based on the advice of its independent scientific
advisory body, the ECDD. To assess the appropriate control of a
psychoactive substance, the ECDD convenes annually to review the
potential of this substance to cause dependence, abuse and harm to
health, as well as any therapeutic applications. In order to perform
this review and make scientific and evidence-based decisions, the
ECDD conducts medical, scientific, and public health evaluations of
the selected psychoactive substances using the best available
information.
    Although the meetings are of a closed nature, Member States are
invited to contribute to the ECDD review process by joining the 43rd
ECDD Open Session on 12 October 2020. The Open Session will allow
interested parties to present information concerning substances
under review to the Expert Committee. Registration information will
be made available on the ECDD website: https://www.who.int/medicines/access/controlled-substances/en/.
    As in the past and in line with the publication ``Guidance on
the WHO review of psychoactive substances for international
control'' (EB126/2010/REC1, Annex 6),\1\ Member States can also
contribute to the ECDD review process by providing accurate
information concerning the substances under review in advance of the
meeting. For this purpose, a questionnaire will be sent to Member
States to gather country information on the legitimate use, harmful
use, status of national control and potential impact of
international control for each substance under evaluation.
    In addition to the questionnaire, Member States are also
encouraged to provide any additional relevant information
(unpublished or published) on substances to be reviewed by the 43rd
ECDD by emailing<EMAIL_ADDRESS>with the subject ``Ref:
C.L.22.2020''.
    The World Health Organization takes this opportunity to renew to
Member States and Associate Members the assurance of its highest
consideration.

GENEVA, 23 June 2020

\1\ https://apps.who.int/gb/ebwha/pdf_files/EB126-REC1/B126_REC1-en.pdf#page=58.

Annex I

43nd Expert Committee on Drug Dependence (ECDD), 12-16 October 2020,
Substances for Review

    The substances listed below have never been formally reviewed by
WHO and are not currently under international control. Information was
brought to WHO's attention that these substances are clandestinely
manufactured, of especially serious risk to public health and society,
and of no recognized therapeutic use by any Party.

                             Critical Review
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------------------------------------------------------------------------
Synthetic Opioids.........................  1. Isotonitazene
Synthetic Cannabinoid Receptor Agonists...  2. MDMB-4en-PINACA
                                            3. CUMYL-PEGALONE
Benzodiazepines...........................  4. Flubromazolam
                                            5. Clonazolam
                                            6. Diclazepam
Dissociative-type substances..............  7. 3-MeO-PCP
                                            8. DIPHENIDINE
                                            9. 2-MEO-DIPHENIDINE
Hallucinogen..............................  10. 5-MEO-SALT
Synthetic Stimulant.......................  11. 3-FLUROPHENMETRAZINE (3-
                                             FPM)
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    FDA has verified the website addresses contained in the WHO notice,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time. Access to view the WHO
questionnaire can be found at https://www.who.int/teams/health-product-and-policy-standards/controlled-substances/ecdd-member-state-questionnaire.

III. Substances Under WHO Review

    Isotonitazene (chemical name: N,N-diethyl-2-(2-(4
isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine) is a
potent synthetic opioid that is abused similar to other synthetic
opioids. Its use has resulted in adverse health effects, including
positively identified in 49 death investigation cases in the United
States between August 2019 and April 2020. Law enforcement data
indicate that isotonitazene has appeared in the United States' illicit
drug market. According to the National Forensic Laboratory Information
System (NFLIS) database, there have been 53 encounters of isotonitazene
in the United States (as of June 2020). There are no commercial or
approved medical uses for isotonitazene. On June 18, 2020, the Drug
Enforcement Administration issued a notice of intent to temporarily
control isotonitazene as a schedule I substance under the CSA.
    MDMB-4en-PINACA is a synthetic cannabinoid that has been sold
online and used to mimic the biological effects of tetrahydrocannabinol
(THC), the main psychoactive constituent in marijuana. Research and
clinical reports have demonstrated that synthetic cannabinoids are
applied onto plant material so that the material may be smoked as users
attempt to obtain a euphoric and psychoactive ``high''. Synthetic
cannabinoids have been marketed under the guise of ``herbal incense,''
and promoted by drug traffickers as legal alternatives to marijuana.
According to the NFLIS database, MDMB-4en-PINACA was first encountered
in the United States in January 2019. There have been 1,436 encounters
of MDMB-4en-PINACA in the United States (as of July 6, 2020). MDMB-4en-
PINACA has also been encountered mixed with opioids including heroin
and fentanyl, with some incidents resulting in violent behaviors,
tachycardia, and hypertension. There are no commercial or approved
medical uses for MDMB-4en-PINACA and MDMB-4en-PINACA is not a
controlled substance under the CSA.
    CUMYL-PEGACLONE is a synthetic cannabinoid that has been sold
online and used to mimic the biological effects of THC, the main
psychoactive constituent in marijuana. Research and clinical reports
have demonstrated that synthetic cannabinoids are applied onto plant
material so that the material may be smoked as users attempt to obtain
a euphoric and psychoactive ``high''. Synthetic cannabinoids have been
marketed under the guise of ``herbal incense,'' and promoted by drug
traffickers as legal alternatives to marijuana. In vitro studies
demonstrate that CUMYL-PEGALCONE binds to and activates the cannabinoid
one receptor. CUMYL-PEGALCONE has not been encountered within the
United States according to the NFLIS database (as of July 6, 2020).
There are no commercial or approved medical uses for CUMYL-PEGALCONE
and is not a controlled substance under the CSA.
    Flubromazolam, clonazolam, and diclazepam belong to a class of
substances known as benzodiazepines. Benzodiazepines produce central
nervous system depression and are commonly used to treat insomnia,
anxiety, and seizure disorders. Flubromazolam is a triazole analogue of
the designer benzodiazepine, flubromazepam. Flubromazolam can be
purchased on the internet and is used as a recreational substance in
the United States. Flubromazolam has been identified in an increasing
number of law enforcement seizures and has been associated with an
increasing number of drug overdose deaths. It is abused by a broad
range of groups including youths, young adults, and older adults.
Clonazolam has been involved in an increasing number of drug seizure
events as well as drug overdose deaths, alone and in combination with
alcohol. Diclazepam is a designer benzodiazepine sold on the internet
and

most often found as a liquid solution, but it may be sold as a powder,
tablet, blotter paper, or pellet. In 2018, flubromazolam, clonazolam,
and dicalazepam were all identified by law enforcement in driving under
the influence of drugs cases in the United States. Flubromazolam,
clonazolam, and diclazepam are not approved for medical use in the
United States and are not controlled substances under the CSA.
    3-MeO-PCP (3-methoxyphencyclidine; chemical name: 1-(1-(3-
methoxyphenyl)cyclohexyl)piperidine) is a novel N-methyl-D-aspartate
(NMDA) receptor antagonist with structural and biochemical similarities
to phencyclcycidine (PCP) and other arylcyclohexylamines. 3-MeO-PCP is
classified as an arylcyclohexylamine and produces dissociative
anesthetic and hallucinogenic effects. Use of this substance is
associated with intoxication and published case reports of both fatal
and non-fatal overdose. 3-MeO-PCP is encountered by law enforcement in
drug seizure reports. 3-MeO-PCP is an analogue of the Schedule II
hallucinogen PCP. There is no approved medical use for 3-MeO-PCP in the
United States. 3-MeO-PCP is not a controlled substance under the CSA.
If intended for human consumption, 3-MeO-PCP may be treated as a
``controlled substance analogue'' under the CSA pursuant to 21 U.S.C
802(32) (A) and 813.
    DIPHENIDINE (chemical name: 1-(1,2-diphenylethyl) piperidine) is a
non-competitive NMDA receptor antagonist classified as a
diarylethylamine and produces dissociative anesthetic and
hallucinogenic effects. It was originally synthesized in the 1920s, but
reports of abuse started in the last decade. Use of this substance is
associated with intoxication and published case reports of both fatal
and non-fatal overdose outside of the United States. DIPHENIDINE is
encountered by law enforcement in drug seizure reports. DIPHENIDINE is
not approved for medical use in the United States and is not a
controlled substance under the CSA.
    2-MeO-DIPHENIDINE (2-methoxy-diphenidine, methoxphenidine) is a
non-competitive NMDA receptor antagonist classified as a
diarylethylamine and produces dissociative anesthetic and
hallucinogenic effects that may produce effects similar to high doses
of dextromethorphan. Use of this substance is associated with
intoxication and non-fatal overdose in published case reports outside
the United States. 2-MeO-DIPHENIDINE is encountered by law enforcement
in drug seizure reports. There is no approved medical use for 2-MeO-
DIPHENIDINE in the United States and 2-MeO-DIPHENIDINE is not a
controlled substance under the CSA.
    5-MeO-DALT (chemical name: N,N-Diallyl-5-methoxytryptamine) is a
tryptamine hallucinogen and is an agonist of the serotonin (5-HT) 5-
HT2A receptor. 5-MeO-DALT appears to produce hallucinogenic
effects similar to other tryptamine hallucinogens and fully substituted
for 2,5-dimethoxy-4-methylamphetamine (DOM) in DOM-trained rats. 5-MeO-
DALT is an analogue of the Schedule I controlled substance 5methoxy-
N,N-diisopropyltryptamine (5-MeO-DiPT). 5-MeO-DALT has been encountered
by law enforcement in drug seizure reports. 5-MeO-DALT is not approved
for medical use in the United States and is not controlled under the
CSA.
    3-FLUOROPHENMETRAZINE (3-FPM) (chemical name: 1-(3-fluorophenyl)-2-
(methylamino)propan-1-one) shares substantial chemical structural
similarity to phenmetrazine, a Schedule II controlled substance that
was prescribed as an appetite suppressant before being withdrawn from
the pharmaceutical drug market in the United States because of its
abuse potential. 3-FPM, which is similar to phenmetrazine and other
stimulant drugs of abuse, increases extracellular concentrations of the
neurotransmitter dopamine by inhibiting the uptake of this
neurotransmitter at the dopamine transporter. Elevated extracellular
dopamine concentrations have been implicated in the mechanism of action
of stimulant drugs of abuse. There is no approved medical use for 3-FPM
in the United States and 3-FPM is not a controlled substance under the
CSA.

IV. Opportunity To Submit Domestic Information

    As required by paragraph (d)(2)(A) of the CSA, FDA, on behalf of
HHS, invites interested persons to submit comments regarding the 11
drug substances. Any comments received will be considered by HHS when
it prepares a scientific and medical evaluation for drug substances
that is responsive to the WHO Questionnaire for these drug substances.
HHS will forward such evaluation of these drug substances to WHO, for
WHO's consideration in deciding whether to recommend international
control/decontrol of any of these drug substances. Such control could
limit, among other things, the manufacture and distribution (import/
export) of these drug substances and could impose certain recordkeeping
requirements on them.
    Although FDA is, through this notice, requesting comments from
interested persons, which will be considered by HHS when it prepares an
evaluation of these drug substances, HHS will not now make any
recommendations to WHO regarding whether any of these drugs should be
subjected to international controls. Instead, HHS will defer such
consideration until WHO has made official recommendations to the
Commission on Narcotic Drugs, which are expected to be made in late-
2020. Any HHS position regarding international control of these drug
substances will be preceded by another Federal Register notice
soliciting public comments, as required by paragraph (d)(2)(B) of the
CSA.

    Dated: July 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-16905 Filed 8-3-20; 8:45 am]
BILLING CODE 4164-01-P


Comment Info: =================

General Comment:As a serious vaper as well as active duty military i can Say Electronic cigs have had nothing but a positive impact on my life and play a major role in my daily activities. i live a very active life and ive never noticed any impact on my life, if anything my health has been better since i quit smokign and switched to vaping. Me and many people i work with in the navy will have a seemingly same story. Vaping is part of our lifes, and we are here to support it. What the big tobacco is, is scared. They are scared to death of what vaping is doing to their industry and they have a right to be afraid. But you cannot let big tobacco run this country and push us around. Many MANY small independent business's cant survive vs something like big tobacco. If this is truly a land of the free, why must there always be bans on so many thigns be it guns our 2nd amendment rights, small business, and no vaping. Seriously vaping? Dangerous?  I would respectfully request that the period for comment be extended to 180 days. Thank you for your time.


[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Rules and Regulations]
[Pages 60920-60927]
[FR Doc No: 2019-23829]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R9-OAR-2018-0821; FRL-10001-65-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: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action 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 the Moderate area attainment date of July 20,
2018. This determination is based on complete, quality-assured, and
certified data for 2015-2017. This final action is necessary to fulfill
the EPA's statutory obligation to determine whether ozone nonattainment
areas attained the NAAQS by the applicable attainment date.

DATES: This rule will be effective on December 12, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2018-0821. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available through https://www.regulations.gov, or please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section for
additional availability information.

FOR FURTHER INFORMATION CONTACT: Nancy Levin, EPA Region IX, 75
Hawthorne St., 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. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Environmental Justice Considerations
V. Statutory and Executive Order Reviews

I. Proposed Action

    On June 13, 2019 (84 FR 27566), the EPA proposed to determine that
the Phoenix NAA attained the 2008 ozone standard \1\ by the 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 also proposed to
determine that the CAA requirement for the State Implementation Plan
(SIP) to provide for contingency measures to be implemented in the
event the area fails to attain (``attainment contingency measures'')
would no longer apply to the Phoenix NAA. Our proposed action contains
more information on our determinations.
---------------------------------------------------------------------------

    \1\ Since the primary and secondary 2008 ozone standards are
identical, we hereinafter refer to ``standards'' in the singular. 73
FR 16436.
---------------------------------------------------------------------------

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received comments from five commenters. We
summarize the comments and provide our responses below.

Commenter #1: Arizona Center for Law in the Public Interest

    Comment: Arizona Center for Law in the Public Interest (ACLIPI)
noted that monitoring data from 2018 and 2019 show multiple exceedances
of the 2008 ozone standard and concluded that the Phoenix NAA does not
``actually'' comply with the standard. ACLIPI asserted that `` `paper
compliance' with the 2008 ozone standard does not solve Phoenix's
ongoing ozone pollution problem'' and the ``EPA's proposed action
allows the State to avoid or significantly delay taking meaningful
action to protect public health [which] contravenes the express policy
of the Clean Air Act that `protection of public health is the highest
priority.' ''
    Response: CAA section 181(b)(2)(A) requires the EPA to determine
whether an ozone nonattainment area (NAA) attained the standard by the
applicable attainment date ``based on the area's design value (as of
the attainment date).'' \2\ The applicable attainment date for the
Phoenix NAA for the 2008 ozone NAAQS is not later than July 20,
2018.\3\ Because the design value for the 2008 ozone NAAQS is based on
the three most recent, complete calendar years of data, attainment must
be evaluated based on 2015-2017 data. Accordingly, we are not permitted
to consider 2018 or 2019 data in evaluating whether the area attained
by the applicable attainment date.
---------------------------------------------------------------------------

    \2\ CAA section 181(b)(2)(A) (emphasis added).
    \3\ 40 CFR 51.1103; 81 FR 26697, 26698.
---------------------------------------------------------------------------

    We note that the more recent monitoring data would be relevant if
we were making a ``clean data determination'' and suspending
attainment-related requirements for the Phoenix NAA under 40 CFR
51.1118. These data would also be relevant if we were redesignating the
area to attainment under CAA section 107(d)(3). However, as explained
in our proposal, we are not taking either of those actions at this
time. Therefore, the designation and classification of the Phoenix NAA
for the 2008 ozone NAAQS will remain Moderate

nonattainment until such time as the EPA determines that the area meets
the CAA requirements for redesignation to attainment. In order to
redesignate the area to attainment, the EPA will have to determine,
among other things, that the Phoenix NAA has continued to attain the
NAAQS at the time of final redesignation, that the air quality
improvement is due to permanent and enforceable emission reductions,
and that the State of Arizona's (``State's'') maintenance plan provides
for maintenance of the NAAQS for at least ten years beyond
redesignation.\4\
---------------------------------------------------------------------------

    \4\ CAA section 107(d)(3)(E) and 175A(a).
---------------------------------------------------------------------------

    Finally, the commenter cited CAA section 319(b)(3)(A), which
establishes five principles that the EPA must follow in developing
implementing regulations for exceptional events, including that
``protection of public health is the highest priority.'' \5\ The
regulatory provisions implementing this principle are found in 40 CFR
51.930, which requires air agencies requesting data exclusion to take
appropriate and reasonable actions to protect public health from
exceedances or violations of the NAAQS.\6\ Specifically, agencies must
promptly notify the public when the air quality exceeds or is expected
to exceed the NAAQS, educate the public regarding steps they can take
to minimize exposure, and provide for the implementation of appropriate
measures to protect public health from exceedances or violations of
ambient air quality standards caused by exceptional events.\7\ The
commenter has not identified whether or how it believes the State has
failed to meet these requirements. Accordingly, we do not agree that
the determination of attainment by the attainment date contravenes the
principle that protection of public health is the highest priority.
---------------------------------------------------------------------------

    \5\ CAA section 319(b)(3)(A)(i).
    \6\ 40 CFR 51.930. See also 81 FR 68216, 68270 (``the regulatory
requirements implementing [319(b)(3)(A)](i) and (iv) are found in 40
CFR 51.930, Mitigation of Exceptional Events'').
    \7\ Id. and 40 CFR 50.14(c)(1).
---------------------------------------------------------------------------

    Comment: ACLIPI noted that, in the proposed determination of
attainment, the EPA excluded exceedances of the 2008 ozone standard on
June 20, 2015 and July 7, 2017, based on the EPA's concurrence with the
State's request to find that these exceedances were due to
``exceptional events'' under the EPA's Exceptional Events Rule. The
commenter claimed that the Arizona Department of Environmental
Protection's (ADEQ's) documentation does not support treating the June
20, 2015 exceedances as exceptional events because the documentation
``does not convincingly establish any causal relationship between the
Lake Fire and the June 2015 exceedances, much less a clear causal
relationship.''
    Response: As indicated by the commenter, one of the required
elements of an exceptional events demonstration is a showing that
``there exists a clear causal relationship between the specific event
and the monitored exceedance or violation.'' \8\ This showing must be
supported by analyses comparing the claimed event-influenced
concentration(s) to concentrations at the same monitoring site at other
times,\9\ and may also be supported by other types of analyses.\10\
---------------------------------------------------------------------------

    \8\ 40 CFR 50.14(c)(3)(iv)(B). See also CAA section
319(b)(3)(B)(ii)(``a clear causal relationship must exist between
the measured exceedances of a national ambient air quality standard
and the exceptional event'').
    \9\ 40 CFR 50.14(c)(3)(iv)(C).
    \10\ 81 FR 68241, Table 1--Example Clear Causal Relationship
Evidence and Analyses.
---------------------------------------------------------------------------

    The EPA reviews the information and analyses in the air agency's
demonstration package using a weight of evidence approach.\11\ As
explained in the preamble to revisions to the Exceptional Events Rule
promulgated in 2016:

    \11\ 81 FR 68242 (``. . . the EPA will use a weight of evidence
approach in reviewing submitted demonstrations and will consider the
`clear causal relationship' information, including the comparison to
historical concentrations showing, along with evidence supporting
the other Exceptional Events Rule criteria.'') See also ``Technical
Support Document for EPA Concurrence On O3 Exceedances
Measured In The Phoenix-Mesa 2008 8-Hour O3 Nonattainment
Area on June 20, 2015 as Exceptional Events,'' (hereinafter
``TSD''), 1.
---------------------------------------------------------------------------

    . . . in applying a ``weight of evidence'' approach to reviewing
individual exceptional events demonstrations, the EPA believes it is
appropriate to consider all relevant evidence and qualitatively
``weigh'' this evidence based on its relevance to the Exceptional
Events Rule criterion being addressed, the degree of certainty, its
persuasiveness, and other considerations appropriate to the
individual pollutant and the nature and type of event.

    Therefore, the EPA considers a variety of evidence when evaluating
whether there is a clear causal relationship between a specific event
and the monitored exceedance or violation, and weighs the available
evidence based on its relevance, degree of certainty, persuasiveness,
and other appropriate considerations.
    The EPA's ``Guidance on the Preparation of Exceptional Events
Demonstrations for Wildfire Events that May Influence Ozone
Concentrations'' (September 2016) (hereinafter ``Wildfire Ozone
Guidance'' or ``Guidance'') recommends a tiered approach for addressing
the clear causal relationship element:

    Tier 1 clear causal analyses should be used for wildfire events
that cause clear O3 impacts in areas or during times of
year that typically experience lower O3 concentrations,
and are thus simpler and less resource intensive than analyses for
other events. Tier 2 clear causal analyses are likely appropriate
when the impacts of the wildfire on O3 levels are less
clear and require more supportive documentation than Tier 1
analyses. Tier 3 clear causal analyses should be used for events in
which the relationship between the wildfire and the O3
exceedance or violation is more complicated than the relationship in
a Tier 2 analysis, and thus would require more supportive
documentation than Tier 2 analyses.\12\
---------------------------------------------------------------------------

    \12\ Guidance, 4. This guidance uses ``O3'' to refer
to ``ozone.''

    The Guidance describes the ``key factors'' and specific types of
technical analyses that can be used to evaluate these factors in order
to determine which tier a particular demonstration falls into and
whether it meets the clear causal criterion.\13\
---------------------------------------------------------------------------

    \13\ Id. at 9-20.
---------------------------------------------------------------------------

    In this case, as part of the discussions between the EPA and ADEQ
after the initial notification and during the air agency's
demonstration development, the EPA found that the June 20, 2015 event
did not meet all the key factors for a wildfire ozone Tier 1 or Tier 2
analysis. Therefore, the EPA and ADEQ agreed that additional evidence
to support the clear causal demonstration (i.e., a Tier 3 analysis) was
appropriate.\14\ In accordance with this finding, ADEQ's documentation
for the June 20, 2015 exceedances included additional evidence to
support that (1) wildfire emissions were transported from the wildfire
to the monitors; (2) wildfire emissions affected the monitors; and (3)
wildfire emissions caused the ozone exceedances.\15\ As described in
further detail below, the EPA evaluated the relevance, persuasiveness,
and certainty of this evidence and found that the weight of

the evidence established the existence of a clear causal relationship
between the Lake Fire and the June 20, 2015 exceedances.
---------------------------------------------------------------------------

    \14\ TSD, 8.
    \15\ Id. ADEQ's documentation for the June 20, 2015 exceedances
consisted of three separate submittals: ``State of Arizona
Exceptional Event Documentation for Wildfire-Caused Ozone
Exceedances on June 20, 2015 in the Maricopa Nonattainment Area,''
(September 2016) (``initial submittal''); ``Addendum to: State of
Arizona Exceptional Event Documentation for Wildfire-Caused
Exceedances on June 20, 2015 in the Maricopa Nonattainment Area--
September 2016; Additional Evidence that Ozone and Ozone Precursor
Emissions From the Lake Fire Reached and Affected Ozone Monitors
Within the Maricopa Nonattainment Area'' (May 2018) (``first
addendum''); and ``Addendum to: State of Arizona Exceptional Event
Documentation for Wildfire-Caused Exceedances on June 20, 2015 in
the Maricopa Nonattainment Area--September 2016; Expanded Conceptual
Model Linking Ozone and Ozone Precursors From the Lake Fire with the
Ozone Exceedances in the Maricopa Nonattainment Area,'' (March 2019)
(``second addendum'').
---------------------------------------------------------------------------

    In order to demonstrate that wildfire emissions were transported to
the monitor, ADEQ's initial submittal presented a trajectory analysis
using the HYbrid Single-Particle Lagrangian Integrated Trajectory model
(HYSPLIT) and satellite imagery of smoke and National Oceanic and
Atmospheric Administration (NOAA) smoke contours for light, medium, and
heavy smoke.\16\ The EPA found that these initial analyses ``provided
evidence that smoke was present over the nonattainment area on June 19,
2015, but did not provide evidence that the smoke was at ground level,
nor that smoke was present over the nonattainment area on June 20,
2015.'' \17\ However, the second addendum to the demonstration included
additional analyses to clarify transport of wildfire emissions and
mechanisms for mixing to ground level along ``upper-air'' and ``lower-
air'' pathways, including updated HYSPLIT analyses, satellite imagery
and data, water vapor and dew point analysis, and meteorological data
regarding boundary layer depths in the nonattainment area on June 20,
2015.\18\ The EPA evaluated these analyses and determined that,
collectively, they adequately established that ``emissions from the
Lake Fire in California were transported to the nonattainment area and
the affected monitoring sites and reached ground level on June 20,
2015.'' \19\
---------------------------------------------------------------------------

    \16\ Id.
    \17\ Id. at 9.
    \18\ Id.
    \19\ Id. at 11.
---------------------------------------------------------------------------

    In order to demonstrate that the wildfire emissions affected the
monitors, the initial submittal provided maps of daily maximum 8-hour
average ozone concentrations from June 17 through June 21, 2015.\20\
These maps showed a regional rise in ozone concentrations across much
of Arizona on June 19 and 20, 2015, suggesting that factors affecting
elevated ozone concentrations within the nonattainment area were
regional in nature. The initial submittal also provided ozone diurnal
profiles of the exceeding monitors on June 20, 2015. The first addendum
supplemented this analysis by providing an expanded analysis of ozone
diurnal hourly concentrations at the exceeding monitors for June 19
through 21, 2015, along with comparisons to historical hourly
concentrations, which showed that ozone concentrations were at or above
the 95th percentile values for several hours on June 20, 2015.\21\ The
initial submittal also provided an analysis of diurnal nitrogen dioxide
(NO2) concentrations, which the first addendum supplemented
with an expanded statistical analysis of NO2 similar to the
expanded ozone analysis. In addition, the initial submittal also
evaluated particulate matter with an aerodynamic diameter less than or
equal to a nominal 2.5 micrometers (PM2.5), which is much
more commonly associated with fire emissions than NO2, but
found that PM2.5 was not elevated within the nonattainment
area prior to or during the exceedance day. To address the lack of
elevated PM2.5 observed in the nonattainment area, the
initial submittal and first addendum examined speciation data for
elemental carbon (EC) and organic carbon (OC).\22\ After examining
these analyses, we concluded that:
---------------------------------------------------------------------------

    \20\ Id.
    \21\ Id.
    \22\ PM2.5 is made of many different chemical
species, including EC and OC. Elevated OC concentrations and low EC/
OC ratios are generally associated with biomass smoke and therefore
indicate the presence of wildfire emissions. See first addendum, 10.

    Overall, the lack of elevated PM2.5 in the
nonattainment area raises questions about the extent to which
wildfire emissions reached the ground and affected the monitor.
However, the supplemental analyses showing elevated OC and
relatively low EC/OC concentrations, and unusually elevated
NO2 and O3 concentrations observed on a
Saturday, along with the robust analysis of transport and mixing
mechanisms described earlier in this document, ultimately support
the conclusion that wildfire emissions reached the ground and
affected measurements at the exceeding monitors on June 20,
2015.\23\
---------------------------------------------------------------------------

    \23\ Id. at 13.

    The initial submittal and addenda also provided additional evidence
to demonstrate that the wildfire emissions caused the ozone exceedances
observed on June 20, 2015, including three ``matching day'' analyses
that (1) compared days in 2010 through 2015 during the month of June
with similar meteorological conditions to June 20, 2015; (2) compared
the conditions of all exceedance days in 2010 through 2015 during the
month of June in comparison to June 20, 2015; and (3) discussed the
characteristics of June 20, 2015, as a rare Saturday exceedance.\24\ We
found that these analyses demonstrated the unusual nature of the June
20, 2015 event. We also found that, along with the previously described
analyses, the matching day analyses sufficiently demonstrated a clear
causal relationship between the emissions generated by the Lake Fire
and the exceedances measured at the Phoenix area monitors.\25\
---------------------------------------------------------------------------

    \24\ Id. at 13-14.
    \25\ Id. at 14-15.
---------------------------------------------------------------------------

    As explained in further detail in response to other comments
elsewhere in this document, the commenter has not provided any evidence
that undermines this finding that the weight of the evidence supports a
clear causal relationship between the Lake Fire and the exceedances.
Accordingly, we conclude that the weight of the evidence establishes
that the clear causal criterion has been met for the June 20, 2015
event.
    Comment: ACLIPI claimed that ``there is nothing `exceptional' about
exceedances of the 2008 ozone standard at the monitors at issue'' since
``these monitors routinely register some of the highest ozone
concentrations in the Phoenix NAA.''
    Response: The term ``exceptional'' in the context of exceptional
events does not require that the concentrations be the highest observed
at the monitoring sites. CAA section 319(b)(1)(A) defines an
``exceptional event'' as an event that:

    (i) affects air quality;
    (ii) is not reasonably controllable or preventable;
    (iii) is an event caused by human activity that is unlikely to
recur at a particular location or a natural event; and
    (iv) is determined by the Administrator through the process
established in the [Exceptional Events Rule] to be an exceptional
event.\26\
---------------------------------------------------------------------------

    \26\ See also 40 CFR 50.1(j).

    A previous version of the Exceptional Events Rule required that, in
addition to meeting these statutory elements criteria, states also
submit evidence that the event was associated with a measured
concentration in excess of normal historical fluctuations, including
background.\27\ However, in the 2016 revisions to the Rule, the EPA
removed this requirement and replaced it with a requirement for states
to provide analyses comparing the claimed event-influenced
concentration(s) to concentrations at the same monitoring site at other
times in support of the clear causal criterion.\28\ The revised rule
also provides that states are not required to prove a specific
percentile point in the distribution of data.\29\ In other words,
``[t]here is no pass or fail threshold for the historical
concentrations data presentation.'' \30\
---------------------------------------------------------------------------

    \27\ 40 CFR 50.14(c)(3)(iv)(C) (2007 version).
    \28\ 40 CFR 50.14(c)(3)(iv)(C) (2017 version). See also 81 FR
68241-68245.
    \29\ 40 CFR 50.14(c)(3)(iv)(C).
    \30\ Wildfire Ozone Guidance, 10.
---------------------------------------------------------------------------

    Nonetheless, to facilitate development and evaluation of
demonstrations for

wildfire-influenced ozone exceedances, the EPA has suggested
statistical benchmarks for comparing the event-related ozone
concentration with non-event-related high ozone concentrations as part
of ``Tier 2 key factor 2.'' \31\ Specifically, for key factor 2, a
state would show that the exceedance is either (1) in the 99th or
higher percentile of the 5-year distribution of ozone monitoring data,
or (2) one of the four highest ozone concentrations within 1 year
(among those concentrations that have not already been excluded under
the Exceptional Events Rule, if any).\32\ If either of these two
criteria is met, then the event-influenced data are generally
considered to be high compared to other data at the monitoring
site.\33\
---------------------------------------------------------------------------

    \31\ Id. at 21.
    \32\ Id.
    \33\ Id.
---------------------------------------------------------------------------

    In this case, as part of the Tier 2 key factor 2 analyses,\34\ ADEQ
demonstrated that five of the six monitors had daily maximum 8-hour
average ozone concentrations during the event at or above the 99th
percentile for the 5-year period, while one monitor (Pinnacle Peak) did
not. However, the event ozone concentration at Pinnacle Peak was the
third highest ozone concentration measured at the site in 2015.\35\
Based on the concentrations observed at these monitors, the event
exceedances meet Tier 2 key factor 2, and are therefore high relative
to other data at the monitoring site.
---------------------------------------------------------------------------

    \34\ The June 20, 2015 event did not qualify for a Tier 2
analysis because it did not meet Tier 2 Factor 1. TSD, 8. However,
the EPA recommends that, as part of a Tier 3 analysis, that states
``explain how the events, monitor and exceedance compare'' with the
Tier 2 key factors. Guidance, 26.
    \35\ TSD, 8.
---------------------------------------------------------------------------

    Comment: The commenter asserted that the exceedances were caused by
local conditions and that ``if a wildfire smoke plume had transported
to the Phoenix NAA and uniformly influenced its monitors, it would have
caused abnormally high concentrations across the nonattainment area, or
at least an atypical pattern of such concentrations,'' but ``[i]nstead
the monitors that recorded the highest ozone concentrations were
predictably located in the upslope/northeastern upslope portion.''
    Response: As noted in the Wildfire Ozone Guidance, ozone production
is non-linear and therefore impacts of wildfire emissions on ozone can
be difficult to predict. While an atypical pattern of exceedances could
provide additional evidence to support that wildfire emissions affected
ozone concentrations, the lack of such a pattern does not preclude a
finding that wildfire emissions influenced a monitor. Similarly, an
area-wide increase is not a necessary factor to demonstrate a clear
causal relationship between the wildfire emissions and observed
exceedances. The EPA evaluated other analyses and evidence provided in
the demonstration and addenda and concluded that the weight of the
evidence established a clear causal relationship between the Lake Fire
and the June 20, 2015 exceedances.
    Comment: The commenter claimed that ``[t]here is nothing unusual
about the fact that the June 2015 exceedances occurred on a Saturday''
and that ``[n]either ADEQ nor EPA has presented any support for the
notion that high ozone concentrations on the weekend must have been
affected by wildfire emissions, and that EPA cannot simply assume this
to be true.''
    Response: ADEQ provided evidence that the characteristics of the
June 20, 2015 Saturday exceedances were unique. ADEQ reviewed all
Saturday exceedances at the six monitors during the month of June from
2010 to 2015 and found that there were only two other Saturdays where
exceedances were measured. These two other Saturday exceedance days
were preceded by higher exceedances on the day prior (Friday) as part
of a multi-day event from the weekday. The June 20, 2015 exceedance,
however, ``is not a part of a prior episode event, and shows an
increase of ozone from a Friday to Saturday,'' and ``the event is
unique when compared to the prior six years of exceedance data and
strongly suggests that an outside source of ozone or ozone precursor
emissions caused the exceedances.'' \36\ The EPA agreed that the
exceedances were unusual, which points to a unique emissions source
contributing to the exceedances, but did not claim that the unusual
nature of these Saturday exceedances alone specifically identified
wildfire emissions as the cause. Rather, the EPA considered the
information indicating that the exceedances were unusual as part of the
weight of evidence approach.
---------------------------------------------------------------------------

    \36\ First addendum, 24.
---------------------------------------------------------------------------

    Comment: The commenter claimed that while the ``EPA correctly found
that PM2.5 concentrations were not elevated in the
nonattainment area and therefore did not demonstrate wildfire
influence, [the] EPA erroneously concluded this could be overcome by
speciated carbon concentration data obtained from the Phoenix JLG
Supersite (`Supersite') monitor.'' The commenter noted that ``the
Supersite [monitor] did not exceed the 2008 standard on June 20, 2015;
showed no signs of being significantly influenced by wildfire smoke on
that day; and is located a minimum of 15 miles away from the nearest
`exceptional events' monitor.''
    Response: Speciated carbon concentration data (i.e., EC and OC
data) are relevant in evaluating the existence of clear causal
relationship between fire emissions and ozone exceedances because
elevated OC concentrations and low EC/OC ratios are generally
associated with biomass smoke and therefore indicative of the presence
of wildfire emissions.\37\ In this case, the Supersite monitor is the
only location within the Phoenix NAA that measures EC and OC and is
therefore the appropriate source of such data.\38\
---------------------------------------------------------------------------

    \37\ See, e.g., J.L. Hand, et al. ``Spatial and Temporal Trends
in PM2.5 Organic and Elemental Carbon across the United
States,'' Advances in Meteorology, Article ID 367674 (2013); Dan
Jaffe, et al. ``Interannual Variations in PM2.5 due to
Wildfires in the Western United States'' Environmental Science and
Technology, 42, 2812-2818 (2008); Dominic Spracklen., et al.
``Wildfires drive interannual variability of organic carbon in the
western U.S. in summer,'' Geophysical Research Letters, 34, L16816
(2007).
    \38\ See Wildfire Ozone Guidance, 22 (supporting analyses of
pollutants associated with wildfire emissions can be ``co-located or
nearby'' the exceeding monitoring site(s) and ``in the same airshed
(or nonattainment/near nonattainment area).'').
---------------------------------------------------------------------------

    The speciated carbon analysis at Supersite indicated elevated OC
concentrations and relatively low EC/OC ratios, suggesting that
wildfire emissions were present in the area. The fact that the
Supersite monitor did not exceed the ozone standard on June 20, 2015,
does not undermine the relevance of these data. Ozone is a secondary
pollutant formed through photochemical production in a non-linear
fashion. While precursors to ozone may be present in one location,
ozone formation may occur on different spatial and temporal scales. In
this instance the Supersite monitor showed elevated OC concentrations,
relatively low EC/OC ratios, and elevated levels of NO2, an
ozone precursor emitted by wildfires; these indicate the presence of
wildfire emissions in the area. While the Supersite monitor did not
itself experience exceedances of the ozone NAAQS during the event,
other monitors in the vicinity did. In addition, two other monitors
besides the Supersite monitor showed elevated levels of
NO2.\39\ This pattern is

consistent with the presence of wildfire emissions in the area
contributing to the formation of ozone at the affected monitoring sites
and thus supports the existence of a clear causal relationship between
the wildfire emissions and the exceedances on June 20, 2015.
---------------------------------------------------------------------------

    \39\ As noted in response to the next comment, these were the
only two other sites with NO2 data determined to be
relevant for this analysis. In addition, none of the other sites in
the Phoenix NAA measure EC and OC, so those sites may have also had
elevated OC concentrations and low EC/OC ratios.
---------------------------------------------------------------------------

    Comment: The commenter claimed that ``ADEQ's reliance on
NO2 concentration data is . . . misplaced'' due to the EPA
statement that ``NO2 is a poor tracer for fire because it is
not specific to fire emissions and is emitted in large amounts by
several anthropogenic sources (e.g., cars, power plants)'' and that the
West Phoenix, Central Phoenix, and Supersite monitors ``did not record
abnormally high ozone concentrations on June 20, 2015'' and ``they are
too far away from the `exceptional events' monitors to provide relevant
data.'' The commenter also stated that ADEQ ``should include data for
all monitors in the NAA and not cherry-pick the data that arguably
support its conclusion.''
    Response: The EPA agrees that NO2 is a poor tracer for
isolating wildfire emissions because NO2 is emitted by both
anthropogenic sources and wildfires. However, given that NO2
is emitted by wildfires and is a precursor to ozone, evidence of the
presence or absence of elevated NO2 concentrations in the
nonattainment area around the time of the exceedances is relevant to
review as part of the weight of evidence for determining whether a
clear causal relationship between the wildfire emissions and the
exceedances exists. Accordingly, in reviewing ADEQ's demonstration, we
found that evidence concerning elevated NO2 concentrations
provided some additional support to the conclusion that the wildfire
emissions affected the monitors.\40\ Specifically, ADEQ's analysis
revealed that ``several of the recorded hourly NO2
concentrations were at or above the 95th percentile on [Saturday] June
20, 2015'' at West Phoenix, Central Phoenix, and Supersite, whereas
daily NO2 concentrations are typically lowest on weekend
days.\41\ Accordingly, we agreed with ADEQ's conclusion that
concentrations of NO2 at these monitors were unusual.
However, we did not claim that the elevated concentrations alone were
sufficient to demonstrate a clear causal relationship between wildfire
emissions and the monitored exceedances. Instead, the EPA considered
the unusual NO2 concentrations as one of several pieces of
evidence that supported the existence of a clear causal relationship
using the weight of evidence approach.
---------------------------------------------------------------------------

    \40\ TSD, 13.
    \41\ First Addendum, 17.
---------------------------------------------------------------------------

    As for the monitors chosen for this analysis, we believe that ADEQ
provided an adequate rationale for focusing on West Phoenix, Central
Phoenix, and Supersite monitoring sites: NO2 is only
monitored at six sites in the area, and the remaining three that were
not included in this analysis were either outside of the Phoenix NAA
(Buckeye) or serve as mobile source-oriented near-road monitors (Diablo
and Thirty-Third Avenue).
    Comment: The commenter claimed that, while ``ADEQ argues based on
regression analysis that it is unusual for ozone concentrations to be
so high at exceeding monitors under prevailing weather conditions,''
this analysis ``mainly proved that the regression equation it used
consistently failed to predict high real-world ozone concentrations
unaffected by wildfire.''
    Response: The EPA agrees that the regression analysis consistently
underpredicted ozone at high concentrations, including for non-event
exceedances. As noted in the Technical Support Document (TSD) for our
concurrence on the June 20, 2015 event, the regression analysis also
did not meet metrics described in the Wildfire Ozone Guidance.\42\ In
evaluating the weight of the evidence, the EPA did not rely on the
regression analysis to support the clear causal determination.
---------------------------------------------------------------------------

    \42\ TSD, 13.
---------------------------------------------------------------------------

    Comment: The commenter stated that the ``matching day analysis did
not bolster the case for an `exceptional event' '' as ``[t]he most this
analysis could show was that the meteorological conditions that existed
on June 20, 2015, would not normally be enough to be the sole cause of
an exceedance of the 2008 ozone standard at the monitors that recorded
exceedances.''
    Response: The EPA agrees that the matching day analysis does not
specifically implicate wildfire emissions. The EPA considered the
matching day analysis as one of several pieces of evidence that
supported the existence of a clear causal relationship using the weight
of evidence approach. As explained in the TSD and elsewhere in this
document, other pieces of evidence provided by ADEQ do implicate
wildfire emissions. The commenter has not suggested an alternative
cause for the unusually elevated levels of ozone on June 20, 2015,
other than wildfire emissions, and we are not aware of any such cause.
    Comment: ACLIPI claimed that satellite images of smoke over the
Phoenix NAA are inconsistent with such smoke originating from the Lake
Fire due to the shape and location of the smoke, and the ``upper air''
and ``lower air'' pathways in the conceptual model are ``difficult to
conceive.''
    Response: We disagree with the commenter's assertions that the
observed smoke is unlikely to be from the Lake Fire and that the
transport pathways within the conceptual model are unlikely. The
observed smoke covers a large area and is both visible in the satellite
imagery and identified as smoke as part of the NOAA smoke maps
discussed further in a subsequent response. The satellite imagery also
shows the smoke only at a snapshot in time; the shape and location of
the smoke at a single point in time is inadequate to judge whether the
smoke was transported from the Lake Fire (as opposed to fires in
Mexico). The HYSPLIT trajectory analyses presented in the demonstration
and addenda are consistent with this smoke originating from the Lake
Fire. The size of the Lake Fire, relative to the fires in Mexico, also
supports that the smoke originated from the Lake Fire.
    As for the ``upper air'' and ``lower air'' pathways, ADEQ clearly
described these in the second addendum and supported them with evidence
including multiple HYSPLIT trajectories from different locations and at
different times, a multi-dimensional dew point and water vapor
analysis, and meteorological data from within the Phoenix NAA regarding
boundary layer depths. The EPA found that these technical analyses
supported the pathways identified in the conceptual model. The
commenters did not provide any technical evidence to contradict these
analyses or support their claim that the pathways are questionable.
    Comment: The commenter stated that ``[t]he NOAA smoke maps tend to
show that any transported Lake Fire smoke (as opposed [to] smoke from
other sources) bypassed the Phoenix NAA completely'' and ``are
inconclusive at best.''
    Response: We disagree with the commenter's claims that the NOAA
smoke maps show that transported Lake Fire smoke bypassed the Phoenix
NAA completely. Multiple NOAA smoke maps show light and moderate levels
of smoke over the nonattainment area. As described in the response to a
previous comment regarding satellite imagery of smoke, this smoke was
consistent with HYSPLIT trajectories showing transport from the Lake
Fire. Additionally, the maps show smoke at a single point in time
(i.e., when a satellite passes overhead); smoke that is near the
Phoenix NAA at the time corresponding to the smoke map may pass through
the

Phoenix NAA at another time. The maps cannot be used to show that smoke
``bypassed the [area] completely'' since they do not represent all
points in time.
    Comment: The commenter claimed that the estimated emissions
quantity over distance (Q/D) ratio of 54 tons per day/kilometers (tpd/
km) is ``well below the value of 100 tpd/km that EPA recommends as
indicating clear causality.''
    Response: The commenter has mischaracterized the nature of the 100
Q/D threshold in the Wildfire Ozone Guidance. A Q/D value of 100 or
more does not by itself indicate clear causality, nor does a Q/D value
less than 100 indicate the absence of clear causality. Rather, the Q/D
ratio is one of two factors that the EPA uses to evaluate whether a
Tier 2 or Tier 3 clear causal analysis is appropriate for a particular
exceptional events demonstration.\43\ The Guidance explains that the
EPA selected 100 tpd/km ``as a conservative indicator'' of ozone
impacts.\44\ The EPA has concurred on a number of fire-related
exceptional events demonstrations with Q/D values well below 100 tpd/
km.\45\
---------------------------------------------------------------------------

    \43\ Guidance, 16-22.
    \44\ Guidance, 17.
    \45\ See, e.g., ``Technical Support Document for EPA Concurrence
on Ozone Exceedances Measured in Connecticut on May 25 and 26, 2016
as Exceptional Events'' (attachment to letter dated July 31, 2017),
7; ``Technical Support Document for EPA Concurrence on Ozone
Exceedances Measured in Massachusetts on May 25 and 26, 2016 as
Exceptional Events'' (attachment to letter dated September 19,
2017), 7;``Technical Support Document for EPA Concurrence on Ozone
Exceedances Measured in Rhode Island on May 25 and 26, 2016 as
Exceptional Events'' (attachment to letter dated September 19,
2017), 7.
---------------------------------------------------------------------------

    Because the ratio for the June 20, 2015 event did not meet the 100
Q/D threshold for a Tier 2 analysis, we determined that a Tier 3
analysis, involving additional supportive documentation, was
appropriate for this event. As described elsewhere in this document,
ADEQ provided such additional documentation in the form of several
different technical analyses. Collectively, the weight of this evidence
establishes a causal relationship between the Lake Fire and the June
20, 2015 exceedances for the June 20, 2015 event.
    Comment: ACLIPI asserted that it is unclear whether ADEQ provided
adequate notice regarding the opportunity to comment on its exceptional
events documentation. Specifically, ACLIPI asserted that ``ADEQ
maintains email lists of parties interested in air quality actions to
which the agency regularly distributes notices regarding upcoming
rulemakings. If ADEQ sent notice to any stakeholders concerning its
proposed exceptional events demonstration, it should explain how and to
whom it sent notice.''
    Response: The Exceptional Events Rule requires that, as part of the
submission of an exceptional events demonstration, a state must (1)
document that it followed a public comment process, including a comment
period of at least 30 days; (2) submit any public comments received;
and (3) address any comments disputing or contradicting factual
evidence provided in the demonstration.\46\ Although emailing
stakeholders is one means of providing public notice of draft
exceptional events demonstration,\47\ nothing in the Exceptional Events
Rule or the Clean Air Act requires states to take this approach.
Rather, ``[p]roviding sufficient opportunity for public comment for a
demonstration is case-by-case and depends on the circumstances and
intended audience.'' \48\
---------------------------------------------------------------------------

    \46\ 40 CFR 50.14(c)(3)(v).
    \47\ See ``2016 Revisions to the Exceptional Events Rule: Update
to Frequently Asked Questions,'' July 2019, 26.
    \48\ Id. at 25.
---------------------------------------------------------------------------

    In this case, for each of the submissions, ADEQ provided public
notice by posting the draft demonstration submissions on its website
and publishing a notice in the Arizona Republic at the start of the 30-
day public comment period.\49\ The EPA considers this to be adequate
public notice under 40 CFR 51.14(c)(3)(v). Therefore, ADEQ is not
required to explain whether or not it sent notice to any stakeholders.
---------------------------------------------------------------------------

    \49\ May 18, 2018 submittal Section I, 4 and Appendix D; letter
dated July 17, 2018, from Timothy Franquist, ADEQ, to Michael
Stoker, EPA Region 9,; Demonstration, 4, Appendix E; First addendum,
2, Appendix B; letter dated July 17, 2018, from Timothy Franquist,
ADEQ, to Michael Stoker, EPA Region 9; Second addendum, 1, Appendix
C; letter dated April 26, 2019, from Timothy Franquist, ADEQ, to
Michael Stoker, EPA Region 9.
---------------------------------------------------------------------------

    Comment: ACLIPI asserted that, for the reasons previously cited in
its comment letter, the EPA's invitation to the State to withdraw its
contingency measure is unwarranted and should be revoked.
    Response: In conjunction with our proposed finding of attainment by
the applicable attainment date, we also proposed to determine that the
CAA requirement for the State to submit a SIP revision to provide for
contingency measures to be implemented in the event the area fails to
attain by its attainment date (``attainment contingency measures'')
will no longer apply for the Phoenix NAA. The State has already
submitted a SIP revision providing for attainment contingency measures,
so we also noted that the State could elect to withdraw the attainment
contingency measures to lift the obligation on the EPA under section
110(k) to act on these measures.
    For the reasons described in our proposal and elsewhere in this
document, we are finalizing our determination that the Phoenix NAA
attained the 2008 ozone standard by its Moderate area attainment date
of July 20, 2018, and our determination that there is no existing
requirement for attainment contingency measures for the 2008 ozone
NAAQS in the Phoenix NAA.
    Comment: ACLIPI argued that the EPA was incorrect that its proposed
rulemaking ``does not directly affect the level of protection provided
for human health or the environment'' and ``does not concern an
environmental health risk'' to children. The commenter asserted that,
if the EPA makes a determination of attainment by the attainment date,
the Phoenix NAA would not be reclassified (``bumped up'') to a
``Serious'' classification, and the State would be ``excused from
having to adopt and implement additional or more effective control
measures, at least until the Phoenix NAA is inevitably reclassified to
``[M]oderate'' for the 2015 ozone standard.'' The commenter concluded
that this delay poses a significant risk to human health, particularly
for children, the elderly, and people with preexisting lung and
cardiovascular diseases.
    Response: We disagree with this comment. As explained in a previous
response, we are required to determine whether the Phoenix NAA attained
the 2008 ozone NAAQS by its Moderate area date of July 20, 2018, based
on 2015-2017 data, which show that the area attained the 2008 ozone
NAAQS during that period. This determination does not in and of itself
affect the level of protection provided for human health, children's
health, or the environment.
    As alluded to by the commenter, if we had determined the Phoenix
NAA had not attained the 2008 NAAQS by the attainment date, we would
have reclassified the area to Serious nonattainment, which would have
triggered additional planning and implementation requirements. However,
this would not have directly altered the level of protection for human
health or the environment within the area since the area would
ultimately have been obligated to meet the same NAAQS.
    In addition, the Phoenix area is currently designated and
classified as a ``Marginal'' nonattainment area for the

2015 ozone NAAQS.\50\ The EPA will determine whether the area has met
the August 3, 2020 Marginal attainment date for the 2015 standard based
on 2017-2019 monitoring data. While the commenter appears to assume
that the area will not attain by the Marginal attainment date, and will
therefore be bumped up to Moderate, the data are not yet available to
make this determination.
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    \50\ 40 CFR 81.303.
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Commenter #2: Public Comment (No Name)

    Comment: The commenter argued that the EPA cannot make a
determination of attainment because the ozone data being used is old
(2015-2017). The commenter suggested that the EPA must have 2018 data,
but that it has not provided updated design values on our public
website. The commenter further noted that ADEQ has made 2018 data
publicly available, and that these data show more than 26 days in 2018
when the 2008 NAAQS was exceeded. The commenter asserted that, with
this number of exceedances, the EPA cannot make a determination of
attainment and has a statutory obligation to bump up the area and
require the State to comply with Serious area requirements.
    Response: As explained above in response to a similar comment from
ACLIPI, we are not permitted to consider 2018 or 2019 data in
evaluating whether the area attained by the applicable attainment date
of July 20, 2018. Our statutory obligation under CAA section
181(b)(2)(A) is to determine whether the Phoenix NAA attained the
standard by the applicable attainment date based on the design value as
of the attainment date. We are fulfilling that obligation with today's
final action.
    We also note that agency air data submitted to the EPA's Air
Quality System (AQS) database is considered preliminary until such data
are certified. Agencies are required to certify the data annually by
May 1 of the following year. For example, the deadline for agencies to
certify data collected during calendar year 2018 was May 1, 2019. After
the certification deadline, the design values are reviewed by EPA staff
before they are posted to the EPA website, which generally occurs
within a few months of the certification deadline. The 2018 design
values were posted to the EPA's website on July 23, 2019. The EPA makes
both preliminary data submitted to the AQS database and data submitted
to AirNow for public notification purposes available on the EPA's Air
Data web page prior to data certification.\51\
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    \51\ https://www.epa.gov/outdoor-air-quality-data.
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Commenter #3: Arizona Chamber of Commerce

    Comment: The commenter expressed support for the proposed
determination and argued that it is proper to exclude the ``Qualifying
Exceptional Events.''
    Response: The EPA acknowledges the commenter's support for this
action.
    Comment: The commenter stated that the main cause of ozone is
emissions from road and non-road engines, additional restrictions on
major sources will not have a measurable impact on ozone levels, the
Phoenix NAA has high background ozone and transport, and that the most
effective way to reduce emissions in the area is to reduce emissions
from on road and non-road engines through an emissions reduction credit
(ERC) program for non-traditional ERCs. The commenter urged the EPA to
help ADEQ and Maricopa County to establish an ERC framework for
nontraditional sources so that the area can reduce emissions from
vehicle emissions for 2015 NAAQS.
    Response: The EPA acknowledges the comment but notes that it is not
relevant to this action.

Commenter #4: Maricopa County

    Comment: The commenter expressed support for the proposed
determination of attainment by the attainment date.
    Response: The EPA acknowledges the commenter's support for this
action.

Commenter #5: ADEQ

    Comment: The commenter expressed support for the proposed
determination of attainment by the attainment date.
    Response: The EPA acknowledges the commenter's support for this
action.

III. EPA Action

    No comments were submitted that change our assessment of the
determinations as described in our proposed action. Therefore, the EPA
is finalizing our determination that the Phoenix NAA attained the 2008
ozone standard by the Moderate area attainment date of July 20, 2018.
We are also finalizing our determination that attainment contingency
measures for this NAAQS no longer apply to the Phoenix NAA.
    This action does not suspend the attainment-related requirements
for the Phoenix NAA under 40 CFR 51.1118. We also note that this
determination that the Phoenix ozone NAA has attained the 2008 ozone
NAAQS does 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 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 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
the 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 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 sent letters to potentially affected
tribes located within or directly adjacent to the boundaries of the
Phoenix NAA informing them of our proposed action and offering
consultation.\52\ We did not receive any requests for consultation.
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    \52\ See letters from Elizabeth Adams, EPA Region IX Air and
Radiation Division Director, to tribal officials, dated June 13,
2019.
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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.''

L. Congressional Review Act (CRA)

    The CRA, 5 U.S.C. 801 et seq., as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, generally provides that
before a rule may take effect, the agency promulgating the rule must
submit a rule report, which includes a copy of the rule, to each House
of the Congress and to the Comptroller General of the United States.
The EPA will submit a report containing this action and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. A major rule cannot take effect until
60 days after it is published in the Federal Register. This action is
not a ``major rule'' as defined by 5 U.S.C. 804(2).

M. Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by January 13, 2020. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

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

    Dated: October 21, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart D--Arizona

0
2. Add Sec.  52.153 to read as follows:

Sec.  52.153  Control strategy and regulations: Ozone.

    (a) Determination of attainment by the attainment date. Effective
December 12, 2019 the EPA has determined that the Phoenix-Mesa Moderate
nonattainment area in Arizona attained the 2008 8-hour ozone National
Ambient Air Quality Standards (NAAQS) by the applicable attainment date
of July 20, 2018, based upon complete, quality-assured, and certified
data for the calendar years 2015-2017. The EPA has also determined that
the requirement of section 172(c)(9) to provide for contingency
measures to be implemented in the event the area fails to attain by its
attainment date for the 2008 8-hour NAAQS does not apply to the area.
    (b) [Reserved]

[FR Doc. 2019-23829 Filed 11-8-19; 8:45 am]
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