[Federal Register Volume 87, Number 236 (Friday, December 9, 2022)]
[Notices]
[Pages 75625-75627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26786]


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ENVIRONMENTAL PROTECTION AGENCY

[ORD-2022-0831; FRL-10465-01-ORD]


Call for Information on the Integrated Science Assessment for 
Oxides of Nitrogen--Health Criteria

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; call for information.

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SUMMARY: The Environmental Protection Agency (EPA) is preparing an 
Integrated Science Assessment (ISA) as part of the review of the 
primary (health-based) National Ambient Air Quality Standards (NAAQS) 
for oxides of nitrogen. For gaseous oxides of nitrogen (i.e., oxidized 
nitrogen compounds), which also include nitric oxide (NO) and gases 
produced from reactions involving NO and NO2, the primary 
NAAQS are specified in terms of nitrogen dioxide (NO2). The 
ISA will be developed by EPA's Center for Public Health and 
Environmental Assessment (CPHEA) within the Office of Research and 
Development. When final, this ISA is intended to update the previous 
Integrated Science Assessment for Oxides of Nitrogen--Health Criteria 
(EPA/600/R-15/068, 2016), published on January 28, 2016 (2016 ISA). 
Interested parties are invited to assist EPA in developing and refining 
the scientific information base for the review of the primary 
NO2 NAAQS by submitting research studies and data that have 
been published in the peer-reviewed scientific literature, accepted for 
publication, or presented at a public scientific meeting since May 15, 
2015.

DATES: All communications and information should be received by EPA 
February 7, 2023.

ADDRESSES: Information may be submitted electronically, by mail, by 
facsimile, or by hand delivery/courier. Please follow the detailed 
instructions as provided in the section of this notice entitled 
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For information on the period of 
submission, contact the Office of Research and Development (ORD) 
Docket; telephone: 202-566-1752; facsimile: 202-566-1753; or email 
[email protected]. For technical information, contact Christine 
Alvarez; phone: 919-541-3881; fax: 919-541-5078 or email: 
[email protected], or Stephanie DeFlorio-Barker; phone 919-541-
4621; fax: 919-541-5078 or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Information About the Document

    Section 108(a) of the Clean Air Act directs the Administrator to 
identify certain air pollutants which, among other things, ``cause or 
contribute to air pollution which may reasonably be anticipated to 
endanger public health or

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welfare''; \1\ and to issue air quality criteria for them. These air 
quality criteria are to ``accurately reflect the latest scientific 
knowledge useful in indicating the kind and extent of all identifiable 
effects on public health or welfare which may be expected from the 
presence of [a] pollutant in the ambient air. . . .''. Under section 
109 of the Act, EPA is then to establish NAAQS for each pollutant for 
which EPA has issued criteria. Section 109(d)(1) of the Act 
subsequently requires periodic review and, if appropriate, revision of 
existing air quality criteria to reflect advances in scientific 
knowledge on the effects of the pollutant on public health or welfare. 
EPA is also required to review and, if appropriate, revise the NAAQS, 
based on the revised air quality criteria (for more information on the 
NAAQS review process, see https://www.epa.gov/naaqs).
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    \1\ Under Clean Air Act section 302(h), welfare effects include, 
but are not limited to, ``effects on soils, water, crops, 
vegetation, manmade materials, animals, wildlife, weather, 
visibility, and climate, damage to and deterioration of property, 
and hazards to transportation, as well as effects on economic values 
and on personal comfort and well-being.''
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    EPA has established NAAQS for six criteria pollutants including 
oxides of nitrogen. Periodically, EPA reviews the scientific basis for 
these standards by preparing an ISA. In conjunction with additional 
technical and policy assessments conducted by EPA's Office of Air 
Quality Planning and Standards (OAQPS), the ISA provides the scientific 
and technical basis for EPA decisions on the adequacy of the current 
NAAQS and the appropriateness of possible alternative standards.
    Early steps in this process include announcing the beginning of 
this periodic NAAQS review and the development of the ISA, and EPA 
requesting that the public submit scientific literature that they want 
to bring to the attention of the Agency for consideration as it begins 
this review process. The Clean Air Scientific Advisory Committee 
(CASAC), whose review and advisory functions are mandated by section 
109(d)(2) of the Clean Air Act, is charged (among other things) with 
independent scientific review of the Agency's air quality criteria. In 
conjunction with the CASAC review, the public will have an opportunity 
to review and comment on the draft ISA. These opportunities will be 
announced in the Federal Register.
    The next ISA for Oxides of Nitrogen--Health Criteria will build on 
the 2016 ISA used in the previous review,\2\ focusing on assessing 
newly available information. The public is encouraged to assist in 
identifying relevant scientific information for the review by 
submitting research studies that were not part of the prior review and 
have been published or accepted for publication in a peer-reviewed 
journal May 15, 2015. The Agency is interested in obtaining information 
from new and emerging toxicological studies examining the effects of 
controlled exposures to oxides of nitrogen in laboratory animals, 
humans and in-vitro systems, as well as epidemiologic (observational) 
studies examining associations between health effects and exposures to 
ambient oxides of nitrogen in human populations. In addition to studies 
that provide information on health outcomes, EPA also seeks recent 
information in other areas of research relevant to oxides of nitrogen 
such as sources and emissions, analytical methods, transport and 
transformation in the environment, and ambient concentrations. This and 
other literature relevant to a review of the primary (health-based) 
NO2 NAAQS will be considered for inclusion in the assessment 
in the forthcoming ISA.
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    \2\ The scientific assessment for the last review is documented 
in the Integrated Science Assessment for Oxides of Nitrogen--Health 
Criteria (Final Report EPA/600/R-15/068, 81 FR 4910, January 28, 
2016).
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    The Agency seeks information regarding the design and scope of the 
review of the air quality criteria to ensure that the ISA addresses key 
policy-relevant issues and considers the new science that is relevant 
to informing our understanding of these issues. The Agency also seeks 
new scientific information that may address key uncertainties 
identified in the last review of the primary NO2 NAAQS, 
which are provided in the Policy Assessment (EPA-452/R-17-003, April 
2017).\3\ Additional opportunities for submission of new peer-reviewed, 
published (or in-press) papers will be possible as part of public 
comment on the draft ISA that will be reviewed by the CASAC.
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    \3\ The 2014 Policy Assessment is available at: https://www3.epa.gov/ttn/naaqs/standards/NO2/data/140501_pa_NO2_fin.pdf.
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II. How To Submit Technical Comments to the Docket at 
www.regulations.gov

    We encourage the public to submit comments to Docket ID No. ORD-
2022-0831 by one of the following methods:
     The web at https://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     Email: [email protected].
     Fax: 202-566-9744.
     Mail: EPA Docket Center, ORD Docket (Mail Code: 28221T), 
U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460. The phone number is 202-566-1752. Due to COVID-
19, there may be a delay in processing comments submitted by mail.
     Hand Delivery or Courier (by scheduled appointment only): 
EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution 
Avenue NW, Washington, DC 20004. The Docket Center's hours of 
operations are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal 
holidays).
    Instructions: Direct your comments to Docket ID No. ORD-2022-0831. 
Please ensure that your comments are submitted within the specified 
comment period, so that EPA has adequate time to consider them. 
Comments received after the closing date will be marked ``late,'' and 
may not be considered if time does not permit. It is EPA's policy to 
include all materials it receives in the public docket without change 
and to make the materials available online at www.regulations.gov, 
including any personal information provided, unless materials include 
information claimed to be Confidential Business Information (CBI) or 
other information whose disclosure is restricted by statute. Do not 
submit information that you consider to be CBI or otherwise protected 
through www.regulations.gov or email. The www.regulations.gov website 
is an ``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an email directly to EPA without going 
through www.regulations.gov, your email address will be automatically 
captured and included as part of the materials that are placed in the 
public docket and made available on the internet. If you submit 
electronic materials, EPA recommends that you include your name and 
other contact information in the body of your materials and with any 
disk or CD-ROM you submit. CD-ROM and disks can only be accepted via 
UPS/FedEx/hand delivery and not through regular mail. If EPA cannot 
read your materials due to technical difficulties and cannot contact 
you for clarification, EPA may not be able to consider the materials 
you submit. Electronic files should avoid the use of special 
characters, any form of encryption, and be free of any defects or 
viruses. For additional information about EPA's public docket visit 
EPA's Docket Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the 
www.regulations.gov index. Although listed in the index, some

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information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other materials, 
such as copyrighted material, are publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in www.regulations.gov or at EPA's Docket Center.

Wayne Cascio,
Director, Center for Public Health and Environmental Assessment, Office 
of Research and Development.
[FR Doc. 2022-26786 Filed 12-8-22; 8:45 am]
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