[Federal Register Volume 85, Number 17 (Monday, January 27, 2020)]
[Notices]
[Pages 4655-4656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01223]


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ENVIRONMENTAL PROTECTION AGENCY

[Docket ID No. EPA-HQ-ORD-2014-0859; FRL-10004-64-ORD]


Integrated Science Assessment for Particulate Matter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of a final document titled, ``Integrated Science 
Assessment for Particulate Matter'' (EPA/600/R-19/188). The document 
was prepared by the Center for Public Health and Environmental 
Assessment (CPHEA) within EPA's Office of Research and Development 
(ORD) as part of the review of the primary (health-based) and secondary 
(welfare-based) National Ambient Air Quality Standards (NAAQS) for 
particulate matter (PM) and represents an update of the 2009 Integrated 
Science Assessment (ISA) for PM. The welfare-based effects evaluated 
consist of non-ecological effects, specifically visibility impairment, 
climate effects, and effects on materials. The ISA provides the 
scientific basis for EPA's decisions, in conjunction with additional 
technical and policy assessments, on the adequacy of the current NAAQS 
and the appropriateness of possible alternative standards. EPA is 
currently developing a separate ISA to support the secondary NAAQS 
review for ecological effects for oxides of nitrogen, oxides of sulfur, 
and particulate matter.

DATES: The document is available on or about January 6, 2020.

ADDRESSES: The ``Integrated Science Assessment for Particulate Matter 
(Final)'' will be available primarily via the internet on EPA's 
Integrated Science Assessment Particulate Matter page at https://www.epa.gov/isa/integrated-science-assessment-isa-particulate-matter or 
the public docket at http://www.regulations.gov, Docket ID: EPA-HQ-ORD-
2014-0859. A limited number of CD-ROM copies will be available. Contact 
Ms. Marieka Boyd by phone: 919-541-0031; fax: 919-541-5078; or email: 
[email protected] to request a CD-ROM, and please provide your name, 
your mailing address, and the document title, ``Integrated Science 
Assessment for Particulate Matter'' to facilitate processing of your 
request.

FOR FURTHER INFORMATION CONTACT: For technical information, contact Mr. 
Jason Sacks, CPHEA; phone: 919-541-9729; fax: 919-541-1818; 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 pollutants which, among other things, ``cause or 
contribute to air pollution which may reasonably be anticipated to 
endanger public health or welfare'' 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

[[Page 4656]]

section 109 of the Act, EPA is then to establish NAAQS for each 
pollutant for which EPA has issued criteria. Section 109(d) of the Act 
subsequently requires review every five years 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 http://www.epa.gov/ttn/naaqs/review.html).
    Particulate matter is one of six criteria pollutants for which EPA 
has established NAAQS. Periodically, EPA reviews the scientific basis 
for these standards by preparing an ISA (formerly called an Air Quality 
Criteria Document). The ISA provides the scientific basis for EPA's 
decisions, in conjunction with additional technical and policy 
assessments, on the adequacy of the current NAAQS and the 
appropriateness of possible alternative standards. The Clean Air 
Scientific Advisory Committee (CASAC), an independent science advisory 
committee 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 EPA's air quality criteria.
    On December 3, 2014 (79 FR 71764), EPA formally initiated its 
current review of the air quality criteria for the health and welfare 
effects of particulate matter and the primary (health-based) and 
secondary (welfare-based) NAAQS, requesting the submission of recent 
scientific information on specified topics. EPA conducted a workshop 
from February 9 to 11, 2015 to gather input from invited scientific 
experts, both internal and external to EPA, as well as from the public, 
regarding key science and policy issues relevant to the review of the 
primary and secondary NAAQS (79 FR 71764). These science and policy 
issues were incorporated into EPA's ``Draft Integrated Review Plan for 
the National Ambient Air Quality Standards for Particulate Matter,'' 
which was available for public comment (81 FR 22977) and discussion by 
the CASAC via publicly accessible teleconference consultation (81 FR 
13362). The ``Final Integrated Review Plan for the National Ambient Air 
Quality Standards for Particulate Matter'' was released December 6, 
2016 (81 FR 87933).
    Subsequent webinar workshops were held on June 9, 13, 20, and 22, 
2016, to discuss initial draft materials prepared in the development of 
the particulate matter ISA with invited EPA and external scientific 
experts (81 FR 29262). The input received during these webinar 
workshops aided in the development of the materials presented in the 
``Integrated Science Assessment for Particulate Matter (External Review 
Draft), which was released on October 23, 2018'' (83 FR 53471), and is 
available at: https://cfpub.epa.gov/ncea/isa/recordisplay.cfm?deid=341593. The CASAC met at a public meeting on 
December 12-13, 2018 (83 FR 55529), to review the draft PM ISA. A 
public teleconference was then held on March 28, 2019 for CASAC to 
review their draft letter to the Administrator on the draft ISA. This 
meeting was announced in the Federal Register on March 8, 2019 (84 FR 
8523). Subsequently, on April 11, 2019, the CASAC provided a letter of 
their review to the Administrator of the EPA, available at: https://
yosemite.epa.gov/sab/sabproduct.nsf/264cb1227d55e02c85257402007446a4/
6CBCBBC3025E13B4852583D90047B352/$File/EPA-CASAC-19-002+.pdf. The 
letter from the CASAC, as well as public comments received on the draft 
PM ISA, can be found in Docket ID No. EPA-HQ-ORD-2014-0859.
    The Administrator responded to the CASAC's letter on the External 
Review Draft of the PM ISA on July 25, 2019, and is available at: 
https://yosemite.epa.gov/sab/sabproduct.nsf/
264cb1227d55e02c85257402007446a4/6CBCBBC3025E13B4852583D90047B352/
$File/EPA-CASAC-19-002_Response.pdf. Administrator Wheeler's letter to 
the CASAC indicated the Agency will ``incorporate the CASAC's comments 
and recommendations, to the extent possible, and create a final PM ISA 
so that it may be available to inform a proposed decision on any 
necessary revisions of the NAAQS in early 2020.'' The U.S. EPA focused 
on addressing comments presented in the main body of the CASAC letter 
(i.e., the cover letter and consensus responses to charge questions), 
and to the extent possible, in the statutorily provided timeframe, 
addressed individual CASAC member comments as well as public comments 
on the draft PM ISA. The consensus CASAC comments on the draft PM 
Policy Assessment (December 16, 2019) stated ``. . . the Draft PM ISA, 
does not provide a comprehensive, systematic review of relevant 
scientific literature; inadequate evidence and rationale for altered 
causal determinations; and a need for clearer discussion of causality 
and causal biological mechanisms and pathways.'' To address these 
comments in the Final PM ISA, the EPA: (1) Added text to the Preface 
and developed a new Appendix to more clearly articulate the process of 
ISA development; (2) revised the causality determination for long-term 
ultrafine particle (UFP) exposure and nervous system effects to 
suggestive of, but not sufficient to infer, a causal relationship; and 
(3) added additional text to the Preface of the PM ISA as well as text 
in the health effects chapters to clarify the discussion of biological 
plausibility and its role in forming causality determinations. 
Additionally, the U.S. EPA focused on addressing those comments that 
contributed to improving clarity, could be addressed in the near-term, 
and identified errors in the draft PM ISA. Lastly, Administrator 
Wheeler noted, ``for those comments and recommendations that are more 
significant or cross-cutting and which were not fully addressed, the 
Agency will develop a plan to incorporate these changes into future PM 
ISAs as well as ISAs for other criteria pollutant reviews.''

    Dated: December 31, 2019.
Wayne E. Cascio,
Director, Center for Public Health and Environmental Assessment.
[FR Doc. 2020-01223 Filed 1-24-20; 8:45 am]
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