[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40641-40643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14575]
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ENVIRONMENTAL PROTECTION AGENCY
[Docket ID No. EPA-HQ-OAR-2020-0312; FRL-10011-92-ORD]
Call for Information on the Integrated Science Assessment for
Lead
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 and secondary National Ambient Air Quality Standards (NAAQS)
for Lead (Pb). The ISA will be completed by EPA's Office of Research
and Development's Center for Public Health and Environmental Assessment
(CPHEA). When final, the ISA is intended to update the previous Pb ISA
(EPA/600/R-10/075F), published on June 26, 2013. Interested parties are
invited to assist EPA in developing and refining the scientific
information base for the review of the Pb NAAQS by submitting research
studies and data that have been published, accepted for publication, or
presented at a public scientific meeting since January 1, 2011.
DATES: All communications and information should be received by EPA by
September 8, 2020.
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 OAR Docket at the EPA Headquarters Docket
Center; phone: 202-566-1742; fax: 202-566-9744; or email: a-and-r-Docket@epa.gov. For technical information, contact Evan Coffman; phone:
919-541-0567; fax: 919-541-1818; or email: Coffman.Evan@epa.gov; or
Meredith Lassiter; phone: 919-541-3200; fax: 919-541-1818; or email:
lassiter.meredith@epa.gov.
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 welfare''; \1\ and to issue air quality
criteria for them. The 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 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
for lead (Pb). 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. 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 as it begins
this 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.
The ISA will build on the scientific assessment for the last
review,\2\ focusing on assessing the information newly available since
that considered in the 2013 ISA. With regard to development of the ISA,
the public is encouraged to assist in identifying relevant scientific
[[Page 40642]]
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. The Agency is interested in
obtaining information from new and emerging studies showing effects or
no effects from Pb exposure. For example, the Agency is interested in
information about studies of effects of controlled exposure to Pb,
including in laboratory animals and in vitro systems; epidemiologic
(observational) studies of associations of health outcomes with
population exposures to Pb; and studies of ecological effects of Pb
exposure. With regard to health effect studies, of particular interest
are those studies that address or provide new information on health
outcomes for which the scientific evidence presented in the 2013 ISA
supported a ``causal relationship'' or ``likely to be causal
relationship'' with Pb, e.g., cognitive effects in children,
cardiovascular effects, and immune system effects; endpoints with less
overall evidence and/or notable uncertainties at the time of the 2013
Pb ISA, such as attention deficit hyperactivity disorder,
neurodegenerative effects, and adult obesity; endpoints not previously
identified in the 2013 Pb ISA; relationships between Pb exposure
concentrations and occurrence of health-related endpoints; health
effects associated with blood lead levels below 10 [micro]g/dL and/or
with near current exposure concentrations; Pb toxicokinetics and
toxicokinetic modeling; information and data useful for assessing
biological plausibility for Pb-related health effects; and
identification of populations and life stages at increased risk of Pb-
related health effects. For ecological effects of Pb, studies that
address or provide new information on terrestrial and aquatic biota are
of particular interest including, but not necessarily limited to,
effects of Pb on vegetation, soil and aquatic fauna, communities and
populations of microorganisms, plants, and animals, as well as research
on fate and transport of Pb in environmental media, and exposure-
response relationships between Pb in ambient air or other media and
ecological endpoints.
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\2\ The scientific assessment for the last review is documented
in the Integrated Science Assessment for Lead (Final Report, July
2013), EPA/600/R-10/075F; 78 FR 38318, June 26, 2013.
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Information particular to air-related pathways of human and
ecological exposure, including those involving deposition, are also of
interest to the Agency. Air-related pathways are those that include air
and may also involve media other than air, including indoor and outdoor
dust, soil, surface water and sediments, vegetation and biota. Air-
related Pb pathways of human exposure include inhalation of ambient air
or ingestion of food, water or other materials, including dust and
soil, containing Pb that has deposited from ambient air.
EPA also seeks recent information in other areas of Pb research
such as human and ecological exposure assessment and exposure
assessment methodologies, sources and emissions, chemistry and physics,
sampling and analytical methodology, ambient concentrations and size
distributions, including environmental media concentration changes in
response to changes in Pb deposition, and other effects on public
welfare or the environment not listed above.
The Agency also seeks information regarding the design and scope of
the review of the air quality criteria and the primary (health-based)
and secondary (welfare-based) Pb standards to ensure that it 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 Pb NAAQS review, which are
provided in the Policy Assessment (EPA-452/R-14, May 2014).\3\ Other
opportunities for submission of new peer-reviewed, published (or in-
press) papers will be possible as part of public comment on the draft
ISAs 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/pb/data/140501_pa_pb_fin.pdf.
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II. How To Submit Technical Comments to the Docket at
www.regulations.gov
Submit your materials identified by Docket ID No. EPA-HQ-OAR-2020-
0312 by one of the following methods:
www.regulations.gov: Follow the on-line instructions for
submitting comments.
Email: a-and-r-Docket@epa.gov.
Fax: 202-566-9744. Due to COVID-19, there may be a delay
in processing comments submitted by fax.
Mail: Office of Air and Radiation (OAR) 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.
Note: The EPA Docket Center and Reading Room is currently in the
reopening process. Visitors may be considered on an exception basis.
Visitors must complete docket material requests in advance and then
make an appointment to retrieve the material. Visitors will be allowed
entrance to the Reading Room by appointment only, and no walk-ins will
be allowed.
Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2020-0312. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. 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 includes 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. 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
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 in hard copy at the OAR Docket in EPA's
Headquarters Docket Center.
[[Page 40643]]
Dated: June 30, 2020.
Wayne Cascio,
Director, Center for Public Health and Environmental Assessment.
[FR Doc. 2020-14575 Filed 7-6-20; 8:45 am]
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