Document ID: EPA-HQ-OAR-2020-0312-0001
Agency: epa
Document Type: Notice
Title: Request for Information: Integrated Science Assessment for Lead
Posted Date: 2020-07-07T04:00Z

[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]
BILLING CODE 6560-50-P