Notice2022-24684
Availability of the IRIS Assessment Plan and Protocol for Assessing Cancer Risk From Inhalation Exposure to Cobalt and Cobalt Compounds
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 14, 2022
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing a 30- day public comment period associated with release of the Integrated Risk Information System (IRIS) Assessment Plan and Systematic Review Protocol for Inhalation Exposure to Cobalt and Compounds (Cancer). This document communicates information on the scoping needs identified by EPA program and regional offices and the IRIS Program's initial problem formulation activities. Specifically, the assessment plan outlines the objectives for the IRIS assessment and the type of evidence considered most pertinent to address the scoping needs. The systematic review protocol describes the methodology of how the assessment will be conducted, including dose-response considerations. EPA is releasing this IRIS assessment plan and systematic review protocol for a 30-day public comment period in advance of a public science webinar planned for November 30, 2022. The Agency encourages the public to comment on all aspects of the assessment plan and the systematic review protocol, including key science issues and identification of any new or missing studies.
Full Text
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<title>Federal Register, Volume 87 Issue 218 (Monday, November 14, 2022)</title>
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[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68151-68152]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-24684]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2022-0833; FRL-10361-01-ORD]
Availability of the IRIS Assessment Plan and Protocol for
Assessing Cancer Risk From Inhalation Exposure to Cobalt and Cobalt
Compounds
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of public comment period.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing a 30-
day public comment period associated with release of the Integrated
Risk Information System (IRIS) Assessment Plan and Systematic Review
Protocol for Inhalation Exposure to Cobalt and Compounds (Cancer). This
document communicates information on the scoping needs identified by
EPA program and regional offices and the IRIS Program's initial problem
formulation activities. Specifically, the assessment plan outlines the
objectives for the IRIS assessment and the type of evidence considered
most pertinent to address the scoping needs. The systematic review
protocol describes the methodology of how the assessment will be
conducted, including dose-response considerations. EPA is releasing
this IRIS assessment plan and systematic review protocol for a 30-day
public comment period in advance of a public science webinar planned
for November 30, 2022. The Agency encourages the public to comment on
all aspects of the assessment plan and the systematic review protocol,
including key science issues and identification of any new or missing
studies.
DATES: The 30-day public comment period begins November 14, 2022 and
ends December 14, 2022. Comments must be received on or before December
14, 2022.
ADDRESSES: The IRIS Assessment Plan and Systematic Review Protocol for
Inhalation Exposure to Cobalt and Compounds (Cancer) will be available
via the internet on the IRIS website at <a href="https://www.epa.gov/iris/iris-recent-additions">https://www.epa.gov/iris/iris-recent-additions</a> and in the public docket at <a href="http://www.regulations.gov">http://www.regulations.gov</a>, Docket ID No. EPA-HQ-ORD-2022-0833.
FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the ORD Docket at the EPA Headquarters Docket Center;
telephone: 202-566-1752; facsimile: 202-566-9744; or email:
<a href="/cdn-cgi/l/email-protection#175378747c7263485845535772677639707861"><span class="__cf_email__" data-cfemail="93d7fcf0f8f6e7ccdcc1d7d3f6e3f2bdf4fce5">[email protected]</span></a>.
For technical information on the IRIS Assessment Plan and
Systematic Review Protocol for Inhalation Exposure to Cobalt and
Compounds (Cancer), contact Garland Waleko, CPHEA; email:
<a href="/cdn-cgi/l/email-protection#4b1c2a272e2024652c2a39272a252f0b2e3b2a652c243d"><span class="__cf_email__" data-cfemail="0a5d6b666f6165246d6b78666b646e4a6f7a6b246d657c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Information About IRIS Assessment Plans and Systematic Review
Protocols
EPA's IRIS Program is a human health assessment program that
evaluates quantitative and qualitative information on the health
effects that may result from exposure to chemicals found in the
environment. Through the IRIS Program, EPA provides high quality
science-based human health assessments to support the Agency's
regulatory activities and decisions to protect public health. As part
of scoping and initial problem formulation activities prior to the
development of an assessment, the IRIS Program carries out a broad,
preliminary literature survey to assist in identifying health effects
that have been studied in relation to the chemical or substance of
interest, as well as science issues that may need to be considered when
evaluating toxicity. This information, in conjunction with scoping
needs identified by EPA program and regional offices, is used to inform
the development of an IRIS assessment plan (IAP).
The IAP communicates the plan for developing each individual
chemical assessment to the public and includes summary information on
the IRIS Program's scoping and initial problem formulation activities,
objectives and specific aims for the assessment, and a
[[Page 68152]]
PECO (Populations, Exposures, Comparators, and Outcomes) for the
systematic review. The PECO provides the framework for developing
detailed literature search strategies and inclusion/exclusion criteria,
particularly with respect to evidence stream (e.g., human, animal,
mechanistic), exposure measures, and outcome measures. EPA also
presents a methods document, referred to as the systematic review
protocol, for conducting a chemical-specific systematic review of the
available scientific literature. Systematic review protocols describe
screening criteria to identify relevant literature, outline the
approach for evaluating study quality, and describe the dose-response
methods.
II. Public Webinar Information
To allow for public input, EPA is convening a public webinar to
discuss the IRIS Assessment Plan and Systematic Review Protocol for
Inhalation Exposure to Cobalt and Compounds (Cancer) on November 30,
2022. Specific teleconference and webinar information regarding this
public meeting will be provided through the IRIS website (<a href="https://www.epa.gov/iris">https://www.epa.gov/iris</a>) and via EPA's IRIS listserv. To register for the IRIS
listserv, visit the IRIS website (<a href="https://www.epa.gov/iris">https://www.epa.gov/iris</a>) or visit
<a href="https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect">https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect</a>.
III. How To Submit Technical Comments to the Docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2022-
0833 for IRIS Assessment Plan and Systematic Review Protocol for
Inhalation Exposure to Cobalt and Compounds (Cancer), by one of the
following methods:
<bullet> <a href="http://www.regulations.gov">www.regulations.gov</a>: Follow the on-line instructions for
submitting comments.
<bullet> Email: <a href="/cdn-cgi/l/email-protection#d397bcb0b8b6a78c9c819793b6a3b2fdb4bca5"><span class="__cf_email__" data-cfemail="8ecae1ede5ebfad1c1dccaceebfeefa0e9e1f8">[email protected]</span></a>.
<bullet> Fax: 202-566-9744.
<bullet> Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460. The phone number is 202-566-1752.
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2022-0833. 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 comments it receives in the public docket
without change and to make the comments available online at
<a href="http://www.regulations.gov">www.regulations.gov</a>, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information for which disclosure is
restricted by statute. Do not submit information through
<a href="http://www.regulations.gov">www.regulations.gov</a> or email that you consider to be CBI or otherwise
protected. The <a href="http://www.regulations.gov">www.regulations.gov</a> 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 comment directly to EPA without going through
<a href="http://www.regulations.gov">www.regulations.gov</a>, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. 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 the
EPA Docket Center homepage at <a href="http://www.epa.gov/epahome/dockets.htm">www.epa.gov/epahome/dockets.htm</a>.
Docket: Documents in the docket are listed in the
<a href="http://www.regulations.gov">www.regulations.gov</a> 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 <a href="http://www.regulations.gov">www.regulations.gov</a> or in hard copy at the ORD Docket in the EPA
Headquarters Docket Center.
Wayne Cascio,
Director, Center for Public Health & Environmental Assessment.
[FR Doc. 2022-24684 Filed 11-10-22; 8:45 am]
BILLING CODE 6560-50-P
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