[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68151-68152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.epa.gov/iris/iris-recent-additions and in the public docket at http://www.regulations.gov, 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: 
[email protected].
    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: 
[email protected].

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 (https://www.epa.gov/iris) and via EPA's IRIS listserv. To register for the IRIS 
listserv, visit the IRIS website (https://www.epa.gov/iris) or visit 
https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect.

III. How To Submit Technical Comments to the Docket at https://www.regulations.gov

    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:
     www.regulations.gov: Follow the on-line instructions for 
submitting comments.
     Email: [email protected].
     Fax: 202-566-9744.
     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 
www.regulations.gov, 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 
www.regulations.gov or email that you consider to be CBI or otherwise 
protected. 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 comment directly to EPA without going through 
www.regulations.gov, 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 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 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]
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