[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Notices]
[Pages 76566-76567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26314]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2018-0654; FRL-10016-99-ORD]


Availability of the ORD Staff Handbook for Developing IRIS 
Assessments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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[[Page 76567]]

SUMMARY: The Environmental Protection Agency (EPA) is announcing a 90-
day public comment period associated with release of the ORD Staff 
Handbook for Developing Integrated Risk Information System (IRIS) 
Assessments, or IRIS Handbook. The IRIS Handbook provides operating 
procedures for developing assessments including problem formulation 
approaches and methods for conducting systematic review, dose response 
analysis, and developing toxicity values. EPA is releasing this 
document and the charge questions for public comment in advance of a 
National Academy of Sciences, Engineering, and Medicine (NASEM) peer 
review. Comments received will be summarized and provided to the 
committee conducting the peer review. This document was prepared by the 
Center for Public Health and Environmental Assessment (CPHEA) within 
EPA's Office of Research and Development (ORD).

DATES: The 90-day public comment period begins November 30, 2020, and 
ends March 1, 2021.

ADDRESSES: The IRIS Handbook will be available via the internet on the 
IRIS website at https://www.epa.gov/iris and in the public docket at 
https://www.regulations.gov, Docket ID: EPA-HQ-ORD-2018-0654.

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: 
Docket_ORD@epa.gov.
    For technical information on the IRIS Handbook, contact Dr. James 
Avery, CPHEA; telephone: 202-564-1494; or email: avery.james@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Background Information on the IRIS Handbook

    The ``ORD Staff Handbook for Developing IRIS Assessments,'' or 
``IRIS Handbook,'' provides operating procedures for developing 
assessments to the scientists in the IRIS Program. The IRIS Handbook 
implements recommendations and input from the National Academy of 
Sciences, Engineering and Medicine (NASEM), EPA Agency reviewers, other 
Federal Agencies, EPA's Science Advisory Board, and workshops involving 
input from experts in systematic review. The steps in the overall IRIS 
process have not changed (https://www.epa.gov/iris/basic-information-about-integrated-risk-information-system#process). The IRIS Handbook is 
designed so that it can be updated, as needed, to allow for 
incorporation of method refinements, advances in assessment science, 
and any updates in EPA guidance (see https://yosemite.epa.gov/sab/sabproduct.nsf/02ad90b136fc21ef85256eba00436459/df0f42c34645448685258570005adfff!OpenDocument&TableRow=2.3#2).

II. Information Regarding the Peer Review

    EPA is announcing that NASEM will conduct an external peer review 
of the IRIS Handbook. Information regarding this peer review 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 https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect.

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

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2018-
0654 for the IRIS Handbook, by one of the following methods:
     https://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     Email: Docket_ORD@epa.gov.
     Fax: 202-566-9744. Due to COVID-19, there may be a delay 
in processing comments submitted by fax.
     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. 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 closed to 
public visitors to reduce the risk of transmitting COVID-19. Docket 
Center staff will continue to provide remote customer service via 
email, phone, and webform. The public can submit comments via 
www.regulations.gov or email. No hand deliveries are currently being 
accepted.
    Instructions: Direct your comments to docket number EPA-HQ-ORD-
2018-0654 for the IRIS Handbook. 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. 2020-26314 Filed 11-27-20; 8:45 am]
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