
[Federal Register Volume 88, Number 216 (Thursday, November 9, 2023)]
[Notices]
[Page 77310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24746]



[[Page 77310]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2017-0496; FRL-11545-01-ORD]


Availability of the Protocol for the Nitrate and Nitrite IRIS 
Assessment (Oral)

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 document 
Protocol for the Nitrate and Nitrite IRIS Assessment (Oral). This 
document communicates the rationale for conducting the human health 
assessment of Nitrate and Nitrite, describes screening criteria to 
identify relevant literature, outlines the approach for evaluating 
study quality, and describes the methods for dose-response analysis.

DATES: The 30-day public comment period begins November 9, 2023 and 
ends December 11, 2023. Comments must be received on or before December 
11, 2023.

ADDRESSES: The Protocol for the Nitrate and Nitrite IRIS Assessment 
(Oral) will be available via the internet on the IRIS website at 
https://www.epa.gov/iris and in the public docket at http://www.regulations.gov, Docket ID: EPA-HQ-ORD-2017-0496.

FOR FURTHER INFORMATION CONTACT: For information on the docket, contact 
the ORD Docket at the EPA Headquarters Docket Center; email: 
[email protected].
    For technical information on the protocol, contact Mr. Dahnish 
Shams, Center for Public Health & Environmental Assessment; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background Information on the IRIS Program and Systematic Review 
Protocols

    EPA's IRIS Program is a human health assessment program that 
evaluates quantitative and qualitative information on 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 developing a draft IRIS assessment, EPA presents a 
methods document, referred to as the protocol, for conducting a 
chemical-specific systematic review of the available scientific 
literature. EPA is seeking public comment on components of the protocol 
including the described strategies for literature searches, criteria 
for study inclusion or exclusion, considerations for evaluating study 
methods, information management for extracting data, approaches for 
synthesis within and across lines of evidence, and methods for 
derivation of toxicity values. The protocol serves to inform the 
subsequent development of the draft assessment and is made available to 
the public. EPA may update the protocol based on the evaluation of the 
literature, and any updates will be posted to the docket and on the 
IRIS website.

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

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2017-
0496 for Nitrate/Nitrite, 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.
    For information on visiting the EPA Docket Center Public Reading 
Room, visit https://www.epa.gov/dockets. The telephone number for the 
Public Reading Room is 202-566-1744. The public can submit comments via 
www.regulations.gov or email.
    Instructions: Direct your comments to docket number EPA-HQ-ORD-
2017-0496 for nitrate/nitrite. 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 https://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 https://www.regulations.gov or email that you consider to be 
CBI or otherwise protected. The https://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 https://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 https://www.epa.gov/dockets.
    Docket: Documents in the docket are listed in the https://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 https://www.regulations.gov or as a hard copy at the ORD Docket in 
the EPA Headquarters Docket Center.

Wayne Cascio,
Director, Center for Public Health & Environmental Assessment.
[FR Doc. 2023-24746 Filed 11-8-23; 8:45 am]
BILLING CODE 6560-50-P


