Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Environmental Protection Agency

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

# AGENCY:

Environmental Protection Agency (EPA).

# ACTION:

Notice of public comment period.

# 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:                         *Docket_ORD@epa.gov.*

                        For technical information on the protocol, contact Mr. Dahnish Shams, Center for Public Health & Environmental Assessment; email:                         *shams.dahnish@epa.gov.*

# 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: Docket_ORD@epa.gov. 
    -  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