Document ID: EPA-HQ-ORD-2011-0676-0005
Agency: epa
Document Type: Notice
Title: Availability of the Systematic Review Protocol for the Polychlorinated Biphenyls (PCBs) Noncancer Integrated Risk Information System (IRIS) Assessment
Posted Date: 2019-12-19T05:00Z

[Federal Register Volume 84, Number 244 (Thursday, December 19, 2019)]
[Notices]
[Pages 69742-69743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27427]

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ENVIRONMENTAL PROTECTION AGENCY

[Docket ID No. EPA-HQ-ORD-2011-0676; FRL-10003-40-ORD]

Availability of the Systematic Review Protocol for the 
Polychlorinated Biphenyls (PCBs) Noncancer Integrated Risk Information 
System (IRIS) Assessment

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 Systematic 
Review Protocol for the Polychlorinated Biphenyls (PCBs) Noncancer IRIS 
Assessment. This document communicates the rationale for

[[Page 69743]]

conducting the assessment of PCBs, describes screening criteria to 
identify relevant literature, outlines the approach for evaluating 
study quality, and describes the process of evidence synthesis/
integration and dose-response methods.

DATES: The 30-day public comment period begins December 19, 2019 and 
ends January 21, 2020. Comments must be received on or before January 
21, 2020.

ADDRESSES: The Systematic Review Protocol for PCBs 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-
2011-0676.

FOR FURTHER INFORMATION CONTACT: For information on the docket, 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 protocol, contact Dr. James Avery, 
Center for Public Health & Environmental Assessment; telephone: 202-
564-1494; or email: avery.james@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 risk 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. Additionally, key scientific issues that 
warrant consideration in this assessment are identified in Section 2.5. 
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. In accordance 
with the most current systematic review practices of the IRIS Program, 
EPA is releasing the PCB protocol to provide similar public engagement 
steps as other IRIS assessments that have started more recently.

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

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2011-
0676 for PCBs, by one of the following methods:
     http://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.
     Hand Delivery: The ORD Docket is located in the EPA 
Headquarters Docket Center, EPA West Building, Room 3334, 1301 
Constitution Avenue NW, Washington, DC 20229.
    The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is 202-566-1744. 
Deliveries are only accepted during the docket's normal hours of 
operation, and special arrangements should be made for deliveries of 
boxed information. If you provide comments by mail or hand delivery, 
please submit three copies of the comments. For attachments, provide an 
index, number pages consecutively with the comments, and submit an 
unbound original and three copies.
    Instructions: Direct your comments to EPA-HQ-ORD-2011-0676 for 
PCBs. 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.

    Dated: December 10, 2019.
Wayne E. Cascio,
Director, Center for Public Health & Environmental Assessment.
[FR Doc. 2019-27427 Filed 12-18-19; 8:45 am]
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