Document ID: EPA-HQ-ORD-2019-0275-0001
Agency: epa
Document Type: Notice
Title: Availability of the Systematic Review Protocol for the PFDA, PFNA, PFHxA, PFHxS, and PFBA IRIS Assessments
Posted Date: 2019-11-08T05:00Z

[Federal Register Volume 84, Number 217 (Friday, November 8, 2019)]
[Notices]
[Pages 60393-60395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24350]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10001-78-ORD; Docket ID No. EPA-HQ-ORD-2019-0275]

Availability of the Systematic Review Protocol for the PFDA, 
PFNA, PFHxA, PFHxS, and PFBA IRIS Assessments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing a 45-
day

[[Page 60394]]

public comment period associated with release of the Systematic Review 
Protocol for the perfluorodecanoic acid (PFDA), perfluorononanoic acid 
(PFNA), perfluorohexanoic acid (PFHxA), perfluorohexanesulfonate 
(PFHxS), and perfluorobutanoic acid (PFBA) Integrated Risk Information 
System (IRIS) assessments. This protocol document presents the methods 
for conducting the systematic reviews and dose response analyses for 
these assessments as well as summarizes the Agency's problem 
formulation activities. Public input will help to inform the subsequent 
development of draft assessments for these per- and polyfluoroalkyl 
substances (PFAS) chemicals.

DATES: The 45-day public comment period begins November 8, 2019 and 
ends December 23, 2019. Comments must be received on or before December 
23, 2019.

ADDRESSES: The Systematic Review Protocol for perfluorodecanoic acid 
(PFDA), perfluorononanoic acid (PFNA), perfluorohexanoic acid (PFHxA), 
perfluorohexanesulfonate (PFHxS), and perfluorobutanoic acid (PFBA) 
assessments 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-2019-0275. 
Information on these chemicals is provided in the SUPPLEMENTARY 
INFORMATION section of this notice.

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. Information on PFAS and Systematic Review Protocols

    Per- and polyfluoroalkyl substances (PFAS) are a large class of 
man-made chemicals widely used in consumer products and industrial 
processes. The basic structure of PFAS consists of a carbon chain 
surrounded by fluorine atoms, with different chemicals possessing 
different end groups. The five toxicity assessments being developed 
according to the scope and methods outlined in this protocol build upon 
several other PFAS assessments that have already been developed, and 
represent only one component of the broader PFAS action plan underway 
at the U.S. EPA (https://www.epa.gov/pfas/epas-pfas-action-plan).
    This protocol document presents the methods for conducting the 
systematic reviews and dose response analyses for assessments of 
perfluorodecanoic acid (PFDA), perfluorononanoic acid (PFNA), 
perfluorohexanoic acid (PFHxA), perfluorohexanesulfonate (PFHxS), and 
perfluorobutanoic acid (PFBA). This includes a summary of why these 
specific PFAS chemicals were prioritized for evaluation, description of 
the objectives and specific aims of the assessments, draft PECO 
(Populations, Exposures, Comparators, and Outcomes) criteria, and 
identification of key areas of scientific complexity. Public input 
received on the protocol is considered during preparation of the draft 
assessments and any adjustments made to the protocol will be reflected 
in an updated version released in conjunction with the draft 
assessments.

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

    Submit your comments on the Systematic Review Protocol for the 
PFDA, PFNA, PFHxA, PFHxS, and PFBA IRIS Assessments to Docket ID No. 
EPA-HQ-ORD-2019-0275, 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.
     Hand Delivery: The ORD Docket is located in the EPA 
Headquarters Docket Center, EPA West Building, Room 3334, 1301 
Constitution Avenue NW, Washington, DC 20004.
    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 on the systematic review 
protocol to Docket ID No. EPA-HQ-ORD-2019-0275. 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 hard copy at the ORD Docket in the 
EPA Headquarters Docket Center.

[[Page 60395]]

    Dated: October 20, 2019.
Wayne E. Cascio,
Director, Center for Public Health & Environmental Assessment.
[FR Doc. 2019-24350 Filed 11-7-19; 8:45 am]
 BILLING CODE 6560-50-P