Availability of the ORD Staff Handbook for Developing IRIS Assessments, 76566-76567 [2020-26314]

Download as PDF 76566 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices a.m. to 4:30 p.m., Monday through Friday (except Federal Holidays). Instructions: All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to https:// www.regulations.gov/, including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the ‘‘Public Participation’’ heading of the SUPPLEMENTARY INFORMATION section of this document. For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https:// www2.epa.gov/dockets/commentingepa-dockets FOR FURTHER INFORMATION CONTACT: Thomas Glazer, Water Law Office (2355A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone: (202) 564–0908; email address: glazer.thomas@epa.gov. SUPPLEMENTARY INFORMATION: TKELLEY on DSKBCP9HB2PROD with NOTICES I. Additional Information About the Proposed Stipulated Partial Dismissal On June 15, 2013, Plaintiffs filed suit in the federal district court for the District of Idaho against the Services. The original complaint alleged that the Services unreasonably delayed or unlawfully withheld completion of ESA consultation with EPA regarding new and revised water quality standards that were submitted in 1996 and/or 1997. On September 24, 2013, Plaintiffs filed an amended complaint adding various CWA and ESA claims against EPA regarding dozens of Idaho water quality standard submissions dating back to 1994. Broadly speaking, Plaintiffs’ claims fell into two categories: claims that EPA failed to consult with the Services on various water quality standard approval actions and claims that EPA failed to complete its mandatory duties under the CWA with respect to various new and revised water quality standards adopted by the State. In April 2015, the Services entered a stipulated dismissal with Plaintiffs, by which they agreed to complete certain ESA obligations. This left EPA as the sole defendant in the case. On February 28, 2019, the court partially granted EPA’s motion to dismiss a number of claims on statute of limitations grounds, dismissing all ESA VerDate Sep<11>2014 20:03 Nov 27, 2020 Jkt 253001 failure-to-consult claims regarding EPA actions that predated September 24, 2007—6 years prior to filing the amended complaint. The court declined to dismiss any CWA mandatory duty claims, finding that the statute of limitations did not require dismissal because Plaintiffs had alleged an ongoing failure to act by EPA. This left seven discrete claims against EPA alleging a failure to undertake various duties pursuant to the ESA and CWA with regard to Idaho water quality standards. The parties have negotiated a settlement framework in the form of a stipulated order of partial dismissal. The court would enter the order and retain jurisdiction to construe, carry out, enforce, modify, or resolve any dispute regarding the terms and conditions of the order. EPA and Plaintiffs negotiated a three-year timeline for EPA to complete an effects determination pursuant to 50 CFR 402.14(a) for its May 22, 2008 approval of Idaho’s revisions to its salmonid spawning timing procedure and, as appropriate, to request initiation of any necessary ESA section 7 consultation with the Services. The State has been informed of the timeline and will be an applicant in any ESA consultation. The Order would also resolve Plaintiffs’ claim for attorney’s fees with an agreement to pay $37,000. For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the obligations of EPA for resolution of the claims contained in the proposed stipulated order of partial dismissal from persons who are not named as original parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed stipulated order of partial dismissal if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the CWA or ESA. Unless EPA or the Department of Justice determines that consent to this proposed stipulated order of partial dismissal should be withdrawn, the terms of the proposed stipulated order of partial dismissal will be affirmed and entered with the court. II. Public Participation Written Comments Submit your comments, identified by Docket ID No. EPA–HQ–OGC–2020– 0561, at https://www.regulations.gov (our preferred method), or the other methods identified in the ADDRESSES section. Once submitted, comments cannot be edited or removed from the PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 docket. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/ commenting-epa-dockets. The EPA is temporarily suspending its Docket Center and Reading Room for public visitors, with limited exceptions, to reduce the risk of transmitting COVID–19. Our Docket Center staff will continue to provide remote customer service via email, phone, and webform. We encourage the public to submit comments via https:// www.regulations.gov/ as there may be a delay in processing mail and faxes. Hand deliveries or couriers will be received by scheduled appointment only. For further information and updates on EPA Docket Center services, please visit us online at https:// www.epa.gov/dockets. The EPA continues to carefully and continuously monitor information from the Centers for Disease Control and Prevention (CDC), local area health departments, and our Federal partners so that we can respond rapidly as conditions change regarding COVID–19. Dated: November 17, 2020. Steven Neugeboren, Associate General Counsel. [FR Doc. 2020–26310 Filed 11–27–20; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–ORD–2018–0654; FRL–10016–99– ORD] Availability of the ORD Staff Handbook for Developing IRIS Assessments Environmental Protection Agency (EPA). ACTION: Notice of public comment period. AGENCY: E:\FR\FM\30NON1.SGM 30NON1 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 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: TKELLEY on DSKBCP9HB2PROD with NOTICES SUMMARY: 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-riskinformation-system#process). The IRIS Handbook is designed so that it can be updated, as needed, to allow for VerDate Sep<11>2014 20:03 Nov 27, 2020 Jkt 253001 incorporation of method refinements, advances in assessment science, and any updates in EPA guidance (see https://yosemite.epa.gov/sab/ sabproduct.nsf/02ad90b136fc21 ef85256eba00436459/df0f42c346454486 85258570005adfff!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/stayingconnected-integrated-risk-informationsystem#connect. III. How To Submit Technical Comments to the Docket at https:// 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 76567 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] BILLING CODE 6560–50–P EXPORT-IMPORT BANK Sunshine Act Meetings; Notice of an Open Meeting of the Board of Directors of the Export-Import Bank of the United States Thursday, December 10, 2020 at 10:00 a.m. PLACE: The meeting will be held via teleconference. TIME AND DATE: E:\FR\FM\30NON1.SGM 30NON1

Agencies

[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.

-----------------------------------------------------------------------

[[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: 
[email protected].
    For technical information on the IRIS Handbook, contact Dr. James 
Avery, CPHEA; telephone: 202-564-1494; or email: [email protected].

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 https://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: [email protected].
     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]
BILLING CODE 6560-50-P
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