83_FR_16429 83 FR 16356 - Availability of the IRIS Assessment Plan for Ammonia and Ammonium Salts: Noncancer Assessment for Oral Exposure

83 FR 16356 - Availability of the IRIS Assessment Plan for Ammonia and Ammonium Salts: Noncancer Assessment for Oral Exposure

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 73 (April 16, 2018)

Page Range16356-16357
FR Document2018-07746

The Environmental Protection Agency (EPA) is announcing a 30- day public comment period associated with release of the draft IRIS Assessment Plan for ammonia and ammonium salts. This document communicates information on the scoping needs identified by EPA program and regional offices and the IRIS Program's initial problem formulation activities. Specifically, the assessment plan outlines the objectives for each assessment and the type of evidence considered most pertinent to address the scoping needs. EPA is releasing this draft IRIS Assessment Plan for public comment at least 30 days in advance of a public science webinar planned on May 23, 2018.

Federal Register, Volume 83 Issue 73 (Monday, April 16, 2018)
[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16356-16357]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07746]


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ENVIRONMENTAL PROTECTION AGENCY

[Docket ID No. EPA-HQ-ORD-2018-0132; FRL-9976-85-ORD]


Availability of the IRIS Assessment Plan for Ammonia and Ammonium 
Salts: Noncancer Assessment for Oral Exposure

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 draft IRIS 
Assessment Plan for ammonia and ammonium salts. This document 
communicates information on the scoping needs identified by EPA program 
and regional offices and the IRIS Program's initial problem formulation 
activities. Specifically, the assessment plan outlines the objectives 
for each assessment and the type of evidence considered most pertinent 
to address the scoping needs. EPA is releasing this draft IRIS 
Assessment Plan for public comment at least 30 days in advance of a 
public science webinar planned on May 23, 2018.

DATES: The 30-day public comment period begins April 16, 2018, and ends 
May 16, 2018.

ADDRESSES: The IRIS Assessment Plan for Ammonia and Ammonium Salts, 
will be available via the internet on IRIS' website at https://cfpub.epa.gov/ncea/iris2/chemicalLanding.cfm?substance_nmbr=422 and in 
the public docket at http://www.regulations.gov, Docket ID: EPA-HQ-ORD-
2018-0132.

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 draft IRIS Assessment Plan for 
ammonia and ammonium salts, contact Dr. James Avery, NCEA; telephone: 
202-564-1494; or email: avery.james@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Background Information on IRIS Assessment Plans

    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 the highest quality science-based human 
health assessments to support the Agency's regulatory activities and 
decisions to protect public health. As part of scoping and initial 
problem formulation activities prior to the development of a draft 
assessment, the IRIS Program carries out a broad, preliminary 
literature survey to assist in identifying health effects that have 
been studied in relation to the chemical or substance of interest, as 
well as science issues that may need to be considered when evaluating 
toxicity. This information, in conjunction with scoping needs 
identified by EPA program and regional offices, is used to inform the 
development of an IRIS Assessment Plan (IAP).
    The IAP communicates the plan for developing each individual 
chemical assessment to the public and includes summary information on 
the IRIS Program's scoping and initial problem formulation, objectives 
and specific aims for the assessment, and a PECO (Populations, 
Exposures, Comparators, and Outcomes) for the systematic review. The 
PECO provides the framework for developing literature search strategies 
and inclusion/exclusion criteria, particularly with respect to evidence 
stream (i.e., human, animal, mechanistic), exposure measures and 
outcome measures. The IAP serves to inform the subsequent development 
of chemical-specific systematic review protocols, which will be made 
publicly available.

II. Public Webinar

    In order to allow for public input, EPA is convening a public 
webinar to discuss the draft IRIS Assessment Plan for ammonia and 
ammonium salts on May 23, 2018. Specific teleconference and webinar 
information regarding this public meeting will be provided through the 
IRIS website (https://www.epa.gov/iris) and via EPA's Human Health Risk 
Assessment (HHRA) and IRIS listservs. To register for the HHRA or IRIS 
listserv, visit the IRIS website (https://www.epa.gov/iris) or visit 
https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect.

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

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2018-
0132 for ammonia, 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 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 docket number EPA-HQ-ORD-
2018-0132 for ammonia and ammonium salts. 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

[[Page 16357]]

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.

    Dated: April 5, 2018.
Tina Bahadori,
Director, National Center for Environmental Assessment.
[FR Doc. 2018-07746 Filed 4-13-18; 8:45 am]
 BILLING CODE 6560-50-P



                                                16356                          Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices

                                                time on the specified comment date.                     EPA Headquarters Docket Center;                       iris) and via EPA’s Human Health Risk
                                                Protests may be considered, but                         telephone: 202–566–1752; facsimile:                   Assessment (HHRA) and IRIS listservs.
                                                intervention is necessary to become a                   202–566–9744; or email: Docket_ORD@                   To register for the HHRA or IRIS
                                                party to the proceeding.                                epa.gov.                                              listserv, visit the IRIS website (https://
                                                   eFiling is encouraged. More detailed                    For technical information on the draft             www.epa.gov/iris) or visit https://
                                                information relating to filing                          IRIS Assessment Plan for ammonia and                  www.epa.gov/iris/forms/staying-
                                                requirements, interventions, protests,                  ammonium salts, contact Dr. James                     connected-integrated-risk-information-
                                                service, and qualifying facilities filings              Avery, NCEA; telephone: 202–564–                      system#connect.
                                                can be found at: http://www.ferc.gov/                   1494; or email: avery.james@epa.gov.
                                                                                                                                                              III. How To Submit Technical
                                                docs-filing/efiling/filing-req.pdf. For                 SUPPLEMENTARY INFORMATION:
                                                                                                                                                              Comments to the Docket at http://
                                                other information, call (866) 208–3676                                                                        www.regulations.gov
                                                                                                        I. Background Information on IRIS
                                                (toll free). For TTY, call (202) 502–8659.              Assessment Plans                                         Submit your comments, identified by
                                                  Dated: April 10, 2018.
                                                                                                           EPA’s IRIS Program is a human health               Docket ID No. EPA–HQ–ORD–2018–
                                                Nathaniel J. Davis, Sr.,                                assessment program that evaluates                     0132 for ammonia, by one of the
                                                Deputy Secretary.                                       quantitative and qualitative risk                     following methods:
                                                [FR Doc. 2018–07883 Filed 4–13–18; 8:45 am]             information on effects that may result                   • www.regulations.gov: Follow the
                                                BILLING CODE 6717–01–P                                  from exposure to chemicals found in the               on-line instructions for submitting
                                                                                                        environment. Through the IRIS                         comments.
                                                                                                        Program, EPA provides the highest                        • Email: Docket_ORD@epa.gov.
                                                ENVIRONMENTAL PROTECTION                                quality science-based human health                       • Fax: 202–566–9744.
                                                AGENCY                                                  assessments to support the Agency’s                      • Mail: U.S. Environmental
                                                                                                        regulatory activities and decisions to                Protection Agency, EPA Docket Center
                                                [Docket ID No. EPA–HQ–ORD–2018–0132;                    protect public health. As part of scoping             (ORD Docket), Mail Code: 28221T, 1200
                                                FRL–9976–85–ORD]                                        and initial problem formulation                       Pennsylvania Avenue NW, Washington,
                                                                                                        activities prior to the development of a              DC 20460. The phone number is 202–
                                                Availability of the IRIS Assessment                                                                           566–1752.
                                                Plan for Ammonia and Ammonium                           draft assessment, the IRIS Program
                                                                                                        carries out a broad, preliminary                         • Hand Delivery: The ORD Docket is
                                                Salts: Noncancer Assessment for Oral                                                                          located in the EPA Headquarters Docket
                                                                                                        literature survey to assist in identifying
                                                Exposure                                                                                                      Center, EPA West Building, Room 3334,
                                                                                                        health effects that have been studied in
                                                AGENCY: Environmental Protection                        relation to the chemical or substance of              1301 Constitution Avenue NW,
                                                Agency (EPA).                                           interest, as well as science issues that              Washington, DC 20229.
                                                                                                        may need to be considered when                           The EPA Docket Center Public
                                                ACTION: Notice of public comment
                                                                                                        evaluating toxicity. This information, in             Reading Room is open from 8:30 a.m. to
                                                period.                                                                                                       4:30 p.m., Monday through Friday,
                                                                                                        conjunction with scoping needs
                                                SUMMARY:   The Environmental Protection                 identified by EPA program and regional                excluding legal holidays. The telephone
                                                Agency (EPA) is announcing a 30-day                     offices, is used to inform the                        number for the Public Reading Room is
                                                public comment period associated with                   development of an IRIS Assessment                     202–566–1744. Deliveries are only
                                                release of the draft IRIS Assessment                    Plan (IAP).                                           accepted during the docket’s normal
                                                Plan for ammonia and ammonium salts.                       The IAP communicates the plan for                  hours of operation, and special
                                                This document communicates                              developing each individual chemical                   arrangements should be made for
                                                information on the scoping needs                        assessment to the public and includes                 deliveries of boxed information. If you
                                                identified by EPA program and regional                  summary information on the IRIS                       provide comments by mail or hand
                                                offices and the IRIS Program’s initial                  Program’s scoping and initial problem                 delivery, please submit three copies of
                                                problem formulation activities.                         formulation, objectives and specific                  the comments. For attachments, provide
                                                Specifically, the assessment plan                       aims for the assessment, and a PECO                   an index, number pages consecutively
                                                outlines the objectives for each                        (Populations, Exposures, Comparators,                 with the comments, and submit an
                                                assessment and the type of evidence                     and Outcomes) for the systematic                      unbound original and three copies.
                                                considered most pertinent to address                    review. The PECO provides the                            Instructions: Direct your comments to
                                                the scoping needs. EPA is releasing this                framework for developing literature                   docket number EPA–HQ–ORD–2018–
                                                draft IRIS Assessment Plan for public                   search strategies and inclusion/                      0132 for ammonia and ammonium salts.
                                                comment at least 30 days in advance of                  exclusion criteria, particularly with                 Please ensure that your comments are
                                                a public science webinar planned on                     respect to evidence stream (i.e., human,              submitted within the specified comment
                                                May 23, 2018.                                           animal, mechanistic), exposure                        period. Comments received after the
                                                                                                        measures and outcome measures. The                    closing date will be marked ‘‘late,’’ and
                                                DATES: The 30-day public comment
                                                                                                        IAP serves to inform the subsequent                   may only be considered if time permits.
                                                period begins April 16, 2018, and ends                                                                        It is EPA’s policy to include all
                                                May 16, 2018.                                           development of chemical-specific
                                                                                                        systematic review protocols, which will               comments it receives in the public
                                                ADDRESSES: The IRIS Assessment Plan                                                                           docket without change and to make the
                                                                                                        be made publicly available.
                                                for Ammonia and Ammonium Salts,                                                                               comments available online at
                                                will be available via the internet on                   II. Public Webinar                                    www.regulations.gov, including any
                                                IRIS’ website at https://cfpub.epa.gov/                    In order to allow for public input,                personal information provided, unless a
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                                                ncea/iris2/chemicalLanding.cfm?                         EPA is convening a public webinar to                  comment includes information claimed
                                                substance_nmbr=422 and in the public                    discuss the draft IRIS Assessment Plan                to be Confidential Business Information
                                                docket at http://www.regulations.gov,                   for ammonia and ammonium salts on                     (CBI) or other information for which
                                                Docket ID: EPA–HQ–ORD–2018–0132.                        May 23, 2018. Specific teleconference                 disclosure is restricted by statute. Do
                                                FOR FURTHER INFORMATION CONTACT: For                    and webinar information regarding this                not submit information through
                                                information on the public comment                       public meeting will be provided through               www.regulations.gov or email that you
                                                period, contact the ORD Docket at the                   the IRIS website (https://www.epa.gov/                consider to be CBI or otherwise


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                                                                               Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices                                           16357

                                                protected. The www.regulations.gov                      Texas SO2 Trading Programs (40 CFR                    functions of the Agency, including
                                                website is an ‘‘anonymous access’’                      part 97, subparts AAAAA–FFFFF)                        whether the information will have
                                                system, which means EPA will not                        (Renewal)’’ (EPA ICR No. 2391.05, OMB                 practical utility; (ii) evaluate the
                                                know your identity or contact                           Control No. 2060–0667) to the Office of               accuracy of the Agency’s estimate of the
                                                information unless you provide it in the                Management and Budget (OMB) for                       burden of the proposed collection of
                                                body of your comment. If you send an                    review and approval in accordance with                information, including the validity of
                                                email comment directly to EPA without                   the Paperwork Reduction Act (PRA) (44                 the methodology and assumptions used;
                                                going through www.regulations.gov,                      U.S.C. 3501 et seq.). Before doing so,                (iii) enhance the quality, utility, and
                                                your email address will be                              EPA is soliciting public comments on                  clarity of the information to be
                                                automatically captured and included as                  specific aspects of the proposed                      collected; and (iv) minimize the burden
                                                part of the comment that is placed in the               information collection as described                   of the collection of information on those
                                                public docket and made available on the                 below. This is a proposed extension of                who are to respond, including through
                                                internet. If you submit an electronic                   the ICR, which is currently approved                  the use of appropriate automated
                                                comment, EPA recommends that you                        through October 31, 2018. An Agency                   electronic, mechanical, or other
                                                include your name and other contact                     may not conduct or sponsor and a                      technological collection techniques or
                                                information in the body of your                         person is not required to respond to a                other forms of information technology,
                                                comment and with any disk or CD–ROM                     collection of information unless it                   e.g., permitting electronic submission of
                                                you submit. If EPA cannot read your                     displays a currently valid OMB control                responses. EPA will consider the
                                                comment due to technical difficulties                   number.                                               comments received and amend the ICR
                                                and cannot contact you for clarification,               DATES: Comments must be submitted on                  as appropriate. The final ICR package
                                                EPA may not be able to consider your                    or before June 15, 2018.                              will then be submitted to OMB for
                                                comment. Electronic files should avoid                  ADDRESSES: Submit your comments,                      review and approval. At that time, EPA
                                                the use of special characters, any form                 referencing Docket ID No. EPA–HQ–                     will issue another Federal Register
                                                of encryption, and be free of any defects               OAR–2018–0209, online using                           notice to announce the submission of
                                                or viruses. For additional information                  www.regulations.gov (our preferred                    the ICR to OMB and the opportunity to
                                                about EPA’s public docket visit the EPA                 method), by email to a-and-r-Docket@                  submit additional comments to OMB.
                                                Docket Center homepage at                               epa.gov, or by mail to: EPA Docket                       Abstract: EPA is renewing an ICR for
                                                www.epa.gov/epahome/dockets.htm.                        Center, Environmental Protection                      the Cross-State Air Pollution Rule
                                                   Docket: Documents in the docket are                  Agency, Mail Code 28221T, 1200                        (CSAPR) trading programs to allow for
                                                listed in the www.regulations.gov index.                Pennsylvania Ave. NW, Washington, DC                  continued implementation of the
                                                Although listed in the index, some                      20460.                                                programs. The information collection
                                                information is not publicly available,                    EPA’s policy is that all comments                   requirements under all five CSAPR
                                                e.g., CBI or other information whose                    received will be included in the public               trading programs are reflected in the
                                                disclosure is restricted by statute.                    docket without change including any                   existing ICR as most recently revised in
                                                Certain other materials, such as                        personal information provided, unless                 2016. In 2017, Texas sources were
                                                copyrighted material, are publicly                      the comment includes profanity, threats,              removed from two CSAPR trading
                                                available only in hard copy. Publicly                   information claimed to be Confidential                programs and EPA promulgated the
                                                available docket materials are available                Business Information (CBI) or other                   Texas SO2 Trading Program using the
                                                either electronically in                                information whose disclosure is                       CSAPR trading programs as a model.
                                                www.regulations.gov or in hard copy at                  restricted by statute.                                This ICR renewal reflects the 2017
                                                the ORD Docket in the EPA                               FOR FURTHER INFORMATION CONTACT:                      termination of information collection
                                                Headquarters Docket Center.                             Karen VanSickle, Clean Air Markets                    requirements for Texas sources under
                                                  Dated: April 5, 2018.                                 Division, Office of Air and Radiation,                the two CSAPR trading programs and
                                                Tina Bahadori,                                          (6204M), Environmental Protection                     the 2019 re-establishment of some of the
                                                Director, National Center for Environmental             Agency, 1200 Pennsylvania Ave. NW,                    same requirements for some of the same
                                                Assessment.                                             Washington, DC 20460; telephone                       sources under the Texas trading
                                                [FR Doc. 2018–07746 Filed 4–13–18; 8:45 am]             number: 202–343–9220; fax number:                     program. Most affected sources under
                                                BILLING CODE 6560–50–P
                                                                                                        202–343–2361; email address:                          the CSAPR and Texas trading programs
                                                                                                        vansickle.karen@epa.gov.                              are also subject to the Acid Rain
                                                                                                        SUPPLEMENTARY INFORMATION:                            Program (ARP). The information
                                                ENVIRONMENTAL PROTECTION                                Supporting documents which explain in                 collection requirements under the
                                                AGENCY                                                  detail the information that EPA will be               CSAPR and Texas trading programs,
                                                                                                        collecting are available in the public                which consist primarily of requirements
                                                [EPA–HQ–OAR–2018–0209; FRL–9976–91–                     docket for this ICR. The docket can be                to monitor and report emissions data in
                                                OAR]                                                                                                          accordance with 40 CFR part 75,
                                                                                                        viewed online at www.regulations.gov
                                                                                                        or in person at the EPA Docket Center,                substantially overlap and are fully
                                                Proposed Information Collection
                                                                                                        WJC West, Room 3334, 1301                             integrated with ARP information
                                                Request; Comment Request; Cross-
                                                                                                        Constitution Ave. NW, Washington, DC.                 collection requirements. The burden
                                                State Air Pollution Rule and Texas SO2
                                                                                                        The telephone number for the Docket                   and costs of overlapping requirements
                                                Trading Programs (Renewal)
                                                                                                        Center is 202–566–1744. For additional                are accounted for in the ARP ICR (OMB
                                                AGENCY: Environmental Protection                        information about EPA’s public docket,                Control Number 2060–0258). This ICR
srobinson on DSK3G9T082PROD with NOTICES




                                                Agency (EPA).                                           visit http://www.epa.gov/dockets.                     accounts for information collection
                                                ACTION: Notice.                                           Pursuant to section 3506(c)(2)(A) of                burden and costs under the CSAPR and
                                                                                                        the PRA, EPA is soliciting comments                   Texas trading programs that are
                                                SUMMARY:   The Environmental Protection                 and information to enable it to: (i)                  incremental to the burden and costs
                                                Agency is planning to submit an                         Evaluate whether the proposed                         already accounted for in the ARP ICR.
                                                information collection request (ICR),                   collection of information is necessary                All data received by EPA will be treated
                                                ‘‘Cross-State Air Pollution Rule and                    for the proper performance of the                     as public information.


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Document Created: 2018-04-14 02:19:05
Document Modified: 2018-04-14 02:19:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public comment period.
DatesThe 30-day public comment period begins April 16, 2018, and ends May 16, 2018.
ContactFor 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]
FR Citation83 FR 16356 

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