83_FR_39240 83 FR 39087 - FIFRA Scientific Advisory Panel; Notice of Public Meeting and Request for Nomination of Ad Hoc Expert Members

83 FR 39087 - FIFRA Scientific Advisory Panel; Notice of Public Meeting and Request for Nomination of Ad Hoc Expert Members

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 153 (August 8, 2018)

Page Range39087-39090
FR Document2018-16990

There will be a 4-day, in-person meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review the Evaluation of a Proposed Approach to Refine the Inhalation Risk Assessment for Point of Contact Toxicity: A Case Study Using a New Approach Methodology (NAM). Preceding the in-person meeting, there will be a half-day virtual preparatory meeting, conducted via webinar using Adobe Connect, to consider and review the clarity and scope of the meeting's draft charge questions. In addition, EPA is requesting nominations of prospective candidates for service as ad hoc members of FIFRA SAP for this meeting. Any interested person or organization may nominate qualified individuals to be considered as prospective candidates for this meeting by following the instructions provided in this document.

Federal Register, Volume 83 Issue 153 (Wednesday, August 8, 2018)
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39087-39090]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16990]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2018-0517; FRL-9980-76]


FIFRA Scientific Advisory Panel; Notice of Public Meeting and 
Request for Nomination of Ad Hoc Expert Members

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: There will be a 4-day, in-person meeting of the Federal 
Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel 
(FIFRA SAP) to consider and review the Evaluation of a Proposed 
Approach to Refine the Inhalation Risk Assessment for Point of Contact 
Toxicity: A Case Study Using a New Approach Methodology (NAM). 
Preceding the in-person meeting, there will be a half-day virtual 
preparatory meeting, conducted via webinar using Adobe Connect, to 
consider and review the clarity and scope of the meeting's draft charge 
questions. In addition, EPA is requesting nominations of prospective 
candidates for service as ad hoc members of FIFRA SAP for this meeting. 
Any interested person or organization may nominate qualified 
individuals to be considered as prospective candidates

[[Page 39088]]

for this meeting by following the instructions provided in this 
document.

DATES: 
    Meeting: The 4-day, in-person meeting will be held December 4 to 
December 7, 2018, from approximately 9 a.m. to 5 p.m.
    Nominations: Nominations of candidates to serve as ad hoc members 
of the FIFRA SAP for this review should be provided on or before 
September 7, 2018.
    Special accommodations: Requests for special accommodations should 
be submitted on or before November 16, 2018, to allow EPA time to 
process your request.
    Comments: Written comments should be submitted on or before October 
19, 2018, and EPA encourages individuals and groups that wish to make 
oral comments to submit the request to make oral comments by November 
9, 2018.

ADDRESSES: 
    Meeting: The in-person meeting will be held at the Environmental 
Protection Agency, Conference Center, Lobby Level, One Potomac Yard 
(South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202. The virtual 
meeting will be webcast. Please refer to the following website for 
information on how to access the webcast: http://www.epa.gov/sap.
    Nominations: Submit nominations of candidates to serve as ad hoc 
members of the FIFRA SAP Meeting to the DFO listed under FOR FURTHER 
INFORMATION CONTACT.
    Special accommodations: For information on access or services for 
individuals with disabilities, and to request accommodation for a 
disability, please contact the Designated Federal Official (DFO) listed 
under FOR FURTHER INFORMATION CONTACT.
    Comments. Submit requests to present oral comments to the DFO 
listed under FOR FURTHER INFORMATION CONTACT.
    Submit your written comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2018-0517, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not 
electronically submit any information you consider to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional information on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets. For additional instructions related to this 
meeting, see Unit I.C. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Dr. Marquea D. King, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone 
number: 202-564-3626; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may 
be of interest to persons who are or may be required to conduct testing 
of chemical substances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA) and FIFRA. Since other entities may also be interested, the 
Agency has not attempted to describe all the specific entities that may 
be affected by this action.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through 
regulations.gov or email. If your comments contain any information that 
you consider to be CBI or otherwise protected, please contact the DFO 
listed under FOR FURTHER INFORMATION CONTACT to obtain special 
instructions before submitting your comments.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

C. How may I participate in both meetings?

    You may participate in both meetings by following the instructions 
in this unit. To ensure proper receipt of comments, nominations or 
other requests by EPA, it is imperative that you identify docket ID 
number EPA-HQ-OPP-2018-0517 in the subject line on the first page of 
your request.
    1. Written comments. Written comments for both the in-person and 
virtual meetings should be submitted, using the instructions in 
ADDRESSES and Unit I.B., on or before October 19, 2018, to provide 
FIFRA SAP the time necessary to consider and review the written 
comments. FIFRA SAP may not be able to fully consider written comments 
submitted after October 19, 2018.
    2. Oral comments. To be included on the meeting agenda, the Agency 
encourages each individual or group wishing to make brief oral comments 
to FIFRA SAP during the in-person or virtual meetings to submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT on or 
before November 9, 2018. To the extent that time permits, the Chair of 
the FIFRA SAP may permit the presentation of oral comments at the 
meeting by interested persons who have not previously requested time. 
Oral comments during the virtual meeting are limited to approximately 5 
minutes due to the time constraints of this webcast. Oral comments 
during the 4-day, in-person meeting are limited to approximately 5 
minutes unless arrangements have been made prior to November 9, 2018. 
The request should identify the name of the individual making the 
presentation, the organization (if any) the individual will represent, 
and any requirements for audiovisual equipment. In addition, each 
speaker should bring 15 copies of his or her oral remarks and 
presentation slides (if required) for distribution to the FIFRA SAP at 
the meeting by the DFO.
    3. Seating at the meeting. Seating at the in-person meeting will be 
open and on a first-come basis.
    4. Request for nominations to serve as ad hoc expert members of 
FIFRA SAP for this meeting. As part of a broader process for developing 
a pool of candidates for each meeting, FIFRA SAP staff routinely 
solicits the stakeholder community for nominations of prospective 
candidates for service as ad hoc members of FIFRA SAP. Any interested 
person or organization may nominate qualified individuals to be 
considered as prospective candidates for a specific meeting. 
Individuals nominated for this meeting should have expertise in one or 
more of the following areas: (i) Development and implementation of new 
approach methodologies (NAMs); (ii) inhalation alternative testing; 
(iii) inhalation toxicology; (iv) inhalation exposure assessment; (v) 
inhalation/computational fluid dynamic (CFD) modeling; and (vi) risk 
assessment. Nominees should be scientists who have sufficient 
professional qualifications, including training and experience, to 
provide expert comments on the scientific issues for this meeting. 
Nominees should be identified by name, occupation, position, address, 
email address, and telephone number. Nominations should be provided to 
the

[[Page 39089]]

DFO listed under FOR FURTHER INFORMATION CONTACT on or before September 
7, 2018. The Agency will consider all nominations of prospective 
candidates for this meeting that are received on or before that date. 
However, final selection of ad hoc members for this meeting is a 
discretionary function of the Agency.
    The selection of scientists to serve on FIFRA SAP is based on the 
function of the Panel and the expertise needed to address the Agency's 
charge to the Panel. No interested scientists shall be ineligible to 
serve by reason of their membership on any other advisory committee to 
a Federal department or agency or their employment by a Federal 
department or agency, except EPA. Other factors considered during the 
selection process include availability of the potential Panel member to 
fully participate in the Panel's review, absence of any conflicts of 
interest or appearance of loss of impartiality, independence with 
respect to the matters under review, and lack of bias. Although 
financial conflicts of interest, the appearance of loss of 
impartiality, lack of independence, and bias may result in 
disqualification, the absence of such concerns does not assure that a 
candidate will be selected to serve on FIFRA SAP. Numerous qualified 
candidates are identified for each Panel; therefore, selection 
decisions involve carefully weighing a number of factors, including the 
candidates' areas of expertise and professional qualifications and 
achieving an overall balance of different scientific perspectives on 
the Panel. In order to have the collective breadth of experience needed 
to address the Agency's peer review charge for this meeting, the Agency 
anticipates selecting approximately 13 ad hoc scientists.
    FIFRA SAP members are subject to the provisions of 5 CFR part 
2634--Executive Branch Financial Disclosure, Qualified Trusts, and 
Certificates of Divestiture, as supplemented by EPA in 5 CFR part 6401. 
In anticipation of this requirement, prospective candidates for service 
on FIFRA SAP will be asked to submit confidential financial information 
which shall fully disclose, among other financial interests, the 
candidate's employment, stocks, and bonds, and where applicable, 
sources of research support. EPA will evaluate the candidate's 
financial disclosure form to assess whether there are financial 
conflicts of interest, appearance of a loss of impartiality, or any 
prior involvement with the development of the documents under 
consideration (including previous scientific peer review) before the 
candidate is considered further for service on FIFRA SAP. Those who are 
selected from the pool of prospective candidates will be asked to 
attend the public meetings and to participate in the discussion of key 
issues and assumptions at these meetings. In addition, they will be 
asked to review and to help finalize the meeting minutes and final 
report. The list of FIFRA SAP members participating at this meeting 
will be posted on the FIFRA SAP website at http://www.epa.gov/scipoly/sap or may be obtained from the OPP Docket at http://www.regulations.gov.

II. Background

A. Purpose of FIFRA SAP

    The FIFRA SAP serves as one of the primary scientific peer review 
mechanisms of EPA's Office of Chemical Safety and Pollution Prevention 
(OCSPP) and is structured to provide independent scientific advice, 
information and recommendations to the EPA Administrator on pesticides 
and pesticide-related issues as to the impact of regulatory actions on 
human health and the environment. FIFRA SAP is a Federal advisory 
committee established in 1975 under FIFRA that operates in accordance 
with requirements of the Federal Advisory Committee Act (5 U.S.C. 
Appendix). The FIFRA SAP is composed of a permanent panel consisting of 
seven members who are appointed by the EPA Administrator from nominees 
provided by the National Institutes of Health (NIH) and the National 
Science Foundation (NSF). FIFRA established a Science Review Board 
(SRB) consisting of at least 60 scientists who are available to FIFRA 
SAP on an ad hoc basis to assist in reviews conducted by FIFRA SAP. As 
a scientific peer review mechanism, FIFRA SAP provides comments, 
evaluations, and recommendations to improve the effectiveness and 
quality of analyses made by Agency scientists. Members of FIFRA SAP are 
scientists who have sufficient professional qualifications, including 
training and experience, to provide expert advice and recommendation to 
the Agency.

B. Public Meeting

    EPA conducts human health risk assessments to evaluate the 
potential health effects of pesticides and toxic chemicals in 
residential and occupational settings based on the use pattern or 
conditions of use. For evaluating effects via the inhalation route, 
registrants and manufacturers conduct subchronic inhalation toxicity 
studies according to test guideline requirements (OPPTS 870.3465, 40 
CFR part 798, OECD TG 412 and 413). In these studies, several groups of 
experimental animals are exposed daily for a defined period to 
graduated concentrations of test substance as a gas or aerosol/
particulate. These studies are used to determine a no observed adverse 
effect concentration (NOAEC) for effects following repeated inhalation 
exposure that may be used for human health risk assessment.
    The anatomy and physiology of human and animal respiratory tracts 
differ in several ways that can impact changes in airflow and 
deposition of inhaled substances and, therefore, influence the animal 
to human dose response extrapolation. Furthermore, traditional in vivo 
toxicity tests used to extrapolate from test species to humans are 
expensive, time-consuming, and can cause stress to laboratory animals. 
As a result, efforts to develop alternative methods and strategies for 
evaluating toxic effects from inhaled chemicals using in vitro test 
systems with human tissues combined with human dosimetry modeling 
provide inherent advantages over using in vivo animal studies. These 
alternatives are also consistent with the National Research Council's 
(NRC) long-range vision to advance toxicity testing in the 21st 
century, as well as the strategic roadmap released by Interagency 
Coordinating Committee on the Validation of Alternative Methods 
(ICCVAM) to accomplish NRC's vision in the United States.
    New approach methodologies (NAMs) has been adopted as a broadly 
descriptive reference to any non-animal technology, methodology, 
approach, or combination thereof that can be used to provide 
information on chemical hazard and risk assessment. An example of a NAM 
for refining inhalation risk assessment has been submitted to the 
Agency for the pesticide chlorothalonil. Chlorothalonil is a contact 
irritant that has been found to be toxic via the inhalation route. Due 
to the irritant nature of chlorothalonil and animal welfare concerns, 
the registrant (Syngenta Crop Protection) indicated that a 90-day 
inhalation toxicity study was not feasible to fulfill the regulatory 
requirement of a subchronic inhalation study. Subsequently, Syngenta 
proposed an alternative approach using an in vitro assay 
(MucilAirTM using human nasal tissue) to characterize the 
hazard of chlorothalonil and derive a point of departure (POD) for use 
in human health risk assessment. In order to calculate human equivalent 
concentrations for the purposes of human health risk assessment, an in

[[Page 39090]]

vitro POD has been proposed in conjunction with surface concentrations 
of deposited chlorothalonil particles from a computational fluid 
dynamic (CFD) model for the upper airway of a human. As a proof of 
concept, Syngenta also used the calculated human equivalent 
concentrations for pesticide operators/applicators to provide potential 
risk estimates supported by this proposed approach.
    The Agency is soliciting advice from the FIFRA Scientific Advisory 
Panel (SAP) on the derivation of the POD from the in vitro assay and 
the integration of the in vitro POD for calculation of human equivalent 
concentrations for the inhalation risk assessment. Chlorothalonil will 
be presented as a case study to solicit advice on the proposed overall 
approach expected to be applied to other pesticides or industrial 
chemicals in the future.
    The 4-day, in-person FIFRA SAP meeting may also be webcast. You may 
refer to the FIFRA SAP website at http://www.epa.gov/sap for 
information on how to access the webcast. Please note that the webcast 
for the in-person meeting is a supplementary public process provided 
only for convenience. If difficulties arise resulting in webcasting 
outages, the in-person meeting will continue as planned.

C. Virtual Preparatory Meeting

    Preceding the in-person meeting, there will be a half-day virtual 
preparatory meeting, conducted via webinar using Adobe Connect, to 
consider and review the clarity and scope of the meeting's draft charge 
questions. The virtual preparatory meeting will be webcast only, and 
registration is required to attend this virtual meeting. The date and 
registration instructions will be announced in a future Federal 
Register Notice and on the FIFRA SAP website (http://www.epa.gov/sap) 
by mid-September.

D. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, charge/questions to FIFRA SAP, and related 
supporting materials will be available by early September 2018. In 
addition, a list of candidates under consideration as prospective ad 
hoc panelists for this meeting will be available for a 15-day public 
comment period by early to mid-September 2018. You may obtain 
electronic copies of most meeting documents, including FIFRA SAP 
composition (i.e., members and ad hoc members for this meeting) and the 
meeting agenda, at http://www.regulations.gov and the FIFRA SAP website 
at http://www.epa.gov/scipoly/sap.
    FIFRA SAP will prepare the meeting minutes and final report 
approximately 90 calendar days after the in-person meeting. The meeting 
minutes and final report will be posted on the FIFRA SAP website: 
https://www.epa.gov/sap and may be accessed in the docket at https://www.regulations.gov.

    Authority:  7 U.S.C. 136 et. seq.; 21 U.S.C. 301 et seq.

    Dated: July 12, 2018.
Stanley Barone, Jr.,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2018-16990 Filed 8-7-18; 8:45 am]
 BILLING CODE 6560-50-P



                                                                                 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices                                                  39087

                                                                        TABLE—REGISTRATION REVIEW PROPOSED INTERIM DECISIONS BEING ISSUED—Continued
                                                        Registration review case name and number                                     Docket ID No.                Chemical review manager and contact information

                                                Gibberellins, Case 4110 ...................................................    EPA–HQ–OPP–2012–0939            Cody Kendrick, kendrick.cody@epa.gov, (703) 347–
                                                                                                                                                                  0468.
                                                Indole-3-Butyric Acid, Case 2330 .....................................         EPA–HQ–OPP–2010–0608            Seiichi Murasaki, murasaki.seiichi@epa.gov, (703)
                                                                                                                                                                  347–0163.
                                                Indoxacarb, Case 7613 ....................................................     EPA–HQ–OPP–2013–0367            Moana Appleyard, appleyard.moana@epa.gov, (703)
                                                                                                                                                                  308–8175.
                                                Methyl Eugenol, Case 6203 .............................................        EPA–HQ–OPP–2016–0173            Chris Pfeifer, pfeifer.chris@epa.gov, (703) 308–0031.
                                                Methyl Isopropenyl, Case 6090 ........................................         EPA–HQ–OPP–2017–0253            Alexandra Boukedes, boukedes.alexandra@epa.gov,
                                                                                                                                                                  (703) 347–0305.
                                                Naphthenate salts, Case 3099 .........................................         EPA–HQ–OPP–2010–0455            Rachel Ricciardi, ricciardi.rachel@epa.gov, (703) 347–
                                                                                                                                                                  0465.
                                                Nuranone, Case 4113 ......................................................     EPA–HQ–OPP–2012–0126            Seiichi Murasaki, murasaki.seiichi@epa.gov, (703)
                                                                                                                                                                  347–0163.
                                                Oxamyl, Case 0253 ..........................................................   EPA–HQ–OPP–2010–0028            Bilin Basu, basu.bilin@epa.gov, (703) 347–0455.
                                                Prometryn, Case 0467 ......................................................    EPA–HQ–OPP–2013–0032            Christina Scheltema, scheltema.christina@epa.gov,
                                                                                                                                                                  (703) 308–2201.
                                                Pyriproxyfen, Case 7424 ..................................................     EPA–HQ–OPP–2011–0677            Khue Nguyen, nguyen.khue@epa.gov, (703) 347–0248.
                                                Quillaja extract (Quillaja Saponins), Case 6512 ...............                EPA–HQ–OPP–2017–0230            Maggie Rudick, rudick.maggie@epa.gov, (703) 347–
                                                                                                                                                                  0257.
                                                Quinoa Saponins (Extract of Chenopodium Quinoa                                 EPA–HQ–OPP–2017–0274            Daniel Schoeff, schoeff.daniel@epa.gov, (703) 347–
                                                  Saponins), Case 6200.                                                                                           0143.
                                                Rhamnolipid biosurfactant, Case 6085 ............................              EPA–HQ–OPP–2017–0275            Cody Kendrick, kendrick.cody@epa.gov, (703) 347–
                                                                                                                                                                  0468.
                                                Salicylic Acid and Methyl Salicylate, Case 4080 ..............                 EPA–HQ–OPP–2017–0328            Maggie Rudick, rudick.maggie@epa.gov, (703) 347–
                                                                                                                                                                  0257.
                                                Trifloxystrobin, Case 7028 ................................................    EPA–HQ–OPP–2013–0074            Moana Appleyard, appleyard.moana@epa.gov, (703)
                                                                                                                                                                  308–8175.
                                                (Z)-9-tricosene (Muscalure), Case 4112 ...........................             EPA–HQ–OPP–2010–0925            Alexandra Boukedes, boukedes.alexandra@epa.gov,
                                                                                                                                                                  (703) 347–0305.



                                                  The registration review docket for a                           of the docket for the pesticides included              ENVIRONMENTAL PROTECTION
                                                pesticide includes earlier documents                             in the Table in Unit IV. Comments                      AGENCY
                                                related to the registration review case.                         received after the close of the comment
                                                For example, the review opened with a                            period will be marked ‘‘late.’’ EPA is not             [EPA–HQ–OPP–2018–0517; FRL–9980–76]
                                                Preliminary Work Plan, for public                                required to consider these late
                                                comment. A Final Work Plan was                                   comments.                                              FIFRA Scientific Advisory Panel;
                                                placed in the docket following public                                                                                   Notice of Public Meeting and Request
                                                                                                                   The Agency will carefully consider all
                                                comment on the Preliminary Work Plan.                                                                                   for Nomination of Ad Hoc Expert
                                                  The documents in the dockets                                   comments received by the closing date
                                                                                                                                                                        Members
                                                describe EPA’s rationales for conducting                         and may provide a ‘‘Response to
                                                additional risk assessments for the                              Comments Memorandum’’ in the                           AGENCY: Environmental Protection
                                                registration review of the pesticides                            docket. The interim registration review                Agency (EPA).
                                                included in the table in Unit IV, as well                        decision will explain the effect that any              ACTION: Notice.
                                                as the Agency’s subsequent risk findings                         comments had on the interim decision
                                                and consideration of possible risk                               and provide the Agency’s response to                   SUMMARY:   There will be a 4-day, in-
                                                mitigation measures. These proposed                              significant comments.                                  person meeting of the Federal
                                                interim registration review decisions are                          Background on the registration review                Insecticide, Fungicide, and Rodenticide
                                                supported by the rationales included in                          program is provided at: http://                        Act Scientific Advisory Panel (FIFRA
                                                those documents. Following public                                www.epa.gov/pesticide-reevaluation.                    SAP) to consider and review the
                                                comment, the Agency will issue interim                                                                                  Evaluation of a Proposed Approach to
                                                or final registration review decisions for                          Authority: 7 U.S.C. 136 et seq.                     Refine the Inhalation Risk Assessment
                                                the pesticides listed in the table in Unit                         Dated: July 16, 2018.                                for Point of Contact Toxicity: A Case
                                                IV.                                                              Yu-Ting Guilaran,                                      Study Using a New Approach
                                                  The registration review final rule at 40                       Director, Pesticide Re-Evaluation Division,            Methodology (NAM). Preceding the in-
                                                CFR 155.58(a) provides for a minimum                             Office of Pesticide Programs.                          person meeting, there will be a half-day
                                                60-day public comment period on all                              [FR Doc. 2018–16988 Filed 8–7–18; 8:45 am]
                                                                                                                                                                        virtual preparatory meeting, conducted
                                                proposed interim registration review                                                                                    via webinar using Adobe Connect, to
                                                                                                                 BILLING CODE 6560–50–P
                                                decisions. This comment period is                                                                                       consider and review the clarity and
                                                intended to provide an opportunity for                                                                                  scope of the meeting’s draft charge
sradovich on DSK3GMQ082PROD with NOTICES




                                                public input and a mechanism for                                                                                        questions. In addition, EPA is
                                                initiating any necessary amendments to                                                                                  requesting nominations of prospective
                                                the proposed interim decision. All                                                                                      candidates for service as ad hoc
                                                comments should be submitted using                                                                                      members of FIFRA SAP for this meeting.
                                                the methods in ADDRESSES, and must be                                                                                   Any interested person or organization
                                                received by EPA on or before the closing                                                                                may nominate qualified individuals to
                                                date. These comments will become part                                                                                   be considered as prospective candidates


                                           VerDate Sep<11>2014      22:37 Aug 07, 2018      Jkt 244001    PO 00000      Frm 00047   Fmt 4703   Sfmt 4703   E:\FR\FM\08AUN1.SGM   08AUN1


                                                39088                      Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices

                                                for this meeting by following the                       follow the instructions at http://                    written comments. FIFRA SAP may not
                                                instructions provided in this document.                 www.epa.gov/dockets/contacts.html.                    be able to fully consider written
                                                DATES:                                                    Additional information on                           comments submitted after October 19,
                                                   Meeting: The 4-day, in-person                        commenting or visiting the docket,                    2018.
                                                meeting will be held December 4 to                      along with more information about                        2. Oral comments. To be included on
                                                December 7, 2018, from approximately                    dockets generally, is available at http://            the meeting agenda, the Agency
                                                9 a.m. to 5 p.m.                                        www.epa.gov/dockets. For additional                   encourages each individual or group
                                                   Nominations: Nominations of                          instructions related to this meeting, see             wishing to make brief oral comments to
                                                candidates to serve as ad hoc members                   Unit I.C. of the SUPPLEMENTARY                        FIFRA SAP during the in-person or
                                                of the FIFRA SAP for this review should                 INFORMATION.                                          virtual meetings to submit their request
                                                be provided on or before September 7,                   FOR FURTHER INFORMATION CONTACT: Dr.
                                                                                                                                                              to the DFO listed under FOR FURTHER
                                                2018.                                                                                                         INFORMATION CONTACT on or before
                                                                                                        Marquea D. King, DFO, Office of
                                                   Special accommodations: Requests                     Science Coordination and Policy                       November 9, 2018. To the extent that
                                                for special accommodations should be                    (7201M), Environmental Protection                     time permits, the Chair of the FIFRA
                                                submitted on or before November 16,                     Agency, 1200 Pennsylvania Ave. NW,                    SAP may permit the presentation of oral
                                                2018, to allow EPA time to process your                                                                       comments at the meeting by interested
                                                                                                        Washington, DC 20460–0001; telephone
                                                request.                                                                                                      persons who have not previously
                                                                                                        number: 202–564–3626; email address:
                                                   Comments: Written comments should                                                                          requested time. Oral comments during
                                                                                                        king.marquea@epa.gov.
                                                be submitted on or before October 19,                                                                         the virtual meeting are limited to
                                                                                                        SUPPLEMENTARY INFORMATION:
                                                2018, and EPA encourages individuals                                                                          approximately 5 minutes due to the
                                                and groups that wish to make oral                       I. General Information                                time constraints of this webcast. Oral
                                                comments to submit the request to make                                                                        comments during the 4-day, in-person
                                                                                                        A. Does this action apply to me?                      meeting are limited to approximately 5
                                                oral comments by November 9, 2018.
                                                                                                           This action is directed to the public              minutes unless arrangements have been
                                                ADDRESSES:
                                                                                                        in general. This action may be of                     made prior to November 9, 2018. The
                                                   Meeting: The in-person meeting will                  interest to persons who are or may be                 request should identify the name of the
                                                be held at the Environmental Protection                 required to conduct testing of chemical               individual making the presentation, the
                                                Agency, Conference Center, Lobby                        substances under the Federal Food,                    organization (if any) the individual will
                                                Level, One Potomac Yard (South Bldg.),                  Drug, and Cosmetic Act (FFDCA) and                    represent, and any requirements for
                                                2777 S. Crystal Dr., Arlington, VA                      FIFRA. Since other entities may also be               audiovisual equipment. In addition,
                                                22202. The virtual meeting will be                      interested, the Agency has not                        each speaker should bring 15 copies of
                                                webcast. Please refer to the following                  attempted to describe all the specific                his or her oral remarks and presentation
                                                website for information on how to                       entities that may be affected by this                 slides (if required) for distribution to the
                                                access the webcast: http://www.epa.gov/                 action.                                               FIFRA SAP at the meeting by the DFO.
                                                sap.                                                                                                             3. Seating at the meeting. Seating at
                                                   Nominations: Submit nominations of                   B. What should I consider as I prepare                the in-person meeting will be open and
                                                candidates to serve as ad hoc members                   my comments for EPA?                                  on a first-come basis.
                                                of the FIFRA SAP Meeting to the DFO                       1. Submitting CBI. Do not submit CBI                   4. Request for nominations to serve as
                                                listed under FOR FURTHER INFORMATION                    information to EPA through                            ad hoc expert members of FIFRA SAP
                                                CONTACT.                                                regulations.gov or email. If your                     for this meeting. As part of a broader
                                                   Special accommodations: For                          comments contain any information that                 process for developing a pool of
                                                information on access or services for                   you consider to be CBI or otherwise                   candidates for each meeting, FIFRA SAP
                                                individuals with disabilities, and to                   protected, please contact the DFO listed              staff routinely solicits the stakeholder
                                                request accommodation for a disability,                 under FOR FURTHER INFORMATION                         community for nominations of
                                                please contact the Designated Federal                   CONTACT to obtain special instructions                prospective candidates for service as ad
                                                Official (DFO) listed under FOR FURTHER                 before submitting your comments.                      hoc members of FIFRA SAP. Any
                                                INFORMATION CONTACT.                                      2. Tips for preparing your comments.                interested person or organization may
                                                   Comments. Submit requests to present                 When preparing and submitting your                    nominate qualified individuals to be
                                                oral comments to the DFO listed under                   comments, see the commenting tips at                  considered as prospective candidates for
                                                FOR FURTHER INFORMATION CONTACT.                        http://www.epa.gov/dockets/                           a specific meeting. Individuals
                                                   Submit your written comments,                        comments.html.                                        nominated for this meeting should have
                                                identified by docket identification (ID)                                                                      expertise in one or more of the
                                                number EPA–HQ–OPP–2018–0517, by                         C. How may I participate in both                      following areas: (i) Development and
                                                one of the following methods:                           meetings?                                             implementation of new approach
                                                   • Federal eRulemaking Portal: http://                  You may participate in both meetings                methodologies (NAMs); (ii) inhalation
                                                www.regulations.gov. Follow the online                  by following the instructions in this                 alternative testing; (iii) inhalation
                                                instructions for submitting comments.                   unit. To ensure proper receipt of                     toxicology; (iv) inhalation exposure
                                                Do not electronically submit any                        comments, nominations or other                        assessment; (v) inhalation/
                                                information you consider to be                          requests by EPA, it is imperative that                computational fluid dynamic (CFD)
                                                Confidential Business Information (CBI)                 you identify docket ID number EPA–                    modeling; and (vi) risk assessment.
                                                or other information whose disclosure is                HQ–OPP–2018–0517 in the subject line                  Nominees should be scientists who have
                                                restricted by statute.                                                                                        sufficient professional qualifications,
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                                                                                                        on the first page of your request.
                                                   • Mail: OPP Docket, Environmental                      1. Written comments. Written                        including training and experience, to
                                                Protection Agency Docket Center (EPA/                   comments for both the in-person and                   provide expert comments on the
                                                DC), (28221T), 1200 Pennsylvania Ave.                   virtual meetings should be submitted,                 scientific issues for this meeting.
                                                NW, Washington, DC 20460–0001.                          using the instructions in ADDRESSES and               Nominees should be identified by name,
                                                   • Hand Delivery: To make special                     Unit I.B., on or before October 19, 2018,             occupation, position, address, email
                                                arrangements for hand delivery or                       to provide FIFRA SAP the time                         address, and telephone number.
                                                delivery of boxed information, please                   necessary to consider and review the                  Nominations should be provided to the


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                                                                           Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices                                            39089

                                                DFO listed under FOR FURTHER                            candidate is considered further for                   requirements (OPPTS 870.3465, 40 CFR
                                                INFORMATION CONTACT on or before                        service on FIFRA SAP. Those who are                   part 798, OECD TG 412 and 413). In
                                                September 7, 2018. The Agency will                      selected from the pool of prospective                 these studies, several groups of
                                                consider all nominations of prospective                 candidates will be asked to attend the                experimental animals are exposed daily
                                                candidates for this meeting that are                    public meetings and to participate in the             for a defined period to graduated
                                                received on or before that date.                        discussion of key issues and                          concentrations of test substance as a gas
                                                However, final selection of ad hoc                      assumptions at these meetings. In                     or aerosol/particulate. These studies are
                                                members for this meeting is a                           addition, they will be asked to review                used to determine a no observed adverse
                                                discretionary function of the Agency.                   and to help finalize the meeting minutes              effect concentration (NOAEC) for effects
                                                  The selection of scientists to serve on               and final report. The list of FIFRA SAP               following repeated inhalation exposure
                                                FIFRA SAP is based on the function of                   members participating at this meeting                 that may be used for human health risk
                                                the Panel and the expertise needed to                   will be posted on the FIFRA SAP                       assessment.
                                                address the Agency’s charge to the                      website at http://www.epa.gov/scipoly/                   The anatomy and physiology of
                                                Panel. No interested scientists shall be                sap or may be obtained from the OPP                   human and animal respiratory tracts
                                                ineligible to serve by reason of their                  Docket at http://www.regulations.gov.                 differ in several ways that can impact
                                                membership on any other advisory                                                                              changes in airflow and deposition of
                                                committee to a Federal department or                    II. Background                                        inhaled substances and, therefore,
                                                agency or their employment by a                         A. Purpose of FIFRA SAP                               influence the animal to human dose
                                                Federal department or agency, except                                                                          response extrapolation. Furthermore,
                                                EPA. Other factors considered during                       The FIFRA SAP serves as one of the                 traditional in vivo toxicity tests used to
                                                the selection process include                           primary scientific peer review                        extrapolate from test species to humans
                                                availability of the potential Panel                     mechanisms of EPA’s Office of                         are expensive, time-consuming, and can
                                                member to fully participate in the                      Chemical Safety and Pollution                         cause stress to laboratory animals. As a
                                                Panel’s review, absence of any conflicts                Prevention (OCSPP) and is structured to               result, efforts to develop alternative
                                                of interest or appearance of loss of                    provide independent scientific advice,                methods and strategies for evaluating
                                                impartiality, independence with respect                 information and recommendations to                    toxic effects from inhaled chemicals
                                                to the matters under review, and lack of                the EPA Administrator on pesticides                   using in vitro test systems with human
                                                bias. Although financial conflicts of                   and pesticide-related issues as to the                tissues combined with human
                                                interest, the appearance of loss of                     impact of regulatory actions on human                 dosimetry modeling provide inherent
                                                impartiality, lack of independence, and                 health and the environment. FIFRA SAP                 advantages over using in vivo animal
                                                bias may result in disqualification, the                is a Federal advisory committee                       studies. These alternatives are also
                                                absence of such concerns does not                       established in 1975 under FIFRA that                  consistent with the National Research
                                                assure that a candidate will be selected                operates in accordance with                           Council’s (NRC) long-range vision to
                                                to serve on FIFRA SAP. Numerous                         requirements of the Federal Advisory                  advance toxicity testing in the 21st
                                                qualified candidates are identified for                 Committee Act (5 U.S.C. Appendix).                    century, as well as the strategic roadmap
                                                each Panel; therefore, selection                        The FIFRA SAP is composed of a                        released by Interagency Coordinating
                                                decisions involve carefully weighing a                  permanent panel consisting of seven                   Committee on the Validation of
                                                number of factors, including the                        members who are appointed by the EPA                  Alternative Methods (ICCVAM) to
                                                candidates’ areas of expertise and                      Administrator from nominees provided                  accomplish NRC’s vision in the United
                                                professional qualifications and                         by the National Institutes of Health                  States.
                                                achieving an overall balance of different               (NIH) and the National Science                           New approach methodologies (NAMs)
                                                scientific perspectives on the Panel. In                Foundation (NSF). FIFRA established a                 has been adopted as a broadly
                                                order to have the collective breadth of                 Science Review Board (SRB) consisting                 descriptive reference to any non-animal
                                                experience needed to address the                        of at least 60 scientists who are available           technology, methodology, approach, or
                                                Agency’s peer review charge for this                    to FIFRA SAP on an ad hoc basis to                    combination thereof that can be used to
                                                meeting, the Agency anticipates                         assist in reviews conducted by FIFRA                  provide information on chemical hazard
                                                selecting approximately 13 ad hoc                       SAP. As a scientific peer review                      and risk assessment. An example of a
                                                scientists.                                             mechanism, FIFRA SAP provides                         NAM for refining inhalation risk
                                                  FIFRA SAP members are subject to                      comments, evaluations, and                            assessment has been submitted to the
                                                the provisions of 5 CFR part 2634—                      recommendations to improve the                        Agency for the pesticide chlorothalonil.
                                                Executive Branch Financial Disclosure,                  effectiveness and quality of analyses                 Chlorothalonil is a contact irritant that
                                                Qualified Trusts, and Certificates of                   made by Agency scientists. Members of                 has been found to be toxic via the
                                                Divestiture, as supplemented by EPA in                  FIFRA SAP are scientists who have                     inhalation route. Due to the irritant
                                                5 CFR part 6401. In anticipation of this                sufficient professional qualifications,               nature of chlorothalonil and animal
                                                requirement, prospective candidates for                 including training and experience, to                 welfare concerns, the registrant
                                                service on FIFRA SAP will be asked to                   provide expert advice and                             (Syngenta Crop Protection) indicated
                                                submit confidential financial                           recommendation to the Agency.                         that a 90-day inhalation toxicity study
                                                information which shall fully disclose,                                                                       was not feasible to fulfill the regulatory
                                                among other financial interests, the                    B. Public Meeting                                     requirement of a subchronic inhalation
                                                candidate’s employment, stocks, and                       EPA conducts human health risk                      study. Subsequently, Syngenta proposed
                                                bonds, and where applicable, sources of                 assessments to evaluate the potential                 an alternative approach using an in vitro
                                                                                                        health effects of pesticides and toxic
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                                                research support. EPA will evaluate the                                                                       assay (MucilAirTM using human nasal
                                                candidate’s financial disclosure form to                chemicals in residential and                          tissue) to characterize the hazard of
                                                assess whether there are financial                      occupational settings based on the use                chlorothalonil and derive a point of
                                                conflicts of interest, appearance of a loss             pattern or conditions of use. For                     departure (POD) for use in human
                                                of impartiality, or any prior involvement               evaluating effects via the inhalation                 health risk assessment. In order to
                                                with the development of the documents                   route, registrants and manufacturers                  calculate human equivalent
                                                under consideration (including previous                 conduct subchronic inhalation toxicity                concentrations for the purposes of
                                                scientific peer review) before the                      studies according to test guideline                   human health risk assessment, an in


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                                                39090                      Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices

                                                vitro POD has been proposed in                          SAP website at http://www.epa.gov/                       Frequency of Response: On occasion,
                                                conjunction with surface concentrations                 scipoly/sap.                                          quarterly and annual reporting
                                                of deposited chlorothalonil particles                     FIFRA SAP will prepare the meeting                  requirements, recordkeeping
                                                from a computational fluid dynamic                      minutes and final report approximately                requirement and third party disclosure
                                                (CFD) model for the upper airway of a                   90 calendar days after the in-person                  requirement.
                                                human. As a proof of concept, Syngenta                  meeting. The meeting minutes and final                   Obligation to Respond: Required to
                                                also used the calculated human                          report will be posted on the FIFRA SAP                obtain or retain benefits. Statutory
                                                equivalent concentrations for pesticide                 website: https://www.epa.gov/sap and                  authority for this information collection
                                                operators/applicators to provide                        may be accessed in the docket at https://             is contained in 47 U.S.C. 151–154, 155,
                                                potential risk estimates supported by                   www.regulations.gov.                                  201–206, 214, 218–220, 251, 252, 254,
                                                this proposed approach.                                   Authority: 7 U.S.C. 136 et. seq.; 21 U.S.C.         256, 303(r), 332, 403, 405, 410, and
                                                   The Agency is soliciting advice from                 301 et seq.                                           1302.
                                                the FIFRA Scientific Advisory Panel                                                                              Total Annual Burden: 63,486 hours.
                                                                                                          Dated: July 12, 2018.                                  Total Annual Cost: No cost.
                                                (SAP) on the derivation of the POD from
                                                                                                        Stanley Barone, Jr.,                                     Privacy Act Impact Assessment: No
                                                the in vitro assay and the integration of
                                                the in vitro POD for calculation of                     Acting Director, Office of Science                    impact(s).
                                                                                                        Coordination and Policy.                                 Nature and Extent of Confidentiality:
                                                human equivalent concentrations for the
                                                inhalation risk assessment.                             [FR Doc. 2018–16990 Filed 8–7–18; 8:45 am]            The Commission notes that USAC must
                                                Chlorothalonil will be presented as a                   BILLING CODE 6560–50–P                                preserve the confidentiality of all data
                                                case study to solicit advice on the                                                                           obtained from respondents; must not
                                                proposed overall approach expected to                                                                         use the data except for purposes of
                                                be applied to other pesticides or                       FEDERAL COMMUNICATIONS                                administering the universal service
                                                industrial chemicals in the future.                     COMMISSION                                            programs; and must not disclose data in
                                                   The 4-day, in-person FIFRA SAP                                                                             company-specific form unless directed
                                                meeting may also be webcast. You may                    Information Collection Approved by                    to do so by the Commission. Privately-
                                                refer to the FIFRA SAP website at http://               the Office of the Management and                      held rate-of-return carriers may file the
                                                www.epa.gov/sap for information on                      Budget (OMB)                                          financial information they disclose in
                                                how to access the webcast. Please note                                                                        FCC Form 481 pursuant to a protective
                                                                                                        AGENCY: Federal Communications
                                                that the webcast for the in-person                                                                            order.
                                                                                                        Commission.                                              Needs and Uses: The Commission
                                                meeting is a supplementary public                       ACTION: Notice.
                                                process provided only for convenience.                                                                        received OMB approval for this revised
                                                If difficulties arise resulting in                      SUMMARY:    The Federal Communications                information collection. On July 7, 2017,
                                                webcasting outages, the in-person                       Commission has received Office of                     the Commission released Connect
                                                meeting will continue as planned.                       Management and Budget (OMB)                           America Fund; ETC Annual Reports and
                                                                                                        approval for a revised information                    Certifications, WC Docket Nos. 10–90
                                                C. Virtual Preparatory Meeting                                                                                and 14–58, Order, FCC 17–87 (ETC
                                                                                                        collection pursuant to the Paperwork
                                                  Preceding the in-person meeting,                      Reduction Act (PRA) of 1995. An agency                Reporting Streamlining Order), which
                                                there will be a half-day virtual                        may not conduct or sponsor a collection               streamlined the annual reporting
                                                preparatory meeting, conducted via                      of information unless it displays a                   requirements for eligible
                                                webinar using Adobe Connect, to                         currently valid OMB control number,                   telecommunications carriers (ETCs) that
                                                consider and review the clarity and                     and no person is required to respond to               receive high-cost universal service
                                                scope of the meeting’s draft charge                     a collection of information unless it                 support by eliminating several rules that
                                                questions. The virtual preparatory                      displays a currently valid OMB control                are either duplicative of other reporting
                                                meeting will be webcast only, and                       number. Comments concerning the                       requirements or are simply no longer
                                                registration is required to attend this                 accuracy of the burden estimates and                  necessary. In doing this, the
                                                virtual meeting. The date and                           any suggestions for reducing the burden               Commission reduced ETCs’ regulatory
                                                registration instructions will be                       should be directed to the person listed               burdens while strengthening the tools
                                                announced in a future Federal Register                  in the FOR FURTHER INFORMATION                        for program oversight in furtherance of
                                                Notice and on the FIFRA SAP website                     CONTACT section below.                                our goal of protecting the high cost
                                                (http://www.epa.gov/sap) by mid-                        FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                              universal support program against
                                                September.                                              Nicole Ongele, Office of the Managing                 waste, fraud, and abuse. Specifically,
                                                                                                        Director, at (202) 418–2991, or via                   the Commission eliminated its annual
                                                D. FIFRA SAP Documents and Meeting                                                                            high-cost reporting rules regarding
                                                Minutes                                                 email: Nicole.Ongele@fcc.gov.
                                                                                                                                                              network outage information, unfulfilled
                                                   EPA’s background paper, charge/                      SUPPLEMENTARY INFORMATION:
                                                                                                                                                              service requests, the number of
                                                questions to FIFRA SAP, and related                       OMB Control Number: 3060–0986.
                                                                                                          OMB Approval Date: July 2, 2018.                    complaints received by an ETC per
                                                supporting materials will be available                    OMB Expiration Date: July 31, 2021.                 1,000 subscribers for both voice and
                                                by early September 2018. In addition, a                   Title: High-Cost Universal Service                  broadband services, pricing for voice
                                                list of candidates under consideration as               Support.                                              and broadband services, service quality
                                                prospective ad hoc panelists for this                     Form Numbers: FCC Form 481 and                      certification, and duplicate filing of the
                                                meeting will be available for a 15-day                  FCC Form 525.                                         FCC Form 481 without compromising
                                                public comment period by early to mid-
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                                                                                                          Respondents: Business or other for-                 its ability to monitor whether ETCs are
                                                September 2018. You may obtain                          profit, not-for-profit institutions and               using high-cost universal service
                                                electronic copies of most meeting                       state, local or tribal government.                    support for its intended purpose,
                                                documents, including FIFRA SAP                            Number of Respondents and                           adopted in the ETC Reporting
                                                composition (i.e., members and ad hoc                   Responses: 1,877 respondents; 14,335                  Streamlining Order.
                                                members for this meeting) and the                       responses.                                               This revised information collection
                                                meeting agenda, at http://                                Estimated Time per Response: 0.5–15                 addresses the removal of those
                                                www.regulations.gov and the FIFRA                       hours.                                                duplicative or otherwise unnecessary


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Document Created: 2018-08-08 02:06:26
Document Modified: 2018-08-08 02:06:26
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.
DatesMeeting: The 4-day, in-person meeting will be held December 4 to December 7, 2018, from approximately 9 a.m. to 5 p.m.
ContactDr. Marquea D. King, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
FR Citation83 FR 39087 

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