FIFRA Scientific Advisory Panel; Notice of Public Meeting and Request for Nomination of Ad Hoc Expert Members, 39087-39090 [2018-16990]
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Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices
39087
TABLE—REGISTRATION REVIEW PROPOSED INTERIM DECISIONS BEING ISSUED—Continued
Docket ID No.
Chemical review manager and contact information
Gibberellins, Case 4110 ...................................................
EPA–HQ–OPP–2012–0939
Indole-3-Butyric Acid, Case 2330 .....................................
EPA–HQ–OPP–2010–0608
Indoxacarb, Case 7613 ....................................................
EPA–HQ–OPP–2013–0367
Methyl Eugenol, Case 6203 .............................................
Methyl Isopropenyl, Case 6090 ........................................
EPA–HQ–OPP–2016–0173
EPA–HQ–OPP–2017–0253
Naphthenate salts, Case 3099 .........................................
EPA–HQ–OPP–2010–0455
Nuranone, Case 4113 ......................................................
EPA–HQ–OPP–2012–0126
Oxamyl, Case 0253 ..........................................................
Prometryn, Case 0467 ......................................................
EPA–HQ–OPP–2010–0028
EPA–HQ–OPP–2013–0032
Pyriproxyfen, Case 7424 ..................................................
Quillaja extract (Quillaja Saponins), Case 6512 ...............
EPA–HQ–OPP–2011–0677
EPA–HQ–OPP–2017–0230
Quinoa Saponins (Extract of Chenopodium Quinoa
Saponins), Case 6200.
Rhamnolipid biosurfactant, Case 6085 ............................
EPA–HQ–OPP–2017–0274
EPA–HQ–OPP–2017–0275
Salicylic Acid and Methyl Salicylate, Case 4080 ..............
EPA–HQ–OPP–2017–0328
Trifloxystrobin, Case 7028 ................................................
EPA–HQ–OPP–2013–0074
(Z)-9-tricosene (Muscalure), Case 4112 ...........................
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Registration review case name and number
EPA–HQ–OPP–2010–0925
Cody Kendrick, kendrick.cody@epa.gov, (703) 347–
0468.
Seiichi Murasaki, murasaki.seiichi@epa.gov, (703)
347–0163.
Moana Appleyard, appleyard.moana@epa.gov, (703)
308–8175.
Chris Pfeifer, pfeifer.chris@epa.gov, (703) 308–0031.
Alexandra Boukedes, boukedes.alexandra@epa.gov,
(703) 347–0305.
Rachel Ricciardi, ricciardi.rachel@epa.gov, (703) 347–
0465.
Seiichi Murasaki, murasaki.seiichi@epa.gov, (703)
347–0163.
Bilin Basu, basu.bilin@epa.gov, (703) 347–0455.
Christina Scheltema, scheltema.christina@epa.gov,
(703) 308–2201.
Khue Nguyen, nguyen.khue@epa.gov, (703) 347–0248.
Maggie Rudick, rudick.maggie@epa.gov, (703) 347–
0257.
Daniel Schoeff, schoeff.daniel@epa.gov, (703) 347–
0143.
Cody Kendrick, kendrick.cody@epa.gov, (703) 347–
0468.
Maggie Rudick, rudick.maggie@epa.gov, (703) 347–
0257.
Moana Appleyard, appleyard.moana@epa.gov, (703)
308–8175.
Alexandra Boukedes, boukedes.alexandra@epa.gov,
(703) 347–0305.
The registration review docket for a
pesticide includes earlier documents
related to the registration review case.
For example, the review opened with a
Preliminary Work Plan, for public
comment. A Final Work Plan was
placed in the docket following public
comment on the Preliminary Work Plan.
The documents in the dockets
describe EPA’s rationales for conducting
additional risk assessments for the
registration review of the pesticides
included in the table in Unit IV, as well
as the Agency’s subsequent risk findings
and consideration of possible risk
mitigation measures. These proposed
interim registration review decisions are
supported by the rationales included in
those documents. Following public
comment, the Agency will issue interim
or final registration review decisions for
the pesticides listed in the table in Unit
IV.
The registration review final rule at 40
CFR 155.58(a) provides for a minimum
60-day public comment period on all
proposed interim registration review
decisions. This comment period is
intended to provide an opportunity for
public input and a mechanism for
initiating any necessary amendments to
the proposed interim decision. All
comments should be submitted using
the methods in ADDRESSES, and must be
received by EPA on or before the closing
date. These comments will become part
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of the docket for the pesticides included
in the Table in Unit IV. Comments
received after the close of the comment
period will be marked ‘‘late.’’ EPA is not
required to consider these late
comments.
The Agency will carefully consider all
comments received by the closing date
and may provide a ‘‘Response to
Comments Memorandum’’ in the
docket. The interim registration review
decision will explain the effect that any
comments had on the interim decision
and provide the Agency’s response to
significant comments.
Background on the registration review
program is provided at: https://
www.epa.gov/pesticide-reevaluation.
Authority: 7 U.S.C. 136 et seq.
Dated: July 16, 2018.
Yu-Ting Guilaran,
Director, Pesticide Re-Evaluation Division,
Office of Pesticide Programs.
[FR Doc. 2018–16988 Filed 8–7–18; 8:45 am]
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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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
There will be a 4-day, inperson 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 inperson 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
SUMMARY:
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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: https://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: https://
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
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follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional information on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
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:
king.marquea@epa.gov.
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
https://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
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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
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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
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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 https://www.epa.gov/scipoly/
sap or may be obtained from the OPP
Docket at https://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
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39089
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
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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 https://
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.
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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
(https://www.epa.gov/sap) by midSeptember.
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 midSeptember 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 https://
www.regulations.gov and the FIFRA
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SAP website at https://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]
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FEDERAL COMMUNICATIONS
COMMISSION
Information Collection Approved by
the Office of the Management and
Budget (OMB)
Federal Communications
Commission.
ACTION: Notice.
AGENCY:
The Federal Communications
Commission has received Office of
Management and Budget (OMB)
approval for a revised information
collection pursuant to the Paperwork
Reduction Act (PRA) of 1995. An agency
may not conduct or sponsor a collection
of information unless it displays a
currently valid OMB control number,
and no person is required to respond to
a collection of information unless it
displays a currently valid OMB control
number. Comments concerning the
accuracy of the burden estimates and
any suggestions for reducing the burden
should be directed to the person listed
in the FOR FURTHER INFORMATION
CONTACT section below.
FOR FURTHER INFORMATION CONTACT:
Nicole Ongele, Office of the Managing
Director, at (202) 418–2991, or via
email: Nicole.Ongele@fcc.gov.
SUPPLEMENTARY INFORMATION:
OMB Control Number: 3060–0986.
OMB Approval Date: July 2, 2018.
OMB Expiration Date: July 31, 2021.
Title: High-Cost Universal Service
Support.
Form Numbers: FCC Form 481 and
FCC Form 525.
Respondents: Business or other forprofit, not-for-profit institutions and
state, local or tribal government.
Number of Respondents and
Responses: 1,877 respondents; 14,335
responses.
Estimated Time per Response: 0.5–15
hours.
SUMMARY:
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Frequency of Response: On occasion,
quarterly and annual reporting
requirements, recordkeeping
requirement and third party disclosure
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Obligation to Respond: Required to
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authority for this information collection
is contained in 47 U.S.C. 151–154, 155,
201–206, 214, 218–220, 251, 252, 254,
256, 303(r), 332, 403, 405, 410, and
1302.
Total Annual Burden: 63,486 hours.
Total Annual Cost: No cost.
Privacy Act Impact Assessment: No
impact(s).
Nature and Extent of Confidentiality:
The Commission notes that USAC must
preserve the confidentiality of all data
obtained from respondents; must not
use the data except for purposes of
administering the universal service
programs; and must not disclose data in
company-specific form unless directed
to do so by the Commission. Privatelyheld rate-of-return carriers may file the
financial information they disclose in
FCC Form 481 pursuant to a protective
order.
Needs and Uses: The Commission
received OMB approval for this revised
information collection. On July 7, 2017,
the Commission released Connect
America Fund; ETC Annual Reports and
Certifications, WC Docket Nos. 10–90
and 14–58, Order, FCC 17–87 (ETC
Reporting Streamlining Order), which
streamlined the annual reporting
requirements for eligible
telecommunications carriers (ETCs) that
receive high-cost universal service
support by eliminating several rules that
are either duplicative of other reporting
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Commission reduced ETCs’ regulatory
burdens while strengthening the tools
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our goal of protecting the high cost
universal support program against
waste, fraud, and abuse. Specifically,
the Commission eliminated its annual
high-cost reporting rules regarding
network outage information, unfulfilled
service requests, the number of
complaints received by an ETC per
1,000 subscribers for both voice and
broadband services, pricing for voice
and broadband services, service quality
certification, and duplicate filing of the
FCC Form 481 without compromising
its ability to monitor whether ETCs are
using high-cost universal service
support for its intended purpose,
adopted in the ETC Reporting
Streamlining Order.
This revised information collection
addresses the removal of those
duplicative or otherwise unnecessary
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[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39087-39090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
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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
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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: https://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: https://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 https://www.epa.gov/dockets/contacts.html.
Additional information on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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 https://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
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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 https://www.epa.gov/scipoly/sap or may be obtained from the OPP Docket at https://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
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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 https://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 (https://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 https://www.regulations.gov and the FIFRA SAP website
at https://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
