FIFRA Scientific Advisory Panel; Notice of Public Meeting and Request for Nomination of Ad Hoc Expert Members, 9307-9310 [2018-04418]
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Federal Register / Vol. 83, No. 43 / Monday, March 5, 2018 / Notices
permissive. Sources are not required to
employ such a method but may choose
to do so in appropriate circumstances.
As per section 63.7(f)(5), however, a
source owner or operator electing to use
an alternative method for 40 CFR part
63 standards must continue to use the
alternative method until otherwise
authorized. Source owners or operators
should, therefore, review the specific
broadly applicable alternative method
approval decision at https://
www.epa.gov/emc/broadly-applicableapproved-alternative-test-methods
before electing to employ any
alternative method.
III. Approved Alternative Test Methods
and Modifications to Test Methods
This notice specifies three broadly
applicable alternative test methods that
the EPA approved between January 1,
2017, and December 1, 2017. The
alternative method decision letter/
memo number, the reference method
affected, sources allowed to use this
alternative, and the modification or
alternative method allowed are
summarized in Table 1 of this notice. A
summary of approval documents was
previously made available on our
Technology Transfer Network between
January 1, 2017, and December 31, 2017.
For more detailed information, please
refer to the complete copies of these
approval documents available at https://
www.epa.gov/emc/broadly-applicableapproved-alternative-test-methods.
As also explained in our January 30,
2007, notice, we will revisit approvals
of alternative test methods in response
to written requests or objections
9307
indicating that a particular approved
alternative test method either should
not be broadly applicable or that its use
should in some way be limited. Any
objection to a broadly applicable
alternative test method, as well as the
resolution of that objection, will be
announced at https://www.epa.gov/emc/
broadly-applicable-approvedalternative-test-methods and in a
subsequent Federal Register notice. If
we decide to retract a broadly applicable
test method, we will likely consider the
need for an appropriate transition
period for users either to request caseby-case approval or to transition to an
approved method.
Dated: February 13, 2018.
Panagiotis E. Tsirigotis,
Director, Office of Air Quality Planning and
Standards.
TABLE 1—APPROVED ALTERNATIVE TEST METHODS AND MODIFICATIONS TO TEST METHODS REFERENCED IN OR PUBLISHED UNDER APPENDICES IN 40 CFR PARTS 60, 61, AND 63 POSTED BETWEEN JANUARY 2017 AND DECEMBER
2017.
Alternative
method decision
letter/memo
number
As an alternative or modification
to . . .
For . . .
You may . . .
ALT–120 ...........
40 CFR 63.1350(k)(2)(ii) and (iii)
Sources subject to 40 CFR part 63, subpart
LLL-National Emission Standards for
Hazardous Air Pollutants from the Portland Cement Manufacturing Industry.
ALT–121 ...........
Method 3-Gas Analysis for the
Determination of Dry Molecular Weight.
ALT–122 ...........
Method 325 A-Volatile Organic
Compounds From Fugitive
and Area Sources: Sampler
Deployment and VOC Sample
Collection and Method 325BVolatile Organic Compounds
From Fugitive and Area
Sources: Sampler Preparation
and Analysis.
Sources subject to 40 CFR part 60, subpart
Ja-Standards of Performance for Petroleum Refineries for Which Construction,
Reconstruction, or Modification Commenced After May 14, 2007.
Sources subject to 40 CFR part 63, subpart
CC-National Emission Standards for Hazardous Air Pollutants From Petroleum
Refineries.
Use the alternative procedure for above
span mercury calibrations through January 1, 2019, only as specified in the
Agency’s approval letter dated December
7, 2017.
Use Method 3A-Determination of Oxygen
and Carbon Dioxide Concentrations in
Emissions From Stationary Sources (Instrumental Analyzer Procedures).
Use the alternative approaches for temperature and pressure corrections, sample collection timing, and duplicate and
field blank samples as specified in the
Agency’s approval letter dated September 11, 2017.
Source owners or operators should review the specific broadly applicable alternative method approval letter at https://www.epa.gov/emc/
broadly-applicable-approved-alternative-test-methods before electing to employ it.
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
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[EPA–HQ–OPP–2017–0617; FRL–9971–35]
FIFRA Scientific Advisory Panel;
Notice of Public Meeting and Request
for Nomination of Ad Hoc Expert
Members
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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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
Resistance of Lepidopteran Pests to
Bacillus thuringiensis (Bt) Plant
Incorporated Protectants in The United
States: EPA’s Analysis of Scientific
Uncertainties Related to Resistance
Management and Options to Enhance
the Current Insect Resistance
Management Program. Preceding the inperson meeting, there will be a half-day
virtual preparatory meeting, conducted
via webinar using Adobe Connect, to
SUMMARY:
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consider and review the clarity and
scope of the meeting’s draft charge
questions. Registration is required to
attend this virtual meeting. The date
and registration instructions will be on
the FIFRA SAP website https://
www.epa.gov/sap by mid-March to early
April.
The virtual preparatory meeting
will be announced in a future Federal
Register Notice and on https://
www.epa.gov/sap. The 4-day, in-person
meeting will be held July 17 to July 20,
2018, from approximately 9 a.m. to 5
p.m.
DATES:
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Meeting: The location of the
4-day, in-person meeting will be
announced in a future Federal Register
Notice and on https://www.epa.gov/sap.
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.
Comments. Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0617, 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 instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
How to submit nominations, requests
to present oral comments, and requests
for special accommodations. Submit
nominations of candidates to serve as ad
hoc members of the FIFRA SAP
Meeting, requests for special
accommodations, or requests to present
oral comments to the DFO listed under
FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT:
Tamue L. Gibson, DFO, Office of
Science Coordination and Policy
(7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: 202–564–7642; email address:
gibson.tamue@epa.gov.
Comments. Written comments should
be submitted for both the virtual
preparatory meeting and the in-person
meeting on or before May 10, 2018.
FIFRA SAP may not be able to fully
consider written comments submitted
after May 10, 2018. Requests to make
oral comments should be submitted on
or before May 24, 2018 by contacting the
Designated Federal Official (DFO) listed
under FOR FURTHER INFORMATION
CONTACT. You may also subscribe to the
following listservs to be notified when
notices regarding this and other SAP
related activities are published. https://
public.govdelivery.com/accounts/
USAEPAOPPT/subscriber/new?topic_
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ADDRESSES:
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id=USAEPAOPPT_101, https://
public.govdelivery.com/accounts/
USAEPAOPPT/subscribers/qualify. For
additional instructions, see Unit I.C. of
the SUPPLEMENTARY INFORMATION.
Nominations. Nominations of
candidates to serve as ad hoc members
of FIFRA SAP for this review should be
provided on or before April 4, 2018.
More information can be found under
unit I.C.4., Request for nominations to
serve as ad hoc expert members of
FIFRA SAP for this meeting.
Webcast. The virtual preparatory
meeting will be webcast only and
registration is required. Please refer to
the following website for information on
how to access the webcast: https://
www.epa.gov/sap. The 4-day, in-person
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.
Special accommodations. For
information on access or services for
individuals with disabilities, and to
request accommodation for a disability,
please contact the DFO listed under FOR
FURTHER INFORMATION CONTACT at least
10 days prior to the meeting to allow
EPA time to process your request.
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
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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–2017–0617 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 May 10, 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 May 10, 2018.
2. Oral comments. 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 May
24, 2018, to be included on the meeting
agenda. Requests to present oral
comments during the in-person meeting
will be accepted until the date of the
meeting and, to the extent that time
permits, the Chair of 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 May 24, 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
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
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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: Field entomologists
with expertise in the southern United
States (U.S.) corn and cotton systems
who are either corn earworm/bollworm
(both systems), fall armyworm, and/or
western bean cutworm experts;
pesticide resistance modelers with a
strong background in entomology,
ecology, and population biology; insect
resistance management experts;
population biologists understanding the
life-history of corn earworm/bollworm,
fall armyworm, and/or western bean
cutworm; corn breeders, molecular
biologists in the field of entomology
with an understanding of the
agricultural system in the southern U.S.;
social scientists with expertise in
resistance management issues and
understanding of dynamics in the
agricultural U.S. (e.g., human and
market factors); and economists with
expertise in the U.S. agricultural system
and Bt technology-related issues.
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
DFO listed under FOR FURTHER
INFORMATION CONTACT on or before April
4, 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
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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
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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
The purpose of the July 2018 SAP is
for the Agency to present major risk
factors believed responsible for
expediting lepidopteran adaptation to Bt
toxins in the U.S. and associated
scientific uncertainties. Furthermore,
the Agency will discuss identified
shortcomings of the current insect
sampling methodologies, rearing and
resistance testing of populations and the
feasibility of successful mitigation when
resistance is confirmed. In addition, the
meeting serves to assess whether it is
warranted scientifically to develop a
resistance management plan for western
bean cutworm. The overall goal of the
meeting is to receive recommendations
that reduce the resistance risks for
lepidopteran pests, increase the
longevity of currently functional Bt
traits and future technologies, and
improve the current insect resistance
management program for lepidopteran
pests of Bt corn and cotton.
Lepidopteran resistance to Bacillus
thuringiensis (Bt) traits of corn and
cotton were published by academic
scientists for the continental U.S. in
2014 for the fall armyworm (Spodoptera
frugiperda), in 2016 for the corn
earworm (Helicoverpa zea), and in 2017
for the western bean cutworm
(Striacosta albicosta). Likewise,
industry reported resistance for the
southwestern corn borer (Diatraea
grandiosella) in their resistance
monitoring reports to the U.S. EPA in
2016. The Agency identified several risk
factors that may have had the greatest
impact on these resistance
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developments. Some of these are: (1)
Lack of high dose traits; (2) use of single
modes of action possible year-after-year;
(3) corn seed blends in the southern
U.S.; (4) poor refuge compliance for Bt
corn in southern states; (5) continuous
selection with same traits expressed in
Bt corn and Bt cotton in a given year;
(6) methodological approaches with
monitoring for resistant field
populations; and (7) challenges with
identifying resistance using diet
bioassays for non-high-dose pests. The
Agency will discuss its analysis of
identified risk factors underlying
lepidopteran resistance development in
the U.S. as well as associated scientific
uncertainties. Furthermore, the Agency
will discuss its analysis of
methodological issues with collecting
insects from the field, rearing and
testing populations for resistance, and
the feasibility of mitigating field
resistance for Lepidopteran pests.
C. FIFRA SAP Documents and Meeting
Minutes
EPA’s background paper, charge/
questions to FIFRA SAP, and related
supporting materials will be available
by mid to late March 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 late March to
early April 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.
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Authority: 7 U.S.C. 136 et. seq.; 21 U.S.C.
301 et seq.
Dated: February 21, 2018.
Stanley Barone Jr.,
Acting Director, Office of Science
Coordination and Policy.
[FR Doc. 2018–04418 Filed 3–2–18; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OAR–2017–0650; FRL–9975–04–
OAR]
Proposed Approval of the Transuranic
Waste Characterization Program at
Idaho National Laboratory’s Advanced
Mixed Waste Treatment Project
Environmental Protection
Agency (EPA).
ACTION: Notice of availability; opening
of public comment period.
AGENCY:
The Environmental Protection
Agency ((EPA) or the Agency) is
announcing the availability of, and
soliciting public comment on, this
proposed action. On August 8–10, 2017,
the Agency conducted a baseline
inspection of the Advanced Mixed
Waste Treatment Project (AMWTP)’s
transuranic (TRU) waste
characterization program at Idaho
National Laboratory (INL), in
accordance with the Waste Isolation
Pilot Plant (WIPP) Compliance Criteria
and Condition 3 of the EPA’s initial May
13, 1998 WIPP certification, as
amended. The inspection evaluated the
technical adequacy of this program’s
characterization of contact-handled TRU
debris and solid waste. The EPA is
proposing to approve a new AMWTP
baseline that includes the significant
changes that have been implemented at
INL since mid-2016. The TRU waste
characterization program changes,
particularly to the Acceptable
Knowledge process, referred to as
‘‘enhanced AK’’, address deficiencies
identified by the Department of Energy
(DOE) as among the root causes of the
February 2014 radiation release at the
WIPP. The EPA’s draft baseline
inspection report is available for review
in the public dockets listed in the
ADDRESSES section of this document.
Until the EPA finalizes its baseline
approval decision, the DOE Carlsbad
Field Office (CBFO) may not recertify
the AMWTP’s TRU waste
characterization program and the
AMWTP may not ship any TRU waste
unless it meets the requirements of the
June 2017 revisions to the DOE’s WIPP
Waste Acceptance Criteria to the WIPP
for disposal.
DATES: Comments must be received on
or before April 19, 2018.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OAR–2017–0650, to the Federal
eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Once submitted, comments cannot be
SUMMARY:
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edited or withdrawn. The EPA may
publish any comment received to its
public docket. Do not electronically
submit any information you consider to
be Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Multimedia submissions (audio, video,
etc.) must be accompanied by a written
comment. The written comment is
considered the official comment and
should include discussion of all points
you wish to make. The EPA will
generally not consider comments or
comment contents located outside of the
primary submission (i.e., on the web,
cloud or other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit:
https://www2.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Rajani Joglekar (202–343–9462) or
Edward Feltcorn (202–343–9422),
Radiation Protection Division, Center
for Waste Management and Regulations,
Mail Code 6608T, U.S. Environmental
Protection Agency, 1200 Pennsylvania
Avenue, Washington, DC, 20460; fax
number: 202–343–2305; email address:
joglekar.rajani@epa.gov or feltcorn.ed@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
What should I consider as I prepare my
comments for EPA?
1. Submitting CBI. Do not submit this
information to the EPA through
www.regulations.gov or email. Clearly
mark the part or all of the information
that you claim to be CBI. For CBI
information in a disk or CD ROM that
you mail to the EPA, mark the outside
of the disk or CD ROM as CBI and then
identify electronically within the disk or
CD ROM the specific information that is
claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for Preparing Your Comments.
When submitting comments, remember
to:
• Identify the rulemaking by docket
number and other identifying
information (subject heading, Federal
Register date and page number).
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[Federal Register Volume 83, Number 43 (Monday, March 5, 2018)]
[Notices]
[Pages 9307-9310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04418]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2017-0617; FRL-9971-35]
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 Resistance of Lepidopteran Pests
to Bacillus thuringiensis (Bt) Plant Incorporated Protectants in The
United States: EPA's Analysis of Scientific Uncertainties Related to
Resistance Management and Options to Enhance the Current Insect
Resistance Management Program. 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. Registration is required to
attend this virtual meeting. The date and registration instructions
will be on the FIFRA SAP website https://www.epa.gov/sap by mid-March to
early April.
DATES: The virtual preparatory meeting will be announced in a future
Federal Register Notice and on https://www.epa.gov/sap. The 4-day, in-
person meeting will be held July 17 to July 20, 2018, from
approximately 9 a.m. to 5 p.m.
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ADDRESSES: Meeting: The location of the 4-day, in-person meeting will
be announced in a future Federal Register Notice and on https://www.epa.gov/sap. 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.
Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2017-0617, 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 instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
How to submit nominations, requests to present oral comments, and
requests for special accommodations. Submit nominations of candidates
to serve as ad hoc members of the FIFRA SAP Meeting, requests for
special accommodations, or requests to present oral comments to the DFO
listed under FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Tamue L. Gibson, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: 202-564-7642; email address: [email protected].
Comments. Written comments should be submitted for both the virtual
preparatory meeting and the in-person meeting on or before May 10,
2018. FIFRA SAP may not be able to fully consider written comments
submitted after May 10, 2018. Requests to make oral comments should be
submitted on or before May 24, 2018 by contacting the Designated
Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT.
You may also subscribe to the following listservs to be notified when
notices regarding this and other SAP related activities are published.
https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101, https://public.govdelivery.com/accounts/USAEPAOPPT/subscribers/qualify. For additional instructions, see Unit
I.C. of the SUPPLEMENTARY INFORMATION.
Nominations. Nominations of candidates to serve as ad hoc members
of FIFRA SAP for this review should be provided on or before April 4,
2018. More information can be found under unit I.C.4., Request for
nominations to serve as ad hoc expert members of FIFRA SAP for this
meeting.
Webcast. The virtual preparatory meeting will be webcast only and
registration is required. Please refer to the following website for
information on how to access the webcast: https://www.epa.gov/sap. The
4-day, in-person 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.
Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation for a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to allow EPA time to
process your request.
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-2017-0617 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 May 10, 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 May 10, 2018.
2. Oral comments. 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 May 24, 2018, to be included
on the meeting agenda. Requests to present oral comments during the in-
person meeting will be accepted until the date of the meeting and, to
the extent that time permits, the Chair of 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 May 24, 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 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
[[Page 9309]]
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:
Field entomologists with expertise in the southern United States (U.S.)
corn and cotton systems who are either corn earworm/bollworm (both
systems), fall armyworm, and/or western bean cutworm experts; pesticide
resistance modelers with a strong background in entomology, ecology,
and population biology; insect resistance management experts;
population biologists understanding the life-history of corn earworm/
bollworm, fall armyworm, and/or western bean cutworm; corn breeders,
molecular biologists in the field of entomology with an understanding
of the agricultural system in the southern U.S.; social scientists with
expertise in resistance management issues and understanding of dynamics
in the agricultural U.S. (e.g., human and market factors); and
economists with expertise in the U.S. agricultural system and Bt
technology-related issues. 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 DFO listed under FOR FURTHER INFORMATION
CONTACT on or before April 4, 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
The purpose of the July 2018 SAP is for the Agency to present major
risk factors believed responsible for expediting lepidopteran
adaptation to Bt toxins in the U.S. and associated scientific
uncertainties. Furthermore, the Agency will discuss identified
shortcomings of the current insect sampling methodologies, rearing and
resistance testing of populations and the feasibility of successful
mitigation when resistance is confirmed. In addition, the meeting
serves to assess whether it is warranted scientifically to develop a
resistance management plan for western bean cutworm. The overall goal
of the meeting is to receive recommendations that reduce the resistance
risks for lepidopteran pests, increase the longevity of currently
functional Bt traits and future technologies, and improve the current
insect resistance management program for lepidopteran pests of Bt corn
and cotton.
Lepidopteran resistance to Bacillus thuringiensis (Bt) traits of
corn and cotton were published by academic scientists for the
continental U.S. in 2014 for the fall armyworm (Spodoptera frugiperda),
in 2016 for the corn earworm (Helicoverpa zea), and in 2017 for the
western bean cutworm (Striacosta albicosta). Likewise, industry
reported resistance for the southwestern corn borer (Diatraea
grandiosella) in their resistance monitoring reports to the U.S. EPA in
2016. The Agency identified several risk factors that may have had the
greatest impact on these resistance
[[Page 9310]]
developments. Some of these are: (1) Lack of high dose traits; (2) use
of single modes of action possible year-after-year; (3) corn seed
blends in the southern U.S.; (4) poor refuge compliance for Bt corn in
southern states; (5) continuous selection with same traits expressed in
Bt corn and Bt cotton in a given year; (6) methodological approaches
with monitoring for resistant field populations; and (7) challenges
with identifying resistance using diet bioassays for non-high-dose
pests. The Agency will discuss its analysis of identified risk factors
underlying lepidopteran resistance development in the U.S. as well as
associated scientific uncertainties. Furthermore, the Agency will
discuss its analysis of methodological issues with collecting insects
from the field, rearing and testing populations for resistance, and the
feasibility of mitigating field resistance for Lepidopteran pests.
C. FIFRA SAP Documents and Meeting Minutes
EPA's background paper, charge/questions to FIFRA SAP, and related
supporting materials will be available by mid to late March 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 late March to early April 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: February 21, 2018.
Stanley Barone Jr.,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2018-04418 Filed 3-2-18; 8:45 am]
BILLING CODE 6560-50-P
