81_FR_42832 81 FR 42706 - FIFRA Scientific Advisory Panel; Notice of Public Meeting

81 FR 42706 - FIFRA Scientific Advisory Panel; Notice of Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 126 (June 30, 2016)

Page Range42706-42708
FR Document2016-15589

There will be a 2-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review a set of scientific issues being considered by the Environmental Protection Agency regarding the human health and ecological risk assessments for SmartStax PRO (MON 89034 x TC1507 x MON 87411 x DAS-59122-7), a plant-incorporated protectant intended to control corn rootworm through ribonucleic acid (RNA) interference.

Federal Register, Volume 81 Issue 126 (Thursday, June 30, 2016)
[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42706-42708]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15589]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0349; FRL-9948-17]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 2-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and review a set of scientific issues being considered by the 
Environmental Protection Agency regarding the human health and 
ecological risk assessments for SmartStax PRO (MON 89034 x TC1507 x MON 
87411 x DAS-59122-7), a plant-incorporated protectant intended to 
control corn rootworm through ribonucleic acid (RNA) interference.

DATES: The meeting will be held on September 27-28, 2016, from 
approximately 9:00 a.m. to 5:00 p.m.
    Comments. The Agency encourages written comments be submitted on or 
before September 13, 2016, to provide adequate time for the FIFRA SAP 
to review and consider the comments. The Agency encourages requests for 
oral comments be submitted on or before September 20, 2016. However, 
written comments and requests to make oral comments may be submitted 
until the date of the meeting, but anyone submitting written comments 
after September 13, 2016, should contact the Designated Federal 
Official (DFO) listed under FOR FURTHER INFORMATION CONTACT. 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 meeting should be provided on or before August 1, 
2016.
    Webcast. This meeting may be webcast. Please refer to the FIFRA SAP 
Web site at http://www.epa.gov/sap for information on how to access the 
meeting webcast. Please note that the webcast is a supplementary public 
process provided only for convenience. If difficulties arise resulting 
in webcasting outages, the meeting will continue as planned.
    Special accommodations. For information on access or services for 
individuals with disabilities, and to request accommodation of a 
disability, please contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT at least 10 days prior to the meeting to give EPA as much time 
as possible to process your request.

ADDRESSES:
    Meeting: The 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.
    Comments: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2016-0349, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically 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

[[Page 42707]]

delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on 
commenting or visiting the docket, along with more information about 
dockets generally, is available at http://www.epa.gov/dockets.
    Nominations, requests to present oral comments, and requests for 
special accommodations. Submit nominations to serve as ad hoc members 
of FIFRA SAP, requests for special accommodations, or requests to 
present oral comments to the DFO listed under FOR FURTHER INFORMATION 
CONTACT.

FOR FURTHER INFORMATION CONTACT: Steven Knott, DFO, Office of Science 
Coordination and Policy (7201M), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-0103; 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, 
however, 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 this meeting?

    You may participate in this meeting by following the instructions 
in this unit. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number EPA-HQ-OPP-2016-0349 in the subject line 
on the first page of your request.
    1. Written comments. The Agency encourages written comments be 
submitted, using the instructions in ADDRESSES and Unit I.B., on or 
before September 13, 2016, to provide FIFRA SAP the time necessary to 
consider and review the written comments. Written comments are accepted 
until the date of the meeting, but anyone submitting written comments 
after September 13, 2016, should contact the DFO listed under FOR 
FURTHER INFORMATION CONTACT. Anyone submitting written comments at the 
meeting should bring 15 copies for distribution to FIFRA SAP by the 
DFO.
    2. Oral comments. The Agency encourages each individual or group 
wishing to make brief oral comments to FIFRA SAP to submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT on or 
before September 20, 2016, in order to be included on the meeting 
agenda. Requests to present oral comments 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. 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. Oral comments before 
FIFRA SAP are limited to approximately 5 minutes unless prior 
arrangements have been made. In addition, each speaker should bring 15 
copies of his or her comments and presentation for distribution to 
FIFRA SAP at the meeting by the DFO.
    3. Seating at the meeting. Seating at the meeting will be open and 
on a first-come basis.
    4. Request for nominations to serve as ad hoc 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: Ecological risk assessment, human health risk assessment, 
entomology, bioinformatics, RNAi technology, biotechnology, plant 
breeding and genomics, and molecular biology. 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 August 1, 2016. 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 reviews, absence of any conflicts of 
interest or appearance of lack of impartiality, independence with 
respect to the matters under review, and lack of bias. Although 
financial conflicts of interest, the appearance of lack 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 the 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. The Agency anticipates selecting 
approximately eight ad hoc scientists to have the collective breadth of 
experience needed to address the Agency's charge for this meeting.
    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 
candidates' employment, stocks, bonds, and where applicable, sources of 
research support. EPA will evaluate the candidates' financial 
disclosure forms to assess whether there are financial conflicts of 
interest, appearance of a lack of impartiality, or any prior 
involvement with the development of

[[Page 42708]]

the documents under consideration (including previous scientific peer 
review) before the candidate is considered further for service on the 
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. The list of FIFRA SAP members 
participating at this meeting will be posted on the FIFRA SAP Web site 
at http://www.epa.gov/sap or may be obtained from the OPP Docket at 
http://www.regulations.gov.

II. Background

A. Purpose of FIFRA SAP

    FIFRA SAP serves as the primary scientific peer review mechanism of 
EPA's Office of Chemical Safety and Pollution Prevention and is 
structured to provide scientific advice, information and 
recommendations to the EPA Administrator on pesticides and pesticide-
related issues as to the impact of regulatory actions on 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). 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 and the National Science Foundation. 
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 the FIFRA SAP are scientists who 
have sufficient professional qualifications, including training and 
experience, to provide expert advice and recommendations to the Agency.

B. Public Meeting

    The use of RNA interference (RNAi) gene silencing technology, 
particularly RNAi for pesticidal purposes to control macroorganism 
pests, is a relatively recent innovation. Post-transcriptional 
silencing of gene function is a very rapid process where double-
stranded RNA (dsRNA) directs sequence-specific degradation of a RNA. As 
EPA anticipated receiving pesticide applications based on RNAi 
technologies and identified the need to better understand the 
scientific issues concerning the assessment of the risks to human 
health and the environment that RNAi technologies pose, it convened a 
January 28, 2014, Federal Insecticide, Fungicide, and Rodenticide Act 
Scientific Advisory Panel (FIFRA SAP). This FIFRA SAP provided EPA with 
scientific advice regarding the framework for assessing RNAi pesticide 
products.
    On October 29, 2015, EPA registered MON 87411, a corn plant-
incorporated protectant (PIP) for seed increase/breeding purposes only 
and not for commercial release, with a time limitation of 2 years and a 
per-season acreage cap of 15,000 acres. In addition to Bacillus 
thuringiensis (Bt) Cry3Bb1 protein, MON 87411 expresses DvSnf7 dsRNA. 
Upon consumption by corn rootworm (CRW), the insect's RNAi machinery 
recognizes DvSnf7 dsRNA, resulting in down-regulation of the targeted 
DvSnf7 gene and leading to CRW mortality. Earlier this year, EPA 
received applications from Monsanto Company and Dow AgroSciences, LLC, 
requesting registration of commercial release RNAi PIPs expressing 
DvSnf7 dsRNA and known by the name SmartStax PRO. SmartStax PRO also 
expresses several Bt insecticidal Cry proteins.
    EPA will present the human health risk assessment conducted for 
DvSnf7 dsRNA, as expressed in SmartStax PRO, and will consider the fate 
of ingested dsRNA and the potential for impacts on gene expression and 
the immune system. The action of a RNA interference construct relies 
upon some level of sequence homology with the target gene transcript; 
however, the fidelity of the sequence match may vary in some instances. 
EPA will discuss the role that bioinformatic analysis may play in 
understanding and predicting possible off-target effects within the 
host genome, as well as in predicting nontarget effects as part of the 
ecological risk assessment.
    EPA will also present an ecological risk assessment for DvSnf7 
dsRNA, as expressed in SmartStax PRO, and will include descriptions of 
environmental fate and nontarget exposure, data reviewed in support of 
the risk assessment, risk characterization and description, and 
uncertainties. The charge to the panel will request expert opinion on 
completeness of the data set and uncertainties related to the risk 
conclusions.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc 
members for this meeting), and the meeting agenda will be available by 
approximately late August. In addition, the Agency may provide 
additional background documents as the materials become available. You 
may obtain electronic copies of these documents, and certain other 
related documents that might be available at http://www.regulations.gov 
and the FIFRA SAP Web site at http://www.epa.gov/sap.
    FIFRA SAP will prepare meeting minutes summarizing its 
recommendations to the Agency approximately 90 days after the meeting. 
The meeting minutes will be posted to the FIFRA SAP Web site or may be 
obtained from the OPP Docket at http://www.regulations.gov.

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

    Dated: June 23, 2016.
Stanley Barone,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2016-15589 Filed 6-29-16; 8:45 am]
 BILLING CODE 6560-50-P



                                                  42706                         Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices

                                                  description of the ICR is given below,                  system is inoperative. These reports are               DATES:   The meeting will be held on
                                                  including its estimated burden and cost                 used by EPA to determine compliance                    September 27–28, 2016, from
                                                  to the public. An Agency may not                        with these standards.                                  approximately 9:00 a.m. to 5:00 p.m.
                                                  conduct or sponsor and a person is not                     Form Numbers: None.                                    Comments. The Agency encourages
                                                  required to respond to a collection of                     Respondents/Affected Entities:                      written comments be submitted on or
                                                  information unless it displays a                        Flexible vinyl and urethane coating and                before September 13, 2016, to provide
                                                  currently valid OMB control number.                     printing facilities.                                   adequate time for the FIFRA SAP to
                                                  DATES: Additional comments may be                          Respondent’s Obligation to Respond:                 review and consider the comments. The
                                                  submitted on or before August 1, 2016.                  Mandatory (40 CFR part 60, subpart                     Agency encourages requests for oral
                                                  ADDRESSES: Submit your comments,                        FFF).                                                  comments be submitted on or before
                                                  referencing Docket ID Number EPA–                          Estimated Number of Respondents: 25                 September 20, 2016. However, written
                                                  HQ–OECA–2012–0657, to: (1) EPA                          (total).                                               comments and requests to make oral
                                                  online using www.regulations.gov (our                      Frequency of Response: Initially and                comments may be submitted until the
                                                  preferred method), or by email to                       semiannually.                                          date of the meeting, but anyone
                                                  docket.oeca@epa.gov, or by mail to: EPA                    Total Estimated Burden: 848 hours                   submitting written comments after
                                                  Docket Center, Environmental                            (per year). Burden is defined at 5 CFR                 September 13, 2016, should contact the
                                                  Protection Agency, Mail Code 28221T,                    1320.3(b).                                             Designated Federal Official (DFO) listed
                                                  1200 Pennsylvania Ave. NW.,                                Total Estimated Cost: $320,000 (per                 under FOR FURTHER INFORMATION
                                                  Washington, DC 20460; and (2) OMB via                   year), which includes $232,000 in both                 CONTACT. For additional instructions,
                                                  email to oira_submission@omb.eop.gov.                   annualized capital/startup and                         see Unit I.C. of the SUPPLEMENTARY
                                                                                                          operation & maintenance costs.                         INFORMATION.
                                                  Address comments to OMB Desk Officer
                                                                                                             Changes in the Estimates: There is an                  Nominations. Nominations of
                                                  for EPA.
                                                     EPA’s policy is that all comments                    adjustment increase in the respondent                  candidates to serve as ad hoc members
                                                  received will be included in the public                 burden and cost, including total O&M                   of FIFRA SAP for this meeting should
                                                  docket without change, including any                    cost, in this ICR. This is not due to                  be provided on or before August 1,
                                                  personal information provided, unless                   program changes; rather, it is due to an               2016.
                                                                                                                                                                    Webcast. This meeting may be
                                                  the comment includes profanity, threats,                increase of one additional source being
                                                                                                                                                                 webcast. Please refer to the FIFRA SAP
                                                  information claimed to be Confidential                  subject to these regulations since the
                                                                                                                                                                 Web site at http://www.epa.gov/sap for
                                                  Business Information (CBI), or other                    last ICR renewal period. In addition,
                                                                                                                                                                 information on how to access the
                                                  information whose disclosure is                         this ICR assumes all existing sources
                                                                                                                                                                 meeting webcast. Please note that the
                                                  restricted by statute.                                  will need to re-familiarize themselves
                                                                                                                                                                 webcast is a supplementary public
                                                  FOR FURTHER INFORMATION CONTACT:                        with the regulation each year. This
                                                                                                                                                                 process provided only for convenience.
                                                  Patrick Yellin, Monitoring, Assistance,                 change in assumption also contributes
                                                                                                                                                                 If difficulties arise resulting in
                                                  and Media Programs Division, Office of                  to an increase in the labor hours and
                                                                                                                                                                 webcasting outages, the meeting will
                                                  Compliance, Mail Code 2227A,                            costs.
                                                                                                                                                                 continue as planned.
                                                  Environmental Protection Agency, 1200                     Dated: June 23, 2016.                                   Special accommodations. For
                                                  Pennsylvania Ave. NW., Washington,                      Matthew Leopard,                                       information on access or services for
                                                  DC 20460; telephone number: (202)                       Director, Office of Information Collection.            individuals with disabilities, and to
                                                  564–2970; fax number: (202) 564–0050;                                                                          request accommodation of a disability,
                                                                                                          [FR Doc. 2016–15567 Filed 6–29–16; 8:45 am]
                                                  email address: yellin.patrick@epa.gov.                                                                         please contact the DFO listed under FOR
                                                                                                          BILLING CODE 6560–50–P
                                                  SUPPLEMENTARY INFORMATION:                                                                                     FURTHER INFORMATION CONTACT at least
                                                  Supporting documents which explain in                                                                          10 days prior to the meeting to give EPA
                                                  detail the information that the EPA will                ENVIRONMENTAL PROTECTION                               as much time as possible to process
                                                  be collecting are available in the public               AGENCY                                                 your request.
                                                  docket for this ICR. The docket can be                                                                         ADDRESSES:
                                                  viewed online at www.regulations.gov                                                                              Meeting: The meeting will be held at
                                                                                                          [EPA–HQ–OPP–2016–0349; FRL–9948–17]
                                                  or in person at the EPA Docket Center,                                                                         the Environmental Protection Agency,
                                                  WJC West, Room 3334, 1301                               FIFRA Scientific Advisory Panel;                       Conference Center, Lobby Level, One
                                                  Constitution Ave. NW., Washington,                      Notice of Public Meeting                               Potomac Yard (South Bldg.), 2777 S.
                                                  DC. The telephone number for the                                                                               Crystal Dr., Arlington, VA 22202.
                                                  Docket Center is 202–566–1744. For                      AGENCY: Environmental Protection                          Comments: Submit your comments,
                                                  additional information about EPA’s                      Agency (EPA).                                          identified by docket identification (ID)
                                                  public docket, visit: http://                           ACTION: Notice.                                        number EPA–HQ–OPP–2016–0349, by
                                                  www.epa.gov/dockets.                                                                                           one of the following methods:
                                                     Abstract: Owners and operators of                    SUMMARY:   There will be a 2-day meeting                  • Federal eRulemaking Portal: http://
                                                  affected facilities are required to comply              of the Federal Insecticide, Fungicide,                 www.regulations.gov. Follow the online
                                                  with reporting and recordkeeping                        and Rodenticide Act Scientific Advisory                instructions for submitting comments.
                                                  requirements for the general provisions                 Panel (FIFRA SAP) to consider and                      Do not submit electronically any
                                                  of 40 CFR part 60, subpart A, as well as                review a set of scientific issues being                information you consider to be
                                                  for the specific requirements at 40 CFR                 considered by the Environmental                        Confidential Business Information (CBI)
                                                  part 60 subpart FFF. This includes                      Protection Agency regarding the human
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                                                                 or other information whose disclosure is
                                                  submitting initial notification reports,                health and ecological risk assessments                 restricted by statute.
                                                  performance tests and periodic reports                  for SmartStax PRO (MON 89034 x                            • Mail: OPP Docket, Environmental
                                                  and results, and maintaining records of                 TC1507 x MON 87411 x DAS–59122–7),                     Protection Agency Docket Center (EPA/
                                                  the occurrence and duration of any                      a plant-incorporated protectant                        DC), (28221T), 1200 Pennsylvania Ave.
                                                  startup, shutdown, or malfunction in                    intended to control corn rootworm                      NW., Washington, DC 20460–0001.
                                                  the operation of an affected facility, or               through ribonucleic acid (RNA)                            • Hand Delivery: To make special
                                                  any period during which the monitoring                  interference.                                          arrangements for hand delivery or


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                                                                                Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices                                           42707

                                                  delivery of boxed information, please                   submitted, using the instructions in                   occupation, position, address, email
                                                  follow the instructions at http://                      ADDRESSES    and Unit I.B., on or before               address, and telephone number.
                                                  www.epa.gov/dockets/contacts.html.                      September 13, 2016, to provide FIFRA                   Nominations should be provided to the
                                                  Additional instructions on commenting                   SAP the time necessary to consider and                 DFO listed under FOR FURTHER
                                                  or visiting the docket, along with more                 review the written comments. Written                   INFORMATION CONTACT on or before
                                                  information about dockets generally, is                 comments are accepted until the date of                August 1, 2016. The Agency will
                                                  available at http://www.epa.gov/                        the meeting, but anyone submitting                     consider all nominations of prospective
                                                  dockets.                                                written comments after September 13,                   candidates for this meeting that are
                                                    Nominations, requests to present oral                 2016, should contact the DFO listed                    received on or before that date.
                                                  comments, and requests for special                      under FOR FURTHER INFORMATION                          However, final selection of ad hoc
                                                  accommodations. Submit nominations                      CONTACT. Anyone submitting written                     members for this meeting is a
                                                  to serve as ad hoc members of FIFRA                     comments at the meeting should bring                   discretionary function of the Agency.
                                                  SAP, requests for special                               15 copies for distribution to FIFRA SAP                  The selection of scientists to serve on
                                                  accommodations, or requests to present                  by the DFO.                                            FIFRA SAP is based on the function of
                                                  oral comments to the DFO listed under                      2. Oral comments. The Agency                        the Panel and the expertise needed to
                                                  FOR FURTHER INFORMATION CONTACT.                        encourages each individual or group                    address the Agency’s charge to the
                                                  FOR FURTHER INFORMATION CONTACT:                        wishing to make brief oral comments to                 Panel. No interested scientists shall be
                                                  Steven Knott, DFO, Office of Science                    FIFRA SAP to submit their request to                   ineligible to serve by reason of their
                                                  Coordination and Policy (7201M),                        the DFO listed under FOR FURTHER                       membership on any other advisory
                                                  Environmental Protection Agency, 1200                   INFORMATION CONTACT on or before                       committee to a federal department or
                                                  Pennsylvania Ave. NW., Washington,                      September 20, 2016, in order to be                     agency, or their employment by a
                                                  DC 20460–0001; telephone number:                        included on the meeting agenda.                        federal department or agency except
                                                  (202) 564–0103; email address:                          Requests to present oral comments will                 EPA. Other factors considered during
                                                  knott.steven@epa.gov.                                   be accepted until the date of the meeting              the selection process include
                                                                                                          and, to the extent that time permits, the              availability of the potential Panel
                                                  SUPPLEMENTARY INFORMATION:
                                                                                                          Chair of FIFRA SAP may permit the                      member to fully participate in the
                                                  I. General Information                                  presentation of oral comments at the                   Panel’s reviews, absence of any conflicts
                                                                                                          meeting by interested persons who have                 of interest or appearance of lack of
                                                  A. Does this action apply to me?                        not previously requested time. The                     impartiality, independence with respect
                                                     This action is directed to the public                request should identify the name of the                to the matters under review, and lack of
                                                  in general. This action may, however, be                individual making the presentation, the                bias. Although financial conflicts of
                                                  of interest to persons who are or may be                organization (if any) the individual will              interest, the appearance of lack of
                                                  required to conduct testing of chemical                 represent, and any requirements for                    impartiality, lack of independence, and
                                                  substances under the Federal Food,                      audiovisual equipment. Oral comments                   bias may result in disqualification, the
                                                  Drug, and Cosmetic Act (FFDCA) and                      before FIFRA SAP are limited to                        absence of such concerns does not
                                                  FIFRA. Since other entities may also be                 approximately 5 minutes unless prior                   assure that a candidate will be selected
                                                  interested, the Agency has not                          arrangements have been made. In                        to serve on the FIFRA SAP. Numerous
                                                  attempted to describe all the specific                  addition, each speaker should bring 15                 qualified candidates are identified for
                                                  entities that may be affected by this                   copies of his or her comments and                      each Panel. Therefore, selection
                                                  action.                                                 presentation for distribution to FIFRA                 decisions involve carefully weighing a
                                                                                                          SAP at the meeting by the DFO.                         number of factors including the
                                                  B. What should I consider as I prepare                     3. Seating at the meeting. Seating at               candidates’ areas of expertise and
                                                  my comments for EPA?                                    the meeting will be open and on a first-               professional qualifications and
                                                    1. Submitting CBI. Do not submit CBI                  come basis.                                            achieving an overall balance of different
                                                  information to EPA through                                 4. Request for nominations to serve as              scientific perspectives on the Panel. The
                                                  regulations.gov or email. If your                       ad hoc members of FIFRA SAP for this                   Agency anticipates selecting
                                                  comments contain any information that                   meeting. As part of a broader process for              approximately eight ad hoc scientists to
                                                  you consider to be CBI or otherwise                     developing a pool of candidates for each               have the collective breadth of
                                                  protected, please contact the DFO listed                meeting, FIFRA SAP staff routinely                     experience needed to address the
                                                  under FOR FURTHER INFORMATION                           solicits the stakeholder community for                 Agency’s charge for this meeting.
                                                  CONTACT to obtain special instructions                  nominations of prospective candidates                    FIFRA SAP members are subject to
                                                  before submitting your comments.                        for service as ad hoc members of FIFRA                 the provisions of 5 CFR part 2634—
                                                    2. Tips for preparing your comments.                  SAP. Any interested person or                          Executive Branch Financial Disclosure,
                                                  When preparing and submitting your                      organization may nominate qualified                    Qualified Trusts, and Certificates of
                                                  comments, see the commenting tips at                    individuals to be considered as                        Divestiture, as supplemented by EPA in
                                                  http://www.epa.gov/dockets/                             prospective candidates for a specific                  5 CFR part 6401. In anticipation of this
                                                  comments.html.                                          meeting. Individuals nominated for this                requirement, prospective candidates for
                                                                                                          meeting should have expertise in one or                service on FIFRA SAP will be asked to
                                                  C. How may I participate in this                        more of the following areas: Ecological                submit confidential financial
                                                  meeting?                                                risk assessment, human health risk                     information which shall fully disclose,
                                                     You may participate in this meeting                  assessment, entomology, bioinformatics,                among other financial interests, the
                                                  by following the instructions in this                   RNAi technology, biotechnology, plant                  candidates’ employment, stocks, bonds,
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                                                  unit. To ensure proper receipt by EPA,                  breeding and genomics, and molecular                   and where applicable, sources of
                                                  it is imperative that you identify docket               biology. Nominees should be scientists                 research support. EPA will evaluate the
                                                  ID number EPA–HQ–OPP–2016–0349 in                       who have sufficient professional                       candidates’ financial disclosure forms to
                                                  the subject line on the first page of your              qualifications, including training and                 assess whether there are financial
                                                  request.                                                experience, to provide expert comments                 conflicts of interest, appearance of a
                                                     1. Written comments. The Agency                      on the scientific issues for this meeting.             lack of impartiality, or any prior
                                                  encourages written comments be                          Nominees should be identified by name,                 involvement with the development of


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                                                  42708                         Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices

                                                  the documents under consideration                       anticipated receiving pesticide                        C. FIFRA SAP Documents and Meeting
                                                  (including previous scientific peer                     applications based on RNAi                             Minutes
                                                  review) before the candidate is                         technologies and identified the need to                   EPA’s background paper, related
                                                  considered further for service on the                   better understand the scientific issues                supporting materials, charge/questions
                                                  FIFRA SAP. Those who are selected                       concerning the assessment of the risks                 to FIFRA SAP, FIFRA SAP composition
                                                  from the pool of prospective candidates                 to human health and the environment                    (i.e., members and ad hoc members for
                                                  will be asked to attend the public                      that RNAi technologies pose, it                        this meeting), and the meeting agenda
                                                  meetings and to participate in the                      convened a January 28, 2014, Federal                   will be available by approximately late
                                                  discussion of key issues and                            Insecticide, Fungicide, and Rodenticide                August. In addition, the Agency may
                                                  assumptions at these meetings. In                       Act Scientific Advisory Panel (FIFRA                   provide additional background
                                                  addition, they will be asked to review                  SAP). This FIFRA SAP provided EPA                      documents as the materials become
                                                  and to help finalize the meeting                        with scientific advice regarding the                   available. You may obtain electronic
                                                  minutes. The list of FIFRA SAP                          framework for assessing RNAi pesticide                 copies of these documents, and certain
                                                  members participating at this meeting                   products.                                              other related documents that might be
                                                  will be posted on the FIFRA SAP Web                        On October 29, 2015, EPA registered                 available at http://www.regulations.gov
                                                  site at http://www.epa.gov/sap or may                                                                          and the FIFRA SAP Web site at http://
                                                                                                          MON 87411, a corn plant-incorporated
                                                  be obtained from the OPP Docket at                                                                             www.epa.gov/sap.
                                                                                                          protectant (PIP) for seed increase/
                                                  http://www.regulations.gov.                                                                                       FIFRA SAP will prepare meeting
                                                                                                          breeding purposes only and not for
                                                  II. Background                                          commercial release, with a time                        minutes summarizing its
                                                                                                          limitation of 2 years and a per-season                 recommendations to the Agency
                                                  A. Purpose of FIFRA SAP                                                                                        approximately 90 days after the
                                                                                                          acreage cap of 15,000 acres. In addition
                                                     FIFRA SAP serves as the primary                      to Bacillus thuringiensis (Bt) Cry3Bb1                 meeting. The meeting minutes will be
                                                  scientific peer review mechanism of                     protein, MON 87411 expresses DvSnf7                    posted to the FIFRA SAP Web site or
                                                  EPA’s Office of Chemical Safety and                     dsRNA. Upon consumption by corn                        may be obtained from the OPP Docket
                                                  Pollution Prevention and is structured                  rootworm (CRW), the insect’s RNAi                      at http://www.regulations.gov.
                                                  to provide scientific advice, information               machinery recognizes DvSnf7 dsRNA,                       Authority: 7 U.S.C. 136 et seq.; 21 U.S.C.
                                                  and recommendations to the EPA                          resulting in down-regulation of the                    301 et seq.
                                                  Administrator on pesticides and                         targeted DvSnf7 gene and leading to                      Dated: June 23, 2016.
                                                  pesticide-related issues as to the impact               CRW mortality. Earlier this year, EPA                  Stanley Barone,
                                                  of regulatory actions on health and the                 received applications from Monsanto                    Acting Director, Office of Science
                                                  environment. FIFRA SAP is a federal                     Company and Dow AgroSciences, LLC,                     Coordination and Policy.
                                                  advisory committee established in 1975                  requesting registration of commercial                  [FR Doc. 2016–15589 Filed 6–29–16; 8:45 am]
                                                  under FIFRA that operates in                            release RNAi PIPs expressing DvSnf7                    BILLING CODE 6560–50–P
                                                  accordance with requirements of the                     dsRNA and known by the name
                                                  Federal Advisory Committee Act (5                       SmartStax PRO. SmartStax PRO also
                                                  U.S.C. Appendix). FIFRA SAP is                          expresses several Bt insecticidal Cry                  FEDERAL COMMUNICATIONS
                                                  composed of a permanent panel                           proteins.                                              COMMISSION
                                                  consisting of seven members who are
                                                                                                             EPA will present the human health
                                                  appointed by the EPA Administrator                                                                             Deletion of Items From Sunshine Act
                                                                                                          risk assessment conducted for DvSnf7
                                                  from nominees provided by the National                                                                         Meeting
                                                                                                          dsRNA, as expressed in SmartStax PRO,
                                                  Institutes of Health and the National
                                                                                                          and will consider the fate of ingested                 June 24, 2016.
                                                  Science Foundation. FIFRA established
                                                                                                          dsRNA and the potential for impacts on                    The following items have been
                                                  a Science Review Board (SRB)
                                                                                                          gene expression and the immune                         deleted from the list of items scheduled
                                                  consisting of at least 60 scientists who
                                                                                                          system. The action of a RNA                            for consideration at the Friday, June 24,
                                                  are available to FIFRA SAP on an ad hoc
                                                                                                          interference construct relies upon some                2016, Open Meeting and previously
                                                  basis to assist in reviews conducted by
                                                                                                          level of sequence homology with the                    listed in the Commission’s Notice of
                                                  FIFRA SAP. As a scientific peer review
                                                                                                          target gene transcript; however, the                   June 17, 2016. Items 1, 2, 4, 5, 6, and
                                                  mechanism, FIFRA SAP provides
                                                                                                          fidelity of the sequence match may vary                7 on the consent agenda have been
                                                  comments, evaluations, and
                                                                                                          in some instances. EPA will discuss the                adopted by the Commission.
                                                  recommendations to improve the
                                                                                                          role that bioinformatic analysis may
                                                  effectiveness and quality of analyses                                                                          2. Public Safety & Homeland Security
                                                                                                          play in understanding and predicting
                                                  made by Agency scientists. Members of                                                                               Bureau:
                                                                                                          possible off-target effects within the host               Title: Amendment of Part 11 of the
                                                  the FIFRA SAP are scientists who have
                                                                                                          genome, as well as in predicting                            Commission’s Rules Regarding the
                                                  sufficient professional qualifications,
                                                                                                          nontarget effects as part of the ecological                 Emergency Alert System (PS Docket
                                                  including training and experience, to
                                                                                                          risk assessment.                                            No. 15–94)
                                                  provide expert advice and
                                                  recommendations to the Agency.                             EPA will also present an ecological                    Summary: The Commission will
                                                                                                          risk assessment for DvSnf7 dsRNA, as                        consider a Report and Order that
                                                  B. Public Meeting                                       expressed in SmartStax PRO, and will                        would revise the Emergency Alert
                                                     The use of RNA interference (RNAi)                   include descriptions of environmental                       System rules by adding new event
                                                  gene silencing technology, particularly                 fate and nontarget exposure, data                           codes covering extreme high winds
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                                                  RNAi for pesticidal purposes to control                 reviewed in support of the risk                             and storm surges caused by
                                                  macroorganism pests, is a relatively                    assessment, risk characterization and                       Category 3 (and greater) hurricanes.
                                                  recent innovation. Post-transcriptional                 description, and uncertainties. The                    *      *    *    *     *
                                                  silencing of gene function is a very                    charge to the panel will request expert
                                                  rapid process where double-stranded                     opinion on completeness of the data set                Consent Agenda
                                                  RNA (dsRNA) directs sequence-specific                   and uncertainties related to the risk                    The Commission will consider the
                                                  degradation of a RNA. As EPA                            conclusions.                                           following subjects listed below as a


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Document Created: 2018-02-08 07:45:36
Document Modified: 2018-02-08 07:45:36
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.
DatesThe meeting will be held on September 27-28, 2016, from approximately 9:00 a.m. to 5:00 p.m.
ContactSteven Knott, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
FR Citation81 FR 42706 

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