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

ENVIRONMENTAL PROTECTION AGENCY

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

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, 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