[Federal Register Volume 82, Number 107 (Tuesday, June 6, 2017)]
[Notices]
[Pages 26097-26099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11694]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2017-0214; FRL-9962-79]
FIFRA Scientific Advisory Panel; Notice of Public Meeting;
Request for Ad Hoc Expert Nominations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 3-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review the ``Continuing Development of Alternative High-
Throughput Screens to Determine Endocrine Disruption, Focusing on
Androgen Receptor, Steroidogenesis, and Thyroid Pathways''.
DATES: The meeting will be held on November 28, 2017 to November 30,
2017, from approximately 9 a.m. to 5 p.m.
Comments. Written comments should be submitted on or before
September 28, 2017. FIFRA SAP may not be able to fully consider written
comments submitted after this date. Requests to make oral comments
should be submitted on or before November 7, 2017 by contacting 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 expert
members of FIFRA SAP for this meeting should be provided on or before
July 21, 2017.
Webcast. This meeting may be webcast. Please refer to the FIFRA SAP
Web site at https://www.epa.gov/sap for information on how to access
the 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 allow EPA time 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-2017-0214, 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 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: Todd Peterson, DFO, Office of Science
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Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-6428; 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
also 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-2017-0214 in the subject line
on the first page of your request.
1. Written comments. Written comments should be submitted, using
the instructions in ADDRESSES and Unit I.B., on or before September 28,
2017, 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 September 28, 2017.
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 November 7, 2017, in order to be included on the meeting agenda.
Requests to present oral comments will be accepted until November 7,
2017 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 before
FIFRA SAP are limited to approximately 5 minutes unless arrangements
have been made prior to November 7, 2017. 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 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, both U.S. citizens and permanent residents who
can demonstrate that they are actively seeking U.S. citizenship will be
considered. For each meeting, FIFRA SAP staff routinely solicits from
the public nominations of prospective expert 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:
Toxicology, physiology, biochemistry, endocrinology (clinical and
research), epidemiology, with an emphasis on androgens,
steroidogenesis, thyroid--particularly ways these endocrine systems can
be disrupted and the means to detect disruption. Expertise in the
development of computational models, high-throughput assays, as well as
biostatistics and performance-based validation, are also desired.
Nominees should be scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing 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 July
21, 2017. 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 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 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 10 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 lack 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
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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 https://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 (OCSPP) 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. The
FIFRA SAP is assisted in their reviews by ad hoc participation from the
Science Review Board (SRB). 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.
B. Public Meeting
The United States EPA's Endocrine Disruptor Screening Program uses
appropriate validated test systems and other scientifically-relevant
information to screen and test for endocrine disrupting chemicals.
Since the issuance of the Federal Register Notice (entitled, ``Use of
High Throughput Assays and Computational Tools; Endocrine Disruptor
Screening Program; Notice of Availability and Opportunity for
Comment'') on June 19, 2015 (FRL-9928-69), EPA has continued the
development of high throughput assays and computational tools for both
the detection of the potential to disrupt the endocrine system, as well
as to estimate levels of exposure. The focus of this meeting is the
SAP's review and comment on the Agency's proposed high-throughput
computational model of androgen receptor pathway activity as an
alternative to the current Tier 1 androgen receptor assay (OCSPP
890.1150: Androgen Receptor Binding Rat Prostate Cytosol).
Additionally, the SAP will assess the Agency's progress in the
development of a high-throughput model of steroidogenesis to be used as
an alternative to the current Tier 1 steroidogenesis assay (OCSPP
890.1550: Steroidogenesis Human Cell Line--H295R); and proposed adverse
outcome pathway-based framework for screening chemicals for potential
thyroid disruption. The use of these methods will accelerate the pace
of screening, reduce animal testing, and significantly decrease costs
associated with screening.
C. FIFRA SAP Documents and Meeting Minutes
EPA's background paper, charge/questions to FIFRA SAP, and related
supporting materials will be available on or before August 14, 2017. In
addition, a list of candidates under consideration as prospective ad
hoc panelists for this meeting will be available for public comment by
August 22, 2017 (see link for listing of nominees to appear on August
4, 2017 at: https://www.epa.gov/sap). Comments should be provided to
the DFO listed under FOR FURTHER INFORMATION CONTACT on or before
September 6, 2017). Your comments will be placed in the public docket
by the DFO. You may obtain electronic copies of most meeting documents,
including FIFRA SAP composition (i.e., members and ad hoc members for
this meeting) and the meeting agenda, at http://www.regulations.gov and
the FIFRA SAP Web site at https://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 on 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: May 26, 2017.
Stanley Barone, Jr.,
Director, Office of Science Coordination and Policy.
[FR Doc. 2017-11694 Filed 6-5-17; 8:45 am]
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