[Federal Register Volume 79, Number 179 (Tuesday, September 16, 2014)]
[Notices]
[Pages 55475-55477]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22044]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2014-0614; FRL-9915-55]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 4-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review Integrated Endocrine Activity and Exposure-based
Prioritization and Screening.
DATES: The meeting will be held on December 2-5, 2014, from
approximately 9 a.m. to 5 p.m.
Comments. The Agency encourages that written comments be submitted
by November 18, 2014, and requests for oral comments be submitted by
November 25, 2014. However, written comments and requests to make oral
comments may be submitted until the date of the meeting, but anyone
submitting written comments after November 18, 2014, 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 September
30, 2014.
Webcast. This meeting may be webcast. Please refer to the FIFRA SAP
Web site at http://www.epa.gov/scipoly/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 give EPA as much time
as possible to process your request.
ADDRESSES: 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-2014-0614, 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.
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.
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 seating accommodations, or requests
to present oral comments to the DFO listed under FOR FURTHER
INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Alva Daniels, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-2661; email address: daniels.alva@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 55476]]
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?
When submitting comments, remember to:
1. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
2. Follow directions. The Agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
4. Describe any assumptions and provide any technical information
and/or data that you used.
5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
6. Provide specific examples to illustrate your concerns and
suggest alternatives.
7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
8. Make sure to submit your comments by the comment period deadline
identified.
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-2014-0614 in the subject line
on the first page of your request.
1. Written comments. The Agency encourages that written comments be
submitted, using the instructions in ADDRESSES, no later than November
18, 2014, 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
November 18, 2014, should contact the DFO listed under FOR FURTHER
INFORMATION CONTACT. Anyone submitting written comments at the meeting
should bring 20 copies for distribution to FIFRA SAP.
2. Oral comments. The Agency encourages that each individual or
group wishing to make oral comments to FIFRA SAP submit their request
to the DFO listed under FOR FURTHER INFORMATION CONTACT no later than
November 25, 2014, 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 (e.g., overhead projector, 35 mm
projector, chalkboard). Oral comments before FIFRA SAP are limited to
approximately 5 minutes unless prior arrangements have been made. In
addition, each speaker should bring 20 copies of his or her comments
and presentation slides for distribution to FIFRA SAP at the meeting.
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: High Throughput Screening (HTS) in vitro assay technology and
applications, QSAR methodology, Tier 1 assays (Uterotrophic and
Hershberger), In vitro assays (Estrogen, Androgen, Thyroid or
Steriodogenesis), reproductive biology and toxicology, endocrinology.
Mathematical modeling of biological Systems, Bioinformatics,
Biomathematics, Statistics, Quantitative modeling and analysis of
complex data including Curve-fitting and Outlier detection,
Computational exposure modeling, Near-field and far-field exposure
modeling, Toxicokinetics and Pharmacokinetics, Environmental fate and
transport, Human exposure assessment (including vulnerable or
susceptible populations), Ecological exposure assessment. Note: In
support of the U.S. Environmental Protection Agency's (EPA) priority of
``Making a Visible Difference in Communities'' across the country, the
Agency is committed to helping minority, low income, tribal and other
vulnerable populations improve their health and environment. In an
effort to ensure that actions being proposed by the Agency are taking
into consideration input from potential communities with environmental
justice concerns, the EPA is offering an opportunity to provide input
on the FIFRA SAP meeting to address scientific issues associated with
``Integrated Endocrine Activity and Exposure-based Prioritization and
Screening''. The EPA encourages all grass-root organizations and
residents to submit public comments on this issue which is being
addressed during the FIFRA Scientific Advisory Panel meeting. The
Agency also encourages community environmental justice advocates to
give a voice to their communities by nominating candidates for
consideration to serve on this panel. 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, and telephone number. Nominations
should be provided to the DFO listed under FOR FURTHER INFORMATION
CONTACT on or before September 30, 2014. 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 the 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
[[Page 55477]]
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 charge
for this meeting, the Agency anticipates selecting approximately 8 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. The 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 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/scipoly/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. 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 peer review mechanism, FIFRA SAP provides
comments, evaluations, and recommendations to improve the effectiveness
and quality of analyses made by Agency scientists. Members of FIFRA SAP
are scientists who have sufficient professional qualifications,
including training and experience, to provide expert advice and
recommendation to the Agency.
B. Public Meeting
This FIFRA SAP meeting will review methods using computational
toxicology and exposure tools (i.e., high throughput screening (HTS)
assays, and computational models), and other data streams for
integrated bioactivity and exposure based prioritization and screening
of the universe of EDSP chemicals. Endocrine bioactivity of chemicals
will be quantified using HTS in vitro estrogen, androgen, and thyroid
receptor assays, along with other potential molecular targets, and
compared with Tier 1 screening and other in vivo assay results obtained
from published and publically available peer-reviewed studies. While
technical advances in high-throughput toxicity testing of chemicals
were presented at a FIFRA SAP meeting in 2013, this SAP will review
further advances in computational toxicology exposure science for
prioritization and screening of the EDSP universe of chemicals. The
ability of the agency to screen the thousands of environmental
chemicals in the EDSP universe is substantially limited by the capacity
of the current Tier 1 screening methods. Rapid screening of 1000s of
chemicals using EPA's ToxCast high throughput assays allows the agency
to focus attention on chemicals with the greatest potential endocrine
bioactivity. In addition, high throughput models of human and
ecological exposure (e.g. ExpoCast) allows the agency to identify
chemicals with the greatest potential for exposures that could result
in bioactive concentrations. This shift in the EDSP framework allows
focus to be placed on chemicals that pose the greatest likelihood of
exposures leading to endocrine bioactivity in humans or wildlife. The
FIFRA SAP will be requested to respond to charge questions regarding
EPA's proposed integrated bioactivity exposure based approach for
ranking chemicals in the EDSP universe for further screening and
testing.
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 October 27, 2014. 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/scipoly/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.
List of Subjects
Environmental protection, Pesticides and pests, Environmental
Justice.
Dated: September 2, 2014.
David J. Dix,
Director, Office of Science Coordination and Policy.
[FR Doc. 2014-22044 Filed 9-15-14; 8:45 am]
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