[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40047-40050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17336]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2019-0417; FRL-9997-78]
FIFRA Scientific Advisory Panel; Notice of Public Meetings and
Request for Nomination of Ad Hoc Expert Reviewers
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 4-day, public, in-person meeting of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific
Advisory Panel (SAP) to consider and review the Approaches for
Quantitative Use of Surface Water Monitoring Data in Pesticide Drinking
Water Assessments. Preceding the in-person meeting, there will be a
preparatory, public, virtual meeting, conducted via teleconference and
webcast using Adobe Connect, to consider the scope and clarity of the
draft charge questions for this peer review. In addition, EPA is
requesting nominations of prospective candidates for service as ad hoc
reviewers to assist the FIFRA SAP with this review. Any interested
person or organization may nominate qualified individuals to be
considered as prospective candidates for this review by following the
instructions provided in this notice.
DATES:
Meetings: The 4-day, public, in-person meeting will be held
November 19 to November 22, 2019, from 9:00 a.m. to approximately 5:00
p.m. (EST). The date, time, and registration instructions for the
preparatory, public, virtual meeting will be announced on the FIFRA SAP
website (http://www.epa.gov/sap) by late-August. You may subscribe to
the following listserv for alerts when notices regarding this and other
SAP-related activities are published: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101.
Nominations: Nominations of candidates to serve as ad hoc
reviewers, to assist the FIFRA SAP with this review, should be provided
on or before September 12, 2019.
Special accommodations: Requests for special accommodations should
be submitted on or before October 29, 2019, to allow EPA time to
process your request.
Comments: The Agency encourages written comments and requests for
oral comments be submitted on or before October 4, 2019. However,
written comments and requests to make oral comments may be submitted
until the date of the in-person meeting, but anyone submitting such
comments and requests after October 4, 2019, should contact the
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION
CONTACT. For additional instructions, see Unit I.D. and Unit I.E. of
the SUPPLEMENTARY INFORMATION.
ADDRESSES:
In-Person Meeting: The location of the 4-day, public, in-person
meeting will be announced on the FIFRA SAP website at http://www.epa.gov/sap. This meeting may also be viewed via webcast. Please
refer to the FIFRA SAP website at http://www.epa.gov/sap for
information on how to access the webcast. Please note that this webcast
is a supplementary public process provided only for convenience. If
difficulties arise resulting in webcasting outages, the in-person
meeting will continue as planned.
Virtual Meeting: The preparatory, virtual meeting is open to the
public and will be conducted via webcast using Adobe Connect and
telephone. Registration is required to participate during the
preparatory, virtual meeting. Please refer to the FIFRA SAP website at
http://www.epa.gov/sap for additional information including how to
register.
Nominations: Submit nominations of candidates to serve as ad hoc
reviewers, to assist the FIFRA SAP with this review, to the DFO listed
under FOR FURTHER INFORMATION CONTACT.
Special accommodations: For information on access or services for
individuals with disabilities, and to request accommodation for a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT.
Comments. Submit requests to present oral comments to the DFO
listed under FOR FURTHER INFORMATION CONTACT.
Submit your written comments, identified by docket identification
(ID) number EPA-HQ-OPP-2019-0417, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not
electronically submit any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional information on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets. For additional instructions related to this
meeting, see Unit I.D. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Tamue L. Gibson, MS, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: 202-564-7642; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general. This action may
be of interest to persons who are or may be required to conduct testing
of chemical substances under the Federal Food, Drug, and Cosmetic Act
(FFDCA) and FIFRA. Since other entities may also be interested, the
Agency has not attempted to describe all the specific
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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 Tips for Effective Comments at http://www.epa.gov/dockets/comments.html.
C. Request for Nominations To Serve as Ad Hoc Expert Reviewers To
Assist the FIFRA SAP With This Review
As part of a broader process for developing a pool of candidates
for each review, FIFRA SAP staff routinely solicits the stakeholder
community for nominations of prospective candidates for service as ad
hoc reviewers. Any interested person or organization may nominate
qualified individuals to be considered as prospective candidates for a
specific topic. Individuals nominated for this meeting should have
expertise in one or more of the following areas: (i) Statistician
(experience in water quality data--preferably pesticides); (ii)
environmental exposure scientist (experience in aquatic modeling
preferably); (iii) environmental risk assessor (experience in
pesticides, environmental fate of pesticides); (iv) water quality
expert (experience in pesticides); (v) water quality monitoring
specialist; (vi) hydrologist; (vii) aquatic modeler; (viii) aquatic
model developer; and (ix) GIS specialist. Nominees should be scientists
who have sufficient professional qualifications, including training and
experience, to provide expert comments on the scientific issues for
this review. 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 September 12, 2019. The Agency will consider all
nominations of prospective candidates for this review that are received
on or before that date. However, final selection of ad hoc reviewers is
a discretionary function of the Agency.
The selection of scientists to serve on a FIFRA SAP review 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
reviewer to fully participate in the Panel's review, absence of any
conflicts of interest or appearance of loss of impartiality,
independence with respect to the matters under review, and lack of
bias. Although financial conflicts of interest, the appearance of loss
of impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on a FIFRA SAP review. Numerous
qualified candidates are identified for each review; 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 review, the
Agency anticipates selecting approximately 12 ad hoc scientists.
FIFRA SAP members and ad hoc reviewers are subject to the
provisions of the Standards of Ethical Conduct for Employees of the
Executive Branch at 5 Code of Federal Regulations Part 2635, conflict
of interest statutes in Title 18 of the United States Code, and related
regulations. In anticipation of these requirements, prospective
candidates for service on FIFRA SAP will be asked to submit
confidential financial information which shall fully disclose, among
other financial interests, the candidate's employment, stocks, and
bonds, and where applicable, sources of research support. EPA will
evaluate the candidate's financial disclosure form to assess whether
there are financial conflicts of interest, appearance of a loss of
impartiality, or any prior involvement with the development of the
documents under consideration (including previous scientific peer
review) before the candidate is considered further for service on FIFRA
SAP. Those who are selected from the pool of prospective candidates
will be asked to attend the public meetings and to participate in the
discussion of key issues and assumptions at these meetings. In
addition, they will be asked to review and to help finalize the meeting
minutes and final report. The list of FIFRA SAP members and ad hoc
reviewers participating at this meeting will be posted on the FIFRA SAP
website at http://www.epa.gov/scipoly/sap or may be obtained from the
OPP Docket at http://www.regulations.gov.
D. How may I participate in the in-person meeting?
You may participate in the in-person meeting by following the
instructions in this unit. To ensure proper receipt of comments,
nominations or other requests by EPA, it is imperative that you
identify docket ID number EPA-HQ-OPP-2019-0417 in the subject line on
the first page of your request.
1. Written comments. The Agency encourages written comments for the
in-person meeting be submitted using the instructions in ADDRESSES and
Unit I.B., on or before October 4, 2019, 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 October
4, 2019. Written comments are accepted until the date of the meeting,
but anyone submitting written comments after October 4, 2019, should
contact the DFO listed under FOR FURTHER INFORMATION CONTACT. Anyone
submitting written comments at the meeting should bring 30 copies for
distribution to the FIFRA SAP by the DFO.
2. Oral comments. The Agency encourages each individual or group
wishing to make brief oral comments to the FIFRA SAP during the in-
person meeting to submit their request to the DFO listed under FOR
FURTHER INFORMATION CONTACT on or before October 4, 2019, in order to
be included on the meeting agenda. Requests to present oral comments
will be accepted until the date of the in-person meeting and, to the
extent that time permits, the Chair of the FIFRA SAP may permit the
presentation of oral comments at the in-person 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 the FIFRA
SAP during the in-person meeting are limited to 5 minutes unless
arrangements have been made prior to October 4, 2019. In addition, each
speaker should bring 30 copies of his or her comments and presentation
to the meeting for distribution to the FIFRA SAP by the DFO.
3. Seating at the meeting. Seating at the in-person meeting will be
open and on a first-come basis.
4. Webcast. This meeting may also be viewed via webcast. Please
refer to the
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FIFRA SAP website at http://www.epa.gov/sap for information on how to
access the webcast. Please note that this webcast is a supplementary
public process provided only for convenience. If difficulties arise
resulting in webcasting outages, the in-person meeting will continue as
planned.
E. How may I participate in the preparatory virtual meeting?
Registration for the preparatory virtual meeting is required. To
participate by listening or making a comment during this meeting,
please visit: http://www.epa.gov/sap to register. Registration online
will be confirmed by email that will include the webcast meeting Adobe
Connect link and audio teleconference information.
1. Written comments. Written comments for the preparatory virtual
meeting should be submitted, using the instructions in ADDRESSES and
Unit I.B., on or before October 4, 2019.
2. Oral comments. Registration is required to participate in the
preparatory virtual meeting. Please visit the FIFRA SAP website at
http://www.epa.gov/sap to register online. Each individual or group
wishing to make brief oral comments to the FIFRA SAP during the
preparatory virtual meeting should submit their request when
registering online or with the DFO listed under FOR FURTHER INFORMATION
CONTACT on or before October 4, 2019. Oral comments before the FIFRA
SAP during the preparatory virtual meeting are limited to approximately
5 minutes due to the time constraints of this meeting.
3. Webcast. The preparatory meeting will be webcast only. Please
refer to the FIFRA SAP website at http://www.epa.gov/sap for
information on how to access the webcast. Registration is required.
II. Background
A. Purpose of the FIFRA SAP
The FIFRA SAP serves as one of the primary scientific peer review
mechanisms of EPA's Office of Chemical Safety and Pollution Prevention
(OCSPP) and is structured to provide independent scientific advice,
information and recommendations to the EPA Administrator on pesticides
and pesticide-related issues as to the impact of regulatory actions on
human health and the environment. FIFRA SAP is a Federal advisory
committee established in 1975 under FIFRA that operates in accordance
with requirements of the Federal Advisory Committee Act (5 U.S.C.
Appendix). The FIFRA SAP is composed of a permanent panel consisting of
seven members who are appointed by the EPA Administrator from nominees
provided by the National Institutes of Health (NIH) and the National
Science Foundation (NSF). FIFRA established a Science Review Board
(SRB) consisting of at least 60 scientists who are available to FIFRA
SAP on an ad hoc basis to assist in reviews conducted by FIFRA SAP. As
a scientific peer review mechanism, FIFRA SAP provides comments,
evaluations, and recommendations to improve the effectiveness and
quality of analyses made by Agency scientists. Members of FIFRA SAP are
scientists who have sufficient professional qualifications, including
training and experience, to provide expert advice and recommendation to
the Agency.
B. Public Meeting
Pesticides are regulated in the U.S. under both FIFRA and FFDCA. In
1996, Congress passed the Food Quality Protection Act (FQPA) which
amended both FIFRA and FFDCA. Under FQPA, for human health, EPA must
consider combined exposures (i.e., aggregate exposure) to a single
pesticide and the associated transformation products across multiple
exposure routes (i.e., oral, dermal, and inhalation) and across
multiple pathways (e.g., food, drinking water, and residential uses).
Historically, the Agency has used aquatic exposure models to estimate
potential pesticide concentrations in drinking water sources across the
country.
Recently, EPA developed a drinking water framework document that
describes the existing and longstanding continuum of approaches used to
assess pesticide exposure in drinking water. EPA used a tiered
approach, which began with simple and conservative assumptions and
moved towards more refined, less conservative assumptions and
approaches, as needed. The most refined tiers considered the use of
surface water monitoring to estimate pesticide concentrations.
Historically, EPA has generally used surface water monitoring for
characterization and not to estimate pesticide concentrations.
Pesticide surface water monitoring data rarely have been used as a
quantitative measure of exposure in drinking water, but rather are
typically used as a line of evidence to support the conceptual exposure
model or ground truth model estimated concentrations.
Further, most surface water monitoring programs typically collect
samples on a nondaily basis, such as weekly or biweekly, even in
relatively high-sampling frequency programs. Based on EPA's review of
available surface water monitoring data, it is not uncommon for
monitoring sites to be sampled once per year or quarterly, and in many
cases, the same monitoring sites are not sampled every year. The
quantitative use of pesticide surface water monitoring data in drinking
water assessments requires an understanding of the impact of numerous
variables on the frequency and magnitude of pesticide occurrence (e.g.,
sample site location, sample frequency, watershed characteristics,
pesticide use, rainfall patterns, etc.). Because of the nature of
pesticide concentrations in surface water (e.g., spikes in
concentration following rainfall events, followed by lower
concentrations over longer periods of time) and limited sampling
frequencies, available surface water data may not provide a reliable
estimate of the true range of pesticide concentrations relevant to the
durations of exposure associated with cancer and non-cancer risks.
Moreover, based on the Agency's review of available surface water
monitoring sites, sampling sites are often not located in the
vulnerable areas where pesticide concentrations are expected to be at
the upper end of the anticipated concentration range, although targeted
surface water monitoring data may be available for some pesticides.
The Agency is interested in using surface water monitoring data to
confidently estimate pesticide concentrations in surface water that may
be sourced by community water systems.
Specifically, the Agency is seeking advice and recommendation from
the FIFRA SAP on scientific issues associated with the evaluation and
utility of SEAsonalWAVEQ with EXtended capabilities model (SEAWAVE-
QEX), long-term sampling bias factors, watershed regressions, and
optimization of short-term sampling bias factors.
EPA has a method for better utilizing available pesticide surface
water quality monitoring data that are temporally and spatially limited
for estimating upper-bound concentrations relevant for use in drinking
water assessments. As part of the SAP, EPA is soliciting comments from
the panel on approaches for quantitative use of surface water
monitoring data in its drinking water assessments.
C. FIFRA SAP Documents and Meeting Minutes
The EPA's background paper, the supporting materials, and draft
charge/questions to FIFRA SAP will be
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available by late-August. In addition, a list of candidates under
consideration as prospective ad hoc panelists for this meeting will be
available for a 15-day public comment period by mid to late-September.
The Agency will provide additional background documents (e.g., the
meeting agenda) 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 in
docket EPA-HQ-OPP-2019-0417 and on the FIFRA SAP website at http://www.epa.gov/sap.
The 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 website at http://www.epa.gov/sap 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: August 2, 2019.
Hayley Hughes,
Director, Office of Science Coordination and Policy.
[FR Doc. 2019-17336 Filed 8-12-19; 8:45 am]
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