[Federal Register Volume 77, Number 249 (Friday, December 28, 2012)]
[Notices]
[Pages 76479-76482]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31277]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2012-0574; FRL-9356-8]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
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 Scientific Issues Concerning the Draft Product
Performance Data Needs Assessment for Products Claiming Efficacy
Against Invertebrate Pests.
DATES: The meeting will be held on March 19-21, 2013, from
approximately 8:30 a.m. to 5:30 p.m.
Comments. The Agency encourages that written comments be submitted
by March 5, 2013, and requests for oral comments be submitted by March
12, 2013. However, written comments and requests to make oral comments
may be submitted until the date of the meeting, but anyone submitting
written comments after March 5, 2013, 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 January
14, 2013.
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Webcast. This meeting may be webcast. Please refer to the FIFRA
SAP's Web site, 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-2012-0574 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), Mail Code: (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.htm. 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 seating accommodations, or requests
to present oral comments to the DFO listed under FOR FURTHER
INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001;
telephone number: (202) 564-2045; fax number; (202) 564-8382; email
address: bailey.joseph@epa.gov.
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), FIFRA, and the Food Quality Protection Act of
1996 (FQPA). 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. If you have any questions regarding the
applicability of this action to a particular entity, consult the DFO
listed under FOR FURTHER INFORMATION CONTACT.
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-2012-0574 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 March 5,
2013, 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 March 5,
2013, should contact the DFO listed under FOR FURTHER INFORMATION
CONTACT. Anyone submitting written comments at the meeting should bring
30 copies for distribution to FIFRA SAP.
2. Oral comments. The Agency encourages that each individual or
group wishing to make brief oral comments to FIFRA SAP submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than March 12, 2013, 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 30 copies of his or
her comments and presentation slides for distribution to the 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:
Insecticide testing/bioassay design,
Medical entomology and pest management,
Veterinary entomology and pest management, and
Urban entomology and pest management.
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,
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occupation, position, address, and telephone number. Nominations should
be provided to the DFO listed under FOR FURTHER INFORMATION CONTACT on
or before January 14, 2013. The Agency will consider all nominations of
prospective candidates for this meeting that are received on or before
this 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 the 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 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. In order to have the collective breadth of
experience needed to address the Agency's 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, as supplemented by the EPA in 5
CFR part 6401. In anticipation of this requirement, prospective
candidates for service on the 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 candidates 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 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/scipoly/sap or may be obtained from the OPP
Regulatory Public Docket at http://www.regulations.gov.
II. Background
A. Purpose of the FIFRA SAP
The 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. The FIFRA SAP is a Federal advisory committee established
in 1975 under FIFRA that operates in accordance with requirements of
the Federal Advisory Committee Act. 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 and the National Science Foundation. FIFRA, as amended by FQPA,
established a Science Review Board consisting of at least 60 scientists
who are available to the SAP on an ad hoc basis to assist in reviews
conducted by the SAP. As a peer review mechanism, the 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 recommendation to the Agency.
B. Public Meeting
The FIFRA SAP will meet to consider scientific issues associated
with product performance data that may be needed for EPA to evaluate
the efficacy of pesticide products used to control invertebrate pests.
The SAP's recommendations will be considered as EPA develops the
proposed invertebrate product performance data requirements. Once EPA
codifies product performance data requirements, the regulations will
provide the regulated community and other interested parties a better
understanding of the data required to support registration of a product
claiming pesticidal activity against three categories of invertebrate
pests.
Recent developments in vector-borne diseases, such as the spread of
the West Nile virus, outbreaks of dengue in Florida, and epidemic Rocky
Mountain spotted fever on Indian Lands, together with the re-emergence
of bed bugs in public housing and multifamily dwellings, have signaled
the need to assess more carefully the threat of invertebrate pests to
public health. At the same time, invasive wood-destroying insects such
as the Emerald Ash Borer or Asian long-horned beetle present
significant economic impacts to homes and native plant species. EPA-
registered insecticide products are an important part of pest
management programs and consumer efforts to accomplish pest control.
EPA is considering the product performance data needed to support the
registration of pesticide products claiming efficacy against
invertebrate pests of significant public health or economic importance.
The data being considered include a category of invertebrate pests
identified to be of significant public health importance (e.g., ticks,
mosquitoes, cockroaches). The other two categories are considered to be
of significant economic importance: Wood-destroying insects (e.g.,
termites), and invasive invertebrate species.
In response to these recent developments, EPA is considering the
product performance data that may be needed for EPA to evaluate the
efficacy of pesticide products used to control invertebrate pests. The
FIFRA SAP will meet to consider certain scientific issues identified by
the Agency. The main topics for consideration by the FIFRA SAP are the
science criteria for: (1) Identifying the public health pests, wood-
destroying insects, and invasive species for which product performance
data are needed; (2) evaluating pest groupings and selection of
appropriate surrogate species for efficacy testing; (3) adequacy of the
performance standards being considered; (4) providing consistency in
product performance studies submitted to EPA; and(5) ensuring the
likelihood that EPA- registered products will perform as expected. The
Agency also believes that revision of these product performance data
requirements will improve the transparency of EPA practices to the
public and registrants.
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C. FIFRA SAP Documents and Meeting Minutes
EPA's background paper, related supporting materials, charge/
questions to the FIFRA SAP, the FIFRA SAP composition (i.e., members
and ad hoc members for this meeting), and the meeting agenda will be
available by mid-February. 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 electronically, at http://www.regulations.gov and the FIFRA SAP homepage at http://www.epa.gov/scipoly/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 Web site or may be
obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: August 1, 2012.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2012-31277 Filed 12-27-12; 8:45 am]
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