[Federal Register Volume 77, Number 138 (Wednesday, July 18, 2012)]
[Notices]
[Pages 42307-42310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17385]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2012-0543; FRL-9355-3]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
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 the Pollinator Risk Assessment Framework.
DATES: The meeting will be held on September 11-14, 2012, from
approximately 9 a.m. to 5:30 p.m.
Comments. The Agency encourages that written comments be submitted
by August 28, 2012 and requests for oral comments be submitted by
September 4, 2012. However, written comments and requests to make oral
comments may be submitted until the date of the meeting, but anyone
submitting written comments after August 28, 2012 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,
2012.
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.
Submit your comments, identified by docket identification (ID)
number EPA-HQ-OPP-2012-0543 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
[[Page 42308]]
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: Fred Jenkins, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-3327; fax number: (202) 564-8382; 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), 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-2012-0543; 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 August
28, 2012, 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
August 28, 2012 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 September 4, 2012, 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: Terrestrial Community Ecology, Entomology (honeybee),
Environmental Fate and Transport, Plant Physiology/Uptake, Residue
Chemistry. 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 August 1,
2012. 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 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 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, 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
[[Page 42309]]
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 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 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, 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, 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 U.S. Environmental Protection Agency (EPA) FIFRA Scientific
Advisory Panel (SAP) meeting will focus on a proposed tiered process
for quantitatively evaluating the potential risk to pollinators (using
honeybees (Apis mellifera) as surrogate) associated with the registered
use of both systemic and non-systemic pesticides and the exposure and
effects data needed to support that process. During this SAP, the EPA
will provide an overview of the proposed tiered process for quantifying
the potential risks of pesticides to honeybees. This overview will
reflect collective efforts with Health Canada Pest Management
Regulatory Agency (PMRA), and California Department of Pesticide
Regulation (CalDPR). This will include an overview of the problem
formulation step, where protection goals are defined, along with the
conceptual model depicting potential routes of exposure and biological
receptors ranging from the individual bee (larvae and adult) to the
whole colony. Consistent with the risk assessment process for other
taxa, the proposed process will consist of a screening-level tier based
on conservative assumptions regarding exposure and laboratory-based
measures of effect and extending to more refined estimates of risk
based on field-based measures of exposure and effects that are more
reflective of how the pesticide may act under actual use conditions.
The proposed process is intended to enhance the ability of EPA, PMRA
and CalDPR to reliably screen chemicals for direct and indirect
effects, specifically on managed honeybee colonies, but EPA will also
request advice from the SAP on the usefulness of this framework for
characterizing potential effects on other, non-Apis pollinators.A
number of sources have reported declines in certain pollinator species
globally. Although a number of factors/agents have been hypothesized as
potential contributors to declines in honey bee health in general, at
this time, no factor has been identified as the single cause. Rather,
the available science suggests that pollinator declines are a result of
multiple factors which may be acting in various combinations. Research
is being directed at identifying the individual and combinations of
stressors that are most strongly associated with pollinator declines.
While the exact cause(s) of the general decline in pollinator
species have not been determined, potential contributing factors
including diseases, habitat destruction/urbanization, agricultural
practices/monocultures, pesticides, nutrition, and bee management
practices are among the factors being considered. Surveys of managed
migratory bee colonies indicate that a broad range of pesticides have
been detected in hive products (e.g., honey, stored pollen, wax).
Typically, pesticides occur in combination with other pesticides. In
spite of the presence of these compounds in honeybee colonies, at this
time, based on the available research there has been no correlation
between pollinator declines in general and the use of any pesticide or
class of pesticides.
Although, the role of pesticides in pollinator declines has not
been well established, global experts from different disciplines (e.g.,
chemistry, ecotoxicology and entomologists) and across various sectors
(e.g., government, academia and industry) agree on the need to advance
the science to better assess potential exposure, hazard and risk to
honey bees and other pollinators from pesticides used in agriculture.
The proposed process which the SAP will be asked to consider reflects a
synthesis of domestic and international efforts to develop a means for
quantifying the potential effects of pesticides to bees.
Consistent with the current risk assessment paradigm used by EPA,
CalDPR, PMRA and other regulatory authorities globally, the proposed
selection of exposure and effects data follows a tiered approach
intended to address specific assessment endpoints of growth, survival
and reproduction. The decision criteria for transitioning to higher
tier testing will also be delineated. The collective aim of the SAP
will be to delineate a process for qualitatively and quantitatively
assessing risks to honeybees and by extension to other insect
pollinators for which honeybees serve as surrogates. The development of
a risk assessment process for honeybees and identification of the data
needed to inform that process relies on a clear articulation of the
problem formulation and risk management goals.
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 mid to 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 electronically, at http://www.regulations.gov and the FIFRA
[[Page 42310]]
SAP homepage 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 Regulatory Public Docket at http://www.regulations.gov.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: July 10, 2012.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2012-17385 Filed 7-16-12; 8:45 am]
BILLING CODE 6560-50-P