FIFRA Scientific Advisory Panel; Notice of Public Meeting, 42307-42310 [2012-17385]
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 138 / Wednesday, July 18, 2012 / Notices
copyrighted material, EPA will provide
a reference to that material in the
version of the comment that is placed in
www.regulations.gov. The entire printed
comment, including the copyrighted
material, will be available in the public
docket. Although identified as an item
in the official docket, information
claimed as CBI, or whose disclosure is
otherwise restricted by statute, is not
included in the official public docket,
and will not be available for public
viewing in www.regulations.gov. For
further information about the electronic
docket, go to www.regulations.gov.
Title: Recordkeeping and Reporting
Requirements for Allegations of
Significant Adverse Reactions to Human
Health or the Environment.
ICR Status: This is a request to renew
an existing approved collection. This
ICR is scheduled to expire on August
31, 2012. Under OMB regulations, the
Agency may continue to conduct or
sponsor the collection of information
while this submission is pending at
OMB.
Abstract: TSCA section 8(c) requires
companies that manufacture, process, or
distribute chemicals to maintain records
of significant adverse reactions to health
or the environment alleged to have been
caused by such chemicals. Since section
8(c) includes no automatic reporting
provision, EPA can obtain and use the
information contained in company files
only by inspecting those files or
requiring reporting of records that relate
to specific substances of concern.
Therefore, under certain conditions, and
using the provisions found in 40 CFR
part 717, EPA may require companies to
report such allegations to the Agency.
EPA uses such information on a casespecific basis to corroborate suspected
adverse health or environmental effects
of chemicals already under review by
EPA. The information is also useful to
identify trends of adverse effects across
the industry that may not be apparent to
any one chemical company. This ICR
addresses the information reporting and
recordkeeping requirements found in 40
CFR part 717.
Responses to the collection of
information are mandatory (see 40 CFR
part 717). Respondents may claim all or
part of a notice as CBI. EPA will
disclose information that is covered by
a CBI claim only to the extent permitted
by, and in accordance with, the
procedures in 40 CFR part 2.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
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Federal Register, are listed in 40 CFR
part 9 and included on the related
collection instrument or form, if
applicable.
Burden Statement: The annual public
reporting and recordkeeping burden for
this collection of information is
estimated to range between
approximately 1 minute and 8 hours per
response, depending upon the type(s) of
activity that a respondent must
complete. Burden is defined in 5 CFR
1320.3(b).
Respondents/Affected Entities:
Entities potentially affected by this
action are companies that manufacture,
process, import, or distribute in
commerce chemical substances or
mixtures.
Frequency of Collection: On occasion.
Estimated No. of Respondents:
13,951.
Estimated Total Annual Burden on
Respondents: 26,978 hours.
Estimated Total Annual Costs:
$1,797,800.
Changes in Burden Estimates: This
request reflects an increase of 3,442
hours (from 23,536 hours to 26,978
hours) in the total estimated respondent
burden from that currently in the OMB
inventory. This increase reflects EPA’s
estimate of a greater number of potential
respondents affected by the reporting
requirement. The Supporting Statement
provides details about the change in
burden estimate. The change is an
adjustment.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2012–17485 Filed 7–17–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2012–0543; FRL–9355–3]
FIFRA Scientific Advisory Panel;
Notice of Public Meeting
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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.
SUMMARY:
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,
DATES:
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42307
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, https://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: https://
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 https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://www.epa.gov/dockets.
Nominations, requests to present oral
comments, and requests for special
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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:
jenkins.fred@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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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.
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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 firstcome 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
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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
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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 https://www.epa.gov/scipoly/sap
or may be obtained from the OPP
Regulatory Public Docket at https://
www.regulations.gov.
II. Background
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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.
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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
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42309
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 https://
www.regulations.gov and the FIFRA
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SAP homepage at https://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 https://
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
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9700–8]
Proposed CERCLA Administrative
Cost Recovery Settlement; City of
Middletown, CT and RLO Properties,
Inc., Omo Manufacturing Site,
Middletown, CT
Environmental Protection
Agency.
ACTION: Notice of proposed settlement;
request for public comment.
AGENCY:
Notice is hereby given of a
proposed administrative settlement for
recovery of response costs under
CERCLA, concerning the Omo
Manufacturing Superfund Site in
Middletown, Connecticut with the
following settling parties: City of
Middletown, Connecticut and RLO
Properties, Inc. The settlement requires:
(1) The City of Middletown, Connecticut
to pay $2,800,000 to the Hazardous
Substance Superfund in five equal
payments, with interest, over time; and
(2) RLO Properties, Inc. to provide EPA
and its representatives and contractors
access at all reasonable times to the Site
and to any other property owned or
controlled by RLO Properties, Inc. to
which access is determined by EPA to
be required for the implementation of
the settlement.
SUPPLEMENTARY INFORMATION: In
accordance with Section 122(i) of the
Comprehensive Environmental
Response Compensation, and Liability
Act, as amended (‘‘CERCLA’’), 42 U.S.C.
Section 9622(i), notice is hereby given
of a proposed administrative settlement
for recovery of response costs under
CERCLA Section 122(h)(1) and
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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104(e)(6), concerning the Omo
Manufacturing Superfund Site in
Middletown, Connecticut with the
following settling parties: City of
Middletown, Connecticut and RLO
Properties, Inc. The settlement requires:
(1) the City of Middletown, Connecticut
to pay $2,800,000 to the Hazardous
Substance Superfund in five equal
payments, with interest, over time; and
(2) RLO Properties, Inc. to provide EPA
and its representatives and contractors
access at all reasonable times to the Site
and to any other property owned or
controlled by RLO Properties, Inc. to
which access is determined by EPA to
be required for the implementation of
the settlement. The settlement includes
a covenant not to sue pursuant to
Sections 106 and 107(a) of CERCLA, 42
U.S.C. 9606 and 9607, relating to the
Site, and protection from contribution
actions or claims as provided by
Sections 113(f)(2) and 122(h)(4) of
CERCLA, 42 U.S.C. 9613(f)(2) and
9622(h)(4). The settlement has been
approved by the Environmental and
Natural Resources Division of the
United States Department of Justice. For
thirty (30) days following the date of
publication of this notice, the Agency
will receive written comments relating
to the settlement. The United States will
consider all comments received and
may modify or withdraw its consent to
the settlement if comments received
disclose facts or considerations which
indicate that the settlement is
inappropriate, improper, or inadequate.
The Agency’s response to any comments
received will be available for public
inspection at 5 Post Office Square,
Boston, MA 02109–3912.
Comments must be submitted by
August 17, 2012 of this notice.
DATES:
Comments should be
addressed to Cynthia Lewis, Senior
Enforcement Counsel, U.S.
Environmental Protection Agency, 5
Post Office Square, Suite 100 (OES04–
3), Boston, MA 02109–3912 (Telephone
No. 617–918–1889) and should refer to:
In re: Omo Manufacturing Superfund
Site, U.S. EPA Docket No. 01–2012–
0040.
ADDRESSES:
A
copy of the proposed settlement may be
obtained from Cynthia Lewis, Senior
Enforcement Counsel, U.S.
Environmental Protection Agency, 5
Post Office Square, Suite 100 (OES04–
3), Boston, MA 02109–3912 (Telephone
No. 617–918–1889); Email
lewis.cindy@epa.gov).
FOR FURTHER INFORMATION CONTACT:
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Dated: June 26, 2012.
James T. Owens, III,
Director, Office of Site Remediation and
Restoration, Region 1.
[FR Doc. 2012–17501 Filed 7–17–12; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL MARITIME COMMISSION
Notice of Agreements Filed
The Commission hereby gives notice
of the filing of the following agreements
under the Shipping Act of 1984.
Interested parties may submit comments
on the agreements to the Secretary,
Federal Maritime Commission,
Washington, DC 20573, within ten days
of the date this notice appears in the
Federal Register. Copies of the
agreements are available through the
Commission’s Web site (www.fmc.gov)
or by contacting the Office of
Agreements at (202) 523–5793 or
tradeanalysis@fmc.gov.
Agreement No.: 012119–001.
Title: Maersk Line/CMA CGM TP5
Space Charter Agreement.
Parties: A.P. Moller-Maersk A/S and
CMA CGM S.A.
Filing Parties: Wayne Rohde, Esq.;
Cozen O’Connor; 1627 I Street NW.;
Suite 1100; Washington, DC 20006.
Synopsis: The amendment would add
China to the geographic scope, add
language reflecting the fact that
Maersk’s TP5 service will be operated in
cooperation with another carrier, and
delete obsolete language.
Agreement No.: 012161–001.
Title: Siem Car Carrier Pacific AS/
Hyundai Glovis Co., Ltd. Space Charter
Agreement.
Parties: Siem Car Carrier Pacific AS;
Hyundai Glovis Co., Ltd.
Filing Party: Ashley W. Craig; Venable
LLP; 575 Seventh Street NW.,
Washington, DC 20004.
Synopsis: The amendment revises the
geographic scope of the agreement to
include Asia (including, but not limited
to Korea, Japan, Philippines, Singapore,
and China), and authorizes the mutual
chartering of space between the parties.
Agreement No.: 012180.
Title: Maersk/MSC Vessel Sharing
Agreement.
Parties: A.P. Moller Maersk A/S and
MSC Mediterranean Shipping Company
S.A.
Filing Party: Wayne R. Rohde,
Esquire; Cozen O’Connor; 1627 I Street
NW., Suite 1100; Washington, DC
20006–4007.
Synopsis: The agreement authorizes
the parties to share vessels in the trades
between China, Korea, and Japan, and
ports in California and Alaska.
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]]>Agencies
[Federal Register Volume 77, Number 138 (Wednesday, July 18, 2012)]
[Notices]
[Pages 42307-42310]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17385]
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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.
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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 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, https://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: https://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 https://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
Nominations, requests to present oral comments, and requests for
special
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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:
jenkins.fred@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-2012-0543; 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
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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 https://www.epa.gov/scipoly/sap or may be obtained
from the OPP Regulatory Public Docket at https://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 https://www.regulations.gov and the FIFRA
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SAP homepage at https://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 https://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
