FIFRA Scientific Advisory Panel; Notice of Public Meeting, 33300-33303 [2010-14092]
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Historically, EPA has met this mandate
by publishing weekly notices of
availability of EPA comments, which
includes a brief summary of EPA’s
comment letters, in the Federal
Register. Since February 2008, EPA has
been including its comment letters on
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eisdata.html. Including the entire EIS
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satisfies the Section 309(a) requirement
to make EPA’s comments on EISs
available to the public. Accordingly, on
March 31, 2010, EPA discontinued the
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EIS No. 20100208, Draft EIS, USA, VA,
Fort Monroe U.S. Army Garrison Base
Realignment and Closure (BRAC)
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VA, Comment Period Ends: 07/12/
2010, Contact: Bob Ross 703–602–
2878.
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at US 74 to US 74 between the Tons
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and U.S. COE 404 Permit, North
Carolina Turnpike Authority,
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Wait Period Ends: 07/12/2010,
Contact: Jennifer Harris 919–571–
3004.
EIS No. 20100210, Draft EIS, USACE,
00, Fargo-Moorhead Metropolitan
Area Flood Risk Management,
Proposed Construction of Flood
Protection Measures, Red River of the
North Basin, ND and MN, Comment
Period Ends: 07/26/2010, Contact:
Aaron Snyder 651–290–5489.
EIS No. 20100211, Final EIS, FHWA,
NV, I–15 Corridor Improvement and
Local Arterial Improvements Project,
Collectively Known as Project NEON,
To Improve the Safety and Travel
Efficiency in the I–15 Corridor, City of
Las Vegas, Clark County, NV, Wait
Period Ends: 07/16/2010, Contact:
Abdelmoez Abdalla 775–687–1204.
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Taos Resource Management Plan, To
Provide Broad-Scale Guidance for the
Management of Public Lands and
Resource Administered by Taos Field
Office, Colfax, Harding, Los Alamos,
Mora, Rio Arriba, Santa Fe, Taos and
Union Counties, NM, Comment
Period Ends: 09/08/2010, Contact:
Brad Higdon 575–751–4725.
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Pennsylvania High-Speed Maglev
Project, Construction between
Pittsburgh International Airport (PIA)
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Period Ends: 07/16/2010, Contact:
John Winkle 202–493–6067.
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15/University Avenue/1860 South
Interchange to 3110 West Street in
Provo, UT, Comment Period Ends: 08/
10/2010, Contact: Edward Woolford
801–963–0182.
EIS No. 20100215, Final EIS, USFS, CO,
Hermosa Park/Mitchell Lakes Land
Exchange Project, Proposed Land
Exchange between Federal and NonFederal Lands, Implementation,
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884–1418.
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Revision to FR Notice Published 06/
04/2010: Due to Non-Distribution of EIS
the Comment Period is being
Recalculated from 07/19/2010 to 07/26/
2010.
Dated: June 8, 2010.
Ken Mittelholtz,
Deputy Director, NEPA Compliance Division,
Office of Federal Activities.
[FR Doc. 2010–14080 Filed 6–10–10; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2010–0481; FRL–8829–5]
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 a set of scientific
issues related to the Re-Evaluation of
Human Health Effects of Atrazine:
Review of Non-Cancer Effects and
Drinking Water Monitoring Frequency.
DATES: The meeting will be held on
September 14 – 17, 2010, from
approximately 8:30 a.m. to 5 p.m.
Comments. The Agency encourages
that written comments be submitted by
August 31, 2010, and requests for oral
comments be submitted by September 7,
2010. 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 31, 2010, 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 June 25, 2010.
Webcast. This meeting may be
webcasted. Please refer to the FIFRA
SAP’s website, 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 for 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–2010–0481, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
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Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility’s telephone number is
(703) 305–5805.
Instructions. Direct your comments to
docket ID number EPA–HQ–OPP–2010–
0481. 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. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
that you include your name and other
contact information in the body of your
comment and with any disk or CD-ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either in the
electronic docket at https://
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www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
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; e-mail 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.
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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–2010–0481 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 31,
2010, 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 31, 2010, 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 7, 2010, 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.
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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: Risk
assessment, environmental
epidemiology, mammary gland
development, mixtures study design
and risk assessment, mode of action
analysis (particularly those with mode
of action (MOA) framework experience),
frameworks to evaluate human
relevance, pharmacokinetics,
neuroendocrinology (hormone-mediated
effects), HPA axis (corticosterone),
reproductive/developmental biology,
and environmental sampling and
statistical modeling. 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 June 25, 2010. 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
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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 15 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 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
website at https://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
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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
recommendations to the Agency.
B. Public Meeting
EPA is undertaking a re-evaluation of
the human health effects of atrazine.
The re-evaluation involves three SAP
meetings in 2010 and one in 2011. The
first was held in February 2010 where
the Agency presented its preliminary
reviews of several atrazine
epidemiology studies on birth outcomes
and described a project plan to evaluate
atrazine epidemiology data from the
Agricultural Health Study https://
aghealth.nci.nih.gov/). The April 2010
SAP meeting focused on:
1. A preliminary review of
experimental toxicology studies from
laboratory mammals and in vitro studies
and recent advancements in
understanding atrazine’s mode of
action.
2. Statistical approaches for
evaluating monitoring frequency in
community water systems (CWS).
In 2011, the Agency will solicit
comments from the SAP on atrazine
cancer epidemiology studies. The
Agency will consider the SAP feedback
from the April meeting to help guide the
preparation for the September meeting
which will focus on the non-cancer
effects of atrazine. The Agency will
include studies available up through
July 15, 2010. At this meeting OPP will
integrate data from in vitro and in vivo
experimental toxicology studies along
with preliminary review of non-cancer
epidemiology studies in a draft weight
of the evidence (WOE) analysis. This
draft WOE analysis will follow the Draft
Framework for Incorporating
Epidemiologic and Human Incident
Data in Health Risk Assessment, which
was reviewed by the SAP in February
2010. This draft framework employs the
modified Bradford Hill Criteria, like that
in the MOA and Human Relevance
Frameworks, and the source to effects
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paradigm described in the 2007
National Research Council Report, as
tools to organize and review data from
multiple sources and from multiple
levels of biological organization. The
Agency will develop a draft MOA
analysis of the animal data describing
key events for the hypothalamicpituitary-adrenal and hypothalamicpituitary-gonadal axes along with a
description of temporal and doseresponse concordance, and the strengths
and remaining uncertainties in the data.
The animal MOA will be integrated
with epidemiology studies on atrazine
into a draft WOE analysis.
The Agency will also discuss
alternative dose metrics for use in risk
assessment and the strengths and
limitations of each. The Agency will
solicit feedback from the SAP on the
implications of alternative dose metrics
for performing dose response
assessment in deriving points of
departure, evaluating potential for
differential lifestage susceptibility, and
in determining the appropriate
frequency of monitoring CWS.
As a condition of reregistration of
atrazine, EPA required the registrants to
implement a monitoring program in
selected CWS in the corn and sorghum
growing area of the U.S. Midwest.
Generally, longer durations of concern
(e.g., annual average concentration for a
long-term chronic effect) require a less
frequent sampling design to
approximate longer term exposures.
However, as the duration of the
exposure of concern shortens, the
frequency and timing of sampling
become more important in determining
how accurately the sample data capture
these short-duration exposures.
Depending on the aquatic resource
being sampled, the likelihood increases
that a spike in exposure may be missed
by less frequent sampling. In light of the
feedback received at the April SAP, the
Agency will update proposed statistical
approaches to determine the appropriate
monitoring frequency for different
toxicological durations of interest.
The Agency will consider feedback
received from the SAP at the September
2010 meeting as it completes the noncancer WOE analysis integrating
experimental toxicology and
epidemiology studies with statistical
analysis for determining whether or not
adjustments are necessary in the
sampling frequency of CWS water
monitoring.
C. FIFRA SAP Documents and Meeting
Minutes
EPA’s background paper, related
supporting materials, charge/questions
to FIFRA SAP, FIFRA SAP composition
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(i.e., members and ad hoc members for
this meeting), and the meeting agenda
will be available by mid-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
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 website or
may be obtained from the OPP
Regulatory Public Docket at https://
www.regulations.gov.
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: June 3, 2010
Steven M. Knott,
Acting Director, Office of Science
Coordination and Policy.
[FR Doc. 2010–14092 Filed 6–10–10; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
[CG Docket No. 09–158; CG Docket No. 98–
170; WC Docket No. 04–36; DA 10–988]
Comment Sought on Measurement of
Mobile Broadband Network
Performance and Coverage
AGENCY: Federal Communications
Commission.
ACTION: Notice.
SUMMARY: In this document, the
Consumer and Governmental Affairs
Bureau (Bureau) seeks to gather
additional information on the
performance of mobile broadband
services. The Bureau seeks comment on
whether and how to pursue a
measurement program for mobile
broadband services given the growing
significance of mobile internet access.
Additionally, the Bureau seeks
comment on how providers can improve
voluntary self-reporting of network
performance and coverage.
DATES: Comments are due on or before
July 1, 2010.
ADDRESSES: Interested parties may
submit comments and reply comments
identified by [CG Docket No. 09–158],
by any of the following methods:
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• Electronic Filers: Comments may be
filed electronically using the Internet by
accessing the Commission’s Electronic
comment Filing System (ECFS), through
the Commission’s Web site: https://
www.fcc.gov/cgb/ecfs/, or the Federal
eRulemaking Portal: https://
www.regulations.gov. Filers should
follow the instructions provided on the
Web site for submitting comments.
• For ECFS filers, in completing the
transmittal screen, filers should include
their full name, U.S. Postal Service
mailing address, and the applicable
docket number, which in this instance
is [CG Docket No. 09–158, CC Docket
No. 98–170, WC Docket No. 04–36].
Parties may also submit an electronic
comment by Internet e-mail. To get
filing instructions, filers should send an
e-mail to ecfs@fcc.gov, and include the
following words in the body of the
message, ‘‘get form .’’ A sample form and
directions will be sent in response.
• Paper Filers: Parties who choose to
file by paper must file an original and
four copies of each filing. Filings can be
sent by hand or messenger delivery, by
commercial overnight courier, or by
first-class or overnight U.S. Postal
Service mail (although the Commission
continues to experience delays in
receiving U.S. Postal Service mail). All
filings must be addressed to the
Commission’s Secretary, Office of the
Secretary, Federal Communications
Commission.
• All hand-delivered or messengerdelivered paper filings for the
Commission’s Secretary must be
delivered to FCC Headquarters at 445
12th St., SW., Room TW–A325,
Washington, DC 20554. The filing hours
are 8 a.m. to 7 p.m. All hand deliveries
must be held together with rubber bands
or fasteners. Any envelopes must be
disposed of before entering the building.
• Commercial overnight mail (other
than U.S. Postal Service Express Mail
and Priority Mail) must be sent to 9300
East Hampton Drive, Capitol Heights,
MD 20743.
• U.S. Postal Service first-class,
Express, and Priority mail should be
addressed to 445 12th Street, SW.,
Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT:
Jordan Usdan, Spectrum & Competition
Policy Division, Wireless
Telecommunications Bureau, at (202)
418–2035 (Voice) or e-mail
Jordan.Usdan@fcc.gov.
This is a
summary of the Consumer and
Governmental Affairs Bureau (Bureau)
Public Notice CG Docket No. 09–158,
CC Docket No. 98–170, WC Docket No.
SUPPLEMENTARY INFORMATION:
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Agencies
[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Notices]
[Pages 33300-33303]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14092]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2010-0481; FRL-8829-5]
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 a set of scientific issues related to the Re-
Evaluation of Human Health Effects of Atrazine: Review of Non-Cancer
Effects and Drinking Water Monitoring Frequency.
DATES: The meeting will be held on September 14 - 17, 2010, from
approximately 8:30 a.m. to 5 p.m.
Comments. The Agency encourages that written comments be submitted
by August 31, 2010, and requests for oral comments be submitted by
September 7, 2010. 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 31, 2010, 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 June 25, 2010.
Webcast. This meeting may be webcasted. Please refer to the FIFRA
SAP's website, 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 for 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-2010-0481, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory
Public Docket (7502P), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental
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Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries are only accepted during the
Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays). Special arrangements
should be made for deliveries of boxed information. The Docket
Facility's telephone number is (703) 305-5805.
Instructions. Direct your comments to docket ID number EPA-HQ-OPP-
2010-0481. 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. EPA's policy is that all comments received
will be included in the docket without change and may be made available
on-line at https://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov website is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
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; e-mail
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-2010-0481 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
31, 2010, 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 31, 2010, 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 7, 2010, 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.
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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: Risk assessment, environmental epidemiology, mammary gland
development, mixtures study design and risk assessment, mode of action
analysis (particularly those with mode of action (MOA) framework
experience), frameworks to evaluate human relevance, pharmacokinetics,
neuroendocrinology (hormone-mediated effects), HPA axis
(corticosterone), reproductive/developmental biology, and environmental
sampling and statistical modeling. 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 June 25, 2010. 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 15 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 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 website at https://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
recommendations to the Agency.
B. Public Meeting
EPA is undertaking a re-evaluation of the human health effects of
atrazine. The re-evaluation involves three SAP meetings in 2010 and one
in 2011. The first was held in February 2010 where the Agency presented
its preliminary reviews of several atrazine epidemiology studies on
birth outcomes and described a project plan to evaluate atrazine
epidemiology data from the Agricultural Health Study https://aghealth.nci.nih.gov/). The April 2010 SAP meeting focused on:
1. A preliminary review of experimental toxicology studies from
laboratory mammals and in vitro studies and recent advancements in
understanding atrazine's mode of action.
2. Statistical approaches for evaluating monitoring frequency in
community water systems (CWS).
In 2011, the Agency will solicit comments from the SAP on atrazine
cancer epidemiology studies. The Agency will consider the SAP feedback
from the April meeting to help guide the preparation for the September
meeting which will focus on the non-cancer effects of atrazine. The
Agency will include studies available up through July 15, 2010. At this
meeting OPP will integrate data from in vitro and in vivo experimental
toxicology studies along with preliminary review of non-cancer
epidemiology studies in a draft weight of the evidence (WOE) analysis.
This draft WOE analysis will follow the Draft Framework for
Incorporating Epidemiologic and Human Incident Data in Health Risk
Assessment, which was reviewed by the SAP in February 2010. This draft
framework employs the modified Bradford Hill Criteria, like that in the
MOA and Human Relevance Frameworks, and the source to effects
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paradigm described in the 2007 National Research Council Report, as
tools to organize and review data from multiple sources and from
multiple levels of biological organization. The Agency will develop a
draft MOA analysis of the animal data describing key events for the
hypothalamic-pituitary-adrenal and hypothalamic-pituitary-gonadal axes
along with a description of temporal and dose-response concordance, and
the strengths and remaining uncertainties in the data. The animal MOA
will be integrated with epidemiology studies on atrazine into a draft
WOE analysis.
The Agency will also discuss alternative dose metrics for use in
risk assessment and the strengths and limitations of each. The Agency
will solicit feedback from the SAP on the implications of alternative
dose metrics for performing dose response assessment in deriving points
of departure, evaluating potential for differential lifestage
susceptibility, and in determining the appropriate frequency of
monitoring CWS.
As a condition of reregistration of atrazine, EPA required the
registrants to implement a monitoring program in selected CWS in the
corn and sorghum growing area of the U.S. Midwest. Generally, longer
durations of concern (e.g., annual average concentration for a long-
term chronic effect) require a less frequent sampling design to
approximate longer term exposures. However, as the duration of the
exposure of concern shortens, the frequency and timing of sampling
become more important in determining how accurately the sample data
capture these short-duration exposures. Depending on the aquatic
resource being sampled, the likelihood increases that a spike in
exposure may be missed by less frequent sampling. In light of the
feedback received at the April SAP, the Agency will update proposed
statistical approaches to determine the appropriate monitoring
frequency for different toxicological durations of interest.
The Agency will consider feedback received from the SAP at the
September 2010 meeting as it completes the non-cancer WOE analysis
integrating experimental toxicology and epidemiology studies with
statistical analysis for determining whether or not adjustments are
necessary in the sampling frequency of CWS water monitoring.
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
mid-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 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 website or may be
obtained from the OPP Regulatory Public Docket at https://www.regulations.gov.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: June 3, 2010
Steven M. Knott,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2010-14092 Filed 6-10-10; 8:45 am]
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