FIFRA Scientific Advisory Panel; Notice of Public Meeting, 21746-21749 [05-8377]
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21746
Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices
launch full text Web sites containing all
required service information for 1996
and later model years. In order to assess
the effectiveness of the web site
provisions of the regulations, EPA
believes that input from independent
technicians must be of primary
consideration. As part of our broader
efforts to evaluate the OEM web sites,
EPA is initiating a process to gather
feedback directly from the technician
community on their experiences with
the web sites and to communicate those
findings directly to the OEMs and the
service industry as a whole. EPA staff
will use this data in conjunction with
other internal analyses to assess the
effectiveness of the service information
web sites that are required by the
regulations. In addition, this
information will be used by the Agency
to determine if manufacturer guidance
or changes to the regulations are
needed. 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 40
CFR are listed in 40 CFR part 9.
The EPA would like to solicit
comments to:
(i) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the Agency, including
whether the information will have
practical utility;
(ii) evaluate the accuracy of the
Agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(iii) enhance the quality, utility, and
clarity of the information to be
collected; and
(iv) minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses.
Burden Statement: Participation in
the audit requires the availability of
desk top or lap top computers in the
maintenance facility or shop. In
addition, internet access is needed in
the facility in order to access the
information on individual automobile
manufacturer Web sites. It is anticipated
that a vast majority of vehicle repair
facilities have already made these
capital investments for the day to day
operations of their businesses and that
no additional costs will be incurred by
technicians who participate in the audit.
In addition, the automobile
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manufacturers have agreed to arrange
for free access to all their Web sites for
participants for the 3–4 month duration
of the audit. Therefore, participants will
not incur any additional charges or fees
as a result of participating in the audit.
EPA otherwise anticipates
approximately 250 technicians to and
that they will spend approximately 1–2
hours per week over a 12-week time
period to electronically complete and
return short audit questionnaires.
Burden means the total time, effort, or
financial resources expended by persons
to generate, maintain, retain, or disclose
or provide information to or for a
Federal agency. This includes the time
needed to review instructions; develop,
acquire, install, and utilize technology
and systems for the purposes of
collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements; train personnel to be able
to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
Dated: April 18, 2005.
Karl Simon,
Acting Director, Office of Transportation and
Air Quality.
[FR Doc. 05–8439 Filed 4–26–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
Nominations: Nominations of
scientific experts to serve as ad hoc
members of the FIFRA SAP for this
meeting should be provided on or before
May 9, 2005.
Special seating: Requests for special
seating arrangements should be made at
least 5 business days prior to the
meeting.
ADDRESSES: The meeting will be held at
the Holiday Inn-National Airport, 2650
Jefferson Davis Highway, Arlington,VA
22202. The telephone number for the
Holiday Inn-National Airport is (703)
684–7200.
Comments: Written comments may
be submitted electronically (preferred),
through hand delivery/courier, or by
mail. Follow the detailed instructions as
provided in Unit I. of the
SUPPLEMENTARY INFORMATION.
Nominations, requests to present oral
comments, and special seating: To
submit nominations for ad hoc members
of the FIFRA SAP for this meeting,
requests for special seating
arrangements, or requests to present oral
comments, notify the Designated
Federal Official (DFO) listed under FOR
FURTHER INFORMATION CONTACT. To
ensure proper receipt by EPA, your
request must identify docket ID number
OPP–2005–0102 in the subject line on
the first page of your request.
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; telephone number: (202)
564–2045; fax number: (202) 564–8382;
e-mail address:bailey.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
[OPP–2005–0102; FRL–7710–7]
I. General Information
FIFRA Scientific Advisory Panel;
Notice of Public Meeting
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.
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: There will be a 2–day meeting
of the Federal Insecticide, Fungicide,
and Rodenticide Act Scientific Advisory
Panel (FIFRA SAP) to consider and
review carbamate dietary exposure
assessment incorporating cholinesterase
recovery into CARES–compatible
modules.
The meeting will be held on June
14-15, 2005, from 8:30 a.m. to
approximately 5 p.m., eastern time.
Comments: For the deadlines for the
submission of requests to present oral
comments and the submission of
written comments, see Unit I.E. of the
SUPPLEMENTARY INFORMATION.
DATES:
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B. How Can I Get Copies of this
Document and Other Related
Information?
1. Docket. EPA has established an
official public docket for this action
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under docket ID number OPP–2005–
0102. The official public docket consists
of the documents specifically referenced
in this action, any public comments
received, and other information related
to this action. Although, a part of the
official docket, the public docket does
not include Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
The official public docket is the
collection of materials that is available
for public viewing at the Public
Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall
#2, 1801 S. Bell St., Arlington, VA. This
docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays. The docket
telephone number is (703) 305–5805.
2. Electronic access. You may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/.
EPA’s position paper, charge/
questions to FIFRA SAP, FIFRA SAP
composition (i.e., members and
consultants for this meeting), and the
meeting agenda will be available as soon
as possible, but no later than mid-to late
May 2005. 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, from the FIFRA
SAP Internet Home Page at https://
www.epa.gov/scipoly/sap.
An electronic version of the public
docket is available through EPA’s
electronic public docket and comment
system, EPA Dockets. You may use EPA
Dockets at https://www.epa.gov/edocket/
to submit or view public comments,
access the index listing of the contents
of the official public docket, and to
access those documents in the public
docket that are available electronically.
Once in the system, select ‘‘search,’’
then key in the appropriate docket ID
number.
Certain types of information will not
be placed in EPA Dockets. Information
claimed as CBI and other information
whose disclosure is restricted by statute,
which is not included in the official
public docket, will not be available for
public viewing in EPA’s electronic
public docket. EPA’s policy is that
copyrighted material will not be placed
in EPA’s electronic public docket but
will be available only in printed, paper
form in the official public docket. To the
extent feasible, publicly available
docket materials will be made available
in EPA’s electronic public docket. When
a document is selected from the index
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list in EPA Dockets, the system will
identify whether the document is
available for viewing in EPA’s electronic
public docket. Although not all docket
materials may be available
electronically, you may still access any
of the publicly available docket
materials through the docket facility
identified in Unit I.B.1. EPA intends to
work towards providing electronic
access to all of the publicly available
docket materials through EPA’s
electronic public docket.
For public commenters, it is
important to note that EPA’s policy is
that public comments, whether
submitted electronically or in paper,
will be made available for public
viewing in EPA’s electronic public
docket as EPA receives them and
without change, unless the comment
contains copyrighted material, CBI, or
other information whose disclosure is
restricted by statute. When EPA
identifies a comment containing
copyrighted material, EPA will provide
a reference to that material in the
version of the comment that is placed in
EPA’s electronic public docket. The
entire printed comment, including the
copyrighted material, will be available
in the public docket.
Public comments submitted on
computer disks that are mailed or
delivered to the docket will be
transferred to EPA’s electronic public
docket. Public comments in hard copy
that are mailed or delivered to the
docket will be scanned and placed in
EPA’s electronic public docket. Where
practical, physical objects will be
photographed, and the photograph will
be placed in EPA’s electronic public
docket along with a brief description
written by the docket staff.
C. How and to Whom Do I Submit
Comments?
You may submit comments
electronically (preferred), through hand
delivery/courier, or by mail. To ensure
proper receipt by EPA, identify the
appropriate docket ID number in the
subject line on the first page of your
comment. Please ensure that your
comments are submitted within the
specified comment period. Comments
received after the close of the comment
period will be marked ‘‘late.’’ EPA is not
required to consider these late
comments. Do not use EPA Dockets or
e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an
electronic comment as prescribed in this
unit, EPA recommends that you include
your name, mailing address, and an email address or other contact
information in the body of your
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comment. Also include this contact
information on the outside of any disk
or CD ROM you submit, and in any
cover letter accompanying the disk or
CD ROM. This ensures that you can be
identified as the submitter of the
comment and allows EPA to contact you
in case EPA cannot read your comment
due to technical difficulties or needs
further information on the substance of
your comment. EPA’s policy is that EPA
will not edit your comment, and any
identifying or contact information
provided in the body of a comment will
be included as part of the comment that
is placed in the official public docket,
and made available in EPA’s electronic
public docket. 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.
i. EPA Dockets. Your use of EPA’s
electronic public docket to submit
comments to EPA electronically is
EPA’s preferred method for receiving
comments. Go directly to EPA Dockets
at https://www.epa.gov/edocket/, and
follow the online instructions for
submitting comments. Once in the
system, select ‘‘search,’’ and then key in
docket ID number OPP–2005–0102. The
system is an ‘‘anonymous access’’
system, which means EPA will not
know your identity, e-mail address, or
other contact information unless you
provide it in the body of your comment.
ii. E-mail. Comments may be sent by
e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP–
2005–0102. In contrast to EPA’s
electronic public docket, EPA’s e-mail
system is not an ‘‘anonymous access’’
system. If you send an e-mail comment
directly to the docket without going
through EPA’s electronic public docket,
EPA’s e-mail system automatically
captures your e-mail address. E-mail
addresses that are automatically
captured by EPA’s e-mail system are
included as part of the comment that is
placed in the official public docket, and
made available in EPA’s electronic
public docket.
iii. Disk or CD ROM. You may submit
comments on a disk or CD ROM that
you deliver as described in Unit I.C.2 or
mail to the address provided in Unit
I.C.3. These electronic submissions will
be accepted in WordPerfect or ASCII file
format. Avoid the use of special
characters and any form of encryption.
2. By hand delivery or courier. Deliver
your comments to: Public Information
and Records Integrity Branch (PIRIB),
Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm.
119, Crystal Mall #2, 1801 South Bell
St., Arlington, VA, Attention: Docket ID
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Number OPP–2005–0102. Such
deliveries are only accepted during the
docket’s normal hours of operation as
identified in Unit I.B.1.
3. By mail. Due to potential delays in
EPA’s receipt and processing of mail,
respondents are strongly encouraged to
submit comments either electronically
or by hand delivery or courier. We
cannot guarantee that comments sent
via mail will be received prior to the
close of the comment period. If mailed,
please send your comments to: Public
Information and Records Integrity
Branch (PIRIB) (7502C), Office of
Pesticide Programs (OPP),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001, Attention: Docket ID
Number OPP–2005–0102.
D. What Should I Consider as I Prepare
My Comments for EPA?
You may find the following
suggestions helpful for preparing your
comments:
1. Explain your views as clearly as
possible.
2. Describe any assumptions that you
used.
3. Provide copies of any technical
information and/or data you used that
support your views.
4. Provide specific examples to
illustrate your concerns.
5. Make sure to submit your
comments by the deadline in this
document.
6. To ensure proper receipt by EPA,
be sure to identify the docket ID number
assigned to this action in the subject
line on the first page of your response.
You may also provide the name, date,
and Federal Register citation.
E. 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 OPP–2005–0102 in the
subject line on the first page of your
request.
1. Oral comments. Oral comments
presented at the meetings should not be
repetitive of previously submitted oral
or written comments. Although requests
to present oral comments are accepted
until the date of the meeting (unless
otherwise stated), to the extent that time
permits, interested persons may be
permitted by the Chair of FIFRA SAP to
present oral comments at the meeting.
Each individual or group wishing to
make brief oral comments to FIFRA SAP
is strongly advised to submit their
request to the DFO listed under FOR
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no later
than noon, eastern time, June 7, 2005, in
order to be included on the meeting
agenda. 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
FIFRA SAP at the meeting.
2. Written comments. Although
written comments are accepted until the
date of the meeting (unless otherwise
stated), the Agency encourages that
written comments be submitted, using
the instructions in Unit I.C., no later
than noon, eastern time, May 31, 2005,
to provide FIFRA SAP the time
necessary to consider and review the
written comments. The DFO listed
under FOR FURTHER INFORMATION
CONTACT should be notified that
comments have been submitted to the
docket or a courtesy copy of the
comments should be provided to the
DFO. There is no limit on the extent of
written comments for consideration by
FIFRA SAP.
3. Seating at the meeting. Seating at
the meeting will be on a first-come
basis. Individuals requiring special
accommodations at this meeting,
including wheelchair access and
assistance for the hearing impaired,
should contact the DFO at least 5
business days prior to the meeting using
the information under FOR FURTHER
INFORMATION CONTACT so that
appropriate arrangements can be made.
4. Request for nominations of
prospective candidates for service as ad
hoc members of the FIFRA SAP for this
meeting. As part of a broader process for
developing a pool of candidates for each
meeting, the FIFRA SAP staff routinely
solicit the stakeholder community for
nominations of prospective candidates
for service as ad hoc members of the
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:
cholinesterase inhibition and recovery,
pharmacokinetics/pharmocodynamics,
statistics, exposure modeling. Nominees
should be scientists who have sufficient
professional qualifications, including
training and experience, to be capable of
providing expert comments on the
FURTHER INFORMATION CONTACT
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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 May 9, 2005. The Agency will
consider all nominations of prospective
candidates for this meeting that are
received on or before this date.
However, final selection of ad hoc
members for this meeting is a
discretionary function of the Agency.
The selection of scientists to serve on
the FIFRA SAP is based on the function
of the panel and the expertise needed to
address the Agency’s charge to the
panel. No interested scientists shall be
ineligible to serve by reason of their
membership on any other advisory
committee to a Federal department or
agency or their employment by a
Federal department or agency (except
the EPA). Other factors considered
during the selection process include
availability of the potential panel
member to fully participate in the
panel’s reviews, absence of any conflicts
of interest or appearance of lack of
impartiality, independence with respect
to the matters under review, and lack of
bias. Though financial conflicts of
interest, the appearance of lack of
impartiality, lack of independence, and
bias may result in disqualification, the
absence of such concerns does not
assure that a candidate will be selected
to serve on the FIFRA SAP. Numerous
qualified candidates are identified for
each panel. Therefore, selection
decisions involve carefully weighing a
number of factors including the
candidates’ areas of expertise and
professional qualifications and
achieving an overall balance of different
scientific perspectives on the panel. In
order to have the collective breadth of
experience needed to address the
Agency’s charge for this meeting, the
Agency anticipates selecting
approximately 10 ad hoc scientists.
If a prospective candidate for service
on the FIFRA SAP is considered for
participation in a particular session, the
candidate is subject to the provisions of
5 CFR part 2634, Executive Branch
Financial Disclosure, as supplemented
by the EPA in 5 CFR part 6401. As such,
the FIFRA SAP candidate is required to
submit a Confidential Financial
Disclosure Form for Special
Government Employees Serving on
Federal Advisory Committees at EPA
(EPA Form 3110–48 5–02) 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 candidate’s
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financial disclosure form to assess that
there are no financial conflicts of
interest, no appearance of lack of
impartiality and no prior involvement
with the development of the documents
under consideration (including previous
scientific peer review) before the
candidate is considered further for
service on the FIFRA SAP.
Those who are selected from the pool
of prospective candidates will be asked
to attend the public meetings and to
participate in the discussion of key
issues and assumptions at these
meetings. In addition, they will be asked
to review and to help finalize the
meeting minutes. The list of FIFRA SAP
members participating at this meeting
will be posted on the FIFRA SAP web
site or may be obtained by contacting
the PIRIB at the address or telephone
number listed in Unit I.
II. Background
A. Purpose of the FIFRA SAP
Amendments to FIFRA enacted
November 28, 1975 (7 U.S.C. 136w(d)),
include a requirement under section
25(d) of FIFRA that notices of intent to
cancel or reclassify pesticide
registrations pursuant to section 6(b)(2)
of FIFRA, as well as proposed and final
forms of regulations pursuant to section
25(a) of FIFRA, be submitted to a SAP
prior to being made public or issued to
a registrant. In accordance with section
25(d) of FIFRA, the FIFRA SAP is to
have an opportunity to comment on the
health and environmental impact of
such actions. The FIFRA SAP also shall
make comments, evaluations, and
recommendations for operating
guidelines to improve the effectiveness
and quality of analyses made by Agency
scientists. Members are scientists who
have sufficient professional
qualifications, including training and
experience, to be capable of providing
expert comments as to the impact on
health and the environment of
regulatory actions under sections 6(b)
and 25(a) of FIFRA. The Deputy
Administrator appoints seven
individuals to serve on the FIFRA SAP
for staggered terms of 4 years, based on
recommendations from the National
Institutes of Health and the National
Science Foundation.
Section 104 of FQPA (Public Law
104–170) established the FQPA Science
Review Board (SRB). These scientists
shall be available to the FIFRA SAP on
an ad hoc basis to assist in reviews
conducted by the FIFRA SAP.
B. Public Meeting
Acute dietary exposure to pesticides
is currently assessed using probabilistic
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models (DEEM–FCID, LifeLine, CARES)
that combine the entire distributions of
consumption and residue data. These
models perform exposure assessments
using total daily 24 hour consumption
amounts. It is known, however, that the
acute toxic effects of certain classes of
chemicals are rapidly reversible. In the
case of cholinesterase inhibition by
carbamates, reversibility occurs within
minutes to hours. Thus, the effect of
exposure to carbamates should be
assessed using consumption data that
refer to single eating occasions, or
shorter periods of time (less than 24
hours) to reflect the toxicology profiles
of these compounds. The FIFRA
Scientific Advisory Panel (February
1999) concurred with the validity of
using the time-dependent recovery of
acetylcholinesterase to assess risks from
repeated exposures to aldicarb.
Recent advances in modeling have
provided the capability to conduct
exposure modeling in periods less than
24 hours. Two modules, designed for
compatibility with the CARES model
maintained by the International Life
Sciences Institute, will be presented.
The first module, referred to as the
Dietary Minute Module (DMM) allocates
daily consumption amount for an
individual by minute of a day as
recorded in the CSFII database. A user
determined elapsed time interval is then
applied that reflects the reversibility of
cholinesterase activity for the carbamate
of interest based on pharmacodynamic
or toxicological studies. The time
entered defines discrete eating
occasions for an individual’s day. Each
discrete eating occasion ends when a
period of consumption is followed by an
elapsed time interval in which no
consumption of carbamate residues has
occurred. A distribution of exposure for
all individuals’ discrete eating occasions
within a day for all days and
individuals in the population of interest
is then created. The second module,
referred to as the Cholinesterase
Activity Module (CAM), is a refinement
of the DMM. It incorporates the time
course for reversibility of exposure to an
acetylcholinesterase inhibitor, rather
than assuming a fixed elapsed time
period. Time dependent changes in
exposure are determined from
corresponding changes in
acetylcholinesterase activity. A more
realistic estimate of exposure can then
be calculated from a summation of
residual activity from all eating events.
C. FIFRA SAP Meeting Minutes
The FIFRA SAP will prepare meeting
minutes summarizing its
recommendations to the Agency in
approximately 90 days after the
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21749
meeting. The meeting minutes will be
posted on the FIFRA SAP web site or
may be obtained by contacting the PIRIB
at the address or telephone number
listed in Unit I.
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: April 19, 2005.
Clifford J. Gabriel,
Director, Office of Science Coordination and
Policy.
[FR Doc. 05–8377 Filed 4–26–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0101; FRL–7712–9]
Pesticide Program Dialogue
Committee and Consumer Pesticide
Label Improvement Work Group;
Notice of Public Meetings
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: Pursuant to the Federal
Advisory Committee Act, EPA gives
notice of a public meeting of the
Pesticide Program Dialogue Committee
(PPDC) on May 11, and 12, 2005. A draft
agenda has been developed and is
posted on EPA’s web site. Agenda topics
will include: Environmental Indicators
and Results; Worker Safety Activities;
Endangered Species; a report from
PPDC’s Registration Review Work
Group and the PRIA (Pesticide
Registration Improvement Act) Process
Improvements Work Group; program
updates on Registration, Reregistration/
Tolerance Reassessment, Fumigants,
Human Studies, Mosquito Labeling,
Spray Drift, Globally Harmonized
System of Classification and Labeling of
Chemicals (GHS), and Data
Requirements for Registration (40 CFR
part 158).
The PPDC Consumer Pesticide Label
Improvement Work Group will meet on
May 12, 2005. An agenda for this
meeting has been developed and is
posted on EPA’s website.
DATES: The PPDC meeting will be held
on Wednesday, May 11, 2005 from 9
a.m. to 5 p.m., and on Thursday, May
12, 2005, from 9 a.m. to 1 p.m.
The PPDC Consumer Pesticide Label
Improvement Work Group will meet on
Thursday, May 12, 2005, from 1 p.m. to
5 p.m.
ADDRESSES: Both meetings will be held
at the National Press Club, 529 14th St.,
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[Federal Register Volume 70, Number 80 (Wednesday, April 27, 2005)]
[Notices]
[Pages 21746-21749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8377]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0102; FRL-7710-7]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: There will be a 2-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review carbamate dietary exposure assessment incorporating
cholinesterase recovery into CARES-compatible modules.
DATES: The meeting will be held on June 14-15, 2005, from 8:30 a.m. to
approximately 5 p.m., eastern time.
Comments: For the deadlines for the submission of requests to
present oral comments and the submission of written comments, see Unit
I.E. of the SUPPLEMENTARY INFORMATION.
Nominations: Nominations of scientific experts to serve as ad hoc
members of the FIFRA SAP for this meeting should be provided on or
before May 9, 2005.
Special seating: Requests for special seating arrangements should
be made at least 5 business days prior to the meeting.
ADDRESSES: The meeting will be held at the Holiday Inn-National
Airport, 2650 Jefferson Davis Highway, Arlington,VA 22202. The
telephone number for the Holiday Inn-National Airport is (703) 684-
7200.
Comments: Written comments may be submitted electronically
(preferred), through hand delivery/courier, or by mail. Follow the
detailed instructions as provided in Unit I. of the SUPPLEMENTARY
INFORMATION.
Nominations, requests to present oral comments, and special
seating: To submit nominations for ad hoc members of the FIFRA SAP for
this meeting, requests for special seating arrangements, or requests to
present oral comments, notify the Designated Federal Official (DFO)
listed under FOR FURTHER INFORMATION CONTACT. To ensure proper receipt
by EPA, your request must identify docket ID number OPP-2005-0102 in
the subject line on the first page of your request.
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; 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. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action
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under docket ID number OPP-2005-0102. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although, a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr/.
EPA's position paper, charge/questions to FIFRA SAP, FIFRA SAP
composition (i.e., members and consultants for this meeting), and the
meeting agenda will be available as soon as possible, but no later than
mid-to late May 2005. 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, from the FIFRA SAP
Internet Home Page at https://www.epa.gov/scipoly/sap.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at https://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments in hard copy that are mailed or delivered to
the docket will be scanned and placed in EPA's electronic public
docket. Where practical, physical objects will be photographed, and the
photograph will be placed in EPA's electronic public docket along with
a brief description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically (preferred), through hand
delivery/courier, or by mail. To ensure proper receipt by EPA, identify
the appropriate docket ID number in the subject line on the first page
of your comment. Please ensure that your comments are submitted within
the specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. Do not use EPA Dockets or e-mail to submit CBI or
information protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. 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.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at https://www.epa.gov/
edocket/, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2005-0102. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2005-0102. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you deliver as described in Unit I.C.2 or mail to the address
provided in Unit I.C.3. These electronic submissions will be accepted
in WordPerfect or ASCII file format. Avoid the use of special
characters and any form of encryption.
2. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 South Bell St., Arlington, VA, Attention: Docket ID
[[Page 21748]]
Number OPP-2005-0102. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
3. By mail. Due to potential delays in EPA's receipt and processing
of mail, respondents are strongly encouraged to submit comments either
electronically or by hand delivery or courier. We cannot guarantee that
comments sent via mail will be received prior to the close of the
comment period. If mailed, please send your comments to: Public
Information and Records Integrity Branch (PIRIB) (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID
Number OPP-2005-0102.
D. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. Provide specific examples to illustrate your concerns.
5. Make sure to submit your comments by the deadline in this
document.
6. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
E. 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 OPP-2005-0102 in the subject line on the
first page of your request.
1. Oral comments. Oral comments presented at the meetings should
not be repetitive of previously submitted oral or written comments.
Although requests to present oral comments are accepted until the date
of the meeting (unless otherwise stated), to the extent that time
permits, interested persons may be permitted by the Chair of FIFRA SAP
to present oral comments at the meeting. Each individual or group
wishing to make brief oral comments to FIFRA SAP is strongly advised to
submit their request to the DFO listed under FOR FURTHER INFORMATION
CONTACT no later than noon, eastern time, June 7, 2005, in order to be
included on the meeting agenda. 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 FIFRA SAP at the meeting.
2. Written comments. Although written comments are accepted until
the date of the meeting (unless otherwise stated), the Agency
encourages that written comments be submitted, using the instructions
in Unit I.C., no later than noon, eastern time, May 31, 2005, to
provide FIFRA SAP the time necessary to consider and review the written
comments. The DFO listed under FOR FURTHER INFORMATION CONTACT should
be notified that comments have been submitted to the docket or a
courtesy copy of the comments should be provided to the DFO. There is
no limit on the extent of written comments for consideration by FIFRA
SAP.
3. Seating at the meeting. Seating at the meeting will be on a
first-come basis. Individuals requiring special accommodations at this
meeting, including wheelchair access and assistance for the hearing
impaired, should contact the DFO at least 5 business days prior to the
meeting using the information under FOR FURTHER INFORMATION CONTACT so
that appropriate arrangements can be made.
4. Request for nominations of prospective candidates for service as
ad hoc members of the FIFRA SAP for this meeting. As part of a broader
process for developing a pool of candidates for each meeting, the FIFRA
SAP staff routinely solicit the stakeholder community for nominations
of prospective candidates for service as ad hoc members of the 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: cholinesterase inhibition and
recovery, pharmacokinetics/pharmocodynamics, statistics, exposure
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 May 9,
2005. The Agency will consider all nominations of prospective
candidates for this meeting that are received on or before this date.
However, final selection of ad hoc members for this meeting is a
discretionary function of the Agency.
The selection of scientists to serve on the FIFRA SAP is based on
the function of the panel and the expertise needed to address the
Agency's charge to the panel. No interested scientists shall be
ineligible to serve by reason of their membership on any other advisory
committee to a Federal department or agency or their employment by a
Federal department or agency (except the EPA). Other factors considered
during the selection process include availability of the potential
panel member to fully participate in the panel's reviews, absence of
any conflicts of interest or appearance of lack of impartiality,
independence with respect to the matters under review, and lack of
bias. Though financial conflicts of interest, the appearance of lack of
impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on the FIFRA SAP. Numerous
qualified candidates are identified for each panel. Therefore,
selection decisions involve carefully weighing a number of factors
including the candidates' areas of expertise and professional
qualifications and achieving an overall balance of different scientific
perspectives on the panel. In order to have the collective breadth of
experience needed to address the Agency's charge for this meeting, the
Agency anticipates selecting approximately 10 ad hoc scientists.
If a prospective candidate for service on the FIFRA SAP is
considered for participation in a particular session, the candidate is
subject to the provisions of 5 CFR part 2634, Executive Branch
Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. As
such, the FIFRA SAP candidate is required to submit a Confidential
Financial Disclosure Form for Special Government Employees Serving on
Federal Advisory Committees at EPA (EPA Form 3110-48 5-02) 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 candidate's
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financial disclosure form to assess that there are no financial
conflicts of interest, no appearance of lack of impartiality and no
prior involvement with the development of the documents under
consideration (including previous scientific peer review) before the
candidate is considered further for service on the FIFRA SAP.
Those who are selected from the pool of prospective candidates will
be asked to attend the public meetings and to participate in the
discussion of key issues and assumptions at these meetings. In
addition, they will be asked to review and to help finalize the meeting
minutes. The list of FIFRA SAP members participating at this meeting
will be posted on the FIFRA SAP web site or may be obtained by
contacting the PIRIB at the address or telephone number listed in Unit
I.
II. Background
A. Purpose of the FIFRA SAP
Amendments to FIFRA enacted November 28, 1975 (7 U.S.C. 136w(d)),
include a requirement under section 25(d) of FIFRA that notices of
intent to cancel or reclassify pesticide registrations pursuant to
section 6(b)(2) of FIFRA, as well as proposed and final forms of
regulations pursuant to section 25(a) of FIFRA, be submitted to a SAP
prior to being made public or issued to a registrant. In accordance
with section 25(d) of FIFRA, the FIFRA SAP is to have an opportunity to
comment on the health and environmental impact of such actions. The
FIFRA SAP also shall make comments, evaluations, and recommendations
for operating guidelines to improve the effectiveness and quality of
analyses made by Agency scientists. Members are scientists who have
sufficient professional qualifications, including training and
experience, to be capable of providing expert comments as to the impact
on health and the environment of regulatory actions under sections 6(b)
and 25(a) of FIFRA. The Deputy Administrator appoints seven individuals
to serve on the FIFRA SAP for staggered terms of 4 years, based on
recommendations from the National Institutes of Health and the National
Science Foundation.
Section 104 of FQPA (Public Law 104-170) established the FQPA
Science Review Board (SRB). These scientists shall be available to the
FIFRA SAP on an ad hoc basis to assist in reviews conducted by the
FIFRA SAP.
B. Public Meeting
Acute dietary exposure to pesticides is currently assessed using
probabilistic models (DEEM-FCID, LifeLine, CARES) that combine the
entire distributions of consumption and residue data. These models
perform exposure assessments using total daily 24 hour consumption
amounts. It is known, however, that the acute toxic effects of certain
classes of chemicals are rapidly reversible. In the case of
cholinesterase inhibition by carbamates, reversibility occurs within
minutes to hours. Thus, the effect of exposure to carbamates should be
assessed using consumption data that refer to single eating occasions,
or shorter periods of time (less than 24 hours) to reflect the
toxicology profiles of these compounds. The FIFRA Scientific Advisory
Panel (February 1999) concurred with the validity of using the time-
dependent recovery of acetylcholinesterase to assess risks from
repeated exposures to aldicarb.
Recent advances in modeling have provided the capability to conduct
exposure modeling in periods less than 24 hours. Two modules, designed
for compatibility with the CARES model maintained by the International
Life Sciences Institute, will be presented. The first module, referred
to as the Dietary Minute Module (DMM) allocates daily consumption
amount for an individual by minute of a day as recorded in the CSFII
database. A user determined elapsed time interval is then applied that
reflects the reversibility of cholinesterase activity for the carbamate
of interest based on pharmacodynamic or toxicological studies. The time
entered defines discrete eating occasions for an individual's day. Each
discrete eating occasion ends when a period of consumption is followed
by an elapsed time interval in which no consumption of carbamate
residues has occurred. A distribution of exposure for all individuals'
discrete eating occasions within a day for all days and individuals in
the population of interest is then created. The second module, referred
to as the Cholinesterase Activity Module (CAM), is a refinement of the
DMM. It incorporates the time course for reversibility of exposure to
an acetylcholinesterase inhibitor, rather than assuming a fixed elapsed
time period. Time dependent changes in exposure are determined from
corresponding changes in acetylcholinesterase activity. A more
realistic estimate of exposure can then be calculated from a summation
of residual activity from all eating events.
C. FIFRA SAP Meeting Minutes
The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency in approximately 90 days after the
meeting. The meeting minutes will be posted on the FIFRA SAP web site
or may be obtained by contacting the PIRIB at the address or telephone
number listed in Unit I.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: April 19, 2005.
Clifford J. Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. 05-8377 Filed 4-26-05; 8:45 am]
BILLING CODE 6560-50-S