FIFRA Scientific Advisory Panel; Notice of Public Meeting, 1239-1243 [05-263]
Download as PDF
<![CDATA[
Federal Register / Vol. 70, No. 4 / Thursday, January 6, 2005 / Notices
notice of intent to file a development
application allows an interested person
to file the competing application no
later than 120 days after the specified
comment date for the particular
application. A competing license
application must conform with 18 CFR
4.30(b) and 4.36.
p. Notice of Intent—A notice of intent
must specify the exact name, business
address, and telephone number of the
prospective applicant, and must include
an unequivocal statement of intent to
submit, if such an application may be
filed, either a preliminary permit
application or a development
application (specify which type of
application). A notice of intent must be
served on the applicant(s) named in this
public notice.
q. Proposed Scope of Studies Under
Permit—A preliminary permit, if issued,
does not authorize construction. The
term of the proposed preliminary permit
would be 36 months. The work
proposed under the preliminary permit
would include economic analysis,
preparation of preliminary engineering
plans, and a study of environmental
impacts. Based on the results of these
studies, the Applicant would decide
whether to proceed with the preparation
of a development application to
construct and operate the project.
r. Comments, Protests, or Motions To
Intervene—Anyone may submit
comments, a protest, or a motion to
intervene in accordance with the
requirements of Rules of Practice and
Procedure, 18 CFR 385.210, .211, .214.
In determining the appropriate action to
take, the Commission will consider all
protests or other comments filed, but
only those who file a motion to
intervene in accordance with the
Commission’s Rules may become a
party to the proceeding. Any comments,
protests, or motions to intervene must
be received on or before the specified
comment date for the particular
application.
Comments, protests and interventions
may be filed electronically via the
Internet in lieu of paper; see 18 CFR
385.2001(a)(1)(iii) and the instructions
on the Commission’s Web site under ‘‘efiling’’ link. The Commission strongly
encourages electronic filing.
s. Filing and Service of Responsive
Documents—Any filings must bear in
all capital letters the title
‘‘COMMENTS’’,
‘‘RECOMMENDATIONS FOR TERMS
AND CONDITIONS’’, ‘‘PROTEST’’, OR
‘‘MOTION TO INTERVENE’’, as
applicable, and the Project Number of
the particular application to which the
filing refers. Any of the above-named
documents must be filed by providing
VerDate jul<14>2003
15:45 Jan 05, 2005
Jkt 205001
the original and the number of copies
provided by the Commission’s
regulations to: The Secretary, Federal
Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
A copy of any motion to intervene must
also be served upon each representative
of the Applicant specified in the
particular application.
t. Agency Comments—Federal, State,
and local agencies are invited to file
comments on the described application.
A copy of the application may be
obtained by agencies directly from the
Applicant. If an agency does not file
comments within the time specified for
filing comments, it will be presumed to
have no comments. One copy of an
agency’s comments must also be sent to
the Applicant’s representatives.
Magalie R. Salas,
Secretary.
[FR Doc. E5–16 Filed 1–5–05; 8:45 am]
BILLING CODE 6717–01–P
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2004–0405; FRL–7692–2]
FIFRA Scientific Advisory Panel;
Notice of Public Meeting
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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 four major issues
associated with the N-methyl carbamate
pesticide cumulative risk assessment:
pilot cumulative analysis. On February
15–16, 2005, the FIFRA SAP will meet
to review issues associated with hazard
assessment and pharmacokinetic/
pharmacodynamic modeling; and on
February 17–18, 2005, to review ground
water models and drinking water
exposure assessment and the integration
of hazard and exposure information.
DATES: The meeting will be held on
February 15–18, 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
January 18, 2005.
Special seating. Requests for special
seating arrangements should be made at
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
1239
least 5 business days prior to the
meeting.
The meeting will be held at
the Holiday Inn, Reagan National
Airport, 2650 Jefferson Davis Highway,
Arlington, VA 22202. The telephone
number for the Holiday Inn – Reagan
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–2004–0405 in the subject line on
the first page of your request.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Myrta R. Christian for the hazard
assessment and pharmacokinetic/
pharmocodynamic modeling sessions
and Joseph E. Bailey for the drinking
water exposure assessment and the
integration of hazard and exposure
assessment sessions. DFOs, Office of
Science Coordination and Policy
(7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone
number: (202) 564–8450; fax number:
(202) 564–8382; e-mail addresses:
christian.myrta@epa.gov or
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 DFOs
listed under FOR FURTHER INFORMATION
CONTACT.
E:\FR\FM\06JAN1.SGM
06JAN1
1240
Federal Register / Vol. 70, No. 4 / Thursday, January 6, 2005 / Notices
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
under docket ID number OPP–2004–
0405. 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 (early
February 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
VerDate jul<14>2003
15:45 Jan 05, 2005
Jkt 205001
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 on 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.
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
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
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–2004–0405. 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–
2004–0405. 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.
E:\FR\FM\06JAN1.SGM
06JAN1
Federal Register / Vol. 70, No. 4 / Thursday, January 6, 2005 / Notices
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 S. Bell St.,
Arlington, VA, Attention: Docket ID
number OPP–2004–0405. 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–2004–0405.
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–2004–0405 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
VerDate jul<14>2003
15:45 Jan 05, 2005
Jkt 205001
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 appropriate
DFO listed under FOR FURTHER
INFORMATION CONTACT no later than
noon, eastern time, February 8, 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,
submission of 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, February 1, 2005, to provide
FIFRA SAP the time necessary to
consider and review the written
comments. The DFOs 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 DFOs. 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 appropriate 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
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
1241
more of the following areas:
Pharmacokinetic/pharmacodynamic
modeling, toxicology and risk
assessment, hazard assessment,
exposure assessment (particularly
drinking water), ground water
modeling/monitoring and integration of
hazard and exposure. 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 appropriate DFO
listed under FOR FURTHER INFORMATION
CONTACTon or before January 18, 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 12 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
E:\FR\FM\06JAN1.SGM
06JAN1
1242
Federal Register / Vol. 70, No. 4 / Thursday, January 6, 2005 / Notices
Financial Disclosure, as supplemented
by 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
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.
EPA will evaluate the candidate’s
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
VerDate jul<14>2003
15:45 Jan 05, 2005
Jkt 205001
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
The Food, Quality Protection Act of
1996 amended the Federal Insecticide,
Fugicide, and Rodenticide Act and the
Federal Food, Drug, and Cosmetic Act.
One of the major changes is the
requirement that EPA consider risk
posed by pesticides acting by a common
mechanism of toxicity. For such groups
of pesticides, EPA’s Office of Pesticide
Programs (OPP) has treated cumulative
risk, under FQPA, as the risk of a
common toxic effect associated with
concurrent exposure by all relevant
pathways and routes. EPA has
determined that the group of pesticides
known as the N-methyl carbamate
pesticide share a common mechanism of
toxicity, and should be treated as a
common mechanism group. Therefore,
EPA is conducting a cumulative risk
assessment that will include the
chemicals comprising this group.
At the meeting being announced by
this notice, EPA plans to discuss key
issues related to development of the
cumulative risk assessment for the Nmethyl carbamate pesticides. Those
issues are as follows: Hazard
assessment, pharmacokinetic/
pharmacodynamic (PBPK/PD) modeling
of carbaryl, drinking water exposure
assessment, and the integration of
hazard and exposure information.
C. Hazard assessment
EPA acknowledges that there are
toxicological characteristics unique to
the N-methyl carbamates which need to
be considered in a cumulative risk
assessment for this group. Specifically,
the mechanism of action for this group
of pesticides is carbamylation of the
acetylcholinesterase (AChE) active site.
This chemical change is reversible,
allowing for relatively rapid recovery
from inhibition. OPP is collaborating
with laboratory scientists and
statisticians from EPA’s National Health
and Environmental Effects Research
Laboratory (NHEERL) to evaluate
biological and empirical aspects of
recovery. EPA expects to solicit
comment from the SAP on specific
issues related to dose-response
modeling of AChE data, empirical
estimation of time to recovery, and the
impact of the laboratory method used to
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
measure AChE inhibition on estimates
of relative potency.
1. PBPK/PD modeling for carbaryl.
OPP is collaborating with scientists
from EPA’s National Exposure Research
Laboratory (NERL) to develop a PBPK/
PD model for carbaryl within the
Exposure Related Dose Estimating
Model (ERDEM) Platform (Blancato et
al., 2002; Okino et al. 2004). The
carbaryl model will form the basic
structure of a generalized model for the
N-methyl carbamates. A Quantitative
Structure Activity Relationship (QSAR)
database of physicochemical descriptors
and provisional PK and PD parameter
values has been assembled for selected
N-methyl carbamates. The completeness
and representativeness of the QSAR
database will influence the application
of the PBPK/PD model for use in the
cumulative risk assessment of the Nmethyl carbamates. EPA will solicit
comment from the SAP on specific
aspects of the appropriate use of ERDEM
for this cumulative risk assessment.
2. Drinking water exposure
assessment. Unlike the
organophosphate (OP) cumulative risk
assessment where the only anticipated
exposure to OP pesticides in drinking
water was expected to be from surface
water sources, EPA must consider both
surface water and ground water sources
of drinking water for the N-methyl
carbamates. OPP will solicit comment
from the SAP on the use of one or more
existing ground water models to provide
a pilot drinking water exposure
assessment for the N-methyl carbamates.
OPP also expects to request feedback
from the Panel on approaches for
refining regional drinking water
exposures in the event that such
exposure from surface water and/or
ground water sources contributes
substantially to the cumulative exposure
in one or more regions.
3. Integration of hazard and exposure
assessment. EPA will present to the SAP
a pilot cumulative analysis of food,
water, and residential exposure using
three different exposure models:
LifeLine, CARES, and Calendex. The
presentation will also include a
discussion of the unique challenges
related to rapid recovery from AChE
inhibition posed by this group of
pesticides and different approaches for
considering these characteristics in the
quantitative estimates of cumulative
risk. EPA expects to request the panel to
provide comment on potential
approaches for integrating hazard and
exposure for this group and specifically
characterizing recovery in risk
estimates.
E:\FR\FM\06JAN1.SGM
06JAN1
Federal Register / Vol. 70, No. 4 / Thursday, January 6, 2005 / Notices
C. FIFRA SAP Meeting Minutes
The FIFRA SAP will prepare meeting
minutes summarizing its
recommendations to the Agency in
approximately 60 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: December 28, 2004.
Joseph J. Merenda, Jr.,
Director, Office of Science Coordination and
Policy.
[FR Doc. 05–263 Filed 1–5–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–7857–9]
Science Advisory Board Staff Office
Notification of Advisory Meeting of the
Science Advisory Board Regulatory
Environmental Modeling (REM)
Guidance Review Panel
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: The Science Advisory Board
(SAB) Regulatory Environmental
Modeling (REM) Guidance Review
Panel will hold two public advisory
meetings, one teleconference and one
face-to-face meeting, to provide the
Agency advice on their Draft Guidance
and Models Knowledge Base related to
modeling activity within the EPA.
DATES: January 21, 2005 and February
7–9, 2005.
January 21, 2005 Public Conference
call: The SAB REM Guidance Review
Panel will meet on January 21, 2005, via
teleconference from 1 p.m. to 3 p.m.
(eastern standard time).
February 7–9, 2005 Public meeting:
The SAB REM Guidance Review Panel
will meet on February 7–9, 2005, in
Washington, DC. The meeting will
commence at 9 a.m. (eastern standard
time) on February 7, 2005, and adjourn
no later than 2:30 p.m. on February 9,
2005.
ADDRESSES: The public teleconference
will take place via teleconference only.
The face-to-face public meeting will
take place at the SAB Conference
Center, 1025 F Street, NW., Suite 3700,
Washington, DC 20004.
FOR FURTHER INFORMATION CONTACT: Any
member of the public who wishes to
VerDate jul<14>2003
15:45 Jan 05, 2005
Jkt 205001
obtain the teleconference call-in
numbers and access codes, would like
to submit written or brief oral comments
(5 minutes or less for the public face-toface meeting, and 3 minutes or less for
the public teleconference meeting), or
who wants further information
concerning these public meetings
should contact Dr. Jack Kooyoomjian,
Designated Federal Officer (DFO), EPA
SAB, 1200 Pennsylvania Avenue, NW.,
(MC 1400F), Washington, DC 20460; via
telephone/voice mail: (202) 343–9984;
fax: (202) 233–0643; or e-mail at:
kooyoomjian.jack@epa.gov. General
information concerning the SAB can be
found on the SAB Web site at: https://
www.epa.gov/sab.
SUPPLEMENTARY INFORMATION:
Background: Pursuant to the Federal
Advisory Committee Act, Pub. L. 92–
463, the SAB Staff Office hereby gives
notice of two public meetings of the
SAB REM Guidance Review Panel. The
EPA’s Office of Research Development
(ORD) requested that the SAB review
the Agency’s draft guidance entitled,
‘‘Draft Guidance on the Development,
Evaluation, and Application of
Regulatory Environmental Models,’’
dated November 2003 (referred to here
also as the Draft Guidance) and ‘‘Models
Knowledge Base.’’ The Draft Guidance
is for those who develop, evaluate, and
apply environmental models. It does not
impose legally binding requirements
and, depending on the circumstances,
may not apply to a particular situation.
The EPA retains the discretion to adopt
approaches that differ from the guidance
on a case-by-case basis. The Models
Knowledge Base is an inventory of
EPA’s environmental models. It
contains information about model use
and model science and is intended to be
a useful tool for environmental
modelers and managers. Additional
background information on this review
activity, such as the Federal Register
notice (68 FR 46602, August 6, 2003)
soliciting nominations for Panel
membership can be found on the SAB
Web site at: https://www.epa.gov/sab/
panels/cremgacpanel.html.
Purpose of the January 21, 2005
Public Teleconference: The purpose of
this public teleconference meeting is to
discuss the charge to the SAB REM
Guidance Review Panel; discuss
available materials and background
materials as they pertain to the charge,
discuss assignments to the Panelists,
and plan for the February 7–9, 2005
face-to-face public advisory meeting.
Purpose of the February 7–9, 2005
Public Face-to-Face Meeting: The
purpose of this meeting is to conduct a
peer review of the Agency’s Draft
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
1243
Guidance and Models Knowledge Base
and any other supplemental materials in
response to the charge questions.
Availability of Meeting Materials:
Copies of the meeting agendas, the
roster of the SAB Review Panel, and the
charge to the SAB described in this
notice will be posted on the SAB Web
site at: https://www.epa.gov/sab/panels/
cremgacpanel.html prior to each
meeting. Persons who wish to obtain
copies of the Agency’s Draft Guidance,
the Models Knowledge Base or other
materials pertinent to this advisory
activity may obtain these materials at
https://www.epa.gov/crem, or https://
www.epa.gov/crem/sab.
For further information regarding the
Agency’s Draft Guidance or Models
Knowledge Base or other relevant
background materials, please contact
Mr. Pasky Pascual of the U.S. EPA,
Office of Research & Development (Mail
Code 8102), by telephone/voice mail at
(202) 564–2259, by fax at (202) 565–
2925; or via e-mail at
pascual.pasky@epa.gov.
Providing Oral or Written Comments
at SAB Meetings: It is the policy of the
SAB Staff Office to accept written
public comments of any length, and to
accommodate oral public comments
wherever possible. The SAB Staff Office
expects the public statements presented
at its meetings will not be repetitive of
previously-submitted oral or written
statements. Oral Comments: In general,
each individual or group requesting an
oral presentation at a public face-to-face
meeting will be limited to a total time
of five minutes (unless otherwise
indicated), and three minutes at a
teleconference meeting (unless
otherwise indicated). Requests to
provide oral comments must be in
writing (e-mail, fax, or mail) and
received by the DFO no later than noon
Eastern Time five business days prior to
the meeting in order to reserve time on
the meeting agenda. Speakers should
bring at least 35 copies of their
comments and presentation slides for
distribution to the reviewers and public
at the meeting. Written Comments:
Although the SAB Staff Office accepts
written comments until the date of the
meeting (unless otherwise stated),
written comments should be received in
the SAB Staff Office no later than noon
Eastern Time five business days prior to
the meeting so that the comments may
be made available to the Panelists for
their consideration. Comments should
be supplied to the DFO (preferably by email) at the address/contact information
noted above in the following formats:
one hard copy with original signature,
and one electronic copy via e-mail
(acceptable file format: Adobe Acrobat
E:\FR\FM\06JAN1.SGM
06JAN1
]]>Agencies
[Federal Register Volume 70, Number 4 (Thursday, January 6, 2005)]
[Notices]
[Pages 1239-1243]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-263]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0405; FRL-7692-2]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: There will be a 4-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review a set of four major issues associated with the N-
methyl carbamate pesticide cumulative risk assessment: pilot cumulative
analysis. On February 15-16, 2005, the FIFRA SAP will meet to review
issues associated with hazard assessment and pharmacokinetic/
pharmacodynamic modeling; and on February 17-18, 2005, to review ground
water models and drinking water exposure assessment and the integration
of hazard and exposure information.
DATES: The meeting will be held on February 15-18, 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 January 18, 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, Reagan National
Airport, 2650 Jefferson Davis Highway, Arlington, VA 22202. The
telephone number for the Holiday Inn - Reagan 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-2004-0405 in
the subject line on the first page of your request.
FOR FURTHER INFORMATION CONTACT: Myrta R. Christian for the hazard
assessment and pharmacokinetic/pharmocodynamic modeling sessions and
Joseph E. Bailey for the drinking water exposure assessment and the
integration of hazard and exposure assessment sessions. DFOs, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number: (202) 564-8450; fax number: (202) 564-8382; e-mail addresses:
christian.myrta@epa.gov or 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 DFOs
listed under FOR FURTHER INFORMATION CONTACT.
[[Page 1240]]
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 under docket ID number OPP-2004-0405. 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
(early February 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 on 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-2004-0405. 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-2004-0405. 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.
[[Page 1241]]
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 S. Bell St., Arlington, VA, Attention: Docket ID
number OPP-2004-0405. 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-2004-0405.
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-2004-0405 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 appropriate DFO listed under FOR FURTHER
INFORMATION CONTACT no later than noon, eastern time, February 8, 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, submission of 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, February
1, 2005, to provide FIFRA SAP the time necessary to consider and review
the written comments. The DFOs 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
DFOs. 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 appropriate 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: Pharmacokinetic/pharmacodynamic
modeling, toxicology and risk assessment, hazard assessment, exposure
assessment (particularly drinking water), ground water modeling/
monitoring and integration of hazard and exposure. 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 appropriate DFO listed under FOR
FURTHER INFORMATION CONTACTon or before January 18, 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 12 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
[[Page 1242]]
Financial Disclosure, as supplemented by 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 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. EPA will evaluate the candidate's 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
The Food, Quality Protection Act of 1996 amended the Federal
Insecticide, Fugicide, and Rodenticide Act and the Federal Food, Drug,
and Cosmetic Act. One of the major changes is the requirement that EPA
consider risk posed by pesticides acting by a common mechanism of
toxicity. For such groups of pesticides, EPA's Office of Pesticide
Programs (OPP) has treated cumulative risk, under FQPA, as the risk of
a common toxic effect associated with concurrent exposure by all
relevant pathways and routes. EPA has determined that the group of
pesticides known as the N-methyl carbamate pesticide share a common
mechanism of toxicity, and should be treated as a common mechanism
group. Therefore, EPA is conducting a cumulative risk assessment that
will include the chemicals comprising this group.
At the meeting being announced by this notice, EPA plans to discuss
key issues related to development of the cumulative risk assessment for
the N-methyl carbamate pesticides. Those issues are as follows: Hazard
assessment, pharmacokinetic/pharmacodynamic (PBPK/PD) modeling of
carbaryl, drinking water exposure assessment, and the integration of
hazard and exposure information.
C. Hazard assessment
EPA acknowledges that there are toxicological characteristics
unique to the N-methyl carbamates which need to be considered in a
cumulative risk assessment for this group. Specifically, the mechanism
of action for this group of pesticides is carbamylation of the
acetylcholinesterase (AChE) active site. This chemical change is
reversible, allowing for relatively rapid recovery from inhibition. OPP
is collaborating with laboratory scientists and statisticians from
EPA's National Health and Environmental Effects Research Laboratory
(NHEERL) to evaluate biological and empirical aspects of recovery. EPA
expects to solicit comment from the SAP on specific issues related to
dose-response modeling of AChE data, empirical estimation of time to
recovery, and the impact of the laboratory method used to measure AChE
inhibition on estimates of relative potency.
1. PBPK/PD modeling for carbaryl. OPP is collaborating with
scientists from EPA's National Exposure Research Laboratory (NERL) to
develop a PBPK/PD model for carbaryl within the Exposure Related Dose
Estimating Model (ERDEM) Platform (Blancato et al., 2002; Okino et al.
2004). The carbaryl model will form the basic structure of a
generalized model for the N-methyl carbamates. A Quantitative Structure
Activity Relationship (QSAR) database of physicochemical descriptors
and provisional PK and PD parameter values has been assembled for
selected N-methyl carbamates. The completeness and representativeness
of the QSAR database will influence the application of the PBPK/PD
model for use in the cumulative risk assessment of the N-methyl
carbamates. EPA will solicit comment from the SAP on specific aspects
of the appropriate use of ERDEM for this cumulative risk assessment.
2. Drinking water exposure assessment. Unlike the organophosphate
(OP) cumulative risk assessment where the only anticipated exposure to
OP pesticides in drinking water was expected to be from surface water
sources, EPA must consider both surface water and ground water sources
of drinking water for the N-methyl carbamates. OPP will solicit comment
from the SAP on the use of one or more existing ground water models to
provide a pilot drinking water exposure assessment for the N-methyl
carbamates. OPP also expects to request feedback from the Panel on
approaches for refining regional drinking water exposures in the event
that such exposure from surface water and/or ground water sources
contributes substantially to the cumulative exposure in one or more
regions.
3. Integration of hazard and exposure assessment. EPA will present
to the SAP a pilot cumulative analysis of food, water, and residential
exposure using three different exposure models: LifeLine, CARES, and
Calendex. The presentation will also include a discussion of the unique
challenges related to rapid recovery from AChE inhibition posed by this
group of pesticides and different approaches for considering these
characteristics in the quantitative estimates of cumulative risk. EPA
expects to request the panel to provide comment on potential approaches
for integrating hazard and exposure for this group and specifically
characterizing recovery in risk estimates.
[[Page 1243]]
C. FIFRA SAP Meeting Minutes
The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency in approximately 60 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: December 28, 2004.
Joseph J. Merenda, Jr.,
Director, Office of Science Coordination and Policy.
[FR Doc. 05-263 Filed 1-5-05; 8:45 am]
BILLING CODE 6560-50-S
