SUMMARY: There will be a meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider
and review the effect of atrazine on amphibians.
DATES:
Pre-meeting teleconference: May 21, 2003, from 1 p.m. to 3 p.m, eastern standard
time.
Face-to-face meetings: June 3-5, 2003, from 8:30 a.m. to 5 p.m,
eastern standard time.
Comments: Deadlines for submission of requests to
present oral comments and submission of written comments, see Unit I.F. of the
SUPPLEMENTARY INFORMATION.
Nominations: Nominations of persons to serve
as an ad hoc member of the FIFRA SAP for the pre-meeting teleconference and
face-to-face meetings should be provided on or before March 6,
2003.
Special seating: Requests for special seating arrangements or other
special accomodations should be made at least 5 business days prior to the
meeting.
ADDRESSES: Pre-meeting teleconference: This meeting will be held
at the Environmental Protection Agency, 1201 Pennsylvania Ave., NW., EPA East
Bldg, Conference Room 4225, Washington, DC. For additional information about the
pre-meeting teleconference, including how to receive the teleconference
telephone number, contact the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT.
Face-to-face meetings:
The meeting will be held at the Sheraton Crystal City Hotel, 1800 Jefferson
Davis Highway, Arlington, VA. 22202. The telephone number for the Sheraton
Crystal City Hotel is (703) 486-1111.
Comments: Written comments may be
submitted electronically, by mail, or through hand delivery/courier. 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 to serve as an ad hoc member of the FIFRA SAP for
the pre- meeting teleconference and face-to-face meetings, or requests for
special seating arrangements, or requests to present oral comments, notify the
DFO listed under FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION
CONTACT: Paul Lewis, DFO, Office of Science Coordination and Policy (7202M),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC
20460; telephone number: (202) 564-8450; fax number: (202) 564-8382; e-mail
address: lewis.paul@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 under docket
identification (ID) number OPP-2003-0024. The official public *8594docket
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, 1921
Jefferson Davis Hwy., 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/. Meeting agendas relevant
to these meetings are now available. EPA's position paper, charge/questions to
FIFRA SAP, and FIFRA SAP composition (i.e., permanent members and ad hoc members
for this meeting) will be available as soon as possible, but no later than early
May 2003. 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 accessible through EPA
Dockets. Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public docket, also
will not be available for public viewing in EPA's electronic public docket. In
addition, 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 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, by mail, or through hand delivery/courier.
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. If you wish
to submit CBI or information that is otherwise protected by statute, please
follow the instructions in Unit I.D. 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-2003-0024. 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-2003-0024. 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 mail to the mailing address
identified in Unit I.C.2. 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 mail. Send your comments to: Public Information and
Records Integrity Branch (PIRIB) (7502C), Office *8595of
Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001, Attention: Docket ID
Number OPP-2003-0024. 3. 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, 1921
Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2003-0024.
Such deliveries are only accepted during the docket's normal hours of operation
as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI electronically
through EPA's electronic public docket or by e-mail. You may claim information
that you submit to EPA as CBI by marking any part or all of that information as
CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the specific
information that is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2. In addition to one
complete version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket and EPA's electronic public docket.
If you submit the copy that does not contain CBI on disk or
CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain
CBI. Information not marked as CBI will be included in the public docket and
EPA's electronic public docket without prior notice. If you have any questions
about CBI or the procedures for claiming CBI, please consult the person listed
under FOR FURTHER INFORMATION CONTACT.
E. 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. If
you estimate potential burden or costs, explain how you arrived at the estimate
that you provide. 5. Provide specific examples to illustrate your
concerns. 6. Offer alternative ways to improve the notice or collection
activity. 7. Make sure to submit your comments by the deadline in this
document. 8. 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. F. How May I Participate in this Meeting?
You may participate in this meeting by following the instructions in
this unit. For submission of CBI, see Unit I.D. To ensure proper receipt by EPA,
it is imperative that you identify docket ID number OPP-2003-0024 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. Each individual or group wishing to make brief oral
comments to the FIFRA SAP is strongly advised to submit their request to the DFO
listed under FOR FURTHER INFORMATION CONTACT no later than noon, eastern
standard time, May 28, 2003, 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 the FIFRA SAP are limited to approximately 5 minutes unless
prior arrangements have been made. In addition, each speaker should bring 30
copies of his or her comments and presentation slides for distribution to the
FIFRA SAP at the meeting. 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., no later than noon, eastern standard time,
May 28, 2003, to provide the FIFRA SAP the time necessary to consider and review
the written comments. There is no limit on the extent of written comments for
consideration by the FIFRA SAP. Persons wishing to submit written comments at
the meeting should contact the DFO listed under FOR FURTHER INFORMATION CONTACT
and submit 30 copies. 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, 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 persons to serve as ad hoc members of the FIFRA SAP for this
meeting. The FIFRA SAP staff routinely solicit the stakeholder community for
nominations to serve as ad hoc members of the FIFRA SAP for each meeting. Any
interested person or organization may nominate qualified individuals to serve on
the FIFRA SAP for a specific meeting. No interested person 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). Individuals nominated should have expertise in one or
more of the following areas: i. Amphibian toxicology and ecology. ii. Xenopus and/or xenopus husbandry. iii. Developmental
biology, gonadal development, and/or endocrinology. iv. Ecotoxicology and
risk assessment. Nominees should be scientists who have sufficient
professional qualifications, including training and experience, to be capable of
providing expert comments on the 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 by March 6, 2003. The criteria for selecting scientists to serve on
the FIFRA SAP are that these persons be recognized scientists-experts in their
fields; that they be as impartial and objective as possible; that they represent
an array of backgrounds and perspectives (within their disciplines); have no
financial conflict of interest; have not previously been involved with the
scientific peer review of the issue(s) presented; and that they be available to
participate fully in the review, which will be conducted over a relatively short
time frame. Nominees will be asked to attend the public meetings and to
participate in the discussion of key issues and assumptions at these meetings.
Finally, they will be asked to review and to help finalize the meeting
minutes. If a FIFRA SAP nominee is considered to assist in a review by the
FIFRA SAP for a particular session, the nominee 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 nominee is
required to submit a *8596Confidential Financial
Disclosure Form for Special Government Employees Serving on Federal Advisory
Committees at the U.S. Environmental Protection Agency (EPA Form 3110-48 5-02)
which shall fully disclose, among other financial interests, the nominee's
employment, stocks, and bonds, and where applicable, sources of research
support. EPA will evaluate the nominee's financial disclosure form to assess
that there are no formal conflict of interests before the nominee is considered
to serve on the FIFRA SAP. Selected FIFRA SAP members will be hired as a Special
Government Employee. The Agency will review all nominations; nominees who are
selected for the 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 pesticides pursuant to
section 6(b)(2) of FIFRA, as well as proposed and final forms
of rulemaking 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. Pre-meeting
Teleconference
This pre-meeting teleconference is open to the public and
seating will be on a first-come basis. The public may also attend via telephone.
For further information concerning the meeting or how to
obtain the telephone number, please contact the DFO listed under FOR FURTHER
INFORMATION CONTACT. The purpose of this public pre-meeting teleconference is
to: 1. Discuss the charge and the adequacy of the review materials provided
to the FIFRA SAP. 2. Clarify any questions and issues relating to the charge
and the review materials. 3. Discuss specific charge assignments to the
Panelists. 4. Clarify specific points of interest raised by the Panelists in
preparation for the face-to-face meetings to be held from June 3-5,
2003.
C. Face-to-Face Public Meeting
The FIFRA SAP will meet to
consider and review the effects of atrazine on amphibians. Recent research has generated
conflicting results on the effects of atrazine on gonadal developmental (e.g., male
hermaphroditism) in amphibians and how these effects influence secondary sexual
characteristics (e.g., laryngeal muscle mass). The FIFRA SAP will be asked to
consider the range of effects associated with exposure of amphibians to atrazine and to determine the
significance of these effects for risk assessment and the likely threshold
exposure value for eliciting these effects. The Agency requests the Panel to identify what additional, specific information, if any, would
significantly reduce uncertainties in determining a causal relationship between
atrazine exposure and development in
amphibians and the extent to which any changes in development can be related to
effects on survival, growth and reproductive performance. To the extent that
significant knowledge gaps or areas of variability in the existing knowledge
base are identified, the FIFRA SAP will be asked to prioritize what additional
types of data would lead to the greatest incremental reductions in risk
assessment uncertainties.
D. FIFRA SAP Meeting Minutes
The FIFRA
SAP will prepare meeting minutes summarizing its recommendations to the Agency
in approximately 60 days. 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: February 11, 2003.
Joseph J. Merenda,
Director, Office of Science
Coordination and Policy.
[FR Doc. 03-4248 Filed 2-21-03; 8:45
am]
BILLING CODE 6560-50-S
68 FR 8593-01, 2003 WL 396083
(F.R.) END OF DOCUMENT
Copr. (C) West 2003
No Claim to Orig. U.S. Govt.
Works