FIFRA Scientific Advisory Panel; Notice of Public Meeting
[Federal Register: May 30, 2003 (Volume 68, Number 104)]
[Notices]
[Page 32490-32493]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my03-64]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0192; FRL-7311-3]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 1-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review issues concerned with ensuring data quality for in
vitro tests used as alternatives to animal studies for regulatory
purposes.
DATES: The meeting will be held on July 16, 2003, from 8:30 a.m. to
approximately 5 p.m., eastern daylight saving time.
Comments. For the deadline 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 June 9, 2003.
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 Sheraton Crystal City Hotel,
1800 Jefferson Davis Hwy., Arlington, VA. 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 ad hoc members of the FIFRA
SAP for this meeting, or 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-
2003-0192 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: Myrta Christian, Designated Federal
Official, 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 address: christian.myrta@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-2003-0192. 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,
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 http://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 July 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 http://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 http://www.regulations.gov/ 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 the 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.
Public commenters should 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, by mail, or through hand
[[Page 32492]]
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. 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 http://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-2003-0192. 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-2003-0192. 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 of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0192.
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-2003-0192. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
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-2003-0192 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 daylight saving time, July 10,
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 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., no later than noon, eastern daylight saving
time, July 10, 2003, to provide 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 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 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
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nominated should have expertise in one or more of the following areas:
Toxicology, in vitro test methods, biostatistics. 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 on
or before June 9, 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 Confidential Financial Disclosure Form
for Special Government Employees Serving on Federal Advisory Committees
at the Environmental Protection Agency (EPA Form 3110-485-02) which
shall fully disclose, among other financial interests, the nominee's
employment, stocks, and bonds, and where applicable, sources of
research support. The EPA will evaluate the nominee's financial
disclosure form to assess that there are no formal conflicts of
interest before the nominee is considered to serve on the FIFRA SAP.
Selected FIFRA SAP members will be hired as Special Government
Employees. The Agency will review all nominations. 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 regulations 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. Face-to-Face Public Meeting
The FIFRA SAP will meet to consider and review issues concerned
with ensuring data quality for in vitro tests used as alternatives to
animal studies for regulatory purposes. Many in vitro methods have been
developed or are under development to replace animal tests.
Organizations may develop in vitro methods using ex vivo tissues or
biological constructs as the target tissue and fully disclose their
test design and the scientific principles of the test. In other cases,
in vitro methods may be developed by commercial sponsors for commercial
marketing as Proprietary Test Methods (PTM). In vitro alternatives to
animal testing pose unique issues regarding quality and performance.
Once a new in vitro method is validated and accepted for regulatory use
to characterize human health and environmental effects, a process is
needed to provide assurance that it will continue to perform in a
manner consistent with the test system as it was originally validated.
Consistency of the in vitro assay system is needed with: Time, any
change in ingredients or manufacturing process in the test system to be
marketed, or variations in interpretation of a method described only
generically in a test guideline. In addition, a process should be
developed to allow ``Me-too'' methods to qualify for regulatory use,
based on the validation originally performed for the PTM.
For this meeting, the FIFRA SAP will consider and review test
guideline approaches to address performance and quality of in vitro
methods when used as alternatives to animal studies. In addition, the
panel will consider core guideline elements, and minimum performance
and procedural standards for three new in vitro corrosivity assays.
C. 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: May 22, 2003.
Joseph J. Merenda,
Director, Office of Science Coordination and Policy.
[FR Doc. 03-13434 Filed 5-29-03; 8:45 am]
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