[Federal Register: September 22, 2003 (Volume 68, Number 183)]
[Notices]
[Page 55048-55051]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22se03-54]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0302; FRL-7327-2]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 2-day consultation 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 October 28-29, 2003, from 8:30 a.m.
to approximately 5 p.m.
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 October 2, 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 Holiday Inn Hotel, 1900
North Fort Myer Drive, Arlington, VA. The telephone number for the
Holiday Inn Hotel is (703) 807-2000.
Comments. Written comments may be submitted electronically 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 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-2003-0302 in the subject line on the first page of
your response.
FOR FURTHER INFORMATION CONTACT: Myrta R. 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 addresses: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.
[[Page 55049]]
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-2003-0302. 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 the 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 October, 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.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 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 delivered to
the docket will be transferred to EPA's electronic public docket.
Public comments in hard copy that are 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 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. 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-2003-0302. 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-2003-0302. 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. These electronic
submissions will be accepted in WordPerfect or ASCII file format. Avoid
the use of special characters and any form of encryption.
2. By hand delivery or courier. Deliver your comments to: Public
Information
[[Page 55050]]
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-2003-0302. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1. For
questions about delivery options, please contact the DFO listed under
FOR FURTHER INFORMATION CONTACT.
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-2003-0302 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, October 21, 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. To the extent that time permits,
interested persons may be permitted by the Chair of the FIFRA SAP to
present oral comments at the meeting. 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.C., no later than noon, eastern time, October
21, 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 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 EPA). Individuals nominated should have expertise in one
or more of the following areas: toxicology, in vitro test methods, and
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 October 2, 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 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. 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 a Special Government
Employee. 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) 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
[[Page 55051]]
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 FIFRA Scientific Advisory Panel will meet to consider and
review issues concerned with processes for regulatory acceptance of and
ensuring the quality of data from in vitro tests used as alternatives
to animal studies for regulatory purposes. A number of such in vitro
methods have been developed or are under development that use ex vivo
tissues, cell cultures, or biological constructs as target tissues.
Some in vitro methods are being developed and marketed as proprietary
test methods. Consistent with its goal of obtaining scientifically
sound test data for hazard and risk assessment of pesticides and toxic
chemicals, EPA is exploring what changes in current policies and
procedures may be needed to facilitate the acceptance of data developed
using in vitro alternatives.
In vitro alternatives to animal testing pose some new issues
regarding assurance of the reliability and quality of test data. To
ensure their ability to detect the adverse effect of concern, new in
vitro methods typically undergo substantial validation testing before
being accepted for regulatory use. However, subsequent changes in the
ingredients or processes used to prepare the test system or shifts in
the methods or criteria used to interpret the test outcome could lead
to failure of the test to perform as it did during the validation.
Therefore, a process is needed to ensure consistency and reliability of
test performance. In addition, EPA wishes to establish a process and
criteria under which additional methods that are mechanistically and
functionally similar to an already validated method can seek to qualify
for regulatory acceptance without repeating the full range of
validation studies initially conducted to qualify that testing
approach.
EPA will consult with the Panel regarding these issues, including
performance standards, essential test method components, and quality
control of test methods, in the context of three new in vitro assays
for dermal corrosivity which will be incorporated into its OPPTS
870.2500 test guideline for Acute Dermal Irritation. These assays are:
Corrositex[reg], the rat skin Transcutaneous Electrical Resistance
(TER) assay, and EpiDermTM/EPISKINTM.
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 serve as the Panel's report and is the formal summary of its
findings. 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: September 16, 2003.
J. Thomas McClintock,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 03-24124 Filed 9-18-03; 12:01 p.m.]
BILLING CODE 6560-50-S