[Federal Register Volume 68, Number 104 (Friday, May 30, 2003)]
[Notices]
[Pages 32490-32493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13434]


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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).

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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: [email protected].

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.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 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

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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 [email protected], 
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]
BILLING CODE 6560-50-S