[Federal Register Volume 68, Number 183 (Monday, September 22, 2003)]
[Notices]
[Pages 55048-55051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24124]


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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:[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.

[[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 [email protected], 
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