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FIFRA Scientific Advisory Panel; Notice of Public Meeting
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: October 24, 2003 (Volume 68, Number 206)]
[Notices]
[Page 60984-60987]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc03-87]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0338; FRL-7332-1]
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 meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review the proposed OPPTS science policy on evaluating
PPAR-alpha agonist induced rodent liver tumors.
DATES: The meeting will be held from December 9-10, 2003, from 8:30
a.m. to approximately 5 p.m.
Comments: Deadlines for 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 November 3, 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 National
Airport, 2650 Jefferson Davis Highway, Arlington, VA telephone number
is: (703) 684-7200.
Comments: Written comments may be submitted electronically
(preferred), 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 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 identification (ID) number OPP-2003-0338 in the subject line on
the first page of your response.
FOR FURTHER INFORMATION CONTACT: Steven M. Knott, DFO, Office of
Science Coordination and Policy 7201M, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (202) 564-8450; fax number: (202) 564-8382; e-mail address:
knott.steven@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
(FQPA) of 1996. 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 ID number OPP-2003-0338. 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
late November 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 EPA's 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 pulic 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
[[Page 60985]]
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-2003-0338. 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-2003-0338. 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 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-2003-0338. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
3. By mail. Due to potential delays in EPA's receipt and processing
of mail, respondents are strongly encouraged to submit comments either
electronically or by hand delivery or courier. We cannot guarantee that
comments sent via mail will be received prior to the close of the
comment period. If mailed, please 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-2003-0338. 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-2003-0338 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 FIFRA
SAP is strongly advised to submit their request to the DFO listed under
FOR FURTHER INFORMATION CONTACT no later than noon, eastern time,
December 1, 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 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 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 time, November 24,
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 FIFRA SAP. Persons wishing to submit
written comments at
[[Page 60986]]
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, especially the data/
criteria necessary to establish the PPAR-alpha agonist mode of action;
the human relevance of the PPAR-alpha agonist mode of action; and
interpretation of the PPAR-alpha agonist mode of action with respect to
the sensitivity of the young. 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
November 3, 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 EPA (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 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 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 SAP will meet to consider and review the proposed OPPTS
science policy on evaluating PPAR-alpha agonist induced rodent liver
tumors. Recent developments in the area of research on peroxisome
proliferating chemicals have led to a reevaluation of the state of the
science to characterize the mode(s) of action (i.e., PPAR-alpha-
agonism) and human relevance of rodent tumors induced by peroxisome
proliferating agents. To that end, ILSI Risk Science Institute (ILSI
RSI) convened a workgroup in 2001 (ILSI document, in press) to evaluate
new information on the association between PPAR-alpha agonism and the
induction of tumors by peroxisome proliferating chemicals. The ILSI
report provides a detailed and comprehensive analysis of the
relationship between peroxisome proliferators and liver tumorigenesis,
data on PPAR-alpha-null mice, data on the human PPAR-alpha, and
epidemiological studies evaluating the impact of prolonged exposure to
known PPAR-alpha agonists on human liver tumorigenesis. The ILSI report
also provides an evaluation of the potential role of PPAR alpha agonism
in the development of pancreatic and Leydig cell tumors. This report
provided background information which was used by OPPTS to develop a
proposed science policy regarding the data necessary to establish PPAR-
alpha induction as the MOA for PPAR agonist-induced rodent liver tumors
and the relevance of this MOA in humans including children. The Agency
will request guidance from the panel on the scientific soundness of the
proposed OPPTS science policy.
C. FIFRA SAP Meeting Minutes
The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency in approximately 60 days after the
meeting. 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.
[[Page 60987]]
Dated: October 16, 2003.
Joseph J. Merenda,
Director, Office of Science Coordination and Policy.
[FR Doc. 03-26758 Filed 10-23-03; 8:45 am]
BILLING CODE 6560-50-S