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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: September 26, 2003 (Volume 68, Number 187)]
[Notices]
[Page 55606-55609]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-63]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0316; FRL-7327-8]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review probabilistic exposure and risk assessment for
children who contact chromated copper arsenate (CCA)-treated wood on
playsets and decks and CCA-containing soil around these structures.
DATES: The meeting will be held from December 3-5, 2003, from 8:30
a.m. to 5 p.m, eastern standard time.
Comments. Deadlines for submission of requests to present oral
comments and submission of written comments, see Unit I.F. of the
SUPPLEMENTARY INFORMATION.
Nominations. Requests for nominations to serve as an ad hoc member
of the FIFRA SAP for the meetings should be provided on or before
October 10, 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 Highway, Arlington, VA 22202. 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 an ad hoc member of the
FIFRA SAP for the meetings, 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-2003-0316 in the subject line on the first page of
your response.
FOR FURTHER INFORMATION CONTACT: Paul Lewis, DFO, Office of Science
Coordination and Policy (7202M), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202)
564-8450; fax number: (202) 564-8450; e-mail address: lewis.paul@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 ID number OPP-2003-0316. 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/.
A meeting agenda relevant to this meeting is now available. EPA's
position paper, charge/questions to FIFRA SAP, and FIFRA SAP
composition (i.e., members and ad-hoc members for this meeting) will be
available as soon as possible, but no later than late 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.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.
For public commenters, it is important to note that EPA's policy
is that public comments, whether submitted electronically or on paper,
will be made available for public viewing in EPA's electronic public
[[Page 55607]]
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 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?
In accordance with the Federal Advisory Committee Act (FACA), the
public is encouraged to submit written comment on the topic of this
meeting. You may submit comments electronically, by mail, or through
hand delivery/courier. EPA would normally accept requests by mail, but
in this time of delays in delivery of government mail due to health and
security concerns, EPA cannot assure your request would arrive in a
timely manner. 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. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. 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-2002-0316. 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-2003-0316. 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-2003-0316.
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-2003-0316. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. 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. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the notice or collection
activity.
7. Make sure to submit your comments by the deadline in this
document.
8. 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.
[[Page 55608]]
F. How May I Participate in this Meeting?
You may participate in this meeting by following the instructions
in this unit. For submission of CBI, see Unit I.D. To ensure proper
receipt by EPA, it is imperative that you identify docket ID number
OPP-2003-0316 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 standard time, November 25, 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 standard time,
November 25, 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 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 nominated should have expertise in
one or more of the following areas: Children's exposure and activities;
bioavailability; dermal absorption; probabilistic exposure and
probabilistic risk assessment. 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 by October 10,
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. EPA will evaluate the nominee's financial
disclosure form to assess that there are no formal conflict of
interests 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; a decision on FIFRA
SAP members for the 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.
The FIFRA SAP will meet to consider and review the Agency's
exposure and risk assessment for children exposed to CCA-treated wood
on public playsets and residential decks and playsets and CCA-
containing soil around these structures. The EPA exposure and risk
assessment takes into consideration recent reviews by the Panel
analyzing (1) the Agency's preliminary evaluation of the non-dietary
hazard and exposure
[[Page 55609]]
to children from contact with CCA-treated wood playground structures
(October 2001 FIFRA SAP meeting); and (2) a scenario specific model
(SHEDS-Wood) to estimate children's exposure and dose to wood
preservatives from treated playsets and residential decks (August 2002
FIFRA SAP meeting). This SAP review is part of the Agency's ongoing
reregistration process for CCA-treated wood.
The Agency requests that the Panel review:
1. The revised methodology for conducting the probabilistic
exposure assessment using EPA's SHEDS-Wood model, including whether
FIFRA SAP comments on the SHEDS-Wood model and inputs (August 2002
FIFRA SAP meeting) have been appropriately addressed in the CCA risk
assessment.
2. SHEDS-Wood model predictions for arsenic and chromium exposure
and dose for the population of interest, including both variability and
uncertainty.
3. Strengths and limitations of exposure, dose and risk assessment
aproaches and results that rely upon probabilistic exposure and dose
estimation methodologies.
To assist the FIFRA SAP in their review, each FIFRA SAP member
will be provided CD(s) containing a technical report describing the
SHEDS-Wood probabilistic CCA exposure assessment, annotated SHEDS-Wood
code, and a technical report presenting the probabilistic CCA risk
assessment. These material will also be available to the public via the
docket as described under SUPPLEMENTARY INFORMATION.
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 17, 2003.
Joseph J. Merenda,
Director, Office of Science Coordination and Policy.
[FR Doc. 03-24402 Filed 9-25-03; 8:45 am]
BILLING CODE 6560-50-S