FIFRA Scientific Advisory Panel; Notice of Public Meeting
[Federal Register: April 16, 2004 (Volume 69, Number 74)]
[Notices]
[Page 20614-20617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ap04-53]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0099; FRL-7353-6]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 3-day meeting of the Federal Insecticide,
Fungicide,
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and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider
and review dermal sensitization issues for exposures to pesticides.
DATES: The meeting will be held from May 4 to 6, 2004, from 8:30 a.m.
to approximately 5 p.m., eastern daylight time.
Comments. For the deadlines for the submission of requests to
present oral comments and the submission of written comments, see Unit
I.E. of the SUPPLEMENTARY INFORMATION.
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 Rosslyn at Key
Bridge, 1900 North Fort Myer Drive, Arlington, VA 22209. The telephone
number for the Holiday Inn Rosslyn at Key Bridge is (703) 807-2000.
Comments. Written comments may be submitted electronically
(preferred), through hand delivery/courier, or by mail. Follow the
detailed instructions as provided in Unit I. of the SUPPLEMENTARY
INFORMATION.
Requests to present oral comments, and special seating. To submit,
requests for special seating arrangements, or requests to present oral
comments, notify the DFO listed under FOR FURTHER INFORMATION CONTACT.
To ensure proper receipt by EPA, your request must identify docket ID
number OPP-2004-0099 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: Paul Lewis, DFO, 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:
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
(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 identification (ID) number OPP-2004-0099. 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
mid April 2004. 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 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 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 (preferred), through hand
delivery/courier, or by mail. 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
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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-2004-0099. 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-2004-0099. 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 or mail to the address
provided in Unit I.C.3. 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-2004-0099. 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-2004-0099.
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-2004-0099 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 time, April 29, 2004, 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 time,
April 29, 2004, 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.
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
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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
EPA is seeking expert advice on how to evaluate general population
exposures to pesticides that are recognized to cause dermal
sensitization. Specifically, the Agency is interested in better
understanding how such exposures may induce sensitization in the
general population and how to establish criteria to protect against
unacceptable dermal reaction. The Agency is also seeking guidance from
the SAP on how such exposures impact individuals already sensitized.
The Agency is seeking this guidance in the context of addressing
exposures to potential dermal sensitizers incorporated into treated
articles (e.g., textiles and wood). Hexavalent chromium, as a component
of a pesticide product intended to be used as a wood preservative, will
be presented to the SAP as a case study to explore methodologies to
assess these types of exposure scenarios. The methods developed for
hexavalent chromium could form the basis for determining the approach/
types of data needed to assess dermal sensitizers potentially used in
products available to consumers. The SAP will meet to consider, review
and to provide expertise in advising the Agency on these general issues.
Historically, EPA has qualitatively assessed pesticide chemicals
with the potential for causing allergic contact dermatitis (ACD) for
occupational and other settings (i.e., to workers mixing, loading, and/
or applying the pesticide or exposed to the pesticide immediately
following treatment as well as residential exposures). While EPA
believes that the greatest exposures would generally occur to
individuals in occupational settings, the Agency recognizes that
following use of these chemicals in treated articles, the general
population also may be potentially at risk of ACD from dermal contact
with these chemicals. EPA has not previously used an assessment of
dermal sensitization risk for pesticides. In cases where dermal
sensitization issues arise from occupational exposure use patterns, the
Agency currently employs labeling to warn of potential sensitization
effects and/or requires use of personal protective equipment to address
the potential concerns for dermal sensitization. Due to the unique
exposures to the general public associated with treated articles, for
example a treated deck, it is not feasible to employ these labeling
approaches in order to avoid exposures for critical periods. Thus,
there is interest in developing quantitative approaches to assessing
the potential for dermal sensitization from exposure to pesticides.
EPA seeks the Panel's advice on several specific issues before
determining an appropriate scientific approach to evaluate potential
dermal sensitization risks for pesticide treated articles. The Agency
is interested in learning of any specific types of data that would be
adequate to determine the magnitude, duration, and frequency of
exposure needed to cause induction of ACD in the unsensitized
population and to elicit ACD in the sensitized population. To assist
the Agency in its deliberations, the SAP will be asked to provide
guidance on any special scientific considerations, including the
relative susceptibility of adults and children to induction of ACD as
well as the elicitation of ACD. For example, would children exposed to
hexavalent chromium while playing on a deck with treated wood have a
greater susceptibility to induction of dermal sensitization than
adults? What uncertainty factors should be considered in the regulatory
process to protect for this specific exposure scenario? EPA is also
interested in determining under what circumstances it would be
appropriate to use a quantitative approach to assess the potential for
induction of ACD for non-occupational exposures.
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.
Dated: April 8, 2004.
Joseph J. Merenda, Jr.,
Director, Office of Science Coordination and Policy.
[FR Doc. 04-8768 Filed 4-14-04; 3:00 pm]
BILLING CODE 6560-50-S
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