[Federal Register Volume 69, Number 74 (Friday, April 16, 2004)]
[Notices]
[Pages 20614-20617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8768]


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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: 
[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 
(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.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 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 [email protected], 
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