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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 27, 2006 (Volume 71, Number 208)]
[Notices]
[Page 63007-63010]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc06-53]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0856; FRL-8099-8]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 4-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel FIFRA SAP to
consider and review Worker Exposure Assessment Methods.
DATES: The meeting will be held on January 9-12, 2007, from 8:30 a.m.
to 5 p.m, eastern time.
Comments: Written comments and requests to make oral comments are
accepted until the date of the meeting. However, the Agency encourages
the submission of written comments by December 26, 2006, and requests
to present oral comments by January 2, 2007. For additional
instructions, see Unit I.C. of the SUPPLEMENTARY INFORMATION.
Nominations: Nominations of candidates to serve as ad hoc members
of the FIFRA SAP for this meeting should be provided on or before
November 8, 2006.
Special Accommodations: For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the Designated Federal Official (DFO) listed
under For Further Information Contact at least 10 days prior to the
meeting to give EPA as
[[Page 63008]]
much time as possible to process your request.
ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center - Lobby Level, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.
Comments: Submit your comments, identified by docket ID number
EPA-HQ-OPP-2006-0856, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments. Your use of
the Federal eRulemaking Portal to submit comments to EPA electronically
is EPA's preferred method for receiving comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0856. If your comments contain any information that you consider
to be CBI or otherwise protected, please contact the DFO listed under
FOR FURTHER INFORMATION CONTACT to obtain special instruction before
submitting your comments. EPA's policy is that all comments received
will be included in the docket without change and may be made available
on-line at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov website is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD ROM you submit. 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. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket are listed in a docket index
that is available at http://www.regulations.gov. Although listed in a
docket index, some information is not publicly available, e.g., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket telephone number
is (703) 305-5805.
Nominations, requests to present oral comments, and requests for
special accommodations: Submit nominations to serve as an ad hoc member
of the FIFRA SAP, requests for special seating accommodations, or
requests to present oral comments to the DFO listed under FOR FURTHER
INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Myrta R. Christian, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number: (202) 564-8498; fax number: (202) 564-8382; e-mail address:
christian.myrta@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. What Should I Consider as I Prepare My Comments for EPA?
1. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information subject heading, Federal Register date and page number.
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
C. 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 EPA-HQ-OPP-2006-0856 in the subject line
on the first page of your request.
1. 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 ADDRESSES, by December 26, 2006, 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.
2. Oral comments. Although, requests to present oral comments are
accepted until the date of the meeting, unless otherwise stated, to the
extent that time
[[Page 63009]]
permits, the Chair of the FIFRA SAP may permit the presentation of oral
comments at the meeting by interested persons who have not previously
requested time. However, each individual or group wishing to make brief
oral comments to FIFRA SAP is encouraged to submit their request to the
DFO listed under FOR FURTHER INFORMATION CONTACT by January 2, 2007, 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.
3. Seating at the meeting. Seating at the meeting will be on a
first-come basis.
4. Request for nominations to serve as ad hoc members of the FIFRA
SAP for this meeting. As part of a broader process for developing a
pool of candidates for each meeting, the FIFRA SAP staff routinely
solicits the stakeholder community for nominations of prospective
candidates for service as ad hoc members of the FIFRA SAP. Any
interested person or organization may nominate qualified individuals to
be considered as prospective candidates for a specific meeting.
Individuals nominated for this meeting should have expertise in one or
more of the following areas: Exposure assessment, statistics,
biological monitoring, pharmacokinetics, and agricultural engineering.
Nominees should be scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing expert comments on the scientific 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 8, 2006.
The Agency will consider all nominations of prospective candidates for
this meeting that are received on or before this date. However, final
selection of ad hoc members for this meeting is a discretionary
function of the Agency. The selection of scientists to serve on the
FIFRA SAP is based on the function of the panel and the expertise
needed to address the Agency's charge to the panel. No interested
scientists 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.
Other factors considered during the selection process include
availability of the potential panel member to fully participate in the
panel's reviews, absence of any conflicts of interest or appearance of
lack of impartiality, independence with respect to the matters under
review, and lack of bias. Though financial conflicts of interest, the
appearance of lack of impartiality, lack of independence, and bias may
result in disqualification, the absence of such concerns does not
assure that a candidate will be selected to serve on the FIFRA SAP.
Numerous qualified candidates are identified for each panel. Therefore,
selection decisions involve carefully weighing a number of factors
including the candidates' areas of expertise and professional
qualifications and achieving an overall balance of different scientific
perspectives on the panel. In order to have the collective breadth of
experience needed to address the Agency's charge for this meeting, the
Agency anticipates selecting approximately 12 ad hoc scientists.
If a prospective candidate for service on the FIFRA SAP is
considered for participation in a particular session, the candidate 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 candidate 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 candidate's employment, stocks, and bonds, and
where applicable, sources of research support. The EPA will evaluate
the candidates financial disclosure form to assess that there are no
financial conflicts of interest, no appearance of lack of impartiality
and no prior involvement with the development of the documents under
consideration (including previous scientific peer review) before the
candidate is considered further for service on the FIFRA SAP. Those who
are selected from the pool of prospective candidates will be asked to
attend the public meetings and to participate in the discussion of key
issues and assumptions at these meetings. In addition, they will be
asked to review and to help finalize the meeting minutes. The list of
FIFRA SAP members participating at this meeting will be posted on the
FIFRA SAP web site at http://epa.gov/scipoly/sap
or may be obtained from the OPP Regulatory Public Docket at
http://www.regulations.gov.
II. Background
A. Purpose of the FIFRA SAP
The FIFRA SAP serves as the primary scientific peer review
mechanism of the United States Environmental Protection Agency (EPA),
Office of Prevention, Pesticides and Toxic Substances and is structured
to provide scientific advice, information and recommendations to the
EPA Administrator on pesticides and pesticide-related issues as to the
impact of regulatory actions on health and the environment. The FIFRA
SAP is a Federal advisory committee established in 1975 under the
Federal Insecticide, Fungicide and Rodenticide Act and operates in
accordance with requirements of the Federal Advisory Committee Act. The
SAP is composed of a permanent panel consisting of seven members,
appointed by the EPA Administrator from nominees provided by the
National Institutes of Health and the National Science Foundation.
FIFRA, as amended by the 1996 Food Quality Protection Act, established
a Science Review Board consisting of at least 60 scientists who are
available to the SAP on an ad hoc basis to assist in reviews conducted
by the Panel. As a peer review mechanism, the FIFRA SAP provides
comments, evaluations and recommendations to improve the effectiveness
and quality of scientific analyses made by Agency scientists. Members
of the FIFRA SAP are scientists who have sufficient professional
qualifications, including training and experience, to provide expert
advice and recommendation to the Agency.
B. Public Meeting
The Agency issued its first occupational exposure testing
guidelines in the early 1980s. These guidelines were intended to
standardize the methodology used to conduct the studies necessary to
allow the Agency to determine the potential exposures, and consequently
risks, associated with the activities surrounding the use of
pesticides. These activities included handling pesticides (i.e.,
mixing, loading and applying) as well as working in treated sites
following pesticide applications (e.g., harvesting, thinning, weeding,
servicing cooling towers). In the early 1990s, two databases--the
Pesticide Handlers
[[Page 63010]]
Exposure Database (PHED) and the Chemical Manufacturers Association
(CMA) data--were constructed in order to estimate exposures resulting
from mixing/loading/applying pesticides. The data assembled for use in
these databases were taken from published literature as well as from
industry studies submitted to the Agency. These databases have been
used as the main sources for estimating occupational exposures to
workers handling pesticides for both registration and reregistration
actions. Since the early 1980s, the Agency has been using a scenario-
based approach in its assessments for estimating exposures for
occupational pesticide handlers (e.g., mixers, loaders, and
applicators). This approach is consistent with the Agency's guidelines
for exposure assessment which can be found on the EPA website at
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=15263.
Over the years since the issuance of the exposure guidelines, there
have been scientific issues raised about the accuracy of exposure
estimates based on data developed using these methods. In addition,
recent protocols for the generation of new agricultural pesticide
handler exposure data are being generated by a pesticide industry task
force and were reviewed by the Agency's Human Subjects Review Board
(HSRB) (see http://www.epa.gov/osa/hsrb/files/
june2006finaldraftreport82806.pdf for further information). The
board raised questions concerning the scientific merits of the proposed
protocols.
Given the scientific issues that have been raised regarding
occupational pesticide exposure estimates and study protocols,
including the recent comments from the HSRB, at this time EPA is asking
the FIFRA Scientific Advisory Panel (SAP) to evaluate, in detail,
issues associated with certain methodologies used to generate exposure
studies and the procedures used to develop exposure estimates. As part
of the background for the SAP meeting, the Agency is developing a case
study that details the procedures and data the Agency uses to evaluate
6 exposure scenarios that are common in agriculture. These data can be
found in the existing Pesticide Handlers Exposure Database.
The following four issues are expected to be the focus of this SAP
review: Sample collection methods (e.g., whole-body dosimetry,
handwashing, facial/neck wipes, and biological monitoring); data needs
(e.g., availability of data in the Pesticide Handlers Exposure
Database); unit exposure (e.g., relating the amount of exposure to the
amount of chemical active ingredient handled); and sample size issues
(e.g., inter-/intra-worker variability and representativeness).
C. FIFRA SAP Documents and Meeting Minutes
EPA's position paper, charge/questions to the FIFRA SAP, FIFRA SAP
composition i.e., members and ad hoc members for this meeting, and the
meeting agenda will be available by mid December 2006. 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, at http://www.regulations.gov
and the FIFRA SAP homepage at http://www.epa.gov/scipoly/sap.
The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency approximately 90 days after the meeting.
The meeting minutes will be posted on the FIFRA SAP web site or may be
obtained from the OPP Regulatory Public Docket at
http://www.regulations.gov.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: October 19, 2006.
Clifford Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. E6-18036 Filed 10-26-06; 8:45 am]
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