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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: December 16, 2005 (Volume 70, Number 241)]
[Notices]
[Page 74810-74814]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de05-66]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0471; FRL-7753-1]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 3-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider the Review of Worker Exposure Assessment Methods.
DATES: The meeting will be held on February 14-16, 2006, from 8:30
a.m. to approximately 5:00 p.m. eastern time.
Comments. For the deadlines for the submission of requests to
present oral comments and 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 December 28, 2005.
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, preferably at least 10- days
prior to the meeting, to give EPA as much time as possible to process
your request.
ADDRESSES: The meeting will be held at [the Holiday Inn Rosslyn at Key
Bridge, 1900 North Fort Myer Drive, Arlington,
[[Page 74811]]
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.
Nominations, requests to present oral comments, and special
accommodations: To submit nominations for ad hoc members of the FIFRA
SAP for this meeting, requests for special accommodation 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 EPA-
HQ-OPP-2005-0471 in the subject line on the first page of your response.
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 addresses:
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. 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 EPA-HQ-OPP-2005-0471. 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, 1801 S. Bell St., 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 under the ``Federal Register'' listings at
http://www.epa.gov/fedrgstr/.
Agency Website. EDOCKET, EPA's electronic public docket and
comment system was replaced on November 25, 2005, by an enhanced
federal-wide electronic docket management and comment system located at
http://www.regulations.gov/. 
Follow the on-line instruction.
EPA's position paper, charge/questions to the FIFRA SAP, FIFRA SAP
composition (i.e., members and consultants for this meeting) and the
meeting agenda will be available by mid-January 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, 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
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 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
[[Page 74812]]
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
EPA-HQ-OPP-2005-0471. 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 EPA-HQ-OPP-2005-0471. 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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
number EPA-HQ-OPP-2005-0471. 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 EPA-HQ-OPP-2005-0471.
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 EPA-HQ-OPP-2005-0471 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 the FIFRA
SAP to present oral comments at the meeting. Each individual or group
wishing to make brief oral comments to the FIFRA SAP is strongly
advised to submit their request to the DFO listed under FOR FURTHER
INFORMATION CONTACT no later than noon, eastern time, February 7, 2006,
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. In
addition, each speaker should bring 30 copies of his or her comments
and presentation slides for distribution to the FIFRA SAP at the meeting.
2. Written comments. Although, written comments will be accepted
until the date of the meeting (unless otherwise stated), the Agency
encourages that written comments be submitted, using the instructions
in Unit I.C., no later than noon, eastern time, January 31, 2006, to
provide the FIFRA SAP the time necessary to consider and review the
written comments. It is requested that persons submitting comments
directly to the docket also notify the DFO listed under FOR FURTHER
INFORMATION CONTACT. There is no limit on the extent of written
comments for consideration by the FIFRA SAP.
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 and assistance for the hearing
impaired, should contact the DFO at least 10 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 of prospective candidates for service 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 solicit 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: Occupational exposure
assessment, occupational exposure monitoring, agricultural practices
(especially hand labor practices), statistics, and risk assessment.
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,
[[Page 74813]]
occupation, position, address, and telephone number. Nominations should
be provided to the DFO listed under FOR FURTHER INFORMATION CONTACT on
or before December 28, 2005. 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. EPA will evaluate the
candidate's 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 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 registrations pursuant to
section 6(b)(2) of FIFRA, as well as proposed and final forms of
regulations 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 shall also 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 the Review of Worker Exposure
Assessment Methods. 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 pesticide exposure.
These activities included handling pesticides (i.e., mixing, loading
and applying) as well as exposures resulting from working in fields
following pesticide applications (e.g., harvesting, thinning, weeding).
In the early 1990s, the Pesticide Handlers Exposure Data base was
constructed in order to estimate exposures resulting from mixing/
loading/applying pesticides. The studies assembled for use in this data
base were taken from published literature as well as from industry-
generated studies. This database has been used as the main source for
estimating occupational exposures to workers handling pesticides for
both registration and reregistration actions. In 1995, in order to
develop a similar data base which could be used to address fieldworker
exposures, the Agency issued a data call-in notice (DCI) for post-
application farmworker exposure data. As a result of this DCI, every
pesticide registrant who manufactured products that could lead to post-
application farmworker exposures needed to generate data that could be
used to quantify exposures to their products.
In response to the issuance of the 1995 DCI, most major pesticide
registrants consolidated their efforts and formed the Agricultural
Reentry Task Force (ARTF). For more details, see http://www.exposuretf.com.
The ARTF has generated the vast majority of the post-application
farmworker exposure monitoring data since that time. It follows that
the bulk of the data that have been generated by ARTF include exposure
monitoring studies for a variety of hand-labor practices in a range of
crops.
The purpose of this meeting of the FIFRA Scientific Advisory Panel
(SAP) is to evaluate certain methodologies used to generate exposure
studies and how the Agency uses these and other studies to conduct
occupational exposure assessments. Three key issues have been
identified by the Agency as the focus of this review. These include:
? Hand Exposure Methods. Based upon review of the data, it
appears that the hands are important contributors to overall exposure
levels. In most monitoring studies used by the Agency, a wash
technique, which is based on methods described in the scientific
literature, is generally utilized to
[[Page 74814]]
measure exposure to the hands. The goal of this evaluation is to
identify issues associated with the use of this technique and to make
recommendations with regard to how these data should be interpreted for
exposure assessment purposes based on factors such as chemical
properties and exposure duration.
? Predictive Capability Of Exposure Monitoring Techniques.
Most exposure data that are currently available are based on the use of
passive dosimetry techniques (e.g., whole-body dosimeters and
handwash). These data quantify the residues that result on the surface
of the skin after completing a job task of some sort. The purpose of
this evaluation is to characterize the performance of passive dosimetry
as a predictive tool for risk assessment purposes (e.g., through
comparison with biological monitoring data and other possible analyses).
? Clustering Of Hand Labor Tasks For Exposure Assessment
Purposes. The crops in the United States that require hand labor for
successful production are extremely varied and range from field crops
such as lettuce (e.g., harvest is a key labor requirement) to tree
fruit such as apples (e.g., thinning and harvest are key labor
requirements). Based on the currently available data and a need to
address exposures related to hand labor across agriculture, the Agency
has created clusters or groups which represent categories of exposures
that are believed to be similar for assessment purposes. These
categories allow the Agency to develop risk estimates for a wide range
of crops and were defined based on agronomic and ergonomic similarities
in crops and workers, respectively. The purpose of this evaluation is
to characterize the methods used to define a representative cluster and
analyze the monitoring data that pertains to that group which are then
used for exposure assessment purposes. An example, based on vineyard
and trellis crops will be used for illustrative purposes.
C. FIFRA SAP Meeting Minutes
The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency in approximately 90 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: December 6, 2005.
Elizabeth Resek,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 05-24139 Filed 12-15-05; 8:45 am]
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