[Federal Register: January 30, 2006 (Volume 71, Number 19)]
[Notices]
[Page 4910-4912]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ja06-48]
[[Page 4910]]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0471; FRL-7760-1]
FIFRA Scientific Advisory Panel; Notice of Rescheduled Public
Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The February 14 - 16, 2006, Federal Insecticide, Fungicide,
and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) meeting to
consider the Review of Worker Exposure Assessment Methods has been
rescheduled.
DATES: The meeting will now be held on April 4 - 6, 2006, from 8:30
a.m. to approximately 5 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.C.
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 February 13, 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 business 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, VA 22209. The telephone
number for the Holiday Inn Rosslyn at Key Bridge is (703) 807-2000.
Comments: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0471, by one of the following methods:
http://www.regulations.gov/. Follow the on-line
instructions for submitting comments.
E-mail: opp-docket@epa.gov.
Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
Hand Delivery: Public Information and Records Integrity
Branch (PIRIB) (7502C), 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. The docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
docket facility is (703) 305-5805. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0471. EPA's policy is that all comments received will be included
in the public 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 captured automatically and included as part
of the comment that is placed in the public 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. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/docket.htm/.
Docket: All documents in the docket are listed in the
regulation.gov index. Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically at
http://www.regulations.gov/ or in hard copy at the Public Information
and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA. The docket facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the docket facility is (703) 305-
5805.
Nominations, requests to present oral comments, and special
accommodations: See Unit I.C. of the SUPPLEMENTARY INFORMATION.
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?
When preparing and submitting comments, remember to use these tips:
1. Identify the document by docket number and other identifying
information (subject heading,Federal Register date and page number).
2. 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.
3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
4. Describe any assumptions and provide any technical information
and/or data that you used.
5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
[[Page 4911]]
8. 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-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 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 time, March 28, 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 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 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 ADDRESSES, no later than noon, eastern time, March 21, 2006, to
provide 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 FIFRA SAP. Persons wishing to submit written comments
at the meeting should bring 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 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, occupation, position, address,
and telephone number. Nominations should be provided to the DFO listed
under FOR FURTHER INFORMATION CONTACT on or before [insert date 12 days
after date of publication in the Federal Register]. 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 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 under
ADDRESSES.
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
[[Page 4912]]
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.
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 exposures. 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 Database was constructed in order to estimate
exposures resulting from mixing/loading/applying pesticides. The
studies assembled for use in this database 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 database, 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 Science 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 exposures
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 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 that 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 Documents and Meeting Minutes
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 by March 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 regulation.gov Web site 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 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 under ADDRESSES.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: January 24, 2006.
Clifford J. Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. E6-1106 Filed 1-27-06; 8:45 am]
BILLING CODE 6560-50-S