![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
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: July 23, 2004 (Volume 69, Number 141)]
[Notices]
[Page 43988-43991]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy04-54]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0242]; FRL-7371-8]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: On August 24-25, 2004, August 26-27, 2004 and September 9-10,
2004, the FIFRA Scientific Advisory Panel (SAP) will hold three
separate meetings to consider and review three fumigant bystander
exposure models. This particular notice announces the September 9-10,
2004 meeting at which the SAP will review the SOil Fumigant Exposure
Assessment system (SOFEA(copyright)) using telone as a case
study. On August 24-25, 2004 the SAP will review the Probabilistic
Exposure and Risk model for FUMigants (PERFUM) using iodomethane as a
case study. On August 26-27, 2004 the SAP will review the Fumigant
Exposure Modeling System (FEMS) using metam sodium as a case study.
Additional details about the September 9-10, 2004 meeting are provided
below. Separate notices are available for each of the other meetings
that provide additional details specific to those meetings.
DATES: The meeting will be held on September 9-10 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 the 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 August 6, 2004.
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 National
Airport, 2650 Jefferson Davis Hwy, Arlington, VA 22202 (703) 684-7200.
The telephone number for the Holiday Inn National Airport is (703) 684-
7200.
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
seating: To submit nominations for ad hoc members of the FIFRA SAP for
this meeting, requests for special seating arrangements, or requests to
present oral comments, notify the Designated Federal Officer (DFO)
listed under FOR FURTHER INFORMATION CONTACT. To ensure proper receipt
by EPA, your request must identify docket ID number OPP-2004-0242 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: Joseph Bailey, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202)
564-2045; fax number: (202) 564-8382; e-mail addresses:
bailey.joseph@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
[[Page 43989]]
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-2004-0242. 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 Street, 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 August, 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 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-2004-0242. 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-2004-0242. 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
[[Page 43990]]
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 OPP-2004-0242. 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-2004-0242.
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-2004-0242 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, September 2, 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 time, August 26,
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 and assistance for the hearing
impaired, 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.
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 the current meeting should have
expertise in one or more of the following areas: Exposure assessment,
statistics, meteorology, air modeling, fumigant volatility and fumigant
agronomic practices. 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 August 6,
2004. 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 needs of the FIFRA SAP and includes consideration of such issues as
adequately covering the areas of expertise (including the different
scientific perspectives within each discipline) necessary to address
the Agency's charge questions. In addition, ad hoc members of the FIFRA
SAP must be available to fully participate in the review; they must not
have any conflicts of interest or appearance of lack of impartiality;
and they must be independent and unbiased with respect to the matter
under review. 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). In order to have the collective breadth of
experience needed to address the Agency's charge for this meeting, the
Agency anticipates selecting more than 10 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.
[[Page 43991]]
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 in Unit.
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 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's Office of Pesticide Programs is engaged in pesticide
tolerance reassessment activities as mandated by the Food Quality
Protection Act (1996). As part of that process, the Agency is currently
involved in the development of a comparative risk assessment for six
soil fumigant pesticides that include chloropicrin, dazomet,
iodomethane, methyl bromide, metam-sodium, and telone. Each of these
chemicals has a degree of volatility associated with it which is a key
characteristic needed to achieve a satisfactory measure of efficacy.
This volatility, however, can contribute to human exposures because
these chemicals can travel to non-target receptors, such as nearby
human populations. Commonly referred to as bystander exposure, it is
considered by the Agency to be the primary pathway through which human
exposure to fumigants may occur.
In order to address bystander exposures, the Agency developed a
method based on a deterministic use of the Office of Air model entitled
Industrial Source Complex Model (ISC3) that is routinely used for
regulatory decisions. ISC3 is publicly available from the following
Agency website (http://www.epa.gov/scram001/tt22.htm#isc). In this
approach, the Agency uses chemical-specific measures of volatility to
quantify field emission rates for modeling purposes. Additionally, the
Agency uses standardized meteorological conditions which represent a
stable atmosphere and unidirectional wind patterns that provide
conservative estimates of exposure.
Stakeholders expressed concern that the conditions represented by
the current approach provide results that are not sufficiently refined
for regulatory actions such as risk mitigation. In response, the Dow
Agrosciences Corporation, the registrant for telone, has submitted a
model entitled SOil Fumigant Exposure Assessment system
(SOFEA(copyright)) for consideration as a possible
refinement to the Agency's approach. The Agency believes that this
model also, may have the potential to be used generically to calculate
risks for the six soil fumigants being evaluated in the current risk
assessment. The key differences between SOFEA(copyright) and
the current Agency approach are that it calculates fumigant
concentrations in air arising from volatility losses from treated
fields for entire agricultural regions using multiple transient source
terms (e.g., different treated fields), GIS information, agronomic
specific variables, user specified buffer zones and field re-entry
intervals. A modified version of the ISC3 is used for air dispersion
calculations.
The purpose of this meeting of the FIFRA Science Advisory Panel
(SAP) is to evaluate the approaches contained in
SOFEA(copyright) for integrating these different factors
into an analysis that considers exposures on a regional level.
Additionally, the Agency is seeking a specific evaluation of the
methods used pertaining to field emission rates, statistical approaches
for data analysis, receptor locations, modifications to ISC3, and
defining the exposed populations. Finally, the Agency is seeking a
determination as to the scientific validity of the overall approach
included in SOFEA(copyright). The proposed agenda for this
SAP meeting will involve an introductory overview of the current risk
assessment approach by the EPA. A detailed presentation of the
SOFEA(copyright) model will then be given by S. A. Cryer, I.
J. van Wesenbeeck, and B. A Houtman of Dow Agrosciences Corporation.
Staff from California's Department of Pesticide Regulation will also be
participating with EPA in this SAP meeting.
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: July 20, 2004.
Joseph J. Merenda, Jr.
Director, Office of Science Coordination and Policy.
[FR Doc. 04-16955 Filed 7-22-04; 8:45 am]
BILLING CODE 6560-50-S