[Federal Register Volume 69, Number 141 (Friday, July 23, 2004)]
[Notices]
[Pages 43988-43991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16955]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0242]; FRL-7371-8]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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: 
[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 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.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 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 [email protected], 
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

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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.

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 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