[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Notices]
[Pages 57281-57284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21507]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0317; FRL-7680-7]


Flumetsulam; Tolerance Reassessment Decision for Low Risk 
Pesticide; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's Tolerance 
Reassessment Decision (TRED) for the pesticide flumetsulam, and opens a 
public comment period on this document, related risk assessments, and 
other support documents. EPA has reviewed the low risk pesticide 
flumetsulam through a modified, streamlined version of the public 
participation process that the Agency uses to involve the public in 
developing pesticide tolerance reassessment and reregistration 
decisions. Through the tolerance reassessment program, EPA is ensuring 
that all pesticides meet current health and food safety standards.

DATES: Comments, identified by docket Identification number OPP-2004-
0317, must be received on or before October 25, 2004.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Mika J. Hunter, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0041; fax 
number: (703) 308-8041; e-mail address:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of 
interest to a wide range of stakeholders including environmental, human 
health, and agricultural advocates; the chemical industry; pesticide 
users; and members of the public interested in the sale, distribution, 
or use of pesticides. Since others also may 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 person 
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 OPP-2004-0317. 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 through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.

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    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 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 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 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, by mail, or through hand 
delivery/courier. 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. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. 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, elect ``search,'' and then key in docket ID number 
OPP-2004-0317. 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-2004-0317. 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 mail to the mailing address identified in Unit I.C.2. 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 mail. 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-2004-0317.
    3. 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-2004-0317. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does

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not contain CBI on disk or CD ROM, mark the outside of the disk or CD 
ROM clearly that it does not contain CBI. Information not marked as CBI 
will be included in the public docket and EPA's electronic public 
docket without prior notice. If you have any questions about CBI or the 
procedures for claiming CBI, please consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

E. 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 any technical information and/or data you used that 
support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at your estimate.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternatives.
    7. Make sure to submit your comments by the comment period deadline 
identified.
    8. To ensure proper receipt by EPA, identify the appropriate docket 
ID number in the subject line on the first page of your response. It 
would also be helpful if you provided the name, date, and Federal 
Register citation related to your comments.

II. Background

A. What Action is the Agency Taking?

    EPA developed the flumetsulam TRED through a modified, streamlined 
version of its public process for making tolerance reassessment and 
reregistration eligibility decisions. Through these programs, the 
Agency is ensuring that pesticides meet current standards under the 
Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended by 
FQPA. EPA must review tolerances and tolerance exemptions that were in 
effect when the FQPA was enacted, to ensure that these existing 
pesticide residue limits for food and feed commodities meet the safety 
standard established by the new law. Tolerances are considered 
reassessed once the safety finding has been made or a revocation 
occurs. EPA has reviewed and made the requisite safety finding for the 
flumetsulam tolerances included in this notice.

    EPA has reassessed the uses of flumetsulam, as well as 4 existing 
tolerances or legal residue limits, and reached a tolerance 
reassessment decision for this low risk pesticide. The Agency is 
issuing for comment the resulting Report on Food Quality Protection Act 
(FQPA) Tolerance Reassessment Progress and Risk Management Decision for 
flumetsulam, known as a TRED, as well as related risk assessments and 
technical support documents.
    Flumetsulam is a herbicide registered for use on soybeans and field 
corn and belongs to the triazolopyrimidine chemical class. Flumetsulam 
can be applied pre-plant, pre-emergence, or post-emergence to control 
broadleaf weeds and may be applied alone or in formulation with other 
active ingredients. The maximum application rate for flumetsulam is 
0.07 lb a.i/acre with a minimum pre-harvest interval range of 70 to 85 
days. The highest usage of flumetsulamis on corn and approximately 
12,000 pounds are used annually. A petition for a new use on dry beans 
has been submitted to the Agency. This use has been included in the 
risk assessment and is awaiting further action by the Registration 
Division.
    Flumetsulam is in Toxicity Category III or IV for acute oral, 
dermal, and inhalation exposure and for dermal and ocular irritation, 
and is not a dermal sensitizer. There was no indication of 
reproductive, neurotoxicant, or carcinogenic effects from flumetsulam 
in the reviewed studies. There are no studies that identify an acute 
hazard based on toxic effects observed following a single oral dose. A 
conservative dietary (food and water) risk assessment concluded that 
for all supported commodities (including proposed dry bean), the 
chronic dietary exposure estimates are below the Agency's level of 
concern for all population subgroups. The toxicology database for 
flumetsulam is adequate for FQPA considerations. Based on the hazard 
data, the Agency recommended that the special FQPA Safety Factor be 
reduced to 1X because there are low concerns, and no residential 
uncertainties with regard to prenatal and/or postnatal toxicity. The 
Agency is, therefore, not concerned with any risk resulting from 
exposure to flumetsulam.
    EPA is applying the principles of public participation to all 
pesticides undergoing reregistration and tolerance reassessment. The 
Agency's Pesticide Tolerance Reassessment and Reregistration; Public 
Participation Process, published in the Federal Register on May 14, 
2004 (69 FR 26819) (FRL-7357-9, explains that in conducting these 
programs, the Agency is tailoring its public participation process to 
be commensurate with the level of risk, extent of use, complexity of 
issues, and degree of public concern associated with each pesticide. 
EPA can expeditiously reach decisions for pesticides like flumetsulam, 
which pose few risk concerns, have low use, and require no risk 
mitigation. Once EPA assesses uses and risks for such pesticides, the 
Agency may go directly to a decision and prepare a document summarizing 
its findings. The Agency therefore is issuing the low-risk flumetsulam 
TRED, risk assessments, and related documents simultaneously for public 
comment.
    The tolerance reassessment program is being conducted under 
Congressionally mandated time frames, and EPA recognizes the need both 
to make timely decisions and to involve the public in finding ways to 
effectively mitigate pesticide risks. Flumetsulam, however, poses no 
risks that require mitigation. The Agency therefore is issuing the 
flumetsulam TRED, its risk assessments, and related support documents 
simultaneously for public comment. The comment period is intended to 
provide an opportunity for public input and a mechanism for initiating 
any necessary amendments to the TRED. All comments should be submitted 
using the methods in Unit I. of the SUPPLEMENTARY INFORMATION, and must 
be received by EPA on or before the closing date. These comments will 
become part of the Agency Docket for flumetsulam. Comments received 
after the close of the comment period will be marked ``late.'' EPA is 
not required to consider these late comments.
    EPA will carefully consider all comments received by the closing 
date and will provide a Response to Comments Memorandum in the Docket 
and electronic EDOCKET. If any comment significantly affects the 
document, EPA also will publish an amendment to the TRED in the Federal 
Register. In the absence of substantive comments requiring changes, the 
decisions reflected in the TRED will be implemented as presented. These 
decisions may be supplemented by risk mitigation measures when EPA 
concludes its cumulative assessment of the pesticides.

B. What is the Agency's Authority for Taking this Action?

    Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to 
review tolerances and exemptions for pesticide residues in effect as of 
August 2, 1996, to determine whether the tolerance or exemption meets 
the requirements of

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section 408(b)(2) or (c)(2) of FFDCA. This review is to be completed by 
August 3, 2006.
    Section 4(g)(2) of FIFRA as amended directs that, after submission 
of all data concerning a pesticide active ingredient, ``the 
Administrator shall determine whether pesticides containing such active 
ingredient are eligible for reregistration,'' before calling in product 
specific data on individual end-use products and either reregistering 
products or taking other ``appropriate regulatory action.''

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: September 16, 2004.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 04-21507 Filed 9-23-04; 8:45 am]
BILLING CODE 6560-50-S