Document ID: EPA-HQ-OPP-2005-0491-0001
Agency: epa
Document Type: Notice
Title: Bitertanol Tolerance Reassessment Decision for Low Risk Pesticide; Notice of Availability
Posted Date: 2006-01-11T14:39:26Z

[Federal Register: January 11, 2006 (Volume 71, Number 7)]
[Notices]               
[Page 1750-1752]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja06-32]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0491; FRL-7756-3]

 
Bitertanol 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 Report of the 
Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and 
Risk Management Decision, known as a TRED, for the fungicide 
bitertanol, and opens a public comment period on this document, related 
risk assessments, and other support documents. EPA has reviewed the low 
risk pesticide bitertanol 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 ID number EPA-HQ-OPP-2005-0491, 
must be received on or before February 10, 2006.

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:  Rosanna Louie, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0037; fax 
number: (703) 308-8005; e-mail address: louie.rosanna@epa.gov.

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 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 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 EPA-HQ-OPP-2005-0491. 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

[[Page 1751]]

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/.

     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 instructions.

     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 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 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, select ``search,'' and then key in docket ID number 
EPA-HQ-OPP-2005-0491. 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-2005-0491. 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 EPA-HQ-OPP-2005-
0491.
    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 EPA-HQ-OPP-2005-0491. 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

[[Page 1752]]

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 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 has, on November 30, 2005, reached a tolerance reassessment 
decision for 1 existing tolerance or residue limit for bitertanol on 
bananas. Bitertanol is a broad-spectrum fungicide used to control black 
sigatoka on banana and plantain plants. The existing tolerance for 
bitertanol allows for residues on imported bananas and plantains, as 
there are no U.S. registrations for bitertanol. The Agency is now 
issuing for comment the resulting Report on Food Quality Protection Act 
(FQPA) Tolerance Reassessment Progress and Risk Management Decision for 
bitertanol, known as a TRED, as well as related risk assessments and 
technical support documents.
     EPA developed the bitertanol 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 
bitertanol tolerance included in this notice.
     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 of 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 bitertanol, 
that pose no risk concerns and require no risk mitigation. Once EPA 
assesses uses and risks for such low risk pesticides, the Agency may go 
directly to a decision and prepare a document summarizing its findings, 
such as the bitertanol TRED.
     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. Bitertanol, however, poses no 
risks that require mitigation. The Agency therefore is issuing the 
bitertanol 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 bitertanol. 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.

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 section 408(b)(2) or (c)(2) of FFDCA. This review 
is to be completed by August 3, 2006.

List of Subjects

     Environmental protection, Pesticides and pests.

    Dated: January 4, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. E6-99 Filed 1-10-06; 8:45 am]

BILLING CODE 6560-50-S