[Federal Register: November 30, 2005 (Volume 70, Number 229)]
[Notices]
[Page 71826-71829]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no05-55]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0266; FRL-7746-3]
Dodine Reregistration Eligibility Decision; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's Reregistration
Eligibility Decision (RED) for the pesticide dodine, and opens a public
comment period on this document. The
[[Page 71827]]
Agency's risk assessments and other related documents are also
available in the dodine docket. Dodine is a fungicide used primarily on
fruits and nuts and is registered for control of a range of pathogenic
fungi that affect a number of agricultural and some ornamental crops.
There are no registered residential uses of dodine. The dodine RED
addresses the tolerance reassessment for all the currently registered
uses of dodine. EPA is reviewing dodine through the public
participation process that the Agency uses to involve the public in
developing pesticide reregistration and tolerance reassessment
decisions. Through these programs, EPA is ensuring that all pesticides
meet current health and safety standards.
DATES: Comments, identified by docket identification number (ID)
number OPP-2005-0266, must be received on or before January 30, 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: Cathryn O'Connell, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0136; fax
number: (703) 308-8041; e-mail address: oconnell.cathryn@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 OPP-2005-0266. 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/.
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
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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-2005-0266. 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-2005-0266. 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-2005-0266.
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-2005-0266. 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 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?
Under section 4 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to
ensure that they meet current scientific and regulatory standards. EPA
has completed a Reregistration Eligibility Decision (RED) for the
pesticide, dodine under section 4(g)(2)(A) of FIFRA. Dodine is a
fungicide used primarily on fruits and nuts and is registered for
control of a range of pathogenic fungi that affect a number of
agricultural and some ornamental crops. There are no registered
residential uses of dodine. The dodine RED addresses the tolerance
reassessment for all the currently registered uses of dodine. Another
active ingredient of similar chemical composition and properties,
dodecylguanidine hydrochloride (DGH), is included with dodine in case
number 0161. DGH has only antimicrobial uses, some of which may occur
in a residential environment, i.e., treatment of paper that comes into
contact with food, paint additives, and anti-bacterial treatment of
diapers. Because of the similarity of these compounds, EPA has
considered the contribution to overall risk of the DGH uses in its
aggregate assessment for dodine. However, the RED for the antimicrobial
uses of DGH will be issued at a later date.
EPA has determined that the data base to support reregistration is
substantially complete and that products containing dodine are eligible
for reregistration provided the risks are mitigated in the manner
described in the RED. Upon submission of any required product-specific
data under section 4(g)(2)(B) and any necessary changes to the
registration and labeling (either to address concerns identified in the
RED or as a result of product-specific data), EPA will make a final
reregistration decision under section 4(g)(2)(C) for products
containing dodine.
EPA must review tolerances and tolerance exemptions that were in
effect when the Food Quality Protection Act was enacted in August 1996,
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 dodine tolerances 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 on May 14,
2004, (69 FR 26819)(FRL-7357-9) explains that in
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conducting these programs, EPA 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. Due to its uses, risks, and other factors, dodine was
reviewed through a modified process. Through this process, EPA worked
extensively with stakeholders and the public to reach the regulatory
decisions for dodine.
The reregistration program is being conducted under
Congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public. The Agency is
issuing the dodine RED for public comment. This comment period is
intended to provide an opportunity for public input and a mechanism for
initiating any necessary amendments to the RED. 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 dodine.
Comments received after the close of the comment period will be marked
``late.'' EPA is not required to consider these late comments.
The Agency will carefully consider all comments received by the
closing date in the Docket and electronic EDOCKET. If any comment
significantly affects the document, EPA will also publish an amendment
to the RED in the Federal Register. In the absence of substantive
comments requiring changes, the dodine RED will be implemented as it is
now presented.
B. What is the Agency's Authority for Taking this Action?
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.''
Section 408(q) of the Federal Food, Drug, and Cosmetic Act
(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: November 16, 2005.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 05-23420 Filed 11-29-05; 8:45 am]
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