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Dimethoate Interim Reregistration Eligibility Decision; Notice of Availability
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: July 12, 2006 (Volume 71, Number 133)]
[Notices]
[Page 39312-39313]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy06-63]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0084; FRL-8064-9]
Dimethoate Interim 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 Interim
Reregistration Eligibility Decision (IRED) for the organophosphate
pesticide dimethoate, and opens a public comment period on this
document. The Agency's risk assessments and other related documents
also are available in the dimethoate Docket. Dimethoate is a systemic
organophosphate insecticide used for control of a wide variety of
insect pests on a number of fruit, vegetable, grain, and field crops,
as well as ornamentals and non-cropland adjacent to agricultural
fields. EPA has reviewed dimethoate 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 must be received on or before September 11, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0084, by one of the following methods:-
? Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
? Mail: Office of Pesticide Programs (OPP) Regulatory
Public Docket (7502P), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
? Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0084. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket
index. Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov,
or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Stephanie Plummer, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-0076; fax
number: (703) 308-8041; e-mail address: plummer.stephanie@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 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. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, 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 claimed as CBI. In addition to one
complete version of the comment that includes 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.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
[[Page 39313]]
vii. Explain your views as clearly as possible, avoiding the use
of profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
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
completed an IRED for the organophosphate pesticide dimethoate on June
12, 2006, and is now issuing this document for public comment.
Dimethoate is a systemic organophosphate insecticide used for control
of a wide variety of insect pests on a number of fruit, vegetable,
grain, and field crops, as well as ornamentals and non-cropland
adjacent to agricultural fields. The dimethoate IRED presents the
Agency's conclusions on the risks posed by exposure to dimethoate
alone; however, section 408(b)(2)(D)(v) of the Federal Food, Drug and
Cosmetic Act (FFDCA) directs the Agency also to consider available
information on the cumulative risk from substances sharing a common
mechanism of toxicity. Because the organophosphate pesticides share a
common mechanism of toxicity, cholinesterase inhibition, the Agency
will evaluate the cumulative risk posed by this group before making
final reregistration eligibility decisions on individual organophosphates.
During the pendency of the organophosphate cumulative assessment,
the Agency is proceeding with risk assessments and interim risk
management for individual organophosphate pesticides. EPA has
determined that, but for the cumulative risk assessment, the data base
to support dimethoate reregistration is substantially complete and that
products containing dimethoate will be eligible for reregistration,
provided the risks are mitigated either in the manner described in the
IRED or by another means that achieves equivalent risk reduction. 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 IRED or as a result of
product specific data), and after assessing organophosphate cumulative
risks, EPA will make a final reregistration decision under section
4(g)(2)(C) for products containing dimethoate. When the Agency
finalizes decisions for dimethoate and other organophosphate
pesticides, further risk mitigation may be required for dimethoate.
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, 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, dimethoate was reviewed
through the full 6 phase public participation process. Through this
process, EPA worked extensively with stakeholders and the public to
reach the regulatory decisions for dimethoate.
The reregistration program is being conducted under
Congressionally mandated time frames, and EPA recognizes the need both
to make timely reregistration decisions and to involve the public. The
Agency is issuing the dimethoate IRED for public comment. This comment
period is intended to provide an additional opportunity for public
input and a mechanism for initiating any necessary amendments to the
IRED. All comments should be submitted using the methods in ADDRESSES,
and must be received by EPA on or before the closing date. These
comments will become part of the Agency Docket for dimethoate. 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 and will provide a Response to Comments Memorandum in the
Docket and regulations.gov. If any comment significantly affects the
document, EPA also will publish an amendment to the IRED in the Federal
Register. In the absence of substantive comments requiring changes, the
risk management decisions reflected in the dimethoate IRED will be
implemented as presented. These decisions may be supplemented by
further risk mitigation measures when EPA considers its cumulative
assessment of the organophosphate pesticides.
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 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: July 5, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-10857 Filed 7-11-06; 8:45 am]
BILLING CODE 6560-50-S