[Federal Register Volume 70, Number 206 (Wednesday, October 26, 2005)]
[Notices]
[Pages 61818-61819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21365]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0281; FRL-7742-4]


Oxydemeton-methyl Interim Reregistration Eligibility Decision and 
Amendment

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 oxydemeton-methyl (ODM) and the ODM IRED Amendment document. 
The Agency's risk assessments and other related documents also are 
available in the ODM Docket (docket number OPP-34167), and on the ODM 
reregistration website located at http://www.epa.gov/oppsrrd1/op/odm.htm. ODM is a systemic, organophosphate insecticide/acaracide 
registered on terrestrial food crops (vegetable, field, tree fruit, and 
nut crops) and terrestrial non-food sites (ornamental uses). EPA has 
reviewed ODM 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.

FOR FURTHER INFORMATION CONTACT: Katie Hall, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0166; fax 
number: (703) 308-8041; e-mail address: <a href="/cdn-cgi/l/email-protection#3159505d5d1f5a50455854715441501f565e47"><span class="__cf_email__" data-cfemail="c4aca5a8a8eaafa5b0ada184a1b4a5eaa3abb2">[email protected]</span></a>.

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 identification (ID) number OPP-2005-0281. 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 <greek-i>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 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. 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. 
Once in the system, select ``search,'' then key in the appropriate 
docket ID number.

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 an IRED for the organophosphate pesticide, ODM under 
section 4(g)(2)(A) of FIFRA. ODM is a systemic, organophosphate 
insecticide/acaricide used to control many insects, primarily aphids, 
mites, and thrips. Registered use sites include terrestrial food crops 
(vegetable, field, tree fruit, and nut crops) and terrestrial non-food 
sites (ornamental uses). The ODM IRED presents the Agency's conclusions 
on the risks posed by exposure to ODM 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 decision 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 ODM reregistration is substantially complete and that 
products containing ODM are eligible for reregistration, provided the 
risks are mitigated in the manner described in the ODM IRED and ODM 
IRED Amendment. Upon submission of any required product-specific data 
under FIFRA 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 FIFRA section 4(g)(2)(C) for products containing ODM. 
When the Agency finalizes decisions for ODM and other organophosphate 
pesticides, further risk mitigation may be required for ODM.
     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

[[Page 61819]]

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 ODM tolerances, pending completion 
of the organophosphate cumulative assessment.
     Although the ODM IRED was signed on August 5, 2002, certain 
components of the document, which did not affect the final regulatory 
decision, were undergoing final editing at that time. These components, 
including the list of additional generic data requirements, summary of 
labeling changes, appendices, and other relevant information, have been 
added to the ODM IRED document. In addition, subsequent to signature, 
EPA identified several minor errors and ambiguities in the document. 
These additions or changes do not alter the conclusions documented in 
the 2002 ODM IRED. Label language and use parameters for use of ODM on 
lettuce were altered based on submission of additional information that 
affected the risk conclusions for this use. Label changes are described 
in detail in the ``Label Changes Summary Table'' in section V.D. of the 
ODM IRED and in the ``Amendment to the 2002 Oxydemeton-methyl IRED,'' 
which are included in the public docket for ODM.
     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, ODM 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 ODM.
     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. Since all issues 
related to this pesticide were resolved through consultations with 
stakeholders before issuing the ODM IRED Amendment, the Agency is 
issuing the ODM IRED and ODM IRED Amendment without a comment period. 
Decisions presented in this IRED may be supplemented by further risk 
mitigation measures when EPA concludes 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 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 the FFDCA. This 
review is to be completed by August 3, 2006.

List of Subjects

     Environmental protection, Pesticides and pests.


    Dated: October 19, 2005.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 05-21365 Filed 10-25-05; 8:45 am]
BILLING CODE 6560-50-S


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