[Federal Register Volume 71, Number 65 (Wednesday, April 5, 2006)]
[Notices]
[Pages 17096-17097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4837]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2002-0269; FRL-7772-9]


Ethoprop, Addendum to the Interim Reregistration Eligibility 
Decision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of an Addendum to EPA's 
2001 Interim Reregistration Eligibility Decision (IRED) for the 
organophosphate pesticide, ethoprop. The Agency's risk assessments and 
other related documents also are available in the ethoprop Docket. The 
2001 IRED for ethoprop described the Agency's interim reregistration 
decision on granular formulated products. A decision on the 
emulsifiable concentrate (EC) formulation was deferred until the 
registrant submitted additional exposure data. The Agency has received 
and reviewed the additional data, and the review is available in the 
ethoprop Docket. This addendum to the 2001 IRED for ethoprop includes 
the regulatory decision on the EC formulation of ethoprop. EPA has 
reviewed ethoprop 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: Jacqueline Guerry, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 305-0024; fax 
number: (703) 308-8005; 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 a docket for this action under 
Docket identification number (ID) EPA-HQ-OPP-2002-0269; FRL-7772-9. 
Publicly available docket materials are available either electronically 
through http://www.regulations.gov or in hard copy 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/.

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 ethoprop in 2001 
that presented an interim reregistration eligiblity decision for 
granular formulated products. The decision on the emulsifiable 
concentrate (EC) formulation was deferred until the registrant 
submitted additional occupational exposure information on the EC 
formulation. The Agency's review of the exposure data is available in 
the ethoprop docket. The addendum

[[Page 17097]]

to the ethoprop IRED, signed on February 25, 2006, presents the 
Agency's conclusions on the risks posed by exposure to EC formulations 
of ethoprop 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, 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 ethoprop reregistration is substantially complete and that 
products containing ethoprop, in addition to the grandular formulators, 
EC formulations are eligible for reregistration provided the risks are 
mitigated in the manner described in the 2001 IRED and in the 2006 
Addendum to 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 ethoprop. When the Agency 
finalizes decisions for ethoprop and other organophosphate pesticides, 
further risk mitigation may be required for ethoprop.
    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, ethoprop 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 ethoprop.
    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. In this case, no additional 
comment period is needed because the 2001 ethoprop IRED was reviewed 
through the full 6-phase public participation process, and all issues 
related to this pesticide were resolved through consultations with 
stakeholders and the submission of data allowing the Agency to conclude 
the decision on the EC formulation. The Agency, therefore, is issuing 
the 2006 ethoprop addendum to the IRED without a comment period. 
Decisions presented in the IRED and in the addendum to the 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.''

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 28, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. E6-4837 Filed 4-4-06; 8:45 am]
BILLING CODE 6560-50-S