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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's Tolerance Reassessment Decision (TRED) for the pesticide oxytetracycline. The Agency's risk assessments and other related documents also are available in the oxytetracycline docket. Through the tolerance reassessment program, EPA is ensuring that all pesticides meet current health and food safety standards.

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FOR FURTHER INFORMATION CONTACT:

Lance Wormell, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 603-0523; fax number: (703) 308-7070; e-mail address: wormell.lance@epa.gov.

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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 (ID) number EPA-HQ-OPP-2005-0492. 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 Office of Pesticide Programs (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 Facility 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?

EPA has reassessed risks associated with use of the oxytetracycline, reassessed two existing tolerances or legal residue limits, and on June 30, 2006, reached a tolerance reassessment and risk management decision. Oxytetracycline is an antibiotic pesticide used to control bacteria, fungi, and mycoplasma-like organisms. The majority of agricultural use of oxytetracycline is on pears. Other crops treated include peaches, nectarines, and apples. Oxytetracycline use on apples has been approved under emergency exemption (Section 18) provisions for several years due to the lack of efficacious alternatives. Oxytetracycline is also registered for use on forest trees and ornamental trees, shrubs, and vines. There are no residential pesticidal uses of oxytetracycline. Oxytetracycline is also registered with FDA to treat infectious diseases in animals and humans and also as a food additive to increase animal weight gain. The Agency is now issuing a Report on Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision for Oxytetracycline, known as a TRED, as well as related technical support documents.

-EPA must review tolerances and tolerance exemptions that were in effect when FQPA 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 Oxytetracycline 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 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, oxytetracycline was reviewed through the modified 4-Phase public participation process. Through this process, EPA worked extensively with stakeholders and the public to reach the regulatory decisions for oxytetracycline.

B. What is the Agency's Authority for Taking this Action

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-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.

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List of Subjects

• -Environmental protection
• Pesticides and pests

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