Document ID: EPA-HQ-OPP-2005-0492-0021
Agency: epa
Document Type: Notice
Title: Oxytetracycline; Tolerance Reassessment Decision
Posted Date: 2006-08-16T13:44:45Z

[Federal Register: August 16, 2006 (Volume 71, Number 158)]
[Notices]               
[Page 47210]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au06-78]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0492; FRL-8086-4]

 
Oxytetracycline; Tolerance Reassessment Decision

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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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.

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.

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?

    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.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 9, 2006.
 Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. E6-13485 Filed 8-15-06; 8:45 am]

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