[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]
BILLING CODE 6560-50-S