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Ethylene Oxide; Tolerance Reassessment Decision for Low Risk Pesticide; Notice of Availability
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Notices]
[Page 45548-45550]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au06-78]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0203; FRL-8083-3]
Ethylene Oxide; Tolerance Reassessment Decision for Low Risk
Pesticide; Notice of Availability
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 ethylene oxide, and
opens a public comment period on this document, related risk
assessments, and other support documents. EPA has reviewed this
pesticide ethylene oxide through a modified, streamlined version of the
public participation process that the Agency uses to involve the public
in developing pesticide tolerance reassessment and reregistration
decisions. Through the tolerance reassessment program, EPA is ensuring
that all pesticides meet current health and food safety standards.
DATES: Comments must be received on or before October 10, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0203, by one of the following methods:
? Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
? Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
? Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0203. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov
or E-mail. The Federal http://www.regulations.gov
Web site is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an E-mail comment directly to EPA
without going through http://www.regulations.gov, your E-mail address
will be automatically captured and included as part of the comment that
is placed in the docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. 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 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 telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Joy Schnackenbeck, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8072; fax
number: (703) 308-7070; E-mail address: schnackenbeck.joy@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.
[[Page 45549]]
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or E-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
EPA has reassessed the uses of ethylene oxide (ETO), and reassessed
the four existing tolerances or legal residue limits established for
residues of this fumigant/sterilant. Additional tolerances are to be
proposed for ethylene chlorhydrin (ECH), a reaction product of ETO. As
a fumigant/sterilant, ETO is used to sterilize medical or laboratory
equipment, pharmaceuticals, and aseptic packaging (21 CFR part 201), or
to reduce microbial load on cosmetics, whole and ground spices or other
seasoning materials (40 CFR part 180) and artifacts, archival material
or library objects. Sterilization/fumigation with ETO must be performed
only in vacuum or gas tight chambers designed for use with ETO. It is
applied by commercial applicators only; there are no residential uses
of ETO.
The Agency is now issuing for comment the resulting Report on Food
Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk
Management Decision for ethylene oxide, known as a TRED, as well as
related risk assessments and technical support documents. This TRED
will be followed by a Reregistration Eligibility Decision (RED) for
ETO, scheduled for 2007. The RED will be prepared once the Agency's
Office of Research and Development (ORD) completes its assessment of
ETO carcinogenicity. These results will be incorporated into the Office
of Pesticide Programs' (OPP) risk assessment for ETO and a RED will be
prepared.
EPA developed the ETO TRED through a modified, streamlined version
of its public process for making tolerance reassessment and
reregistration eligibility decisions. Through these programs, the
Agency is ensuring that pesticides meet current standards under the
Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended by
FQPA. EPA must review tolerances and tolerance exemptions that were in
effect when the FQPA was enacted, 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
ETO tolerances.
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 of May 14,
2004 (69 FR 26819) (FRL-7357-9), explains that in conducting these
programs, the Agency 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.
EPA can expeditiously reach decisions for pesticides like ETO, which
pose no risk concerns after risk mitigation. This mitigation includes
the voluntary cancellation of ethylene oxide use on basil and the
mandatory requirement of a sterilization method that uses a single
sterilization chamber to pre-condition and aerate with an alternating
vacuum and aeration purging procedure which reduces ethylene oxide and
reaction product residues. Once EPA assesses uses and risks for such
low risk pesticides, the Agency may go directly to a decision and
prepare a document summarizing its findings, such as the ETO TRED.
The tolerance reassessment 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 finding ways to
effectively mitigate pesticide risks. ETO, however, poses no risks
after mitigation. The Agency therefore is issuing the ETO TRED, its
risk assessments, and related support documents simultaneously for
public comment. The comment period is intended to provide an
opportunity for public input and a mechanism for initiating any
necessary amendments to the TRED. All comments should be submitted
using the methods in ADDRESSES, and must be received by EPA on or
before the closing date. These comments will become part of the Agency
docket for ETO. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
EPA will carefully consider all comments received by the closing
date and will provide a Response to Comments Memorandum in the docket
and http://www.regulations.gov. If any comment significantly affects
the document, EPA also will publish an amendment to the TRED in the
Federal Register. In the absence of substantive comments requiring
changes, the decisions reflected in the TRED will be implemented as
presented.
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.
[[Page 45550]]
Dated: August 1, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-12906 Filed 8-8-06; 8:45 am]
BILLING CODE 6560-50-S