Document ID: EPA-HQ-OPP-2005-0203-0084
Agency: epa
Document Type: Notice
Title: Ethylene Oxide; Tolerance Reassessment Decision for Low Risk Pesticide; Notice of Availability
Posted Date: 2006-08-09T12:50:18Z

[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