Environmental Protection Agency (EPA).
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.
Comments must be received on or before October 10, 2006.
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.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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.Start Printed 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.
-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.Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
Dated: August 1, 2006.
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