Environmental Protection Agency (EPA).
This notice announces the availability of EPA's revised risk assessments for the fumigant/sterilant pesticide ethylene oxide (ETO). In addition, this notice solicits public comment on risk reduction options for ETO. The public is encouraged to suggest risk management ideas or proposals to address the risks identified. EPA is developing a Reregistration Eligibility Decision (RED), for ETO through the full, 6-Phase public participation process that the Agency uses to involve the public in developing pesticide reregistration and tolerance reassessment decisions. Through these programs, EPA is ensuring that all pesticides meet current health and safety standards.
Comments must be received on or before April 24, 2006.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2005-0203, by one of the following methods:
- http://www.regulations.gov/. Follow the on-line instructions for submitting comments.
- Mail. Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand delivery. Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-2005-0203. The docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the docket facility is (703) 305-5805. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
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 public 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 regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity Start Printed Page 9111or 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 regulations.gov, your e-mail address will be captured automatically and included as part of the comment that is placed in the public 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. For additional information about EPA's public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/docket.htm/.
Docket. All documents in the docket are listed in the regulation.gov index. Although, listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically at http://www.regulations.gov/ or in hard copy at the Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. The docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the docket facility is (703) 305- 5805.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Susan Bartow, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 603-0065; fax number: (703) 308-8041; e-mail address: email@example.com.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; the medical industry; the spice industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others may also 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. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through 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 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.
A. What Action is the Agency Taking?
EPA is making available the Agency's revised risk assessments, initially issued for comment through a Federal Register notice published on August 3, 2005 (70 FR 44632) (FRL-7729-2); a response to comments; and related documents for ETO. EPA is also soliciting public comment on risk reduction options for ETO. EPA developed the risk assessments for ETO as part of its public process for making pesticide reregistration eligibility and tolerance reassessment decisions. Through these programs, EPA is ensuring that pesticides meet current standards under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
ETO is a fumigant/sterilant used to sterilize medical or laboratory equipment, pharmaceuticals, and aseptic packaging, or to reduce microbial load on cosmetics, whole and ground spices or other seasoning materials, and artifacts, archival material or library objects.
EPA is providing an opportunity, through this notice, for interested parties to provide risk management proposals or otherwise comment on risk management for ETO. Risks of concern associated with the use of ETO are as follows: The dietary risk assessment indicates that for all supported commodities, the acute dietary exposure estimates for ethylene chlorohydrin (a reaction product of ETO) are above the Agency's level of concern. In addition, the Agency's occupational exposure assessment for ETO's use as a sterilant for the spice and medical industries indicates that cancer risk are of concern at the current regulatory levels established by the Occupational Safety and Health Administration (OSHA) and recommended by the National Institute of Occupational Safety and Health (NIOSH). Non-cancer worker exposure/risk is estimated to be of concern at the OSHA permissible exposure limit (PEL), but not of concern at the NIOSH recommended exposure limit. Based on available data, the Agency anticipates the following spice and medical industry-related activities to result in potential worker exposure to ETO: Inhalation exposure to ETO during sterilization activities; inhalation exposure to off-gassed ETO from treated items during post-sterilization activities.
A summary of these potential risks of concern as well as specific questions for which the Agency is requesting input, are provided in a separate document titled Request for Additional Information and Risk Management Suggestions for the Reregistration of Ethylene Oxide. In targeting these risks of concern, the Agency solicits Start Printed Page 9112information on effective and practical risk reduction measures. In addition, a paper outlining benefits of various ETO uses is also included as a separate document. The Agency is interested in information related to these benefits.
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, ETO is being reviewed through the full 6-Phase public participation process.
All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. Comments and proposals 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.
After considering comments received, EPA will develop and issue the ETO RED.
B. What is the Agency's Authority for Taking this Action?
Section 4(g)(2) of FIFRA as amended directs that, after submission of all data concerning a pesticide active ingredient, “the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration,” before calling in product specific data on individual end-use products and either reregistering products or taking other “appropriate regulatory 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: February 15, 2006.
Director, Special Review and Reregistration Division, Office of Pesticide Programs.
[FR Doc. E6-2463 Filed 2-21-06; 8:45 am]
BILLING CODE 6560-50-S