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Notice

Ethylene Oxide; Receipt of Application for Emergency Exemption, Solicitation of Public Comment

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA has received a quarantine exemption request from the United States Department of Agriculture (USDA) to use the pesticide ethylene oxide (EtO); Receipt (CAS No. 75-21-8) to sterilize the interior surfaces of enclosed animal isolator units to control microorganisms to create a germ free environment for research at USDA National Veterinary Services laboratories (NVSL) and at the National Animal Disease Center (NADC) in Ames, IA. The application proposes the use of a pesticide containing an active ingredient which is the subject of a Special Review. Due to the urgent nature of the emergency and the very narrow and extremely limited use being requested, EPA has eliminated the public comment period. Nonetheless, interested parties may still contact the Agency with comments about this notice and treatment program.

DATES:

Comments must be received on or before May 4, 2007.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2007-0018 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 Bldg.), 2777 S. Crystal Dr., 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-2007-0018. 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 regulations.gov or e-mail. The Federal regulations.gov website 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 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 available in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. 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 Bldg.), 2777 S. Crystal Dr., 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.

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FOR FURTHER INFORMATION CONTACT:

Princess Campbell, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8033; fax number: (703) 308-5433; e-mail address: campbell.princess@epa.gov.

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SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

  • Crop production (NAICS code 111).
  • Animal production (NAICS code 112).
  • Food manufacturing (NAICS code 311).
  • Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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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 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

What Action is the Agency Taking?

Under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the Administrator, a Federal or State agency may be exempted from any provision of FIFRA if the Administrator determines that emergency conditions exist which require the exemption. USDA has requested the Administrator to issue a quarantine exemption for the use of EtO on the interior surfaces of enclosed animal isolator units to inactivate forms of microbial life in an inanimate environment, including all forms of vegetative bacteria, bacterial spores, fungi, fungal spores, and viruses to create a germ free environment for animal research. Information in accordance with 40 CFR part 166 was submitted as part of this request.

As part of this request, the Applicant asserts that there are no control products labeled for this use on animal isolator units which could provide the degree of sterilization required for the conduct of this research. Without the ability to sterilize the animal isolator units, NVSL and NADC would not be able to conduct studies of national importance.

The Applicant proposes to make no more than 20 applications of the chemical per year, using the EPA registered product Oxyfume® 2002 ethylene oxide sterilant (a blend of 10% ethylene oxide; 90% refrigerant gas), to sterilize a maximum of nine tub isolators for pigs, nine auxiliary isolators that attach to the tub isolators for pigs, two tub isolators for calves and two auxiliary isolators that attach to the tub isolators for calves. A total of five pounds of the chemical mixture will be used to sterilize each animal isolator unit for a maximum of 1,000 lbs of Oxyfume® 2002 per year. A maximum of 100 lbs a.i. will be applied per year. The chemical will be used to sterilize the animal isolator units on an as needed basis to conduct research at NVSL and NADC over the period for which the quarantine exemption will be granted (3 years).

The regulations governing section 18 of FIFRA require publication of a Notice of Receipt of an application for a quarantine exemption under certain circumstances. The applicant proposes the use of a pesticide containing an active ingredient which is the subject of a Special Review and that is one of the criteria for preparing a Notice of Receipt for certain emergency exemption requests (40 CFR 166.24). As noted above, the Agency has eliminated the comment period due to the urgent nature of the emergency situation and the very narrow and extremely limited use being requested. Nonetheless, interested parties may still contact the Agency with comments about this notice and treatment program.

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List of Subjects

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Dated: March 27, 2007.

Daniel J. Rosenblatt,

Acting Director, Registration Division, Office of Pesticide Programs.

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[FR Doc. E7-6249 Filed 4-3-07; 8:45 am]

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