Applications for Emergency Exemptions: Ethylene Oxide

This Notice document was issued by the Environmental Protection Agency (EPA)

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[EPA-HQ-OPP-2013-0276; FRL-9385-2]

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


Environmental Protection Agency (EPA).




EPA has received a quarantine exemption request from the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) to use the pesticide ethylene oxide (CAS No. 75-21-8) to sterilize the interior surfaces of enclosed animal isolator units to control microorganisms. The applicant proposes a use of a pesticide which contains an active ingredient which is or has been the subject of a Special Review, and which could pose a risk similar to the risk which is or has been the subject of the Special Review. EPA is soliciting public comment before making the decision whether or not to grant the exemption.


Comments must be received on or before May 13, 2013.


Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2013-0276, by one of the following methods:

  • Federal eRulemaking Portal: Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
  • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
  • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at

For Further Information Contact

Keri Grinstead, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8373; fax number: (703) 605-0781; email address:

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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

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

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through or email. 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 Registerdate 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.

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide(s) discussed in this document, compared to the general population.

II. 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 EPA Administrator, a Federal or State agency may be exempted from any provision of FIFRA if the EPA Administrator determines that emergency conditions exist which require the exemption. USDA APHIS has requested the EPA Administrator to issue a quarantine exemption for the use of ethylene oxide to sterilize interiorsurfaces of enclosed animal isolator units used at USDA National Veterinary Services Laboratories (NVSL) and the National Animal Disease Center (NADC) in Ames, IA. Information in accordance with 40 CFR part 166 was submitted as part of this request.

As part of this request, the applicant asserts that without the ability to sterilize animal isolators, NVSL and NADC would not be able to conduct studies of national importance. NVSL and NADC provide diagnosis for animal diseases and diagnostic support for disease control and eradication. Ethylene oxide is an effective sterilizer, yet is non-corrosive on delicate instruments and electrical equipment.

The applicant proposes that enclosed animal isolator units used at USDA NVSL and NADC in Ames, IA will be sterilized 5 to 7 times over the 3-year term of the exemption. Six pounds of product (8.6% ethylene oxide) will be applied to each unit for each sterilization.

This notice does not constitute a decision by EPA on the application itself. The regulations governing FIFRA section 18 require publication of a notice of receipt of an application for a quarantine exemption proposing use of a pesticide which contains an active ingredient which is or has been the subject of a Special Review, and which could pose a risk similar to the risk which is or has been the subject of the Special Review. The notice provides an opportunity for public comment on the application. The Agency will review and consider all comments received during the comment period in determining whether to issue the quarantine exemption requested by the USDA APHIS.

List of Subjects

Environmental protection, Pesticides and pests.

Dated: April 19, 2013.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2013-09954 Filed 4-25-13; 8:45 am]
Comment Period Closed
May 13 2013, at 11:59 PM ET
ID: EPA-HQ-OPP-2013-0276-0001
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Document Information

Date Posted: Apr 26, 2013
Federal Register Number: 2013-09954
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Comments Received*

Docket Information

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Related RINs: None
Related Documents: None

* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.

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