E8-25674. Ethylene Oxide; Preliminary Determination to Terminate Special Review

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces EPA's preliminary determination to terminate the Special Review of ethylene oxide (ETO). On January 27, 1978, EPA initiated Special Review based on developmental toxicity, mutagenicity, and neurotoxic effects in workers (43 FR 3801). In the early 1980s, the carcinogenicity of ETO became of concern and was added to the Special Review. Since the initiation of the Special Review, additional data and more comprehensive reviews of potential risks associated with ETO exposure have been completed, including those described in the 2006 Tolerance Reassessment and Risk Management Decision (TRED) (http://www.epa.gov/​oppsrrd1/​REDs/​ethylene_​oxide_​tred.pdf) and the 2008 Reregistration Eligibility Decision (RED) (http://www.epa.gov/​oppsrrd1/​/REDs/​ethylene-oxide-red.pdf) for ETO. In the 2008 RED, the Agency addressed occupational risk concerns that were the focus of the Special Review. During the reregistration process EPA conducted a public, intensive review of ETO risks and benefits to determine whether or not ETO registrations meet the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) standard for registration. The Agency determined that the benefits of ETO use outweigh the occupational risks associated with its use provided that the risk mitigation measures outlined in the RED are adopted and label amendments are made to reflect those measures. Because the risks that were the basis of the Special Review have been evaluated and the Agency has made a determination under FIFRA, as outlined above, the Agency is proposing to terminate the Special Review of ETO

.

DATES:

Comments must be received on or before November 28, 2008.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2005-0283, 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 Facility'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 Facility telephone number is [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2005-0283. 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 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 at http://www.regulations.gov. 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 Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Susan Bartow, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 703-603-0065; fax number: 703-308-8005; e-mail address: [e-mail].

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.

B. What Should I Consider as I Prepare My Comments for EPA

?

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

A. What Action is the Agency Taking?

On January 27, 1978, EPA initiated Special Review based on developmental toxicity, mutagenicity, and neurotoxic effects in workers (43 FR 3801). In the early 1980s, the carcinogenicity of ETO became of concern and was added to the Special Review. Since the initiation of the Special Review, additional data and more comprehensive reviews of potential risks associated with ETO exposure have been completed, including those described in the 2006 TRED (http://www.epa.gov/​oppsrrd1/​REDs/​ethylene_​oxide_​tred.pdf) and the 2008 RED (http://www.epa.gov/​oppsrrd1/​/REDs/​ethylene-oxide-red.pdf) for ETO. In the 2008 RED, the Agency addressed occupational risk concerns that were the focus of the Special Review. During the reregistration process EPA conducted a public, intensive review of ETO risks and benefits to determine whether or not ETO registrations meet the FIFRA standard for registration. The Agency determined that the benefits of ETO use outweigh the occupational risks associated with its use provided that the risk mitigation measures outlined in the RED are adopted and label amendments are made to reflect those measures. The final risk management decision regarding the risk to workers exposed to ETO was completed with the 2008 RED. A detailed description of the rationale and supporting documents can be found in http://www.regulations.gov under EPA-HQ-OPP-2005-0203. As described above and in the 2008 RED, concerns were addressed under FIFRA and no further action is required at this time. Because the risks that were the basis of the Special Review have been evaluated and the Agency has made a determination under FIFRA, as outlined above, the Agency is proposing to terminate the Special Review of ETO.

B. What is the Agency's Authority for Taking this Action?

A pesticide product may be sold or distributed in the United States only if it is registered or exempt from registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as amended (7 U.S.C. 136 et seq.). Before a product can be registered it must be shown, among other things, that it can be used without causing “unreasonable adverse effects on the environment,” FIFRA section 3(c)(5). The term unreasonable adverse effects on the environment means:

(1) Any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide; or

(2) A human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug and Cosmetic Act FIFRA section 2(bb)

.

The burden of proving that a pesticide meets this standard for registration is, at all times, on the proponent of initial or continued registration. If at any time the Agency determines that a pesticide no longer meets this standard, the Administrator may cancel this registration under section 6 of FIFRA.

The Special Review process provides a mechanism to permit public participation in EPA's deliberations prior to issuance of any Notice of Final Determination pursuant to a Special Review describing the regulatory action which the Administrator has selected. The Special Review process, which was previously called the Rebuttable Presumption Against Registration (RPAR) process, is set forth in 40 CFR part 154, published in the Federal Register of November 27, 1985 (50 FR 49015). The purpose of this process is to help the Agency determine whether to initiate procedures to cancel, deny, or reclassify registration of a pesticide product because uses of that product may cause unreasonable adverse effects on the environment, in accordance with FIFRA

.

Prior to formal initiation of a Special Review, a preliminary notification is sent to registrants and applicants for registration pursuant to 40 CFR 154.21 announcing that the Administrator may initiate a Special Review of a pesticide use. Registrants and applicants for registration are allowed 30 days from receipt of the notification to comment on the Agency's preliminary notification that it may commence a Special Review.

If the Agency determines, after issuance of a notification pursuant to 40 CFR 154.21, that it will initiate a Special Review, 40 CFR 154.25(c) requires the Administrator to publish a Notice of Special Review in the Federal Register. To conclude the Special Review after a Special Review has been initiated, 40 CFR 154.31 requires the Administrator to first publish a Notice of Preliminary Determination in the Federal Register. This notice concerning ETO is being issued pursuant to 40 CFR 154.31

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That regulation requires the Administrator to respond to all significant comments received on the Notice of Special Review and, among other things, make a preliminary determination of whether any of the applicable risk criteria have been satisfied. Finally, after receipt and evaluation of comments on the Notice of Preliminary Determination, 40 CFR 154.33 requires that the Administrator publish in the Federal Register a Notice of Final Determination, including the reasons for the determination

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List of Subjects

• Environmental protection
• Pesticides
• Pests

Dated: October 21, 2008.

James B. Gulliford

Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.