Document ID: EPA-HQ-OPP-2005-0283-0166
Agency: epa
Document Type: Notice
Title: Ethylene Oxide; Preliminary Determination to Terminate Special Review
Posted Date: 2008-10-29T04:00Z

[Federal Register: October 29, 2008 (Volume 73, Number 210)]
[Notices]               
[Page 64318-64320]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc08-55]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0283; FRL-8380-9]

 
Ethylene Oxide; Preliminary Determination to Terminate Special 
Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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 (703) 305-5805.
    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

[[Page 64319]]

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 (703) 
305-5805.

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: bartow.susan@epa.gov.

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

[[Page 64320]]

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.
    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.

List of Subjects

    Environmental protection, Pesticides, Pests.

    Dated: October 21, 2008.
James B. Gulliford
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.
[FR Doc. E8-25674 Filed 10-28-08; 8:45 am]

BILLING CODE 6560-50-S