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Ethylene Oxide; Revised Risk Assessments, Notice of Availability and Solicitation of Risk Reductions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.



[Federal Register: May 30, 2007 (Volume 72, Number 103)]
[Notices]
[Page 29997-29999]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my07-70]

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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0203; FRL-8130-1]

Ethylene Oxide; Revised Risk Assessments, Notice of Availability
and Solicitation of Risk Reductions

AGENCY:  Environmental Protection Agency (EPA).
ACTION:  Notice.

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SUMMARY:  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 to protect ETO workers and a revised alternatives assessment.
The Agency is having this second Phase-5 to focus on ETO's risks to
workers under FIFRA. 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.

DATES:  July 30, 2007.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0203, 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,

[[Page 29998]]

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-
2005-0203. 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 Building), 2777 S. Crystal Drive, 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.

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?

    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 also is soliciting public
comment on risk reduction options for ETO relating to workers risks
revised alternatives assessment for identified risks of concern. 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, aseptic packaging, musical instruments, and
beekeeping equipment 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 proposalsor occupational
issues or otherwise comment on risk management for ETO. Risks of
concern associated with the use of ETO are as follows: The Agency's
occupational exposure assessment for ETO's use as a sterilant indicates
that cancer risks are of concern at the current regulatory levels
established by the Occupational Safety

[[Page 29999]]

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 (REL). Based on available data, the Agency anticipates
the following activities to result in potential worker exposure to ETO:
Inhalation exposure to ETO during sterilization activities; dermal
exposure to ethylene glycol and the halohydrins during post-
sterilization activities; and inhalation exposure to off-gassed ETO
from treated items during post-sterilization activities. In targeting
these risks of concern, the Agency solicits information on effective
and practical risk reduction measures. A revised paper outlining
various ETO alternatives is also included as a separate document in the
ETO docket EPA-HQ-OPP-2005-0203. The Agency is interested in
information related to these alternatives.
    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.''

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: May 16, 2007.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-10341 Filed 5-30-07; 8:45 am]
BILLING CODE 6560-50-S

 
 

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