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Ethylene Oxide (ETO) Revised Risk Assessments; Notice of Availability, and Solicitation of Risk Reduction Options (Phase 5 of 6-Phase Process)
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: February 22, 2006 (Volume 71, Number 35)]
[Notices]
[Page 9110-9112]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22fe06-83]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0203; FRL-7764-4 ]
Ethylene Oxide (ETO) Revised Risk Assessments; Notice of Availability,
and Solicitation of Risk Reduction Options (Phase 5 of 6-Phase Process)
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 for ETO. 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: Comments must be received on or before April 24, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0203, by one of the following methods:
? http://www.regulations.gov/. 
Follow the on-line
instructions for submitting comments.
? Mail. Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand delivery. Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-2005-0203. The
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the docket
facility is (703) 305-5805. Such deliveries are only accepted during
the Docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
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 public 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
[[Page 9111]]
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 captured
automatically and included as part of the comment that is placed in the
public 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. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at http://www.epa.gov/epahome/docket.htm.
Docket. All documents in the docket are listed in the
regulation.gov index. Although, listed in the index, some information
is not publicly available, i.e., CBI or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at http://www.regulations.gov/ or in hard copy at the
Public Information and Records Integrity Branch (PIRIB) (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119,
Crystal Mall #2, 1801 S. Bell St., Arlington, VA. The docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the docket facility
is (703) 305- 5805.
FOR FURTHER INFORMATION CONTACT: Susan Bartow, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 603-0065; fax
number: (703) 308-8041; 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; the medical
industry; the spice industry; pesticide users; and members of the
public interested in the sale, distribution, or use of pesticides.
Since others may also 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
http://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 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 is also soliciting public
comment on risk reduction options for ETO. 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, and aseptic packaging, 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 proposals or otherwise
comment on risk management for ETO. Risks of concern associated with
the use of ETO are as follows: The dietary risk assessment indicates
that for all supported commodities, the acute dietary exposure
estimates for ethylene chlorohydrin (a reaction product of ETO) are
above the Agency's level of concern. In addition, the Agency's
occupational exposure assessment for ETO's use as a sterilant for the
spice and medical industries indicates that cancer risk are of concern
at the current regulatory levels established by the Occupational Safety
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. Based on available data, the Agency anticipates the
following spice and medical industry-related activities to result in
potential worker exposure to ETO: Inhalation exposure to ETO during
sterilization activities; inhalation exposure to off-gassed ETO from
treated items during post-sterilization activities.
A summary of these potential risks of concern as well as specific
questions for which the Agency is requesting input, are provided in a
separate document titled Request for Additional Information and Risk
Management Suggestions for the Reregistration of Ethylene Oxide. In
targeting these risks of concern, the Agency solicits
[[Page 9112]]
information on effective and practical risk reduction measures. In
addition, a paper outlining benefits of various ETO uses is also
included as a separate document. The Agency is interested in
information related to these benefits.
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.''
Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to
review tolerances and exemptions for pesticide residues in effect as of
August 2, 1996, to determine whether the tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review
is to be completed by August 3, 2006.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: February 15, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-2463 Filed 2-21-06; 8:45 am]
BILLING CODE 6560-50-S