Jump to main content.

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

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

 
[Federal Register: April 4, 2007 (Volume 72, Number 64)]
[Notices]
[Page 16356-16357]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap07-62]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0018; FRL-8114-3]

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

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

-----------------------------------------------------------------------

SUMMARY:  EPA has received a quarantine exemption request from the
United States Department of Agriculture (USDA) to use the pesticide
ethylene oxide (EtO); Receipt (CAS No. 75-21-8) to sterilize the
interior surfaces of enclosed animal isolator units to control
microorganisms to create a germ free environment for research at USDA
National Veterinary Services laboratories (NVSL) and at the National
Animal Disease Center (NADC) in Ames, IA. The application proposes the
use of a pesticide containing an active ingredient which is the subject
of a Special Review. Due to the urgent nature of the emergency and the
very narrow and extremely limited use being requested, EPA has
eliminated the public comment period. Nonetheless, interested parties
may still contact the Agency with comments about this notice and
treatment program.

DATES:  Comments must be received on or before May 4, 2007.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0018 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, 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-
2007-0018. 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 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
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:  Princess Campbell, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8033; fax number: (703) 308-5433; e-
mail address: campbell.princess@epa.gov.

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.
Potentially affected entities may include, but are not limited to:
    ? Crop production (NAICS code 111).
    ? Animal production (NAICS code 112).
    ? Food manufacturing (NAICS code 311).
    ? Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

[[Page 16357]]

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 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

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
Administrator, a Federal or State agency may be exempted from any
provision of FIFRA if the Administrator determines that emergency
conditions exist which require the exemption. USDA has requested the
Administrator to issue a quarantine exemption for the use of EtO on the
interior surfaces of enclosed animal isolator units to inactivate forms
of microbial life in an inanimate environment, including all forms of
vegetative bacteria, bacterial spores, fungi, fungal spores, and
viruses to create a germ free environment for animal research.
Information in accordance with 40 CFR part 166 was submitted as part of
this request.
    As part of this request, the Applicant asserts that there are no
control products labeled for this use on animal isolator units which
could provide the degree of sterilization required for the conduct of
this research. Without the ability to sterilize the animal isolator
units, NVSL and NADC would not be able to conduct studies of national
importance.
    The Applicant proposes to make no more than 20 applications of the
chemical per year, using the EPA registered product Oxyfume® 2002
ethylene oxide sterilant (a blend of 10% ethylene oxide; 90%
refrigerant gas), to sterilize a maximum of nine tub isolators for
pigs, nine auxiliary isolators that attach to the tub isolators for
pigs, two tub isolators for calves and two auxiliary isolators that
attach to the tub isolators for calves. A total of five pounds of the
chemical mixture will be used to sterilize each animal isolator unit
for a maximum of 1,000 lbs of Oxyfume® 2002 per year. A maximum of
100 lbs a.i. will be applied per year. The chemical will be used to
sterilize the animal isolator units on an as needed basis to conduct
research at NVSL and NADC over the period for which the quarantine
exemption will be granted (3 years).
    The regulations governing section 18 of FIFRA require publication
of a Notice of Receipt of an application for a quarantine exemption
under certain circumstances. The applicant proposes the use of a
pesticide containing an active ingredient which is the subject of a
Special Review and that is one of the criteria for preparing a Notice
of Receipt for certain emergency exemption requests (40 CFR 166.24). As
noted above, the Agency has eliminated the comment period due to the
urgent nature of the emergency situation and the very narrow and
extremely limited use being requested. Nonetheless, interested parties
may still contact the Agency with comments about this notice and
treatment program.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 27, 2007.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E7-6249 Filed 4-3-07; 8:45 am]
BILLING CODE 6560-50-S

 
 

Local Navigation

Jump to main content.