Document ID: EPA-HQ-OPP-2005-0203-0153
Agency: epa
Document Type: Notice
Title: Ethylene Oxide; Reregistration Eligibility Decision
Posted Date: 2008-04-16T04:00Z

[Federal Register: April 16, 2008 (Volume 73, Number 74)]
[Notices]               
[Page 20661-20662]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ap08-56]                         

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0302; FRL-8359-8]

 
Ethylene Oxide; Reregistration Eligibility Decision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's Reregistration 
Eligibility Decision (RED) for the pesticide ethylene oxide (ETO). The 
Agency's risk assessments and other related documents also are 
available in the ETO Docket. ETO is used to sterilize medical or 
laboratory equipment, pharmaceuticals, and aseptic packaging, or to 
reduce microbial load on musical instruments, cosmetics, whole and 
ground spices or other seasoning materials and artifacts, archival 
material or library objects. In North Carolina, ETO is also used to 
fumigate beehive equipment (e.g., woodenware boxes and frames) and wax 
or plastic combs that are contaminated with the bacteria Paenibacillus 
larvae, the cause of American Foulbrood Disease. EPA has

[[Page 20662]]

reviewed ETO through the 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.

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 and 
human health 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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPP-2005-0203. 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 Office of Pesticide Programs (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.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr.

II. Background

A. What Action is the Agency Taking?

    Under section 4 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to 
ensure that they meet current scientific and regulatory standards. EPA 
has completed a RED for the pesticide, ETO under section 4(g)(2)(A) of 
FIFRA. ETO is used to sterilize medical or laboratory equipment, 
pharmaceuticals, and aseptic packaging, or to reduce microbial load on 
musical instruments, cosmetics, whole and ground spices or other 
seasoning materials and artifacts, archival material or library 
objects. In North Carolina, ETO is also used to fumigate beehive 
equipment (e.g., woodenware boxes and frames) and wax or plastic combs 
that are contaminated with the bacteria.
    Paenibacillus larvae, the cause of American Foulbrood Disease. EPA 
has determined that the database to support reregistration is 
substantially complete and that products containing ETO are eligible 
for reregistration provided the risks are mitigated in the manner 
described in the RED. Upon submission of any required product specific 
data under section 4(g)(2)(B) of FIFRA and any necessary changes to the 
registration and labeling (either to address concerns identified in the 
RED or as a result of product specific data), EPA will make a final 
reregistration decision under section 4(g)(2)(C) of FIFRA for products 
containing ETO.
    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 was reviewed through the 
full 6-Phase public participation process. Through this process, EPA 
worked extensively with stakeholders and the public to reach the 
regulatory decisions for ETO.
    The reregistration program is being conducted under congressionally 
mandated time frames, and EPA recognizes the need both to make timely 
decisions and to involve the public. During the reregistration process, 
the Agency has provided ample opportunity for public comment and 
stakeholder input through a full 6-Phase public participation process. 
The Agency therefore is issuing the ETO RED without a comment period.

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: April 3, 2008.
Steven Bradbury,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. E8-7997 Filed 4-15-08; 8:45 am]

BILLING CODE 6560-50-S