[Federal Register Volume 70, Number 148 (Wednesday, August 3, 2005)]
[Notices]
[Pages 44632-44634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15219]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0203; FRL-7729-2]


Ethylene Oxide Risk Assessment; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's human health 
risk assessment and related documents for the pesticide, ethylene oxide 
(ETO), and opens a public comment period on these documents. 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. This notice 
opens phase 3 of the 6-phase process.

DATES: Comments, identified by docket identification (ID) number OPP-
2005-0203, must be received on or before October 3, 2005.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

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: [email protected].

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. How can I get copies of this document and other related information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2005-0203. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket 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/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing

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in EPA's electronic public docket. EPA's policy is that copyrighted 
material will not be placed in EPA's electronic public docket but will 
be available only in printed, paper form in the official public docket. 
To the extent feasible, publicly available docket materials will be 
made available in EPA's electronic public docket. When a document is 
selected from the index list in EPA Dockets, the system will identify 
whether the document is available for viewing in EPA's electronic 
public docket. Although not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B.1. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. 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.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2005-0203. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2005-0203. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0203.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0203. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
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 CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any 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 and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.

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    3. Provide any technical information and/or data you used that 
support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at your estimate.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternatives.
    7. Make sure to submit your comments by the comment period deadline 
identified.
    8. To ensure proper receipt by EPA, identify the appropriate docket 
ID number in the subject line on the first page of your response. It 
would also be helpful if you provided the name, date, and Federal 
Register citation related to your comments.

II. Background

A. What Action is the Agency Taking?

    EPA is making available the human health risk assessment for ETO. 
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. The 
Agency developed this risk assessment 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).
    Sterilization/fumigation with ETO must be performed only in vacuum 
or gas tight chambers designed for use with ETO. It is applied by 
commercial applicators only; there are no residential uses of ETO. 
Approximately 8.2 million pounds of ETO are used annually in the United 
States for commercial fumigation/sterilization. Approximately 7.4 
million pounds are used annually for sterilization of medical and 
laboratory items/equipment. ETO treatment is the principal method used 
to reduce bacterial levels in spices, herbs, and black walnuts. 
Approximately 800,000 pounds are used annually for the fumigation of 
herbs and spices. All other uses account for less than 1% of the total 
annual usage.
    Regarding risks to humans from ETO alone, there are no aggregate 
risks of concern from acute and chronic dietary sources (food and water 
only). However, cancer risks for workers 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 risk is also 
estimated to be of concern at the OSHA levels, but not of concern at 
the NIOSH recommended limit. Since there are no outdoor uses of ETO, 
exposure to terrestrial wildlife and aquatic organisms is not expected.
    The ETO reaction products, ethylene chlorohydrin and ethylene 
glycol, have been identified as residues of concern for dietary 
exposure due to persistent high levels of these compounds found after 
sterilization. For all supported commodities, the acute dietary 
exposure estimates for ethylene chlorohydrin are above the Agency's 
level of concern. The chronic dietary exposure estimates for both 
ethylene chlorohydrin and ethylene glycol are below the Agency's level 
of concern.
    EPA is providing an opportunity, through this notice, for 
interested parties to provide comments and input on the Agency's risk 
assessment for ETO. Such comments and input could address, for example, 
the availability of additional data to further refine the risk 
assessments, such as worker exposure data, or could address the 
Agency's risk assessment methodologies and assumptions as applied to 
this specific pesticide.
    EPA seeks to achieve environmental justice, the fair treatment and 
meaningful involvement of all people, regardless of race, color, 
national origin, or income, in the development, implementation, and 
enforcement of environmental laws, regulations, and policies. To help 
address potential environmental justice issues, the Agency seeks 
information on any groups or segments of the population who, as a 
result of their location, cultural practices, or other factors, may 
have atypical, unusually high exposure to ETO, compared to the general 
population.
    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. 
EPA plans to review ETO through the full, 6-Phase public participation 
process. However, if as a result of comments received during the 
current Phase 3 public comment period the Agency finds that issues can 
be resolved without a second comment period in Phase 5, EPA may proceed 
directly to the end of the process and develop a risk management 
decision.
    Comments should be limited to issues raised within the risk 
assessment and associated documents. Failure to comment on any such 
issues as part of this opportunity will not limit a commenter's 
opportunity to participate in any later notice and comment processes on 
this matter. All comments should be submitted using the methods in Unit 
I. of the SUPPLEMENTARY INFORMATION, and must be received by EPA on or 
before the closing date. Comments 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.

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: July 27, 2005.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 05-15219 Filed 7-28-05; 2:31 pm]
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