Document ID: EPA-HQ-OPP-2013-0244-0044
Agency: epa
Document Type: Notice
Title: Pesticide Registration Review: Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide
Posted Date: 2023-04-13T04:00Z

[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22447-22449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07727]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0244; FRL-10818-01-OCSPP]

Pesticide Registration Review; Proposed Interim Decision and 
Draft Risk Assessment Addendum for Ethylene Oxide; Notice of 
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of and solicits public 
comment on EPA's proposed interim registration review decision and 
draft risk assessment addendum for ethylene oxide.

DATES: Comments must be received on or before June 12, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2013-0244, through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow

[[Page 22448]]

the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. Additional instructions on commenting and visiting the 
docket, along with more information about dockets generally, is 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: The Chemical Review Manager for 
ethylene oxide as listed in table 1.

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; distributors and users of medical devices; 
owners and operators of commercial sterilization facilities; 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 Chemical Review Manager for ethylene 
oxide identified in table 1 in unit IV.

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 email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information on 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 preparing and submitting 
your comments, see the commenting tips at: https://www.epa.gov/dockets/commenting-epa-dockets.
    3. Environmental justice. EPA seeks to achieve environmental 
justice, the fair treatment and meaningful involvement of any group, 
including minority and/or low-income populations, 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 or disproportionately high and adverse human 
health impacts or environmental effects from exposure to ethylene oxide 
(EtO) discussed in this document, compared to the general population.

II. Background

    Registration review is EPA's periodic review of pesticide 
registrations to ensure that each pesticide continues to satisfy the 
statutory standard for registration, that is, the pesticide can perform 
its intended function without unreasonable adverse effects on human 
health or the environment. As part of the registration review process, 
the Agency has completed a proposed interim decision and draft risk 
assessment addendum for ethylene oxide (table 1). Through this program, 
EPA is ensuring that each pesticide's registration is based on current 
scientific and other knowledge, including its effects on human health 
and the environment.

III. Authority

    EPA is conducting its registration review of ethylene oxide 
pursuant to section 3(g) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) and the Procedural Regulations for Registration 
Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, 
among other things, that the registrations of pesticides are to be 
reviewed every 15 years. Under FIFRA, a pesticide product may be 
registered or remain registered only if it meets the statutory standard 
for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). 
When used in accordance with widespread and commonly recognized 
practice, the pesticide product must perform its intended function 
without unreasonable adverse effects on the environment; that is, 
without any unreasonable risk to man or the environment, or a human 
dietary risk from residues that result from the use of a pesticide in 
or on food.

IV. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability 
of EPA's proposed interim registration review decisions for ethylene 
oxide and the draft risk assessment addendum and opens a 60-day public 
comment period on these documents.

       Table 1--Ethylene Oxide Registration Review Docket Details
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                                                        Chemical review
  Registration review case name                           manager and
             and No.                 Docket ID No.          contact
                                                          information
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Ethylene oxide Case Number 2275.  EPA-HQ-OPP-2013-02  Jessica Bailey
                                   44.                 [email protected].
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    The registration review docket for a pesticide includes earlier 
documents related to the registration review case. For example, the 
review opened with a Preliminary Work Plan, for public comment. A Final 
Work Plan was placed in the docket following public comment on the 
Preliminary Work Plan.
    The documents in the docket describe EPA's rationales for 
conducting additional risk assessments for the registration review of 
ethylene oxide, as well as the Agency's subsequent risk findings and 
consideration of possible risk mitigation measures. The proposed 
interim registration review decision is supported by the rationale 
included in those documents. Following public comment, the Agency will 
issue an interim or final registration review decision for ethylene 
oxide.
    The registration review final rule at 40 CFR 155.58(a) provides for 
a minimum 60-day public comment period on all proposed interim 
registration review decisions. This comment period is intended to 
provide an opportunity for public input and a mechanism for initiating 
any necessary amendments to the proposed interim decision. All comments 
should be submitted using the methods in ADDRESSES and must be received 
by EPA on or before the closing date. These comments will become part 
of the docket for ethylene oxide. Comments received after the close of 
the comment period will be marked ``late.'' EPA is not required to 
consider these late comments.

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    The Agency will carefully consider all comments received by the 
closing date and may provide a ``Response to Comments Memorandum'' in 
the docket. The interim registration review decision will explain the 
effect that any comments had on the interim decision and provide the 
Agency's response to significant comments.
    Background on the registration review program is provided at: 
https://www.epa.gov/pesticide-reevaluation.
    Authority: 7 U.S.C. 136 et seq.

    Dated: March 28, 2023.
Anita Pease,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. 2023-07727 Filed 4-12-23; 8:45 am]
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