Notice2023-07727
Pesticide Registration Review; Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide; Notice of Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 13, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 71 (Thursday, April 13, 2023)</title>
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[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22447-22449]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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
<a href="http://regulations.gov">regulations.gov</a> 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: <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
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. <a href="/cdn-cgi/l/email-protection#c18e9191a4b5a9b8ada4afa4aeb9a8a5a4a8afb0b4a8b3a8a4b281a4b1a0efa6aeb7"><span class="__cf_email__" data-cfemail="da958a8abfaeb2a3b6bfb4bfb5a2b3bebfb3b4abafb3a8b3bfa99abfaabbf4bdb5ac">[email protected]</span></a>.
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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:
<a href="https://www.epa.gov/pesticide-reevaluation">https://www.epa.gov/pesticide-reevaluation</a>.
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]
BILLING CODE 6560-50-P
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