Notice2022-13340
Spirodiclofen; Rescinding Cancellation Order for Certain Pesticide Registrations
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
June 22, 2022
Effective
June 22, 2022
Issuing agencies
Environmental Protection Agency
Abstract
In the Federal Register of November 19, 2021, EPA amended the effective date of the cancellation for the two spirodiclofen registrations, EPA Registration Nos. 10163-382 and 10163-383, as requested by the registrant (Gowan), for the two registrations from December 31, 2021, until June 30, 2022. This notice announces that EPA is rescinding the cancellation order based on the submission of outstanding data that facilitated the risk assessments and registration review decision for spirodiclofen, as well as the registrant's commitment to implement label changes that adequately address the Agency's risk concerns. The registrant has submitted an amended label for the sole end-use product (EPA Registration No. 10163-383) that reflects the risk mitigation proposed by the Agency.
Full Text
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<title>Federal Register, Volume 87 Issue 119 (Wednesday, June 22, 2022)</title>
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[Federal Register Volume 87, Number 119 (Wednesday, June 22, 2022)]
[Notices]
[Pages 37332-37333]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13340]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2017-0466; FRL-9928-01-OCSPP]
Spirodiclofen; Rescinding Cancellation Order for Certain
Pesticide Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: In the Federal Register of November 19, 2021, EPA amended the
effective date of the cancellation for the two spirodiclofen
registrations, EPA Registration Nos. 10163-382 and 10163-383, as
requested by the registrant (Gowan), for the two registrations from
December 31, 2021, until June 30, 2022. This notice announces that EPA
is rescinding the cancellation order based on the submission of
outstanding data that facilitated the risk assessments and registration
review decision for spirodiclofen, as well as the registrant's
commitment to implement label changes that adequately address the
Agency's risk concerns. The registrant has submitted an amended label
for the sole end-use product (EPA Registration No. 10163-383) that
reflects the risk mitigation proposed by the Agency.
DATES: This recission of the cancellation order for the two
spirodiclofen registrations, EPA Registration Nos. 10163-382 and 10163-
383 is effective June 22, 2022.
FOR FURTHER INFORMATION CONTACT: Veronica Dutch, Pesticide Re-
evaluation Division (7508M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 566-2352; email address:
<a href="/cdn-cgi/l/email-protection#9afeefeef9f2b4ecffe8f5f4f3f9fbdaffeafbb4fdf5ec"><span class="__cf_email__" data-cfemail="37534243545f1941524558595e54567752475619505841">[email protected]</span></a>.
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.
B. How can I get copies of this document and other related information?
The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2017-0466, is available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about the docket and
visiting EPA for docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. What action is the Agency taking?
This notice is being issued to rescind the cancellation order for
the two spirodiclofen registrations (EPA Registration Nos. 10163-382
and 10163-383). Bayer CropScience had requested the voluntary
cancellation of these registrations in August 2017, as an alternative
to developing data required by the registration review data call-in for
spirodiclofen, GDCI-124871-1883. The notice of receipt of the request
to cancel was published in the Federal Register on October 3, 2017 (82
FR 46052) (FRL-9966-85). The Agency solicited public comment on the
notice and received no comments.
The history of subsequent related FRN actions is summarized in the
table below.
Table--Cancellation Actions for EPA Registration Nos. 10163-382 and 10163-383
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FR citation Title Effective date Notes
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FRL-9971-10, 80 FR 60985, 12/26/2017.. Product Cancellation 6/30/2019 .............................
Order for Certain
Pesticide Registrations
and Amendments to
Terminate Uses.
FRL-9975-97, 83 FR 16076, 4/13/2018... Product Cancellation 12/31/2020 This notice amended the
Orders: Certain previous order to correct an
Pesticide Registrations error in the effective date.
and Amendments to
Terminate Uses;
Correction.
FRL-10017-47, 85 FR 83078, 12/21/2020. Product Cancellation 12/31/2021 This notice extended the
Order for Certain cancellation effective date
Pesticide Registrations. for the two spirodiclofen
registrations to allow time
for generating the
outstanding data from GDCI-
124871-1883.
FRL-9272-01, 86 FR 64929, 11/19/2021.. Product Cancellation 6/30/2022 This notice extended the
Order for Certain cancellation effective date
Pesticide; Amendment. for the two spirodiclofen
product registrations to
allow time for developing
the spirodiclofen
registration review risk
assessments.
FRL-9928-01 6/22/2022................. Spirodiclofen; Rescinding 6/22/2022 This notice rescinds the
Cancellation Order for cancellation order for the
Certain Pesticide two spirodiclofen product
Registrations. registrations.
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[[Page 37333]]
A history of subsequent related actions is summarized here. The
Agency issued the spirodiclofen registration review generic data call-
in (GDCI-124871-1883) on May 11, 2016. Bayer CropScience requested the
voluntary cancellation of spirodiclofen as an alternative to developing
the required data. The two spirodiclofen registrations were transferred
from Bayer CropScience to Gowan Company effective March 18, 2021, and
Gowan requested that the cancellation order be amended to facilitate
the submission of outstanding data identified in the GDCI before the
cancellations would become effective. Based on data submitted by both
Bayer and Gowan to fulfill the requirements of the DCI, EPA
subsequently completed draft ecological and human health risk
assessments (DRAs) for the registration review of spirodiclofen. The
DRAs were published for public comment on October 29, 2021 and
identified potential risks of concern associated with the use of
spirodiclofen. EPA subsequently extended the effective date of
cancellation to allow time for developing the proposed interim
registration review decision (PID) for spirodiclofen. On April 4, 2022,
EPA issued a PID addressing the human health and ecological risks of
concern identified in the spirodiclofen DRAs and proposing measures to
mitigate those risks. Gowan subsequently submitted an amended end-use
product label that is responsive to the risk mitigation measures
proposed by EPA. The comment period on the PID closed on June 6, 2022.
The Agency intends to issue an Interim Decision (ID) for spirodiclofen
after considering comments received on the PID. Because the
cancellation order for the spirodiclofen product registrations was set
to take effect on June 30, 2022, and because Gowan has acted in good
faith to address the Agency's risk concerns and Gowan has submitted an
amended label for the sole end-use product (EPA Registration No. 10163-
383) that reflects the risk mitigation proposed by the Agency, EPA is
now rescinding the cancellation order. The ID will account for any
comments received on the PID as well as the amended label submitted by
Gowan.
The cancellation order for EPA Registration Nos. 10163-382 and
10163-383 is hereby rescinded.
Authority: 7 U.S.C. 136 et seq.
Dated: June 15, 2022.
Mary Elissa Reaves,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2022-13340 Filed 6-21-22; 8:45 am]
BILLING CODE 6560-50-P
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