[Federal Register Volume 87, Number 119 (Wednesday, June 22, 2022)]
[Notices]
[Pages 37332-37333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 
[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.

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 https://www.regulations.gov. Additional information about the docket and 
visiting EPA for docket access, visit https://www.epa.gov/dockets.

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
----------------------------------------------------------------------------------------------------------------
              FR citation                         Title            Effective date              Notes
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


[[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


