Notice2026-05998
Pesticide Product Registration; Emergency Exemption Request and Application for a New Active Ingredient
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Published
March 27, 2026
Issuing agencies
Environmental Protection Agency
Abstract
This document announces the Agency's receipt of and solicits comment on an application from the United States Department of Agriculture (USDA) to register a new pesticide product containing an unregistered pesticide, NovoFly male- only genetically engineered (GE) New World screwworm (NWS) in USDA's Sterile Insect Technique (SIT) programs. Additionally, the Agency received a Section 18 quarantine emergency exemption application requesting use of the same pesticide to maintain broad suppression of and help prevent the pest from moving further northward from Mexico toward the United States. The Agency is providing this notice in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Due to the urgent nature of the emergency, the limited time available to authorize the Section 18 quarantine emergency exemption request, and the related FIFRA Section 3 product registration application under review for the same use, EPA is waiving the comment period associated with the emergency exemption request, but is soliciting public comment in conjunction with the application for Section 3 product registration of NovoFly.
Full Text
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<title>Federal Register, Volume 91 Issue 59 (Friday, March 27, 2026)</title>
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[Federal Register Volume 91, Number 59 (Friday, March 27, 2026)]
[Notices]
[Pages 14839-14841]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05998]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2026-1420; EPA-HQ-OPP-2026-0991; EPA-HQ-OPP-2026-1256; FRL-
13274-01-OCSPP]
Pesticide Product Registration; Emergency Exemption Request and
Application for a New Active Ingredient
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of receipt and request for comment.
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SUMMARY: This document announces the Agency's receipt of and solicits
comment on an application from the
[[Page 14840]]
United States Department of Agriculture (USDA) to register a new
pesticide product containing an unregistered pesticide, NovoFly male-
only genetically engineered (GE) New World screwworm (NWS) in USDA's
Sterile Insect Technique (SIT) programs. Additionally, the Agency
received a Section 18 quarantine emergency exemption application
requesting use of the same pesticide to maintain broad suppression of
and help prevent the pest from moving further northward from Mexico
toward the United States. The Agency is providing this notice in
accordance with the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). Due to the urgent nature of the emergency, the limited time
available to authorize the Section 18 quarantine emergency exemption
request, and the related FIFRA Section 3 product registration
application under review for the same use, EPA is waiving the comment
period associated with the emergency exemption request, but is
soliciting public comment in conjunction with the application for
Section 3 product registration of NovoFly.
DATES: Comments must be received on or before April 27, 2026.
ADDRESSES: Submit your comments on the Section 3 product registration
application, identified by the docket identification (ID) number, EPA-
HQ-OPP-2026-0991 and the EPA File Symbol, 91213-L, as shown in Unit II.
of this document, online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow 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, are
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Each application summary in Unit II.
specifies a contact division. The appropriate division contacts are
identified as follows:
<bullet> BPPD (Biopesticides and Pollution Prevention Division)
(Mail Code 7511M); Shannon Borges; main telephone number: (202) 566-
1400; email address: <a href="/cdn-cgi/l/email-protection#1f5d4f4f5b594d51706b767c7a6c5f7a6f7e31787069"><span class="__cf_email__" data-cfemail="226072726664706c4d564b414751624752430c454d54">[email protected]</span></a>.
<bullet> RD (Registration Division) (Mail Code 7505T); Charles
Smith; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#bdeff9fbeff3d2c9d4ded8cefdd8cddc93dad2cb"><span class="__cf_email__" data-cfemail="bbe9fffde9f5d4cfd2d8dec8fbdecbda95dcd4cd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action provides information that is directed to the public in
general.
B. What is the Agency's authority for taking this action?
EPA is taking this action pursuant to section 3(c)(4) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136a(c)(4), and 40 CFR 152.102.
C. What action is the Agency taking?
EPA is hereby providing notice of receipt of an application to
register a new Section 3 pesticide product containing an unregistered
active ingredient in addition to receipt of an application requesting
authorization of a Section 18 quarantine emergency exemption. EPA is
providing an opportunity to comment on the application to register a
new Section 3 pesticide product containing an unregistered active
ingredient. This document identifies applications that were received
and are currently being evaluated by EPA in accordance with FIFRA.
Notice of receipt of these applications does not imply a decision by
the Agency on either the Section 3 pesticide product registration or
Section 18 quarantine emergency exemption applications. For the Section
3 product registration being evaluated under EPA's public participation
process, there will be an additional opportunity for public comment on
the proposed decisions. Please see EPA's public participation website
for additional information on this process (<a href="https://www.epa.gov/pesticide-registration/public-participation-process-registration-actions">https://www.epa.gov/pesticide-registration/public-participation-process-registration-actions</a>).
D. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. If you wish to include CBI in your
comment, please follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the
information that you claim to be CBI. In addition to one complete
version of the comment that includes CBI, a copy of the comment without
CBI must be submitted for inclusion in the public docket. Information
marked as CBI 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>.
II. Applications To Register and Authorize New Pesticide Product and
Section 18 Quarantine Emergency Exemption, Respectively
This unit provides the following information about each application
received: The EPA File Symbol or Emergency Exemption Number; EPA docket
ID number for the application; Name and address of the applicant; Name
of the active ingredient, product type and proposed uses; and the
division to contact for that application. Additional information about
the application may also be available in the docket for the application
as identified in this unit.
A. Application for a New Active Ingredient
File Symbol: 91213-L. Docket ID number: EPA-HQ-OPP-2026-0991.
Applicant: United States Department of Agriculture--Agricultural
Research Service (USDA-ARS), George Washington Carver Center, 5601
Sunnyside Ave., Beltsville, MD 20706. Product Name: NovoFly. Active
Ingredients: (1) Lshid\Ala2\ protein and the genetic material necessary
to produce the protein in vivo in female embryos Cochliomyia
hominivorax; and (2) tTAo protein and the genetic material necessary to
produce the protein in vivo in female embryos Cochliomyia hominivorax.
Product Type: Biopesticide. Proposed Use: Cochliomyia hominivorax (New
World Screwworm) female lethal trait to be used as part of wide area
sterilization and eradication program. Date of Receipt: January 30,
2026. Contact: BPPD.
B. Section 18 Emergency Exemption
Under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the EPA
Administrator, a Federal or State agency may be exempted from any
provision of FIFRA if the EPA Administrator determines that emergency
conditions exist which require the exemption. This notice does not
constitute a decision by EPA on the application itself. The regulations
governing FIFRA section 18 require publication of a notice of receipt
of an application for a quarantine exemption proposing a new use of a
pesticide (i.e., an active ingredient) which has not been registered by
EPA. Due to the urgent nature of the emergency, the limited time
available to authorize the Section 18 quarantine emergency exemption
request, and the related FIFRA Section
[[Page 14841]]
3 product registration application under review for the same use, EPA
is waiving the comment period associated with the emergency exemption
request, but is soliciting public comment in conjunction with the
application for product registration of NovoFly.
As part of this request, the applicant asserts that the NWS
(Cochliomyia hominivorax) is a devastating pest that causes serious and
often deadly damage to livestock, wildlife, pets, and in rare cases,
humans. Recent detections have been identified, spreading north in
Mexico, thereby threatening re-emergence in the United States and
necessitating new tools to stop it. If NWS enters and establishes in
the United States, widespread economic losses are expected; each
outbreak can cause millions of dollars in production losses and
economic damage. It has been calculated that an outbreak in Texas would
cost $1.8 billion to the Texas economy today. USDA-ARS has developed
the NovoFly GE NWS using sterile insect technique (SIT), which results
in all flies raised being males. Use of male-only NWS populations in
SIT effectively doubles the output of traditional SIT (which is
dependent on sterile male NWS), providing a significant efficiency. The
NovoFly males will be sterilized through irradiation prior to release,
which will achieve rapid population control. Current registered
insecticides can be applied to animals to control adult flies or kill
larvae developing in animal wounds. However, because NWS has been
eradicated from the U.S. for so long, many of the products historically
applied to animals are no longer available.
File Symbol: 26DA05. Docket ID number: EPA-HQ-OPP-2026-1256.
Applicant: United States Department of Agriculture--Agricultural
Research Service (USDA-ARS), George Washington Carver Center, 5601
Sunnyside Ave., Beltsville, MD 20706. Product Name: NovoFly. Active
Ingredients: (1) Lshid\Ala2\ protein and the genetic material necessary
to produce the protein in vivo in female embryos Cochliomyia
hominivorax; and (2) tTAo protein and the genetic material necessary to
produce the protein in vivo in female embryos Cochliomyia hominivorax.
Product Type: Biopesticide. Proposed Use: Cochliomyia hominivorax (New
World Screwworm) female lethal trait to be used as part of wide area
sterilization and eradication program across areas where NWS is
detected, and sterile insect dispersal areas to maintain broad
suppression and help prevent the pest from moving further north from
Mexico toward the United States. NovoFly NWS Cochliomyia hominivorax
carry traits that allow inducible sex-selection which is lethal to
female NWS at the embryonic stage during production. This genetically
engineered trait allows for the controlled mass-rearing of male-only
populations of NWS. NovoFly males are sterilized through irradiation
using typical SIT procedures prior to release, making them incapable of
reproducing. Use of male-only NWS populations in SIT effectively
doubles the output of traditional SIT (which is dependent on sterile
male NWS), providing a significant efficiency. USDA ARS is requesting
that sterile male-only NovoFly be integrated into existing or future
mass-rearing and SIT programs to prevent the establishment of, and to
control NWS (Cochliomyia hominivorax), a devastating pest that causes
serious and often deadly damage to livestock, wildlife, pets, and in
rare cases, humans. The applicant proposes the use of a new active
ingredient in a pesticide which has not been registered by EPA.
Area-wide releases of sterile, male-only Novofly will follow
typical SIT procedures. According to the USDA, sterile insect
technique, when paired with surveillance, animal movement restrictions,
and education and outreach, is a proven and effective tool for
controlling and eradicating NWS. Female NWS flies only mate once in
their lives, so if they mate with a sterile male, they lay unfertilized
eggs that do not hatch. USDA currently produces sterile flies for
dispersal through aerial or ground releases. The historical range
(prior to eradication) of NWS is 45[deg] N and 45[deg] S, and NWS could
remain established during mild winters as far north as 35[deg] N. USDA
closely evaluates the location and circumstances of each new case to
adjust sterile insect release efforts and locations as needed. USDA's
Animal and Plant Health Inspection Service (APHIS) determines the SIT
dispersal area based on NWS detections. Changes to the sterile insect
dispersal area, or polygon, occur as needed to maintain broad
suppression and help prevent the pest from moving further north toward
the United States. For the current dispersal polygon see the current
status page on <a href="http://screwworm.gov">screwworm.gov</a> (<a href="https://www.aphis.usda.gov/livestock-poultry-disease/stop-screwworm/current-status">https://www.aphis.usda.gov/livestock-poultry-disease/stop-screwworm/current-status</a>).
The applicant proposes to release NovoFly males from aircraft and/
or via ground releases. Flies are released from the aircraft at a rate
of 1500 to 3000 flies per nautical mile. Flight plans typically cover
665 nautical miles flying parallel lines over the specified release
polygon. Ground releases utilize hanging chambers which hold up to 10
liters of pupae (roughly 90,000 pupae). For male-only releases, 5
liters (roughly 45,000 pupae) are recommended. As adults emerge, they
disperse and provide localized control 2-5 kilometers in radius from
the release point. Typically, release chambers are refilled once per
week for three subsequent weeks when targeting specific cases. The
total release polygon can vary in size from 25 million to 40 million
acres. At a maximum production capacity of 5.72 billion flies per year,
annual release density is 143 to 229 flies per acre if the site remains
with the polygon. The active ingredients contained in Novofly are (1)
Lshid\Ala2\ protein and the genetic material necessary to produce the
protein in vivo in female embryos Cochliomyia hominivorax, <0.00007%;
and (2) tTAo protein and the genetic material necessary to produce the
protein in vivo in female embryos Cochliomyia hominivorax, <0.00003%.
Date of Receipt: January 30, 2026. Contact: RD.
Authority: 7 U.S.C. 136 et seq.
Dated: March 25, 2026.
Edward Messina,
Director, Office of Pesticide Programs.
[FR Doc. 2026-05998 Filed 3-26-26; 8:45 am]
BILLING CODE 6560-50-P
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