Rule2025-23420
Flupyradifurone; Pesticide Tolerance for Emergency Exemption
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
December 19, 2025
Effective
December 19, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes time-limited tolerances for residues of flupyradifurone, including its metabolites and degradates, in or on sugarcane, cane and sugarcane, molasses. This action is in response to EPA's concurrence of a crisis exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on sugarcane. This regulation establishes a maximum permissible level for residues of flupyradifurone in or on these commodities. The time-limited tolerances expire on December 31, 2028.
Full Text
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<title>Federal Register, Volume 90 Issue 242 (Friday, December 19, 2025)</title>
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[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Rules and Regulations]
[Pages 59389-59393]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23420]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2025-1973; FRL-13080-01-OCSPP]
Flupyradifurone; Pesticide Tolerance for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of flupyradifurone, including its metabolites and degradates,
in or on sugarcane, cane and sugarcane, molasses. This action is in
response to EPA's concurrence of a crisis exemption under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
the pesticide on sugarcane. This regulation establishes a maximum
permissible level for residues of flupyradifurone in or on these
commodities. The time-limited tolerances expire on December 31, 2028.
DATES: This rule is effective December 19, 2025. Objections and
requests for hearings must be received on or before February 17, 2026
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2025-1973, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the
[[Page 59390]]
docket in person, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#9bc9dfddc9d5f4eff2f8fee8dbfeebfab5fcf4ed"><span class="__cf_email__" data-cfemail="bceef8faeef2d3c8d5dfd9cffcd9ccdd92dbd3ca">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. What is EPA's authority for taking this action?
In accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA)
sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(l)(6), EPA
is establishing time-limited tolerances for residues of
flupyradifurone, including its metabolites and degradates, in or on
sugarcane, cane at 3 parts per million (ppm) and sugarcane, molasses at
90 ppm. These time-limited tolerances expire on December 31, 2028.
C. How can I file an objection or hearing request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
If you fail to file an objection to the final rule within the time
period specified in the final rule, you will have waived the right to
raise any issues resolved in the final rule. You must file your
objection or request a hearing on this regulation in accordance with
the instructions provided in 40 CFR part 178. To ensure proper receipt
by EPA, you must identify docket ID number EPA-HQ-OPP-2025-1973 in the
subject line on the first page of your submission. All objections and
requests for a hearing must be in writing and must be received by the
Hearing Clerk on or before February 17, 2026.
The EPA's Office of Administrative Law Judges (OALJ), in which the
Hearing Clerk is housed, urges parties to file and serve documents by
electronic means only, notwithstanding any other particular
requirements set forth in other procedural rules governing those
proceedings. See ``Revised Order Urging Electronic Filing and
Service,'' dated June 22, 2023, which can be found at <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
Although the EPA's regulations require submission via U.S. Mail or hand
delivery, the EPA intends to treat submissions filed via electronic
means as properly filed submissions; therefore, the EPA believes the
preference for submission via electronic means will not be prejudicial.
When submitting documents to the OALJ electronically, a person should
utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf</a>.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket 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 CBI or other
information whose disclosure is restricted by statute. If you wish to
include CBI in your request, 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. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice.
II. Background and Statutory Findings
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions
related to FIFRA section 18 time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative (i.e., without having
received any petition from an outside party).
FFDCA Section 408(b)(2)(A)(i) allows EPA to establish a tolerance
(the legal limit for a pesticide chemical residue in or on a food) only
if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Flupyradifurone on Sugarcane and FFDCA
Tolerances
The Louisiana Department of Agriculture and Forestry (LDAF)
utilized a crisis exemption under FIFRA for the use of flupyradifurone
to control West Indian canefly, sugarcane aphid, and yellow sugarcane
aphid. The applicant asserts that an emergency pest situation exists
due to simultaneous widespread infestations of hemipteran insects such
as caneflies and aphids. According to LDAF, there is a lack of
available insecticides to control these pests that can fit with
integrated pest management in sugarcane. Without an effective control,
Louisiana sugarcane growers affected by uncontrolled caneflies and
aphids face significant economic yield losses.
After having reviewed the crisis exemption, EPA concurred on the
crisis exemption and determined that an emergency condition exists for
this
[[Page 59391]]
State, and that the criteria for approval of an emergency exemption are
met.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of
flupyradifurone in or on sugarcane, cane and sugarcane, molasses. In
doing so, EPA considered the safety standard in FFDCA section
408(b)(2), and EPA decided that the necessary tolerances under FFDCA
section 408(l)(6) would be consistent with the safety standard and with
FIFRA section 18. Consistent with the need to move quickly on the
emergency exemption in order to address an urgent non-routine situation
and to ensure that the resulting food is safe and lawful, EPA is
issuing these tolerances without notice and opportunity for public
comment as provided in FFDCA section 408(l)(6). Although these time-
limited tolerances expire on December 31, 2028, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amount
specified in the tolerances remaining in or on sugarcane, cane and
sugarcane, molasses after that date will not be unlawful, provided the
pesticide was applied in a manner that was lawful under FIFRA, and the
residues do not exceed a level that was authorized by these time-
limited tolerances at the time of that application. EPA will take
action to revoke the time-limited tolerances earlier if any experience
with, scientific data on, or other relevant information about this
pesticide indicates that the residues are not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
flupyradifurone meets FIFRA's registration requirements for use on
sugarcane or whether permanent tolerances for this use would be
appropriate. Under these circumstances, EPA does not believe that these
time-limited tolerance decisions serve as a basis for registration of
flupyradifurone by a State for special local needs under FIFRA section
24(c). Nor do these tolerances by themselves serve as the authority for
persons in any State other than Louisiana to use this pesticide on
sugarcane under FIFRA section 18 absent the issuance of an emergency
exemption applicable within that State. For additional information
regarding the emergency exemption for flupyradifurone, contact the
Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure expected as a result of the use proposed by this
emergency exemption request and the time-limited tolerances for
residues of flupyradifurone on sugarcane, cane at 3 ppm and sugarcane,
molasses at 90 ppm. EPA's assessment of exposures and risks associated
with establishing these time-limited tolerances follows. On September
23, 2016 (81 FR 65552) (FRL-9951-68), and August 21, 2020 (85 FR 51668-
51672) (FRL-10010-98), EPA published final rules that established
tolerances for residues of flupyradifurone in or on multiple
commodities based on the Agency's determination that aggregate exposure
to flupyradifurone resulting from the residues subject to those
tolerances is safe for the U.S. general population, including infants
and children. The toxicity profile for flupyradifurone has not changed
since the September 23, 2016 (81 FR 65552) (FRL-9951-68), rule was
published, therefore EPA is relying upon the discussion of that profile
(Unit III) and the identified toxicological endpoints (Unit III) as
part of this rulemaking.
EPA's most recent exposure assessment for flupyradifurone appears
in the comprehensive risk assessment dated April 6, 2023, titled:
``Flupyradifurone. Human Health Risk Assessment for the Proposed Use on
Indoor and Outdoor Non-Food Uses,'' as that assessment included dietary
and aggregate exposures to flupyradifurone in or on multiple
agricultural and non-agricultural commodities, including for
flupyradifurone on sugarcane in Louisiana submitted in 2021 (sugarcane,
cane at 3 ppm and sugarcane, molasses at 90 ppm).
For aggregate risk assessment, risk estimates resulting from food,
drinking water, and residential uses are combined. Acute, short- and
intermediate-term, and long-term (chronic) aggregate assessments were
performed for flupyradifurone, and no risk estimates of concern were
identified. Further information about EPA's risk assessment and
determination of safety supporting these tolerances can be found at
<a href="http://www.regulations.gov">http://www.regulations.gov</a> in the document titled ``Flupyradifurone.
Human Health Risk Assessment for the Proposed Use on Indoor and Outdoor
Non-Food Uses,'' dated April 6, 2023, and identified by docket ID EPA-
HQ-OPP-2022-0444.
In the 2023 assessment, EPA conducted unrefined acute and partially
refined chronic dietary analyses for all current uses of
flupyradifurone together with the emergency use in or on sugarcane,
cane and sugarcane, molasses. The assessments incorporated tolerance-
level residues, average residues for some commodities (chronic), Health
Effects Division default and empirical processing factors, and
conservative drinking water estimates, and assumed that 100% of the
proposed crops were treated. The results of the acute and chronic
analyses do not exceed the Agency's level of concern. That is, less
than 100% of the acute population adjusted dose (aPAD) or less than
100% of the chronic population adjusted dose (cPAD) are not of concern
for the general U.S. population and all population subgroups. At the
95th percentile of exposure, the acute dietary (i.e., food and drinking
water) risk estimates utilized 27% of the aPAD for the general U.S.
population and 55% of the aPAD for children 1-2 years old, the most
highly exposed population subgroup. The chronic dietary (i.e., food and
drinking water) risk estimates utilized 30% of the cPAD for the general
U.S. population and 70% of the cPAD for children 1-2 years old, the
group with the highest exposed population subgroup.
The aggregate exposure assessment for flupyradifurone is based on
food and drinking water as well as residential uses. No acute or long-
term (chronic)
[[Page 59392]]
residential exposures are expected, therefore acute and chronic
aggregate risks are equivalent to acute and chronic dietary exposure
estimates, respectively. Since the dermal and incidental oral point of
departures are the same for both short- and intermediate-term
durations, the short-term aggregate risk estimates are considered
protective of any potential intermediate-term exposures and risks.
Aggregate short-term residential exposure to adults (residential
handlers) and children (residential post-application exposures) plus
background (chronic) dietary exposure yields margins of exposure (MOEs)
of 270 for adults, 180 for children (1 to <2 years old), and 210 for
children (6 to <11 years old); no aggregate risk estimates are of
concern because EPA considers MOEs of less than 100 to be of concern
for aggregate risk.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general U.S. population, or to infants and children from
aggregate exposure to flupyradifurone residues. More detailed
information on the subject action to establish time-limited tolerances
in or on sugarcane, cane and sugarcane, molasses can be found at <a href="http://www.regulations.gov">http://www.regulations.gov</a> in the document titled ``Flupyradifurone: Human
Health Risk Assessment for Section 18 Emergency Exemption Request for
Use on Sugarcane in Louisiana.'' This document can be found in docket
ID number EPA-HQ-OPP-2025-1973.
V. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology (Method RV-001-P10-03) is
available to enforce the tolerance expression for flupyradifurone. This
method uses high-performance liquid chromatography with tandem mass
spectrometry to quantitate residues of flupyradifurone in various
crops. This method may be requested from the Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Road, Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
<a href="/cdn-cgi/l/email-protection#acdec9dfc5c8d9c9c1c9d8c4c3c8dfecc9dccd82cbc3da"><span class="__cf_email__" data-cfemail="4d3f283e242938282028392522293e0d283d2c632a223b">[email protected]</span></a>.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. There are no Codex MRLs
established on sugarcane.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
flupyradifurone, in or on sugarcane, cane at 3 ppm and sugarcane,
molasses at 90 ppm. These tolerances expire on December 31, 2028.
VII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review
This action is exempt from review under Executive Order 12866 (58
FR 51735, October 4, 1993), because it establishes a time-limited
tolerance or an exemption from the requirement of a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866.
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because actions that establish a tolerance under FFDCA section 408 are
exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
D. Regulatory Flexibility Act (RFA)
Since tolerance actions that are established in accordance with
FFDCA sections 408(e) and 408(1)(6), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the RFA, 5 U.S.C. 601 et seq., do not apply.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars and adjusted annually for inflation) as described
in UMRA, 2 U.S.C. 1531-1538 and does not significantly or uniquely
affect small governments. The action imposes no enforceable duty on any
State, local, or Tribal governments or on the private sector.
F. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000) because it will
not have substantial direct effects on Tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because tolerance actions like this one are exempt from
review under Executive Order 12866. However, EPA's 2021 Policy on
Children's Health applies to this action. This rule finalizes tolerance
actions under the FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
.'' (FFDCA 408(b)(2)(C)). The Agency's consideration is summarized in
Unit IV.
[[Page 59393]]
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not subject to Executive Order 13211 (66 FR 28355)
(May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.
J. National Technology Transfer Advancement Act (NTTAA)
This action does not involve technical standards that would require
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 4, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
For the reasons set forth in the preamble, 40 CFR chapter I is
amended as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.679, add paragraph (b) to read as follows:
Sec. 180.679 Flupyradifurone; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. The time-limited tolerances
specified in the following table are established for residues of
flupyradifurone, including its metabolites and degradates, in or on the
commodities in the table. Compliance with the tolerance levels
specified in this paragraph (b) is to be determined by measuring only
flupyradifurone,4-[[(6-chloro-3-pyridinyl)methyl](2,2-
difluoroethyl)amino]-2(5H)-furanone, in or on the specified
agricultural commodities, resulting from use of the pesticide pursuant
to FIFRA section 18 emergency exemption. The tolerances expire on the
date specified in the table.
Table 2 to Paragraph (b)
------------------------------------------------------------------------
Commodity Parts per million Expiration date
------------------------------------------------------------------------
Sugarcane, cane................... 3 12/31/2028
Sugarcane, molasses............... 90 12/31/2028
------------------------------------------------------------------------
* * * * *
[FR Doc. 2025-23420 Filed 12-18-25; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.