Rule2025-20177
Fluopyram; Pesticide Tolerances
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
November 18, 2025
Effective
November 18, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of fluopyram (CASRN 658066-35-4) in or on mango. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), The United States Department of Agriculture--Foreign Agricultural Service (USDA-FAS) submitted a petition to EPA requesting that EPA establish a maximum permissible level for residues of this pesticide in or on the identified commodity.
Full Text
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<title>Federal Register, Volume 90 Issue 220 (Tuesday, November 18, 2025)</title>
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[Federal Register Volume 90, Number 220 (Tuesday, November 18, 2025)]
[Rules and Regulations]
[Pages 51562-51565]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20177]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0176; FRL-12909-01-OCSPP]
Fluopyram; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fluopyram (CASRN 658066-35-4) in or on mango. Under the Federal Food,
Drug, and Cosmetic Act (FFDCA), The United States Department of
Agriculture--Foreign Agricultural Service (USDA-FAS) submitted a
petition to EPA requesting that EPA establish a maximum permissible
level for residues of this pesticide in or on the identified commodity.
DATES: This rule is effective on November 18, 2025. Objections and
requests for hearings must be received on or before January 20, 2026
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of this document).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2024-0176, 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 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#cb998f8d9985a4bfa2a8aeb88baebbaae5aca4bd"><span class="__cf_email__" data-cfemail="50021416021e3f2439333523103520317e373f26">[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.
Potentially affected entities may include:
<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?
EPA is issuing this rulemaking under section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 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.'' FFDCA section
408(b)(2)(A)(ii) 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. FFDCA section 408(b)(2)(C)
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 . . .''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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 the docket ID number EPA-HQ-
OPP-2024-0176 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 January 20, 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 https://
www.epa.gov/system/files/documents/2023-06/2023-06-22%20-
[[Page 51563]]
%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.
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 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. Petitioned-For Tolerance
In the Federal Register of July 1, 2024 (89 FR 54,398, 54,401)
(FRL-11682-05-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 3E9060) by the USDA Foreign Agricultural Service, 1400
Independence Ave. Washington, DC 20250. The petition requested that 40
CFR 180 be amended by establishing an import tolerance for residues of
the fungicide fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]ethyl]-2-(trifluoromethyl)benzamide, in or on mango at 1
parts per million (ppm). That document referenced a summary of the
petition prepared by the petitioner, which is available in the docket,
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. There were no comments received in response
to the notice of filing.
III. Final Tolerance Action
A. Aggregate Risk Assessment and Determination of Safety
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 for fluopyram including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with fluopyram follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published in tolerance rulemakings for the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published tolerance rulemakings for fluopyram,
most recently in the Federal Register of February 1, 2023 (88 FR 6636)
(FRL-10566-01), in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to fluopyram and established tolerances
for residues of that pesticide chemical. EPA is incorporating
previously published sections from the February 1, 2023 rulemaking as
described further in this rulemaking, as they remain unchanged.
B. Toxicological Profile
For a discussion of the Toxicological Profile of fluopyram, see
Unit III.A. of the February 1, 2023 rulemaking.
C. Toxicological Points of Departure/Levels of Concern
A summary of the toxicological endpoints for fluopyram used for the
human health risk assessment is discussed in Unit III.B. of the
February 1, 2023 rulemaking.
D. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluopyram, EPA considered exposure under the petitioned-for
tolerances as well as all existing fluopyram tolerances in 40 CFR
180.661. EPA assessed dietary exposures from fluopyram in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for fluopyram.
In estimating acute dietary exposure, EPA used the Dietary Exposure
Evaluation Model software using the Food Commodity Intake Database
(DEEM-FCID) Version 4.02, which uses the 2005-2010 food consumption
data from the United States Department of Agriculture's (USDA's)
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, the acute dietary
exposure assessment used tolerance-level values for mango and for
commodities with established tolerances with the exception of cereal
grains, canola commodities, and coffee, for which the Highest Average
Field Trial (HAFT) values were used. One hundred percent crop treated
(PCT) was assumed.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA's 2005-
2010 NHANES/WWEIA and DEEM-FCID; version 4.02. As to residue levels in
food, the chronic dietary exposure assumed tolerance-level residues for
mango and used mean field trial data for all other commodities. The
chronic dietary assessment used a combination of average PCT for some
commodities and 100 PCT for other commodities.
iii. Cancer. Based on the toxicological profile in Unit III.A of
the February 1, 2023 rulemaking, EPA has concluded that fluopyram does
not pose a cancer risk to humans. Therefore, a dietary exposure
assessment for the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA's estimated PCTs for existing uses are unchanged from the February
1, 2023 rulemaking and can be found in section Unit III.C.1.iv.
2. Drinking water, non-occupational, and cumulative exposures. For
more discussion of the estimated drinking water concentrations, non-
occupational (residential), and cumulative exposures for fluopyram, see
Unit III.C.2., Unit III.C.3. and Unit III.C.4. of the February 1, 2023
rulemaking.
E. Safety Factor for Infants and Children
EPA continues to conclude that there is reliable data to support
the reduction of the Food Quality Protection Act (FQPA) safety factor
to 1X. See Unit III.D. of the February 1, 2023 rulemaking for a
discussion of the Agency's rationale for that determination.
F. Aggregate Risk and Determination of Safety
Acute, chronic, short-, and intermediate-term aggregate risk, as
well
[[Page 51564]]
as aggregate cancer risk estimates remain unchanged from the previous
rulemaking. Based on the lack of evidence of carcinogenicity in two
adequate rodent carcinogenicity studies, fluopyram is not expected to
pose a cancer risk to humans. For discussion of these exposure
estimates, see Unit III.E. of the February 1, 2023 rulemaking.
Consequently, based on these risk assessments and information
described in the February 1, 2023 rulemaking, EPA concludes that there
is a reasonable certainty that no harm will result to the general
population, or to infants and children from aggregate exposure to
fluopyram residues. More detailed information can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the document titled ``Fluopyram. Human Health
Risk Assessment for the Proposed Section 3 Tolerance Request without
U.S. Registration for Mango.'' in docket ID number EPA-HQ-OPP-2024-
0176.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the February 1, 2023 rulemaking.
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.
The Codex has established MRLs for fluopyram in or on mango at 1
ppm. These MRLs are the same as the tolerances established for
fluopyram in the United States.
V. Conclusion
Therefore, tolerances are established for residues of fluopyram, N-
[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, in or on mango at 1 ppm.
VI. 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 or modifies a
pesticide tolerance or a tolerance exemption under FFDCA section 408 in
response to a petition submitted to the Agency. 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 on the basis of a
petition under FFDCA section 408(d), 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 to this
action.
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 documented in the pesticide-specific registration
review documents, located in each chemical docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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).
[[Page 51565]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 3, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, EPA is amending 40 CFR chapter I 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. 180.661, table 1 to paragraph (a)(1) is amended by adding
in alphabetical order the entry ``Mango'' to read as follows:
Sec. 180.661 Fluopyram; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Commodity Parts per million
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* * * * *
Mango \1\......................................... 1.0
* * * * *
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\1\ There are no U.S. registrations.
* * * * *
[FR Doc. 2025-20177 Filed 11-17-25; 8:45 am]
BILLING CODE 6560-50-P
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