Rule2025-19917
Fluazinam; 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 17, 2025
Effective
November 17, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of fluazinam (CASRN 79622-59-6) in or on pear, Asian. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), ISK Biosciences Corporation submitted a petition to EPA requesting that EPA establish a maximum permissible level for residues of this pesticide on in or on the identified commodity.
Full Text
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<title>Federal Register, Volume 90 Issue 219 (Monday, November 17, 2025)</title>
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[Federal Register Volume 90, Number 219 (Monday, November 17, 2025)]
[Rules and Regulations]
[Pages 51115-51118]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19917]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0319; FRL-12959-01-OCSPP]
Fluazinam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fluazinam (CASRN 79622-59-6) in or on pear, Asian. Under the Federal
Food, Drug, and Cosmetic Act (FFDCA), ISK Biosciences Corporation
submitted a petition to EPA requesting that EPA establish a maximum
permissible level for residues of this pesticide on in or on the
identified commodity.
DATES: This regulation is effective on November 17, 2025. Objections
and requests for hearings must be received on or before before January
16, 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-2023-0319, 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 (RD) (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#fdafb9bbafb39289949e988ebd988d9cd39a928b"><span class="__cf_email__" data-cfemail="5b091f1d0915342f32383e281b3e2b3a753c342d">[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 applicablility 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
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and may also request a hearing on those objections. 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-2023-0319 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 16, 2026. Addresses for mail and
hand delivery of objections and hearing requests are provided in 40 CFR
178.25(b).
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. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2023-0319, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Petitioned-For Tolerance
In the Federal Register of December 19, 2023 (88 FR 87733) (FRL-
10579-11-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 3E9057) by ISK Biosciences Corporation, 7470 Auburn Rd.,
Suite A, Concord, Ohio 44077. The petition requested that 40 CFR part
180 be amended by establishing tolerances for residues of the fungicide
fluazinam, (3-chloro-N-[3-chloro-2,6-dinitro-4-
(trifluoromethyl)phenyl]-5-(trifluoromethyl)-2-pyridinamine), in or on
pear, Asian at 0.2 parts per million (ppm). That document referenced a
summary of the petition prepared by ISK Biosciences Corporation, the
registrant, which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the commodity definition to be consistent with Agency
nomenclature.
III. Final Tolerance Action
A. Aggregate Risk Assessment and Determination of Safety
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 fluazinam including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fluazinam 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 three tolerance rulemakings for
fluazinam (i.e., November 7, 2012, rule (77 FR 66723) (FRL-9366-6),
April 8, 2016, rule (81 FR 20545) (FRL-9942-99), and September 20, 2021
(86 FR 52077) (FRL-8664-01-OCSPP)), in which EPA concluded, based on
the available information, that there is a reasonable certainty that no
harm would result from aggregate exposure to fluazinam and established
tolerances for residues of that pesticide chemical. EPA is
incorporating previously published sections from those rulemakings as
described further in this rulemaking, as they remain unchanged.
B. Toxicological Profile
For a discussion of the Toxicological Profile of fluazinam, see
Unit III.A. of the 2016 rulemaking establishing tolerances for residues
of fluazinam in or on several commodities. The endpoint selection
remains unchanged since that most recent comprehensive assessment.
However, the hazard characterization was updated to clarify effects
observed in the developmental neurotoxicity (DNT) study and how the
doses at which they occurred compare to the doses selected for risk
assessment. The guideline study database was re-evaluated to ensure
that offspring were protected from effects which may occur after a
single exposure in all studies, including at doses higher than the
study no observed adverse effect level (NOAEL). There were effects
observed in the developmental neurotoxicity study at doses similar to
those used for the general population acute dietary point of departure
(POD). Upon review, it was determined that the effects in question were
either not attributable to a single exposure or were not appropriate to
assess for the general population. The effects that are potentially
relevant to an in utero acute exposure are adequately protected for by
the POD selected for the females 13-49 assessment.
C. Toxicological Points of Departure/Levels of Concern
A summary of the toxicological points of departure/levels of
concern used for the human health risk assessment, see Unit III.B. of
the 2012 rulemaking establishing tolerances for residues of fluazinam
in or on several commodities.
D. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
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exposure to fluazinam, EPA considered exposure under the petitioned-for
tolerance as well as all existing fluazinam tolerances in 40 CFR
180.574. EPA assessed dietary exposures from fluazinam 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 fluazinam.
In estimating acute dietary exposure, EPA used the Dietary Exposure
Evaluation Model software with 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, EPA utilized
tolerance-level residues and 100 percent crop treated (PCT) for all
commodities, default processing factors, and Estimated Drinking Water
Concentrations (EDWCs), when appropriate.
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, EPA utilized a combination of tolerance-level residues, average
field trial residues, mean residue values from the USDA Pesticide Data
Program (PDP) monitoring data, empirical processing factors and/or
default processing factors, and average PCT estimates, when
appropriate.
iii. Cancer. Based on the toxicological profile in Unit III.A of
the 2016 rulemaking, EPA has concluded that fluazinam 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 2021
rulemaking establishing tolerances for residues of fluazinam in or on
several commodities and can be found in Unit III of that rulemaking.
2. Dietary exposure from drinking water. For more discussion of the
estimated drinking water concentrations for fluazinam, see Unit III. of
the 2021 rulemaking.
3. From non-dietary exposure. See Unit III.C.3. of the 2016
rulemaking for a discussion of non-dietary exposure, which included
residential exposures to golf course turf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to fluazinam and
any other substances, and fluazinam does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
action, therefore, EPA has not assumed that fluazinam has a common
mechanism of toxicity with other substances.
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.
See Unit III.D. of the 2016 rulemaking for a discussion of the Agency's
rationale for that determination.
F. Aggregate Risk and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short, intermediate, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD: They are 33% of the aPAD for females 13 to 49 years old,
the population subgroup with the highest risk estimate. Chronic dietary
risks are below the Agency's level of concern of 100% of the cPAD, they
are 99% of the cPAD for all infants, the population subgroup with the
highest exposure estimate. The short-term aggregate risk assessments
resulted in MOEs that are greater than the Agency's level of concern of
100 and therefore are not of concern. The MOEs are 500 for children 6
to less than 11 years old; 600 for youths 11 to less than 16 years old;
and 550 for adults. Intermediate-term and long-term residential
exposures are not expected.
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 population, or to infants and children, from
aggregate exposure to fluazinam residues. More detailed information
about the Agency's analysis can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
in the document titled ``Fluazinam. Human Health Risk Assessment for a
Proposed Tolerance without U.S. Registration on Pear, Oriental.'' in
docket ID number EPA-HQ-OPP-2023-0319.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A of the 2016 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 not
established a MRL for fluazinam in or on pear, Asian.
V. Conclusion
Therefore, tolerances are established for residues of fluazinam (3-
chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine), in or on pear, Asian at 0.2 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/regulations/and-executive-orders">https://www.epa.gov/regulations/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
[[Page 51118]]
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).
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--[AMENDED]
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. Amend Sec. 180.574 by:
0
a. In Table 1 to Paragraph (a)(1):
0
i. Adding in alphabetical order an entry for ``Pear, Asian''; and
0
ii. Revising footnote 1.
The addition and revision read as follows:
Sec. 180.574 Fluazinam; tolerance for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
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Commodity Parts per million
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* * * * *
Pear, Asian \1\..................................... 0.2
* * * * *
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\1\ There are no U.S. registrations.
* * * * *
[FR Doc. 2025-19917 Filed 11-14-25; 8:45 am]
BILLING CODE 6560-50-P
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