Rule2025-22174
Azoxystrobin; 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
December 8, 2025
Effective
December 8, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance for residues of azoxystrobin in or on black pepper. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the American Spice Trade Association (ASTA) 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 233 (Monday, December 8, 2025)</title>
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[Federal Register Volume 90, Number 233 (Monday, December 8, 2025)]
[Rules and Regulations]
[Pages 56691-56695]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22174]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0460; FRL-13046-01-OCSPP]
Azoxystrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
azoxystrobin in or on black pepper. Under the Federal Food, Drug, and
Cosmetic Act (FFDCA), the American Spice Trade Association (ASTA)
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 regulation is effective December 8, 2025. Objections and
requests for hearings must be received on or before February 6, 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-2024-0460, is available at <a href="http://www.regulations.gov">http://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; telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#5b091f1d0915342f32383e281b3e2b3a753c342d"><span class="__cf_email__" data-cfemail="eab8aeacb8a4859e83898f99aa8f9a8bc48d859c">[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-2024-0460 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 6, 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
[[Page 56692]]
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. Petitioned-for Tolerance
In the Federal Register of July 3, 2025 (90 FR 29515) (FRL-12474-05
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
4E9103) by the American Spice Trade Association (1101 17th Street NW,
Suite 700, Washington, DC 20036). The petition requested that 40 CFR
180.507 be amended by establishing a tolerance for residues of the
fungicide azoxystrobin in or on pepper, black at 1 part per million
(ppm). That document referenced a summary of the petition prepared by
the petitioner and included in the docket at <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
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 for azoxystrobin, including exposure resulting from
the tolerance established by this action. EPA's assessment of exposures
and risks associated with azoxystrobin follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking, 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 several tolerance rulemakings for
azoxystrobin in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to azoxystrobin and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from these rulemakings as described
further in this rulemaking, as they remain unchanged.
Specific information on the risk assessment conducted in support of
this action can be found in the document titled ``Azoxystrobin. Human
Health Risk Assessment for the Establishment of Tolerance without U.S.
registration for Residues in/on Pepper, Black'' and the documents cited
therein, which are available in the docket for this action at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
B. Toxicological Profile
For a discussion of the toxicological profile of azoxystrobin, see
Unit III.A. of the final rule published in the Federal Register of
November 15, 2018 (83 FR 57333) (FRL-9985-45).
C. Toxicological Points of Departure/Levels of Concern
For a summary of the toxicological points of departure/levels of
concern used for the risk assessment, see Unit III.B. of the final rule
published in the Federal Register of November 15, 2018 (83 FR 57333)
(FRL-9985-45).
D. Exposure Assessment
For a description of EPA's approach to and assumptions used for the
hazard assessment and residential exposure assessment for azoxystrobin,
see Unit III.C. of the final rule published in the Federal Register of
November 15, 2018 (83 FR 57333) (FRL-9985-45) and for the dietary and
aggregate assessments see the final rule published in the Federal
Register of March 20, 2023 (88 FR 16570) (FRL-10603-01), along with the
updates described below.
1. Dietary exposure from food and feed uses. EPA's dietary exposure
assessments have been updated to include the additional exposure
associated with the petitioned-for tolerance. For the acute dietary
exposure assessment, EPA used tolerance-level residues for all
commodities, except citrus fruits (which used the highest residues from
residue trials), 100 percent crop treated (PCT) for all commodities,
and default processing factors with the Dietary Exposure Evaluation
Model (DEEM 4.02) for all commodities except where tolerances were
established for processed commodities, and utilizing USDA NHANES/WWEIA
food consumption data (2005-2010). For the chronic dietary exposure
assessment, EPA used tolerance-level residues for all commodities, 100
PCT for all commodities, and default processing factors with DEEM for
all commodities except where tolerances were established for processed
commodities.
2. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1)
[[Page 56693]]
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. For the present action, EPA will
issue such data call-ins as are required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section 408(f)(1). Data will be required to
be submitted no later than 5 years from the date of issuance of these
tolerances.
EPA did not use PCT information in the dietary exposure assessment
for azoxystrobin. 100 PCT was assumed for all food commodities.
3. Drinking water exposure. Drinking water exposures are not
impacted by this action, which is for a tolerance without a
corresponding U.S. registration (i.e., an import tolerance). The
estimated drinking water concentrations (EDWCs) of azoxystrobin are
69.4 parts per billion (ppb) for acute exposure and 20.7 ppb for
chronic exposure, which were calculated with the Surface Water
Concentration Calculator.
4. Non-occupational exposure. Non-occupational/residential
exposures are not impacted by the import tolerance in this action.
Azoxystrobin is currently registered for use on turf, ornamentals, and
antimicrobial uses as a materials preservative in paints and plastics
that could result in residential exposures. The residential risk
estimate that was used in the aggregate assessment is hand-to-mouth
incidental oral exposures to preserved vinyl flooring for children aged
1 to less than 2 years old.
5. Cumulative exposures. FFDCA section 408(b)(2)(D)(v) requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have 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 azoxystrobin and any other substances, and
azoxystrobin does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, EPA has
not assumed that azoxystrobin has a common mechanism of toxicity with
other substances.
E. Safety Factor for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) safety factor. In applying this provision, EPA either retains
the default value of 10X, or uses a different additional safety factor
when reliable data available to EPA support the choice of a different
factor.
EPA continues to conclude that there is reliable data to support
the reduction of the FQPA safety factor to 1X for all exposure
scenarios except acute exposure. For assessing acute dietary risk, EPA
continues to retain an FQPA safety factor of 3X. See Unit III.D. of the
final rule published in the Federal Register of November 15, 2018 (83
FR 57333) (FRL-9985-45) for a discussion of the Agency's rationale for
that determination.
F. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute population adjusted dose (aPAD) and chronic population adjusted
dose (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 points of departure (PODs) to ensure that an
adequate margin of exposure (MOE) exists.
1. Acute risk. Acute dietary risks are below the Agency's level of
concern of 100% of the aPAD; they are 29% of the aPAD for children 1 to
2 years old, the population group receiving the greatest exposure.
2. Chronic risk. Chronic dietary risks are below the Agency's level
of concern of 100% of the cPAD; they are 66% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
3. Short- and intermediate-term risk. Short-term aggregate exposure
takes into account short-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
The Agency analyzed short-term aggregate risk by aggregating
chronic dietary (food and drinking water) exposure with incidental oral
hand-to-mouth post-application exposure to children 1 to less than 2
years old from preserved vinyl flooring uses of azoxystrobin. The
combined short-term food, water, and residential exposures result in an
aggregate MOE of 200 for children 1 to less than 2 years old, the
population group receiving the greatest exposure. Because EPA's level
of concern for azoxystrobin is an MOE of less than 100, this MOE is not
of concern.
Intermediate-term aggregate exposure takes into account
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Because no
intermediate-term adverse effect was identified, azoxystrobin is not
expected to pose an intermediate-term risk. Therefore, the
intermediate-term aggregate risk would be equivalent to the chronic
dietary exposure estimate.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, azoxystrobin is not expected to pose a cancer risk to humans.
5. Determination of safety. Based on the risk assessments and
information described above, 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 azoxystrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the final rule published in the Federal Register of
November 15, 2018 (83 FR 57333) (FRL-9985-45). The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; email address: <a href="/cdn-cgi/l/email-protection#a1d3c4d2c8c5d4c4ccc4d5c9cec5d2e1c4d1c08fc6ced7"><span class="__cf_email__" data-cfemail="60120513090415050d0514080f0413200510014e070f16">[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). Codex 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
[[Page 56694]]
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 azoxystrobin in or on
black pepper.
C. Effective and Expiration Date(s)
In general, a tolerance action is effective on the date of
publication of the final rule in the Federal Register. For actions in
the final rule that lower or revoke existing tolerances, EPA will set
an expiration date for the existing tolerance of six months after the
date of publication of the final rule in the Federal Register, in order
to allow a reasonable interval for producers in exporting members of
the World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS)
Measures Agreement to adapt to the requirements.
V. Conclusion
Therefore, a tolerance is established for residues of azoxystrobin
in or on pepper, black 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 summarized in
Unit III.E.
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 26, 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. 180.507, in paragraph (a)(1) amend Table 1 to Paragraph
(a)(1) by:
0
a. Adding in alphabetical order the entry ``Pepper, black''; and
0
b. Adding footnote 3 at the end of the table.
The additions read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Pepper, black \3\........................................... 1
[[Page 56695]]
* * * * *
------------------------------------------------------------------------
* * * * *
\3\ There are no U.S. registrations for use of
azoxystrobin on pepper, black as of
December 8, 2025.
* * * * *
[FR Doc. 2025-22174 Filed 12-5-25; 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.