Rule2025-15555
Mandipropamid; Pesticide Tolerance
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
August 15, 2025
Effective
August 15, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance action for residues of mandipropamid in or on papaya. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Syngenta Crop Protection, LLC submitted a petition to EPA requesting that EPA establish a maximum permissible level for residues of this pesticide in or on the identified commodities.
Full Text
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<title>Federal Register, Volume 90 Issue 156 (Friday, August 15, 2025)</title>
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[Federal Register Volume 90, Number 156 (Friday, August 15, 2025)]
[Rules and Regulations]
[Pages 39335-39339]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15555]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0407; FRL-12919-01-OCSPP]
Mandipropamid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance action for residues of
mandipropamid in or on papaya. Under the Federal Food, Drug, and
Cosmetic Act (FFDCA), Syngenta Crop Protection, LLC submitted a
petition to EPA requesting that EPA establish a maximum permissible
level for residues of this pesticide in or on the identified
commodities.
DATES: This regulation is effective on August 15, 2025. Objections and
requests for hearings must be received on or before October 14, 2025
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-2023-0407, is available online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or in-person at the Office of Pesticide
Programs Regulatory Public Docket (OPP Docket) in the Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC
20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the OPP Docket is (703) 305-5805. Please review the visitor
instructions and additional information about the docket available at
<a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
[[Page 39336]]
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#8cdec8cadec2e3f8e5efe9ffcce9fceda2ebe3fa"><span class="__cf_email__" data-cfemail="a3f1e7e5f1edccd7cac0c6d0e3c6d3c28dc4ccd5">[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 might apply 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. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Federal Register's
e-CFR site at <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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. 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-2023-0407 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 October 14, 2025. 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/HomePage?ReadForm">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm</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-2023-0407, 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/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-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. Summary of Petitioned-For Tolerance
In the Federal Register of September 19, 2023 (88 FR 64398 (FRL-
10579-08-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 3E9047) by Syngenta Crop Protection, LLC (P.O. Box 18300,
Greensboro, NC 27419). The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the fungicide
mandipropamid in or on; papaya, whole fruit at 0.8 part per million
(ppm); papaya, peel at 3 ppm; and papaya, pulp at 0.015 ppm. That
document referenced a summary of the petition that was prepared by
Syngenta, 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 is
establishing the tolerance on Papaya at 0.9 ppm. The reason for this
change is explained in Unit IV.C.
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 mandipropamid including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with mandipropamid 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
[[Page 39337]]
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
mandipropamid in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to mandipropamid 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. ``Mandipropamid.
Human Health Risk Assessment for Proposed Label Amendments for the
Tuberous and Corm Vegetable Crop Subgroup (1C) and Tobacco, a Tolerance
Without U.S. Registration for Papaya, and Non-Food Status for Non-
Bearing Strawberries and Non-Bearing Members of the Tree Nut Crop Group
14-12,'' which is 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 mandipropamid, see
Unit III.A. of the rulemaking published in the Federal Register of
March 22, 2019 (84 FR 10695) (FRL-9987-25). In 2020 the Agency
published a draft risk assessment for the registration review of
mandipropamid, but this assessment did not result in any changes to the
conclusions from the 2019 rulemaking.
C. Toxicological Points of Departure/Levels of Concern
A summary of the toxicological endpoints for mandipropamid used for
human health risk assessment is discussed in Unit III.B of the March
22, 2019 final rule.
D. Exposure Assessment
In evaluating dietary exposure to mandipropamid, EPA considered
exposure under the petitioned-for tolerances as well as all existing
tolerances in 40 CFR 180.637. An acute dietary risk assessment was not
performed since no endpoint attributable to a single exposure (dose)
was identified from the available oral toxicity database. In conducting
the chronic dietary exposure assessment, 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 (USDA) National
Health and Nutrition Examination Survey, What We Eat in America
(NHANES/WWEIA). The chronic dietary exposure assessment is unrefined,
assuming tolerance level residues and 100 percent crop treated (PCT).
Based on the lack of evidence of carcinogenicity or genotoxicity, the
Agency has classified mandipropamid as ``Not Likely to be Carcinogenic
to Humans'' and therefore, there is no concern for cancer risk.
I. Dietary Exposure From Drinking Water
Since this request is for a tolerance without U.S. registration the
action will not impact drinking water exposure estimates. The estimated
drinking water concentrations (EDWCs) included all residues of concern
in drinking water: mandipropamid, SYN504851, and SYN500003. EPA used
the Pesticide in Water Calculator (PWC) to determine both the
groundwater and surface water EDWCs. For the chronic dietary risk
assessment, the mandipropamid EDWCs are 21.9 ppb in surface water and
62.8 ppb in groundwater. The groundwater value was based on the
Wisconsin corn scenario. Because the groundwater value is higher than
the surface water value, it was used in the chronic dietary exposure
assessment. It was incorporated into the DEEM-FCID model in the food
categories ``water, direct, all sources'' and ``water, indirect, all
sources.''
II. From Non-Dietary Exposure
There are no residential (non-occupational) uses proposed or
currently registered for mandipropamid. Therefore, residential
exposures were not assessed.
III. Cumulative Effects From Substances With a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of FFDCA 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
mandipropamid and any other substances and mandipropamid does not
appear to produce a toxic metabolite produced by other substances.
Therefore, for the purposes of this action, EPA has not assumed that
mandipropamid has a common mechanism of toxicity with other substances.
E. Safety Factor for Infants and Children
FFDCA section 408(b)(2)(C) 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 (SF). 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 are reliable data to support
the reduction of the Food Quality Protection Act (FQPA) safety factor
from 10X to 1X. See Unit III.D. of the March 22, 2019, 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 dietary exposure estimates to the acute
population adjusted dose (aPAD) and the chronic population adjusted
dose (cPAD). Short-, intermediate-, and chronic term aggregate risks
are evaluated by comparing the estimated total food, water, and
residential exposure to the appropriate points of departure to ensure
that an adequate margin of exposure (MOE) exists.
An acute dietary exposure assessment was not performed as there
were no indications of an adverse effect attributable to a single dose.
Chronic dietary risks (food and water) are below the Agency's level of
concern of 100% of the cPAD; they are 44% of the cPAD for children 1 to
less than 2 years old, the population subgroup receiving the highest
exposure. As there are no residential uses for mandipropamid, the
short-term and chronic aggregate risk estimates are equivalent to the
chronic dietary risk estimates, which are not of concern.
Cancer risk was not assessed for mandipropamid because it is
classified as ``Not Likely to be Carcinogenic to Humans.''
[[Page 39338]]
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 mandipropamid residues, including its metabolites
and degradates. 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
``Mandipropamid. Human Health Risk Assessment for Proposed Label
Amendments for the Tuberous and Corm Vegetable Crop Subgroup (1C) and
Tobacco, a Tolerance Without U.S. Registration for Papaya, and Non-Food
Status for Non-Bearing Strawberries and Non-Bearing Members of the Tree
Nut Crop Group 14-12'' in docket ID number EPA-HQ-OPP-2023-0407.
IV. Other Considerations
A. Analytical Enforcement Methodology
Under a previous action, Syngenta submitted an updated version of
Method 415/01. HED reviewed the updated method, Method 415/02 (W. Drew,
D428278, 2/23/2016). This method is essentially the same as Method RAM
415/01, with the exception that it was modified by the addition of a
second ion transition for determination of mandipropamid, inclusion of
specific LC/MS/MS conditions, and modification to include analysis of
hops. Method 415/02 underwent a successful independent laboratory
validation, has a validated LOQ of 0.010 ppm, and is adequate for
enforcement of mandipropamid tolerances.
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 does not have
established MRLs for mandipropamid on papaya.
C. Revisions to Petitioned-For Tolerances
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is establishing a tolerance that varies from what was requested. The
petitioner proposed a tolerance of 0.8 ppm for Papaya, Whole Fruit; 3
ppm for Papaya, Peel; and 0.015 ppm for Papaya, Pulp. Although the
proposed tolerances are for Papaya, Whole Fruit; Papaya, Peel; and
Papaya, Pulp, EPA has determined that a tolerance for Papaya only is
appropriate because papaya is the only commodity of the three
petitioned-for commodities for which the U.S. establishes tolerances,
based on the OCSPP residue chemistry guideline 860.1000. Using papaya
only, the OECD MRL calculation procedures generated a value of 0.9 ppm
as the appropriate tolerance. As a result, the EPA-recommended
tolerance for papaya is higher than the tolerance proposed by the
petitioner.
V. Conclusion
Therefore, a tolerance is established for residues of mandipropamid
(4-chloro-N-[2-[3-methoxy-4-(2-propyn-1-yloxy)phenyl]ethyl]-[alpha]-(2-
propyn-1-yloxy)benzeneacetamide) in or on Papaya at 0.9 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.
[[Page 39339]]
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: August 6, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
For the reasons set forth in the preamble, 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. Amend Sec. 180.637 by:
0
a. In the table in paragraph (a):
0
i. Adding the table heading, ``Table 1 to Paragraph (a)'';
0
ii. Adding in alphabetical order an entry for ``Papaya''.
The additions read as follows:
Sec. 180.637 Mandipropamid; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Papaya \2\.................................................. 0.9
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations allowing use of mandipropamid on
cacao as of October 28, 2019.
\2\ There is no U.S. registration for use of this pesticide on papaya as
of August 15, 2025.
* * * * *
[FR Doc. 2025-15555 Filed 8-14-25; 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.