[Federal Register Volume 90, Number 188 (Wednesday, October 1, 2025)]
[Rules and Regulations]
[Pages 47235-47239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19144]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2024-0330; FRL-12992-01-OCSPP]


Amicarbazone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
amicarbazone (CASRN 129909-90-6) in or on sugarcane, cane; and 
sugarcane, molasses. Under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), UPL Delaware, Inc. 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 October 1, 2025. Objections and 
requests for hearings must be received on or before December 1, 2025 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2024-0330, is available at 
https://www.regulations.gov. Additional information about dockets 
generally, along with instructions for visiting the docket in person, 
is available at https://www.epa.gov/dockets.

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: 
[email protected].

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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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, 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 
docket ID number EPA-HQ-OPP-2024-0330 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

[[Page 47236]]

by the Hearing Clerk on or before December 1, 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 https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%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 https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.
    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 https://www.regulations.gov. 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 https://www.epa.gov/dockets/commenting-epa-dockets#rules 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 
4E9122) by UPL Delaware, Inc., 630 Freedom Business Center, Suite 402, 
King of Prussia, PA 19406. The petition requested that 40 CFR 180.615 
be amended by establishing tolerances for residues of amicarbazone, [4-
amino-N-tert-butyl-4,5-dihydro-3-isopropyl-5-oxo-1H-1,2,4-triazole-1-
carboxamide], including its metabolites and degradates, in or on 
imported sugarcane, cane at 0.2 parts per million (ppm) and imported 
sugarcane, molasses at 0.5 ppm. That document referenced a summary of 
the petition prepared by UPL Delaware, Inc., the registrant, which is 
available in the docket, https://www.regulations.gov. 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 Amicarbazone including exposure resulting from 
the tolerances established by this action. EPA's assessment of 
exposures and risks associated with Amicarbazone is summarized in this 
unit.

B. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    In subchronic/chronic animal studies, amicarbazone caused decreased 
body weight and liver effects. Changes in thyroid hormones and thyroid 
vacuolization were also seen, although mechanistic studies indicated 
that these changes were secondary to liver effects. Mice were more 
sensitive to the effects of amicarbazone than dogs and rats, which were 
equally sensitive. Minimal progression of toxicity was observed between 
subchronic and chronic exposure to amicarbazone, which is consistent 
with the rapid metabolism seen in the absorption, distribution, 
metabolism, and elimination (ADME) studies. Clinical signs of 
neurotoxicity (eyelid ptosis, decreased approach response, and red 
staining of the nasal area) were seen following acute exposure. 
Evidence of neurotoxicity was not seen in the subchronic or 
developmental neurotoxicity studies or any other study in the database. 
There was no evidence of quantitative or qualitative susceptibility in 
the rat and rabbit developmental, rat developmental neurotoxicity, and 
rat reproductive toxicity studies. There was no evidence of systemic 
toxicity following dermal exposure. Amicarbazone is classified as ``Not 
likely to be carcinogenic to humans'' based on the lack of evidence for 
carcinogenicity in mice and rats and the lack of concern for 
mutagenicity. Evidence of immunotoxicity (decreased number of spleen 
cells per spleen, suppressed antibody response, and decreased spleen 
weight) was observed in the immunotoxicity study, but at doses higher 
than those that caused decreased body weight or liver effects in other 
studies.
    Specific information on the studies received and the nature of the 
adverse effects caused by amicarbazone as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document titled ``Amicarbazone. Human Health 
Risk Assessment for the Proposed Tolerance on Sugarcane Without a U.S. 
Registration'' (hereafter referred to as the ``Amicarbazone Human 
Health Assessment'') on pages 24-30 in docket ID number EPA-HQ-OPP-
2024-0330.

C. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the NOAEL and the LOAEL. Uncertainty/safety factors are used 
in conjunction with the POD to calculate a safe exposure level--
generally referred to as a population-adjusted dose (PAD) or a 
reference dose (RfD)--and a safe margin of exposure (MOE). For non-
threshold risks, the Agency assumes that any amount of exposure will 
lead to some degree of risk. Thus, the Agency estimates risk in terms 
of the probability of an occurrence of the adverse effect expected in a 
lifetime. For more information on the general principles EPA uses in 
risk characterization and a complete description of the risk assessment 
process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for amicarbazone used for 
human risk assessment is discussed in section 4.3 (Toxicity Endpoint 
and Point of Departure Selections) of the

[[Page 47237]]

Amicarbazone Human Health Assessment.

D. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to amicarbazone, EPA considered exposure under the petitioned-
for tolerances as well as all existing amicarbazone tolerances in 40 
CFR 180.615. EPA assessed dietary exposures from amicarbazone 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 amicarbazone.
    In estimating acute dietary exposure, EPA used the Dietary Exposure 
Evaluation Model software with the Food Commodity Intake Database 
(DEEM-FCID) Version 4.02. This software uses 2005-2010 food consumption 
data from the U.S. 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 assumed 100 percent crop 
treated and used tolerance-level residues adjusted for metabolite 
factors. Processing factors were reduced to 1X for several processed 
commodities based on processing data showing that the raw agricultural 
commodity tolerances are adequate to cover residues in processed 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2005-2010 
CSFII. As to residue levels in food, assumed 100 percent crop treated 
and used tolerance-level residues adjusted for metabolite factors. 
Processing factors were reduced to 1X for several processed commodities 
based on processing data showing that the raw agricultural commodity 
tolerances are adequate to cover residues in processed commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that amicarbazone 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 PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for amicarbazone. Tolerance level residues adjusted for metabolite 
factors and 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for amicarbazone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of amicarbazone. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide in Water Calculator (PWC), the estimated 
drinking water concentrations (EDWCs) of amicarbazone for acute 
exposures are estimated to be 223 parts per billion (ppb) for ground 
water. The chronic exposures are estimated to be 149 ppb for ground 
water. The groundwater numbers were used because they are higher than 
the surface water numbers. Modeled estimates of drinking water 
concentrations were directly entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    While there are no proposed residential uses for these tolerances, 
Amicarbazone is currently registered for the following uses that could 
result in residential exposures: residential lawns, golf courses, sod 
farms, commercial turf sites, parks, recreation areas, and school 
grounds. EPA assessed residential exposure using the following 
assumptions: Residential handler exposure is not expected. There is 
expected to be residential post-application exposure. There is no POD 
for the dermal route of exposure; therefore, dermal exposures have not 
been estimated. The post application exposure to children 1 to less 
than 2 years old, reflecting hand-to-mouth exposures resulting from 
outdoor (turf) applications, was used in the aggregate assessment. Food 
is the only route of exposure resulting from the petitioned-for 
tolerances. However, EPA's risk assessment considers all relevant 
exposure pathways. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. 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 amicarbazone and any other 
substances and amicarbazone does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
action, therefore, EPA has not assumed that amicarbazone has a common 
mechanism of toxicity with other substances. In 2016, EPA's Office of 
Pesticide Programs released a guidance document titled, Pesticide 
Cumulative Risk Assessment: Framework for Screening Analysis https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. This document provides guidance 
on how to screen groups of pesticides for cumulative evaluation using a 
two-step approach beginning with the evaluation of available 
toxicological information and if necessary, followed by a risk-based 
screening approach. This framework supplements the existing guidance 
documents for establishing common mechanism groups (CMGs) and 
conducting cumulative risk assessments. During registration review, the 
Agency will utilize this framework to determine if the available 
toxicological data for amicarbazone suggests a candidate CMG may be 
established with other pesticides. If a CMG is established, a 
screening-level toxicology and exposure analysis may be conducted to 
provide an initial screen for multiple pesticide exposure.

E. Safety Factor for Infants and Children

    1. In general. 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 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.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
quantitative or qualitative susceptibility in the rat

[[Page 47238]]

and rabbit developmental, rat developmental neurotoxicity, and rat 
reproductive toxicity studies. There was no evidence of systemic 
toxicity following dermal exposure. Evidence of immunotoxicity 
(decreased number of spleen cells per spleen, suppressed antibody 
response, and decreased spleen weight) was observed in the 
immunotoxicity study, but at doses higher than those that caused 
decreased body weight or liver effects in other studies.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for amicarbazone is complete.
    ii. Acute neurotoxicity was observed in the database. A clear NOAEL 
was established for the acute neurotoxic effects, and the endpoints and 
PODs selected for risk assessment are protective of the clinical signs 
observed in the acute neurotoxicity study.
    iii. No evidence of increased quantitative or qualitative 
susceptibility was seen in rat and rabbit developmental toxicity, rat 
reproduction, or rat developmental neurotoxicity studies. All effects 
in the young were observed in the presence of comparable maternal 
toxicity. Delayed skeletal development and incomplete ossification were 
observed in the rat and rabbit developmental studies, respectively, at 
doses where dams had decreased body weight. In the reproduction study, 
decreased pup weight was seen at the same doses as decreased body 
weight in the dams. The endpoints selected for risk assessment are 
protective of all effects observed in these studies.
    iv. There is no residual uncertainty with respect to the exposure 
assessments conducted for amicarbazone. The dietary exposure estimates 
in this assessment rely on conservative estimates of all residues of 
concern from both the food and drinking water exposure pathways. The 
aggregate assessment, which includes children's exposures to residues 
on treated turf, is expected to be conservative due to the use of 
default turf transferable residue (TTR) data, whereas the greatest 
herbicidal effectiveness is achieved when it is watered in.

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 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.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to amicarbazone will occupy 45% of the aPAD for all infants less than 1 
year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
amicarbazone from food and water will utilize 61% of the cPAD for all 
infants less than 1 year old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
amicarbazone is not expected.
    3. Short-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). Amicarbazone 
is currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to amicarbazone.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 400 for children 
1-2 years old, the only population group of concern. Because EPA's 
level of concern for amicarbazone is an MOE of 100 or below, this MOE 
is not of concern.
    4. Intermediate-term risk. 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).
    An intermediate-term adverse effect was identified; however, 
amicarbazone is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
amicarbazone.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, amicarbazone is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, 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 amicarbazone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (LC-MS/MS) is available to enforce 
the tolerance expression.

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 has not established a MRL for amicarbazone in or on 
sugarcane.

V. Conclusion

    Therefore, tolerances are established for residues of amicarbazone 
in or on sugarcane, cane at 0.2 ppm; and sugarcane, molasses at 0.5 
ppm.

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders 
can be found at https://www.epa.gov/regulations/and-executive-orders.

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 47239]]

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 https://www.regulations.gov.

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: September 24, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 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.  180.615, amend the table in paragraph (a) by:
0
a. Adding a table heading;
0
b. Adding in alphabetical order entries for ``Sugarcane, cane'' and 
``Sugarcane, molasses''; and
0
c. Adding footnote 1.
    The additions read as follows:


Sec.  180.615  Amicarbazone; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sugarcane, cane \1\........................................          0.2
Sugarcane, molasses \1\....................................          0.5
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no current U.S. registrations

* * * * *
[FR Doc. 2025-19144 Filed 9-30-25; 8:45 am]
BILLING CODE 6560-50-P