Rule2025-19144
Amicarbazone; 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
October 1, 2025
Effective
October 1, 2025
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#b2e0f6f4e0fcddc6dbd1d7c1f2d7c2d39cd5ddc4"><span class="__cf_email__" data-cfemail="97c5d3d1c5d9f8e3fef4f2e4d7f2e7f6b9f0f8e1">[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).
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 <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
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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no
comments received in response to the notice of filing.
III. Final Tolerance Action
A. Aggregate Risk Assessment and Determination of Safety
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/pesticides/factsheets/riskassess.htm">https://www.epa.gov/pesticides/factsheets/riskassess.htm</a>.
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 <a href="https://www.epa.gov/oppefed1/models/water/index.htm">https://www.epa.gov/oppefed1/models/water/index.htm</a>.
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 <a href="https://www.epa.gov/pesticides/trac/science/trac6a05.pdf">https://www.epa.gov/pesticides/trac/science/trac6a05.pdf</a>.
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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework</a>. 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 <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 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 <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: 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
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