Rule2025-14282
Pyroxasulfone; 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
July 29, 2025
Effective
July 29, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of pyroxasulfone in or on the nut, tree, group 14-12; the fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F; and almond hulls. K-I Chemical U.S.A., Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 90 Issue 143 (Tuesday, July 29, 2025)</title>
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[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Rules and Regulations]
[Pages 35620-35624]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14282]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0212; FRL-12816-01-OCSPP]
Pyroxasulfone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
pyroxasulfone in or on the nut, tree, group 14-12; the fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F; and almond
hulls. K-I Chemical U.S.A., Inc. requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 29, 2025. Objections and
requests for hearings must be received on or before September 29, 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-2024-0212, 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; telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#feacbab8acb0918a979d9b8dbe9b8e9fd0999188"><span class="__cf_email__" data-cfemail="1d4f595b4f537269747e786e5d786d7c337a726b">[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.
<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
[[Page 35621]]
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 docket ID number EPA-HQ-OPP-2024-0212 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 September 29, 2025.
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 December 9, 2024 (89 FR 97577) (FRL-
11682-10-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 3F9073) by K-I Chemical U.S.A., Inc., c/o Landis
International, Inc., P.O. Box 5126, Valdosta, GA 31603-5126. The
petition requested that 40 CFR 180.659 be amended by establishing
tolerances for residues of pyroxasulfone, (3-[(5-difluoromethoxy-1-
methyl-3-(trifluoromethyl)pyrazol-4-ylmethylsulfonyl]-4,5-dihydro-5,5-
dimethyl-1,2-oxazole), including its metabolites M-1, M-3, M-25, and M-
28, in or on nut, tree, group 14-12 at 0.07 parts per million (ppm);
fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at
0.07 ppm; and almond, hulls at 0.15 ppm. That document referenced a
summary of the petition prepared by the petitioner and included in the
docket.
There were no comments received in response to the notice of
filing.
III. Final Tolerance Action
A. EPA's Safety Determination
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 pyroxasulfone including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with pyroxasulfone is summarized in this
unit. In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published in tolerance rulemakings for the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA previously published several tolerance rulemakings for
pyroxasulfone, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to pyroxasulfone and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections of those rulemakings that remain
unchanged, as described further in this rulemaking. Specific
information on the risk assessment conducted in support of this action,
including on the studies received and the nature of the adverse effects
caused by pyroxasulfone, can be found in the document titled
``Pyroxasulfone: Human Health Risk Assessment for the New Section 3
Uses on Fruit, Small, Vine Climbing, Except Fuzzy Kiwifruit, Subgroup
13-07F and Nut, Tree, Group 14-12'' (hereinafter ``Pyroxasulfone Human
Health Risk Assessment), which is available in the docket.
B. Toxicological Profile
For a discussion of the Toxicological Profile of pyroxasulfone, see
Unit III.A. of the rulemaking published in the Federal Register of
October 29, 2018 (83 FR 54259) (FRL-9983-29).
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 dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(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/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides</a>.
More detailed information on the toxicological endpoints for
pyroxasulfone used for human health risk assessment can be found in the
Pyroxasulfone Human Health Risk Assessment that is in the docket.
D. Exposure Assessment
Much of the exposure assessment remains unchanged from the
rulemaking of October 29, 2018, as described in Unit III.C. of that
rulemaking, although
[[Page 35622]]
the new exposure assessment incorporates the additional dietary
exposure from the petitioned-for tolerances. Other changes are
described in this unit.
Acute and chronic dietary exposure assessments were conducted using
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).
For both the acute and chronic risk assessments EPA assumed 100
percent crop treated (PCT). Residues in or on food were based on
tolerance level residues for all commodities with the following
exceptions, which were based on tolerance level residues adjusted to
include additional metabolites of concern for risk assessment: cereal
grains (i.e., corn, field, grain; corn, pop, grain; corn, sweet, kernel
plus cob with husks removed (K+CWHR); and wheat, grain); cottonseed,
subgroup 20C; milk; and soybean, seed. The assessments used default
processing factors and the highest estimated drinking water
concentrations (EDWCs) from acute and chronic ground water exposures.
For a summary of the drinking water numbers used, see Unit III.C.
of the rulemaking of October 29, 2018. For the acute dietary risk
assessment, a water concentration value of 210 parts per billion (ppb)
was used to assess the contribution to drinking water. For the chronic
dietary risk assessment, a water concentration value of 174 ppb was
used to assess the contribution to drinking water.
The registered and proposed uses of pyroxasulfone are not expected
to result in residential exposure. There are no proposed residential
uses at this time and existing registrations with residential use sites
are not expected to result in residential handler or post-application
exposure based on the label directions and directed use patterns (soil-
directed application), providing no residential contribution to the
aggregate. Therefore, the acute and chronic exposure estimates
represent all aggregate exposure.
E. Cumulative Exposure
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
pyroxasulfone and any other substances, and pyroxasulfone does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this action, therefore, EPA has not assumed that
pyroxasulfone has a common mechanism of toxicity with other substances.
F. Safety Factor for Infants and Children
1. In general. 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.
2. Prenatal and postnatal sensitivity. Pyroxasulfone did not
exhibit developmental toxicity in the rat guideline study at the limit
dose of 1000 mg/kg/day although it exhibited slight developmental
toxicity in rabbits (reduced fetal weight and increase fetal
resorptions) at the limit dose of 1000 mg/kg/day. However,
developmental effects (decreased brain weight and morphometric changes)
were noted in offspring at 300 mg/kg/day in the rat developmental
neurotoxicity (DNT) study compared to no maternal toxicity at >=900 mg/
kg/day. In a reproductive toxicity in rats, reduced pup body weight
during lactation occurred at similar or higher doses causing pronounced
maternal toxicity (reduced body weight and cardiac, nerve, liver,
muscle and urinary system toxicity).
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA safety factor were reduced to 1X. That decision is based on the
following findings:
<bullet> The toxicity database for pyroxasulfone is complete.
<bullet> The neurotoxicity database, including acute, subchronic
and chronic studies, shows adverse effects from pyroxasulfone exposure
in mice, rats and dogs, with dogs showing the most sensitivity.
Although the DNT study indicated offspring are more sensitive to
neurotoxic effects of pyroxasulfone, the dose-response is well
characterized for neurotoxicity and a NOAEL is identified; therefore,
there is no residual uncertainty with regard to neurotoxic effects for
which a 10X must be retained.
<bullet> The available database shows evidence of increased
susceptibility of fetuses and offspring in a DNT study in rats and in a
developmental study in rabbits following in utero or post-natal
exposure to pyroxasulfone. The Agency concludes, however, that there is
no residual uncertainty concerning these effects. The available studies
show clear NOAELs and LOAELs for these effects, which are occurring
only at doses much higher than the endpoints on which the Agency is
regulating (i.e., all PODs selected for risk assessment are protective
of the offspring effects).
<bullet> There are no residual uncertainties in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues or residues based on field
trials. EPA made conservative (protective) assumptions in the ground or
surface water modeling used to assess exposure to pyroxasulfone in
drinking water. These assessments will not underestimate the exposure
and risks posed by pyroxasulfone.
G. 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). 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 (POD) to
ensure that an adequate margin of exposure (MOE) exists.
Acute dietary (food and drinking water) risks are below the
Agency's level of concern of 100% of the aPAD; they are 4.0% of the
aPAD for all infants less than 1 year old, which is the population
subgroup with the highest exposure estimate. Chronic dietary (food and
drinking water) risks are below the Agency's level of concern of 100%
of the cPAD; they are 70% of the cPAD for all infants less than 1 year
old, which is the population subgroup with the highest exposure
estimate.
The Agency has determined that the quantification of risk using a
non-linear approach (i.e., RfD) will adequately account for all chronic
toxicity, including carcinogenicity, that could result from exposure to
pyroxasulfone. Therefore, a separate cancer dietary (food and drinking
water) exposure and risk assessment was not conducted.
[[Page 35623]]
Therefore, based on the risk assessment and information described
in this document, 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 pyroxasulfone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. in the rulemaking of October 29, 2018.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for residues of pyroxasulfone
in or on any of the petitioned-for commodities associated with this
regulatory action.
V. Conclusion
Therefore, tolerances are established for residues of
pyroxasulfone, including its metabolites and degradates, in or on the
Nut, tree, group 14-12 at 0.07 ppm; fruit, small, vine climbing, except
fuzzy kiwifruit, subgroup 13-07F at 0.07 ppm; and almond, hulls at 0.15
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 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: July 24, 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:
[[Page 35624]]
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. 180.659, add alphabetically to the table in paragraph
(a)(5) the commodities ``Almond, hulls''; ``Fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F''; and ``Nut, tree,
group 14-12'' to read as follows:
Sec. 180.659 Pyroxasulfone; tolerances for residues.
(a) * * *
(5) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond, hulls...................................... 0.15
* * * * * * *
Fruit, small, vine climbing, except fuzzy 0.07
kiwifruit, subgroup 13-07F........................
* * * * * * *
Nut, tree, group 14-12............................. 0.07
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2025-14282 Filed 7-28-25; 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.