Rule2024-04017
Triclopyr; 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
February 28, 2024
Effective
February 28, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance for residues of triclopyr, including its metabolites and degradates, in or on sugarcane, cane. The Interregional Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 89 Issue 40 (Wednesday, February 28, 2024)</title>
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[Federal Register Volume 89, Number 40 (Wednesday, February 28, 2024)]
[Rules and Regulations]
[Pages 14591-14594]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-04017]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0890; FRL-11763-01-OCSPP]
Triclopyr; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
triclopyr, including its metabolites and degradates, in or on
sugarcane, cane. The Interregional Project Number 4 (IR-4) requested
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 28, 2024. Objections and
requests for hearings must be received on or before April 29, 2024, 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-2022-0890, 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 and the OPP Docket is (202) 566-
1744. For the latest status information on EPA/DC services, docket
access, visit <a href="https://www.epa.gov/">https://www.epa.gov/</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#a8faeceefae6c7dcc1cbcddbe8cdd8c986cfc7de"><span class="__cf_email__" data-cfemail="a0f2e4e6f2eecfd4c9c3c5d3e0c5d0c18ec7cfd6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
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. 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 Office of the
Federal Register's e-CFR site at <a href="https://www.ecfr.gov/current/">https://www.ecfr.gov/current/</a>.
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-2022-0890 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
April 29, 2024. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
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-2022-0890, 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/">https://www.epa.gov/</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/">https://www.epa.gov/</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of July 5, 2023 (88 FR 42935) (FRL-10579-
05-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of pesticide petition
(PP2E9028) by the Interregional Research Project No. 4 (IR-4), North
Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210,
Raleigh, NC 27606. The petition requests to amend 40 CFR 180.417 by
establishing a tolerance for residues of triclopyr, 2-[(3,5,6-
trichloro-2- pyridinyl)oxy]acetic acid, including its metabolites and
degradates, in or on sugarcane, cane at 0.04 parts per million (ppm)
resulting from the application of the butoxyethyl ester of triclopyr,
triethylamine salt of triclopyr, or choline salt of triclopyr. The
petition also requests to remove the established time-limited tolerance
for residues of triclopyr in or on sugarcane, cane at 40 ppm. That
document referenced a summary of the petition prepared by IR-4, the
petitioner, which is available in the docket (EPA-HQ-OPP-2022-0890),
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
III. 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
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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 triclopyr including exposure resulting from the tolerances
established by this action. EPA's assessment of exposures and risks
associated with triclopyr 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 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 has previously published tolerance rulemakings for triclopyr in
which EPA concluded, based on the available information, that there is
a reasonable certainty that no harm would result from aggregate
exposure to triclopyr 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.
Toxicological Profile. For a discussion of the Toxicological
Profile of triclopyr, see Unit III.A. of the final rule published in
the Federal Register of February 25, 2016 (81 FR 9353) (FRL-9941-87).
Toxicological Points of Departure/Levels of Concern. A summary of
the toxicological endpoints and points of departure for triclopyr used
for human risk assessment can be found in the document, ``Triclopyr.
Human Health Risk Assessment for Section 3 Use on Sugarcane'' in docket
ID EPA-HQ-OPP-2022-0890. As explained in the Food Quality Protection
Act (FQPA) section below, the FQPA safety factor for short- and
intermediate-term inhalation exposures has decreased from 10X to 1X
since the February 25, 2016, final rule so the level of concern for
short- and intermediate-term inhalation exposures is now 100.
Exposure Assessment. EPA's dietary exposure assessments have been
updated to include the additional exposures from the petitioned-for
tolerance. Acute and chronic dietary (food and drinking water) exposure
and risk assessments were conducted using the Dietary Exposure
Evaluation Model software using the Food Commodity Intake Database
(DEEM-FCID) Version 4.02. This software uses 2005-2010 food consumption
data from the USDA's National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). The acute dietary exposure
assessment was unrefined, using tolerance-level residues for all
registered and proposed commodities. The chronic dietary exposure
assessment was slightly refined, using tolerance-level residues for all
commodities except milk. An anticipated residue calculated from a
recently submitted livestock feeding study was used for milk. HED
default processing factors were used to estimate residues in processed
commodities. Drinking water was incorporated directly into the dietary
assessment. The acute and chronic dietary exposure assessments assumed
100% crop treated for all registered and proposed commodities.
The Agency classified triclopyr as a ``Group D Chemical--unable to
be classified as to human carcinogenicity.'' This is based on marginal
evidence of mammary tumors in female rats and mice and benign adrenal
pheochromocytomas in male rats. There was no evidence of mutagenicity
in a full battery of studies for triclopyr. Therefore, a cancer risk
assessment was not conducted. The use of the chronic reference dose
(RfD), which is derived from the most protective point of departure
(POD) from the tox database, will adequately account for all chronic
toxicity, including potential carcinogenicity that could result from
exposure to triclopyr. A 100X uncertainty factor (10X for interspecies
extrapolation and 10X for intraspecies variation) was incorporated into
the chronic RfD. Since the FQPA SF has been reduced to 1X, the chronic
population-adjusted dose (cPAD) is equal to the chronic RfD.
Drinking water exposure. EPA revised the triclopyr drinking water
assessment since the February 25, 2016, final rule as part of
Registration Review using current models, newly submitted studies and
changes in labels. The estimated drinking water concentrations (EDWCs)
were higher for surface water sources than for ground water sources.
The acute dietary exposure assessment used the highest 1-in-10-year
acute EDWC of 758 ppb of triclopyr and the chronic dietary exposure
assessment incorporated the highest 1-in-10-year chronic EDWC of 396
ppb of triclopyr. The drinking water models, and their descriptions are
available at the EPA internet site: <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment</a>.
Non-occupational exposure. The proposed use on sugarcane does not
involve applications by homeowners or commercial applicators in
residential settings. Therefore, no new residential exposure is
expected. The residential exposure assessment used the same assumptions
as described in the February 25, 2016, final rule.
Cumulative exposures. 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
triclopyr and any other substances. 3,5,6-trichloro-2-pyridinol,
commonly known as TCP, is a metabolite of triclopyr, chlorpyrifos, and
chlorpyrifos-methyl. Risk assessment of TCP was conducted in 2002,
which concluded that the acute and chronic dietary aggregate exposure
estimates are below EPA's level of concern. As TCP is not a residue of
concern in plants and the proposed use on sugarcane will not result in
any additional exposure to TCP, the results of the 2002 TCP assessment
are still considered valid. For the purposes of this action, EPA has
not assumed that triclopyr has a common mechanism of toxicity with
other substances.
Safety Factor for Infants and Children. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply an additional tenfold (10X) margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
database on toxicity and exposure unless EPA determines based on
reliable data that a different margin of safety will be safe for
infants and children. This additional margin of safety is commonly
referred to as the Food Quality Protection Act Safety Factor (FQPA 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.
Prenatal and postnatal sensitivity. Offspring and developmental
effects occurred in the presence of maternal and parental toxicity. In
the two-generation reproduction study with triclopyr acid, rare
malformations, including exencephaly (brain protrudes outside of the
skull) and ablepharia (absence of eyelids), were seen in rat pups at
the mid- and high-doses (25 mg/kg/day and 250 mg/kg/day, respectively).
These malformations were considered, using a weight-of-evidence (WOE)
approach, to be evidence of increased qualitative susceptibility. In
the rat developmental toxicity study with triclopyr acid, cleft palate,
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brachycephaly (flat head syndrome), and delayed ossification occurred
at the highest dose tested (200 mg/kg/day) while the no-observed-
adverse-effect level (NOAEL) for maternal toxicity was not established
since clinical signs of severe toxicity due to the bolus administration
of a low pH compound were seen at the lowest dose tested (50 mg/kg/
day). There were no other concerns for susceptibility identified in the
other developmental studies where developmental and maternal effects
were seen at 100 mg/kg/day and 300 mg/kg/day in the rabbit and rat,
respectively.
Conclusion. EPA has determined that reliable data show the safety
of infants and children would be adequately protected if the FQPA SF
were reduced from 10X to 1X for all exposure scenarios based on the
following considerations:
1. The existing toxicological database is adequate for
characterizing triclopyr toxicity and quantification of hazard for
dietary and occupational exposures. The developmental toxicity studies
in rats and rabbits and two-generation reproduction toxicity studies in
rats are available to assess potential fetal/offspring sensitivity;
2. There is no evidence of neurotoxicity from triclopyr exposure;
3. While there is evidence of increased qualitative susceptibility
to offspring from triclopyr exposure in the two-generation reproduction
toxicity study, the concern is low since effects are well-characterized
with clearly established NOAEL/lowest-observed-adverse-effect level
(LOAEL) values, effects were seen in the presence of parental toxicity,
and selected endpoints are protective of the observed effects; and
4. There are no residual uncertainties with respect to exposure
data. The dietary food exposure assessment utilizes tolerance-level
residues (established or recommended) except milk (an anticipated
residue was used for milk in the chronic assessment) and 100% crop
treated for all proposed/established commodities. By using these
assumptions, the acute and chronic exposures/risks will not be
underestimated.
The dietary drinking water assessment utilizes water concentration
values generated by models and associated modeling parameters that are
designed to provide conservative, health-protective, high-end estimates
of water concentrations that will not likely be exceeded. The
residential handler and post-application exposure assessments are based
upon the residential standard operating procedures (SOPs) in
conjunction with Pesticide Handlers Exposure Database unit exposures.
The residential SOPs are based upon reasonable worst-case assumptions
and are not expected to underestimate risk. These assessments of
exposure are not likely to underestimate the resulting estimates of
risk from exposure to triclopyr.
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 chronic PAD (cPAD). Short-, intermediate-, and chronic-term risks
are evaluated by comparing the estimated total food, water, and
residential exposure to the appropriate PODs to ensure that an adequate
margin of exposure (MOE) exists.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 53% of the aPAD for females 13-49 years old and
8% of the aPAD for all infants, the most highly exposed population
subgroup. No acute residential/recreational exposures are expected, so
the acute aggregate risk is equivalent to the acute dietary risk and is
not of concern. Chronic dietary risks are below the Agency's level of
concern of 100% of the cPAD; they are 46% of the cPAD for all infants,
the most highly exposed population subgroup. No long-term residential
exposures are expected, so the chronic aggregate risk is equivalent to
the chronic dietary risk and is not of concern.
For the short-term aggregate risk assessment, potential residential
exposures were combined with food and drinking water exposures.
Specifically, the short-term aggregate assessment for adults combines
dietary (food + drinking water) exposures with handler inhalation
exposures resulting from the registered turf use and the MOE is 410.
For children 1 to <2 years old, the short-term aggregate assessment
combines dietary (food + drinking water) exposure with potential post-
application incidental oral exposure resulting from the registered turf
use and the MOE is 360. For children 3 to <6 years old, the short-term
aggregate assessment combines dietary (food + drinking water) exposure
with potential post-application inhalation and incidental oral swimmer
exposure resulting from the registered aquatic use and the MOE is 120.
As the short-term aggregate MOEs are greater than 100, the risks are
not of concern. Although there are intermediate-term residential
exposures, an intermediate-term aggregate was not separately assessed
since: 1. the short- and intermediate-term points of departure are the
same and 2. the short-term aggregate provides a worst-case estimate of
residential exposure. For these reasons, the short-term aggregate is
protective of the longer-term exposures.
As stated in Unit III.A. of the February 25, 2016, final rule, EPA
has determined that an aggregate exposure risk assessment for cancer
risk is not required based on WOE conclusions on the marginal evidence
of carcinogenicity in two adequate rodent carcinogenicity studies and
the use of the chronic RfD which will adequately account for any
potential carcinogenic effects.
Therefore, based on the risk assessments and information described
above, EPA concludes that there is a reasonable certainty that no harm
will result to the general population, or to infants and children, from
aggregate exposure to triclopyr residues. More detailed information on
this action can be found in the document titled ``Triclopyr. Human
Health Risk Assessment for Section 3 Use on Sugarcane'' in docket ID
EPA-HQ-OPP-2022-0890.
IV. Other Considerations
A. Analytical Enforcement Methodology
For details about the analytical enforcement methodology, see Unit
IV.A. of the final rule published in the Federal Register of February
25, 2016.
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 any MRLs for
triclopyr.
C. Revisions to Petitioned-For Tolerances
EPA is not removing the established time-limited tolerance for
residues of triclopyr in or on sugarcane, cane at 40 ppm. The use
pattern in the emergency exemption for triclopyr on sugarcane is
different than the Section 3 use supported by this tolerance rule and
there may be sugarcane in the channels of trade with higher residues
from use under the emergency exemption.
V. Conclusion
Therefore, a tolerance is established for residues of the herbicide
triclopyr, including its metabolites and degradates, in or on
sugarcane, cane at
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0.04 ppm, resulting from the application of the butoxyethyl ester of
triclopyr, triethylamine salt of triclopyr, or choline salt of
triclopyr.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) 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, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions To Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions 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 Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination With Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. 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: February 21, 2024.
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. 180.417, amend paragraph (a)(1) by adding a heading for the
table and adding in alphabetical order an entry for ``Sugarcane, cane''
to read as follows:
Sec. 180.417 Triclopyr; tolerance for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Sugarcane, cane............................................ 0.04
------------------------------------------------------------------------
* * * * *
[FR Doc. 2024-04017 Filed 2-27-24; 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.