[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 [www.gpo.gov]
[FR Doc No: 2024-04017]



[[Page 14591]]

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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 
https://www.regulations.gov 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 https://www.epa.gov/.

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 https://www.ecfr.gov/current/.

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: 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.
    <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 https://www.epa.gov/.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/.

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), 
https://www.regulations.gov.

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

[[Page 14592]]

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: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.
    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,

[[Page 14593]]

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

[[Page 14594]]

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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