Rule2025-09679
Florylpicoxamid; 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
May 29, 2025
Effective
May 29, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of florylpicoxamid in or on multiple commodities which are identified and discussed later in this document. Corteva Agriscience, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 90 Issue 102 (Thursday, May 29, 2025)</title>
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[Federal Register Volume 90, Number 102 (Thursday, May 29, 2025)]
[Rules and Regulations]
[Pages 22642-22649]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09679]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0449; FRL-12713-01-OCSPP]
Florylpicoxamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
florylpicoxamid in or on multiple commodities which are identified and
discussed later in this document. Corteva Agriscience, LLC requested
[[Page 22643]]
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective on May 29, 2025. Objections and
requests for hearings must be received on or before July 28, 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-2020-0449, 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, 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#85d7c1c3d7cbeaf1ece6e0f6c5e0f5e4abe2eaf3"><span class="__cf_email__" data-cfemail="77253331253918031e1412043712071659101801">[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).
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 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 the docket ID number EPA-HQ-
OPP-2020-0449 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 July 28, 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. Summary of Petitioned-For Tolerance
In the Federal Register of October 27, 2020 (85 FR 68030 (FRL-
10015-86-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 0F8836) by Dow AgroSciences LLC (currently Corteva
Agriscience, LLC), 9330 Zionsville Road, Indianapolis, IN. The petition
requested that 40 CFR part 180 be amended by establishing tolerances
for residues of the fungicide florylpicoxamid, (1S)-2,2-bis(4-
fluorophenyl)-1-methylethyl N-[[3-(acetyloxy)-4-methoxy-2-
pyridinyl]carbonyl]-L-alaninate in or on barley, bran at 0.2 parts per
million (ppm); barley, grain at 0.05 ppm; barley, hay at 2.0 ppm;
barley, straw at 0.9 ppm; beans, dried shelled (except soybean), straw
at 0.9 ppm; beet, sugar, dried pulp at 0.4 ppm; beet, sugar, roots at
0.05 ppm; beet, sugar, tops at 0.3 ppm; pea and bean, dried shelled,
except soybean, subgroup 6C at 0.02 ppm; pea, dried shelled, hay at 8.0
ppm; pea, dried shelled, vines at 3.0 ppm; rapeseed subgroup 20A,
fodder/straw at 2.0 ppm; rapeseed subgroup 20A, seed at 0.04 ppm;
wheat, aspirated grain fractions at 0.1 ppm; wheat, bran at 0.05 ppm;
wheat, forage at 2.0 ppm; wheat, grain at 0.02 ppm; wheat, hay at 4.0
ppm; wheat, straw at 0.3 ppm; and in or on the raw agricultural
commodity cattle, fat at 0.02 ppm; cattle, meat at 0.02 ppm; cattle,
meat byproducts at 0.02 ppm; egg at 0.02 ppm; goat, fat at 0.02 ppm;
goat, meat at 0.02 ppm; goat, meat byproducts at 0.02 ppm; hog, fat at
0.02 ppm; hog, meat at 0.02 ppm; hog, meat byproduct at 0.02 ppm;
horse, fat at 0.02 ppm; horse, meat at 0.02 ppm; horse, meat byproduct
at 0.02 ppm; milk at 0.02 ppm; poultry, fat at 0.02 ppm;
[[Page 22644]]
poultry, liver at 0.02 ppm; poultry, muscle at 0.02 ppm; sheep, fat at
0.02 ppm; sheep, meat at 0.02 ppm; sheep, meat byproducts at 0.02 ppm.
The Agency's notice of filing document referenced a summary of the
petition prepared by Corteva Agriscience, LLC, the registrant, which is
available in the docket. Two comments were received on the notice of
filing. EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
modified several tolerance expressions, the tolerances, and commodity
definitions. The reasons for these changes are explained in this
document.
III. Aggregate Risk Assessment and Determination of Safety
A. EPA's Safety Determination
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 florylpicoxamid including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with florylpicoxamid
follows.
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. Florylpicoxamid is a picolinamide fungicide that inhibits the
quinone oxidase enzyme of Complex III in the mitochondrial electron
transport chain, leading to disruption of cellular respiration. A
mammalian mode of action is not known. The studies available in the
toxicity database indicate that toxicity is low for florylpicoxamid and
are protective of toxicity from mammalian metabolites of
florylpicoxamid. The only adverse effects were observed in a 90-day
oral study in dogs, a developmental study in rabbits, and a combined
chronic/carcinogenicity study in rats. In the other studies, effects
were not observed at the highest doses tested, ranging from 123 mg/kg/
day to the limit dose of 1000 mg/kg/day. The systemic effect of
decreased body weight, an effect common to the picolinamide chemical
class, was the most consistent seen throughout the database.
Adaptive liver effects including increased liver weights and very
slight to slight hepatocellular hypertrophy were among the most common
observations in the florylpicoxamid database. In the absence of
corroborating toxic effects such as clinical chemistry (e.g., liver
enzymes) or other histopathological changes (e.g., hepatocellular
necrosis and inflammation), these effects are considered an adaptive
response of the liver as it activates to metabolize the xenobiotic,
rather than being adverse.
No increased fetal or offspring susceptibility was observed in
developmental toxicity studies in rats and rabbits or in reproductive
and fertility effects studies in rats. The only effect of note in those
studies was late abortions seen in two maternal rabbits.
No evidence of neurotoxicity or immunotoxicity was seen throughout
the toxicity database for florylpicoxamid, and a non-guideline 90-day
oral study in rats that evaluated these systems did not reveal
treatment-related effects up to the highest dose tested (185 mg/kg/
day). No toxicity was seen up to the limit dose in a 28-day dermal
study. Florylpicoxamid has low acute oral, inhalation, and dermal
toxicity, and is not a skin or eye irritant (Toxicity Category IV,
except for oral and dermal Toxicity Categories of III), or a skin
sensitizer.
Specific information on the studies received and the nature of the
adverse effects caused by florylpicoxamid 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 in the document
``Florylpicoxamid: Human Health Risk Assessment for the New Active
Ingredient'' at pages 20-23 in docket ID number EPA-HQ-OPP-2020-0449.
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/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides">https://www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides</a>.
For more detailed information on the toxicological endpoints for
florylpicoxamid used for human risk assessment can be found in the
document ``Florylpicoxamid Human Health Risk Assessment for the New
Active Ingredient'' in docket ID number EPA-HQ-OPP-2020-0449.
D. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to florylpicoxamid, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
florylpicoxamid 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. No such effects were
identified in the toxicological studies for florylpicoxamid; therefore,
a quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America (USDA 2005-2010 NHANES/
WWEIA). As to residue levels in food, EPA conducted a partially refined
chronic aggregate dietary (food and drinking water) exposure and risk
assessment and incorporated 100% crop treated (PCT) for all
commodities. The chronic dietary exposure analysis incorporated
recommended tolerances for livestock commodities, as the residues of
concern for both tolerance enforcement and risk assessment are the same
in livestock. While the residue of concern for tolerance enforcement in
plants is parent florylpicoxamid only, the residues of concern for risk
assessment are florylpicoxamid and
[[Page 22645]]
metabolite X12485649. Therefore, to account for the residues of concern
for risk assessment, the chronic dietary exposure analysis incorporated
average field trial residues of florylpicoxamid and metabolite
X12485649 for all plant commodities (raw and processed) in this action.
The analysis incorporated default processing factors. Additionally,
the submitted wheat and barley residue data demonstrate that residues
of X12485649 concentrate in wheat bran and barley bran. Therefore,
anticipated residues of 0.054 ppm and 0.051 ppm based on the residues
of concern for risk assessment were used for barley bran and wheat
bran, respectively.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that florylpicoxamid does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is not required.
iv. Anticipated residue and PCT information. EPA did not use PCT
information in the dietary assessment for florylpicoxamid. Tolerance
level residues were assumed for all livestock commodities. 100 PCT was
assumed for all crop commodities.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for florylpicoxamid in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of florylpicoxamid. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at <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>.
Based on the Pesticide in Water Calculator model (PWC Version
2.001), which utilizes the Pesticide Root Zone Model (PRZM5) and the
Variable Volume Water Model (VVWM), the estimated drinking water
concentrations (EDWCs) of florylpicoxamid residues of concern for acute
exposures are estimated to be 37.5 parts per billion (ppb) for surface
water and 318 ppb for ground water. EDWCs for chronic exposures for
non-cancer assessments are estimated to be 32 ppb for surface water and
212 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 212 ppb was used to assess
the contribution to drinking water.
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).
Florylpicoxamid is not currently registered for any specific use
patterns that would result in residential handler exposure, but there
are residential post-application exposures expected from contact with
previously treated turf on golf courses. There is the potential for
dermal post-application exposure for youth (11 to <16 years old) and
adults exposed as a result of golfing on treated turf. Residential
post-application exposure is expected to be short-term in duration.
Intermediate-term exposures are not likely. Dermal exposures only are
anticipated while golfing on treated turf; however, there is no dermal
endpoint selected for children. Therefore, only dermal exposures for
adults and youths (11 to <16 years old) have been quantitatively
assessed and there are no additional routes to combine.
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 florylpicoxamid and any
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that florylpicoxamid does not have a common mechanism
of toxicity with other substances. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at <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>.
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. No increased prenatal or
postnatal susceptibility was detected in developmental or reproductive
studies in rats and rabbits, as no fetal or offspring effects were
observed in either study. The late abortions observed in rabbit are
considered a maternal effect only.
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 florylpicoxamid is complete.
ii. There is no indication that florylpicoxamid is a neurotoxic
chemical, and there is no need for a developmental neurotoxicity study
or additional Uncertainty Factors to account for neurotoxicity.
iii. There is no evidence that florylpicoxamid results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the two-generation
reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. The partially refined chronic dietary assessment utilized
tolerance-level residues for livestock commodities, field trial residue
data for all plant commodities (raw and processed) to account for
residues of concern for risk assessment, 100 PCT, and default
processing factors. EPA made conservative (protective) assumptions in
[[Page 22646]]
the ground and surface water modeling used to assess exposure to
florylpicoxamid in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by florylpicoxamid.
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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
florylpicoxamid is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
florylpicoxamid from food and water will utilize 4.3% of the cPAD for
females 13-49 years old the population group with the highest risk
estimate. The population subgroup with the highest dietary exposure is
all infants (<1 year old), with an exposure of 0.016275 mg/kg/day at
3.5% of the cPAD. As there are no anticipated long-term residential
exposures based on the explanation in Unit III.C.3., the chronic
aggregate assessment is equivalent to the chronic dietary assessment.
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).
Florylpicoxamid 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 florylpicoxamid.
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 2,200 for adults
and 2,900 for youth (11 to <16 years). Dermal exposures only are
anticipated while golfing on treated turf. Because EPA's level of
concern for florylpicoxamid is a MOE of 100 or below, these MOEs are
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). Because there are no residential exposure scenarios which are
expected to be intermediate-term, florylpicoxamid is not expected to
pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, florylpicoxamid 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 florylpicoxamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The petitioner has proposed a multi-residue method (quick, easy,
cheap, effective, rugged and safe; QuEChERS; JRFA Method No. AU298R0)
for the determination of florylpicoxamid in plant and livestock
commodities.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
<a href="/cdn-cgi/l/email-protection#463423352f2233232b23322e2922350623362768212930"><span class="__cf_email__" data-cfemail="1c6e796f757869797179687473786f5c796c7d327b736a">[email protected]</span></a>.
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 MRLs for florylpicoxamid.
C. Response to Comments
Two comments were received in response to the October 27, 2020,
notice of filing. One comment was from Sheryl Kunickis, Ph.D., Director
at the United States Department of Agriculture in support of the
petition, discussing reported efficacy of florylpicoxamid, describing
it as having ``excellent foliar uptake and redistribution properties on
dicot and monocot plants, as well as excellent curative reachback
activity'' and being ``highly active against a broad spectrum of
diseases''. Dr. Kunickis discussed the benefits of florylpicoxamid as a
novel mode of action with no cross resistance and states ``[b]ased on
its reported efficacy and novel mode of action, USDA believes that
florylpicoximide [sic] demonstrates potential to serve as a beneficial
new tool for U.S. growers.'' The Agency appreciates the supportive
comments from Dr. Kunickis, and one additional Anonymous commenter, and
is moving forward with issuing the tolerance.
D. Revisions to Petitioned-For Tolerances
Based on EPA's review of the data supporting the petition, EPA is
establishing tolerances that vary from what the petitioner requested
under its authority in FFDCA section 408(d)(4)(A)(i). Some commodity
terms are altered to be consistent with Agency nomenclature and to
reflect the crop group definition updates from 2022. EPA is not
establishing tolerances on barley, bran; beet, sugar, dried pulp;
wheat, aspirated grain fractions; and wheat, bran. The Agency
determined that the residue of concern is parent only and parent did
not concentrate in these processed commodities. Therefore, separate
tolerances are not required as they are covered by the tolerances on
the associated raw agricultural commodities.
EPA is removing the plant metabolite X12485649 as a residue of
concern for tolerance enforcement for plants. Both parent and
metabolite X12485649 were the major residues in plant metabolism
studies, and both were found in quantifiable amounts in magnitude of
the residue for crops. Residues of parent florylpicoxamid would be
sufficient to detect misuse and serve as the residue
[[Page 22647]]
of concern for tolerance enforcement for plants. Therefore, the
tolerance expression for plant commodities is parent only.
To support the updated 2022 crop group definitions, EPA updated the
crop commodity definitions by changing pea and bean, dried shelled,
except soybean, subgroup 6C to vegetable, legume, pulse, bean, dried
shelled, except soybean, subgroup 6-22E and vegetable, legume, pulse,
pea, dried shelled, subgroup 6-22F; and pea, dried shelled, vines and
pea, dried shelled, hay to vegetable, legume, forage and hay, except
soybean, subgroup 7-22A. EPA also corrected the commodity definitions
by changing poultry, muscle to poultry, meat, and beet, sugar, tops to
beet, sugar, leaves. To align with the labeled uses, the Agency is not
establishing tolerances on the full rapeseed subgroup 20A and is
instead establishing a tolerance only on canola.
EPA is establishing tolerance levels lower than what the petitioner
requested for barley, grain corrected to 0.03 ppm, barley, hay to 1.5
ppm, barley, straw to 0.5 ppm, beet, sugar, leaves to 0.1 ppm, beet,
sugar, roots to 0.01 ppm, vegetable, legume, pulse, bean, dried
shelled, except soybean, subgroup 6-22E to 0.01 ppm, vegetable, legume,
pulse, pea, dried shelled, subgroup 6-22F to 0.01 ppm, vegetable,
legume, forage and hay, except soybean, subgroup 7-22A to 6 ppm,
rapeseed subgroup 20A to 0.015 ppm, wheat, forage to 1.5 ppm, wheat,
grain to 0.01 ppm, wheat, hay to 3 ppm, and wheat, straw to 0.05 ppm.
This corrects for the plant residue of concern for tolerance expression
being the florylpicoxamid parent compound only.
V. Conclusion
Therefore, tolerances are established for residues of
florylpicoxamid, (1S)-2,2-bis(4-fluorophenyl)-1-methylethyl N-[[3-
(acetyloxy)-4-methoxy-2-pyridinyl]carbonyl]-L-alaninate, in or on
barley, grain at 0.03; barley, hay at 1.5; barley, straw at 0.5; beet,
sugar, leaves at 0.1; beet, sugar, roots at 0.01; vegetable, legume,
pulse, bean, dried shelled, except soybean, subgroup 6-22E at 0.01;
vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at 0.01;
vegetable, legume, forage and hay, except soybean, subgroup 7-22A at 6;
canola at 0.015; wheat, forage at 1.5; wheat, grain at 0.01; wheat, hay
at 3; wheat, straw at 0.05 ppm. Tolerances are established for residues
of florylpicoxamid, (1S)-2,2-bis(4-fluorophenyl)-1-methylethyl N-[[3-
(acetyloxy)-4-methoxy-2-pyridinyl]carbonyl]-L-alaninate, and its
metabolite, (2S)-1,1-bis(4-fluorophenyl)propan-2-yl N-[(3-hydroxy-4-
methoxypyridin-2-yl)carbonyl]-L-alaninate, in or on cattle, fat at
0.02; cattle, meat at 0.02; cattle, meat byproducts at 0.02; egg at
0.02; goat, fat at 0.02; goat, meat at 0.02; goat, meat byproducts at
0.02; hog, fat at 0.02; hog, meat at 0.02; hog, meat byproducts at
0.02; horse, fat at 0.02; horse, meat at 0.02; horse, meat byproducts
at 0.02; milk at 0.02; poultry, fat at 0.02; poultry, liver at 0.02;
poultry, meat at 0.02; sheep, fat at 0.02; sheep, meat at 0.02; sheep,
meat byproducts at 0.02 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 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.
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,
[[Page 22648]]
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 22, 2025.
Edward Messina,
Office Director, Office of Pesticide Programs.
For the reasons set forth in the preamble, EPA is amending 40 CFR
chapter I 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. Add Sec. 180.727 to subpart C to read as follows:
Sec. 180.727 Florylpicoxamid; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
florylpicoxamid, including its metabolites and degradates, in or on the
commodities in table 1 to this paragraph (a)(1). Compliance with the
tolerance levels specified in table 1 is to be determined by measuring
only florylpicoxamid ((1S)-2,2-bis(4-fluorophenyl)-1-methylethyl N-[[3-
(acetyloxy)-4-methoxy-2-pyridinyl]carbonyl]-L-alaninate) in or on the
commodity.
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Barley, grain..................................... 0.03
Barley, hay....................................... 1.5
Barley, straw..................................... 0.5
Beet, sugar, leaves............................... 0.1
Beet, sugar, roots................................ 0.01
Canola............................................ 0.015
Vegetable, legume, pulse, bean, dried shelled, 0.01
except soybean, subgroup 6-22E...................
Vegetable, legume, pulse, pea, dried shelled, 0.01
subgroup 6-22F...................................
Vegetable, legume, forage and hay, except soybean, 6
subgroup 7-22A...................................
Wheat, forage..................................... 1.5
Wheat, grain...................................... 0.01
Wheat, hay........................................ 3
Wheat, straw...................................... 0.05
------------------------------------------------------------------------
(2) Tolerances are established for residues of florylpicoxamid,
including its metabolites and degradates, in or on the commodities in
table 2 to this paragraph (a)(2). Compliance with the tolerance levels
specified in table 2 is to be determined by measuring only the sum of
florylpicoxamid ((1S)-2,2-bis(4-fluorophenyl)-1-methylethyl N-[[3-
(acetyloxy)-4-methoxy-2-pyridinyl]carbonyl]-L-alaninate) and its
metabolite (2S)-1,1-bis(4-fluorophenyl)propan-2-yl N-[(3-hydroxy-4-
methoxypyridin-2-yl)carbonyl]-L-alaninate, calculated as the
stoichiometric equivalent of florylpicoxamid, in or on the commodity.
Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat....................................... 0.02
Cattle, meat...................................... 0.02
Cattle, meat byproducts........................... 0.02
Egg............................................... 0.02
Goat, fat......................................... 0.02
Goat, meat........................................ 0.02
Goat, meat byproducts............................. 0.02
Hog, fat.......................................... 0.02
Hog, meat......................................... 0.02
Hog, meat byproducts.............................. 0.02
Horse, fat........................................ 0.02
Horse, meat....................................... 0.02
Horse, meat byproducts............................ 0.02
Milk.............................................. 0.02
Poultry, fat...................................... 0.02
Poultry, liver.................................... 0.02
Poultry, meat..................................... 0.02
Sheep, fat........................................ 0.02
Sheep, meat....................................... 0.02
Sheep, meat byproducts............................ 0.02
------------------------------------------------------------------------
[[Page 22649]]
(b)-(d) [Reserved]
[FR Doc. 2025-09679 Filed 5-28-25; 8:45 am]
BILLING CODE 6560-50-P
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