[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Rules and Regulations]
[Pages 6636-6643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02109]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0449; FRL-10566-01-OCSPP]


Fluopyram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revises the tolerance for residues of 
fluopyram in or on coffee, green bean and establishes tolerances for 
residues of fluopyram in or on multiple commodities which are 
identified and discussed later in this document. The Interregional 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective on February 1, 2023. Objections and 
requests for hearings must be received

[[Page 6637]]

on or before April 3, 2023, 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-2021-0449, is available 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/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, 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: 
[email protected].

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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     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/title-40.

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-2021-0449 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 
April 3, 2023. 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-2021-0449, by one of 
the following methods:
     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.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 22, 2021 (86 FR 52624) (FRL-
8792-03-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 1E8932) by the Interregional Research Project Number 4 
(IR-4), Project Headquarters, North Carolina University, 1730 Varsity 
Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requests 
to amend 40 CFR 180.661(a)(1) by establishing tolerances for residues 
of the fungicide fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]ethyl]-2-(trifluoromethyl)benzamide, in or on the following 
raw agricultural commodities: Brassica, leafy greens, subgroup 4-16B at 
50 parts per million (ppm); celtuce at 20 ppm; coffee, green bean at 
0.03 ppm; fennel, Florence, fresh leaves and stalk at 20 ppm; kohlrabi 
at 4 ppm; leafy greens subgroup 4-16A at 40 ppm; leaf petiole vegetable 
subgroup 22B at 20 ppm; papaya at 1.5 ppm; peppermint, dried leaves at 
0.8 ppm; peppermint, fresh leaves at 0.6 ppm; spearmint, dried leaves 
at 0.8 ppm; spearmint, fresh leaves at 0.6 ppm; spice group 26 at 70 
ppm; vegetable, Brassica, head and stem, group 5-16 at 4 ppm; 
individual commodities of proposed crop subgroup 6-XXA; edible podded 
bean legume vegetable subgroup at 4 ppm; individual commodities of 
proposed crop subgroup 6-XXB edible podded pea legume vegetable 
subgroup at 4 ppm; individual commodities of proposed crop subgroup 6-
XXC: succulent shelled bean subgroup at 0.2 ppm; individual commodities 
of proposed crop subgroup 6-XXD: succulent shelled pea subgroup at 0.2 
ppm; and the individual commodities of proposed crop subgroup 6-XXE: 
dried shelled bean, except soybean, subgroup at 0.7 ppm. Due to the 
length of the list of commodities, please refer to the document EPA 
issued in the Federal Register on September 22, 2021, for a complete 
list of the tolerances requested. The petition also requested the 
removal of the tolerances for residues of fluopyram in or on bean, dry 
at 0.70 ppm; Brassica, head and stem, subgroup 5A at 4.0 ppm; Brassica, 
leafy greens, subgroup 5B at 50 ppm; dill, seed at 70 ppm; leafy greens 
subgroup 4A at 40 ppm; leafy petioles subgroup 4B at 20 ppm; pea and 
bean, succulent shelled, subgroup 6B at 0.20 ppm; and vegetable, 
legume, edible podded, subgroup 6A at 4.0 ppm. That document referenced 
a summary of the petition prepared by IR-4, the petitioner, which is 
available in the docket, https://www.regulations.gov. Three comments 
were received on the Notice of Filing; however, the comments were not 
relevant to the petition for fluopyram tolerances that are the subject 
of this action.

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

[[Page 6638]]

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 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 fluopyram including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with fluopyram follows.

A. 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. The toxicological database for fluopyram has been re-
evaluated as part of registration review and relevant studies were 
updated in accordance with current practices. The fluopyram database is 
considered complete.
    Liver effects, thyroid effects, and decreased body weight were the 
most common and frequent findings in the subchronic and chronic oral 
toxicity studies in rats, mice, and dogs, and appeared to be the most 
sensitive effects in the fluopyram toxicological database. Increased 
liver tumors were observed in female rats in the carcinogenicity study 
at the highest dose tested (89 mg/kg/day). Thyroid effects (increased 
thyroid weight along with follicular cell hypertrophy and hyperplasia) 
were observed at dose levels similar to those that produced liver 
effects in rats and mice. In male mice, there was an increased 
incidence of thyroid adenomas at the highest dose tested (105 mg/kg/
day). Fluopyram induces liver enzymes following constitutive androstane 
receptor and pregnane X receptor (CAR/PXR) activation, which causes 
increased metabolism of thyroid hormones. These changes lead to liver 
and thyroid hypertrophy and proliferation, eventually leading to liver 
tumors (female rat) and thyroid tumors (male mice). EPA classified 
fluopyram as ``Not Likely to be Carcinogenic to Humans'' at doses that 
do not induce cellular proliferation in the liver or thyroid glands. 
This classification was based on evidence that non-genotoxic modes of 
action for liver tumors in rats and thyroid tumors in mice have been 
established and that the carcinogenic effects have been demonstrated as 
a result of a mode of action dependent on activation of the CAR/PXR 
receptors. EPA determined that quantification of risk is not required. 
There is sufficient data to ascertain the mode of action of fluopyram. 
The chronic Reference Dose (RfD) is derived using the no-observed 
adverse-effect level (NOAEL) of 6 mg/kg/day as the POD which is below 
the dose of 11 mg/kg/day that caused cell proliferation in the liver (a 
key event in tumor formation) and the subsequent liver tumors at a 
higher dose (89 mg/kg/day). Additionally, there is no concern for 
mutagenicity.
    Fluopyram did not elicit developmental or offspring effects, nor 
did it adversely affect reproductive parameters. No evidence of 
increased qualitative or quantitative susceptibility was observed in 
developmental or reproduction toxicity studies. There is no evidence of 
neurotoxicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by fluopyram 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 titled 
``Fluopyram. Human Health Risk Assessment for Proposed Uses on Coffee, 
Green Bean, Papaya, Peppermint, Spearmint and Crop Group Expansions/
Conversions.'' (hereinafter ``Fluopyram Human Health Risk Assessment'') 
on pages 43-52 in docket ID number EPA-HQ-OPP-2021-0449.

B. 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 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints and PODs for fluopyram 
used for human risk assessment can be found in the Fluopyram Human 
Health Risk Assessment on pages 25-26.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluopyram, EPA considered exposure under the petitioned-for 
tolerances as well as all existing fluopyram tolerances in 40 CFR 
180.661. EPA assessed dietary exposures from fluopyram in food as 
follows:
    i. Acute and exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for fluopyram.
    In estimating acute dietary exposure, EPA used the Dietary Exposure 
Evaluation Model software using the Food Commodity Intake Database 
(DEEM-FCID) Version 4.02, which uses the 2005-2010 food consumption 
data from the United States Department of Agriculture's (USDA's) 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, a partially 
refined acute dietary exposure assessment was conducted, incorporating 
field trial residues for coffee and the commodities of crop group 15 
and crop subgroup 20A, and tolerance-level residues for all other crop 
commodities. One hundred percent crop treated (PCT) was assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure

[[Page 6639]]

assessment, EPA used the food consumption data from the USDA's 2005-
2010 NHANES/WWEIA and DEEM-FCID; version 4.02. As to residue levels in 
food, the chronic dietary exposure assumed tolerance-level residues for 
mint and papaya and used mean field trial data and empirical processing 
factors for all other commodities. Average PCT estimates were used for 
some crops.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluopyram does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. 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 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.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if the following conditions are met:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, and the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows: almonds, 
20%; apples, 25%; apricots, 5%; artichoke, 15%; broccoli, 2.5%; 
cabbage, 2.5%; carrots, 1%; cauliflower, 1%; cherries, 25%; cotton, 1%; 
dry beans and peas, 1%; grapefruit, 10%; grapes, raisins, 1%; table 
grapes, 5%; wine grapes; 20%; lemons, 1%; lettuce, 1%; onions, 1%; 
oranges, 15%; peaches, 1%; peanuts, 2.5%; pears, 5%; peppers, 5%; 
pistachios, 15%; potatoes, 20%; strawberries, 10%; tomatoes, 1%; 
walnuts, 10%; and watermelons, 15%. EPA assumed 100 PCT for all other 
commodities included in the chronic assessment.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and California Department of 
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis and a maximum PCT for 
acute dietary risk analysis. The average PCT figure for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding to 
the nearest 5%, except for those situations in which the average PCT is 
less than 1% or less than 2.5%. In those cases, the Agency would use 
less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which fluopyram may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fluopyram in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluopyram. Further information regarding EPA 
drinking water models used in pesticide exposure assessments can be 
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-risk-assessment.
    Based on the Surface Water Concentration Calculator (SWCC) and 
Pesticide Root Zone Model--Ground Water (PRZM-GW) model, the estimated 
drinking water concentrations (EDWCs) of fluopyram for acute exposures 
are estimated to be 50.6 parts per billion (ppb) for surface water and 
97.6 ppb for ground water. For chronic exposures for non-cancer 
assessments, the EDWCs of fluopyram are estimated to be 17.3 ppb for 
surface water and 90.5 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 97.6 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of 90.5 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).
    There are no residential exposures associated with the proposed 
uses of fluopyram on coffee, mint, and papaya in this action; however, 
residential post-application exposures are anticipated from other 
registered uses of fluopyram on golf course turf, residential lawns, 
fruit trees, nut trees, ornamentals, and gardens. From the reevaluation 
of the toxicity database, the endpoints selected for residential 
exposures include incidental oral and short- and intermediate-term 
inhalation endpoints, but a dermal endpoint is no longer selected. A 
dermal endpoint was not selected as there were no adverse effects 
observed in the route-specific dermal

[[Page 6640]]

toxicity study, which included evaluation of fluopyram target organs, 
up to the limit dose of 1,000 mg/kg/day. Additionally, there was no 
evidence of increased quantitative susceptibility in the fluopyram 
database.
    EPA assessed residential exposure using the following assumptions. 
Residential handler exposures and risk are not assessed in this 
document because the existing registered uses for residential sites are 
from end-use products that require handlers to wear specific clothing 
and personal protective equipment (PPE). Thus, EPA has assumed that 
those products are not for homeowner use and a quantitative residential 
handler assessment is not warranted at this time. There are residential 
post-application exposures from existing turf uses that have been 
previously assessed. The residential exposure for use in the children 1 
to less than 2 years old aggregate assessment reflects incidental oral 
hand-to-mouth post-application exposure to treated lawns. The MOE is 
5,400, which is greater than the level of concern of 100 and therefore 
is not of concern. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to fluopyram and any other 
substances, and fluopyram does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this action, 
therefore, EPA has not assumed that fluopyram has 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. 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 Food Quality 
Protection Act (FQPA) Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility following in utero and/or postnatal exposure 
in the developmental toxicity studies in rats or rabbits, or in the 2-
generation rat reproduction study. There is no evidence of 
neurotoxicity, and there are no residual uncertainties in the exposure 
database. While thyroid effects are observed throughout the database, 
EPA determined that the comparative thyroid assay (CTA) be waived based 
on a weight-of-evidence approach.
    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 from 10X to 1X. That decision is based on the 
following findings:
    i. The toxicology database for fluopyram is complete and adequate 
for risk assessment. EPA waived the subchronic inhalation toxicity 
study requirement and the previously required CTA for fluopyram for the 
following reasons: (1) the margins of exposure are low using the 
current endpoints; (2) thyroid effects are well-characterized and 
protected for using the current endpoints; and (3) acute inhalation 
toxicity is low and the compound is unlikely to volatilize. The 
toxicology database includes acceptable developmental toxicity studies 
in the rat and rabbit and an acceptable reproductive toxicity study in 
the rat, as well as acute and subchronic neurotoxicity studies.
    ii. Potential signs of neurotoxicity were observed in the rat acute 
neurotoxicity study (decreased motor activity) and in the rat chronic/
carcinogenicity study (reduced use of hind-limbs and limited motor 
activity). However, these effects are not specific to neurotoxicity, 
occur in the presence of other effects, and can also be attributed to 
systemic toxicity. There is a low degree of concern for potential 
neurotoxic effects since (1) clear NOAELs were identified for these 
effects, (2) no other neurotoxic effects were identified in the 
database, (3) potentially neurotoxic effects are not the most sensitive 
effect in the toxicity database, and (4) the endpoints chosen for risk 
assessment are protective of these potentially neurotoxic effects.
    iii. The available developmental toxicity studies in rats and 
rabbits and the multi-generation reproduction in rats demonstrate no 
evidence of increased susceptibility in the developing or young animals 
which were exposed during pre- or post-natal periods. No developmental 
or offspring effects were noted in these studies.
    iv. There are no residual uncertainties in the exposure database. 
The acute dietary exposure assessment was performed using conservative 
exposure inputs, including field trial residue levels or tolerance 
level residues for all crops; and average field-trial residue levels 
were assumed for all crops in the chronic dietary exposure assessment. 
The acute dietary assessment assumed 100 PCT, whereas the chronic 
dietary assessment utilized average PCT numbers for some crops. Both 
acute and chronic dietary assessments incorporated empirical or default 
processing factors. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to 
fluopyram 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 fluopyram.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute population adjusted dose (aPAD) and chronic population adjusted 
dose (cPAD). For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-, intermediate-, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary

[[Page 6641]]

exposure from food and water to fluopyram will occupy 25% of the aPAD 
for children 1 to 2 years old, the population group receiving the 
greatest exposure. The aggregate acute risk estimate includes only 
exposure to residues of fluopyram in food and drinking water, which is 
below the Agency's level of concern of 100% of the aPAD and is not of 
concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fluopyram from food and water will utilize 16% of the cPAD for all 
infants less than 1 year old, the population group receiving the 
greatest exposure. Chronic residential exposure to residues of 
fluopyram is not expected. Therefore, the chronic aggregate exposure is 
equivalent to the chronic dietary exposure, which is below the Agency's 
level of concern of 100% of the cPAD and is not of concern.
    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). Fluopyram is 
currently registered for uses that could result in short-term 
residential post-application exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with short-term residential exposures to fluopyram. 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 2,100 for children (1 to less 
than 2 years old). Because EPA's level of concern for fluopyram is an 
MOE of 100 or below, the short-term aggregate risk is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    The short-and intermediate-term PODs are the same and the 
intermediate-term exposures are smaller than the short-term exposures, 
thus, the short-term aggregate exposure assessment is protective of any 
intermediate-term exposures.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fluopyram is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these 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 fluopyram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology DFG Method S19 using GC/MSD (gas 
chromatography with mass-selective detection) is available to enforce 
the tolerance expression.
    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: 
[email protected].

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.
    There are no established Codex MRLs for Brassica, leafy greens, 
subgroup 4-16B; celtuce; coffee, green bean; fennel, Florence, fresh 
leaves and stalk; kohlrabi; leaf petiole vegetable subgroup 22B; mint; 
papaya; or edible podded peas. The U.S. tolerance for spice group 26 is 
harmonized with the Codex MRL of 70 ppm in/on dill seed, which is the 
representative crop for spice group 26. The U.S. tolerances for the 
succulent shelled bean subgroup 6-22C and succulent shelled pea 
subgroup 6-22D are harmonized with the Codex MRL of 0.2 ppm for the 
commodities in those subgroups.
    For the remaining commodities (leafy greens subgroup 4-16A; 
vegetable, Brassica, head and stem, group 5-16; edible podded bean 
subgroup 6-22A; and dried shelled bean, except soybean, subgroup 6-
22E), the established Codex MRLs are lower than the U.S. tolerances. 
Harmonization is not possible because decreasing the U.S. tolerances 
would put U.S. growers at risk of having violative residues despite 
legal use of fluopyram according to the label.

C. Revisions to Petitioned-For Tolerances

    Because the final Phase VI crop group rule has been published, EPA 
is establishing tolerances for new subgroups in legume vegetable crop 
group 6-22 rather than for each individual commodity in those subgroups 
as requested by the petitioner. The Phase VI crop group rule allows the 
commodities to be covered as part of the new group or subgroups instead 
of needing to be listed separately. The Phase VI crop group was 
published on September 21, 2022, and was effective on November 21, 2022 
(87 FR 57627) (FRL-5031-13-OCSPP).

V. Conclusion

    Therefore, tolerances are established for residues of fluopyram, N-
[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, in or on Brassica, leafy greens, subgroup 
4-16B at 50 ppm; celtuce at 20 ppm; fennel, Florence, fresh leaves and 
stalk at 20 ppm; kohlrabi at 4 ppm; leaf petiole vegetable subgroup 22B 
at 20 ppm; leafy greens subgroup 4-16A at 40 ppm; papaya at 1.5 ppm; 
peppermint, dried leaves at 0.8 ppm; peppermint, fresh leaves at 0.6 
ppm; spearmint, dried leaves at 0.8 ppm; spearmint, fresh leaves at 0.6 
ppm; spice group 26 at 70 ppm; vegetable, Brassica, head and stem, 
group 5-16 at 4 ppm; vegetable, legume, bean, edible podded, subgroup 
6-22A at 4 ppm; vegetable, legume, pea, edible podded, subgroup 6-22B 
at 4 ppm; vegetable, legume, bean, succulent shelled, subgroup 6-22C at 
0.2 ppm; vegetable, legume, pea, succulent shelled, subgroup 6-22D at 
0.2 ppm; and vegetable, legume, pulse, bean, dried shelled, except 
soybean, subgroup 6-22E at 0.7 ppm. The tolerance for coffee, green 
beans at 0.03 ppm is revised to remove the footnote. The following 
tolerances are removed: bean, dry at 0.70 ppm; Brassica, head and stem, 
subgroup 5A at 4.0 ppm; Brassica, leafy greens, subgroup 5B at 50 ppm; 
dill, seed at 70 ppm; leafy greens subgroup 4A at 40 ppm; leafy 
petioles subgroup 4B at 20 ppm; pea and bean, succulent shelled, 
subgroup 6B; and vegetable, legume, edible podded, subgroup 6A.

[[Page 6642]]

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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 tolerances 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: January 26, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated 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. In Sec.  180.661, table 1 to paragraph (a)(1) is amended by:
0
a. Removing the entries for ``Bean, dry'' and ``Brassica, head and 
stem, subgroup 5A'';
0
b. Adding in alphabetical order the entry ``Brassica, leafy greens, 
subgroup 4-16B'';
0
c. Removing the entry for ``Brassica, leafy greens, subgroup 5B'';
0
d. Adding in alphabetical order the entry ``Celtuce'';
0
e. Revising the entry for ``Coffee, green beans'' by removing the 
footnote;
0
f. Removing the entry for ``Dill, seed'';
0
g. Adding in alphabetical order the entries ``Fennel, Florence, fresh 
leaves and stalk'', ``Kohlrabi'', ``Leaf petiole vegetable subgroup 
22B'' and ``Leafy greens subgroup 4-16A'';
0
h. Removing the entries for ``Leafy greens subgroup 4A'' and ``Leafy 
petioles subgroup 4B'';
0
i. Adding in alphabetical order the entry ``Papaya'';
0
j. Removing the entry ``Pea and bean, succulent shelled, subgroup 6B'';
0
k. Adding in alphabetical order the entries ``Peppermint, dried 
leaves'', ``Peppermint, fresh leaves'', ``Spearmint, dried leaves'', 
``Spearmint, fresh leaves'', ``Spice group 26'', ``Vegetable, Brassica, 
head and stem, group 5-16'', ``Vegetable, legume, bean, edible podded, 
subgroup 6-22A'', and ``Vegetable, legume, bean, succulent shelled, 
subgroup 6-22C'';
0
l. Removing the entry ``Vegetable, legume, edible podded, subgroup 
6A'';
0
m. Adding in alphabetical order the entries ``Vegetable, legume, pea, 
edible podded, subgroup 6-22B'', ``Vegetable, legume, pea, succulent 
shelled, subgroup 6-22D''and ``Vegetable, legume, pulse, bean, dried 
shelled, except soybean, subgroup 6-22E''; and
0
n. Removing footnote 2.
    The additions and revisions read as follows:


Sec.  180.661  Fluopyram; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
 
                              * * * * * * *
Brassica, leafy greens, subgroup 4-16B...............                 50
 
                              * * * * * * *
Celtuce..............................................                 20
 

[[Page 6643]]

 
                              * * * * * * *
Coffee, green beans..................................               0.03
 
                              * * * * * * *
Fennel, Florence, fresh leaves and stalk.............                 20
 
                              * * * * * * *
Kohlrabi.............................................                  4
Leaf petiole vegetable subgroup 22B..................                 20
Leafy greens subgroup 4-16A..........................                 40
 
                              * * * * * * *
Papaya...............................................                1.5
 
                              * * * * * * *
Peppermint, dried leaves.............................                0.8
Peppermint, fresh leaves.............................                0.6
 
                              * * * * * * *
Spearmint, dried leaves..............................                0.8
Spearmint, fresh leaves..............................                0.6
Spice group 26.......................................                 70
 
                              * * * * * * *
Vegetable, Brassica, head and stem, group 5-16.......                  4
 
                              * * * * * * *
Vegetable, legume, bean, edible podded, subgroup 6-                    4
 22A.................................................
Vegetable, legume, bean, succulent shelled, subgroup                 0.2
 6-22C...............................................
Vegetable, legume, pea, edible podded, subgroup 6-22B                  4
Vegetable, legume, pea, succulent shelled, subgroup 6-               0.2
 22D.................................................
Vegetable, legume, pulse, bean, dried shelled, except                0.7
 soybean, subgroup 6-22E.............................
 
                              * * * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations.

* * * * *
[FR Doc. 2023-02109 Filed 1-31-23; 8:45 am]
BILLING CODE 6560-50-P