[Federal Register Volume 87, Number 138 (Wednesday, July 20, 2022)]
[Rules and Regulations]
[Pages 43214-43219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15410]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0356; FRL-9839-01-OCSPP]


Spiropidion; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
insecticide spiropidion and its metabolites and degradates in or on 
multiple commodities which are identified and discussed later in this 
document. Syngenta Crop Protection, LLC requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 20, 2022. Objections and 
requests for hearings must be received on or before September 19, 2022 
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-2021-0356, is available at 
https://www.regulations.gov or 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. Please review the 
visitor instructions and additional information about the EPA Docket 
Center and Reading Room that are available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, 
Registration Division (7505T), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Avenue NW, 
Washington, DC 20460; 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-2021-0356 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
September 19, 2022. 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-

[[Page 43215]]

2021-0356, 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/contacts.html. 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 June 28, 2021 (86 FR 33924) (FRL-10025-
08), 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 
0E8880) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR part 180 be amended 
by establishing tolerances for residues of the insecticide spiropidion, 
[3-(4-chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-2-oxo-1,8-
diazaspiro[4.5]dec-3-en-4-yl ethyl carbonate] and its metabolite 
SYN547305 [3-(4-chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-1,8-
diazaspiro[4.5]decane-2,4-dione; and 2-(4-chloro-2,6-dimethyl-phenyl)-
1-hydroxy-8-methoxy-4-methyl-4,8-diazaspiro[4.5]dec-1-en-3-one], in or 
on the following raw agricultural/processed and livestock commodities: 
cucurbit vegetables (crop group 9) at 0.8 parts per million (ppm); 
fruiting vegetables (crop group 8) at 1.5 ppm; soybeans at 3 ppm; 
potato (crop subgroup 1C) at 1.5 ppm; poultry meat at 0.01 ppm; meat 
byproducts of poultry at 0.01 ppm; fat of poultry at 0.01 ppm; eggs at 
0.01 ppm; milk and milk byproducts at 0.01 ppm; meat byproducts of 
cattle, goat, hogs, horses and sheep at 0.3 ppm; fat of cattle, goat, 
hogs, horses and sheep at 0.04 ppm; wet tomato peel at 3 ppm; dried 
tomato pomace at 40 ppm; tomato paste at 3 ppm; tomato puree at 2 ppm; 
dried tomatoes at 15 ppm; soy meal at 5 ppm; soy flour at 5 ppm; 
pollard at 4 ppm; soy aspirated grain fractions at 6 ppm; raw peeled 
potatoes at 3 ppm; baked potatoes with skin at 3 ppm; potato chips/
fries at 2 ppm; potato granules/flakes at 5 ppm; potato process waste 
at 3 ppm; dried potato pulp at 3 ppm; and potato protein at 5 ppm. That 
document referenced a summary of the petition prepared by Syngenta Crop 
Protection, LLC, the registrant, which is available in the docket, 
https://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based on review of the data supporting the petition and EPA policy, 
EPA has revised some of the commodity definitions and tolerance levels 
from the petition. The reason for these changes are explained in Unit 
IV.C.

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 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 spiropidion including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with spiropidion 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 spiropidion is complete and 
indicates that decreased body weight and mortality were the most common 
adverse effects observed. The dog was the most sensitive species with 
effects including severe clinical signs (salivation, unsteadiness on 
feet, ataxia, being subdued, twitching, abnormal breathing, 
hypersensitivity, and tremors) leading to humane euthanasia after 
acute, subchronic and chronic exposure at doses >=30 mg/kg/day. No 
additional treatment related effects in dogs were observed at doses 
that did not cause severe clinical signs. These effects occurred at 
doses ~4x lower and ~7x lower than the doses at which effects were 
observed in rats and mice, respectively. In rats, decreased body weight 
was observed at the highest dose tested following a 28-day exposure. 
Additionally, in rats, minimal to mild thyroid follicular cell 
hypertrophy was consistently observed across subchronic durations. In 
mice, premature death was observed in both sexes at the highest dose 
tested (448.6/465.4 mg/kg/day male/female) following subchronic 
exposure. At lower dose levels in mice, increased urea and blood urea 
nitrogen concentrations, increased alkaline phosphatase levels 
(females), decreased albumin levels and albumin/globulin ratio 
(females), and increased liver weights (males) were observed. However, 
these findings were not considered adverse, as there were no 
corroborating macroscopic or microscopic pathology findings noted in 
mice. Following chronic exposure in the rat and mouse, no adverse 
effects were observed up to the highest dose tested. Decreased body 
weight in males and severe convulsions in females were observed at a 
relatively high dose (500 mg/kg) in the acute neurotoxicity study in 
rats. No adverse effects were observed in rats following exposures via 
the dermal route up to the limit dose.
    There was no evidence of increased pre- or post-natal sensitivity 
or susceptibility observed in the database. No adverse parental, 
offspring, or reproductive effects were observed in the two-generation 
reproductive toxicity study up to the highest dose tested. No adverse 
parental or developmental effects were observed in the rat and rabbit 
developmental toxicity studies up to the highest dose tested.
    Spiropidion is classified as ``Not Likely to Be Carcinogenic to 
Humans'' based on a lack of treatment related neoplastic lesions in two 
species and no mutagenic concerns.
    Specific information on the studies received and the nature of the 
adverse effects caused by spiropidion as well as the no observed 
adverse effect level

[[Page 43216]]

(NOAEL) and the lowest observed adverse effect level (LOAEL) from the 
toxicity studies can be found at https://www.regulations.gov in the 
document entitled ``Spiropidion: First Food Use; Human Health Risk 
Assessment for the Establishment of Permanent Tolerances without U.S. 
Registration for Residues in or on Soybean, Tomato, Bell and Nonbell 
Peppers, Muskmelon, Watermelon, Cucumber, Pumpkin, and Potato'' in 
docket ID number EPA-HQ-OPP-2021-0356.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies points of departure (PODs) and levels of concern (LOCs) to 
use in evaluating the risk posed by human exposure to the pesticide. 
For hazards that have a threshold below which there is no appreciable 
risk, the toxicological POD is used as the basis for derivation of 
reference values for risk assessment. PODs are developed based on a 
careful analysis of the doses in each toxicological study to determine 
the dose at which no adverse effects are observed (the NOAEL) and the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL). Uncertainty/safety factors are used in conjunction with the POD 
to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/risk.
    A summary of the toxicological endpoints for spiropidion used for 
human risk assessment can be found in the Spiropidion Human Health Risk 
Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spiropidion, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from spiropidion 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. Such effects were identified 
for spiropidion. Acute dietary (food only) exposure and risk 
assessments were conducted using the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database (DEEM-FCID) Version 
4.02. This software uses 2005-2010 food consumption data from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). The current 
assessment includes bell and nonbell pepper, cucumber, muskmelon, 
potato, pumpkin, soybean, tomato, watermelon, and fat and meat 
byproducts of cattle, goats, horses, and sheep.
    EPA conducted an unrefined acute dietary (food only) exposure 
assessment for the proposed uses of spiropidion. EPA's default 
processing factors for potato dry commodities, dried tomato, tomato 
paste, tomato puree, and soybean flour were set to 1 as processing data 
for these commodities are available and no appreciable concentration of 
residues that would require an additional tolerance was identified. In 
addition, EPA's default processing factors were also used for dried 
bell and dried nonbell pepper. It was assumed that 100% of the crops 
were treated. As the request is for tolerances without U.S. 
registration, residues in drinking water are not expected.
    Results of the acute dietary assessment indicate that the general 
U.S. population and all other population subgroups have exposure and 
risk estimates below EPA's level of concern (LOC). The acute dietary 
exposure estimate is 3.2% of the aPAD for the general U.S. population, 
and 7.3% of the aPAD for the highest exposed population subgroup, 
children 1-2 years old.
    ii. Chronic exposure. In conducting the chronic dietary (food only) 
exposure assessment, EPA used DEEM-FCID Version 4.02 with 2005-2010 
food consumption data from the USDA's NHANES/WWEIA. EPA's default 
processing factors for potato dry commodities, dried tomato, tomato 
paste, tomato puree, and soybean flour were set to 1 as processing data 
for these commodities are available and no concentration of residues 
that would require an additional tolerance was required. In addition, 
EPA's default processing factors were also used for dried bell and 
dried nonbell pepper. It was assumed that 100% of the crops were 
treated. As the request is for tolerances without U.S. registration, 
residues in drinking water are not expected.
    EPA conducted an unrefined chronic dietary (food only) exposure 
assessment for the proposed uses of spiropidion. Results of the chronic 
dietary assessment indicate that the general U.S. population and all 
other population subgroups have exposure and risk estimates below EPA's 
LOC. The chronic dietary exposure estimate is 2.3% of the cPAD for the 
general U.S. population, and 6.7% of the cPAD for the highest exposed 
population subgroup, children 1-2 years old.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the data summarized in Unit 
III.A., EPA has concluded that spiropidion does not pose a cancer risk 
to humans. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk was unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for spiropidion. Tolerance level residues and/or 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. Spiropidion is not 
registered for use in the United States; therefore, EPA assumes that 
there is no exposure through groundwater or surface water sources of 
drinking water. Because residues are not expected in drinking water, 
dietary risk estimates include exposures from food only.
    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 fleas and tick control on pets). Spiropidion is not 
registered for any specific use patterns that would result in 
residential exposure.
    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

[[Page 43217]]

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.''
    EPA has not found spiropidion to share a common mechanism of 
toxicity with any other substances, and spiropidion does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, EPA has assumed that spiropidion 
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 https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional ten-fold (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 accordance with Section 
408(b)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA 
either retains the default value of 10x margin of safety 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. The toxicology database is 
complete and is adequate for the purpose of assessing prenatal and 
postnatal susceptibility based on the following considerations: (1) the 
toxicity database is complete and includes adequate studies to assess 
potential susceptibility in the young; (2) no effects were identified 
in the prenatal developmental studies or in the two-generation 
reproduction toxicity study up to the highest dose tested; and (3) the 
endpoints chosen for risk assessment are protective of any potential 
susceptibility that may occur at higher doses.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF of 10x were reduced to 1x. That decision is based on the 
following findings:
    i. The toxicology database is considered complete and is adequate 
for the purpose of assessing prenatal and postnatal susceptibility. 
Acceptable guideline studies for developmental, reproductive toxicity, 
and neurotoxicity are available for FQPA SF assessment.
    ii. There is evidence of potential neurotoxicity in the acute 
neurotoxicity study (ACN) (severe convulsions in females) and in the 
subchronic and chronic dog studies (clinical signs indicative of 
potential neurotoxicity); however, concern is low because (1) the 
effects observed in the ACN were observed at a relatively high dose 
(500 mg/kg); (2) clear NOAELs were identified for the neurotoxic 
effects; and (3) the points of departure chosen for risk assessment are 
protective of any potential neurotoxicity observed in the database.
    iii. There was no evidence of increased quantitative or qualitative 
pre-natal susceptibility in the rabbit or rat developmental toxicity 
studies or postnatal susceptibility in the two-generation reproduction 
toxicity study up to the highest doses tested. Even though these 
studies did not test up to the limit dose, there is little concern 
about the potential for toxicity and/or susceptibility at higher doses 
than those tested since (1) the current POD (15 mg/kg/day) is 
protective of any potential developmental and/or reproductive effects 
that may occur above the highest tested doses used in these studies 
(>30.6/24.1 mg/kg/day [M/F]) and (2) the dog is the more sensitive 
species and additional developmental and reproductive studies in the 
rat and rabbit are not expected to have a lower POD than currently 
used.
    iv. There are no residual uncertainties identified in the exposure 
databases. An unrefined dietary exposure assessment was completed, and 
tolerance level residues and 100 PCT were assumed; therefore, dietary 
exposures will not underestimate the exposure and risks posed by 
spiropidion.

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 
aPAD and 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. Imported commodities will be the only source of 
exposure for spiropidion in the U.S.; therefore, the aggregate 
assessment was limited to food exposure (acute and chronic). As a 
result, the aggregate assessments are equivalent to the dietary 
assessments and are not of concern. Based on the explanation in Unit 
III.C.3., acute residential exposure to residues of spiropidion is not 
expected.
    2. Chronic risk. Imported commodities will be the only source of 
exposure for spiropidion in the U.S.; therefore, the aggregate 
assessment was limited to food exposure (acute and chronic). As a 
result, the aggregate assessments are equivalent to the dietary 
assessments and are not of concern. Based on the explanation in Unit 
III.C.3., chronic residential exposure to residues of spiropidion is 
not expected.
    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). Because no 
short-term exposure scenario has been identified for spiropidion, no 
short-term aggregate exposure is expected.
    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 no intermediate-term exposure scenario has been 
identified for spiropidion, no intermediate-term aggregate exposure is 
expected.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, spiropidion 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 U.S. population, or to infants and children from 
aggregate exposure to spiropidion residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Syngenta has submitted an acceptable method description and method 
validation data and an independent laboratory validation (ILV) for a 
``Quick, Easy, Cheap, Effective, Rugged, and Safe'' method (QuEChERS) 
liquid chromatography done with tandem mass spectroscopy (LC/MS/MS), 
Method No. BPL19-0035, for the determination of residues of spiropidion

[[Page 43218]]

and metabolite SYN547305 in crop commodities for purposes of regulatory 
enforcement. In addition, Syngenta has submitted an acceptable method 
description and method validation data and an ILV for LC/MS/MS Method 
No. PG26LL for the determination of residues of metabolites SYN547305 
(free and conjugated) in livestock commodities for purposes of 
regulatory enforcement.
    These methods may be requested from: Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Road, Suite 5350, 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.
    The Joint Meeting on Pesticide Residues (JMPR) proposed Codex MRLs 
for residues of spiropidion in or on soybean; melon, watermelon, 
cucumber, tomato, potato, pumpkin, bell and nonbell pepper; meat 
byproduct of cattle, goat, hogs, horses, and sheep; fat of cattle, 
goat, hogs, horses, and sheep. The JMPR recommendations will be 
considered by the Codex Committee on Pesticide Residues (CCPR) and 
potentially adopted by the Codex Alimentarius Commission this year. The 
tolerance level for residues in pumpkin and tomato have been harmonized 
to the proposed Codex MRLs. The tolerance level for residues in bell 
and nonbell pepper have not been harmonized with the proposed Codex 
MRLs because the MRL is lower than the tolerance for pepper and 
harmonizing could result in a situation where compliance with label 
directions results in residues in excess of the tolerance.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing tolerances for most of the commodities 
requested by the petitioner; however, a number of the tolerances being 
established as part of this action differ from what was initially 
requested in the tolerance petition. All of the revisions and/or 
changes to the petitioned-for tolerances and the reasoning behind those 
changes were presented to the petitioner and subsequently accepted. The 
reasoning for those revisions are explained in full detail below.
    EPA revised the commodity definitions for the requested tolerances 
for soybeans; cucurbit vegetables (crop group 9); fruiting vegetables 
(crop group 8); potato (crop subgroup 1C); fat of cattle, goat, horse 
and sheep; and meat byproduct of cattle, goat, horse and sheep to be 
consistent with EPA's commodity vocabulary. Several of the requested 
tolerances are being established at levels that differ from what was 
requested based on available residue data and the use of the 
Organization for Economic Co-operation and Development (OECD) MRL 
calculator and/or for harmonization purposes. EPA has also determined 
that tolerances for residues in the processed commodities of potato and 
tomato are not required because the tolerances for the raw commodities 
are sufficient to cover the processed commodities. In addition, based 
upon estimated dietary burden and the results of the metabolism study, 
hog and poultry tolerances are not needed. Further, a tolerance for 
milk is not being established based upon results in the ruminant 
feeding study in that milk does not contain residues of spiropidion.
    EPA has determined that tolerances for residues in the processed 
commodities of soybean and pollard are not required. Soybean and 
pollard are considered to be minor livestock feed items, and EPA does 
not set tolerances for, nor does it require residue data on minor 
livestock feed items. The tolerance for soybean, seed is sufficient to 
cover these processed commodities; therefore, a tolerance for soybean 
and pollard are not needed. Based upon a soybean processing study, EPA 
has also determined that a tolerance for soybean aspirated grain 
fractions is not required because it is covered by the tolerance set on 
soybean, seed.
    Although the petitioner originally requested tolerances for crop 
group 8, crop group 9 and crop subgroup 1C, EPA is establishing 
tolerances only for the representative commodities for which residue 
data were submitted.

V. Conclusion

    Therefore, tolerances are established for residues of the 
insecticide spiropidion and its metabolites and degradates in or on 
cucumber at 0.8 ppm; muskmelon at 0.9 ppm; pepper, bell at 1.5 ppm; 
pepper, nonbell at 1.5 ppm; potato at 1.5 ppm; pumpkin at 0.9 ppm; 
soybean, seed at 3 ppm; tomato at 0.8 ppm; watermelon at 0.9 ppm; 
cattle, fat at 0.03 ppm; cattle, meat byproducts at 0.3 ppm; goat, fat 
at 0.03 ppm; goat, meat byproducts at 0.3 ppm; horse, fat at 0.03ppm; 
horse, meat byproducts at 0.3 ppm; sheep, fat at 0.03 ppm; sheep, meat 
byproducts at 0.3 ppm. Compliance with tolerances for the plant 
commodities will be determined by measuring only the sum of spiropidion 
[3-(4-chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-2-oxo-1,8-
diazaspiro[4.5]dec-3-en-4-yl ethyl carbonate] and its metabolite 
SYN547305 [3-(4-chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-1,8-
diazaspiro[4.5]decane-2,4-dione; and 2-(4-chloro-2,6-dimethyl-phenyl)-
1-hydroxy-8-methoxy-4-methyl-4,8-diazaspiro[4.5]dec-1-en-3-one], 
calculated as the stoichiometric equivalent of spiropidion, in or on 
the plant commodities. Compliance with the tolerances for the livestock 
commodities will be determined by measuring only SYN547305 [3-(4-
chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-1,8-
diazaspiro[4.5]decane-2,4-dione; and 2-(4-chloro-2,6-dimethyl-phenyl)-
1-hydroxy-8-methoxy-4-methyl-4,8-diazaspiro[4.5]dec-1-en-3-one], 
calculated as the stoichiometric equivalent of spiropidion, in or on 
the livestock commodities.

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

[[Page 43219]]

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: July 13, 2022.
Edward Messina,
Director, 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. Add Sec.  180.723 to subpart C to read as follows:


Sec.  180.723  Spiropidion; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide spiropidion, 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 to this paragraph (a)(1) 
is to be determined by measuring only the sum of spiropidion [3-(4-
chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-2-oxo-1,8-
diazaspiro[4.5]dec-3-en-4-yl ethyl carbonate] and its metabolite 
SYN547305 [3-(4-chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-1,8-
diazaspiro[4.5]decane-2,4-dione; and 2-(4-chloro-2,6-dimethyl-phenyl)-
1-hydroxy-8-methoxy-4-methyl-4,8-diazaspiro[4.5]dec-1-en-3-one], 
calculated as the stoichiometric equivalent of spiropidion, in or on 
the following plant commodities:

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cucumber \1\................................................         0.8
Muskmelon \1\...............................................         0.9
Pepper, bell \1\............................................         1.5
Pepper, nonbell \1\.........................................         1.5
Potato \1\..................................................         1.5
Pumpkin \1\.................................................         0.9
Soybean, seed \1\...........................................           3
Tomato \1\..................................................         0.8
Watermelon \1\..............................................         0.9
------------------------------------------------------------------------
\1\ There are no U.S. registrations for this commodity as of July 20,
  2022.

    (2) Tolerances are established for residues of the insecticide 
spiropidion, 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 to this paragraph (a)(2) is to be 
determined by measuring only SYN547305 [3-(4-chloro-2,6-dimethyl-
phenyl)-8-methoxy-1-methyl-1,8-diazaspiro[4.5]decane-2,4-dione; and 2-
(4-chloro-2,6-dimethyl-phenyl)-1-hydroxy-8-methoxy-4-methyl-4,8-
diazaspiro[4.5]dec-1-en-3-one], calculated as the stoichiometric 
equivalent of spiropidion, in or on the following livestock 
commodities:

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat \1\.............................................        0.03
Cattle, meat byproducts \1\.................................         0.3
Goat, fat \1\...............................................        0.03
Goat, meat byproducts \1\...................................         0.3
Horse, fat \1\..............................................        0.03
Horse, meat byproducts \1\..................................         0.3
Sheep, fat \1\..............................................        0.03
Sheep, meat byproducts \1\..................................         0.3
------------------------------------------------------------------------
\1\ There are no U.S. registrations for this commodity as of July 20,
  2022.

    (b)-(d) [Reserved]

[FR Doc. 2022-15410 Filed 7-19-22; 8:45 am]
BILLING CODE 6560-50-P


