Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Rules and Regulations 42327 

Dated: July 7, 2022. 

Martha Guzman Aceves, 

Regional Administrator, Region IX. 

For the reasons stated in the 

preamble, EPA amends part 52, chapter 

I, Title 40 of the Code of Federal 

Regulations as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart D—Arizona 

§ 52.120 [Amended] 

■ 2. In § 52.120 in paragraph (c) amend 

‘‘Table 4 to Paragraph (c)—EPAApproved Maricopa County Air 

Pollution Control Regulations’’ by 

removing the entries for ‘‘Rule 27’’, 

‘‘Rule 32 (Paragraphs A through F 

only)’’, ‘‘Rule 81’’, and ‘‘Rule 340’’. 

[FR Doc. 2022–15026 Filed 7–14–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0185; FRL–9925–01– 

OCSPP] 

Benoxacor; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

tolerances for residues of benoxacor in 

or on field corn, popcorn, and sweet 

corn commodities when used as an inert 

ingredient (herbicide safener) in 

pesticide formulations. Management 

Contract Service, Inc., on behalf of 

Landis International, submitted a 

petition requesting this tolerance 

amendment under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

15, 2022. Objections and requests for 

hearings must be received on or before 

September 13, 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–2021–0185, 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 OPP Docket 

is (202) 566–1744. Please review the 

visitor instructions and additional 

information about the docket available 

at https://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, 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: RDFRNotices@epa.gov. 

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 40 CFR part 180 

through the Office of the Federal 

Register’s e-CFR site at https://

www.ecfr.gov/current/title-40. 

C. 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. 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–2021–0185 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 13, 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– 

2021–0185, 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 1, 2021 

(86 FR 29229), EPA issued a document 

pursuant to FFDCA section 408, 21 

U.S.C. 346a, announcing the receipt of 

a pesticide petition (PP IN–11407) filed 

by Management Contract Services, Inc. 

on behalf of Landis International, Inc., 

P.O. Box 5126, Valdosta, GA 31603. The 

petition requested that EPA amend the 

tolerance in 40 CFR 180.460 for residues 

of benoxacor (4-(dichloroacetyl)-3,4- 

dihydro-3-methyl-2H-1,4-benzoxazine) 

(CAS Reg. No. 98730–04–2) as an inert 

safener in or on the raw agricultural 

commodity for which tolerances have 

been established for metolachlor or Smetolachlor at 0.01 ppm for all pesticide 

formulations. The published petition 

summary requested to amend benoxacor 

tolerances when used as a pesticide 

inert ingredient (safener) in pesticide 

formulations to include any herbicide in 

or on raw agricultural commodities for 

which tolerances have been established 

at 0.01 parts per million (ppm). That 

document referenced a summary of the 

petition prepared by the petitioner, 


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which is in the docket, and solicited 

comments on the petitioner’s request. 

The Agency did not receive any 

significant public comments. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. 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 to benoxacor, 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with benoxacor 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. 

Benoxacor has low acute toxicity via 

the oral, dermal, and inhalation routes. 

It is not a skin irritant, but it is a 

moderate eye irritant and a skin 

sensitizer. In repeated-dose toxicity 

studies, the kidneys, liver, and stomach 

are the major target organs. There is no 

evidence of susceptibility in the 

available developmental and 

reproduction toxicity studies. No 

adverse maternal or developmental 

effects were found in the developmental 

toxicity study in rabbits and the 

offspring effects observed in the 

developmental and reproduction 

toxicity studies in rats occurred at the 

same doses at which maternal toxicity 

was observed. Negative results were 

observed in mutagenicity and 

genotoxicity studies with benoxacor. 

Although stomach tumors were 

observed in mice and rats, these results 

were considered equivocal and to be of 

little or no relevance to humans. 

Consequently, EPA described the 

carcinogenic potential of benoxacor as 

‘‘cannot be determined but suggestive’’, 

based on the 1996 Proposed Guidelines 

for Carcinogenic Risk Assessment, 

which can be found here https://

cfpub.epa.gov/ncea/risk/ 

recordisplay.cfm?deid=55868. Based on 

the cancer classification, the chronic 

reference dose is considered protective 

of the potential for cancer effects. 

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/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for benoxacor used for human 

risk assessment is shown in Table 1 of 

this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BENOXACOR FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute Dietary (General Population including infants and 

Children).

NOAEL = 100 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.0 mg/ 

kg/day.

aPAD = 1.0 mg/kg/ 

day 

Developmental (Rat): LOAEL = 400 mg/kg/day based on early 

resorptions. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BENOXACOR FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Chronic Dietary (All Populations).NOAEL= 0.4 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.004 

mg/kg/day.

cPAD = 0.004 mg/ 

kg/day 

Combined Chronic/Carcinogenicity (Rat): LOAEL = 2 mg/kg/ 

day based on increased incidence of centro-lobular hepatic 

enlargement with or without hepatocyte vacuolation in the 

males. 

Incidental Oral Short-Term (1– 

30 days) and IntermediateTerm (1–6 months).

NOAEL = 50 ppm 

(4.6 mg/kg/day).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE < 100 Reproduction toxicity study in rats MRID 42888703 LOAEL = 

500 ppm (64 mg/kg/day for the F1 generation and 72.3 mg/ 

kg/day for the F2 generation), based on decreased pup body 

weight on lactation day 21. 

Dermal Short-Term (1–30 days) 

and Intermediate-Term (1–6 

months).

No dermal endpoint selected because no systemic effects were observed in the dermal study up to the limit 

dose and there is no evidence of increased susceptibility in the young. 

Inhalation Short-Term (1–30 

days) and Intermediate-Term 

(1–6 months).

NOAEL = 50 ppm 

(4.6 mg/kg/day).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE < 100 Reproduction toxicity study in rats MRID 42888703 LOAEL = 

500 ppm (64 mg/kg/day for the F1 generation and 72.3 mg/ 

kg/day for the F2 generation), based on decreased pup body 

weight on lactation day 21 and decreased parental weight. 

Cancer (Oral, Dermal, Inhalation).The carcinogenic potential of 

benoxacor was described as ‘‘cannot 

be determined but 

suggestive’’. The 

use of the RfD approach is protective of any potential carcinogenicity.

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. NOAEL = no observed adverse effect 

level. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal 

to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to benoxacor, EPA considered 

exposure under the existing and 

petitioned-for tolerances. EPA assessed 

dietary exposures from benoxacor 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 benoxacor. 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 every 

commodity available in DEEM. 

EPA conducted an unrefined acute 

dietary (food only) exposure assessment 

for the proposed uses of benoxacor. 

Food residues for all commodities were 

assumed to be at the tolerance level for 

100% of crops treated; that is, a value 

of 0.01 ppm was assumed for all 

commodities upon which a tolerance 

has been established for metolachlor or 

S-metolachlor. 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). 

ii. Chronic exposure. In conducting 

the chronic dietary (food only) exposure 

assessment, EPA used DEEM–FCID 

Version 4.02 with 2005–10 food 

consumption data from the USDA’s 

NHANES/WWEIA. The current 

assessment includes every commodity 

available in DEEM. 

EPA conducted an unrefined chronic 

dietary (food only) exposure assessment 

for the proposed uses of benoxacor. 

Food residues for all commodities were 

assumed to be at the tolerance level for 

100% of crops treated; that is, a value 

of 0.01 ppm was assumed for all 

commodities upon which a tolerance 

has been established for metolachlor or 

S-metolachlor. 

iii. Cancer. Based on the data 

summarized in Unit IV.A., EPA has 

concluded that the chronic reference 

dose will be protective of the potential 

for cancer effects in humans. Therefore, 

a separate dietary exposure assessment 

for the purpose of assessing cancer risk 

was not performed. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for benoxacor. Tolerance level residues 

and/or 100% CT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. A drinking water concentration 

of 0.025 ppm (24.8 ppb) was used for 

both acute and chronic exposure 

scenarios based on modeling using the 

US EPA Pesticide Water Calculator 


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42330 Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Rules and Regulations 

(PWC) Version 1.52. Water modeling 

assumptions included 5% benoxacor in 

formulation and application rate of 0.5 

lb/acre of benoxacor. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

fleas and tick control on pets). The 

proposed use of benoxacor in corn crops 

is not anticipated to result in residential 

exposure. Residential exposure (postapplication only) to benoxacor may 

occur from existing pesticide uses in 

formulations with s-metolachlor (e.g., 

uses on warm-season turf grasses, and 

other non-crop land including golf 

courses, sports fields, parks, lawns, and 

ornamental gardens that would result in 

residential post-application exposures). 

There are no current or proposed 

residential handler uses for benoxacor; 

therefore, a residential handler 

assessment was not conducted. For 

residential post-application exposure 

scenarios (short- and intermediate-term 

child hand to mouth) and dietary 

exposure were used for the aggregate 

exposure assessments. 

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.’’ 

EPA has not found benoxacor to share 

a common mechanism of toxicity with 

any other substances, and benoxacor 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that benoxacor 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 

FQPA Safety factor (SF). in applying 

this provision, the 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 susceptibility in 

the available developmental and 

reproduction toxicity studies. No 

adverse maternal or developmental 

effects were found in the developmental 

toxicity study in rabbits and the 

offspring effects observed in the 

developmental and reproduction 

toxicity studies in rats occurred at the 

same doses at which maternal toxicity 

was observed. There are no residual 

uncertainties identified in the exposure 

databases. An unrefined dietary 

exposure assessment was completed, 

and tolerance level residues and 100% 

CT were assumed. EPA used similarly 

conservative assumptions to assess postapplication exposures of children. Thus, 

these assessments will not 

underestimate the exposure and risks 

posed by benoxacor. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children is adequately 

protected when reducing the FQPA SF 

from 10x to 1x. The FQPA safety factor 

has been reduced to 1x because: (1) the 

toxicity database is adequate to 

characterize potential pre- and postnatal 

risk for infants and children; (2) no 

reproductive effects were observed in 

rats; (3) although there were slight 

developmental/offspring effects in the 

reproductive and developmental studies 

in rats, these were seen in the presence 

of comparable parental toxicity, thus, 

there is no evidence of increase 

susceptibility in the young; (4) the 

endpoints selected are protective of any 

potential neurotoxic effects; (5) the 

PODs selected for risk assessment 

purposes are protective of the offspring 

effects seen in the database; and (6) the 

exposure assumptions are unlikely to 

underestimate risk. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption from food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to benoxacor will 

occupy 0.17% of the aPAD for the 

general U.S. population, and 0.50% of 

the aPAD for the highest exposed 

population subgroup, non-nursing 

infants. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to benoxacor from 

food and water will utilize 18.0% of the 

cPAD for the general U.S. population, 

and 75.5% of the cPAD for the highest 

exposed population subgroup, nonnursing infants. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

benoxacor 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). The short-term 

aggregate MOE is 550 for adults and 125 

for children. As the level of concern is 

for MOEs that are lower than 100, 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). The 

intermediate-term aggregate MOE is 550 

for adults and 127 for children. As the 

level of concern is for MOEs that are 

lower than 100, there are no concerns 

for intermediate-term aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. The RfD methodology is 

considered protective of any potential 

carcinogenicity. Because the aggregate 

chronic risk is not of concern, EPA 

concludes that there is not a cancer risk 

from aggregate exposure to benoxacor. 

6. Determination of safety. Based on 

its 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 benoxacor 

residues. 


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V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with nitrogen 

phosphorous detection (GC/NPD)) 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: 

residuemethods@epa.gov. 

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). 

Codex is a joint United Nations Food 

and Agriculture Organization/World 

Health Organization food standards 

program, and it is recognized as an 

international food safety standardssetting 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 a MRL 

for benoxacor. 

C. Revisions to Petitioned-For 

Tolerances 

After submitting its original petition 

seeking tolerances of 0.01 ppm on all 

commodities on which any herbicidal 

formulations may be used, the petitioner 

revised its request to tolerances for 

residues of benoxacor on only field 

corn, popcorn, and sweet corn 

commodities when benoxacor is used in 

any herbicidal formulation. The 

available residue data was limited to 

corn commodities, and because residues 

may differ between commodities, there 

was not sufficient data to support 

extending the benoxacor tolerances 

beyond corn commodities. 

VI. Conclusion 

Taking into consideration all available 

information on benoxacor, EPA has 

determined that there is a reasonable 

certainty that no harm to the general 

population or any population subgroup, 

including infants and children, will 

result from aggregate exposure to 

benoxacor residues. Therefore, 

tolerances are established for residues of 

benoxacor, including its metabolites and 

degradates, in or on corn, field, forage; 

corn, field, grain; corn, field, stover; 

corn, pop, grain; corn, pop, stover; corn, 

sweet, forage; corn, sweet, kernel plus 

cob with husks removed; and corn, 

sweet, stover at 0.01 ppm. Compliance 

with the tolerances is to be determined 

by measuring only benoxacor (4- 

(dichloroacetyl)-3,4-dihydro-3-methyl2H-1,4-benzoxazine). 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 final rule 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 section 408(d) of FFDCA, 

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 

final rule 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 section 

408(n)(4) of FFDCA. 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 final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 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 of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VIII. 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 8, 2022. 

Marietta Echeverria 

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 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.460, paragraph (a) is 

revised to read as follows: 

§ 180.460 Benoxacor; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the inert 

ingredient (safener) benoxacor (4- 

(dichloroacetyl)-3,4-dihydro-3-methyl2H–1, 4-benzoxazine) at 0.01 parts per 

million (ppm) when used in pesticide 

formulations containing metolachlor or 

S-metolachlor in or on raw agricultural 

commodities for which tolerances have 


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42332 Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Rules and Regulations 

been established for metolachlor or 

S-metolachlor. 

(2) Tolerances are established for 

residues of benoxacor, including its 

metabolites and degradates, in or on the 

commodities in the following table, 

when used as an inert ingredient 

(herbicide safener) in pesticide 

formulations. Compliance with the 

tolerance levels specified in the 

following table is to be determined by 

measuring only benoxacor (4- 

(dichloroacetyl)-3,4-dihydro-3-methyl2H-1,4-benzoxazine). 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

Corn, field forage .................................. 0.01 

Corn, field, grain .................................... 0.01 

Corn, field, stover .................................. 0.01 

Corn, pop, grain .................................... 0.01 

Corn, pop, stover .................................. 0.01 

Corn, sweet, forage ............................... 0.01 

Corn, sweet, kernel plus cob with 

husks removed .................................. 0.01 

Corn, sweet, stover ............................... 0.01 

* * * * * 

[FR Doc. 2022–15018 Filed 7–14–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0388; FRL–9952–01– 

OCSPP] 

Tribenuron Methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tribenuron 

methyl in or on multiple commodities 

that are identified and discussed later in 

this document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food Drug 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

15, 2022. Objections and request for 

hearings must be received on or before 

September 13, 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–2021–0388, is 

available online at https://

www.regulations.gov or in-person at the 

Office of Pesticide Programs Regulatory 

Public Docket (OPP Docket) in the 

Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room and OPP Docket 

is (202) 566–1744. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, 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: RDFRNotices@epa.gov. 

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 eCFR 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–2021–0388 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 13, 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– 

2021–0388, 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 October 21, 

2021 (86 FR 58239) (FRL–8792–04), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petition (PP 1E8898) by 

Interregional Research Project No. 4 (IR– 

4), North Carolina State University, 

1730 Varsity Drive, Venture IV, Suite 

210, Raleigh, NC 27606. The petition 

requested EPA to establish tolerances in 

40 CRF part 180 for residues of 

tribenuron methyl (methyl-2-[[[[N-(4- 

methoxy-6-methyl-1,3,5-triazin-2-yl) 

methylamino] carbonyl] amino] 

sulfonyl] benzoate) and its metabolites 

and degradates in or on 242 separate 

commodities and to revise the tolerance 

for residues of tribenuron methyl in or 

on oat, hay. Due to the length of the list 

of commodities, please refer to the 

Notice of Filing referenced above for a 

complete list of commodities with 

tolerances to be established. The 

petition requested to remove the 

established tolerances for residues of 

tribenuron methyl and its metabolites 


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