[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Rules and Regulations]
[Pages 42327-42332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15018]


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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.

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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: 
[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 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 S-
metolachlor 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,

[[Page 42328]]

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-and-assessing-pesticide-risks/assessing-human-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
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General Population  NOAEL = 100 mg/kg/    Acute RfD = 1.0 mg/  Developmental (Rat): LOAEL = 400
 including infants and Children).   day.                  kg/day.              mg/kg/day based on early
                                   UFA = 10x...........  aPAD = 1.0 mg/kg/     resorptions.
                                   UFH = 10x...........   day.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------

[[Page 42329]]

 
Chronic Dietary (All Populations)  NOAEL= 0.4 mg/kg/day  Chronic RfD = 0.004  Combined Chronic/Carcinogenicity
                                   UFA = 10x...........   mg/kg/day.           (Rat): LOAEL = 2 mg/kg/day based
                                   UFH = 10x...........  cPAD = 0.004 mg/kg/   on increased incidence of centro-
                                   FQPA SF = 1x........   day.                 lobular hepatic enlargement with
                                                                               or without hepatocyte vacuolation
                                                                               in the males.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-Term (1-30   NOAEL = 50 ppm (4.6   LOC for MOE < 100..  Reproduction toxicity study in
 days) and Intermediate-Term (1-6   mg/kg/day).                                rats MRID 42888703 LOAEL = 500
 months).                          UFA = 10x...........                        ppm (64 mg/kg/day for the F1
                                   UFH = 10x...........                        generation and 72.3 mg/kg/day for
                                   FQPA SF = 1x........                        the F2 generation), based on
                                                                               decreased pup body weight on
                                                                               lactation day 21.
----------------------------------------------------------------------------------------------------------------
Dermal Short-Term (1-30 days) and  No dermal endpoint selected because no systemic effects were observed in the
 Intermediate-Term (1-6 months).    dermal study up to the limit dose and there is no evidence of increased
                                    susceptibility in the young.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-Term (1-30 days)  NOAEL = 50 ppm (4.6   LOC for MOE < 100..  Reproduction toxicity study in
 and Intermediate-Term (1-6         mg/kg/day).                                rats MRID 42888703 LOAEL = 500
 months).                          UFA = 10x...........                        ppm (64 mg/kg/day for the F1
                                   UFH = 10x...........                        generation and 72.3 mg/kg/day for
                                   FQPA SF = 1x........                        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

[[Page 42330]]

(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 non-occupational, 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 (post-application 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 post-application 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, non-nursing 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.

[[Page 42331]]

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: 
[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). 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 standards-setting 
organization in trade agreements to which the United States is a party. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, FFDCA section 408(b)(4) requires that EPA explain the reasons 
for departing from the Codex level.
    The Codex has not established 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-methyl-2H-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

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.  180.460, paragraph (a) is revised to read as follows:


Sec.  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-
methyl-2H-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

[[Page 42332]]

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-methyl-2H-1,4-benzoxazine).

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             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


