Rule2022-15018
Benoxacor; Pesticide Tolerances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 15, 2022
Effective
July 15, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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).
Full Text
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<title>Federal Register, Volume 87 Issue 135 (Friday, July 15, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#37657371657958435e5452447752475619505841"><span class="__cf_email__" data-cfemail="b8eafcfeeaf6d7ccd1dbddcbf8ddc8d996dfd7ce">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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.
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/contacts.html">https://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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 <a href="https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=55868">https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=55868</a>. 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides</a>.
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........
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[[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.
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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 <a href="https://www.epa.gov/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
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:
<a href="/cdn-cgi/l/email-protection#5b293e28323f2e3e363e2f33343f281b3e2b3a753c342d"><span class="__cf_email__" data-cfemail="aedccbddc7cadbcbc3cbdac6c1caddeecbdecf80c9c1d8">[email protected]</span></a>.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). 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
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