Document ID: EPA-HQ-OPP-2022-0493-0008
Agency: epa
Document Type: Rule
Title: Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Mefenoxam
Posted Date: 2023-06-15T04:00Z

[Federal Register Volume 88, Number 115 (Thursday, June 15, 2023)]
[Rules and Regulations]
[Pages 39185-39189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12544]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0493; FRL-10992-01-OCSPP]

Mefenoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective June 15, 2023. Objections and 
requests for hearings must be received on or before August 14, 2023, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2022-0493, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room and the OPP Docket is (202) 566-1744. Please review the 
visitor instructions and additional information about the docket 
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Federal Register 
Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2022-0493 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 
August 14, 2023. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2022-0493, by one of 
the following methods:
     Federal eRulemaking Portal: http://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.

[[Page 39186]]

     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 30, 2022 (87 FR 52868) (FRL-9410-
04), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petitions (PP 
1F8970 and 1F8971) by Syngenta Crop Protection, LLC., P.O. Box 18300, 
Greensboro, NC 27419. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the fungicide, 
mefenoxam, (methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-D-
alaninate), in or on leafy greens subgroup 4-16A (except spinach) at 5 
parts per million (ppm); Brassica leafy greens subgroup 4-16B at 5 ppm; 
Brassica head and stem vegetable crop group 5-16 at 2 ppm; stalk and 
stem vegetable subgroup 22A (except celtuce, florence fennel and 
kohlrabi) at 7 ppm; celtuce at 5 ppm; florence fennel at 5 ppm; 
kohlrabi at 2 ppm; leaf petiole vegetable subgroup 22B at 5 ppm; 
fruiting vegetables subgroup 8-10 at 1 ppm; succulent shelled pea and 
bean crop subgroup 6B at 0.2 ppm; cottonseed crop subgroup 20C at 0.1 
ppm; and sugarcane at 0.1 ppm (PP 1F8971). That document referenced a 
summary of the petition prepared by Syngenta Crop Protection, LLC., the 
registrant, which is available in the docket, http://www.regulations.gov. Two comments were received on the notice of 
filing. EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA 
is establishing the tolerances at different levels than requested. The 
reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified therein, EPA has reviewed the available scientific data and 
other relevant information in support of this action. EPA has 
sufficient data to assess the hazards of and to make a determination on 
aggregate exposure for mefenoxam including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with mefenoxam follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections of the rule that repeat what 
has been previously published in tolerance rulemakings for the same 
pesticide chemical. Where scientific information concerning a 
particular chemical remains unchanged, the content of those sections 
would not vary between tolerance rulemakings, and EPA considers 
referral back to those sections as sufficient to provide an explanation 
of the information EPA considered in making its safety determination 
for the new rulemaking.
    EPA has previously published a number of tolerance rulemakings for 
mefenoxam in which EPA concluded, based on the available information, 
that there is a reasonable certainty that no harm would result from 
aggregate exposure to mefenoxam and established tolerances for residues 
of that chemical. EPA is incorporating previously published sections 
from those rulemakings as described further in this rule, as they 
remain unchanged.

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.
    Mefenoxam (metalaxyl-m) is a systemic phenylamide fungicide which 
inhibits protein synthesis in fungi. Mefenoxam is an R-isomer enriched 
formulation. Metalaxyl is the racemic R/S isomer formulation. The 
Agency compared the available chemistry and toxicity data for mefenoxam 
and metalaxyl and concluded that metalaxyl data may be used in support 
of mefenoxam regulatory actions because the two chemicals have similar 
toxicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by mefenoxam as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies are discussed in Unit III.A. of the 
final rule published in the Federal Register of December 21, 2018 (83 
FR 65541) (FRL-9985-52).

B. Toxicological Points of Departure/Levels of Concern

    A summary of the toxicological endpoints for mefenoxam used for 
human health risk assessment is discussed in Unit III.B. of the final 
rule published in the Federal Register of December 21, 2018 (83 FR 
65541) (FRL-9985-52).

C. Exposure Assessment

    Much of the exposure assessment remains the same although updates 
have occurred to accommodate exposures from petitioned-for tolerances. 
These updates are discussed in this section; for a description of the 
rest of the EPA approach to and assumptions for the exposure 
assessment, please reference Unit III.C of the December 2018 
rulemaking.
    1. Dietary exposure from food and feed uses. EPA's dietary exposure 
assessments have been updated to include the additional exposure from 
the petitioned-for tolerances of mefenoxam on the crops requested in 
this action. In evaluating dietary exposure to mefenoxam, EPA 
considered exposure under the petitioned-for tolerances as well as all 
existing mefenoxam and metalaxyl tolerances in 40 CFR 180.546 and 40 
CFR 180.408, respectively.
    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. The acute dietary assessment 
is based on tolerance levels adjusted to account for all of the 
residues of concern and assumes 100 percent crop

[[Page 39187]]

treated (PCT). The assessment was conducted using the Dietary Exposure 
Evaluation Model software with the Food Commodity Intake Database 
(DEEM-FCID) Version 4.02. EPA with 2005-2010 food consumption 
information from the United States Department of Agriculture's (USDA's) 
National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA). Empirical processing factors were included 
where available. Otherwise, DEEM-FCID default processing factors were 
used.
    ii. Chronic exposure. There is no increase in toxicity from the 
acute duration studies. Toxicity did not increase with an increase in 
exposure duration. Therefore, a chronic dietary POD was not selected. 
The acute endpoint and dietary exposure assessment are protective of 
potential effects from chronic duration dietary exposures.
    iii. Cancer. EPA has concluded that mefenoxam does not pose a 
cancer risk to humans based on no evidence of carcinogenicity observed 
in the relevant studies. Therefore, a dietary exposure assessment for 
the purpose of assessing cancer risk is unnecessary.
    2. Dietary exposure from drinking water. Exposure modeling for 
mefenoxam is not necessary because exposure estimates for metalaxyl are 
expected to exceed those for mefenoxam and are therefore protective. 
Maximum annual application rates for metalaxyl, up to 12.3 lb ai/A, 
were modeled. These rates are approximately twice those of mefenoxam. 
The maximum estimated drinking water concentrations (EDWCs) based on 
metalaxyl are 350 [mu]g/L for acute exposure (which is based on surface 
water sources) and 135 [micro]g/L for chronic exposure (which is based 
on groundwater sources).
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). There are no uses for 
mefenoxam being proposed as part of this action or that have been added 
since the most recent risk assessment that would impact the residential 
(non-occupational) or residential post-application exposure and risk 
estimates found in the most recent risk assessment of mefenoxam; 
therefore, EPA relied on the previously assessed residential exposure 
for assessing aggregate risk.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to mefenoxam and metalaxyl 
with any other substances and mefenoxam and metalaxyl do not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this action, therefore, EPA has not assumed that mefenoxam 
and metalaxyl have a common mechanism of toxicity with other 
substances.

D. Safety Factor for Infants and Children

    EPA continues to conclude that there are reliable data to support 
the reduction of the Food Quality Protection Act (FQPA) safety factor 
to 1X. See Unit III.D. of the December 2018 rulemaking for a discussion 
of the Agency's rationale for that determination.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing dietary exposure estimates to the aPAD 
and chronic population-adjusted dose (cPAD). Short-, intermediate-, and 
chronic-term aggregate risks are evaluated by comparing the estimated 
total aggregate food, water, and residential exposure to the 
appropriate points of departure (PODs) to ensure that an adequate 
margin of exposure (MOE) exists.
    1. Acute risk. The acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water is 
27% of the acute population-adjusted dose (aPAD) for the general U.S. 
population, and 56% of the aPAD for the highest exposed population 
group, children 1-2 years old. Because these levels are below the 
Agency's level of concern (LOC) of 100% of the aPAD, the Agency 
concludes that aggregate exposure to mefenoxam will not pose an acute 
risk.
    2. Chronic risk. No hazard endpoint was selected for chronic 
dietary exposure for mefenoxam; therefore, a chronic aggregate 
assessment was not warranted. However, chronic dietary exposure was 
estimated for inclusion in the aggregate analysis.
    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). Mefenoxam is 
currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to mefenoxam.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 270 for children 
1-2, the most highly exposed group. Because EPA's level of concern for 
mefenoxam is 100, which means any MOE below 100 may indicate risks of 
concern, this MOE is not of concern.
    4. Intermediate-term risk. There are no intermediate-term 
residential exposures for mefenoxam, and therefore an intermediate-term 
aggregate exposure assessment was not warranted.
    5. Aggregate cancer risk for U.S. population. Mefenoxam is 
classified as ``not likely to be carcinogenic to humans'', therefore, 
EPA concludes that exposure to mefenoxam will not pose an aggregate 
cancer risk.
    6. Determination of safety. Therefore, based on the risk 
assessments and information described above, EPA concludes that there 
is a reasonable certainty that no harm will result to the general 
population, or to infants and children, from aggregate exposure to 
mefenoxam residues. More detailed information on this action can be 
found in the document titled ``Metalaxyl, Mefenoxam (Metalaxyl-M). 
Human Health Risk Assessment for the Petition for Amendment of 
Tolerances for Residues in/on Leafy Greens Subgroup, 4-16A (Except 
Spinach), and Brassica Leafy Greens Subgroup 4-16B; Brassica Head and 
Stem Vegetable Crop Group 5-16; Expansions of Crop Tolerances to Stalk 
and Stem Vegetable Subgroup 22A and Leaf Petiole Vegetable Subgroup 
22B; Fruiting Vegetables Crop Group 8-10; Succulent Shelled Pea & Bean 
Subgroup 6B; and Cottonseed Crop Subgroup 20C. Establishment of an 
Inadvertent Tolerance for Residues in/on Sugarcane.'' in docket ID 
number EPA-HQ-OPP-2022-0493.

[[Page 39188]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available enforcement analytical methods, 
see Unit IV.A. of the December 21, 2018, rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    While Codex has not established MRLs for mefenoxam, it has 
established tolerances for residues of metalaxyl. Since compliance with 
U.S. tolerances for mefenoxam is determined by measuring metalaxyl 
residues, EPA is evaluating harmonization of the mefenoxam tolerances 
by comparing to the metalaxyl MRLs. Codex has not established MRLs for 
metalaxyl for leafy greens, subgroup 4-16A; Brassica leafy greens, 
subgroup 4-16B; stalk and stem vegetable, subgroup 22A; leaf petiole 
vegetable, subgroup 22B; fruiting vegetables, group 8-10; succulent 
shelled pea and bean, subgroup 6B and sugarcane; thus, harmonization 
with Codex is not an issue for these commodities and groups/subgroups.
    Codex has established MRLs for metalaxyl on several members of the 
Brassica head & stem vegetable, group 5-16: 2 ppm for Chinese cabbage 
and cauliflower (members of Brassica (cole) leafy vegetables group 5-
16) and 0.5 ppm for residues in/on broccoli, cabbage, and Brussels 
sprouts (members of Brassica (cole) leafy vegetables group 5-16). EPA's 
tolerance for group 5-16 is harmonized with the higher Codex MRL for 
commodities in this group. Codex has an MRL for residues in/on 
cottonseed at 0.05 ppm while the U.S. tolerance is set at 0.1 ppm. EPA 
is not harmonizing since the lower tolerance level may result in 
residues exceeding the tolerance from application consistent with 
approved labeling; however, this does not create a barrier to import as 
the US tolerance is inclusive of the Codex MRL.

C. Response to Comments

    Two comments were received in response to the notice of filing. One 
comment was received from an anonymous commenter applauding the 
government's process to petition for new uses. The second comment 
argued against the use of mefenoxam on greens and expressed concern 
about the overall toxicity of pesticides. The commenter has provided no 
information that would support a determination that these tolerances 
are unsafe. Although the Agency recognizes that some individuals 
believe that pesticides should be banned on agricultural crops, the 
existing legal framework provided by FFDCA section 408 authorizes EPA 
to establish tolerances when it determines that the tolerance is safe. 
Upon consideration of the validity, completeness, and reliability of 
the available data as well as other factors the FFDCA requires EPA to 
consider, EPA has determined that these mefenoxam tolerances are safe. 
The commenter has provided no information supporting a contrary 
conclusion.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing the tolerance on Leafy vegetable, Crop Group 4-
16 (except spinach) at 5 ppm rather than the petitioned-for Leafy 
Greens Subgroup 4-16A (except spinach) and Brassica Leafy Greens 
Subgroup 4-16B. The entire crop group 4-16 is inclusive of both 
subgroups. Additionally, the Agency is not establishing separate 
tolerances for Celtuce, Florence fennel and Kohlrabi and excepting them 
from Stalk and Stem Vegetable Subgroup 22A. The proposed tolerance of 7 
ppm for Stalk and Stem Vegetable Subgroup 22A is greater than the 
proposed tolerances of 5, 5, and 2 ppm, for celtuce, Florence fennel, 
and kohlrabi respectively, and is therefore inclusive of these 
tolerances. Lastly, because the final Phase VI crop group rule has been 
published, the commodity definition for Succulent Shelled Pea and Bean 
Crop Subgroup 6B has been revised to be Vegetable, legume, bean, 
succulent shelled, subgroup 6-22C and Vegetable, legume, pea, succulent 
shelled, subgroup 6-22D. The Phase VI crop group rule was published on 
September 21, 2022, and was effective on November 21, 2022 (87 FR 
57627) (FRL-5031-13-OCSPP).

V. Conclusion

    Therefore, tolerances are established for residues of mefenoxam, 
[methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-D-alaninate], in or on 
Cottonseed, subgroup 20C at 0.1 ppm; Leaf petiole, subgroup 22B at 5 
ppm; Leafy Vegetable, Crop Group 4-16 (except spinach) at 5 ppm; 
Sugarcane at 0.1 ppm; Vegetable, Brassica, head and stem, group 5-16 at 
2 ppm; Vegetable, fruiting, group 8-10 at 1 ppm; Vegetable, legume, 
bean, succulent shelled, subgroup 6-22C at 0.2 ppm; Vegetable, legume, 
pea, succulent shelled, subgroup 6-22D at 0.2 ppm; Vegetable, stalk and 
stem, subgroup 22A at 7 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency

[[Page 39189]]

has determined that this action will not have a substantial direct 
effect on States or tribal governments, on the relationship between the 
national government and the States or tribal governments, or on the 
distribution of power and responsibilities among the various levels of 
government or between the Federal Government and Indian tribes. Thus, 
the Agency has determined that Executive Order 13132, entitled 
``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 
13175, entitled ``Consultation and Coordination with Indian Tribal 
Governments'' (65 FR 67249, November 9, 2000) do not apply to this 
action. In addition, this action does not impose any enforceable duty 
or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 25, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended 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.  180.546:
0
a. In paragraph (a) amend table 1 by adding entries for the commodities 
``Cottonseed, subgroup 20C'', ``Leaf petiole, subgroup 22B'', ``Leafy 
Vegetable, Crop Group 4-16 (except spinach)'', ``Vegetable, Brassica, 
head and stem, group 5-16'', ``Vegetable, fruiting, group 8-10'', 
``Vegetable, legume, bean, succulent shelled, subgroup 6-22C'', 
``Vegetable, legume, pea, succulent shelled, subgroup 6-22D'', 
``Vegetable, stalk and stem, subgroup 22A'', in alphabetical order; and
0
b. Revise paragraph (d).
    The additions and revision read as follows:

Sec.  180.546  Mefenoxam; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
Cottonseed, subgroup 20C.....................................        0.1
 
                                * * * * *
Leaf petiole, subgroup 22B...................................          5
Leafy Vegetable, Crop Group 4-16 (except spinach)............          5
 
                                * * * * *
Vegetable, Brassica, head and stem, group 5-16...............          2
Vegetable, fruiting, group 8-10..............................          1
Vegetable, legume, bean, succulent shelled, subgroup 6-22C...        0.2
Vegetable, legume, pea, succulent shelled, subgroup 6-22D....        0.2
Vegetable, stalk and stem, subgroup 22A......................          7
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for indirect or inadvertent residues of mefenoxam in or on the food 
commodities when present therein as a result of the application of 
mefenoxam to growing crops listed in paragraph (a) of this section and 
other non-food crops to read as follows:

                        Table 2 to Paragraph (d)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Sugarcane...................................................        0.1
------------------------------------------------------------------------

[FR Doc. 2023-12544 Filed 6-14-23; 8:45 am]
BILLING CODE 6560-50-P