
[Federal Register Volume 88, Number 165 (Monday, August 28, 2023)]
[Rules and Regulations]
[Pages 58506-58509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18410]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0139; FRL-11276-01-OCSPP]


Methoxyfenozide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
methoxyfenozide in or on coffee bean, sugar cane, and sugar cane 
molasses. There are no U.S. registrations associated with these 
tolerances. Corteva Agrisciences, LLC requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 28, 2023. Objections and 
requests for hearings must be received on or before October 27, 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-2022-0139, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room and the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services, docket access, visit https://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 Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(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-2022-0139 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 
October 27, 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-2022-0139, 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 July 5, 2023 (88 FR 42935) (FRL-10579-
05), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1E8910) by Corteva Agriscience LLC, 9330 Zionsville Rd., Indianapolis, 
IN 46268. The petition requested that 40 CFR 180.544 be amended by 
establishing tolerances for residues of the insecticide 
methoxyfenozide, including its metabolites and degradates, in or on 
coffee at 0.15 parts per million (ppm) and sugarcane at 0.03 ppm and in 
the processed commodity sugarcane molasses at 0.1 ppm. Compliance with 
the tolerance levels is to be determined by measuring only 
methoxyfenozide (3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide). That document 
referenced a summary of the petition prepared by Corteva Agrisciences, 
LLC, which is available in the docket, https://www.regulations.gov. 
There were no comments received in response to the notice of filing.

[[Page 58507]]

    Based upon review of the data supporting the petition, EPA has 
recommended revisions in commodity definitions. The reasons for these 
changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified 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 methoxyfenozide including exposure resulting 
from the tolerances established by this action. EPA's assessment of 
exposures and risks associated with methoxyfenozide follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections 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 tolerance rulemakings for 
methoxyfenozide in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to methoxyfenozide and established 
tolerances for residues of that chemical. EPA is incorporating 
previously published sections from those rulemakings as described 
further in this rulemaking, as they remain unchanged.
    Toxicological profile. For a discussion of the Toxicological 
Profile of methoxyfenozide, see Unit III.A. of the methoxyfenozide 
tolerance rulemaking published in the Federal Register of March 12, 
2019 (84 FR 8820) (FRL-9985-06).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
methoxyfenozide used for human health risk assessment, see Unit III.B. 
of the March 12, 2019, rulemaking.
    Exposure assessment. Much of the exposure assessment for 
methoxyfenozide remains unchanged from the discussions in Unit III.C. 
of the March 12, 2019, rulemaking and Unit III.C. of the 
methoxyfenozide tolerance rulemaking published in the Federal Register 
of October 11, 2022 (87 FR 61259) (FRL-9525-01), except as described 
below.
    Dietary exposure from food and feed uses. The exposure assessment 
has been updated to include the additional dietary exposure from the 
new tolerances for residues of methoxyfenozide on coffee bean and sugar 
cane commodities using the same previous assumptions of tolerance level 
residues and 100 percent crop treated (PCT) described in Unit III.C.1. 
of the March 12, 2019, rulemaking.
    Dietary exposure from drinking water. Because the requested 
tolerances for residues of methoxyfenozide in or on coffee bean and 
sugar cane commodities do not include registrations for use on coffee 
bean and sugar cane commodities in the United States, the estimated 
drinking water concentrations have not changed. For a detailed summary 
of the drinking water analysis for methoxyfenozide used for the human 
health risk assessment, see Unit III.C.2. of the March 12, 2019, 
rulemaking and Unit III.C. of the October 11, 2022, rulemaking.
    Non-occupational exposure. As described in Unit III.C. of the 
October 11, 2022, rulemaking, the Agency assumes that when labels 
require specific clothing and/or personal protective equipment (PPE) 
such products are not for residential use. The methoxyfenozide label 
requires specific clothing and/or PPE; therefore, the Agency has made 
the assumption that the registered methoxyfenozide labels are not 
intended for use by residential handlers and a quantitative residential 
handler assessment has not been conducted. The approach to assessing 
post-application exposure is the same as described in Unit III.C.3 of 
the March 12, 2019, rulemaking.
    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.'' In 2016, EPA's Office of 
Pesticide Programs released a guidance document entitled Pesticide 
Cumulative Risk Assessment: ``Framework for Screening Analysis'' 
(https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework). This document provides 
guidance on how to screen groups of pesticides for cumulative 
evaluation using a two-step approach beginning with the evaluation of 
available toxicological information and, if necessary, followed by a 
risk-based screening approach. This framework supplements the existing 
guidance documents for establishing common mechanism groups (CMGs) and 
conducting cumulative risk assessments (CRA).
    The Agency has utilized this framework for methoxyfenozide and 
determined that the diacylhydrazine class of insecticides 
(methoxyfenozide, halofenozide and tebufenozide) form a candidate CMG. 
This group of pesticides is considered a candidate CMG because they 
share characteristics to support a testable hypothesis for a common 
mechanism of action.
    Following this determination, the Agency conducted a screening-
level cumulative risk assessment consistent with the 2016 guidance 
document. This assessment included only methoxyfenozide and 
tebufenozide since there are no registered uses for halofenozide. The 
current screening assessments for methoxyfenozide and tebufenozide are 
below the Agency's levels of concern. No further cumulative evaluation 
is necessary for methoxyfenozide.
    For more information, see Appendix E of the document titled 
``Methoxyfenozide. Human Health Risk Assessment for the Petition to 
Establish Permanent Tolerances without a U.S. Registration on Coffee 
Beans and Sugar Cane,'' available at docket ID number EPA-HQ-OPP-2022-
0139.
    Safety factor for infants and children. EPA continues to conclude 
that there are reliable data to support the reduction of the Food 
Quality Protection

[[Page 58508]]

Act (FQPA) safety factor from 10X to 1X. See Unit III.D. of the March 
12, 2019, rulemaking for a discussion of the Agency's rationale for 
that determination.
    Aggregate risks and determination of safety. EPA determines whether 
acute and chronic dietary pesticide exposures are safe by comparing 
aggregate exposure estimates to the acute population adjusted dose 
(aPAD) and chronic population adjusted dose (cPAD). Short-, 
intermediate-, and chronic-term risks are evaluated by comparing the 
estimated aggregate food, water, and residential exposure to the 
appropriate points of departure to ensure that an adequate margin of 
exposure (MOE) exists. For linear cancer risks, EPA calculates the 
lifetime probability of acquiring cancer given the estimated aggregate 
exposure.
    An acute dietary risk assessment was not needed for methoxyfenozide 
since no toxic effects attributable to a single dose were identified in 
the toxicity database. Chronic dietary risks are below the Agency's 
level of concern of 100% of the cPAD; they are 78% of the cPAD for 
children 1 to 2 years old, the group with the highest exposure. There 
are currently no residential handler uses for methoxyfenozide, and none 
are pending before the Agency. Therefore short- and intermediate-term 
exposure to methoxyfenozide is not expected, and the short- and 
intermediate-term risk is equivalent to the chronic dietary risk, which 
is not of concern. Methoxyfenozide is classified as ``Not Likely to Be 
Carcinogenic to Humans''; therefore, EPA does not expect 
methoxyfenozide exposures to pose an aggregate cancer risk.
    Determination of safety. Therefore, based on the risk assessments 
and information described above, EPA concludes there is a reasonable 
certainty that no harm will result to the general population, or to 
infants and children, from aggregate exposure to methoxyfenozide 
residues. More detailed information on this action can be found in the 
document titled ``Methoxyfenozide. Human Health Risk Assessment for the 
Petition to Establish Permanent Tolerances without a U.S. Registration 
on Coffee Beans and Sugar Cane,'' available at docket ID number EPA-HQ-
OPP-2022-0139.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the March 12, 2019, 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.
    The Codex has not established a MRL for methoxyfenozide in/on 
coffee bean or sugar cane commodities.

C. Revisions to Petitioned-For Tolerances

    EPA is changing the commodity definitions from coffee to coffee 
bean, sugarcane to sugar cane, and sugarcane, molasses to sugar cane, 
molasses to be consistent with Agency nomenclature.

V. Conclusion

    Therefore, tolerances are established for residues of 
methoxyfenozide, in or on coffee bean at 0.15 ppm, sugar cane at 0.03 
ppm, and sugar cane, molasses at 0.1 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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the National Government 
and the States or Tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999), and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000), do not apply to this action. In addition, 
this action does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides

[[Page 58509]]

and pests, Reporting and recordkeeping requirements.

    Dated: August 18, 2023.
Charles Smith,
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.  180.544, in paragraph (a)(1) amend the table by:
0
a. Adding in alphabetical order the entries ``Coffee bean''; ``Sugar 
cane''; and ``Sugar cane, molasses''; and
0
b. Adding footnote 2 at the end of the table.
    The additions read as follows:


Sec.  180.544  Methoxyfenozide; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Coffee bean \2\.............................................        0.15
 
                                * * * * *
Sugar cane \2\..............................................        0.03
Sugar cane, molasses \2\....................................         0.1
 
                                * * * * *
------------------------------------------------------------------------
 * * * * *
\2\ There are no U.S. registrations as of August 28, 2023.

[FR Doc. 2023-18410 Filed 8-25-23; 8:45 am]
BILLING CODE 6560-50-P


