2023-18410. Methoxyfenozide; Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

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: [e-mail].

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.

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 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

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

1. The authority citation for part 180 continues to read as follows:

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

2. In § 180.544, in paragraph (a)(1) amend the table by:

a. Adding in alphabetical order the entries “Coffee bean”; “Sugar cane”; and “Sugar cane, molasses”; and

b. Adding footnote 2 at the end of the table.

The additions read as follows:

§ 180.544

Methoxyfenozide; tolerances for residues.

(a) * * *

(1) * * *

Table 1 to Paragraph ( a )(1)

Commodity	Parts per 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.