89 FR 51 pgs. 18549-18553 - Cloquintocet-mexyl in Pesticide Formulations; Tolerances for Residues
Type: RULEVolume: 89Number: 51Pages: 18549 - 18553
Pages: 18549, 18550, 18551, 18552, 18553Docket number: [EPA–HQ–OPP–2022–0850; FRL–11811–01–OCSPP]
FR document: [FR Doc. 2024–05434 Filed 3–13–24; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0850; FRL-11811-01-OCSPP]
Cloquintocet-mexyl in Pesticide Formulations; Tolerances for Residues
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation amends the tolerance expression for residues of the safener cloquintocet-mexyl (acetic acid, [(5-chloro-8-quinolinyl)oxy]-, 1-methylhexyl ester) (CAS Reg. No. 99607-70-2) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid) by removing the active ingredients listed in the tolerance expression so that the safener can be used in any herbicide formulation applied to the listed commodities. Corteva Agriscience submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the revision to the tolerance expression for residues of the safener cloquintocet-mexyl. There is no change to the numerical tolerances or the listed commodities.
DATES:
This regulation is effective March 14, 2024. Objections and requests for hearings must be received on or before May 13, 2024 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-2022-0850, 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. Please review the visitor instructions and additional information about the docket available at 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: RDFRNotices@epa.gov.
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SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR part 180 through the Federal Register Office's e-CFR site at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.
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-2022-0850 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 May 13, 2024. 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-2022-0850, 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/where-send-comments-epa-dockets.
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 December 19, 2023 (88 FR 87733, FRL-10579-11-OSCPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11655) by Corteva Agriscience, 9330 Zionsville Road, Indianapolis, IN 46268. The petition requested that the tolerance expression under 40 CFR 180.560 for the safener cloquintocet-mexyl (acetic acid, [(5-chloro-8-quinolinyl)oxy]-, 1-methylhexyl ester) (CAS Reg. No. 99607-70-2) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid), be amended to remove the active ingredients listed. There was no proposed change to the numerical tolerances or the listed commodities. This change would permit the use of the safener, cloquintocet-mexyl, in any herbicide formulation applied to the listed commodities in accordance with the established numerical tolerances. That document referenced a summary of the petition prepared by Corteva Agriscience, which is available in the docket at https://www.regulations.gov. There were no comments received in response to the notice of filing.
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. When making a safety determination for a tolerance, 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. . . ." Section 408(b)(2)(D) lists other factors for EPA's consideration in making safety determinations, including, for example, the validity, completeness, and reliability of available data, nature of toxic effects, available information concerning the cumulative effects of the pesticide chemical and other substances with a common mechanism of toxicity, and available information concerning aggregate exposure levels to the pesticide chemical and other related substances.
EPA establishes tolerances only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(b)(2)(A), and the factors specified in FFDCA section 408(b)(2)(C) and (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 for cloquintocet-mexyl, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cloquintocet-mexyl follows.
[top] In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings for the same chemical. Where scientific information concerning a particular
EPA has previously published tolerance rulemakings for cloquintocet-mexyl in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to cloquintocet-mexyl and established tolerances for residues of that chemical. EPA is incorporating previously published sections from these rulemakings as described further in this rulemaking, as they remain unchanged.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their 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. For a discussion of the toxicological profile of cloquintocet-mexyl, please see Unit III.A. of the final rule published in the Federal Register of December 16, 2005 (70 FR 74679) (FRL-7753-4), in which the Agency presented the available toxicity data for cloquintocet-mexyl. There have been no changes to that toxicity data, and a summary is presented below.
The toxicity database is sufficient for cloquintocet-mexyl. Cloquintocet-mexyl exhibits low levels of acute toxicity via the oral, dermal, and inhalation routes of exposure. It is not a skin irritant but is a skin sensitizer. It is slightly irritating to the eyes.
Although fetal effects were seen in a reproductive and developmental study, they were seen at maternally toxic doses; therefore, there is no concern for offspring susceptibility. Available studies show no evidence of neurotoxicity. Cloquintocet-mexyl is not genotoxic and is classified as "not likely to be a human carcinogen."
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level-generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)-and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
The hazard profile of cloquintocet-mexyl is adequately defined. An acute reference dose (RfD) was selected for the subpopulation of females 13-50 years old of 1 mg/kg/day (NOAEL of 100 mg/kg/day) from a developmental toxicity in rats (MRID 44387429) where an increased incidence of skeletal variants and decreased fetal body weight was observed in the presence of maternal toxicity at 400 mg/kg/day. An acute RfD for the general population was not identified.
The Agency selected a chronic RfD of 0.04 mg/kg/day based on a two-year combined chronic/oncogenicity study in rats (MRID 44387431). In this study, the NOAEL of 4.3 mg/kg/day was based on increased incidence of thyroid follicular epithelial hyperplasia in females at 41.2 mg/kg/day (LOAEL).
C. Exposure Assessment
To determine if removal of the active ingredients from the tolerance expression would affect residue levels of cloquintocet-mexyl, EPA relied on various residue trials on wheat and barley conducted with 5 different herbicides. EPA found, based on consistent results from these studies, that regardless of the chemical or class of chemistry, the residue profile does not change for cloquintocet-mexyl. These residues consistently remained below the currently established tolerances for those commodities.
Based on a review of the data, there is no expected increase in residue levels associated with removing the active ingredients from the tolerance expression. Since no change is being made to the numerical tolerances or the listed commodities, there is no expected change in dietary exposure.
1. Dietary exposure from food and feed uses. Dietary exposure has already been assessed based on the conservative assumption that all three commodities for which there are currently established tolerances ( i.e., wheat, barley, and teff) are treated with cloquintocet-mexyl at tolerance-level residues. These residue levels have been found by the Agency to be safe. For a discussion of the dietary exposure to cloquintocet-mexyl, please see Unit III.C. of the final rule published in the Federal Register of August 2, 2016 (81 FR 50630) (FRL-9947-78), Unit III. of the final rule published in the Federal Register of March 22, 2017 (82 FR 14620) (FRL-9959-11), and Unit III. of the final rule published in the Federal Register of September 11, 2018 (83 FR 45841) (FRL-9980-90).
2. From non-dietary exposure. The term "residential exposure" is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). There are currently no registered uses for products containing cloquintocet-mexyl that would result in residential exposures.
3. 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 cloquintocet-mexyl to share a common mechanism of toxicity with any other substances, and cloquintocet-mexyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this final rule, therefore, EPA has assumed that cloquintocet-mexyl does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Additional Safety Factor for the Protection of Infants and Children
[top] Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
EPA has concluded that the FQPA safety factor can be removed for cloquintocet-mexyl for the following reasons. The toxicology database is complete for cloquintocet-mexyl. There is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to cloquintocet-mexyl in the available toxicity data, and EPA has determined that a developmental neurotoxicity study is not required for cloquintocet-mexyl. The dietary (food and drinking water) exposure assessments will not underestimate the potential exposures for infants and children from the use of cloquintocet-mexyl. Currently there are no proposed residential uses, and therefore non-occupational exposure is not expected.
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 acute PAD (aPAD) and chronic PAD (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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to cloquintocet-mexyl will occupy less than one percent (<1%) of the aPAD for females aged 13-49, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cloquintocet-mexyl from food and water will utilize <1% of the cPAD for all subpopulations. There are no residential uses for cloquintocet-mexyl.
3. Short- and intermediate-term risk. Because cloquintocet-mexyl is not registered for use in pesticide formulations that will result in residential exposure, EPA concludes that cloquintocet-mexyl will not pose a short-term or intermediate-term risk.
4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity, cloquintocet-mexyl is not expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, 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 cloquintocet-mexyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, chromatography with ultraviolet detection (HPLC-UV) for cloquintocet-mexyl and its acid metabolite, 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: residuemethods@epa.gov.
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 cloquintocet-mexyl (acetic acid, [(5- chloro-8-quiniolinyl)oxy]-, 1- methylhexyl ester) or its acid metabolite.
V. Conclusion
Therefore, EPA is removing the active ingredients: clodinafop-propargyl (wheat only), dicamba (wheat only), flucarbazone-sodium (wheat only), halauxifen-methyl (wheat or barley), pinoxaden (wheat or barley), pyroxsulam (wheat or teff), florasulam (teff), or fluroxypyr 1-methylheptyl ester (teff) listed in the tolerance expression for cloquintocet-mexyl.
VI. Statutory and Executive Order Reviews
This action amends a tolerance 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.
[top] 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
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: March 11, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, the EPA amends 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 §?180.560:
a. Revise paragraph (a) introductory text; and
b. Add the table heading "Table 1 to Paragraph (a)".
The revision and addition reads as follows:
§?180.560 Cloquintocet-mexyl; tolerances for residues.
(a) General. Tolerances are established for residues of the inert ingredient cloquintocet-mexyl, including its metabolites and degradates, in or on the commodities in the following table when used as a safener in herbicide formulations. Compliance with the tolerance levels specified is to be determined by measuring the combined residues of cloquintocet-mexyl, (acetic acid [(5-chloro-8-quinolinyl)oxy]-, 1-methylhexyl ester; CAS Reg. No. 99607-70-2) and its acid metabolite (5-chloro-8-quinolinoxyacetic acid), expressed as cloquintocet-mexyl, in or on the following commodities:
Table 1 to Paragraph (a)
[FR Doc. 2024-05434 Filed 3-13-24; 8:45 am]
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