89 FR 164 pgs. 68114-68117 - Ethaboxam; Pesticide Tolerances
Type: RULEVolume: 89Number: 164Pages: 68114 - 68117
Pages: 68114, 68115, 68116, 68117Docket number: [EPA-HQ-OPP-2023-0259; FRL-12119-01-OCSPP]
FR document: [FR Doc. 2024-19000 Filed 8-22-24; 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-2023-0259; FRL-12119-01-OCSPP]
Ethaboxam; Pesticide Tolerances
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation establishes a tolerance for residues of ethaboxam in or on leaf petiole vegetable subgroup 22B. The Interregional Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES:
This regulation is effective August 23, 2024. Objections and requests for hearings must be received on or before October 22, 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-2023-0259, is available at https://www.regulations.gov or in-person 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: RDFRNotices@epa.gov.
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?
[top] Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an
EPA's Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See "Revised Order Urging Electronic Service and Filing", dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. Although EPA's regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm.
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-2023-0259, 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 February 9, 2024 (89 FR 9103) (FRL-10579-12-OCSPP), 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 3E9052) by Interregional Project Number 4 (IR-4), North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR 180.622 be amended to establish a tolerance for residues of the fungicide ethaboxam, including its metabolites and degradates, in or on leaf petiole vegetable subgroup 22B at 0.15 parts per million (ppm). That document referenced a summary of the petition prepared by IR-4, the petitioner, which is available in the docket, 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. 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 ethaboxam including exposure resulting from the tolerance established by this action. EPA's assessment of exposures and risks associated with ethaboxam follows.
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 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 of the new rulemaking.
EPA has previously published a number of tolerance rulemakings for ethaboxam in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to ethaboxam and established a tolerance 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. Since the toxicological doses and endpoints for ethaboxam have not changed since the most recent risk assessment, see Unit III.A. of the August 3, 2017, rulemaking (82 FR 36086) (FRL-9961-69) for a discussion of the Toxicological Profile.
Toxicological points of departure/Levels of concern. For a summary of the Toxicological Points of Departure/Levels of Concern for ethaboxam used for human health risk assessment, see Unit III.B. of the August 3, 2017, rulemaking.
Exposure assessment. Much of the exposure assessment remains unchanged from the previous rulemakings, although updates have occurred to accommodate for exposures from the petitioned-for tolerance and additional exposures from the tolerances established since the August 3, 2017, rulemaking. For a description of EPA's approach to and assumptions for the exposure assessment, refer to Unit III.C. of the August 3, 2017, rulemaking.
[top] EPA's dietary exposure assessments have been updated to include the additional exposure from the new use of ethaboxam in or on leaf petiole vegetable subgroup 22B in greenhouses and the exposures assessed in rulemakings since 2017. An acute endpoint attributable to a single dose
Drinking water exposure. The new use does not result in an increase in the estimated residue levels in drinking water, so EPA used the same estimated drinking water concentrations in the chronic dietary exposure assessments as identified in Unit III.C.2 of the August 3, 2017, rulemaking.
Non-occupational exposure. There are no residential (non-occupational) uses proposed or currently registered for ethaboxam. Therefore, residential exposures were not assessed.
Cumulative exposure. 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 ethaboxam and any other substances and ethaboxam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that ethaboxam has a common mechanism of toxicity with other substances.
Safety factor for infants and children. Section 408(b)(2)(C) requires the application of an additional tenfold margin of safety to account for potential risks to infants and children, in the case of threshold effects. 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 August 3, 2017, 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 dietary exposure estimates to the acute population adjusted dose (aPAD) and the chronic population adjusted dose (cPAD).Short-, intermediate-, and chronic term aggregate risks are evaluated by comparing the estimated total food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists.
An acute endpoint attributable to a single dose exposure was not identified; therefore, an acute dietary risk assessment is not necessary. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD; they are 39% of the cPAD for children 1 to 2 years old, the population group with the highest estimated exposure. There is no short- or intermediate-term residential exposure expected since there are no proposed or previously registered residential uses of ethaboxam. Therefore, the chronic aggregate risks consist only of the dietary risks from food and water and, as stated above, are below the Agency's level of concern.
Ethaboxam is classified as showing "suggestive evidence of carcinogenic potential" based on increased incidence of benign Leydig cell tumors in males. The Agency determined that quantification of cancer risk using a nonlinear approach would adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to ethaboxam. Therefore, the noncancer chronic reference dose is protective of cancer dietary risk and is not of concern.
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 ethaboxam residues, including its metabolites and degradates. More detailed information about the Agency's analysis can be found at https://www.regulations.gov in the document titled "Ethaboxam. Human Health Risk Assessment for the Proposed New Uses on Leaf Petiole Vegetable (Crop Subgroup 22B) in Greenhouses." in docket ID number EPA-HQ-OPP-2023-0259.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method, see Unit IV.A. of the August 3, 2017, 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).
Codex does not have established MRLs for ethaboxam in commodities that are members of the leaf petiole vegetable subgroup 22B.
V. Conclusion
Therefore, a tolerance is established for residues of ethaboxam, including its metabolites and degradates, in or on leaf petiole vegetable subgroup 22B at 0.15 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.
[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
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: August 20, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR part 180 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 §?180.622, amend table 1 to paragraph (a) by adding in alphabetical order an entry for "Leaf petiole vegetable subgroup 22B" to read as follows:
§?180.622 Ethaboxam; tolerances for residues.
(a) * * *
| Commodity | Parts per million |
|---|---|
| * * * * * | |
| Leaf petiole vegetable subgroup 22B | 0.15 |
| * * * * * |
[FR Doc. 2024-19000 Filed 8-22-24; 8:45 am]
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