89 FR 234 pgs. 96566-96569 - Cyazofamid; Pesticide Tolerances
Type: RULEVolume: 89Number: 234Pages: 96566 - 96569
Pages: 96566, 96567, 96568, 96569Docket number: [EPA-HQ-OPP-2023-0257; FRL-12338-01-OCSPP]
FR document: [FR Doc. 2024-28467 Filed 12-4-24; 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-2023-0257; FRL-12338-01-OCSPP]
Cyazofamid; Pesticide Tolerances
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation establishes tolerances for residues of cyazofamid in or on multiple crops listed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES:
This regulation is effective December 5, 2024. Objections and requests for hearings must be received on or before February 3, 2025 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-2023-0257, 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: 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?
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-2023-0257 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 February 3, 2025.
The 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 Filing and Service," 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 the EPA's regulations require submission via U.S. Mail or hand delivery, the EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, the 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.
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-2023-0257, 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.
• 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, are available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of October 26, 2023 (88 FR 73571) (FRL-10579-09-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 3E9064) by IR-4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested to establish tolerances in 40 CFR 180.601 for residues of the fungicide cyazofamid, including its metabolites and degradates, in or on the following raw agricultural commodities: Chick pea, edible podded at 0.5 ppm; Chick pea, succulent shelled at 0.08 ppm; Edible podded bean subgroup 6-22A at 0.5 ppm; Parsnip root at 0.09 ppm; Pulses, dried shelled bean, except soybean, subgroup 6-22E at 0.03 ppm; and Succulent shelled bean subgroup 6-22C at 0.08 ppm. The petition also proposed to remove established tolerances for residues of cyazofamid in or on the following: Bean, succulent at 0.5 ppm and Bean, succulent shelled at 0.08 ppm.
[top] EPA has modified some of the commodity definitions to be consistent with Agency nomenclature, but the
That document referenced a summary of the petition, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice.
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 cyazofamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyazofamid 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 rulemaking of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking, 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 several tolerance rulemakings for cyazofamid, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to cyazofamid and established tolerances for residues of that chemical. EPA is incorporating previously published sections of those rulemakings that remain unchanged, as described further in this rulemaking. Specific information on the risk assessment conducted in support of this action, including on the studies received and the nature of the adverse effects caused by cyazofamid, can be found in the document titled "Cyazofamid: Human Health Risk Assessment for New Uses of Cyazofamid on Parsnip, Root and Pulses, Dried Shelled Bean (Except Soybean), Subgroup 6-22E and Crop Group Expansions to Edible Podded Bean Subgroup 6-22A and Succulent Shelled Bean Subgroup 6-22C" which is available in the docket for this action at https://www.regulations.gov.
Toxicological profile. For a discussion of the Toxicological Profile of cyazofamid, see Unit III.A. of the rulemaking published in the Federal Register of March 18, 2020 (85 FR 15387) (FRL-10005-85).
Toxicological points of departure/Levels of concern. For a summary of the Toxicological Points of Departure/Levels of Concern used for the safety assessment of cyazofamid, see Unit III.B. of the rulemaking published in the Federal Register of February 3, 2016 (81 FR 5600) (FRL-9940-46).
Exposure assessment. Much of the exposure assessment remains unchanged from the March 18, 2020, rulemaking, although the new exposure assessment incorporates the additional dietary exposure from the petitioned-for tolerances. Other changes are described below.
No acute dietary toxicity endpoint could be identified based on the toxicology data currently available for cyazofamid; therefore, a quantitative acute assessment was not performed.
Chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 4.02. This software uses 2005-2010 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The conservative chronic analysis assumed that cyazofamid residues are present in/on all proposed and registered food commodities at tolerance levels and 100 percent crop treated.
Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for cyazofamid. Tolerance-level residues and 100 PCT were assumed for all food commodities.
Drinking water and non-occupational exposures. For a summary of the drinking water numbers used, see Unit III.A. of the March 18, 2020, rulemaking. A chronic estimated drinking water concentration (EDWC) of 211 parts per billion (ppb) was used in the chronic dietary exposure assessment.
Cyazofamid is currently registered for the following uses that could result in residential exposures: Turf and ornamentals. The post-application assessment includes only post-application exposure (to turf and ornamentals) from hand-to-mouth exposures for children 1 to less than 2 years old.
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." In 2016, EPA's Office of Pesticide Programs released a guidance document entitled, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis. 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 cyazofamid and determined that although cyazofamid shares some chemical and/or toxicological characteristics ( e.g., chemical structure or apical endpoint) with other pesticides, the toxicological database does not support a testable hypothesis for a common mechanism of action. No further data are required to determine that no common mechanism of toxicity exists for cyazofamid and other pesticides and no further cumulative evaluation is necessary for cyazofamid.
[top] Safety factor for infants and children. EPA continues to conclude that there are reliable data showing that the safety of infants and children would be adequately protected if the Food Quality Protection Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for that decision are articulated in Unit III.D. of the March 18, 2020, rulemaking.
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 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.
No acute dietary toxicity endpoint could be identified based on the toxicology data currently available for cyazofamid; therefore, a quantitative acute assessment was not performed. Chronic dietary (food and drinking water) risks are below the Agency's level of concern of 100% of the cPAD; they are 2.1% of the cPAD for all infants less than 1 year old, which is the population subgroup with the highest exposure estimate.
The short-term aggregate risks combine chronic dietary (food and drinking water) and short-term residential exposures. For the short-term aggregate risk for children 1 to less than 2 years old, the aggregate MOE combining dietary exposure and incidental oral (hand-to-mouth) exposure is 6300. MOEs below 100 are of concern; this MOE is above 100 and therefore is not of concern.
Intermediate-term exposure is not expected for the residential exposure pathway. Therefore, the intermediate-term aggregate risk estimate is equivalent to chronic dietary exposure estimates, which are not of concern.
Chronic exposure is not expected for the residential exposure pathway. Therefore, the chronic aggregate risk estimate is equivalent to chronic dietary exposure estimates and are not of concern.
Because cyazofamid is classified as "not likely to be carcinogenic to humans", EPA has concluded that aggregate exposure to cyazofamid is not likely to pose a cancer risk.
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 cyazofamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method, see Unit IV.A. of the March 18, 2020, 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).
There are no Codex MRLs established on parsnip, root; chickpea, edible podded; chickpea, succulent shelled; or any of the commodities in the Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E.
The proposed US tolerances for expansions to crop subgroups 6-22A and 6-22C are not harmonized with similar individually established slightly lower Codex MRLs for these commodities. The U.S. tolerances are slightly higher because the U.S. tolerance expression includes the parent compound and a metabolite, while the Codex tolerance expression includes only the parent compound.
V. Conclusion
Therefore, tolerances are established for residues of cyazofamid in or on Chickpea, edible podded at 0.5 ppm; Chickpea, succulent shelled at 0.08 ppm; Parsnip, roots at 0.09 ppm; Vegetable, legume, bean, edible podded, subgroup 6-22A at 0.5 ppm; Vegetable, legume, bean, succulent shelled, subgroup 6-22C at 0.08 ppm; and Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E at 0.03 ppm.
Additionally, the established tolerances on Bean, succulent; and Bean, succulent shelled are removed as unnecessary.
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 to 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
[top] 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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides, and pests, Reporting and recordkeeping requirements.
Dated: November 22, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter 1 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 §?180.601, add a heading to the table in paragraph (a) and revise and republish the table to read as follows:
§?180.601 Cyazofamid; tolerances for residues.
(a) * * *
| Commodity | Parts per million |
|---|---|
| Brassica, leafy greens, subgroup 4-16B | 15 |
| Bulb vegetables, group 3-07 | 2.0 |
| Carrot, roots | 0.09 |
| Chickpea, edible podded | 0.5 |
| Chickpea, succulent shelled | 0.08 |
| Ginseng | 0.3 |
| Herb subgroup 19A | 90 |
| Hop dried cones | 10.0 |
| Kohlrabi | 1.5 |
| Leafy greens subgroup 4-16A | 10 |
| Parsnip, roots | 0.09 |
| Vegetable, brassica, head and stem, group 5-16 | 1.5 |
| Vegetable, cucurbit, group 9 | 0.10 |
| Vegetable, fruiting, group 8-10 | 0.9 |
| Vegetable, legume, bean, edible podded, subgroup 6-22A | 0.5 |
| Vegetable, legume, bean, succulent shelled, subgroup 6-22C | 0.08 |
| Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E | 0.03 |
| Vegetable, tuberous and corm, subgroup 1C | 0.02 |
[FR Doc. 2024-28467 Filed 12-4-24; 8:45 am]
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