Flazasulfuron; Pesticide Tolerance

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, 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-2023-0269 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 December 6, 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-2023-0269, 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 September 20, 2023 (88 FR 64909) (FRL-10578-08-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 3F9055) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077. The petition requested that 40 CFR 180.655 be amended by a establishing tolerance for residues of the herbicide Flazasulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-pyridylsulfonyl)urea, in or on Avocado at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by ISK Biosciences Corporation, the registrant, which is available in the docket, https://www.regulations.gov . One comment was received on the notice of filing. EPA's response to this comment is discussed 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 in FFDCA section 408(b)(2)(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 flazasulfuron including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flazasulfuron 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 of 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 republishing the same sections are unnecessary. 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 evaluated the available toxicity data and considered its 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. Specific information on the studies received and the nature of the toxic effects caused by flazasulfuron as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found in Unit II.A, of the May 25, 2017, rulemaking.

There are no changes to the prior endpoint selections from the 2015 Draft Risk Assessment for Registration Review. In that risk assessment some studies used for endpoint selection were judged to have conservative NOAEL/LOAEL values because they were not updated to reflect current standards for evaluating toxicity studies. Such updates would likely result in higher NOAEL/LOAEL values and given the current risk picture, would not impact the overall findings of this risk assessment. Therefore, these studies were not re-evaluated in conjunction with this risk assessment. A detailed description of endpoint selection can be found at https://www.regulations.gov, “Flazasulfuron: Human Health Draft Risk Assessment for Registration Review, dated September 15, 2015.

The acute and chronic dietary risk assessments for flazasulfuron are unrefined assessments which incorporate tolerance-level residues, 100% crop treated (CT), and modeled estimated drinking water concentrations (EDWCs). The processing factors were set to 1 for the processed commodities that are in table 1 (860.1000). A default processing factor was used for hazelnut. The results of acute dietary (food and drinking water) analysis are below the Agency's level of concern (LOC) for all population subgroups. The acute dietary risk estimates utilized <1.0% of the acute population-adjusted dose (aPAD) for the general U.S. population and 3.3% of the aPAD for infants (<1 years old), the most highly exposed population subgroup. The results of chronic dietary (food and drinking water) analysis are below the Agency's LOC for all population subgroups. The chronic dietary risk estimates utilized 8.8% of the chronic population-adjusted dose (cPAD) for the general U.S. population and 32% of the cPAD for infants (<1 years old), the most highly exposed population subgroup. Based on the data summarized in Unit III.A. of the May 25, 2017, rulemaking, EPA has concluded that flazasulfuron does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

EDWCs from the previous drinking water assessment are considered protective of the new use and may be used to represent EDWCs for the proposed new use on avocados. EDWCs include total toxic residues of flazasulfuron ( i.e., all of the degradates: DTPU, DTPP, HTPP, TPSA, ADMP, and 2,3-GTF). The highest EDWCs from the previous assessment were from ground water and were modeled using Pesticide Root Zone Model for Ground Water (PRZM-GW). EPA's conclusions remain unchanged from Unit II. C.2 of the May 25, 2017, rulemaking.

There is no residential exposure associated with the proposed use in this action; however, there is residential exposure from an existing registered use on turf that has been previously assessed using current data and assumptions for flazasulfuron. Risk estimates have been presented for the purpose of aggregate assessment; and conclude all residential risk estimates are not of concern. For more details, see Unit II.C.3 of the May 25, 2017, rulemaking. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

No further data are required to determine that no common mechanism of toxicity exists for flazasulfuron and other pesticides. As a result, no further cumulative evaluation is necessary for flazasulfuron as published in Unit II.C.4 of the May 25, 2017, rulemaking.

The toxicity database for flazasulfuron is complete and adequate to assess susceptibility in the young. While there is evidence of increased qualitative and quantitative susceptibility in the young based on rat malformations and decreased fetal weight in two rat developmental toxicity studies, the Food Quality Protection Act (FQPA) Safety Factor (SF) is reduced to 1X and is protective of the observed offspring susceptibility because: (1) there are clear NOAELs for the developmental effects in the two rat studies developmental toxicity studies and the PODs selected for risk assessment are protective of those effects, (2) there is no evidence of neurotoxicity, and (3) exposure estimates are unlikely to underestimate risk. These conclusions are further discussed in Unit II.D of the May 25, 2017, rulemaking.

There are no acute and chronic residential exposure scenarios; therefore, the acute and chronic aggregate risks are equivalent to the acute and chronic dietary (food and drinking water) risk estimates and are not of concern. For risk conclusions specific to flazasulfuron in/on avocado, refer to Unit III section for acute and chronic dietary risk assessments within this document.

Flazasulfuron is currently registered for a use that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to flazasulfuron.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1660 for adults and 860 for children. Because EPA's level of concern for flazasulfuron is a MOE of 100 or greater, these MOEs are not of concern.

Further, no intermediate-term adverse effect was identified, as a result, intermediate-term risk is not expected.

Aggregate cancer risk for U.S. population. A cancer aggregate risk assessment was not conducted because there was no evidence of carcinogenicity to humans based on lack of carcinogenic effects in the rat and mouse carcinogenicity studies. Flazasulfuron was classified as “not likely to be carcinogenic to humans;” therefore, a cancer dietary assessment was not performed.

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 flazasulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

An adequate enforcement method for flazasulfuron is available. The method uses high-performance liquid chromatography/tandem mass spectrometry with multiple reaction monitoring (HPLC/MS-MS/MRM). The validated limit of quantitation (LOQ) is 0.01 ppm.

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 flazasulfuron. There are currently no MRLs established by Codex or Canada; therefore, there are no issues regarding international harmonization to date.

C. Response to Comments

One comment was received in favor of this action from the United States Department of Agriculture (USDA). Given the potential herbicide resistance management value for flazasulfuron in avocado, USDA strongly supports the application for registration of flazasulfuron in avocado.

V. Conclusion

Therefore, a tolerance is established for residues of flazasulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-pyridylsulfonyl)urea, in or on Avocado at 0.01 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.

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).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

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

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

2. In § 180.655, amend the table in paragraph (a) by:

a. Adding the table heading “Table 1 to Paragraph (a)”; and

b. Adding in alphabetical order the commodity “Avocado”.

The additions read as follows:

(a) * * *